Synoptic document version 2005 - Contact alimentaire

EUROPEAN COMMISSIONHEALTH & CONSUMER PROTECTION DIRECTORATE-GENERALDirectorate D – Food Safety: production and distribution chainD3 – Chemicals, contaminants and pesticidesSANCO D3/AS D(2005)File:SYNOPTIC DOCUMENT(2005.07.25)“SYNOPTIC DOCUMENT”PROVISIONAL LIST OF MONOMERS AND ADDITIVES NOTIFIED TO EUROPEAN COMMISSION ASSUBSTANCES WHICH MAY BE USED IN THE MANUFACTURE OF PLASTICS OR COATINGS INTENDEDTO COME INTO CONTACT WITH FOODSTUFFS(updated to June 2005)- Please read carefully the Explanatory Note to avoid any misunderstanding.- This document may also be found at the following internet address:http://europa.eu.int/comm/food/food/chemicalsafety/foodcontact/synoptic_doc_en.pdf1

NOTE FOR READER1. Documents that explain the Community legislation on food contact materials and thus mayhelp the reader with interpretation of the “Synoptic Document” can be found athttp://europa.eu.int/comm/food/food/chemicalsafety/foodcontact/documents_en.htm.2. The meaning of some abbreviations and words is explained in the document “List of theabbreviations and explanations”.3. If you notice mistakes, or you have suggestions, to improve this or the other documentsappearing on the website, e.g. addition of new sections and/or texts please send yoursuggestions to European Commission (for the attention of Ms. Annette Schaefer) (foraddress see document “EU and National Authorities”). The Commission may insert theseproposals in an updated version of this document or in the “Practical Guide”.2

TABLE OF CONTENTSCONTENTPAGENote for reader 2Table of contents 3Warning 4Explanatory Note 5Appendix 1: General information or abbreviations of the main terms 7Appendix 2: Definition of SCF lists 14Appendix 3: Notes related to the column “Restrictions and/or Specifications 16Table: Status of the substances 193

WARNINGIf you notice a mistake in the document, please inform as soon as possible Ms A. Schaefer by e-mail: Annette.Schaefer@cec.eu.int or by fax: +32.2.299.18.56.1. Any information concerning the evaluation by the European Food Safety Authority (EFSA) andthe SCF should be addressed to EFSA/AFC Panel to Mr D. Spyropoulos (E-mail:dimitrios.spyropoulos@efsa.eu.int) (see “EU and National Authorities” document).2. It is recommended to consult the website of EFSA in order to know the results of the last meetings,held after the date of the update of the Synoptic document:http://www.efsa.eu.int/science/afc/afc_opinions/catindex_en.html.3. An explanation of the columns is given in Appendix 1. The meaning of some numbers or asterisks,which appear in the field “Restrictions and Specifications”, is explained in Appendix 3.4. This document should be considered as a working document and not as a legal or binding documentand therefore it may be subject to relevant updates, changes or modifications.4

EXPLANATORY NOTE1. This document contains all the monomers and additives (see an explanation of the terms in theappendix 1 and 2) notified to the European Commission in view of their use in plastic materialsintended to come into contact with foodstuffs. It summarises the Community situation and theevaluations of the listed substances carried out by a) the Scientific Committee on Food (SCF)until May 2003 and b) the AFC Panel on food additives, flavourings, processing aids andmaterials in contact with food of the European Food Safety Authority (EFSA), which replacedthe SCF, until 27 April 2005. This document should not be considered the appropriatedocument to examine the legal situation of surface coatings even if a certain number ofsubstances that are used only in surface coatings appear in this document. The documentcontains the monomers and additives listed in the inventory list of the Council of EuropeResolution AP (2004) on coatings intended to come into food contact. However, not allsubstances listed have been evaluated by the SCF or by EFSA.2. In principle, this document does not contain aids to polymerisation, colorants, inks, adhesivesand solvents, although some may be listed. Moreover, it must be stressed that the substancesappearing in this document shall not be considered, at this stage, as the only monomers andadditives legally used at Community level because the process of harmonisation of the nationallists is ongoing. To know whether or not a substance, which does not appear in the Communitydirectives, is authorised in the Member States, it is necessary to examine national laws or toconsult the national authorities, whose address can be found in the document “EU andNational Authorities”.In conclusion this document should be considered as a working documentand not as a legal or binding document, and, therefore, it may be subject torelevant modifications (integration, deletion and changes).3. The Commission services intend to include definitively in the future Community lists, if any,only the substances classified into lists 0-4 by SCF or EFSA. The date when the list ofadditives (see definition later) becomes a positive list will be fixed before 31 December 2007.The persons interested in a substance classified into SCF lists 6-9, are invited to submit assoon as possible and not later than 31 December 2006 the data requested by EFSA followingthe recommendations of “Note for Guidance”, included in the website. The authorisationprocedure is described in the Framework Regulation (EC) No 1935/2004. For furtherinformation on the list of additives see "Practical Guide", Chapter I, Section 3 Paragraph3.2.4. At this stage, the Commission services are unable to specify whether the list will be extendedto aids to polymerisation ("substances which directly influence the formation of polymers"),colorants, solvents, inks and adhesives. Therefore any extrapolation of the list to thesesubstances is premature. Moreover, the Commission services can only add a) that thediscussion on the type of rules to be applied to these substances will start after the Communitylists for monomers and additives for plastics and coatings are adopted and b) that they areunable to specify any date on this matter.5

5. In principle the Commission services intend to update this document when the relevant numberof changes justifies an update (e.g. adoption of a Directive or EFSA opinion).In order to know the last evaluations of the substances, see also the website of EFSA:http://www.efsa.eu.int/science/afc/afc_opinions/catindex_en.htmlAny information concerning the EFSA evaluation should be addressed to EFSA AFC Panel,to Mr D. Spyropoulos (E-mail: dimitrios.spyropoulos@efsa.eu.int) (see “EU and NationalAuthorities” document).6

APPENDIX 1GENERAL INFORMATIONS OR ABBREVIATIONS OF THE MAIN TERMSUSED IN THIS DOCUMENTMonomers and other starting substances“Monomer and other starting substance", means any substance used in the manufacture of amacromolecule, which constitutes the repeating unit of a polymer chain or polymer network of anysubstance used in the manufacture of a plastic for food contact application. It also includes substancesused to modify existing natural or synthetic macromolecular substances. According to Directive2002/72/EC, Annex 2, paragraph 1, the following substances are included in this definition:"- substances undergoing polymerisation, which include polycondensation, polyaddition or anyother similar process, to manufacture macromolecules;- natural or synthetic macromolecular substances used in the manufacture of modifiedmacromolecules, if the monomers or the other starting substances required to synthesise themare not included in the list;- substances used to modify existing natural or synthetic macromolecular substances."Although the definition and the examples seem very precise, some difficulties arise in theidentification of "monomers and other starting substances" in practice. Therefore, it is recommended toread carefully the explanation given in Practical Guide, Chapter I, Section 3, paragraph 2.AdditivesSee also paragraph 3 of the explanatory note of this document.The list set out in the Table shall contain all the other substances not included in the definition ofmonomers and other starting substances and not included in the definition of aids to polymerisation(see below).Therefore this list shall include:a) substances which are incorporated into plastics to achieve a technical effect in the finishedproduct; they are intended to be present in the finished articles ("additive");b) substances used to provide a suitable medium in which polymerisation occurs or substanceswhich directly influence the formation of polymers (conventionally these substances will called"polymer production aids")7

Therefore this list will include for example the following categories of substances:"Category I"- antifoaming agents- antiskinning agents- antioxidants- antistatic agents- driers- emulsifiers- fillers- flame retardants- foaming agents- hardening agents- impact modifiers- lubricants- miscellaneous additives- optical brighteners- plasticizers- preservatives- protective colloids- reinforcements- release agents- solvents (see paragraph 2 of the Explanatory Note)- stabilizers- thickeners- UV absorbers8

"Category II"Polymer production aids- anti-foam reagents/de-gassing agents- blowing agents- buffering agents- build-up suppressants- dispersing aids- emulsifiers- flow control agents- nucleating agents- pH regulators- solvents (see paragraph 2 of the Explanatory Note)- surfactants- suspension agents- stabilisers- thickening agents- water treatment reagents"Category III"Aids to polymerisationThey are "Substances which directly influence the formation of polymers"- accelerators- catalysts- catalyst de-activators- catalyst supports- catalyst modifiers- chain scission reagents- chain transfer or extending agents- chain stop reagents- cross-linking agents- initiators and promoters- molecular weight regulators- polymerization inhibitors- redox agents9

EXPLANATION OF THE COLUMNSA short explanation of the fields and of some abbreviations is given below.Column 1 ("REF_N")This contains the substance reference numbers. Conventionally the following numbers have beenassigned:Monomers: 10000-29999Additives: >30000A substance listed as a monomer as well as an additive will be assigned two different REF.N. In somecases, a cross-reference of the REF.N. is inserted in order to find a substance having a synonym,commonly used.Column 2 ("CAS_N")This contains the CAS (Chemical Abstracts Service) registry number, if any. If the substance is amixture of substances, the CAS number refers to the mixture. Where an indent has been placed in thecolumn, it means that a research for CAS N. has been made, but that the result was negative. If theresult of the search was found to be doubtful or that the research has not yet been made, a questionmark appears in the column. Where there is inconsistency between the CAS number and the chemicalname, the chemical name shall take precedence over the CAS number. If there is inconsistencybetween the CAS number reported in EINECS and the one in the CAS-Register, the CAS-number inthe CAS-Register shall apply.Column 3 ("NAME")This contains the chemical name attributed by the Commission services.In some cases, a cross-reference of the REF.N. is inserted in order to find a substance having asynonym, commonly used (see Column 4)Column 4 ("SYNONIM")This contains the REF.N. of a substance being a synonym, commonly used.Column 5 ("DIR")This indicates that a) the substance is included in the Commission Directive 2002/72/EC, relating toplastic materials and articles intended to come into contact with foodstuffs (as amended by Directive2004/1/EC and Directive 2004/19/EC); b) the substance is proposed to be inserted in the nextamendment to Directive 2002/72/EC (usually referred as 3 rd amendment) or c) the substance wasmentioned in previous directives but it was later deleted for a particular reason. There are severalreasons why a substance is deleted. For example:The substance appears under another more appropriate nameThe substance is no longer requested by the petitionerThe individual substance can be covered under a generic nameThe generic name has been deleted because the substances have been introduced individuallyDeleted because considered as “basic polymer”. Basic polymers mean any polymeric substance, such asplastic or polymer, which is capable of functioning as the main structural component of finishedmaterials and articles. They are not listed if their monomers are listed and they comply with Article 2 ofFramework Directive.10

The following abbreviations appear in this column:DIR = a) Substance included in the Directive 2002/72/EC of 6 of August 2002 (as last amended)3AM = b) Substance proposed to be inserted in the 3 rd amendment of the Directive 2002/72/ECD = c) Substance previously mentioned in former directives but later deleted for a particular reasonOnly the monomers and additives which are mentioned in the other document "EU SUBSTANCES"(document available on the website) are considered substances approved at EU level. The otherappearing in the table below are substances which likely have been approved at national level butwhich will not be included in the EU lists if the data requested by EFSA is not supplied on time (seealso paragraph 3 of the explanatory note of this document)Column 6 ("RESTRICTIONS AND SPECIFICATIONS")This column contains the restrictions and/or specifications for the use of the substance as they appearin the Directive 2002/72/EC and amendments. See also Appendix 2 (definition of the SCF lists) andAppendix 3 (notes related to the column “restrictions and/or specifications”).It may include: specific migration limit (SML), maximum permitted quantity of the substance in the finished material or article (QM), maximum permitted quantity of the substance in the finished material or article expressed asmg per 6 dm 2 of the surface in contact with foodstuffs (QMA), other restriction specifically mentioned, specifications related to the substance or to the polymer.For some of the substances the Specific migration limits (SML) are specified. SML are obtained by theCommission Services using the following conversions:1) For substances with an ADI/TDI established - by multiplying the ADI/TDI values by a factor of 60.This factor is derived from the convention that a person of 60 kg daily could ingest up to 1 kg offoodstuffs in contact with a plastic article always containing the considered substance at aconcentration corresponding to the SML;2) For substances where an ADI/TDI is not established – For these cases, restrictions can bementioned, frequently derived from reduced toxicity dossiers, leading directly to fixed migration limitse.g. R=0.05 or R=5mg/kg food or food simulant. For these substances the SML generally correspondsto the restriction (=R) which appears in the toxicological SCF/EFSA assessment.Sometimes the QMA is mentioned. The relationship between the two restrictions SML and QMA isQMA = SML*kg/6dm 2 . The value is derived from the SML by assuming a) that the substance migratescompletely (% of migration) and b) S/V report equal 6 dm²/1 liter.For substances where the specific migration limits or other restrictions, are not indicated, the overallmigration limit of 60 mg/kg or 10 mg/dm 2 , according to the case, is applied.For other abbreviations see explanation for column 811

Table: Relation between the SCF List, restriction and SMLSCF ListRESTRICTIONL0 In principle, no restrictionL1 SML = ADI x 60L2 SML = TDI x 60L3 SML = Restriction (=R) proposed by SCF/EFSAL4 SML = not detectable, detection limit: 10 ppb or 20 ppb (whenanalytical tolerance is included)L5 Not authorisedL6A Not authorisedL6B Not authorisedRestriction (=R) proposed by SCF/EFSA may be indicatedL7 Not established – data neededL8 Not established – data neededL9 Not established – data neededNote: Only substances classified in L0-L4 appear in the Directives.Column 7 ("SCF_List")This contains the number of the list in which the substance is classified by the EFSA, SCF or by SCF-WG “FCM”. The meanings of the number or other abbreviations, which appear in this column, aredescribed in Appendix 2.When letter “P” appears, this means “Postponed”. If a substance was already evaluated in the past, Pclarifies that the previous classification is not longer valable pending the examination of the new datasubmitted to the SCF/EFSA and a re-evaluation of the substance.Column 8 ("EFSA/SCF OP")This contains the opinion of the SCF or EFSA updated to 27 April 2005.As from September 2002, the SCF changed the format of the opinions. A more extensive and detailedtext summarises the historical background of the substances as well as the assessment given by theSCF. Therefore, it has been decided to link the substance directly with the SCF opinion published onInternet and no longer to repeat all the content of the SCF evaluation.For EFSA opinions the proposed restrictions and the remarks for the Commission are indicated and thelink for the opinion published on the Internet is also provided.When the substance was re-evaluated by EFSA, only the EFSA opinion is indicated. The link for theprevious SCF opinion is in some cases mentioned in the background of the opinion for information.Other abbreviations which may appear in this Column:Ac Substances which is requested to be used only in coatingsADI Acceptable Daily IntakeDET DetectableDL Limit of detectionFS Food simulantsNCO Isocyanate moietyNS Not specifiedQM Maximum permitted quantity of the "residual" substance in the material or article.12

QMA maximum permitted quantity of the substance in the finished material or article expressedas mg per 6 dm² of the surface in contact with foodstuffs (QMA). The value is derivedfrom the SML by assuming a) that the substance migrates completely (100 % of migration)and b) S/V report equal 6 dm²/1 liter.QM (T) Maximum permitted quantity of the "residual" substance in the material or articleexpressed as total of moiety/ substance(s) indicated.SML Specific migration limit in foods or in food stimulant.SML (T) Specific migration limit in foods or in food simulant expressed as total ofmoiety/substance(s) indicated. The number between brackets which appears after therestriction refers to the Notes appearing in Annex VI of Directive 2002/72/EC.TDI Tolerable Daily Intake (this is a concept equivalent to the ADI, but applicable only to thepackaging sector and not to food additives).Column 9 ("PL")The sign + means that the substance was requested for plastics.Column 10 ("CT")The sign + means that the substance is listed in the inventory list of the Council of Europe ResolutionAP (2004) on coatings intended to come into food contact.Other abbreviations which may appear in the Document:W when it appears in column "SCF_L", it refers to a "new substance". If it is alone, it meansthat the substance is not yet evaluated. If it is followed by a number, this number indicatesthe SCF-L."? Means that there is a doubt on the information given.FP Finished product (= material or article in finished state)13

APPENDIX 2DEFINITION OF THE SCF LISTSSubstances for which the Committee was able to express an opinionList 0Substances, e.g. foods, which may be used in the production of plastic materials and articles, e.g. foodingredients and certain substances known from the intermediate metabolism in man and for which anADI need not be established for this purpose.List 1Substances, e.g. food additives, for which an ADI (=Acceptable Daily Intake), a t-ADI (=temporaryADI), a MTDI (=Maximum Tolerable Daily Intake), a PMTDI (=Provisional Maximum TolerableDaily Intake), a PTWI (=Provisional Tolerable Weekly Intake) or the classification "acceptable" hasbeen established by this Committee or by JECFA.List 2Substances for which a TDI or a t-TDI has been established by this Committee.List 3Substances for which an ADI or a TDI could not be established, but where the present use could beaccepted.Some of these substances are self-limiting because of their organoleptic properties or are volatile andtherefore unlikely to be present in the finished product. For other substances with very low migration,a TDI has not been set, but the maximum level to be used in any packaging material or a specific limitof migration is stated. This is because the available toxicological data would give a TDI which allowsthat a specific limit of migration or a composition limit could be fixed at levels very much higher thanthe maximum likely intakes arising from present uses of the additive.LIST 4 (for monomers)Section 4ASubstances for which an ADI or TDI could not be established, but which could be used if thesubstance migrating into foods or in food simulants is not detectable by an agreed sensitive method.Section 4BSubstances for which an ADI or TDI could not be established, but which could be used if the levels ofmonomer residues in materials and articles intended to come into contact with foodstuffs are reducedas much as possible.LIST 4 (for additives)Substances for which an ADI or TDI could not be established, but which could be used if thesubstance migrating into foods or in food simulants is not detectable by an agreed sensitive method.14

List 5Substances which should not be used.List 6Substances for which there exist suspicions about their toxicity and for which data is lacking or isinsufficient.The allocation of substances to this list is mainly based upon similarity of structure with that ofchemical substances already evaluated or known to have functional groups that indicate carcinogenicor other severe toxic properties.Section 6A: Substances suspected to have carcinogenic properties. These substances should not bedetectable in foods or in food simulants by an appropriate sensitive method for each substance.Section 6B: Substances suspected to have toxic properties (other than carcinogenic). Restrictions maybe indicated.List 7Substances for which some toxicological data exist, but for which an ADI or a TDI could not beestablished. The required additional information should be furnished.List 8Substances for which no or only scanty and inadequate data was available.List 9Substances and groups of substances which could not be evaluated due to lack of specifications(substances) or to lack of adequate description (groups of substances).Groups of substances should be replaced, where possible, by individual substances actually in use.Polymers for which the data on identity specified in "SCF Guidelines" are not available.List W"Waiting list". Substances not yet included in the Community lists, as they should be considered "new"substances, i.e. substances never approved at national level. These substances cannot be included in theCommunity lists, lacking the data requested by the Committee.In the substances used only for coatings this letter means that the substance is listed in the inventorylist of the Council of Europe Resolution AP (2004) on coatings intended to come into food contact andare not evaluated by the SCF or EFSA.List W7Substances for which some toxicological data exists, but for which an ADI or a TDI could not beestablished. The required additional information should be furnished.List W8Substances for which no or only scanty and inadequate data was available.List W9Substances and groups of substances which could not be evaluated due to lack of specifications(substances) or to lack of an adequate description (groups of substances).15

APPENDIX 3NOTES RELATED TO THE COLUMN “RESTRICTIONS AND/OR SPECIFICATIONS(1) Warning: there is a risk that the SML could be exceeded in fatty food simulants.(2) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration of the following substances mentioned as reference Nos: 10060 and 23920.(3) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration of the following substances mentioned as reference Nos: 15760, 16990, 47680, 53650and 89440.(4) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration of the following substances mentioned as reference Nos: 19540, 19960 and 64800.(5) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration of the following substances mentioned as reference Nos: 14200, 14230 and 41840.(6) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration of the following substances mentioned as reference Nos: 66560 and 66580.(7) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 30080, 42320, 45195,45200, 53610, 81760, 89200 and 92030.(8) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 38000, 42400, 64320,67896, 73040, 85760, 85840, 85920 and 95725.(9) Warning: there is a risk that the migration of the substance deteriorates the organolepticcharacteristics of the food in contact and then, that the finished product does not comply with thesecond indent of Article 2 of Directive 89/109/EEC.(10) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 30180, 40980, 63200,65120, 65200, 65280, 65360, 65440 and 73120.(11) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels (expressed as Iodine) of the following substances mentioned as reference Nos:45200, 64320, 81680 and 86800.(12) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 36720, 36800, 36840and 92000.16

(13) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 39090 and 39120.(14) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 44960, 68078, 82020and 89170.(15) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 15970, 48640, 48720,48880, 61280, 61360 and 61600.(16) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 49600, 67520 and83599.(17) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 50160, 50240, 50320,50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120.(18) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 67600, 67680 and67760.(19) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 60400, 60480 and61440.(20) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 66400 and 66480.(21) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 93120 and 93280.(22) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 17260, 18670, 54880and 59280.(23) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 13620, 36840, 40320and 87040.(24) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 13720 and 40580.(25) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 16650 and 51570.17

(26) QM(T) in this specific case means that the restriction shall not be exceeded by the sum of theresidual quantities of the following substances mentioned as reference Nos: 14950, 15700, 16240,16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.(27) QMA(T) in this specific case means that the restriction shall not be exceeded by the sum of theresidual quantities of the following substances mentioned as reference Nos: 10599/90A,10599/91, 10599/92A and 10599/93.(28) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 13480 and 39680.(29) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 22775 and 69920.(30) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 86480, 86960 and87120(31) Compliance testing when there is a fat contact should be performed using saturated fatty foodsimulants as simulant D.(32) Compliance testing when there is a fat contact should be performed using isoctane as substitute ofsimulant D (unstable).(33) QMA(T) in this specific case means that the restriction shall not be exceeded by the sum of theresidual quantities of the following substances mentioned as reference Nos: 14800 and 45600.(34) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of themigration levels of the following substances mentioned as reference Nos: 55200, 55280 and55360.’18

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT10030 000514-10-3 Abietic acid DIR 2 Group TDI: 1 mg/kg b.w.90-day and 2-year oral rat studies.(Ind Bio Test, 1962).(SCF, 17th Report, 1986).10060 000075-07-0 Acetaldehyde DIR SML(T) = 6 mg/kg (2) 2 Group TDI = 0.1 mg/kg b.w. (calculated asacetaldehyde (including 10060 and 23920)+ ++ +19Toxicity profiles similar to methaldehyde. A2-year oral rat study and a 3-generation oralrat study including teratogenicity withmethamethaldehide. The reports on nasalcarcinogenicity after inhalation wereconsidered without relevance for effectsfrom oral intake of smaller doses.(adopted at 113rd SCF meeting)(17-18September 1998)http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html10090 000064-19-7 Acetic acid Same 30000 DIR 1 Group ADI: not specified.+ +(SCF, 25th Series, 1990).10120 000108-05-4 Acetic acid, vinyl ester DIR SML = 12 mg/kg 2 TDI: 0.2 mg/kg b.w.+ +90-day oral studies and metabolism studiesin mice and rats, teratogenicity studies inrats and several mutagenicity studiesnegative.(Hazleton: 2146-51/4 January 1980; 2511-51/11-14 and 2195-51/6 & 7).10150 000108-24-7 Acetic anhydride Same 30280 DIR 2 Group TDI: included in the ADI not +specified for acetic acid.(SCF, 25th Series, 1990).10155 000542-02-9 Acetoguanamine Same 15280 D 8 +10160 002206-94-2 alpha-Acetoxystyrene D 6A +10162 010521-96-7 beta-Acetoxystyrene D 6A +10180 000556-08-1 p-(Acetylamino)benzoicD 8 SCF_List 8+acidNeeded data or information:Data according to the new SCF-Guidelines.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT181_en.pdf10210 000074-86-2 Acetylene DIR 3 Residues of this gas in plastics are very +small. The gas has low toxic potential.Migration into food will be toxicologicallynegligible.(NIOSH, Criteria for a recommendedstandard, HEW Publ. n. 76-195).10240 - Acids, aliphatic,D 9 +dicarboxylic, esters withalcohols, aliphatic,monohydric10270 - Acids, aliphatic,D 9 +dicarboxylic (C3-C12),esters with alcohols,unsaturated (C3-C18)10300 - Acids, aliphatic,D 9 +dicarboxylic, saturated(C4-C18)10330 - Acids, aliphatic,D 9 +dicarboxylic, unsaturated(C4-C12)10360 - Acids, aliphatic,D 9 +dicarboxylic,unsaturated, esters withpolyethyleneglycol10390 - Acids, aliphatic,D 9 +dicarboxylic,unsaturated, esters withpolypropyleneglycol10420 - Acids, aliphatic, mono-D 9 +and dicarboxylic (C2-C20), vinyl esters10450 - Acids, aliphatic,D 9 +monocarboxylic (C3-C12), esters withalcohols, unsaturated(C3-C18)10480 - Acids, aliphatic,monocarboxylic,D 9 +20

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTsaturated (C2-C24)10510 - Acids, aliphatic,monocarboxylic,unsaturated (C3-C24)10540 - Acids, aliphatic,monocarboxylic,unsaturated (C3-C8),esters with alcohols,aliphatic, monohydric,saturated (C2-C12)10570 - Acids, aliphatic,monocarboxylic,unsaturated, esters withpolypropyleneglycol10599/65 068955-98-6 Acids, fatty, saturated(C16-C18) andunsaturated (C18)10599/70 ? Acids, fatty,unsaturated(C18)10599/90 061788-89-4 Acids, fatty,unsaturated(C18), dimers10599/90A 061788-89-4 Acids, fatty, unsaturated(C18), dimers, distilledSame10599/90Aand10599/91Same10599/90and10599/91D 9 +D 9 +D 9 +W +D 9 +D D +DIRQMA(T) = 0.05 mg/6dm² (27)3 L3.http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdfGroup restriction: 0.05 mg/kg of food (for10599/90A-10599/91-10599/92A and10599/93).Remark for Commission: only a method forresidual content is available. A QMA-limitis applicable.+ +10599/91 061788-89-4 Acids, fatty, unsaturated(C18), dimers, nonSame10599/90DIRQMA(T) = 0.05 mg/6dm² (27)See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/outcome_en.htmlopinions(SCF/CS/PM/GEN/M89)3 Same references as 10599/90A.http://europa.eu.int/comm/food/fs/sc/scf/out+ +21

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTdistilled10599/92 068783-41-5 Acids, fatty,unsaturated(C18),dimers, hydrogenated10599/92A 068783-41-5 Acids, fatty, unsaturated(C18), dimers,hydrogenated, distilled10599/93 068783-41-5 Acids, fatty, unsaturated(C18), dimers,hydrogenated, nondistilled10600 - Acids, linear, with aneven number of carbonatoms (C8-C22), and thedimers and trimers of theunsaturated acidsand10599/90ASame10599/92A,10599/93and 17190Same10599/92,10599/93and 17190Same10599/92,10599/92A,1719022140_en.pdfD D +DIRDIRQMA(T) = 0.05 mg/6dm² (27)QMA(T) = 0.05 mg/6dm² (27)10630 000079-06-1 Acrylamide DIR SML = ND (DL = 0.01mg/kg)10660 015214-89-8 2-Acrylamido-2-methylpropanesulphonicacid3 Same references as 10599/90A.http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf3 Same references as 10599/90A.http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdfD D +4ANeurotoxic for all 6 animal species tested.Teratogenic in rats. Genotoxic in severalshort term tests and carcinogenic in rats.(RIVM doc. March 1991).DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.Available: Migration data and mutagenicitytests. Considered non-genotoxic based onthe available studies (CS/PM/2083).10690 000079-10-7 Acrylic acid DIR 2 Group t-TDI: 0.1 mg/kg b.w. pending resultsof ongoing teratogenicity studies on acrylicacid.Available: a 90-day oral rat study, an oralreproduction study, 2- year oral rat and dogstudies with acrylic acid and an oralteratogenicity study in rats with ethylacrylate, 3-year oral rat and dog studies withacrylic acid, ethylene glycol monoester.(NTP; Union Carbide report N. 43-529 (26August 1980) and N. 43-528 (22 August1980); RIVM report 65116008 (June 1984);report Dow, 1967 and 1967; RIVM report+ ++ ++ ++ ++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT06-02-1990).http://europa.eu.int/comm/food/fs/sc/scf/reports/scf_reports_30.pdf10720 000999-55-3 Acrylic acid, allyl ester D 6A + +10750 002495-35-4 Acrylic acid, benzyl ester DIR 2 Group TDI: 0.1 mg/kg bw (as acrylic acid). + +Hydrolysis (complete) data allow to allocatethe same TDI as acrylic acid.10775 084100-23-2 Acrylic acid, 4-tert-D 8 +butylcyclohexyl ester10780 000141-32-2 Acrylic acid, n-butylester10810 002998-08-5 Acrylic acid, sec-butylester10840 001663-39-4 Acrylic acid, tert-butylesterDIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylicacid).See references for acrylic acid.+ +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylic + +acid).See references for acrylic acid.DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylic + +acid).See references for acrylic acid.D 8 +10870 002206-89-5 Acrylic acid, 2-chloroethyl ester10900 - Acrylic acid,D 8 +cyclohexylaminoethylester10930 003066-71-5 Acrylic acid, cyclohexylD 8 Available: hydrolysis data, but hydrolysis is + +esternot complete.10960 016868-13-6 Acrylic acid, cyclopentylD 8 +ester10990 002156-96-9 Acrylic acid, decyl ester D 7 Needed: hydrolysis data. + +11000 050976-02-8 Acrylic acid,+dicyclopentadienyl ester11005 012542-30-2 Acrylic acid,dicyclopentenyl ester11010 024447-78-7 Acrylic acid, diester with2,2-bis(4-hydroxyphenyl)propane bis(2-DIR QMA = 0.05 mg/6 dm² 3 R = 0.05 mg/kg of food.Available: Migration by worst casecalculation < 50 ppb, 3 mutagenicity testsnegative.(RIVM/TNO/ISS SDS CS/PM/2743,January 1996).D3 R = 0.05 mg/kg of food. +3AMD 8 +23

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CThydroxyethyl) ether11020 019485-03-1 Acrylic acid, diester with1,3-butanediol11050 001070-70-8 Acrylic acid, diester with1,4-butanediol11080 004074-88-8 Acrylic acid, diester withdiethyleneglycol11090 002223-82-7 Acrylic acid, diester with2,2-dimethyl-1,3-propanediol11110 002274-11-5 Acrylic acid, diester withethyleneglycol11140 013048-33-4 Acrylic acid, diester with1,6-hexanediol11170 026570-48-9 Acrylic acid, diester withpolyethyleneglycol11180 017831-71-9 Acrylic acid, diester withtetraethyleneglycol11190 001680-21-3 Acrylic acid, diester with11195 068901-05-3and 042978-66-5triethyleneglycolAcrylic acid, diester withtripropyleneglycol11200 002426-54-2 Acrylic acid, 2-(diethylamino)ethyl ester11230 002439-35-2 Acrylic acid, 2-(dimethylamino)ethylester11245 002156-97-0 Acrylic acid, dodecylesterD 8 +D 8 + +D 8 + +8 +D 8 + +D 8 + +D 8 + +D 8 + +8 +D 8 +D 8 +D 7 Needed: hydrolysis data. + +DIR SML = 0.05 mg/kg (1) 3 R = 0.05 mg/kg of food.Available: Migration data, 3 (negative)mutagenicity studies.(ISS/TNO SDS, March 1997 =CS/PM/2996/11245).+ +Remark: Since high migration into fat hasbeen demonstrated the WG recommends thatthe Commission take the necessary measuresso that the restriction proposed is notexceeded.24

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT11260 000106-90-1 Acrylic acid, 2,3- Same 16116 D 6A + +epoxypropyl ester11290 - Acrylic acid, esters withD 9 +alcohols,aliphatic,monohydric,saturated (C1-C21)11320 - Acrylic acid, esters withD 9 +alcohols, aliphatic,monohydric, unsaturated(C4-C18)11350 - Acrylic acid, esters withD 9 +alcohols, aliphatic,polyhydric (C2-C21)11380 - Acrylic acid, esters withD 9 +etheralcohols11390 - Acrylic acid, esters withD +etheralcohols, aliphatic,monohydric, saturated(C1-C21)11410 - Acrylic acid, esters withD 9 +glycolethers obtainedfrom mono- and/ordiglycols with alcohols,aliphatic, monohydric(C1-C18)11425 ? Acrylic acid, ester with8 +methoxydiethyleneglycol11440 044992-01-0 Acrylic acid, ester withD 8 + +trimethylethanolammonium chloride11470 000140-88-5 Acrylic acid, ethyl ester DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylic + +acid).See references for acrylic acid.11500 000103-11-7 Acrylic acid, 2-ethylhexyl esterDIR 3 Restriction: 0.05 mg/kg of foodhttp://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf+ +25http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT11505 013402-02-3 Acrylic acid, hexadecylester11510 000818-61-1 Acrylic acid,hydroxyethyl ester11520 002918-23-2 Acrylic acid, 2-hydroxyisopropyl ester(= acrylic acid, 2-hydroxy-1-methylethylester)11530 000999-61-1 Acrylic acid, 2-hydroxypropyl esterW +Same 11830 DIR See "Acrylic acid,monoester withethyleneglycol"+ +D 7 Needed: hydrolysis data. +DIRQMA = 0.05 mg/6 dm²for the sum of acrylicacid, 2-hydroxypropylester and acrylic acid,2-hydroxyisoprpylester and in compliancewith the specificationslaid down in Annex V.3 R = 0.05 mg/kg of food (for the mixture).Based on the reduced core set oftoxicological data according to the migrationlevel, see Appendix 2Available: calculation of worst casemigration is < 0.05 mg/kg of food; genemutation assay in bacteria (negative);chromosomal aberration assay in culturedmammalian cells (positive); gene mutationassay in cultured mammalian cells(negative); micronucleus assay (negative).RIVM/ISS/TNO SDS, July 2000 =CS/PM/3117 REV. I/11530.+ +Remark for Commission:- Only a residual Q method is available. AQMA of 50 ug/6 dm2 is proposed.11532 002761-08-2 Acrylic acid, 3-hydroxypropyl ester11560 005888-33-5 Acrylic acid, isobornylester11590 000106-63-8 Acrylic acid, isobutylester(Adopted at the 126th SCF meeting, 28February 2001)http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdfD 8 +D 8 +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylicacid).See references for acrylic acid.+ +26

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT11620 001330-61-6 Acrylic acid, isodecylester11650 029590-42-9 Acrylic acid, isooctylester11680 000689-12-3 Acrylic acid, isopropylester11695 003121-61-7 Acrylic acid, 2-methoxyethyl ester11710 000096-33-3 Acrylic acid, methylester11740 010095-13-3 Acrylic acid, monoesterwith 1,3-butanediol11770 002478-10-6 Acrylic acid, monoesterwith 1,4-butanediol11800 013533-05-6 Acrylic acid, monoesterwith diethyleneglycol11830 000818-61-1 Acrylic acid, monoesterwith ethyleneglycol11860 - Acrylic acid, monoesterwith propyleneglycol11875 004813-57-4 Acrylic acid, octadecylester11890 002499-59-4 Acrylic acid, n-octylesterD 8 + +D 8 + +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylicacid).See references for acrylic acid.+ +D 6B + +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylicacid).See references for acrylic acid.+ +D 7 Needed: hydrolysis data. +D 8 + +D 7 Needed: hydrolysis data. +Same 11510 DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylicacid).See references for acrylic acid.+ +D 9 +D 7 Needed: hydrolysis data. + +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylicacid).Hydrolysis (complete) data allow to allocatethe same TDI as acrylic acid.+ +D 8 +11920 005048-82-8 Acrylic acid,phenylaminoethyl ester11950 000937-41-7 Acrylic acid, phenylD 7 Needed: hydrolysis data. +ester11980 000925-60-0 Acrylic acid, propyl ester DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylicacid).See references for acrylic acid.12010 040074-09-7 Acrylic acid, 2-D 8 +sulphoethyl ester12040 039121-78-3 Acrylic acid, D 8 +27+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTsulphopropyl ester12055 094160-26-6 Acrylic acid, triester withD 8 +glycerol tris(2-hydroxypropyl) ether12062 075577-70-7 Acrylic acid, triester withD 8 + +1,1,1-trimethylolpropanetris(2-hydroxyethyl)ether12070 002177-18-6 Acrylic acid, vinyl ester D 7 Needed: hydrolysis data. + +12100 000107-13-1 Acrylonitrile DIR SML = ND (DL 4A (SCF, 13th Series, 1982). + +=0.020 mg/kg,analytical toleranceincluded)12130 000124-04-9 Adipic acid Same 31730 DIR 1 ADI: 5 mg/kg b.w.+ +(SCF, 25th Series, 1990).12160 002998-04-1 Adipic acid, diallyl ester Same 32200 D 6A +12190 000105-97-5 Adipic acid, di-n-decylester12220 027178-16-1 Adipic acid, diisodecylester12250 000123-79-5 Adipic acid, di-n-octylester12265 004074-90-2 Adipic acid, divinyl ester DIR QM = 5 mg/kg in FP.For use only as comonomer.Same 32320 D 8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.050 mg/kg, peroxisomeproliferation study, too.Same 32560 D 9 Group R: 0.05 mg/kg b.w.Needed: in first instance specifications andthen on the specified substancestoxicological data depending on migrationlevel (see SCF guidelines) and, if migrationexceeds 0.050 mg/kg, peroxisomeproliferation studies too.Same 32880 D 8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCFguidelines) and, ifmigration exceeds 0.050 mg/kg, peroxisomeproliferation study too.283 R = 0.5% (w/w) as co-monomer.Hydrolysis data, inadequate. Howeverresidue level very low.(TNO SDS 1995-01-06).+++ +12280 002035-75-8 Adipic anhydride DIR 2 Group TDI: 5 mg/kg b.w. + ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTIncluded in group ADI for adipic acid.12310 - Albumin DIR 0 +12340 - Albumin, coagulated byformaldehyde12370 - Alcohols, aliphatic,monohydric, saturated,primary, secondary ortertiary (C4-C22)12375 - Alcohols, aliphatic,monohydric, saturated,linear, primary (C4-C22)12400 - Alcohols, aliphatic,monohydric, unsaturated(up to C18)12430 - Alcohols, aliphatic,polyhydric (up to C18)12460 - Alcohols, cycloaliphatic,mono- and/orpolyhydric, substituted(up to C18)DIR 3 Though albumin is a food component, it hasbeen modified by formaldehyde which isclassified in list 3 in 17th Series, SCF, 1986.D 7 Needed: actual use, 28-day oral study of onelower and one higher alcohol.DIR 3 90-day oral studies, metabolic and/ormutagenicity studies with some substancesout of the group.+ +D 9 +D 9 +D 9 +12490 - Aldehydes (C4) D 9 +12520 - Alkadienes D 9 +12550 - n-Alkenes (up to C16) D 9 + +12573 068609-97-2 Alkyl(C12-C14)-2,3-epoxypropyl ethers12576 - Alkylphenols See also1257812578 - Alkyl(C1-C4)phenols(consisting of a mixtureof mono, di, tri and tetraalkyl substituted phenolsand up to 2% phenol)D +9 +5 Substance which should not be used.Available: inadequate migration data, acutetoxicity data on several components ofmixture.Evaluation is not possible from the dataprovided. Sources for the mixture mentioneddo not exclude presence of toxiccomponents. Quantitative ranges are lackingfor many substances.(RIVM/TNO SDS, February 1997 =+++29

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTCS/PM/2993/12578).12580 - p-Alkyl(C4-C9)phenols D 9 +12610 000107-18-6 Allyl alcohol D 6A +12640 000106-92-3 Allyl 2,3-epoxypropylD 6A +ether12650 - Allyl ethers of mono-,9 +di-, or trimethylolphenol12670 002855-13-2 1-Amino-3-aminomethyl-3,5,5-trimethylcyclohexaneSame 19145 DIR SML = 6 mg/kg 2 t-TDI: 0.1 mg/kg b.w.Available: 13-week oral rat study, 2 negativemutagenicity studies. (RIVM summary data,April 1991)(CS/PM/921).Needed: in-vitro chromosome aberration andgene mutation in mammalian cells.12700 000150-13-0 4-Aminobenzoic acid D 8 SCF_List 8Needed data or information:Data according to the new SCF-Guidelines.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf12730 000060-32-2 6-Aminocaproic acid D 8 +12760 - omega-Aminocarboxylicacids, aliphatic, linear(C6-C12)D 9 +12761 000693-57-2 12-Aminododecanoicacid12763 000141-43-5 2-Aminoethanol Same 22337and 67420DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.Mutagenicity tests are negative andmigration is low (less than 50 ppb).(RIVM/TNO doc. CS/PM/2162).DIRSML = 0.05 mg/kg.Not for use in polymerscontacting foods forwhich simulant D islaid down in Directive85/572/EEC and forindirect food contactonly, behind the PETlayer303 R = 0.05 mg/kg of food.Available: migration data from multilayerbottle and residual content in polymer; genemutation assay in bacteria (negative);chromosomal aberration assay in culturedmammalian cells (negative); gene mutationassay in cultured mammalian cells(negative); in vitro cell transformation assay(negative); toxicology summary onreproductive toxicity; general toxicologicaloverview on MEA (made by the applicant).RIVM/TNO SDS, August 1999 =+ ++++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTCS/PM/3337/22337.Remark: substance evaluated only for therequested use of indirect contact with nonfattyfood.12765 084434-12-8 N-(2-Aminoethyl)-betaalanine,sodium salt(Adopted at the 121 SCF meeting (20 June2000))http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdfSame 35180 DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of foodhttp://europa.eu.int/comm/food/fs/sc/scf/out61_en.pdfAvailable: specific migration in 3% aceticacid, 15% ethanol and 95% ethanol < 0.03mg/kg food; gene mutation assay in bacteria(negative); chromosomal aberration assay incultured mammalian cells (negative); genemutation assay in cultured mammalian cells(negative)RIVM/ISS/TNO SDS, November 1999 =CS/PM/3352 REV. I/35180.+12771 000111-41-1 N-(2-Aminoethyl)ethanolamineRemark for Commission:* Send a letter to the applicant, concerningthe "preparation" of the petition (poorquality of the dossier)* The commercial product (as 40% aqueoussolution) is tested in the mutagenicity assays(Adopted at the 121 SCF meeting (20 June2000))Same 35284 W7 Available: Mutagenicity tests, migrationdata inadequate.Needed: Validation of analytical methods, invitro chromosomal aberration study inmammalian cells.(RIVM Doc. CS/PM/2164).12772 000140-31-8 N-Aminoethylpiperazine 8 +12775 000124-68-5 2-Amino-2-methyl-1- 8 +31+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTpropanol12786 000919-30-2 3-Aminopropyltriethoxysilane12788 002432-99-7 11-Aminoundecanoicacid3AM 3 Residual extractable content of 3-aminopropyltriethoxysilane to beless than 3 mg/kg filler.Remark for the Commission: Used only forthe reactive surface treatment of inorganicfillers.http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdfDIR SML = 5 mg/kg 3 R: 5 mg/kg of foods.Available: 3-month oral mouse and ratstudy, 2-year oral mouse and rat studies,several in vitro and in vivo mutagenicitytests negative.12789 007664-41-7 Ammonia Same 35320 DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1991).12789/5 009037-22-3 Amylopectin W +12790 000080-46-6 p-tert-Amylphenol D 8 +12795 - Anhydrides of acids,D +aliphatic,monocarboxylic (C2-C24)12820 000123-99-9 Azelaic acid DIR 2 Group TDI: 3 mg/kg b.w.+ +A subacute oral rat study and absence ofmutagenicity in bacterial systems withazelaic acid and a subacute oral rat studywith sebacic acid.(Arch. f. Exp. Path. u. Pharmak., 197, 1941,587-610).12850 029602-44-6 Azelaic acid, bis(2-D 8 +hydroxyethyl) ester12880 000123-98-8 Azelaic acid dichloride D 7 Needed: hydrolysis and migration data.Pending these results necessity for furtherstudies to be considered.http://europa.eu.int/comm/food/fs/sc/scf/out161_en.pdf+12910 001732-10-1 Azelaic acid, dimethylesterD 8 Group R : 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, if32+++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTmigration exceeds 0.050 mg/kg, peroxisomeproliferation studies too.12940 004080-88-0 Azelaic acid, diphenylD 8 +ester12970 004196-95-6 Azelaic anhydride DIR 2 Group TDI: 3 mg/kg b.w.+ +Included in the group TDI for azelaic acid.12974 BADGE Same13510;13610;39700+ +According toCommission Directive2002/16/EC of 20February 2002 on theuse of certain epoxyderivatives in materialsand articles intended tocome into contact withfoodstuffs332-3 On the basis of the available experimentaldata, a TDI can be established for BADGEand its hydrolysis products. Considering theNOAEL of 15 mg/kg b.w./day observed inthe oral chronic toxicity/carcinogenicitystudy in the rat with BADGE, and applyingan uncertainty factor of 100, a TDI of 0.15mg/kg b.w. can be established for BADGE.As BADGE is rapidly and extensivelymetabolised in vivo into the correspondingmono- and bis-diol derivatives, the Panelincludes these in the TDI.For the other regulated BADGE reactionproducts, i.e. the BADGE chlorohydrinsBADGE.2HCl, BADGE.HCl,BADGE.HCl.H2O, in view of the lack ofgenotoxicity, the Panel considers that thecurrent restriction of 1 mg/kg of foodremains appropriate.The Panel is aware that other BADGEreaction products, with undefinedtoxicological propertiesand chemical identity, may be found at lowlevels in the migrate from epoxy coatings.For the assessment of these, and in generalof minute amounts of unknown migrantsfrom food contact materials, a generalapproach is currently under consideration bythe Panel.EFSA opinion from 13 July 2004http://www.efsa.eu.int/science/afc/afc_opinions/508/opinion_afc13_ej86_badge_v2_en1.pdfSee the individual opinion on the substance

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT12976 054208-63-8 BFDGE Same13460;39665DAccording toCommission Directive2002/16/EC of 20February 2002 on theuse of certain epoxyderivatives in materialsand articles intended tocome into contact withfoodstuffsCan still be used inheavy duty coatings(CS/PM/2812 Rev.1) which is reported inthe Internet website:http://europa.eu.int/comm/food/fs/sc/scf/out28_en.pdf7 http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf+ +12980 008015-74-5 Beechnut oil 3 Food fat. +12983/1 - Beechnut oil fatty acids 3/D Constituents of food fats. +13000 001477-55-0 1,3-Benzenedimethanamine13030 000539-48-0 1,4-Benzenedimethanamine13050 000528-44-9 1,2,4-Benzenetricarboxylicacid13060 004422-95-1 1,3,5-Benzenetricarboxylicacid trichlorideDIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg of food.Mutagenicity tests are negative andmigration is very low (less than 5 ppb).+ +Same 37400 D 8 +Same 25540 DIR See "Trimellitic acid" + +DIRQMA = 0.05 mg/6dm² measured as 1,3,5-benzenetricarboxylicacid.3 R = 0.05 mg/6 dm² measured as 1,3,5-benzenetricarboxylic acid.Available: Calculation of worst casemigration assuming 100% migration ofresidual monomer, three (negative) in vitromutagenicity studies.Remark for Commission: no method ofanalysis is available for the enforcement ofan SML.(RIVM/ISS/TNO SDS, October 1997 =CS/PM/3075/13060)(Adopted at 111th SCF meeting (18-19March 1998)).http://europa.eu.int/comm/food/fs/sc/scf/out+34

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT10_en.pdf13075 000091-76-9 Benzoguanamine Same 15310 DIR See "2,4-Diamino-6-+ +phenyl-1,3,5-triazine"13090 000065-85-0 Benzoic acid Same 37600 DIR 1 Group ADI: 5 mg/kg b.w.+ +(JECFA 27 M., 1983).13120 000769-78-8 Benzoic acid, vinyl ester D 7 Needed: hydrolysis data. +13150 000100-51-6 Benzyl alcohol Same 38400 DIR 1 Group ADI: 5 mg/kg b.w. in the ADI for + +benzoic acid.(SCF, 11th Series, 1981).13160 039817-09-9 BFDGE and NOGE(inserted for memo)D7 http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf+ +See:12976;13460;39665;22552;68200According toCommission Directive2002/16/EC of 20February 2002 on theuse of certain epoxyderivatives in materialsand articles intended tocome into contact withfoodstuffs.Can still be used inheavy duty coatings.13180 000498-66-8 Bicyclo[2.2.1]hept-2-ene Same 22550 DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html+13210 001761-71-3 Bis(4-Aminocyclohexyl)methaAvailable: Adequate migration data;adequate Ames test (negative); adequategene mutation assay in cultured mammaliancells (negative); inadequate chromosomalaberration assay in cultured mammaliancells; adequate chromosomal aberrationassay in cultured mammalian cells(negative).(RIVM/ISS/TNO SDS, January 1998 =CS/PM/2851 REV. I/13180).(adopted at 113rd SCF meeting)(17-18September 1998)DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.Available: Adequate migration data and+ +35

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTne13240 003377-24-0 2,2-Bis(4-aminocyclohexyl)propane13250 000101-77-9 Bis(4-aminophenyl)methane13270 022287-56-5 4,4'-Bis(4-chlorophenylsulphonyl)biphenyl13300 038050-97-4 1,4-Bis(4',4''-dihydroxytriphenylmethyl)benzene13317 132459-54-2 N,N'-Bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide13323 000102-40-9 1,3-Bis(2-hydroxyethoxy)benzeneanalytical report, showing specific migrationof bis(4-aminocyclohexyl)methane is < 0.05mg/kg food; inadequate report of genemutation test in bacteria; gene mutationassay in bacteria (negative); chromosomalaberration assay in cultured mammaliancells (negative); genemutation assay in cultured mammalian cells(negative).(RIVM/ISS/TNO SDS, April 1998 =CS/PM/ 2852 REV. I /13210).(Adopted at 114th SCF meeting) (10December 1998)http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdfD 8 +4A Considered as genotoxic carcinogen.Available: 2 oral carcinogenicity studies inrats and mice, positive Ames test(CS/PM/2009).D W8 +D 8 +3AM 3 Restriction: 0.05 mg/kg foodRemark for Commission: FRF is applicableN,N'-Bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide(> 98.1 %) is requested as a co-monomer(max. 4 %) for polyesters (likePET, PBT).http://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdfDIR SML = 0.05 mg/kg 3 Restriction: 0.05 mg/kg of food.http://europa.eu.int/comm/food/fs/sc/scf/out36+++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT13326 000111-46-6 Bis(2-hydroxyethyl)ether13328 000104-38-1 Bis(2-hydroxyethyl)ether of hydroquinone13330 - Bis(2-hydroxyethyl)etherof hydroquinone and itscondensation productswith propylene oxide13360 001620-68-4 2,6-Bis(2-hydroxy-5-methylbenzyl)-4-methylphenol13380 000077-99-6 2,2-Bis(hydroxymethyl)-1-butanol13390 000105-08-8 1,4-Bis(hydroxymethyl)cyclohexane13395 004767-03-7 2,2-Bis(hydroxymethyl)propionic acid13420 000843-55-0 1,1-Bis(4-hydroxyphenyl)cyclohexaneSame15760,39160and 47680Same 25600,39560 and94960140_en.pdfDIR See "Diethyleneglycol" + +D 8 +D 9 +D 7 Needed: 90-day oral study, migration data. +DIRSee "1,1,1-Trimethylolpropane"Same 14880 DIR 3 A limited 36-day oral rat study showed noadverse effects at 50 mg/kg b.w./day.(Eastman Kodak report, April 1966).DIRQMA = 0.05 mg/6dm²3 R: 0.05 mg/kg of food.http://europa.eu.int/comm/food/fs/sc/scf/out61_en.pdfAvailable: calculation of worst casemigration based on extraction values;analytical method for quantification inaqueous simulants and in 95% ethanol isproperly described; gene mutation assay inbacteria (negative); chromosomal aberrationassay in cultured mammalian cells(negative); gene mutation assay in culturedmammalian cells (negative).RIVM/FR SDS, November 1999 =CS/PM/3358 REV. I/13395.Remark for Commission: No method ofanalysis in olive oil is available. A QMAwould be indicated. (Adopted at the 121)D 8 +++ ++ +37

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT13450 000125-13-3 3,3-Bis(4-hydroxyphenyl)-2-indolinone13453 001333-16-0;087139-40-0;002467-02-9;000620-92-8;002467-03-0Bis(hydroxyphenyl)methane, mixture of Bis(2-and 4- and 2,4hydroxyphenyl)methane13455 002467-02-9 Bis(2-hydroxyphenyl)methane13457 000620-92-8 Bis(4-hydroxyphenyl)methane13460 054208-63-8 Bis(2-hydroxyphenyl)methanebis(2,3-epoxypropyl)ether (=BFDGE)13465 000126-00-1 4,4-Bis(hydroxyphenyl)pentanoic acid13480 000080-05-7 2,2-Bis(4-hydroxyphenyl)propaneD 8 +7 SCF_list: 7.Needed:-A properly validated method including datafor the determination of Bisphenol F in atypical final productOrA properly validated method including dataconcerning the specific migration into foodsimulants of Bisphenol F from a typical finalproduct.http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdfSame 13615 7 SCF_list: 7.See 13453.http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdfSame 39650 7 SCF_list: 7.See 13453.http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdfSame 39665;12976DAccording toCommission Directive2002/16/EC of 20February 2002 on theuse of certain epoxyderivatives in materialsand articles intended tocome into contact withfoodstuffs.Can still be used inheavy duty coatings.387 http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf+++ ++ +Same 16525 8 +Same13607/39680/62540/400DIRSML(T) = 0.6 mg/kg(28)2 See the specific opinion on this substancesadopted on 17, April 2002.http://europa.eu.int/comm/food/fs/sc/scf/out+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT13510 001675-54-3 2,2-Bis(4-hydroxyphenyl)propanebis(2,3-epoxypropyl)ether (=BADGE)60/19255 128_en.pdfSame DIR12974;13610;39700According toCommission Directive2002/16/EC of 20February 2002 on theuse of certain epoxyderivatives in materialsand articles intended tocome into contact withfoodstuffs392-3 On the basis of the available experimentaldata, a TDI can be established for BADGEand its hydrolysis products. Considering theNOAEL of 15 mg/kg b.w./day observed inthe oral chronic toxicity/carcinogenicitystudy in the rat with BADGE, and applyingan uncertainty factor of 100, a TDI of 0.15mg/kg b.w. can be established for BADGE.As BADGE is rapidly and extensivelymetabolised in vivo into the correspondingmono- and bis-diol derivatives, the Panelincludes these in the TDI.For the other regulated BADGE reactionproducts, i.e. the BADGE chlorohydrinsBADGE.2HCl, BADGE.HCl,BADGE.HCl.H2O, in view of the lack ofgenotoxicity, the Panel considers that thecurrent restriction of 1 mg/kg of foodremains appropriate.The Panel is aware that other BADGEreaction products, with undefinedtoxicological propertiesand chemical identity, may be found at lowlevels in the migrate from epoxy coatings.For the assessment of these, and in generalof minute amounts of unknown migrantsfrom food contact materials, a generalapproach is currently under consideration bythe Panel.EFSA opinion from 13 July 2004http://www.efsa.eu.int/science/afc/afc_opinions/508/opinion_afc13_ej86_badge_v2_en1.pdfSee the individual opinion on the substance(CS/PM/2812 Rev.1) which is reported inthe Internet website:http://europa.eu.int/comm/food/fs/sc/scf/out28_en.pdf+ +13518 025036-25-3 2,2-bis(4- W +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CThydroxyphenyl)propane -2,2-bis(4-hydroxyphenyl)propanebis(2,3-epoxypropyl)ether, copolymer13520 000116-37-0 2,2-Bis(4-hydroxyphenyl)propanebis(2-hydroxypropyl)ether13530 038103-06-9 2,2-Bis(4-hydroxyphenyl)propane,bis(phthalic anhydride)13540 002444-90-8 2,2-Bis(4-hydroxyphenyl)propane,disodium salt13545 129188-99-4 1,1-Bis(4-hydroxyphenyl)-3,3,5-trimethylcyclohexane3 R: 0.05 mg/kg of food (only to be used inthe manufacture of adhesives).Available: 3 mutagenicity studies, negative.The worst case calculation as component ofan adhesive gives a maximum migrationvalue less than 50 ppb.(RIVM doc. 1994-11-08 = CS/PM/2460).+Same 13614 DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg of food.+1 month oral rat study, 3 mutagenicity testsand migration data.(Rivm doc. 90/678908/010).D +40W7 Available: specific migration data < 0.05mg/kg food; gene mutation assay in bacteria(negative); chromosomal aberration assay incultured mammalian cells (negative); genemutation assay in cultured mammalian cells(negative); micronucleus assay (negative);acute toxicity data; 90-day oral rat study;reproduction study; teratogenicity study;scientific statement provided by theapplicant.Needed: test for endocrine activity inaccordance with US-EPA tiered approach.RIVM/TNO SDS, February 2000 =CS/PM/2644 REV.III/13545.(Adopted at the 123rd SCF meeting, 19October 2000)http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf13550 000110-98-5 Bis(hydroxypropyl) ether DIR See+ +"Dipropyleneglycol"13560 005124-30-1 Bis(4- Same 15700 DIR See + ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTisocyanatocyclohexyl)methane13565 002778-42-9 1,3 - bis(alphaisocyanatoisopropyl)benzene13570 000141-07-1 1,3-Bis(methoxymethyl)urea13600 047465-97-4 3,3-Bis(3-methyl-4-hydroxyphenyl)-2-indolinone13607 000080-05-7 Bisphenol A Same13480/62540/40060/19255/3968013610 001675-54-3 Bisphenol A bis(2,3- Sameepoxypropyl)ether 13510;39700;12974"Dicyclohexylmethane-4,4'-diisocyanate"W +D 8 +DIR SML = 1.8 mg/kg 2 TDI: 0.03 mg/kg b.w.A 90-day oral rat study.DIRDIRSee "2,2-Bis(4-hydroxyphenyl)propane"See "2,2-Bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl)ether"(Bayer Bericht Nr. 8086, January 3, 1979).Under re-evaluationhttp://europa.eu.int/comm/food/fs/sc/scf/out128_en.pdf2-3 On the basis of the available experimentaldata, a TDI can be established for BADGEand its hydrolysis products. Considering theNOAEL of 15 mg/kg b.w./day observed inthe oral chronic toxicity/carcinogenicitystudy in the rat with BADGE, and applyingan uncertainty factor of 100, a TDI of 0.15mg/kg b.w. can be established for BADGE.As BADGE is rapidly and extensivelymetabolised in vivo into the correspondingmono- and bis-diol derivatives, the Panelincludes these in the TDI.For the other regulated BADGE reactionproducts, i.e. the BADGE chlorohydrinsBADGE.2HCl, BADGE.HCl,BADGE.HCl.H2O, in view of the lack ofgenotoxicity, the Panel considers that thecurrent restriction of 1 mg/kg of foodremains appropriate.The Panel is aware that other BADGEreaction products, with undefinedtoxicological propertiesand chemical identity, may be found at lowlevels in the migrate from epoxy coatings.For the assessment of these, and in generalof minute amounts of unknown migrants++ ++ +41

