2011R0010 — EN — 30.12.2011 — 002.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B COMMISSION REGULATION (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance) (OJ L 012, 15.1.2011, p.1)

Amended by:









▼B

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)







THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC ( 1 ), and in particular Article 5(1)(a), (c), (d), (e), (f), (h), (i) and (j) thereof, After consulting the European Food Safety Authority, Whereas: (1) Regulation (EC) No 1935/2004 lays down the general principles for eliminating the differences between the laws of the Member States as regards food contact materials. Article 5(1) of that Regulation provides for the adoption of specific measures for groups of materials and articles and describes in detail the procedure for the authorisation of substances at EU level when a specific measure provides for a list of authorised substances. (2) This Regulation is a specific measure within the meaning of Article 5(1) of Regulation (EC) No 1935/2004. This Regulation should establish the specific rules for plastic materials and articles to be applied for their safe use and repeal Commission Directive 2002/72/EC of 6 August 2002 on plastic materials and articles intended to come into contact with foodstuffs ( 2 ). (3) Directive 2002/72/EC sets out basic rules for the manufacture of plastic materials and articles. The Directive has been substantially amended 6 times. For reasons of clarity the text should be consolidated and redundant and obsolete parts removed. (4) In the past Directive 2002/72/EC and its amendments have been transposed into national legislation without any major adaptation. For transposition into national law usually a time period of 12 months is necessary. In case of amending the lists of monomers and additives in order to authorise new substances this transposition time leads to a retardation of the authorisation and thus slows down innovation. Therefore it seems appropriate to adopt rules on plastic materials and articles in form of a Regulation directly applicable in all Member States. (5) Directive 2002/72/EC applies to materials and articles purely made of plastics and to plastic gaskets in lids. In the past these were the main use of plastics on the market. However, in recent years, besides materials and articles purely made of plastics, plastics are also used in combination with other materials in so called multi-material multi-layers. Rules on the use of vinyl chloride monomer laid down in Council Directive 78/142/EEC of 30 January 1978 on the approximation of the laws of the Member States relating to materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs ( 3 ) already apply to all plastics. Therefore it seems appropriate to extend the scope of this Regulation to plastic layers in multi-material multi-layers. (6) Plastic materials and articles may be composed of different layers of plastics held together by adhesives. Plastic materials and articles may also be printed or coated with an organic or inorganic coating. Printed or coated plastic materials and articles as well as those held together by adhesives should be within the scope of the Regulation. Adhesives, coatings and printing inks are not necessarily composed of the same substances as plastics. Regulation (EC) No 1935/2004 foresees that for adhesives, coatings and printing inks specific measures can be adopted. Therefore plastic materials and articles that are printed, coated or held together by adhesives should be allowed to contain in the printing, coating or adhesive layer other substances than those authorised at EU level for plastics. Those layers may be subject to other EU or national rules. (7) Plastics as well as ion exchange resins, rubbers and silicones are macromolecular substances obtained by polymerisation processes. Regulation (EC) No 1935/2004 foresees that for ion exchange resins, rubbers and silicones specific measures can be adopted. As those materials are composed of different substances than plastics and have different physico-chemical properties specific rules for them need to apply and it should be made clear that they are not within the scope of this Regulation. (8) Plastics are made of monomers and other starting substances which are chemically reacted to a macromolecular structure, the polymer, which forms the main structural component of the plastics. To the polymer additives are added to achieve defined technological effects. The polymer as such is an inert high molecular weight structure. As substances with a molecular weight above 1 000 Da usually cannot be absorbed in the body the potential health risk from the polymer itself is minimal. Potential health risk may occur from non- or incompletely reacted monomers or other starting substances or from low molecular weight additives which are transferred into food via migration from the plastic food contact material. Therefore monomers, other starting substances and additives should be risk assessed and authorised before their use in the manufacture of plastic materials and articles. (9) The risk assessment of a substance to be performed by the European Food Safety Authority (hereinafter the Authority) should cover the substance itself, relevant impurities and foreseeable reaction and degradation products in the intended use. The risk assessment should cover the potential migration under worst foreseeable conditions of use and the toxicity. Based on the risk assessment the authorisation should if necessary set out specifications for the substance and restrictions of use, quantitative restrictions or migration limits to ensure the safety of the final material or article. (10) No rules have yet been set out at EU level for the risk assessment and use of colorants in plastics. Therefore their use should remain subject to national law. That situation should be reassessed at a later stage. (11) Solvents used in the manufacture of plastics to create a suitable reaction environment are expected to be removed in the manufacturing process as they are usually volatile. No rules have yet been set out at EU level for the risk assessment and use of solvents in the manufacture of plastics. Therefore their use should remain subject to national law. That situation should be reassessed at a later stage. (12) Plastics can also be made of synthetic or natural occurring macromolecular structures which are chemically reacted with other starting substances to create a modified macromolecule. Synthetic macromolecules used are often intermediate structures which are not fully polymerised. Potential health risk may occur from the migration of non- or incompletely reacted other starting substances used to modify the macromolecule or an incompletely reacted macromolecule. Therefore the other starting substances as well as the macromolecules used in the manufacture of modified macromolecules should be risk assessed and authorised before their use in the manufacture of plastic materials and articles. (13) Plastics can also be made by micro-organisms that create macromolecular structures out of starting substances by fermentation processes. The macromolecule is then either released to a medium or extracted. Potential health risk may occur from the migration of non- or incompletely reacted starting substances, intermediates or by-products of the fermentation process. In this case the final product should be risk assessed and authorised before its use in the manufacture of plastic materials and articles. (14) Directive 2002/72/EC contains different lists for monomers or other starting substances and for additives authorised for the manufacture of plastic materials and articles. For monomers, other starting substances and additives the Union list is now complete, this means that only substances authorised at EU level may be used. Therefore a separation of monomers or other starting substances and of additives in separate lists due to their authorisation status is no longer necessary. As certain substances can be used both as monomer or other starting substances and as additive for reasons of clarity they should be published in one list of authorised substances indicating the authorised function. (15) Polymers can not only be used as main structural component of plastics but also as additives achieving defined technological effects in the plastic. If such a polymeric additive is identical to a polymer that can form the main structural component of a plastic material the risk from polymeric additive can be regarded as evaluated if the monomers have already been evaluated and authorised. In such a case it should not be necessary to authorise the polymeric additive but it could be used on the basis of the authorisation of its monomers and other starting substances. If such a polymeric additive is not identical to a polymer that can form the main structural component of a plastic material then the risk of the polymeric additive can not be regarded as evaluated by evaluation of the monomers. In such a case the polymeric additive should be risk assessed as regards its low molecular weight fraction below 1 000 Da and authorised before its use in the manufacture of plastic materials and articles. (16) In the past no clear differentiation has been made between additives that have a function in the final polymer and polymer production aids (PPA) that only exhibit a function in the manufacturing process and are not intended to be present in the final article. Some substances acting as PPA had already been included in