Regulation source

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.

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

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.

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 Union or national provisions applicable to substances that may be used in the manufacture of adhesives, coatings and printing inks and applied on or incorporated in plastic materials and articles.

Article 3

Definitions

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

(1)

‘plastic materials and articles’ means:

(a)

materials and articles referred to in points (a), (b) and (c) of Article 2(1); and

(b)

plastic layers referred to in Article 2(1)(d) and (e);

(2)

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

(3)

‘polymer’ means any macromolecular substance obtained by:

(a)

a polymerisation process such as polyaddition or polycondensation, or by any other similar process of monomers and other starting substances; or

(b)

chemical modification of natural or synthetic macromolecules; or

(c)

microbial fermentation;

(4)

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

(5)

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

(6)

‘monomer or other starting substance’ means:

(a)

a substance undergoing any type of polymerisation process to manufacture polymers; or

(b)

a natural or synthetic macromolecular substance used in the manufacture of modified macromolecules; or

(c)

a substance used to modify existing natural or synthetic macromolecules;

(7)

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

(8)

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

(9)

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

(10)

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

(11)

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

(12)

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

(13)

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

(14)

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

(15)

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

(16)

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

(17)

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

(18)

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

(19)

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

(20)

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

(21)

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

Article 3a

High degree of purity

(i)

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

(ii)

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

(iii)

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

(iv)

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

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; and

(f)

comply with Commission Regulation (EU) 2022/1616 (2) if they fall within the scope of that 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 used in the manufacture of plastic materials and articles.

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.

4.
In case of doubt over the resulting designated identity of a substance, a Member State or the Commission may consult the Authority.

Article 6

Derogations for substances not included in the Union list

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 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 materials and articles subject to national law.

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

(a)

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

(b)

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

(c)

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

(d)

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

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

(a)

non-intentionally added substances;

(b)

aids to polymerisation.

5.
By way of derogation from Article 5, substances with a biocidal function used in biocidal products that may be made available on the Union market in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (3) for product-type 4 for use that covers incorporation into plastic materials and articles which may enter into contact with food, may be used as additives in the manufacturing of plastic materials and articles.

▼M18

6.
By way of derogation from Article 5, 2,2-bis(4-hydroxyphenyl)propane (‘bisphenol A’ or ‘BPA’) (CAS No 80-05-7) and other hazardous bisphenols or hazardous bisphenol derivatives as defined and falling within the scope of Regulation (EU) 2024/3190 may only be used in the manufacture of plastic materials and articles in accordance with that Regulation.

▼M19 —————

SECTION 2

General requirements, restrictions and specifications

Article 8

General requirements on substances

1.
Substances used in the manufacture of plastic materials and articles that may be present in the final plastic material, including those manufactured from waste, shall be of a high degree of purity and shall be of a technical quality suitable for the intended and foreseeable use of the materials or articles.

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

2.
By derogation from paragraph 1, as regards purity, UVCB substances that are identified by a name in this Regulation that refers to a natural multi constituent material the source of which is biological or mineral, may be used as obtained from their natural origin, provided they do not contain substances or materials that do not correspond to its identity as designated by that name. Any additional specifications or requirements applicable to a substance or material of natural origin set out in Table 1 of Annex I, applicable to the substance or material, shall apply.

Article 9

Specific requirements on substances

Substances used in the manufacture of ►M19 ————— ◄ 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 and requirements concerning the composition of plastic materials and articles

1.
Plastic materials and articles shall meet the restrictions on plastic materials and articles laid down in Annex II.

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

(a)

it is a by-product in accordance with Article 5 of Directive 2008/98/EC of the European Parliament and of the Council (4);

(b)

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

(c)

it originates from one of the following off-cuts and scraps from plastic materials and articles:

(i)

off-cuts and scraps from plastic materials and articles referred to in point (a) of Article 2(1) that meet the compositional requirements set out in Chapter II of this Regulation, or

(ii)

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

(d)

it does not contain substances in an amount which could:

(i)

exceed migration limits applicable for the substance as specified in this Regulation; or

(ii)

cause any other non-compliance of those plastic materials and articles with Article 3 of Regulation (EC) No 1935/2004.

3.
Where intended for repeated use in contact with food, the composition and the design of final food contact articles shall be such, so as to guarantee that no increase in the migration of constituents of the material or article to the food would occur when subjected to subsequent use cycles of the articles in accordance with the instructions for intended use as described in documentation or labelling.

Article 11

Specific migration limits

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 —————

(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.

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.

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 (5) and 2006/125/EC (6), 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.

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 ►M19 ————— ◄ .

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.

The substances not listed in the Union list ►M19 ————— ◄ 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 (7);

(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 ►M19 ————— ◄ .

The substances not listed in the Union list ►M19 ————— ◄ referred to in paragraph 2 shall not belong to either of the following categories:

(a)

(b)

substances in nanoform.

4.
Articles 11 and 12 apply to multi-material multi-layer materials and articles when the surface layer that is in contact with food is made of a material falling within the scope of this Regulation.

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

CHAPTER IV

LABELLING, DECLARATION OF COMPLIANCE AND DOCUMENTATION

Article 14a

Labelling

(a)

appropriate instructions designed to slow down deterioration of the article;

(b)

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

(c)

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

—

specific foods or groups of foods,

—

contact time and/or temperature, and/or

—

heating conditions such as oven and microwave use.

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

Article 15

Declaration of compliance

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.

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

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.

3.
Manufacturers of plastic materials and articles, and of products from intermediate stages of their manufacturing, shall ensure that documentation showing compliance with paragraphs 1 to 2 of Article 8 is part of the documentation referred to in paragraph 1.

4.
Manufacturers of plastic materials and articles, and of products from intermediate stages of their manufacturing, shall ensure that competent authorities can take samples during the carrying out of official controls to verify their degree of purity and their composition, including that of the substances and materials used for their manufacture.

CHAPTER V

COMPLIANCE

Article 17

Expression of migration test results

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.

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

(a)

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

(b)

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

(c)

sheets and films that are not yet in contact with food;

(d)

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

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

(a)

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

(b)

mg/article if the intended use of the article is unknown.

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

(a)

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

(b)

mg/article if the intended use of the article is unknown.

Article 18

Rules for assessing compliance with migration limits

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.

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.

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.

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.

Article 19

Assessment of substances not included in the Union list

CHAPTER VI

FINAL PROVISIONS

Article 20

Amendments of EU acts

The Annex to Council Directive 85/572/EEC (9) 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.

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 used in glass fibre sizing for glass fibre reinforced plastics, shall apply from 31 December 2015.

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

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

ANNEX I

Substances

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

Table 1 contains the following information:

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

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

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

Column 4 (Substance Name): the chemical name

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

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

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

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

Column 9 (SML(T) mg/kg): 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.