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT13614 038103-06-9 Bisphenol A bis(phthalicanhydride)Same 13530 DIR See "2,2-Bis(4-hydroxyphenyl)propane, bis(phthalicanhydride)"42from food contact materials, a generalapproach is currently under consideration bythe Panel.EFSA opinion from 13 July 2004http://www.efsa.eu.int/science/afc/afc_opinions/508/opinion_afc13_ej86_badge_v2_en1.pdfSee the individual opinion on the substance(CS/PM/2812 Rev.1) which is reported inthe Internet website:http://europa.eu.int/comm/food/fs/sc/scf/out28_en.pdf13615 002467-02-9 Bisphenol F Same 13455 7 SCF_list: 7.See 13453.http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf13617 000080-09-1 Bisphenol S Same 16090 DIR See "4,4'-Dihydroxydiphenylsulphone"13618 16068-37-4 1,2-Bis(triethoxysilyl)ethane13620 010043-35-3 Boric acid Same 40320 DIR SML(T) = 6 mg/kg(23) (expressed asBoron) withoutprejudice to theprovisions of Directive98/83/EC on water forhuman consumption(*).+++ +W +2 Re-evaluation on the basis of an opinion ofthe SCF in another context.Group-TDI = 0.1 mg/kg b.w. (as B) (withREF_n. 36840, 40320 and 87040).The TDI is based on the No Adverse EffectLevel (NOAEL) of 9.6 mg/kg b.w./day foreffects on fetal body weight and skeletalanomalies in the rat developmental study. ASafety Factor (SF) of 100 is used.“Opinion of the Scientific Committee onFood on Arsenic, Barium, Fluoride, Boronand Manganese in Natural Mineral Waters(expressed on 13 December 1996, 105thplenary meeting of the SCF, completed on13 June 1997 at the 107th plenary meeting+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT13630 000106-99-0 Butadiene DIR QM = 1 mg/kg in FP orSML =ND (DL =0.020mg/kg, analyticaltolerance included)4Aof the SCF; 43rd Series of Reports of theSCF, 2000”. This opinion is also availableon Internet.(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdfSuspected of having carcinogenic potential(NTP report 83-071, NIH publ. n. 84-2544,1983).+ +13660 000584-03-2 1,2-Butanediol D 8 +13690 000107-88-0 1,3-Butanediol DIR 1 ADI: 4 mg/kg b.w.+ +(JECFA 23 M., 1979).13720 000110-63-4 1,4-Butanediol Same 40580 DIR SML(T) = 0.05 mg/kg(24)3 5 mg/kg food+ +http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdfhttp://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf13750 000513-85-9 2,3-Butanediol D 8 +13780 002425-79-8 1,4-Butanediol bis(2,3-DIR QM = 1 mg/kg in FP 4A Genotoxic similar to glycidylethers.+ +epoxypropyl) ether(expressed as Epoxy(CS/PM/2958).group, Mw=43)13810 000505-65-7 1,4-Butanediol formal Same 21821 DIR QMA = 0.05 mg/6 dm² 3 R = 0.05 mg/kg of food.+ +http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdfAvailable: calculated (worst case) migrationis < 0.05 mg/kg of food; gene mutationassay in bacteria (negative); chromosomalaberration assay in cultured mammaliancells (positive); gene mutation assay incultured mammalian cells (negative);micronucleus assay (negative); in vivo UDSassay (negative)RIVM/ISS/TNO SDS, January 2000 =CS/PM/2853 REV.I/13810.Remark for Commission: only a method for43

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTthe residual quantity in the finished product(FP) is available. A QMA is proposed.(Adopted at the 123rd SCF meeting, 19October 2000)13840 000071-36-3 1-Butanol Same 40590 DIR 3 See references for "Alcohols, aliphatic, + +monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N. 12375) in SCF list 3.13845 000075-65-0 tert-Butanol Same 40594 3 Residue in food less than 10 mg/kg.+(EHC,65).13870 000106-98-9 1-Butene DIR 3 Residues of this gas in plastics are very + +small. The gas has low toxic potential.Migration into food will be toxicologicallynegligible. (Patty's Industrial Hygiene andToxicology, 3rd ed. 1981).13900 000107-01-7 2-Butene DIR 3 Residues of this gas in plastics are very + +small. The gas has low toxic potential.Migration into food will be toxicologicallynegligible.(Patty's Industrial Hygiene and Toxicology,3rd ed. 1981).13930 006117-91-5 2-Buten-1-ol D 8 +13932 000598-32-3 3-Buten-2-ol Same 40610 DIR QMA = ND (DL =0.02 mg/6 dm²). To beused only as a comonomerfor thepreparation ofpolymeric additive444An.d. (DL = 0.01 mg/kg)Available: worst case migration of

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT13960 001852-16-0 N-D 6A + +(Butoxymethyl)acrylamide13990 005153-77-5 N-D 6A + +(Butoxymethyl)methacrylamide14001 001320-16-7 tert-Butylbenzoic acid 8 +14002 000098-73-7 p-tert-Butylbenzoic acid 7 Available: some data at RIVM.+Needed: migration and mutagenicity studies.14005 000098-29-3 4-tert-Butylcatechol Same 40640 8 +14008 000098-52-2 4-tert-Butylcyclohexanol D 8 +14020 000098-54-4 4-tert-Butylphenol Same 40850 DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.+ +Available: Adequate migration data forpolycarbonate; calculation of worst-casemigration for epoxy systems and butylatedalkylphenolic resins; three (negative)mutagenicity studies.(RIVM/TNO SDS, March 1997 =CS/PM/2991 /14020).(Adopted at 111th SCF meeting (18-19March 1998))http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf14035 001746-23-2 4-tert-Butylstyrene D 6A +14050 000111-34-2 Butyl vinyl ether D 7 Needed: hydrolysis data. +14080 000926-02-3 tert-Butyl vinyl ether D 7 Needed: provided hydrolysis can be+demonstrated, data on tert-butanol arerequested.14095 000503-17-3 2-Butyne 8 +14110 000123-72-8 Butyraldehyde DIR 3 Occurs naturally in food. Used as flavour in + +food at 0.1-10 mg/kg. Migration into foodwould be self-limiting because of its taste.14140 000107-92-6 Butyric acid DIR 0 +14170 000106-31-0 Butyric anhydride DIR 3 Hydrolyses to corresponding acid. +14185 008015-80-3 Candlenut oil 8 +14188/1 - Candlenut oil fatty acids 8/D +14200 000105-60-2 Caprolactam Same 41840 DIR SML(T) = 15 mg/kg 2 Group TDI = 0.25 mg/kg b.w. + +45

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT14230 002123-24-2 Caprolactam, sodium salt DIR SML(T) = 15 mg/kg(5) (expressed asCaprolactam)(5) Two 90-day oral rat studies and 90-day oralstudies in mice and dogs.(CIVO report 3489 June 1971 and NTPTech. Rep. Ser. 214, NTP 80-26).2 Group TDI = 0.25 mg/kg b.w.See references for caprolactam.14260 000502-44-3 Caprolactone Same 41880 DIR 3 0.05 mg/kg food expressed as the sum ofcaprolactone and 6-hydroxyhexanoic acid++ +46http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdfhttp://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf14290 - Caprolactone, substituted D 9 +14320 000124-07-2 Caprylic acid Same 41960 DIR 0 + +and 6856014350 000630-08-0 Carbon monoxide DIR 3 Low migration. +14380 000075-44-5 Carbonyl chloride Same 23155 DIR QM = 1 mg/kg in FP 4A Residues of this gas in plastics will be very + +small. It is readily hydrolysed to CO2 andHCl. Has a strong odour. Migration intofood would therefore be self-limiting.14390 - Cardura +14411 008001-79-4 Castor oil Same 42880 DIR 3 SCF_List: 3+ +Restriction: none. In small dosesmetabolised similarly to food fatsSee SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf14440 064147-40-6 Castor oil, dehydrated Same 42960 D 3 Similar to food fats. + +14445 - Castor oil fatty acids 3/D Constituents of food fats. +14450/1 - Castor oil fatty acids,3 Identical with or similar to constituents of+dehydratedfood fats.14453 061790-39-4 Castor oil fatty acids,3 Identical with or similar to constituents of+hydrogenatedfood fats.14470 008001-78-3 Castor oil, hydrogenated Same 43120 D 3 Similar to food fats. + +14500 009004-34-6 Cellulose Same 43280 DIR 0 + +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT14505 009004-35-7 Cellulose acetate 3 Inert material, modified natural cellulose. +14508 009004-36-8 Cellulose acetate Same 43300 3 Inert material, modified natural cellulose. +butyrate14512 009004-39-1 Cellulose acetate3 Inert material, modified natural cellulose. +propionate14520 008001-20-5 Chinawood oil 8 +14523/1 - Chinawood oil fatty8/D +acids14527 000115-28-6 Chlorendic acid Same 18250 +14530 007782-50-5 Chlorine DIR 3 Residues of this gas in plastics will be very +small. Migration into food would be selflimitingbecause of odour.14560 000126-99-8 2-Chloro-1,3-butadiene D 6A All data considered show that chloroprene is +hepatotoxic, teratogenic, mutagenic andcauses chromosomal abnormalities inexposed workers. It affects testicularfunction in man and animals.14570 000106-89-8 1-Chloro-2,3-Same 16750 DIR See "Epichlorohydrin" + +epoxypropane14587 001204-28-0 4-(Chloroformyl)phthalic Same 131403 QM = 0.05 mg/6 dm² for the chloride to be+anhydrideand 25552measured as trimellitic acid.Available: Hydrolysis data; calculation ofworst case migration assuming 100%migration of residual trimellitic acid; twoAmes assays (negative); two in vitrocytogenetic assays in Chinese hamster cells(negative); two HPRT assys (negative);acute oral toxicity data; subacute oraltoxicity in the rat (trimellitic acid);inadequate subchronic oral toxicity in ratand guinea pig; teratogenicity study in therat and guinea pig by inhalation; dermaleffects in rabbit (trimellitic acid); effect onimmune system by inhalation; eye irritationstudy in rabbit (trimellitic acid); sensitisationstudy in guinea pigs.(RIVM/ISS/TNO SDS, October 1997 =CS/PM3080/14587).(Adopted at 111th SCF meeting (18-1947

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTMarch 1998))http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf14590 000615-67-8 Chlorohydroquinone D 8 +14620 057981-99-4 ChlorohydroquinoneD 8 +diacetate14650 000079-38-9 Chlorotrifluoroethylene DIR QMA = 0.5 mg/6 dm² 3 R = 0.5 mg/6 dm². Based on the reduced +core set of toxicological data according tothe migration level.The substance is extremely volatile and thetoxicity data support an R = 0.05 mg/kgfood. However this is analytically notenforceable due to the lack of a method foran SML. The residual content QM = 0.05mg/6dm2, assuming 100% migration, israised 10-fold as it has been demonstratedthat more than 95% of migrants appear inthe headspace because of the extremevolatility of the additive.Available: data on residual content ofchlorotrifluoroethylene (CTFE); poorrecovery of CTFE from food simulants;liquid/vapour partitioning data of CTFE infood simulants; gene mutation assay inbacteria (negative); chromosomal aberrationassay in cultured mammalian cells(negative); gene mutation assay in culturedmammalian cells (negative); limited in vivoSCE assay (negative).RIVM/IT/TNO SDS, March 2001 =CS/PM/2795 REV. II/14650.(Adopted at the 128th SCF meeting, 12 July2001)http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf14680 000077-92-9 Citric acid Same 44160 DIR 1 Group ADI: not specified for citric acid and + +its salts.(SCF, 25th Series, 1990).14685 008001-31-8 Coconut oil 3 Food fat. +48

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT14687 008050-09-7 Colophony Same+ +24100,24130,45055 and8384014693 008001-30-7 Corn oil 3 Food fat. +14695/1 - Corn oil fatty acids 3/D Constituents of food fats. +14698 008001-29-4 Cottonseed oil 3 Food fat. +14700/1 - Cottonseed oil fatty acids 3/D Constituents of food fats. +14710 000108-39-4 m-Cresol DIR 3 28-day oral rat study showed no adverse + +effects at 25 mg/kg b.w./day.(Shell Report, April 1978).14740 000095-48-7 o-Cresol DIR 3 28-day oral rat study showed no adverse + +effects at 12 mg/kg b.w./day.(Shell Report, April 1978).14770 000106-44-5 p-Cresol DIR 3 28-day oral rat study showed no adverseeffect at 25 mg/kg b.w./day.+ +14800 003724-65-0 Crotonic acid Same 45600 DIR QMA(T) = 0.05mg/6dm² (33)14830 - Crotonic acid, esters withalcohols, mono- andpolyhydric14833 000623-43-8 Crotonic acid, methyl(Shell Report, April 1978).3 SCF_list: 3Restriction: 0.05 mg/kg of food.Remark for Commission: A QMA isproposed (QMA = 0.05 mg/6 dm2), becauseonly a method for the residual content isavailable, however an SML is set forREF_n. 18888.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out141_en.pdfD 9 +D 8 +ester14836 014861-06-4 Crotonic acid, vinyl ester 7? Needed: provided hydrolysis can bedemonstrated, data on crotonic acid arerequested.http://europa.eu.int/comm/food/fs/sc/scf/out161_en.pdf14839 000623-68-7 Crotonic anhydride 6A Needed: information on crotonic acid. ++ ++49

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT14841 000599-64-4 4-Cumylphenol DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.+ +Available: migration data, 3 mutagenicitytests, negative.(TNO SDS 1995-01-16, RIVM SDS 1994-05-31).14860 - Cycloalkenes D 9 +14862 010016-20-3 alpha-Cyclodextrin same 46070 7 Under evaluation +14863 007585-39-9 beta-Cyclodextrin 7 Under evaluation +14864 017465-86-0 gamma-Cyclodextrin 7 Under evaluation +14875 001687-30-5 1,2-CyclohexanedicarboxylicSame 18436 +acid14880 000105-08-8 1,4-CyclohexanedimethanolSame 13390 DIR See "1,4-Bis(hydroxymethyl)cyclohexane"Deleted because same as 13390. + +14910 000108-94-1 Cyclohexanone Same 45720 6A Needed: adequate test for gene mutation andchromosomal aberration.(IARC (1989), 47, 151-169).14920 002842-38-8 2-(Cyclohexylamino)ethanol14950 003173-53-3 Cyclohexyl isocyanate DIR QM(T) = 1 mg/kg(expressed as NCO)(26).D 8 +4ASee references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.14980 001631-25-0 N-Cyclohexylmaleimide D 6A +15010 001131-60-8 p-Cyclohexylphenol D 8 +15020 002182-55-0 Cyclohexyl vinyl ether D 7 Needed: provided hydrolysis can bedemonstrated, data on cyclohexanol arerequested.15030 000931-88-4 Cyclooctene DIR SML = 0.05 mg/kg.For use only inpolymers contactingfoods for whichsimulant A is laiddown in Directive85/572/EEC.3 R: 0.05 mg/kg of food; only for aqueousfoodstuffs.Available: migration data frompolyoctenamer and from blends withpolypropylene in aqueous food simulants;migration data from polyoctenamer inHB307; three negative mutagenicity studiesperformed with cyclooctene; acute toxicitydata.++++50

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(RIVM/TNO SDS, October 1998 =CS/PM/2529 REV. III/15030).(Adopted at 117th SCF meeting) (17 June1999)http://europa.eu.int/comm/food/fs/sc/scf/out37_en.pdf15040 000542-92-7 1,3-Cyclopentadiene D 8 +15060 000142-29-0 Cyclopentene D 8 +15070 001647-16-1 1,9-Decadiene DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg of food.+5 negative mutagenicity tests, 28-day oralstudy, bioaccumulation.(CS/PM/2221).15095 000334-48-5 Decanoic acid Same 45940 DIR 0 Food constituent. + +15100 000112-30-1 1-Decanol Same 46050 DIR 3 See references for "Alcohols+ +aliphatic,monohydric, saturated, linear,primary (C4-C22)" (PM/REF.N 12375) inSCF list 3.15130 000872-05-9 1-Decene DIR SML = 0.05 mg/kg 3 R = 0,05 mg/kg of food.+ +Available: Migration data and 3mutagenicity tests negative.(RIVM/TNO/ISS SDS CS/PM/2744,January 1996).15160 000765-05-9 Decyl vinyl ether D 7 Needed: hydrolysis data. +15190 - Diamines, aliphatic,D 9 +linear (C2-C12)15220 000088-63-1 2,4-D +Diaminobenzenesulphonic acid15250 000110-60-1 1,4-Diaminobutane DIR 2 TDI: 0.6 mg/kg b.w.+28- and 90-day oral rat studies, mutagenicitytests.(RIVM report 88/6788097003, 03-05-1988).15260 000646-25-3 1,10-Diaminodecane D 8 +15267 000080-08-0 4,4'-Diaminodiphenylsulphone4,4-sulfonyldianiline,Benzeneamine, 4,47 Under evaluation +51

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT15270 002783-17-7 1,12-Diaminododecane D 8 +15272 000107-15-3 1,2-Diaminoethane Same 16960 DIR See "Ethylenediamine" + +and 5354015274 000124-09-4 1,6-Diaminohexane Same 18460 DIR See+ +and 59240 "Hexamethylenediamine"15280 000542-02-9 2,4-Diamino-6-methyl- Same 10155 D 8 Data inadequate. +1,3,5-triazine15295 000373-44-4 1,8-Diaminooctane D 8 +15310 000091-76-9 2,4-Diamino-6-phenyl-1,3,5-triazineSame 13075 DIR QMA = 5 mg/6 dm² 3 Restriction : 5 mg/kg of food. Based on thereduced core set of toxicological dataaccording to the migration level.Available : migration data on aqueous foodsimulants and 50% ethanol ; log Po/w ; genemutation assay in bacteria (negative) ; genemutation assay in cultured mammalian cells(slightly positive at only toxic doses) ;chromosomal aberration assay in culturedmammalian cells (positive) ; micronucleusassay (equivocal) ; micronucleus assay withextended sampling time (72h) and scoring ofat least 2000 PCE’s per animal (negative) ;90-day oral rat study and 18 months oralcarcinogenicity studies in mice and rats(limited studies due to too few animals andthe use of only 2 dose levels).RIVM/ISS/FR/TNO SDS, October 2001 =CS/PM/3469 REV. IV/15310.Remark for Commission: primary aminescan react with oil constituents and thereforea QMA seems an appropriate type of limit.(Adopted at the 130th SCF meeting, 13December 2001)http://europa.eu.int/comm/food/fs/sc/scf/out115_en.pdf15340 000109-76-2 1,3-Diaminopropane D 8 +15355 025513-64-8 Mixture of (40% w/w)1,6-diamino-2,2,4-trimethylhexane andSame 22331 3 Re-evaluation to align this evaluation withother evaluations done by the SCF.R = 5 mg/6 dm2.+52+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(60% w/w)1,6-diamino-2,4,4-trimethylhexane15370 003236-53-1 1,6-Diamino-2,2,4-trimethylhexaneRemark for Commission: A QM would beindicated. The choice of a QM instead ofSML is due to the reactivity of the substancewith fat simulant.Available: migration data; three negativemutagenicity studies; 90-day oral rat study;2-generation reproduction study (rat); twoteratogenicity studies (rat and rabbit).RIVM/TNO SDS, November 2000 =CS/PM/2914/15355.(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdfD QMA = 5 mg/6 dm². 3 R = 5 mg/6 dm2.Remark for Commission: A QM would beindicated. The choice of a QM instead ofSML is due to the reactivity of the substancewith fat simulant.Available: migration data; three negativemutagenicity studies; 90-day oral rat study;2-generation reproduction study (rat); twoteratogenicity studies (rat and rabbit).RIVM/TNO SDS, November 2000 =CS/PM/2914/15355.+15400 003236-54-2 1,6-Diamino-2,4,4-trimethylhexane15430 003749-77-7 4,4'-Dicarboxydiphenoxybutane(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdfD QMA = 5 mg/6 dm² 3 R = 5 mg/6dm2. Same references as for +REF_N. 15370(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdfD 8 +15460 003753-05-7 4,4'- D 8 +53

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTDicarboxydiphenoxyethane15490 002215-89-6 4,4'-DicarboxydiphenylD 8 +ether15520 004919-48-6 4,4'-DicarboxydiphenylD 8 +sulphide15550 002449-35-6 4,4'-DicarboxydiphenylD 8 +sulphone15565 000106-46-7 1,4-Dichlorobenzene DIR SML = 12 mg/kg 2 TDI : 0.2 mg/kg bw.+ +A 4-week oral rat study, 3 and 6 month oralrat and mouse studies, teratogenicity study,mutagenicity studies not showinggenotoxicity. Oral carcinogenicity studies inmice and rats indicate that there is limitedevidence of carcinogenic potential inexperimental animals.(NTP report n. 319, NIH publ, 87-2575,RIVM report 710401005 April 1991).15580 001653-19-6 2,3-Dichloro-1,3-D 6A +butadiene15610 000080-07-9 4,4'-DichlorodiphenylsulphoneDIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Based on thereduced core set of toxicological dataaccording to the migration level, seeAppendix 2Available: migration data (< 0.05 mg/kg offood); gene mutation assay in bacteria(negative); two gene mutation assays incultured mammalian cells (one negative andone positive); micronucleus assay (negative,however substance did not reach the bonemarrow); in vitro/in vivo UDS assay(negative).RIVM/ISS SDS, May 2000 = CS/PM/3062REV.I/15610.(Adopted at the 126th SCF meeting, 28February 2001)http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf15640 000156-59-2 cis-1,2-Dichloroethylene D 8 ++ +54

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT15670 000156-60-5 trans-1,2-Dichloroethylene15695 000461-58-5 Dicyanodiamide Same 45670and 4744015700 005124-30-1 Dicyclohexylmethane-4,4'-diisocyanateD 8 +Same 13560 DIR QM(T) = 1 mg/kg(expressed as NCO)(26).2 TDI : 1 mg/kg b.w.2 year oral rat and dog studies and Amestests.(American Cyanamide report 1969).4A See references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.15730 000077-73-6 Dicyclopentadiene DIR/D 7 Under re-evaluation +15735 000111-42-2 Diethanolamine Same 47620 8 Data inadequate.R: contact with food containing nitriteshould be avoided.15760 000111-46-6 Diethyleneglycol Same 13326,39160 and47680DIRSML(T) = 30 mg/kg(3)2 Group TDI: 0.5 mg/kg b.w.(SCF, 17th Series, 1986).15790 000111-40-0 Diethylenetriamine DIR SML = 5 mg/kg 3 R: 5 mg/kg of food.Available: 3-month oral rat study, severalmutagenicity studies negative.(RIVM 90/678608/009).15820 000345-92-6 4,4'-DifluorobenzophenoneDIR SML = 0.05 mg/kg 3 R : 0.05 mg/kg in food.Available: three mutagenicity tests negative,very low migration.(Rivm report, April1992).15850 000383-29-9 4,4'-Difluorodiphenylsulphone15880 000120-80-9 1,2-Dihydroxybenzene Same 24051 DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w.A 90-day oral rat study, negative in vitro andin vivo mutagenicity tests, promoting effectin mouse skin painting assay.(SCC, 1983).15910 000108-46-3 1,3-Dihydroxybenzene Same 24072 DIR SML = 2.4 mg/kg 2 TDI: 0.04 mg/kg b.w.A 90-day oral rat study 5 days a week,metabolism in rabbit and man, severalnegative in vitro mutagenicity tests and noimmunosuppressive action.(Henkel report 29-01-1980).15940 000123-31-9 1,4-Dihydroxybenzene Same 18867,48620 andDIR SML = 0.6 mg/kg 2 TDI: 0.01 mg/kg b.w.(SCF, 17th Series, 1986).++ +++ ++ ++++ ++ ++ +55

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT15970 000611-99-4 4,4'-Dihydroxybenzophenone60060Same 48720 DIR SML(T) = 6 mg/kg(15)562 Group TDI: 0.1 mg/kg b.w. (for 4,4'-dihydroxybenzophenone; 2,2'-dihydroxy-4-methoxybenzophenone;2-hydroxy-4-hexoxybenzophenone;2-hydroxy-4-noctoxybenzophenone).90-day oral rat studies (2,2'-dihydroxy-4-methoxybenzophenone, 2-hydroxy-4-methoxybenzophenone, 2-hydroxy-4-noctyloxybenzophenone)a 18-week oral dogstudy (2-hydroxy-4-noctyloxybenzophenone)and 2-year rat anddog studies (2-hydroxy-4-noctyloxybenzophenone),a reproductionstudy (2-hydroxy-4-noctyloxybenzophenone)plus metabolism.(J.Occup.Med. 1969, 11, 703, FoodCosm.Tox. 1972, 10, 41-50, RIVM reportOctober 1972).16000 000092-88-6 4,4'-Dihydroxybiphenyl Same 48760 DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w.90-day oral rat study and limitedmutagenicity studies.(RIVM Doc/Tox 300/495 June 1984).16030 001965-09-9 4,4'-Dihydroxydiphenylether16060 002664-63-3 4,4'-Dihydroxydiphenylsulphide16090 000080-09-1 4,4'-DihydroxydiphenylsulphoneD 8 +D 8 +Same 13617 DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.Available: the substance is used as acomonomer for kitchen utensils, mainlyintended for repeated use, and for ovencooking; migration has been tested upto 218°C and is always below 0.05 mg/kg food(aqueous simulants, HB307); gene mutationassay in bacteria (negative); chromosomalaberration assay in cultured mammaliancells (positive); gene mutation assay incultured mammalian cells (negative);micronucleus assay (negative).RIVM/FR/ISS/TNO SDS, February 2000 =+++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTCS/PM/2854 REV. II/16090.(Adopted at the 121 SCF meeting (20 June2000))http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf16100 060793-35-3 1,4-Dihydroxy-2-8 +methylcyclohexane16115 025167-70-8 Diisobutene 8 +16116 000106-90-1 Glycidyl acrylate Same 11260 D +16118 - Glycidyl ester ofD + +trialkyl(C5-C15) aceticacid16119 000106-91-2 Glycidyl methacrylate Same 20590 D +16120 000110-97-4 Diisopropanolamine Same 49065 D 8 R: contact with food containing nitrite +should be avoided.16150 000108-01-0 Dimethylaminoethanol Same 49235 DIR SML = 18 mg/kg 2 TDI: 0.3 mg/kg b.w.+ +A 90-day oral rat study, studies in otherspecies and observations in man.(Arch. Ind. Hyg. Occup. Med., 4, 1951, 119-122).16180 005205-93-6 N-D 6A +(Dimethylaminopropyl)methacrylamide16190 000121-69-7 N,N-Dimethylaniline Same 49280 8 +16200 000616-38-6 Dimethyl carbonate W8 Data inadequate. +16210 006864-37-5 3,3'-Dimethyl-4,4'-diaminodicyclohexylmethaneDIRSML = 0.05 mg/kg(32). To be used onlyin polyamides.3 SCF_list:3Restriction: 0.05 mg/kg of food.Remark for Commission: substance is notstable in fat simulant. Only to be used inpolyamides+16240 000091-97-4 3,3'-Dimethyl-4,4'-diisocyanatobiphenylDIRQM(T) = 1 mg/kg(expressed as NCO)(26).See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdf4A (SCF, 17th Series, 1986). +57

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT16252 000110-03-2 2,5-Dimethyl-2,5-D 8 +hexanediol16265 156065-00-8 alpha-Dimethyl-3-(4'-W7 Under evaluation +hydroxy-3'-methoxyphenyl)propylsilyloxy, omega-3-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl)propylsilyl polydimethylsiloxane16270 000526-75-0 2,3-Dimethylphenol Same 26377 D 8 + +16300 000105-67-9 2,4-Dimethylphenol Same 26375 D 8 + +16330 000095-87-4 2,5-Dimethylphenol Same 26379 D 8 + +16360 000576-26-1 2,6-Dimethylphenol DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.+ +Available: Migration data showing notdetectable at

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(RIVM/FR SDS, December 1998 =CS/PM/3251/16390).Remark: petitioner has to clarify the 40%(weight) in the formulation.(Adopted at 117th SCF meeting) (17 June1999)http://europa.eu.int/comm/food/fs/sc/scf/out37_en.pdf16420 000123-91-1 Dioxane Same 51160 D 6A +16450 000646-06-0 1,3-Dioxolane DIR SML = 0.05 mg/kg 3 Under re-evaluation+-----------------------------------------------------R = 0.05 mg/kg of food.Available: migration and usage datashowing exposure will be below 50 ppb,adequate 14-day, inadequate 28-day and 7-month oral toxicity studies, 3 inadequatereproduction studies, adequate teratogenicitystudy, several in vitro and in vivomutagenicity studies.(CS/PM/2325, 1993-12-21).16480 000126-58-9 Dipentaerythritol Same 51200 DIR 2 Group TDI: 1 mg/kg b.w. (with+ +pentaerythritol).(SCF, 17th Series, 1986).16510 000138-86-3 Dipentene Same 51300 D 8 Data made available for assessment of + +chewing gum not available for this group.16540 000102-09-0 Diphenyl carbonate Same 51420 DIR SML = 0.05 mg/kg 3 SCF_List: 3Restriction: 0.05 mg/kg of food Based onthe reduced core set of toxicological dataaccording to the migration level.Remark for Commission: In the absence ofrelevant information, the Fat (Consumption)Reduction Factor should not be applied tothis substanceSee SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf+16570 004128-73-8 Diphenylether-4,4'-diisocyanateDIRQM(T) = 1 mg/kg(expressed as NCO)594ASee references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(26).16600 005873-54-1 Diphenylmethane-2,4'-diisocyanateDIR QM(T) = 1 mg/kg(expressed as NCO)(26).16630 000101-68-8 Diphenylmethane-4,4'-DIR QM(T) = 1 mg/kgdiisocyanate(expressed as NCO)(26).16650 000127-63-9 Diphenyl sulphone Same 51570 DIR SML(T) = 3 mg/kg(25)604A4ASee references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.See references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.3 R = 3 mg/kg food (same reference asREF_N. 51570).Remark : the same substance was previouslyevaluated as an additive (see Opinion on anadditional list of monomers and additives forfood contact materias expressed on 23September 1999, at the 118th meeting of theSCF) and the same evaluation is extendednow to its requested use as monomer.(Adopted at the 128th SCF meeting, 12 July2001)http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf+ ++ +16660 000110-98-5 Dipropyleneglycol DIR 2 t-TDI: 1.5 mg/kg b.w.+ +(SCF, 6th Series, 1978).16670 034590-94-8 Dipropyleneglycol Same 51870 8 Data inadequate. +monomethyl ether16690 001321-74-0 Divinylbenzene DIR QMA = 0.01 mg/6 dm²or SML = ND (DL =0.02 mg/kg, analyticaltolerance included) forthe sum ofDivinylbenzene andEthylvinylbenzene andin compliance with thespecifications laiddown in Annex V4A+ +R = Not detectable. Sum of divinylbenzeneand ethylvinylbenzene (DL = 0.01 mg/kg).Available: calculated worst case migration

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(Adopted at the 128th SCF meeting, 12 July2001)http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf16697 000693-23-2 n-Dodecanedioic acid DIR 3 Toxicologically acceptable.+ +Available: migration data in food simulants;gene mutation assay in bacteria (negative);gene mutation assay in cultured mammaliancells (negative); micronucleus assay(negative); 90-day oral rat study.RIVM/DK/TNO SDS, November 2000 =CS/PM/3793/16697.Remark: A high log Po/w of 3.17 canindicate the potential for accumulation butas the substance is readily metabolised bythe normal fat metabolising route this is notthe case for DDDA. For this reason there isalso no reason for specifying a migrationlimit.(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf16701 000112-53-8 1-Dodecanol Same 51975 3 See references for "Alcohols, aliphatic,+monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N. 12375) in SCF list 3.16704 000112-41-4 1-Dodecene DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.+Available: Adequate migration data,showing specific migration of 1-dodecene is

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT16720 000826-62-0 EndomethylenetetrahydrD 8 +ophthalic anhydride16750 000106-89-8 Epichlorohydrin Same 14570 DIR QM = 1 mg/kg in FP 4A Highly toxic. Induces forestomach tumours + +in rats after oral administration.(Report from Nat. Inst. of Publ. Health,Bilthoven 1982; International Program onChemical Safety, Series EnvironmentalHealth Criteria, WHO, 33, 1984).16778 000107-21-1 1,2-Ethanediol Same 16990 D 2 + +and 5365016780 000064-17-5 Ethanol Same 52800 DIR 1 Acceptable.+ +(SCF, 11th Series, 1981).16810 - Ether alcohols D 9 +16840 - Ethers of N-D 9 +methylolacrylamide16870 - Ethers of N-D 9 +methylolmethacrylamide16900 013036-41-4 N-D 6A +(Ethoxymethyl)acrylamide16910 000111-35-3 3-Ethoxy-1-propanol 8 +16925 009004-57-3 Ethylcellulose Same 53280 2 Group TDI : not specified based on Group+ADI (=not specified) for certain modifiedcellulose.(JECFA 35 M., 1989).16930 000075-00-3 Ethyl chloride D 8 +16950 000074-85-1 Ethylene DIR 3 Residues of this gas in plastics are very + +small. The gas has low toxic potential.Migration into food will be toxicologicallynegligible.(Patty's Industrial Hygiene and Toxicology,3rd ed. 1981).16955 000096-49-1 Ethylene carbonate 3AM 3 Restriction: Residual content of ethylenecarbonate: 5 mg/kg hydrogel at amaximum ratio of 10 g hydrogel/kg food.Ethylene glycol: SML= 30 mg/kg foodRemark for Commission: No methodavailable for specific migration; only a QMmethod for the monomer and ethylene+62

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTglycol (hydrolysis product)16960 000107-15-3 Ethylenediamine Same 15272and 5354016990 000107-21-1 Ethyleneglycol Same 16778and 5365016993 000111-76-2 Ethyleneglycolmonobutyl ether16996 000110-80-5 Ethyleneglycolmonoethyl etherhttp://www.efsa.eu.int/science/afc/afc_opinions/190/opinion_afc_06_en1.pdfhttp://europa.eu.int/comm/food/fs/sc/scf/out141_en.pdfDIR SML = 12 mg/kg 2 TDI: 0.2 mg/kg b.w.Two 90-day oral rat studies.DIRSML(T) = 30 mg/kg(3)17005 000151-56-4 Ethyleneimine Same 53950 DIR SML = ND (DL = 0.01mg/kg).(ICI report, April 1975).2 Group TDI = 0.5 mg/kg b.w. (withdiethyleneglycol).See references for diethyleneglycol.Same 53765 2 Group t-TDI : 0.05 mg/kg b.w. (with15780=48050, 16993=53765, 16996=53820,16999, 17002=53860, 30015, 30120, 30200,48030).See references for 16996.Same 53820 2 Group t-TDI : 0.05 mg/kg b.w. (with15780=48050, 16993=53765, 16996=53820,16999, 17002=53860, 30015, 30120, 30200,48030, 48050) pending evaluation of NTPrat and mouse studies.Several short term oral rat and dog studies,reproduction and teratogenicity studies.Carcinogenicity studies in mice and rats notreported. Mutagenicity studies inadequate.(RIVM summary, March 1991(=CS/PM/922) and RIVM SDS, July 1996(= CS/PM/2916).4AHighly toxic by all exposure routes.Carcinogenic for mice orally.(IARC Monographs Vol 9, p. 37, Lyon1975).17020 000075-21-8 Ethylene oxide DIR QM = 1 mg/kg in FP 4A Strongly mutagenic in several studies.Induces forestomach tumours in rats afteroral administration.(Brit. J. Cancer, 1982, 46, 924; IARCMonographs Vol. 11 and Suppl. 4, Lyon1976 and 1982; Toxicity of ethylene oxideand its relevance to man. ECETOC,+ ++ ++++ ++ +63

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTTechnical Report n. 5, 1982).17040 000149-57-5 2-Ethylhexanoic acid Same 54120 D 6B Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg of food,peroxisome proliferation studies too.17050 000104-76-7 2-Ethyl-1-hexanol DIR SML = 30 mg/kg 1 ADI: 0.5 mg/kg b.w.(JECFA 41 M., 1993)17080 000103-44-6 2-Ethylhexyl vinyl ether D 7 Needed: provided hydrolysis can bedemonstrated, data on 2-ethylhexanol arerequested.17110 016219-75-3 5-Ethylidenebicyclo[2.2.1]hept-2-ene17111 038233-76-0 2-Ethylidene-1,4:5,8-dimethano-1,2,3,4,4a,5,8,8aoctahydronaphthaleneDIRQMA = 0.05 mg/6dm².The ratiosurface/quantity offood shall be lowerthan 2 dm²/kg3 SCF_L: 3Restriction: 0.05 mg/kg of food. Based onthe reduced core set of toxicological dataaccording to the migration level.Remark for Commission: Only a QMmethod is available, therefore a QMA limitis applicable.(Adopted at the 136th SCF meeting, 5March 2003)http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf+ ++ +++ +17116 005877-42-9 4-Ethyl-1-octyn-3-ol D 8 +17118 025429-37-2 Ethylphenol 8 +17120 000090-00-6 2-Ethylphenol 8 +17121 000620-17-7 3-Ethylphenol 8 +17122 000123-07-9 4-Ethylphenol 8 +17140 000109-92-2 Ethyl vinyl ether D 7 Needed: hydrolysis data. +17150 000078-27-3 1-Ethynylcyclohexanol D 8 +17160 000097-53-0 Eugenol DIR SML = ND (DL = 0.02mg/kg, analyticaltolerance included)4AMetabolize into epoxyeugenol havinginitiating activity.(RIVM summary data, 12.05.1992(cs/pm/1586)).17170 061788-47-4 Fatty acids, coco DIR 3 Equal to or similar to food fats. + +++64

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT17175 068938-15-8 Fatty acids, coco,3 Toxicologically acceptable. +hydrogenated17195 091051-35-3 Fatty acids, peanut oil W +17200 068308-53-2 Fatty acids, soya Same 88650 DIR 3 Equal to or similar to food fats. + +17215 - Fatty acids, sunflower oil 3/D Equal to or similar to food fats. +17230 061790-12-3 Fatty acids, tall oil Same DIR 3 + +54710/0 and54710/117233 073138-53-1 Fatty acids, tall oil,8 +dimers17245 008016-13-5 Fish oil 3 Food fat. +17247/1 - Fish oil fatty acids 3 Constituents of food fats. +17260 000050-00-0 Formaldehyde Same 54880 DIR SML(T) = 15 mg/kg 3 Residues of this gas in plastics will be very + +(22)small. Formaldehyde is a normalintermediate in human metabolism.Carcinogenic for rats by inhalation atconcentrations irritant to the respiratorytract.(Final report on a chronic inhalation study inrats and mice exposed to formaldehyde).(Battelle Columbus Labs. Columbus, Ohio,1981).17275 000064-18-6 Formic acid Same 55040 1 Group ADI : 3 mg/kg b.w. for formic acid+and ethyl formate.(JECFA 17 M., 1973).17290 000110-17-8 Fumaric acid Same 55120 DIR 1 ADI: 6 mg/kg b.w.+ +(SCF, 25th Series, 1990).17305 000141-02-6 Fumaric acid, bis(2-D 8 +ethylhexyl) ester17320 002807-54-7 Fumaric acid, diallylD 6A +ester17350 000105-75-9 Fumaric acid, dibutylD 7 Needed: hydrolysis data. + +ester17365 002402-58-6 Fumaric acid, didodecyl7 Needed: hydrolysis data. +ester17380 000623-91-6 Fumaric acid, diethylD 7 Needed: hydrolysis data. +ester17392 007283-70-7 Fumaric acid, 7 Available: 100% hydrolysis in intestinal +65

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTdiisopropyl esterfluid within 30-40 minutes to monoisopropylesterof fumaric acid andisopropanol.Needed: migration and toxicological data offumaric acid, diisopropyl ester according tothe guidelines.(RIVM/TNO SDS, January 1999 =CS/PM/3252/17392).(Adopted at 117th SCF meeting) (17 June1999)http://europa.eu.int/comm/food/fs/sc/scf/out37_en.pdf17398 007283-68-3 Fumaric acid,D 7 Needed: hydrolysis data. +dioctadecyl ester17410 - Fumaric acid, esters withD 9 +alcohols, aliphatic,monohydric, saturated(C1-C18)17440 - Fumaric acid, esters withD 9 +alcohols, aliphatic,monohydric, unsaturated(C3-C18)17470 - Fumaric acid, esters withD 9 +alcohols, polyhydric17500 000098-01-1 Furfural D 7 Needed: 90-day oral study and mutagenicity + +studies.17505 000098-00-0 Furfurol Same 55160 8 +17530 000050-99-7 Glucose DIR 0 +17560 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose and 1,3-butanediol17590 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose and 1,4-butanediol17620 - Glucosides obtainedD 7 Needed: hydrolysys data. +from glucose anddiethyleneglycol17650 - Glucosides obtained D 7 Needed: hydrolysis data. +66

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTfrom glucose and 2,2-dimethyl-1,3-propanediol17680 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose andethyleneglycol17710 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose andglycerol17740 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose and 1,6-hexanediol17770 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose and 1,2,6-hexanetriol17800 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose andpentaerythritol17830 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose andpolyethyleneglycol (Mw> 200)17860 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose andpolypropyleneglycol(Mw > 400)17890 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose andpropanediol17920 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose andsorbitol17950 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose and sucrose17980 - Glucosides obtainedD 7 Needed: hydrolysis data. +from glucose and 1,1,1-trimethylolpropane18010 000110-94-1 Glutaric acid Same 55680 DIR 0 +18040 029733-18-4 Glutaric acid, diisodecyl Same 55760 D 8 +67

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTester18070 000108-55-4 Glutaric anhydride DIR 3 Hydrolises to corresponding acid. +18100 000056-81-5 Glycerol Same 55920 DIR 1 Group ADI: not specified for glycerol, + +glycerol diacetate, glycerol triacetate andglycerol monoacetate.(SCF, 11th Series, 1981).18115 031566-31-1 Glycerol monostearate Same 57520 1 ADI : not specified.+(JECFA 17 M., 1973).18120 000107-22-2 Glyoxal Same 58310 6A +18124 008016-24-8 Hempseed oil 3 Food fat. +18126/1 - Hempseed oil fatty acids 3/D Constituents of food fats. +18130 004371-64-6 1,1-D 8 +Heptadecanedicarboxylicacid18150 000111-70-6 1-Heptanol 3 See references for "Alcohols, aliphatic,+monohydric, saturated, linear, primary (C4-C22)" (PM/REF_N. 12375) in SCF list 3.18160 025339-56-4 Heptene D 8 +18190 000592-76-7 1-Heptene D 8 +18220 068564-88-5 N-Heptylaminoundecanoicacid18250 000115-28-6 Hexachloroendomethylenetetrahydrophthalic acid18280 000115-27-5 HexachloroendomethylenetetrahydrophthalicanhydrideDIR SML = 0.05 mg/kg (1) 3 R:= 0.05 mg/kg of food.Available: migration into non-fat simulants,5 negative mutagenicity studies, 90-day oralrat study (CS/PM/2376).Same 14527 DIR SML = ND (DL = 0.01mg/kg)DIR SML = ND (DL = 0.01mg/kg)684A4ARemark: since high migration into fat hasbeen demonstrated, the WG recommendsthat the Commission take the necessarymeasures so that the restriction proposed isnot exceeded.Cancer in lung and liver of rats and mice,positive in mutagenicity study in mouselymphoma cells.(NTP techn. Rep. 304, NIH publ. 87-2560April 1987).Hydrolyses easily to acid known forinduction of lung cancer.18310 036653-82-4 1-Hexadecanol Same 58790 DIR 3 See references for "Alcohols, aliphatic, + ++++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTmonohydric, saturated,linear, primary (C4-C22)" (PM/REF.N. 12375) in SCF list 3.18340 000822-28-6 Hexadecyl vinyl ether D 7 Needed: hydrolysis data. +18370 000592-45-0 1,4-Hexadiene DIR 7 Available: calculated worst case migration

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf18436 001687-30-5 Hexahydrophthalic acid Same 14875 D 8 +18441 000085-42-7 HexahydrophthalicD 8 +anhydride18444 001076-97-7 Hexahydroterephthalicacid18449 003089-11-0 N,N,N',N',N'',N''-Hexakis(methoxymethyl)-2,4,6-triamino-1,3,5-triazine18460 000124-09-4 Hexamethylenediamine Same 15274and 5924018490 015511-81-6 Hexamethylenediamineadipate18520 038775-37-0 Hexamethylenediamineazelate18550 - Hexamethylenediaminedodecanedicarboxylate18580 - Hexamethylenediamineheptadecanedicarboxylate18610 006422-99-7 Hexamethylenediaminesebacate18640 000822-06-0 Hexamethylenediisocyanate707 (Adopted at 114th SCF meeting) (10December 1998)http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf+8 +DIR SML = 2.4 mg/kg 2 TDI: 0.04 mg/kg b.w.A 28-day oral rat study.(RIV report n. 48/80 March 1981).+ +D 8 +D 7 Needed: hydrolysis data. +D 8 +D 8 +D 8 +DIRQM(T) = 1 mg/kg(expressed as NCO)(26).18670 000100-97-0 Hexamethylenetetramine Same 59280 DIR SML(T) = 15 mg/kg(22) (expressed asFormaldehyde)4ASee references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl (PM/REF.N. 16240).3 Formaldehyde liberator. Evaluated byJECFA as a preservative for food. Amountsof formaldehyde likely to migrate into foodare of no toxicological significance.(JECFA 17 M., 1993)18700 000629-11-8 1,6-Hexanediol DIR SML = 0.05 mg/kg 3 SCF_list: 3Restriction: 0.05 mg/kg of food.+ ++ ++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTSee SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf18730 002935-44-6 2,5-Hexanediol D 7 +18760 000106-69-4 1,2,6-Hexanetriol D 8 +18780 000111-27-3 1-Hexanol 3 See references for "Alcohols, aliphatic, + +monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N.12375) in SCF list 3.18790 025264-93-1 Hexene D 8 +18820 000592-41-6 1-Hexene DIR SML = 3 mg/kg 3 R = 3 mg/kg of food.+ +Available: Migration data, 5 mutagenicitystudies negative, 28-day and inadequate 90-day oral rat studies, 90-day inhalation ratstudy, combined reproduction/developmenttoxicity screening study in rats,bioaccumulation.(TNO (Nov. 95) and Elias (Feb. 96) SDSCS/PM/2742, and RIVM summary data, 14-02-1991).18850 000107-41-5 Hexyleneglycol Same 22072 D 7 Needed: purity, physicochemical state, +and 59600migration data.18865 003031-66-1 3-Hexyn-2,5-diol D 8 +18867 000123-31-9 Hydroquinone Same 15940,48620 and6006018875 151841-65-5 Hydroxy aluminiumbis[2,4,8,10-tetra-tert.butyl-6-hydroxy-12h-dibenzo[d,g][1.3.2]-DIR See "1,4-Dihydroxybenzene"34650 3 +dioxaphosphocin-6-oxide18880 000099-96-7 p-Hydroxybenzoic acid DIR 2 TDI: 10 mg/kg b.w.The value of the TDI is based upon theevaluation of the esters.(JECFA 17 M., 1993)18888 080181-31-3 3-Hydroxybutanoic acid-3-hydroxyopentanoicacid, copolymerDIRIn compliance withspecifications includedin Annex V713 SML = 0.05 mg/kg of food (for crotonicacid).Available: Extensive data on productionprocess and impurities; on copolymer, 28-day and 90-day oral rat studies, and two+ +++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTmutagenicity studies, negative; on theimpurity crotonic acid, two mutagenicitytests, negative.(CS/PM/1510 of 25.03.92; CS/PM/2317 and2538 of 10.02.95).Toxicologically acceptable provided thefollowing specifications are met:STRUCTURAL FORMULACH3CH3 O CH2 O[-0-CH-CH2-C-]m-[O-CH-CH2-C-]nn/(m + n) greater than 0 and less or equal to0.25DESCRIPTIONThese copolymers are produced by thecontrolled fermentation of Alcaligeneseutrophus using mixtures of glucose andpropanoic acid as carbon sources. Theorganism used has not been geneticallyengineered and has been derived from asingle wild-type organism Alcaligeneseutrophus strain H16 NCIMB 10442.Master stocks of the organism are stored asfreeze-dried ampoules. Asubmaster/working stock is prepared fromthe master stock and stored in liquidnitrogen and used to prepare inocula for thefermenter. Fermenter samples will beexamined daily both microscopically and forany changes in colonial morphology on avariety of agars at different temperatures.The copolymers are isolated from heattreated bacteria by controlled digestion ofthe other cellular components, washing and72

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTdrying. After isolation these copolymers arein the form of a white to off-white powder.These copolymers are normally offered asformulated, melt formed granules containingadditives such as nucleating agents,plasticisers, fillers, stabilisers and pigmentswhich all conform to the general andindividual specifications. These copolymersare soluble in chlorinated hydrocarbonssuch as chloroform or dichloromethane butpractically insoluble in ethanol, aliphaticalkanes and water.MOLECULAR WEIGHTThis copolymer must have a weight averagemolecular weight which is not less than150,000 Daltons as measured by gelpermeation chromatography.PURITYThe migration of crotonic acid should notexceed 0.05 mg/kg food.Prior to granulation the raw materialcopolymer powder must contain:- not less than 98% poly(3-Dhydroxybutanoate-co-3-Dhydroxypentanoate)analysed afterhydrolysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxypentanoic acids;- nitrogen content must be less than or equalto 2500 micrograms per gram;- zinc content must be less than or equal to100 mg/Kg of plastic- copper content must be less than or equalto 5 mg/kg of plastic- lead content must be less than or equal to2 mg/kg of plastic- arsenic content must be less than or equalto 1 mg/kg of plastic - chromium contentmust be less than or equal to 1 mg/kg of73

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT18896 001679-51-2 4-(Hydroxymethyl)-1-cyclohexene18897 016712-64-4 6-Hydroxy-2-naphthalenecarboxylicacidplastic.DIR SML = 0.05 mg/kg 3 SCF_List: 3Restriction: 0.05 mg/kg of food. Based onthe reduced core set of toxicological dataaccording to the migration level.Remark for Commission: used in oxygenscavenging polymer; no direct food contact(except for dry foods).See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdfDIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg foodAvailable: migration data from monolayer indirect contact with food simulants (SM

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT18905 002628-17-3 4-Hydroxystyrene D 6A +18910 000288-32-4 Imidazole D 8 +18940 000095-13-6 Indene D 8 +18960 000089-65-6 Isoascorbic acid W +18970 000078-83-1 Isobutanol Same 62270 D 8 Residue less than 1 mg/kg in food. No + +mutagenicity and oral data.(Directive 88/344/EEC).19000 000115-11-7 Isobutene DIR 3 Residues of this gas in plastics are very + +small. The gas has low toxic potential.Migration into food will be toxicologicallynegligible.(Patty's Industrial Hygiene and Toxicology,3rd ed, 1981).19030 016669-59-3 N-D 6A +(Isobutoxymethyl)acrylamide19045 004548-27-0 N-6A +(Isobutoxymethyl)methacrylamide19060 000109-53-5 Isobutyl vinyl ether DIR QM = 5 mg/kg in FP 3 R = 0.05 mg/kg of food.+ +Available: Hydrolysis data for isobutylvinylether,showing rapid total (100%)hydrolysis of the monomer in simulatedgastric fluid into isobutanol andacetaldehyde; calculated (worst case)migration is

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT19120 025339-17-7 Isodecanol D 8 +19130 026896-18-4 Isononanoic acid D 8 +19140 026952-21-6 Isooctanol D 8 +19145 002855-13-2 Isophorone diamine Same 12670 D + +19147 004098-71-9 Isophorone diisocyanate Same 19110 D + +19150 000121-91-5 Isophthalic acid DIR SML = 5 mg/kg 3 R = 5 mg/kg of food.+ +Available: Migration data, 7 mutagenicitystudies regarded as non-genotoxic, 28-dayinhalation and 90-day oral rat studies,inhalation rat teratology study limitedabsorption and excretion data (RIVM/TNOSDS CS/PM/2757, January 96).19180 000099-63-8 Isophthalic acidD 7 Needed: original data on migration and + +dichloride19210 001459-93-4 Isophthalic acid,dimethyl estergenotoxicity.DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg in food.Available: 3 mutagenicity tests, negative.Migration data less than 0.050 mg/kg.(Rivm summary data, May 1991,CS/PM/969).76+ +19240 000744-45-6 Isophthalic acid,D 8 + +diphenyl ester19243 000078-79-5 Isoprene Same 21640 DIR See "2-Methyl-1,3-+ +butadiene"19255 000080-05-7 4,4'-Isopropylidenediphenolhttp://europa.eu.int/comm/food/fs/sc/scf/out128_en.pdf+ +Same13480/13607/62540/40060/3968019270 000097-65-4 Itaconic acid DIR 0 Normal human metabolite. + +19300 002155-60-4 Itaconic acid, dibutylD 7 Needed: hydrolysis data. +ester19315 000617-52-7 Itaconic acid, dimethyl8 +ester19330 007748-43-8 Itaconic acid, 2,3-D 6A +epoxypropyl diester19360 - Itaconic acid, 2,3-D 6A +epoxypropyl monoester19390 - Itaconic acid, esters withalcohols, aliphatic,D 9 +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTmonohydric,saturated(C1-C18)19420 - Itaconic acid, esters withD 9 +alcohols, polyhydric19435 - Itaconic acid, methyl9 +esters19450 - Lactams of omegaaminocarboxylicD 9 +acids,aliphatic, linear (C7-C12)19460 000050-21-5 Lactic acid Same 62960 DIR 1 ADI : not specified.+ +(SCF, 25th Series, 1990).19470 000143-07-7 Lauric acid Same 63280 DIR 0 + +19480 002146-71-6 Lauric acid, vinyl ester DIR 3 Complete hydrolysis in simulated intestinal + +fluid to lauric acid and acetaldehyde(CS/PM/2334).Positive in gene mutation and chromosomeaberration studies in vitro, most likely due toformation of acetaldehyde (CS/PM/2385).19490 000947-04-6 Laurolactam DIR SML = 5 mg/kg 3 R = 5 mg/kg of food.+ +Available: specific migration data; genemutation assay in bacteria (negative);chromosomal aberration assay in culturedmammalian cells (negative); gene mutationassay in cultured mammalian cells(negative); 90-day oral rat study.(RIVM/TNO SDS, July 1999 =CS/PM/2574 REV. II/19490).(Adopted at the 119th SCF meeting) (2December 1999)http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf19510 011132-73-3 Lignocellulose DIR 3 Natural, non digestible fibre. +19518 000060-33-3 Linoleic acid Same 64015 0 +19526 028290-79-1 Linolenic acid Same 64150 0 +19532 008001-26-1 Linseed oil Same 64160 3 Food fat. +19534/1 - Linseed oil fatty acids 3/D Constituents of food fats. +19540 000110-16-7 Maleic acid Same 64800 DIR SML(T) = 30 mg/kg 2 Group TDI = 0.5 mg/kg b.w. as maleic acid. + +77

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(4) (SCF, 17th Series, 1986).19570 000999-21-3 Maleic acid, diallyl ester D 6A + +19600 000105-76-0 Maleic acid, dibutyl ester D 7 Under evaluation + +19630 071550-61-3 Maleic acid, diester withD 7 Needed: hydrolysis data. +1,2-propanediol19660 000141-05-9 Maleic acid, diethyl ester D 7 Needed: hydrolysis data. +19690 014234-82-3 Maleic acid, diisobutylD 7 Needed: hydrolysis data. +ester19720 001330-76-3 Maleic acid, diisooctylD 7 Needed: hydrolysis data. +ester19750 000624-48-6 Maleic acid, dimethylD 7 Needed: hydrolysis data. + +ester19780 002915-53-9 Maleic acid, dioctyl ester D 7 Needed: hydrolysis data. + +19810 - Maleic acid, esters withD 9 +alcohols, aliphatic,saturated (C1-C18)19840 - Maleic acid, esters withD 9 +alcohols, polyhydric19870 - Maleic acid, ester withD 7 Needed: hydrolysis data. +1,3-butanediol19900 002424-58-0 Maleic acid, monoallylD 6A + +ester19915 000925-21-3 Maleic acid, monobutylD 7 Needed: hydrolysis data. +ester19930 - Maleic acid, monoestersD 9 +with alcohols, aliphatic,monohydric,unsaturated(C3-C18)19936 007423-42-9 Maleic acid, mono(2-D 8 + +ethylhexyl) ester19945 003052-50-4 Maleic acid,7 Needed : hydrolysis data. +monomethyl ester19960 000108-31-6 Maleic anhydride Same 64900 DIR SML(T) = 30 mg/kg(4) (expressed asMaleic acid).782 Group TDI = 0.5 mg/kg b.w. as maleic acid.(SCF, 6th Series, 1978).+ +19972 000087-78-5 Mannitol Same 65520 1 ADI : acceptable.+(SCF, 16th Series, 1985).19975 000108-78-1 Melamine Same 25420, DIR See "2,4,6-Triamino- 2 See references for the same substance in + +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT65360 and 1,3,5-Triazine"additive list.9372019977 000060-24-2 2-Mercaptoethanol 8 +19990 000079-39-0 Methacrylamide DIR SML = ND (DL =0.02mg/kg, analyticaltolerance included)4A The classification is based on the decisionmade on the structurally related compoundacrylamide classified in L4A and because itis not detected in food/food simulants.+ +20005 051410-72-1 Methacrylamidopropyltrimethylammoniumchloride79Available: migration data; Ames test;dominant lethal assay; 2 generationreproduction study; teratogenicity study inmiceand three neurotoxicity studies.(RIVM/TNO SDS, November 1996 =CS/PM/2961).6A +20020 000079-41-4 Methacrylic acid DIR 2 Group t-TDI: 0.1 mg/kg b.w. pending theresults of an adequate oral study.Available: a 2-year oral rat study and severalother studies in several animal species withmethyl methacrylate.(Tox. Appl. Pharmacol., 6, 1984, 29-36;RIV doc. Tox. 300730, February 1983).20040 090551-76-1 Methacrylic acid,alkyl(C12-C16) esters20045 090551-83-0 Methacrylic acid,alkyl(C16-C18) esters20050 000096-05-9 Methacrylic acid, allylester+ +W +W +DIR SML = 0.05 mg/kg 3 R : 0.05 mg/kg of food.Available: Adequate migration data andanalytical method and stability data in foodsimulants; three negative mutagenicitystudies.(RIVM/DK/TNO SDS, June 1998=CS/PM/3077/Rev.1/20050).(Adopted at 114th SCF meeting) (10December 1998)http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT20080 002495-37-6 Methacrylic acid, benzylester20090 003775-90-4 Methacrylic acid, 2-(tertbutylamino)ethylester20095 046729-07-1 Methacrylic acid, 4-tertbutylcyclohexylester20110 000097-88-1 Methacrylic acid, butylester20140 002998-18-7 Methacrylic acid, secbutylester20170 000585-07-9 Methacrylic acid, tertbutylester20200 001888-94-4 Methacrylic acid, 2-chloroethyl ester20230 - Methacrylic acid,cyclohexylaminoethylester20260 000101-43-9 Methacrylic acid,cyclohexyl ester20290 016868-14-7 Methacrylic acid,cyclopentyl ester20320 003179-47-3 Methacrylic acid, decylester20350 - Methacrylic acid, (ditert-butylamino)ethylDIR 2 Group t-TDI: 0.1 mg/kg bw (as methacrylicacid).Hydrolysis (complete) data allow theallocation of the same TDI as methacrylicacid.+ +W +D 8 +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as methacrylicacid).See references for methacrylic acid.+ +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as methacrylic + +acid).See references for methacrylic acid.DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as methacrylic + +acid).See references for methacrylic acid.D 8 +D 8 +DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.Remark for Commission: Method availablefor the determination of specific migrationin aqueous and substitute food simulants(iso-octane).(Adopted at the 126th SCF meeting, 28February 2001)http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdfD 8 ++ +D 7 Needed: hydrolysis data. + +D 8 +80

