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Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food Text with EEA relevance

Type Regulation

Publication 2011-01-15

Last updated 2026-07-14

State In force

Department European Commission

Source EUR-Lex

articles 24

Reform history JSON API

CHAPTER I GENERAL PROVISIONS

Article 1

Subject matter

This Regulation is a specific measure within the meaning of Article 5 of Regulation (EC) No 1935/2004.

This Regulation establishes specific requirements for the manufacture and marketing of plastic materials and articles:

(a) intended to come into contact with food; or

(b) already in contact with food; or

Article 2

Scope

This Regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories:

(a) materials and articles and parts thereof consisting exclusively of plastics;

(b) plastic multi-layer materials and articles held together by adhesives or by other means;

(d) plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials;

(e) plastic layers in multi-material multi-layer materials and articles.

This Regulation shall not apply to the following materials and articles which are placed on the EU market and are intended to be covered by other specific measures:

(a) ion exchange resins;

(b) rubber;

This Regulation shall be without prejudice to Union or national provisions applicable to substances that may be used in the manufacture of adhesives, coatings and printing inks and applied on or incorporated in plastic materials and articles.

Article 3

Definitions

For the purpose of this Regulation, the following definitions shall apply:

(1) ‘plastic materials and articles’ means:
(a) materials and articles referred to in points (a), (b) and (c) of Article 2(1); and
(b) plastic layers referred to in Article 2(1)(d) and (e);

(2) ‘plastic’ means polymer to which additives or other substances may have been added, which is capable of functioning as a main structural component of final materials and articles;

(3) ‘polymer’ means any macromolecular substance obtained by:
(a) a polymerisation process such as polyaddition or polycondensation, or by any other similar process of monomers and other starting substances; or
(b) chemical modification of natural or synthetic macromolecules; or
(c) microbial fermentation;

(4) ‘plastic multi-layer’ means a material or article composed of two or more layers of plastic;

(5) ‘multi-material multi-layer’ means a material or article composed of two or more layers of different types of materials, at least one of them a plastic layer;

(6) ‘monomer or other starting substance’ means:
(a) a substance undergoing any type of polymerisation process to manufacture polymers; or
(b) a natural or synthetic macromolecular substance used in the manufacture of modified macromolecules; or
(c) a substance used to modify existing natural or synthetic macromolecules;

(7) ‘additive’ means a substance which is intentionally added to the plastic to achieve a physical or chemical effect during processing of the plastic or in the final material or article and it is intended to be present in the final material or article, including substances in a solid state the surface of which becomes bonded to the polymers that constitute the plastic;

(8) ‘polymer production aid’ means any substance used to provide a suitable medium for polymer or plastic manufacturing; it may be present but is neither intended to be present in the final materials or articles nor has a physical or chemical effect in the final material or article;

(9) ‘non-intentionally added substance’ means an impurity in the substances used or a reaction intermediate formed during the production process or a decomposition or reaction product;

(10) ‘aid to polymerisation’ means a substance which initiates polymerisation and/or controls the formation of the macromolecular structure;

(11) ‘overall migration limit’ (OML) means the maximum permitted amount of non-volatile substances released from a material or article into food simulants;

(12) ‘food simulant’ means a test medium imitating food; in its behaviour the food simulant mimics migration from food contact materials;

(13) ‘specific migration limit’ (SML) means the maximum permitted amount of a given substance released from a material or article into food or food simulants;

(14) ‘total specific migration limit’ (SML(T)) means the maximum permitted sum of particular substances released in food or food simulants expressed as total of moiety of the substances indicated;

(15) ‘functional barrier’ means a barrier consisting of one or more layers of any type of material which ensures that the final material or article complies with Article 3 of Regulation (EC) No 1935/2004 and with the provisions of this Regulation;

(16) ‘non-fatty food’ means a food for which in migration testing only food simulants other than food simulants D1 or D2 are laid down in Table 2 of Annex III to this Regulation;

(17) ‘restriction’ means limitation of use of a substance or migration limit or limit of content of the substance in the material or article;

(18) ‘specification’ means composition of a substance, purity criteria for a substance, physico-chemical characteristics of a substance, details concerning the manufacturing process of a substance or further information concerning the expression of migration limits;

(19) ‘hot-fill’ means the filling of any article with a food with a temperature not exceeding 100 °C at the moment of filling, after which the food cools down to 50 °C or below within 60 minutes, or to 30 °C or below within 150 minutes.