▼M7 —————

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).
▼M16 —————
▼B
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
▼M16 —————
▼B
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 — ◄
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)
▼M18 —————
▼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
▼M18 —————
▼B
155	23470	0000080-56-8	α-pinene	no	yes	no
156	21130	0000080-62-6	methacrylic acid, methyl ester	no	yes	no		(23)
▼M16
157	74880	0000084-74-2	phthalic acid, dibutyl ester (‘DBP’)	yes	no	no	0,12	(32); (36)	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 % (w/w) in the final product.	(7)
▼B
158	23380	0000085-44-9	phthalic anhydride	yes	yes	no
76320
▼M16
159	74560	0000085-68-7	phthalic acid, benzyl butyl ester (‘BBP’)	yes	no	no	6	(32); (36)	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 formula and follow-on formula (7);; (c) technical support agent in concentrations up to 0,1 % (w/w) in the final product.	(7)
▼B
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 — ◄
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 — ◄
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
▼M15
236	23050	0000108-45-2	1,3-phenylenediamine	no	yes	no	ND			(28)
▼B
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
▼M16
283	74640	0000117-81-7	phthalic acid, bis(2-ethylhexyl) ester (‘DEHP’)	yes	no	no	0,6	(32); (36)	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 % (w/w) in the final product.	(7)
▼B
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 — ◄
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
▼M15
398	35760	0001309-64-4	antimony trioxide	yes	no	no				(6)
▼B
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 — ◄
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)
▼M12
467	14800	3724-65-0	crotonic acid	yes	yes	no		(35)
45600
▼B
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 — ◄
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 — ◄
503	46080	0007585-39-9	β-dextrin	yes	no	no
504	86240	0007631-86-9	silicon dioxide	yes	no	no			For synthetic amorphous silicon dioxide: primary particles of 1 – 100 nm which are aggregated to a size of 0,1 – 1 μm which may form agglomerates within the size distribution of 0,3 μm to the mm size.
505	86480	0007631-90-5	sodium bisulphite	yes	no	no		(19)
506	86920	0007632-00-0	sodium nitrite	yes	no	no	0,6
507	59990	0007647-01-0	hydrochloric acid	yes	no	no
508	86560	0007647-15-6	sodium bromide	yes	no	no
509	23170	0007664-38-2	phosphoric acid	yes	yes	no
72640
510	12789	0007664-41-7	ammonia	yes	yes	no
35320
511	91920	0007664-93-9	sulphuric acid	yes	no	no
512	81680	0007681-11-0	potassium iodide	yes	no	no		(6)
513	86800	0007681-82-5	sodium iodide	yes	no	no		(6)
514	91840	0007704-34-9	sulphur	yes	no	no
515	26360	0007732-18-5	water	yes	yes	no			In compliance with Directive 98/83/EC (2)
95855
516	86960	0007757-83-7	sodium sulphite	yes	no	no		(19)
517	81520	0007758-02-3	potassium bromide	yes	no	no
518	35845	0007771-44-0	arachidonic acid	yes	no	no
519	87120	0007772-98-7	sodium thiosulphate	yes	no	no		(19)
520	65120	0007773-01-5	manganese chloride	yes	no	no
521	58320	0007782-42-5	graphite	yes	no	no
522	14530	0007782-50-5	chlorine	no	yes	no
523	45195	0007787-70-4	copper bromide	yes	no	no
524	24520	0008001-22-7	soybean oil	no	yes	no
525	62640	0008001-39-6	japan wax	yes	no	no
526	43440	0008001-75-0	ceresin	yes	no	no
527	14411	0008001-79-4	castor oil	yes	yes	no
42880
528	63760	0008002-43-5	lecithin	yes	no	no
529	67850	0008002-53-7	montan wax	yes	no	no
530	41760	0008006-44-8	candelilla wax	yes	no	no
531	36880	0008012-89-3	beeswax	yes	no	no
532	88640	0008013-07-8	soybean oil, epoxidised	yes	no	no	60; 30(*)	(32)	(*) In the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC, the SML is lowered to 30 mg/kg.; Oxirane < 8 %, iodine number < 6.
533	42720	0008015-86-9	carnauba wax	yes	no	no
534	80720	0008017-16-1	polyphosphoric acids	yes	no	no
535	24100	0008050-09-7	rosin	yes	yes	no
24130
24190
83840
536	84320	0008050-15-5	rosin, hydrogenated, ester with methanol	yes	no	no
537	84080	0008050-26-8	rosin, ester with pentaerythritol	yes	no	no
538	84000	0008050-31-5	rosin, ester with glycerol	yes	no	no
539	24160	0008052-10-6	rosin tall oil	no	yes	no
540	63940	0008062-15-5	lignosulphonic acid	yes	no	no	0,24		Only to be used as dispersant for plastics dispersions
541	58480	0009000-01-5	gum arabic	yes	no	no
542	42640	0009000-11-7	carboxymethylcellulose	yes	no	no
543	45920	0009000-16-2	dammar	yes	no	no
544	58400	0009000-30-0	guar gum	yes	no	no
545	93680	0009000-65-1	tragacanth gum	yes	no	no
546	71440	0009000-69-5	pectin	yes	no	no
547	55440	0009000-70-8	gelatin	yes	no	no
548	42800	0009000-71-9	casein	yes	no	no
549	80000	0009002-88-4	polyethylene wax	yes	no	no
550	81060	0009003-07-0	polypropylene wax	yes	no	no
551	79920	0009003-11-6; 0106392-12-5	poly(ethylene propylene) glycol	yes	no	no
552	81500	0009003-39-8	polyvinylpyrrolidone	yes	no	no			The substance shall meet the purity criteria as laid down in Commission Directive 2008/84/EC (3)
553	14500	0009004-34-6	cellulose	yes	yes	no
43280
554	43300	0009004-36-8	cellulose acetate butyrate	yes	no	no
555	53280	0009004-57-3	ethylcellulose	yes	no	no
556	54260	0009004-58-4	ethylhydroxyethylcellulose	yes	no	no
557	66640	0009004-59-5	methylethylcellulose	yes	no	no
558	60560	0009004-62-0	hydroxyethylcellulose	yes	no	no
559	61680	0009004-64-2	hydroxypropylcellulose	yes	no	no
560	66700	0009004-65-3	methylhydroxypropylcellulose	yes	no	no
561	66240	0009004-67-5	methylcellulose	yes	no	no
562	22450	0009004-70-0	nitrocellulose	no	yes	no
563	78320	0009004-97-1	polyethyleneglycol monoricinoleate	yes	no	yes	42
564	24540	0009005-25-8	starch, edible	yes	yes	no
88800
565	61120	0009005-27-0	hydroxyethyl starch	yes	no	no
566	33350	0009005-32-7	alginic acid	yes	no	no
567	82080	0009005-37-2	1,2-propyleneglycol alginate	yes	no	no
568	79040	0009005-64-5	polyethyleneglycol sorbitan monolaurate	yes	no	no
569	79120	0009005-65-6	polyethyleneglycol sorbitan monooleate	yes	no	no
570	79200	0009005-66-7	polyethyleneglycol sorbitan monopalmitate	yes	no	no
571	79280	0009005-67-8	polyethyleneglycol sorbitan monostearate	yes	no	no
572	79360	0009005-70-3	polyethyleneglycol sorbitan trioleate	yes	no	no
573	79440	0009005-71-4	polyethyleneglycol sorbitan tristearate	yes	no	no
574	24250	0009006-04-6	rubber, natural	yes	yes	no
84560
575	76721	0063148-62-9	polydimethylsiloxane (Mw > 6 800 Da)	yes	no	no			Viscosity at 25 °C not less than 100 cSt (100 × 10-6 m2/s)
576	60880	0009032-42-2	hydroxyethylmethylcellulose	yes	no	no
577	62280	0009044-17-1	isobutylene-butene copolymer	yes	no	no
578	79600	0009046-01-9	polyethyleneglycol tridecyl ether phosphate	yes	no	no	5		For materials and articles intended for contact with aqueous foods only.; Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.
579	61800	0009049-76-7	hydroxypropyl starch	yes	no	no
580	46070	0010016-20-3	α-dextrin	yes	no	no
581	36800	0010022-31-8	barium nitrate	yes	no	no
582	50240	0010039-33-5	di-n-octyltin bis(2-ethylhexyl maleate)	yes	no	no		(10)
583	40400	0010043-11-5	boron nitride	yes	no	no		(16)
584	13620	0010043-35-3	boric acid	yes	yes	no		(16)
40320
585	41120	0010043-52-4	calcium chloride	yes	no	no
586	65280	0010043-84-2	manganese hypophosphite	yes	no	no
587	68400	0010094-45-8	octadecylerucamide	yes	no	yes	5
588	64320	0010377-51-2	lithium iodide	yes	no	no		(6)
589	52645	0010436-08-5	cis-11-eicosenamide	yes	no	no
590	21370	0010595-80-9	methacrylic acid, 2-sulphoethyl ester	no	yes	no	ND			(1)
591	36160	0010605-09-1	ascorbyl stearate	yes	no	no
592	34690	0011097-59-9	aluminium magnesium carbonate hydroxide	yes	no	no
593	44960	0011104-61-3	cobalt oxide	yes	no	no
594	65360	0011129-60-5	manganese oxide	yes	no	no
595	19510	0011132-73-3	lignocellulose	no	yes	no
596	95935	0011138-66-2	xanthan gum	yes	no	no
597	67120	0012001-26-2	mica	yes	no	no
598	41600	0012004-14-7; 0037293-22-4	calcium sulphoaluminate	yes	no	no
599	36840	0012007-55-5	barium tetraborate	yes	no	no		(16)
600	60030	0012072-90-1	hydromagnesite	yes	no	no
601	35440	0012124-97-9	ammonium bromide	yes	no	no
602	70240	0012198-93-5	ozokerite	yes	no	no
603	83460	0012269-78-2	pyrophyllite	yes	no	no
604	60080	0012304-65-3	hydrotalcite	yes	no	no
605	11005	0012542-30-2	acrylic acid, dicyclopentenyl ester	no	yes	no	0,05			(1)
606	65200	0012626-88-9	manganese hydroxide	yes	no	no
607	62245	0012751-22-3	iron phosphide	yes	no	no			Only to be used in PET polymers and copolymers
608	40800	0013003-12-8	4,4′-butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite)	yes	no	yes	6
609	83455	0013445-56-2	pyrophosphorous acid	yes	no	no
610	93440	0013463-67-7	titanium dioxide	yes	no	no
611	35120	0013560-49-1	3-aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether	yes	no	no
612	16694	0013811-50-2	N,N′-divinyl-2-imidazolidinone	no	yes	no	0,05			(10)
613	95905	0013983-17-0	wollastonite	yes	no	no
614	45560	0014464-46-1	cristobalite	yes	no	no
615	92080	0014807-96-6	talc	yes	no	no
616	83470	0014808-60-7	quartz	yes	no	no
617	10660	0015214-89-8	2-acrylamido-2-methylpropanesulphonic acid	no	yes	no	0,05
618	51040	0015535-79-2	di-n-octyltin mercaptoacetate	yes	no	no		(10)
619	50320	0015571-58-1	di-n-octyltin bis(2-ethylhexyl mercaptoacetate)	yes	no	no		(10)
620	50720	0015571-60-5	di-n-octyltin dimaleate	yes	no	no		(10)
621	17110	0016219-75-3	5-ethylidenebicyclo[2,2,1]hept-2-ene	no	yes	no	0,05			(9)
622	69840	0016260-09-6	oleylpalmitamide	yes	no	yes	5
623	52640	0016389-88-1	dolomite	yes	no	no
624	18897	0016712-64-4	6-hydroxy-2-naphthalenecarboxylic acid	no	yes	no	0,05
625	36720	0017194-00-2	barium hydroxide	yes	no	no
626	57800	0018641-57-1	glycerol tribehenate	yes	no	no
627	59760	0019569-21-2	huntite	yes	no	no
628	96190	0020427-58-1	zinc hydroxide	yes	no	no
629	34560	0021645-51-2	aluminium hydroxide	yes	no	no
630	82240	0022788-19-8	1,2-propyleneglycol dilaurate	yes	no	no
631	59120	0023128-74-7	1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide)	yes	no	yes	45
632	52880	0023676-09-7	4-ethoxybenzoic acid, ethyl ester	yes	no	no	3,6
633	53200	0023949-66-8	2-ethoxy-2′-ethyloxanilide	yes	no	yes	30
634	25910	0024800-44-0	tripropyleneglycol	no	yes	no
635	40720	0025013-16-5	tert-butyl-4-hydroxyanisole	yes	no	no	30
636	31500	0025134-51-4	acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer	yes	no	no	0,05	(22)	SML expressed as acrylic acid, 2-ethylhexyl ester
637	71635	0025151-96-6	pentaerythritol dioleate	yes	no	no	0,05		Not to be used for articles in contact with fatty foods for which ►M7 simulant D1 and/or D2 ◄ is laid down
638	23590	0025322-68-3	polyethyleneglycol	yes	yes	no
76960
639	23651	0025322-69-4	polypropyleneglycol	yes	yes	no
80800
640	54930	0025359-91-5	formaldehyde-1-naphthol, copolymer	yes	no	no	0,05
▼M7
641	22331	0025513-64-8	mixture of (35-45 % w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexane	no	yes	no	0,05
▼B
642	64990	0025736-61-2	maleic anhydride-styrene, copolymer, sodium salt	yes	no	no			The fraction with molecular weight below 1 000 Da ►M7 shall ◄ not exceed 0,05 % (w/w)
643	87760	0026266-57-9	sorbitan monopalmitate	yes	no	no
644	88080	0026266-58-0	sorbitan trioleate	yes	no	no
645	67760	0026401-86-5	mono-n-octyltin tris(isooctyl mercaptoacetate)	yes	no	no		(11)
646	50480	0026401-97-8	di-n-octyltin bis(isooctyl mercaptoacetate)	yes	no	no		(10)
647	56720	0026402-23-3	glycerol monohexanoate	yes	no	no
648	56880	0026402-26-6	glycerol monooctanoate	yes	no	no
649	47210	0026427-07-6	dibutylthiostannoic acid polymer	yes	no	no			Molecular unit = (C8H18S3Sn2)n (n = 1,5-2)
650	49600	0026636-01-1	dimethyltin bis(isooctyl mercaptoacetate)	yes	no	no		(9)
651	88240	0026658-19-5	sorbitan tristearate	yes	no	no
652	38820	0026741-53-7	bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite	yes	no	yes	0,6
653	25270	0026747-90-0	2,4-toluene diisocyanate dimer	no	yes	no		(17)	1 mg/kg in final product expressed as isocyanate moiety	(10)
654	88600	0026836-47-5	sorbitol monostearate	yes	no	no
655	25450	0026896-48-0	tricyclodecanedimethanol	no	yes	no	0,05
656	24760	0026914-43-2	styrenesuphonic acid	no	yes	no	0,05
657	67680	0027107-89-7	mono-n-octyltin tris(2-ethylhexyl mercaptoacetate)	yes	no	no		(11)
658	52000	0027176-87-0	dodecylbenzenesulphonic acid	yes	no	no	30
659	82800	0027194-74-7	1,2-propyleneglycol monolaurate	yes	no	no
660	47540	0027458-90-8	di-tert-dodecyl disulphide	yes	no	yes	0,05
661	95360	0027676-62-6	1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione	yes	no	yes	5
662	25927	0027955-94-8	1,1,1-tris(4-hydroxyphenol)ethane	no	yes	no	0,005		Only to be used in polycarbonates	►M8 — ◄
663	64150	0028290-79-1	linolenic acid	yes	no	no
664	95000	0028931-67-1	trimethylolpropane trimethacrylate-methyl methacrylate copolymer	yes	no	no