the incomplete list of additives in the past. These PPA should remain in the Union list of authorised substances. However, it should be made clear that the use of other PPA will remain possible, subject to national law. That situation should be reassessed at a later stage. (17) The Union list contains substances authorised to be used in the manufacture of plastics. Substances such as acids, alcohols and phenols can also occur in form of salts. As the salts usually are transformed in the stomach to acid, alcohol or phenol the use of salts with cations that have undergone a safety evaluation should in principle be authorised together with the acid, alcohol or phenol. In certain cases, where the safety assessment indicates concerns on the use of the free acids, only the salts should be authorised by indicating in the list the name as ‘… acid(s), salts’. (18) Substances used in the manufacture of plastic materials or articles may contain impurities originating from their manufacturing or extraction process. These impurities are non-intentionally added together with the substance in the manufacture of the plastic material (non-intentionally added substance – NIAS). As far as they are relevant for the risk assessment the main impurities of a substance should be considered and if necessary be included in the specifications of a substance. However it is not possible to list and consider all impurities in the authorisation. Therefore they may be present in the material or article but not included in the Union list. (19) In the manufacture of polymers substances are used to initiate the polymerisation reaction such as catalysts and to control the polymerisation reaction such as chain transfer, chain extending or chain stop reagents. These aids to polymerisation are used in minute amounts and are not intended to remain in the final polymer. Therefore they should at this point of time not be subject to the authorisation procedure at EU level. Any potential health risk in the final material or article arising from their use should be assessed by the manufacturer in accordance with internationally recognised scientific principles on risk assessment. (20) During the manufacture and use of plastic materials and articles reaction and degradation products can be formed. These reaction and degradation products are non-intentionally present in the plastic material (NIAS). As far as they are relevant for the risk assessment the main reaction and degradation products of the intended application of a substance should be considered and included in the restrictions of the substance. However it is not possible to list and consider all reaction and degradation products in the authorisation. Therefore they should not be listed as single entries in the Union list. Any potential health risk in the final material or article arising from reaction and degradation products should be assessed by the manufacturer in accordance with internationally recognised scientific principles on risk assessment. (21) Prior to the establishment of the Union list of additives, other additives than those authorised at EU level could be used in the manufacture of plastics. For those additives which were permitted in the Member States, the time limit for the submission of data for their safety evaluation by the Authority with a view to their inclusion in the Union list expired on 31 December 2006. Additives for which a valid application was submitted within this time limit were listed in a provisional list. For certain additives on the provisional list a decision on their authorisation at EU level has not yet been taken. For those additives, it should be possible to continue to be used in accordance with national law until their evaluation is completed and a decision is taken on their inclusion in the Union list. (22) When an additive included in the provisional list is inserted in the Union list or when it is decided not to include it in the Union list, that additive should be removed from the provisional list of additives. (23) New technologies engineer substances in particle size that exhibit chemical and physical properties that significantly differ from those at a larger scale, for example, nanoparticles. These different properties may lead to different toxicological properties and therefore these substances should be assessed on a case-by-case basis by the Authority as regards their risk until more information is known about such new technology. Therefore it should be made clear that authorisations which are based on the risk assessment of the conventional particle size of a substance do not cover engineered nanoparticles. (24) Based on the risk assessment the authorisation should if necessary set out specific migration limits to ensure the safety of the final material or article. If an additive that is authorised for the manufacture of plastic materials and articles is at the same time authorised as food additive or flavouring substance it should be ensured that the release of the substance does not change the composition of the food in an unacceptable way. Therefore the release of such a dual use additive or flavouring should not exhibit a technological function on the food unless such a function is intended and the food contact material complies with the requirements on active food contact materials set out in Regulation (EC) No 1935/2004 and Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food ( 4 ). The requirements of Regulations (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives ( 5 ) or (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC ( 6 ) should be respected where applicable. (25) According to Article 3(1)(b) of Regulation (EC) No 1935/2004 the release of substances from food contact materials and articles should not bring about unacceptable changes in the composition of the food. According to good manufacturing practice it is feasible to manufacture plastic materials in such a way that they are not releasing more than 10 mg of substances per 1 dm2 of surface area of the plastic material. If the risk assessment of an individual substance is not indicating a lower level, this level should be set as a generic limit for the inertness of a plastic material, the overall migration limit. In order to achieve comparable results in the verification of compliance with the overall migration limit, testing should be performed under standardised test conditions including testing time, temperature and test medium (food simulant) representing worst foreseeable conditions of use of the plastic material or article. (26) The overall migration limit of 10 mg per 1 dm2 results for a cubic packaging containing 1kg of food to a migration of 60 mg per kg food. For small packaging where the surface to volume ratio is higher the resulting migration into food is higher. For infants and small children which have a higher consumption of food per kilogram bodyweight than adults and do not yet have a diversified nutrition, special provisions should be set in order to limit the intake of substances migrating from food contact materials. In order to allow also for small volume packaging the same protection as for high volume packaging, the overall migration limit for food contact materials that are dedicated for packaging foods for infants and small children should be linked to the limit in food and not to the surface area of the packaging. (27) In recent years plastic food contact materials are being developed that do not only consist of one plastic but combine up to 15 different plastic layers to attain optimum functionality and protection of the food, while reducing packaging waste. In such a plastic multi-layer material or article, layers may be separated from the food by a functional barrier. This barrier is a layer within food contact materials or articles preventing the migration of substances from behind that barrier into the food. Behind a functional barrier, non-authorised substances may be used, provided they fulfil certain criteria and their migration remains below a given detection limit. Taking into account foods for infants and other particularly susceptible persons, as well as the large analytical tolerance of the migration analysis, a maximum level of 0,01 mg/kg in food should be established for the migration of a non-authorised substance through a functional barrier. Substances that are mutagenic, carcinogenic or toxic to reproduction should not be used in food contact materials or articles without previous authorisation and should therefore not be covered by the functional barrier concept. New technologies that engineer substances in particle size that exhibit chemical and physical properties that significantly differ from those at a larger scale, for example, nanoparticles, should be assessed on a case-by-case basis as regards their risk until more information is known about such new technology. Therefore, they should not be covered by the functional barrier concept. (28) In recent years food contact materials and articles are being developed that consist of a combination of several materials to achieve optimum functionality and protection of the food while reducing packaging waste. In these multi-material multi-layer materials and articles plastic layers should comply with the same compositional requirements as plastic layers which are not combined with other materials. For plastic layers in a multi-material multi-layer which are separated from the food by a functional barrier the functional barrier concept should apply. As other materials