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Draft Commission Regulation on ceramic materials and

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EUROPEAN COMMISSION<br />

Brussels, XXX<br />

[…](2012) XXX draft<br />

DRAFT - DRAFT<br />

COMMISSION REGULATION (EU) No …/..<br />

of XXX<br />

<strong>on</strong> <strong>ceramic</strong> <strong>materials</strong> <strong>and</strong> articles intended to come into c<strong>on</strong>tact with food<br />

DRAFT - DRAFT<br />

(Text with EEA relevance)<br />

EN<br />

EN


COMMISSION REGULATION (EU) No …/..<br />

of XXX<br />

<strong>on</strong> <strong>ceramic</strong> <strong>materials</strong> <strong>and</strong> articles intended to come into c<strong>on</strong>tact with food<br />

FIRST DRAFT - FIRST DRAFT<br />

(Text with EEA relevance)<br />

THE EUROPEAN COMMISSION,<br />

Having regard to the Treaty <strong>on</strong> the Functi<strong>on</strong>ing of the European Uni<strong>on</strong>,<br />

Having regard to <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC) No 1935/2004 of the European Parliament <strong>and</strong> of the<br />

Council of 27 October 2004 <strong>on</strong> <strong>materials</strong> <strong>and</strong> articles intended to come into c<strong>on</strong>tact with food<br />

<strong>and</strong> repealing Directives 80/590/EEC <strong>and</strong> 89/109/EEC 1 , <strong>and</strong> in particular Article 5(1) (e), (g),<br />

(h), (i), <strong>and</strong> (j) thereof,<br />

After c<strong>on</strong>sulting with the European Food Safety Authority,<br />

Whereas (not complete yet?):<br />

(1) <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC) No 1935/2004 lays down the general principles for eliminating the<br />

differences between the laws of the Member States as regards food c<strong>on</strong>tact <strong>materials</strong>.<br />

Article 5(1) of that <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> provides for the adopti<strong>on</strong> of specific measures for<br />

groups of <strong>materials</strong> <strong>and</strong> articles.<br />

(2) This <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> is a specific measure within the meaning of Article 5(1) of <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g><br />

(EC) No 1935/2004. This <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> should establish the specific rules for <strong>ceramic</strong><br />

<strong>materials</strong> <strong>and</strong> articles to be applied for their safe use <strong>and</strong> supersedes Council Directive<br />

84/500/EEC of 15 October 1984 <strong>on</strong> the approximati<strong>on</strong> of the laws of the Member<br />

States relating to <strong>ceramic</strong> articles intended to come into c<strong>on</strong>tact with foodstuffs 2 , <strong>and</strong><br />

amended by <str<strong>on</strong>g>Commissi<strong>on</strong></str<strong>on</strong>g> Directive 2005/31/EC of 29 April 2005 3 .<br />

(3) Directive 84/500/EEC sets out limits for the transfer of lead <strong>and</strong> cadmium from<br />

<strong>ceramic</strong> articles which are intended to come into c<strong>on</strong>tact with food. New scientific<br />

1<br />

2<br />

3<br />

OJ L 338, 13.11.2004, p. 4.<br />

OJ L 287, 20.10.1984, p. 12.<br />

OJ L 110, 30.4.2005, p. 36<br />

EN DRAFT 2 DRAFT EN


evidence published by the European Food Safety Authority shows that these limits<br />

need to be reduced 4,5 .<br />

(4) In the future scientific evidence may become available for other metals, requiring the<br />

additi<strong>on</strong> of further limits. The Directive does not establish a means for changing or<br />

adding such limits. In additi<strong>on</strong> other aspects of the Directive require changes <strong>and</strong><br />

updates for reas<strong>on</strong>s of clarity <strong>and</strong> c<strong>on</strong>sistency with other legislati<strong>on</strong> in the food c<strong>on</strong>tact<br />

<strong>materials</strong> sector, including the provisi<strong>on</strong>s laying down the testing rules, declarati<strong>on</strong> of<br />

compliance <strong>and</strong> supporting documentati<strong>on</strong>, <strong>and</strong> the overall structure. Therefore a new<br />

measure under Article 5(1) of <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC) No 1935/2004 is c<strong>on</strong>sidered the most<br />

appropriate.<br />

(5) In the past Directive 84/500/EEC <strong>and</strong> its amendment have been transposed into<br />

nati<strong>on</strong>al legislati<strong>on</strong> without any major adaptati<strong>on</strong>. For transpositi<strong>on</strong> into nati<strong>on</strong>al law<br />

usually a time period of 12 m<strong>on</strong>ths is necessary. Because due to the nature of this<br />

legislati<strong>on</strong> there is little room for adaptati<strong>on</strong> during transpositi<strong>on</strong> without affecting the<br />

single market, it seems appropriate to adopt rules <strong>on</strong> <strong>ceramic</strong> <strong>materials</strong> <strong>and</strong> articles in<br />

form of a <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> directly applicable in all Member States.<br />