665	83120	0029013-28-3	1,2-propyleneglycol monopalmitate	yes	no	no
666	87280	0029116-98-1	sorbitan dioleate	yes	no	no
667	55190	0029204-02-2	gadoleic acid	yes	no	no
668	80240	0029894-35-7	polyglycerol ricinoleate	yes	no	no
669	56610	0030233-64-8	glycerol monobehenate	yes	no	no
670	56800	0030899-62-8	glycerol monolaurate diacetate	yes	no	no		(32)
671	74240	0031570-04-4	phosphorous acid, tris(2,4-di-tert-butylphenyl)ester	yes	no	no
672	76845	0031831-53-5	polyester of 1,4-butanediol with caprolactone	yes	no	no		(29); (30)	The fraction with molecular weight below 1 000 Da ►M7 shall ◄ not exceed 0,5 % (w/w)
673	53670	0032509-66-3	ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]	yes	no	yes	6
674	46480	0032647-67-9	dibenzylidene sorbitol	yes	no	no
675	38800	0032687-78-8	N,N′-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide	yes	no	yes	15
676	50400	0033568-99-9	di-n-octyltin bis(isooctyl maleate)	yes	no	no		(10)
677	82560	0033587-20-1	1,2-propyleneglycol dipalmitate	yes	no	no
678	59200	0035074-77-2	1,6-hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)	yes	no	yes	6
679	39060	0035958-30-6	1,1-bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane	yes	no	yes	5
680	94400	0036443-68-2	triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate]	yes	no	no	9
681	18310	0036653-82-4	1-hexadecanol	no	yes	no
682	53270	0037205-99-5	ethylcarboxymethylcellulose	yes	no	no
683	66200	0037206-01-2	methylcarboxymethylcellulose	yes	no	no
684	68125	0037244-96-5	nepheline syenite	yes	no	no
685	85950	0037296-97-2	silicic acid, magnesium-sodium-fluoride salt	yes	no	no	0,15		SML expressed as fluoride.; Only to be used in layers of multi-layer materials not coming into direct contact with food.
686	61390	0037353-59-6	hydroxymethylcellulose	yes	no	no
687	13530	0038103-06-9	2,2-bis(4-hydroxyphenyl)propane bis(phthalic anhydride)	no	yes	no	0,05
13614
688	92560	0038613-77-3	tetrakis(2,4-di-tert-butyl-phenyl)-4,4′-biphenylylene diphosphonite	yes	no	yes	18
689	95280	0040601-76-1	1,3,5-tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione	yes	no	yes	6
690	92880	0041484-35-9	thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate)	yes	no	yes	2,4
691	13600	0047465-97-4	3,3-bis(3-methyl-4-hydroxyphenyl)2-indolinone	no	yes	no	1,8
692	52320	0052047-59-3	2-(4-dodecylphenyl)indole	yes	no	yes	0,06
693	88160	0054140-20-4	sorbitan tripalmitate	yes	no	no
694	21400	0054276-35-6	methacrylic acid, sulphopropyl ester	no	yes	no	0,05			(1)
695	67520	0054849-38-6	monomethyltin tris(isooctyl mercaptoacetate)	yes	no	no		(9)
696	92205	0057569-40-1	terephthalic acid, diester with 2,2′-methylenebis(4-methyl-6-tert-butylphenol)	yes	no	no
697	67515	0057583-34-3	monomethyltin tris(ethylhexyl mercaptoacetate)	yes	no	no		(9)
698	49595	0057583-35-4	dimethyltin bis(ethylhexyl mercaptoacetate)	yes	no	no		(9)
699	90720	0058446-52-9	stearoylbenzoylmethane	yes	no	no
700	31520	0061167-58-6	acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl ester	yes	no	yes	6
701	40160	0061269-61-2	N,N′-bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer	yes	no	no	2,4
702	87920	0061752-68-9	sorbitan tetrastearate	yes	no	no
703	17170	0061788-47-4	fatty acids, coco	no	yes	no
704	77600	0061788-85-0	polyethyleneglycol ester of hydrogenated castor oil	yes	no	no
705	10599/90A	0061788-89-4	acids, fatty, unsaturated (C18), dimers, non hydrogenated, distilled and non-distilled	no	yes	no		(18)		(1)
10599/91
706	17230	0061790-12-3	fatty acids, tall oil	no	yes	no
707	46375	0061790-53-2	diatomaceous earth	yes	no	no
708	77520	0061791-12-6	polyethyleneglycol ester of castor oil	yes	no	no	42
709	87520	0062568-11-0	sorbitan monobehenate	yes	no	no
710	38700	0063397-60-4	bis(2-carbobutoxyethyl)tin-bis(isooctyl mercaptoacetate)	yes	no	yes	18
711	42000	0063438-80-2	(2-carbobutoxyethyl)tin-tris(isooctyl mercaptoacetate)	yes	no	yes	30
712	42960	0064147-40-6	castor oil, dehydrated	yes	no	no
▼M6
713	43480	0064365-11-3	charcoal, activated	yes	no	no			Only for use in PET at maximum 10 mg/kg of polymer.; Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 (4) with exception of ash content which can be up to 10 % (w/w).
0007440-44-0
▼B
714	84400	0064365-17-9	rosin, hydrogenated, ester with pentaerythritol	yes	no	no
715	46880	0065140-91-2	3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester, calcium salt	yes	no	no	6
716	60800	0065447-77-0	1-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl piperidine-succinic acid, dimethyl ester, copolymer	yes	no	no	30
717	84210	0065997-06-0	rosin, hydrogenated	yes	no	no
718	84240	0065997-13-9	rosin, hydrogenated, ester with glycerol	yes	no	no
719	65920	0066822-60-4	N-methacryloyloxyethyl-N,N-dimethyl-N-carboxymethylammonium chloride, sodium salt -octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers	yes	no	no
720	67360	0067649-65-4	mono-n-dodecyltin tris(isooctyl mercaptoacetate)	yes	no	no		(25)
721	46800	0067845-93-6	3,5-di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester	yes	no	no
722	17200	0068308-53-2	fatty acids, soya	no	yes	no
723	88880	0068412-29-3	starch, hydrolysed	yes	no	no
724	24903	0068425-17-2	syrups, hydrolysed starch, hydrogenated	no	yes	no			In compliance with the purity criteria for maltitol syrup E 965(ii) as laid down in Commission Directive 2008/60/EC (5)
▼M6 —————
▼B
726	83599	0068442-12-6	reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin	yes	no	yes		(9)
727	43360	0068442-85-3	cellulose, regenerated	yes	no	no
▼M16
728	75100	0068515-48-0 0028553-12-0	phthalic acid, diesters with primary, saturated C 8-C 10 branched alcohols, more than 60 % C 9 (‘DINP’)	yes	no	no		(26); (32)	Only to be used as:; (a) plasticiser in repeated use materials and articles;; (b) plasticiser in single-use materials and articles contacting non-fatty foods except for infant formula and follow-on formula (7); (c) technical support agent in concentrations up to 0,1 % (w/w) in the final product.; Not to be used in combination with FCM substances 157, 159, 283, or 1085.	(7)
▼B
729	75105	0068515-49-1; 0026761-40-0	phthalic acid, diesters with primary, saturated C9-C11 alcohols more than 90 % C10	yes	no	no		(26); (32)	Only to be used as:; (a) plasticiser in repeated use materials and articles;; (b) plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC;; (c) technical support agent in concentrations up to 0,1 % in the final product.	(7)
730	66930	0068554-70-1	methylsilsesquioxane	yes	no	no			Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane
731	18220	0068564-88-5	N-heptylaminoundecanoic acid	no	yes	no	0,05			(2)
732	45450	0068610-51-5	p-cresol-dicyclopentadiene-isobutylene, copolymer	yes	no	yes	5
733	10599/92A	0068783-41-5	acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled and non-distilled	no	yes	no		(18)		(1)
10599/93
734	46380	0068855-54-9	diatomaceous earth, soda ash flux-calcined	yes	no	no
735	40120	0068951-50-8	bis(polyethyleneglycol)hydroxymethylphosphonate	yes	no	no	0,6
736	50960	0069226-44-4	di-n-octyltin ethyleneglycol bis(mercaptoacetate)	yes	no	no		(10)
737	77370	0070142-34-6	polyethyleneglycol-30 dipolyhydroxystearate	yes	no	no
738	60320	0070321-86-7	2-[2-hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole	yes	no	yes	1,5
739	70000	0070331-94-1	2,2′-oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]	yes	no	no
740	81200	0071878-19-8	poly[6-[(1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl) imino]	yes	no	yes	3
741	24070	0073138-82-6	resin acids and rosin acids	yes	yes	no
83610
742	92700	0078301-43-6	2,2,4,4-tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21-one, polymer	yes	no	yes	5
743	38950	0079072-96-1	bis(4-ethylbenzylidene)sorbitol	yes	no	no
▼M12
744	18888	080181-31-3	3-hydroxybutanoic acid-3- hydroxypentanoic acid, copolymer	no	yes	no		(35)	The substance is used as product obtained by bacterial fermentation. In compliance with the specifications mentioned in the Table 4 of Annex I.
▼B
745	68145	0080410-33-9	2,2′,2′-nitrilo(triethyl tris(3,3′,5,5′-tetra-tert-butyl-1,1′-bi-phenyl-2,2′-diyl)phosphite)	yes	no	yes	5		SML expressed as sum of phosphite and phosphate
746	38810	0080693-00-1	bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite	yes	no	yes	5		SML expressed as sum of phosphite and phosphate
747	47600	0084030-61-5	di-n-dodecyltin bis(isooctyl mercaptoacetate)	yes	no	yes		(25)
748	12765	0084434-12-8	N-(2-aminoethyl)-β-alanine, sodium salt	no	yes	no	0,05
749	66360	0085209-91-2	2,2′-methylene bis(4,6-di-tert-butylphenyl) sodium phosphate	yes	no	yes	5
750	66350	0085209-93-4	2,2′-methylenebis(4,6-di-tert-butylphenyl) lithium phosphate	yes	no	no	5
751	81515	0087189-25-1	poly(zinc glycerolate)	yes	no	no
▼M7
752	39890	0087826-41-3; 0069158-41- 4; 0054686-97-4; 0081541-12-0	bis(methylbenzylidene)sorbitol	yes	no	no
▼B
753	62800	0092704-41-1	kaolin, calcined	yes	no	no
754	56020	0099880-64-5	glycerol dibehenate	yes	no	no
755	21765	0106246-33-7	4,4′-methylenebis(3-chloro-2,6-diethylaniline)	no	yes	no	0,05			(1)
756	40020	0110553-27-0	2,4-bis(octylthiomethyl)-6-methylphenol	yes	no	yes		(24)
757	95725	0110638-71-6	vermiculite, reaction product with citric acid, lithium salt	yes	no	no
758	38940	0110675-26-8	2,4-bis(dodecylthiomethyl)-6-methylphenol	yes	no	yes		(24)
759	54300	0118337-09-0	2,2′-ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphonite	yes	no	yes	6
760	83595	0119345-01-6	reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product of phosphorous trichloride and biphenyl	yes	no	no	18		Composition:; — 4,4′-biphenylene-bis0,0-bis(2,4-di-tert-butylphenyl)phosphonite (36-46 % w/w ()),; — 4,3′-biphenylene-bis0,0-bis(2,4-di-tert-butylphenyl)phosphonite (17-23 % w/w ()),; — 3,3′-biphenylene-bis0,0-bis(2,4-di-tert-butylphenyl)phosphonite (1-5 % w/w ()),; — 4-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0091362-37-7) (11-19 % w/w ()),; — tris(2,4-di-tert-butylphenyl)phosphite (CAS No 0031570-04-4) (9-18 % w/w ()),; — 4,4′-biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS No 0112949-97-0) (< 5 % w/w ()); (*) Quantity of substance used/quantity of formulation; Other specifications:; — Phosphor content of min. 5,4 % to max. 5,9 %,; — Acid value of max. 10 mg KOH per gram,; — Melt range of 85– 110 °C,
761	92930	0120218-34-0	thiodiethanolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyridine-3-carboxylate)	yes	no	no	6
762	31530	0123968-25-2	acrylic acid, 2,4-di-tert-pentyl-6-(1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl)phenyl ester	yes	no	yes	5
763	39925	0129228-21-3	3,3-bis(methoxymethyl)-2,5-dimethylhexane	yes	no	yes	0,05
764	13317	0132459-54-2	N,N′-bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide	no	yes	no	0,05		Purity > 98,1 % (w/w).; Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT).
765	49485	0134701-20-5	2,4-dimethyl-6-(1-methylpentadecyl)phenol	yes	no	yes	1
766	38879	0135861-56-2	bis(3,4-dimethylbenzylidene)sorbitol	yes	no	no
767	38510	0136504-96-6	1,2-bis(3-aminopropyl)ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine	yes	no	no	5
768	34850	0143925-92-2	amines, bis(hydrogenated tallow alkyl) oxidised	yes	no	no			Not to be used for articles in contact with fatty foods for which ►M7 simulant D1 and/or D2 ◄ is laid down.; Only to be used in:; (a) polyolefins at 0,1 % (w/w) concentration and in; (b) PET at 0,25 % (w/w) concentration.	(1)
769	74010	0145650-60-8	phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester	yes	no	yes	5		SML expressed as sum of phosphite and phosphate
770	51700	0147315-50-2	2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol	yes	no	no	0,05
771	34650	0151841-65-5	aluminium hydroxybis [2,2′-methylenebis (4,6-di-tert-butylphenyl) phosphate]	yes	no	no	5
772	47500	0153250-52-3	N,N′-dicyclohexyl-2,6-naphthalene dicarboxamide	yes	no	no	5
773	38840	0154862-43-8	bis(2,4-dicumylphenyl)pentaerythritol-diphosphite	yes	no	yes	5		SML expressed as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol)
774	95270	0161717-32-4	2,4,6-tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediol phosphite	yes	no	yes	2		SML expressed as sum of phosphite, phosphate and the hydrolysis product = TTBP
775	45705	0166412-78-8	1,2-cyclohexanedicarboxylic acid, diisononyl ester	yes	no	no		(32)
776	76723	0167883-16-1	polydimethylsiloxane, 3-aminopropyl terminated, polymer with dicyclohexylmethane-4,4′-diisocyanate	yes	no	no			The fraction with molecular weight below 1 000 Da ►M7 shall ◄ not exceed 1,5 % (w/w)
777	31542	0174254-23-0	acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters	yes	no	no			0,5 % in final product	(1)
778	71670	0178671-58-4	pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)	yes	no	yes	0,05
▼M7
779	39815	0182121-12-6	9,9-bis(methoxymethyl)fluorene	yes	no	yes	0,05			►M8 — ◄
▼B