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTester20380 001189-08-8 Methacrylic acid, diesterwith 1,3-butanediol20410 002082-81-7 Methacrylic acid, diesterwith 1,4-butanediolD 8 Available: hydrolysis study showsincomplete hydrolysis.DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.Available: specific migration data inaqueous simulants and in iso-octane; twogene mutation assays in bacteria (negative);chromosomal aberration assay in culturedmammalian cells (positive); gene mutationassay in cultured mammalian cells(negative); in vivo micronucleus assay(negative). acute toxicity test (LD50); threesensitisation tests (two positive and onenegative);RIVM/UK/TNO SDS, December 1998 =CS/PM/3219 REV. I/20410.+ ++ +20425 002358-84-1 Methacrylic acid, diesterwith diethyleneglycol20430 001985-51-9 Methacrylic acid, diesterwith 2,2-dimethyl-1,3-propanediol20440 000097-90-5 Methacrylic acid, diesterwith ethyleneglycol20455 006606-59-3 Methacrylic acid, diesterwith 1,6-hexanediol20470 025852-47-5 Methacrylic acid, diesterwith polyethyleneglycol20490 000109-17-1 Methacrylic acid, diesterwith tetraethyleneglycol(Adopted at the 121 SCF meeting (20 June2000))http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf8 +8 +DIR SML = 0.05 mg/kg 3 SCF_List: 3Restriction: 0.05 mg/kg of food. Based onthe reduced core set of toxicological dataaccording to the migration level.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf+ +D 8 + +D 8 +8 +81

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT20495 000109-16-0 Methacrylic acid, diesterwith triethyleneglycol20500 000105-16-8 Methacrylic acid, 2-(diethylamino)ethyl ester20530 002867-47-2 Methacrylic acid, 2-(dimethylamino)ethylester20560 000142-90-5 Methacrylic acid,dodecyl ester20590 000106-91-2 Methacrylic acid, 2,3-epoxypropyl ester20620 - Methacrylic acid, esterswith alcohols, aliphatic,monohydric,saturated(C1-C21)W +D 8 +DIR SML = ND (DL = 0.02mg/kg, analyticaltolerance included)4A R = not detectable (detection limit = 10ppb).Remark for Commission:* No method of analysis is available for theenforcement of an SML.* The substance hydrolyses readily atneutral pH and above and so it will beunstable in many foods. The substance isstable in simulant B and will not hydrolysein simulant D.+ +(Adopted at 114th SCF meeting) (10December 1998)http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdfD 7 Needed: hydrolysis data. + +Same 16119 DIR QMA = 0.02 mg/6 dm² 4B QMA: 20 ug/6 dm².Remark for Commission:- Including the epoxide hydrolysis productsis not needed if the restriction is on a QMbasis.- If a future application is made for a higherrestriction level, which could then permituse as an additive in PVC organosols, thenchlorohydrin formation would need to beconsidered.(Adopted at 117th SCF meeting) (17 June1999)http://europa.eu.int/comm/food/fs/sc/scf/out37_en.pdfD 9 ++ +82

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT20650 - Methacrylic acid, esterswith alcohols, aliphatic,monohydric,unsaturated(C4-C18)20680 - Methacrylic acid, esterswith alcohols, polyhydric(C2-C21)20710 - Methacrylic acid, esterswith etheralcohols20740 039670-09-2 Methacrylic acid, esterwithethoxytriethyleneglycol20770 - Methacrylic acid, esterswith glycolethersobtained from monoand/or diglycols withalcohols, aliphatic,monohydric (C1-C18)20800 024493-59-2 Methacrylic acid, esterwithmethoxytriethyleneglycol20830 - Methacrylic acid, esterswith 1,2-propanediol20860 005039-78-1 Methacrylic acid, esterwithtrimethylethanolammonium chloride20875 002370-63-0 Methacrylic acid, 2-ethoxyethyl ester20890 000097-63-2 Methacrylic acid, ethylester20920 000688-84-6 Methacrylic acid, 2-ethylhexyl ester20935 002495-27-4 Methacrylic acid,hexadecyl ester20940 000142-09-6 Methacrylic acid, hexylesterD 9 +D 9 +D 9 +D 8 Available: hydrolysis (incomplete) data. + +D 9 +D 8 +D 8 + +D 8 + +8 +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as methacrylicacid).See references for methacrylic acid.+ +D 8 + +7 Needed : hydrolysis data. +7 Needed : hydrolysis data. +83

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT20945 004664-49-7 Methacrylic acid, 2-hydroxyisopropyl ester(=methacrylic acid, 2-hydroxy-1-methylethylester)20950 000923-26-2 Methacrylic acid, 2-hydroxypropyl ester20965 002761-09-3 Methacrylic acid, 3-hydroxypropyl ester20980 007534-94-3 Methacrylic acid,isobornyl ester21010 000097-86-9 Methacrylic acid,isobutyl ester21040 029964-84-9 Methacrylic acid,isodecyl ester21070 028675-80-1 Methacrylic acid,isooctyl ester21100 004655-34-9 Methacrylic acid,isopropyl ester21115 000816-74-0 Methacrylic acid,methallyl ester21130 000080-62-6 Methacrylic acid, methylester21160 - Methacrylic acid,monoester with 1,3-butanediol21170 000997-46-6 Methacrylic acid,monoester with 1,4-butanediol21190 000868-77-9 Methacrylic acid,monoester withethyleneglycol21220 032360-05-7 Methacrylic acid,octadecyl ester21250 002157-01-9 Methacrylic acid, n-octylesterD 7 Needed: hydrolysis data. +D 8 Available: hydrolysis data. However no + +significant hydrolysis has been measured.D 8 +D 8 + +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as methacrylicacid).See references for methacrylic acid.+ +D 8 + +D 8 +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as methacrylicacid).See references for methacrylic acid.+ +D 6A +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as methacrylicacid).See references for methacrylic acid.+ +D 8 +D 8 +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as methacrylicacid).See references for methacrylic acid.+ +D 8 Hydrolysis negligible (CS/PM/1689). + +D 7 Needed: hydrolysis data. + +84

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT21280 002177-70-0 Methacrylic acid, phenylester21310 003683-12-3 Methacrylic acid,phenylethyl ester21340 002210-28-8 Methacrylic acid, propylester21370 010595-80-9 Methacrylic acid, 2-sulphoethyl ester21400 054276-35-6 Methacrylic acid,sulphopropyl ester,potassium saltDIR 2 Group t-TDI: 0.1 mg/kg bw. (as methacrylicacid).Hydrolysis (complete) data allow theallocation of the same TDI as methacrylicacid.+ +D 8 +DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as methacrylicacid).See references for methacrylic acid.+ +DIR 4A Restriction: Not detectable+ +Remark for Commission: Monomer is usedin coatings and a specific migration (SM)method is not available. QMA restriction isapplicable in this case.http://www.efsa.eu.int/science/afc/afc_opinions/190/opinion_afc_06_en1.pdfhttp://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdfDIR QMA = 0.05 mg/6dm² 3 SCF_List: 3+ +Restriction: R = 0.05 mg/kg food. Based onthe reduced core set of toxicological dataand on the very low migration.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf7 Needed : hydrolysis data. +21415 002549-53-3 Methacrylic acid,tetradecyl ester21420 007779-31-9 Methacrylic acid, 3,3,5-W +trimethylcyclohexyl ester21430 004245-37-8 Methacrylic acid, vinylD 7 Needed: hydrolysis data. + +ester21460 000760-93-0 Methacrylic anhydride DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as methacrylic + +acid).See references for methacrylic acid.21490 000126-98-7 Methacrylonitrile DIR SML = ND (DL =0.020 mg/kg, analyticaltolerance included)21495 004203-89-8 3-[2-(Methacryloxy)ethyl]-854AThe chemical structure is similar toacrylonitrile. Methacrylonitrile should betreated in the same way as acrylonitrile.+ +W +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT2,2-spirocyclohexyloxazolidine21520 001561-92-8 Methallylsulphonic acid,sodium saltDIR SML = 5 mg/kg 3 R = 5 mg/kg of food.Remark: since the substance is very solublein water and has no lipophilic structuralelements, the absence of accumulation canbe expected. No additional data concerningthe absence of accumulation are requested.+ +(Adopted at the 123rd SCF meeting, 19October 2000)http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf21540 006143-33-5 1,4-Methano-1,4,4a,9atetrahydro-9H-fluorene7 Under evaluation +21550 000067-56-1 Methanol Same 65960 DIR 3 The toxicity profile well known also from + +intoxication of man. The potential migrationinto food will not be of toxicologicalsignificance.(SCF, 6th Series, 1978).21580 003644-11-9 N-D 6A + +(Methoxymethyl)acrylamide21610 003644-12-0 N-D 6A + +(Methoxymethyl)methacrylamide21615 000150-76-5 4-Methoxyphenol Same 66030 8 +21620 000107-98-2 1-Methoxy-2-propanol Same 66050 8 +21630 001187-59-3 N-Methylacrylamide 6A +21640 000078-79-5 2-Methyl-1,3-butadiene Same 19243 DIR QM = 1 mg/kg in FP orSML = ND (DL = 0.02mg/kg, analyticaltolerance included)864AN.D.Remark for Commission: no method ofanalysis is available. However, the CENmethodfor butadiene can be adapted.(Adopted at the 123rd SCF meeting, 19October 2000)http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf21670 000563-46-2 2-Methyl-1-butene D 8 ++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT21700 000513-35-9 2-Methyl-2-butene D 8 +21730 000563-45-1 3-Methyl-1-butene DIR QMA = 0.006 mg/6 4B R = Only to be used in polypropylene at +dm². For use only inPolypropylene.maximum residue level 0.001 mg/dm² ofmaterial.Available: Analytical data and migration byworst case calculation, 3 mutagenicity testsof which gene mutation in bacterial cells andin mammalian cells in vitro negative,chromosome aberration test in mammaliancells in vitro positive.(RIVM/TNO/ISS CS/PM/2745, January1996).21733 000115-19-5 2-Methyl-3-butyn-2-ol D 8 4-week oral rat study. Data inadequate. +(Bayer Rep. 12557, 1984-03-22).21736 002549-61-3 alpha-Methyl-epsiloncaprolactoneD 8 +21739 002549-60-2 beta-Methyl-epsiloncaprolactoneD 8 +21742 002549-58-8 delta-Methyl-epsiloncaprolactoneD 8 +21745 002549-59-9 epsilon-Methyl-epsiloncaprolactoneD 8 +21748 002549-42-0 gamma-Methyl-epsiloncaprolactoneD 8 +21760 000694-91-7 5-Methylenebicyclo(2,2,1)hept-2-eneD 8 +21765 106246-33-7 4,4'-Methylenebis(3-chloro-2,6-diethylaniline)DIR QMA = 0.05 mg/6 dm² 3 R = 0.05 mg/kg of food.http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdfAvailable: residual content; calculation ofworst case migration < 0.05 mg/kg food; logPo/w; two gene mutation assays in bacteria(negative); chromosomal aberration assay incultured mammalian cells (negative);micronucleus assay (negative); in vivo UDSassay (negative).RIVM/IT/UK SDS, April 2000 =CS/PM/3413/21765.+87

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTRemark for Commission: only a method forthe residual quantity in the finished product(FP) is available. A QMA is proposed.(Adopted at the 123rd SCF meeting, 19October 2000)21790 000110-26-9 Methylenebisacrylamide D 6A + +21820 013093-19-1 MethylenebiscaprolactaD 8 +m21821 000505-65-7 1,4-Same 13810 DIR See "1,4-Butanediol+ +(Methylenedioxy)butaneformal"21827 000078-93-3 Methyl ethyl ketone Same 66655 3 R: 5 mg/kg of food.+Same references as 66655.21837 001116-90-1 4-Methyl-1,4-hexadiene D 6A +21850 000095-71-6 Methylhydroquinone Same 66680 D 8 +21880 000717-27-1 MethylhydroquinoneD 8 +diacetate21910 000814-78-8 Methyl isopropenyl Same 66740 D 8 +ketone21940 000924-42-5 N-Methylolacrylamide DIR SML = ND (DL = 0.01 4A Genotoxic carcinogen.+ +21970 000923-02-4 N-Methylolmethacrylamidemg/kg)(RIVM report 04-03-1991).Same 66820 DIR 7 SCF_list: 7Needed data or information: Analyticalproof of the residual content.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf22000 001118-58-7 2-Methyl-1,3-pentadiene D 8 +22030 001115-08-8 3-Methyl-1,4-pentadiene D 8 +22060 000926-56-7 4-Methyl-1,3-pentadiene D 8 +22090 000763-29-1 2-Methyl-1-pentene D 8 +22120 000760-20-3 3-Methyl-1-pentene D 8 +22150 000691-37-2 4-Methyl-1-pentene DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg in food.+28- and 90-day oral rat studies. Ames testnegative, cytogenicity study doubtful.(RIVM summary 1990-02-22).22180 004461-48-7 4-Methyl-2-pentene D 8 ++ +88

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT22190 002163-42-0 2-Methyl-1,3-propanediol22210 000098-83-9 alpha-Methylstyrene DIR 3 0.05 mg/kg food3 R = 5 mg/kg of food.Available: Worst case migration < 0.6mg/kg food; log Po/w; three (negative)mutagenicity studies; 14-day oral rat study;90-day oral rat study.(RIVM/ISS/TNO SDS, April 1997 =CS/PM/2998/22190).(Adopted at 111th SCF meeting (18-19March 1998)).http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf++ +89http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdfhttp://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf22240 000622-97-9 p-Methylstyrene Same 26292 D 6A + +22242 006144-04-3 alpha-MethylstyreneD +dimer22270 000107-25-5 Methyl vinyl ether D 7 Needed: hydrolysis data. +22300 000078-94-4 Methyl vinyl ketone D 6A +22330 001822-74-8 Methyl vinyl thioether D 6A +22330/50 - Mixture of (80%) 2,4-7 SCF_list: 7+diamino-3,5-Needed data or information:diethyltoluene and (20%)- an in vivo/in vitro rat liver UDS on a2,6-diamino-3,5-representative batchdiethyltoluene- an explanation for the contradictory resultsobserved in the Ames test.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out22331 025513-64-8 Mixture of (35-45%w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65% w/w)1,6-diamino-2,4,4-trimethylhexane140_en.pdfSame 15355 DIR QMA = 5 mg/6 dm² 3 Re-evaluation to align this evaluation withother evaluations done by the SCF.R = 5 mg/6 dm2.Remark for Commission: A QM would beindicated. The choice of a QM instead ofSML is due to the reactivity of the substance+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT22332 - Mixture of (40% w/w)2,2,4-trimethylhexane-1,6-diisocyanate and(60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanateDIRQM(T) = 1 mg/kg(expressed as NCO)(26).90with fat simulant.Available: migration data; three negativemutagenicity studies; 90-day oral rat study;2-generation reproduction study (rat); twoteratogenicity studies (rat and rabbit).RIVM/TNO SDS, November 2000 =CS/PM/2914/15355.(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf4A Not detectable +22333 000079-11-8 Monochloroacetic acid 3 R = 0.05 mg/kg of food.Available: migration data in water; two genemutation assays in bacteria (negative);chromosomal aberration assay in culturedmammalian cells (negative); gene mutationassay in cultured mammalian cells(equivocal); in vitro SCE assay (positive);sex-linked recessive lethal assay inDrosophila melanogaster (negative); 16-dayoral mouse and rat studies; 90-day oralmouse and rat studies; 2-year oral mouseand rat studies.(RIVM/DE/TNO SDS, October 1998 =CS/PM/3065 REV. II/22333).(Adopted at 117th SCF meeting) (17 June1999)http://europa.eu.int/comm/food/fs/sc/scf/out37_en.pdf22337 000141-43-5 2-Aminoethanol Same 35170,674203 R = 0.05 mg/kg of food.Available: migration data from multilayerbottle and residual content in polymer; genemutation assay in bacteria (negative);chromosomal aberration assay in cultured++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTmammalian cells (negative); gene mutationassay in cultured mammalian cells(negative); in vitro cell transformation assay(negative); toxicology summary onreproductive toxicity; general toxicologicaloverview on MEA (made by the applicant).RIVM/TNO SDS, August 1999 =CS/PM/3337/22337.Remark: substance evaluated only for therequested use of indirect contact with nonfattyfood.(Adopted at the 121 SCF meeting (20 June2000))http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf22340 000074-89-5 Monomethylamine W8 Data inadequate. +22350 000544-63-8 Myristic acid Same 67891 DIR 1 ADI: Not specified.+ +22360 001141-38-4 2,6-Naphthalenedicarboxylicacid22390 000840-65-3 2,6-Naphthalenedicarboxylicacid, dimethyl ester(SCF, 25th Series, 1989).DIR SML = 5 mg/kg 3 R: 5 mg/kg of foodAvailable: migration tests according to EUdirectives; extraction tests according toFDA; log Po/w; acute toxicity data; skin andeye irritation studies; gene mutation assay inbacteria (negative); two chromosomalaberration assays in cultured mammaliancells (one positive and one inadequate); genemutation assay in cultured mammalian cells(negative); micronucleus assay (negative);90-day oral rat study.(RIVM/ISS/TNO SDS, April 1999 =CS/PM/2220 REV. II/22360).(Adopted at the 118th SCF meeting) (23September 1999)http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdfDIR SML = 0.05 mg/kg 7 Available: specific migration < 0.024 mg/kgfood in water and 15% ethanol and

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CThydrolysis data; acute toxicity data; 90-dayoral rat study; gene mutation assay inbacteria (negative); chromsomal aberrationassay in cultured mammalian cells(negative); gene mutation assay in culturedmammalian cells (negative); micronucleusassay (negative).Needed: information on the absence ofaccumulation of the compound.RIVM/TNO SDS, September 1999 =CS/PM/3085 REV. I/22390.22420 003173-72-6 1,5-NaphthalenediisocyanateDIRQM(T) = 1 mg/kg(expressed as NCO)(26).924A(Adopted at the 121 SCF meeting (20 June2000)http://europa.eu.int/comm/food/fs/sc/scf/out61_en.pdfSee references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.+ +22424 026761-45-5 Neodecanoic acid, 2,3-6A Covered by 25360. +epoxypropyl ester22428 051000-52-3 Neodecanoic acid, vinylD 7/D Deleted because covered by 25380. +ester22437 000126-30-7 Neopentylglycol Same 16390 DIR See "2,2-Dimethyl-1,3-+ +Propanediol"22450 009004-70-0 Nitrocellulose Same 43330 DIR 3 (SCF, 6th Series, 1978). + +22465 000112-05-0 Nonanoic acid Same 68150 D 8 +22480 000143-08-8 1-Nonanol DIR 3 See references for "Alcohols, aliphatic, + +monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N. 12375) in SCF list 3.22510 027215-95-8 Nonene D 8 + +22535 025154-52-3 Nonylphenol Same 68175 9 +22540 000104-40-5 4-Nonylphenol Same 68185 D 8 + +22550 000498-66-8 Norbornene Same 13180 DIR See"Bicyclo[2.2.1]hept-2-D +22552 - Novolac glycidyl ethers(=NOGE)Same 68200See 13160Dene"According toCommission Directive7 http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT2002/16/EC of 20February 2002 on theuse of certain epoxyderivatives in materialsand articles intended tocome into contact withfoodstuffs.Can still be used inheavy coatings.22555 000112-92-5 1-Octadecanol Same 68225 3 See references for "Alcohols, aliphatic,monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N.12375) in SCF list 3.22570 000112-96-9 Octadecyl isocyanate DIR QM(T) = 1 mg/kg(expressed as NCO)(26).934ASee references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.22580 000930-02-9 Octadecyl vinyl ether D 7 Needed: hydrolysis data. +22585 003710-30-3 1,7-Octadiene D 8 +22600 000111-87-5 1-Octanol Same 68750 DIR 3 See references for "Alcohols, aliphatic, + +monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N. 12375) in SCF list 3.22630 025377-83-7 Octene (except 1-octene) D 8 +22660 000111-66-0 1-Octene DIR SML = 15 mg/kg 2 t-TDI: 0.25 mg/kg b.w. pending results of + +fertility and teratogenicity studies.Available: a 90-day oral rat study andmutagenicity studies.(CIVO rep. V86.408/251091, 26 September1986).22690 001806-26-4 4-Octylphenol D 8 + +22720 000140-66-9 4-tert-Octylphenol Same 25185 DIR/D See "4-(1,1,3,3- D See REF.N°. 25185. + +Tetramethylbutyl)phenol"22750 000929-62-4 Octyl vinyl ether D 7 Needed: hydrolysis data. +22755 008016-35-1 Oiticica oil 8 Not food fat. +22757/1 - Oiticica oil fatty acids 8/D It is not an oil from food sources. +22763 000112-80-1 Oleic acid Same 69040 DIR 1 ADI : not specified.+ +(SCF, 25th Series, 1990).22766 000143-28-2 Oleyl alcohol Same 69760 3 Precursor of oleic acid. +22775 000144-62-7 Oxalic acid Same 69920 DIR SML(T) = 6 mg/kg 2 TDI : 0.1 mg/kg b.w. + +++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT22778 007456-68-0 4,4'-Oxybis(benzenesulphonyl azide)(29) 2-year oral rat study, observations in man.(J. Am. Pharm. Ass. 1947, 36, 217-219,Patty).DIR QMA = 0.05 mg/6 dm² 3 R = 0.05 mg/kg of food.Remark for Commission: only a method forthe residual quantity in the finished product(FP) is available. A QMA is proposed.+(Adopted at the 123rd SCF meeting, 19October 2000)http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf22780 000057-10-3 Palmitic acid Same 70400 DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1990).22810 000504-60-9 1,3-Pentadiene D 8 +22811 000591-93-5 1,4-Pentadiene D 8 +22840 000115-77-5 Pentaerythritol Same 71600 DIR 2 Group TDI: 1 mg/kg b.w. (with+ +dipentaerythritol).See references for dipentaerythritol.22842 002590-16-1 Pentaerythritol diallylD 6A +ether22858 005343-92-0 1,2-Pentanediol D 8 +22861 000111-29-5 1,5-Pentanediol D 8 +22870 000071-41-0 1-Pentanol DIR 3 See references for "Alcohols, aliphatic, + +monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N. 12375) in SCF list 3.22900 000109-67-1 1-Pentene DIR SML = 5 mg/kg 3 R: 5 mg/kg of food.+Available: migration data showing specificmigration < 0.05 mg/kg in food; log Po/w;gene mutation assay in bacteria (negative);chromosomal aberration assay in culturedmammalian cells (negative); two genemutation assays in cultured mammalian cells(one inadequate and one negative); 90-dayoral rat study.RIVM/TNO/ISS SDS, October 1999 =CS/PM/2855 REV. IV/22900.94(Adopted at the 121 SCF meeting (20 June

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT2000))http://europa.eu.int/comm/food/fs/sc/scf/out61_en.pdf22901 000109-68-2 2-Pentene D 8 +22912 000627-19-0 1-Pentyne 8 +22930 - Perfluoroalkyl (C1-C3)D 9 +perfuorovinyl ethers22932 001187-93-5 Perfluoromethylperfluorovinyl etherD3AM953 Restriction: 0.05 mg/kg foodRemark for Commission: QMA restrictionof 0.05 mg/6dm2 could be more appropriatefor enforcement purposes.Only to be used for anti-stick coatings.http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdfhttp://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf22935 003823-94-7 Perfluoromethyl vinylD 7 Needed: provided hydrolysis can be+etherdemonstrated, data on perfluoromethanol arerequested.22937 001623-05-8 PerfluoropropylDIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.+ +perfluorovinyl etherMigration data and three mutagenicitystudies negative.(RIVM SDS, May 1996 = CS/PM/2799).22940 006996-01-6 Perfluoropropyl vinylD 7 Needed: provided hydrolysis can be+etherdemonstrated, data on perfluoropropanol arerequested.22960 000108-95-2 Phenol DIR 2 TDI: 1.5 mg/kg b.w.+ +90-day oral studies in mice and rats,multigeneration studies oral in rats and 2-year studies oral in mice and rats.(NTP 80-15, NIH Tech. report 203, J.Pharm. Exp. Ther. 184, 1973, 695).22990 - Phenols, mono- andD 9 +dihydric, alkoxylated orhydrogenated23020 028994-41-4 alpha-Phenyl-o-cresol D 8 +23050 000108-45-2 1,3-Phenylenediamine DIR SML = ND (DL = 0.02 4A Since the data on carcinogenicity by the oral + ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT23070 000102-39-6 (1,3-Phenylenedioxy)diaceticacidmg/kg , analyticaltolerance included)route were inadequate and the substancedemonstrated some genotoxic potential, it isonly acceptable for use provided there is nodetectable migration into food by an agreedsensitive method.DIR QMA = 0.05 mg/6dm² 3 SCF_list:3Restriction: 0.05 mg/kg of food. .Remark for Commission:No method of analysis for specific migrationavailable. QMA= 0.05mg/6dm²+See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdf23080 001079-21-6 Phenylhydroquinone D 8 +23110 058244-28-3 PhenylhydroquinoneD 8 +diacetate23125 000103-71-9 Phenyl isocyanate 4A Isocyanates can hydrolyse to corresponding +amines. Some aromatic amines arecarcinogenic.23140 000092-69-3 4-Phenylphenol Same 72320 D 8 + +23155 000075-44-5 Phosgene Same 14380 DIR See "Carbonyl+ +chloride"23170 007664-38-2 Phosphoric acid Same 72640 DIR 1 MTDI: 70 mg/kg b.w. (as P).+ +(SCF, 25th Series, 1990).23173 001314-56-3 Phosphoric anhydride 1 MTDI : 70 mg/kg b.w. (as P).+23175 000122-52-1 Phosphorous acid,triethyl esterSame 25525 DIR QM = ND (DL = 1mg/kg in FP)96(SCF, 25th Series, 1990).3 QM = n.d. in the polymer (limit of detection= 1 ppm).Available: Adequate analytical method fordetermination of the residual content;calculation worst case migration; genemutation assay in bacteria (negative);chromosomal aberration assay in culturedmammalian cells (negative); gene mutationassay in cultured mammalian cells(positive); in vivo UDS assay in rat liver(negative).(RIVM/ISS/UK SDS, July 1998 =+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTCS/PM/3195/25525).(Adopted at 114th SCF meeting) (10December 1998)http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf23185 - Phthalic acids D D +23187 - Phthalic acid DIR See "Terephtahalic+acid"23200 000088-99-3 o-Phthalic acid Same 74480 DIR 2 Group TDI: 1 mg/kg b.w.+ +Included in the group TDI for phthalicanhydride.23230 000131-17-9 Phthalic acid, diallylDIR SML = ND (DL = 0.01 4A Genotoxic carcinogen (mouse and rat). + +estermg/kg)(RIVM doc. 91/679112/001).23260 000088-95-9 o-Phthalic acidD 7 Needed: hydrolysis data. +dichloride23290 - Phthalic acid,D 9 +halogenated derivatives23320 - Phthalic acids,D 9 +hydrogenated23350 - Phthalic acids,D 9 +hydrogenated,substituted,endosubstituted, andtheir halogenatedderivatives23380 000085-44-9 Phthalic anhydride Same 76320 DIR 2 Group TDI: 1 mg/kg b.w.+ +(SCF, 17th Series, 1986).23410 - Phthalic anhydride,D 9 +hydrogenated23440 000111-16-0 Pimelic acid D 8 +23470 000080-56-8 alpha-Pinene DIR 3 Occurs naturally in food. Used as a flavour. + +Migration into food would be self-limiting,because of its taste.(Fd Cosmetic Tox. 16, 1978 suppl. 1, 853).23500 000127-91-3 beta-Pinene DIR 3 Occurs naturally in food. Used as a flavourup to 600 mg/kg of food. Migration intofood would be self-limiting because of itstaste.+ +97

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT23530 025190-06-1 Poly(1,4-butyleneglycol)(Mw>1000)23547 009016-00-6and 063148-62-9Polydimethylsiloxane(Mw> 6800)23560 - Polyethers based onethylene oxide,propylene oxide and/ortetrahydrofuran,containing free hydroxylgroups(Food Cosmet. Toxicol. 16 (suppl.1) 1978,859-861).Same 76570 D 7 Needed: molecular weight distributioncurve.Same 76721 DIR In compliance with thespecifications laiddown in Annex V2 See the SCF opinion for the substancePM/REF.N. 76721.(Adopted at 111th SCF meeting (18-19March 1998)D 9 +23590 025322-68-3 Polyethyleneglycol Same 76960 DIR 2 Group TDI: 5 mg/kg b.w. (withtriethyleneglycol).See references for triethyleneglycol.(SCF, 6th Series, 1978).23592 157567-90-3 Polyethyleneglycolisotridecyl ethermethacrylate23615 029435-48-1 Polyhydroxybutyrate.tobe deleted here andintroduced in a specialannex if authorized.23620 - Polyols derived fromphenols and bisphenols,hydrogenated and/orcondensed withepoxyalkanes and/orarylepoxyalkanespossibly halogenated,alkoxylated, aryloxylated++ ++ +W +D +D 9 +23650 025322-69-4 Polypropyleneglycol Same 23651 D 3 Toxicologically acceptable. +(Mw>400)and 8080023651 025322-69-4 Polypropyleneglycol Same 23650 DIR 3 Toxicologically acceptable. + +and 8080023680 009002-89-5 Polyvinylalcohols Same 81280 D D + +98

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT23710 063148-65-2 Polyvinylbutyrals D 9 + +23730 008002-11-7 Poppyseed oil 3 Food fat. +23740 000057-55-6 1,2-Propanediol Same 81840 DIR 1 ADI: 25 mg/kg b.w.+ +and 82065(JECFA 17 M., 1973).23770 000504-63-2 1,3-Propanediol DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.+ +Available: Adequate migration data; Amestests (negative); in vitro cytogenetic assay inChinese hamster cells (positive); HPRTforward mutation assay in Chinese hamstercells (negative); mouse bone marrowmicronucleus assay (negative);teratogenicity study (segment II).(RIVM/ISS/TNO SDS, August 1997 =CS/PM/3066/23770).(Adopted at 111th SCF meeting (18-19March 1998)).http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf23800 000071-23-8 1-Propanol Same 81880 DIR 3 (SCF, 11th Series, 1981; JECFA 25 M., + +1981).23830 000067-63-0 2-Propanol Same 62480 DIR 1 t-ADI: 1.5 mg/kg b.w.+ +and 81882(SCF, 11th Series, 1981)23860 000123-38-6 Propionaldehyde DIR 3 Occurs naturally in food. Used as a flavour +up to 13 mg/kg of food. Migration into foodwill be self-limiting because of its taste.23890 000079-09-4 Propionic acid Same 82000 DIR 1 Group ADI: not specified.+23920 000105-38-4 Propionic acid, vinylesterDIR SML(T) = 6 mg/kg (2)(expressed asAcetaldehyde)(SCF, 1st Series, 1974).2 Group-TDI = 0.1 mg/kg b.w. (included inthe group-TDI of acetaldehyde).Available: Hydrolysis data for propionicacid vinylester, showing total (100%hydrolysis of the monomer in intestinalfluid, after 1hr at 37 °C, into propionic acidand acetaldehyde); calculation of (worstcase) migration is

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTaberrations in vitro (positive).Remark for the Commission: no method ofanalysis is available for the enforcement ofan SML.(RIVM/ISS/TNO SDS, January 1997 =CS/PM/2909/23920).(Adopted at 111th SCF meeting (18-19March 1998)).http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf23950 000123-62-6 Propionic anhydride DIR 1 Group ADI: included in the ADI not +specified for propionic acid.(SCF, 1stReport, 1974).23980 000115-07-1 Propylene DIR 3 Residues of this gas in plastics are very + +small. The gas has a low toxic potential.Migration into food will be toxicologicallynegligible.(Patty's Industrial Hygiene andToxicology, 3rd ed., 1981).24010 000075-56-9 Propylene oxide DIR QM = 1 mg/kg in FP 4A Mutagenic in several studies. Induces + +forestomach tumours in rats after oraladministration.(Brit. J. Cancer 1982, 46, 924).24040 000764-47-6 Propyl vinyl ether D 7 Needed: hydrolysis data. +24045 008016-49-7 Pumpkinseed oil 3 Food fat. +24051 000120-80-9 Pyrocatechol Same 15880 DIR See "1,2-+ +Dihydroxybenzene"24055 000089-05-4 Pyromellitic acid Same 13040 3 R: 0.05 mg/kg in food.+24057 000089-32-7 Pyromellitic anhydride DIR SML = 0.05 mg/kg(expressed asPyromellitic acid)100Same references as pyromellyitic anhydride.3 R: 0.050 mg/kg in food.Available data: 3 requested mutagenicity,studies negative, no bioaccumulation,migration less than 0.05 mg/kg in all foodsimulants.24070 073138-82-6 Resin acids and rosinacidsSame 83610 DIR 2 Group TDI: 1 mg/kg b.w.(SCF, 17th Series, 1986).24072 000108-46-3 Resorcinol Same 15910 DIR See "1,3-Dihydroxybenzene"24073 000101-90-6 Resorcinol diglycidylDIR QMA = 0.005 mg/6etherdm² - Not for use in3 R= 0.005 mg/kg of food; only to be usedbehind the PET barrier.+ ++ ++ ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT24100 008050-09-7 Rosin Same14687,24130,45055 and8384024115 008050-31-5 Rosin, ester withglycerol24130 008050-09-7 Rosin gum Same14687,24100,45055 and83840polymers contactingfoods for whichsimulant D is laiddown in Directive85/572/EEC and forindirect food contactonly, behind the PETlayer.101Available: data on residual content in PHAEpolymer, resulting in a worst case migrationof 0.001 mg/kg food; gene mutation assay inbacteria (positive); chromosomal aberrationassay in cultured mammalian cells(positive); micronucleus assay (negative)(the target organ was not reached); 2-weekoral mouse and rat studies; 13-week oralmouse and rat studies; mouse and ratcarcinogenicity studies; conclusions made inother scopes.RIVM/TNO SDS, August 1999 =CS/PM/3338/24073.Remark: Substance evaluated for therequested use of indirect contact with nonfatty food.(Adopted at the 121 SCF meeting (20 June2000))http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdfDIR 2 Group TDI: 1 mg/kg b.w.(SCF, 17h Series, 1986).Same 84000 1 ADI= 12.5 mg/kg b.w.(SCF, 32nd Series, 1994).DIR See "Rosin" 2-D Group TDI: 1 mg/kg b.w.(SCF, 6th Series, 1978).+ +24150 Rosin, polymerized 9 +24160 008052-10-6 Rosin tall oil DIR 3 + +24190 008050-09-7 Rosin wood DIR 2 Group TDI: 1 mg/kg b.w.+(SCF, 6th Series, 1978).24220 009006-03-5 Rubber, chlorinated Same 84480 D 9 +24250 009006-04-6 Rubber, natural Same 84560 DIR 3 Migration unlikely. + +24260 008001-23-8 Safflower oil 3 Food fat. +24270 000069-72-7 Salicylic acid Same 84640 DIR 3 Naturally occurring in food in lowconcentration.+ +++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT24280 000111-20-6 Sebacic acid Same 85030 DIR 2 Group TDI: 3 mg/kg b.w.(SCF, 17th Series 1986).24310 000111-19-3 Sebacic acid dichloride D 7? Needed: migration and hydrolysis data.Pending these results necessity for a 28-dayoral study and further studies to beconsidered.http://europa.eu.int/comm/food/fs/sc/scf/out161_en.pdf24340 002432-89-5 Sebacic acid, di-n-decylD 8 Group R: 0.05 mg/kg b.w.esterNeeded: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.050 mg/kg, peroxisome24370 000106-79-6 Sebacic acid, dimethylesterproliferation studies too.Same 85540 D 8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.050 mg/kg, peroxisomeproliferation studies too.+ +24400 002918-18-5 Sebacic acid, diphenylD 8 +ester24430 002561-88-8 Sebacic anhydride DIR 2 Group TDI : 3 mg/kg b.w.+ +Included in the group TDI for sebacic acid.24435 008008-74-0 Sesame oil 3 Food fat. +24440 009000-59-3 Shellac Same 85550 1 ADI: Acceptable.+(SCF, 26th Series, 1992).24460 000124-41-4 Sodium methanolate D +24475 001313-82-2 Sodium sulphide DIR 3 Organoleptically self limiting. + +24490 000050-70-4 Sorbitol Same 88320 DIR 1 Acceptable.+ +(SCF, 16th Series, 1985).24520 008001-22-7 Soybean oil Same DIR 3 Food fat. + +88630/0 and86630/124525 - Soybean oil fatty acids,8/D +dimers24540 009005-25-8 Starch, edible Same 88800 DIR 0 +24545 068412-29-3 Starch, hydrolysed Same 88880 DIR 0 + +24550 000057-11-4 Stearic acid Same 89040 DIR 1 ADI: not specified.(SCF, 25th Series, 1990).+ ++++102

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT24560 000111-63-7 Stearic acid, vinyl ester D 8 Hydrolysis negligible (CS/PM/1895). + +24610 000100-42-5 Styrene DIR 4B Several oral studies performed: 6-month rat, + +19-month dog, carcinogenicity in mice (3)and in rats (4), 3-generation reproductionand teratogenicity in rats. Mutagenicitystudies positive only with activation.(RIVM doc. 1990-05-03 (CS/PM/428),BGA doc. 1990-07-17 (CS/PM/475),CS/PM/915).NOTA BENE: the wg wishes to establish alimit for styrene in food and asked theCommission to provide migration data.The wg of the SCF has the intention torecommend to the Commission a ban forstyrene in oven ware due to unacceptablyhigh migration.24640 - Styrene substituted byD 9 +alkyl groups (alpha)24670 - Styrene substituted in theD 9 +benzene ring24700 - Styrene substituted byD 9 +halogens (alpha or beta)24730 - Styrene substituted in theD 9 +vinyl group24760 026914-43-2 Styrenesulphonic acid DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.+ +Available: Adequate migration data in foodsimulants up to and including 175 °C;analytical method; four (negative) in vitromutagenicity studies; acute toxicity;sensitisation study; eye irritation study.(RIVM/TNO SDS, August 1997 =CS/PM/2087 Rev I/24760).(Adopted at 111th SCF meeting (18-19March 1998)).http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf24790 000505-48-6 Suberic acid D 8 +24820 000110-15-6 Succinic acid Same 90960 DIR 1 ADI: not specified.(SCF, 25th Series, 1990).+ +103

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT24835 000106-65-0 Succinic acid, dimethyl Same 91135 7 Needed : hydrolysys data. +ester24850 000108-30-5 Succinic anhydride Same 91170 DIR 2 TDI : not specified based on ADI (=not + +specified) for succinic acid.24880 000057-50-1 Sucrose Same 91185 DIR 0 +24887 006362-79-4 5-Sulphoisophthalic acid,monosodium saltDIR SML = 5 mg/kg 3 R: 5 mg/kg in food.90-day oral rat study, 3 mutagenicity studiesnegative, bioaccumulation and migrationdata.(Rivm summary data, May 1992+ +24888 003965-55-7 5-Sulphoisophthalic acid,monosodium salt,dimethyl ester(CS/PM/1590)).DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg in food.Available: 3 mutagenicity tests, negative.Migration data less than 0.05 mg/kg.(Rivm summary data, August 1992(cs/pm/1638)).24895 008001-21-6 Sunflower oil 3 Food fat. +24900 - Sunflower oil fatty acids,D +dimers24903 068425-17-2 Syrups, hydrolysedstarch, hydrogenatedPolyglycitolsyrup+3AM 3 In compliance with the purity criteria formaltitol syrup, E 965 (ii)http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf24905 008002-26-4 Tall oil 3 Not a food oil but toxicologicallyacceptable.(SCF, 17th Series, 1986).24910 000100-21-0 Terephthalic acid DIR SML = 7.5 mg/kg 2 t-TDI: 0.125 mg/kg b.w.Available: 3-month and 2-year oral ratstudies, mutagenicity test negative.Needed: full reports from CIIT and ICI.(CIIT, 1982)(UK document "Terephthalicacid: proposed use in animal foodstuffs",1984).24940 000100-20-9 Terephthalic aciddichlorideDIRSML(T) = 7.5 mg/kg(as Terephthalic acid)1042 Group TDI: 0.175 mg/Kg b.w.(asterephthalic acid)Hydrolysis (complete) data allow theallocation of the same TDI of terephthalicacid.+++ ++ +24970 000120-61-6 Terephthalic acid, DIR 2 TDI: 1 mg/kg b.w. + +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTdimethyl ester90-day oral mouse and rat studies and longtermstudies in mice and rats not indicatingtumour induction.(NCI Tech.report Series N. 121, 1979).25000 001539-04-4 Terephthalic acid,D 8 +diphenyl ester25030 016646-44-9 Tetra(allyloxy)ethane D 6A +25035 013810-83-8 Tetrabromophthalic acid 5 [Some organobromo compounds have a +bioaccumulation potential and 1,2-dibromoethane is a category 2 carcinogen(EC classification).]25050 005593-70-4 Tetrabutyl titanate W +25060 000632-58-6 Tetrachlorophthalic acid D 8 +25063 021635-90-5 Tetracyclo[4.4.0.12,5.1.77 Under evaluation +,10]dodeca-3-ene25070 000112-72-1 1-Tetradecanol Same 92300 3 See references for "Alcohols, aliphatic, + +monohydric, saturated, linear, primary (C24-C22)" (PM/REF.N. 12375) in SCF list 3.25080 001120-36-1 1-Tetradecene DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.+ +Available: Adequate migration data,showing specific migration of 1-tetradeceneis < 0.05 mg/kg food; three (negative)mutagenicitystudies.(RIVM/ISS/TNO SDS, January 1997 =CS/PM/2910/25080).(Adopted at 111th SCF meeting (18-19March 1998)).http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf25090 000112-60-7 Tetraethyleneglycol Same 92350 DIR 1 ADI: 10 mg/kg b.w.+ +(JECFA 23 M., 1979).25105 000112-57-2 Tetraethylenepentamine 8 +25120 000116-14-3 Tetrafluoroethylene DIR SML = 0.05 mg/kg 3 R: 0.050 mg/kg in food.+ +Available 3 mutagenicity studies negative.No migration data available.(Summary data from RIVM, CS/PM/925).25150 000109-99-9 Tetrahydrofuran Same 92430 DIR SML = 0.6 mg/kg 2 TDI: 0.01 mg/kg b.w.6-month oral studies in mice, rats and+ +105

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT25158 000088-98-2 1,2,3,6-Tetrahydrophthalic acid25161 000085-43-8 1,2,3,6-Tetrahydrophthalicanhydride25163 002426-02-0 3,4,5,6-Tetrahydrophthalicanhydride25180 000102-60-3 N,N,N,'N'-Tetrakis(2-hydroxypropyl)ethylenediamine25185 000140-66-9 4-(1,1,3,3-Tetramethylbutyl)phenolrabbits.(Gig. Sanit. 34, 1969, 114, EPA 560/11-80-011, April 1980).D 8 +D 8 1-year oral rat study inadequate.(Allied Chem. Corp. 1958).+ +8 +Same 92640 DIR 2 TDI: 1 mg/kg b.w.A 90-day oral rat study.(Hilltop Research Inst. Inc. January 3,1956).Same 22720 DIR/D 6B R= not detectable.Available: Inadequate migration data,inadequate mutagenicity studies, acutetox.data, 28-day oral rat study, two 90-dayoral rat studies, reproduction study (specialdesign), excretion study, skin and eyeirritation studies, two oestrogenic studies.++ +Needed: Confirmation of the claim of nondetectabilityat 5 ppb level; information onthe composition of the test samples(particularly the amount of 4-(1,1,3,3-tetramethylbutyl)phenol used in thepolycondensation process should beindicated); reasons for deviation fromstandard test conditions in migrationexperiments; a more extensive description ofthe method of determination (preferablyaccording to the standard format) andsufficient information to allow evaluation ofthe data provided; detailed data on the levelof 4-tert.octylphenol in the recoveryexperiments. In vitro chromosomalaberration assay in cultured mammaliancells; dependent of the outcome of the106

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTmigration studies a one-generationreproduction study (special attention to begiven to effects on male reproductiveorgans) may be needed.(RIVM/LST/TNO SDS, November 1996 =CS/PM/2793).25208 026471-62-5 Toluene diisocyanate 4A See references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.25210 000584-84-9 2,4-Toluene diisocyanate DIR QM(T) = 1 mg/kg(expressed as NCO)(26).25240 000091-08-7 2,6-Toluene diisocyanate DIR QM(T) = 1 mg/kg(expressed as NCO)(26).25270 026747-90-0 2,4-Toluene diisocyanatedimerDIRQM(T) = 1 mg/kg(expressed as NCO)(26).4A4A4ASee references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.See references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.See references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.++ ++ +25300 000088-19-7 o-Toluenesulphonamide D 8 + +25330 000070-55-3 p-Toluenesulphonamide D 7 Needed: mutagenicity and reproductionstudies on the commercial mixture to bespecified.+25360 - Trialkyl(C5-C15)aceticacid, 2,3-epoxypropylester25380 - Trialkyl acetic acid (C7-C17), vinyl esters(=vinyl versatate)DIRQM = 1 mg/kg in FP(expressed as Epoxygroup, Mw=43)4AAvailable: a 5-week oral rat study andmutagenicity tests.(Summary data only (CS/PM/932)).Structural similarity taken into account.DIR QMA = 0.05 mg/6 dm² 3 R = 0.05 mg/kg of food.Remark for Commission: only a method forthe residual quantity in thin films isavailable. A QMA is proposed.++ ++ +25385 000102-70-5 Triallylamine DIR In compliance with thespecifications laiddown in Annex V(Adopted at the 123rd SCF meeting, 19October 2000)http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf3 R = 40 mg/kg hydrogel at a ratio of 1 kgfood to a max of 1.5 g hydrogel. Only to beused in hydrogels intended for non-directfood contact use.Available: adequate data on residual content+107

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTof triallylamine in hydrogel; calculatedmigration; five in vitro (one positive) and invivo mutagenicity tests. Although the onenegative in vivo mutagenicity study is notenough to rule out the genotoxic potentialcompletely, the risk is thought to be verylow, if at all, based on the technicalinformation (i.e. no migration) and therestriction for use. The WG therefore doesnot require a further in vivo mutagenicitystudy.(RIVM/TNO/ISS SDS CS/PM/2856, June1996).25390 000101-37-1 Triallyl cyanurate D 6A + +25405 001025-15-6 Triallyl isocyanurate 6A +25420 000108-78-1 2,4,6-Triamino-1,3,5-triazine25450 026896-48-0 TricyclodecanedimethanolSame 19975,65360 and93720DIR SML = 30 mg/kg 2 TDI: 0.5 mg/kg b.w.(SCF, 17th Series, 1986).DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Based on thereduced core set of toxicological dataaccording to the migration level, seeAppendix 2+ ++ +Available: adequate information on theidentity of the substance; incompletespecific migration data in ethanol instead ofolive oil; gene mutation assay in bacteria(negative); chromosomal aberration assay incultured mammalian cells (negative); genemutation assay in cultured mammalian cells(negative).RIVM/FR SDS, July 2000 = CS/PM/3253REV. II/25450http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf25480 000102-71-6 Triethanolamine Same 25922 D 8 + +and 9400025510 000112-27-6 Triethyleneglycol Same 94320 DIR 2 Group TDI: 5 mg/kg b.w. (with+ +polyethyleneglycol).108

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(SCF, 17th Series, 1986).25520 000112-24-3 Triethylenetetramine 8 +25525 000122-52-1 Triethylphosphite Same 23175 D +25540 000528-44-9 Trimellitic acid Same 13050 DIR QM(T) = 5 mg/kg inFP.3 Restriction: 5 mg/kg of foodRemark for Commission: Group restrictiontogether with the trimellitic anhydride REFNo 25550http://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdf+ +25550 000552-30-7 Trimellitic anhydride DIR QM(T) = 5 mg/kg inFP (expressed asTrimellitic acid).http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf3 Restriction: 5 mg/kg of food, expressed astrimellitic acidRemark for Commission: Group restrictiontogether with the trimellitic acid REF No25540http://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdf+ +http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf25561 002768-02-7 (Trimethoxy)vinylsilane Same 26320 D +25570 000067-48-1 Trimethylethanolammoni Same 94880 D 8 +um chloride25573 016938-22-0 2,2,4-Trimethylhexane-4A +1,6-diisocyanate25574 015646-96-5 2,4,4-Trimethylhexane-4A +1,6-diisocyanate25595 000077-85-0 Trimethylolethane 9 +25600 000077-99-6 1,1,1-DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w.+ +TrimethylolpropaneA 90-day oral rat study.25630 037275-47-1 1,1,1-TrimethylolpropanediacrylateSame 13380,39560 and94960(Report Perstorp, Sweden).D 7 Needed: hydrolysis data. +109

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT25645 000682-09-7 1,1,1-Trimethylolpropanediallyl ether25660 019727-16-3 1,1,1-Trimethylolpropanedimethacrylate25690 - 1,1,1-Trimethylolpropanemaleates25720 007024-08-0 1,1,1-Trimethylolpropanemonoacrylate25750 007024-09-1 1,1,1-Trimethylolpropanemonomethacrylate25780 025723-16-4 1,1,1-Trimethylolpropane,propoxylated25810 015625-89-5 1,1,1-TrimethylolpropanetriacrylateD 6A +D 7 Needed: hydrolysis data. + +D 8 +D 7 Needed: hydrolysis data. +D 7 Needed: hydrolysis data. +D 8 +D 8 Available: hydrolysis only to the diacrylateand acrylic acid (CS/PM/2156). Knownsensitiser.(Food Chem. Tox. 23, 124, 1985).+ +25840 003290-92-4 1,1,1-TrimethylolpropanetrimethacrylateNeeded: in addition to data according toSCF guidelines, information on potential forsensitisation to plastics made from thismonomer.DIR SML = 0.05 mg/kg 3 Restriction : 0.05 mg/kg of food. Based onthe reduced core set of toxicological dataaccording to the migration level.110Available : migration data ; 2 gene mutationassays in bacteria (one negative, however noexperimental details given (publication), oneweak positive) ; chromosomal aberrationassay in cultured mammalian cells (positive); 2 gene mutation assays in culturedmammalian cells (one positive, however noexperimental details given (publication), onenegative) ; in vivo micronucleus assay+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(negative) ; in vivo/in vitro UDS assay in ratliver (negative).RIVM/FR/DE SDS, October 2001 =CS/PM/3440 REV. III/25840.(Adopted at the 130th SCF meeting, 13December 2001)http://europa.eu.int/comm/food/fs/sc/scf/out115_en.pdf25870 000107-39-1 2,4,4-Trimethyl-1-D 8 +pentene25900 000110-88-3 Trioxane DIR SML = 0.05 mg/kg 3 Under re-evaluation.+ +R = 0.05 mg/kg of food.(Adopted at 117th SCF meeting) (17 June1999)http://europa.eu.int/comm/food/fs/sc/scf/out37_en.pdf25910 024800-44-0 Tripropyleneglycol DIR 2 Group TDI: 1.5 mg/kg b.w. (withpolypropyleneglycol anddipropyleneglycol).See references for dipropylenglycol.+ +25915 000090-72-2 2,4,6-Tris((Dimethylamino)methyl)phenol25922 000102-71-6 Tris(2-hydroxyethyl)amine25927 027955-94-8 1,1,1-Tris(4-hydroxyphenyl)ethane25930 001067-53-4 Tris(2-methoxyethoxy)vinylsilaneSame 95400 8 +Same 25480and 94000D D +DIRQM = 0.5 mg/kg in FP.For use only inpolycarbonates.3 R = 0.5 mg/kg in finished product(polycarbonate).Available: calculated worst case migration;Ames /E. Coli assay; in vitro chromosomalaberration assay; two in vivo micronucleusassays; in vivo UDS assay; acute toxicityassay.(RIVM/TNO SDS, December 1996 =CS/PM/2911).D 6A ++111

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT25960 000057-13-6 Urea Same 95630 DIR 0 + +25980 - Versatic acid (=acids,D +aliphatic,monocarboxylic,saturated, branched(C5-C15)25990 000689-97-4 Vinylacetylene D 6A +25995 - Vinyl alcohol See 10120 D +26020 001484-13-5 N-Vinylcarbazole D 6A +26050 000075-01-4 Vinyl chloride DIR See Council Directive 4A (SCF, 1st Series, 1975). + +78/142/EEC26080 - Vinyl ethers of alcohols,D 9 +aliphatic, monohydric,saturated (C2-C18)26110 000075-35-4 Vinylidene chloride DIR QM = 5 mg/kg in FP or 4B (SCF 13th Series, 1982). + +SML = ND (DL = 0.05mg/kg)26140 000075-38-7 Vinylidene fluoride DIR SML = 5 mg/kg 3 R: 5 mg/kg of food.+ +Many inhalation studies, 1-year oral ratstudy, carcinogenicity studies by inhalationin mice and rats negative, mutagenicitystudies negative, reproduction studynegative.(RIVM report 1992-10-29).26155 001072-63-5 1-Vinylimidazole DIR QM = 5 mg/kg in FP 3 R = 0.05 mg/kg of food.Available: Adequate analytical method fordetermination of residual 1-vinylimidazolein terpolymer; calculated worst casemigration is < 0.17 ppb into food; threenegative mutagenicitystudies.(RIVM/TNO SDS, April 1998 =CS/PM/3158 /95805).+ +112REMARK for Commission: Only a methodfor the determination for the residual contentis available.(Adopted at 114th SCF meeting) (10

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT26170 003195-78-6 N-Vinyl-NmethylacetamideDecember 1998).http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdfDIR QM = 2 mg/kg in FP 3 R = 2 mg/kg in finished product.+Available: 5 mutagenicity studies consideredto be non-genotoxic, physical-chemical dataon VIMA; adequate analytical data andmethod for the residual content of VIMA infinal product; calculation of worst casemigration assuming 100% migration ofresidual monomer.(RIVM SDS, May 1994 = CS/PM/2371 andTNO SDS, August 1996 = CS/PM/2857).D 6A +26200 002867-48-3 N-Vinyl-Nmethylformamide26215 000100-69-6 2-Vinylpyridine 6A +26217 000100-43-6 4-Vinylpyridine 6A +26230 000088-12-0 Vinylpyrrolidone Same 95810 DIR 4A SCF_list: 4ARestriction: n.d. by an agreed sensitivemethod.Remark for Commission: only to be used inadhesives for paper and board and QMA

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTfood simulants.(Adopted at 116th SCF meeting) (24 March1999)http://europa.eu.int/comm/food/fs/sc/scf/out27_en.pdf26340 008024-09-7 Walnut oil 3 Food fat. +26345/1 - Walnut oil fatty acids 3/D Constituents of food fats. +26360 007732-18-5 Water Same 95855 DIR In compliance with the 0 Specification: Impurity levels not to exceed + +Directive 98/83/EC.those set in the Drinking water Directive.26370 001330-20-7 Xylene Same 95945 3 R: 0.02 mg/kg bw (with+95945,95947,95949,95951) based onallowing 1/10 of TDI for food contactmaterials.2-year oral rat study, mutagenicity testnegative.(WHO draft, Geneva, September1992)(CS/PM/1712).26375 000105-67-9 m-Xylenol Same 16300 D D +26377 000526-75-0 o-Xylenol Same 16270 D D +26379 000095-87-4 p-Xylenol Same 16330 D D +30000 000064-19-7 Acetic acid Same 10090 DIR 1 Group ADI: not specified.+ +(SCF, 25th Series, 1991).30045 000123-86-4 Acetic acid, butyl ester DIR 1 t-ADI: 6 mg/kg bw.+ +(SCF, 25th Series, 1991).30060 000071-48-7 Acetic acid, cobalt II salt W +30080 004180-12-5 Acetic acid, copper salt DIR SML(T) = 30 mg/kg(7) (expressed asCopper)30100 000111-55-7 Acetic acid, diester withethyleneglycol30120 000111-15-9 Acetic acid, 2-ethoxyethyl ester1142 For Copper, R = 5 mg/person based onhttp://europa.eu.int/comm/food/fs/sc/scf/out176_en.pdf.+7 Needed: hydrolysis data. +2 Group t-TDI : 0.05 mg/kg b.w. (with15780=48050, 16993=53765, 16996=53820,16999, 17002=53860, 30015, 30120, 30200,48030)+9 R : 0.05 mg/kg of food. +30130 ? Acetic acid,ethoxypropyl ester30140 000141-78-6 Acetic acid, ethyl ester DIR 1 ADI: not specified. + +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(SCF, 11th Series, 1981).30160 see 30180 D +30165 000108-21-4 Acetic acid, isopropyl7 Needed: hydrolysis data. +ester30180 002180-18-9 Acetic acid, manganesesaltDIRSML(T) = 0.6 mg/kg(10) (expressed asManganese)1-2 L2 for Manganese.Group TDI: 0.01 mg/kg b.w. (as Mn).Recommended daily allowance 2-3 mg/day.Average daily intake 10 mg.(Manganese. Environmental Health Criteria17, WHO, Geneva 1981).L1 for acetic acid.Group ADI: Not specified.(SCF, 25th Series, 1991).30190 see 30280 D +30225 000628-63-7 Acetic acid, pentyl ester 7 Needed: hydrolysis data. +30240 see 30330 D +30245 000109-60-4 Acetic acid, propyl ester 7 Needed: hydrolysis data. +30280 000108-24-7 Acetic anhydride Same 10150 DIR 2 Group TDI: included in the ADI not +specified for acetic acid.(SCF, 25th Series, 1991).30295 000067-64-1 Acetone DIR 3 Residue in food less than 5 mg/kg.+ +(SCF, 11th Series, 1981).30320 see 30370 D +30330 - Acetone-nonylphenolthiodipropionic9 +aciddidodecyl ester,copolymer30340 330198-91-9 12-(Acetoxy)stearic acid,2,3-bis(acetoxy)propylester3AM 3 Restriction: NoneRemark for Commission: FRF is applicablehttp://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf++30345 001118-84-9 Acetylacetic acid, allylesterhttp://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdfW +115

