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Document 02011R0010-20160914

Consolidated text: 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)

ELI: http://data.europa.eu/eli/reg/2011/10/2016-09-14

2011R0010 — EN — 14.09.2016 — 006.001


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

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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)

(OJ L 012 15.1.2011, p. 1)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION IMPLEMENTING REGULATION (EU) No 321/2011 of 1 April 2011

  L 87

1

2.4.2011

►M2

COMMISSION REGULATION (EU) No 1282/2011 of 28 November 2011

  L 328

22

10.12.2011

►M3

COMMISSION REGULATION (EU) No 1183/2012 of 30 November 2012

  L 338

11

12.12.2012

►M4

COMMISSION REGULATION (EU) No 202/2014 of 3 March 2014

  L 62

13

4.3.2014

 M5

COMMISSION REGULATION (EU) No 865/2014 of 8 August 2014

  L 238

1

9.8.2014

►M6

COMMISSION REGULATION (EU) 2015/174 of 5 February 2015

  L 30

2

6.2.2015

►M7

COMMISSION REGULATION (EU) 2016/1416 of 24 August 2016

  L 230

22

25.8.2016


Corrected by:

►C1

Corrigendum, OJ L 349, 19.12.2012, p.  77 (1183/2012)




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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)



CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

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

2.  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

(c) which can reasonably be expected to come into contact with food.

Article 2

Scope

1.  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;

(c) materials and articles referred to in points a) or b) that are printed and/or covered by a coating;

(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.

2.  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;

(c) silicones.

3.  This Regulation shall be without prejudice to the EU or national provisions applicable to printing inks, adhesives or coatings.

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 plastics to achieve a physical or chemical effect during processing of the plastic or in the final material or article; it is intended to be present in the final material or article;

(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;

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(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;

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

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(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;

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(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.

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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

(c) comply with the traceability requirements set out in Article 17 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 ( 1 ); and

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



CHAPTER II

COMPOSITIONAL REQUIREMENTS



SECTION 1

Authorised substances

Article 5

Union list of authorised substances

1.  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 intentionally used in the manufacture of plastic layers in plastic materials and articles.

2.  The Union list shall contain:

(a) monomers or other starting substances;

(b) additives excluding colorants;

(c) polymer production aids excluding solvents;

(d) macromolecules obtained from microbial fermentation.

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

Article 6

Derogations for substances not included in the Union list

1.  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 layers in plastic materials and articles subject to national law.

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

3.  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:

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(a) all salts of aluminium, ammonium, barium, calcium, cobalt, copper, iron, lithium, magnesium, manganese, potassium, sodium, and zinc of authorised acids, phenols or alcohols;

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(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.

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

(a) non-intentionally added substances;

(b) aids to polymerisation.

5.  By derogation from Article 5, additives not included in the Union list may continue to be used subject to national law after 1 January 2010 until a decision is taken to include or not to include them in the Union list provided they are included in the provisional list referred to in Article 7.

Article 7

Establishment and management of the provisional list

1.  The provisional list of additives that are under evaluation by the European Food Safety Authority (hereinafter referred to as the Authority) that was made public by the Commission in 2008 shall be regularly updated.

2.  An additive shall be removed from the provisional list:

(a) when it is included in the Union list set out in Annex I; or

(b) when a decision is taken by the Commission not to include it in the Union list; or

(c) if during the examination of the data, the Authority calls for supplementary information and that information is not submitted within the time limits specified by the Authority.



SECTION 2

General requirements, restrictions and specifications

Article 8

General requirement on substances

Substances used in the manufacture of plastic layers in plastic materials and articles shall be of a technical quality and a purity suitable for the intended and foreseeable use of the materials or articles. The composition shall be known to the manufacturer of the substance and made available to the competent authorities on request.

Article 9

Specific requirements on substances

1.  Substances used in the manufacture of plastic layers in 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;

(c) the restrictions and specifications set out in column 10 of Table 1 of point 1 of Annex I;

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

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

Article 10

General restrictions on plastic materials and articles

General restrictions related to plastic materials and articles are laid down in Annex II.

Article 11

Specific migration limits

1.  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).

▼M7 —————

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3.  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.

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4.  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.

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Article 12

Overall migration limit

1.  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).

2.  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 ( 2 ) and 2006/125/EC ( 3 ), 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

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

2.  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 in the provisional list.

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3.  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.

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4.  The substances not listed in the Union list or provisional 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 ( 4 );

(b) substances in nanoform.

5.  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

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

2.  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.

3.  The substances not listed in the Union list or provisional 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.

4.  By derogation from paragraph 1, Articles 11 and 12 of this Regulation do not apply to plastic layers in multi-material multi-layer materials and articles.

5.  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.

6.  In a multi-material multi-layer material or article, specific and overall migration limits for plastic layers and for the final material or article may be established by national law.



CHAPTER IV

DECLARATION OF COMPLIANCE AND DOCUMENTATION

Article 15

Declaration of compliance

1.  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.

2.  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.

3.  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

1.  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.

2.  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.



CHAPTER V

COMPLIANCE

Article 17

Expression of migration test results

1.  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.

2.  By derogation from paragraph 1 for:

(a) containers and other articles, containing or intended to contain, less than 500 millilitres or grams or more than 10 litres,

(b) materials and articles for which, due to their form it is impracticable to estimate the relationship between the surface area of such materials or articles and the quantity of food in contact therewith,

(c) sheets and films that are not yet in contact with food,

(d) sheets and films containing less than 500 millilitres or grams or more than 10 litres,

the value of migration shall be expressed in mg/kg applying a surface to volume ratio of 6 dm2 per kg of food.

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 Directives 2006/141/EC and 2006/125/EC.

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

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(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;

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

4.  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

1.  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.

2.  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.

3.  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.

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4.  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.

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5.  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.

6.  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.

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7.  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.

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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 ( 5 ) 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

1.  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.

2.  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.

3.  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.

4.  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.

5.  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).

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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).

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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.

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Table 1

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

(10)

(11)

FCM substance No

Ref. No

CAS No

Substance name

Use as additive or polymer production aid

(yes/no)

Use as monomer or other starting substance or macromolecule obtained from microbial fermentation

(yes/no)

FRF applicable

(yes/no)

SML

[mg/kg]

SML(T)

[mg/kg]

(Group restriction No)

Restrictions and specifications

Notes on verification of compliance

1

12310

0266309-43-7

albumin

no

yes

no

 

 

 

 

2

12340

albumin, coagulated by formaldehyde

no

yes

no

 

 

 

 

3

12375

alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)

no

yes

no

 

 

 

 

4

22332

mixture of (40 % w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60 % w/w) 2,4,4-trimethylhexane-1,6-diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety.

(10)

5

25360

trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl ester

no

yes

no

ND

 

1 mg/kg in final product expressed as epoxygroup.

Molecular weight is 43 Da.

 

6

25380

trialkyl acetic acid (C7-C17), vinyl esters

no

yes

no

0,05

 

 

(1)

7

30370

acetylacetic acid, salts

yes

no

no

 

 

 

 

8

30401

acetylated mono- and diglycerides of fatty acids

yes

no

no

 

(32)

 

 

9

30610

acids, C2-C24, aliphatic, linear, monocarboxylic from natural oils and fats, and their mono-, di- and triglycerol esters (branched fatty acids at naturally occuring levels are included)

yes

no

no

 

 

 

 

10

30612

acids, C2-C24, aliphatic, linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters

yes

no

no

 

 

 

 

11

30960

acids, aliphatic, monocarboxylic (C6-C22), esters with polyglycerol

yes

no

no

 

 

 

 

12

31328

acids, fatty, from animal or vegetable food fats and oils

yes

no

no

 

 

 

 

13

33120

alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24)

yes

no

no

 

 

 

 

14

33801

n-alkyl(C10-C13)benzenesulphonic acid

yes

no

no

30

 

 

 

15

34130

alkyl, linear with even number of carbon atoms (C12-C20) dimethylamines

yes

no

yes

30

 

 

 

16

34230

alkyl(C8-C22)sulphonic acids

yes

no

no

6

 

 

 

17

34281

alkyl(C8-C22)sulphuric acids, linear, primary with an even number of carbon atoms

yes

no

no

 

 

 

 

18

34475

aluminium calcium hydroxide phosphite, hydrate

yes

no

no

 

 

 

 

19

39090

N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine

yes

no

no

 

(7)

 

 

20

39120

N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochlorides

yes

no

no

 

(7)

SML(T) expressed excluding HCl

 

21

42500

carbonic acid, salts

yes

no

no

 

 

 

 

22

43200

castor oil, mono- and diglycerides

yes

no

no

 

 

 

 

23

43515

chlorides of choline esters of coconut oil fatty acids

yes

no

no

0,9

 

 

(1)

24

45280

cotton fibers

yes

no

no

 

 

 

 

25

45440

cresols, butylated, styrenated

yes

no

no

12

 

 

 

26

46700

5,7-di-tert-butyl-3-(3,4- and 2,3-dimethylphenyl)-3H-benzofuran-2-one containing: a) 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80 to 100 % w/w) and b) 5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0 to 20 % w/w)

yes

no

no

5

 

 

 

27

48960

9,10-dihydroxy stearic acid and its oligomers

yes

no

no

5

 

 

 

28

50160

di-n-octyltin bis(n-alkyl(C10-C16) mercaptoacetate)

yes

no

no

 

(10)

 

 

29

50360

di-n-octyltin bis(ethyl maleate)

yes

no

no

 

(10)

 

 

30

50560

di-n-octyltin 1,4-butanediol bis(mercaptoacetate)

yes

no

no

 

(10)

 

 

31

50800

di-n-octyltin dimaleate, esterified

yes

no

no

 

(10)

 

 

32

50880

di-n-octyltin dimaleate, polymers (n = 2-4)

yes

no

no

 

(10)

 

 

33

51120

di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate

yes

no

no

 

(10)

 

 

34

54270

ethylhydroxymethylcellulose

yes

no

no

 

 

 

 

35

54280

ethylhydroxypropylcellulose

yes

no

no

 

 

 

 

36

54450

fats and oils, from animal or vegetable food sources

yes

no

no

 

 

 

 

37

54480

fats and oils, hydrogenated, from animal or vegetable food sources

yes

no

no

 

 

 

 

38

55520

glass fibers

yes

no

no

 

 

 

 

39

55600

glass microballs

yes

no

no

 

 

 

 

40

56360

glycerol, esters with acetic acid

yes

no

no

 

 

 

 

41

56486

glycerol, esters with acids, aliphatic, saturated, linear, with an even number of carbon atoms (C14-C18) and with acids, aliphatic, unsaturated, linear, with an even number of carbon atoms (C16-C18)

yes

no

no

 

 

 

 

42

56487

glycerol, esters with butyric acid

yes

no

no

 

 

 

 

43

56490

glycerol, esters with erucic acid

yes

no

no

 

 

 

 

44

56495

glycerol, esters with 12-hydroxystearic acid

yes

no

no

 

 

 

 

45

56500

glycerol, esters with lauric acid

yes

no

no

 

 

 

 

46

56510

glycerol, esters with linoleic acid

yes

no

no

 

 

 

 

47

56520

glycerol, esters with myristic acid

yes

no

no

 

 

 

 

48

56535

glycerol, esters with nonanoic acid

yes

no

no

 

 

 

 

49

56540

glycerol, esters with oleic acid

yes

no

no

 

 

 

 

50

56550

glycerol, esters with palmitic acid

yes

no

no

 

 

 

 

51

56570

glycerol, esters with propionic acid

yes

no

no

 

 

 

 

52

56580

glycerol, esters with ricinoleic acid

yes

no

no

 

 

 

 

53

56585

glycerol, esters with stearic acid

yes

no

no

 

 

 

 

54

57040

glycerol monooleate, ester with ascorbic acid

yes

no

no

 

 

 

 

55

57120

glycerol monooleate, ester with citric acid

yes

no

no

 

 

 

 

56

57200

glycerol monopalmitate, ester with ascorbic acid

yes

no

no

 

 

 

 

57

57280

glycerol monopalmitate, ester with citric acid

yes

no

no

 

 

 

 

58

57600

glycerol monostearate, ester with ascorbic acid

yes

no

no

 

 

 

 

59

57680

glycerol monostearate, ester with citric acid

yes

no

no

 

 

 

 

60

58300

glycine, salts

yes

no

no

 

 

 

 

62

64500

lysine, salts

yes

no

no

 

 

 

 

63

65440

manganese pyrophosphite

yes

no

no

 

 

 

 

64

66695

methylhydroxymethylcellulose

yes

no

no

 

 

 

 

65

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

yes

no

no

 

 

Not more than 0,05 % (w/w) (quantity of substance used/quantity of the formulation).

Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %):(13-17 %).

 

66

67600

mono-n-octyltin tris(alkyl(C10-C16) mercaptoacetate)

yes

no

no

 

(11)

 

 

67

67840

montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol

yes

no

no

 

 

 

 

68

73160

phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters

yes

no

yes

0,05

 

 

 

69

74400

phosphorous acid, tris(nonyl-and/or dinonylphenyl) ester

yes

no

yes

30

 

 

 

70

76463

polyacrylic acid, salts

yes

no

no

 

(22)

 

 

71

76730

polydimethylsiloxane, γ-hydroxypropylated

yes

no

no

6

 

 

 

72

76815

polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids

yes

no

no

 

(32)

The fraction with molecular weight below 1 000 Da ►M7  shall ◄ not exceed 5 % (w/w)

 

73

76866

polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, which may be end-capped with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanol

yes

no

yes

 

(31)

(32)

 

 

74

77440

polyethyleneglycol diricinoleate

yes

no

yes

42

 

 

 

75

77702

polyethyleneglycol esters of aliph. monocarb. acids (C6-C22) and their ammonium and sodium sulphates

yes

no

no

 

 

 

 

76

77732

polyethylene glycol (EO = 1-30, typically 5) ether of butyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylate

yes

no

no

0,05

 

Only for use in PET

 

77

77733

polyethyleneglycol (EO = 1-30, typically 5) ether of butyl-2-cyano-3-(4-hydroxyphenyl) acrylate

yes

no

no

0,05

 

Only for use in PET

 

78

77897

polyethyleneglycol (EO = 1-50) monoalkylether (linear and branched, C8-C20) sulphate, salts

yes

no

no

5

 

 

 

79

80640

polyoxyalkyl (C2-C4) dimethylpolysiloxane

yes

no

no

 

 

 

 

80

81760

powders, flakes and fibres of brass, bronze, copper, stainless steel, tin, iron and alloys of copper, tin and iron

yes

no

no

 

 

 

 

81

83320

propylhydroxyethylcellulose

yes

no

no

 

 

 

 

82

83325

propylhydroxymethylcellulose

yes

no

no

 

 

 

 

83

83330

propylhydroxypropylcellulose

yes

no

no

 

 

 

 

84

85601

silicates, natural (with the exception of asbestos)

yes

no

no

 

 

 

 

85

85610

silicates, natural, silanated (with the exception of asbestos)

yes

no

no

 

 

 

 

86

86000

silicic acid, silylated

yes

no

no

 

 

 

 

▼M7

87

86285

 

Silicon dioxide, silanated

yes

no

no

 

 

For synthetic amorphous silicon dioxide, silanated: primary particles of 1–100 nm which are aggregated to a size of 0,1–1 μm and may form agglomerates within the size distribution of 0,3 μm to the mm size.

 

▼B

88

86880

sodium monoalkyl dialkylphenoxybenzenedisulphonate

yes

no

no

9

 

 

 

89

89440

stearic acid, esters with ethyleneglycol

yes

no

no

 

(2)

 

 

90

92195

taurine, salts

yes

no

no

 

 

 

 

91

92320

tetradecyl-polyethyleneglycol(EO = 3-8) ether of glycolic acid

yes

no

yes

15

 

 

 

92

93970

tricyclodecanedimethanol bis(hexahydrophthalate)

yes

no

no

0,05

 

 

 

93

95858

waxes, paraffinic, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, low viscosity

yes

no

no

0,05

 

Not to be used for articles in contact with fatty foods for which ►M7  simulant D1 and/or D2 ◄ is laid down.

Average molecular weight not less than 350 Da.

Viscosity at 100 °C not less than 2,5 cSt (2,5 × 10-6 m2/s).

Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w).

 

94

95859

waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, high viscosity

yes

no

no

 

 

Average molecular weight not less than 500 Da.

Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2/s).

Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w).

 

95

95883

white mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks

yes

no

no

 

 

Average molecular weight not less than 480 Da.

Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2/s).

Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w).

 

96

95920

wood flour and fibers, untreated

yes

no

no

 

 

 

 

97

72081/10

petroleum hydrocarbon resins (hydrogenated)

yes

no

no

 

 

Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermalpolymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoidarylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing.