780	81220	0192268-64-7	poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl)-n-butylamino]-1,3,5-triazine-2,4-diyl][(2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanediyl[(2,2,6,6-tetramethyl-4-piperidinyl)imino]]-α-[N,N,N′,N′-tetrabutyl-N"-(2,2,6,6-tetramethyl-4-piperidinyl)-N"-[6-(2,2,6,6-tetramethyl-4-piperidinylamino)-hexyl]-[1,3,5-triazine-2,4,6-triamine]-ω-N,N,N′,N′-tetrabutyl-1,3,5-triazine-2,4-diamine]	yes	no	no	5
781	95265	0227099-60-7	1,3,5-tris(4-benzoylphenyl) benzene	yes	no	no	0,05
782	76725	0661476-41-1	polydimethylsiloxane, 3-aminopropyl terminated, polymer with 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane	yes	no	no			The fraction with molecular weight below 1 000 Da ►M7 shall ◄ not exceed 1 % (w/w)
783	55910	0736150-63-3	glycerides, castor-oil mono-, hydrogenated, acetates	yes	no	no		(32)
▼M6
784	95420	0745070-61-5	1,3,5-tris (2,2-di-methylpropanamido) benzene	yes	no	no	5
▼B
785	24910	0000100-21-0	terephthalic acid	no	yes	no		(28)
786	14627	0000117-21-5	3-chlorophthalic anhydride	no	yes	no	0,05		SML expressed as 3-chlorophthalic acid
787	14628	0000118-45-6	4-chlorophthalic anhydride	no	yes	no	0,05		SML expressed as 4-chlorophthalic acid
788	21498	0002530-85-0	[3-(methacryloxy)propyl]trimethoxysilane	no	yes	no	0,05		Only to be used as a surface treatment agent of inorganic fillers	(1); (11)
789	60027	—	hydrogenated homopolymers and/or copolymers made of 1-hexene and/or 1-octene and/or 1-decene and/or 1-dodecene and/or 1-tetradecene (Mw: 440–12 000 )	yes	no	no			Average molecular weight not less than 440 Da.; Viscosity at 100 °C not less than 3,8 cSt (3,8 × 10-6 m2/s).	(2)
790	80480	0090751-07-8; 0082451-48-7	poly(6-morpholino-1,3,5-triazine-2,4-diyl)-[(2,2,6,6-tetramethyl-4-piperidyl)imino)] hexa-methylene-[(2,2,6,6-tetramethyl-4-piperidyl)imino)]	yes	no	no	5		Average molecular weight not less than 2 400 Da.; Residual content of morpholine ≤ 30 mg/kg, of N,N′-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15 000 mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.	(16)
791	92470	0106990-43-6	N,N′,N″,N″-tetrakis(4,6-bis(N-butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine	yes	no	no	0,05
792	92475	0203255-81-6	3,3′,5,5′-tetrakis(tert-butyl)-2,2′-dihydroxybiphenyl, cyclic ester with [3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propyl]oxyphosphonous acid	yes	no	yes	5		SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis products
▼M16
793	94000	0000102-71-6	triethanolamine	yes	no	no		(37)
▼M2
794	18117	0000079-14-1	glycolic acid	no	yes	no			Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.
▼B
795	40155	0124172-53-8	N,N′-bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N′-diformylhexamethylenediamine	yes	no	no	0,05			(2); (12)
796	72141	0018600-59-4	2,2′-(1,4-phenylene)bis[4H-3,1-benzoxazin-4-one]	yes	no	yes	0,05		SML including the sum of its hydrolysis products
▼M2
797	76807	0073018-26-5	polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol	yes	no	yes		(31); (32)
▼B
798	92200	0006422-86-2	terephthalic acid, bis(2-ethylhexyl)ester	yes	no	no	60	(32)
▼M6
799	77708		polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols	yes	no	no	1,8		In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.
▼B
800	94425	0000867-13-0	triethyl phosphonoacetate	yes	no	no			Only for use in PET
801	30607	—	acids, C2-C24, aliphatic, linear, monocarboxylic, from natural oils and fats, lithium salt	yes	no	no
802	33105	0146340-15-0	alcohols, C12-C14 secondary, β-(2-hydroxyethoxy), ethoxylated	yes	no	no	5			(12)
803	33535	0152261-33-1	α-alkenes(C20-C24) copolymer with maleic anhydride, reaction product with 4-amino-2,2,6,6-tetramethylpiperidine	yes	no	no			Not to be used for articles in contact with fatty foods for which ►M7 simulant D1 and/or D2 ◄ is laid down.; Not to be used in contact with alcoholic foods.	(13)
804	80510	1010121-89-7	poly(3-nonyl-1,1-dioxo-1-thiopropane-1,3-diyl)-block-poly(x-oleyl-7-hydroxy-1,5-diiminooctane-1,8-diyl), process mixture with x = 1 and/or 5, neutralised with dodecylbenzenesulfonic acid	yes	no	no			Only to be used as polymer production aid in polyethylene (PE), polypropylene (PP) and polystyrene (PS)
805	93450	—	titanium dioxide, coated with a copolymer of n-octyltrichlorosilane and [aminotris(methylenephosphonic acid), penta sodium salt]	yes	no	no			The content of the surface treatment copolymer of the coated titanium dioxide is less than 1 % w/w
806	14876	0001076-97-7	1,4-cyclohexanedicarboxylic acid	no	yes	no	5		Only to be used for manufacture of polyesters
▼M3
807	93485	—	titanium nitride, nanoparticles	yes	no	no			No migration of titanium nitride nanoparticles.; Only to be used in polyethylene terephthalate (PET) up to 20 mg/kg.; In the PET, the agglomerates have a diameter of 100-500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.
▼B
808	38550	0882073-43-0	bis(4-propylbenzylidene)propylsorbitol	yes	no	no	5		SML including the sum of its hydrolysis products
809	49080	0852282-89-4	N-(2,6-diisopropylphenyl)-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-1H-benzo[de]isoquinolin-1,3(2H)-dione	yes	no	yes	0,05		Only for use in PET	(6); (14); (15)
810	68119		neopentyl glycol, diesters and monoesters with benzoic acid and 2-ethylhexanoic acid	yes	no	no	5	(32)	Not to be used for articles in contact with fatty foods for which ►M7 simulant D1 and/or D2 ◄ is laid down.
811	80077	0068441-17-8	polyethylene waxes, oxidised	yes	no	no	60
▼M2
812	80350	0124578-12-7	poly(12-hydroxystearic acid)-polyethyleneimine copolymer	yes	no	no			Only to be used in plastics up to 0,1 % w/w.; Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.
▼B
813	91530	—	sulphosuccinic acid alkyl (C4-C20) or cyclohexyl diesters, salts	yes	no	no	5
814	91815	—	sulphosuccinic acid monoalkyl (C10-C16) polyethyleneglycol esters, salts	yes	no	no	2
815	94985	—	trimethylolpropane, mixed triesters and diesters with benzoic acid and 2-ethylhexanoic acid	yes	no	no	5	(32)	Not to be used for articles in contact with fatty foods for which ►M7 simulant D1 and/or D2 ◄ is laid down
816	45704	—	cis-1,2-cyclohexanedicarboxylic acid, salts	yes	no	no	5
817	38507	—	cis-endo-bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, salts	yes	no	no	5		Not to be used with polyethylene in contact with acidic foods.; Purity ≥ 96 %.
818	21530	—	methallylsulphonic acid, salts	no	yes	no	5
819	68110	—	neodecanoic acid, salts	yes	no	no	0,05		Not to be used in polymers contacting fatty foods.; Not to be used for articles in contact with fatty foods for which ►M7 simulant D1 and/or D2 ◄ is laid down.; SML expressed as neodecanoic acid.
820	76420	—	pimelic acid, salts	yes	no	no
821	90810	—	stearoyl-2-lactylic acid, salts	yes	no	no
▼M16
822	71983	14797-73-0	Perchloric acid, salts (perchlorate)	yes	no	no		(38)
▼B
823	24889	—	5-Sulphoisophthalic acid, salts	no	yes	no	5
854	71943	0329238-24-6	perfluoro acetic acid, α-substituted with the copolymer of perfluoro-1,2-propylene glycol and perfluoro-1,1-ethylene glycol, terminated with chlorohexafluoropropyloxy groups	yes	no	no			Only to be used in concentrations up to 0,5 % w/w in the polymerisation of fluoropolymers that are processed at temperatures at or above 340 °C and are intended for use in repeated use articles
▼M2
855	40560		(butadiene, styrene, methyl methacrylate) copolymer cross-linked with 1,3-butanediol dimethacrylate	yes	no	no			Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.
▼M9
856	40563	25101-28-4	(butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate	yes	no	no			Only to be used in:; — rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below; or; — at up to 40 % w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA) repeat-use articles at room temperature or below, and when either in contact only with aqueous, acidic and/or low alcoholic (< 20 %) foodstuffs for less than 1 day, or when in contact only with dry foodstuffs for any duration of time.
▼M2
857	66765	0037953-21-2	(methyl methacrylate, butyl acrylate, styrene, glycidyl methacrylate) copolymer	yes	no	no			Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.
▼C1
858	38565	0090498-90-1	3,9-bis[2-(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5]undecane	yes	no	yes	0,05		SML expressed as the sum of the substance and its oxidation product 3-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5]-undecane in equilibrium with its para quinone methid tautomer.	(2)
▼M6
859			(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene, in nanoform	yes	no	no			Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.; When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.; The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
▼B
860	71980	0051798-33-5	perfluoro[2-(poly(n-propoxy))propanoic acid]	yes	no	no			Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles
861	71990	0013252-13-6	perfluoro[2-(n-propoxy)propanoic acid]	yes	no	no			Only to be used in the polymerisation of fluoropolymers that are processed at temperatures at or above 265 °C and are intended for use in repeated use articles
▼M2
862	15180	0018085-02-4	3,4-diacetoxy-1-butene	no	yes	no	0,05		SML including the hydrolysis product 3,4-dihydroxy-1-butene; Only to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers.	(17); (19)
▼M2
863	15260	0000646-25-3	1,10-decanediamine	no	yes	no	0,05		Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.
▼B
864	46330	0000056-06-4	2,4-diamino-6-hydroxypyrimidine	yes	no	no	5		Only to be used in rigid poly(vinyl chloride) (PVC) in contact with non-acidic and non-alcoholic aqueous food
▼M3
865	40619	0025322-99-0	(butyl acrylate, methyl methacrylate, butyl methacrylate) copolymer	yes	no	no			Only to be used in:; (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 1 % w/w;; (b) polylactic acid (PLA) at a maximum level of 5 % w/w.
▼B
866	40620	—	(butyl acrylate, methyl methacrylate) copolymer, cross-linked with allyl methacrylate	yes	no	no			Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 7 %
867	40815	0040471-03-2	(butyl methacrylate, ethyl acrylate, methyl methacrylate) copolymer	yes	no	no			Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 %
▼M3
868	53245	0009010-88-2	(ethyl acrylate, methyl methacrylate) copolymer	yes	no	no			Only to be used in:; (a) rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % w/w;; (b) polylactic acid (PLA) at a maximum level of 5 % w/w;; (c) polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
▼B
869	66763	0027136-15-8	(butyl acrylate, methyl methacrylate, styrene) copolymer	yes	no	no			Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 3 %
870	95500	0160535-46-6	N,N′,N″-tris(2-methylcyclohexyl)-1,2,3-propane-tricarboxamide	yes	no	no	5
▼M7
871		0287916-86-3	dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene	yes	no	no			Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 μg/kg food.	(23)
▼M4
872		0006607-41-6	2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine	no	yes	no	0,05		To be used only as a co-monomer in polycarbonate copolymers	(20)
▼M2
873	93460		titanium dioxide reacted with octyltriethoxysilane	yes	no	no			Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.
▼M3
874	16265	0156065-00-8	α-dimethyl-3-(4’-hydroxy-3’-methoxyphenyl)propylsilyloxy, ω-3-dimethyl-3-(4’-hydroxy-3’-methoxyphenyl)propylsilyl polydimethylsiloxane	no	yes	no	0,05	(33)	Only to be used as comonomer in siloxane modified polycarbonate.; The oligomeric mixture shall be characterised by the formula; C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).
▼B
875	80345	0058128-22-6	poly(12-hydroxystearic acid) stearate	yes	no	yes	5
878	31335	—	acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with branched alcohols, aliphatic, monohydric, saturated, primary (C3-C22)	yes	no	no
879	31336	—	acids, fatty (C8-C22) from animal or vegetable fats and oils, esters with alcohols, linear, aliphatic, monohydric, saturated, primary (C1-C22)	yes	no	no
▼M6
880	31348		acids, fatty (C8-C22), esters with pentaerythritol'	yes	no	no
881	25187	0003010-96-6	2,2,4,4-tetramethylcyclobutane-1,3-diol	no	yes	no	5		Only for:; (a) repeated use articles for long term storage at room temperature or below and hotfill;; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.
▼B
882	25872	0002416-94-6	2,3,6-trimethylphenol	no	yes	no	0,05
883	22074	0004457-71-0	3-methyl-1,5-pentanediol	no	yes	no	0,05		Only to be used in materials in contact with food at a surface to mass ratio up to 0,5 dm2/kg
884	34240	0091082-17-6	alkyl(C10-C21)sulphonic acid, esters with phenol	yes	no	no	0,05		Not to be used for articles in contact with fatty foods for which ►M7 simulant D1 and/or D2 ◄ is laid down.