(6) Final articles made of <strong>ceramic</strong> <strong>materials</strong> may be enamelled or glazed, <strong>and</strong> may be<br />

decorated. The <strong>ceramic</strong> material, the enamel or glazing, <strong>and</strong> the decorati<strong>on</strong> may all<br />

c<strong>on</strong>tribute to the migrati<strong>on</strong> of the c<strong>on</strong>stituents of the final article into food. These<br />

<strong>materials</strong> were c<strong>on</strong>sidered in the scope of Directive 84/500/EEC but without adequate<br />

definiti<strong>on</strong>s. For reas<strong>on</strong>s of clarity such definiti<strong>on</strong>s should be inserted.<br />

(7) Articles <strong>and</strong> <strong>materials</strong> in the scope of this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> may be produced from a large<br />

number of starting <strong>materials</strong>. From a health point of view the regulati<strong>on</strong> should allow<br />

to set specific migrati<strong>on</strong> limits for substances taking into account the foreseen use of<br />

the material. Therefore it is appropriate to add specific limits <strong>on</strong> the migrati<strong>on</strong> of<br />

certain substances or groups of substances from <strong>ceramic</strong> <strong>materials</strong> into or <strong>on</strong> to food<br />

that are c<strong>on</strong>sidered unsafe without such limits.<br />

(8) To ensure <strong>and</strong>/or to check compliance with the limits required by this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> or<br />

with Articles 3 <strong>and</strong> 4 of <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC) No 1935/2004, in some cases it may be<br />

needed to either complement or replace a limit <strong>on</strong> a substance with specific rules. Such<br />

rules may include specific labelling requirements, requirements for the declarati<strong>on</strong> of<br />

compliance or supporting documentati<strong>on</strong> <strong>and</strong> specific rules <strong>and</strong> derogati<strong>on</strong>s applicable<br />

to <strong>ceramic</strong> articles or <strong>materials</strong> in stock after entry into force of a limit or for antiques.<br />

For this purpose it should be possible to specify restricti<strong>on</strong>s other than migrati<strong>on</strong> limits<br />

for substances possibly migrating from <strong>materials</strong> <strong>and</strong> articles in the scope of this<br />

<str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g>.<br />

(9) The specific migrati<strong>on</strong> limit is a maximum permitted amount of a substance in food.<br />

This limit should ensure that the food c<strong>on</strong>tact material does not pose a risk to health. It<br />

should be ensured by the manufacturer that <strong>materials</strong> <strong>and</strong> articles in the scope of this<br />

<str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> will respect these limits when brought into c<strong>on</strong>tact with food under the<br />

4<br />

5<br />

EFSA Panel <strong>on</strong> C<strong>on</strong>taminants in the Food Chain (CONTAM); Scientific Opini<strong>on</strong> <strong>on</strong> cadmium in food.<br />

The EFSA Journal (2009) 980, 1-139<br />

EFSA Journal 2010; 8(4):1570 [147 pp.].<br />

EN DRAFT 3 DRAFT EN


worst foreseeable c<strong>on</strong>tact c<strong>on</strong>diti<strong>on</strong>s. Given that the size <strong>and</strong> shape of the final <strong>ceramic</strong><br />

articles <strong>and</strong> <strong>materials</strong> is known, migrati<strong>on</strong> shall be determined using the size <strong>and</strong> shape<br />

of the final article.<br />

(10) Parts of final articles in the scope of this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> may come into direct c<strong>on</strong>tact with<br />

the mouth. From such parts, notably from the rim of cups, exposure is different due to<br />

oral c<strong>on</strong>tact <strong>and</strong> has to be tested therefore in a different way. In additi<strong>on</strong> these parts<br />

may be made out of different <strong>materials</strong> than the rest of the article. Specific procedures<br />

<strong>and</strong> limits for these parts are therefore required to protect human health against<br />

hazards arising from oral c<strong>on</strong>tact with such articles.<br />

(11) Article 16(1) of <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC) No 1935/2004 provides that <strong>materials</strong> <strong>and</strong> articles<br />

covered by specific measures be accompanied by a written declarati<strong>on</strong> of compliance<br />

stating that they comply with the rules applicable to them. To strengthen the<br />

coordinati<strong>on</strong> <strong>and</strong> resp<strong>on</strong>sibility of the suppliers at each stage of manufacture, including<br />

that of the starting substances, the resp<strong>on</strong>sible pers<strong>on</strong>s should document the<br />

compliance with the relevant rules in a declarati<strong>on</strong> of compliance which is made<br />

available to their customers.<br />

(12) Article 17(1) of <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC) No 178/2002 of the European Parliament <strong>and</strong> of the<br />