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT30350 000141-97-9 Acetylacetic acid, ethyl7 Needed: hydrolysis data. +ester30370 - Acetylacetic acid, salts DIR 0 +30385 000123-54-6 Acetylacetone 8 +30400 - Acetylated diglycerides DIR 1 ADI: not specified.+(SCF, 7th report, 1978).30401 - Acetylated mono- and3AM 1 ADI: not specified. +diglycerides of fattyacids30480 000140-04-5 Acetylricinoleic acid,7 Needed: hydrolysis data. +butyl ester30560 see 30620 D +30610 - Acids C2-C24 aliphatic,DIR 3 Toxicologically acceptable. + +linear, monocarboxylicfrom natural oils and fatsand their mono-, di- andtriglycerol esters(branched fatty acids atnaturally occurring levelsare included).30612 - Acids C2-C24 aliphatic,DIR 3 Toxicologically acceptable. + +linear, monocarboxylic,synthetic and theirmono-, di- andtriglycerol esters30620 - Acids, aliph. monocarb.9 +(C6-C24)30640 - Acids, aliph., monocarb.9 +(C8-C22), sec-butyl andoleyl esters30720 - Acids, aliph., monocarb.9 +(C8-C22), compoundswith diethanolamine30725 068603-38-3 Acids, aliph., monocarb.7 Same references as 39280. +(C16-C18), compoundswith diethanolamine30800 - Acids, aliph., monocarb.(more than C5), esterswith mannitol9 +116

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT30880 - Acids, aliph., monocarb.(more than C5), esterswith pentaerythritol30960 - Acids, aliph., monocarb.(C6-C22) esters withpolyglycerol31040 - Acids, aliph., monocarb.,hydroxylated (C12-C20)and their sulphonatedand acetylatedderivatives31120 - Acids, aliph., monocarb.(C6-C24), Li, Mn and Snsalts31200 - Acids, aliph., monocarb.,sat.(more than C7),esters with alcohols,aliph. monoh.31280 - Acids, aliph., monocarb.(C8-C22), compoundswith triethanolamine31302 - Acids carboxylic, esterswith alcohols (for memotobe del.later)31304 085566-24-1 Acids, fatty (C14-C18),alkyl (C14-C18) esters31306 092797-30-3 Acids, fatty (C14-C22),alkyl (C16-C24) esters31307 095912-87-1 Acids, fatty (C16-C18),alkyl (C12-C18) esters31328 - Acids, fatty from animalor vegetable food fatsand oils31330 - Acids, fatty from animalor vegetable fats andoils, methyl esters31350 125109-79-7 Acids, fatty (C14-C22),esters withpentaerythritol9 +DIR 1 Group ADI: 25 mg/kg b.w.(SCF, 7th Series, 1978).9 +9 +9 +9 +D +Same 30490 8 +9 +9 +DIR 3/D Constituent of food fats. ++ +9 +9 +117

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT31352 085116-93-4 Acids, fatty (C16-C18),9 +esters withpentaerythritol31360 see 31470 D +31382 - Acids, fatty,unsaturated(C18),dimers, hydrogenated -adipic acid-2ethylhexanol-1,2-propanediol, copolymer31384 - Acids, fatty,unsaturated(C18),dimers, hydrogenatedadipicacid-1,2-propanediol, copolymer1187 Available: Molecular mass distribution andhydrolysis in simulated gastric juice (nohydrolysis). 3 mutagenicity tests with thedimeric acids were negative.Needed: Information on items 2 and 3 in theSCF guidelines in first instance (see page50-51 of the "Practical Guide N.1").(RIVM/TNO SDS, CS/PM/2648).7? Available: Same text as 31382.Needed: Same text as 31382.31440 - see 31490 D +31455 - Acids, fatty, dimerized 9 +31470 - Acids, sat., linear (C5-C10), esters withdipentaerythritol31490 - Acids, substituted (C9-C20), and their triethaNolamine salts31492 - Acrylamide-acrylic acidethylacrylateethyleneglycolmethacrylatepolyethyleneglycol(EO=5) dodecylaminetoluenediisocyanate,copolymer (Mw= 5000-15000)31495 - Acrylamide-acrylic acidmethacrylicacidpolyethyleneglycol(EO=5 and 15)dodecylamine,9 +9 +7? Available: molecular weight distributioncurve.Needed: chemical structure, migration andtoxicity data for the polymer according toSCF guidelines. Chemical structure of andand 3 mutagenicity tests forpolyethyleneglycol (EO=5) dodecylamine.7 Needed: molecular weight distributioncurve. Chemical structure ofthe polymer. Chemical structure of and 3mutagenicity tests for methacrylic acid ester++++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTcopolymer (Mw=10000-20000)31497 - Acrylamide-acrylic acidmethacrylicacidpolyethyleneglycol(EO=50)nonylphenylether, copolymer (Mw=10000-20000)31500 025134-51-4 Acrylic acid, acrylicacid, 2-ethylhexyl ester,copolymerwith polyethylenglycol (EO=15)dodecylamine and with methacrylic acidpolyethyleneglycol (EO=5) dodecylamine.7 Available: Use and average molecular mass.Needed: Structure of the polymer andmolecular mass distribution in first instance.(CS/PM/2632).3AM 3 Group restriction 6mg/kg food for acrylicacid and 0.05 mg/kg food for acrylic acid, 2-ethylhexyl ester.http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf++31505 - Acrylic acid, acrylicesters of alcohols,monohydric, primary,linear (C1-C18),copolymers31520 061167-58-6 Acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl ester31530 123968-25-2 Acrylic acid, 2,4-di-tertpentyl-6-[1-(3,5-di-tertpentyl-2-hydroxyphenyl)ethyl]phenyl ester31532 048076-38-6 Acrylic acid, eicosylester31534 025135-39-1 Acrylic acid-ethylacrylate-methylmethacrylate, copolymer31536 009010-77-9 Acrylic acid-ethylene,copolymerhttp://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdfD +DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w.3-month oral rat study. Mutagenicity studies.Migration data.No bioaccumulation in fish.(RIVM 90/678608/007; CS/PM/926).DIR SML = 5 mg/kg 3 R = 5 mg/kg food.3-month oral rat study, 3 mutagenicity tests,negative, migration data.(TNO 1994-08-08).+ +W +W +W ++119

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT31540 - Acrylic acid-maleicanhydride, copolymer(Mw= 5000-20000)31542 174254-23-0 Acrylic acid, methylester, telomer with 1-dodecanethiol, C16-C18alkyl estersSame 81960 3AM QM=0.5% w/w in finalarticle7? Needed: migration and toxicity data for thepolymer according to SCF guidelines.3 Restriction: Maximum quantity 0.5% w/w inthe final articleRemark for Commission: Restriction onmaximum quantity (QM) is proposed tocontrol migration of dodecylmercaptane ifany.++http://www.efsa.eu.int/science/afc/afc_opinions/768/afc_fcm_op_list6_2004.12.171.pdf31545 025322-25-2 Acrylic acid-methylmethacrylate, copolymer(average Mw=1000-2000dalton)31550 - Acrylic acid-methylmethacrylateethyleneglycolmonomethacrylatephosphate, copolymer(Mw= 5000-20000)120http://www.efsa.eu.int/science/afc/afc_opinions/195/opinion_afc_01_en1.pdf7? Needed: migration and toxicity dataaccording to SCF guidelines on thepolymeric additive itself.7? Available: Use.Needed: Mw distribution curve, 3mutagenicity tests for ethylenglycolmonomethacrylate phosphate monomer. Theneed for further mutagenicity tests is underdiscussion.(CS/PM/2632).D + +31560 025085-34-1 Acrylic acid-styrene,copolymer31580 - Acrylic acidvinylpyrrolidone,9 +copolymer31595 - Acrylic polymers 9 +31600 see 31700 D +31605 009003-18-3 Acrylonitrile-butadiene,copolymer31610 009010-81-5 Acrylonitrile-butadienemethacrylicacid,copolymerD +W +++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT31620 009010-94-0 Acrylonitrile-butadienemethylD +methacrylate-styrene, copolymer31640 009003-56-9 Acrylonitrile-butadienestyrene,D +copolymer31660 009003-54-7 Acrylonitrile-styrene,D +copolymer31680 see 31730 D + +31700 068411-97-2 N-Acylsarcosines where8 +the acyl group is derivedfrom the fatty acids ofcoconut oil31730 000124-04-9 Adipic acid Same 12130 DIR 1 ADI: 5 mg/kg b.w.+ +(SCF, 25th Series, 1991).31760 - Adipic acid, alkyl,9 Group R= 0.05 mg/kg b.w. +31840 025805-74-7and 025718-70-1primary (C4-C13) estersAdipic acid-1,3-benzenedimethanamine,copolymer (=adipic acid,m-xylylenediamine,copolymers)31920 000103-23-1 Adipic acid, bis(2-ethylhexyl) ester32000 000105-96-4 Adipic acid, bis(6-methylheptyl) ester32080 000110-29-2 Adipic acid, n-decyl n-octyl ester32160 068515-75-3 Adipic acid, dialkylesters (C7-C9)7? Available: Range of numerical molecularmass (Mn): 14.000 - 21300 D.Needed: Mw distribution curve.(CS/PM/2632).DIR SML = 18 mg/kg (1) 2 Statement on a new intake study.CS/PM/3276 REV.I/31920.http://europa.eu.int/comm/food/fs/sc/scf/reports/scf_reports_36.pdf8 Group R: 0.05 mg/kg b.w.Needed : toxicological data depending onmigration level (see SCF guidelines) and ifmigration exceeds 0.05 mg/kg peroxisomeproliferation studies too.8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.9 Group R: 0.05 mg/kg b.w.Available: 90-day oral rat study.Needed: in first instance specifications.++ ++++121

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTToxicological data depending on migrationlevel (see SCF guidelines) and, if migrationdata exceeds 0.05 mg/kg, peroxisomeproliferation study of the specifiedsubstances.32200 002998-04-1 Adipic acid, diallyl ester Same 12160 6A +32240 000105-99-7 Adipic acid, dibutyl ester 8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisome+32320 000105-97-5 Adipic acid, di-n-decylester32395 025212-19-5 Adipic aciddiethylenetriamineepichlorohydrin,copolymer32400 072088-98-3 Adipic aciddiethylenetriamineepichlorohydrinethyleneimine,copolymer32480 000141-04-8 Adipic acid, diisobutylester32560 027178-16-1 Adipic acid, diisodecylesterproliferation study too.Same 12190 8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation study too.1227 Available: Molecular mass distributioncurve, data on use, impurities, residualamounts of starting substances.Needed: In first instance, information onidentity of the fraction below 1000 D.DE/TNO SDS, June 1998 = CS/PM/3163REV.1/32395).(Adopted at 114th SCF meeting) (10December 1998)http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdfD +7 Group R: 0.05 mg/kg b.w.Available: inadequate 2-year oral rat study.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation study too.Same 12220 9 Group R: 0.05 mg/kg b.w.Needed: in first instance specifications and++++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT32640 033703-08-1 Adipic acid, diisononylester32720 001330-86-5 Adipic acid, diisooctylester32760 000627-93-0 Adipic acid, dimethylester32800 000151-32-6 Adipic acid, di-n-nonylester32840 001119-74-0 Adipic acid, di-noctadecylester32880 000123-79-5 Adipic acid, di-n-octylesterthen on the specified substancestoxicological data depending on migrationlevel (see SCF guidelines) and, if migrationexceeds 0.05 mg/kg, peroxisomeproliferation studies too.9 Group R: 0.05 mg/kg b.w.Available: 90-day oral rat and dog studiesand two mutagenicity studies.Needed: in first instance specifications, testfor chromosome aberrations in mammaliancells in vitro and then the remainingtoxicological tests depending on migrationlevel (see SCF guidelines) and, if migrationexceeds 0.05 mg/kg, peroxisomeproliferation studies too.9 Group R: 0.05 mg/kg b.w.Needed: in first instance specifications andthen on the specified substances providetoxicological data depending on migrationlevel (see SCF guidelines) and, if migrationexceeds 0.05 mg/kg, peroxisomeproliferation study too.8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation study too.8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation study too.8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.Same 12250 8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, if++++++123

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT32920 - Adipic acid, esters withdiols from C2-C632960 - Adipic acid, mixed esterswith 1,2-propyleneglycoland alcohols,monoh.,sat., linear (C8-C10)33040 094109-12-3 Adipic acid, mono-noctadecylester, calciumsalt33105 146340-15-0 Alcohols C12-C14secondary.beta.-(2-hydroxyethoxy)-ethoxylated33120 - Alcohols, aliph, monoh.,sat., linear, primary (C4-C24)33200 - Alcohols, aliph, monoh.,sat., linear orsecondary(C4-C22)33280 - Alcohols, aliph., monoh.,unsat., linear, (C16-C22)(except oleyl alcohol)33320 - Alcohols, cycloaliph.,monoh.(up to C18), andsubstitutedmigration exceeds 0.05 mg/kg, peroxisomeproliferation study too.9 Group R: 0.05 mg/kg b.w. +W9Group R: 0.05 mg/kg bw.Provide informations on identity.7 Needed: hydrolysis data. +W7 Evaluated in EFSA-AFC and classified inList7.http://www.efsa.eu.int/science/afc/afc_opinions/195/opinion_afc_01_en1.pdf+DIR 3 90-day oral studies, metabolic and/or + +mutagenicity studies with some substancesout of the group.(SCF, 17th Series, 1986).9 +8 Needed: toxicological data on tworepresentatives of the group according SCFguidelines.N.B. The evaluation is not applicable tooleyl alcohol.+9 +33350 009005-32-7 Alginic acid DIR 1 ADI: not specified.+(JECFA, 39M., 1992).33360 - Alginic acid, salts D ADI: 50 mg/kg b.w.+(JECFA 17 M., 1973).33440 - Alkanes (b.p.up to 1009 +degrees celsius)33460 - Alkanes, n, and iso,(C4-C14)9 ++124

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT33520 - n-Alkenes (C2-C14) 9 +33535 152261-33-1 alpha-Alkenes(C20-W +C24)maleic anhydride-4-amino-2,2,6,6-tetramethylpiperidine,polymer33540 068439-57-6 alpha-Alkene(C14-W +C16)sulphonic acid,sodium salt33550 - Alkenylnorborneneethylene,D +copolymer33565 - Alkenylnorborneneethylene-propylene,9 +copolymer33600 - C-alkenyl(C12-C18)9 +succinalkyl(C12-C18)imide33680 - Alkyl(C8-9 + +C20)arylsulphonic acid33760 - Alkyl(C8-9 +C18)arylsulphuric acid33800 - Alkyl(C10-9 +C13)benzenesulphonicacid33801 - n-Alkyl(C10-DIR SML = 30 mg/kg 2 TDI = 0.5 mg/kg b.w. based on TDI for +C13)benzenesulphonicacid52000.33820 093062-35-2 Alkyl(C8-C14)benzenesulphonicD +acid, sodiumsalt33840 - Alkyl(C11-9 +C14)bis(hydroxyethyl)sulphonium bisulphate33920 - Alkyl(C11-9 +C14)bis(hydroxyethyl)sulphonium glycolsulphate34000 - n-Alkyl(C11-C15)bis(hydroxyethyl)sulphonium sulphate9 +125

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT34015 - Alkyl caprolactone9 +phosphate34080 - n-Alkyl(C11-9 +C14)hydroxyethylsulphide34160 see 34230 D + +34165 - Alkyl(C8-9 +C18)phenoxybenezenedisulphonic acid, salts34180 - Alkyl(C14-9 +C29)poly(ethyleneglycol)glycolic acid34195 - Alkyl(C8-9 +C18)poly(ethyleneand/orpropylene-and/orbutyleneglycol)glycolicacid34225 068037-49-0 Alkyl(C10-W9 +C18)sulphonic acids34230 - Alkyl(C8-C22)sulphonicDIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w.+ +acids1- and 2-year oral rat studies (Bayer report1960).34231 - n-Alkyl(C8-2 TDI: 0.1 mg/kg bw based on TDI for 34230. +C22)sulphonic acids34240 - Alkyl(C10-C20)sulphonic acid,esters with phenolsD 7 SCF_List: 7Needed data or information:Chromosomal aberration assay in vitroaccording to prevailing guidelines,controlling the effects of test article on pHand osmolality of the medium, andproviding historical data on spontaneousaberration frequencies in the test system.Data to demonstrate the absence of potentialfor accumulation in man.(Adopted at the 136th SCF meeting, 5March 2003)http://europa.eu.int/comm/food/fs/sc/scf/out+126

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT34241 - Alkyl(C10-C20)sulphonic acidesters with cresols orcresols and phenols34245 085711-69-9 Alkyl(C13-C17-sec)sulphonic acid,sodium salts34250 085711-70-2 Alkyl(C14-C18-sec)sulphonic acid,sodium salts34275 085586-07-8 Alkyl(C12-C14)sulphuric acid, salts34280 - Alkyl(C8-C22)sulphuricacids34281 - Alkyl(C8-C22)sulphuricacids, linear, primary,with an even number ofcarbon atoms34290 - Alkyl(C16-C18)sulphuric acid, salts34292 068585-47-7 Alkyl(C10-C16)sulphuric acid,sodium salt34295 085586-07-8 Alkyl(C12-C14)sulphuric acid,sodium salt34297 073296-89-6 Alkyl(C12-C16)sulphuric acid,sodium salts34300 068955-20-4 Alkyl(C16-C18)sulphuric acid,sodium salt34400 - Alkyl(C12-C16)trimethylammoniumbromide34415 - Alkyl(C1-C12) vinylethers-allyl alcohol,copolymers127172_en.pdf9 +W +W +Same 34295 9 Look at 34281. + +9 Look at 34281. +DIR 3 Toxicologically acceptable.(CS/PM/2472 = Elias SDS 1994-11-24).9 Look at 34281. +D Covered by 34280. +Same 34275 D Covered by 34275. ++ +W +D Covered by 34290. +8 +9 +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT34430 - Alkyl(C1-C12) vinylethers - maleic acid orallyl alcohol, copolymer34445 - Alkyl(C1-C12) vinylethers-maleic acid,copolymers34452 - Allyl alcohol-vinylacetate, copolymer34470 - Aluminium calciumhydrophosphite34475 - Aluminium calciumhydroxide phosphite,hydrate34480 - Aluminium fibers, flakesand powders9 +9 +9 +D +DIR 2-3 For AluminiumL2.Group TDI= 1mg/kg b.w. based on PTWIfor Al of 7 mg/kg b.w. (SCF, 25th Series,1991).For phosphite.L3.Phosphite easily oxidised to phosphate.Available: migration data, 28-day oral ratstudy, 4 mutagenicity studies.(RIVM SDS, August 1994).DIR 2 TDI : 1 mg/kg b.w. (as Al) based on PTWI=7 mg/kg (as Al)(SCF, 25th Series, 1991).34560 021645-51-2 Aluminium hydroxide DIR 2 TDI: 1 mg/kg bw (as Al) based on PTWI: 7mg/kg b.w. (as Al).(SCF, 25th Series, 1991).34640 013170-05-3 Aluminium hydroxidebis(4-tert-butylbenzoate)W8L2 for Al.TDI: 1 mg/kg bw (as Al) based on PTWI: 7mg/kg bw (as Al).(SCF, 25th Series, 1991).++ ++ ++34650 151841-65-5 Aluminium hydroxybis[2,2’-methylenebis (4,6-di-tert.butylphenyl)phosphateW8 for bis(4-tert.butylbenzoate).18875 DIR SML = 5 mg/kg 3 SCF_List: 3Restriction: 5 mg/kg of food. Based on thereduced core set of toxicological dataaccording to the migration level.(Opinion adopted by the SCF at the 136thmeeting, 5 march 2003)http://europa.eu.int/comm/food/fs/sc/scf/out128+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT172_en.pdf34690 011097-59-9 Aluminium magnesium Same 64480 DIR 3 Inert material. +carbonate hydroxide34720 001344-28-1 Aluminium oxide DIR 2 TDI: 1 mg/kg bw (as (Al) based on PTWI: 7mg/kg b.w. (as Al).(SCF, 25th Series, 1991).34750 - Aluminium silicate,silanated34790 015306-17-9 Aluminium tris(ethylacetylacetate)34800 - Amides of acids, aliph.,monocarb. (C6-C22)34850 143925-92-2 Amines,bis(hydrogenated tallowalkyl) oxidisedDIR QM = For use only :(a) in PO at 0.1%(w/w) but not in LDPEwhen it is in contactwith foods for whichthe Dir. 85/572establishes a RF< 3; (b)in PETat 0.25 % (w/w)in contact with foodsother of those forwhich simulant D islaid down inDir.85/5721299 L2 for Al.TDI: 1 mg/kg bw based on PTWI: 7 mg/kgbw (as Al).(SCF, 25th Series 1991).+ +L9 for "silanated".W +9 +3 SCF_List: 3Restriction: Only to be used:·in polyolefins at 0.1 % (w/w) and not forfatty food with a simulant D ReductionFactor less than 3·in PET at 0.25% (w/w) and only for foodfor which simulant D is not required.Remark for Commission: To make sure thatalso for the migration of Bis(hydrogenatedtallow, C16-C18, alkyl) nitrones and(Hydrogenated tallow, C16-C18, alkyl)oximes into fatty foods a sufficient safetymargin to the NOEL in the subchronic oralrat study exists the following restriction isproposed: Qm 0,1 % in polyolefins, not forfatty foods with a Reduction Factor < 3.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf+9 +34875 - omega-Aminoacids (C6-C12)34880 - Aminoacids, salts 9 +34895 000088-68-6 2-Aminobenzamide DIR SML = 0.05 mg/kg. To 3 SCF_List: 3 ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTbe used only for PETfor water andbeverages.Restriction: 0.05 mg/kg of food. Based onthe reduced core set of toxicological dataaccording to the migration level.Remark for Commission: only requested incontact with water and beverages. Substancemay be reactive with fat components,therefore authorisation should be restrictedto requested application (PET for water andbeverages).34925 061789-40-0 3-Amino-N-(carboxymethyl)-N,N,-dimethyl-1-propanaminium, N-cocoacyl derivativeshydroxides, inNer salt34940 014205-40-4 3-Aminocrotonic acid,diester withethyleneglycol34960 - 3-Aminocrotonic acid,esters withbutyleneglycol35040 - 3-Aminocrotonic acid,esters with mono- ordihydric alcohols35120 013560-49-1 3-Aminocrotonic acid,diester with thiobis (2-hydroxyethyl) ether35160 006642-31-5 6-Amino-1,3-dimethyluracil(Opinion adopted by the SCF at the 136thmeeting, 5 March 2003)http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdfW8 +8 Available: summary on 90-day study,migration into oil (< 0.25 ppm).7 Available: 90-day oral rat study, inadequatemigration data (CS/PM/ 2034).Needed: 3 mutagenicity studies, physicochemicaland migration data, analyticalmethod.+9 +Same 92820 DIR 2 t-TDI: 5 mg/kg b.w. pending results ofmutagenicity studies.Available: 28-day and 90-day oral ratstudies, metabolism, very low migration.DIR SML = 5 mg/kg 3 R = 5 mg/kg of food.Remark for Commission: 6-amino-1,3-dimethyl-uracil hydrolyses in acetic acid.+++130

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT35170 000141-43-5 2-Aminoethanol Same67420-12763-2233735180 084434-12-8 N-(2-Aminoethyl)-betaalanine,sodium salt35200 034730-59-1 N-(2-Aminoethyl)-2-aminoethanesulphonicacid, sodium salt35280 - N-(2-Aminoethyl)-3-aminopropanesulphonicacid, saltsDIRSML = 0.05 mg/kg.Not for use in polymerscontacting foods forwhich simulant D islaid down in Directive85/572/EEC and forindirect food contactonly, behind the PETlayer131(Adopted at the 119th SCF meeting) (2December 1999)http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf3 + +Same 12765 D Available: specific migration in 3% aceticacid, 15% ethanol and 95% ethanol < 0.03mg/kg food; gene mutation assay in bacteria(negative); chromosomal aberration assay incultured mammalian cells (negative); genemutation assay in cultured mammalian cells(negative)RIVM/ISS/TNO SDS, November 1999 =CS/PM/3352 REV. I/35180.Remark for Commission:* PM/REF No. should be changed* Send a letter to the applicant, concerningthe "preparation" of the petition (poorquality of the dossier)* The commercial product (as 40% aqueoussolution) is tested in the mutagenicity assayshttp://europa.eu.int/comm/food/fs/sc/scf/out61_en.pdf8 +8 +35284 000111-41-1 N-(2- Same 12771 DIR SML = 0.05 mg/kg. 3 R = 0.05 mg/kg of food. + ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTAminoethyl)ethanolamine35288 093820-52-1 N-(2-Aminoethyl)-N-(2-hydroxyethyl)-betaalanine,N-cocoacylderivatives,monosodium salts(+)35294 090268-48-7 4-Amino-4-oxo-2-sulfobutyric acid, N-tallow alkyl derivatives,disodium saltsNot for use in polymerscontacting foods forwhich simulant D islaid down in Directive85/572/EEC and forindirect food contactonly, behind the PETlayer.Remark: substance evaluated only for therequested use for indirect contact with nonfattyfood.(Adopted at the 121 SCF meeting (20 June2000))http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdfW8 +W8 +35320 007664-41-7 Ammonia Same12789 DIR 1 ADI: not specified.+ +(SCF, 25th series, 1991).35340 001066-33-7 Ammonium bicarbonate D +35440 012124-97-9 Ammonium bromide DIR 1 Group ADI: 1 mg/kg b.w. (as Br) aspesticide residue.(JMPR "Pesticide residues in food", 1988,paper 93/2).+35520 012125-02-9 Ammonium chloride 1/D ADI: not specified.(SCF, 25th Series, 1991).35600 001336-21-6 Ammonium hydroxide DIR 1 ADI: not specified.(SCF, 25th Series, 1991)35680 001314-60-9 Antimony pentoxide 6B R : 0.01 mg/kg (as Sb) in food.Very low EEC limit for drinking water: 0.01mg/1.Needed: actual use.35760 001309-64-4 Antimony trioxide DIR SML = 0.02 mg/kg(expressed asAntimony andanalytical toleranceincluded)3 Restriction 0.04 mg/kg of food (as Sb)Remark for Commission: Migration limitmight be exceeded at very high temperature.http://www.efsa.eu.int/science/afc/afc_opinions/190/opinion_afc_06_en1.pdf+ ++ +++ +132

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CThttp://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf35840 000506-30-9 Arachidic acid Same 12810 DIR 0 + +35845 007771-44-0 Arachidonic acid Same 12813 DIR 0 + +35880 - Aromatic sulphonic9 +acids-formaldehyde,copolymer35920 - Arylsulphonic acid 9 +35960 001332-21-4 Asbestos 5 [There is well-known occupational hazard +and the disposal of materials containingasbestos may constitute an environmentalhazard.]36000 000050-81-7 Ascorbic acid DIR 1 Acceptable.+ +(SCF, 22th Series, 1989).36080 000137-66-6 Ascorbyl palmitate DIR 1 Acceptable.+(SCF, 22th Series, 1989).36160 010605-09-1 Ascorbyl stearate DIR 1 Acceptable.+Covered by the assessment for ascorbylpalmitate.36240 - Azelaic acid, alkyl,9 Group R: 0.05 mg/kg b.w. +primary(C1-C12) esters36320 000103-24-2 Azelaic acid, bis(2-ethylhexyl) ester36400 000106-03-6 Azelaic acid, bis(6-methylheptyl) ester36480 000109-31-9 Azelaic acid, di-n-hexylester1337 Group R: 0.05 mg/kg b.w.Available: inadequate 90-day study.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeprn_8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation study too.7 Group R: 0.05 mg/kg b.w.Available: 90-day and 2-year oral rat, 1-yearoral dog studies.Needed: toxicological data depending onmigration level (see SCF guidelines) and ifmigration exceeds 0.05 mg/kg peroxisome+++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT36560 002064-80-4 Azelaic acid, di-n-octylester36640 000123-77-3 Azodicarbonamide DIR See CommissionDirective 2004/1/EC‘For use only asblowing agent. Useprohibited as from 2August 2005.’36720 017194-00-2 Barium hydroxide DIR SML(T) = 1 mg/kg(12) (expressed asBarium)36800 010022-31-8 Barium nitrate DIR SML(T) = 1 mg/kg(12) (expressed asBarium)proliferation studies too.8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF g uidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation study too.3 SCF_List: 3Restriction: Only as a blowing agent and notfor materials intended for contact withalcoholic beverages.http://www.efsa.eu.int/science/afc/afc_opinions/1005/afc_op_ej219_semicarbazide_en1.pdf.http://www.efsa.eu.int/science/afc/afc_documents/364/p_afc_doc_03_en11.pdfhttp://www.efsa.eu.int/science/afc/afc_documents/525/semicarbazide_afc_state02_1oct_en1.pdfhttp://www.efsa.eu.int/science/afc/afc_documents/365/p_afc_doc_0111.pdfSee SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf3 R: 1 mg/kg (as Ba) in food(Rivm doc. May 1992 (CS/PM/1584)).2-3 List 2 for nitrateTDI: 3 mg/kg bw (for nitrate) based on ADI= 5 mg/kg bw on sodiumnitrate.(SCF, 26 Series, 1992).+++ ++List 3 for BariumR: 1 mg/kg (as Ba) in food.(Rivm doc., May 1992 (CS/PM/1584)).36840 012007-55-5 Barium tetraborate DIR SML(T) = 1 mg/kg 2-3 Re-evaluation on the basis of an opinion of +134

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTexpressed as Barium(12) and SML(T) = 6mg/kg (23) (expressedas Boron) withoutprejudice to theprovisions of Directive98/83/EC on water forhuman consumption(OJ L 330, 5.12.1998,p.32).135the SCF in another context.List 3 for Barium.R = 1 mg/kg (as Ba in food).RIVM SDS, May 1992 = CS/PM/1584.List 2 for Borate.Group-TDI = 0.1 mg/kg b.w. (as B) (withREF_n. 36840, 40320 and 87040).The TDI is based on the No Adverse EffectLevel (NOAEL) of 9.6 mg/kg b.w./day foreffects on fetal body weight and skeletalanomalies in the rat developmental study. ASafety Factor (SF) of 100 is used.“Opinion of the Scientific Committee onFood on Arsenic, Barium, Fluoride, Boronand Manganese in Natural Mineral Waters(expressed on 13 December 1996, 105thplenary meeting of the SCF, completed on13 June 1997 at the 107th plenary meetingof the SCF; 43rd Series of Reports of theSCF, 2000”. This opinion is also availableon Internet.(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf36880 008012-89-3 Beeswax DIR 0 + +36960 003061-75-4 Behenamide DIR 3 Metabolized to ammonia and behenic acid +37040 000112-85-6 Behenic acid Same 12990 DIR 0 + +37120 - Behenic acid, esters with7 Needed: hydrolysis data. +pentaerythritol37200 053161-46-9 Behenic acid,7 Needed: hydrolysis data. +monoesters withpentaerythritol37240 - Behenic acid, salts D +37280 001302-78-9 Bentonite DIR 3 Inert material. + +37360 000100-52-7 Benzaldehyde DIR In compliance with 1 Group ADI = 5 mg/kg b.w. as benzoic acid. +note 9 in Annex VI(JECFA 11 M., 1967)37440 000080-17-1 Benzenesulphonic acidhydrazide6A +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT37520 002634-33-5 1,2-Benzisothiazolin-3-one7 Under re-evaluationMicrobiological data missing.t-TDI: 0.02 mg/kg bw.+ +? Under re-evaluation +37530 111337-53-2 1,2-Benzisothiazolin-3-one, lithium salt37600 000065-85-0 Benzoic acid Same 13090 DIR 1 Group ADI: 5 mg/kg b.w.(JECFA 27 M., 1983).37680 000136-60-7 Benzoic acid, butyl ester DIR 2 Group TDI: 5 mg/kg b.w. as benzoic acidfor butyl-, ethyl-, methyl-, propylbenzoateon the basis of the Group ADI for benzoicacid.(JECFA 27 M., 1983)37760 - Benzoic acid, esters withD +1,2-propanediol37840 000093-89-0 Benzoic acid, ethyl ester DIR 2 Group TDI: 5 mg/kg b.w. as benzoic acidfor butyl-, ethyl-, methyl-, propylbenzoateon the basis of the Group ADI for benzoicacid.(JECFA 27 M., 1983).+37920 000136-36-7 Benzoic acid, 3-hydroxyphenyl ester38000 000553-54-8 Benzoic acid, lithium salt DIR SML(T) = 0.6 mg/kg(8) (expressed asLithium)7 Needed: hydrolysis data. +1-2 L1 for benzoic acid.Group ADI: 5 mg/kg b.w..(JECFA 27M., 1983).+++38080 000093-58-3 Benzoic acid, methylester38160 002315-68-6 Benzoic acid, propylesterL2 for Lithium.Group TDI: 0.01 mg/kg b.w. (as Li).Available: 90-day oral rat studies,mutagenicity data, therapeutic use of Lisalts.(Rivm summary, Sept. 1991).DIR 2 Group TDI: 5 mg/kg b.w. as benzoic acidfor butyl-, ethyl-, methyl-, propylbenzoateon the basis of the Group ADI for benzoicacid.(JECFA 27 M., 1983).DIR 2 Group TDI: 5 mg/kg b.w. as benzoic acidfor butyl-, ethyl-, methyl-, propylbenzoateon the basis of the Group ADI for benzoicacid.136++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(JECFA 27 M., 1983).38240 000119-61-9 Benzophenone DIR SML = 0.6 mg/kg 2 Group TDI: 0.01 mg/kg b.w.90-day oral rat study and metabolism study(CIVO report R 3301, 1970).38320 005242-49-9 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene38480 000056-93-9 Benzyltrimethylammonium chloride38500 066822-60-4 Betaine type methacrylicpolymer (Nmethacrylolylethyl-N,Ndimethylammonium-alpha-Nmethylcarboxylate,octadecyl methacrylate,ethylmethacrylate,cyclohexylmethacrylate,n-vinyl-2-pyrrolidone,copolymers38505 351870-33-2 cis-endo-Bicyclo[2.2.1]heptane-2,3-dicarboxylic acid,disodium saltDIRIn compliance with thespecifications laiddown in Annex V1373 R = Maximum amount to be used 0.05%(w/w).8 +Same 65920 D +3AM 3 Restriction: 5 mg/kg of food (based on adaily consumption of 1 kg of packaged foodper person. This restriction wouldcorrespond to a maximum intake of 0.1 mgcis-endo-bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, disodium salt /kg b.w./daySuch figure is at least two orders ofmagnitude lower than the NOAEL whichcan be extrapolated from the results on themost sensitive species.)Remark for Commission: Not to be usedwith polyethylene in contact with acidicfoodsHydrophilic substance (based on logPo/w,and on highest migration into acidic foods)The purity of the substance tested was >=98.8%The petitioner applies only forpolypropylene (all food types) andpolyethylene (non acidic foods)http://www.efsa.eu.int/science/afc/afc_opini+++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT38510 136504-96-6 1,2-Bis(3-aminopropyl)ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and2,4,6-trichloro-1,3,5-triazine38515 001533-45-5 4,4'-Bis(2-benzoxazolyl)stilbeneons/190/opinion_afc_06_en1.pdfDIR SML = 5 mg/kg 3 R: 5 mg/kg of food. +DIR SML = 0.05 mg/kg (1) 3 R: 0.05 mg/kg food.Available: 3 mutagenicity tests, negative andmigration data.(RIVM SDS of 1994-10-25 and 1996-05-03= CS/PM/2463 and CS/PM/2791).+ +38530 032509-66-3 Bis(3,3-bis(4-hydroxy-3-tert-butylphenyl)butanoicacid), ester withethyleneglycol38560 007128-64-5 2,5-Bis(5-tert-butyl-2-benzoxazolyl)thiophene38565 090498-90-1 3,9-Bis[2-(3-(tert.butyl-4-hydroxy-5-methylphenyl)propionyloxy)-tert.butyl]-2,4,8,10-tetraoxaspiro[5.5]undecane38580 057569-40-1 Bis(2-tert-butyl-4-methyl-6-(3-tert-butyl-5-methyl-2-Remark: since high migration into fat hasbeen demonstrated with the exception ofPET, the WG recommends that theCommission take the necessary measures sothat the restriction proposed is not exceeded.Same 53670 D + +DIR SML = 0.6 mg/kg 2 TDI: 0.01 mg/kg b.w.90-day oral dog and rat studies, 1-year (+0.5-year recovery) study in mice showedaccumulation in tissues by fluorescence.(RIVM, doc. tox. 300/277, June 1981).W7 Available: Migration data, 3-month oral ratstudy; 3 (negative) in vitro mutagenicitystudies, high bioaccumulation potential.138Needed: data demonstrating absence ofbioaccumulation in vivo, especially in liverand fat.(RIVM SDS, = CS/PM/2994/38565).Same 92205 D ++ ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CThydroxybenzyl)phenyl)terephthalate38600 000078-63-7 2,5-Bis(tert-9 Specification for use. +butylperoxy)-2,5-dimethylhexane38615 002212-81-9 1,3-Bis(tertbutylperoxyisopropyl)be9 Specification for use. +nzene38625 002781-00-2 1,4-Bis(tertbutylperoxyisopropyl)be9 Specification for use. +nzene38640 see 38700 D +38700 063397-60-4 Bis(2-carbobutoxyethyl)tinbis(isooctylmercaptoacetate)38720 105350-68-3 2,2-Bis[4-(2-(3,5-di-tertbutyl-4-hydroxyhydrocinnamoyloxy))ethoxyphenyl]-propane38750 000118-82-1 Bis(3,5-di-tert-butyl-4-hydroxyphenyl)methane38780 023128-74-7 N,N'-Bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hexamethylenediamine38800 032687-78-8 N,N'-Bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide38810 080693-00-1 Bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphiteDIR SML = 18 mg/kg 2 t-TDI: 0.3 mg/kg b.w. pending additionalmutagenicity studies.Available: 28-day in young rats and 90-dayoral rat studies and Ames test.(RIVM report 89/678608/003, 1989-04-04).+W +Same 66320 D +Same 59120 D + +DIR SML = 15 mg/kg 2 TDI: 0.25 mg/kg b.w.3 month oral rat study, mutagenicity studies.Migration data.(RIVM, September 1990).DIRSML = 5 mg/kg (sumof phosphite andphosphate)3 R = 5 mg/kg of food (sum of phosphite andphosphate).Remark for Commission: only migrationdata of the additive from polypropylene intofood simulants are available.(Adopted at 111th SCF meeting (18-19March 1998)).+ ++139

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT38820 026741-53-7 Bis(2,4-di-tertbutylphenyl)pentaerythritoldiphosphite38840 154862-43-8 Bis(2,4-dicumylphenyl)pentaerythritol-diphosphite38879 135861-56-2 Bis(3,4-dimethylbenzylidene)sorbitolhttp://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdfDIR SML = 0.6 mg/kg 2 TDI: 0.01 mg/kg b.w.90-day oral rat and 4-month oral dog studiesand Ames test.(RIVM, Doc. Tox. 300/335, June 1982).DIR SML = 5 mg/kg (as 3 R =5 mg/kg of food (assigned to Doverphossum of the substanceS-9228 including the stabiliser itself, itsitself, its oxidised form oxidised form bis (2,4-dicumylphenol)bis(2,4-pentaerythritol-phosphate and its hydrolyseddicumylphenyl)pentaer product (2,4-dicumylphenol).ythritol-phosphate andits hydrolysis product (Adopted at the 126th SCF meeting, 28(2,4-dicumylphenol)). February 2001)http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdfDIR 2 Group TDI = 1 mg/kg bw (with 39760 and38920).Available: 3 mutagenicity studies negative,3 months oral rat study, bioaccumulationand migration data.(RIVM report 1995-08-22, CS/PM/2650).38880 see 38820 D +38885 002725-22-6 2,4-Bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-octyloxyphenyl)-1,3,5-triazineW7 +38920 see 38950 D +38940 110675-26-8 2,4-Bis(dodecylthiomethyl)-6-methylphenol+38950 079072-96-1 Bis(4-ethylbenzylidene)sorbitol3AM 3 Restriction: Group restriction of 5 mg/kgfood as sum of 2,4-bis(dodecylthiomethyl)-6-methylphenol and2,4-bis(octylthiomethyl)-6-methylphenolRemark for Commission: FRF is applicablehttp://www.efsa.eu.int/science/afc/afc_opinions/768/afc_fcm_op_list6_2004.12.171.pdfDIR 2 Group TDI: 1 mg/kg b,w. (with bis(4-ethylbenzylidene) sorbitol,bis(methylbenzylidene) sorbitol and++++140

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTdibenzylidene sorbitol).Several 90-day mouse and rat studies,several mutagenicity tests negative.(RIVM Doc. 88/678608/008, 1 Nov. 1988;RIVM Doc. Tox 300/425, May 1983, RIVM15 Nov. 1989).38960 035958-30-6 2,2-Ethylidene-bis-(4,6- Same 39060 D +di-t-butylphenol)38970 - N,N-Bis-(2-8 +ethylhexyl)glycine,sodium salt39010 000088-24-4 Bis(2-hydroxy-3-tert-Same 66400 D +butyl-5-ethylphenyl)methane39025 000119-47-1 Bis(2-hydroxy-3-tert-Same 66480 D +butyl-5-methylphenyl)methane39040 see 39090 D + +39045 004066-02-8 Bis(2-hydroxy-3- Same 66560 D +cyclohexyl-5-methylphenyl)methane39060 035958-30-6 1,1-Bis(2-hydroxy-3,5-di-tertbutylphenyl)ethaneSame 38960 DIR SML = 5 mg/kg 3 R: 5 mg/kg in food.Available: 3-month oral rat and dog studies,reproduction study and tests formutagenicity negative.+39090 - N,N-Bis(2-hydroxyethyl)alkyl(C8-C18)amineDIRSML(T) = 1.2 mg/kg(13)(RIVM doc. February 1992).2 Nota beneSubstance evaluated in the past (AdditionalList of Monomers and Additives Evaluatedby the WG "Food Contact Materials" of theSCF During the 69th-70th Meetings(adopted during the 107th SCF meeting of12 and 13 June 1997 seehttp://europa.eu.int/comm/food/fs/sc/oldcomm7/out12_en.html ) Only a clarification ofthe expression "free amine" appearing in theSCF restrictions of the substance 39120 (seebelow) was requested to the SCF. Therefore,this is not a re-evaluation of the substance+ +141

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT39120 - N,N-Bis(2-hydroxyethyl)alkyl(C8-C18)aminehydrochlorides39140 000136-26-5 N,N-Bis(2-hydroxyethyl)decanamide39160 000111-46-6 Bis(2-hydroxyethyl)ether39200 006200-40-4 Bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy)methylammonium chloride39280 000120-40-1 N,N-Bis(2-hydroxyethyl)lauramideSame15760,13326and 47680DIRSML(T) = 1.2 mg/kg(13) expressed astertiary amine(expressed excludingHCl)because of new data.Group t-TDI = 0.02 mg/kg b.w. (with REFn.39120).Needed: three in vitro mutagenicity studiesaccording to guidelines on either REF_N.39090 or 39120.Remark: on the basis of the available studiesit remains included in the group t-TDIpending the results of the requiredmutagenicity studies. If negative it will beclassified in L3 with a restriction of 5 mg/kgof food.NOTE: both substances are covered whenthe mutagenicity studies are submitted.(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf2 Group t-TDI = 0.02 mg/kg b.w. expressed as +tertiary amine (expressed excluding HCl)(with REF_n. 39090).(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf7? Same references as 39280. +D +DIR SML = 1.8 mg/kg 2 TDI: 0.03 mg/kg b.w.90-day oral rat study.(CIVO report R2491 September. 1967 and2628 February 1968).Same 63560 7? Available: 3-month oral rat and dog studieswith different diethanolamides of fatty acids.Three mutagenicity studies, negative.Migration data.++142

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT39360 - N,N-Bis(2-hydroxyethyl)octadecylamine, N(2-hydroxyethyl-N-octadecylglycine(monosodium salt/and N,N'-bis(hydroxyethyl)-N-(carboxymethyl)octadecanaminiumhydroxide (inNer salt)compon. mixt. ofreaction as maJorcomponents of mixtureprepared by reac39440 058767-50-3 N,N-Bis(2-hydroxyethyl)-N-(noctyl)-Nmethylammonium4-toluenesulphonate39480 000093-83-4 N,N-Bis(2-hydroxyethyl)oleamide39520 000093-82-3 N,N-Bis(2-hydroxyethyl)stearamide39560 000077-99-6 2,2-Bis(hydroxymethyl)-1-butanol39600 000077-62-3 Bis(2-hydroxy-3-(1-methylcyclohexyl)-5-methylphenyl)methane39665 054208-63-8 Bis(2-hydroxyphenyl)methanebis(2,3-epoxypropyl)ether (=BFDGE)143Needed: Reason for the choice of testsample (polymer and concentration ofadditive) for migration test, stability ofadditive in food simulants under the testconditions applied, physical-chemical dataincluding Po/w and data on use.(RIVM SDS May 1996 = CS/PM/2801).9 +8 +7? Same references as 39280. +7? Same references as 39280. +Same 13380,25600 and94960D + +Same 66580 D +Same 13460;12976DAccording toCommission Directive2002/16/EC of 20February 2002 on the7 http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT39680 000080-05-7 2,2-Bis(4-hydroxyphenyl)propane39700 001675-54-3 2,2-Bis(4-hydroxyphenyl)propanebis(2,3-epoxypropyl)ether (=BADGE)Same13480/13607/62540/40060/19255Same1297413510;13610;use of certain epoxyderivatives in materialsand articles intended tocome into contact withfoodstuffs.Can still be used inheavy duty coatings.DIR SML= 0.6 mg/kg (28) 2 http://europa.eu.int/comm/food/fs/sc/scf/out128_en.pdfDIRAccording toCommission Directive2002/16/EC of 20February 2002 on theuse of certain epoxyderivatives in materialsand articles intended tocome into contact withfoodstuffs2-3 On the basis of the available experimentaldata, a TDI can be established for BADGEand its hydrolysis products. Considering theNOAEL of 15 mg/kg b.w./day observed inthe oral chronic toxicity/carcinogenicitystudy in the rat with BADGE, and applyingan uncertainty factor of 100, a TDI of 0.15mg/kg b.w. can be established for BADGE.As BADGE is rapidly and extensivelymetabolised in vivo into the correspondingmono- and bis-diol derivatives, the Panelincludes these in the TDI.For the other regulated BADGE reactionproducts, i.e. the BADGE chlorohydrinsBADGE.2HCl, BADGE.HCl,BADGE.HCl.H2O, in view of the lack ofgenotoxicity, the Panel considers that thecurrent restriction of 1 mg/kg of foodremains appropriate.The Panel is aware that other BADGEreaction products, with undefinedtoxicological propertiesand chemical identity, may be found at lowlevels in the migrate from epoxy coatings.For the assessment of these, and in generalof minute amounts of unknown migrantsfrom food contact materials, a generalapproach is currently under consideration bythe Panel.++ +144

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT39715 025036-25-3 2,2-Bis(4-hydroxyphenyl)propane -2,2-bis(4-hydroxyphenyl)propanebis(2,3-epoxy-propyl)ether, copolymer39730 025068-38-6 2,2-Bis(4-hydroxyphenyl)propaneepichlorohydrin39750 025265-71-8and 000110-98-5EFSA opinion from 13 July 2004http://www.efsa.eu.int/science/afc/afc_opinions/508/opinion_afc13_ej86_badge_v2_en1.pdfSee the individual opinion on the substance(CS/PM/2812 Rev.1) which is reported inthe Internet website:http://europa.eu.int/comm/food/fs/sc/scf/out28_en.pdfW +9 +copolymerBis(hydroxypropyl) ether Same 51760 D + +39760 see 39890 D + +39815 182121-12-6 9,9-Bis(methoxymethyl)fluorene+DIR QMA = 0.05 mg/6 dm² 3 R: 0.05 mg/kg of food.Available: Maximum worst case migrationis calculated to be 0.034 mg/kg; Ames assay(negative); in vitro chromosomal aberrationassay (positive); in vitro mammalian cellgene mutationassay (negative); mouse bone marrowmicronucleus assay (negative); rat bonemarrow chromosome analysis (negative); invivo UDS in rat liver (negative).(RIVM/ISS/UK SDS, October 1997 =CS/PM/ 3081/39815).(adopted at 113rd SCF meeting)(17-18September 1998)http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html145

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT39890 087826-41-3and 069158-41-4 and054686-97-4/081541-12-0Bis(methylbenzylidene)sorbitol39920 000085-60-9 1,1-Bis(2-methyl-4-hydroxy-5-tertbutylphenyl)butane39925 129228-21-3 3,3-Bis(methoxymethyl)-2,5-dimethylhexaneDIR 2 Group TDI: 1 mg/kg b.w. (with bis(4-ethylbenzylidene)sorbitol andbis(methylbenzylidene) sorbitol).28- and 90-day oral rat studies, one in-vitromutagenicity study.See references for bis(4-ethylbenzylidene)sorbitol.Same 40770 7? Available: data from 30- and 90-day oral ratstudies inadequate.Needed: in first instance migration andmutagenicity data.DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg of food.Available: worst case migration levels basedon compositional analysis and assumptionof 1000% migration from 250 um layerthickness; gene mutation assay in bacteria(negative); chromosomal aberration assay incultured mammalian cells (negative); twogene mutation assays in cultured mammaliancells (positive); in vivo UDS assay in ratliver (negative); in vivo micronucleus assay(negative).(RIVM/ISS/UK SDS, November 1998 =CS/PM/3223 REV. I/39925).Remark for Commission: No method ofanalysis for the determination of an SML isavailable.+ +++39980 - Bis(N,N'-methyl-beta-hydroxyethyl)-hexamethylenebisurea40000 000991-84-4 2,4-Bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-(Adopted at 116th SCF meeting) (24 March1999)http://europa.eu.int/comm/food/fs/sc/scf/out27_en.pdf8 +DIR SML = 30 mg/kg 2 TDI: 0.5 mg/kg b.w.90-day oral rat and dog studies.(RIVM monograph 300/211, December+ +146

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTtriazine 1980).DIR SML(T) = 5 mg/kg(41) with 3894040020 110553-27-0 2,4-Bis(octylthiomethyl)-6-methylphenol1472 TDI: 0.1 mg/kg b.w.Available: 1- and 3-month oral rat studiesand teratogenicity studies in rats.Bioaccumulation and mutagenicity studiesand migration data. (RIVM90/6786008/008).40040 013259-35-3 Bis(pentaerythritol)9 +adipate40060 000080-05-7 Bisphenol A SameD http://europa.eu.int/comm/food/fs/sc/scf/out +13480/13607/19255//39680/62540128_en.pdf40080 013879-32-8 Bis(phenoxyethyl)formal 8 +40120 - Bis(polyethyleneglycol)hydroxymethylphosphonate+DIR SML = 0.6 mg/kg 3 R = 0.6 mg/kg foodAvailable: migration data (< 0.1 mg/kg);gene mutation assay in bacteria (negative);chromosomal aberration assay in culturedmammalian cells (negative); gene mutationassay in cultured mammalian cells(negative); 90-day oral rat study.Remark: no accumulation is expected.RIVM SDS, November 2000 =CS/PM/3813/40120.Remark (reasoning for calculating therestriction):Current approach is not setting a TDI basedon abovementioned data-package.The restriction is calculated based on the“LOAEL” of 5 mg/kg b.w. (90-day study;change in thymus weight and liver changes)and making use of a safety factor of 500 (10for intraspecies; 10 for interspecies and 5 forLOAEL to NOAEL). Body weight of 60 kgis used in the calculation.(Adopted at the 128th SCF meeting, 12 July2001)+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT40160 061269-61-2 N,N'-Bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane,copolymerhttp://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdfDIR SML = 2.4 mg/kg 2 t-TDI: 0.04 mg/kg b.w.Available: 90-day oral rat study, ratteratogenicity study and mutagenicity study.(HRC reports MTI 135/85733/ST, 24Sept.1985 and MTI 133/85540, 14 August1985 plus Farmitalia report 6 March 1985).+40240 - Bis(triethyleneglycol)hydroxymethylphosphonate40320 010043-35-3 Boric acid Same 13620 DIR SML(T) = 6 mg/kg(23) (expressed asBoron) withoutprejudice to theprovisions of Directive98/83/EC on water forhuman consumption*.148Needed: Usage data, results of mutagenicitystudy in eukaryotic cells.(CS/PM/2632).D t-TDI: 0.01 mg/kg b.w.Available: 90-day oral rat study andmigration < 0.1 ppm.(RIVM doc. Oct. 1970).Needed: mutagenicity studies.2 Re-evaluation on the basis of an opinion ofthe SCF in another context.Group-TDI = 0.1 mg/kg b.w. (as B) (withREF_n. 36840, 40320 and 87040).The TDI is based on the No Adverse EffectLevel (NOAEL) of 9.6 mg/kg b.w./day foreffects on fetal body weight and skeletalanomalies in the rat developmental study. ASafety Factor (SF) of 100 is used.“Opinion of the Scientific Committee onFood on Arsenic, Barium, Fluoride, Boronand Manganese in Natural Mineral Waters(expressed on 13 December 1996, 105thplenary meeting of the SCF, completed on13 June 1997 at the 107th plenary meetingof the SCF; 43rd Series of Reports of theSCF, 2000”. This opinion is also availableon Internet.(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT40400 010043-11-5 Boron nitride DIR 3 Inert, insoluble material. +40460 000052-51-7 2-Bromo-2-nitro-1,3-8 +propanediol40480 007166-19-0 2-Bromo-2-nitrostyrene 8 +40490 009041-40-1 Butadienedivinylbenzene,9 +copolymer40500 - Butadienedivinylbenzene-methyl9 +methacrylate-styrene,copolymer40510 009052-84-0 Butadienedivinylbenzene-styrene,9 +copolymer40520 - Butadiene-methacrylic9 +esters of alcohols,aliphatic, monohydric,saturated (C1-C18)-styrene, copolymers40530 - Butadiene-2-methyl-1,3-9 +butadiene, copolymer40535 - Butadiene-2-methyl-1,3-9 +butadiene-styrene,copolymer40545 025053-09-2 Butadiene-methylD +methacrylate-styrene,copolymer40555 009003-55-8 Butadiene-styrene,D +copolymer40560 see 40630 D +40570 000106-97-8 Butane DIR 3 Volatile compound. +40580 000110-63-4 1,4-Butanediol Same 13720 DIR SML(T) = 0.05 mg/kg 3 Same reference as 13720.+ +(24)(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf40590 000071-36-3 1-Butanol Same 13840 3 See references for "Alcohols, aliphatic,monohydric, saturated, linear, primary (C4-C24)" (PM/REF.N. 33120) in SCF list 3.+ +149

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT40592 000078-92-2 2-Butanol Same 13842 8 + +40594 000075-65-0 tert-Butanol Same 13845 3 Residue in food less than 10 mg/kg.+(SCF, 11th Series, 1981; EHC 65).40597 025895-47-0 1-Butene-ethylenepropylene,copolymer3 Specifications: copolymer with averagemolecular weight about 58000 Daltons, max.% of use = 2% in finished product.+40600 - Butene-ethylenepropylene-vinylestersunsaturatedaliphaticacids (inCluding theirsalts and esters),copolymers150Toxicologically acceptable.(RIVM SDS 1995-01-24).D +40618 005131-66-8 1-Butoxy-2-propanol 8 +40621 025767-47-9 Butyl acrylate-styrene,W +copolymer40624 028185-36-6 Butyl acrylatevinylpyrrolidone,copolymer9 +40630 002782-40-3 N-Butylbenzamide 8 +40632 004299-07-4 2-Butyl-benzo[d]isothiazolin-3-one+7 Available: calculation of maximummigration assuming 100% migration of theadditive over lifetime of the FCM; analyticalmethod for the determination of 2-butylbenzo[d]isothiazolin-3-onein PVC; logPo/w; gene mutation assay in bacteria(negative); chromosomal aberration assay incultured mammalian cells (positive); genemutation assay in cultured mammalian cells(negative); in vivo micronucleus assay(negative; however no indication that thesubstance reached the bone marrow); in vivoUDS assay (negative); 90-day oral rat study.Needed:. "Evidence of absence of any preservativeeffect with the food". Migration data and a well-described

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTmethod.RIVM/TNO SDS, August 2000 =CS/PM/3132 REV. I/40632.Remark: discussion with WG-FMH on themethod/details (will be determined later on).(Adopted by the SCF :http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html )40640 000098-29-3 4-tert-butylcatechol Same 14005 8 +40700 000075-91-2 tert-Butyl hydroperoxide W +40720 025013-16-5 tert-Butyl-4-DIR SML = 30 mg/kg 1 t-ADI: 0.5 mg/kg b.w.+hydroxyanisole (=BHA)(SCF, 22th Series, 1989).40770 000085-60-9 4,4'-Butylidenebis(6-tert-Same 39920 D +butyl-m-cresol)40800 013003-12-8 4,4'-Butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecylphosphite)40820 009011-53-4 Butyl methacrylateisobutylmethacrylate,copolymer40830 025608-33-7 Butyl methacrylatemethylmethacrylate,copolymerDIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w.90-day oral rat study.(CIVO report 5254, February 1977).W +W +40840 001638-22-8 4-Butylphenol 8 +40865 050696-71-4 tert-Butylphenol Same 47120 D +disulphide40880 015666-29-2 Butylthiostannoic acid D See '47210'. +40960 026935-10-4 Butylurethaneformaldehyde,copolymerSame 40635 D +40980 019664-95-0 Butyric acid, manganesesaltDIRSML(T) = 0.6 mg/kg(10) (expressed asManganese)2 L0 for butyric acid.L2= 0.01 mg/kg b.w. (as Mn).TDI: 0.01 mg/kg (as Mn).See references for 30180 in L2 in this report.41000 000096-48-0 gamma-Butyrolactone 8 +41010 ? Calcium aluminium D +++151