(20) ‘reprocessing of plastic’ means the remelting, mixing, reacting or otherwise processing of plastic materials that result as a by-product from an intermediate or final manufacturing operation in the manufacture of plastic materials and articles, alone or combined with material originating from other manufacturing operations, by applying, if necessary, transfer and operations to make the use of these by-products possible again;

(21) ‘UVCB substance’ means a substance of unknown or variable composition, complex reaction products or a material of a biological or other natural origin.

Article 3a

High degree of purity

A substance used in the manufacture of plastic materials and articles shall be considered as having a high degree of purity where all of its constituents correspond to its identity, and it otherwise contains only a minor amount of non-intentionally added substances that individually fulfil one of the following conditions:

(i) they comply with the specifications or restrictions specified in the authorisation of the substance in Table 1 of Annex I, if any;

(ii) they have been subject to a risk assessment in accordance with Article 19 and considered compliant;

(iii) they have been subject to a toxicological assessment in accordance with the relevant guidance adopted by the Authority, which concludes that genotoxicity is ruled out, and that, on the basis of documented analysis concerning their foreseeable use, characteristics and fate during subsequent manufacturing stages, it can be reasonably assumed that none of the substances will be present in the final plastic material or article at a level that could give rise to a migration such as to their individual presence in food exceeding 0,05 mg/kg;

(iv) they have not been subject to an assessment specified in points (ii) or (iii), but to a risk assessment which concludes, on the basis of documented analysis concerning their foreseeable use, characteristics and fate during subsequent manufacturing stages, that it can be reasonably assumed that they cannot be present in the final plastic material or article at a level that could give rise to a migration into food such as to their individual presence in food exceeding 0,00015 mg/kg.

For the purpose of point (iii), the individual assessment of genotoxicity may be substituted with a group assessment of genotoxicity, if the assessed substances are chemically related and belong to the same or similar functional groups that could give rise to toxicity, or if the substances are obtained as a mixture representative for migration into food and this mixture is assessed through appropriate methods.

Article 4

Placing on the market of plastic materials and articles

Plastic materials and articles may only be placed on the market if they:

(a) comply with the relevant requirements set out in Article 3 of Regulation (EC) No 1935/2004 under intended and foreseeable use; and

(b) comply with the labelling requirements set out in Article 15 of Regulation (EC) No 1935/2004; and

(d) are manufactured according to good manufacturing practice as set out in Commission Regulation (EC) No 2023/2006 ([^E0001]); and

(e) comply with the compositional and declaration requirements set out in Chapters II, III and IV of this Regulation; and

(f) comply with Commission Regulation (EU) 2022/1616 ([^E0002]) if they fall within the scope of that Regulation.

CHAPTER II COMPOSITIONAL REQUIREMENTS

SECTION 1 Authorised substances

Article 5

Union list of authorised substances

Only the substances included in the Union list of authorised substances (hereinafter referred to as the Union list) set out in Annex I may be used in the manufacture of plastic materials and articles.

The Union list shall contain:

(a) monomers or other starting substances;

(b) additives excluding colorants;

(d) macromolecules obtained from microbial fermentation.

The Union list may be amended in accordance with the procedure established by Articles 8 to 12 of Regulation (EC) No 1935/2004.

In case of doubt over the resulting designated identity of a substance, a Member State or the Commission may consult the Authority.

Article 6

Derogations for substances not included in the Union list

By way of derogation from Article 5, substances other than those included in the Union list may be used as polymer production aids in the manufacture of plastic materials and articles subject to national law.

By way of derogation from Article 5, colorants and solvents may be used in the manufacture of plastic materials and articles subject to national law.

The following substances not included in the Union list are authorised subject to the rules set out in Articles 8, 9, 10, 11 and 12:

(a) all salts of substances for which ‘yes’ is indicated in column 2 in Table 1 of Annex II of authorised acids, phenols or alcohols, and subject to the restrictions set out in column 3 and 4 of that table;

(b) mixtures obtained by mixing authorised substances without a chemical reaction of the components;

(c) when used as additives, natural or synthetic polymeric substances of a molecular weight of at least 1 000 Da, except macromolecules obtained from microbial fermentation, complying with the requirements of this Regulation, if they are capable of functioning as the main structural component of final materials or articles;

(d) when used as monomer or other starting substance, pre-polymers and natural or synthetic macromolecular substances, as well as their mixtures, except macromolecules obtained from microbial fermentation, if the monomers or starting substances required to synthesise them are included in the Union list.