are combined with the plastic layers and for these other materials specific measures are not yet adopted at EU level it is not yet possible to set out requirements for the final multi-material multi-layer materials and articles. Therefore specific migration limits and the overall migration limit should not be applicable except for vinyl chloride monomer for which such a restriction is already in place. In the absence of a specific measure at EU level covering the whole multi-material multi-layer material or article Member States may maintain or adopt national provisions for these materials and articles provided they comply with the rules of the Treaty. (29) Article 16(1) of Regulation (EC) No 1935/2004 provides that materials and articles covered by specific measures be accompanied by a written declaration of compliance stating that they comply with the rules applicable to them. To strengthen the coordination and responsibility of the suppliers at each stage of manufacture, including that of the starting substances, the responsible persons should document the compliance with the relevant rules in a declaration of compliance which is made available to their customers. (30) Coatings, printing inks and adhesives are not yet covered by a specific EU legislation and therefore not subject to the requirement of a declaration of compliance. However, for coatings, printing inks and adhesives to be used in plastic materials and articles adequate information should be provided to the manufacturer of the final plastic article that would enable him to ensure compliance for substances for which migration limits have been established in this Regulation. (31) Article 17(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ( 7 ) requires the food business operator to verify that foods are compliant with the rules applicable to them. To this end and subject to the requirement of confidentiality, food business operators should be given access to the relevant information to enable them to ensure that the migration from the materials and articles to food complies with the specifications and restrictions laid down in food legislation. (32) At each stage of manufacture, supporting documentation, substantiating the declaration of compliance, should be kept available for the enforcement authorities. Such demonstration of compliance may be based on migration testing. As migration testing is complex, costly and time consuming it should be admissible that compliance can be demonstrated also by calculations, including modelling, other analysis, and scientific evidence or reasoning if these render results which are at least as severe as the migration testing. Test results should be regarded as valid as long as formulations and processing conditions remain constant as part of a quality assurance system. (33) When testing articles not yet in contact with food, for certain articles, such as films or lids, it is often not feasible to determine the surface area that is in contact with a defined volume of food. For these articles specific rules should be set out for verification of compliance. (34) The setting of migration limits takes into account a conventional assumption that 1kg of food is consumed daily by a person of 60 kg bodyweight and that the food is packaged in a cubic container of 6 dm2 surface area releasing the substance. For very small and very large containers the real surface area to volume of packaged food is varying a lot from the conventional assumption. Therefore, their surface area should be normalised before comparing testing results with migration limits. These rules should be reviewed when new data on food packaging uses become available. (35) The specific migration limit is a maximum permitted amount of a substance in food. This limit should ensure that the food contact material does not pose a risk to health. It should be ensured by the manufacturer that materials and articles not yet in contact with food will respect these limits when brought into contact with food under the worst foreseeable contact conditions. Therefore compliance of materials and articles not yet in contact with food should be assessed and the rules for this testing should be set out. (36) Food is a complex matrix and therefore the analysis of migrating substances in food may pose analytical difficulties. Therefore test media should be assigned that simulate the transfer of substances from the plastic material into food. They should represent the major physico-chemical properties exhibited by food. When using food simulants standard testing time and temperature should reproduce, as far as possible, the migration which may occur from the article into the food. (37) For determining the appropriate food simulant for certain foods the chemical composition and the physical properties of the food should be taken into account. Research results are available for certain representative foods comparing migration into food with migration into food simulants. On the basis of the results, food simulants should be assigned. In particular, for fat containing foods the result obtained with food simulant may in certain cases significantly overestimate migration into food. In these cases it should be foreseen that the result in food simulant is corrected by a reduction factor. (38) The exposure to substances migrating from food contact materials was based on the conventional assumption that a person consumes daily 1 kg of food. However, a person ingests at most 200 g of fat on a daily basis. For lipophilic substances that only migrate into fat this should be taken into consideration. Therefore a correction of the specific migration by a correction factor applicable to lipophilic substances in accordance with the opinion of the Scientific Committee on Food (SCF) ( 8 ) and the opinion of the Authority ( 9 ) should be foreseen. (39) Official control should establish testing strategies which allow the enforcement authorities to perform controls efficiently making best use of available resources. Therefore it should be admissible to use screening methods for checking compliance under certain conditions. Non-compliance of a material or article should be confirmed by a verification method. (40) Basic rules on migration testing should be set out in this Regulation. As migration testing is a very complex issue, these basic rules can, however, not cover all foreseeable cases and details necessary for performing the testing. Therefore a EU guidance document should be established, dealing with more detailed aspects of the implementation of the basic migration testing rules. (41) The updated rules on food simulants and migration testing provided by this Regulation will supersede those in Directive 78/142/EEC and the Annex to Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs ( 10 ). (42) Substances present in the plastic but not listed in Annex I to this Regulation have not necessarily been risk assessed as they had not been subject to an authorisation procedure. Compliance with Article 3 of Regulation (EC) No 1935/2004 for these substances should be assessed by the relevant business operator in accordance with internationally recognised scientific principles taking into account exposure from food contact materials and other sources. (43) Recently additional monomers, other starting substances and additives have received a favourable scientific evaluation by the Authority and should now be added to the Union list. (44) As new substances are added to the Union list the Regulation should apply as soon as possible to allow for manufacturers to adapt to technical progress and allow for innovation. (45) Certain migration testing rules should be updated in view of new scientific knowledge. Enforcement authorities and industry need to adapt their current testing regime to these updated rules. To allow for this adaptation it seems appropriate that the updated rules only apply 2 years after the adoption of the Regulation. (46) Business operators are currently basing their declaration of compliance on supporting documentation following the requirements set out in Directive 2002/72/EC. Declaration of compliance need, in principle, only to be updated when substantial changes in the production bring about changes in the migration or when new scientific data are available. In order to limit the burden to business operators, materials which have been lawfully placed on the market based on the requirements set out in Directive 2002/72/EC should be able to be placed on the market with a declaration of compliance based on supporting documentation in accordance with Directive 2002/72/EC until 5 years after the adoption of the Regulation. (47) Analytical methods for testing migration and residual content of vinyl chloride monomer as described in Commission Directives 80/766/EEC of 8 July 1980 laying down the Community method of analysis for the official control of the vinyl chloride monomer level in materials and articles which are intended to come into contact with foodstuffs ( 11 ) and 81/432/EEC of 29 April 1981 laying down the Community method of analysis for the official control of vinyl chloride released by materials and articles into foodstuffs ( 12 ) are outdated. Analytical methods should comply with the criteria set out in Article 11 of Regulation (EC) No 882/2004 ( 13 ) of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Therefore Directives 80/766/EEC and 81/432/EEC should be repealed. (48) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Whereas: HAS ADOPTED THIS REGULATION:







CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

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

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

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

(b) already in contact with food; or

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

Article 2

Scope

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

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

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

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

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

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

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

(a) ion exchange resins;

(b) rubber;

(c) silicones.

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

Article 3

Definitions

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

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

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

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

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

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

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

(7) ‘additive’ means a substance which is intentionally added to plastics to achieve a physical or chemical effect during processing of the plastic or in the final material or article; it is intended to be present in the final material or article;

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

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

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

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

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

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

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

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

(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 V 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.

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 ( 14 ); and

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







CHAPTER II

COMPOSITIONAL REQUIREMENTS







SECTION 1

Authorised substances

Article 5

Union list of authorised substances

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

2. The Union list shall contain:

(a) monomers or other starting substances;

(b) additives excluding colorants;

(c) polymer production aids excluding solvents;

(d) macromolecules obtained from microbial fermentation.

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

Article 6

Derogations for substances not included in the Union list

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

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

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

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

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

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

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

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

(a) non-intentionally added substances;

(b) aids to polymerisation.

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

Article 7

Establishment and management of the provisional list

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

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

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

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

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







SECTION 2

General requirements, restrictions and specifications

Article 8

General requirement on substances

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

Article 9

Specific requirements on substances

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

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

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

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

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

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

Article 10

General restrictions on plastic materials and articles

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

Article 11

Specific migration limits

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

2. For substances for which no specific migration limit or other restrictions are provided in Annex I, a generic specific migration limit of 60 mg/kg shall apply.

3. By derogation from paragraphs 1 and 2, additives which are also authorised as food additives by Regulation (EC) No 1333/2008 or as flavourings by Regulation (EC) No 1334/2008 shall not migrate into foods in quantities having a technical effect in the final foods and shall not:

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

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

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 ( 15 ) and 2006/125/EC ( 16 ), shall not transfer their constituents to food simulants in quantities exceeding 60 milligrams of total of constituents released per kg of food simulant.







CHAPTER III

SPECIFIC PROVISIONS FOR CERTAIN MATERIALS AND ARTICLES

Article 13

Plastic multi-layer materials and articles

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

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

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

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

3. The migration of the substances under paragraph 2(b) into food or food simulant shall not be detectable measured with statistical certainty by a method of analysis set out in Article 11 of Regulation (EC) No 882/2004 with a limit of detection of 0,01 mg/kg. That limit shall always be expressed as concentration in foods or food simulants. That limit shall apply to a group of compounds, if they are structurally and toxicologically related, in particular isomers or compounds with the same relevant functional group, and shall include possible set-off transfer.

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

(a) substances classified as ‘mutagenic’, ‘carcinogenic’ or ‘toxic to reproduction’ in accordance with the criteria set out in sections 3.5, 3.6. and 3.7 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and the Council ( 17 );

(b) substances in nanoform.

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

Article 14

Multi-material multi-layer materials and articles

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

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

3. The substances not listed in the Union list or provisional list referred to in paragraph 2 shall not belong to either of the following categories:

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

(b) substances in nanoform.

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

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

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







CHAPTER IV

DECLARATION OF COMPLIANCE AND DOCUMENTATION

Article 15

Declaration of compliance

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

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

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

Article 16

Supporting documents

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

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







CHAPTER V

COMPLIANCE

Article 17

Expression of migration test results

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

2. By derogation from paragraph 1 for:

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

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

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

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

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

2. This paragraph does not apply to plastic materials and articles intended to be brought into contact with or already in contact with food for infants and young children, as defined by Directives 2006/141/EC and 2006/125/EC.

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

(a) mg/kg using the actual content of the container for which the closure is intended or in mg/dm2 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.

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

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

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

Article 18

Rules for assessing compliance with migration limits

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

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

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

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 A, B, C, D1 and D2 as set out in Annex III in accordance with the rules set out in Chapter 3, Section 3.1 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 in Chapter 4 of Annex V shall be applied in accordance with the rules set out therein.

Article 19

Assessment of substances not included in the Union list

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







CHAPTER VI

FINAL PROVISIONS

Article 20

Amendments of EU acts

The Annex to Council Directive 85/572/EEC ( 18 ) is replaced by the following:

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

Article 21

Repeal of EU acts

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

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

Article 22

Transitional provisions

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

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

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

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

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

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

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

Article 23

Entry into force and application

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

It shall apply from 1 May 2011.

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

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

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

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









ANNEX I

Substances

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

Table 1 contains the following information:

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

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

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

Column 4 (Substance Name): the chemical name

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

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

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

Column 8 (SML [mg/kg]): the specific migration limit applicable for the substance. It is expressed in mg substance per kg food. It is indicated ND if the substance shall not migrate in detectable quantities.

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

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

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

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

If in Column 8 the specific migration limit is non-detectable (ND) a detection limit of 0,01 mg substance per kg food is applicable unless specified differently for an individual substance.