Properties:

— Viscosity at 120 °C: > 3 Pa.s,

— Softening point: > 95 °C as determined by ASTM Method E 28-67,

— Bromine number: < 40 (ASTM D1159),

— The colour of a 50 % solution in toluene < 11 on the Gardner scale,

— Residual aromatic monomer ≤ 50 ppm,

 

98

17260

0000050-00-0

formaldehyde

yes

yes

no

 

(15)

 

 

54880

99

19460

0000050-21-5

lactic acid

yes

yes

no

 

 

 

 

62960

100

24490

0000050-70-4

sorbitol

yes

yes

no

 

 

 

 

88320

101

36000

0000050-81-7

ascorbic acid

yes

no

no

 

 

 

 

102

17530

0000050-99-7

glucose

no

yes

no

 

 

 

 

103

18100

0000056-81-5

glycerol

yes

yes

no

 

 

 

 

55920

104

58960

0000057-09-0

hexadecyltrimethylammonium bromide

yes

no

no

6

 

 

 

105

22780

0000057-10-3

palmitic acid

yes

yes

no

 

 

 

 

70400

106

24550

0000057-11-4

stearic acid

yes

yes

no

 

 

 

 

89040

107

25960

0000057-13-6

urea

no

yes

no

 

 

 

 

108

24880

0000057-50-1

sucrose

no

yes

no

 

 

 

 

109

23740

0000057-55-6

1,2-propanediol

yes

yes

no

 

 

 

 

81840

110

93520

0000059-02-9

0010191-41-0

α-tocopherol

yes

no

no

 

 

 

 

111

53600

0000060-00-4

ethylenediaminetetraacetic acid

yes

no

no

 

 

 

 

112

64015

0000060-33-3

linoleic acid

yes

no

no

 

 

 

 

113

16780

0000064-17-5

ethanol

yes

yes

no

 

 

 

 

52800

114

55040

0000064-18-6

formic acid

yes

no

no

 

 

 

 

115

10090

0000064-19-7

acetic acid

yes

yes

no

 

 

 

 

30000

116

13090

0000065-85-0

benzoic acid

yes

yes

no

 

 

 

 

37600

117

21550

0000067-56-1

methanol

no

yes

no

 

 

 

 

118

23830

0000067-63-0

2-propanol

yes

yes

no

 

 

 

 

81882

119

30295

0000067-64-1

acetone

yes

no

no

 

 

 

 

120

49540

0000067-68-5

dimethyl sulphoxide

yes

no

no

 

 

 

 

121

24270

0000069-72-7

salicylic acid

yes

yes

no

 

 

 

 

84640

122

23800

0000071-23-8

1-propanol

no

yes

no

 

 

 

 

123

13840

0000071-36-3

1-butanol

no

yes

no

 

 

 

 

124

22870

0000071-41-0

1-pentanol

no

yes

no

 

 

 

 

125

16950

0000074-85-1

ethylene

no

yes

no

 

 

 

 

126

10210

0000074-86-2

acetylene

no

yes

no

 

 

 

 

127

26050

0000075-01-4

vinyl chloride

no

yes

no

ND

 

1 mg/kg in final product

 

128

10060

0000075-07-0

acetaldehyde

no

yes

no

 

(1)

 

 

129

17020

0000075-21-8

ethylene oxide

no

yes

no

ND

 

1 mg/kg in final product

(10)

130

26110

0000075-35-4

vinylidene chloride

no

yes

no

ND

 

 

(1)

131

48460

0000075-37-6

1,1-difluoroethane

yes

no

no

 

 

 

 

132

26140

0000075-38-7

vinylidene fluoride

no

yes

no

5

 

 

 

133

14380

0000075-44-5

carbonyl chloride

no

yes

no

ND

 

1 mg/kg in final product

(10)

23155

134

43680

0000075-45-6

chlorodifluoromethane

yes

no

no

6

 

Content of chlorofluoromethane less than 1 mg/kg of the substance

 

135

24010

0000075-56-9

propylene oxide

no

yes

no

ND

 

1 mg/kg in final product

 

136

41680

0000076-22-2

camphor

yes

no

no

 

 

 

(3)

137

66580

0000077-62-3

2,2′-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)

yes

no

yes

 

(5)

 

 

138

93760

0000077-90-7

tri-n-butyl acetyl citrate

yes

no

no

 

(32)

 

 

139

14680

0000077-92-9

citric acid

yes

yes

no

 

 

 

 

44160

140

44640

0000077-93-0

citric acid, triethyl ester

yes

no

no

 

(32)

 

 

141

13380

0000077-99-6

1,1,1-trimethylolpropane

yes

yes

no

6

 

 

 

25600

94960

142

26305

0000078-08-0

vinyltriethoxysilane

no

yes

no

0,05

 

Only to be used as a surface treatment agent

(1)

143

62450

0000078-78-4

isopentane

yes

no

no

 

 

 

 

144

19243

0000078-79-5

2-methyl-1,3-butadiene

no

yes

no

ND

 

1 mg/kg in final product

 

21640

145

10630

0000079-06-1

acrylamide

no

yes

no

ND

 

 

 

146

23890

0000079-09-4

propionic acid

yes

yes

no

 

 

 

 

82000

147

10690

0000079-10-7

acrylic acid

no

yes

no

 

(22)

 

 

148

14650

0000079-38-9

chlorotrifluoroethylene

no

yes

no

ND

 

 

(1)

149

19990

0000079-39-0

methacrylamide

no

yes

no

ND

 

 

 

150

20020

0000079-41-4

methacrylic acid

no

yes

no

 

(23)

 

 

151

13480

0000080-05-7

2,2-bis(4-hydroxyphenyl)propane

no

yes

no

0,6

 

►M1  Not to be used for the manufacture of polycarbonate infant (6) feeding bottles (7). ◄

 

13607

152

15610

0000080-07-9

4,4′-dichlorodiphenyl sulphone

no

yes

no

0,05

 

 

 

153

15267

0000080-08-0

4,4′-diaminodiphenyl sulphone

no

yes

no

5

 

 

 

154

13617

0000080-09-1

4,4′-dihydroxydiphenyl sulphone

no

yes

no

0,05

 

 

 

16090

155

23470

0000080-56-8

α-pinene

no

yes

no

 

 

 

 

156

21130

0000080-62-6

methacrylic acid, methyl ester

no

yes

no

 

(23)

 

 

157

74880

0000084-74-2

phthalic acid, dibutyl ester

yes

no

no

0,3

(32)

Only to be used as:

(a)  plasticiser in repeated use materials and articles contacting non-fatty foods;

(b)  technical support agent in polyolefins in concentrations up to 0,05 % in the final product.

(7)

158

23380

0000085-44-9

phthalic anhydride

yes

yes

no

 

 

 

 

76320

159

74560

0000085-68-7

phthalic acid, benzyl butyl ester

yes

no

no

30

(32)

Only to be used as:

(a)  plasticiser in repeated use materials and articles;

(b)  plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;

(c)  technical support agent in concentrations up to 0,1 % in the final product.

(7)

160

84800

0000087-18-3

salicylic acid, 4-tert-butylphenyl ester

yes

no

yes

12

 

 

 

▼M6

161

92160

000087-69-4

L-(+)-tartaric acid

yes

no

no

 

 

 

 

▼B

162

65520

0000087-78-5

mannitol

yes

no

no

 

 

 

 

163

66400

0000088-24-4

2,2′-methylene bis(4-ethyl-6-tert-butylphenol)

yes

no

yes

 

(13)

 

 

164

34895

0000088-68-6

2-aminobenzamide

yes

no

no

0,05

 

Only for use in PET for water and beverages

 

165

23200

0000088-99-3

o-phthalic acid

yes

yes

no

 

 

 

 

74480

166

24057

0000089-32-7

pyromellitic anhydride

no

yes

no

0,05

 

 

 

167

25240

0000091-08-7

2,6-toluene diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

168

13075

0000091-76-9

2,4-diamino-6-phenyl-1,3,5-triazine

no

yes

no

5

 

 

(1)

15310

169

16240

0000091-97-4

3,3′-dimethyl-4,4′-diisocyanatobiphenyl

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

170

16000

0000092-88-6

4,4′-dihydroxybiphenyl

no

yes

no

6

 

 

 

171

38080

0000093-58-3

benzoic acid, methyl ester

yes

no

no

 

 

 

 

172

37840

0000093-89-0

benzoic acid, ethyl ester

yes

no

no

 

 

 

 

173

60240

0000094-13-3

4-hydroxybenzoic acid, propyl ester

yes

no

no

 

 

 

 

174

14740

0000095-48-7

o-cresol

no

yes

no

 

 

 

 

175

20050

0000096-05-9

methacrylic acid, allyl ester

no

yes

no

0,05

 

 

 

176

11710

0000096-33-3

acrylic acid, methyl ester

no

yes

no

 

(22)

 

 

177

16955

0000096-49-1

ethylene carbonate

no

yes

no

30

 

SML expressed as ethyleneglycol.

Residual content of 5 mg ethylene carbonate per kg of hydrogel with max 10 g of hydrogel in contact with 1 kg of food.

 

178

92800

0000096-69-5

4,4′-thiobis(6-tert-butyl-3-methylphenol)

yes

no

yes

0,48

 

 

 

179

48800

0000097-23-4

2,2′-dihydroxy-–5,5′-dichlorodiphenylmethane

yes

no

yes

12

 

 

 

▼M3

180

17160

0000097-53-0

eugenol

no

yes

no

 

(33)

 

 

▼B

181

20890

0000097-63-2

methacrylic acid, ethyl ester

no

yes

no

 

(23)

 

 

182

19270

0000097-65-4

itaconic acid

no

yes

no

 

 

 

 

183

21010

0000097-86-9

methacrylic acid, isobutyl ester

no

yes

no

 

(23)

 

 

184

20110

0000097-88-1

methacrylic acid, butyl ester

no

yes

no

 

(23)

 

 

185

20440

0000097-90-5

methacrylic acid, diester with ethyleneglycol

no

yes

no

0,05

 

 

 

186

14020

0000098-54-4

4-tert-butylphenol

no

yes

no

0,05

 

 

 

187

22210

0000098-83-9

α-methylstyrene

no

yes

no

0,05

 

 

 

188

19180

0000099-63-8

isophthalic acid dichloride

no

yes

no

 

(27)

 

 

189

60200

0000099-76-3

4-hydroxybenzoic acid, methyl ester

yes

no

no

 

 

 

 

190

18880

0000099-96-7

p-hydroxybenzoic acid

no

yes

no

 

 

 

 

191

24940

0000100-20-9

terephthalic acid dichloride

no

yes

no

 

(28)

 

 

192

23187

phthalic acid

no

yes

no

 

(28)

 

 

193

24610

0000100-42-5

styrene

no

yes

no

 

 

 

 

194

13150

0000100-51-6

benzyl alcohol

no

yes

no

 

 

 

 

195

37360

0000100-52-7

benzaldehyde

yes

no

no

 

 

 

(3)

196

18670

0000100-97-0

hexamethylenetetramine

yes

yes

no

 

(15)

 

 

59280

197

20260

0000101-43-9

methacrylic acid, cyclohexyl ester

no

yes

no

0,05

 

 

 

198

16630

0000101-68-8

diphenylmethane-4,4′-diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

199

24073

0000101-90-6

resorcinol diglycidyl ether

no

yes

no

ND

 

Not to be used for articles in contact with fatty foods for which ►M7  simulant D1 and/or D2 ◄ is laid down.

For indirect food contact only, behind a PET layer.

(8)

200

51680

0000102-08-9

N,N′-diphenylthiourea

yes

no

yes

3

 

 

 

201

16540

0000102-09-0

diphenyl carbonate

no

yes

no

0,05

 

 

 

202

23070

0000102-39-6

(1,3-phenylenedioxy)diacetic acid

no

yes

no

0,05

 

 

(1)

203

13323

0000102-40-9

1,3-bis(2-hydroxyethoxy)benzene

no

yes

no

0,05

 

 

 

204

25180

0000102-60-3

N,N,N′,N′-tetrakis(2-hydroxypropyl)ethylenediamine

yes

yes

no

 

 

 

 

92640

205

25385

0000102-70-5

triallylamine

no

yes

no

 

 

40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel.

Only to be used in hydrogels intended for non-direct food contact use.

 

206

11500

0000103-11-7

acrylic acid, 2-ethylhexyl ester

no

yes

no

0,05

 

 

 

207

31920

0000103-23-1

adipic acid, bis(2-ethylhexyl) ester

yes

no

yes

18

(32)

 

(2)

208

18898

0000103-90-2

N-(4-hydroxyphenyl) acetamide

no

yes

no

0,05

 

 

 

209

17050

0000104-76-7

2-ethyl-1-hexanol

no

yes

no

30

 

 

 

210

13390

0000105-08-8

1,4-bis(hydroxymethyl)cyclohexane

no

yes

no

 

 

 

 

14880

211

23920

0000105-38-4

propionic acid, vinyl ester

no

yes

no

 

(1)

 

 

212

14200

0000105-60-2

caprolactam

yes

yes

no

 

(4)

 

 

41840

213

82400

0000105-62-4

1,2-propyleneglycol dioleate

yes

no

no

 

 

 

 

214

61840

0000106-14-9

12-hydroxystearic acid

yes

no

no

 

 

 

 

215

14170

0000106-31-0

butyric anhydride

no

yes

no

 

 

 

 

216

14770

0000106-44-5

p-cresol

no

yes

no

 

 

 

 

217

15565

0000106-46-7

1,4-dichlorobenzene

no

yes

no

12

 

 

 

218

11590

0000106-63-8

acrylic acid, isobutyl ester

no

yes

no

 

(22)

 

 

219

14570

0000106-89-8

epichlorohydrin

no

yes

no

ND

 

1 mg/kg in final product

(10)

16750

220

20590

0000106-91-2

methacrylic acid, 2,3-epoxypropyl ester

no

yes

no

0,02

 

 

(10)

221

40570

0000106-97-8

butane

yes

no

no

 

 

 

 

222

13870

0000106-98-9

1-butene

no

yes

no

 

 

 

 

223

13630

0000106-99-0

butadiene

no

yes

no

ND

 

1 mg/kg in final product

 

224

13900

0000107-01-7

2-butene

no

yes

no

 

 

 

 

225

12100

0000107-13-1

acrylonitrile

no

yes

no

ND

 

 

 

226

15272

0000107-15-3

ethylenediamine

no

yes

no

12

 

 

 

16960

227

16990

0000107-21-1

ethyleneglycol

yes

yes

no

 

(2)

 

 

53650

228

13690

0000107-88-0

1,3-butanediol

no

yes

no

 

 

 

 

229

14140

0000107-92-6

butyric acid

no

yes

no

 

 

 

 

230

16150

0000108-01-0

dimethylaminoethanol

no

yes

no

18

 

 

 

231

10120

0000108-05-4

acetic acid, vinyl ester

no

yes

no

12

 

 

 

232

10150

0000108-24-7

acetic anhydride

yes

yes

no

 

 

 

 

30280

233

24850

0000108-30-5

succinic anhydride

no

yes

no

 

 

 

 

234

19960

0000108-31-6

maleic anhydride

no

yes

no

 

(3)

 

 

235

14710

0000108-39-4

m-cresol

no

yes

no

 

 

 

 

236

23050

0000108-45-2

1,3-phenylenediamine

no

yes

no

ND

 

 

 

237

15910

0000108-46-3

1,3-dihydroxybenzene

no

yes

no

2,4

 

 

 

24072

238

18070

0000108-55-4

glutaric anhydride

no

yes

no

 

 

 

 

▼M2

239

19975

0000108-78-1

2,4,6-triamino-1,3,5-triazine

yes

yes

no

2,5

 

 

 

25420

93720

▼B

240

45760

0000108-91-8

cyclohexylamine

yes

no

no

 

 

 

 

▼M6

241

22960

0000108-95-2

phenol

no

yes

no

3

 

 

 

▼B

242

85360

0000109-43-3

sebacic acid, dibutyl ester

yes

no

no

 

(32)

 

 

243

19060

0000109-53-5

isobutyl vinyl ether

no

yes

no

0,05

 

 

(10)

244

71720

0000109-66-0

pentane

yes

no

no

 

 

 

 

245

22900

0000109-67-1

1-pentene

no

yes

no

5

 

 

 

246

25150

0000109-99-9

tetrahydrofuran

no

yes

no

0,6

 

 

 

247

24820

0000110-15-6

succinic acid

yes

yes

no

 

 

 

 

90960

248

19540

0000110-16-7

maleic acid

yes

yes

no

 

(3)

 

 

64800

249

17290

0000110-17-8

fumaric acid

yes

yes

no

 

 

 

 

55120

250

53520

0000110-30-5

N,N′-ethylenebisstearamide

yes

no

no

 

 

 

 

251

53360

0000110-31-6

N,N′-ethylenebisoleamide

yes

no

no

 

 

 

 

252

87200

0000110-44-1

sorbic acid

yes

no

no

 

 

 

 

253

15250

0000110-60-1

1,4-diaminobutane

no

yes

no

 

 

 

 

254

13720

0000110-63-4

1,4-butanediol

yes

yes

no

 

(30)

 

 

40580

255

25900

0000110-88-3

trioxane

no

yes

no

5

 

 

 

256

18010

0000110-94-1

glutaric acid

yes

yes

no

 

 

 

 

55680

▼M3

257

13550

0000110-98-5

dipropyleneglycol

yes

yes

no

 

 

 

 

16660

0025265-71-8

51760

 

▼B

258

70480

0000111-06-8

palmitic acid, butyl ester

yes

no

no

 

 

 

 

259

58720

0000111-14-8

heptanoic acid

yes

no

no

 

 

 

 

260

24280

0000111-20-6

sebacic acid

no

yes

no

 

 

 

 

261

15790

0000111-40-0

diethylenetriamine

no

yes

no

5

 

 

 

262

35284

0000111-41-1

N-(2-aminoethyl)ethanolamine

yes

no

no

0,05

 

Not to be used for articles in contact with fatty foods for which ►M7  simulant D1 and/or D2 ◄ is laid down.

For indirect food contact only, behind a PET layer.

 

263

13326

0000111-46-6

diethyleneglycol

yes

yes

no

 

(2)

 

 

15760

47680

264

22660

0000111-66-0

1-octene

no

yes

no

15

 

 

 

265

22600

0000111-87-5

1-octanol

no

yes

no

 

 

 

 

266

25510

0000112-27-6

triethyleneglycol

yes

yes

no

 

 

 

 

94320

267

15100

0000112-30-1

1-decanol

no

yes

no

 

 

 

 

268

16704

0000112-41-4

1-dodecene

no

yes

no

0,05

 

 

 

269

25090

0000112-60-7

tetraethyleneglycol

yes

yes

no

 

 

 

 

92350

270

22763

0000112-80-1

oleic acid

yes

yes

no

 

 

 

 

69040

271

52720

0000112-84-5

erucamide

yes

no

no

 

 

 

 

272

37040

0000112-85-6

behenic acid

yes

no

no

 

 

 

 

273

52730

0000112-86-7

erucic acid

yes

no

no

 

 

 

 

274

22570

0000112-96-9

octadecyl isocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

275

23980

0000115-07-1

propylene

no

yes

no

 

 

 

 

276

19000

0000115-11-7

isobutene

no

yes

no

 

 

 

 

277

18280

0000115-27-5

hexachloroendomethylenetetrahydrophthalic anhydride

no

yes

no

ND

 

 

 

278

18250

0000115-28-6

hexachloroendomethylenetetrahydrophthalic acid

no

yes

no

ND

 

 

 

279

22840

0000115-77-5

pentaerythritol

yes

yes

no

 

 

 

 

71600

280

73720

0000115-96-8

phosphoric acid, trichloroethyl ester

yes

no

no

ND

 

 

 

281

25120

0000116-14-3

tetrafluoroethylene

no

yes

no

0,05

 

 

 

282

18430

0000116-15-4

hexafluoropropylene

no

yes

no

ND

 

 

 

283

74640

0000117-81-7

phthalic acid, bis(2-ethylhexyl) ester

yes

no

no

1,5

(32)

Only to be used as:

(a)  plasticiser in repeated use materials and articles contacting non-fatty foods;

(b)  technical support agent in concentrations up to 0,1 % in the final product.