The following substances not included in the Union list may be present in plastic materials or articles:

(a) non-intentionally added substances;

(b) aids to polymerisation.

By way of derogation from Article 5, substances with a biocidal function used in biocidal products that may be made available on the Union market in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council ([^E0003]) for product-type 4 for use that covers incorporation into plastic materials and articles which may enter into contact with food, may be used as additives in the manufacturing of plastic materials and articles.

By way of derogation from Article 5, 2,2-bis(4-hydroxyphenyl)propane (‘bisphenol A’ or ‘BPA’) (CAS No 80-05-7) and other hazardous bisphenols or hazardous bisphenol derivatives as defined and falling within the scope of Regulation (EU) 2024/3190 may only be used in the manufacture of plastic materials and articles in accordance with that Regulation.

SECTION 2 General requirements, restrictions and specifications

Article 8

General requirements on substances

Substances used in the manufacture of plastic materials and articles that may be present in the final plastic material, including those manufactured from waste, shall be of a high degree of purity and shall be of a technical quality suitable for the intended and foreseeable use of the materials or articles.

The composition shall be known to the manufacturer of the substance.

By derogation from paragraph 1, as regards purity, UVCB substances that are identified by a name in this Regulation that refers to a natural multi constituent material the source of which is biological or mineral, may be used as obtained from their natural origin, provided they do not contain substances or materials that do not correspond to its identity as designated by that name. Any additional specifications or requirements applicable to a substance or material of natural origin set out in Table 1 of Annex I, applicable to the substance or material, shall apply.

Article 9

Specific requirements on substances

Substances used in the manufacture of ————— plastic materials and articles shall be subject to the following restrictions and specifications:

(a) the specific migration limit set out in Article 11;

(b) the overall migration limit set out in Article 12;

(d) the detailed specifications set out in point 4 of Annex I.

Substances in nanoform shall only be used if explicitly authorised and mentioned in the specifications in Annex I.

Article 10

General restrictions and requirements concerning the composition of plastic materials and articles

Plastic materials and articles shall meet the restrictions on plastic materials and articles laid down in Annex II.

Plastic materials and articles may contain reprocessed plastic if such reprocessed plastic meets the following conditions:

(a) it is a by-product in accordance with Article 5 of Directive 2008/98/EC of the European Parliament and of the Council ([^E0004]);

(b) it is collected and used in accordance with section C of the Annex to Regulation (EC) No 2023/2006;

(c) it originates from one of the following off-cuts and scraps from plastic materials and articles:
(i) off-cuts and scraps from plastic materials and articles referred to in point (a) of Article 2(1) that meet the compositional requirements set out in Chapter II of this Regulation, or
(ii) off-cuts and scraps from plastic materials and articles referred to points (b) and (c) of Article 2(1), provided that such reprocessed plastic does not contain a layer which functions as a functional barrier and all of its individual constituents either meet the compositional requirements set out in Chapter II of this Regulation, or have been subject to risk assessment on the basis of Article 19 taking into account the conditions of reprocessing and their presence in the reprocessed material;

(d) it does not contain substances in an amount which could:
(i) exceed migration limits applicable for the substance as specified in this Regulation; or
(ii) cause any other non-compliance of those plastic materials and articles with Article 3 of Regulation (EC) No 1935/2004.

Where intended for repeated use in contact with food, the composition and the design of final food contact articles shall be such, so as to guarantee that no increase in the migration of constituents of the material or article to the food would occur when subjected to subsequent use cycles of the articles in accordance with the instructions for intended use as described in documentation or labelling.

Article 11

Specific migration limits

Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. Those specific migration limits (SML) are expressed in mg of substance per kg of food (mg/kg).

By derogation from paragraph 1, additives which are also authorised as food additives by Regulation (EC) No 1333/2008 or as flavourings by Regulation (EC) No 1334/2008 shall not migrate into foods in quantities having a technical effect in the final foods and shall not:

(a) exceed the restrictions provided for in Regulation (EC) No 1333/2008 or in Regulation (EC) No 1334/2008 or in Annex I to this Regulation for foods for which their use is authorised as food additive or flavouring substances; or

(b) exceed the restrictions set out in Annex I to this Regulation in foods for which their use is not authorised as food additive or flavouring substances.

Where it is specified that no migration of a particular substance is permitted, compliance shall be established using appropriate migration test methods selected in accordance with Article 11 of Regulation (EC) No 882/2004 that can confirm the absence of migration above a specified limit of detection.

For the purposes of the first subparagraph, unless specific detection limits have been set for particular substances or groups of substances, a detection limit of 0,01 mg/kg shall apply.