885	45676	0263244-54-8	cyclic oligomers of (butylene terephthalate)	yes	no	no			Only to be used in poly(ethylene terephthalate) (PET), poly(butylene terephthalate) (PBT), polycarbonate (PC), polystyrene (PS) and rigid poly(vinyl chloride) (PVC) plastics in concentrations up to 1 % w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature.
▼M2
894	93360	0016545-54-3	thiodipropionic acid, ditetradecyl ester	yes	no	no		(14)
895	47060	0171090-93-0	3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoic acid, esters with C13-C15 branched and linear alcohols	yes	no	no	0,05		Only to be used in polyolefins in contact with foods other than fatty/high-alcoholic and dairy products.
896	71958	0958445-44-8	3H-perfluoro-3-[(3-methoxy-propoxy)propanoic acid], ammonium salt	yes	no	no			Only to be used in the polymerisation of fluoropolymers when:; — processed at temperatures higher than 280 °C for at least 10 minutes,; — processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles.
▼M3
902		0000128-44-9	1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt	yes	no	no			The substance shall comply with the specific purity criteria as set out in Commission Regulation (EU) No 231/2012 (6).
▼M6
903		37486-69-4	2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether]	yes	no	no			Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for:; (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times;; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.
▼M2
923	39150	0000120-40-1	N,N-bis(2-hydroxyethyl)dodecanamide	yes	no	no	5		The residual amount of diethanolamine in plastics, as an impurity and decomposition product of the substance, ►M7 shall ◄ not result in a migration of diethanolamine higher than 0,3 mg/kg food.	(18)
924	94987		trimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acids	yes	no	no	0,05		Only for use in PET in contact with all types of foods other than fatty, high-alcoholic and dairy products.
926	71955	0908020-52-0	perfluoro[(2-ethyloxy-ethoxy)acetic acid], ammonium salt	yes	no	no			Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.
▼M6
969		24937-78-8	ethylene-vinyl acetate copolymer wax	yes	no	no			Only to be used as a polymeric additive up to 2 % w/w in polyolefins.; The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.
▼M2
971	25885	0002459-10-1	trimethyl trimellitate	no	yes	no			Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.	(17)
972	45197	0012158-74-6	copper hydroxide phosphate	yes	no	no
973	22931	0019430-93-4	(perfluorobutyl)ethylene	no	yes	no			Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures.
▼M11
974	74050	939402-02-5	phosphorous acid, mixed 2,4-bis(1,1- dimethylpropyl)phenyl and 4-(1,1- dimethylpropyl)phenyl triesters	yes	no	yes	10		SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol. The migration of 2,4-di-tert- amylphenol shall not exceed 1 mg/kg food.
▼M3
979	79987	—	(polyethylene terephthalate, hydroxylated polybutadiene, pyromellitic anhydride) copolymer	yes	no	no			Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.
▼M4
988		3634-83-1	1,3-bis(isocyanatomethyl)benzene	no	yes	no		(34)	SML(T) applies to the migration of its hydrolysis product, 1,3-benzenedimethanamine; To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film
▼M6
998			(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked, in nanoform	yes	no	no			Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.; When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.; The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
▼M16
1007		976-56-7	diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate	no	yes	no			Only to be used up to 0,2 % (w/w) based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET) and poly(ethylene 2,5-furandicarboxylate) (PEF)
▼M8
1016			(methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform	yes	no	no			Only to be used up to:; (a) 10 % w/w in non-plasticised PVC;; (b) 15 % w/w in non-plasticised PLA.; The final material shall be used at room temperature or below.
▼M6
1017		25618-55-7	polyglycerol	yes	no	no			To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.
▼M8
1030			montmorillonite clay modified by dimethyldialkyl(C16-C18)ammonium chloride	yes	no	no			Only to be used up to 12 % (w/w) in polyolefins in contact with dry foods to which simulant E is assigned in table 2 of Annex III at room temperature or below.; The sum of the specific migration of 1-chlorohexadecane and 1-chlorooctadecane shall not exceed 0,05 mg/kg food.; Can contain platelets in the nanoform that are only in one dimension thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
▼M7
1031		3238-40-2	furan-2,5-dicarboxylic acid	no	yes	no	5		Only to be used as a monomer in the production of polyethylene furanoate. The migration of the oligomeric fraction of less than 1 000 Da shall not exceed 50 μg/kg food (expressed as furan-2,5-dicarboxylic acid).	(22); (23)
1034		3710-30-3	1,7-octadiene	no	yes	no	0,05		Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions.
▼M6
1043			(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform	yes	no	no			Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.; When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances.; The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.
▼M7
1045		1190931-27-1	perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt	yes	no	no			Only to be used as a polymer production aid during the manufacture of fluoropolymers under high temperature conditions of at least 370 °C.
1046			zinc oxide, nanoparticles, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)	yes	no	no			Only to be used in unplasticised polymers.; The restrictions and specifications specified for FCM substance No 788 shall be respected.
1048		624-03-3	ethylene glycol dipalmitate	yes	no	no		(2)	Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.
1050			zinc oxide, nanoparticles, uncoated	yes	no	no			Only to be used in unplasticised polymers.
1051		42774-15-2	N,N′-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide	yes	no	no	5
1052		1455-42-1	2,4,8,10-tetraoxaspiro[5,5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl- (‘SPG’)	no	yes	no	5		Only to be used as a monomer in the production of polyesters. The migration of oligomers of less than 1 000 Da shall not exceed 50 μg/kg food (expressed as SPG).	(22); (23)
1053			fatty acids, C16–18 saturated, esters with dipentaerythritol	yes	no	no			Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils
▼M8
1055		7695-91-2; 58-95-7	α-tocopherol acetate	yes	no	no			Only to be used as antioxidant in polyolefins.	(24)
▼M16
1059		147398-31-0	Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (‘PHBH’)	no	yes	no		(35)	The substance is a macromolecule obtained from microbial fermentation.; Only to be used at temperature conditions not exceeding the conditions defined in point 2.1.4(d) of Annex V. The migration of all oligomers with a molecular weight below 1 000 Da shall not exceed 5,0 mg/kg food.	(23)
▼M8
1060			ground sunflower seed hulls	yes	no	no			Only to be used at room temperature or below in contact with foods for which Table 2 of Annex III assigns food simulant E.; The seed hulls shall be obtained from sunflower seeds that are fit for human consumption.; The processing temperature of the plastic containing the additive shall not exceed 240 °C.
▼M9
1061		80512-44-3	2,4,4′-trifluorobenzophenone	no	yes	no			Only to be used as a co-monomer in the manufacture of polyether ether ketone plastics up to 0,3 % w/w of the final material.
▼M8
1062			mixture composed of 97 % tetraethyl orthosilicate (TEOS) with CAS No 78-10-4 and 3 % hexamethyldisilazane (HMDS) with CAS No 999-97-3	no	yes	no			Only to be used for the production of recycled PET and at up to 0,12 % (w/w).
▼M9
1063		1547-26-8	2,3,3,4,4,5,5-heptafluoro-1-pentene	no	yes	no			Only to be used together with tetrafluoroethylene and/or ethylene co-monomers to manufacture fluorocopolymers for application as polymer processing aid at up to 0,2 % w/w of the food contact material, and when the low-molecular mass fraction below 1 500 Da in the fluorocopolymer does not exceed 30 mg/kg.
1064		39318-18-8	tungsten oxide	yes	no	no	0,05		Stoichiometry: WOn, n = 2,72-2,90	(25)
1065		85711-28-0	mixture of methyl-branched and linear C14-C18 alkanamides, derived from fatty acids	yes	no	no	5		Only to be used in the manufacture of articles made of polyolefins, and which do not come into contact with foods for which food simulant D2 is assigned in Table 2 of Annex III.	(26)
▼M12
1066		23985-75-3	1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester	no	yes	no	0,05		Only to be used as a co-monomer in the manufacture of a polyester non-food contact layer in a plastic multilayer material, which is to be used only in contact with foods for which food simulants A, B, C and/or D1 are assigned in Table 2 of Annex III. The specific migration limit in column 8 refers to the sum of the substance and of its dimers (cyclic and open chain).
▼M12
1067		616-38-6	dimethyl carbonate	no	yes	no			Only to be used:; a) with 1,6-hexanediol in the manufacture of polycarbonate pre-polymers that are used at up to 30 % to manufacture thermoplastic polyurethanes with 4,4′-methylenediphenyldiisocyanate and diols, such as polypropylene glycol and 1,4-butanediol. The resulting material shall only be applied in repeated use articles intended to come into short–term contact (≤ 30 min at room temperature) with food for which simulants A and/or B are assigned in Table 2 of Annex III; or; b) for the production of other polycarbonates and/or under other conditions provided that the migration of dimethyl carbonate does not exceed 0,05 mg/kg food and that the migration of all polycarbonate oligomers with a molecular weight below 1 000 Da together does not exceed 0,05 mg/kg food.	(27)
▼M12
1068		2530-83-8	[3-(2,3-epoxypropoxy)propyl]trimethoxy silane	no	yes	no			Only to be used as a component of a sizing agent to treat glass fibres to be embedded in glass-fibre-reinforced low diffusivity plastics (polyethylene terephthalate (PET), polycarbonate (PC), polybutylene terephthalate (PBT), thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In treated glass fibres, residues of the substance must not be detectable at 0,01 mg/kg for the substance and 0,06 mg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).
▼M12
1069		75-28-5	isobutane	yes	no	no			Only to be used as a blowing agent.
▼M15
1075			Montmorillonite clay modified with hexadecyltrimethylammonium bromide	yes	no	no			Only to be used as additive at up to 4,0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below.; Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.
▼M16
1076		1227937-46-3	Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters	yes	no	no	0,05		To be used only:; a) as an additive at up to 0,2 % w/w in high impact polystyrene materials and articles intended for contact with food at room temperature and below, including hot-fill and/or heating up to 100 °C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III.; b) as an additive at up to 0,025 % w/w in acrylonitrile-butadiene-styrene (ABS) materials for use at room temperature and below
▼M15
1077			Titanium dioxide surface-treated with fluoride-modified alumina	yes	no	no			Only to be used at up to 25,0 % w/w, including in the nanoform.	29
▼M16
1078		3319-31-1	tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate	yes	no	no	1	(32)	Only to be used as plasticiser to manufacture soft poly(vinyl chloride); Not to be used in contact with foods intended for infants (7)
▼M17
1079		84731-70-4	bis(2-ethylhexyl) cyclohexane-1,4- dicarboxylate (DEHCH)	yes	no	no	0,05		Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III.
▼M16
1080		156157-97-0	(triethanolamine-perchlorate, sodium salt) dimer	yes	no	no		(37); (38)	Only to be used in rigid poly(vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III
1081		-	N, N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids	yes	no	no		(7)	Only to be used at up to 2 % (w/w) in plastic materials and articles intended for the packaging by food business operators of dry foods for which simulant E is assigned in table 2 of Annex III.	(30)
1082		52628-03-2	Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate	no	yes	no	0,05		Only to be used at up to 0,35 % (w/w) to manufacture polymethylmethacrylate.; SML expressed as the sum of the mono-, di- and triesters of phosphoric acid and the mono-, di-, tri- and tetraesters of diphosphoric acid
1083		2421-28-5	Benzophenone-3,3',4,4'-tetracarboxylic dianhydride (‘BTDA’)	no	yes	no	0,05		Only to be used at up to 43 % (w/w) as a co-monomer in the production of polyimides for use in contact with foods for which only simulants B and/or D2 are laid down in table 2 of Annex III at temperatures up to 250 °C.