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CThydroxyphosphite, basic41020 065140-91-2 Calcium bis(3,5-di-tertbutyl-4-hydroxybenzyl-Same 46880 D + +monoethyl)phosphonate41040 005743-36-2 Calcium butyrate DIR 0 + +41120 010043-52-4 Calcium chloride DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1991)41200 007789-75-5 Calcium fluoride 7? Needed: migration data. +41280 001305-62-0 Calcium hydroxide DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1991)41360 010101-39-0 Calcium metasilicate 7? Needed: migration data. +41440 - Calcium 2-8 +methoxybenzoate41520 001305-78-8 Calcium oxide DIR 1 ADI: not specified.+ +41600 012004-14-7and 037293-22-4Calciumsulphoaluminate(SCF, 25th Series, 1991)DIR 2 TDI: 1 mg/kg bw (as Al) based on PTWI= 7mg/kg bw (as Al).(SCF, 25th Series, 1991).41680 000076-22-2 Camphor DIR In compliance with 3 Natural compound with strong flavour. +note 9 in Annex VI41760 008006-44-8 Candelilla wax DIR 3 Natural wax. Purity to be specified. + +41800 000142-62-1 Caproic acid Same 18770D + +and 5936041840 000105-60-2 Caprolactam Same 14200. DIR SML(T) = 15 mg/kg(5)+41920 - epsilon-Caprolactoneethyleneimine-lauricacid, copolymer41960 000124-07-2 Caprylic acid Same 1432042000 063438-80-2 (2-Carbobutoxyethyl)tintris(isooctylmercaptoacetate)and 685601522 Group TDI: 0.25 mg/kg b.w.Two 90-day oral rat studies and 90-day oralstudies in mice and dogs.(CIVO report 3489 June 1971 and NTP tech.Rep. Ser. 214, NTP 80-26).W9In first instance provide information onidentity.DIR 0 + +DIR SML = 30 mg/kg 2 t-TDI: 0.5 mg/kg b.w. pending additionalmutagenicity studiesAvailable: 35-day in young and 90-day oralrat studies and Ames test.(RIVM report 89/678608/002, 1989-04-04).+++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT42080 001333-86-4 Carbon black 3 Under re-evaluation.+ +----------------------------------------------------Criteria purity shall be established. Carbonblack should be free from aromatichydrocarbons (CS/PM/2041).42160 000124-38-9 Carbon dioxide DIR 1 ADI: not specified.+(JECFA 23rd M., 1980).42240 - Carbon fibers 9 +42320 007492-68-4 Carbonic acid, coppersaltDIRSML(T) = 30 mg/kg(7) (expressed asCopper)2 For Copper. Same as Ref.No 30080. +42360 010290-71-8 Carbonic acid, iron salt D + +42400 010377-37-4 Carbonic acid, lithiumDIR SML(T) = 0.6 mg/kg 2 Group TDI: 0.01 mg/kg b.w. (as Li). +salt(8) (expressed asSee references for benzoic acid, lithium salt.42480 000584-09-8 Carbonic acid, rubidiumsaltLithium)DIR SML = 12 mg/kg 2 TDI: 0.2 mg/kg b.w.90-day oral rat study on diet low in K+.Normal food may contain up to 140 mg/kg,average daily intake for man 1-4 mg.(RIVM 617601002, 1981).42500 - Carbonic acid, salts DIR 1 ADI: not specified for carbonate.(SCF, 25th Series, 1991)42560 - Carbon vegetable 1/D Food grade acceptable.(SCF, 4th Series, 1977).42640 009000-11-7 Carboxymethylcellulose DIR 2 Group TDI: not specified based on GroupADI (=not specified) for certain modifiedcelluloses.(JECFA 35 M, 1989).42680 003401-73-8 N-(3-Carboxy-2-sulphopropionyl)-Noctadecyl-l-asparticacid,tetrasodium saltW8 +++ +++ +42720 008015-86-9 Carnauba wax DIR 3 Natural wax. Purity to be specified. + +42800 009000-71-9 Casein DIR 0 + +42880 008001-79-4 Castor oil Same 14411 DIR 3 Same as 14411+ +http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf42960 064147-40-6 Castor oil, dehydrated Same 14440 DIR 3 Similar to fats food. +153

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT43040 - Castor oil, epoxidized8 +(oxirane less than 5%,iodine Number less than6)43120 008001-78-3 Castor oil, hydrogenated Same 14470 3 Identical with or similar to food fat. + +43200 - Castor oil, mono- andDIR 3 Toxicologically acceptable. +diglycerides43201 - Castor oil fatty acidsmono- and diglycerides1543 SCF_List: 3Restriction: none. In small dosesmetabolised similarly to food fatsSee SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf+ +43230 008002-33-3 Castor oil, sulphated 9 +43232 068187-76-8 Castor oil, sulphated,W +sodium salt43265 - Castor oil, sulphonated,8 +sodium salt43280 009004-34-6 Cellulose Same 14500 DIR 0 + +43300 009004-36-8 Cellulose acetate Same 14508 DIR 3 Inert material, modified natural cellulose. + +butyrate43330 009004-70-0 Cellulose nitrate Same 22450 D +43360 068442-85-3 Cellulose, regenerated DIR 2 Group TDI: not specified based on GroupADI (=not specified) for certain modifiedcellulose.(JECFA 35 M., 1989).+43390 009012-09-3 Cellulose triacetate 9 +43410 008001-75-0 Ceresin Same 43440 D +43440 008001-75-0 Ceresin Same 43410 DIR 3 Refined, natural, crystalline wax. Purity tobe specified.43480 064365-11-3 Charcoal, activated 3AM 3 Restriction: Only to be used in polyethyleneterephthalate (PET) at a maximumamount of 10 mg/kg polymer.Purity criteria: in compliance with vegetablecarbon (E 153), except for the ash contentwhich can be up to 10%.http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT43490 001332-58-7 China clay (=natural Same 62720 D +aluminium silicate)43495 066402-68-4 China clay, calcined D +43515 - Chlorides of cholineesters of coconut oil fattyacidsSame 54660and 63400DIR QMA = 0.9 mg/6 dm² 3 R : to be used at a maximum amount of0.015 g/m² (150 ug/dm²).Available: Method for determination ofresidual content; three (negative)mutagenicity studies (performed withlauroyl choline chloride); 28-day and 90-dayoral rat studies (on coconut fatty acid estersof choline chloride, the largest component ofwhich is lauric acid ester of cholinechloride); bioaccumulation study (in Zebrafish).Remark: change name into 'Fatty acids ofcoconut oil, esters with choline chloride'.Remark: Given the physical/chemical data,there is no need for asking further data onpossible accumulation.Remark: If hydrolysis data are provided(showing complete hydrolysis), then therestriction may be deleted.(RIVM/ISS/TNO SDS, April 1997 =CS/PM/2999/63400).+ +43520 - Chlorides of cholineesters of linear naturalmonocarb.acids155REMARK for Commission: No method ofanalysis is available for the enforcement ofan SML.(Adopted at 113th SCF meeting)(17-18September 1998)http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html9 +43590 000079-07-2 Chloroacetamide W +43600 004080-31-3 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantanechlorideDIR SML = 0.3 mg/kg 2 TDI: 0.005 mg/kg b.w.Two 90-day oral rat and a dog studies andteratogenicity studies in rats and rabbits andnegative mutagenicity studies.+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT43650 000075-68-3 1-Chloro-1,1-difluoroethane43680 000075-45-6 Chlorodifluoromethane DIR SML = 6 mg/kg and incompliance with thespecifications laiddown in Annex V.(RIVM doc. December 1983).W7? Available: semichronic and chronicinhalation studies in rats, 2 inhalationteratogenicity studies in rats, several Amestests and two in vivo mutagenicity studies,migration data.Needed: reproduction study.2 TDI: 0.1 mg/kg b.w. (based onteratogenicity study).Specification: content ofchlorofluoromethane less than 1 ppm.Oneyear oral rat study. Several inhalation studiesin several animal species, includingteratogenicity in rabbits. Mutagenicity testsin-vitro and in-vivo.++43760 026172-55-4 5-Chloro-2-methyl-4-isothiazolin-3-one43820 - Chromic chloridecomplex with linearsat.monocarb.acids (C16and above)43840 015659-56-0 Chromic chloridemyristate43920 015242-96-3 Chromic chloridestearateN.B. The Committee has not considered theenvironmental implications of the use of thesolvent in food technology, but recognisesthat environmental considerations may takeprecedence over its own evaluations on thisoccasion.7 90-day oral rat and dog studies.+ +Reproduction and teratogenicity studies inrabbits, 3 mutagenicity studies.(RIVM Doc.Tox.300/430 May 1979,September 1983, June 1984). Very potentsensitizer.D +8 +9 +43980 001308-38-9 Chromium (III) oxide 9 +44000 001333-82-0 Chromium trioxide 5 Cr(VI) is a genotoxic carcinogen (IARC +monograph 1980, vol. 23).156

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT44080 000104-55-2 Cinnamaldehyde 8 (Adopted at 111th SCF meeting (18-19 +March 1998)).http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf44160 000077-92-9 Citric acid Same 14680 DIR 1 Group ADI: not specified for citric acid and + +its salts.(SCF, 25th Series, 1990).44240 - Citric acid, alkyl,9 Group R: 0.05 mg/kg b.w. +44300 110638-71-6*primary (C2-C12), estersCitric acid, lithium salt,reaction product withvermiculiteSame 95725 D See PM/REF.N. 95725. +44320 001321-57-9 Citric acid,monoisopropyl ester7 Needed: hydrolysis data and reports fromDuel et al., (1951).44400 001323-66-6 Citric acid, mono-noctadecyl7 Needed: hydrolysis data and reports fromesterDuel et al., (1951).44560 000077-94-1 Citric acid, tributyl ester 8 Group R: 0.05 mg/kg b.w.Needed: toxµ$icological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation study too.44640 000077-93-0 Citric acid, triethyl ester DIR 1 ADI: 20 mg/kg b.w.(JECFA 28 M., 1984).44720 007775-50-0 Citric acid, tri-noctadecylester44800 007147-34-4 Citric acid, tris(2-ethylhexyl) ester1578 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and ifmigration exceeds 0.05 mg/kg peroxisomeproliferation study too.8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation study too.44880 001333-88-6 Cobalt aluminate 2-3 L2 for Al.TDI: 1 mg/kg bw (as Al) based on PTWI: 7mg/kg bw (as Al).(SCF, 25th Series, 1991).L3 fo Co.R: 0.05 mg/kg of food (as Co).+++ ++ ++++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(Rivm, summary data, October1992)(CS/PM/1707).44960 011104-61-3 Cobalt oxide DIR SML(T) = 0.05 mg/kg 3 L3 for Cobalt.+(14) (expressed asCobalt)R: 0.05 mg/kg of food (as Co).(RIVM, summary data, October1992=CS/PM/1707).44980 061788-46-3 Cocoalkylamines W +44985 061791-14-8 Cocoalkylamines,W +ethoxylated44995 061791-63-7 N-W +Cocoalkyltrimethylenediamines45040 061790-63-4 Coconut oil fatty acids7? Same references as 39280. + +68603-42-9anddiethanolamide (addcas_N = 68440-04-0)45055 008050-09-7 Colophony SameD +14687,24100,24130 and8384045060/0 008002-13-9 Colza oil SameD + +45060/1,83580/0 and83580/145075 - Condensation products9 +of ethylene oxide withalkyl- and dialkylamines(C1-C20)45105 - Copolymers of acrylic or9 +methacrylic esters withvinylpyrrolidone45120 - Copolymers ofacrylic,fumaric,itaconic,maleic and methacrylicacids with butadiene,butene, divinylbenzene,esters of these acids withsat. monoh. aliph.alcohols(C1-C18),ethylene, ethylene oxide,9 +158

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTetC..45130 - Copolymer of 1-alkenes(C20-C24) and diestersof maleic acid and tallowalcohol (C16-C18)containing max 13%tallow alcohol and max5% 1-alkenes (C20-C24)45165 - Copolymers of linear orbranched 1-alkenes(C3-C38) and mono- ordiesters of maleic acidwith linear or branchedalcohols (C2-C36),ethoxylated alcohols(C1-C36) withethoxylation degreebetween 2-3645195 007787-70-4 Copper bromide DIR SML(T) = 30 mg/kg(7) (expressed asCopper)45200 001335-23-5 Copper iodide DIR SML(T) = 30 mg/kg(7) (expressed asCopper) and SML = 1mg/kg (11) (expressed1597? Needed: Migration data and also 3mutagenicity tests on 1-alkenes, unless theindustry confirms that they have straightchain.9 Look at 45130. +2 For Copper. Same as Ref.No 30080. +2 For Copper. Same as Ref.No 30080. +as Iodine)45280 - Cotton fibers DIR 3 Inert, insoluble material. +45360 008001-29-4 Cottonseed oil 3/D Equal to or similar to food fats. +45440 - Cresols, butylated,styrenatedDIR SML = 12 mg/kg 2 t-TDI: 0.2 mg/kg b.w.Available: 3-month oral rat and 2-year oralrat and dog studies, rat reproduction study.(Food Drug Research Lab. 1964).Needed: specification and Mw distributioncurve, in first instance.(to be confirmed by SCF)45450 068610-51-5 p-Cresol- DIR SML = 5 mg/kg 3 SCF_list: 3 + +++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTdicyclopentadieneisobutylene,Restriction: 5 mg/kg of food.copolymerSee SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf45520 - p-Cresol, styrenated 9 +45560 014464-46-1 Cristobalite DIR 3 Inert material. + +45600 003724-65-0 Crotonic acid Same 14800 DIR QMA(T) = 0.05mg/6dm² (33)45610 025609-89-6 Crotonic acid-vinylacetate, copolymer45640 005232-99-5 2-Cyano-3,3-diphenylacrylic acid,ethyl ester45650 006197-30-4 2-Cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester45670 000461-58-5 Cyanoguanidine Same 15695and 474403 Same references as 14800http://europa.eu.int/comm/food/fs/sc/scf/out141_en.pdf+9 +DIR SML = 0.05 mg/kg 3 SCF_list:3Restriction: 0.05 mg/kg of food.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdfDIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg food.+Available: migration data (< 0.05 mg/kgfood); gene mutation assay in bacteria(negative); chromosomal aberration assay incultured mammalian cells (negative); genemutation assay in cultured mammalian cells(negative); micronucleus assay (negative);acute toxicity data; 90-day oral rat study;teratogenicity study with rats.RIVM/TNO SDS, January 2001 =CS/PM/3818/45650.Remark: If data on the absence of potentialfor accumulation were available then arestriction of 5 mg/kg food could beassigned to this substance.(Adopted at the 128th SCF meeting, 12 July2001)http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdfD + ++160

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT45680 - Cycloalkanes (0-1009 +degrees celsius)45690 000291-64-5 Cycloheptane 8 +45700 000110-82-7 Cyclohexane 8 +45705 166412-78-8 1,2-Hexahydrop7 Under re-evaluation +Cyclohexanedicarboxylic hthalic acid,acid, diisononyl ester diisononylester45710 000108-93-0 Cyclohexanol Same 14905 8 +45720 000108-94-1 Cyclohexanone Same 14910 6A Needed: adequate test for gene mutation andchromosomal aberration.(IARC (1989), 47, 151-169).45760 000108-91-8 Cyclohexylamine DIR 2 TDI: 1 mg/kg b.w. calculated with reference +to the ADI for cyclamic acid of 11 mg/kgb.w.45840 - Cyclopentadienecyclopentenedicyclopentadiene-2-pentene-2-methyl-2-butene-1,3-pentadiene,copolymers,hydrogenated or Not45841 - Cyclopentadienecyclopentenedicyclopenbtadiene-2-pentene-2-methyl-2-butene-1,3-pentadiene,copolymers45842 - Cyclopentadienecyclopentenedicyclopentadiene-2-pentene-2-methyl-2-butene-1,3-pentadiene,copolymers,hydrogenated(JECFA 26 M., 1982).9 +7? Needed: Mw distribution curve, 3mutagenicity tests on monomers not in L 0-4, in first instance.8 Needed: data according to SCF guidelineson polymeric additives.45880 000287-92-3 Cyclopentane 8 +45920 009000-16-2 Dammar Same DIR 3 Natural wax. Purity to be specified. +15065,45925+++161

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTand 4593045925 009000-16-2 Damar resin Same 15065,D +45920 and4593045930 009000-16-2 Damar wax Same 15065,D +45920 and4592545940 000334-48-5 n-Decanoic acid Same 15095 DIR 0 Food constituent. + +46000 see 46070 D + +46070 010016-20-3 alpha-Dextrin DIR 0 + +46080 007585-39-9 beta-Dextrin DIR 0 + +46160 - Dialkyl or alkyl (more9 +than C8) phosphate46240 - Dialkyldithiocarbamic9 +acid, salts46320 - Dialkyl(C8-C20)ketones 9 +46375 061790-53-2 Diatomaceous earth Same 62880 DIR 3 Inert material. +46380 068855-54-9 Diatomaceous earth, Same 62885 DIR 3 Inert material. + +soda ash flux-calcined46400 000120-78-5 Dibenzothiazyl8 +disulphide46440 000094-36-0 Dibenzoyl peroxide 8 + +46480 032647-67-9 Dibenzylidene sorbitol DIR 2 Group TDI: 1 mg/kg b.w. (with bis(4- + +ethylbenzylidene)sorbitol andbis(methylbenzylidene) sorbitol).Several 90-day oral mouse and rat studies,several mutagenicity studies negative.See references for bis(4-ethylbenzylidene)sorbitol.46560 000106-93-4 1,2-Dibromoethane 5 [Some organobromo compounds have a +bioaccumulation potential and 1,2-dibromoethane is a category 2 carcinogen(EC classification).]46640 000128-37-0 2,6-Di-tert-butyl-p-cresolDIR SML = 3.0 mg/kg 1 ADI: 0.05 mg/kg b.w.+ +(=BHT)46700 - 5,7-di-tert-Butyl-3-(3,4-and 2,3-dimethylphenyl)-3H-benzofuran-2-one(SCF, 22th Series, 1989).Same 67170 DIR SML = 5 mg/kg 3 R = 5 mg/kg of food.http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf162+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTcontaining: a) 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3Hbenzofuran-2-one(80 to100% w/w) and b) 5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3Hbenzofuran-2-one(0 to20% w/w)46720 004130-42-1 2,6-Di-tert-butyl-4-ethylphenol46750 000088-58-4 2,5-Di-tertbutylhydroquinone46790 004221-80-1 3,5-Di-tert-butyl-4-hydroxybenzoic acid,2,4-di-tert-butylphenylester46800 067845-93-6 3,5-Di-tert-butyl-4-hydroxybenzoic acid,hexadecyl ester46870 003135-18-0 3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester46880 065140-91-2 3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester,calcium salt46960 030947-30-9 3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester,DIR QMA = 4.8 mg/6 dm² 3 R: 0.8 mg/dm².Available: 3 negative mutagenicity studies,90-day oral rat and dog studies,bioaccumulation, calculation of the worstcase as well as analytical method.(RIVM 93/6/3330/001, 1993-01-26=CS/PM/2011, TNO 1995-04-03=CS/PM/2580).+W +Same 47200 DIR 2 TDI: 2 mg/kg bw.90-day oral rat study.(RIVM report May 1973).Same 58800 DIR 2 TDI: 2.5 mg/kg b.w.90-day oral rat and dog studies, reproductionstudy in rats, mutagenicity studies.(RIVM doc. 88/678608/001, 1 November1988).Same 49760 DIR 2 TDI: 1 mg/kg bw.A 90-day oral rat study.(CIBA-GEIGY report, 14 February 1970).Same 41020 DIR SML = 6 mg/kg 2 TDI = 0.1 mg/kg b.w.A 4+4 week, a 13+4 week and a two yearoral rat studies.(Ciba-Geigy reports CBG 174/78110, 10-07-1978 and CBG 192/781233, 22-03-1979,CBG 261/821163, 4 April 1984).8 ++ ++++ +163

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTnickel salt47040 034137-09-2 3,5-Di-tert-butyl-4-hydroxyhydrocinnamicacid, triester with 1,3,5-tris(2-hydroxyethyl)-1,3,5- triazine-2,4,6-(1h,3h,5h)trione8 Available: 90-day oral rat and dog studiesand a reproduction study were inadequate.47080 000110-05-4 Di-tert-butyl peroxide 8 +47120 050696-71-4 Di(tert-butylphenol) Same 40865 8 +disulphide47200 004221-80-1 2,4-Di-tert-butylphenyl3,5-di-tert-butyl-4-hydroxybenzoateSame 46790 D TDI: 2 mg/kg b.w.90-day oral rat study.(RIVM report May 1973).+ +47210 026427-07-6 Dibutylthiostannoic acidpolymer [= thiobis(butyltinsulphide), polymer]Same as40880DIRin compliance with thespecifications laiddown in Annex V.2 t-TDI: 25 mg/kg b.w.Available: 70- and 90-day and 2-year oralrat studies, observations in man andmigration data.Needed: mutagenicity studies.47215 000683-18-1 Dibutyltin dichloride W +47220 000077-58-7 Dibutyltindilaurate 8 +47280 002782-57-2 Dichlorocyanuric acid D +47360 000075-71-8 Dichlorodifluoromethane 7 Needed: migration data and specifications. +47380 068611-44-9 Dichlorodimethylsilane,reaction products withsilica47440 000461-58-5 Dicyanodiamide Same 15695and 4567047500 153250-52-3 N,N'-Dicyclohexyl-2,6-naphthalenedicarboxamide47520 - Dicyclopentadieneindene-styrenealpha.methylstyrenevinyltoluene-isobutylene,copolymer, hydrogenatedW +DIR 2 TDI: 1 mg/kg b.w.2-year oral rat and dog studies and Amestests.(American Cyanamid report 1969).3 Restriction: 5 mg/kg foodhttp://www.efsa.eu.int/science/afc/afc_opinions/960/afc_op_ej218_8thlist_en1.pdf3 R: 5 mg/kg of food. Specifications to beadded (range of percentage of comonomers,percentage with Mw < 1000 Daltons)?Toxicologically acceptable.Available: migration data, 5 Ames tests andan in vivo mutagenicit y study (negative)+++ +++ +164

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTand a 3-month oral rat study.(RIVM February 1993, CS/PM/855).47535 007173-51-5 Didecyldimethylammonium chloride47540 027458-90-8 Di-tert-dodecyldisulphide165Remark: since high migration into fat hasbeen demonstrated, the WG recommendsthat the Commission take the necessarymeasures so that the restriction proposed isnot exceeded.W8 +DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.Available: migration data; gene mutationassay in bacteria (negative); chromosomalaberration assay in cultured mammaliancells (negative); gene mutation assay incultured mammalian cells (negative); acutetoxicity studies with di-tert-dodecyltrisulfide (TPS20) and di-tert-dodecylpentasulfide (TPS32); 4-week oral rat studywith di-tert-dodecyl pentasulfide (TPS32);skin and eye irritation studies performedwith TPS20 and TPS32; sensitisation studiesperformed with TPS20 and TPS32.(RIVM/TNO SDS, September 1999 =CS/PM/2964 REV. II/47540).(Adopted at the 119th SCF meeting) (2December 1999)http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf47550 002123-19-5 Didodecyl ketone 8 +47600 084030-61-5 Di-n-dodecyltinbis(isooctylmercaptoacetate)+DIR SML = 12 mg/kg 3 Restriction: 0.05 mg/kg food (as sum ofmono-n-dodecyltin tris(isooctylmercaptoacetate), di-n- dodecyltinbis(isooctyl mercaptoacetate),monododecyltin trichloride and didodecyltindichloride) expressed as the sumof mono- and di-dodecyltin chloride.http://www.efsa.eu.int/science/afc/afc_opinions/960/afc_op_ej218_8thlist_en1.pdf47620 000111-42-2 Diethanolamine Same 15735 W8 Data inadequate. + ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT47630 000143-00-0 Diethanolamine dodecylsulphate47660 027027-16-3 3-Diethylaminoethylmethacrylate-methylmethacrylate, copolymer47680 000111-46-6 Diethyleneglycol Same13326,15760and 39160Restriction: contact with nitrite containingfood should be avoided.Same 52400 D Same as 52400. +DIRSML(T) = 30 mg/kg(3)166D +2 Group TDI = 0.5 mg/kg b.w.(SCF, 17th Series, 1986).47720 000120-55-8 DiethyleneglycolW + +dibenzoate47760 021209-30-3 Diethyleneglycol7 Needed: hydrolysis data. +dioleate47840 068818-39-3 Diethyleneglycol7 Needed: hydrolysis data. +dipalmitate47920 074356-18-6 Diethyleneglycol7 Needed: hydrolysis data. +diricinoleate48000 000109-30-8 Diethyleneglycol7 Needed: hydrolysis data. +distearate48080 000106-12-7 Diethyleneglycol7 Needed: hydrolysis data. +monooleate48160 036381-62-1 Diethyleneglycol7 Needed: hydrolysis data. +monopalmitate48240 005401-17-2 Diethyleneglycol7 Needed: hydrolysis data. +monoricinoleate48320 000106-11-6 Diethyleneglycol7 Needed: hydrolysis data. +monostearate48370 000100-37-8 Diethylethanolamine Same 48400 8 +48400 000100-37-8 Diethylhydroxyethylami Same 48370 D + +ne48460 000075-37-6 1,1-Difluoroethane DIR 3 Toxicologically acceptable.Available: Migration data, 2 gene mutationtests in bacteria and 1 in Drosophila, chronictoxicity/carcinogenicity rat inhalation study,rat inhalation teratology study.(RIVM/TNO SDS CS/PM/2747, November95).+48470 029658-26-2 4,4'- 9 ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTDifluorobenzophenonehydroquinone,copolymer48480 059113-36-9 Diglycerol Same 15855 8 +48500 000504-53-0 Di-n-heptadecyl ketone 8 +48520 022986-69-2 Di-n-hexadecyl ketone 8 +48560 036265-41-5 1,4-Dihydro-2,6-dimethyl-3,5-dicarbododecyloxypyridine48590 086088-85-9 4,5-Dihydro-1-methyl-2-Nortallow alkyl-3-(2-tallow amidoethyl)-imidazolium, methylsulphate48620 000123-31-9 1,4-Dihydroxybenzene Same 15940,18867 and6006048640 000131-56-6 2,4-Dihydroxybenzophenone48720 000611-99-4 4,4'-Dihydroxybenzophenone48800 000097-23-4 2,2'-Dihydroxy-5,5'-dichlorodiphenylmethane48880 000131-53-3 2,2'-Dihydroxy-4-methoxybenzophenone48960 000120-87-6 9,10-Dihydroxystearicacid49040 001115-01-1 9,10-Dihydroxystearicacid, methyl ester1678 Available: oral studies in rats and dogs wereinappropriate.W8 +DIR SML = 0.6 mg/kg 2 TDI: 0.01 mg/kg b.w.(SCF, 17th Series, 1986).DIRSML(T) = 6 mg/kg(15)Same 15970. DIR SML(T) = 6 mg/kg(15)2 Group TDI: 0.1 mg/kg b.w.See references for 4,4'-dihydroxybenzophenone in list 2.2 Group TDI: 0.1 mg/kg b.w.See references for 4,4'-dihydroxybenzophenone in list 2.DIR SML = 12 mg/kg 2 TDI: 0.2 mg/kg b.w.2-week and 13-week oral rat studies andobservations in man from its therapeutic use.(J. Am. Leather. Chemists Assoc. 1944, 39,203-209; J. Pharmacol. Exper. Therap.1949, 96, 238-249).DIRSML(T) = 6 mg/kg(15)2 Group TDI: 0.1 mg/kg b.w.See references for 4,4'-dihydroxybenzophenone in list 2.7 Evaluated in EFSA-AFC and classified inlist7.http://www.efsa.eu.int/science/afc/afc_opinions/195/opinion_afc_01_en1.pdf8 ++++++++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT49050 000108-83-8 Diisobutyl ketone 8 Available: no adequate oral data, Ames test. +49055 027213-90-7 Diisobutylnaphthalenesul9 No data are available. +phonic acid, sodium salt49065 000110-97-4 Diisopropanolamine Same 16120 8 R: contact with food containing nitrite +should be avoided.49120 003271-22-5 2,4-Dimethoxy-6-(1-7 Needed: information on tissue accumulation. +pyrenyl)-1,3,5-triazine49160 000127-19-5 Dimethylacetamide 6B Suspected embryotoxicity/teratogenicity. +49200 - Dimethylalkyl(C8-9 Existing data are not available to the SCF. +C18)benzylammoniumchlorideProvide them.49202 068391-01-5 Dimethylalkyl(C12-9 +C18)benzylammoniumchloride49235 000108-01-0 Dimethylaminoethanol Same 16150 2 TDI: 0.3 mg/kg b.w.+See references for same substance(PM/REF. 16150) in monomer report.49280 000121-69-7 N,N-Dimethylaniline Same 16190 8 +49330 001879-09-0 2,4-Dimethyl-6-tert.-8 +butylphenol49340 061789-71-7 Dimethyl(cocoalkyl)benz9 Existing data are not available to the SCF. + +ylammonium chlorideProvide them.49360 - Dimethyldialkyl(C8-9 +C18)ammonium chloride49465 000068-12-2 Dimethylformamide 6B Suspected of embryotoxicity/teratogenicity. +49472 095009-13-5 N,N-Dimethyl-2-hydroxy-N-(2-hydroxypropyl)-1-propanaminium, diesterwith vegetable oil fattyacids methyl sulphate49485 134701-20-5 2,4-Dimethyl-6-(1-methylpentadecyl)-phenol168(EHC 114).W8 +DIR SML = 1 mg/kg 3 R = 1 mg/kg of food.Available: Adequate migration data showingspecific migration into aqueous foodsimulants is < 0.05 mg/kg food and intoolive oil < 0.12-0.48 mg/kg food; three(negative) mutagenicity studies; 28-day oralrat study; 90-day oral rat study (relatively+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT49510 - alpha,omega-Dimethylpoly(obutyl(polypropyleneglycol)(polyethyleneglycol)(polydimethylsiloxane)low NOAEL + effects still observed afterthe recovery period); log Po/w; ADMEstudy.Remark: Based on the hepatotoxic effectsobserved in both the 28-day and 90-day oralrat studies which resulted in the same lowNOAEL of 10 mg/kg b.w., the SCF used asafety factor of 500 and a 60 kg person toestablish a restriction of 1 mg/kg of food.(RIVM SDS, February 1998 = CS/PM/2917REV. I/49485).(adopted at 113rd SCF meeting)(17-18September 1998)http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html9 +49520 see 49580 D +49540 000067-68-5 Dimethyl sulphoxide Same 16410 DIR 3 DMSO is used as carrier of drugs to +facilitate skin penetration.49580 029351-51-7 Dimethylthianthrene 8 +49595 057583-35-4 Dimethyltinbis(ethylhexylmercaptoacetate)+see 49600 3AM 2 L2 for tinIsooctyl refers to industrial mixtureincluding substances with a branched chainof 8 atoms of carbon. Usually, x-methyl-C7,x,y-dimethyl-C6 are the major componentsof an isooctyl “mixture” (more than 90%).x-ethyl-C6 are present but not in a largequantities (less than 10%). The compositionof this mixture could be slightly differentaccording the oil feedstock used for thesynthesis of it and of the process used for the“oxo” reaction..In contrast, ethylhexyl (ethyl-C6) refersusually to 2-ethylhexyl structure which isperfectly defined chemically.169

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT49600 026636-01-1 Dimethyltin bis(isooctylmercaptoacetate)DIRSML(T) = 0.18 mg/kg(16) (expressed as Tin)In the scope of organotin compounds forwhich the toxicity is related to organic tin,studies done either with the “isooctyl” or the“ethylhexyl” could be used for evaluation ofbranched C8 organotin compounds.2 Group TDI: 0.003 mg/kg b.w. (as Sn) (with67520 and 83599).+See references for 83599 in list 2.49680 000093-46-9 N,N'-Di-(2-naphthyl)-pphenylenediamine7 Needed: purity specification especially on +presence of beta-naphthylamine49720 - 2,4-Dinonylphenyl bis-D +(4-monononylphenyl)phosphite49760 003135-18-0 Di-n-octadecyl 3,5-di-Same 46870 2/D TDI: 1 mg/kg b.w.+tert-butyl-4-A 90-day oral rat study.hydroxybenzyl(Ciba-Geigy report 14 February 1970).phosphonate49840 002500-88-1 Dioctadecyl disulphide DIR SML = 3 mg/kg 2 TDI: 0.05 mg/kg b.w.+ +A 90-day oral rat study.(Hoechst report 1967).49920 020297-71-6 Dioctadecyl 3-methyl-4-8 +hydroxy-5-tert-butylbenzylmalonate50000 001844-09-3 Dioctadecyl8 +monosulphide50080 003806-34-6 Dioctadecylpentaerythritoldiphosphite170W7Available: Acute toxicity data; 90-day oralrat study (IBT study);90-day oral dog study (IBT study); review ofthe IBT rat and dog studies; neurotoxicitystudy in the hen.Needed: Migration data (on the phosphiteand phosphate); three in vitro mutagenicitystudies and data to demonstrate the absenceof potential for accumulation.(RIVM SDS, August 1996 = CS/PM/2903/50080).(Adopted at 111th SCF meeting (18-19March 1998)).http://europa.eu.int/comm/food/fs/sc/scf/out+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT50160 - Di-n-octyltin bis(nalkyl(C10-C16)mercaptoacetate)50240 010039-33-5 Di-n-octyltin bis(2-ethylhexyl maleate)50320 015571-58-1 Di-n-octyltin bis(2-ethylhexylmercaptoacetate)50360 - Di-n-octyltin bis(ethylmaleate)50400 033568-99-9 Di-n-octyltin bis(isooctylmaleate)50480 026401-97-8 Di-n-octyltin bis(isooctylmercaptoacetate)DIRSML(T) = 0.04 mg/kg(17) (expressed as Tin)Same 64840 DIR SML(T) = 0.04 mg/kg(17) (expressed as Tin)DIRDIRDIRDIRSML(T) = 0.04 mg/kg(17) (expressed as Tin)SML(T) = 0.04 mg/kg(17) (expressed as Tin)SML(T) = 0.04 mg/kg(17) (expressed as Tin)SML(T) = 0.04 mg/kg(17) (expressed as Tin)10_en.pdf2 Group-TDI: 0.0006 mg/kg bw (as Sn) for alldi-n-octyltin derivatives.See references for 50480.http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf2 Group-TDI: 0.0006 mg/kg bw (as Sn) for alldi-n-octyltin derivatives.See references for 50480.http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf2 Group-TDI: 0.0006 mg/kg bw (as Sn) for alldi-n-octyltin derivatives.See references for 50480.http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf2 Group-TDI: 0.0006 mg/kg bw (as Sn) for alldi-n-octyltin derivatives.See references for 50480.http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf2 Group-TDI: 0.0006 mg/kg bw (as Sn) for alldi-n-octyltin derivatives.See references for 50480.http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf2 Group-TDI: 0.0006 mg/kg bw (as Sn) fordioctyltin stabilisers (REF_N 50480)Group-TDI = 0.02 mg/kg b.w. (as Sn) formonooctyltin stabilisers (REF_N 67760)++++++Available: migration data; several subacutestudies in rats and dogs (performed withMOTTG, DOTTG, MOTC, DOTC andformulation of MOTC and DOTC); severalsemichronic studies in rats and dogs(performed with MOTTG, DOTTG andformulation of MOTTG and DOTTG); 2-year rat and dog studies (performed withDOTTG and formulation of MOTC and171

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT50560 - Di-n-octyltin 1,4-butanediolbis(mercaptoacetate)DIRSML(T) = 0.04 mg/kg(17) (expressed as Tin)50640 003648-18-8 Di-n-octyltin dilaurate DIR SML(T) = 0.04 mg/kg(17) (expressed as Tin)172DOTC); gene mutation assays in bacteria(negative) (performed with MOTC, DOTCand formulation of MOTTG and DOTTG);gene mutation assays in cultured mammaliancells (negative) (performed with MOTC andDOTC); in vitro UDS assay (negative)(performed with DOTC); in vitro covalentDNA binding assay (negative) (performedwith DOTC); micronucleus assays(negative; however, it was noted that nocytotoxicity was observed when performedwith MOTC) (negative with formulationwith MOTTG and DOTTG); in vivo SCEassay (negative) (performed with DOTC); 2-generation reproduction study in rats(performed with formulation of MOTTGand DOTTG); teratogenicity study in rats(performed with formulation of MOTTGand DOTTG); teratogenicity study in rabbits(performed with formulation of MOTTGand DOTTG).(RIVM SDS, October 1998 =CS/PM/3255/50480/67760).Remark for Commission: no analyticalmethod is available.(Adopted at the 118th SCF meeting) (23September 1999)http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf2 Group-TDI: 0.0006 mg/kg bw (as Sn) for alldi-n-octyltin derivatives.See references for 50480.http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf2 Group-TDI: 0.0006 mg/kg bw (as Sn) for alldi-n-octyltin derivatives.See references for 50480.http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf50720 015571-60-5 Di-n-octyltin dimaleate DIR SML(T) = 0.04 mg/kg 2 Group-TDI: 0.0006 mg/kg bw (as Sn) for all +++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT50800 - Di-n-octyltin dimaleate,esterified50880 - Di-n-octyltin dimaleate,polymers (n=2-4)50960 069226-44-4 Di-n-octyltinethyleneglycolbis(mercaptoacetate)51040 015535-79-2 Di-n-octyltinmercaptoacetate51120 - Di-n-octyltinthiobenzoate 2-ethylhexylmercaptoacetateDIRDIRDIRDIRDIR(17) (expressed as Tin) di-n-octyltin derivatives.See references for 50480.http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdfSML(T) = 0.04 mg/kg(17) (expressed as Tin)SML(T) = 0.04 mg/kg(17) (expressed as Tin)SML(T) = 0.04 mg/kg(17) (expressed as Tin)SML(T) = 0.04 mg/kg(17) (expressed as Tin)SML(T) = 0.04 mg/kg(17) (expressed as Tin)2 Group-TDI: 0.0006 mg/kg bw (as Sn) for alldi-n-octyltin derivatives.See references for 50480.http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf2 Group-TDI: 0.0006 mg/kg bw (as Sn) for alldi-n-octyltin derivatives.See references for 50480.Evaluated in accordance with the previousguidelines. Decision endorsed despite lackof compliance with recent guidelines, in thelight of the very low group t-TDI.(CS/PM/2632).http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf2 Group-TDI: 0.0006 mg/kg bw (as Sn) for alldi-n-octyltin derivatives.See references for 50480.http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf2 Group-TDI: 0.0006 mg/kg bw (as Sn) for alldi-n-octyltin derivatives.See references for 50480.http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf2 Group-TDI: 0.0006 mg/kg bw (as Sn) for alldi-n-octyltin derivatives.See references for 50480.http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf51160 000123-91-1 Dioxane Same 16420 6A IARC evaluation: group IIb carcinogen. EUclassification: Category 3 carcinogen.Primarily to be evaluated as monomer, alsoused as additive, hence cross reference. Ascontaminant (e.g. 46720) in finishedproducts, dioxane should not be detectable++++++173

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTin food or food simulants by an appropriatesensitive method.51200 000126-58-9 Dipentaerythritol Same 16480 DIR 2 Group TDI: 1 mg/kg b.w. (with+pentaerythritol).(SCF, 17th Series, 1986).51300 000138-86-3 Dipentene Same 16510 8 Data made available for assessment of +chewing gum not available for this group.51440 015647-08-2 Diphenyl 2-ethylhexyl8 +phosphite51470 007144-65-2 o-Diphenyl glycidyl Same 72560 D +ether51500 000102-06-7 Diphenylguanidine D +51520 026401-27-4 Diphenyl isooctyl8 +phosphite51570 000127-63-9 Diphenyl sulphone Same 16650 DIR SML(T) = 3 mg/kg(25)3 R: 3 mg/kg of foodAvailable: migration data; log Po/w; genemutation assay in bacteria (negative);chromosomal aberration assay in culturedmammalian cells (negative); gene mutationassay in cultured mammalian cells(negative); 4-week oral rat study; 3-monthsoral rat study.(RIVM/TNO SDS, April 1999 =CS/PM/2651 REV. II/51570).(Adopted at the 118th SCF meeting) (23September 1999)http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf51600 003375-11-9 Diphenylsulphone-3,3'- Same 91400 6A +disulphonylhydrazide51680 000102-08-9 N,N'-Diphenylthiourea DIR SML = 3 mg/kg 2 TDI: 0.05 mg/kg b.w.+28-day, 1-year and 2-year oral rat studies.(RIVM January 1967 and May 1973).51700 147315-50-2 2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenolDIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food.Available: Adequate migration data, three invitro mutagenicity assays.(RIVM/ISS/TNO SDS, November 1996 =CS/PM/2748).++174

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT51760 025265-71-8and 000110-98-551840 027138-31-4 DipropyleneglycoldibenzoateDipropyleneglycol Same 39750 DIR 2 t-TDI: 1,5 mg/kg b.w.(SCF, 6th Series, 1978).51870 034590-94-8 Dipropyleneglycolmonomethyl ether51900 028519-02-0 Disodium dodecyldiphenyletherdisulphonate51920 007558-79-4 Disodium hydrogenphosphate51930 055963-33-2 Distarch phosphate(=E1412)51932 068130-14-3 Distarch phosphate (=E1414)51933 064741-88-4 Distillates (petroleum),solvent-refined heavyparaffinic51935 064741-89-5 Distillates (petroleum),solvent-refined lightparaffinic51938 068131-89-5 Distillates (petroleum),steam cracked, polymerswith ethylene-manuf,-byproductpiperylene-cutalkenes175+ +7? Available: 3 month oral rat and dog studies(inadequate), metabolism, Ames test andmigration data.(RIVM 06-09-88; Velsicol 14-09-1988).Needed: 3 month oral rat study chromosomeaberration in vitro, gene mutation inmammalian cells.+Same 16670 8 Data inadequate. +Same 52240 8/D +D +W +W +W +W +W +51940 000540-09-0 Diundecyl ketone 8 +51950 - Diurethans arising fromhexamethylenediisocyanate andalcohols aliph., monoh.,sat. (C2-C20)9 +51975 000112-53-8 1-Dodecanol Same 16701 3 See references for the same substance in + +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT51985 009002-92-0 alpha-n-Dodecanolomegahydroxypoly(oxyethylene)52000 027176-87-0 Dodecylbenzenesulphonic acid52080 026264-05-1 Dodecylbenzenesulphonic acid, isopropylaminesalt52160 025155-30-0 Dodecylbenzenesulphonic acid, sodium saltSame 77737and 77920176monomer list.9/D +DIR SML = 30 mg/kg 2 TDI: 0.5 mg/kg b.w.Two 2-year oral rat studies, mutagenicitystudies.(RIVM Summary report March 1965).+ +8 +D +52210 000112-55-0 n-Dodecylmercaptan W +52240 028519-02-0 Dodecylphenoxybenzenedisulphonic acid,disodium saltSame 51900and 86880+ +52320 052047-59-3 2-(4-Dodecylphenyl)indole52400 000143-00-0 Dodecylsulphuric acid,diethanolamine saltDIR SML = 0.06 mg/kg 2 TDI: 0.001 mg/kg b.w.A 90-day oral rat study.(Inst. f. Biol. Forsch. Koln, report 1976).Same 47630 8 For dodecylsulphuric acidL3. Toxicologically acceptable.Same references as for 34281.For diethanolamineL8. Not in contact with food containingnitrite.52480 004722-98-9 Dodecylsulphuric acid, Same 67460 D Covered by 67441. +monoethanolamine salt52560 - Dodecylsulphuric acid,D Covered by 34295. + +salts52565 000151-21-3 Dodecylsulphuric acid,D Covered by 34281. + +sodium salt52640 016389-88-1 Dolomite DIR 3 Inert material. Purity to be specified. + +52645 010436-08-5 cis-11-Eicosenamide DIR 3 Hydrolyses to innocuous substances. +Available: specific migration in 3% aceticacid and 15% ethanol < 0.04 mg/kg, in oliveoil maximum 2.8 mg/kg into food;++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTcomparable with oleamide and erucamideand thus complete hydrolysis to be expectedin intestinal fluid in fatty acid and ammonia;gene mutation assay in bacteria (negative).(RIVM/TNO SDS, March 1999 =CS/PM/3269/52645).(Adopted at the 118th SCF meeting) (23September 1999)http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf52650 000112-79-8 Elaidic acid 8 +52660 - Epichlorohydrin-9 (Adopted at 111th SCF meeting (18-19 +polyamide, copolymer52700 029564-58-7 2,3-Epoxypropylmethacrylate-methylmethacrylate- styrene,copolymers177March 1998)9 +52720 000112-84-5 Erucamide DIR 3 See the references for 68960. + +52730 000112-86-7 Erucic acid Same 16775 DIR 3 Occurs in small amounts in some vegetable + +oils.52780 - Esters of 12-hydroxystearic andstearic acid with C20-guerbet alcohols+7? Available: 2 mutagenicity studies (negative)and 4-week oral rat study (insufficient forthe substances to be used for food contactmaterials).Needed: detailed information on the methodof analysis and on decompositionproducts, gene mutation in mammalian cells,3-month oral rat study, bioaccumulation,information on decomposition products fromhigh temperature usage.(RIVM 1994-10-25 = CS/PM/2581).52800 000064-17-5 Ethanol Same 16780 DIR 1 Acceptable.(SCF, 11th Series, 1981).52880 023676-09-7 4-Ethoxybenzoic acid,ethyl esterDIR SML = 3.6 mg/kg 2 t-TDI: 0.06 mg/kg b.w.Available: 28-days oral rat study and 3mutagenicity tests.(RIVM, 17th March 1987).Needed: 90-day oral study.52960 035001-51-5 2-Ethoxy-5-tert-butyl-2'- 8 ++ ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTethyl-4'-tert-butyloxalicacid bisanilide53040 035001-52-6 2-Ethoxy-5-tert-butyl-2'-ethyloxalic acidbisanilide (=2-ethoxy-5-tert-butyl-2'-ethyloxanilide)53080 - Ethoxycarbonylmethyldiethylphosphonate53120 065816-20-8 N-(4-Ethoxycarbonylphenyl)-N'ethyl-N'-phenylformamidine53200 023949-66-8 2-Ethoxy-2'-ethyloxanilide53230 - Ethyl acrylate-ethylenemethylacrylate-methylmethacrylate-vinylacetate and/or vinylbenzoate, copolymers53232 026376-86-3 Ethyl acrylate-2-ethylhexyl acrylate,copolymer53235 - Ethyl acrylatemethacrylicacidethyleneglycolmonomethacrylatepolyethyleneglycol(EO=50) nonyl phenylether-toluenediisocyanate, copolymer(Mw=50000-500000)53238 - Ethyl acrylatemethacrylicacidpolyethyleneglycol(EO=25) alkyl(C32)ether, copolymer (Mw=8 +7 Available: migration data, 4-week oral ratstudy, 2 mutagenicity studies negative.Needed: 90-day oral study, gene mutation inmammalian cells. (CS/PM/1709)+W8 +DIR SML = 30 mg/kg 2 TDI: 0.5 mg/kg b.w.90-day and 2-year oral rat studies.(Sandoz reports 1973 and 1975).+ +9 +W +7? Available: Uses (as coating additive).Needed: Structure of the polymer, Mwdistribution curve, toxicity testing inaccordance with the guidelines on polymericadditives (version updated to 15 December1995, CS/PM/2632).(Adopted at 111th SCF meeting (18-19March 1998)D ++178

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT100000-500000)53240 072275-83-3 Ethyl acrylatemethacrylicacid-poly(ethyleneglycol)-lauryl methacrylateether, terpolymer7? Needed: In first instance, information on thenature of the residue.(TNO, SDS, 1992 = CS/PM/2582 /53240.(Adopted at 111th SCF meeting (18-19March 1998)53255 000100-41-4 Ethylbenzene 3 R: 0.01 mg/kg b.w. based on allowing 1/10of TDI (= 1 mg/kg.b.w.) for food packaginguses.Available: 6-month rat inhalation study,mutagenicity studies.53270 037205-99-5 EthylcarboxymethylcelluloseDIR 2 Group TDI: not specified based on groupADI (=not specified) for certain modifiedcelluloses.(JECFA 35 M., 1989).53280 009004-57-3 Ethylcellulose Same 16925 DIR 2 Group TDI: not specified based on GroupADI (=not specified) for certain modifiedcelluloses.(JECFA 35M., 1989).53310 - Ethylene-acrylic acidand/or maleic anhydrideand/or vinyl acetate,copolymers53360 000110-31-6 N,N'-Ethylenebisoleamide53440 005518-18-3 N,N'-Ethylenebispalmitamide53520 000110-30-5 N,N'-Ethylenebisstearamide53540 000107-15-3 Ethylenediamine Same 15272and 1696053570 027014-42-2and 025214-63-5Ethylenediamineethyleneoxide and/orpropylene oxide,copolymer53600 000060-00-4 Ethylenediaminetetraacetic acidD +++ +++ +DIR 3 Chemically similar to 53520 in list 3. + +DIR 3 90-day oral monkey study. Chemicallysimilar to N'N-ethylene bisstearammide.+DIR 3 Two inadequate 2-year oral rat studies and + +low migration (Hoechst report 13/05, 1963).2 TDI: 0.2 mg/kg b.w.+Two 90-day oral rat studies.(ICI report, April 1975).9 +DIR 2 TDI: 2.5 mg/kg b.w. as calcium disodiumsalt on the basis of JECFA ADI for calciumdisodium EDTA.+ +179

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT53610 054453-03-1 Ethylenediaminetetraacetic acid, copper salt53650 000107-21-1 Ethyleneglycol Same 16990and 1677853670 032509-66-3 Ethyleneglycol bis [3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate](JECFA 17 M., 1973; SCF 4th Series, 1977)DIR SML(T) = 30 mg/kg 2 R= 5 mg/person (as Copper).(7) (expressed asbased on (a) for copper same references asCopper)30080 and (b) for calcium disodium EDTA(=2.5 mg/kg.bw, SCF, 4th Series, 1977).DIR SML(T) = 30 mg/kg 2 Group TDI = 0.5 mg/kg b.w. (with(3)diethyleneglycol).(SCF, 17th Series, 1986).Same 38530 2 TDI = 0.1 mg/kg b.w.Available: acute oral toxicity data; 90-dayoral rat study; 16-week oral rat study (afterin utero exposure); 90-day oral dog study; 2-year oral dog study; 2.5 year oral rat study(combined chronic/ carcinogenicity study);one-generation reproduction study with rats;three negative mutagenicity studies.(RIVM SDS, January 1998 = CS/PM/3157/53670).REMARK for Commission: No method ofanalysis is available for the enforcement ofan SML.(Adopted at 114th SCF meeting) (10December 1998)http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf180++ ++ +53680 see 53610 D +53685 000624-04-4 Ethyleneglycol dilaurate Same 63360 D +53760 see 53670 D + +53820 000110-80-5 Ethyleneglycolmonoethyl etherSame 16996 2 Group t-TDI : 0.05 mg/kg b.w. (with15780=48050, 16993=53765, 16996=53820,16999, 17002=53860, 30015, 30120, 30200,48030).See references for 16996.53840 see 54005 D +53845 004219-48-1 Ethyleneglycol Same 63440 D +monolaurate53860 000109-86-4 Ethyleneglycolmonomethyl ether+Same 17002 2 Group t-TDI : 0.05 mg/kg b.w. (with15780=48050, 16993=53765, 16996=53820,16999, 17002=53860, 30015, 30120, 30200,+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT53900 050586-59-9 Ethyleneglycoltrimethylolpropane,copolymer48030).(See references for 16996)9 +53920 see 54120 D +53930 025038-37-3 Ethylene-1,4-hexadienepropylene,D +copolymer53950 000151-56-4 Ethyleneimine Same 17005 4 See references for same substance in +monomer report.53970 009006-26-2 Ethylene-maleicD +anhydride, copolymer53985 009010-79-1 Ethylene oxidevinylpyrrolidone,copolymer9 +54000 see 54170 D +54005 005136-44-7 Ethylene-N-palmitamide-N'-stearamideDIR 3 Chemically similar to 53520 in list 3. +54020 - Ethylene-propylene,copolymer54040 - Ethyleneureaformaldehydeisophthalicacid diamide,copolymerD +9 +54060 024937-78-8 Ethylene-vinyl acetate,D +copolymer54080 see 54260 D +54085 - Ethylene-vinyl benzoate,9 +copolymer54100 - Ethylene-vinyl esters ofsat., aliph., monocarb.,acids (C2-C18),copolymer9 +54120 000149-57-5 2-Ethylhexanoic acid Same 17040 6B Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg of food,peroxisome proliferation study too.+ +181

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT54130 024593-34-8 2-Ethylhexanoic acid,cerium salt6BL6B for 2-ethylhexanoic acidNeeded: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg of food,peroxisome proliferation study too.+54140 000136-52-7 2-Ethylhexanoic acid,cobalt(II) salt6BL8 for cerium.L3 for Cobalt.R: 0.05 mg/kg of food (as Co).(RIVM, summary data, 0ctober1992=CS/PM/1707).+ +L6B for 2-ethylhexanoic acid.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg of food,peroxisome proliferation study too.54160 see 54300 D +54170 093777-46-9 2-Ethylhexanoic acid,decyl ester54190 015956-58-8 2-Ethylhexanoic acid,manganese salt6B6BL0 for n-decanoic acid.L6B for 2-ethylhexanoic acid.Needed: toxicological data depending onmigration level (SCF guidelines) and, ifmigration exceeds 0.05 mg/kg of food,peroxisome proliferation study too.L2 for the Mn.Group TDI: 0.01 mg/kg b.w. (as Mn).See references for 30180 in L2 in this report.++54220 022464-99-9 2-Ethylhexanoic acid,zirconium salt6BL6B for 2-ethylhexanoic acid.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg of food,peroxisome proliferation study too.L6B for 2-ethylhexanoic. Needed: same as17040.+L7 for zirconium.Available: Oral life span study in mice andrats and oral studies in rabbits and dogs182

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(reports not seen).Needed: migration data and toxicity dataaccording to SCF guidelines.(RIVM doc; (CS/PM/2091)).54240 see 54380 D +54245 - 2-Ethylhexyl maleate-9 +vinyl acetate copolymer54260 009004-58-4 Ethylhydroxyethylcellulose54270 - Ethylhydroxymethylcellulose54280 - Ethylhydroxypropylcellulose54300 118337-09-0 2,2'-Ethylidenebis(4,6-di-tert-butyl phenyl)fluorophosphoniteDIR 2 Group TDI: not specified based on GroupADI (=not specified) for certain modifiedcelluloses.(JECFA 35 M., 1989).DIR 2 Group TDI : not specified based on GroupADI (=not specified) for certain modifiedcelluloses.(JECFA, 35 M., 1989).DIR 2 Group TDI : not specified based on groupADI (=not specified) for certain modifiedcelluloses.(JECFA, 35 M., 1989).DIR SML = 6 mg/kg 2 TDI = 0.1 mg/kg b.w.3 month oral dog and 3 month combinedoral fertility study in rats. Mutagenicity testsnegative.(doc. CS/PM/841)54320 see 54420 D +54380 008047-99-2 N-Ethyltoluenesulphonamide8 +54395 035835-94-0 Ethyltriphenylphosphoni8 +um acetate54400 see 54450 D + +54420 000121-32-4 Ethylvanillin 1 ADI : 5 mg/kg b.w.+(JECFA 35 M., 1990).54450 - Fats and oils, fromanimal or vegetable foodsourcesDIR 3 Food fat. + +54480 - Fats and oils,hydrogenated, fromanimal or vegetable foodDIR 3 Similar to food fats. + +183++++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTsources54560 - Fats and oils, refined,arising from bones, withunsaponifiable matter upto 1%54640 - Fats and oils, sulphated,derived from animal orvegetable sources54650 - Fats and oils,sulphonated, derivedfrom animal or vegetablesources54660 - Fatty acids of coconoutoil, esters with cholinechlorideSame 43515and 634009 +9 +9 +Dhttp://europa.eu.int/comm/food/fs/sc/scf/out16_en.html+ +54710/1 061790-12-3 Fatty acids, tall oil Same 172303 +and 54710/054720 see 54650 D +54730/1 - Fatty acids, tall oil,cobalt salts3 L3 for fatty acids tall oil.+54766 115438-43-2 Fatty acids, tallow,hydrogenated, 2-ethylhexylester54768 064755-02-8 Fatty acids, tallow,lithium saltsL3 for Cobalt.R: 0.05 mg/kg of food (as Co).(RIVM, summary data, October1992=CS/PM/1707).9 +54800 see 54860 D +54820 - Fibers, natural, syntheticD +or metallic54840 007782-41-4 Fluorine W +54860 016961-83-4 Fluorosilicic acid 7 Needed: use levels, migration data. +54880 000050-00-0 Formaldehyde Same 17260. DIR SML(T) = 15 mg/kg(22)3 See references for the same substance inmonomer list.(SCF, 17th Series, 1986).++ +54900 009017-33-8 Formaldehyde- 9 + +184

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTnaphthalenesulphonicacid, copolymer54930 025359-91-5 Formaldehyde-1-naphthol copolymer[=poly(1-hydroxynaphthylmethane)]54960 001338-51-8and 025035-71-6Formaldehydetoluenesulphonamide,copolymer54970 009003-08-1 Formaldehyde-2,4,6-triamino-1,3,5-triazine,copolymerSame 80330 DIR SML = 0.05 mg/kg 3 Available: Adequate migration data;mutagenicity studies on the polymericadditive itself (negative); mutagenicity dataon themonomer 1-naphthol (negative).(RIVM/TNO SDS, October 1997 = CS/PM/3086/54930).++9 +185D +55030 009011-05-6 Formaldehyde-urea,D +copolymer55040 000064-18-6 Formic acid Same 17275 DIR 1 Group ADI: 3 mg/kg b.w. for formic acidand ethyl formate.(JECFA 17 M., 1973).55120 000110-17-8 Fumaric acid Same 17290 DIR 1 ADI: 6 mg/kg b.w.+(SCF, 25th Series, 1990).55160 000098-00-0 Furfurol Same 17505 8 +55190 029204-02-2 Gadoleic acid Same 17510 DIR 0 +55200 001166-52-5 Gallic acid, dodecyl ester DIR SML(T) = 30 mg/kg(34)55280 001034-01-1 Gallic acid, octyl ester DIR SML(T) = 30 mg/kg(34)55360 000121-79-9 Gallic acid, propyl ester DIR SML(T) = 30 mg/kg(34)1 Group ADI: 0.5 mg/kg b.w. for gallic acid,octyl ester and gallic acid, propyl ester.(SCF, 22th Series, 1989).1 Group ADI: 0.5 mg/kg b.w. for gallic acid,dodecyl ester and gallic acid, propyl ester.(SCF, 22th Series, 1989).1 Group ADI: 0.5 mg/kg b.w. for gallic acid,dodecyl ester and gallic acid, octyl ester.(SCF, 22th Series, 1989).+ +55440 009000-70-8 Gelatin DIR 0 +55520 - Glass fibers DIR 3 Inert material. +55600 - Glass microballs DIR 3 Inert material. +55630 000526-95-4 Gluconic acid (= E574) W +55680 000110-94-1 Glutaric acid Same 18010 DIR 0 ++++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT55760 029733-18-4 Glutaric acid, diisodecyl Same 18040 8 +ester55840 028880-25-3 Glutaric acid, diisooctyl8 +ester55920 000056-81-5 Glycerol Same 18100 DIR 1 Group ADI: not specified for glycerol, +glycerol diacetate, glycerol triacetate andglycerol monoacetate.(SCF, 11th Series, 1981).56000 025395-31-7 Glycerol diacetate 1 Group ADI: not specified for glycerol, + +glycerol diacetate, glycerol triacetate andglycerol monoacetate.(SCF, 11th Series, 1981).56020 099880-64-5 Glycerol dibehenate DIR 3 Toxicologically acceptable. + +56040 - Glycerol dibutyrate 3 Toxicologically acceptable. + +56055 027638-00-2 Glycerol dilaurate 3 Toxicologically acceptable. + +56070 053563-63-6 Glycerol dimyristate 3 Toxicologically acceptable. + +56080 025637-84-7 Glycerol dioleate 1 ADI: not specified.+ +(JECFA 17 M., 1973).56120 026657-95-4 Glycerol dipalmitate 3 Toxicologically acceptable. + +56160 026402-29-9 Glycerol dipropionate 3 Toxicologically acceptable. + +56240 027902-24-5 Glycerol diricinoleate 3 Toxicologically acceptable. + +56320 001323-83-7 Glycerol distearate Same 89240 1 ADI: not specified.+ +(JECFA 17 M., 1973).56360 - Glycerol esters withDIR + +acetic acid56400 - Glycerol, esters with9 +acids, aliph., monocarb.(more than C6)56480 - Glycerol, esters with9 +acids, aliph., monocarb.,hydroxylated (C12-C20)56485 091052-28-7 Glycerol, esters with9 +acids, aliph.,sat.(C14-C18) and acids, aliph.unsat (C16-C18)56486 - Glycerol, esters withacids, aliph.,sat., linearwith an even number ofDIR 3 Toxicologically acceptable. + +186