Article 12

Overall migration limit

Plastic materials and articles shall not transfer their constituents to food simulants in quantities exceeding 10 milligrams of total constituents released per dm² of food contact surface (mg/dm²).

By derogation from paragraph 1, plastic materials and articles intended to be brought into contact with food intended for infants and young children, as defined by Commission Directives 2006/141/EC ([^E0005]) and 2006/125/EC ([^E0006]), shall not transfer their constituents to food simulants in quantities exceeding 60 milligrams of total of constituents released per kg of food simulant.

CHAPTER III SPECIFIC PROVISIONS FOR CERTAIN MATERIALS AND ARTICLES

Article 13

Plastic multi-layer materials and articles

In a plastic multi-layer material or article, the composition of each plastic layer shall comply with this Regulation.

By derogation from paragraph 1, a plastic layer which is not in direct contact with food and is separated from the food by a functional barrier, may:

(a) not comply with the restrictions and specifications set out in this Regulation except for vinyl chloride monomer as provided in Annex I; and/or

(b) be manufactured with substances not listed in the Union list or —————.

Substances under paragraph 2(b) shall not migrate into food or food simulant, in accordance with Article 11(4). The detection limit set out in the second subparagraph of Article 11(4) shall apply to groups of substances if they are structurally and toxicologically related, including isomers or substances with the same relevant functional group, or to individual substances that are not related, and shall include possible set-off transfer.

The substances not listed in the Union list ————— referred to in paragraph 2(b) shall not belong to either of the following categories:

(a) substances classified as ‘mutagenic’, ‘carcinogenic’ or ‘toxic to reproduction’ in accordance with the criteria set out in sections 3.5, 3.6. and 3.7 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and the Council ([^E0007]);

(b) substances in nanoform.

The final plastic multi-layer material or article shall comply with the specific migration limits set out in Article 11 and the overall migration limit set out in Article 12 of this Regulation.

Article 14

Multi-material multi-layer materials and articles

In a multi-material multi-layer material or article, the composition of each plastic layer shall comply with this Regulation.

By derogation from paragraph 1, in a multi-material multi-layer material or article a plastic layer which is not in direct contact with food and is separated from the food by a functional barrier, may be manufactured with substances not listed in the Union list or the provisional list.

The substances not listed in the Union list ————— referred to in paragraph 2 shall not belong to either of the following categories:

(a) substances classified as ‘mutagenic’, ‘carcinogenic’ or ‘toxic to reproduction’ in accordance with the criteria set out in sections 3.5, 3.6. and 3.7 of Annex I to Regulation (EC) No 1272/2008;

(b) substances in nanoform.

Articles 11 and 12 apply to multi-material multi-layer materials and articles when the surface layer that is in contact with food is made of a material falling within the scope of this Regulation.

The plastic layers in a multi-material multi-layer material or article shall always comply with the restrictions for vinyl chloride monomer laid down in Annex I to this Regulation.

If the surface layer that is in contact with food is made of a material falling not within the scope of this Regulation, specific and overall migration limits for plastic layers and for the final material or article may be established by national law.

CHAPTER IV LABELLING, DECLARATION OF COMPLIANCE AND DOCUMENTATION

Article 14a

Labelling

The manufacturer or other operator responsible for placing on the market a final plastic food contact article intended for repeated use, shall provide to its users in accordance with Articles 15(7) and (8) of Regulation (EC) No 1935/2004 the following:

(a) appropriate instructions designed to slow down deterioration of the article;

(b) a description of observable changes of the article that may indicate the deterioration of the article or material;

(c) a warning in case specific damages or foreseeable misuse would cause increased migration or would cause the article to become otherwise unsuitable for further use in contact with food.

Plastic materials and articles intended to be brought into contact with food but which are not yet in contact with it shall be accompanied at the moment of their sale or supply to consumers at retail stage with instructions of use, in accordance with Article 15(1) of Regulation (EC) No 1935/2004, directed at the consumer of that final food contact article, where they are manufactured with substances included in the Union list of authorised substances, for which column 10 of Table 1 of Annex I sets out restrictions related to one or more of the following elements:

— specific foods or groups of foods,

— contact time and/or temperature, and/or

— heating conditions such as oven and microwave use.

The instructions of use shall mention the restrictions and provide the consumer with adequate information to avoid using the article under conditions not complying such restrictions.