Council of 28 January 2002 laying down the general principles <strong>and</strong> requirements of<br />

food law, establishing the European Food Safety Authority <strong>and</strong> laying down<br />

procedures in matters of food safety 6 requires the food business operator to verify that<br />

foods are compliant with the rules applicable to them. To this end <strong>and</strong> subject to the<br />

requirement of c<strong>on</strong>fidentiality, food business operators should be given access to the<br />

relevant informati<strong>on</strong> to enable them to ensure that the migrati<strong>on</strong> from the <strong>materials</strong> <strong>and</strong><br />

articles to food complies with the specificati<strong>on</strong>s <strong>and</strong> restricti<strong>on</strong>s laid down in food<br />

legislati<strong>on</strong>.<br />

(13) Competent authorities should be able to c<strong>on</strong>sult compliance informati<strong>on</strong> at the retail<br />

stage for c<strong>on</strong>trol <strong>and</strong> traceability purposes. Food business operators, notably<br />

restaurants, may procure final <strong>ceramic</strong> <strong>materials</strong> <strong>and</strong> articles at the retail stage <strong>and</strong><br />

require compliance informati<strong>on</strong> to fulfil their legal obligati<strong>on</strong>s. Therefore it appears<br />

appropriate to provide the declarati<strong>on</strong> of compliance also with the final <strong>materials</strong> <strong>and</strong><br />

articles at the retail stage.<br />

(14) At each stage of manufacture, sales <strong>and</strong> retail, supporting documentati<strong>on</strong>,<br />

substantiating the declarati<strong>on</strong> of compliance, should be kept available for the<br />

competent authorities. Such dem<strong>on</strong>strati<strong>on</strong> of compliance may be based <strong>on</strong> migrati<strong>on</strong><br />

testing or bring forward other grounds which would justify compliance. Therefore<br />

compliance of <strong>materials</strong> <strong>and</strong> articles in the scope of this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> should be assessed<br />

<strong>and</strong> the rules for this testing should be set out. Test results or other forms of<br />

justificati<strong>on</strong> should be regarded as valid as l<strong>on</strong>g as formulati<strong>on</strong>s <strong>and</strong> processing<br />

c<strong>on</strong>diti<strong>on</strong>s remain c<strong>on</strong>stant as assured by a quality assurance system.<br />

(15) Importers may need to protect their commercial interests when importing from outside<br />

the Uni<strong>on</strong>. Therefore they may omit the names of the manufacturers of a material or<br />

article from the declarati<strong>on</strong> of compliance. However to ensure traceability informati<strong>on</strong><br />

6<br />

OJ L 31, 1.2.2002, p. 1.<br />

EN DRAFT 4 DRAFT EN


identifying the manufacturers outside the Uni<strong>on</strong> should be available to the competent<br />

authorities in the supporting documentati<strong>on</strong>.<br />

(16) As migrati<strong>on</strong> testing is complex, costly <strong>and</strong> time c<strong>on</strong>suming it should be admissible<br />

that compliance can be dem<strong>on</strong>strated also by ensuring by other means than migrati<strong>on</strong><br />

testing that regulated substances are not migrating above the permitted limits set out in<br />

this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g>. Such dem<strong>on</strong>strati<strong>on</strong> should be adequately justified in supporting<br />

documentati<strong>on</strong>, <strong>and</strong> c<strong>on</strong>trolled by manufacturing practices. It should be limited to<br />

dem<strong>on</strong>strating that food or mouth c<strong>on</strong>tact surfaces are either free of restricted<br />

substances because they were not present in the starting or intermediate <strong>materials</strong> used<br />

in the manufacturing of the final articles or <strong>materials</strong>, or by the use of manufacturing<br />

c<strong>on</strong>diti<strong>on</strong>s or techniques preventing their migrati<strong>on</strong>. The supporting documentati<strong>on</strong><br />

provided with starting or intermediate <strong>materials</strong> should therefore either substantiate<br />

that regulated substances are not present in these <strong>materials</strong> or articles, or provide<br />

instructi<strong>on</strong>s for further processing which ensure compliance. Even if testing by<br />

business operators is omitted <strong>on</strong> these grounds, competent authorities should not be<br />

prevented to carry out migrati<strong>on</strong> testing for c<strong>on</strong>trol <strong>and</strong> enforcement purposes.<br />

(17) The updated rules <strong>on</strong> food simulants <strong>and</strong> migrati<strong>on</strong> testing provided by this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g><br />

will supersede those in Directive 84/500/EC.<br />

(18) Certain specific migrati<strong>on</strong> limits <strong>and</strong> migrati<strong>on</strong> testing rules are updated in view of<br />

new scientific knowledge. Enforcement authorities <strong>and</strong> industry need to adapt their<br />

current testing <strong>and</strong> producti<strong>on</strong> regime to these updated limits <strong>and</strong> rules. To allow for<br />

this adaptati<strong>on</strong> it is necessary to provide for a transiti<strong>on</strong>al period of x years from the<br />

date of entry into force of this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g>.<br />

(19) The measures provided for in this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> are in accordance with the opini<strong>on</strong> of the<br />

Committee <strong>on</strong> the Food Chain <strong>and</strong> Animal Health <strong>and</strong> neither the European Parliament<br />

nor the Council has opposed them,<br />

HAS ADOPTED THIS REGULATION:<br />

Chapter I<br />

GENERAL PROVISIONS<br />

Article 1<br />

Subject matter<br />

1. This <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> is a specific measure within the meaning of Article 5 of <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g><br />

(EC) No 1935/2004.<br />

2. This <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> establishes specific requirements for the manufacture <strong>and</strong> marketing<br />

of <strong>ceramic</strong> <strong>materials</strong> <strong>and</strong> articles:<br />

