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Document 02011R0010-20180914

    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/2011/10/2018-09-14

    02011R0010 — EN — 14.09.2018 — 010.001


    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

    ►M8

    COMMISSION REGULATION (EU) 2017/752 of 28 April 2017

      L 113

    18

    29.4.2017

    ►M9

    COMMISSION REGULATION (EU) 2018/79 of 18 January 2018

      L 14

    31

    19.1.2018

    ►M10

    COMMISSION REGULATION (EU) 2018/213 of 12 February 2018

      L 41

    6

    14.2.2018

    ►M11

    COMMISSION REGULATION (EU) 2018/831 of 5 June 2018

      L 140

    35

    6.6.2018


    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.

    ▼B

    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.

    ▼B

    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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    ▼B



    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

    ►M8  (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)

     

     

    ▼M10

    151

    13480

    0000080-05-7

    2,2-bis(4-hydroxyphenyl)propane

    no

    yes

    no

    0,05

     

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

    Not to be used for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants (9) and young children (10).

     

    13607

    ▼B

    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

     

     

    ►M8  (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

     

     

    ►M8  (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

     

     

    ►M8  (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

     

     

    ►M8  (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

     

     

    ►M8  (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

    ►M8  (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

     

     

    ►M8  (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)