▼B
(1) ; OJ L 302, 19.11.2005, p. 28.; (2) ; OJ L 330, 5.12.1998, p. 32.; (3) ; OJ L 253, 20.9.2008, p. 1.; ►M6 (4) ; Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications of food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).; ◄; (5) ; OJ L 158, 18.6.2008, p. 17.; ►M3 (6) ; OJ L 83, 22.3.2012, p. 1.; ◄; (7) ; Infant, infant formula and follow-on formula as defined in Article 2(2) of Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

2. Group restriction of substances

Table 2 on Group restrictions contains the following information:

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

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

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

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

Table 2

(1)	(2)	(3)	(4)
Group Restriction No	FCM substance No	SML (T); [mg/kg]	Group restriction specification
1	128; 211	6	expressed as acetaldehyde
▼M7
2	89; 227; 263; 1048	30	expressed as ethyleneglycol
▼B
3	234; 248	30	expressed as maleic acid
4	212; 435	15	expressed as caprolactam
5	137; 472	3	expressed as the sum of the substances
6	412; 512; 513; 588	1	expressed as iodine
▼M16
7	19; 20; 1081	1,2	expressed as tertiary amine
▼B
8	317; 318; 319; 359; 431; 464	6	expressed as the sum of the substances
9	650; 695; 697; 698; 726	0,18	expressed as tin
10	28; 29; 30; 31; 32; 33; 466; 582; 618; 619; 620; 646; 676; 736	0,006	expressed as tin
11	66; 645; 657	1,2	expressed as tin
12	444; 469; 470	30	expressed as the sum of the substances
13	163; 285	1,5	expressed as the sum of the substances
▼M2
14	294	5	expressed as the sum of the substances and their oxidation products
368
894
▼M6
15	98; 196; 344	15	expressed as formaldehyde
▼B
16	407; 583; 584; 599	6	expressed as boron; Without prejudice to the provisions of Directive 98/83/EC
17	4; 167; 169; 198; 274; 354; 372; 460; 461; 475; 476; 485; 490; 653	ND	expressed as isocyanate moiety
18	705; 733	0,05	expressed as the sum of the substances
19	505; 516; 519	10	expressed as SO2
20	290; 386; 390	30	expressed as the sum of the substances
21	347; 349	5	expressed as trimellitic acid
22	70; 147; 176; 218; 323; 325; 365; 371; 380; 425; 446; 448; 456; 636	6	expressed as acrylic acid
23	150; 156; 181; 183; 184; 355; 370; 374; 439; 440; 447; 457; 482	6	expressed as methacrylic acid
24	756; 758	5	expressed as the sum of the substances
25	720; 747	0,05	sum of mono-n-dodecyltin tris(isooctylmercaptoacetate), di-n-dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride
▼M16
26	728; 729	1,8	expressed as the sum of the substances
▼B
27	188; 291	5	expressed as isophthalic acid
28	191; 192; 785	7,5	expressed as terephthalic acid
29	342; 672	0,05	expressed as the sum of 6-hydroxyhexanoic acid and caprolactone
▼M6
30	254; 344; 672	5	expressed as 1,4-butanediol
▼B
31	73; 797	30	expressed as the sum of the substances
▼M16
32	8; 72; 73; 138; 140; 157; 159; 207; 242; 283; 532; 670; 728; 729; 775; 783; 797; 798; 810; 815; 1078; 1085*	60	expressed as the sum of the substances (plasticisers); * Diisobutyl phthalate, FCM No 1085, with synonyms 1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate or ‘DIBP’ and CAS number 84-69-5 is not listed as an authorised substance in Table 1. However, it may co-occur with other phthalates as a consequence of its use as an aid to polymerisation and is included in group restrictions with the assignment FCM No 1085.
▼M3
33	180; 874	ND	expressed as eugenol
▼M4
34	421; 988	0,05	Expressed as 1,3-benzenedimethanamine
▼M12
35	467; 744; 1059	0,05	expressed as crotonic acid
▼M16
36	157; 159; 283; 1085*	0,6	sum of phthalic acid, dibutyl ester (DBP), diisobutyl phthalate (DIBP), phthalic acid, benzyl butyl ester (BBP) and phthalic acid, bis(2-ethylhexyl) ester (DEHP) expressed as DEHP equivalents using the following equation: DBP5 + DIBP4 + BBP0,1 + DEHP1.; * See remark on FCM No 1085 in row 32
37	793; 1080	0,05	expressed as the sum of triethanolamine and the hydrochloride adduct expressed as triethanolamine
38	822; 1080	0,002	expressed as perchlorate – note 4 of table 3 applies
▼B

3. Notes on verification of compliance

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

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

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

Table 3

(1)	(2)
Note No	Notes on verification of compliance
(1)	Verification of compliance by residual content per food contact surface area (QMA) pending the availability of an analytical method.
(2)	There is a risk that the SML or OML could be exceeded in fatty food simulants.
(3)	There is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the final product does not comply with Article 3(1) c of the Framework Regulation (EC) No 1935/2004.
▼M3
(4)	Compliance testing when there is a fat contact ►M7 shall ◄ be performed using saturated fatty food simulants as simulant D2.
▼B
(5)	Compliance testing when there is a fat contact ►M7 shall ◄ be performed using isooctane as substitute of simulant D2 (unstable).
(6)	Migration limit might be exceeded at very high temperature.
(7)	If testing in food is performed, Annex V 1.4 shall be taken into account.
(8)	Verification of compliance by residual content per food contact surface area (QMA); QMA = 0,005 mg/6 dm2.
(9)	Verification of compliance by residual content per food contact surface area (QMA) pending the availability of analytical method for migration testing. The ratio surface to quantity of food shall be lower than 2dm2/kg.
(10)	Verification of compliance by residual content per food contact surface area (QMA) in case of reaction with food or simulant.
(11)	Only a method of analysis for the determination of the residual monomer in the treated filler is available.
(12)	There is a risk that the SML could be exceeded from polyolefins.
(13)	Only a method for determination of the content in polymer and a method for determination of the starting substances in food simulants are available.
(14)	There is a risk that the SML could be exceeded from plastics containing more than 0,5 % w/w of the substance.
(15)	There is a risk that the SML could be exceeded in contact with foods with high alcoholic content.
(16)	There is a risk that the SML could be exceeded from low-density polyethylene (LDPE) containing more than 0,3 % w/w of the substance when in contact with fatty foods
(17)	Only a method for determination of the residual content of the substance in the polymer is available
▼M2
(18)	There is a risk that the SML could be exceeded from low-density polyethylene (LDPE)
(19)	There is a risk that the OML could be exceeded in direct contact with aqueous foods from ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers
▼M4
(20)	The substance contains aniline as an impurity; verification of compliance with the restriction set for primary aromatic amines in Annex II (2) is necessary
▼M6
(21)	In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded.
▼M7
(22)	When used in contact with non-alcoholic foods for which Table 2 of Annex III assigns food simulant D1, food simulant C shall be used for verification of compliance instead of food simulant D1.
(23)	When a final material or article containing this substance is placed on the market, a well described method to determine whether the oligomer migration complies with the restrictions specified in column 10 of Table 1 shall form part of the supporting documentation referred to in Article 16. This method shall be suitable for use by a competent authority to verify compliance. If an adequate method is publicly available, reference shall be made to that method. If the method requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.
▼M8
(24)	The substance or its hydrolysis products are authorised food additives and compliance with Article 11(3) shall be verified.
▼M9
(25)	When used as reheat agent in polyethylene terephthalate (PET) verification of compliance with the specific migration limit is not required; in all other cases compliance with the specific migration limit shall be verified in accordance with Article 18; the specific migration limit is expressed as mg tungsten/kg food.
(26)	Migration of stearamide, listed in Table 1 under FCM substance No 306 to which no specific migration limit applies, shall be excluded from verification of the compliance of the migration of the mixture with the specific migration limit laid down for the mixture.
▼M12
(27)	When a final material or article containing this substance and produced under conditions other than those described in point (a) column 10 of Table 1 is placed on the market, a well described method to determine whether the oligomer migration complies with the restrictions specified in point (b) column 10 of Table 1 shall form part of the supporting documentation referred to in Article 16. This method shall be suitable for use by a competent authority to verify compliance. If an adequate method is publicly available, reference shall be made to that method. If the method requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.
▼M15
(28)	A detection limit of 0,002 mg/kg food or food simulant applies
(29)	In polar polymers which swell in contact with foods for which simulant B is assigned in Annex III, there is a risk that under severe contact conditions the migration limits for aluminium and fluoride are exceeded. Under contact conditions above 4 hours at 100 °C this exceedance can be high.
▼M16
(30)	There is a risk that migration limits may be exceeded; migration increases with the thickness of the plastic in which the substance is contained, and with a decreasing polarity of the polymer and a decreasing degree of esterification of the substance itself.
▼B

4. Detailed specification on substances

Table 4 on detailed specifications on substances contains the following information

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

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

Table 4

(1)	(2)
FCM substance No	Detailed specification on the substance
744	Definition	The copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been genetically engineered and has been derived from a single wildtype organism Alcaligenes eutrophus strain H16 NCIMB 10442. Master stocks of the organism are stored as freeze-dried ampoules. A submaster/working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat treatment bacteria by controlled digestion of the other cellular components, washing and drying. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications
	Chemical name	Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)
	CAS number	0080181-31-3
	Structural formula	where n/(m + n) greater than 0 and less or equal to 0,25
	Average molecular weight	Not less than 150 000 Daltons (measured by gel permeation chromatography)
	Assay	Not less than 98 % poly(3-D-hydroxybutanoate-co-3-D-hydoxy-pentanoate) analysed after hydrolysis as a mixture of 3-D-hydro-xybutanoic and 3-D-hydroxypentanoic acids
	Description	White to off-white powder after isolation
	Characteristics
	Identification tests:
	Solubility	Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water
	►M12 Restriction	Specific migration limit for crotonic acid is 0,05 mg/kg food ◄
	Purity	Prior to granulation the raw material copolymer powder must contain:
	— nitrogen,	Not more than 2 500 mg/kg of plastic
	— zinc,	Not more than 100 mg/kg of plastic
	— copper,	Not more than 5 mg/kg of plastic
	— lead,	Not more than 2 mg/kg of plastic
	— arsenic,	Not more than 1 mg/kg of plastic
	— chromium,	Not more than 1 mg/kg of plastic

ANNEX II

Restrictions on plastic materials and articles

The following restrictions on plastic materials and articles apply:

Plastic materials and articles shall not release the substances in Table 1 below in quantities exceeding the specific migration limits expressed in mg/kg food or simulant specified in column (3), and subject to the remarks in Column (4).

Substances listed in Table 1 shall only be used in accordance with the compositional requirements set out in Chapter II. If Chapter II does not provide a basis for the authorised use of such a substance, that substance may only be present as an impurity subject to the restrictions specified in Table 1.

Table 1

General list of migration limits for substances migrating from plastic materials and articles

(1)	(2)	(3)	(4)
Name	Salts allowed in accordance with Article 6(3)(a)	SML [mg/kg food or food simulant]	Remark
Aluminium	yes	1
Ammonium	yes	-	(1)
Antimony	no	0,04	(2)
Arsenic	no	ND
Barium	yes	1
Cadmium	no	ND (LOD 0,002)
Calcium	yes	-	(1)
Chromium	no	ND	(3)
Cobalt	yes	0,05
Copper	yes	5
Europium	yes	0,05	(4)
Gadolinium	yes	0,05	(4)
Iron	yes	48
Lanthanum	yes	0,05	(4)
Lead	no	ND
Lithium	yes	0,6
Magnesium	yes	-	(1)
Manganese	yes	0,6
Mercury	no	ND
Nickel	no	0,02
Potassium	yes	-	(1)
Sodium	yes	-	(1)
Terbium	yes	0,05	(4)
Zinc	yes	5
ND: Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4); LOD: specified Limit of Detection.; Remarks; (1) The migration is subject to Article 11(3) and Article 12; (2) The note in Annex I, Table 1, FCM No 398 applies: SML might be exceeded at very high temperature; (3) To verify compliance with the Regulation, the detection limit of 0,01 mg/kg shall apply for total chromium. However if the operator that placed the material on the market can prove on the basis of pre-existing documentary evidence that the presence of hexavalent chromium in the material is excluded because it is not used or formed or during the entire production process, a limit for the total chromium of 3,6 mg/kg food shall apply.; (4) The lanthanide substances europium, gadolinium, lanthanum, and/or terbium can be used in accordance with Article 6(3)(a) provided that:; (a) The sum of all lanthanide substances migrating to the food or food simulant does not exceed the specific migration limit of 0,05 mg/kg; and; (b) analytical evidence using a well described methodology demonstrating that the lanthanide substance(s) used are present in dissociated ionic form in the food or the food simulant, forms part of the documentation referred to in Article 16.