(7)

284

84880

0000119-36-8

salicylic acid, methyl ester

yes

no

no

30

 

 

 

285

66480

0000119-47-1

2,2′-methylene bis(4-methyl-6-tert-butylphenol)

yes

no

yes

 

(13)

 

 

286

38240

0000119-61-9

benzophenone

yes

no

yes

0,6

 

 

 

287

60160

0000120-47-8

4-hydroxybenzoic acid, ethyl ester

yes

no

no

 

 

 

 

288

24970

0000120-61-6

terephthalic acid, dimethyl ester

no

yes

no

 

 

 

 

289

15880

0000120-80-9

1,2-dihydroxybenzene

no

yes

no

6

 

 

 

24051

290

55360

0000121-79-9

gallic acid, propyl ester

yes

no

no

 

(20)

 

 

291

19150

0000121-91-5

isophthalic acid

no

yes

no

 

(27)

 

 

292

94560

0000122-20-3

triisopropanolamine

yes

no

no

5

 

 

 

293

23175

0000122-52-1

phosphorous acid, triethyl ester

no

yes

no

ND

 

1 mg/kg in final product

(1)

294

93120

0000123-28-4

thiodipropionic acid, didodecyl ester

yes

no

yes

 

(14)

 

 

295

15940

0000123-31-9

1,4-dihydroxybenzene

yes

yes

no

0,6

 

 

 

18867

48620

296

23860

0000123-38-6

propionaldehyde

no

yes

no

 

 

 

 

297

23950

0000123-62-6

propionic anhydride

no

yes

no

 

 

 

 

298

14110

0000123-72-8

butyraldehyde

no

yes

no

 

 

 

 

299

63840

0000123-76-2

levulinic acid

yes

no

no

 

 

 

 

300

30045

0000123-86-4

acetic acid, butyl ester

yes

no

no

 

 

 

 

301

89120

0000123-95-5

stearic acid, butyl ester

yes

no

no

 

 

 

 

302

12820

0000123-99-9

azelaic acid

no

yes

no

 

 

 

 

303

12130

0000124-04-9

adipic acid

yes

yes

no

 

 

 

 

31730

304

14320

0000124-07-2

caprylic acid

yes

yes

no

 

 

 

 

41960

305

15274

0000124-09-4

hexamethylenediamine

no

yes

no

2,4

 

 

 

18460

306

88960

0000124-26-5

stearamide

yes

no

no

 

 

 

 

307

42160

0000124-38-9

carbon dioxide

yes

no

no

 

 

 

 

308

91200

0000126-13-6

sucrose acetate isobutyrate

yes

no

no

 

 

 

 

309

91360

0000126-14-7

sucrose octaacetate

yes

no

no

 

 

 

 

310

16390

0000126-30-7

2,2-dimethyl-1,3-propanediol

no

yes

no

0,05

 

 

 

22437

311

16480

0000126-58-9

dipentaerythritol

yes

yes

no

 

 

 

 

51200

312

21490

0000126-98-7

methacrylonitrile

no

yes

no

ND

 

 

 

313

16650

0000127-63-9

diphenyl sulphone

yes

yes

no

3

 

 

 

51570

314

23500

0000127-91-3

β-pinene

no

yes

no

 

 

 

 

315

46640

0000128-37-0

2,6-di-tert-butyl-p-cresol

yes

no

no

3

 

 

 

316

23230

0000131-17-9

phthalic acid, diallyl ester

no

yes

no

ND

 

 

 

317

48880

0000131-53-3

2,2′-dihydroxy-4-methoxybenzophenone

yes

no

yes

 

(8)

 

 

318

48640

0000131-56-6

2,4-dihydroxybenzophenone

yes

no

no

 

(8)

 

 

319

61360

0000131-57-7

2-hydroxy-4-methoxybenzophenone

yes

no

yes

 

(8)

 

 

320

37680

0000136-60-7

benzoic acid, butyl ester

yes

no

no

 

 

 

 

321

36080

0000137-66-6

ascorbyl palmitate

yes

no

no

 

 

 

 

322

63040

0000138-22-7

lactic acid, butyl ester

yes

no

no

 

 

 

 

323

11470

0000140-88-5

acrylic acid, ethyl ester

no

yes

no

 

(22)

 

 

324

83700

0000141-22-0

ricinoleic acid

yes

no

yes

42

 

 

 

325

10780

0000141-32-2

acrylic acid, n-butyl ester

no

yes

no

 

(22)

 

 

326

12763

0000141-43-5

2-aminoethanol

yes

yes

no

0,05

 

Not to be used for articles in contact with fatty foods for which ►M7  simulant D1 and/or D2 ◄ is laid down.

For indirect food contact only, behind a PET layer.

 

35170

327

30140

0000141-78-6

acetic acid, ethyl ester

yes

no

no

 

 

 

 

328

65040

0000141-82-2

malonic acid

yes

no

no

 

 

 

 

329

59360

0000142-62-1

hexanoic acid

yes

no

no

 

 

 

 

330

19470

0000143-07-7

lauric acid

yes

yes

no

 

 

 

 

63280

331

22480

0000143-08-8

1-nonanol

no

yes

no

 

 

 

 

332

69760

0000143-28-2

oleyl alcohol

yes

no

no

 

 

 

 

333

22775

0000144-62-7

oxalic acid

yes

yes

no

6

 

 

 

69920

334

17005

0000151-56-4

ethyleneimine

no

yes

no

ND

 

 

 

335

68960

0000301-02-0

oleamide

yes

no

no

 

 

 

 

336

15095

0000334-48-5

n-decanoic acid

yes

yes

no

 

 

 

 

45940

337

15820

0000345-92-6

4,4′-difluorobenzophenone

no

yes

no

0,05

 

 

 

338

71020

0000373-49-9

palmitoleic acid

yes

no

no

 

 

 

 

339

86160

0000409-21-2

silicon carbide

yes

no

no

 

 

 

 

▼M4

340

47440

0000461-58-5

dicyanodiamide

yes

no

no

60

 

 

 

▼B

341

13180

0000498-66-8

bicyclo[2.2.1]hept-2-ene

no

yes

no

0,05

 

 

 

22550

342

14260

0000502-44-3

caprolactone

no

yes

no

 

(29)

 

 

343

23770

0000504-63-2

1,3-propanediol

no

yes

no

0,05

 

 

 

▼M6

344

13810

0000505-65-7

1,4-butanediol formal

no

yes

no

0,05

15

30

 

(21)

21821

▼B

345

35840

0000506-30-9

arachidic acid

yes

no

no

 

 

 

 

346

10030

0000514-10-3

abietic acid

no

yes

no

 

 

 

 

347

13050

0000528-44-9

trimellitic acid

no

yes

no

 

(21)

 

 

25540

348

22350

0000544-63-8

myristic acid

yes

yes

no

 

 

 

 

67891

349

25550

0000552-30-7

trimellitic anhydride

no

yes

no

 

(21)

 

 

350

63920

0000557-59-5

lignoceric acid

yes

no

no

 

 

 

 

351

21730

0000563-45-1

3-methyl-1-butene

no

yes

no

ND

 

Only to be used in polypropylene

(1)

352

16360

0000576-26-1

2,6-dimethylphenol

no

yes

no

0,05

 

 

 

353

42480

0000584-09-8

carbonic acid, rubidium salt

yes

no

no

12

 

 

 

354

25210

0000584-84-9

2,4-toluene diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

355

20170

0000585-07-9

methacrylic acid, tert-butyl ester

no

yes

no

 

(23)

 

 

356

18820

0000592-41-6

1-hexene

no

yes

no

3

 

 

 

357

13932

0000598-32-3

3-buten-2-ol

no

yes

no

ND

 

Only to be used as a co-monomer for the preparation of polymeric additive

(1)

358

14841

0000599-64-4

4-cumylphenol

no

yes

no

0,05

 

 

 

359

15970

0000611-99-4

4,4′-dihydroxybenzophenone

yes

yes

no

 

(8)

 

 

48720

360

57920

0000620-67-7

glycerol triheptanoate

yes

no

no

 

 

 

 

361

18700

0000629-11-8

1,6-hexanediol

no

yes

no

0,05

 

 

 

362

14350

0000630-08-0

carbon monoxide

no

yes

no

 

 

 

 

363

16450

0000646-06-0

1,3-dioxolane

no

yes

no

5

 

 

 

▼M6

364

15404

0000652-67-5

1,4:3,6-dianhydrosorbitol

no

yes

no

5

 

Only to be used as:

(a)  a co-monomer in poly(ethylene-co-isosorbide terephthalate);

(b)  a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters.

Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.

 

▼B

365

11680

0000689-12-3

acrylic acid, isopropyl ester

no

yes

no

 

(22)

 

 

366

22150

0000691-37-2

4-methyl-1-pentene

no

yes

no

0,05

 

 

 

367

16697

0000693-23-2

n-dodecanedioic acid

no

yes

no

 

 

 

 

368

93280

0000693-36-7

thiodipropionic acid, dioctadecyl ester

yes

no

yes

 

(14)

 

 

369

12761

0000693-57-2

12-aminododecanoic acid

no

yes

no

0,05

 

 

 

370

21460

0000760-93-0

methacrylic anhydride

no

yes

no

 

(23)

 

 

371

11510

0000818-61-1

acrylic acid, monoester with ethyleneglycol

no

yes

no

 

(22)

 

 

11830

372

18640

0000822-06-0

hexamethylene diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

373

22390

0000840-65-3

2,6-naphthalenedicarboxylic acid, dimethyl ester

no

yes

no

0,05

 

 

 

374

21190

0000868-77-9

methacrylic acid, monoester with ethyleneglycol

no

yes

no

 

(23)

 

 

375

15130

0000872-05-9

1-decene

no

yes

no

0,05

 

 

 

▼M2

376

66905

0000872-50-4

N-methylpyrrolidone

yes

no

no

60

 

 

 

▼B

377

12786

0000919-30-2

3-aminopropyltriethoxysilane

no

yes

no

0,05

 

Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers.

SML = 0,05 mg/kg when used for the surface treatment of materials and articles.

 

378

21970

0000923-02-4

N-methylolmethacrylamide

no

yes

no

0,05

 

 

 

379

21940

0000924-42-5

N-methylolacrylamide

no

yes

no

ND

 

 

 

380

11980

0000925-60-0

acrylic acid, propyl ester

no

yes

no

 

(22)

 

 

381

15030

0000931-88-4

cyclooctene

no

yes

no

0,05

 

Only to be used in polymers contacting foods for which simulant A is laid down

 

382

19490

0000947-04-6

laurolactam

no

yes

no

5

 

 

 

383

72160

0000948-65-2

2-phenylindole

yes

no

yes

15

 

 

 

384

40000

0000991-84-4

2,4-bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine

yes

no

yes

30

 

 

 

385

11530

0000999-61-1

acrylic acid, 2-hydroxypropyl ester

no

yes

no

0,05

 

SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester.

It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2).

(1)

386

55280

0001034-01-1

gallic acid, octyl ester

yes

no

no

 

(20)

 

 

387

26155

0001072-63-5

1-vinylimidazole

no

yes

no

0,05

 

 

(1)

388

25080

0001120-36-1

1-tetradecene

no

yes

no

0,05

 

 

 

389

22360

0001141-38-4

2,6-naphthalenedicarboxylic acid

no

yes

no

5

 

 

 

390

55200

0001166-52-5

gallic acid, dodecyl ester

yes

no

no

 

(20)

 

 

▼M7

391

22932

0001187-93-5

perfluoromethyl perfluorovinyl ether

no

yes

no

0,05

 

Only to be used in:

— anti-stick coatings;

— fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with at least 150 kg food.

 

▼B

392

72800

0001241-94-7

phosphoric acid, diphenyl 2-ethylhexyl ester

yes

no

yes

2,4

 

 

 

393

37280

0001302-78-9

bentonite

yes

no

no

 

 

 

 

394

41280

0001305-62-0

calcium hydroxide

yes

no

no

 

 

 

 

395

41520

0001305-78-8

calcium oxide

yes

no

no

 

 

 

 

396

64640

0001309-42-8

magnesium hydroxide

yes

no

no

 

 

 

 

397

64720

0001309-48-4

magnesium oxide

yes

no

no

 

 

 

 

398

35760

0001309-64-4

antimony trioxide

yes

no

no

0,04

 

SML expressed as antimony

(6)

399

81600

0001310-58-3

potassium hydroxide

yes

no

no

 

 

 

 

400

86720

0001310-73-2

sodium hydroxide

yes

no

no

 

 

 

 

401

24475

0001313-82-2

sodium sulphide

no

yes

no

 

 

 

 

402

96240

0001314-13-2

zinc oxide

yes

no

no

 

 

 

 

403

96320

0001314-98-3

zinc sulphide

yes

no

no

 

 

 

 

404

67200

0001317-33-5

molybdenum disulphide

yes

no

no

 

 

 

 

405

16690

0001321-74-0

divinylbenzene

no

yes

no

ND

 

SML expressed as the sum of divinylbenzene and ethylvinylbenzene.

It may contain up to 45 % (m/m) of ethylvinylbenzene.

(1)

406

83300

0001323-39-3

1,2-propyleneglycol monostearate

yes

no

no

 

 

 

 

407

87040

0001330-43-4

sodium tetraborate

yes

no

no

 

(16)

 

 

408

82960

0001330-80-9

1,2-propyleneglycol monooleate

yes

no

no

 

 

 

 

409

62240

0001332-37-2

iron oxide

yes

no

no

 

 

 

 

▼M6

410

62720

0001332-58-7

kaolin

yes

no

no

 

 

Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi-layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food.

 

▼B

411

42080

0001333-86-4

carbon black

yes

no

no

 

 

Primary particles of 10 – 300 nm which are aggregated to a size of 100 – 1 200 nm which may form agglomerates within the size distribution of 300 nm – mm.

Toluene extractables: maximum 0,1 %, determined according to ISO method 6209.

UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a generally recognised method of analysis.

Benzo(a)pyrene content: max 0,25 mg/kg carbon black.

Maximum use level of carbon black in the polymer: 2,5 % w/w.

 

412

45200

0001335-23-5

copper iodide

yes

no

no

 

(6)

 

 

413

35600

0001336-21-6

ammonium hydroxide

yes

no

no

 

 

 

 

414

87600

0001338-39-2

sorbitan monolaurate

yes

no

no

 

 

 

 

415

87840

0001338-41-6

sorbitan monostearate

yes

no

no

 

 

 

 

416

87680

0001338-43-8

sorbitan monooleate

yes

no

no

 

 

 

 

417

85680

0001343-98-2

silicic acid

yes

no

no

 

 

 

 

418

34720

0001344-28-1

aluminium oxide

yes

no

no

 

 

 

 

419

92150

0001401-55-4

tannic acids

yes

no

no

 

 

According to the JECFA specifications

 

420

19210

0001459-93-4

isophthalic acid, dimethyl ester

no

yes

no

0,05

 

 

 

▼M4

421

13000

0001477-55-0

1,3-benzenedimethanamine

no

yes

no

 

(34)

 

 

▼B

422

38515

0001533-45-5

4,4′-bis(2-benzoxazolyl)stilbene

yes

no

yes

0,05

 

 

(2)

423

22937

0001623-05-8

perfluoropropylperfluorovinyl ether

no

yes

no

0,05

 

 

 

424

15070

0001647-16-1

1,9-decadiene

no

yes

no

0,05

 

 

 

425

10840

0001663-39-4

acrylic acid, tert-butyl ester

no

yes

no

 

(22)

 

 

426

13510

0001675-54-3

2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether

no

yes

no

 

 

In compliance with Commission Regulation (EC) No 1895/2005 (1)

 

13610

427

18896

0001679-51-2

4-(hydroxymethyl)-1-cyclohexene

no

yes

no

0,05

 

 

 

428

95200

0001709-70-2

1,3,5-trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene

yes

no

no

 

 

 

 

429

13210

0001761-71-3

bis(4-aminocyclohexyl)methane

no

yes

no

0,05

 

 

 

430

95600

0001843-03-4

1,1,3-tris(2-methyl-4-hydroxy-5-tert-butylphenyl) butane

yes

no

yes

5

 

 

 

431

61600

0001843-05-6

2-hydroxy-4-n-octyloxybenzophenone

yes

no

yes

 

(8)

 

 

432

12280

0002035-75-8

adipic anhydride

no

yes

no

 

 

 

 

433

68320

0002082-79-3

octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

yes

no

yes

6

 

 

 

434

20410

0002082-81-7

methacrylic acid, diester with 1,4-butanediol

no

yes

no

0,05

 

 

 

435

14230

0002123-24-2

caprolactam, sodium salt

no

yes

no

 

(4)

 

 

436

19480

0002146-71-6

lauric acid, vinyl ester

no

yes

no

 

 

 

 

437

11245

0002156-97-0

acrylic acid, dodecyl ester

no

yes

no

0,05

 

 

(2)

▼M2

438

13303

0002162-74-5

bis(2,6-diisopropylphenyl) carbodiimide

no

yes

no

0,05

 

Expressed as the sum of bis(2,6-diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline

 

▼B

439

21280

0002177-70-0

methacrylic acid, phenyl ester

no

yes

no

 

(23)

 

 

440

21340

0002210-28-8

methacrylic acid, propyl ester

no

yes

no

 

(23)

 

 

441

38160

0002315-68-6

benzoic acid, propyl ester

yes

no

no

 

 

 

 

442

13780

0002425-79-8

1,4-butanediol bis(2,3-epoxypropyl)ether

no

yes

no

ND

 

Residual content = 1 mg/kg in final product expressed as epoxygroup.

Molecular weight is 43 Da.

(10)

443

12788

0002432-99-7

11-aminoundecanoic acid

no

yes

no

5

 

 

 

444

61440

0002440-22-4

2-(2′-hydroxy-5′-methylphenyl)benzotriazole

yes

no

no

 

(12)

 

 

445

83440

0002466-09-3

pyrophosphoric acid

yes

no

no

 

 

 

 

446

10750

0002495-35-4

acrylic acid, benzyl ester

no

yes

no

 

(22)

 

 

447

20080

0002495-37-6

methacrylic acid, benzyl ester

no

yes

no

 

(23)

 

 

448

11890

0002499-59-4

acrylic acid, n-octyl ester

no

yes

no

 

(22)

 

 

▼M3

449

49840

0002500-88-1

dioctadecyl disulphide

yes

no

yes

0,05

 

 

 

▼B

450

24430

0002561-88-8

sebacic anhydride

no

yes

no

 

 

 

 

451

66755

0002682-20-4

2-methyl-4-isothiazolin-3-one

yes

no

no

0,5

 

Only to be used in aqueous polymer dispersions and emulsions

 

▼M2

452

38885

0002725-22-6

2,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine

yes

no

no

5

 

 

 

▼B

453

26320

0002768-02-7

vinyltrimethoxysilane

no

yes

no

0,05

 

 

(10)

454

12670

0002855-13-2

1-amino-3-aminomethyl-3,5,5-trimethylcyclohexane

no

yes

no

6

 

 

 

455

20530

0002867-47-2

methacrylic acid, 2-(dimethylamino)-ethyl ester

no

yes

no

ND

 

 

 

456

10810

0002998-08-5

acrylic acid, sec-butyl ester

no

yes

no

 

(22)

 

 

457

20140

0002998-18-7

methacrylic acid, sec-butyl ester

no

yes

no

 

(23)

 

 

458

36960

0003061-75-4

behenamide

yes

no

no

 

 

 

 

459

46870

0003135-18-0

3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester

yes

no

no

 

 

 

 

460

14950

0003173-53-3

cyclohexyl isocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

461

22420

0003173-72-6

1,5-naphthalene diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

462

26170

0003195-78-6

N-vinyl-N-methylacetamide

no

yes

no

0,02

 

 

(1)

463

25840

0003290-92-4

1,1,1-trimethylolpropane trimethacrylate

no

yes

no

0,05

 

 

 

464

61280

0003293-97-8

2-hydroxy-4-n-hexyloxybenzophenone

yes

no

yes

 

(8)

 

 

465

68040

0003333-62-8

7-[2H-naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin

yes

no

no

 

 

 

 

466

50640

0003648-18-8

di-n-octyltin dilaurate

yes

no

no

 

(10)

 

 

467

14800

0003724-65-0

crotonic acid

yes

yes

no

0,05

 

 

(1)

45600

468

71960

0003825-26-1

perfluorooctanoic acid, ammonium salt

yes

no

no

 

 

Only to be used in repeated use articles, sintered at high temperatures

 

469

60480

0003864-99-1

2-(2′-hydroxy-3,5′-di-tert-butylphenyl)-5-chlorobenzotriazole

yes

no

yes

 

(12)

 

 

470

60400

0003896-11-5

2-(2′-hydroxy-3′-tert-butyl-5′-methylphenyl)-5-chlorobenzotriazole

yes

no

yes

 

(12)

 

 

471

24888

0003965-55-7

5-sulphoisophthalic acid, monosodium salt, dimethyl ester

no

yes

no

0,05

 

 

 

472

66560

0004066-02-8

2,2′-methylenebis(4-methyl-6-cyclohexylphenol)

yes

no

yes

 

(5)

 

 

473

12265

0004074-90-2

adipic acid, divinyl ester

no

yes

no

ND

 

5 mg/kg in final product.