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTcarbon atoms (C14-C18)and with acids aliph.,unsat., linear, with aneven number of carbonatoms (C16-C18)56487 - Glycerol esters withDIR + +butyric acid56490 - Glycerol, esters withDIR 3 Toxicologically acceptable. + +erucic acid56495 - Glycerol esters with 12-DIR 3 Toxicologically acceptable. +hydroxystearic acid56500 - Glycerol, esters withDIR 3 Toxicologically acceptable. + +lauric acid56510 - Glycerol, esters withDIR 3 Toxicologically acceptable. + +linoleic acid56520 - Glycerol, esters withDIR 3 Toxicologically acceptable. + +myristic acid56535 - Glycerol, esters withDIR 3 Toxicologically acceptable. + +nonanoic acid56540 - Glycerol, esters withDIR 3 Toxicologically acceptable. + +oleic acid56550 - Glycerol, esters withDIR 3 Toxicologically acceptable. + +palmitic acid56560 see 56600 D + +56565 - Glycerol, esters with Same 56535 D D + +pelargonic acid56570 - Glycerol, esters withDIR + +propionic acid56580 - Glycerol, esters withricinoleic acidDIR 3 SCF_List: 3Restriction: none. In small dosesmetabolised similarly to food fats.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf+ +DIR + +56585 - Glycerol, esters withstearic acid56600 026446-35-5 Glycerol monoacetate 1 Group ADI: not specified for glycerol,glycerol diacetate, glycerol triacetate andglycerol monoacetate.187+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(SCF, 11th Series, 1981).56610 030233-64-8 Glycerol monobehenate DIR 3 Toxicologically acceptable. + +56640 026999-06-4 Glycerol monobutyrate 3 Toxicologically acceptable. + +56720 026402-23-3 Glycerol monohexanoate DIR 3 Toxicologically acceptable. + +56760 001323-43-9 Glycerol mono(12-3 Toxicologically acceptable. +hydroxystearate)56780 027215-38-9 Glycerol monolaurate 3 Toxicologically acceptable. + +56800 030899-62-8 Glycerol monolaurateDIR 3 Chemically similar to natural fats. +diacetate56840 027214-38-6 Glycerol monomyristate 3 Toxicologically acceptable. + +56880 026402-26-6 Glycerol monooctanoate DIR 3 Toxicologically acceptable. + +56960 025496-72-4 Glycerol monooleate 1 ADI: not specified.+ +57040 - Glycerol monooleate,ester with ascorbic acid57120 - Glycerol monooleate,ester with citric acid(JECFA 17 M., 1973).DIR 2 Group TDI: not specified. Similarity withthe citric acid esters.(JECFA 17 M., 1973).DIR 1 ADI: not specified for citric and fatty acidesters of glycerol.(SCF, 7th Series, 1978).57150 026657-96-5 Glycerol monopalmitate 3 Toxicologically acceptable. + +57200 - Glycerol monopalmitate,ester with ascorbic acidDIR 2 Group TDI= not specified. Similarity withthe citric acid esters.+57280 - Glycerol monopalmitate,ester with citric acid(JECFA 17 M., 1973)DIR 1 ADI: not specified for citric and fatty acidesters of glycerol.(SCF, 7th Series, 1978).57360 026894-50-8 Glycerol3 Toxicologically acceptable. + +monopropionate57440 001323-38-2 Glycerol3 Toxicologically acceptable. + +monoricinoleate57520 031566-31-1 Glycerol monostearate Same 18115 1 ADI: not specified.+ +(JECFA 17 M., 1973).57600 - Glycerol monostearate,ester with ascorbic acidDIR 2 Group TDI= not specified. Similarity withthe citric acid esters.+57680 - Glycerol monostearate,ester with citric acid(JECFA 17 M., 1973).DIR 1 ADI: not specified for citric and fatty acidesters of glycerol.(SCF, 7th Series, 1978).188++++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT57760 000102-76-1 Glycerol triacetate Same 93695 1 Group ADI: not specified for glycerol, + +glycerol diacetate, glycerol triacetate andglycerol monoacetate.(SCF, 11th Series, 1981).57800 018641-57-1 Glycerol tribehenate DIR 3 Toxicologically acceptable. + +57840 000060-01-5 Glycerol tributyrate Same 93810 3 Toxicologically acceptable. + +57880 - Glycerol, triesters with9 +acids, aliph., monocarb.(more than C6)57920 000620-67-7 Glycerol triheptanoate DIR 3 Toxicologically acceptable. + +57960 000538-24-9 Glycerol trilaurate 3 Toxicologically acceptable. + +58000 068476-38-0 Glycerol trimontanate 7 Needed: hydrolysis data. +58040 000555-45-3 Glycerol trimyristate 3 Toxicologically acceptable. + +58060 000555-44-2 Glycerol tripalmitate 3 Toxicologically acceptable. + +58080 000139-45-7 Glycerol tripropionate Same 95260 3 Toxicologically acceptable. + +58160 000139-44-6 Glycerol tris(12- Same 62040 3 Toxicologically acceptable. +hydroxystearate)58240 000555-43-1 Glycerol tristearate 3 Toxicologically acceptable. + +58300 - Glycine, salts DIR 1 ADI: acceptable.+(SCF, 25th Series, 1991).58310 000107-22-2 Glyoxal Same 18120 D + +58320 007782-42-5 Graphite DIR 3 Inert material. +58400 009000-30-0 Guar gum DIR 1 ADI: not specified.+(SCF, 7th Series, 1978).58480 009000-01-5 Gum arabic DIR 1 ADI: not specified.+ +(JECFA, 35 M., 1989).58560 - Gums, natural 9 +58600 012173-47-6 Hectorite W +58640 015655-33-1 2-Heptadecyl-4,4'-bis(methylene stearate)-1,3- oxazoline1897 Needed: report of 90-day oral study(BIBRA).58680 000142-82-5 n-Heptane 8 +58720 000111-14-8 Heptanoic acid DIR 3 Fatty acid from food. + +58770 025637-99-4 Hexabromocyclododecane5 [Some organobromo compounds have abioaccumulation potential and 1,2-dibromoethane is a category 2 carcinogen++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT58800 067845-93-6 Hexadecyl 3,5-di-tertbutyl-4-hydroxybenzoate58840 029316-77-6 Hexadecyl methacrylateoctadecylmethacrylate,copolymer58880 000123-03-5 Hexadecylpyridiniumchloride58960 000057-09-0 Hexadecyltrimethylammonium bromide59040 009011-17-0 Hexafluoropropylenevinylidenefluoride,copolymer (Mw>70.000)59080 166412-78-8 Hexahydrophthalaticacid, diisononyl ester59120 023128-74-7 1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide)59200 035074-77-2 1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl--4-hydroxyphenyl)propionate)(EC classification).]Same 46800 D +190W +8 +Same 18330 DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w.400-day oral rat study.(RIVM report, September 1978).+3 Average Mw above 70000. +1,2-cyclohexanedicarboxylicacid, diison59240 000124-09-4 Hexamethylenediamine Same 15274and 1846059280 000100-97-0 Hexamethylenetetramine Same 18670. DIR SML(T) = 15 mg/kg(22) (35)(expressed asFormaldehyde)7 +Same 38780 DIR SML = 45 mg/kg 2 TDI: 0.75 mg/kg b.w.2-year and 90-day oral rat studies,teratogenicity studies in mice, rats, rabbits.(RIVM report 88/678608/010, 1989-01-24).DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w.90-day oral rat and dog (plus 4-weekrecovery period) studies and a 2-year oralstudy.(RIVM July 1975, report CBG 182/80928, 5april 1982).2 TDI: 0.04 mg/kg b.w.See references for the same substance inmonomer report.3 See references for the same substance inmonomer list.59330 000110-54-3 n-Hexane 8 +59332 - Hexane (isomers) 9 +59360 000142-62-1 Hexanoic acid Same 18770and 41800+ ++ +++ +DIR 0 + +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT59440 - 2,8,14,18,24,30-8 +Hexaoxa-6,10,22,26-tetrathio-7,9,23,25-tetrastanna-7,7,9,9,23,23,25,25-octa-(n-dodecyl)-spiro(15,15)hentriacontane-3,13,19,29-tetraoxide59520 002425-77-6 2-Hexyldecanol 8 +59600 000107-41-5 Hexyleneglycol Same 188507 Needed: purity, physicochemical state, +and 22072migration data.59760 019569-21-2 Huntite DIR 3 Inert, insoluble material. +59815 - Hydrocarbon resins (forD +memo.to be deleted later)59816 267233-58-9 Hydrocarbon resins,W +aliphatic59817 267233-95-4 Hydrocarbon resins,W +aromatic59818 267233-62-5 Hydrocarbon resins,W +cyclodiene59819 267233-74-9 Hydrocarbon resins,W +hydrogenated59825 - Hydrocarbons, aliphatic9 +up to C859840 - Hydrocarbons, aliphatic,9 +(C10-C14) (b.p. 180-260°C)59841 see 59935 D +59842 see 59950 D +59920 see 59980 D +59935 - Hydrocarbons (b.p. 180-9 +260 °C, hydrogenated)59950 - Hydrocarbons (b.p. 180-D +260 °C, conventional)59980 - Hydrocarbon wax,9 +oxidized59990 007647-01-0 Hydrochloric acid DIR 1 ADI: not specified.(SCF, 25th Series, 1991)+ +191

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT60005 - Hydrochloric acid, salts D Deleted because the acid appears in the list. +60020 010026-04-7 Hydrochloric acid,D +tetrasilicon salt60030 012072-90-1 Hydromagnesite DIR 3 Inert material. Purity to be specified. +60060 000123-31-9 Hydroquinone Same 15940,D +18867 and4862060080 012304-65-3 Hydrotalcite DIR 3 Inert, insoluble material. +60160 000120-47-8 4-Hydroxybenzoic acid,ethyl esterDIR 1 Group ADI: 10 mg/kg b.w. for ethyl, methyland propyl esters.+60180 004191-73-5 4-Hydroxybenzoic acid,isopropyl ester60200 000099-76-3 4-Hydroxybenzoic acid,methyl ester60240 000094-13-3 4-Hydroxybenzoic acid,propyl ester60320 070321-86-7 2-[2-Hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole60400 003896-11-5 2-(2'-Hydroxy-3'-tert-butyl-5'-methylphenyl)-5-chlorobenzotriazole60480 003864-99-1 2-(2'-Hydroxy-3,5'-di-tert-butylphenyl)-5-chlorobenzotriazole(SCF, 1st Series, 1975).DIR 2 Group-TDI: 10 mg/kg bw based on groupADI = 10 mg/kg bw for ethyl, methyl andpropyl esters.DIR 1 Group ADI: 10 mg/kg b.w. for ethyl, methyland propyl esters.(SCF, 1st Series, 1975).DIR 1 Group ADI: 10 mg/kg b.w. for ethyl, methyland propyl esters.(SCF, 1st Series, 1975).DIR SML = 1.5 mg/kg 2 TDI: 0.025 mg/kg b.w.90-day oral rat study, 3 mutagenicitystudies.(RIVM doc. 27 October 1987).DIRDIRSML(T) = 30 mg/kg(19)SML(T) = 30 mg/kg(19)1922 Group TDI: 0.5 mg/kg b.w. for 2-(2'-hydroxy-3,5'-di-tert.butylphenyl)-5-chlorobenzotriazoleand 2-(2'-hydroxy-5'methylphenyl)benzotriazole.2 Group TDI: 0.5 mg/kg b.w. for 2-(2'-hydroxy-3'-tert.butyl-5'-methylphenyl)-5-chlorobenzotriazole and 2-(2'-hydroxy-5'-methyl phenyl)benzotriazole.60560 009004-62-0 Hydroxyethylcellulose DIR 2 Group TDI: not specified based on GroupADI (=not specified) for certain modifiedcelluloses.(JECFA 35 M., 1989).60640 000150-39-0 N-(2-Hydroxyethyl)ethylenediaminetriacetic acid++ +++ ++ ++ ++ +8 +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT60800 065447-77-0 1-(2-Hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl piperidinesuccinicacid, dimethylester, copolymer60880 009032-42-2 HydroxyethylmethylcelluloseDIR SML = 30 mg/kg 2 TDI : 0.5 mg/kg b.w.90-Day oral rat and dog studies, 2-year oralrat study.(HRC report CBG 237/92271, 10 May 1983)+ +DIR 2 Group TDI: not specified based on GroupADI (=not specified) for certain modifiedcelluloses.(JECFA 35 M., 1989).+ +8 +60960 - Hydroxyethyloctadecylamine61040 000111-58-0 N-(2-Same 69500 8 +Hydroxyethyl)oleamide61055 000122-99-6 2-Hydroxyethyl phenyl8 +ether61120 009005-27-0 Hydroxyethyl starch DIR 2 Group TDI: not specified.+(JECFA 26 M., 1982).61200 070198-29-7 1-(2-Hydroxyethyl)-9 +2,2,6,6-tetramethyl-4-hydroxypiperidine/succinic acid,copolymer61280 003293-97-8 2-Hydroxy-4-nhexyloxybenzophenoneDIRSML(T) = 6 mg/kg(15)2 Group TDI: 0.1 mg/kg b.w.See references for 4,4'-dihydroxybenzophenone in list 2.61340 000149-44-0 Hydroxymethanesulphini Same 70160 8 + +c acid, sodium salt61360 000131-57-7 2-Hydroxy-4-DIR SML(T) = 6 mg/kg 2 Group TDI: 0.1 mg/kg b.w.+ +methoxybenzophenone(15)See references for 4,4'-dihydroxybenzophenone in list 2.61390 037353-59-6 Hydroxymethylcellulose DIR 2 Group TDI: not specified based on GroupADI (=not specified) for certain modifiedcelluloses.(JECFA 35 M., 1989).+61440 002440-22-4 2-(2'-Hydroxy-5'-methylphenyl)benzotriazoleDIRSML(T) = 30 mg/kg(19)2 Group TDI: 0.5 mg/kg b.w. for 2-(2'-hydroxy-3'-tert.butyl-5'-methylphenyl)-5-chlorobenzotriazole, 2-(2'-hydroxy-3,5'-ditert.butylphenyl)-5-chloro-benzotriazoleand2-(2'-hydroxy-5'-methylphenyl)benzotriazole.++ +193

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT61480 - Hydroxymethyl-1-phospha-2,6,7-trioxybicyclo(2.2.2)octane-3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate61520 004710-34-3 2-Hydroxyoctadecanesulphonic acid, sodium salt61600 001843-05-6 2-Hydroxy-4-noctyloxybenzophenoneDIRSML(T) = 6 mg/kg(15)Several 90-day oral rat and dog studies and a2-year oral rat study and 3-4 month oraldosing of man.(HRC report CBG 161/78164).D +8 +2 Group TDI: 0.1 mg/kg b.w.See references for 4,4'-dihydroxybenzophenone in list 2.61680 009004-64-2 Hydroxypropylcellulose DIR 2 Group TDI: not specified based on GroupADI (=not specified) for certain modifiedcelluloses.(JECFA 35 M., 1989).61760 009004-65-3 HydroxypropylmethylcelluloseSame 66700 D Group TDI: not specified based on GroupADI (=not specified) for certain modifiedcelluloses.(JECFA 35 M., 1989).61800 009049-76-7 Hydroxypropyl starch DIR 1 ADI: not specified.(SCF, 13th Series 1982).61840 000106-14-9 12-Hydroxystearic acid Same 18900 DIR 3 SCF_List: 3Restriction: none. In small dosesmetabolised similarly to food fats.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf61880 078616-19-0 12-Hydroxystearic acid,diester with glycerol61920 - 12-Hydroxystearic acid-3-dimethylaminopropylamine, copolymer62000 - 12-Hydroxystearic acid,esters with glycerol3 Toxicologically acceptable. +W9 +D Toxicologically acceptable. ++ ++ ++ ++ ++ +194

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT62080 - 12-Hydroxystearic acid-3-dimethylaminopropylamine- dimethylsulphate, copolymer62095 056780-58-6 2-Hydroxy-3-(trimethylammonio)propyl starch chloride62110 007681-52-9 Hypochlorous acid,sodium salt195W9In first instance provide information onidentity.W +6A Positive in several mutagenicity studies. + +(RIVM doc. CS/PM/2093).62140 006303-21-5 Hypophosphorous acid DIR 3 Easily oxidized to phosphoric acid. + +62160 007681-53-0 Hypophosphorous acid,3 Easily oxidized to phosphorous acid. +sodium salt62175 010025-82-8 Indium trichloride 8 +62220 010045-89-3 Iron(ii) diammoniumbisulphate3 Iron maximum provisional tolerable dailyintake 0.8 mg/kg bw.+(27th M, JECFA, 1983).62230 020344-49-4 Iron hydroxide oxide W +62240 001332-37-2 Iron oxide DIR 2 ADI: not specified.+ +(SCF, 1st Series 1975).62245 012751-22-3 Iron phosphide 3AM 3 Restriction: None (Inert, insoluble material) +Remark for Commission: It is requestedonly for use in PET polymers and copolymers.http://www.efsa.eu.int/science/afc/afc_opinions/768/afc_fcm_op_list6_2004.12.171.pdf62250 000089-65-6 Isoascorbic acid W +62270 000078-83-1 Isobutanol Same 18970 8 Residue less than 1 mg/kg in food. Nomutagenicity or oral data.(Directive 88/344/EEC)+62280 09003-29-6 Isobutylene-butene Similar to7 Under evaluation +copolymers7652062295 - Isobutene-2-methyl-1,3-D +butadiene, copolymer62320 see 62435 D +62400 see 62450 D +62405 031807-55-3 Isododecane 9 +62415 097259-92-2 Isononanoic acid, butylesterW ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT62420 025103-52-0 isooctanoic acid Same 19135 8 +62435 011087-88-0 Isooctyl epoxystearate 6A +62450 000078-78-4 Isopentane DIR 3 Volatile. +62480 000067-63-0 Isopropanol Same 23830D +62500 - 1,1(Isopropylidenebis(p-phenyleneoxy))-bis(3-(p-(2,3-epoxypropoxy)-alpha,alphadimethylbenzyl)phenoxy))2-propanol62540 000080-05-7 4,4'-Isopropylidenediphenol62560 092908-32-2 4,4'-Isopropylidenediphenylalkyl(C12-C15)phosphitesand 81882Same13480/13607/40060/19255/396801966A +Dhttp://europa.eu.int/comm/food/fs/sc/scf/out128_en.pdf9 +62640 008001-39-6 Japan wax DIR 3 Refined, natural wax. Purity to be specified. + +62720 001332-58-7 Kaolin Same 43490 DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1990).62800 - Kaolin, calcined DIR 3 Inert material. + +62880 061790-53-2 Kieselguhr Same 46375 D +62885 068855-54-9 Kieselguhr, soda ash flux Same 46380 D + +calcined62960 000050-21-5 Lactic acid Same 19460 DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1990).63040 000138-22-7 Lactic acid, butyl ester DIR 2 Group TDI= not specified.+ +Similarity with lactic acid, ethyl ester forwhich an ADI not specified was establishedby JECFA 26 M., 1982.63120 007100-07-4 Lactic acid, iron salt D +63200 051877-53-3 Lactic acid, manganesesaltDIR+SML(T) = 0.6 mg/kg(10) (expressed asManganese)1-2 L1 for lactic acid.ADI: not specified.(SCF, 25th Series, 1991).L2 for Manganese.Group TDI: 0.01 mg/kg bw (as Mn)+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTSee references for acetic acid, manganese(II)salt (PM/REF.N. 30180) in list 2.63240 008006-54-0 Lanolin (pharmacopeia0 +grade)63260 091079-06-0 Lard oil, sulphated,9 +ammonium salt63280 000143-07-7 Lauric acid Same 19470 DIR 0 + +63360 000624-04-4 Lauric acid, diester with Same 53685 7 Needed: hydrolysis data. +ethyleneglycol63400 025234-60-0 Lauric acid, ester with Same asD http://europa.eu.int/comm/food/fs/sc/scf/out + +choline chloride 43515 and5466016_en.html63440 004219-48-1 Lauric acid, monoester Same 53845 7 Needed: hydrolysis data. +with ethyleneglycol63480 001338-39-2 Lauric acid, monoester Same 87600 D +with sorbitan63520 001793-68-6 Lauric acid, monoester7 Needed: hydrolysis data. +with triethanolamine63560 000120-40-1 Lauric diethanolamide Same 39280 D Same references as 39280. +63600 000097-78-9 N-Lauroylsarcosine 8 +63680 001344-40-7 Lead phosphite, dibasic D +63760 008002-43-5 Lecithin DIR 1 ADI: not specified.+ +(JECFA 17 M., 1973).63840 000123-76-2 Levulinic acid DIR 0 +63880 - Light petroleum9 Specifications on identity. +hydrocarbons, odorless63920 000557-59-5 Lignoceric acid DIR 0 +63940 008062-15-5 Lignosulphonic acid 3AM 3 R = 0.04 mg/dm² = 0.24 mg/kg of food forthe requested use, i.e. as dispersant forplastics dispersions.Available: molecular mass distributioncurve; calculation of worst case migrationassuming 100% transfer into food; genemutation assay in bacteria (negative) and 16-week oral rat study.(RIVM/DE SDS, May 1999 = CS/PM/3284REV. I/63940).Remark for Commission: No analytical+ +197

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTmethod is available.(Adopted at the 118th SCF meeting) (23September 1999)http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf64000 003999-01-7 Linoleamide 8 +64015 000060-33-3 Linoleic acid Same 19518 DIR 0 + +64080 - Linoleic acid, esters with9 +alcohols, aliph., monoh.64150 028290-79-1 Linolenic acid Same 19526 DIR 0 + +64160 008001-26-1 Linseed oil Same 19532 3 Food fat. + +64240 008016-11-3 Linseed oil, epoxidized(oxirane less than10%,iodine Number lessthan 6)7 Available: inadequate 20 week oral ratstudy, Ames test said to be negative (noreport supplied)(CS/PM/1517).Needed: data according to SCF guidelines.(N.B. Epoxidised linseed oil cannot becovered by data on epoxidised soya beanoil).64300 001310-65-2 Lithium hydroxide 2 Group TDI: 0.01 mg/kg b.w. (as Li).See references for 38000 in list 2.64320 010377-51-2 Lithium iodide DIR SML(T) = 1 mg/kg 2 L2 for I.(11) (expressed asGroup-TDI based on PMTDI: 0.017 mg/kgIodine) and SML(T) = b.w. (as I).0.6 mg/kg (8)(JECFA 33 M., 1988).(expressed as Lithium)L2 for Li.Group TDI: 0.01 mg/kg bw (as Li).90-day oral rat studies and metabolism andhuman use of lithium salts in therapy.(RIVM tox 105/76 July 1976, tox 204/78,November 1978, tox 126/79 October 1979).For Li see references for benzoic acid,lithium salt in list 2.+ +64400 001345-05-7 Lithopone 3 Free from water soluble barium. Insoluble, + +inert material.64480 011097-59-9 Magnesium aluminium Same 34690 D Inert, insoluble material. +hydroxide carbonate64500 - Lysine, salts DIR 0 +++198

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT64560 007786-30-3 Magnesium chloride 1/D ADI: not specified.+ +(SCF, 25th Series, 1991)64640 001309-42-8 Magnesium hydroxide DIR 1 ADI: not specified.+(SCF, 25th Series, 1991)64720 001309-48-4 Magnesium oxide DIR 1 ADI: not specified.+(SCF, 25th Series, 1991)64800 000110-16-7 Maleic acid Same 19540. DIR SML(T) = 30 mg/kg 2 Group TDI: 0.5 mg/kg b.w. as maleic acid. +(4)(SCF, 17th Series, 1986).64820 000142-16-5 Maleic acid, bis(2-W +ethylhexyl) ester64840 010039-33-5 Maleic acid, di-n-octyltin Same 50240 D Same references as 50240. +bis (2-ethylhexyl) ester64860 - Maleic acid, esters with9 +pentaerythritol64880 - Maleic acid,7 Needed: hydrolysis data. +monohexadecyl ester,potassium salt64900 000108-31-6 Maleic anhydride Same 19960 D +64920 - Maleic anhydride-buteneD +and/or ethylene and/orpropylene, copolymers64940 - Maleic anhydrideethylene9 +or styrene ormethyl vinyl ether,copolymer64955 025119-65-7 Maleic anhydride-methylD +methacrylate, copolymer64960 see 65020 D +64970 - Maleic anhydride-methyl9 +vinyl ether, copolymer64972 028133-65-5 Maleic anhydride methyl7 Needed: In first instance, Mw distribution +vinyl ether, copolymer,sodium salt (Mw>70000)curve of the polymer (maleic anhydridemethyl vinyl ether, copolymer, sodium salt).Remark: Monomer, i.e. methyl vinyl ether(PM/REF No. 22270) not yet evaluated(provide hydrolysis data).(Adopted at 111th SCF meeting (18-19March 1998)64985 025722-45-6 Maleic anhydride- 9 +199

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTpropylene, copolymer64990 025736-61-2 Maleic anhydridestyrene,copolymer,sodium salt65000 - Maleic anhydride-vinylesters, copolymers3AM 3 Restriction: Nonehttp://www.efsa.eu.int/science/afc/afc_opinions/768/afc_fcm_op_list6_2004.12.171.pdf+D +65020 006915-15-7 Malic acid Same 19965 DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1990).65040 000141-82-2 Malonic acid Same 19968 DIR 3 Occurs in plants. +65120 007773-01-5 Manganese chloride DIR SML(T) = 0.6 mg/kg(10) (expressed asManganese)2 Group TDI: 0.01 mg/kg b.w. (as Mn).(Environmental Health Criteria 17, WHO1981).+65200 012626-88-9 Manganese hydroxide DIR SML(T) = 0.6 mg/kg(10) (expressed asManganese)65280 010043-84-2 ManganesehypophosphiteDIRSML(T) = 0.6 mg/kg(10) (expressed asManganese)2 Group TDI: 0.01 mg/kg b.w. (as Mn).See references for acetic acid, manganese(II)salt in list 2.2-3 L2 for manganeseGroup TDI: 0.01 mg/kg b.w. (as Mn).See references for acetic acid, manganese(II)salt in list 2.++65360 011129-60-5 Manganese oxide DIR SML(T) = 0.6 mg/kg(10) (expressed asManganese)65440 - ManganesepyrophosphiteDIRSML(T) = 0.6 mg/kg(10) (expressed asManganese)L3 for hypophosphite.Hypophosphite easily oxidised tpphosphoric acid.2 Group TDI: 0.01 mg/kg b.w. (as Mn).See references for acetic acid, manganese(II)salt.2-3 L2 for manganese.Group TDI: 0.01 mg/kg b.w. (as Mn).See references for acetic acid, manganese(II)salt in list 2.++L3 for pyrophosphite.Easily oxidized to pyrophosphoric acid.65520 000087-78-5 Mannitol Same 19972 DIR 1 ADI: acceptable.+(SCF, 16th Series, 1985).65630 000108-78-1 Melamine SameD See "2,4,6-triamino-1,3,5-triazine". + +19975,25420and 9372065768 000149-30-4 2-Mercaptobenzothiazole 6A Statement on 2-Mercaptobenzothiazole +200

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(MBT)The Committee has received a request tocomment on the safety of the proposed CENextraction limit for MBT from rubbermaterials used for soothers and teats.- Considering that on the basis of wellconductedgenotoxicity studies thepreviously expressed concern of possiblecarcinogenic effects related to the migrationof low amounts of MBT from finishedproducts can now be discounted.- Considering that based on the limit of 8 mgMBT/kg rubber extracted over 24 hours asproposed by CEN, a worst case exposure toMBT was calculated not to exceed 22 ug/kgb.w. for a baby weighing 2 kg, fed 8 times aday using a new teat of 5 g at each occasionand- In view of the existing toxicologicalstudies, albeit insufficient for establishing aTDI, which show a NOAEL of 94 mg/kgb.w. from a 90-day oral mouse study leadingto a margin of safety of around 4200,The Committee concludes that the potentialoral exposure to MBT resulting frommaterials in compliance with the proposedCEN limit of 8 mg/kg rubber extracted overa 24 hour period does not constitute a healthhazard.However, the Committee is aware that MBThas been reported, primarily in occupationalsettings, to induce sensitisation after dermalcontact. As this issue is not related to foodsafety it is considered to be outside the remitof the Committee.Therefore the SCF recommends that theCommission seeks appropriate advice toconsider whether direct contact exposure toMBT, through teats and soothers, constitutesa sensitisation hazard.201

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT65770 002492-26-4 2-Mercaptobenzothiazole,sodium salt6AAvailable: inadequate migration data andworst case calculations; gene mutationassays in bacteria (negative); chromosomalaberration assay in cultured mammaliancells (positive); gene mutation assays incultured mammalian cells (one assaynegative and one assay weakly positive);SCE assay in vitro (positive); mouse bonemarrow micronucleus assay (negative); invivo rat liver UDS assay (negative); limitedin vivo DNA binding assay (negative); three16-day oral mouse and rat studies (oneinadequate); two 90-day oral mouse and ratstudies; 2 carcinogenicity studies (mouseand rat); two teratogenicity studies (rat);metabolism study; skin and eye irritationstudies; sensitisation study; human dataconcerning sensitisation.RIVM/DK/ISS/TNO SDS, March 2000 =CS/PM/3224 A+B REV.IV/65768/65770.(Adopted at the 123rd SCF meeting, 19October 2000http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdfStatement on 2-Mercaptobenzothiazole(MBT)The Committee has received a request tocomment on the safety of the proposed CENextraction limit for MBT from rubbermaterials used for soothers and teats.- Considering that on the basis of wellconductedgenotoxicity studies thepreviously expressed concern of possiblecarcinogenic effects related to the migrationof low amounts of MBT from finishedproducts can now be discounted.- Considering that based on the limit of 8 mgMBT/kg rubber extracted over 24 hours asproposed by CEN, a worst case exposure to+202

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTMBT was calculated not to exceed 22 ug/kgb.w. for a baby weighing 2 kg, fed 8 times aday using a new teat of 5 g at each occasionand- In view of the existing toxicologicalstudies, albeit insufficient for establishing aTDI, which show a NOAEL of 94 mg/kgb.w. from a 90-day oral mouse study leadingto a margin of safety of around 4200,The Committee concludes that the potentialoral exposure to MBT resulting frommaterials in compliance with the proposedCEN limit of 8 mg/kg rubber extracted overa 24 hour period does not constitute a healthhazard.However, the Committee is aware that MBThas been reported, primarily in occupationalsettings, to induce sensitisation after dermalcontact. As this issue is not related to foodsafety it is considered to be outside the remitof the Committee.Therefore the SCF recommends that theCommission seeks appropriate advice toconsider whether direct contact exposure toMBT, through teats and soothers, constitutesa sensitisation hazard.Available: inadequate migration data andworst case calculations; gene mutationassays in bacteria (negative); chromosomalaberration assay in cultured mammaliancells (positive); gene mutation assays incultured mammalian cells (one assaynegative and one assay weakly positive);SCE assay in vitro (positive); mouse bonemarrow micronucleus assay (negative); invivo rat liver UDS assay (negative); limitedin vivo DNA binding assay (negative); three16-day oral mouse and rat studies (oneinadequate); two 90-day oral mouse and rat203

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT65800 068039-13-4 Methacrylamidopropyltrimethylammoniumchloride, polymer (Mw=10000-100000)65805 - Methacrylamidopropyltrimethylammoniumchloridetrimethylethanolammonium chloridemethacrylate, copolymer(Mw=10000-100000)65830 000109-16-0 Methacrylic acid, diesterwith triethyleneglycol65905 007779-31-9 Methacrylic acid, 3,3,5-trimethylcyclohexyl ester65910 002530-85-0 [3-(Methacryloxy)propyl]trimethoxysilane65920 066822-60-4 [N-Methacryloyloxyethyl-N,N-dimethyl-Ncarboxymethylammonium chloride, sodium salt -octadecyl methacrylateethylmethacrylatecyclohexylmethacrylate-N-vinyl-2-pyrrolidone,copolymersW7W7studies; 2 carcinogenicity studies (mouseand rat); two teratogenicity studies (rat);metabolism study; skin and eye irritationstudies; sensitisation study; human dataconcerning sensitisation.RIVM/DK/ISS/TNO SDS, March 2000 =CS/PM/3224 A+B REV.IV/65768/65770.(Adopted at the 123rd SCF meeting, 19October 2000http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdfNeeded: Mw distribution curve; threemutagenicity studies with the monomer(which is now listed in L6A).(Adopted at 111th SCF meeting (18-19March 1998)Needed: Mw distribution curve; threemutagenicity tests with the monomers(which are listed in L6A or in L8).(Adopted at 111th SCF meeting (18-19March 1998)W +W +8 +Same 38500 DIR 2 TDI: 1 mg/kg b.w.90-day oral rat study. Mutagenicity data notneeded for this polymer.(RIVM doc. Tox 300/482 March 1984).+++204

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT66000 - 3'-Methoxy-4'-8 +hydroxyphenyl-2-indole66030 000150-76-5 4-Methoxyphenol Same 21615 8 +66080 000613-93-4 N-Methylbenzamide 8 +66160 016515-58-5 7-(5'-Methyl-6'-n-8 +butoxy-benzotriazole(2))-3-phenylcoumarin66200 037206-01-2 MethylcarboxymethylcelDIR 2 Group TDI: not specified based on Group +luloseADI (= not specified) for certain modifiedcelluloses.(JECFA 35 M., 1989).66240 009004-67-5 Methylcellulose DIR 2 Group TDI: not specified based on Group + +ADI (=not specified) for certain modifiedcelluloses.(JECFA 35 M., 1989).66270 000096-37-7 Methylcyclopentane 8 +66320 000118-82-1 4,4'-Methylenebis(2,6- Same 38750 8 +di-tert-butylphenol)66350 085209-93-4 2,2'-Methylenebis(4,6-di-tert-butylphenyl)lithium phosphate66360 085209-91-2 2,2'-Methylene bis(4,6-di-tert-butylphenyl)sodium phosphate66400 000088-24-4 2,2'-Methylene bis(4-ethyl-6-tert-butylphenol)66480 000119-47-1 2,2'-Methylene bis(4-methyl-6-tertbutylphenol)3AM 3 Restriction: 5 mg/kg food.Remark for the Commission: Lithium:Group restriction of 0.6 mg/kg food.http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdfDIR SML = 5 mg/kg 3 R: 5 mg/kg in food.Available: 3-month oral rat study,mutagenicity tests negative, migration data.Same 39010 DIR SML(T) = 1.5 mg/kg(20)Same 39025 DIR SML(T) = 1.5 mg/kg(20)205(RIVM doc. 15 Oct. 1991).2 Group TDI: 0.025 mg/kg b.w.(with 66480).Available for 66480: two 90-day oral ratstudies, 4-month oral dog study andmutagenicity studies.(RIVM Doc/Tox 300/418 April 1983 andCS/PM/171).2 Group TDI: 0,025 mg/kg b.w.(with 66400).Available: two 90-day oral rat studies, 4-month oral dog study, mutagenicity studies.(RIVM doc./Tox 300/418 April 1983 andCS/PM/171).++++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT66560 004066-02-8 2,2'-Methylenebis(4-methyl-6-cyclohexylphenol)66580 000077-62-3 2,2'-Methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)66600 026545-58-4 Methylenebis(naphthalenesulphonic acid),disodium saltSame 39045 DIR SML(T) = 3 mg/kg (6) 2 TDI = 0.05 mg/kg b.w. (with 66580).Available for 66580 short-term oral rat anddog study, 90-day oral dog study and 2-yearoral rat and dog study.(RIVM doc. CS/PM/2205).+Same 39600 DIR SML(T) = 3 mg/kg (6) 2 Group TDI = 0.05 mg/kg b.w. (with 66560). +Available: short-term oral rat and dog study,90-day oral dog study and 2-year oral ratand dog study (RIVM doc. CS/PM/2205).8 +66620 000075-09-2 Methylene chloride 3 R: 0.05 mg/kg of foods.(SCF, 29th Series, 1992).66640 009004-59-5 Methylethylcellulose DIR 2 Group TDI: not specified based on GroupADI (=not specified) for certain modifiedcelluloses.(JECFA, 35 M., 1989).66655 000078-93-3 Methyl ethyl ketone Same 21827 3 R: 5 mg/kg of food.Available: 3 and 6 month inhalation studiesin rats, teratogenicity studies by inhalation inmice and rats, mutagenicity tests.(RIVM doc. CS/PM/2098),(SCF, 29thSeries, 1992).66675 ? MethylheptadecanoicD +acid66680 000095-71-6 Methylhydroquinone Same 21850 8 +66695 - Methylhydroxymethylcellulose+66700 009004-65-3 MethylhydroxypropylcelluloseDIR 2 Group TDI: not specified based on groupADI (= not specified) for certain modifiedcelluloses.(JECFA 35 M., 1989).Same 61760 DIR 2 Group TDI: not specified based on groupADI (= not specified) for certain modifiedcelluloses.(JECFA 35M., 1989).206++++ +66715 000693-98-1 2-Methylimidazole 8 +66720 see 66755 D + +66725 000108-10-1 Methyl isobutyl ketone 3 R: 5 mg/kg of food.Available: 3 month oral rat study and 3+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT66740 000814-78-8 Methyl isopropenylketone (=2-methyl-2-penten-4-one)66745 - Methyl isopropenylketone-styrene,copolymer66755 002682-20-4 2-Methyl-4-isothiazolin-3-onemonth inhalation studies mice, rats, dogsand monkeys, teratogenicity studies byinhalation in mice and rats , mutagenicitytests.(WHO Env. Health Crit. n. 117 (1990)Geneva).Same 21910 8 +DIR SML = ND (DL = 0.02mg/kg, analyticaltolerance included)9 +4A See references for 43760 in list 4. + +66800 000139-99-1 Methyl oleate, sulphated D L8 +66820 000923-02-4 N-Same 21970 7 +Methylolmethacrylamide66840 000107-83-5 2-Methylpentane 8 +66860 000108-11-2 4-Methyl-2-pentanol Same 22080 8 +66880 see 66950 D + +66905 000872-50-4 N-Methylpyrrolidone 3AM 2 Restriction: None.Used as solvent.http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf66930 068554-70-1 Methylsilsesquioxane Same 86426 3AM 3 Residual monomer in methylsilsesquioxane:< 1 mg methyltrimethoxysilane /kg ofmethylsilsesquioxanehttp://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdf++66940 - alpha-Methylstyrene-N-octadecylmaleimide-N-(2,2,6,6-tetramethyl-4-piperidyl)maleimide,copolymerW7http://europa.eu.int/comm/food/fs/sc/scf/out114_en.pdfAvailable: Inadequate migration data, Mw,Mn, mutagenicity studies on the polymericadditive itself.Needed: Mw distribution,additionalinformation on overall migration in olive oil+207

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT66950 - alpha-Methylstyrenestyrene,copolymer,hydrogenated66960 068441-38-3 alpha-Methylstyrenevinyltoluene,copolymer,hydrogenatedand on specific migration, 3 mutagenicitytests on each of the starting substances noton List 0-4(RIVM 1994-09-06).3 R: 5 mg/kg of food.See the opinion for PM/REF.N. 66960.3 R: 5 mg/kg of food.Available: molecular weight distributioncurve and migration data showing highmigration in fat simulants. Mutagenicitydata (from 47520), 3-month oral rat and dogstudies.(TNO 1995-05-22 = CS/PM/2594)(EliasCS/PM/838).+ ++ +67040 014295-72-8 1(4-Methylsulphonylphenyl)-3-(4-chlorophenyl)-delta-2-pyrazoline208Remark: since high migration into fat hasbeen demonstrated the WG recommends thatthe Commission take the necessary measuresso that the restriction proposed is notexceeded.8 +67120 012001-26-2 Mica DIR 3 Inert silicate. + +67155 - Mixture of 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene,4,4'-bis(2-benzoxazolyl)stilbene and 4,4'-bis(5-methyl-2-benzoxazolyl)stilbene)3AM 3 R = Maximum amount to be used 0.05%(w/w).+67160 - Mixt.of:60% alkyl(C11-C14)-bis(hydroxyethyl)sulphoniumglycolsulphate;17.9%alkyl(C11-C14)-D +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTbis(hydroxyethyl)sulphonium sulphate;2,6%alkyl (C11-C14)bis(hydroxyethyl)sulphonium bisulphate;19.5% alkyl etC.67161 068439-49-6 Mixture of a)fattyalcohols(C16-C18)(approx. 48%);b)ethyleneglycolmonoalkyl(C16-C18)ether(approx.24%);c)polyethyleneglycol(e0=2-6)monoalkyl(C16-C18)ether(approx. 28%)67162 - Mixture of lauric andmyristic alcohol withtheir polyethyleneglycolethers (1-10EO)67165 - Mixture of:a)40-100%react.product of 2-mercaptoethyl oleatewith dimethyltindichloride,methyltintrichloride and sodiumsulphide;b)0-40% 2-mercaptoethyloleate;c)0-5% 2-mercaptoethanol;d)0-40% paraffin etC.67170 - Mixture of (80 to 100%w/w) 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-2(3H)-benzofuranoneand (0 to 20% w/w)5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-2(3H)-benzofuranoneSame 77895 D +2097 Needed: Migration and toxicity data onpolyethyleneglycol ethers.D +Same 83598 D SML = 5 mg/kg 3 R = 5 mg/kg of food.Available: Adequate migration data; logPo/w; three negative mutagenicity studies;90-day oral rat study (including examinationof the activity of the peroxisome associatedenzymes); metabolism study (in vitro and invivo) in rats; in vitro gene mutation assay inbacteria with the dimer (CG33-0941); ADEstudy.(RIVM/TNO SDS, March 1998 =++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT67180 - Mixture of (50% w/w)phthalic acid n-decyl n-octyl ester, (25% w/w)phthalic acid di-n-decylester, (25% w/w)phthalic acid di-n- octylester.67185 028679-16-5 Mixture of (40% w/w)2,2,4-trimethylhexane-1,6-diisocyanate and(60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanateCS/PM/2965 REV. I/67170).(Adopted at 114th SCF meeting) (10December 1998)http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdfSame 75850 DIR SML = 5 mg/kg (1) 3 R = 5 mg/kg of food or food simulant. +Available: 3 mutagenicity studies negative,3 months oral rat study, test on liverperoxisome proliferation, migration inaqueous food simulants only.Remark: high migration into fatty food islikely.(RIVM report 1995-09-04 (=CS/PM/2655)).Same 22332 D Not detectable +67200 001317-33-5 Molybdenum disulphide DIR 3 Inert, insoluble material. +67240 023850-94-4 Monobutyltin tris(2-W +ethylhexanoate)67280 000108-90-7 Monochlorobenzene 2 TDI: 0.6 mg/kg b.w.90-day oral rat study, 2 year oral mouse andrat studies, Ames list negative, in vitromutagenicity test positive.(Appendix to RIVM report 758701004March 1990).+67355 - Mono-, di- andtrialkyl(C4-C18)phenylethers of poly(ethyleneand/orpropylene- and/orbutyleneglycol)aceticacid67360 067649-65-4 Mono-n-dodecyltintris(isooctylmercaptoacetate)2109 +DIR SML = 24 mg/kg 3 Restriction: 0.05 mg/kg food (as sum ofmono-n-dodecyltin tris(isooctylmercaptoacetate), di-n- dodecyltinbis(isooctyl mercaptoacetate),monododecyltin trichloride and didodecyltindichloride) expressed as the sum+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT67420 000141-43-5 Monoethanolamine Same 12763and 35170of mono- and di-dodecyltin chloride.http://www.efsa.eu.int/science/afc/afc_opinions/960/afc_op_ej218_8thlist_en1.pdf3 R = 0.05 mg/kg of food.Available: migration data from multilayerbottle and residual content in polymer; genemutation assay in bacteria (negative);chromosomal aberration assay in culturedmammalian cells (negative); gene mutationassay in cultured mammalian cells(negative); in vitro cell transformation assay(negative); toxicology summary onreproductive toxicity; general toxicologicaloverview on MEA (made by the applicant).RIVM/TNO SDS, August 1999 =CS/PM/3337/22337.Remark: substance evaluated only for therequested use of indirect contact with nonfattyfood.+67440 - Monoethanolamine alkylsulphate67441 - Monoethanolaminealkyl(C8-C22)sulphate,linear, primary, evennumbered(Adopted at the 121 SCF meeting (20 June2000))D Partially covered by 67441. +8 L3 and L8.For alkyl(C8-C22)sulphuric acids, linear,primary, even numbered.L3. Toxicologically acceptable.Same references as for 34281.+For monoethanolamine.67442 090583-16-7 Monoethanolaminealkyl(C12-C14)sulphate67515 057583-34-3 Monomethyltintris(ethylhexylL8.D Partially covered by 67441. +see 67520 3AM 2 L2 for tinIsooctyl refers to industrial mixture+211

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTmercaptoacetate)including substances with a branched chainof 8 atoms of carbon. Usually, x-methyl-C7,x,y-dimethyl-C6 are the major componentsof an isooctyl “mixture” (more than 90%).x-ethyl-C6 are present but not in a largequantities (less than 10%). The compositionof this mixture could be slightly differentaccording the oil feedstock used for thesynthesis of it and of the process used for the“oxo” reaction..In contrast, ethylhexyl (ethyl-C6) refersusually to 2-ethylhexyl structure which isperfectly defined chemically.67520 054849-38-6 Monomethyltintris(isooctylmercaptoacetate)67600 - Mono-n-octyltintris(alkyl(C10-C16)mercaptoacetate)67680 027107-89-7 Mono-n-octyltin tris(2-ethylhexylmercaptoacetate)67760 026401-86-5 Mono-n-octyltintris(isooctylmercaptoacetate)DIRDIRDIRDIRSML(T) = 0.18 mg/kg(16) (expressed as Tin)SML(T) = 1.2 mg/kg(18) (expressed as Tin)SML(T) = 1.2 mg/kg(18) (expressed as Tin)SML(T) = 1.2 mg/kg(18) (expressed as Tin)In the scope of organotin compounds forwhich the toxicity is related to organic tin,studies done either with the “isooctyl” or the“ethylhexyl” could be used for evaluation ofbranched C8 organotin compounds.2 Group TDI: 0.003 mg/kg bw (as Sn) (with49600 and 83599).See references for 83599 in list 2. .2 Group-TDI: 0.02 mg/kg bw (as Sn) with67680 and 67760.See references for 677602 Group-TDI: 0.02 mg/kg bw (as Sn)(with67760 and 67600).See references for 67760 in list 2.2 Group-TDI: 0.02 mg/kg bw (as Sn) formonooctyltin stabilisers (REF_N 67760)Group-TDI: 0.0006 mg/kg bw (as Sn) fordioctyltin stabilisers (REF_N 50480)++++Available: migration data; several subacutestudies in rats and dogs (performed withMOTTG, DOTTG, MOTC, DOTC andformulation of MOTC and DOTC); severalsemichronic studies in rats and dogs212

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT67840 - Montanic acids and/ortheir esters withethyleneglycol and/orwith 1,3-butanedioland/or with glycerol(performed with MOTTG, DOTTG andformulation of MOTTG and DOTTG); 2-year rat and dog studies (performed withDOTTG and formulation of MOTC andDOTC); gene mutation assays in bacteria(negative) (performed with MOTC, DOTCand formulation of MOTTG and DOTTG);gene mutation assays in cultured mammaliancells (negative) (performed with MOTC andDOTC); in vitro UDS assay (negative)(performed with DOTC); in vitro covalentDNA binding assay (negative) (performedwith DOTC); micronucleus assays(negative; however, it was noted that nocytotoxicity was observed when performedwith MOTC) (negative with formulationwith MOTTG and DOTTG); in vivo SCEassay (negative) (performed with DOTC); 2-generation reproduction study in rats(performed with formulation of MOTTGand DOTTG); teratogenicity study in rats(performed with formulation of MOTTGand DOTTG); teratogenicity study in rabbits(performed with formulation of MOTTGand DOTTG).(RIVM SDS, October 1998 =CS/PM/3255/50480/67760).Remark for Commission: no analyticalmethod is available.(Adopted at the 118th SCF meeting) (23September 1999)http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdfDIR 3 3-4 month oral dog, 3 month rat and 2-yearrat studies plus negative Ames tests.(RIVM report 05-03-1990).213+ +67850 008002-53-7 Montan wax DIR 3 Inert compound, specifications needed. + +67870 000110-91-8 Morpholine 5 [Possibility of the formation of carcinogenic +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT67878 - Morpholine, its salts ofacids, aliph., monocarb.,sat., more than C767882 - Morpholine, its salts ofacids, aliph., monocarb.,unsat., more than C7N-nitrosomorpholine in nitrite-containingfoodstuffs, as well as from nitrite in saliva.To a minor extent this nitrosamine can alsobe formed from N-substituted morpholines.]5 [Possibility of the formation of carcinogenicN-nitrosomorpholine in nitrite-containingfoodstuffs, as well as from nitrite in saliva.To a minor extent this nitrosamine can alsobe formed from N-substituted morpholines.]5 [Possibility of the formation of carcinogenicN-nitrosomorpholine in nitrite-containingfoodstuffs, as well as from nitrite in saliva.To a minor extent this nitrosamine can alsobe formed from N-substituted morpholines.]67891 000544-63-8 Myristic acid Same 22350 DIR 1 ADI: NS+ +(SCF, 25th Series, 1989).67895 025263-97-2 Myristic acid, isobutyl7 Needed: hydrolysis data. +ester67896 020336-96-3 Myristic acid, lithiumsaltDIR+SML(T) = 0.6 mg/kg(8) (expressed asLithium)1-2 Based on the above-mentioned data thesubstance is classified:SCF_List: L1 for myristic acid (ADI: Notspecified).SCF_List: L2 for lithium (Group-TDI = 0.01mg/kg bw. (as Li))http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf67898 000544-64-9 Myristoleic acid Same 67898 8 +67910 000085-47-2 1-Naphthalenesulphonic8 +acid67912 000120-18-3 2-Naphthalenesulphonic8 +acid67918 001338-24-5 Naphthenic acids W +67921 061789-36-4 Naphthenic acids,W +calcium salts67930 061789-51-3 Naphthenic acids, cobaltsalts+9 L3 for Cobalt.R: 0.05 mg/kg of food (as Co).(RIVM, summary data, October1992=CS/PM/1707).++214

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT67936 001338-02-9 Naphthenic acids, coppersalts67946 001336-93-2 Naphthenic acids,manganese saltL9 for napthenic acids.W +9 L9 for naphthenic acids.L2 for the Mn.Group TDI: 0.01 mg/kg b.w.See references for 30180 in L2 in this report.68000 - Naphthenic mineral oil 9 +68001 - Naphthenic mineral oilD +(hydrogenated)68002 - Naphthenic mineral oilD +(conventional)68040 003333-62-8 7-(2H-Naphtho-(1,2-D)triazol-2-yl)-3-phenylcoumarinDIR 2 TDI: 1 mg/kg b.w.90-day oral rat and dog studies, twomutagenicity tests.+(RIVM 300/234 Tox/75, July 1981).68050 026896-20-8 Neodecanoic acid W +68070 052270-44-7 Neodecanoic acid, cobalt Similar to+(ii) salt680783/D L3 for neodecanoic acid.R: 0.05 mg/kg of food for neodecanoic acid.Not for fatty foods.Available: 3 negative mutagenicity tests andmigration data for non-fatty foods forneodecanoic acid.+68078 027253-31-2 Neodecanoic acid, cobaltsaltSimilar to68070DIRSML(T) = 0.05 mg/kg(expressed asNeodecanoic acid) andSML(T) = 0.05 mg/kg(14) (expressed asCobalt). Not for use inpolymers contactingfoods for whichsimulant D is laiddown in DirectiveL3 for Cobalt.R: 0.05 mg/kg of food (as Co).(RIVM, summary data, October1992=CS/PM/1707).3 List 3 for neodecanoic acid.R: 0.05 mg/kg of food for neodecanoic acid.Not for fatty foods.Available: 3 negative mutagenicity tests andmigration data for non-fatty foods forneodecanoic acid.List 3 for Cobalt.R: 0.05 mg/kg of food (as Co).(RIVM, summary data, October1992=CS/PM/1707)."+215

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT85/572/EEC. (Adopted at the 126th SCF meeting, 28February 2001)http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf68080 see 68040 D +68112 027253-29-8 Neodecanoic acid, zincW +salt68125 037244-96-5 Nepheline syenite DIR 3 Inert material. +68140 007697-37-2 Nitric acid 2 TDI: 3 mg/kg bw based on ADI= 5 mg/kgbw on sodium nitrate.(SCF, 38th Series, 1997)+68145 080410-33-9 2,2',2"-Nitrilo[triethyltris(3,3',5,5'-tetra-tert-butyl-1,1'-bi-phenyl-2,2'-diyl)phosphite]DIRSML = 5 mg/kg (sumof phosphite andphosphate)2163 R = 5 mg/kg of food (covering the sum ofphosphite and phosphate).Available: adequate migration data, three invitro mutagenicity studies; 90-day oral ratstudy, acute delayed neurotoxicity study; logPo/w.(RIVM/TNO SDS, November 1996 =CS/PM/2749).+ +68150 000112-05-0 Nonanoic acid Same 22465 8 +68180 see 68125 D +68185 000104-40-5 4-Nonylphenol Same 22540 8 +68200 - Novolac glycidyl ethers(=NOGE)68210 032536-52-0 Octabromodiphenylethersame 22552See 13160DAccording toCommission Directive2002/16/EC of 20February 2002 on theuse of certain epoxyderivatives in materialsand articles intended tocome into contact withfoodstuffs.Can still be used inheavy coatings.7 http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf5 [Some organobromo compounds have abioaccumulation potential and 1,2-dibromoethane is a category 2 carcinogen(EC classification).]68225 000112-92-5 1-Octadecanol Same 22555 3 See references for same substance inmonomer report.+++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT68240 000124-30-1 Octadecylamine 8 +68320 002082-79-3 Octadecyl 3-(3,5-di-tert-DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w.+ +butyl-4-hydroxyphenyl)propionateSeveral oral rat studies (3-weeks to 3-months), 2-year oral studies in mice and rats,two-generation and teratogenicity studies,mutagenicity tests.(RIVM doc. 31-03-92).68400 010094-45-8 Octadecylerucamide DIR SML = 5 mg/kg 3 R: 5 mg/kg of food+Available: specific migration in aqueousfood simulants

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT68690 006535-19-9 n-Octanoic acid,manganese saltL0 for n-octanoic acid.2 L2 for the Mn.Group TDI: 0.01 mg/kg b.w. (as Mn).See references for 30180 in L2 in this report.+L0 for n-octanoic acid.68720 see 68775 D +68730 018312-04-4 Octanoic acid, zirconium9 L9 for octanoic acid.+saltL7 for zirconium.See references for 54220.68775 005333-42-6 2-Octyldodecanol 8 +68800 000106-84-3 Octyl epoxystearate Same 70040 6A +68840 000111-88-6 n-Octylmercaptan 8 +68860 004724-48-5 n-Octylphosphonic acid DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Based on the +reduced core set of toxicological dataaccording to the migration level.Available : migration data (SM < 15 ppb) ;gene mutation assay in bacteria (negative) ;chromosomal aberration assay in culturedmammalian cells (negative) ; gene mutationassay in cultured mammalian cells(negative).RIVM/TNO SDS, June 2001 = CS/PM/3847REV. I/68860.(Adopted at the 130th SCF meeting, 13December 2001)http://europa.eu.int/comm/food/fs/sc/scf/out114_en.pdf68880 000992-55-2 2-n-Octylthio-4,6-bis(4-8 +hydroxy-3,5-di-tert-butylphenoxy)-1,3,5-triazine68960 000301-02-0 Oleamide DIR 3 Hydrolyses to innocuous substances. + +Available: Migration data, Ames test,hydrolysis tests.(RIVM doc. 1990-09-12, CS/PM/2434).69040 000112-80-1 Oleic acid Same 22763 DIR 1 ADI: not specified. + +218

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(SCF, 25th Series, 1990).69120 000142-77-8 Oleic acid, butyl ester 7 Needed: hydrolysis data. + +69160 014666-94-5 Oleic acid, cobalt salt 3AM 3 SCF_List: 3 -Restriction : 0.05 mg/kg forcobaltSCF_List: 1 for oleic acid ; food additive"ADI not specified"Remark for Commission: Intended to beused in active packaging.+http://www.efsa.eu.int/science/afc/afc_opinions/195/opinion_afc_01_en1.pdfhttp://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf69200 - Oleic acid, esters with7 Needed: hydrolysis data. +alcohols aliph., monoh.69280 000111-62-6 Oleic acid, ethyl ester 7 Needed: hydrolysis data. +69360 042254-63-7 Oleic acid, heptyl ester 7 Needed: hydrolysis data. +69440 022393-86-8 Oleic acid, hexadecyl7 Needed: hydrolysis data. +ester69500 000111-58-0 Oleic acid,Same 61040 D +monoethanolamide69520 032953-65-4 Oleic acid, octyl ester 7 Needed: hydrolysis data. +69560 003687-45-4 Oleic acid, oleyl ester 7 Needed: hydrolysis data. +69600 000142-57-4 Oleic acid, pentyl ester 7 Needed: hydrolysis data. +69680 000110-25-8 N-Oleoylsarcosine 8 +69760 000143-28-2 Oleyl alcohol Same 22766 DIR 3 Precursor of oleic acid. + +69840 016260-09-6 Oleylpalmitamide DIR SML = 5 mg/kg 3 R: 5 mg/kg of food.+Available: 3-month oral rat study,mutagenicity studies negative, migrationdata.(RIVM doc. 17.03.92).69848 - Organopolysiloxanes 9 +69900 000122-51-0 Orthoformic acid, Same 94160 D +triethyl ester69920 000144-62-7 Oxalic acid Same 22775 DIR SML(T) = 6 mg/kg(29)2 TDI: 0.1 mg/kg b.w.2-year oral rat study, observations in man.+ +219

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT70000 070331-94-1 2,2'-Oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]70040 000106-84-3 Oxiraneoctanoic acid, 3-octyl, octyl ester70080 000080-51-3 4,4'-Oxybis(benzenesulphonyl hydrazide)(J. Am. Pharm. Ass. 1947, 36, 217-219,Patty).DIR 2 TDI: 10 mg/kg b.w.+90-day oral rat and dog studies, 2-generationrat study, 2 mutagenicity tests.(RIVM 85/627915/128 November, 1985).Same 68800 D +6A Waiting for an answer to the letter fromEEC (CS/PM/374) to the interested industryusing RIVM conclusions in CS/PM/366.+Same 61340 D +70160 000149-44-0 Oxymethanesulphinicacid, sodium salt70240 012198-93-5 Ozokerite DIR 3 Mineral wax. Purity to be specified. + +70320 000629-54-9 Palmitamide 8 +70400 000057-10-3 Palmitic acid Same 22780 DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1990).70480 000111-06-8 Palmitic acid, butyl ester 7 Needed: hydrolysis data. +70560 000628-97-7 Palmitic acid, ethyl ester 7 Needed: hydrolysis data. +70640 026718-83-2 Palmitic acid, heptyl7 Needed: hydrolysis data. +ester70720 000540-10-3 Palmitic acid, hexadecyl7 Needed: hydrolysis data. +ester70760 020259-32-9 Palmitic acid, iron (III)D +salt70780 000110-34-9 Palmitic acid, isobutyl7 Needed: hydrolysis data. +ester70800 059231-33-3 Palmitic acid, isodecylW8 +ester70870 002598-99-4 Palmitic acid, octadecyl7 Needed: hydrolysis data. +ester70880 016958-85-3 Palmitic acid, octyl ester 7 Needed: hydrolysis data. +70960 031148-31-9 Palmitic acid, pentyl7 Needed: hydrolysis data. +ester71020 000373-49-9 Palmitoleic acid Same 22785 DIR 0 + +71040 017281-74-2 Palmitoylbenzoylmethan8 +e71100 063449-39-8 Paraffins, chlorinated 5 [IARC (1989; volume 48) has classified +220