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 should 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 87 86285 — silicon dioxide, silanated yes no no 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 simulant D is laid down. Average molecular weight not less than 350 Da. Viscosity at 100 °C not less than 2,5 cSt (2,5 × 10-6 m2/s). Content of hydrocarbons with Carbon number less than 25, not more than 40 % (w/w). 94 95859 — waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, high viscosity yes no no Average molecular weight not less than 500 Da. Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w). 95 95883 — white mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks yes no no Average molecular weight not less than 480 Da. Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2/s). Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w). 96 95920 — wood flour and fibers, untreated yes no no 97 72081/10 — petroleum hydrocarbon resins (hydrogenated) yes no no Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermalpolymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoidarylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing. Properties: — Viscosity at 120 °C: > 3 Pa.s, — Softening point: > 95 °C as determined by ASTM Method E 28-67, — Bromine number: < 40 (ASTM D1159), — The colour of a 50 % solution in toluene < 11 on the Gardner scale, — Residual aromatic monomer ≤ 50 ppm, 98 17260 0000050-00-0 formaldehyde yes yes no (15) 54880 99 19460 0000050-21-5 lactic acid yes yes no 62960 100 24490 0000050-70-4 sorbitol yes yes no 88320 101 36000 0000050-81-7 ascorbic acid yes no no 102 17530 0000050-99-7 glucose no yes no 103 18100 0000056-81-5 glycerol yes yes no 55920 104 58960 0000057-09-0 hexadecyltrimethylammonium bromide yes no no 6 105 22780 0000057-10-3 palmitic acid yes yes no 70400 106 24550 0000057-11-4 stearic acid yes yes no 89040 107 25960 0000057-13-6 urea no yes no 108 24880 0000057-50-1 sucrose no yes no 109 23740 0000057-55-6 1,2-propanediol yes yes no 81840 110 93520 0000059-02-9 0010191-41-0 α-tocopherol yes no no 111 53600 0000060-00-4 ethylenediaminetetraacetic acid yes no no 112 64015 0000060-33-3 linoleic acid yes no no 113 16780 0000064-17-5 ethanol yes yes no 52800 114 55040 0000064-18-6 formic acid yes no no 115 10090 0000064-19-7 acetic acid yes yes no 30000 116 13090 0000065-85-0 benzoic acid yes yes no 37600 117 21550 0000067-56-1 methanol no yes no 118 23830 0000067-63-0 2-propanol yes yes no 81882 119 30295 0000067-64-1 acetone yes no no 120 49540 0000067-68-5 dimethyl sulphoxide yes no no 121 24270 0000069-72-7 salicylic acid yes yes no 84640 122 23800 0000071-23-8 1-propanol no yes no 123 13840 0000071-36-3 1-butanol no yes no 124 22870 0000071-41-0 1-pentanol no yes no 125 16950 0000074-85-1 ethylene no yes no 126 10210 0000074-86-2 acetylene no yes no 127 26050 0000075-01-4 vinyl chloride no yes no ND 1 mg/kg in final product 128 10060 0000075-07-0 acetaldehyde no yes no (1) 129 17020 0000075-21-8 ethylene oxide no yes no ND 1 mg/kg in final product (10) 130 26110 0000075-35-4 vinylidene chloride no yes no ND (1) 131 48460 0000075-37-6 1,1-difluoroethane yes no no 132 26140 0000075-38-7 vinylidene fluoride no yes no 5 133 14380 0000075-44-5 carbonyl chloride no yes no ND 1 mg/kg in final product (10) 23155 134 43680 0000075-45-6 chlorodifluoromethane yes no no 6 Content of chlorofluoromethane less than 1 mg/kg of the substance 135 24010 0000075-56-9 propylene oxide no yes no ND 1 mg/kg in final product 136 41680 0000076-22-2 camphor yes no no (3) 137 66580 0000077-62-3 2,2′-methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol) yes no yes (5) 138 93760 0000077-90-7 tri-n-butyl acetyl citrate yes no no (32) 139 14680 0000077-92-9 citric acid yes yes no 44160 140 44640 0000077-93-0 citric acid, triethyl ester yes no no (32) 141 13380 0000077-99-6 1,1,1-trimethylolpropane yes yes no 6 25600 94960 142 26305 0000078-08-0 vinyltriethoxysilane no yes no 0,05 Only to be used as a surface treatment agent (1) 143 62450 0000078-78-4 isopentane yes no no 144 19243 0000078-79-5 2-methyl-1,3-butadiene no yes no ND 1 mg/kg in final product 21640 145 10630 0000079-06-1 acrylamide no yes no ND 146 23890 0000079-09-4 propionic acid yes yes no 82000 147 10690 0000079-10-7 acrylic acid no yes no (22) 148 14650 0000079-38-9 chlorotrifluoroethylene no yes no ND (1) 149 19990 0000079-39-0 methacrylamide no yes no ND 150 20020 0000079-41-4 methacrylic acid no yes no (23) 151 13480 0000080-05-7 2,2-bis(4-hydroxyphenyl)propane no yes no 0,6 ►M1 Not to be used for the manufacture of polycarbonate infant (6) feeding bottles (7). ◄ 13607 152 15610 0000080-07-9 4,4′-dichlorodiphenyl sulphone no yes no 0,05 153 15267 0000080-08-0 4,4′-diaminodiphenyl sulphone no yes no 5 154 13617 0000080-09-1 4,4′-dihydroxydiphenyl sulphone no yes no 0,05 16090 155 23470 0000080-56-8 α-pinene no yes no 156 21130 0000080-62-6 methacrylic acid, methyl ester no yes no (23) 157 74880 0000084-74-2 phthalic acid, dibutyl ester yes no no 0,3 (32) Only to be used as: (a) plasticiser in repeated use materials and articles contacting non-fatty foods; (b) technical support agent in polyolefins in concentrations up to 0,05 % in the final product. (7) 158 23380 0000085-44-9 phthalic anhydride yes yes no 76320 159 74560 0000085-68-7 phthalic acid, benzyl butyl ester yes no no 30 (32) Only to be used as: (a) plasticiser in repeated use materials and articles; (b) plasticiser in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC; (c) technical support agent in concentrations up to 0,1 % in the final product. (7) 160 84800 0000087-18-3 salicylic acid, 4-tert-butylphenyl ester yes no yes 12 161 92160 0000087-69-4 tartaric acid yes no no 162 65520 0000087-78-5 mannitol yes no no 163 66400 0000088-24-4 2,2′-methylene bis(4-ethyl-6-tert-butylphenol) yes no yes (13) 164 34895 0000088-68-6 2-aminobenzamide