Only to be used as co-monomer.

(1)

474

43600

0004080-31-3

1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride

yes

no

no

0,3

 

 

 

475

19110

0004098-71-9

1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

476

16570

0004128-73-8

diphenylether-4,4′-diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

477

46720

0004130-42-1

2,6-di-tert-butyl-4-ethylphenol

yes

no

yes

4,8

 

 

(1)

478

60180

0004191-73-5

4-hydroxybenzoic acid, isopropyl ester

yes

no

no

 

 

 

 

479

12970

0004196-95-6

azelaic anhydride

no

yes

no

 

 

 

 

480

46790

0004221-80-1

3,5-di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester

yes

no

no

 

 

 

 

481

13060

0004422-95-1

1,3,5-benzenetricarboxylic acid trichloride

no

yes

no

0,05

 

SML expressed as 1,3,5-benzenetricarboxylic acid

(1)

482

21100

0004655-34-9

methacrylic acid, isopropyl ester

no

yes

no

 

(23)

 

 

483

68860

0004724-48-5

n-octylphosphonic acid

yes

no

no

0,05

 

 

 

484

13395

0004767-03-7

2,2-bis(hydroxymethyl)propionic acid

no

yes

no

0,05

 

 

(1)

485

13560

0005124-30-1

dicyclohexylmethane-4,4′-diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

15700

486

54005

0005136-44-7

ethylene-N-palmitamide-N′-stearamide

yes

no

no

 

 

 

 

487

45640

0005232-99-5

2-cyano-3,3-diphenylacrylic acid, ethyl ester

yes

no

no

0,05

 

 

 

488

53440

0005518-18-3

N,N′-ethylenebispalmitamide

yes

no

no

 

 

 

 

489

41040

0005743-36-2

calcium butyrate

yes

no

no

 

 

 

 

490

16600

0005873-54-1

diphenylmethane-2,4′-diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

491

82720

0006182-11-2

1,2-propyleneglycol distearate

yes

no

no

 

 

 

 

492

45650

0006197-30-4

2-cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester

yes

no

no

0,05

 

 

 

493

39200

0006200-40-4

bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy)methylammonium chloride

yes

no

no

1,8

 

 

 

494

62140

0006303-21-5

hypophosphorous acid

yes

no

no

 

 

 

 

495

35160

0006642-31-5

6-amino-1,3-dimethyluracil

yes

no

no

5

 

 

 

496

71680

0006683-19-8

pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]

yes

no

no

 

 

 

 

497

95020

0006846-50-0

2,2,4-trimethyl-1,3-pentanediol diisobutyrate

yes

no

no

5

 

Only to be used in single-use gloves

 

498

16210

0006864-37-5

3,3′-dimethyl-4,4′-diaminodicyclohexylmethane

no

yes

no

0,05

 

Only to be used in polyamides

(5)

499

19965

0006915-15-7

malic acid

yes

yes

no

 

 

In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis

 

65020

500

38560

0007128-64-5

2,5-bis(5-tert-butyl-2-benzoxazolyl)thiophene

yes

no

yes

0,6

 

 

 

501

34480

aluminium fibers, flakes and powders

yes

no

no

 

 

 

 

502

22778

0007456-68-0

4,4′-oxybis(benzenesulphonyl azide)

no

yes

no

0,05

 

 

(1)

503

46080

0007585-39-9

β-dextrin

yes

no

no

 

 

 

 

504

86240

0007631-86-9

silicon dioxide

yes

no

no

 

 

For synthetic amorphous silicon dioxide: primary particles of 1 – 100 nm which are aggregated to a size of 0,1 – 1 μm which may form agglomerates within the size distribution of 0,3 μm to the mm size.

 

505

86480

0007631-90-5

sodium bisulphite

yes

no

no

 

(19)

 

 

506

86920

0007632-00-0

sodium nitrite

yes

no

no

0,6

 

 

 

507

59990

0007647-01-0

hydrochloric acid

yes

no

no

 

 

 

 

508

86560

0007647-15-6

sodium bromide

yes

no

no

 

 

 

 

509

23170

0007664-38-2

phosphoric acid

yes

yes

no

 

 

 

 

72640

510

12789

0007664-41-7

ammonia

yes

yes

no

 

 

 

 

35320

511

91920

0007664-93-9

sulphuric acid

yes

no

no

 

 

 

 

512

81680

0007681-11-0

potassium iodide

yes

no

no

 

(6)

 

 

513

86800

0007681-82-5

sodium iodide

yes

no

no

 

(6)

 

 

514

91840

0007704-34-9

sulphur

yes

no

no

 

 

 

 

515

26360

0007732-18-5

water

yes

yes

no

 

 

In compliance with Directive 98/83/EC (2)

 

95855

516

86960

0007757-83-7

sodium sulphite

yes

no

no

 

(19)

 

 

517

81520

0007758-02-3

potassium bromide

yes

no

no

 

 

 

 

518

35845

0007771-44-0

arachidonic acid

yes

no

no

 

 

 

 

519

87120

0007772-98-7

sodium thiosulphate

yes

no

no

 

(19)

 

 

520

65120

0007773-01-5

manganese chloride

yes

no

no

 

 

 

 

521

58320

0007782-42-5

graphite

yes

no

no

 

 

 

 

522

14530

0007782-50-5

chlorine

no

yes

no

 

 

 

 

523

45195

0007787-70-4

copper bromide

yes

no

no

 

 

 

 

524

24520

0008001-22-7

soybean oil

no

yes

no

 

 

 

 

525

62640

0008001-39-6

japan wax

yes

no

no

 

 

 

 

526

43440

0008001-75-0

ceresin

yes

no

no

 

 

 

 

527

14411

0008001-79-4

castor oil

yes

yes

no

 

 

 

 

42880

528

63760

0008002-43-5

lecithin

yes

no

no

 

 

 

 

529

67850

0008002-53-7

montan wax

yes

no

no

 

 

 

 

530

41760

0008006-44-8

candelilla wax

yes

no

no

 

 

 

 

531

36880

0008012-89-3

beeswax

yes

no

no

 

 

 

 

532

88640

0008013-07-8

soybean oil, epoxidised

yes

no

no

60

30(*)

(32)

(*)  In the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC, the SML is lowered to 30 mg/kg.

Oxirane < 8 %, iodine number < 6.

 

533

42720

0008015-86-9

carnauba wax

yes

no

no

 

 

 

 

534

80720

0008017-16-1

polyphosphoric acids

yes

no

no

 

 

 

 

535

24100

0008050-09-7

rosin

yes

yes

no

 

 

 

 

24130

24190

83840

536

84320

0008050-15-5

rosin, hydrogenated, ester with methanol

yes

no

no

 

 

 

 

537

84080

0008050-26-8

rosin, ester with pentaerythritol

yes

no

no

 

 

 

 

538

84000

0008050-31-5

rosin, ester with glycerol

yes

no

no

 

 

 

 

539

24160

0008052-10-6

rosin tall oil

no

yes

no

 

 

 

 

540

63940

0008062-15-5

lignosulphonic acid

yes

no

no

0,24

 

Only to be used as dispersant for plastics dispersions

 

541

58480

0009000-01-5

gum arabic

yes

no

no

 

 

 

 

542

42640

0009000-11-7

carboxymethylcellulose

yes

no

no

 

 

 

 

543

45920

0009000-16-2

dammar

yes

no

no

 

 

 

 

544

58400

0009000-30-0

guar gum

yes

no

no

 

 

 

 

545

93680

0009000-65-1

tragacanth gum

yes

no

no

 

 

 

 

546

71440

0009000-69-5

pectin

yes

no

no

 

 

 

 

547

55440

0009000-70-8

gelatin

yes

no

no

 

 

 

 

548

42800

0009000-71-9

casein

yes

no

no

 

 

 

 

549

80000

0009002-88-4

polyethylene wax

yes

no

no

 

 

 

 

550

81060

0009003-07-0

polypropylene wax

yes

no

no

 

 

 

 

551

79920

0009003-11-6

0106392-12-5

poly(ethylene propylene) glycol

yes

no

no

 

 

 

 

552

81500

0009003-39-8

polyvinylpyrrolidone

yes

no

no

 

 

The substance shall meet the purity criteria as laid down in Commission Directive 2008/84/EC (3)

 

553

14500

0009004-34-6

cellulose

yes

yes

no

 

 

 

 

43280

554

43300

0009004-36-8

cellulose acetate butyrate

yes

no

no

 

 

 

 

555

53280

0009004-57-3

ethylcellulose

yes

no

no

 

 

 

 

556

54260

0009004-58-4

ethylhydroxyethylcellulose

yes

no

no

 

 

 

 

557

66640

0009004-59-5

methylethylcellulose

yes

no

no

 

 

 

 

558

60560

0009004-62-0

hydroxyethylcellulose

yes

no

no

 

 

 

 

559

61680

0009004-64-2

hydroxypropylcellulose

yes

no

no

 

 

 

 

560

66700

0009004-65-3

methylhydroxypropylcellulose

yes

no

no

 

 

 

 

561

66240

0009004-67-5

methylcellulose

yes

no

no

 

 

 

 

562

22450

0009004-70-0

nitrocellulose

no

yes

no

 

 

 

 

563

78320

0009004-97-1

polyethyleneglycol monoricinoleate

yes

no

yes

42

 

 

 

564

24540

0009005-25-8

starch, edible

yes

yes

no

 

 

 

 

88800

565

61120

0009005-27-0

hydroxyethyl starch

yes

no

no

 

 

 

 

566

33350

0009005-32-7

alginic acid

yes

no

no

 

 

 

 

567

82080

0009005-37-2

1,2-propyleneglycol alginate

yes

no

no

 

 

 

 

568

79040

0009005-64-5

polyethyleneglycol sorbitan monolaurate

yes

no

no

 

 

 

 

569

79120

0009005-65-6

polyethyleneglycol sorbitan monooleate

yes

no

no

 

 

 

 

570

79200

0009005-66-7

polyethyleneglycol sorbitan monopalmitate

yes

no

no

 

 

 

 

571

79280

0009005-67-8

polyethyleneglycol sorbitan monostearate

yes

no

no

 

 

 

 

572

79360

0009005-70-3

polyethyleneglycol sorbitan trioleate

yes

no

no

 

 

 

 

573

79440

0009005-71-4

polyethyleneglycol sorbitan tristearate

yes

no

no

 

 

 

 

574

24250

0009006-04-6

rubber, natural

yes

yes

no

 

 

 

 

84560

575

76721

0063148-62-9

polydimethylsiloxane (Mw > 6 800 Da)

yes

no

no

 

 

Viscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s)

 

576

60880

0009032-42-2

hydroxyethylmethylcellulose

yes

no

no

 

 

 

 

577

62280

0009044-17-1

isobutylene-butene copolymer

yes

no

no

 

 

 

 

578

79600

0009046-01-9

polyethyleneglycol tridecyl ether phosphate

yes

no

no

5

 

For materials and articles intended for contact with aqueous foods only.

Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.

 

579

61800

0009049-76-7

hydroxypropyl starch

yes

no

no

 

 

 

 

580

46070

0010016-20-3

α-dextrin

yes

no

no

 

 

 

 

581

36800

0010022-31-8

barium nitrate

yes

no

no

 

 

 

 

582

50240

0010039-33-5

di-n-octyltin bis(2-ethylhexyl maleate)

yes

no

no

 

(10)

 

 

583

40400

0010043-11-5

boron nitride

yes

no

no

 

(16)

 

 

584

13620

0010043-35-3

boric acid

yes

yes

no

 

(16)

 

 

40320

585

41120

0010043-52-4

calcium chloride

yes

no

no

 

 

 

 

586

65280

0010043-84-2

manganese hypophosphite

yes

no

no

 

 

 

 

587

68400

0010094-45-8

octadecylerucamide

yes

no

yes

5

 

 

 

588

64320

0010377-51-2

lithium iodide

yes

no

no

 

(6)

 

 

589

52645

0010436-08-5

cis-11-eicosenamide

yes

no

no

 

 

 

 

590

21370

0010595-80-9

methacrylic acid, 2-sulphoethyl ester

no

yes

no

ND

 

 

(1)

591

36160

0010605-09-1

ascorbyl stearate

yes

no

no

 

 

 

 

592

34690

0011097-59-9

aluminium magnesium carbonate hydroxide

yes

no

no

 

 

 

 

593

44960

0011104-61-3

cobalt oxide

yes

no

no

 

 

 

 

594

65360

0011129-60-5

manganese oxide

yes

no

no

 

 

 

 

595

19510

0011132-73-3

lignocellulose

no

yes

no

 

 

 

 

596

95935

0011138-66-2

xanthan gum

yes

no

no

 

 

 

 

597

67120

0012001-26-2

mica

yes

no

no

 

 

 

 

598

41600

0012004-14-7

0037293-22-4

calcium sulphoaluminate

yes

no

no

 

 

 

 

599

36840

0012007-55-5

barium tetraborate

yes

no

no

 

(16)

 

 

600

60030

0012072-90-1

hydromagnesite

yes

no

no

 

 

 

 

601

35440

0012124-97-9

ammonium bromide

yes

no

no

 

 

 

 

602

70240

0012198-93-5

ozokerite

yes

no

no

 

 

 

 

603

83460

0012269-78-2

pyrophyllite

yes

no

no

 

 

 

 

604

60080

0012304-65-3

hydrotalcite

yes

no

no

 

 

 

 

605

11005

0012542-30-2

acrylic acid, dicyclopentenyl ester

no

yes

no

0,05

 

 

(1)

606

65200

0012626-88-9

manganese hydroxide

yes

no

no

 

 

 

 

607

62245

0012751-22-3

iron phosphide

yes

no

no

 

 

Only to be used in PET polymers and copolymers

 

608

40800

0013003-12-8

4,4′-butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite)

yes

no

yes

6

 

 

 

609

83455

0013445-56-2

pyrophosphorous acid

yes

no

no

 

 

 

 

610

93440

0013463-67-7

titanium dioxide

yes

no

no

 

 

 

 

611

35120

0013560-49-1

3-aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether

yes

no

no

 

 

 

 

612

16694

0013811-50-2

N,N′-divinyl-2-imidazolidinone

no

yes

no

0,05

 

 

(10)

613

95905

0013983-17-0

wollastonite

yes

no

no

 

 

 

 

614

45560

0014464-46-1

cristobalite

yes

no

no

 

 

 

 

615

92080

0014807-96-6

talc

yes

no

no

 

 

 

 

616

83470

0014808-60-7

quartz

yes

no

no

 

 

 

 

617

10660

0015214-89-8

2-acrylamido-2-methylpropanesulphonic acid

no

yes

no

0,05

 

 

 

618

51040

0015535-79-2

di-n-octyltin mercaptoacetate

yes

no

no

 

(10)

 

 

619

50320

0015571-58-1

di-n-octyltin bis(2-ethylhexyl mercaptoacetate)

yes

no

no

 

(10)

 

 

620

50720

0015571-60-5

di-n-octyltin dimaleate

yes

no

no

 

(10)

 

 

621

17110

0016219-75-3

5-ethylidenebicyclo[2,2,1]hept-2-ene

no

yes

no

0,05

 

 

(9)

622

69840

0016260-09-6

oleylpalmitamide

yes

no

yes

5

 

 

 

623

52640

0016389-88-1

dolomite

yes

no

no

 

 

 

 

624

18897

0016712-64-4

6-hydroxy-2-naphthalenecarboxylic acid

no

yes

no

0,05

 

 

 

625

36720

0017194-00-2

barium hydroxide

yes

no

no

 

 

 

 

626

57800

0018641-57-1

glycerol tribehenate

yes

no

no

 

 

 

 

627

59760

0019569-21-2

huntite

yes

no

no

 

 

 

 

628

96190

0020427-58-1

zinc hydroxide

yes

no

no

 

 

 

 

629

34560

0021645-51-2

aluminium hydroxide

yes

no

no

 

 

 

 

630

82240

0022788-19-8

1,2-propyleneglycol dilaurate

yes

no

no

 

 

 

 

631

59120

0023128-74-7

1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide)

yes

no

yes

45

 

 

 

632

52880

0023676-09-7

4-ethoxybenzoic acid, ethyl ester

yes

no

no

3,6

 

 

 

633

53200

0023949-66-8

2-ethoxy-2′-ethyloxanilide

yes

no

yes

30

 

 

 

634

25910

0024800-44-0

tripropyleneglycol

no

yes

no

 

 

 

 

635

40720

0025013-16-5

tert-butyl-4-hydroxyanisole

yes

no

no

30

 

 

 

636

31500

0025134-51-4

acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer

yes

no

no

0,05

(22)

SML expressed as acrylic acid, 2-ethylhexyl ester

 

637

71635

0025151-96-6

pentaerythritol dioleate

yes

no

no

0,05

 

Not to be used for articles in contact with fatty foods for which ►M7  simulant D1 and/or D2 ◄ is laid down

 

638

23590

0025322-68-3

polyethyleneglycol

yes

yes

no

 

 

 

 

76960

639

23651

0025322-69-4

polypropyleneglycol

yes

yes

no

 

 

 

 

80800

640

54930

0025359-91-5

formaldehyde-1-naphthol, copolymer

yes

no

no

0,05

 

 

 

▼M7

641

22331

0025513-64-8

mixture of (35-45 % w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexane

no

yes

no

0,05

 

 

 

▼B

642

64990

0025736-61-2

maleic anhydride-styrene, copolymer, sodium salt

yes

no

no

 

 

The fraction with molecular weight below 1 000 Da ►M7  shall ◄ not exceed 0,05 % (w/w)

 

643

87760

0026266-57-9

sorbitan monopalmitate

yes

no

no

 

 

 

 

644

88080

0026266-58-0

sorbitan trioleate

yes

no

no

 

 

 

 

645

67760

0026401-86-5

mono-n-octyltin tris(isooctyl mercaptoacetate)

yes

no

no

 

(11)

 

 

646

50480

0026401-97-8

di-n-octyltin bis(isooctyl mercaptoacetate)

yes

no

no

 

(10)

 

 

647

56720

0026402-23-3

glycerol monohexanoate

yes

no

no

 

 

 

 

648

56880

0026402-26-6

glycerol monooctanoate

yes

no

no

 

 

 

 

649

47210

0026427-07-6

dibutylthiostannoic acid polymer

yes

no

no

 

 

Molecular unit = (C8H18S3Sn2)n (n = 1,5-2)

 

650

49600

0026636-01-1

dimethyltin bis(isooctyl mercaptoacetate)

yes

no

no

 

(9)

 

 

651

88240

0026658-19-5

sorbitan tristearate

yes

no

no

 

 

 

 

652

38820

0026741-53-7

bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite

yes

no

yes

0,6

 

 

 