(a)<br />

(b)<br />

(c)<br />

intended to come into c<strong>on</strong>tact with food; or<br />

already in c<strong>on</strong>tact with food; or<br />

which can reas<strong>on</strong>ably be expected to come into c<strong>on</strong>tact with food.<br />

EN DRAFT 5 DRAFT EN


Article 2<br />

Scope<br />

This <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> shall apply to <strong>materials</strong> <strong>and</strong> articles which are placed <strong>on</strong> the EU market <strong>and</strong><br />

fall under the following categories:<br />

(a)<br />

(b)<br />

<strong>materials</strong> <strong>and</strong> articles or parts thereof c<strong>on</strong>sisting exclusively of <strong>ceramic</strong> <strong>materials</strong><br />

<strong>materials</strong> <strong>and</strong> articles or parts thereof c<strong>on</strong>sisting of <strong>ceramic</strong> <strong>materials</strong>, but which are<br />

glazed, enamelled <strong>and</strong>/or decorated.<br />

Article 3<br />

Definiti<strong>on</strong>s<br />

For the purposes of this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g>, the relevant definiti<strong>on</strong>s laid down in Article 2 of<br />

<str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC) No 1935/2004 <strong>and</strong> in Article 2 of <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC) No 882/2004 shall apply.<br />

The following definiti<strong>on</strong>s shall also apply:<br />

(1) 'Ceramic <strong>materials</strong>' means <strong>materials</strong> manufactured from a mixture of inorganic<br />

<strong>materials</strong> with a generally high argillaceous or silicate c<strong>on</strong>tent to which small<br />

quantities of organic <strong>materials</strong> may have been added. These articles are first shaped<br />

<strong>and</strong> the shape thus obtained is permanently fixed by firing;<br />

(2) 'enamel' means an opaque vitreous coating directly fused <strong>on</strong> <strong>ceramic</strong> <strong>materials</strong> to<br />

decorate, strengthen, protect or waterproof the material;<br />

(3) 'glazing' means a vitreous coating of coloured, opaque, or transparent material fused<br />

over <strong>on</strong>e or more decorative or other layers or directly to the <strong>ceramic</strong> material, to<br />

decorate, strengthen, protect or waterproof it;<br />

(4) 'decorati<strong>on</strong>' means any material applied to enhance the attractiveness of a material or<br />

article by printing, painting or any other technique;<br />

(5) 'Specific Migrati<strong>on</strong> Limit' (SML) means the maximum permitted amount of a given<br />

substance released from a material or article into food simulants or into food;<br />

(6) 'food simulant' means a test medium imitating food; in its behaviour the food<br />

simulant mimics migrati<strong>on</strong> from food c<strong>on</strong>tact <strong>materials</strong>;<br />

(7) 'n<strong>on</strong>-intenti<strong>on</strong>ally added substance' means an impurity in the substances used or a<br />

reacti<strong>on</strong> intermediate formed during the producti<strong>on</strong> process or a decompositi<strong>on</strong> or<br />

reacti<strong>on</strong> product;<br />

(8) 'restricti<strong>on</strong>' means limitati<strong>on</strong> of use of a substance or migrati<strong>on</strong> limit or limit of<br />

c<strong>on</strong>tent of the substance in the material or article;<br />

(9) 'specificati<strong>on</strong>' means compositi<strong>on</strong> of a substance, purity criteria for a substance,<br />

physico-chemical characteristics of a substance, details c<strong>on</strong>cerning the<br />

manufacturing process of a substance or further informati<strong>on</strong> c<strong>on</strong>cerning the<br />

expressi<strong>on</strong> or determinati<strong>on</strong> of migrati<strong>on</strong> limits;<br />

EN DRAFT 6 DRAFT EN


(10) 'final material or article' means a material or article that will not be modified by any<br />

further manufacturing stages, <strong>and</strong> which has attained its final form, shape <strong>and</strong><br />

compositi<strong>on</strong> in which it will be used by the end user.<br />

Article 4<br />

Placing <strong>on</strong> the market of <strong>ceramic</strong> <strong>materials</strong> <strong>and</strong> articles<br />

Ceramic <strong>materials</strong> <strong>and</strong> articles may <strong>on</strong>ly be placed <strong>on</strong> the market if they:<br />

(a)<br />

(b)<br />

(c)<br />

(d)<br />

(e)<br />

comply with the relevant requirements set out in Article 3 of <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC)<br />

No 1935/2004 under intended <strong>and</strong> foreseeable use; <strong>and</strong><br />

comply with the labelling requirements set out in Article 15 of <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC)<br />

No 1935/2004; <strong>and</strong><br />

comply with the traceability requirements set out in Article 17 of <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC)<br />

No 1935/2004; <strong>and</strong><br />

are manufactured according to good manufacturing practice as set out in <str<strong>on</strong>g>Commissi<strong>on</strong></str<strong>on</strong>g><br />

<str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC) No 2023/2006 7 ; <strong>and</strong><br />

comply with the compositi<strong>on</strong>al <strong>and</strong> declarati<strong>on</strong> requirements set out in Chapters II<br />