Article 15

Declaration of compliance

At the marketing stages other than at the retail stage, a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004 shall be available for plastic materials and articles, products from intermediate stages of their manufacturing as well as for the substances intended for the manufacturing of those materials and articles.

The written declaration referred to in paragraph 1 shall be issued by the business operator and shall contain the information laid down in Annex IV.

The written declaration shall permit an easy identification of the materials, articles or products from intermediate stages of manufacture or substances for which it is issued. It shall be renewed when substantial changes in the composition or production occur that bring about changes in the migration from the materials or articles or when new scientific data becomes available.

Article 16

Supporting documents

Appropriate documentation to demonstrate that the materials and articles, products from intermediate stages of their manufacturing as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of this Regulation shall be made available by the business operator to the national competent authorities on request.

For substances used in the manufacture of plastic materials and articles, documentation on the composition shall be made available to the competent authorities on request, together with any documentation regarding their degree of purity.

That documentation shall contain the conditions and results of testing, calculations, including modelling, other analysis, and evidence on the safety or reasoning demonstrating compliance. Rules for experimental demonstration of compliance are set out in Chapter V.

Manufacturers of plastic materials and articles, and of products from intermediate stages of their manufacturing, shall ensure that documentation showing compliance with paragraphs 1 to 2 of Article 8 is part of the documentation referred to in paragraph 1.

Manufacturers of plastic materials and articles, and of products from intermediate stages of their manufacturing, shall ensure that competent authorities can take samples during the carrying out of official controls to verify their degree of purity and their composition, including that of the substances and materials used for their manufacture.

CHAPTER V COMPLIANCE

Article 17

Expression of migration test results

To check the compliance, the specific migration values shall be expressed in mg/kg applying the real surface to volume ratio in actual or foreseen use.

By derogation from paragraph 1, a surface to volume ratio equal or higher than 6 dm² per kg of food may be applied for the following materials and articles:

(a) containers and other articles, containing or intended to contain a volume of less than 500 ml or more than 10 litres;

(b) a material or article for which, due to its form, it is impracticable to estimate the relationship between its surface area and the quantity of food in contact therewith;

(d) for sheets and films containing a volume less than 500 ml, or more than 10 litres.

This paragraph does not apply to plastic materials and articles intended to be brought into contact with or already in contact with food for infants and young children, as defined by Regulation (EU) No 609/2013 of the European Parliament and of the Council ([^E0008]).

By derogation from paragraph 1, for caps, gaskets, stoppers and similar sealing articles the specific migration value shall be expressed in:

(a) mg/kg using the actual content of the container for which the closure is intended applying the total contact surface of sealing article and sealed container if the intended use of the article is known, while taking into account the provisions of paragraph 2;

(b) mg/article if the intended use of the article is unknown.

For caps, gaskets, stoppers and similar sealing articles the overall migration value shall be expressed in:

(a) mg/dm² applying the total contact surface of sealing article and sealed container if the intended use of the article is known;

(b) mg/article if the intended use of the article is unknown.

Article 18

Rules for assessing compliance with migration limits

For materials and articles already in contact with food verification of compliance with specific migration limits shall be carried out in accordance with the rules set out in Chapter 1 of Annex V.

For materials and articles not yet in contact with food verification of compliance with specific migration limits shall be carried out in food or in food simulants set out in Annex III in accordance with the rules set out in Chapter 2, Section 2.1 of Annex V.

For materials and articles not yet in contact with food screening of compliance with the specific migration limit can be performed applying screening approaches in accordance with the rules set out in Chapter 2, Section 2.2 of Annex V. If a material or article fails to comply with the migration limits in the screening approach a conclusion of non-compliance has to be confirmed by verification of compliance in accordance with paragraph 2.

For materials and articles not yet in contact with food verification of compliance with the overall migration limit shall be carried out in food simulants as set out in Annex III in accordance with the rules set out in Chapter 3 of Annex V.

For materials and articles not yet in contact with food screening of compliance with the overall migration limit can be performed applying screening approaches in accordance with the rules set out in Chapter 3, Section 3.4 of Annex V. If a material or article fails to comply with the migration limit in the screening approach a conclusion of non-compliance has to be confirmed by verification of compliance in accordance with paragraph 4.

The results of specific migration testing obtained in food shall prevail over the results obtained in food simulant. The results of specific migration testing obtained in food simulant shall prevail over the results obtained by screening approaches.

Before comparing specific and overall migration test results with the migration limits the correction factors set out in point 3 of Annex III and Chapter 4 of Annex V shall be applied in accordance with the rules set out therein.