653

25270

0026747-90-0

2,4-toluene diisocyanate dimer

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

654

88600

0026836-47-5

sorbitol monostearate

yes

no

no

 

 

 

 

655

25450

0026896-48-0

tricyclodecanedimethanol

no

yes

no

0,05

 

 

 

656

24760

0026914-43-2

styrenesuphonic acid

no

yes

no

0,05

 

 

 

657

67680

0027107-89-7

mono-n-octyltin tris(2-ethylhexyl mercaptoacetate)

yes

no

no

 

(11)

 

 

658

52000

0027176-87-0

dodecylbenzenesulphonic acid

yes

no

no

30

 

 

 

659

82800

0027194-74-7

1,2-propyleneglycol monolaurate

yes

no

no

 

 

 

 

660

47540

0027458-90-8

di-tert-dodecyl disulphide

yes

no

yes

0,05

 

 

 

661

95360

0027676-62-6

1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

yes

no

yes

5

 

 

 

662

25927

0027955-94-8

1,1,1-tris(4-hydroxyphenol)ethane

no

yes

no

0,005

 

Only to be used in polycarbonates

(1)

663

64150

0028290-79-1

linolenic acid

yes

no

no

 

 

 

 

664

95000

0028931-67-1

trimethylolpropane trimethacrylate-methyl methacrylate copolymer

yes

no

no

 

 

 

 

665

83120

0029013-28-3

1,2-propyleneglycol monopalmitate

yes

no

no

 

 

 

 

666

87280

0029116-98-1

sorbitan dioleate

yes

no

no

 

 

 

 

667

55190

0029204-02-2

gadoleic acid

yes

no

no

 

 

 

 

668

80240

0029894-35-7

polyglycerol ricinoleate

yes

no

no

 

 

 

 

669

56610

0030233-64-8

glycerol monobehenate

yes

no

no

 

 

 

 

670

56800

0030899-62-8

glycerol monolaurate diacetate

yes

no

no

 

(32)

 

 

671

74240

0031570-04-4

phosphorous acid, tris(2,4-di-tert-butylphenyl)ester

yes

no

no

 

 

 

 

672

76845

0031831-53-5

polyester of 1,4-butanediol with caprolactone

yes

no

no

 

(29)

(30)

The fraction with molecular weight below 1 000 Da ►M7  shall ◄ not exceed 0,5 % (w/w)

 

673

53670

0032509-66-3

ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]

yes

no

yes

6

 

 

 

674

46480

0032647-67-9

dibenzylidene sorbitol

yes

no

no

 

 

 

 

675

38800

0032687-78-8

N,N′-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide

yes

no

yes

15

 

 

 

676

50400

0033568-99-9

di-n-octyltin bis(isooctyl maleate)

yes

no

no

 

(10)

 

 

677

82560

0033587-20-1

1,2-propyleneglycol dipalmitate

yes

no

no

 

 

 

 

678

59200

0035074-77-2

1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)

yes

no

yes

6

 

 

 

679

39060

0035958-30-6

1,1-bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane

yes

no

yes

5

 

 

 

680

94400

0036443-68-2

triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate]

yes

no

no

9

 

 

 

681

18310

0036653-82-4

1-hexadecanol

no

yes

no

 

 

 

 

682

53270

0037205-99-5

ethylcarboxymethylcellulose

yes

no

no

 

 

 

 

683

66200

0037206-01-2

methylcarboxymethylcellulose

yes

no

no

 

 

 

 

684

68125

0037244-96-5

nepheline syenite

yes

no

no

 

 

 

 

685

85950

0037296-97-2

silicic acid, magnesium-sodium-fluoride salt

yes

no

no

0,15

 

SML expressed as fluoride.

Only to be used in layers of multi-layer materials not coming into direct contact with food.

 

686

61390

0037353-59-6

hydroxymethylcellulose

yes

no

no

 

 

 

 

687

13530

0038103-06-9

2,2-bis(4-hydroxyphenyl)propane bis(phthalic anhydride)

no

yes

no

0,05

 

 

 

13614

688

92560

0038613-77-3

tetrakis(2,4-di-tert-butyl-phenyl)-4,4′-biphenylylene diphosphonite

yes

no

yes

18

 

 

 

689

95280

0040601-76-1

1,3,5-tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

yes

no

yes

6

 

 

 

690

92880

0041484-35-9

thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate)

yes

no

yes

2,4

 

 

 

691

13600

0047465-97-4

3,3-bis(3-methyl-4-hydroxyphenyl)2-indolinone

no

yes

no

1,8

 

 

 

692

52320

0052047-59-3

2-(4-dodecylphenyl)indole

yes

no

yes

0,06

 

 

 

693

88160

0054140-20-4

sorbitan tripalmitate

yes

no

no

 

 

 

 

694

21400

0054276-35-6

methacrylic acid, sulphopropyl ester

no

yes

no

0,05

 

 

(1)

695

67520

0054849-38-6

monomethyltin tris(isooctyl mercaptoacetate)

yes

no

no

 

(9)

 

 

696

92205

0057569-40-1

terephthalic acid, diester with 2,2′-methylenebis(4-methyl-6-tert-butylphenol)

yes

no

no

 

 

 

 

697

67515

0057583-34-3

monomethyltin tris(ethylhexyl mercaptoacetate)

yes

no

no

 

(9)

 

 

698

49595

0057583-35-4

dimethyltin bis(ethylhexyl mercaptoacetate)

yes

no

no

 

(9)

 

 

699

90720

0058446-52-9

stearoylbenzoylmethane

yes

no

no

 

 

 

 

700

31520

0061167-58-6

acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl ester

yes

no

yes

6

 

 

 

701

40160

0061269-61-2

N,N′-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer

yes

no

no

2,4

 

 

 

702

87920

0061752-68-9

sorbitan tetrastearate

yes

no

no

 

 

 

 

703

17170

0061788-47-4

fatty acids, coco

no

yes

no

 

 

 

 

704

77600

0061788-85-0

polyethyleneglycol ester of hydrogenated castor oil

yes

no

no

 

 

 

 

705

10599/90A

0061788-89-4

acids, fatty, unsaturated (C18), dimers, non hydrogenated, distilled and non-distilled

no

yes

no

 

(18)

 

(1)

10599/91

706

17230

0061790-12-3

fatty acids, tall oil

no

yes

no

 

 

 

 

707

46375

0061790-53-2

diatomaceous earth

yes

no

no

 

 

 

 

708

77520

0061791-12-6

polyethyleneglycol ester of castor oil

yes

no

no

42

 

 

 

709

87520

0062568-11-0

sorbitan monobehenate

yes

no

no

 

 

 

 

710

38700

0063397-60-4

bis(2-carbobutoxyethyl)tin-bis(isooctyl mercaptoacetate)

yes

no

yes

18

 

 

 

711

42000

0063438-80-2

(2-carbobutoxyethyl)tin-tris(isooctyl mercaptoacetate)

yes

no

yes

30

 

 

 

712

42960

0064147-40-6

castor oil, dehydrated

yes

no

no

 

 

 

 

▼M6

713

43480

0064365-11-3

charcoal, activated

yes

no

no

 

 

Only for use in PET at maximum 10 mg/kg of polymer.

Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 (4) with exception of ash content which can be up to 10 % (w/w).

 

0007440-44-0

▼B

714

84400

0064365-17-9

rosin, hydrogenated, ester with pentaerythritol

yes

no

no

 

 

 

 

715

46880

0065140-91-2

3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester, calcium salt

yes

no

no

6

 

 

 

716

60800

0065447-77-0

1-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl piperidine-succinic acid, dimethyl ester, copolymer

yes

no

no

30

 

 

 

717

84210

0065997-06-0

rosin, hydrogenated

yes

no

no

 

 

 

 

718

84240

0065997-13-9

rosin, hydrogenated, ester with glycerol

yes

no

no

 

 

 

 

719

65920

0066822-60-4

N-methacryloyloxyethyl-N,N-dimethyl-N-carboxymethylammonium chloride, sodium salt -octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers

yes

no

no

 

 

 

 

720

67360

0067649-65-4

mono-n-dodecyltin tris(isooctyl mercaptoacetate)

yes

no

no

 

(25)

 

 

721

46800

0067845-93-6

3,5-di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester

yes

no

no

 

 

 

 

722

17200

0068308-53-2

fatty acids, soya

no

yes

no

 

 

 

 

723

88880

0068412-29-3

starch, hydrolysed

yes

no

no

 

 

 

 

724

24903

0068425-17-2

syrups, hydrolysed starch, hydrogenated

no

yes

no

 

 

In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC (5)

 

▼M6 —————

▼B

726

83599

0068442-12-6

reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin

yes

no

yes

 

(9)

 

 

727

43360

0068442-85-3

cellulose, regenerated

yes

no

no

 

 

 

 

728

75100

0068515-48-0

0028553-12-0

phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9

yes

no

no

 

(26)

(32)

Only to be used as:

(a)  plasticiser in repeated use materials and articles;

(b)  plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;

(c)  technical support agent in concentrations up to 0,1 % in the final product.

(7)

729

75105

0068515-49-1

0026761-40-0

phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10

yes

no

no

 

(26)

(32)

Only to be used as:

(a)  plasticiser in repeated use materials and articles;

(b)  plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;

(c)  technical support agent in concentrations up to 0,1 % in the final product.

(7)

730

66930

0068554-70-1

methylsilsesquioxane

yes

no

no

 

 

Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane

 

731

18220

0068564-88-5

N-heptylaminoundecanoic acid

no

yes

no

0,05

 

 

(2)

732

45450

0068610-51-5

p-cresol-dicyclopentadiene-isobutylene, copolymer

yes

no

yes

5

 

 

 

733

10599/92A

0068783-41-5

acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled and non-distilled

no

yes

no

 

(18)

 

(1)

10599/93

734

46380

0068855-54-9

diatomaceous earth, soda ash flux-calcined

yes

no

no

 

 

 

 

735

40120

0068951-50-8

bis(polyethyleneglycol)hydroxymethylphosphonate

yes

no

no

0,6

 

 

 

736

50960

0069226-44-4

di-n-octyltin ethyleneglycol bis(mercaptoacetate)

yes

no

no

 

(10)

 

 

737

77370

0070142-34-6

polyethyleneglycol-30 dipolyhydroxystearate

yes

no

no

 

 

 

 

738

60320

0070321-86-7

2-[2-hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole

yes

no

yes

1,5

 

 

 

739

70000

0070331-94-1

2,2′-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]

yes

no

no

 

 

 

 

740

81200

0071878-19-8

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]

yes

no

yes

3

 

 

 

741

24070

0073138-82-6

resin acids and rosin acids

yes

yes

no

 

 

 

 

83610

742

92700

0078301-43-6

2,2,4,4-tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymer

yes

no

yes

5

 

 

 

743

38950

0079072-96-1

bis(4-ethylbenzylidene)sorbitol

yes

no

no

 

 

 

 

744

18888

0080181-31-3

3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer

no

yes

no

 

 

The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I

 

745

68145

0080410-33-9

2,2′,2′-nitrilo(triethyl tris(3,3′,5,5′-tetra-tert-butyl-1,1′-bi-phenyl-2,2′-diyl)phosphite)

yes

no

yes

5

 

SML expressed as sum of phosphite and phosphate

 

746

38810

0080693-00-1

bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite

yes

no

yes

5

 

SML expressed as sum of phosphite and phosphate

 

747

47600

0084030-61-5

di-n-dodecyltin bis(isooctyl mercaptoacetate)

yes

no

yes

 

(25)

 

 

748

12765

0084434-12-8

N-(2-aminoethyl)-β-alanine, sodium salt

no

yes

no

0,05

 

 

 

749

66360

0085209-91-2

2,2′-methylene bis(4,6-di-tert-butylphenyl) sodium phosphate

yes

no

yes

5

 

 

 

750

66350

0085209-93-4

2,2′-methylenebis(4,6-di-tert-butylphenyl) lithium phosphate

yes

no

no

5

 

 

 

751

81515

0087189-25-1

poly(zinc glycerolate)

yes

no

no

 

 

 

 

▼M7

752

39890

0087826-41-3

0069158-41- 4

0054686-97-4

0081541-12-0

bis(methylbenzylidene)sorbitol

yes

no

no

 

 

 

 

▼B

753

62800

0092704-41-1

kaolin, calcined

yes

no

no

 

 

 

 

754

56020

0099880-64-5

glycerol dibehenate

yes

no

no

 

 

 

 

755

21765

0106246-33-7

4,4′-methylenebis(3-chloro-2,6-diethylaniline)

no

yes

no

0,05

 

 

(1)

756

40020

0110553-27-0

2,4-bis(octylthiomethyl)-6-methylphenol

yes

no

yes

 

(24)

 

 

757

95725

0110638-71-6

vermiculite, reaction product with citric acid, lithium salt

yes

no

no

 

 

 

 

758

38940

0110675-26-8

2,4-bis(dodecylthiomethyl)-6-methylphenol

yes

no

yes

 

(24)

 

 

759

54300

0118337-09-0

2,2′-ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphonite

yes

no

yes

6

 

 

 

760

83595

0119345-01-6

reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product of phosphorous trichloride and biphenyl

yes

no

no

18

 

Composition:

— 4,4′-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0038613-77-3) (36-46 % w/w (*)),

— 4,3′-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-00-4) (17-23 % w/w (*)),

— 3,3′-biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS No 0118421-01-5) (1-5 % w/w (*)),

— 4-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0091362-37-7) (11-19 % w/w (*)),

— tris(2,4-di-tert-butylphenyl)phosphite (CAS No 0031570-04-4) (9-18 % w/w (*)),

— 4,4′-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0112949-97-0) (< 5 % w/w (*))

(*)  Quantity of substance used/quantity of formulation

Other specifications:

— Phosphor content of min. 5,4 % to max. 5,9 %,

— Acid value of max. 10 mg KOH per gram,

— Melt range of 85– 110 °C,

 

761

92930

0120218-34-0

thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyridine-3-carboxylate)

yes

no

no

6

 

 

 

762

31530

0123968-25-2

acrylic acid, 2,4-di-tert-pentyl-6-(1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl)phenyl ester

yes

no

yes

5

 

 

 

763

39925

0129228-21-3

3,3-bis(methoxymethyl)-2,5-dimethylhexane

yes

no

yes

0,05

 

 

 

764

13317

0132459-54-2

N,N′-bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide

no

yes

no

0,05

 

Purity > 98,1 % (w/w).

Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT).

 

765

49485

0134701-20-5

2,4-dimethyl-6-(1-methylpentadecyl)phenol

yes

no

yes

1

 

 

 

766

38879

0135861-56-2

bis(3,4-dimethylbenzylidene)sorbitol

yes

no

no

 

 

 

 

767

38510

0136504-96-6

1,2-bis(3-aminopropyl)ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine

yes

no

no

5

 

 

 

768

34850

0143925-92-2

amines, bis(hydrogenated tallow alkyl) oxidised

yes

no

no

 

 

Not to be used for articles in contact with fatty foods for which ►M7  simulant D1 and/or D2 ◄ is laid down.

Only to be used in:

(a)  polyolefins at 0,1 % (w/w) concentration and in

(b)  PET at 0,25 % (w/w) concentration.

(1)

769

74010

0145650-60-8

phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester

yes

no

yes

5

 

SML expressed as sum of phosphite and phosphate

 

770

51700

0147315-50-2

2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol

yes

no

no

0,05

 

 

 

771

34650

0151841-65-5

aluminium hydroxybis [2,2′-methylenebis (4,6-di-tert-butylphenyl) phosphate]

yes

no

no

5

 

 

 

772

47500

0153250-52-3

N,N′-dicyclohexyl-2,6-naphthalene dicarboxamide

yes

no

no

5

 

 

 

773

38840

0154862-43-8

bis(2,4-dicumylphenyl)pentaerythritol-diphosphite

yes

no

yes

5

 

SML expressed as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol)

 

774

95270

0161717-32-4

2,4,6-tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediol phosphite

yes

no

yes

2

 

SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP

 

775

45705

0166412-78-8

1,2-cyclohexanedicarboxylic acid, diisononyl ester

yes

no

no

 

(32)

 

 

776

76723

0167883-16-1

polydimethylsiloxane, 3-aminopropyl terminated, polymer with dicyclohexylmethane-4,4′-diisocyanate

yes

no

no

 

 

The fraction with molecular weight below 1 000 Da ►M7  shall ◄ not exceed 1,5 % (w/w)

 

777

31542

0174254-23-0

acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters

yes

no

no

 

 

0,5 % in final product

(1)

778

71670

0178671-58-4

pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)

yes

no

yes

0,05

 

 

 

▼M7

779

39815

0182121-12-6

9,9-bis(methoxymethyl)fluorene

yes

no

yes

0,05

 

 

(2)

▼B

780

81220

0192268-64-7

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]]-α-[N,N,N′,N′-tetrabutyl-N"-(2,2,6,6-tetramethyl-4-piperidinyl)-N"-[6-(2,2,6,6-tetramethyl-4-piperidinylamino)-hexyl]-[1,3,5-triazine-2,4,6-triamine]-ω-N,N,N′,N′-tetrabutyl-1,3,5-triazine-2,4-diamine]

yes

no

no

5

 

 

 

781

95265

0227099-60-7

1,3,5-tris(4-benzoylphenyl) benzene

yes

no

no

0,05

 

 

 

782

76725

0661476-41-1

polydimethylsiloxane, 3-aminopropyl terminated, polymer with 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane

yes

no

no

 

 

The fraction with molecular weight below 1 000 Da ►M7  shall ◄ not exceed 1 % (w/w)

 

783

55910

0736150-63-3

glycerides, castor-oil mono-, hydrogenated, acetates

yes

no

no

 

(32)

 

 

▼M6

784

95420

0745070-61-5

1,3,5-tris (2,2-di-methylpropanamido) benzene

yes

no

no

5

 

 

 

▼B

785

24910

0000100-21-0

terephthalic acid

no

yes

no

 

(28)

 

 

786

14627

0000117-21-5

3-chlorophthalic anhydride

no

yes

no

0,05

 

SML expressed as 3-chlorophthalic acid

 

787

14628

0000118-45-6

4-chlorophthalic anhydride

no

yes

no

0,05

 

SML expressed as 4-chlorophthalic acid

 

788

21498

0002530-85-0

[3-(methacryloxy)propyl]trimethoxysilane

no

yes

no

0,05

 

Only to be used as a surface treatment agent of inorganic fillers

(1)

(11)

789

60027

hydrogenated homopolymers and/or copolymers made of 1-hexene and/or 1-octene and/or 1-decene and/or 1-dodecene and/or 1-tetradecene (Mw: 440–12 000 )

yes

no

no

 

 

Average molecular weight not less than 440 Da.

Viscosity at 100 °C not less than 3,8 cSt (3,8 × 10-6 m2/s).

(2)

790

80480

0090751-07-8

0082451-48-7

poly(6-morpholino-1,3,5-triazine-2,4-diyl)-[(2,2,6,6-tetramethyl-4-piperidyl)imino)] hexa-methylene-[(2,2,6,6-tetramethyl-4-piperidyl)imino)]

yes

no

no

5

 

Average molecular weight not less than 2 400 Da.