<strong>and</strong> III of this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g>.<br />

Chapter II<br />

COMPOSITIONAL REQUIREMENTS<br />

Article 5<br />

General requirement <strong>on</strong> substances<br />

Substances used in the manufacture of <strong>ceramic</strong> <strong>materials</strong> <strong>and</strong> articles shall be:<br />

(a)<br />

(b)<br />

(c)<br />

of a technical quality <strong>and</strong> a purity suitable for the intended <strong>and</strong> foreseeable use of the<br />

<strong>materials</strong> or articles;<br />

manufactured according to good manufacturing practice as set out in <str<strong>on</strong>g>Commissi<strong>on</strong></str<strong>on</strong>g><br />

<str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC) No 2023/2006;<br />

of a compositi<strong>on</strong> known to the manufacturer of the substance <strong>and</strong> made available to<br />

the competent authorities <strong>on</strong> request.<br />

7<br />

OJ L 384, 29.12.2006, p. 75.<br />

EN DRAFT 7 DRAFT EN


Article 6<br />

Specific requirement <strong>on</strong> substances<br />

Substances used in the manufacture of <strong>ceramic</strong> <strong>materials</strong> <strong>and</strong> articles, whether intenti<strong>on</strong>ally or<br />

n<strong>on</strong>-intenti<strong>on</strong>ally added substances, shall be subject to the specific migrati<strong>on</strong> limit set out in<br />

Article 8.<br />

Article 7<br />

Restricted Substances<br />

Substances included in the Uni<strong>on</strong> list of restricted substances (hereinafter referred to as 'the<br />

Uni<strong>on</strong> list') set out in Annex I may <strong>on</strong>ly be used for the manufacture of <strong>ceramic</strong> <strong>materials</strong><br />

subject to the restricti<strong>on</strong>s <strong>and</strong> specificati<strong>on</strong>s set out in the Uni<strong>on</strong> list.<br />

Article 8<br />

Specific Migrati<strong>on</strong> Limits<br />

1. Final <strong>ceramic</strong> <strong>materials</strong> <strong>and</strong> articles included <strong>on</strong> the Uni<strong>on</strong> List shall not transfer<br />

substances to foods in quantities exceeding the specific migrati<strong>on</strong> limits (SML) set<br />

out in column 3, 4 or 5 of the Uni<strong>on</strong> list for its respective category as set out in<br />

paragraph 2.<br />

For the purpose of migrati<strong>on</strong> testing, substances or groups of substances shall be<br />

expressed as specified in column 2 of the Uni<strong>on</strong> List.<br />

2. The following three categories are established:<br />

– Category I:<br />

Articles or <strong>materials</strong> which cannot be filled <strong>and</strong> articles which can be filled, the<br />

internal depth of which, measured from the lowest point to the horiz<strong>on</strong>tal plane<br />

passing through the upper rim, does not exceed 25 mm.<br />

– Category II:<br />

All other articles that can be filled <strong>and</strong> do not fall under category I or III.<br />

– Category III:<br />

Cooking ware; packaging <strong>and</strong> storage vessels having a capacity of more than<br />

three litres.<br />

3. In case of final <strong>materials</strong> or articles covered by Category I defined in the sec<strong>on</strong>d<br />

paragraph of this article, the SML shall be expressed in g/dm 2 . In all other cases it<br />

shall be expressed in g/litre.<br />

4. When a <strong>ceramic</strong> article c<strong>on</strong>sists of a c<strong>on</strong>tainer fitted with a <strong>ceramic</strong> lid, the SML<br />

which may not be exceeded (g/dm 2 or g/litre) shall be that which applies to the<br />

vessel al<strong>on</strong>e. The vessel al<strong>on</strong>e <strong>and</strong> the inner surface of the lid shall be tested<br />

separately <strong>and</strong> under the same c<strong>on</strong>diti<strong>on</strong>s. The sum of the two migrati<strong>on</strong> levels of the<br />

EN DRAFT 8 DRAFT EN


substance thus obtained shall be related as appropriate to the surface area or the<br />

volume of the vessel al<strong>on</strong>e.<br />

5. Whenever a specific part of the final article in its foreseeable use will come in<br />

c<strong>on</strong>tact with the mouth, this part shall not transfer its c<strong>on</strong>stituents in quantities<br />

exceeding the SML set out in column 6 of the Uni<strong>on</strong> List.<br />

Chapter III<br />

COMPLIANCE AND DOCUMENTATION<br />

Article 9<br />

Declarati<strong>on</strong> of compliance<br />

1. At all marketing stages up to <strong>and</strong> including the retail stage, a written declarati<strong>on</strong> in<br />

accordance with Article 16 of <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC)No 1935/2004 shall be available for<br />

<strong>ceramic</strong> <strong>materials</strong> <strong>and</strong> articles, products from intermediate stages of their<br />

manufacturing as well as for the substances intended for the manufacturing of those<br />

<strong>materials</strong> <strong>and</strong> articles.<br />

2. The written declarati<strong>on</strong> referred to in paragraph 1 shall be issued by the business<br />

operator <strong>and</strong> shall c<strong>on</strong>tain the informati<strong>on</strong> laid down in Annex II<br />