yes no no 0,05 Only for use in PET for water and beverages 165 23200 0000088-99-3 o-phthalic acid yes yes no 74480 166 24057 0000089-32-7 pyromellitic anhydride no yes no 0,05 167 25240 0000091-08-7 2,6-toluene diisocyanate no yes no (17) 1 mg/kg in final product expressed as isocyanate moiety (10) 168 13075 0000091-76-9 2,4-diamino-6-phenyl-1,3,5-triazine no yes no 5 (1) 15310 169 16240 0000091-97-4 3,3′-dimethyl-4,4′-diisocyanatobiphenyl no yes no (17) 1 mg/kg in final product expressed as isocyanate moiety (10) 170 16000 0000092-88-6 4,4′-dihydroxybiphenyl no yes no 6 171 38080 0000093-58-3 benzoic acid, methyl ester yes no no 172 37840 0000093-89-0 benzoic acid, ethyl ester yes no no 173 60240 0000094-13-3 4-hydroxybenzoic acid, propyl ester yes no no 174 14740 0000095-48-7 o-cresol no yes no 175 20050 0000096-05-9 methacrylic acid, allyl ester no yes no 0,05 176 11710 0000096-33-3 acrylic acid, methyl ester no yes no (22) 177 16955 0000096-49-1 ethylene carbonate no yes no 30 SML expressed as ethyleneglycol. Residual content of 5 mg ethylene carbonate per kg of hydrogel with max 10 g of hydrogel in contact with 1 kg of food. 178 92800 0000096-69-5 4,4′-thiobis(6-tert-butyl-3-methylphenol) yes no yes 0,48 179 48800 0000097-23-4 2,2′-dihydroxy-–5,5′-dichlorodiphenylmethane yes no yes 12 180 17160 0000097-53-0 eugenol no yes no ND 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 simulant D is laid down. For indirect food contact only, behind a PET layer. (8) 200 51680 0000102-08-9 N,N′-diphenylthiourea yes no yes 3 201 16540 0000102-09-0 diphenyl carbonate no yes no 0,05 202 23070 0000102-39-6 (1,3-phenylenedioxy)diacetic acid no yes no 0,05 (1) 203 13323 0000102-40-9 1,3-bis(2-hydroxyethoxy)benzene no yes no 0,05 204 25180 0000102-60-3 N,N,N′,N′-tetrakis(2-hydroxypropyl)ethylenediamine yes yes no 92640 205 25385 0000102-70-5 triallylamine no yes no 40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel. Only to be used in hydrogels intended for non-direct food contact use. 206 11500 0000103-11-7 acrylic acid, 2-ethylhexyl ester no yes no 0,05 207 31920 0000103-23-1 adipic acid, bis(2-ethylhexyl) ester yes no yes 18 (32) (2) 208 18898 0000103-90-2 N-(4-hydroxyphenyl) acetamide no yes no 0,05 209 17050 0000104-76-7 2-ethyl-1-hexanol no yes no 30 210 13390 0000105-08-8 1,4-bis(hydroxymethyl)cyclohexane no yes no 14880 211 23920 0000105-38-4 propionic acid, vinyl ester no yes no (1) 212 14200 0000105-60-2 caprolactam yes yes no (4) 41840 213 82400 0000105-62-4 1,2-propyleneglycol dioleate yes no no 214 61840 0000106-14-9 12-hydroxystearic acid yes no no 215 14170 0000106-31-0 butyric anhydride no yes no 216 14770 0000106-44-5 p-cresol no yes no 217 15565 0000106-46-7 1,4-dichlorobenzene no yes no 12 218 11590 0000106-63-8 acrylic acid, isobutyl ester no yes no (22) 219 14570 0000106-89-8 epichlorohydrin no yes no ND 1 mg/kg in final product (10) 16750 220 20590 0000106-91-2 methacrylic acid, 2,3-epoxypropyl ester no yes no 0,02 (10) 221 40570 0000106-97-8 butane yes no no 222 13870 0000106-98-9 1-butene no yes no 223 13630 0000106-99-0 butadiene no yes no ND 1 mg/kg in final product 224 13900 0000107-01-7 2-butene no yes no 225 12100 0000107-13-1 acrylonitrile no yes no ND 226 15272 0000107-15-3 ethylenediamine no yes no 12 16960 227 16990 0000107-21-1 ethyleneglycol yes yes no (2) 53650 228 13690 0000107-88-0 1,3-butanediol no yes no 229 14140 0000107-92-6 butyric acid no yes no 230 16150 0000108-01-0 dimethylaminoethanol no yes no 18 231 10120 0000108-05-4 acetic acid, vinyl ester no yes no 12 232 10150 0000108-24-7 acetic anhydride yes yes no 30280 233 24850 0000108-30-5 succinic anhydride no yes no 234 19960 0000108-31-6 maleic anhydride no yes no (3) 235 14710 0000108-39-4 m-cresol no yes no 236 23050 0000108-45-2 1,3-phenylenediamine no yes no ND 237 15910 0000108-46-3 1,3-dihydroxybenzene no yes no 2,4 24072 238 18070 0000108-55-4 glutaric anhydride no yes no ▼M2 239 19975 0000108-78-1 2,4,6-triamino-1,3,5-triazine yes yes no 2,5 25420 93720 ▼B 240 45760 0000108-91-8 cyclohexylamine yes no no 241 22960 0000108-95-2 phenol no yes no 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 257 13550 0000110-98-5 dipropyleneglycol yes yes no 16660 51760 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 simulant D is laid down. For indirect food contact only, behind a PET layer. 263 13326 0000111-46-6 diethyleneglycol yes yes no (2) 15760 47680 264 22660 0000111-66-0 1-octene no yes no 15 265 22600 0000111-87-5 1-octanol no yes no 266 25510 0000112-27-6 triethyleneglycol yes yes no 94320 267 15100 0000112-30-1 1-decanol no yes no 268 16704 0000112-41-4 1-dodecene no yes no 0,05 269 25090 0000112-60-7 tetraethyleneglycol yes yes no 92350 270 22763 0000112-80-1 oleic acid yes yes no 69040 271 52720 0000112-84-5 erucamide yes no no 272 37040 0000112-85-6 behenic acid yes no no 273 52730 0000112-86-7 erucic acid yes no no 274 22570 0000112-96-9 octadecyl isocyanate no yes no (17) 1 mg/kg in final product expressed as isocyanate moiety (10) 275 23980 0000115-07-1 propylene no yes no 276 19000 0000115-11-7 isobutene no yes no 277 18280 0000115-27-5 hexachloroendomethylenetetrahydrophthalic anhydride no yes no ND 278 18250 0000115-28-6 hexachloroendomethylenetetrahydrophthalic acid no yes no ND 279 22840 0000115-77-5 pentaerythritol yes yes no 71600 280 73720 0000115-96-8 phosphoric acid, trichloroethyl ester yes no no ND 281 25120 0000116-14-3 tetrafluoroethylene no yes no 0,05 282 18430 0000116-15-4 hexafluoropropylene no yes no ND 283 74640 0000117-81-7 phthalic acid, bis(2-ethylhexyl) ester yes no no 1,5 (32) Only to be used as: (a) plasticiser in repeated use materials and articles contacting non-fatty foods; (b) technical support agent in concentrations up to 0,1 % in the final product. (7) 284 84880 0000119-36-8 salicylic acid, methyl ester yes no no 30 285 66480 0000119-47-1 2,2′-methylene