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTchlorinated paraffins of average carbonchainlength C12 and average degree ofchlorination approximately 60% as possiblycarcinogenic to humans (group 2B).]71120 008012-95-1 Paraffin oil 9 + +71121 - Paraffin oilD + +(hydrogenated)71122 - Paraffin oilD + +(conventional)71150 068188-18-1 Paraffin oils,W +chlorosulphonated,saponified71200 - Paraffin, synthetic 9 + +71201 - Paraffin, syntheticD + +(hydrogenated)71202 - Paraffin, syntheticD + +71280 008002-74-2and 063231-60-771281 008002-74-2and 063231-60-7(conventional)Hydrocarbon waxes,paraffin andmicrocrystallineHydrocarbon waxes,paraffin andmicrocrystalline(hydrogenated)71282 - Hydrocarbon waxes,paraffin andmicrocrystalline(conventional)71283 063231-60-7 Paraffin wax andhydrocarbon waxes,microcrystalline71300 064742-51-4 Paraffin waxes(petroleum),hydrotreated2219 + +D + +D + +D + +W +71360 008002-03-7 Peanut oil 3 Food fat. +71440 009000-69-5 Pectin DIR 1 ADI: not specified.+(SCF, 7th Series, 1978).71470 032534-81-9 Pentabromodiphenylether5 [Some organobromo compounds have abioaccumulation potential and 1,2-+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTdibromoethane is a category 2 carcinogen(EC classification).]71520 000117-97-5 Pentachlorothiophenol,8 +zinc salt71600 000115-77-5 Pentaerythritol Same 22840 DIR 2 Group TDI: 1 mg/kg b.w. (with+ +dipentaerythritol).(SCF, 17th Series, 1986).71625 054381-53-2 Pentaerythritol7 Needed: hydrolysis data. +dimyristate71635 025151-96-6 Pentaerythritol dioleate DIR SML = 0.05 mg/kg.Not for use in polymerscontacting foods forwhich simulant D islaid down in Directive85/572/EEC.71645 068818-38-2 Pentaerythritolmonomyristate71660 010332-32-8 Pentaerythritolmonooleate71670 178671-58-4 Pentaerythritol tetrakis(2-cyano-3,3-diphenylacrylate)2223 R = 0.05 mg/kg food.Available: migration data, 3 mutagenicitytests, not regarded as genotoxic.Remark: Since high migration into fat hasbeen demonstrated, the SCF recommendsthat the Commission take the necessarymeasures, so that the restriction proposed isnot exceeded.(RIVM SDS, October 1994= CS/PM/2465).(adopted at 113rd SCF meeting)(17-18September 1998)http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html+7 Needed : hydrolysis data. +7 Needed : hydrolysis data. +DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg food.Available: migration data (< 0.05 mg/kgfood); gene mutation assay in bacteria(negative); chromosomal aberration assay incultured mammalian cells (negative); genemutation assay in cultured mammalian cells(negative); acute toxicity data; 4-week oralrat study.RIVM/TNO SDS, January 2001 =CS/PM/3819/71670.(Adopted at the 128th SCF meeting, 12 July2001)http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT71680 006683-19-8 Pentaerythritoltetrakis[3-(3,5-di-tertbutyl-4-hydroxyphenyl)-propionate]71686 007575-23-7 Pentaerythritoltetrakis(3-mercaptopropionate)71695 000115-83-3 Pentaerythritoltetrastearate71710 000098-77-1 Pentamethyleneammonium-pentamethylenedithiocarbamateSame 92655 DIR 2 TDI: 3 mg/kg b.w.Oral studies for 3 months and 2 years in rats,3 and 4 months in dogs, lifetime in mice,reproduction and teratogenicity in mice andrats and mutagenicity studies.(RIVM report 89/678608/013, 1989-06-13).+ +8 +223D +8 +71720 000109-66-0 Pentane DIR 3 Volatile. +71760 see 71686 D +71840 see 71710 D +71920 see 71720 D +71935 007601-89-0 Perchloric acid, sodiumsalt monohydrateDIRSML = 0.05 mg/kg(31)3 SCF_list:3Restriction: 0.05 mg/kg of food.Remark for Commission: for fatty foodmethod only applicable with saturated fattyfood simulant (e.g. HB307, Mygliol).See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdf+8 + +71960 003825-26-1 perfluorooctanoic acid,ammonium salt72000 see 72060 D + +72001 see 72061 D + +72002 see 72062 D +72046 007727-54-0 Persulphuric acid,ammonium salt72048 007727-21-1 Persulphuric acid,potassium salt72060 008009-03-8 Petrolatum Same 72062and 956958 +8 +D + +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT72061 - Petrolatum(hydrogenated)72062 008009-03-8 Petrolatum(conventional)72080 - Petroleum hydrocarbonresins72081 - Petroleum hydrocarbonresins (hydrogenated)72081/10 088526-47-0 Petroleum hydrocarbonresins (hydrogenated)Same 72060and 95695D + +D +9 +7 Available: molecular weight and molecularweight distribution curve; residual amountsof monomers, hydrogenated monomersand catalysts; three (negative) mutagenicitystudies (performedwith the hydrogenated hydrocarbon resin).Needed: In first instance, migration data onthe polymeric additive; explanation why theresidual amount of the hydrogenatedmonomers and unpolymerizable componentsare rather high (in the product), because theWG expressed its concern for the lack oftoxicity data; more information onspecification, i.e. information onhydrogenation, purification and viscosity offinal product.(RIVM/DE SDS, October 1997 =CS/PM/3082/72081).+7 Under re-evaluation+http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf9 +72082 - Petroleum hydrocarbonresins (conventional)72105 - Phenols and/or cresolsstyrene9 +and/or alpha-methylstyrene and/or(C3-C12) olefins,copolymers72135 000092-84-2 Phenothiazine 8 +72160 000948-65-2 2-Phenylindole DIR SML = 15 mg/kg 2 TDI: 0.25 mg/kg b.w.+1 and 2-year oral rat studies, migration data.(Arch. Toxicol. 1964, 20, 220-225).72240 000090-43-7 2-Phenylphenol D +224

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT72320 000092-69-3 4-Phenylphenol Same 23140 8 +72400 000132-27-4 2-Phenylphenol, sodiumD Deleted. Covered by 72240. +salt72480 003645-61-2 4-Phenylphenol, sodiumD Deleted. Covered by 72320. +salt72560 007144-65-2 3-(2-Phenyl)phenoxy- Same 51470 6A +1,2-epoxypropane72620 - Phosphonic acid, esters 9 +72640 007664-38-2 Phosphoric acid Same 23170 DIR 1 MTDI: 70 mg/kg b.w. (as P).+ +(SCF, 25th Series, 1990).72650 068515-98-0 Phosphoric acid,W +alkyl(C3-C9) esters72710 000107-66-4 Phosphoric acid, dibutylW +ester72720 002197-63-9 Phosphoric acid, di-nhexadecylesters6B Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies and neurotoxicity+72760 003138-43-0 Phosphoric acid, di-nnonylester72800 001241-94-7 Phosphoric acid,diphenyl 2-ethylhexylester2256Bstudies too.Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferations studies and neurotoxicitystudies too.Same 72910 DIR SML = 2.4 mg/kg 2 TDI: 0.04 mg/kg b.w. (based on a 90-daystudy).The entire profile of this substance allows toallocate a TDI.Available: Acute toxicity data; two 90-dayoral rat studies; inadequate 2-year oral ratand dog studies; one-generationreproduction study using rats; teratogenicitystudy; Ames assay (negative); gene mutationassay in mouse lymphoma cells (negative);in vivo bone marrow cytogenetic assay(negative); neurotoxicity study; peroxisomeproliferation study.++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT72880 097489-40-2 Phosphoric acid,ethanolamine hexylbranched and linear ester72910 001241-94-7 Phosphoric acid, 2-ethylhexyl diphenyl ester72915 012645-31-7 Phosphoric acid, 2-ethylhexyl ester(RIVM SDS, June 1996 =CS/PM/2858/72800).Remark for Commission: no method ofanalysis is available for the enforcement ofan SML.(Adopted at 111th SCF meeting (18-19March 1998)).http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf9 Group R: 0.05 mg/kg b.w. +Same 72800 D +W +72940 010402-24-1 Phosphoric acid, iron salt D +72960 007446-27-7 Phosphoric acid, lead (II)D +salt73040 013763-32-1 Phosphoric acid, lithiumsaltsDIR+SML(T) = 0.6 mg/kg(8) (expressed asLithium)1-2 L2 for lithium.Group TDI: 0.01 mg/kg b.w. (as Li).See references for benzoic acid, lithium salt.73120 010124-54-6 Phosphoric acid,manganese saltDIRSML(T) = 0.6 mg/kg(10) (expressed asManganese)L1 for phosphoric acid.MTDI: 70 mg/kg bw (as P).(SCF, 25th Series, 1991).1-2 L2 for Manganese.Group TDI: 0.01 mg/kg b.w. (as Mn).See references for acetic acid, manganese(II)salt.+73160 - Phosphoric acid, monoanddi-n-alkyl (C16 andC18) estersL1 for Phosphoric acid.MTDI: 70 mg/kg bw. (as P)(SCF, 25th Series, 1991)DIR SML = 0.05 mg/kg 3 All 4 constituents of the mixture areallocated in List 3 with R = 0.05 mg/kg offood.The four constituents of the mixture are:- Phosphoric acid, mono-octadecyl ester+ +226

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(CAS no. 2958-09-9)- Phosphoric acid, di-octadecyl ester (CASno. 3037-89-6)- Phosphoric acid, mono-hexadecyl ester(CAS no. 3539-43-3)- Phosphoric acid, di-hexadecyl ester (CASno. 2197-63-9)73200 - Phosphoric acid, monoanddiesters withalcohols, aliph. (C9-C18), diethanolaminesalt73280 - Phosphoric acid, monoand diesters withalcohols, aliph. (C9-C18), salts73360 003539-43-3 Phosphoric acid, monon-hexadecylester73440 003900-04-7 Phosphoric acid, monon-hexylester73480 - Phosphoric acid, nonylester, sodium salt73520 039471-52-8 Phosphoric acid,octadecyl esters73600 000078-51-3 Phosphoric acid,tributoxyethyl ester73680 000126-73-8 Phosphoric acid, tributylester(Adopted at the 126th SCF meeting, 28February 2001)http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf9 Group R : 0.05 mg/kg b.w. +9 Group R: 0.05 mg/kg bw. +3 R: 0.05 mg/kg of food.Based on data for 73160.7 Needed: hydrolysis data. +9 Group R: 0.05 mg/kg b.w. +D Group R: 0.05 mg/kg bw. +6B6BGroup R: 0.05 mg/kg b.w.Available: Ames test, 14-day and 18-weekoral rat studies.Needed: Full report of 18 week oral ratstudy by Monsanto (1987) and tests for genemutation and chromosome aberration inmammalian cells in vitro in the firstinstance.Group R: 0.05 mg/kg b.w.Available: Ames test and several subchronic+++227

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT73720 000115-96-8 Phosphoric acid,trichloroethyl ester73760 - Phosphoric acid,triethanol ester73840 000126-71-6 Phosphoric acid,triisobutyl ester73920 000115-86-6 Phosphoric acid,triphenyl ester74000 000078-42-2 Phosphoric acid, tris(2-ethylhexyl) ester74010 145650-60-8 Phosphorous acid,bis(2,4-di-tert.-butyl-6-methylphenyl) ethyl esterDIR SML = ND (DL = 0.02mg/kg, analyticaltolerance included)DIRSML = 5 mg/kg (sumof phosphite andphosphate)2284Aoral rat studies.Needed: remaining toxicological datadepending on migration level (see SCFguidelines) and, if migration exceeds 0.05mg/kg, peroxisome proliferation studies andneurotoxicity studies too.Carcinogenic to rats.(NTP Tech. Rep. Ser. N. 391, May 1991).9 Group R: 0.05 mg/kg b.w. +6B Group R: 0.05 mg/kg bw.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg peroxisomeproliferation studies and neurotoxicitystudies too.6B Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, neurotoxicitystudies too.6B Group R: 0.05 mg/kg b.w.Available: Ames test, 90-day and 2-year oralmouse and rat studies.Needed: remaining toxicological datadepending on migration level (see SCFguidelines) and, if migration exceeds 0.05mg/kg, peroxisome proliferation studies andneurotoxicity studies too.3 R = 5 mg/kg of food (covering the sum ofphosphite and phosphate).Available: migration data, three in vitromutagenicity tests, Ames/E. coli test withthe oxidation product, 28-day oral rat study,90-day oral rat study, "limited" delayedneurotoxicity study in hens.(RIVM/TNO SDS, October 1996 =CS/PM/2916).74080 025448-25-3 Phosphorous acid, 6B Group R: 0.05 mg/kg b.w. +++ ++++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTtriisodecyl ester74160 013423-78-4 Phosphorous acid, tris-2-(cyclohexylphenyl) ester74240 031570-04-4 Phosphorous acid,tris(2,4-di-tertbutylphenyl)ester74320 039865-35-5 Phosphorous acid,tris((3-ethyl-3-oxetanyl)-methyl) ester74400 - Phosphorous acid,tris(nonyl-and/ordinonylphenyl) ester74455 - Phthalate mixture of theethyl- or butylester ofglycolic acid with aliph,monoh, alcohols (C1-C4)Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies and neurotoxicitystudies too.6B Needed: toxicological data depending on +migration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, neurotoxicitystudies too.DIR 2 TDI: 1 mg/kg b.w.+ +90-day and 2-year oral rat studies, 2-generation study in rats and mutagenicitystudies.(HRC report CBG 167/76339, 18 Aug.1976,LSR 80/CIA 015/111, 21 Oct. 1980, Ciba-Geigy 82 0873 Feb. 1985).6B Needed: toxicological data depending on +migration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, neurotoxicitystudies too.DIR SML = 30 mg/kg 2 TDI: 0.5 mg/kg b.w.+ +90-day oral rat and 2-year oral rat and dogstudies, 3 generation oral rat reproductionstudy, 3 negative mutagenicity studies.(RIVM 08-1-1990).D +74480 000088-99-3 o-Phthalic acid Same 23200 DIR 2 Group TDI: 1 mg/kg b.w.Included in the group TDI for phthalicanhydride.74560 000085-68-7 Phthalic acid, benzylbutyl ester74640 000117-81-7 Phthalic acid, bis(2-ethylhexyl) ester2 Under re-evaluation + +2 Under re-evaluation-------------------------------------------------TDI: 0.05 mg/kg b.w.(see the individual report, CS/PM/2161FINAL).++ +229

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT74720 000117-82-8 Phthalic acid, bis(2-methoxyethyl) ester74800 068515-42-4 Phthalic acid, dialkyl(C7-C11) esters74880 000084-74-2 Phthalic acid, dibutylester8 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 6B to List 8. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.R: 0.05 mg/kg of food (by analogy with53860). Suspected ofembriotoxicity/teratogenicity.Available: some studies, but inadequate.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf7 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 6B to List 7. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.Group R: 0.05 mg/kg b.w.Needed: in first instance specifications onidentity.Toxicological data depending on migrationlevel (see SCF guidelines) and, if migrationexceeds 0.05 mg/kg, peroxisomeproliferation studies on specified substances.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf2 Under re-evaluation.------------------------------------TDI = 0.1 mg/kg b.w.Available: acute oral toxicity data; skin- andeye irritation data; ADME data; 3-week oralrat study; 4-week oral rat study; 13-weekoral rat studies; peroxisome proliferation+++ +230

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT74960 000084-61-7 Phthalic acid,dicyclohexyl esterstudies; metabolism study; two-generationreproduction study in rats; two teratogenicitystudies in rats (one is limited); mutagenicitydata; human data; 90-day mouse and ratstudies; 2-generation reproduction study; 5teratogenicity studies with rats; placentaltransfer study; androgen-regulateddevelopmental study; peroxisomeproliferation study; estrogenicity studies;conclusion of other scopes (a.o. CSTEEopinion).RIVM SDS, July 2000 = CS/PM/853 REV.I/74880.NOTE: The TDI is based on the LOAEL of52 mg/kg b.w. from the 2-generation ratstudy with a continuous breeding protocol.Making use of an uncertainty factor of 500(10 for interspecies; 10 for intraspecies and5 for extrapolating from a LOAEL to aNOAEL), a TDI of 0.1 mg/kg b.w. isderived.Remark: no long-term/carcinogenicity studyis available: not considered necessary.(To be adopted by the SCF)7 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 2 to List 7. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.t-TDI: 0.1 mg/kg b.w.Available: three 90-day oral rat studies,limited in vitro mutagenicity studies (RIVM1988).Needed: reproduction and teratogenicitystudies, tests for gene mutation andchromosome aberrations in mammalian cellsin vitro.http://www.efsa.eu.int/science/afc/afc_docu+231

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT75040 - Phthalic acid, diesterswith hexadecanol and/oroctadecanol75100 - Phthalic acid, diesterswith primary, saturatedC8-C10 branchedalcohols, more than 60%C9.75105 - Phthalic acid, diesterswith primary, saturatedC9-C11 branchedalcohols more than 90%C1075120 000084-66-2 Phthalic acid, diethylesterments/469/statement01_afc_phthalates_en1.pdf7 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 2 to List 7. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.Group t-TDI : 0.15 mg/kg bw (with 76120).Available: 3 months oral rat study,teratogenicity study and Ames test negative.(RIVM doc. 1990-09-11, CS/PM/529).Needed: reproduction study, peroxisomeproliferation, gene mutation andchromosome aberration in mammalian cellsin vitro.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf2 Under re-evaluation.http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf2 Under re-evaluation.http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf7 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 2 to List 7. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.t-TDI: 0.2 mg/kg b.w.Available: a 3-month oral rat study, in vitromutagenicity studies, i.p. teratogenicity++ ++ ++ +232

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT75200 003648-21-3 Phthalic acid, di-n-heptylester75280 000084-69-5 Phthalic acid, diisobutylesterstudies and peroxisome proliferation studies.(Fd. Cosm. Toxicol. 1978, 16, 415-422,RIVM 1986, June).Needed: reproduction and teratogenicitystudy.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf7 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 6B to List 7. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.Group R: 0.05 mg/kg b.w.Available: Ames test.Needed: remaining toxicological datadepending on migration level (see SCFguidelines) and, if migration exceeds 0.05mg/kg, peroxisome proliferation studies too.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf8 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 6B to List 8. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.++ +Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf75360 026761-40-0 Phthalic acid, diisodecyl D This item is changed into a new item (see +233

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTester 75105).75440 028553-12-0 Phthalic acid, diisononylesterD This item is changed into a new item (see75100).75520 027554-26-3 Phthalic acid, diisooctyl8 Due to the lack of data according to newesterSCF guidelines, the substance is transferredfrom List 9 to List 8. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.++75600 000131-11-3 Phthalic acid, dimethylester75680 000084-76-4 Phthalic acid, di-n-nonylesterGroup R: 0.05 mg/kg b.w.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf7 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 6B to List 7. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.Group R: 0.05 mg/kg b.w.Available: limited oral rat chronictoxicity/carcinogenicity study, oralteratogenicity studies in rats and mice, Amestest.Needed: gene mutation and chromosomeaberration in mammalian cells in vitro andmigration data in the first instance.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf8 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 6B to List 8. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.Group R: 0.05 mg/kg b.w.+ ++234

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT75760 014117-96-5 Phthalic acid, di-noctadecylester75840 000117-84-0 Phthalic acid, di-n-octylesterNeeded: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf8 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 6B to List 8. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf7 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 6B to List 7. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.Group R: 0.05 mg/kg b.w.Available: Ames test, peroxisomeproliferation study, oral mouse reproductionstudy, inadequate oral rat 90-day study,inadequate oral rat chronictoxicity/carcinogenicity study.Needed: gene mutation and chromosomeaberration study in mammalian cells in vitroand migration data in the first instance.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.++ +235

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT75850 - Phthalic acid, di-n-octyland/or di-n-decyl and/orn-decyl n-octyl esters75920 000119-06-2 Phthalic acid, di-ntridecylester76000 - Phthalic acid, mixedesters with butylglycolate and alcohols,aliph.,monoh., (C1-C4)pdfSame 67180 7 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 3 to List 7. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.236R: 5 mg/kg of food or food simulant.Available: 3 mutagenicity studies negative,3 months oral rat study, test on liverperoxisome proliferation, migration inaqueous food simulants only.Remark: high migration into fatty food islikely.(RIVM report 1995-09-04 (=CS/PM/2655)).http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf7 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 6B to List 7. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.Group R: 0.05 mg/kg b.w.Available: Ames test.Needed: remaining toxicological datadepending on migration level (see SCFguidelines) and, if migration exceeds 0.05mg/kg, peroxisome proliferation studies too.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf8 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 9 to List 8. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are also+++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT76005 000085-70-1 Phthalic acid, mixedesters with butylglycolate and butanol76080 - Phthalic acid, mixedesters with ethylglycolate and alcohols,aliph.,monoh., (C1-C4)76085 000084-72-0 Phthalic acid, mixedesters with ethylglycolate and ethanolneeded.Group R: 0.05 mg/kg b.w.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf7 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 6B to List 7. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.Group R: 0.05 mg/kg b.w.Available: 30-day and 1-year oral rat studiesand mutagenicity studies all inadequate.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg peroxisomeproliferation studies too.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf8 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 9 to List 8. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.Group R: 0.05 mg/kg b.w.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf7 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 6B to List 7. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.+++237

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT76160 001240-18-2 o-Phthalic acid, n-pentylbenzyl esterGroup R: 0.05 mg/kg b.w.Available: 4-month and 2-year rat and 1-year dog studies all inadequate.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf8 Due to the lack of data according to newSCF guidelines, the substance is transferredfrom List 6B to List 8. In first instance moredata on the migration and use are needed inorder to judge if further toxicity data are alsoneeded.+76240 068389-55-9 o-Phthalic acid-2,2-triethyleneglycolbenzoate, copolymer238Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf9 +76320 000085-44-9 Phthalic anhydride Same 23380 DIR 2 Group TDI: 1 mg/kg b.w.(SCF, 17th Series, 1986).76400 007681-93-8 Pimaricin D Postponed. Waiting for an answer to thecircular letter from EEC (CS/PM/324)asking informations on technologicalfunction of the substance. Date limit:30.6.90.76415 019455-79-9 Pimelic acid, calciumsaltSame as234403AM 3 Restriction: None (the substance is ametabolite of a non toxic fatty acid)http://www.efsa.eu.int/science/afc/afc_opinions/190/opinion_afc_06_en1.pdf+ +++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT76455 - Polyacrylates and/orD +polymethacrylates, salts76460 009003-01-4 Polyacrylic acid 9 Look at 76461. +76461 009003-01-4 Polyacrylic acid 7 Under re-evaluation+ +------------------------------------------------(Restriction 5mg/kg)76480 - Polyamides (Mw>6000) D In first instance, specify the nature of +starting substances and provide the MWdistribution curve.76500 - Polyamides made byD +reacting acids,dicarboxylic, linear (C2-C4) with diamines (C2-C4)76510 009003-17-2 Polybutadiene D +76513 - Polybutadiene,9 +maleimidised76516 - Polybutadiene, silylated 9 +76520 009003-29-6 Polybutene Same 62280 D + +76540 009003-49-0 Polybutyl acrylate 9 +76560 see 76670 D +76640 see 76690 D +76660 - Polycarbonates D +76665 025267-51-0 Poly(cyclooctene) 7 Awaiting data on the monomer withPM/REF.No 15030.+239Needed: Migration of monomer fromrelevant plastic materials.(RIVM/TNO SDS, February 1997 =CS/PM/2995/76665).Remark: Migration of this polymericadditive is covered by the limit for globalmigration. No need for bioaccumulationdata, since no effects were seen in thelymphonodes and Kupfer cells in the 90-daystudy.76670 - Polycyclopentadiene, D (Adopted at 111th SCF meeting (18-19 +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT76680 068132-00-3 Polycyclopentadiene,hydrogenatedhydrated March 1998)DIR SML = 5 mg/kg (1) 3 R: 5 mg/kg of food.Toxicologically acceptable.Available: migration data, mutagenicitystudies in vitro and in vivo negative, 3-month oral rat and dog studies, 2 generationand teratogenicity oral rat studies andbioaccumulation.(RIVM, March 1995 = CS/PM/2585).+ +76681 - Polycyclopentadiene,hydrogenatedRemark: since high migration into fat hasbeen demonstrated, the WG recommendsthat the Commission take the necessarymeasures so that the restriction proposed isnot exceeded.3AM Old 76680 3 R: 5 mg/kg of foodToxicologically acceptable.Available: migration data, mutagenicitystudies in vitro and in vivo negative, 3-month oral rat and dog studies, 2 generationand teratogenicity oral rat studies andbioaccumulation.(RIVM, March 1995 = CS/PM/2585).+76685 - Poly 1-decene,homopolymer,hydrogenated76690 - Polydienic resinsynthetic, (m.w. about1000)76720 009016-00-6and 063148-62-9Polydimethylsiloxane Same 49525and 23547.Remark: since high migration into fat hasbeen demonstrated, the WG recommendsthat the Commission take the necessarymeasures so that the restriction proposed isnot exceeded.7 Specifications: Average ponderal Mw < +10000 Daltons.Available: 3-month oral rat study andmutagenicity data on 1-decene, negative.Needed: migration data in first instance.9 +D 2 TDI = 1.5 mg/kg b.w. based on ADI of 1.5mg/kg bw. Specification of Mw > 6800.(JECFA 37 M).+ +240

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT76721 009016-00-6and 063148-62-9Polydimethylsiloxane(Mw> 6800)76730 - Polydimethylsiloxane,gammahydroxypropylated76750 - Polyesters of acrylic andmethacrylic acids withalcohols, aliphatic,monohydric, saturated(C1-C18)76760 - Polyesters of adipic acidand/or azelaic acid with1,2-propanediol, 1,3- and1,4-butanediol or 1,6-hexanediol76780 024937-93-7 Polyester of adipic acidwith 1,3-butanediol76790 - Polyester of adipic acidwith 1,3- and/or 1,4-butanediol and/or 1,2-propanediol, with freehydroxyl groupsacetylatedSame 49525and 23547(Adopted at 111th SCF meeting (18-19March 1998)DIR In compliance with the 2 TDI = 1.5 mg/kg b.w. based on ADI of 1.5 +specifications laidmg/kg bw. Specification of Mw > 6800.down in Annex V.(JECFA 37 M).DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w.+ +90-day oral rat study, in-vitro and in-vivomutagenicity tests.(RIVM report, 1990-04-26).9 +9 +2 Group-TDI: 0.5 mg/kg .b.w. (with PM/REFNos. 76790, 76865 and 80820).Same references as 76865.(Adopted at 114th SCF meeting) (10December 1998)http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf2 Group-TDI: 0.5 mg/kg .b.w. (with PM/REFNos. 76780, 76865 and 80820).Same references as 76865.(Adopted at 114th SCF meeting) (10December 1998)http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf76800 see 76940 D +76805 - Polyester of adipic acidwith 1,3-butanediol and1,6-hexanediol9 +76810 - Polyesters produced byreacting adipic acid,9 +++241

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTglycerol, and acids,aliphatic,monocarboxylic,saturated, linear (C6-C22)76815 - Polyester of adipic acidwith glycerol orpentaerythritol, esterswith even numbered,unbranched C12-C22fatty acids76820 - Polyester of adipic acidwith propanediol76824 - Polyester of adipic acidwith 1,2-propanediol, n-octanol, n-decanol76830 - Polyester formed fromadipic,azelaic,decanedicarboxylic,glutaric,maleic,phthalic,sebacic,succinic acids with one or morediols (C2-C6),glycerol,mannitol,2,2-bis(4-hydroxyphenyl)propane,pentaerythritol sorbitol,the terminal group maybe ester.…76840 - Polyesters of azelaic acidwith n-hexanol and 2-ethylhexanol76845 031831-53-5 Polyester of 1,4-butanediol withcaprolactonePolycaprolactone diol3AM 3 Restriction: Specifications: Fraction withMw

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT76850 - Polyester ofpentaerythritol withadipic acid and oleic acid76860 - Polyester ofpentaerythritol withadipic acid andunsubstituted aliph.,monocarb. acids (C16-C22)76865 - Polyesters of 1,2-propanediol and/or 1,3-and/or 1,4-butanedioland/orpolypropyleneglycolwith adipic acid, alsoend-capped with aceticacid or fatty acids C10-C18 or n-octanol and/orn-decanol76866 - Polyesters of 1,2-propanediol and/or 1,3-and/or 1,4-butanedioland/orpolypropyleneglycolwith adipic acid, alsoend-capped with aceticacid or fatty acids C12-C18 or n-octanol and/orn-decanol76868 026222-20-8 Polyester of 1,2-propanediol with sebacicacid76870 - Polyesters prod.byreacting 5 moles ofpentaerythritol with 4m.of adipic acid and 12m.of oleic acid and/orrespected.http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf9 +9 +D SML = 30 mg/kg 2 http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdfSame 76865 DIR SML = 30 mg/kg 2 Group-TDI = 0.5 mg/kg .b.w. (withPM/REF Nos. 76780, 76790and 80820). Remark: The group TDI isbased on analytical and toxicologicalstudies carried out with different polyesterscovered by thegeneral description of PM Ref. N. 76865.http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf+ +W +9 ++243

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTpolyester prod.byreacting 7 m.ofpentaerythritol with 6m.of adipic acid and 16m.of sat. etC.76880 see 76950 D +76920 - Polyesters of terephthalicD +acid76930 - Polyesters, unsaturated D +76940 - Polyether ether ketone 9 +76945 - Polyetherpolyols W +76950 009002-88-4 Polyethylene Similar toD Deleted because covered by 76951. +76951 - Polyethylene andpolyethylene wax76954 064754-90-1 Polyethylene, chlorinatedwith a chlorine contentup to 56%80000Same76950/80000244DAvailable: migration data from PE, PS andPVC (samples do not contain the maximumindicated concentration of the additive).Needed:- characterisation of the type of PE materialused in the migration test;- migration data into olive oil or a suitablealternative fatty food simulant.RIVM/DE SDS, June 2000 =CS/PM/3787/76951.7 Needed: Mw distribution curve; migration ofthe low molecular weight range; identity ofthe migrants, if not possible theninformation on the carbon chain length andthe degree of chlorination.(TNO SDS, September 1995 =CS/PM/2662)(Adopted at 111th SCF meeting (18-19March 1998)76960 025322-68-3 Polyethyleneglycol Same 23590 DIR 2 Group TDI: 5 mg/kg b.w. (withtriethyleneglycol).See references for triethyleneglycol.(SCF, 6th Series, 1978).76980 024938-37-2 Poly(ethyleneglycoladipate)+ +++ +7 Needed: hydrolysis data. + +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT77020 - Polyethyleneglycolalkyl(C3-C18) ether77022 - Polyethyleneglycol(EO=25) alkyl(C32)ether (Mw=1500-3000)77025 - Polyethyleneglycol(EO=25) alkyl(C32)ether monomethacrylate(Mw=1500-3000)77030 068891-38-3 Polyethyleneglycolalkyl(C12-C14) ethersodium sulphate77035 068891-38-3 Polyethyleneglycol(EO=2-3) alkyl(C12-C14)ether sodiumsulphate2459 +W7 Needed: In first instance, Mw distributioncurve and structure of the C32 alcohol.(Adopted at 111th SCF meeting (18-19March 1998)+W7 Needed: In first instance, Mw distribution +curve and structure of the C32 alcohol.(Adopted at 111th SCF meeting (18-19March 1998)Same 77035 9 + +Same 77030 8 + +77040 see 76980 D + +77070 068954-91-6 Polyethyleneglycolalkyl(C10-C12) ethersulphosuccinate,disodium salt9 +77072 068815-56-5 Polyethyleneglycolalkyl(C10-C16) ethersulphosuccinate,disodium salt77105 068410-69-5 Polyethyleneglycolbis(tallow acyl amidoethyl)methyl ammoniummethosulphate77120 - Polyethyleneglycol tertbutylether77200 061791-14-8 Polyethyleneglycolcocoamine77280 009005-02-1 Polyethyleneglycoldilaurate77320 - PolyethyleneglycoldimyristateD + +W8 +9 +9 +2 Group TDI: 10 mg/kg bw for all PEG estersof food fatty acids.(CS/PM/1656).2 Group TDI: 10 mg/kg bw for all PEG estersof food fatty acids.++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT77360 009005-07-6 Polyethyleneglycoldioleate77370 070142-34-6 Polyethyleneglycol-30dipolyhdroxystearate(CS/PM/1656).2 Group TDI: 10 mg/kg bw for all PEG estersof food fatty acids.(CS/PM/1656).Same 77850 3AM 3 Restriction: nonehttp://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf++77440 - Polyethyleneglycoldiricinoleate77480 - Polyethyleneglycoldodecyl ether77500 009014-92-0 Polyethyleneglycoldodecylphenyl ether77520 061791-12-6 Polyethyleneglycol esterof castor oil77521 - Polyethyleneglycol esterof castor oil fatty acids77522 061791-12-6 Polyethyleneglycol (EO= 20-40) ester of castoroil77570 - Polyethyleneglycolesters of (C6-C22) fattyacids77600 061788-85-0 Polyethyleneglycol esterof hydrogenated castoroil77601 - Polyethyleneglycol esterof hydrogenated castoroil fatty acids77602 061788-85-0 Polyethyleneglycol (EO= 40) ester ofhydrogenated castor oilSame 77522and 77521http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdfDIR SML = 42 mg/kg 2 TDI: 0.7 mg/kg bw based on TDI for castor +oil.(SCF, 7th Series, 1978)(CS/PM/1656).9 +W +DIR SML = 42 mg/kg 2 TDI: 0.7 mg/kg bw based on TDI for castoroil.(SCF, 7th Series, 1978)(CS/PM/1656).Same 77520 2 TDI: 0.7 mg/kg bw based on TDI for castoroil.(SCF, 7th Series, 1978)(CS/PM/1656).Same 77520 9 +Same 77602and 77601D +DIR 3 L3. Based on TDI for 77520 and L3 for14470.Same 77600 3 L3. Based on TDI for 77520 and L3 for14470.Same 77600 D ++ +++ ++246

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT77660 - Polyethyleneglycolesters of natural fattyacids2 Group TDI: 10 mg/kg bw for all PEG estersof food fatty acids.(CS/PM/1656).77680 see 77710 D + +77702 - Polyethyleneglycolesters of aliph.monocarb. acids (C6-C22) and theirammonium and sodiumsulphatesDIR 2 Group TDI: 10 mg/kg bw for all PEG estersof food fatty acids.(CS/PM/1656).+ +77705 - Polyethyleneglycol(>2OEO)ethers of alkylphenols, sodiumsulphates77708 09002-92-0;09004-95-9;09043-30-5;09002-92-0;68439-49-6;etcPolyethyleneglycol (EO=1-50) ethers of primarylinear and branched C8-C22 alcohols77708/10 069013-19-0 Polyethyleneglycolethers of C8-C22alcohols77710 - Polyethyleneglycolethers of C10-C20alcohols77710/5 068439-54-3 Polyethyleneglycolethers of C11-C13-branched alcohols77711 068439-50-9 Polyethyleneglycolethers of C12-C14alcohols77712 068213-23-0 Polyethyleneglycolethers of C12-C18alcohols77713 009005-00-9 Polyethyleneglycol(EO=2) ethers of C18 alcohols77720 - Polyethyleneglycol etherof benzylphenol, andSame 78140and 785509 + +7 Under re-evaluation +D +9 Look also at 67162. + +W +D + +D + +9 +9 ++247

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTtheir sulphates and/ortheir sodium andammonium sulphonates77732 - Polyethyleneglycol(EO=1-30, typically 6)ether of butyl 2-cyano-3-(4-hydroxy-3-methoxyphenyl)acrylate77733 - Polyethyleneglycol(EO=1-30, typically 5)ether of butyl 2-cyano-3-(4-hydroxyphenyl)acrylate77735 059269-54-4 Polyethyleneglycol etherof dodecylphenol,sodium sulphate77737 009002-92-0 Polyethyleneglycol etherof dodecylalcohol77740 009014-90-8 Polyethyleneglycol etherof nonylphenol, sodiumsulphate77747 058853-83-1 Polyethyleneglycol etherof octylphenol, sodiumsulphate77750 053694-15-8 Polyethyleneglycol etherof sorbitol77760 061791-28-4 Polyethyleneglycol etherof tallow fatty alcohol77775 - Polyethyleneglycol etherof trimethylolpropane77790 009004-95-9 Polyethyleneglycolhexadecyl ether77800 068071-98-7 Polyethyleneglycolhydrogenated tallowamine ethylsulphate77840 068951-50-8 Polyethyleneglycolhydroxymethylphosphonate7 Under re-evaluation. +7 Under re-evaluation. +9 + +Same 519859 +and 77920Same 78460 D +9 + +9 +D + +9 +9 +9 +D +77850 070142-34-6 Polyethyleneglycol 12- W7-D SCF_list: 7 +248

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CThydroxystearate77880 009043-30-5 Polyethyleneglycolisotridecyl ether77890 - Polyethyleneglycolisotridecyl ethersulphate, salts77895 068439-49-6 Polyethyleneglycol(EO=2-6)monoalkyl(C16-C18)etherSame 67161 DIR SML = 0.05 mg/kg andin compliance with thespecifications laiddown in Annex V249Needed data or information:- Molecular weight distribution curve(differential and cumulative)- Details on MS spectra- Clarification of the inconsistency in thedata from the petitioner in respect to thesolubility of the test compound in varioussolvents.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdf8 +8 +3 R = 0.05 mg/kg of food.Available: Adequate migration data;inadequate gene mutation assay in bacteria;incomplete chromosomal aberration assay incultured mammalian cells (missing oddpages of the report); gene mutation assay inbacteria (negative); gene mutation assay incultured mammalian cells (negative);chromosomal aberration assay inmammalian cells (negative).(RIVM/ISS/TNO SDS, April 1998 =CS/PM/2859 REV.II/77895).(Adopted at 114th SCF meeting) (9-10December 1998)REMARK: The sum of all componentspresent in Marlipal 1618/1 was determinedin the migration experiments. A shift of thequantitative composition of the componentsmigrated into the food simulants related tothe initial composition of Marlipal 1618/1was observed. The method is suitable todetermine the sum of free fatty alcohol andthe homologues of ethylene glycol ethers.REMARK :The toxicity studies were+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT77920 009002-92-0 Polyethyleneglycolmonododecyl ether78000 052019-36-0 Polyethyleneglycolmonodecyl phosphate78080 009004-81-3 Polyethyleneglycolmonolaurate78120 - Polyethyleneglycolmonomyristate78140 009005-00-9 Polyethyleneglycolmonooctadecyl ether78160 009004-96-0 Polyethyleneglycolmonooleate78190 009004-98-2 Polyethyleneglycolmonooleyl ether78240 009004-94-8 Polyethyleneglycolmonopalmitate78320 009004-97-1 Polyethyleneglycolmonoricinoleate78360 009004-99-3 Polyethyleneglycolmonostearate78400 009016-45-9 Polyethyleneglycolnonylphenyl ether78440 026027-38-3 Polyethyleneglycol,4-nonylphenyl etherSame 51985and 77737Same 77713and 78550performed with Marlipal 1618/1(commercial product with the specificationsas given in the dossier).Adopted at 114th SCF meeting)(10December 1998)http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf9 +9 +2 Group TDI : 10 mg/kg bw for all PEG estersof food fatty acids.(CS/PM/1656).+2 Group TDI: 10 mg/kg bw for all PEG esters +of food fatty acids.(CS/PM/1656).8 +2 Group TDI: 10 mg/kg bw for all PEG estersof food fatty acids.(CS/PM/1656).+9 +2 Group TDI: 10 mg/kg b.w. for all PEGesters of food fatty acids.(CS/PM/1656).+DIR SML = 42 mg/kg 2 TDI: 0.7 mg/kg bw based on TDI for castor +oil.(SCF, 7th Series, 1978)(CS/PM/1656).D +P + +W7Needed: in the first instance, information onthe composition of the substances used.RIVM doc. CS/PM/2223 (in CS/PM/2223change title to "4-nonylphenylpolyethyleneglycolethers(PM/REF.N.78440)").+ +250

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT78460 009014-90-8 Polyethyleneglycolnonylphenyl ether,sodium sulphate78480 051811-79-1 Polyethyleneglycol78520 009040-38-4and 067999-57-9nonylphenyl phosphatePolyethyleneglycolnonylphenylsulphosuccinate,disodium salt78550 009005-00-9 Polyethyleneglycol(EO=2) octadecylether78555 062362-49-6 Polyethyleneglycol(EO=2) octadecyl etherphosphate78560 009002-93-1and 009036-19-5Polyethyleneglycoloctylphenyl ether78640 - Polyethyleneglycoland/orpolypropyleneglycolesters of aliph.,monocarb.,acids (C6-C22) and theirammonium and sodiumsulphates78720 - Polyethyleneglycoland/orpolypropyleneglycolethers of aliph.,monoh.,alcohols (C8-C20) and theirammonium and sodiumsulphates78800 - Polyethyleneglycoland/orpolypropyleneglycolethers of alkylphenolsand their ammonium andsodium sulphatesSame 77740 P + +Same 77713and 781409 + +9 + +7 Available: Toxicological review.+Needed : migration data in first instance.W +9 + +D +9 Confirmed.Remark: some individual compounds arelisted.(Adopted at 111th SCF meeting (18-19March 1998)+ +9 + +251

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT78880 - Polyethyleneglycoland/orpolypropyleneglycolethers oftrimethylolpropaneand/or sorbitol78960 - Polyethyleneglycolsorbitan79040 009005-64-5 Polyethyleneglycolsorbitan monolaurate79120 009005-65-6 Polyethyleneglycolsorbitan monooleate79200 009005-66-7 Polyethyleneglycolsorbitan monopalmitate79280 009005-67-8 Polyethyleneglycolsorbitan monostearate79360 009005-70-3 Polyethyleneglycolsorbitan trioleate79440 009005-71-4 Polyethyleneglycolsorbitan tristearate9 +9 +DIR 1 Group ADI: 10 mg/kg b.w. forpolyethyleneglycol sorbitan monooleate,polyethyleneglycol sorbitan monopalmitate,polyethyleneglycol sorbitan monostearate,polyethyleneglycol sorbitan tristearate.(SCF, 15th Series, 1985).DIR 2 Group TDI: 10 mg/kg b.w. forpolyethylenglycol sorbitan monolaurate,polyethyleneglycol sorbitan monooleate,polyethyleneglycol sorbitan monostearate,polyethyleneglycol sorbitan tristearate.(SCF, 15th Series 1985).DIR 1 Group ADI: 10 mg/kg b.w. forpolyethyleneglycol sorbitan monooleate,polyethyleneglycol sorbitan monolaurate,polyethyleneglycol sorbitan monostearate,polyethyleneglycol sorbitan tristearate.(SCF, 15th Series, 1985).DIR 1 Group ADI: 10 mg/kg b.w. forpolyethyle~eglycol sorbitan monooleate,polyethyleneglycol sorbitan monopalmitate,polyethyleneglycol sorbitan monolaurate,polyethyleneglycol sorbitan tristearate.(SCF, 15th Series, 1985).DIR 2 Group TDI: 10 mg/kg b.w. based on thegroup ADI 10 mg/kg b.w. forpolyethyleneglycol sorbitan monolaurateand other polyethyleneglycol sorbitan esters.(SCF, 15th Series, 1985).DIR 1 Group ADI: 10 mg/kg b.w. forpolyethyleneglycol sorbitan monooleate,polyethyleneglycol sorbitan monopalmitate,+ +++ ++ +++252

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT79520 - Polyethyleneglycolstearate79550 009014-85-1 Polyethyleneglycol2,4,7,9-tetramethyl-5-decyN-4,7-diol ether79600 009046-01-9 Polyethyleneglycoltridecyl ether phosphate79680 026913-06-4and 009002-98-6polyethyleneglycol sorbitan monostearate,polyethyleneglycol sorbitan monolaurate.(SCF, 15th Series, 1985).2 Group TDI: 10 mg/kg bw for all PEG estersof food fatty acids.(CS/PM/1656).3 Only to be used for no-stickpolytetrafluoroethane (PTFE) coatingsmanufactured by sintering.Available: information on the nature of thedecomposition residue of the substance (S-440); calculated worst case migration is0.002 mg residue/dm2 from the final PTFEcoating, assuming 100% migration of thesolid residue; gene mutation assay inbacteria (negative); chromosomal aberrationassay in cultured mammalian cells(negative); gene mutation assay in culturedmammalian cells (negative); acute toxicitydata; limited 28-day range-finding study;inadequate 90-day oral rat study; inadequateone-generation reproduction study.RIVM/TNO SDS, January 2001 =CS/PM/2906 REV. I/79550.(Adopted at the 128th SCF meeting, 12 July2001)http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf3AM 3 Restriction: 5 mg/kgRemark for Commission: Specifications:Polyethyleneglycol (EO

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTmodified with adipicacid, diethylenetriamine,and epichlorohydrin79760 - Polyethyleneimine,butylated79840 - Polyethyleneimine,modified79841 103479-08-9 Polyethyleneimine,modified79842 114133-44-7 Polyethyleneimine,modified79920 009003-11-6 Poly(ethylene propylene)and 106392- glycol12-579930 - Poly(ethylenepropyleneglycol)(>20EO and >20 P0)79950 - Poly(ethylene and/orpropyleneglycol)- aliph.,monoh., alcohols (C8-C20),copolymers andtheir ammonium andsodium sulphates79960 111905-54-5 Poly(ethylenepropylene)glycol alkyl(C13-C15)ethers79965 067167-17-3 Poly(ethylenepropylene)glycoldioleate2 TDI: 0.1 mg/kg b.w.Specification for ethyleneimine (R= 0.010mg/kg).90-day oral rat study, mutagenicity studiesnegative.(RIVM report 90/678608/002 February1990).+9 In principle List 9.+Some substances covered by 79840 havebeen identified:(polymin (R) SN (CAS N. 103479-08-9)(seeCS/PM 330) but documentation isinadequate. The substances must be listedindividually and assessed accordingly. L8.D +D +7 Under re-evaluation +9 + +D +D Same as 79968. +9 +254

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT79967 055126-40-4 Poly(ethylenepropylene)glycoldistearate79968 069227-21-0and 111905-54-5Poly(ethylene propylene)glycol ethers of C13-C15alcohols79969 037251-69-7 Poly(ethylenepropylene)glycolnonylphenyl ether80000 009002-88-4 Polyethylene wax Similar to769509 +8 +P +3AM 3 Restriction: Nonehttp://www.efsa.eu.int/science/afc/afc_opinions/11/opinion_afc_07_en1.pdf+http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf80077 068441-17-8 Polyethylene, oxidized 7 Needed data or information:+ +-In first instance, mutagenicity tests on awell characterised (GPC profile, content ofepoxy groups, content of peroxide groupsand oxygen) low molecular weight fraction.-If the migration data stand, then the fullcore set of the toxicity data will be needed.-If a SML has to be allocated there will alsobe a need for an in house validated methodfor the determination in food simulants.http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf80080 068441-17-8 Polyethylene waxes, Similar toD + +oxidized8007780160 037349-34-1 Polyglycerol1 ADI: 25 mg/kg b.w.+monostearate(SCF, 7th Series, 1978).80240 029894-35-7 Polyglycerol ricinoleate DIR 1 ADI: 7.5 mg/kg b.w.+(SCF, 7th Series, 1978).80320 009009-32-9 Polyglycerol stearate 1 ADI: 25 mg/kg b.w.+(JECFA 26 M., 1982).80330 025359-91-5 Poly(1-Same 54930 D See 54930. +hydroxynaphthylmethane)(=formaldehyde-1-naphtalenol copolymer)255

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT80340 027924-99-8 Poly(12-hydroxystearicacid)7 Available: Ames test + micronucleus testwith 2 commercial product s; inadequatemigration data.+80345 058128-22-6 Poly(12-hydroxystearicacid) stearateoctadecanoicacid, 12-hydroxy-,homopoly256Needed: Mw distribution curve and adequatemigration data.W7 Under re-evaluation +80360 009003-27-4 Polyisobutene 7 Available: contradictory information on Mwdistribution.Needed: migration of products on the marketwith low average Mw.80365 026335-74-0 Poly(isobutyl acrylate) 9 +80380 009003-04-7 Polymer of acrylic acid,D +sodium salt80400 see 80340 D +80410 - Polymers of dioctyltinbis(2-ethylhexylmaleate)9 +80425 - Polymers of dioctyltinbis(2-ethylhexylmercaptoacetate)9 +80440 - Polymers of di-n-octyltin9 +dimaleate80460 025087-26-7 Polymethacrylic acid D +80470 - Polymethacrylic acids,D +salts80480 082451-48-7 Poly(6-morpholino-1,3,5,-triazine-2,4,-diyl)-[(2,2,6,6,-tetramethyl-4-piperidyl)imino]-hexamethylene-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]7 Under re-evaluation. +80550 - Polyolefins (low9 Look also at 76685. +molecular weight)80560 068410-99-1 Polyolefins, chlorinated 9 ++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTwith a chlorine contentof up to 56%80640 - Polyoxyalkyl(C2-C4)dimethylpolysiloxaneDIR 3 Available: average MW ~7600, 2 negativemutagenicity tests, 90-day oral rat study(RIVM doc. CS/PM/91, 1987).257+ +80670 - Polyphenylene oxide D +80720 008017-16-1 Polyphosphoric acids DIR 1 MTDI: 70 mg/kg b.w. (as P).+ +(JECFA 26 M., 1982).80760 009003-07-0 Polypropylene D Look at 80765. +80765 - Polypropylene andD +polypropylene wax80800 025322-69-4 Polypropyleneglycol Same 23650 DIR 3 Toxicologically acceptable. +and 2365180820 025101-03-5 PolypropyleneglycoladipateD Deleted. Covered by 76865.http://europa.eu.int/comm/food/fs/sc/scf/out+80845 029408-67-1 Polypropyleneglycolazelate (end-capped withstearic acid)W820_en.pdfNeeded: data according to SCF guidelineson polymeric additives.Remark: name need eventually be modified,add: end-capped with stearic acid.80850 - Polypropyleneglycol9 +butyl ether80880 see 80820 D +80890 - PolypropyleneglycolD +esters with acids, aliph.,monocarb., sat. (C12-C20)80895 - Polypropyleneglycolesters ofaliph.,monocarb.,acids(C6-C22) and theirammonium and sodiumsulphates80930 - Polypropyleneglycolether oftrimethylolpropane80940 - Polypropyleneglycollaurate9 +9 +9 ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT80950 - PolypropyleneglycolW9 +octadecyl phosphate80960 see 80950 D +80970 - Polypropyleneglycol9 +oleate80985 - Polypropyleneglycol9 +oleate butyl ether81000 009003-11-6 PolypropyleneglycolD +polyoxyethylated81015 - Polypropyleneglycol9 +ricinoleate81030 - Polypropyleneglycol9 +stearate81040 see 81100 D +81060 009003-07-0 Polypropylene wax Same 80765 3AM 3 Restriction: None+ +http://www.efsa.eu.int/science/afc/afc_opinions/11/opinion_afc_07_en1.pdfhttp://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf81080 009003-53-6 Polystyrene D +81100 068441-35-0 Polystyrene,D +hydrogenated81120 - Polyterpenes 9 Confirmed. + +81122 - Polyterpenes,9 +hydrogenated81123 - Polyterpenes,hydrogenated7 Available: Migration data, 3 mutagenicitystudies on the polymeric additive itselfnegative, unacceptable 90-day oral rat study(unvalidated IBT study).Needed: Information on whether thesubstance tested is representative of otherbrands of polyterpene, hydrogenated resins.In first instance , explanation of presence ofunhydrogenated monomer (100 ppm) in thepolymeric additive (if presence is confirmed,3 mutagenicity tests on unhydrogenatedmonomer will be required) as well a 90-dayoral rat study on the polymeric additiveitself.+258

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(RIVM/TNO SDS CS/PM/2750, January96).81160 009002-84-0 Polytetrafluoroethylene D + +81200 071878-19-8 Poly[6-[(1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl)imino]81215 065447-77-0 Poly/(2,2,6,6-tetramethylpiperidine-1,4-diyl)ethyleneoxysuccinyloxyl81220 192268-64-7 Poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl)-n-butylamino]-1,3,5-triazine-2,4-diyl][(2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanediyl[(2,2,6,6-tetramethyl-4-piperidinyl)imino]]-alpha-[N,N,N',N'-tetrabutyl-N"-(2,2,6,6-tetramethyl-4-piperidinyl)-NDIR SML = 3 mg/kg 2 TDI: 0.05 mg/kg b.w.3-month oral dog and 3- and 6-month oralrat studies, mutagenicity studies.(RIVM rep.89/678608/006 1989-04-11).Same 91150 D Same as 60800. +DIR SML = 5 mg/kg 3 R = 5 mg/kg of foodAvailable: molecular mass distributioncurve, specifications; specific migration;gene mutation assay in bacteria (negative);chromosomal aberration assay in culturedmammalian cells (negative); gene mutationassay in cultured mammalian cells(negative); 28-day oral rat study; genemutation assay with two migrating byproducts(negative).(RIVM/DE SDS, September 1999 =CS/PM/3272 REV. I/81220).(Adopted at the 119th SCF meeting) (2December 1999)http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf81230 - Polyurethanes 9 +81245 009003-20-7 Polyvinyl acetate D +81260 - Polyvinyl acetate,partially hydrolyzed2597 Available: molecular weight distributioncurve.Needed: migration data and toxicity dataaccording to SCF guidelines on thecompound with the highest concentration of+ ++ ++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTthe low molecular weight fraction.81280 009002-89-5 Polyvinyl alcohols Same 23680 7 Needed: migration data on the compound + +with the highest concentration of the lowmolecular weight fraction.81310 009002-86-2 Polyvinyl chloride D +81325 025498-06-0 Polyvinylcyclohexane W7 Available: 3-mutagenicity tests on the +polymer, negative and migration data, Amestest on the monomer. Molecular weightdistribution curve.Needed: remaining mutagenicity studiesaccording to the SCF guidelines on themonomer.(RIVM-TNO 1995-04-10 = CS/PM/2587)81360 - Polyvinylethers 9 +81390 025104-37-4 Poly(vinyl ethyl ether) 9 +81440 024937-79-9 Polyvinylidene fluoride D +81460 - Poly-N-vinyl-Nmethylacetamide9 +81475 - Poly-N-vinyl-Nmethylformamide9 +(m.w.>40.000)81485 025035-84-1 Polyvinyl propionate 9 +81500 009003-39-8 Polyvinylpyrrolidone 9 +81515 087189-25-1 Poly(zinc glycerolate) DIR 2-3 L3.Toxicologically acceptable.(TNO, 1995-04-11 = CS/PM/2588)+ +L2 for ZincSame as for 9618081520 007758-02-3 Potassium bromide DIR 1 Group ADI: 1 mg/kg b.w. (as Br) aspesticide residue.See references for ammonium bromide inlist 2.81600 001310-58-3 Potassium hydroxide DIR 1 ADI: not specified.(SCF, 25th Series, 1991)81680 007681-11-0 Potassium iodide DIR SML(T) = 1 mg/kg 1 PMTDI: 0.017 mg/kg b.w. (as I).(11) (expressed as(JECFA 33 M., 1988).Iodium)++ ++ +260

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT81760 - Powders, flakes andfibers of brass, bronze,copper, stainless steel,tin and alloys of copper,tin and iron81761 - Powders, flakes andfibres of chromium,molybdenum, nickel andtheir alloys81820 120498-03-5 1,3-Propanediamine,N,N"1,2-ethanediylbis-,polymerwith N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and2,4,6-trichloro-1,3,5-triazine81840 000057-55-6 1,2-Propanediol Same 23740DIRSML(T) = 30 mg/kg(7) (expressed asCopper); SML = 48mg/kg (expressed asIron)2612 For Copper. Same as Ref.No 30080. +7 Needed: Migration data and justification ofuse.Same 38510 3 R: 5 mg/kg of food.Available: Specific migration is 0.1-0.6mg/kg food; three negative mutagenicitystudies; acute toxicity data; 90-day ratgavage study (no NOAEL); skin/eyeirritation studies; 90-day oral rat study.(RIVM/TNO SDS, March 1998 =CS/PM/2805 REV. I/81820).(Adopted at 114th SCF meeting) (10December 1998)http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdfDIR 1 ADI: 25 mg/kg b.w.and 82065(JECFA 17 M., 1973).+++ +81880 000071-23-8 1-Propanol Same 23800 3 See references for same substance in+monomer report.81882 000067-63-0 2-Propanol Same 23830 DIR 1 t-ADI : 1.5 mg/kg b.w.+ +and 62480(SCF, 11th Series, 1981).81920 005520-20-7 1-Propanol,3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl) oxy] disiloxanyl]-,hydrogen sulphate,compound with 2-propanamine(1:1)W +81960 174254-23-0 2-Propenoic acid, methylester, telomer with 1-dodecanethiol, C16-18alkylesters (name to bechecked)Same 31542 D +82000 000079-09-4 Propionic acid Same 23890 DIR 1 Group ADI: not specified.(SCF, 1st Series, 1974).+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT82020 019019-51-3 Propionic acid, cobaltsaltDIRSML(T) = 0.05 mg/kg(14) (expressed asCobalt)1-3 L3 for Cobalt.R: 0.05 mg/kg of food (as Cobalt).(RIVM, summary data, October 1992=CS/PM/1707).+82065 000057-55-6 1,2-Propyleneglycol Same 23740and 8184082080 009005-37-2 1.2-Propyleneglycolalginate82160 - 1,3-Propyleneglycolalginate82240 022788-19-8 1,2-Propyleneglycoldilaurate82320 - 1,3-Propyleneglycoldilaurate82400 000105-62-4 1,2-Propyleneglycoldioleate82480 000821-69-2 1,3-Propyleneglycoldioleate82560 033587-20-1 1,2-Propyleneglycoldipalmitate82640 056414-56-3 1,2-Propyleneglycoldiricinoleate82720 006182-11-2 1,2-Propyleneglycoldistearate82800 027194-74-7 1,2-PropyleneglycolmonolaurateL1 for propionic acid.See references for propionic acid.D +DIR 1 Group ADI: 25 mg/kg b.w.+(JECFA 17 M., 1973).8 +DIR 1 Group ADI: 25 mg/kg b.w. (aspropyleneglycol) for 1,2-propyleneglycolesters of fatty acids.(JECFA 17 M., 1973).+8 +DIR 1 Group ADI: 25 mg/kg b.w. (aspropyleneglycol) for 1,2-propyleneglycolesters of fatty acids.(JECFA 17 M., 1973).+8 +DIR 1 Group ADI: 25 mg/kg b.w. (aspropyleneglycol) for 1,2-propyleneglycolesters of fatty acids.(JECFA 17 M., 1973).7? Needed: hydrolysis and migration data.http://europa.eu.int/comm/food/fs/sc/scf/out161_en.pdfDIR 1 Group ADI: 25 mg/kg b.w. (aspropyleneglycol) for 1,2-propyleneglycolesters of fatty acids.(JECFA 17 M., 1973).DIR 1 Group ADI: 25 mg/kg b.w. (aspropyleneglycol) for 1,2-propyleneglycolesters of fatty acids.++++262