Residual content of morpholine ≤ 30 mg/kg, of N,N′-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15 000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.

(16)

791

92470

0106990-43-6

N,N′,N″,N″-tetrakis(4,6-bis(N-butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine

yes

no

no

0,05

 

 

 

792

92475

0203255-81-6

3,3′,5,5′-tetrakis(tert-butyl)-2,2′-dihydroxybiphenyl, cyclic ester with [3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propyl]oxyphosphonous acid

yes

no

yes

5

 

SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis products

 

793

94000

0000102-71-6

triethanolamine

yes

no

no

0,05

 

SML expressed as the sum of triethanolamine and the hydrochloride adduct expressed as triethanolamine

 

▼M2

794

18117

0000079-14-1

glycolic acid

no

yes

no

 

 

Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.

 

▼B

795

40155

0124172-53-8

N,N′-bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N′-diformylhexamethylenediamine

yes

no

no

0,05

 

 

(2)

(12)

796

72141

0018600-59-4

2,2′-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one]

yes

no

yes

0,05

 

SML including the sum of its hydrolysis products

 

▼M2

797

76807

0073018-26-5

polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol

yes

no

yes

 

(31)

(32)

 

 

▼B

798

92200

0006422-86-2

terephthalic acid, bis(2-ethylhexyl)ester

yes

no

no

60

(32)

 

 

▼M6

799

77708

 

polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols

yes

no

no

1,8

 

In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.

 

▼B

800

94425

0000867-13-0

triethyl phosphonoacetate

yes

no

no

 

 

Only for use in PET

 

801

30607

acids, C2-C24, aliphatic, linear, monocarboxylic, from natural oils and fats, lithium salt

yes

no

no

 

 

 

 

802

33105

0146340-15-0

alcohols, C12-C14 secondary, β-(2-hydroxyethoxy), ethoxylated

yes

no

no

5

 

 

(12)

803

33535

0152261-33-1

α-alkenes(C20-C24) copolymer with maleic anhydride, reaction product with 4-amino-2,2,6,6-tetramethylpiperidine

yes

no

no

 

 

Not to be used for articles in contact with fatty foods for which ►M7  simulant D1 and/or D2 ◄ is laid down.

Not to be used in contact with alcoholic foods.

(13)

804

80510

1010121-89-7

poly(3-nonyl-1,1-dioxo-1-thiopropane-1,3-diyl)-block-poly(x-oleyl-7-hydroxy-1,5-diiminooctane-1,8-diyl), process mixture with x = 1 and/or 5, neutralised with dodecylbenzenesulfonic acid

yes

no

no

 

 

Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS)

 

805

93450

titanium dioxide, coated with a copolymer of n-octyltrichlorosilane and [aminotris(methylenephosphonic acid), penta sodium salt]

yes

no

no

 

 

The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w

 

806

14876

0001076-97-7

1,4-cyclohexanedicarboxylic acid

no

yes

no

5

 

Only to be used for manufacture of polyesters

 

▼M3

807

93485

titanium nitride, nanoparticles

yes

no

no

 

 

No migration of titanium nitride nanoparticles.

Only to be used in polyethylene terephthalate (PET) up to 20 mg/kg.

In the PET, the agglomerates have a diameter of 100-500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.

 

▼B

808

38550

0882073-43-0

bis(4-propylbenzylidene)propylsorbitol

yes

no

no

5

 

SML including the sum of its hydrolysis products

 

809

49080

0852282-89-4

N-(2,6-diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dione

yes

no

yes

0,05

 

Only for use in PET

(6)

(14)

(15)

810

68119

 

neopentyl glycol, diesters and monoesters with benzoic acid and 2-ethylhexanoic acid

yes

no

no

5

(32)

Not to be used for articles in contact with fatty foods for which ►M7  simulant D1 and/or D2 ◄ is laid down.

 

811

80077

0068441-17-8

polyethylene waxes, oxidised

yes

no

no

60

 

 

 

▼M2

812

80350

0124578-12-7

poly(12-hydroxystearic acid)-polyethyleneimine copolymer

yes

no

no

 

 

Only to be used in plastics up to 0,1 % w/w.

Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.

 

▼B

813

91530

sulphosuccinic acid alkyl (C4-C20) or cyclohexyl diesters, salts

yes

no

no

5

 

 

 

814

91815

sulphosuccinic acid monoalkyl (C10-C16) polyethyleneglycol esters, salts

yes

no

no

2

 

 

 

815

94985

trimethylolpropane, mixed triesters and diesters with benzoic acid and 2-ethylhexanoic acid

yes

no

no

5

(32)

Not to be used for articles in contact with fatty foods for which ►M7  simulant D1 and/or D2 ◄ is laid down

 

816

45704

cis-1,2-cyclohexanedicarboxylic acid, salts

yes

no

no

5

 

 

 

817

38507

cis-endo-bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, salts

yes

no

no

5

 

Not to be used with polyethylene in contact with acidic foods.

Purity ≥ 96 %.

 

818

21530

methallylsulphonic acid, salts

no

yes

no

5

 

 

 

819

68110

neodecanoic acid, salts

yes

no

no

0,05

 

Not to be used in polymers contacting fatty foods.

Not to be used for articles in contact with fatty foods for which ►M7  simulant D1 and/or D2 ◄ is laid down.

SML expressed as neodecanoic acid.

 

820

76420

pimelic acid, salts

yes

no

no

 

 

 

 

821

90810

stearoyl-2-lactylic acid, salts

yes

no

no

 

 

 

 

822

71938

perchloric acid, salts

yes

no

no

0,05

 

 

(4)

823

24889

5-Sulphoisophthalic acid, salts

no

yes

no

5

 

 

 

854

71943

0329238-24-6

perfluoro acetic acid, α-substituted with the copolymer of perfluoro-1,2-propylene glycol and perfluoro-1,1-ethylene glycol, terminated with chlorohexafluoropropyloxy groups

yes

no

no

 

 

Only to be used in concentrations up to 0,5 % w/w in the polymerisation of fluoropolymers that are processed at temperatures at or above 340 °C and are intended for use in repeated use articles

 

▼M2

855

40560

 

(butadiene, styrene, methyl methacrylate) copolymer cross-linked with 1,3-butanediol dimethacrylate

yes

no

no

 

 

Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.

 

856

40563

 

(butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate

yes

no

no

 

 

Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.

 

857

66765

0037953-21-2

(methyl methacrylate, butyl acrylate, styrene, glycidyl methacrylate) copolymer

yes

no

no

 

 

Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.

 

▼C1

858

38565

0090498-90-1

3,9-bis[2-(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5]undecane

yes

no

yes

0,05

 

SML expressed as the sum of the substance and its oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5]-undecane in equilibrium with its para quinone methid tautomer.

(2)

▼M6

859

 

 

(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene, in nanoform

yes

no

no

 

 

Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.

When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.

The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.

 

▼B

860

71980

0051798-33-5

perfluoro[2-(poly(n-propoxy))propanoic acid]

yes

no

no

 

 

Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles

 

861

71990

0013252-13-6

perfluoro[2-(n-propoxy)propanoic acid]

yes

no

no

 

 

Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles

 

▼M2

862

15180

0018085-02-4

3,4-diacetoxy-1-butene

no

yes

no

0,05

 

SML including the hydrolysis product 3,4-dihydroxy-1-butene

Only to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers.

(17)

(19)

▼M2

863

15260

0000646-25-3

1,10-decanediamine

no

yes

no

0,05

 

Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.

 

▼B

864

46330

0000056-06-4

2,4-diamino-6-hydroxypyrimidine

yes

no

no

5

 

Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food

 

▼M3

865

40619

0025322-99-0

(butyl acrylate, methyl methacrylate, butyl methacrylate) copolymer

yes

no

no

 

 

Only to be used in:

(a)  rigid poly(vinyl chloride) (PVC) at a maximum level of 1 % w/w;

(b)  polylactic acid (PLA) at a maximum level of 5 % w/w.

 

▼B

866

40620

(butyl acrylate, methyl methacrylate) copolymer, cross-linked with allyl methacrylate

yes

no

no

 

 

Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %

 

867

40815

0040471-03-2

(butyl methacrylate, ethyl acrylate, methyl methacrylate) copolymer

yes

no

no

 

 

Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %

 

▼M3

868

53245

0009010-88-2

(ethyl acrylate, methyl methacrylate) copolymer

yes

no

no

 

 

Only to be used in:

(a)  rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % w/w;

(b)  polylactic acid (PLA) at a maximum level of 5 % w/w;

(c)  polyethylene terephthalate (PET) at a maximum level of 5 % w/w.

 

▼B

869

66763

0027136-15-8

(butyl acrylate, methyl methacrylate, styrene) copolymer

yes

no

no

 

 

Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %

 

870

95500

0160535-46-6

N,N′,N″-tris(2-methylcyclohexyl)-1,2,3-propane-tricarboxamide

yes

no

no

5

 

 

 

▼M7

871

 

0287916-86-3

dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene

yes

no

no

 

 

Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 μg/kg food.

(23)

▼M4

872

 

0006607-41-6

2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine

no

yes

no

0,05

 

To be used only as a co-monomer in polycarbonate copolymers

(20)

▼M2

873

93460

 

titanium dioxide reacted with octyltriethoxysilane

yes

no

no

 

 

Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.

 

▼M3

874

16265

0156065-00-8

α-dimethyl-3-(4’-hydroxy-3’-methoxyphenyl)propylsilyloxy, ω-3-dimethyl-3-(4’-hydroxy-3’-methoxyphenyl)propylsilyl polydimethylsiloxane

no

yes

no

0,05

(33)

Only to be used as comonomer in siloxane modified polycarbonate.

The oligomeric mixture shall be characterised by the formula

C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).

 

▼B

875

80345

0058128-22-6

poly(12-hydroxystearic acid) stearate

yes

no

yes

5

 

 

 

878

31335

acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with branched alcohols, aliphatic, monohydric, saturated, primary (C3-C22)

yes

no

no

 

 

 

 

879

31336

acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with alcohols, linear, aliphatic, monohydric, saturated, primary (C1-C22)

yes

no

no

 

 

 

 

▼M6

880

31348

 

acids, fatty (C8-C22), esters with pentaerythritol'

yes

no

no

 

 

 

 

881

25187

0003010-96-6

2,2,4,4-tetramethylcyclobutane-1,3-diol

no

yes

no

5

 

Only for:

(a)  repeated use articles for long term storage at room temperature or below and hotfill;

(b)  single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.

 

▼B

882

25872

0002416-94-6

2,3,6-trimethylphenol

no

yes

no

0,05

 

 

 

883

22074

0004457-71-0

3-methyl-1,5-pentanediol

no

yes

no

0,05

 

Only to be used in materials in contact with food at a surface to mass ratio up to 0,5 dm2/kg

 

884

34240

0091082-17-6

alkyl(C10-C21)sulphonic acid, esters with phenol

yes

no

no

0,05

 

Not to be used for articles in contact with fatty foods for which ►M7  simulant D1 and/or D2 ◄ is laid down.

 

885

45676

0263244-54-8

cyclic oligomers of (butylene terephthalate)

yes

no

no

 

 

Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature.

 

▼M2

894

93360

0016545-54-3

thiodipropionic acid, ditetradecyl ester

yes

no

no

 

(14)

 

 

895

47060

0171090-93-0

3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoic acid, esters with C13-C15 branched and linear alcohols

yes

no

no

0,05

 

Only to be used in polyolefins in contact with foods other than fatty/high-alcoholic and dairy products.

 

896

71958

0958445-44-8

3H-perfluoro-3-[(3-methoxy-propoxy)propanoic acid], ammonium salt

yes

no

no

 

 

Only to be used in the polymerisation of fluoropolymers when:

— processed at temperatures higher than 280 °C for at least 10 minutes,

— processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles.

 

▼M3

902

 

0000128-44-9

1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt

yes

no

no

 

 

The substance shall comply with the specific purity criteria as set out in Commission Regulation (EU) No 231/2012 (8).

 

▼M6

903

 

37486-69-4

2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether]

yes

no

no

 

 

Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for:

(a)  repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times;

(b)  repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.

 

▼M2

923

39150

0000120-40-1

N,N-bis(2-hydroxyethyl)dodecanamide

yes

no

no

5

 

The residual amount of diethanolamine in plastics, as an impurity and decomposition product of the substance, ►M7  shall ◄ not result in a migration of diethanolamine higher than 0,3 mg/kg food.

(18)

924

94987

 

trimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acids

yes

no

no

0,05

 

Only for use in PET in contact with all types of foods other than fatty, high-alcoholic and dairy products.

 

926

71955

0908020-52-0

perfluoro[(2-ethyloxy-ethoxy)acetic acid], ammonium salt

yes

no

no

 

 

Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.

 

▼M6

969

 

24937-78-8

ethylene-vinyl acetate copolymer wax

yes

no

no

 

 

Only to be used as a polymeric additive up to 2 % w/w in polyolefins.

The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.

 

▼M2

971

25885

0002459-10-1

trimethyl trimellitate

no

yes

no

 

 

Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.

(17)

972

45197

0012158-74-6

copper hydroxide phosphate

yes

no

no

 

 

 

 

973

22931

0019430-93-4

(perfluorobutyl)ethylene

no

yes

no

 

 

Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures.

 

▼M7

974

74050

939402-02-5

phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters

yes

no

yes

5

 

SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol.

The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/kg food.

 

▼M3

979

79987

(polyethylene terephthalate, hydroxylated polybutadiene, pyromellitic anhydride) copolymer

yes

no

no

 

 

Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.

 

▼M4

988

 

3634-83-1

1,3-bis(isocyanatomethyl)benzene

no

yes

no

 

(34)

SML(T) applies to the migration of its hydrolysis product, 1,3-benzenedimethanamine

To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film

 

▼M6

998

 

 

(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked, in nanoform

yes

no

no

 

 

Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.

When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.

The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.

 

1017

 

25618-55-7

polyglycerol

yes

no

no

 

 

To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.

 

▼M7

1031

 

3238-40-2

furan-2,5-dicarboxylic acid

no

yes

no

5

 

Only to be used as a monomer in the production of polyethylene furanoate. The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 μg/kg food (expressed as furan-2,5-dicarboxylic acid).

(22)

(23)

1034

 

3710-30-3

1,7-octadiene

no

yes

no

0,05

 

Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions.

 

▼M6

1043

 

 

(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform

yes

no

no

 

 

Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.

When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances.

The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.

 

▼M7

1045

 

1190931-27-1

perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt

yes

no

no

 

 

Only to be used as a polymer production aid during the manufacture of fluoropolymers under high temperature conditions of at least 370 °C.

 

1046

 

 

zinc oxide, nanoparticles, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)

yes

no

no

 

 

Only to be used in unplasticised polymers.

The restrictions and specifications specified for FCM substance No 788 shall be respected.

 

1048

 

624-03-3

ethylene glycol dipalmitate

yes

no

no

 

(2)

Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.

 

1050

 

 

zinc oxide, nanoparticles, uncoated

yes

no

no

 

 

Only to be used in unplasticised polymers.

 

1051

 

42774-15-2

N,N′-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide

yes

no

no

5

 

 

 

1052

 

1455-42-1

2,4,8,10-tetraoxaspiro[5,5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl- (‘SPG’)

no

yes

no

5

 

Only to be used as a monomer in the production of polyesters. The migration of oligomers of less than 1 000 Da shall not exceed 50 μg/kg food (expressed as SPG).

(22)

(23)

1053

 

 

fatty acids, C16–18 saturated, esters with dipentaerythritol

yes

no

no

 

 

Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils

 

▼B

(1)   OJ L 302, 19.11.2005, p. 28.

(2)   OJ L 330, 5.12.1998, p. 32.

(3)   OJ L 253, 20.9.2008, p. 1.

(4)   Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications of food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

(5)   OJ L 158, 18.6.2008, p. 17.

(6)   Infant as defined in Article 2 of Directive 2006/141/EC.

(7)   This restriction is applicable from 1 May 2011 as regards the manufacture and from 1 June 2011 as regards the placing on the market and importation into the Union.

(8)   OJ L 83, 22.3.2012, p. 1.

2.   Group restriction of substances

Table 2 on Group restrictions contains the following information:

Column 1 (Group restriction No): contains the identification number of the group of substances for which the group restriction applies. It is the number referred to in Column 9 in Table 1 of this Annex.

Column 2 (FCM substance No): contains the unique identification numbers of the substances for which the group restriction applies. It is the number referred to in Column 1 in Table 1 of this Annex.

Column 3 (SML (T) [mg/kg]): contains the total specific migration limit for the sum of substances applicable to this group. It is expressed in mg substance per kg food. It is indicated ND if the substance shall not migrate in detectable quantities.

Column 4 (Group restriction specification): contains an indication of the substance whose molecular weight forms the basis for expression of the result.



Table 2

(1)

(2)

(3)

(4)

Group Restriction No

FCM substance No

SML (T)

[mg/kg]

Group restriction specification

1

128

211

6

expressed as acetaldehyde

▼M7

2

89

227

263

1048

30

expressed as ethyleneglycol

▼B

3

234

248

30

expressed as maleic acid

4

212

435

15

expressed as caprolactam

5

137

472

3

expressed as the sum of the substances

6

412

512

513

588

1

expressed as iodine

7

19

20

1,2

expressed as tertiary amine

8

317

318

319

359

431

464

6

expressed as the sum of the substances

9

650

695

697

698

726

0,18

expressed as tin

10

28

29

30

31

32

33

466

582

618

619

620

646

676

736

0,006

expressed as tin

11

66

645

657

1,2

expressed as tin

12

444

469

470

30

expressed as the sum of the substances

13

163

285

1,5

expressed as the sum of the substances

▼M2

14

294

5

expressed as the sum of the substances and their oxidation products

368

894

▼M6

15

98

196

344

15

expressed as formaldehyde

▼B

16

407

583

584

599

6

expressed as boron

Without prejudice to the provisions of Directive 98/83/EC

17

4

167

169

198

274

354

372

460

461

475

476

485

490

653

ND

expressed as isocyanate moiety

18

705

733

0,05

expressed as the sum of the substances

19

505

516

519

10

expressed as SO2

20

290

386

390

30

expressed as the sum of the substances

21

347

349

5

expressed as trimellitic acid

22

70

147

176

218

323

325

365

371

380

425

446

448

456

636

6

expressed as acrylic acid

23

150

156

181

183

184

355

370

374

439

440

447

457

482

6

expressed as methacrylic acid

24

756

758

5

expressed as the sum of the substances

25

720

747

0,05

sum of mono-n-dodecyltin tris(isooctylmercaptoacetate), di-n-dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride

26

728

729

9

expressed as the sum of the substances

27

188

291

5

expressed as isophthalic acid

28

191

192

785

7,5

expressed as terephthalic acid

29

342

672

0,05

expressed as the sum of 6-hydroxyhexanoic acid and caprolactone

▼M6

30

254

344

672

5

expressed as 1,4-butanediol

▼B

31

73

797

30

expressed as the sum of the substances

32

8

72

73

138

140

157

159

207

242

283

532

670

728

729

775

783

797

798

810

815

60

expressed as the sum of the substances

▼M3

33

180

874

ND

expressed as eugenol

▼M4

34

421

988

0,05

Expressed as 1,3-benzenedimethanamine

▼B

3.   Notes on verification of compliance

Table 3 on notes on verification of compliance contains the following information:

Column 1 (Note No): contains the identification number of the Note. It is the number referred to in Column 11 in Table 1 of this Annex.