bis(4-methyl-6-tert-butylphenol) yes no yes (13) 286 38240 0000119-61-9 benzophenone yes no yes 0,6 287 60160 0000120-47-8 4-hydroxybenzoic acid, ethyl ester yes no no 288 24970 0000120-61-6 terephthalic acid, dimethyl ester no yes no 289 15880 0000120-80-9 1,2-dihydroxybenzene no yes no 6 24051 290 55360 0000121-79-9 gallic acid, propyl ester yes no no (20) 291 19150 0000121-91-5 isophthalic acid no yes no (27) 292 94560 0000122-20-3 triisopropanolamine yes no no 5 293 23175 0000122-52-1 phosphorous acid, triethyl ester no yes no ND 1 mg/kg in final product (1) 294 93120 0000123-28-4 thiodipropionic acid, didodecyl ester yes no yes (14) 295 15940 0000123-31-9 1,4-dihydroxybenzene yes yes no 0,6 18867 48620 296 23860 0000123-38-6 propionaldehyde no yes no 297 23950 0000123-62-6 propionic anhydride no yes no 298 14110 0000123-72-8 butyraldehyde no yes no 299 63840 0000123-76-2 levulinic acid yes no no 300 30045 0000123-86-4 acetic acid, butyl ester yes no no 301 89120 0000123-95-5 stearic acid, butyl ester yes no no 302 12820 0000123-99-9 azelaic acid no yes no 303 12130 0000124-04-9 adipic acid yes yes no 31730 304 14320 0000124-07-2 caprylic acid yes yes no 41960 305 15274 0000124-09-4 hexamethylenediamine no yes no 2,4 18460 306 88960 0000124-26-5 stearamide yes no no 307 42160 0000124-38-9 carbon dioxide yes no no 308 91200 0000126-13-6 sucrose acetate isobutyrate yes no no 309 91360 0000126-14-7 sucrose octaacetate yes no no 310 16390 0000126-30-7 2,2-dimethyl-1,3-propanediol no yes no 0,05 22437 311 16480 0000126-58-9 dipentaerythritol yes yes no 51200 312 21490 0000126-98-7 methacrylonitrile no yes no ND 313 16650 0000127-63-9 diphenyl sulphone yes yes no 3 51570 314 23500 0000127-91-3 β-pinene no yes no 315 46640 0000128-37-0 2,6-di-tert-butyl-p-cresol yes no no 3 316 23230 0000131-17-9 phthalic acid, diallyl ester no yes no ND 317 48880 0000131-53-3 2,2′-dihydroxy-4-methoxybenzophenone yes no yes (8) 318 48640 0000131-56-6 2,4-dihydroxybenzophenone yes no no (8) 319 61360 0000131-57-7 2-hydroxy-4-methoxybenzophenone yes no yes (8) 320 37680 0000136-60-7 benzoic acid, butyl ester yes no no 321 36080 0000137-66-6 ascorbyl palmitate yes no no 322 63040 0000138-22-7 lactic acid, butyl ester yes no no 323 11470 0000140-88-5 acrylic acid, ethyl ester no yes no (22) 324 83700 0000141-22-0 ricinoleic acid yes no yes 42 325 10780 0000141-32-2 acrylic acid, n-butyl ester no yes no (22) 326 12763 0000141-43-5 2-aminoethanol yes yes no 0,05 Not to be used for articles in contact with fatty foods for which simulant D 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 340 47440 0000461-58-5 dicyanodiamide yes no no 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 0,05 344 13810 0000505-65-7 1,4-butanediol formal no yes no ND (10) 21821 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 5 364 15404 0000652-67-5 1,4:3,6-dianhydrosorbitol no yes no 5 Only to be used as a co-monomer in poly(ethylene-co-isosorbide terephthalate) 365 11680 0000689-12-3 acrylic acid, isopropyl ester no yes no (22) 366 22150 0000691-37-2 4-methyl-1-pentene no yes no 0,05 367 16697 0000693-23-2 n-dodecanedioic acid no yes no 368 93280 0000693-36-7 thiodipropionic acid, dioctadecyl ester yes no yes (14) 369 12761 0000693-57-2 12-aminododecanoic acid no yes no 0,05 370 21460 0000760-93-0 methacrylic anhydride no yes no (23) 371 11510 0000818-61-1 acrylic acid, monoester with ethyleneglycol no yes no (22) 11830 372 18640 0000822-06-0 hexamethylene diisocyanate no yes no (17) 1 mg/kg in final product expressed as isocyanate moiety (10) 373 22390 0000840-65-3 2,6-naphthalenedicarboxylic acid, dimethyl ester no yes no 0,05 374 21190 0000868-77-9 methacrylic acid, monoester with ethyleneglycol no yes no (23) 375 15130 0000872-05-9 1-decene no yes no 0,05 ▼M2 376 66905 0000872-50-4 N-methylpyrrolidone yes no no 60 ▼B 377 12786 0000919-30-2 3-aminopropyltriethoxysilane no yes no 0,05 Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers. SML = 0,05 mg/kg when used for the surface treatment of materials and articles. 378 21970 0000923-02-4 N-methylolmethacrylamide no yes no 0,05 379 21940 0000924-42-5 N-methylolacrylamide no yes no ND 380 11980 0000925-60-0 acrylic acid, propyl ester no yes no (22) 381 15030 0000931-88-4 cyclooctene no yes no 0,05 Only to be used in polymers contacting foods for which simulant A is laid down 382 19490 0000947-04-6 laurolactam no yes no 5 383 72160 0000948-65-2 2-phenylindole yes no yes 15 384 40000 0000991-84-4 2,4-bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-triazine yes no yes 30 385 11530 0000999-61-1 acrylic acid, 2-hydroxypropyl ester no yes no 0,05 SML expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester. It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 0002918-23-2). (1) 386 55280 0001034-01-1 gallic acid, octyl ester yes no no (20) 387 26155 0001072-63-5 1-vinylimidazole no yes no 0,05 (1) 388 25080 0001120-36-1 1-tetradecene no yes no 0,05 389 22360 0001141-38-4 2,6-naphthalenedicarboxylic acid no yes no 5 390 55200 0001166-52-5 gallic acid, dodecyl ester yes no no (20) 391 22932 0001187-93-5 perfluoromethyl perfluorovinyl ether no yes no 0,05 Only to be used in anti-stick coatings 392 72800 0001241-94-7 phosphoric acid, diphenyl 2-ethylhexyl ester yes no yes 2,4 393 37280 0001302-78-9 bentonite yes no no 394 41280 0001305-62-0 calcium hydroxide yes no no 395 41520 0001305-78-8 calcium oxide yes no no 396 64640 0001309-42-8 magnesium hydroxide yes no no 397 64720 0001309-48-4 magnesium oxide yes no no 398 35760 0001309-64-4 antimony trioxide yes no no 0,04 SML expressed as antimony (6) 399 81600 0001310-58-3 potassium hydroxide yes no no 400 86720 0001310-73-2 sodium hydroxide yes no no 401 24475 0001313-82-2 sodium sulphide no yes no 402 96240 0001314-13-2 zinc oxide yes no no 403 96320 0001314-98-3 zinc sulphide yes no no 404 67200 0001317-33-5 molybdenum