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT82880 - 1,3-Propyleneglycolmonolaurate82960 001330-80-9 1,2-Propyleneglycolmonooleate83040 - 1,3-Propyleneglycolmonooleate83120 029013-28-3 1,2-Propyleneglycolmonopalmitate83200 - 1,3-Propyleneglycolmonopalmitate83280 026402-31-3 1,2-Propyleneglycolmonoricinoleate83300 001323-39-3 1,2-Propyleneglycolmonostearate83320 - Propylhydroxyethylcellulose83325 - Propylhydroxymethylcellulose83330 - Propylhydroxypropylcellulose263(JECFA 17M., 1973).8 +DIR 1 Group ADI: 25 mg/kg b.w. (aspropyleneglycol) for 1,2-propyleneglycolesters of fatty acids.(JECFA 17 M., 1973)+8 +DIR 1 Group ADI: 25 mg/kg b.w. (aspropyleneglycol) for 1,2-propyleneglycolesters of fatty acids.(JECFA 17 M., 1973)+8 +Same 83775 7? Needed: hydrolysis and migration data.http://europa.eu.int/comm/food/fs/sc/scf/out161_en.pdfDIR 1 Group ADI: 25 mg/kg b.w. (aspropyleneglycol) for 1,2-propyleneglycolesters of fatty acids.(JECFA 17 M., 1973)DIR 2 TDI: not specified based on group ADI(=not specified) for certain modifiedcelluloses.(JECFA 35M., 1989).DIR 2 Group TDI: not specified based on groupADI (=not specified) for certain modifiedcelluloses.(JECFA 35M., 1989).DIR 2 Group TDI: not specified based on groupADI (=not specified) for certain modifiedcelluloses.(JECFA 35M., 1989).83360 see 83300 D +83440 002466-09-3 Pyrophosphoric acid DIR 1 MTDI: 70 mg/kg b.w. (as P).+ +(JECFA 26 M., 1982).83455 013445-56-2 Pyrophosphorous acid DIR 3 Easily oxidized to phosphoric acid. +83460 012269-78-2 Pyrophyllite DIR 3 Inert material. ++++++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT83470 014808-60-7 Quartz DIR 3 Inert material. + +83475 121888-66-2 Quaternary ammoniumW +compounds,benzylbis(hydrogenatedtallow alkyl)methyl,benzoate lauryl sulphate,salts with bentonite83480 121888-67-3 Quaternary ammonium9 +compounds,benzylbis(hydrogenatedtallow alkyl)methyl,bis(hydrogenated tallowalkyl)dimethylammonium salt with hectorite83510 121888-68-4 Quaternary ammonium9 +compounds,benzyl(hydrogenatedtallow alkyl)dimethyl,chlorides, compoundswith bentonite andsodium stearate83520 see 83610 D +83530 071011-24-0 Quaternary ammonium9 +compounds,benzyl(hydrogenatedtallow alkyl)dimethyl,chlorides, compoundswith bentonite83535 068989-03-7 Quaternary ammonium9 +compounds, coco alkylbis(hydroxyethyl)-methyl, ethoxylatedmethyl sulphate83555 071011-27-3 Quaternary ammoniumcompounds,bis(hydrogenated tallowalkyl)dimethyl,chlorides, compoundswith hectoriteW +264

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT83560 068953-58-2 Quaternary ammoniumcompounds,bis(hydrogenated tallowalkyl)dimethyl, salts withbentonite83565 093572-63-5 Quaternary ammoniumcompounds N,N,N'-tris(hydroxyethyl)-N,N'-dimethyl-N'-tallowalkyltrimethylene di-,bis(methyl sulphates),salts83580/0 008002-13-9 Rapeseed oil (food gradequality)Same45060/0,45060/1,and83580/183580/1 008002-13-9 Rapeseed oil Same45060/0,45060/1 and83580/083595 119345-01-6 Reaction product of ditert-butylphosphonitewith biphenyl, obtainedby condensation of 2,4-di-tert-butylphenol withFriedel Craft reactionproduct of phosphorustrichloride and biphenyl83598 181314-48-7 Reaction prod.of 3-hydroxy-5,7-di-tert.butylbenzofuran-2-one with o-xyleneconsisting of 5,7-di-tert.butyl-3-(2,3-dimethylphenyl)-(3h)-benzofuran-2-one and 5-7-di-tert.butyl-3-(3,4-dimethylphenyl)-(3h)-benzof.DIRSML = 18 mg/kg andin compliance with thespecificationsmentioned in Annex V.2659 +W9 +D + +3 Food fat. + +2 TDI: 0.3 mg/kg b.w.90-day oral rat study and mutagenicitystudies.(Sandoz report 1979).Same 67170 D +83599 068442-12-6 Reaction products of DIR SML(T) = 0.18 mg/kg 2 Group-TDI: 0.003 mg/kg b.w. (as Sn) (with ++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CToleic acid, 2-mercaptoethyl ester, withdichlorodimethyltin,sodium sulphide andtrichloromethyltin(16) (expressed as Tin) 49600 and 67520).Available: migration data from PVC;hydrolysis in gastric fluid; two bacterialreversion assays; a mouse bone marrowmicronucleus assay; with methyltincompounds two bacterial reversion assays; amammalian cell gene mutation assay; an invitro chromosomal aberration assay; amouse bone marrow micronucleus test; an invivo/in vitro UDS in rat liver; acute toxicitydata; a subacute oral rat study; 90-days oralrat studies on 3 representative mixtures ofmethyltin stabilisers, on methyltin chloridesand on mercaptoethyloctadecenoic.(RIVM/ISS/TNO October1996,=CS/PM/2908)(Adopted at 111th SCF meeting (18-19March 1998)).http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf83600 see 83690 D +83610 073138-82-6 Resin acids and rosin Same 24070 DIR 2 Group TDI: 1 mg/kg b.w.+acids83650 009008-34-8 Resin acids and rosinacids, manganese salts(SCF, 17th Series, 1986)2 L2 (= 1 mg/kg b.w.) for resin acids.L2 for the Mn.Group TDI: 0.01 mg/kg b.w. (as Mn).See references for 30180 in L2 in this report.83680 see 83700 D +83690 035732-94-6 Ricinoleamide 8 +83700 000141-22-0 Ricinoleic acid Same 24075 DIR SML = 42 mg/kg 3 SCF_List: 3+Restriction: none. In small dosesmetabolised similarly to food fats.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf83760 - Ricinoleic acid, esterswith alcohols, aliph.,monoh.9 ++266

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT83775 026402-31-3 Ricinoleic acid, esters Same 83280 D +with 1,2-propanediol83840 008050-09-7 Rosin Same DIR 2 Group TDI: 1 mg/kg b.w.+14687,24100,24130 and45055(SCF, 17th Series, 1986).83880 009010-69-9 Rosin acids, zinc salt Same 96280 D +83920 - Rosin derivatives 9 +84000 008050-31-5 Rosin, ester with Same 24115 DIR 1 ADI= 12.5 mg/kg b.w.+ +glycerol(SCF, 32th Series, 1992).84080 008050-26-8 Rosin, ester withDIR 2 Group TDI= 1 mg/kg b.w.+ +pentaerythritolIncluded in the group TDI for colophony of1 mg/kg b.w.(SCF, 6th Series, 1978) also including rosins(SCF, 17th Series, 1986).84090 065997-04-8 Rosin, fumarated W +84095 068201-58-1 Rosin, fumarated,W +polymer withformaldehyde84100 065997-11-7 Rosin, fumarated,W +polymer withpentaerythritol84210 065997-06-0 Rosin, hydrogenated Same 84420 DIR 2 Group TDI: 1 mg/kg bw.+ +Included in the TDI for24070/24130/24190/83610/83840/84080/84320/84400/84420.(SCF, 17th Series, 1986).84240 065997-13-9 Rosin, hydrogenated,DIR 3 Toxicologically acceptable. + +ester with glycerol84320 008050-15-5 Rosin, hydrogenated,ester with methanol84400 064365-17-9 Rosin, hydrogenated,ester with pentaerythritolDIR 2 Group TDI= 1 mg/kg b.w.Included in the group TDI for colophony of1 mg/kg b.w.(SCF 6th, Series 1978) also including rosins(SCF, 17th Series, 1986).DIR 2 Group TDI= 1 mg/kg b.w.Included in the group TDI for colophony of1 mg/kg b.w.(SCF, 6th Series 1978) also including rosins(SCF, 17th Series, 1986).267++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT84410 008050-28-0 Rosin, maleated W +84420 065997-06-0 Rosin, partially Same 84210 2 Group TDI: 1 mg/kg bw.+hydrogenatedIncluded in the TDI for24070/24130/24190/83610/83840/84080/84210 84320/84400.(SCF, 17th series, 1986).84425 065997-07-1 Rosin, polymer withW +formaldehyde84430 068475-37-6 Rosin, polymerised, esterW +with glycerol84435 083137-13-7 Rosin, reaction productsW +with acrylic acid84480 009006-03-5 Rubber, chlorinated Same 24220 9 +84560 009006-04-6 Rubber, natural Same 24250 DIR 3 Migration unlikely. +84570 - Rubber, synthetic 9 +84640 000069-72-7 Salicylic acid Same 24270 DIR 3 Naturally occurring in food in low+concentration.84720 000118-58-1 Salicylic acid, benzyl7 Needed: hydrolysis data. +ester84800 000087-18-3 Salicylic acid, 4-tertbutylphenylesterDIR SML = 12 mg/kg 2 TDI: 0.2 mg/kg b.w.2-year oral rat study.(RIVM March 1972).+ +DIR SML = 30 mg/kg 1 ADI: 0.5 mg/kg b.w.+ +(JECFA 11 M., 1967).7 Needed: hydrolysis data. +84880 000119-36-8 Salicylic acid, methylester84960 000118-55-8 Salicylic acid, phenylester85030 000111-20-6 Sebacic acid Same 24280 D + +85040 - Sebacic acid, alkyl (C6-9 Group R: 0.05 mg/kg b.w. +C12) esters85120 000122-62-3 Sebacic acid, bis(2-+ethylhexyl) ester85200 027214-90-0 Sebacic acid, bis(6-methylheptyl) ester2687 Group R: 0.05 mg/kg b.w.Available: Ames test and 3-week oral ratstudy.Needed: remaining toxicological datadepending on migration level (see SCFguidelines) and, if migration exceeds 0.05mg/kg, peroxisome proliferation studies too.8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending on+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT85280 052829-07-9 Sebacic acid, bis(2,2,6,6-tetramethyl-4-piperidyl)ester85360 000109-43-3 Sebacic acid, dibutylestermigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg peroxisomeproliferation studies too.7 Available: 4 mutagenicity studies.Needed: migration data, use, stability duringproduction and use.DIR 3 Toxicologically acceptable (hydrolyses inintestinal fluid to sebacic acid and butanol).++ +85440 000106-79-6 Sebacic acid, dimethylester85520 002432-87-3 Sebacic acid, di-n-octylesterAvailable: migration data in olive oil;hydrolysis data; inadequate semichronic oralrat and chronic oral rat and reproductionstudy; inadequate Ames test; inadequateDrosophila study; inadequate micronucleusassay; three adequate in vitro mutagenicitystudies; peroxisome proliferations study.(RIVM/TNO July 1996,=CS/PM/2860)Same 24370 8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg peroxisomeproliferation studies too.8 Group R: 0.05 mg/kg b.w.Available: "data inadequate"(extract fromLefaux book".Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.85550 009000-59-3 Shellac Same 24440 1 ADI: acceptable.+(SCF, 26th Series, 1992).85580 007631-86-9 Silica Same 86240 D +85600 - Silicates, natural D 3 Inert material. Some specific silicates havebeen allocated an ADI, not specified.(SCF, 25th Series, 1991)+ +85601 - Silicates, natural (withthe exception ofasbestos)Same 85600 DIR 3 +85610 - Silicates, natural, DIR 3 Inert material. + +++269

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTsilanated (with theexception of asbestos)85680 001343-98-2 Silicic acid See also85980/8642785760 012068-40-5 Silicic acid, lithiumaluminium salt(2:1:1)DIR 2 TDI: not specified based on ADI: notspecified for silicon dioxide.(SCF, 25th Series, 1991)DIRSML(T) = 0.6 mg/kg(8) (expressed asLithium)2-3 L2 for LiGroup TDI: 0.01 mg/kg b.w. (as Li).See references for 38000 in L2 in this report.L2 for AlTDI: 1 mg/kg bw (as Al) based on PTWI: 7mg/kg bw (as Al).(SCF, 25th Series, 1991).+ ++85840 053320-86-8 Silicic acid, lithiummagnesium sodium saltDIRSML(T) = 0.6 mg/kg(8) (expressed asLithium)85920 012627-14-4 Silicic acid, lithium salt DIR SML(T) = 0.6 mg/kg(8) (expressed asLithium)85950 037296-97-2 Silicic acid, magnesiumsodium-fluoridesaltL2 for silicic acid.TDI: not specified, based on ADI: notspecified for silicon dioxide and severalsilicates.(SCF, 25th Series, 1990)2-3 Group TDI = 0.01 mg/kg b.w. (as Li).See references for benzoic acid, lithium salt.L2 for silicic acid.TDI: not specified, based on ADI: notspecified for silicon dioxide and severalsilicates.(SCF, 25th Series, 1990)2-3 Group TDI: 0.01 mg/kg b.w. (as Li).See references for benzoic acid, lithium salt.L2 for silicic acid.TDI: not specified, based on ADI: notspecified for silicon dioxide and severalsilicates.(SCF, 25th Series, 1990)3AM 3 Restriction: 0.15 mg fluoride/kg foodRemark for Commission: This is a GroupRestriction. No direct contact intended.Restriction may include this condition of useif necessary.+++270

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CThttp://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf85980 - Silicic acid, salts 85680/8642 D 2 TDI: not specified, based on ADI: not + +7specified for silicon dioxide.(SCF, 25th Series, 1991)86000 - Silicic acid, silylated DIR 3 Inert material. + +86030 004766-57-8 Silicic acid, tetrabutyl8 +ester86050 000078-10-4 Silicic acid, tetraethyl8 +ester86052 068412-37-3 Silicic acid (H4SiO4),W +tetraethyl ester,hydrolysed86080 010101-52-7 Silicic acid, zirconium7 L3 for silicic acid.+saltL7 for zirconium.See references for 54220.86160 000409-21-2 Silicon carbide DIR 3 Inert material. + +86240 007631-86-9 Silicon dioxide Same 85580 DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1991)86260 - Silicon dioxide8 +amorphous, fluorinated86280 - Silicon dioxide3-D Inert material. +amorphous, silanated86285 - Silicon dioxide, silanated DIR 3 Inert material. + +86300 063148-62-9 Silicone oils 9 +86320 - Silicones 9 +86360 158061-44-0 Siloxanes and silicones,W +alkyl(C24-C28) methyl86380 133101-81-2 Siloxanes and silicones,W +dimethyl, ethoxy methyl,ethoxy phenyl, polymerswith methylsilsesquioxanes andphenyl silsesquioxanes,ethoxy-terminated86400 - Siloxanes and silicones,dimethyl, ethyl9 + +271

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CThydrogen, reactionproducts withpolyethyleneglycolmonoallyl ether86401 189354-75-4 Siloxanes and silicones,dimethyl, hexadecylmethyl, 3-hydroxypropylmethyl, ethoxylatedpropoxylated86402 068037-78-5 Siloxanes and silicones,dimethyl,hexadecylmethyl, methyloctadecyl86404 - Siloxanes and silicones,dimethyl,hexadecylmethyl,octadecyl methyl, 11-methoxy-11-oxoundecylmethyl86405 151662-01-0 Siloxanes and silicones,dimethyl, 3-hydroxypropyl groupterminated,ethoxylatedpropoxylated86405/5 068938-54-5 Siloxanes and silicones,dimethyl, 3-hydroxypropyl methyl,ethers withpolyethyleneglycolmonomethyl ether86406 068937-54-2 Siloxanes and silicones,dimethyl, 3-hydroxypropyl methyl,ethoxylated86408 068937-55-3 Siloxanes and silicones,dimethyl, 3-hydroxypropyl methyl,ethoxylated propoxylated86408/5 128192-17-6 Siloxanes and silicones,dimethyl, 3-W +9 + +9 +W +W +9 + +9 + +W +272

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CThydroxypropyl methyl,3-hydroxypropyl groupterminated,ethoxylatedpropoxylated86409 070131-67-8 Siloxanes and silicones,dimethyl, hydroxyterminated86410 129893-29-4 Siloxanes and silicones,dimethyl, hydroxyterminated,ethers withpolyethylenepolypropyleneglycolmonobutyl ether86411 155490-71-4 Siloxanes and silicones,dimethyl, hydroxyterminated,ethers withpolyethylenepolypropyleneglycolmonomethyl ether86412 067762-96-3 Siloxanes and silicones,dimethyl, hydroxyterminated,ethers withpolypropyleneglycolmonobutyl ether86414 064365-23-7 Siloxanes and silicones,dimethyl, hydroxyterminated,ethoxylatedpropoxylated86416 067762-83-8 Siloxanes and silicones,dimethyl,methyloctadecyl86418 068554-66-5 Siloxanes and silicones,dimethyl, polymers withmethylsilsesquioxanes,ethoxy-terminated86420 068554-67-6 Siloxanes and silicones,dimethyl, polymers withmethylsilsesquioxanes,hydroxy-terminatedW +9 + +W +9 + +9 + +9 + +9 + +9 + +273

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT86422 068554-65-4 Siloxanes and silicones,dimethyl, polymers withmethylsilsesquioxanesand polyethylenepolypropyleneglycolmonobutyl ether86424 068554-64-3 Siloxanes and silicones,dimethyl, polymers withmethylsilsesquioxanesand polypropyleneglycolmonobutyl ether86424/5 155419-55-9 Siloxanes and silicones,dimethyl, polymers withphenylsilsesquioxanes,ethoxy-terminated86425 067762-90-7 Siloxanes and silicones,dimethyl, reactionproducts with silica86426 068554-70-1 Silsesquioxanes, methyl Same as6693086426/5 133101-85-6 Silsesquioxanes, phenyl,ethoxy-terminated86427 001318-02-1 Silver alumino silicate replaced by86432 - Silver-containing glass(Silver-magnesiumcalcium-phosphateborate)959959 + +9 + +W +W +D +W +D +3 Restriction: Group restriction of 0.05 mgAg/kg of food.Remark for Commission: It is a surfacebiocidehttp://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdf86432/10 - Silver in glass +86434 - Silver sodium hydrogenzirconium phosphate+3 Restriction: Group restriction of 0.05 mgAg/kg of food.Remark for Commission: It is a surfacebiocidehttp://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdfhttp://europa.eu.int/comm/food/fs/sc/scf/out+274

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT86437 - Silver zeolite A (silverzinc sodium ammoniumalumino silicate), silvercontent 2- 5 %86437/50 - Silver-zinc- aluminium -boron - phosphate glass,mixed with 5-20%barium sulphate, silvercontent 0.35-0.6%86438 - Silver zinc zeolite A (silver-zinc sodiumalumino silicate calciummetaphosphate), silvercontent 1-1.6%Same95995/1Similar to86437 and86438/5062_en.pdf3 Group restriction: 0.05 mg Ag/kg food,based on the human NOEL of about 10 g ofsilver for a total lifetime oral intakeallocated by WHO (WHO, 2004) fordrinking water.Maximum content in polymer: 10% (w/w)of silver zeolite A ≤ containing 5% silver.Only for repeated use articles made frompolyolefins(up to 40°C for contact times below 1 day)and for poly(alkylene terephthalate) basedpolymers (up to 99°C for contact timesbelow 2 hours)Remark for the Commission: It is a biocidehttp://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf3 Group restriction: 0.05 mg Ag/kg food,based on the human NOAEL of about 10 gof silver for a total lifetime oral intakeallocated by WHO (WHO, 2004) fordrinking water.Group restriction: 1 mg Ba/kg foodGroup restriction: 6 mg B/kg foodMaximum content in plastic: 1% (w/w)Remark for Commission: It is a biocidehttp://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf3 Group restriction: 0.05 mg Ag/kg of food,based on the human NOAEL of about 10 gof silver for a total lifetime oral intakeallocated by WHO (WHO, 2004) fordrinking water.Remark for Commission: It is a biocideThe Commission is advised to specify:- the maximum amount of additive (1%) and- the max. amount of silver in the additive(1.6%) or in the final food contact materialhttp://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf+++275

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT86438/50 - Silver zinc zeolite A (silver-zinc sodiummagnesium aluminosilicate calciumphosphate), silvercontent 0.34-0.54%Similar to86437 and864382763 Group restriction: 0.05 mg Ag/kg of food,based on the human NOAEL of about 10 gof silver for a total lifetime oral intakeallocated by WHO (WHO, 2004) fordrinking water.Remark: It is a biocideThe Commission is advised to specify:- the maximum amount of additive (1%) and- the max. amount of silver in the additive(1.6%) or in the final food contact materialhttp://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf86440 ? Sodium aluminate 2 TDI: 1 mg/kg bw (as Al) based on PTWI : 7mg/kg b.w. (as Al).(SCF, 25th Report, 1991).86480 007631-90-5 Sodium bisulphite DIR SML(T) = 10 mg/kg(30) (expressed asSO2)1 Group ADI: 0.7 mg/kg b.w. as SO2(JECFA 27 M., 1983).86560 007647-15-6 Sodium bromide DIR 1 Group ADI: 1 mg/kg b.w. (as Br) aspesticide residue.See references for ammonium bromide inlist 2.86640 009004-32-4 SodiumcarboxymethylcelluloseDGroup TDI not specified for natural,regenerated and modified cellulose (SCF 7thReport, 1978 and JECFA 17 M., 1973 andfollowin g).+++ +86655 - Sodium9 +dialkylsulphonimides86670 007775-14-6 Sodium dithionite 8 +86720 001310-73-2 Sodium hydroxide DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1991)86800 007681-82-5 Sodium iodide DIR SML(T) = 1 mg/kg(11) (expressed asIodine)1 PMTDI: 0.017 mg/kg b.w. (as I)(JECFA 33 M., 1988).+86840 007681-57-4 Sodium metabisulphite W +86880 - Sodium monoalkyldialkylphenoxybenzenedisulphonateDIR SML = 9 mg/kg 2 t-TDI: 0.15 mg/kg b.w. pendingreproduction and teratogenicity studies.Available: 2-year oral rat and dog studies.+ +++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT86920 007632-00-0 Sodium nitrite DIR SML = 0.6 mg/kg 3 R: 0.01 mg/kg bw based on allowing 1/10 oft-TDI for food packaging uses.(SCF, 26th Series, 1992).86960 007757-83-7 Sodium sulphite DIR SML(T) = 10 mg/kg(30) (expressed asSO2)87040 001330-43-4 Sodium tetraborate DIR SML(T) = 6 mg/kg(23) (expressed asBoron) withoutprejudice to theprovisions of Directive98/83/EC on water forhuman consumption(OJ L 330,5.12.1998,p.32)87120 007772-98-7 Sodium thiosulphate DIR SML(T) = 10 mg/kg(30) (expressed asSO2)2771 Group ADI: 0.7 mg/kg b.w. as SO2(JECFA 27 M., 1983).2 Re-evaluation on the basis of an opinion ofthe SCF in another context.Group-TDI = 0.1 mg/kg b.w. (as B) (withREF_n. 36840, 40320 and 87040).The TDI is based on the No Adverse EffectLevel (NOAEL) of 9.6 mg/kg b.w./day foreffects on fetal body weight and skeletalanomalies in the rat developmental study. ASafety Factor (SF) of 100 is used.“Opinion of the Scientific Committee onFood on Arsenic, Barium, Fluoride, Boronand Manganese in Natural Mineral Waters(expressed on 13 December 1996, 105thplenary meeting of the SCF, completed on13 June 1997 at the 107th plenary meetingof the SCF; 43rd Series of Reports of theSCF, 2000”.(Adopted by the SCF at the 127th meeting,30 May 2001)http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf1 Group ADI: 0.7 mg/kg b.w. as SO2.Included in the group ADI for sulphites.(JECFA 27 M., 1983).87200 000110-44-1 sorbic acid DIR 1 ADI: 25 mg/kg b.w.(SCF, 6th Series, 1978).87280 029116-98-1 Sorbitan dioleate DIR 2 Group TDI: 5 mg/kg b.w. based on thegroup ADI 5 mg/kg b.w. for sorbitan estersof lauric and oleic acids.(SCF, 7th Series, 1978).87360 - Sorbitan, esters withacids, aliph., monocarb.(more than C5)9 +87440 071902-01-7 Sorbitan isostearate 9 ++ ++ ++ +++ ++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT87520 062568-11-0 Sorbitan monobehenate DIR 2 Group TDI= 5 mg/kg b.w. based on the + +group ADI 5 mg/kg b.w., for sorbitan estersof lauric and oleic acids.(SCF, 7th Series, 1978).87560 054392-26-6 Sorbitan monoisostearate 8 +87600 001338-39-2 Sorbitan monolaurate Same 63480 DIR 1 Group ADI: 5 mg/kg b.w. for sorbitan + +monolaurate and sorbitan monooleate.(SCF, 7th Series, 1978).87680 001338-43-8 Sorbitan monooleate DIR 1 Group ADI: 5 mg/kg b.w. for sorbitan + +monolaurate and sorbitan monooleate.(SCF, 7th Series, 1978).87760 026266-57-9 Sorbitan monopalmitate DIR 1 Group ADI: 25 mg/kg b.w. for sorbitan + +monostearate, sorbitan monopalmitate andsorbitan tristearate.(SCF, 7th Series, 1978).87840 001338-41-6 Sorbitan monostearate DIR 1 Group ADI: 25 mg/kg b.w. for sorbitan + +monostearate, sorbitan monopalmitate andsorbitan tristearate.(SCF, 7th Series, 1978).87920 061752-68-9 Sorbitan tetrastearate DIR 2 Group TDI: 5 mg/kg b.w. based on the + +group ADI 5 mg/kg b.w. for sorbitan estersof lauric and oleic acids.(SCF, 7th Series, 1978).88000 054392-27-7 Sorbitan triisostearate 9 +88080 026266-58-0 Sorbitan trioleate DIR 2 Group TDI: 5 mg/kg b.w. based on the + +group ADI 5 mg/kg b.w. for sorbitan estersof lauric and oleic acids.(SCF, 7th Series, 1978).88160 054140-20-4 Sorbitan tripalmitate DIR 2 Group TDI: 5 mg/kg b.w. based on the + +group ADI 5 mg/kg b.w. for sorbitan estersof lauric and oleic acids.(SCF, 7th Series, 1978).88240 026658-19-5 Sorbitan tristearate DIR 1 Group ADI: 25 mg/kg b.w. for sorbitan + +monostearate, sorbitan monopalmitate andsorbitan tristearate.(SCF, 7th Series, 1978).88320 000050-70-4 Sorbitol Same 24490 DIR 1 Acceptable.+ +(SCF, 16th Series, 1985).88400 - Sorbitol, esters with 9 +278

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTacids, aliph., monocarb.(more than C5)88480 - Sorbitol, esters with9 +acids, hydroxylated,monocarb. (C12-C20)88560 see 88600 D +88600 026836-47-5 Sorbitol monostearate DIR 2 TDI= not specified based on the ADI for + +sorbitol.(SCF, 17th Series, 1986).88630/1 008001-22-7 Soybean oil Same 245203 Food fat. +and 88630/088640 008013-07-8 Soybean oil, epoxidized DIR In compliance with thespecifications laiddown in Annex V.2 Restriction for baby food:http://www.efsa.eu.int/science/afc/afc_opinions/467/opinion_afc10_ej64_epox_soyoil_en1.pdf---------------------------------------TDI: 1 mg/kg b.w.Available: 15-week and 2-year oral ratstudies and 1-year oral dog study,reproduction and teratogenicity studies.ADI's and TDI's are allocated in the light oflife long average exposure and allowing forsporadic intakes above the set limits. For theinfants, however, the actual consumptionpattern surveys have revealed intakes forprolonged periods of time which mayexceed the TDI.(Bibra report n. 515/86; summary reportprepared by UK January 1988).+ +88650 068308-53-2 Soybean oil fatty acids, Same 17200 D +polymerized88680 008002-23-1 Spermaceti wax 8 +88720 - Sperm oil, hydrogenated 8 +88770 009045-28-7 Starch acetate (= E1420) W +88780 009057-06-1 Starch carboxymethylW +ether88800 009005-25-8 Starch, edible Same 24540 DIR 0 + +279

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT88880 068412-29-3 Starch, hydrolysed Same 24545 DIR 0 + +88920 066829-29-6 Starch octenylsuccinate,W +sodium salt (= E1450)88930 065996-62-5 Starch, oxidised (=W +E1404)88940 011120-02-8 Starch phosphate (=W +E1410)88950 039316-70-6 Starch succinate W +88960 000124-26-5 Stearamide DIR 3 Same references as 68960. + +89040 000057-11-4 Stearic acid Same 24550 DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1990).89120 000123-95-5 Stearic acid, butyl ester 7 Needed: hydrolysis data. + +89170 013586-84-0 Stearic acid, cobalt salt Same 89165 DIR SML(T) = 0.05 mg/kg(14) (expressed asCobalt)1-3 L3 for Cobalt.R: 0.05 mg/kg of food (as Co).(RIVM, summary data, October1992=CS/PM/1707).+89200 007617-31-4 Stearic acid, copper salt DIR SML(T) = 30 mg/kg(7) (expressed asCopper)280L1 for stearic acid.See references for stearic acid.2 For Copper. Same as Ref.No 30080. +89240 001323-83-7 Stearic acid, diglyceride Same 56320 D +89280 005303-25-3 Stearic acid, dodecylD Needed: hydrolysis data. +ester89360 - Stearic acid, esters with7 Needed: hydrolysis data. +alcohols, aliph.(C4-C22)89440 - Stearic acid, esters withDIR SML(T) = 30 mg/kg 2 TDI = 0.5 mg/kg b.w.+ethyleneglycol(3)(SCF, 6th Series, 1978).89520 008045-34-9 Stearic acid, esters with7 Needed: hydrolysis data. +pentaerythritol89600 000111-61-5 Stearic acid, ethyl ester 7 Needed: hydrolysis data. +89680 022047-49-0 Stearic acid, 2-7 Needed: hydrolysis data. +ethylhexyl ester89760 026739-53-7 Stearic acid, guanidineD +salt89840 024466-84-0 Stearic acid, heptyl ester 7 Needed: hydrolysis data. +89920 001190-63-2 Stearic acid, hexadecyl 7 Needed: hydrolysis data. +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTester89950 003460-37-5 Stearic acid, hexyl ester 7 Needed: hydrolysis data. +89970 005136-76-5 Stearic acid, iron salt D +90000 000646-13-9 Stearic acid, isobutyl7 Needed: hydrolysis data. + +ester90080 031565-38-5 Stearic acid, isodecyl8 +ester90120 031565-37-4 Stearic acid, isotridecylW +ester90160 052652-59-2 Stearic acid, leadD +(dibasic) salt90240 007428-48-0 Stearic acid, lead salt D +90305 028084-19-7 Stearic acid, nonyl ester 9 +90320 002778-96-3 Stearic acid, octadecyl7 Needed: hydrolysis data. +ester90400 000109-36-4 Stearic acid, octyl ester 7 Needed: hydrolysis data. +90480 006382-13-4 Stearic acid, pentyl ester 7 Needed: hydrolysis data +90560 014351-40-7 Stearic acid, 2-7 Needed: hydrolysis data. +stearamidoethyl ester90640 031556-45-3 Stearic acid, tridecyl7 Needed: hydrolysis data. +ester90720 058446-52-9 Stearoylbenzoylmethane DIR 2 TDI: 1.5 mg/kg b.w.+ +30-day oral rat, 90-day oral dog, 2-generation oral rat studies, mutagenicity andmigration data.(RIVM report June 1979).90800 005793-94-2 Stearoyl-2-lactylic acid, Same 90840 DIR 1 ADI: 20 mg/kg b.w.+calcium salt90840 005793-94-2 2-(2-Stearoyloxypropionyl)oxy)propionic acid,calcium salt(SCF, 7th Series, 1978).Same 90800 D +90880 000142-48-3 N-Otearoylsarcosine 8 +90930 - Styrene copolymers 9 +90960 000110-15-6 Succinic acid Same 24820 DIR 1 ADI: not specified.+(SCF, 25th Series, 1990).91040 028801-70-9 Succinic acid, diisodecyl 8 +281

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTester91120 028880-24-2 Succinic acid, diisooctyl8 +ester91135 000106-65-0 Succinic acid, dimethyl Same 24835 7 Needed: hydrolysis data. +ester91150 065447-77-0 Succinic acid, dimethyl Same 81215 D +ester-(4-hydroxy-2,2,6,6-tetramethylpiperidyl)ethanol,copolymer91200 000126-13-6 Sucrose acetateDIR 1 ADI: 10 mg/kg bw.+ +isobutyrate(SCF, 25th Series, 1991)91280 - Sucrose esters of9 +monocarb. Acids91360 000126-14-7 Sucrose octaacetate DIR 3 Bitter taste. +91400 003375-11-9 3,3'-Sulphonylbis(benzenesulphonicSame 51600 D +acid)dihydrazide91440 - Sulphoricinic acid, salts 9 +91520 005138-18-1 Sulphosuccinic acid 8 +91540 - Sulphosuccinic acid,9 Group R: 0.05 mg/kg bw. +alkyl(C4-C20) esters,salts91545 090268-36-3 Sulphosuccinic acid,alkyl(C12-C18) esters,disodium saltD +91560 002373-38-8 Sulphosuccinic acid,bis(1,3-dimethylbutyl)ester, sodium salt91570 010041-19-7 Sulphosuccinic acid,bis(2-ethylhexyl)ester91572 000577-11-7 Sulphosuccinic acid,bis(2-ethylhexyl)ester,sodium salt2828 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies.8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and ifmigration exceeds 0.05 mg/kg peroxisomeproliferation studies too.++ +D + +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT91580 023386-52-9 Sulphosuccinic acid,8 +dicyclohexyl ester,sodium salt91600 see 91540 D +91630 003006-15-3 Sulphosuccinic acid,dihexyl ester, sodium salt91650 000127-39-9 Sulphosuccinic acid,diisobutyl ester, sodiumsalt91665 029857-13-4 Sulphosuccinic acid,diisodecyl ester, sodiumsalt91672 055184-72-0 Sulphosuccinic acid,diisotridecyl ester,sodiium salt91680 001639-66-3 Sulphosuccinic acid,dioctyl ester, sodium salt91720 000922-80-5 Sulphosuccinic acid,dipentyl ester, sodiumsalt91760 002673-22-5 Sulphosuccinic acid,ditridecyl ester, sodiumsalt8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.8 Group R: 0.05 mg/kg bw.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg bw,peroxisome proliferation studies too.8 Group R: 0.05 mg/kg bw.Needed: toxicological data depending onmigration level(see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg peroxisomeproliferation studies too.8 Group R: 0.05 mg/kg bw.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg peroxisomeproliferation studies too.8 Group R: 0.05 mg/kg bw.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.8 Group R: 0.05 mg/kg bw.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg peroxisomeproliferation studies too.8 Group R: 0.05 mg/kg bw.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.+ +++++ ++ ++ +283

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT91780 067893-42-9 Sulphosuccinic acid, 4-[2-[(12-hydroxy-1-oxooleyl)-amino]ethyl]ester,disodium salt91800 037294-49-8 Sulphosuccinic acid,isodecyl ester, disodiumsaltW8 +8 Group R: 0.05 mg/kg bw.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg peroxisomeproliferation studies too.91840 007704-34-9 Sulphur DIR 3 Inert material. +91920 007664-93-9 Sulphuric acid DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1991)92000 007727-43-7 Sulphuric acid, bariumsaltDIR+ +SML(T) = 1 mg/kg(12) (expressed asBarium)3 L3 for Barium.R: 1 mg/kg (as Ba) in food or in foodsimulant.(Rivm doc., May 1992 (CS/PM/1584)).+92030 010124-44-4 Sulphuric acid, coppersaltDIRSML(T) = 30 mg/kg(7) (expressed asCopper)L3 for the compound.Insoluble material.2 L1 for sulphuric acid.ADI = not specified.See references for sulphuric acid in list 1.+ +92040 012202-17-4and 052732-72-6Sulphuric acid, lead (triandtetrabasic) salt284For copper(II).Same as Ref.No 30080.D +92080 014807-96-6 Talc DIR 1 ADI: not specified.+ +(SCF, 25th Series, 1991)92100 061789-97-7 Tallow 3 Toxicologically acceptable. +92120 - Tallow, sulphated,ammonium, potassium,or sodium salt9 +92150 001401-55-4 Tannic acids DIR According to theJECFA specifications3 Toxicologically acceptable with JECFAspecifications.(Doc. 1995-02-01 = CS/PM/2536)92160 000087-69-4 Tartaric acid DIR 1 ADI: 30 mg/kg b.w. + ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT(SCF, 25th Series, 1991)92180 000087-92-3 Tartaric acid, dibutyl7 Needed: hydrolysis data. +ester92195 - Taurine, salts DIR 0 +92205 057569-40-1 Terephthalic acid, diester Same 38580 DIR 2 TDI: 1 mg/kg b.w.+with 2,2'-methylenebis(4-methyl-6-tert-butylphenol)A 90-day oral rat study.(CIVO report 5569, December 1977).92240 see 92180 D +92280 see 92205 D +92320 - Tetradecylpolyethyleneglycol(EO=3-8) ether of glycolicacidDIR SML = 15 mg/kg 2 t-TDI: 0.25 mg/kg b.w.Available: 28- and 90-day oral rat studies.(CIVO/TNO 3108 October 1970, 3287October 1970).Needed: mutagenicity data on polymericadditive itself and specify monomercontent.Remark: after verification, name to bechanged into "tetradecylpolyethyleneglycol[E0= 3-8] ether ofglycolic acid"92350 000112-60-7 Tetraethyleneglycol Same 25090 DIR 1 ADI : 10 mg/kg b.w.+(SCF, 17th Series, 1986).92400 000097-77-8 N.N'-Tetraethylthiuram8 +disulphide92430 000109-99-9 Tetrahydrofuran Same 25150. 2 TDI: 0.01 mg/kg b.w.+See references for same substance inmonomer report.92450 000097-99-4 Tetrahydrofurfurol 8 +92480 - Tetrakis(2,4-di-tert-7 Needed: neurotoxicity study in hens. +butylphenyl)-2,4'-biphenylylenediphosphonite92560 038613-77-3 Tetrakis(2,4-di-tert-butyl-phenyl)-4,4'-biphenylylenediphosphoniteDIR SML = 18 mg/kg 2 TDI: 0.3 mg/kg b.w.90-day oral rat study and mutagenicitystudies.(Sandoz report 1979).++285

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT92640 000102-60-3 N.N.N.'N'-Tetrakis(2-hydroxypropyl)ethylenediamine92655 006683-19-8 Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxy)hydrocinnamate]methane92700 078301-43-6 2,2,4,4-Tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro[5.1.11.2]-heneicosan-21-one,polymer92720 000137-26-8 N.N'-Tetramethylthiuramdisulphide92740 011067-82-6 Tetrapropylene benzenesulphonic acid, sodiumsalt92760 000096-69-5 Thiobis(6-tert-butyl-mcresol)Same 92800and 9284092800 000096-69-5 4,4'-Thiobis(6-tert-butyl- Same 927603-methylphenol) and 9284092820 013560-49-1 Thiobis(ethyleneglycol3-aminoCrotonate)92840 000096-69-5 Thiobis(2-methyl-4-hydroxy-5-tertbutyl)benzene92880 041484-35-9 Thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate)92900 041484-35-9 Thiodiethylenebis(3,5-di-tert-butyl-4-Same 25180 DIR 2 TDI: 1 mg/kg b.w.(SCF, 17th Series, 1986).Same 71680 D +DIR SML = 5 mg/kg 3 R = 5 mg/kg of food.286Available: adequate migration data; acutetoxicity data; 90-day oral study (HostavinN30); three in vitro mutagenicity studies(Hostavin N30) and three in vitromutagenicity studies (Hostavin N20).(RIVM/TNO SDS, July 1996 =CS/PM/2861).8 +8 +D +DIR SML = 0.48 mg/kg 2 t-TDI: 0.008 mg/kg b.w. pending results ofongoing 2-year and reproduction studies.Available: 28- and 90-day oral rat studies,one in-vitro mutagenic test.(RIVM doc. 88/678608/007, 1 November1988).Same 35120 D +Same 92760and 92800D +++ +Same 92900 DIR SML = 2.4 mg/kg 2 TDI: 0.04 mg/kg b.w.90-day oral rat study, mutagenicity studies.Desirable: migration data.(RIVM report 88/678608/009, 1989-01-24).+ +Same 92880 D ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CThydroxyhydrocinnamate)92930 120218-34-0 Thiodiethanolbis(5-methoxycarbonyl-2-6-dimethyl-1,4-dihydropyridine-3-carboxylate)DIR SML = 6 mg/kg 2 TDI = 0.1 mg/kg b.w.90-day oral rat study, mutagenicity testsnegative, absence of bioaccumulation.(CS/PM/305,336,358,460).92960 000111-17-1 Thiodipropionic acid 8 +93040 - Thiodipropionic acid,dibehenyl ester+93120 000123-28-4 Thiodipropionic acid,didodecyl esterDIRSML(T) = 5 mg/kg(21)2878 Group R: 0.05 mg/kg bw.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.3 Group R: 5 mg/kg of food (withthiodipropionic acid, dioctadecylester=93280)Available: Adequate migration data fromPVC and ABS; acute toxicity data; 28-dayoral rat study; 90-day oral rat study;inadequate data on long-term toxicity; threeoral teratogenicity studies using mice,hamsters and rabbits; studies on absorption,distribution, metabolism and excretion;peroxisome proliferationstudy (this study deviated from the SCFguidelines on peroxisomalproliferation); two Ames assays (negative);in vitro chromosomalaberration assay (negative); gene mutationassay in mouse limphoma cells (negative).Remark: Data insufficient for allocating aTDI (no reproductionstudy and no long-term study). The WGdecided not to ask for a new peroxisomeproliferation study, since the 90-day studyshowed only increased liver weights (nomorphological changes) at very high doses(1000 mg/kg b.w.). In view of the structureof the compound and the metabolism dataprovided there is no need for demonstrationof the absence of potential for accumulation.++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT93200 003287-12-5 Thiodipropionic acid,dihexadecyl ester93280 000693-36-7 Thiodipropionic acid,dioctadecyl ester93360 016545-54-3 Thiodipropionic acid,ditetradecyl esterDIRSML(T) = 5 mg/kg(21)No need for a long-term toxicity study, sincemyocarditis was not seen after the recoveryperiod of the 90-day study.(RIVM/TNO SDS, May 1996 =CS/PM/2862/93120).(adopted at 113rd SCF meeting)(17-18September 1998)http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html8 Group R: 0.05 mg/kg bw.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.3 Group R: 5 mg/kg of food (with 93120=dilauryl thiodipropionate) based on dataavailable for 93120.(adopted at 113rd SCF meeting)(17-18September 1998)http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html8 Group R: 0.05 mg/kg bw.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.05 mg/kg, peroxisomeproliferation studies too.93420 007646-78-8 Tin(iv) chloride 1 PTWI: 14 mg/kg b.w.(JECFA, 33M., 1989).93440 013463-67-7 Titanium dioxide DIR 1 Acceptable.(SCF, 1st Series, 1975).93520 000059-02-9 alpha-Tocopherol DIR 1 Acceptable.and 010191-(SCF, 22th Series, 1989).41-093540 000108-88-3 Toluene Same 25205 3 R: 1.2 mg/kg of food.See references for the same substance (PMREF. 25205) in monomer report.++ ++++ +++ +93585 000104-15-4 p-Toluenesulphonic acid 8 +93680 009000-65-1 Tragacanth gum DIR 1 ADI: not specified.+(SCF, 21th Series, 1989).288

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT93695 000102-76-1 Triacetin Same 57760 D +93720 000108-78-1 2,4,6-Triamino-1,3,5- Same 19975, DIR SML = 30 mg/kg 2 TDI: 0.5 mg/kg b.w.+ +triazine25420 and65360(SCF, 17th Series, 1986).93730 2,4,6-Triamino-1,3,5-9 +triazine resins93760 000077-90-7 Tri-n-butyl acetyl citrate New studies on-going.------------------------------------------------------R = 5 mg/kg of food.Available: specific migration values in 3%acetic acid and olive oil ranging from 9.0-28.2 mg/6 dm2; 14-day range-finding ratstudy; 90-day rat study; 2-generationreproduction study using rats; gene mutationassay in bacteria (negative); twochromosomal aberration assays in culturedmammalian cells (both negative); two genemutation assays in cultured mammalian cells(one negative and one positive); in vivoUDS assay (negative); metabolism study(rat); skin and eye irritation studies (onlysummaries available); sensitisation study.RIVM/ISS/TNO SDS, January 2000 =CS/PM/2966 REV.II/93760.Remark for Commission: since highmigration into fat has been demonstratedwith the exception of PET, it wasrecommended that the Commission take thenecessary measures so that the restrictionproposed is not exceeded.+ +http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf93810 000060-01-5 Tributyrin Same 57840 D +93840 000087-90-1 Trichlorocyanuric acid D +93870 000071-55-6 1,1,1-Trichloroethane D +93872 000079-00-5 1,1,2-Trichloroethane D +93900 000079-01-6 Trichloroethylene D +289

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT93920 000075-69-4 Trichlorofluoromethane 7 Needed: migration data and specifications. +93930 003380-34-5 2,4,4'-Trichloro-2'-hydroxydiphenyl ether3 Restriction: 5 mg/kg of foodRemark for Commission:- Migration could exceed 5 mg/kg of food- The use of this substance should not lead toa lowering of hygienic standards in foodhandling- The Fat (consumption) Reduction Factor isnot applicable despite log Po/w = 4.8,because migration in aqueous simulantsmaybe higher than 10 % of the SMLallocated to this substance,i.e. 5 ppm.- Concerning efficacy, none of the datasubmitted demonstrated whether there is asignificant effect on microbial numbersunder in-use conditions of triclosan and towhat extent the substance might contributeto reduce cross contamination.- The Panel noted that no data weresubmitted to demonstrate activity againstcommon food pathogens such asCampylobacter spp.http://www.efsa.eu.int/science/afc/afc_opinions/11/opinion_afc_07_en1.pdfhttp://europa.eu.int/comm/food/fs/sc/scf/out+93970 - Tricyclodecanedimethanolbis(hexahydrophthalate)94000 000102-71-6 Triethanolamine Same 25480and 2592294040 085665-45-8 Triethanolaminealkyl(C8-C14)sulphate94060 090583-18-9 Triethanolaminealkyl(C12-C14)sulphate94080 - Triethanolaminealkylsulphuric acids,salts94081 - Triethanolaminealkyl(C8-C22)sulphuric29062_en.pdf7 Under re-evaluation.http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf8 + +D +D +D +8 For alkyl(C8-C22)sulphuric acids, linear,primary, even numbered.++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTacids, linear, primary,even numbered and itssaltsL3. Toxicologically acceptable.Same references as for 34281.For triethanolamine.L8.94100 002717-15-9 Triethanolamine oleate 8 L8 for triethanolamine.+L1 for oleic acid.ADI : not specified.(SCF, 25th Series, 1990).94160 000122-51-0 Triethoxymethane Same 69900 8 +94240 000077-89-4 Triethyl acetylcitrate 8 + +94320 000112-27-6 Triethyleneglycol Same 25510 DIR 2 Group TDI: 5 mg/kg b.w. (with+ +polyethyleneglycol).94400 036443-68-2 Triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy -5-methylphenyl)propionate](SCF 17th Series, 1986).DIR SML = 9 mg/kg 2 SCF_list: 2TDI = 0.15 mg/kg b.w.See SCF evaluation in the website:http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf94480 026523-64-8 Trifluorotrichloroethane 7 Needed: migration data and specification. +94560 000122-20-3 Triisopropanolamine DIR SML = 5 mg/kg 3 R: 5 mg/kg of food.Available: migration, 3 negativemutagenicity tests, 90-day oral rat and dogstudies.(CS/PM/2324).Hydrophilic so no data on bioaccumulationrequired.+94640 - 1,3,5-Triisopropylbenzene-2,4-polycarbodiimide94720 068515-60-6 Trimellitic acid,trialkyl(C7-C9) ester94800 003319-31-1 Trimellitic acid, tris(2-ethylhexyl) ester2918 +W9 Group R: 0.05 mg/kg bw. +W6B Group R: 0.05 mg/kg b.w.Available: Ames test and indication ofperoxisome proliferation.Needed: peroxisome proliferation study andtests for gene mutation and chromosome+ ++

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTaberrations in mammalian cells in vitro.94880 000067-48-1 Trimethylethanolammoni Same 25570 8 +um chloride94960 000077-99-6 1,1,1-TrimethylolpropaneDIR SML = 6 mg/kg 2 TDI = 0.1 mg/kg b.w.(SCF, 17th Series, 1986).+ +95000 028931-67-1 Trimethylolpropanetrimethacrylate-methylmethacrylate copolymerSame 13380,25600 and39560DIR 3 Toxicologically acceptable.Available : data on use; data on residualmonomers and the fraction with molecularmass < 1000 D.Remark: the two monomers (startingsubstances) have been evaluated by the SCFin the past and classified in list 2 and list 3,respectively. The two monomers are:? Methyl methacrylate (REF_N. 21130); list2 with a group t-TDI = 0.1 mg/kg b.w. (asmethacrylic acid) (Reference: ScientificCommittee for Food 42nd series of reportsof the SCF, 2000)? Trimethylolpropane trimethacrylate(REF_N. 25840); list 3 with a restriction of0.05 mg/kg of food. (Reference: Opinion ofthe Scientific Committee on Food on the16th additional list of monomers andadditives for food contact materials, adoptedby the SCF on 13/12/2001)RIVM/DE SDS, April 2001 = CS/PM/3324REV. I/95000.(Adopted at the 131st SCF meeting, 27February 2002)http://europa.eu.int/comm/food/fs/sc/scf/out124_en.pdf95040 001462-84-6 2,3,6-Trimethylpyridine 8 +95120 000108-75-8 2,4,6-Trimethylpyridine 8 +95200 001709-70-2 1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzeneDIR 2 t-TDI: 1 mg/kg b.w. pending check of thereports.2-year oral studies in rats and dogs and oralcarcinogenicity studies in mice and rats.(Shell reports n. TLGR 0023.68. March292++ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT1969, TLGR. 0024.68, Sept. 1968, TLGR.0019.69, March 1969).95260 000139-45-7 Tripropionin Same 58080 D +95265 227099-60-7 1,3,5-Tris(4-benzoylphenyl) benzene95270 161717-32-4 2,4,6-Tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediolphosphite95280 040601-76-1 1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione95360 027676-62-6 1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione95400 000090-72-2 2,4,6-Tris[(dimethylamino)methyl]phenol95440 000144-15-0 Tris(2-ethylhexyl)acetylcitrate95520 068958-97-4 1,1,3-Tris(2-methyl-4-ditridecyl phosphite-5-3AM 3 Restriction: 0.05 mg/kg foodhttp://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdfhttp://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdfDIRSML = 2 mg/kg (assum of phosphite,phosphate and thehydrolysis product =TTBP)3 R = 2 mg/kg food (sum of phosphite,phosphate and the hydrolysis product(TTBP))Remark for Commission: in aqueous foodsimulants to be measured as 2,4,6-tri-tertbutylphenol.(Adopted at the 119th SCF meeting) (2December 1999)http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdfDIR SML = 6 mg/kg 2 t-TDI: 0.1 mg/kg b.w.Available: 90-day oral rat and dog studies.(RIVM document, June 1989).Needed: mutagenicity and migration data,impurities to be specified.DIR SML = 5 mg/kg 3 R: 5 mg/kg of foodAvailable: 3-month oral rat study,mutagenicity studies negative, migrationdata.(RIVM doc. February 1992).++++ +Same 25915 8 +8 Group R: 0.05 mg/kg b.w.Needed: toxicological data depending onmigration level (see SCF guidelines) and, ifmigration exceeds 0.050 mg/kg, peroxisomeproliferation studies too.+8 +293

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTtert-butylphenyl) butane95600 001843-03-4 1,1,3-Tris(2-methyl-4-hydroxy-5-tertbutylphenyl)butaneDIR SML = 5 mg/kg 3 R: 5 mg/kg of foodAvailable: adequate migration data (SM0.003-1.8 mg/dm2); log Po/w; acute toxicitydata; inadequate 90-day oral dog study;inadequate 12-week oral rat study; 13-weekoral rat study; gene mutation assay inbacteria (negative); chromosomal aberrationassay in cultured mammalian cells(negative); gene mutation assay in culturedmammalian cells (negative); excretionstudies.(RIVM/TNO SDS, April 1999 =CS/PM/2905 REV. I/95600).(Adopted at the 118th SCF meeting) (23September 1999)http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf95630 000057-13-6 Urea Same 25960 D + +95645 - Urea resins D +95680 000121-33-5 Vanillin 1 ADI: 10 mg/kg b.w.+(JECFA 11 M., 1967).95695 008009-03-8 Vaseline Same 72060D +and 7206295710 - Vegetable oils, from3 Food fats or similar to food fats. +food sources,hydrogenated or not95720 - Vegetable oils, inedible D +95725 110638-71-6 Vermiculite, reaction Same 44300 DIR SML(T) = 0.6 mg/kg 2 Group TDI = 0.01 mg/kg b.w. as Li (see +product with citric acid,lithium salt(8) (expressed asLithium)references for 38000).Available: Migration data, 28-day oral ratstudy, Ames test, in vivo micronucleus test.No further data needed in view of its mineralnature.(RIVM SDS CS/PM/2423).95726 025213-24-5 Vinyl acetate-vinylW +alcohol, copolymer95728 025086-48-0 Vinyl acetate-vinylalcohol, vinyl chloride,W +294+

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTcopolymer95730 009003-22-9 Vinyl acetate-vinylD + +chloride, copolymer95735 009005-09-8 Vinyl acetate-vinylW +chloride-maleic acid,copolymer95740 - Vinyl acetate-vinyl9 +chloride-vinylpropionate, copolymer95755 025086-89-9 Vinyl acetatevinylpyrrolidone,9 +copolymers95760 see 95880 D + +95761 see 95881 D + +95762 see 95882 D +95770 - Vinyl chloride-vinyl9 +esters of sat., aliph.,monocarb., acids (C2-C18),copolymers95780 025853-89-8 Vinyl chloride-vinyl9 +propionate, copolymer95800 - Vinylidene chloride9 +copolymers95810 000088-12-0 Vinylpyrrolidone Same 26230 4A Same references as 26230+http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf95820 - Vinylpyrrolidonemethacrylic9 +acid, esterswith alcoholsaliph.,monoh.,sat.(C1-C18), copolymers95830 - Vinylpyrrolidone-vinyl9 +acetate and/or vinylpropionate, copolymers95835 003039-83-6 Vinylsulphonic acid,W +sodium salt95840 see 95905 D +95855 007732-18-5 Water Same 26360 DIR In compliance with the 0 Specification: Impurity levels not to exceed + +295

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CT95857 - Waxes=mineralhydrocarbons (only fordocuments allocation)95859 - Waxes, refined, derivedfrom petroleum based orsynthetic hydrocarbonfeedstocksDIRDirective 98/83/EC.In compliance with thespecifications laiddown in Annex V.296those set in the Drinking Water Directive.D +2 Group ADI = 20 mg/kg bw for waxesconforming to the following specification:Viscosity not less than 11 centiStokes at100°C;Carbon number not less than 25 at the 5%boiling point.Average molecular weight not less than 500.(SCF, 37th Series, 1997)+ +95860 - Waxes, natural D + +95870 - Wheat protein 0 +95880 008042-47-5 White mineral oil Same 95882 9 + +95881 - White mineral oil(hydrogenated)95882 008042-47-5 White mineral oil(conventional)95883 - White mineral oils,paraffinic, derived frompetroleum basedhydrocarbon feedstocksD + +Same 95880 D +DIRIn compliance with thespecifications laiddown in Annex V.2 Group ADI = 4 mg/kg bw for oilsconforming to the following specifications:Viscosity: not less than 8.5 centiStokes at100xC;Carbon number: not less than 25 at the 5%boiling point;Average molecular weight: not less than480.(SCF, 37th Series, 1997)+ +95890 008002-74-2 White soft paraffin D +95905 013983-17-0 Wollastonite DIR 3 Inert material. + +95920 - Wood flour and fibers,DIR 3 Inert material. +untreated95921 - Wood flour and fibers 9 Confirmed. +95935 011138-66-2 Xanthan gum DIR 1 ADI : not specified.+ +(JECFA, 30M., 1986).95945 001330-20-7 Xylene Same 26370 3 Group R: 0.02 mg/kg bw (with95947,95949,95951) based onallowing 1/10 of TDI for food contact+ +

REF_N CAS_N NAME SYNONIM DIRRESTRICTIONSANDSPECIFICATIONSSCFListEFSA/SCF_OP PL CTmaterials.2-year oral rat study, mutagenicity testnegative.(WHO draft, Geneva, September1952)(CS/PM/1712).95995 001318-02-1 Zeolites Ex 86427 W +95995/1 - Zeolite A, silver Same as+8643796000 - Zinc9 +alkylaryldithiocarbamate96080 - Zinc9 +dialkyldithiocarbamate96160 000136-23-2 Zinc8 +dibutyldithiocarbamate96180 - Zinc dust 2 Group TDI= 1 mg/kg b.w.(as Zn) based on+JECFA PMTDI= 1 mg/kg b.w. (asZn)(JECFA, 26M, 1982).96190 020427-58-1 Zinc hydroxide DIR 2 Same as for 96180. + +96200 055799-16-1 Zinc hydroxyphosphite 2-3 L2 for ZnFor Zinc the same reference as for 96180.+L3 for phosphite.Phosphite easily oxidised to phosphate.96220 000557-09-5 Zinc octanoate D + +96240 001314-13-2 Zinc oxide DIR 2 Same as for 96180. + +96280 009010-69-9 Zinc salt of resinic acids Same 83880 D +96320 001314-98-3 Zinc sulphide DIR 2 Same as for 96180. + +96400 053801-45-9 Zirconium oxide 7 L7 for zirconium.+See references for 54220.****** THE END ******297