Primary aromatic amines (‘PAAs’) listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (10) and for which no migration limit is specified in Table 1 of Annex I shall not migrate or shall not otherwise be released from plastic materials and articles into food or food simulant. They shall not be detectable using analytical equipment with a limit of detection of 0,002 mg/kg food or food simulant applied to each individual primary aromatic amine (‘PAA’), in accordance with Article 11(4).

For PAAs not listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006, but for which no specific migration limit is specified in Annex I, compliance with Article 3 of Regulation (EC) No 1935/2004 shall be verified in accordance with Article 19. The sum of those PAAs shall however not exceed 0,01 mg/kg in food or food simulant.

ANNEX III

Food simulants

1. Food simulants

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

Table 1

List of food simulants

Food simulant	Abbreviation
Ethanol 10 % (v/v)	Food simulant A
Acetic acid 3 % (w/v)	Food simulant B
Ethanol 20 % (v/v)	Food simulant C
Ethanol 50 % (v/v)	Food simulant D1
Any vegetable oil containing less than 1 % unsaponifiable matter	Food simulant D2
poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm	Food simulant E

2. General assignment of food simulants to foods

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

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

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

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

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

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

Table 2 contains the following information:

—

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

—

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

—

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

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

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

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

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

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

Table 2

food category specific assignment of food simulants

(1)	(2)	(3)
Reference number	Description of food	Food simulants
A	B	C	D1	D2	E
01	Beverages
01.01	Non-alcoholic beverages or alcoholic beverages of an alcoholic strength lower than or equal to 6 % vol.:
	A. Clear drinks:; Water, ciders, clear fruit or vegetable juices of normal strength or concentrated, fruit nectars, lemonades, syrups, bitters, infusions, coffee, tea, beers, soft drinks, energy drinks and the like, flavoured water, liquid coffee extract		X(*)	X
	B. cloudy drinks:; juices and nectars and soft drinks containing fruit pulp, musts containing fruit pulp, liquid chocolate		X(*)		X
01.02	Alcoholic beverages of an alcoholic strength of between 6 %vol and 20 %.			X
01.03	Alcoholic beverages of an alcoholic strength above 20 % and all cream liquors				X
01.04	Miscellaneous: undenaturated ethyl alcohol		X(*)			Substitute 95 % ethanol
02	Cereals, cereal products, pastry, biscuits, cakes and other bakers’ wares
02.01	Starches						X
02.02	Cereals, unprocessed, puffed, in flakes (including popcorn, corn flakes and the like)						X
02.03	Cereal flour and meal						X
02.04	Dry pasta e.g. macaroni, spaghetti and similar products and fresh pasta						X
02.05	Pastry, biscuits, cakes, bread, and other bakers’ wares, dry:
	A. With fatty substances on the surface					X/3
	B. Other						X
02.06	Pastry, cakes, bread, dough and other bakers’ wares, fresh:
	A. With fatty substances on the surface					X/3
	B. Other						X
03	Chocolate, sugar and products thereof; Confectionery products
03.01	Chocolate, chocolate-coated products, substitutes and products coated with substitutes					X/3
03.02	Confectionery products:
	A. In solid form:
	I. With fatty substances on the surface					X/3
	II. Other						X
	B. In paste form:
	I. With fatty substances on the surface					X/2
	II. Moist			X
03.03	Sugar and sugar products
	A. In solid form: crystal or powder						X
	B. Molasses, sugar syrups, honey and the like	X
04	Fruit, vegetables and products thereof
▼M7
04.01	Fruit, fresh or chilled:
A. unpeeled and uncut						X/10
B. peeled and/or cut	X	X (*)
▼B
04.02	Processed fruit:
	A. Dried or dehydrated fruits, whole, sliced, flour or powder						X
	B. Fruit in the form of purée, preserves, pastes or in its own juice or in sugar syrup (jams, compote, and similar products)		X(*)	X
	C. Fruit preserved in a liquid medium:
	I. In an oily medium					X
	II. In an alcoholic medium				X
04.03	Nuts (peanuts, chestnuts, almonds, hazelnuts, walnuts, pine kernels and others):
	A. Shelled, dried, flaked or powdered						X
	B. Shelled and roasted						X
	C. In paste or cream form	X				X
▼M7
04.04	Vegetables, fresh or chilled:
	A. unpeeled and uncut						X/10
	B. peeled and/or cut	X	X (*)
04.05	Processed vegetables:; A. Dried or dehydrated vegetables whole, sliced or in the form of flour or powder.						X
B. (obsolete)
C. Vegetables in the form of purée, preserves, pastes or in its own juice (including pickled and in brine).		X (*)	X
D. Preserved vegetables:
I. In an oily medium	X				X
II. In an alcoholic medium				X
▼B
05	Fats and oils
05.01	Animals and vegetable fats and oils, whether natural or treated (including cocoa butter, lard, resolidified butter)					X
05.02	Margarine, butter and other fats and oils made from water emulsions in oil					X/2
06	Animal products and eggs
06.01	Fish:
	A. Fresh, chilled, processed, salted or smoked including fish eggs	X				X/3(**)
	B. Preserved fish:
	I. In an oily medium	X				X
	II. In an aqueous medium		X(*)	X
06.02	Crustaceans and molluscs (including oysters, mussels, snails)
	A. Fresh within the shell
	B. Shell removed, processed, preserved or cooked with the shell
	I. In an oily medium	X				X
	II. In an aqueous medium		X(*)	X
06.03	Meat of all zoological species (including poultry and game):
	A. Fresh, chilled, salted, smoked	X				X/4(**)
	B. Processed meat products (such as ham, salami, bacon, sausages, and other) or in the form of paste, creams	X				X/4(**)
	C. Marinated meat products in an oily medium	X				X
06.04	Preserved meat:
	A. In an fatty or oily medium	X				X/3
	B. In an aqueous medium		X(*)		X
06.05	Whole eggs, egg yolk, egg white
	A. Powdered or dried or frozen						X
	B. Liquid and cooked				X
07	Milk products
07.01	Milk
	A. Milk and milk based drinks whole, partly dried and skimmed or partly skimmed				X
	B. Milk powder including infant formula (based on whole milk powder)						X
07.02	Fermented milk such as yoghurt, buttermilk and similar products		X(*)		X
07.03	Cream and sour cream		X(*)		X
▼M19
07.04	Cheeses:
	A. Whole cheese with inedible rind						X
	B. Unripened soft cheese (fresh cheese), e.g. cottage cheese, quark, ricotta, cream cheese, fromage frais, and similar cheeses		X (*)		X
	C. Sliced ripened soft, firm or hard cheese or whole with edible rind, e.g. gouda, cheddar, gruyère, parmesan, stilton, tallegio, beaufort, tomino, brie, camembert, and similar cheeses					X/3
	D. Processed cheese, e.g. wedges, spreads and slices					X/3
	E. Brined or fresh cheese in a liquid medium e.g. feta and mozzarella:
	I. in an oily medium					X
	II. in an aqueous medium		X (*)		X
▼B
08	Miscellaneous products
08.01	Vinegar		X
08.02	Fried or roasted foods:
	A. Fried potatoes, fritters and the like	X				X/5
	B. Of animal origin	X				X/4
08.03	Preparations for soups, broths, sauces, in liquid, solid or powder form (extracts, concentrates); homogenised composite food preparations, prepared dishes including yeast and raising agents
	A. Powdered or dried:
	I. With fatty character					X/5
	II. Other						X
	B. any other form than powdered or dried:
	I. With fatty character	X	X(*)			X/3
	II. Other		X(*)	X
08.04	Sauces:
	A. With aqueous character		X(*)	X
	B. With fatty character e.g. mayonnaise, sauces derived from mayonnaise, salad creams and other oil/water mixtures e.g. coconut based sauces	X	X(*)			X
08.05	Mustard (except powdered mustard under heading 08.14)	X	X(*)			X/3(**)
08.06	Sandwiches, toasted bread pizza and the like containing any kind of foodstuff
	A. With fatty substances on the surface	X				X/5
	B. Other						X
08.07	Ice-creams			X
08.08	Dried foods:
	A. With fatty substances on the surface					X/5
	B. Other						X
08.09	Frozen or deep-frozen foods						X
08.10	Concentrated extracts of an alcoholic strength equal to or exceeding 6 % vol.		X(*)		X
08.11	Cocoa:
	A. Cocoa powder, including fat-reduced and highly fat reduced						X
	B. Cocoa paste					X/3
08.12	Coffee, whether or not roasted, decaffeinated or soluble, coffee substitutes, granulated or powdered						X
08.13	Aromatic herbs and other herbs such as camomile, mallow, mint, tea, lime blossom and others						X
08.14	Spices and seasonings in the natural state such as cinnamon, cloves, powdered mustard, pepper, vanilla, saffron, salt and other						X
08.15	Spices and seasoning in oily medium such as pesto, curry paste					X

▼M8

4. Food simulant assignment for testing overall migration

For tests to demonstrate compliance with the overall migration limit food simulants shall be chosen as set out in Table 3:

Table 3

Food simulant assignment for demonstrating compliance with the overall migration limit

Foods covered	Food simulants in which testing shall be performed
all types of food	1. distilled water or water of equivalent quality or food simulant A;; 2. food simulant B; and; 3. food simulant D2.
all types of food except for acidic foods	1. distilled water or water of equivalent quality or food simulant A; and; 2. food simulant D2.
▼M12
all aqueous and alcoholic foods and milk products with a pH ≥ 4,5	food simulant D1
all aqueous and alcoholic foods and milk products with a pH < 4,5	food simulant D1 and food simulant B
▼M8
all aqueous foods and alcoholic foods up to an alcohol content of 20 %	food simulant C
all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20 %	1. food simulant C; and; 2. food simulant B.

5. General derogation to the assignment of food simulants

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

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

ANNEX IV

Declaration of compliance

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

(1)

the identity and address of the business operator issuing the declaration of compliance;

(2)

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

(3)

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

(4)

the date of the declaration;

(5)

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

(6)

adequate information allowing the downstream business operators to ensure compliance with this Regulation relative to the substances used for which restrictions and/or specifications are set out in Annexes I and II, including adequate information on the presence of non-intentionally added substances if present in an amount that could cause non-compliance of a final material with Article 3 of Regulation (EC) No 1935/2004.

At intermediate stages, this information shall include the identification and amount of the following substances contained in the intermediate material:

—

substances that are subject to restrictions and/or specifications in Annex II, or

—

substances for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to an individual migration into food from the final plastic material or article exceeding 0,00015 mg/kg food;

(7)

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

(8)

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

(i)

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

(ii)

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

▼M8

(iii)

the highest food contact surface area to volume ratio for which compliance has been verified in accordance with Article 17 and 18 or equivalent information;

(9)

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

(10)

when the plastic material is a batch of material intended for reprocessing:

(a)

the confirmation that it complies with Articles 10(1) and 10(2) of this Regulation and that it has been collected and used in accordance with point C of the Annex to Regulation (EC) No 2023/2006; and

(b)

as appropriate, a specification of its composition and instructions for reprocessing;

(11)

when the plastic material has been manufactured with one or more substances included in the Union list of authorised substances in accordance with Article 5 of this Regulation that have been manufactured from waste, a confirmation that the substances used are compliant with point (1) of Article 8 of this Regulation.

ANNEX V

COMPLIANCE TESTING

For testing compliance of migration from plastic food contact materials and articles, an analytical method in accordance with the requirements of Article 34 of Regulation (EU) 2017/625 of the European Parliament and of the Council (11) shall be selected, applying the following specific performance criteria:

(i)

The analytical method working range of analytical methods shall be at least RL × SML to RU × SML, as described in the relevant guidance documents, where

—

RL is the relative lower method working range threshold,

—

RU is the relative upper method working range threshold,

—

RU shall be 2. RL shall be 0,2 unless 0,2 × SML is below the analytical limit of quantification (LOQ) of the substance then the RL × SML is set at the LOQ of the substance.

(ii)

Prior to the verification of compliance with a SML, the specific migration test result, m, needs to be corrected, if relevant: (1) by the real surface-to-volume ratio ((S/V)real) and the surface-to-volume ratio (S/V)test in accordance with Article 17; and/or (2) by the correction factor (CT2) used in the sub-columns for the food simulants D2 and E in Table 2 of Annex III to Regulation (EU) No 10/2011; and/or (3) by the FRF in accordance with point 4.1 of this Annex. When the results are corrected in application of CT2 in combination with the FRF, in accordance with point 4.1 in Annex V, the combined correction factor shall not exceed 5, unless the correction factor laid down in Table 2 of Annex III exceeds 5.