3. The written declarati<strong>on</strong> shall permit an easy identificati<strong>on</strong> of the <strong>materials</strong>, articles or<br />

products from intermediate stages of manufacture or substances for which it is<br />

issued. It shall be renewed when substantial changes in the compositi<strong>on</strong> or<br />

producti<strong>on</strong> occur that bring about changes in the migrati<strong>on</strong> from the <strong>materials</strong> or<br />

articles or when new scientific data becomes available.<br />

Article 10<br />

Supporting documents<br />

1. Appropriate documentati<strong>on</strong> to dem<strong>on</strong>strate that the final <strong>materials</strong> <strong>and</strong> articles,<br />

products from intermediate stages of their manufacturing, as well as the substances<br />

intended for the manufacturing of those <strong>materials</strong> <strong>and</strong> articles comply with the<br />

requirements of this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> shall be made available by the business operator to<br />

the competent authorities <strong>on</strong> request.<br />

2. That documentati<strong>on</strong> shall c<strong>on</strong>tain if relevant the c<strong>on</strong>diti<strong>on</strong>s <strong>and</strong> results of testing,<br />

calculati<strong>on</strong>s, including modelling, other analysis, <strong>and</strong> evidence <strong>on</strong> the safety or<br />

reas<strong>on</strong>ing dem<strong>on</strong>strating compliance in accordance with the rules for assessing<br />

compliance set out in Article 11, <strong>and</strong> if applicable, justificati<strong>on</strong> for omitting testing<br />

of compliance under Article 11(3).<br />

3. If a <strong>ceramic</strong> material or article is imported into the Uni<strong>on</strong> the supporting documents<br />

provided by the importer to the competent authorities shall c<strong>on</strong>tain the identity <strong>and</strong><br />

address of the company which has manufactured the <strong>ceramic</strong> material or article<br />

outside of the Uni<strong>on</strong>.<br />

EN DRAFT 9 DRAFT EN


Article 11<br />

Rules for assessing compliance with Migrati<strong>on</strong> Limits<br />

1. Compliance with the SML set out in Article 8(1) shall be tested following the<br />

procedure laid down in Annex IIIa for <strong>materials</strong> <strong>and</strong> articles<br />

2. Compliance with the SML set out in Article 8(5) shall be tested following the<br />

procedure laid down in Annex IIIb for <strong>materials</strong> <strong>and</strong> articles<br />

3. Testing of compliance can be omitted if<br />

(a)<br />

(b)<br />

(c)<br />

a test is to be carried out under paragraph 1 of this Article, but it is<br />

dem<strong>on</strong>strated by other means that n<strong>on</strong>e of the c<strong>on</strong>stituents used in <strong>materials</strong> <strong>on</strong><br />

the side or in the part of the article which in its foreseeable use will be in<br />

c<strong>on</strong>tact with food are included <strong>on</strong> the Uni<strong>on</strong> List; or<br />

a test is to be carried out under paragraph 2 of this Article, but it is<br />

dem<strong>on</strong>strated by other means that n<strong>on</strong>e of the c<strong>on</strong>stituents of a part of the final<br />

article that may in its foreseeable use come in c<strong>on</strong>tact with the mouth are<br />

included <strong>on</strong> the Uni<strong>on</strong> List; or<br />

a test is to be carried out under paragraph 1 or 2 of this Article, or tests are to<br />

be carried out under both these paragraphs, but it is dem<strong>on</strong>strated that the<br />

following c<strong>on</strong>diti<strong>on</strong>s are both satisfied;<br />

(1) the manufacturers of the intermediate <strong>materials</strong> with c<strong>on</strong>stituents which<br />

are included <strong>on</strong> the Uni<strong>on</strong> List provide detailed instructi<strong>on</strong>s describing<br />

c<strong>on</strong>diti<strong>on</strong>s of use <strong>and</strong> processing of these <strong>materials</strong>, which when followed<br />

by the manufacturer of the final material or article will ensure<br />

compliance with Article 8 of this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g>; such instructi<strong>on</strong>s may<br />

include but are not limited to firing c<strong>on</strong>diti<strong>on</strong>s, type of (over)glazing,<br />

maximum amounts <strong>and</strong> methods of applicati<strong>on</strong>, <strong>and</strong><br />

(2) the manufacturer of the final material or article follows the instructi<strong>on</strong>s<br />

provided by the suppliers of such <strong>materials</strong> <strong>and</strong> records the<br />

manufacturing c<strong>on</strong>diti<strong>on</strong>s in its supporting documentati<strong>on</strong> for each batch.<br />

Chapter IV<br />

FINAL PROVISIONS<br />

TBD (if needed)<br />

Article 12<br />

Transiti<strong>on</strong>al Provisi<strong>on</strong>s<br />

EN DRAFT 10 DRAFT EN


Article 13<br />

Entry into force <strong>and</strong> applicati<strong>on</strong><br />

This <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> shall enter into force <strong>on</strong> the 20th day following that of its publicati<strong>on</strong> in the<br />

