food contact materials - European Commission - Europa

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NOTE FOR READER1. The Annex I of this document collects in a consolidated list all monomers as well asadditives of Sections A and B appearing in the EC Directives on plastics for foodapplications i.e. in the Directive 2002/72/EC (O.J. L 220 of 18.8.2002, p. 193) and itsamendments 2004/1/EC (OJ L 7 of 13.1.2004, p. 45), 2004/19/EC (O.J. L 71 of10.03.2004, p 247), 2005/79/EC (OJ L 302 of 19.11.2005, p.35), 2007/19/EC (OJ L97of 12.04.07, p. 50-69), 2008/39/EC (OJ L 63 of 07/03/2008, p. 6-13) and (EC) No975/2009 (OJ L 274/3 of 20/10/2009).2. This document should be considered as a working document for information only andnot as a legal or binding document. If you notice mistakes, please inform Ms. FriedleVanhee (friedle.vanhee(a)ec.europa.eu).3. The substances not included in this document are not necessarily forbidden. In factthey may be used in plastics not yet regulated at EU level (plastics excluded from thefield of application of Directive 2002/72/EC) or they may be authorised as additive atnational level until 1 January 2010, when the list of additives becomes a positive list.4. Directive 2008/39/EC amending Directive 2002/72/EC on plastics establishes that theCommunity list of additives to be used in plastic food contact materials becomes apositive list on 1 January 2010, meaning that after this date only those additives listedwill be permitted for the manufacture of plastics. However, substances on theprovisional list may continue to be used subject to national law after 1 January 2010until a decision is taken on their possible inclusion in the positive list of additives.This provisional list includes all additives that are under evaluation by EFSA and forwhich a petition was submitted until December 2006 in accordance with therequirements set in Article 4a. Directive 2008/39/EC also clarifies the criteria forremoval of an additive from the provisional list. You can find the provisional list inthe Europa website:http://ec.europa.eu/food/food/chemicalsafety/foodcontact/documents_en.htm5. Specifications on the substances are in the Annex II.6. For plastic food contact materials an overall migration limit of 60 mg/kg food or foodsimulant exists.7. For verification of compliance with migration limits rules are laid down in Directives82/711/EEC, 85/572/EEC, 93/8/EEC and 97/48/EC.8. Vinyl chloride is authorised as monomer in Directive 78/142/EEC with a maximumresidual level of 1 mg/kg in the final product. Migration into food should not bedetectable with a detection limit of 0.01 mg/kg food.2 of 41

ANNEX IRef. No CAS No Name Restrictions and/orspecifications(1) (2) (3) (4)MONOMERS10030 000514-10-3 Abietic acid10060 000075-07-0 Acetaldehyde SML(T) = 6 mg/kg (2)10090 000064-19-7 Acetic acid10120 000108-05-4 Acetic acid, vinyl ester SML = 12 mg/kg10150 000108-24-7 Acetic anhydride10210 000074-86-2 Acetylene10599/90A 061788-89-4 Acids, fatty, unsaturated (C18), dimers, QMA(T) = 0.05 mg/6 dm² (27)distilled10599/91 061788-89-4 Acids, fatty, unsaturated (C18), dimers, non QMA(T) = 0.05 mg/6 dm² (27)distilled10599/92A 068783-41-5 Acids, fatty, unsaturated (C18), dimers, QMA(T) = 0.05 mg/6 dm² (27)hydrogenated, distilled10599/93 068783-41-5 Acids, fatty, unsaturated (C18), dimers, QMA(T) = 0.05 mg/6 dm² (27)hydrogenated, non distilled10630 000079-06-1 Acrylamide SML = ND (DL = 0.01 mg/kg)10660 015214-89-8 2-Acrylamido-2-methylpropanesulphonic acid SML = 0.05 mg/kg10690 000079-10-7 Acrylic acid SML(T) = 6 mg/kg (36)10750 002495-35-4 Acrylic acid, benzyl ester SML(T) = 6 mg/kg (36)10780 000141-32-2 Acrylic acid, n-butyl ester SML(T) = 6 mg/kg (36)10810 002998-08-5 Acrylic acid, sec-butyl ester SML(T) = 6 mg/kg (36)10840 001663-39-4 Acrylic acid, tert-butyl ester SML(T) = 6 mg/kg (36)11005 012542-30-2 Acrylic acid, dicyclopentenyl ester QMA = 0.05 mg/6 dm²11245 002156-97-0 Acrylic acid, dodecyl ester SML = 0.05 mg/kg (1)11470 000140-88-5 Acrylic acid, ethyl ester SML(T) = 6 mg/kg (36)11500 000103-11-7 Acrylic acid, 2-ethylhexyl ester SML = 0.05 mg/kg11510 000818-61-1 Acrylic acid, hydroxyethyl ester See "Acrylic acid, monoesterwith ethyleneglycol"11530 000999-61-1 Acrylic acid, 2-hydroxypropyl ester QMA = 0.05 mg/6 dm² for thesum of acrylic acid, 2-hydroxypropyl ester and acrylicacid, 2-hydroxyisoprpyl esterand in compliance with thespecifications laid down inAnnex V.11590 000106-63-8 Acrylic acid, isobutyl ester SML(T) = 6 mg/kg (36)11680 000689-12-3 Acrylic acid, isopropyl ester SML(T) = 6 mg/kg (36)11710 000096-33-3 Acrylic acid, methyl ester SML(T) = 6 mg/kg (36)11830 000818-61-1 Acrylic acid, monoester with ethyleneglycol SML(T) = 6 mg/kg (36)11890 002499-59-4 Acrylic acid, n-octyl ester SML(T) = 6 mg/kg (36)11980 000925-60-0 Acrylic acid, propyl ester SML(T) = 6 mg/kg (36)12100 000107-13-1 Acrylonitrile SML = ND (DL =0.020 mg/kg,analytical tolerance included)12130 000124-04-9 Adipic acid12265 004074-90-2 Adipic acid, divinyl ester QM = 5 mg/kg in FP. For useonly as co-monomer.12280 002035-75-8 Adipic anhydride12310 - Albumin12340 - Albumin, coagulated by formaldehyde12375 - Alcohols, aliphatic, monohydric, saturated,linear, primary (C4-C22)3 of 41

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