(iii)

The reproducibility coefficient of variation CVR, which can be expressed in percentage if multiplied by 100, is used to calculate the relative standard measurement uncertainty with the purpose to evaluate compliance. The formulas for calculating the CVR are as follows:

CVR = 0,22 for mc <0,12 × 10-6 kg /kg; and,

CVR = 2(1-½log(mc))/100 for 0,12 × 10-6 kg/kg ≤ mc ≤ 0,138 kg/kg.

Where mc is the specific migration test result of a substance or, if relevant, the corrected specific migration result that is to be evaluated against the SML set out in this Regulation, the standard measurement uncertainty of mc of a substance, u(mc ), shall be determined as follows: u(mc ) = CVR × mc .

(iv)

The compliance with the SML shall then be evaluated by applying the following specific performance criterion, where mc is to be evaluated against the SML:

If (mc - SML)/[(u(mc )] > 1,64, then mc exceeds the SML.

If mc is higher than the SML the mc of a substance shall be considered non-compliant. In addition, the rules in Chapter 1-4 of this Annex shall apply.

CHAPTER 1

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

1.1. Sample preparation

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

1.2. Conditions of testing

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

1.3. Analysis of migrated substances

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

1.4. Account of substances originating from other sources

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

CHAPTER 2

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

2.1. Verification method

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

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

2.1.1. Sample preparation

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

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

2.1.2. Choice of food simulant

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

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

2.1.3. Conditions of contact when using food simulants

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

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

(i)

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

(ii)

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

(iii)

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

(iv)

if the plastic material or article intended to come into contact with food of which the compliance must be verified becomes in its final application part of a food processing equipment or an appliance, or a part thereof, the migration tests may be carried out by determining the specific migration into the food or food simulant produced or processed by the whole equipment or appliance, or the part thereof, as appropriate, subject to the following conditions:

—

the food or food simulant is processed during testing by the equipment or part thereof in accordance with the worst foreseeable conditions that can be achieved if the equipment or its part is operated in accordance with its operating instructions, and

—

the migration from parts used for storage such as from reservoirs, containers, or capsules or pads which are part of the equipment during the processing of the food, is determined using conditions representative for their use, unless the applied testing conditions for the whole tested equipment or appliance are representative also of their use.

When migration testing is done under the above conditions, and the transfer of constituents from the equipment or appliance as a whole does not exceed the migration limits, the plastic parts or materials present in the equipment or appliance shall be considered to comply with Article 11(1).

The testing of the parts used for storage or supply such as reservoirs, containers, capsules or pads shall be under conditions representative of their use, and shall include the foreseeable storage conditions of the food in these parts.

The supporting documentation referred to in Article 16 shall clearly document the testing on the whole food processing and/or food producing equipment or appliance, or on parts thereof. It shall demonstrate that the testing was representative of its foreseeable use, and shall indicate for which substances migration testing was carried out and provide all testing results. The manufacturer of individual plastic parts shall ensure the absence of migration for substances for which the Regulation specifies that their migration shall not be detectable at a specified level of detection in accordance with Article 11(4).

Compliance documentation supplied in accordance with the Regulation to the producer of the final equipment or appliance, or part thereof, shall list all substances subject to migration limits that might be exceeded under the foreseeable use of the supplied part or material.

When the result is not in compliance with the Regulation it shall be determined whether the source of the non-compliance is a plastic part subject to the Regulation or a part made from another material not subject to the Regulation on the basis of documentary evidence or analytical testing. Without prejudice to Article 3 of Regulation (EU) No 1935/2004, non-compliance to the Regulation shall only be established if the migration originates from a plastic part.

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

Table 1

Selection of test time

Contact time in worst foreseeable use	►M7 Time to be selected for testing ◄
t ≤ 5 min	5 min
5 min < t ≤ 0,5 hour	0,5 hour
0,5 hours < t ≤ 1 hour	1 hour
1 hour < t ≤ 2 hours	2 hours
2 hours < t ≤ 6 hours	6 hours
6 hours < t ≤ 24 hours	24 hours
1 day < t ≤ 3 days	3 days
3 days < t ≤ 30 days	10 days
Above 30 days	See specific conditions

Table 2

Selection of test temperature

Worst foreseeable contact temperature	Contact temperature to be selected for testing
T ≤ 5 °C	5 °C
5 °C < T ≤ 20 °C	20 °C
20 °C < T ≤ 40 °C	40 °C
40 °C < T ≤ 70 °C	70 °C
70 °C < T ≤ 100 °C	100 °C or reflux temperature
100 °C < T ≤ 121 °C	121 °C (*1)
121 °C < T ≤ 130 °C	130 °C (*1)
130 °C < T ≤ 150 °C	150 °C (*1)
150 °C < T < 175 °C	175 °C (*1)
175 °C < T ≤ 200 °C	200 °C (*1)
T > 200 °C	225 °C (*1)
(*1) ; This temperature shall be used only for food simulants D2 and E. For applications heated under pressure, migration testing under pressure at the relevant temperature may be performed. For food simulants A, B, C or D1 the test may be replaced by a test at 100 °C or at reflux temperature for duration of four times the time selected according to the conditions in Table 1.

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

For contact times above 30 days (long term) at room temperature and below, the specimen shall be tested in accelerated test conditions at elevated temperature for a maximum of 10 days at 60 °C (12).

(a)

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

(b)

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

(c)

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

(d)

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

(e)

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

(f)

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

t2 = t1 * Exp (9627 * (1/T2 – 1/T1))

t1 is the contact time

t2 is the testing time

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

T2 is the testing temperature in Kelvin.

2.1.5. Specific conditions for combinations of contact times and temperature

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

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

2.1.6. Repeated use materials and articles

If the material or article is intended to come into repeated contact with foods, the migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. Compliance of the material or article shall then be verified on the basis of the level of the specific migration observed in the third migration test and on the basis of the stability of the material or article. The specific migration observed in the second migration test shall not exceed the level observed in the first test, and the specific migration in the third test shall not exceed the level observed in the second test.

For the purpose of the first paragraph, the sample shall be considered non-compliant if:

mc, 3 >SML, or,

mc, 1 < mc, 2, or,

mc, 2 < mc, 3, or,

mc, 1 < mc, 3,

where mc, 1, mc, 2, and mc, 3 are respectively the mc during the first, the second and the third migration test carried out in accordance with the first subparagraph.

The compliance with the SML and the stability rule shall be evaluated applying the following criteria:

—

If (mc, 3 – SML)/[(u(mc, 3)] > 1,64, then the third migration is higher than the SML,

—

If (mc, 2 – mc, 1)/[(u(mc, 2) + u(mc, 1)] > 1,64, then the first migration is smaller than the second migration,

—

If (mc,3 – mc, 2)/[(u(mc, 3) + u(mc, 2)] > 1,64, then the second migration is smaller than the third migration,

—

If (mc, 3 – mc, 1)/[(u(mc, 3) + u(mc, 1)] > 1,64, the first migration is smaller than the third migration.

In case mc is smaller than RL × SML, the mc shall be considered equal to RL × SML. This mc shall be used for determining the corresponding standard measurement uncertainty of the mc and for evaluating the compliance with the performance criteria set out in this point.

However, if there is scientific proof that the level of the specific migration is not increasing as described in the second paragraph above in the course of the second and third migration tests and if the SML is not exceeded during the first migration test, the material or article is considered compliant with the SML laid down in this Regulation.

Irrespective of the above rules, a material or article shall never be considered to comply with this Regulation where in any of the migration tests a substance that is prohibited from migrating or from being released in detectable quantities under Article 11(4) of this Regulation is detected.

2.1.7. Analysis of migrating substances

At the end of the prescribed contact time, the specific migration is analysed in the food or food simulant using an analytical method in accordance with the applicable performance criteria laid down in this Annex.

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

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

2.2. Screening approaches

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

2.2.1. Replacing specific migration by overall migration

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

2.2.2. Residual content

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

2.2.3. Migration modelling

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

2.2.4. Food simulant substitutes

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

2.2.5. Single test for successive combinations of time and temperature

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

CHAPTER 3

Testing for overall migration

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

3.1. Standardised testing conditions

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

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

Table 3

Standardised conditions for testing the overall migration

Column 1	Column 2	Column 3
Test number	Contact time in days [d] or hours [h] at Contact temperature in [°C] for testing	Intended food contact conditions
OM0	30 min at 40 °C	Any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes).
OM1	10 d at 20 °C	Any food contact at frozen and refrigerated conditions
OM2	10 d at 40 °C	Any long-term storage at room temperature or below, including when packaged under hot-fill conditions, and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for a maximum of t = 120/2^((T-70)/10) minutes.
OM3	2 h at 70 °C	Any food contact conditions that include hot-fill and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for maximum of t = 120/2^((T-70)/10) minutes, which are not followed by long-term room temperature or refrigerated storage.
OM4	1 h at 100 °C or at reflux	High temperature applications for all types of food at temperature up to 100 °C.
OM5	2 h at 100 °C or at reflux or alternatively 1 h at 121 °C	High temperature applications up to 121 °C.
OM6	4 h at 100 °C or at reflux	Any food contact conditions at a temperature exceeding 40 °C, and with foods for which point 4 of Annex III assigns simulants A, B, C or D1.
OM7	2 h at 175 °C	High temperature applications with fatty foods exceeding the conditions of OM5.

Test OM 7 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4, OM5. It represents the worst case conditions for fatty food simulants in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in paragraph 3.2.

Test OM 6 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B and C in contact with non-polyolefins.

Test OM 5 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.

Test OM 2 covers also food contact conditions described for OM0, OM1 and OM3.

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

If it is not technically feasible to perform one or more of the tests OM0 to OM6 in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a test shall be done using food simulant E in case the worst foreseeable conditions of use exceed 100 °C. The test that results in the highest overall migration shall be used to establish compliance with the Regulation.

In case it is technically not feasible to perform OM7 with food simulant D2, either test OM8 or test OM9 shall be selected as a replacement test by selecting the most appropriate of these two tests on the basis of the intended and the foreseeable use of the material or article that is being tested. Subsequently, a migration test shall be done at each of the two test conditions specified for the selected test, using a new test sample for each test condition. The test condition that results in the higher overall migration shall be used to establish compliance with the Regulation.

Test number	Test conditions	Intended food contact conditions	Covers the intended food contact conditions described in
OM8	Food simulant E for 2 hours at 175 °C and food simulant D2 for 2 hours at 100 °C	High temperature applications only	OM1, OM3, OM4, OM5 and OM6
OM9	Food simulant E for 2 hours at 175 °C and food simulant D2 for 10 days at 40 °C	High temperature applications including long term storage at room temperature	OM1, OM2, OM3, OM4, OM5 and OM6

3.3. Verification of compliance

3.3.1. Single use articles and materials

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

3.3.2. Repeated use articles and materials

The applicable overall migration test shall be carried out three times on a single sample using a different portion of food simulant on each occasion. The migration shall be determined using an analytical method in accordance with the requirements of Article 34 of Regulation (EU) 2017/625. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found during the third test and on the basis of the stability of the material or article i.e. the overall migration during the second test shall not exceed the level observed in the first test, and the overall migration in the course of the third test shall not exceed the level observed during the second test. The compliance shall be evaluated in accordance with the specific performance criteria described in point 2.1.6 in Chapter 2 of Annex V. However, the standard measurement uncertainty of the analytical method as determined by the laboratory shall be used to determine u(m), instead of the standard measurement uncertainty derived on the basis of the approach as specified in the introductory part on compliance testing preceding Chapter 1.

If it is not technically feasible to test the same sample three times, such as when testing in vegetable oil, the overall migration test can be carried out by testing different samples for three different periods of time lasting one, two and three times the applicable contact test time. The first migration, the difference between the second and the first migration and the difference between the third and the second migration shall be considered to represent the three successive overall migrations.

However, if there is scientific proof that the level of the migration, as described in point 2.1.6 in Chapter 2 of Annex V, is not increasing during the second and third migration tests and if the migration limit is not exceeded in the course of the first migration test, the material or article is considered compliant with the overall migration limit.

3.4. Screening approaches

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

3.4.1. Residual content

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

3.4.2. Food simulant substitutes

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

CHAPTER 4

Correction factors applied when comparing migration test results with migration limits

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

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

The FRF shall be applied according to the following rules.

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

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

(a)

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

(b)

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

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

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

▼M7 —————