Official Journal of the European Uni<strong>on</strong>.<br />

The limits in Annex I shall be applicable as from [date of the entry into force of this<br />

<str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> + x years] Until that date the limits set out in 84/500/EEC remain applicable.<br />

This <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> shall be binding in its entirety <strong>and</strong> directly applicable in the Member States in<br />

accordance with the Treaties.<br />

D<strong>on</strong>e at Brussels,<br />

For the <str<strong>on</strong>g>Commissi<strong>on</strong></str<strong>on</strong>g><br />

The President<br />

On behalf of the President<br />

[Positi<strong>on</strong>]<br />

EN DRAFT 11 DRAFT EN


ANNEX I<br />

UNION LIST OF RESTRICTED SUBSTANCES<br />

Table 1<br />

(1) (2) (3) (4) (5) (6) (7)<br />

Substance or<br />

substance group<br />

name<br />

Substances<br />

c<strong>on</strong>taining Lead<br />

Substances<br />

c<strong>on</strong>taining<br />

Cadmium<br />

Expressed as<br />

SML<br />

Cat. I<br />

(g/dm 2 )<br />

SML<br />

Cat. II<br />

(g/l)<br />

SML<br />

Cat. III<br />

(g/l)<br />

SML<br />

Rim<br />

(g/l)<br />

Lead (Pb) 2,0 10,0 3,8 ??<br />

Cadmium (Cd) 1,0 5,0 1,9 ??<br />

Additi<strong>on</strong>al<br />

restricti<strong>on</strong>s,<br />

specificati<strong>on</strong>s <strong>and</strong><br />

tests<br />

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ANNEX II<br />

DECLARATION OF COMPLIANCE<br />

The written declarati<strong>on</strong> referred to in Article 9 shall c<strong>on</strong>tain the following informati<strong>on</strong>:<br />

(1) the identity <strong>and</strong> address of the business operator issuing the declarati<strong>on</strong> of<br />

compliance;<br />

(2) the identity <strong>and</strong> address of the business operator located in the European Uni<strong>on</strong> or<br />

EEA which manufactures or imports the <strong>ceramic</strong> <strong>materials</strong> or articles or products or<br />

the <strong>materials</strong> or substances intended for the manufacuring of those;<br />

(3) the identity of the <strong>materials</strong>, the articles, or products or the <strong>materials</strong> or substances<br />

intended for the manufacuring of those;<br />

(4) the date of the declarati<strong>on</strong>;<br />

(5) adequate informati<strong>on</strong> relative to the substances listed in the Uni<strong>on</strong> list <strong>and</strong> to relevant<br />

restricti<strong>on</strong>s;<br />

(6) if applicable the c<strong>on</strong>firmati<strong>on</strong> that final <strong>ceramic</strong> <strong>materials</strong> or articles meet relevant<br />

requirements laid down in this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> <strong>and</strong> <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g> (EC) No 1935/2004;<br />

(7) if applicable c<strong>on</strong>firmati<strong>on</strong> that the final material or article complies with the SML set<br />

out in Article 8 <strong>and</strong> this is determined following the rules set out in Article 11. If<br />

testing is omitted, the ground shall be indicated making reference to subparagraph<br />

(a), (b), or (c) of Article 11(3) under which omitting is justified;<br />

(8) if applicable informati<strong>on</strong> relative to instructi<strong>on</strong>s, processing c<strong>on</strong>diti<strong>on</strong>s, or other<br />

specificati<strong>on</strong>s as referred to in Article 11(3)(c).<br />

EN DRAFT 13 DRAFT EN


ANNEX IIIa<br />

BASIC RULES FOR DETERMINING THE MIGRATION OF SUBSTANCES FROM<br />

CERAMIC ARTICLES AND MATERIALS<br />

1. BASIC RULES FOR DETERMINING THE MIGRATION OF SUBSTANCES<br />

1.1. General C<strong>on</strong>siderati<strong>on</strong>s<br />

The rules in this annex can be amended by testing specificati<strong>on</strong>s set out in column 7<br />

of Annex I of this <str<strong>on</strong>g>Regulati<strong>on</strong></str<strong>on</strong>g><br />

1.2. Test liquid (‘simulant’)<br />

1.3. Test c<strong>on</strong>diti<strong>on</strong>s<br />

4 % (v/v) acetic acid, in a freshly prepared aqueous soluti<strong>on</strong>.<br />

(a)<br />

(b)<br />

(c)<br />

Carry out the test at a temperature of 22 ± 2 °C for a durati<strong>on</strong> of 24 ± 0,5 hours.<br />

When the migrati<strong>on</strong> of lead is to be determined, cover the sample by an<br />

appropriate means of protecti<strong>on</strong> <strong>and</strong> expose it to the usual lighting c<strong>on</strong>diti<strong>on</strong>s<br />

in a laboratory.<br />

When the migrati<strong>on</strong> of cadmium or of lead <strong>and</strong> cadmium is to be determined,<br />

cover the sample so as to ensure that the surface to be tested is kept in total<br />

darkness.<br />

1.4. Filling<br />

1.4.1. Samples which can be filled<br />

Fill the article with a 4 % (v/v) acetic acid soluti<strong>on</strong> to a level no more than 1 mm<br />

from the overflow point; the distance is measured from the upper rim of the sample.<br />