Column 2 (Notes on verification of compliance): contains rules that shall be respected when testing for compliance of the substance with specific migration limits or other restrictions or it contains remarks on situations where there is a risk of non-compliance.



Table 3

(1)

(2)

Note No

Notes on verification of compliance

(1)

Verification of compliance by residual content per food contact surface area (QMA) pending the availability of an analytical method.

(2)

There is a risk that the SML or OML could be exceeded in fatty food simulants.

(3)

There is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the final product does not comply with Article 3(1) c of the Framework Regulation (EC) No 1935/2004.

▼M3

(4)

Compliance testing when there is a fat contact ►M7  shall ◄ be performed using saturated fatty food simulants as simulant D2.

▼B

(5)

Compliance testing when there is a fat contact ►M7  shall ◄ be performed using isooctane as substitute of simulant D2 (unstable).

(6)

Migration limit might be exceeded at very high temperature.

(7)

If testing in food is performed, Annex V 1.4 shall be taken into account.

(8)

Verification of compliance by residual content per food contact surface area (QMA); QMA = 0,005 mg/6 dm2.

(9)

Verification of compliance by residual content per food contact surface area (QMA) pending the availability of analytical method for migration testing. The ratio surface to quantity of food shall be lower than 2dm2/kg.

(10)

Verification of compliance by residual content per food contact surface area (QMA) in case of reaction with food or simulant.

(11)

Only a method of analysis for the determination of the residual monomer in the treated filler is available.

(12)

There is a risk that the SML could be exceeded from polyolefins.

(13)

Only a method for determination of the content in polymer and a method for determination of the starting substances in food simulants are available.

(14)

There is a risk that the SML could be exceeded from plastics containing more than 0,5 % w/w of the substance.

(15)

There is a risk that the SML could be exceeded in contact with foods with high alcoholic content.

(16)

There is a risk that the SML could be exceeded from low-density polyethylene (LDPE) containing more than 0,3 % w/w of the substance when in contact with fatty foods

(17)

Only a method for determination of the residual content of the substance in the polymer is available

▼M2

(18)

There is a risk that the SML could be exceeded from low-density polyethylene (LDPE)

(19)

There is a risk that the OML could be exceeded in direct contact with aqueous foods from ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers

▼M4

(20)

The substance contains aniline as an impurity; verification of compliance with the restriction set for primary aromatic amines in Annex II (2) is necessary

▼M6

(21)

In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded.

▼M7

(22)

When used in contact with non-alcoholic foods for which Table 2 of Annex III assigns food simulant D1, food simulant C shall be used for verification of compliance instead of food simulant D1.

(23)

When a final material or article containing this substance is placed on the market, a well described method to determine whether the oligomer migration complies with the restrictions specified in column 10 of Table 1 shall form part of the supporting documentation referred to in Article 16. This method shall be suitable for use by a competent authority to verify compliance. If an adequate method is publicly available, reference shall be made to that method. If the method requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.

▼B

4.   Detailed specification on substances

Table 4 on detailed specifications on substances contains the following information

Column 1 (FCM substance No): contains the unique identification number of the substances referred to in Column 1 in Table 1 of Annex I to which the specification applies.

Column 2 (Detailed specification on the substance): contains the specification on the substance.



Table 4

(1)

(2)

FCM substance No

Detailed specification on the substance

744

Definition

The copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been genetically engineered and has been derived from a single wildtype organism Alcaligenes eutrophus strain H16 NCIMB 10442. Master stocks of the organism are stored as freeze-dried ampoules. A submaster/working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat treatment bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications

 

Chemical name

Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)

 

CAS number

0080181-31-3

 

Structural formula

image where n/(m + n) greater than 0 and less or equal to 0,25

 

Average molecular weight

Not less than 150 000 Daltons (measured by gel permeation chromatography)

 

Assay

Not less than 98 % poly(3-D-hydroxybutanoate-co-3-D-hydoxy-pentanoate) analysed after hydrolysis as a mixture of 3-D-hydro-xybutanoic and 3-D-hydroxypentanoic acids

 

Description

White to off-white powder after isolation

 

Characteristics

 

 

Identification tests:

 

 

Solubility

Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water

 

Restriction

QMA for crotonic acid is 0,05 mg/6 dm2

 

Purity

Prior to granulation the raw material copolymer powder must contain:

 

— nitrogen,

Not more than 2 500 mg/kg of plastic

 

— zinc,

Not more than 100 mg/kg of plastic

 

— copper,

Not more than 5 mg/kg of plastic

 

— lead,

Not more than 2 mg/kg of plastic

 

— arsenic,

Not more than 1 mg/kg of plastic

 

— chromium,

Not more than 1 mg/kg of plastic




ANNEX II

Restrictions on materials and articles

1.

Plastic materials and articles shall not release the following substances in quantities exceeding the specific migration limits below:

Barium = 1 mg/kg food or food simulant.

Cobalt = 0,05 mg/kg food or food simulant.

Copper = 5 mg/kg food or food simulant.

Iron = 48 mg/kg food or food simulant.

Lithium = 0,6 mg/kg food or food simulant.

Manganese = 0,6 mg/kg food or food simulant.

Zinc = 25 mg/kg food or food simulant.

▼M7

2.

Primary aromatic amines which are not listed in Table 1 of Annex I shall not migrate or shall not otherwise be released from plastic materials and articles into food or food simulant in accordance with Article 11(4). The detection limit referred to in the second subparagraph of Article 11(4) applies to the sum of primary aromatic amines released.

▼B




ANNEX III

Food simulants

1.   Food simulants

For demonstration of compliance for plastic materials and articles not yet in contact with food the food simulants listed in Table 1 below are assigned.

▼M7



Table 1

List of food simulants

Food simulant

Abbreviation

Ethanol 10 % (v/v)

Food simulant A

Acetic acid 3 % (w/v)

Food simulant B

Ethanol 20 % (v/v)

Food simulant C

Ethanol 50 % (v/v)

Food simulant D1

Any vegetable oil containing less than 1 % unsaponifiable matter

Food simulant D2

poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm

Food simulant E

▼B

2.   General assignment of food simulants to foods

Food simulants A, B and C are assigned for foods that have a hydrophilic character and are able to extract hydrophilic substances. Food simulant B shall be used for those foods which have a pH below 4.5. Food simulant C shall be used for alcoholic foods with an alcohol content of up to 20 % and those foods which contain a relevant amount of organic ingredients that render the food more lipophilic.

Food simulants D1 and D2 are assigned for foods that have a lipophilic character and are able to extract lipophilic substances. Food simulant D1 shall be used for alcoholic foods with an alcohol content of above 20 % and for oil in water emulsions. Food simulant D2 shall be used for foods which contain free fats at the surface.

Food simulant E is assigned for testing specific migration into dry foods.

▼M7

3.    Specific assignment of food simulants to foods for migration testing of materials and articles not yet in contact with food

For testing migration from materials and articles not yet in contact with food the food simulants that corresponds to a certain food category shall be chosen according to Table 2 below.

For testing migration from materials and articles intended to come into contact with foods not listed in Table 2 below, or a combination of foods, the general food simulant assignments in point 2 shall be used for specific migration testing, and for overall migration testing the food simulant assignments in point 4 shall be applicable.

Table 2 contains the following information:

 Column 1 (Reference number): contains the reference number of the food category

 Column 2 (Description of food): contains a description of the foods covered by the food category

 Column 3 (Food simulants): contains sub-columns for each of the food simulants

The food simulant for which a cross is contained in the respective sub-column of column 3 shall be used when testing migration of materials and articles not yet in contact with food.

For food categories where in sub-column D2 or E the cross is followed by an oblique stroke and a figure, the migration test result shall be corrected by dividing the result by this figure. The corrected test result shall then be compared to the migration limit to establish compliance. The test results for substances that shall not migrate in detectable quantities shall not be corrected in this way.

For food category 01.04 food simulant D2 shall be replaced by 95 % ethanol.

For food categories where in sub-column B the cross is followed by (*) the testing in food simulant B can be omitted if the food has a pH of more than 4,5.

For food categories where in sub-column D2 the cross is followed by (**) the testing in food simulant D2 can be omitted if it can be demonstrated that there is no ‘fatty contact’ with the plastic food contact material.

▼B



Table 2

food category specific assignment of food simulants

(1)

(2)

(3)

Reference number

Description of food

Food simulants

A

B

C

D1

D2

E

01

Beverages

 

 

 

 

 

 

01.01

Non-alcoholic beverages or alcoholic beverages of an alcoholic strength lower than or equal to 6 % vol.:

 

 

 

 

 

 

 

A.  Clear drinks:

Water, ciders, clear fruit or vegetable juices of normal strength or concentrated, fruit nectars, lemonades, syrups, bitters, infusions, coffee, tea, beers, soft drinks, energy drinks and the like, flavoured water, liquid coffee extract

 

X(*)

X

 

 

 

 

B.  cloudy drinks:

juices and nectars and soft drinks containing fruit pulp, musts containing fruit pulp, liquid chocolate

 

X(*)

 

X

 

 

01.02

Alcoholic beverages of an alcoholic strength of between 6 %vol and 20 %.

 

 

X

 

 

 

01.03

Alcoholic beverages of an alcoholic strength above 20 % and all cream liquors

 

 

 

X

 

 

01.04

Miscellaneous: undenaturated ethyl alcohol

 

X(*)

 

 

Substitute 95 % ethanol

 

02

Cereals, cereal products, pastry, biscuits, cakes and other bakers’ wares

 

 

 

 

 

 

02.01

Starches

 

 

 

 

 

X

02.02

Cereals, unprocessed, puffed, in flakes (including popcorn, corn flakes and the like)

 

 

 

 

 

X

02.03

Cereal flour and meal

 

 

 

 

 

X

02.04

Dry pasta e.g. macaroni, spaghetti and similar products and fresh pasta

 

 

 

 

 

X

02.05

Pastry, biscuits, cakes, bread, and other bakers’ wares, dry:

 

 

 

 

 

 

 

A.  With fatty substances on the surface

 

 

 

 

X/3

 

 

B.  Other

 

 

 

 

 

X

02.06

Pastry, cakes, bread, dough and other bakers’ wares, fresh:

 

 

 

 

 

 

 

A.  With fatty substances on the surface

 

 

 

 

X/3

 

 

B.  Other

 

 

 

 

 

X

03

Chocolate, sugar and products thereof

Confectionery products

 

 

 

 

 

 

03.01

Chocolate, chocolate-coated products, substitutes and products coated with substitutes

 

 

 

 

X/3

 

03.02

Confectionery products:

 

 

 

 

 

 

 

A.  In solid form:

 

 

 

 

 

 

 

I.  With fatty substances on the surface

 

 

 

 

X/3

 

 

II.  Other

 

 

 

 

 

X

 

B.  In paste form:

 

 

 

 

 

 

 

I.  With fatty substances on the surface

 

 

 

 

X/2

 

 

II.  Moist

 

 

X

 

 

 

03.03

Sugar and sugar products

 

 

 

 

 

 

 

A.  In solid form: crystal or powder

 

 

 

 

 

X

 

B.  Molasses, sugar syrups, honey and the like

X

 

 

 

 

 

04

Fruit, vegetables and products thereof

 

 

 

 

 

 

04.01

Whole fruit, fresh or chilled, unpeeled

 

 

 

 

 

 

04.02

Processed fruit:

 

 

 

 

 

 

 

A.  Dried or dehydrated fruits, whole, sliced, flour or powder

 

 

 

 

 

X

 

B.  Fruit in the form of purée, preserves, pastes or in its own juice or in sugar syrup (jams, compote, and similar products)

 

X(*)

X

 

 

 

 

C.  Fruit preserved in a liquid medium:

 

 

 

 

 

 

 

I.  In an oily medium

 

 

 

 

X

 

 

II.  In an alcoholic medium

 

 

 

X

 

 

04.03

Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, pine kernels and others):

 

 

 

 

 

 

 

A.  Shelled, dried, flaked or powdered

 

 

 

 

 

X

 

B.  Shelled and roasted

 

 

 

 

 

X

 

C.  In paste or cream form

X

 

 

 

X

 

04.04

Whole vegetables, fresh or chilled, unpeeled

 

 

 

 

 

 

04.05

Processed vegetables:

 

 

 

 

 

 

 

A.  Dried or dehydrated vegetables whole, sliced or in the form of flour or powder

 

 

 

 

 

X

 

B.  Fresh vegetables, peeled or cut

X

 

 

 

 

 

 

C.  Vegetables in the form of purée, preserves, pastes or in its own juice (including pickled and in brine)

 

X(*)

X

 

 

 

 

D.  Preserved vegetables:

 

 

 

 

 

 

 

I.  In an oily medium

X

 

 

 

X

 

 

II.  In an alcoholic medium

 

 

 

X

 

 

05

Fats and oils

 

 

 

 

 

 

05.01

Animals and vegetable fats and oils, whether natural or treated (including cocoa butter, lard, resolidified butter)

 

 

 

 

X

 

05.02

Margarine, butter and other fats and oils made from water emulsions in oil

 

 

 

 

X/2

 

06

Animal products and eggs

 

 

 

 

 

 

06.01

Fish:

 

 

 

 

 

 

 

A.  Fresh, chilled, processed, salted or smoked including fish eggs

X

 

 

 

X/3(**)

 

 

B.  Preserved fish:

 

 

 

 

 

 

 

I.  In an oily medium

X

 

 

 

X

 

 

II.  In an aqueous medium

 

X(*)

X

 

 

 

06.02

Crustaceans and molluscs (including oysters, mussels, snails)

 

 

 

 

 

 

 

A.  Fresh within the shell

 

 

 

 

 

 

 

B.  Shell removed, processed, preserved or cooked with the shell

 

 

 

 

 

 

 

I.  In an oily medium

X

 

 

 

X

 

 

II.  In an aqueous medium

 

X(*)

X

 

 

 

06.03

Meat of all zoological species (including poultry and game):

 

 

 

 

 

 

 

A.  Fresh, chilled, salted, smoked

X

 

 

 

X/4(**)

 

 

B.  Processed meat products (such as ham, salami, bacon, sausages, and other) or in the form of paste, creams

X

 

 

 

X/4(**)

 

 

C.  Marinated meat products in an oily medium

X

 

 

 

X

 

06.04

Preserved meat:

 

 

 

 

 

 

 

A.  In an fatty or oily medium

X

 

 

 

X/3

 

 

B.  In an aqueous medium

 

X(*)

 

X

 

 

06.05

Whole eggs, egg yolk, egg white

 

 

 

 

 

 

 

A.  Powdered or dried or frozen

 

 

 

 

 

X

 

B.  Liquid and cooked

 

 

 

X

 

 

07

Milk products

 

 

 

 

 

 

07.01

Milk

 

 

 

 

 

 

 

A.  Milk and milk based drinks whole, partly dried and skimmed or partly skimmed

 

 

 

X

 

 

 

B.  Milk powder including infant formula (based on whole milk powder)

 

 

 

 

 

X

07.02

Fermented milk such as yoghurt, buttermilk and similar products

 

X(*)

 

X

 

 

07.03

Cream and sour cream

 

X(*)

 

X

 

 

07.04

Cheeses:

 

 

 

 

 

 

 

A.  Whole, with not edible rind

 

 

 

 

 

X

 

B.  Natural cheese without rind or with edible rind (gouda, camembert, and the like) and melting cheese

 

 

 

 

X/3(**)

 

 

C.  Processed cheese (soft cheese, cottage cheese and similar)

 

X(*)

 

X

 

 

 

D.  Preserved cheese:

 

 

 

 

 

 

 

I.  In an oily medium

X

 

 

 

X

 

 

II.  In an aqueous medium (feta, mozarella, and similar)

 

X(*)

 

X

 

 

08

Miscellaneous products

 

 

 

 

 

 

08.01

Vinegar

 

X

 

 

 

 

08.02

Fried or roasted foods:

 

 

 

 

 

 

 

A.  Fried potatoes, fritters and the like

X

 

 

 

X/5

 

 

B.  Of animal origin

X

 

 

 

X/4

 

08.03

Preparations for soups, broths, sauces, in liquid, solid or powder form (extracts, concentrates); homogenised composite food preparations, prepared dishes including yeast and raising agents

 

 

 

 

 

 

 

A.  Powdered or dried:

 

 

 

 

 

 

 

I.  With fatty character

 

 

 

 

X/5

 

 

II.  Other

 

 

 

 

 

X

 

B.  any other form than powdered or dried:

 

 

 

 

 

 

 

I.  With fatty character

X

X(*)

 

 

X/3

 

 

II.  Other

 

X(*)

X

 

 

 

08.04

Sauces:

 

 

 

 

 

 

 

A.  With aqueous character

 

X(*)

X

 

 

 

 

B.  With fatty character e.g. mayonnaise, sauces derived from mayonnaise, salad creams and other oil/water mixtures e.g. coconut based sauces

X

X(*)

 

 

X

 

08.05

Mustard (except powdered mustard under heading 08.14)

X

X(*)

 

 

X/3(**)

 

08.06

Sandwiches, toasted bread pizza and the like containing any kind of foodstuff

 

 

 

 

 

 

 

A.  With fatty substances on the surface

X

 

 

 

X/5

 

 

B.  Other

 

 

 

 

 

X

08.07

Ice-creams

 

 

X

 

 

 

08.08

Dried foods:

 

 

 

 

 

 

 

A.  With fatty substances on the surface

 

 

 

 

X/5

 

 

B.  Other

 

 

 

 

 

X

08.09

Frozen or deep-frozen foods

 

 

 

 

 

X

08.10

Concentrated extracts of an alcoholic strength equal to or exceeding 6 % vol.

 

X(*)

 

X

 

 

08.11

Cocoa:

 

 

 

 

 

 

 

A.  Cocoa powder, including fat-reduced and highly fat reduced

 

 

 

 

 

X

 

B.  Cocoa paste

 

 

 

 

X/3

 

08.12

Coffee, whether or not roasted, decaffeinated or soluble, coffee substitutes, granulated or powdered

 

 

 

 

 

X

08.13

Aromatic herbs and other herbs such as camomile, mallow, mint, tea, lime blossom and others

 

 

 

 

 

X

08.14

Spices and seasonings in the natural state such as cinnamon, cloves, powdered mustard, pepper, vanilla, saffron, salt and other

 

 

 

 

 

X

08.15

Spices and seasoning in oily medium such as pesto, curry paste

 

 

 

 

X

 

4.   Food simulant assignment for testing overall migration

To demonstrate compliance with the overall migration limit for all type of foods testing in distilled water or water of equivalent quality or food simulant A and food simulant B and simulant D2 shall be performed.

To demonstrate compliance with the overall migration limit for all types of food except for acidic foods testing in distilled water or water of equivalent quality or food simulant A and food simulant D2 shall be performed.

To demonstrate compliance with the overall migration limit for all aqueous and alcoholic foods and milk products testing in food simulant D1 shall be performed.

To demonstrate compliance with the overall migration limit for all aqueous, acidic and alcoholic foods and milk products testing in food simulant D1 and food simulant B shall be performed.