Article 19

Assessment of substances not included in the Union list

Compliance with Article 3 of Regulation (EC) No 1935/2004 of substances referred to in Articles 6(1), 6(2), 6(4), 6(5) and 14(2) of this Regulation which are not covered by an inclusion in Annex I to this Regulation shall be assessed in accordance with internationally recognised scientific principles on risk assessment.

CHAPTER VI FINAL PROVISIONS

Article 20

Amendments of EU acts

The Annex to Council Directive 85/572/EEC ([^E0009]) is replaced by the following:

‘The food simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with a single food or specific groups of foods are set out in point 3 of Annex III to Commission Regulation (EU) No 10/2011.’

Article 21

Repeal of EU acts

Directives 80/766/EEC, 81/432/EEC, and 2002/72/EC are hereby repealed with effect from 1 May 2011.

References to the repealed Directives shall be construed as references to this Regulation and shall be read in accordance with the correlation tables in Annex VI.

Article 22

Transitional provisions

Until 31 December 2012 the supporting documents referred to in Article 16 shall be based on the basic rules for overall and specific migration testing set out in the Annex to Directive 82/711/EEC.

As from 1 January 2013 the supporting documents referred to in Article 16 for materials, articles and substances placed on the market until 31 December 2015, may be based on:

(a) the rules for migration testing set out in Article 18 of this Regulation; or

(b) the basic rules for overall and specific migration testing set out in the Annex to Directive 82/711/EEC.

As from 1 January 2016, the supporting documents referred to in Article 16 shall be based on the rules for migration testing set out in Article 18, without prejudice to paragraph 2 of this Article.

Until 31 December 2015 additives used in glass fibre sizing for glass fibre reinforced plastics which are not listed in Annex I have to comply with the risk assessment provisions set out in Article 19.

Materials and articles that have been lawfully placed on the market before 1 May 2011 may be placed on the market until 31 December 2012.

Article 23

Entry into force and application

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 1 May 2011.

The provision of Article 5 as regards the use of additives, others than plasticisers, shall apply for plastic layers or plastic coatings in caps and closures referred to in Article 2(1)(d), as from 31 December 2015.

The provision of Article 5 as regards the use of additives used in glass fibre sizing for glass fibre reinforced plastics, shall apply from 31 December 2015.

The provisions of Articles 18(2), 18(4) and 20 shall apply from 31 December 2012.

This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.

ANNEX I

Substances

1. Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids

Table 1 contains the following information:

Column 1 (FCM substance No): the unique identification number of the substance

Column 2 (Ref. No): the EEC packaging material reference number

Column 3 (CAS No): the Chemical Abstracts Service (CAS) registry number

Column 4 (Substance Name): the chemical name

Column 5 (Use as additive or polymer production aid (PPA) (yes/no)): an indication if the substance is authorised to be used as additive or polymer production aid (yes) or if the substance is not authorised to be used as additive or polymer production aid (no). If the substance is only authorised as PPA it is indicated (yes) and in the specifications the use is restricted to PPA.

Column 6 (Use as monomer or other starting substance or macromolecule obtained from microbial fermentation (yes/no)): an indication if the substance is authorised to be used as monomer or other starting substance or macromolecule obtained from microbial fermentation (yes) or if the substance is not authorised to be used as monomer or other starting substance or macromolecule obtained from microbial fermentation (no). If the substance is authorised as macromolecule obtained from microbial fermentation it is indicated (yes) and in the specifications it is indicated that the substance is a macromolecule obtained from microbial fermentation.

Column 7 (FRF applicable (yes/no)): an indication if for the substance the migration results can be corrected by the Fat Consumption Reduction Factor (FRF) (yes) or if they cannot be corrected by the FRF (no).

Column 8 (SML [mg/kg]): the specific migration limit applicable for the substance. It is expressed in mg substance per kg food. It is marked as ND (‘not-detectable’) if the substance is one in respect of which no migration is permitted, to be determined in accordance with Article 11(4).

Column 9 (SML(T) [mg/kg] (group restriction No)): contains the identification number of the group of substances for which the group restriction in Column 1 in Table 2 of this Annex applies.

Column 10 (Restrictions and specifications): contains other restrictions than the specific migration limit specifically mentioned and it contains specifications related to the substance. In case detailed specifications are set out a reference to Table 4 is included.

Column 11 (Notes on verification of compliance): contains the Notes number which refers to the detailed rules applicable for verification of compliance for this substance included in Column 1 in Table 3 of this Annex.

If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound.

Table 1

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