Samples with a flat or slightly sloping rim should be filled so that the distance<br />

between the surface of the liquid <strong>and</strong> the overflow point is no more than 6 mm<br />

measured al<strong>on</strong>g the sloping rim.<br />

1.4.2. Samples which cannot be filled<br />

The surface of the sample which is not intended to come into c<strong>on</strong>tact with foodstuffs<br />

is first covered with a suitable protective layer able to resist the acti<strong>on</strong> of the 4 %<br />

(v/v) acetic acid soluti<strong>on</strong>. The sample is then immersed in a recipient c<strong>on</strong>taining a<br />

known volume of acetic acid soluti<strong>on</strong> in such a way that the surface intended to come<br />

into c<strong>on</strong>tact with foodstuffs is completely covered by the test liquid.<br />

1.5. Determinati<strong>on</strong> of the surface area<br />

The surface area of the articles in category 1 is equal to the surface area of the meniscus<br />

formed by the free liquid surface obtained by complying with the filling requirements set out<br />

in secti<strong>on</strong> 1.4 above.<br />

EN DRAFT 14 DRAFT EN


2. METHODS OF ANALYSIS FOR DETERMINATION OF SUBSTANCES<br />

This text is still specific to lead <strong>and</strong> cadmium; a soluti<strong>on</strong> is required to make it more<br />

general for instance through the use of tables.<br />

2.1. Object <strong>and</strong> field of applicati<strong>on</strong><br />

The method allows the specific migrati<strong>on</strong> of lead <strong>and</strong>/or cadmium to be determined.<br />

2.2. 2. Principle<br />

The determinati<strong>on</strong> of the specific migrati<strong>on</strong> of lead <strong>and</strong>/or cadmium is carried out by an<br />

instrumental method of analysis that fulfils the performance criteria of point 4.<br />

2.3. 3. Reagents<br />

– All reagents must be of analytical quality, unless otherwise specified.<br />

– Where reference is made to water, it shall always mean distilled water or water of<br />

equivalent quality.<br />

2.3.1. 4 % (v/v) acetic acid, in aqueous soluti<strong>on</strong><br />

Add 40 ml of glacial acetic acid to water <strong>and</strong> make up to 1 000 ml.<br />

2.3.2. Stock soluti<strong>on</strong>s<br />

Prepare stock soluti<strong>on</strong>s c<strong>on</strong>taining 1 000 mg/litre of lead <strong>and</strong> at least 500mg/litre of<br />

cadmium respectively in a 4 % acetic acid soluti<strong>on</strong>, as referred to in point 3.1.<br />

2.4. Performance criteria of the instrumental method of analysis<br />

2.4.1. The detecti<strong>on</strong> limit for lead <strong>and</strong> cadmium must be equal to or lower than:<br />

TBD<br />

2.4.2. The limit of quantificati<strong>on</strong> for lead <strong>and</strong> cadmium must be equal to or lower than:<br />

– TBD<br />

2.4.3. Recovery<br />

TBD<br />

2.4.4. Specificity<br />

The instrumental method of analysis used must be free from matrix <strong>and</strong> spectral<br />

interferences.<br />

EN DRAFT 15 DRAFT EN


2.5. Method<br />

2.5.1. Preparati<strong>on</strong> of the sample<br />

The sample must be clean <strong>and</strong> free from grease or other matter likely to affect the<br />

test. Wash the sample in a soluti<strong>on</strong> c<strong>on</strong>taining a household liquid detergent at a<br />

temperature of approximately 40 °C. Rinse the sample first in tap-water <strong>and</strong> then in<br />

distilled water or water of equivalent quality. Drain <strong>and</strong> dry so as to avoid any stain.<br />

The surface to be tested is not to be h<strong>and</strong>led after it has been cleaned.<br />

2.5.2. Determinati<strong>on</strong> of lead <strong>and</strong>/or cadmium<br />

– The sample thus prepared is tested under the c<strong>on</strong>diti<strong>on</strong>s laid down in Chapter 1<br />

of this Annex<br />

– Before taking the test soluti<strong>on</strong> for determining lead <strong>and</strong>/or cadmium,<br />

homogenise the c<strong>on</strong>tent of the sample by an appropriate method, which avoids<br />

any loss of soluti<strong>on</strong> or abrasi<strong>on</strong> of the surface being tested.<br />

– Carry out a blank test <strong>on</strong> the reagent used for each series of determinati<strong>on</strong>s.<br />

– Carry out determinati<strong>on</strong>s for lead <strong>and</strong>/or cadmium under appropriate<br />

c<strong>on</strong>diti<strong>on</strong>s.<br />

EN DRAFT 16 DRAFT EN


ANNEX IIIb<br />

BASIC RULES FOR DETERMINING THE MIGRATION OF SUBSTANCES FROM<br />

THE RIM OF CERAMIC ARTICLES<br />

TBD Based <strong>on</strong> ISO 6486<br />

EN DRAFT 17 DRAFT EN

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