To demonstrate compliance with the overall migration limit for all aqueous foods and alcoholic foods up to an alcohol content of 20 % testing in food simulant C shall be performed.

To demonstrate compliance with the overall migration limit for all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20 % testing in food simulant C and food simulant B shall be performed.

▼M7

5.    General derogation to the assignment of food simulants

By derogation from the assignments of food simulants in points 2 to 4 of this Annex, where testing with several food simulants is required, a single food simulant shall be sufficient if on the basis of evidence acquired using generally recognised scientific methods this food simulant is shown to be the most severe food simulant for the particular material or article being tested under the applicable time and temperature conditions selected in accordance with Chapters 2 and 3 of Annex V.

The scientific basis on which this derogation is used shall in such cases form part of the documentation required under Article 16 of this Regulation.

▼B




ANNEX IV

Declaration of compliance

The written declaration referred to in Article 15 shall contain the following information:

(1) the identity and address of the business operator issuing the declaration of compliance;

(2) the identity and address of the business operator which manufactures or imports the plastic materials or articles or products from intermediate stages of their manufacturing or the substances intended for the manufacturing of those materials and articles;

(3) the identity of the materials, the articles, products from intermediate stages of manufacture or the substances intended for the manufacturing of those materials and articles;

(4) the date of the declaration;

▼M7

(5) confirmation that the plastic materials or articles, products from intermediate stages of manufacture or the substances meet the relevant requirements laid down in this Regulation and in Article 3, 11(5), 15 and 17 of Regulation (EC) No 1935/2004;

▼B

(6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annexes I and II to this Regulation to allow the downstream business operators to ensure compliance with those restrictions;

(7) adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives 2008/60/EC, 95/45/EC and 2008/84/EC to enable the user of these materials or articles to comply with the relevant EU provisions or, in their absence, with national provisions applicable to food;

(8) specifications on the use of the material or article, such as:

(i) type or types of food with which it is intended to be put in contact;

(ii) time and temperature of treatment and storage in contact with the food;

(iii) ratio of food contact surface area to volume used to establish the compliance of the material or article;

(9) when a functional barrier is used in a multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of this Regulation.




ANNEX V

COMPLIANCE TESTING

For testing compliance of migration from plastic food contact materials and articles the following general rules apply.

CHAPTER 1

Testing for specific migration of materials and articles already in contact with food

1.1.   Sample preparation

The material or article shall be stored as indicated on the packaging label or under conditions adequate for the packaged food if no instructions are given. The food shall be removed from contact with the material or article before its expiration date or any date by which the manufacturer has indicated the product should be used for reasons of quality or safety.

1.2.   Conditions of testing

The food shall be treated in accordance with the cooking instructions on the package if the food is to be cooked in the package. Parts of the food which are not intended to be eaten shall be removed and discarded. The remainder shall be homogenised and analysed for migration. The analytical results shall always be expressed on the basis of the food mass that is intended to be eaten, in contact with the food contact material.

1.3.   Analysis of migrated substances

The specific migration is analysed in the food using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004.

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1.4.    Account of substances originating from other sources

In case there is evidence linked to the food sample that a substance partially or wholly originates from a source or sources other than the material or article for which the test is being carried out, the test results shall be corrected for the amount of that substance originating from the other source or sources before comparing the test results to the applicable specific migration limit.

▼B

CHAPTER 2

Testing for specific migration of materials and articles not yet in contact with food

2.1.   Verification method

Verification of compliance of migration into foods with the migration limits shall be carried out under the most extreme conditions of time and temperature foreseeable in actual use taking into account paragraphs 1.4, 2.1.1, 2.1.6 and 2.1.7.

Verification of compliance of migration into food simulants with the migration limits shall be carried out using conventional migration tests according to the rules set out in paragraphs 2.1.1 to 2.1.7.

2.1.1.   Sample preparation

The material or article shall be treated as described by accompanying instructions or by provisions given in the declaration of compliance.

Migration is determined on the material or article or, if this is impractical, on a specimen taken from the material or article, or a specimen representative of this material or article. For each food simulant or food type, a new test specimen is used. Only those parts of the sample which are intended to come into contact with foods in actual use shall be placed in contact with the food simulant or the food.

2.1.2.   Choice of food simulant

Materials and articles intended for contact with all types of food shall be tested with food simulant A, B and D2. However, if substances that may react with acidic food simulant or foods are not present testing in food simulant B can be omitted.

Materials and articles intended only for specific types of foods shall be tested with the food simulants indicated for the food types in Annex III.

2.1.3.   Conditions of contact when using food simulants

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The sample shall be placed in contact with the food simulant in a manner representing the worst of the foreseeable conditions of use as regard contact time in Table 1 and as regard contact temperature in Table 2.

By way of derogation to the conditions set out in Tables 1 and 2, the following rules apply:

(i) If it is found that carrying out the tests under the combination of contact conditions specified in Tables 1 and 2 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place;

(ii) if the material or article during it intended use is subjected only to precisely controlled time and temperature conditions in food processing equipment, either as part of food packaging or as part of the processing equipment itself, testing may be done using the worst foreseeable contact conditions that can occur during the processing of the food in that equipment;

(iii) if the material or article is intended to be employed only for hot-fill conditions, only a 2-hour test at 70 °C shall be carried out. However, if the material or article is intended to be used also for storage at room temperature or below, the test conditions set out in Tables 1 and 2 of this Section or in Section 2.1.4 of this Chapter apply depending on the duration of storage.

If the testing conditions representative for the worst foreseeable conditions of intended use of the material or article, are not technically feasible in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a migration test shall be done using food simulant E if the temperature under the worst foreseeable conditions of intended use exceeds 100 °C. The test that results in the highest specific migration shall be used to establish compliance with this Regulation.

▼B



Table 1

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Selection of test time

▼B

Contact time in worst foreseeable use

►M7  Time to be selected for testing ◄

t ≤ 5 min

5 min

5 min < t ≤ 0,5 hour

0,5 hour

0,5 hours < t ≤ 1 hour

1 hour

1 hour < t ≤ 2 hours

2 hours

2 hours < t ≤ 6 hours

6 hours

6 hours < t ≤ 24 hours

24 hours

1 day < t ≤ 3 days

3 days

3 days < t ≤ 30 days

10 days

Above 30 days

See specific conditions

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Table 2

Selection of test temperature

Worst foreseeable contact temperature

Contact temperature to be selected for testing

T ≤ 5 °C

5 °C

5 °C < T ≤ 20 °C

20 °C

20 °C < T ≤ 40 °C

40 °C

40 °C < T ≤ 70 °C

70 °C

70 °C < T ≤ 100 °C

100 °C or reflux temperature

100 °C < T ≤ 121 °C

121 °C (1)

121 °C < T ≤ 130 °C

130 °C (1)

130 °C < T ≤ 150 °C

150 °C (1)

150 °C < T < 175 °C

175 °C (1)

175 °C < T ≤ 200 °C

200 °C (1)

T > 200 °C

225 °C (1)

(1)   This temperature shall be used only for food simulants D2 and E. For applications heated under pressure, migration testing under pressure at the relevant temperature may be performed. For food simulants A, B, C or D1 the test may be replaced by a test at 100 °C or at reflux temperature for duration of four times the time selected according to the conditions in Table 1.

2.1.4.    Specific conditions for contact times above 30 days at room temperature and below

For contact times above 30 days (long term) at room temperature and below, the specimen shall be tested in accelerated test conditions at elevated temperature for a maximum of 10 days at 60 °C ( 6 ).

(a) Testing for 10 days at 20 °C shall cover all storage times at frozen condition. This test can include the freezing and defrosting processes if labelling or other instructions ensure that 20 °C is not exceeded and the total time above – 15 °C does not exceed 1 day in total during the foreseeable intended use of the material or article.

(b) Testing for 10 days at 40 °C shall cover all storage times at refrigerated and frozen conditions including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes.

(c) Testing for 10 days at 50 °C shall cover all storage times of up to 6 months at room temperature, including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes.

(d) Testing for 10 days at 60 °C shall cover storage above 6 months at room temperature and below, including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes.

(e) For storage at room temperature the testing conditions can be reduced to 10 days at 40 °C if it is shown by scientific evidence that migration of the respective substance in the polymer has reached equilibration under this test condition.

(f) For worst foreseeable conditions of intended use not covered by the test conditions set out in points (a) to (e), the testing time and temperature conditions shall be based on the following formula:

t2 = t1 * Exp (9627 * (1/T2 – 1/T1))

t1 is the contact time

t2 is the testing time

T1 is the contact temperature in Kelvin. For room temperature storage this is set at 298K (25 °C). For refrigerated conditions it is set at 278K (5 °C). For frozen storage it is set at 258 K (– 15 °C).

T2 is the testing temperature in Kelvin.

▼B

2.1.5.   Specific conditions for combinations of contact times and temperature

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If a material or article is intended for different applications covering different combinations of contact time and temperature the testing shall be restricted to the test conditions which are recognised to be the most severe on the basis of scientific evidence.

▼B

If the material or article is intended for a food contact application where it is successively subject to a combination of two or more times and temperatures, the migration test shall be carried out subjecting the test specimen successively to all the applicable worst foreseeable conditions appropriate to the sample, using the same portion of food simulant.

2.1.6.   Repeated use articles

If the material or article is intended to come into repeated contact with foods, the migration test(s) shall be carried out three times on a single sample using another portion of food simulant on each occasion. Its compliance shall be checked on the basis of the level of the migration found in the third test.

However, if there is conclusive proof that the level of the migration does not increase in the second and third tests and if the migration limits are not exceeded on the first test, no further test is necessary.

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The material or article shall respect the specific migration limit already in the first test for substances that are prohibited from migrating or from being released in detectable quantities under Article 11(4).

▼B

2.1.7.   Analysis of migrating substances

At the end of the prescribed contact time, the specific migration is analysed in the food or food simulant using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004.

2.1.8.   Verification of compliance by residual content per food contact surface area (QMA)

For substances which are unstable in food simulant or food or for which no adequate analytical method is available it is indicated in Annex I that verification of compliance shall be undertaken by verification of residual content per 6 dm2 of contact surface. For materials and articles between 500 ml and 10 l the real contact surface is applied. For materials and articles below 500 ml and above 10 l as well as for articles for which it is impractical to calculate the real contact surface the contact surface is assumed to be 6 dm2 per kg food.

2.2.   Screening approaches

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To screen if a material or article complies with the migration limits any of the following approaches can be applied which are considered at least as severe as the verification method described in section 2.1.

▼B

2.2.1.   Replacing specific migration by overall migration

To screen for specific migration of non-volatile substances, determination of overall migration under test conditions at least as severe as for specific migration can be applied.

2.2.2.   Residual content

To screen for specific migration the migration potential can be calculated based on the residual content of the substance in the material or article assuming complete migration.

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2.2.3.    Migration modelling

To screen for specific migration, the migration potential can be calculated based on the residual content of the substance in the material or article applying generally recognised diffusion models based on scientific evidence that are constructed in a way that must never underestimate real levels of migration.

2.2.4.    Food simulant substitutes

To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants result in migration that is at least as severe as migration that would be obtained using the food simulants specified in Section 2.1.2.

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2.2.5.    Single test for successive combinations of time and temperature

If the material or article is intended for a food contact application where it is successively subject to two or more time and temperature combinations, a single migration contact test time can be defined based on the highest contact test temperature from Section 2.1.3 and/or 2.1.4 by using the equation as described in point (f) of Section 2.1.4. The reasoning justifying that the resulting single test is at least as severe as the combined time and temperature combinations shall be documented in the supporting documentation provided for in Article 16.

▼B

CHAPTER 3

Testing for overall migration

Overall migration testing shall be performed under the standardised testing conditions set out in this chapter.

3.1.   Standardised testing conditions

The overall migration test for materials and articles intended for the food contact conditions described in column 3 of Table 3 shall be performed for the time specified and at the temperature specified in column 2. For test OM5 the test can be performed either for 2 hours at 100 °C (food simulant D2) or at reflux (food simulant A, B, C, D1) or for 1 hour at 121 °C. The food simulant shall be chosen in accordance with Annex III.

If it is found that carrying out the tests under the contact conditions specified in Table 3 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place.

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Table 3

Standardised conditions for testing the overall migration

Column 1

Column 2

Column 3

Test number

Contact time in days [d] or hours [h] at contact temperature in [°C] for testing

Intended food contact conditions

OM1

10 d at 20 °C

Any food contact at frozen and refrigerated conditions.

OM2

10 d at 40 °C

Any long term storage at room temperature or below, including when packaged under hot-fill conditions, and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for a maximum of t = 120/2^((T-70)/10) minutes.

OM3

2 h at 70 °C

Any food contact conditions that include hot-fill and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for maximum of t = 120/2^((T-70)/10) minutes, which are not followed by long term room temperature or refrigerated storage.

OM4

1 h at 100 °C

High temperature applications for all types of food at temperature up to 100 °C.

OM5

2 h at 100 °C or at reflux or alternatively 1 h at 121 °C

High temperature applications up to 121 °C.

OM6

4 h at 100 °C or at reflux

Any food contact conditions at a temperature exceeding 40 °C, and with foods for which point 4 of Annex III assigns simulants A, B, C or D1.

OM7

2 h at 175 °C

High temperature applications with fatty foods exceeding the conditions of OM5.

Test OM7 also covers food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents the worst case conditions for food simulant D2 in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in Section 3.2.

Test OM6 covers also food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B, C and D1 in contact with non-polyolefins.

Test OM5 covers also food contact conditions described for OM1, OM2, OM3, and OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.

Test OM2 covers also food contact conditions described for OM1 and OM3.

3.2.    Substitute overall migration tests for tests with food simulant D2

If it is not technically feasible to perform one or more of the tests OM1 to OM6 in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a test shall be done using food simulant E in case the worst foreseeable conditions of use exceed 100 °C. The test that results in the highest specific migration shall be used to establish compliance with this Regulation.

In case it is technically not feasible to perform OM7 with food simulant D2 the test can be replaced by either test OM8 or test OM9 as appropriate given the intended or foreseeable use. Both tests involve testing at two test conditions for which a new test sample shall be used for each test. The test condition that results in the highest overall migration shall be used to establish compliance with this Regulation.



Test number

Test conditions

Intended food contact conditions

Covers the intended food contact conditions described in

OM8

Food simulant E for 2 hours at 175 °C and food simulant D2 for 2 hours at 100 °C

High temperature applications only

OM1, OM3, OM4, OM5 and OM6

OM9

Food simulant E for 2 hours at 175 °C and food simulant D2 for 10 days at 40 °C

High temperature applications including long term storage at room temperature

OM1, OM2, OM3, OM4, OM5 and OM6

3.3.    Verification of compliance

3.3.1.    Single use articles and materials

At the end of the prescribed contact time, to verify compliance the overall migration is analysed in the food simulant using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004.

3.3.2.    Repeated use articles and materials

The applicable overall migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. The migration shall be determined using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004. The overall migration in the second test shall be lower than in the first test, and the overall migration in the third test shall be lower than in the second test. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found in the third test.

If it is not technically feasible to test the same sample three times, such as when testing in oil, the overall migration test can be carried out by testing different samples for three different periods of time lasting one, two and three times the applicable contact test time. The difference between the third and the second test results shall be considered to represent the overall migration. Compliance shall be verified on the basis of this difference, which shall not exceed the overall migration limit. In addition, it shall not be higher than the first result and the difference between the second and the first test results.

By derogation from the first paragraph, if, on the basis of scientific evidence, it is established that for the material or article being tested the overall migration does not increase in the second and third tests and if the overall migration limit is not exceeded in the first test, the first test alone shall be sufficient.

▼B

3.4.   Screening approaches

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To screen if a material or article complies with the migration limits, any of the following approaches can be applied which are considered at least as severe as the verification method described in Sections 3.1 and 3.2.

▼B

3.4.1.   Residual content

To screen for overall migration the migration potential can be calculated based on the residual content of migratable substances determined in a complete extraction of the material or article.

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3.4.2.    Food simulant substitutes

To screen for overall migration, food simulants can be replaced if based on scientific evidence the substitute food simulants result in migration that is at least as severe as migration that would be obtained using the food simulants specified in Annex III.

▼B

CHAPTER 4

Correction factors applied when comparing migration test results with migration limits

4.1.   Correction of specific migration in foods containing more than 20 % fat by the Fat Reduction Factor (FRF)

For lipophilic substances for which in Annex I it is indicated in column 7 that the FRF is applicable the specific migration can be corrected by the FRF. The FRF is determined according to the formula FRF = (g fat in food/kg of food)/200 = (% fat × 5)/100.

The FRF shall be applied according to the following rules.

The migration test results shall be divided by the FRF before comparing with the migration limits.

The correction by the FRF is not applicable in the following cases:

(a) when the material or article is or is intended to be brought in contact with food intended for infants and young children as defined by Directives 2006/141/EC and 2006/125/EC;

(b) for materials and articles for which it is impracticable to estimate the relationship between the surface area and the quantity of food in contact therewith, for example due to their shape or use, and the migration is calculated using the conventional surface area/volume conversion factor of 6 dm2/kg.

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The specific migration in food or food simulant shall not exceed 60 mg/kg food before application of the FRF.

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When testing is performed in food simulant D2 or E and when the test results are corrected in application of the correction factor laid down in Table 2 of Annex III this correction may be applied in combination with the FRF by multiplying both factors. The combined correction factor shall not exceed 5, unless the correction factor laid down in Table 2 of Annex III exceeds 5.

▼M7 —————

▼B




ANNEX VI

Correlation tables



Directive 2002/72/EC

This Regulation

Article 1(1)

Article 1

Article 1(2), (3) and (4)

Article 2

Article 1a

Article 3

Article 3(1), Article 4(1) and Article 5

Article 5

Article 4(2), Article 4a(1) and (4), Article 4d, Annex II (2) and (3) and Annex III (2) and (3)

Article 6

Article 4a(3) and (6)

Article 7

Annex II (4) and Annex III (4)

Article 8

Article 3(1) and Article 4(1)

Article 9

Article 6

Article 10

Article 5a(1) and Annex I (8)

Article 11

Article 2

Article 12

Article 7a

Article 13

Article 9(1) and (2)

Article 15

Article 9(3)

Article 16

Article 7 and Annex I (5a)

Article 17

Article 8

Article 18

Annex II (3) and Annex III (3)

Article 19

Annex I, Annex II, Annex IV, Annex IVa, Annex V Part B, and Annex VI

Annex I

Annex II (2), Annex III (2) and Annex V, Part A

Annex II

Article 8(5) and Annex VIa

Annex IV

Annex I

Annex V



Directive 93/8/EEC

This Regulation

Article 1

Article 11

Article 1

Article 12

Article 1

Article 18

Annex

Annex III

Annex

Annex V



Directive 97/48/EC

This Regulation

Annex

Annex III

Annex

Annex V



( 1 ) OJ L 384, 29.12.2006, p. 75.

( 2 ) OJ L 401, 30.12.2006, p. 1.

( 3 ) OJ L 339, 6.12.2006, p. 16.

( 4 ) OJ L 353, 31.12.2008, p. 1.

( 5 ) OJ L 372, 31.12.1985, p. 14.

( 6 ) When testing at these accelerated test conditions the test specimen shall not undergo any physical or other changes compared to the real conditions of use, including a phase transition of the material.

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