disulphide yes no no 405 16690 0001321-74-0 divinylbenzene no yes no ND SML expressed as the sum of divinylbenzene and ethylvinylbenzene. It may contain up to 45 % (m/m) of ethylvinylbenzene. (1) 406 83300 0001323-39-3 1,2-propyleneglycol monostearate yes no no 407 87040 0001330-43-4 sodium tetraborate yes no no (16) 408 82960 0001330-80-9 1,2-propyleneglycol monooleate yes no no 409 62240 0001332-37-2 iron oxide yes no no 410 62720 0001332-58-7 kaolin yes no no 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 0,05 421 13000 0001477-55-0 1,3-benzenedimethanamine no yes no 0,05 422 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) 449 49840 0002500-88-1 dioctadecyl disulphide yes no yes 3 450 24430 0002561-88-8 sebacic anhydride no yes no 451 66755 0002682-20-4 2-methyl-4-isothiazolin-3-one yes no no 0,5 Only to be used in aqueous polymer dispersions and emulsions ▼M2 452 38885 0002725-22-6 2,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine yes no no 5 ▼B 453 26320 0002768-02-7 vinyltrimethoxysilane no yes no 0,05 (10) 454 12670 0002855-13-2 1-amino-3-aminomethyl-3,5,5-trimethylcyclohexane no yes no 6 455 20530 0002867-47-2 methacrylic acid, 2-(dimethylamino)-ethyl ester no yes no ND 456 10810 0002998-08-5 acrylic acid, sec-butyl ester no yes no (22) 457 20140 0002998-18-7 methacrylic acid, sec-butyl ester no yes no (23) 458 36960 0003061-75-4 behenamide yes no no 459 46870 0003135-18-0 3,5-di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester yes no no 460 14950 0003173-53-3 cyclohexyl isocyanate no yes no (17) 1 mg/kg in final product expressed as isocyanate moiety (10) 461 22420 0003173-72-6 1,5-naphthalene diisocyanate no yes no (17) 1 mg/kg in final product expressed as isocyanate moiety (10) 462 26170 0003195-78-6 N-vinyl-N-methylacetamide no yes no 0,02 (1) 463 25840 0003290-92-4 1,1,1-trimethylolpropane trimethacrylate no yes no 0,05 464 61280 0003293-97-8 2-hydroxy-4-n-hexyloxybenzophenone yes no yes (8) 465 68040 0003333-62-8 7-[2H-naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin yes no no 466 50640 0003648-18-8 di-n-octyltin dilaurate yes no no (10) 467 14800 0003724-65-0 crotonic acid yes yes no 0,05 (1) 45600 468 71960 0003825-26-1 perfluorooctanoic acid, ammonium salt yes no no Only to be used in repeated use articles, sintered at high temperatures 469 60480 0003864-99-1 2-(2′-hydroxy-3,5′-di-tert-butylphenyl)-5-chlorobenzotriazole yes no yes (12) 470 60400 0003896-11-5 2-(2′-hydroxy-3′-tert-butyl-5′-methylphenyl)-5-chlorobenzotriazole yes no yes (12) 471 24888 0003965-55-7 5-sulphoisophthalic acid, monosodium salt, dimethyl ester no yes no 0,05 472 66560 0004066-02-8 2,2′-methylenebis(4-methyl-6-cyclohexylphenol) yes no yes (5) 473 12265 0004074-90-2 adipic acid, divinyl ester no yes no ND 5 mg/kg in final product. Only to be used as co-monomer. (1) 474 43600 0004080-31-3 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride yes no no 0,3 475 19110 0004098-71-9 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane no yes no (17) 1 mg/kg in final product expressed as isocyanate moiety (10) 476 16570 0004128-73-8 diphenylether-4,4′-diisocyanate no yes no (17) 1 mg/kg in final product expressed as isocyanate moiety (10) 477 46720 0004130-42-1 2,6-di-tert-butyl-4-ethylphenol yes no yes 4,8 (1) 478 60180 0004191-73-5 4-hydroxybenzoic acid, isopropyl ester yes no no 479 12970 0004196-95-6 azelaic anhydride no yes no 480 46790 0004221-80-1 3,5-di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester yes no no 481 13060 0004422-95-1 1,3,5-benzenetricarboxylic acid trichloride no yes no 0,05 SML expressed as 1,3,5-benzenetricarboxylic acid (1) 482 21100 0004655-34-9 methacrylic acid, isopropyl ester no yes no (23) 483 68860 0004724-48-5 n-octylphosphonic acid yes no no 0,05 484 13395 0004767-03-7 2,2-bis(hydroxymethyl)propionic acid no yes no 0,05 (1) 485 13560 0005124-30-1 dicyclohexylmethane-4,4′-diisocyanate no yes no (17) 1 mg/kg in final product expressed as isocyanate moiety (10) 15700 486 54005 0005136-44-7 ethylene-N-palmitamide-N′-stearamide yes no no 487 45640 0005232-99-5 2-cyano-3,3-diphenylacrylic acid, ethyl ester yes no no 0,05 488 53440 0005518-18-3 N,N′-ethylenebispalmitamide yes no no 489 41040 0005743-36-2 calcium butyrate yes no no 490 16600 0005873-54-1 diphenylmethane-2,4′-diisocyanate no yes no (17) 1 mg/kg in final product expressed as isocyanate moiety (10) 491 82720 0006182-11-2 1,2-propyleneglycol distearate yes no no 492 45650 0006197-30-4 2-cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester yes no no 0,05 493 39200 0006200-40-4 bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy)methylammonium chloride yes no no 1,8 494 62140 0006303-21-5 hypophosphorous acid yes no no 495 35160 0006642-31-5 6-amino-1,3-dimethyluracil yes no no 5 496 71680 0006683-19-8 pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate] yes no no 497 95020 0006846-50-0 2,2,4-trimethyl-1,3-pentanediol diisobutyrate yes no no 5 Only to be used in single-use gloves 498 16210 0006864-37-5 3,3′-dimethyl-4,4′-diaminodicyclohexylmethane no yes no 0,05 Only to be used in polyamides (5) 499 19965 0006915-15-7 malic acid yes yes no In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis 65020 500 38560 0007128-64-5 2,5-bis(5-tert-butyl-2-benzoxazolyl)thiophene yes no yes 0,6 501 34480 — aluminium fibers, flakes and powders yes no no 502 22778 0007456-68-0 4,4′-oxybis(benzenesulphonyl azide) no yes no 0,05 (1) 503 46080 0007585-39-9 β-dextrin yes no no 504 86240 0007631-86-9 silicon dioxide yes no no For synthetic amorphous silicon dioxide: primary particles of 1 – 100 nm which are aggregated to a size of 0,1 – 1 μm which may form agglomerates within the size distribution of 0,3 μm to the mm size. 505 86480 0007631-90-5 sodium bisulphite yes no no (19) 506 86920 0007632-00-0 sodium nitrite yes no no 0,6 507 59990 0007647-01-0 hydrochloric acid yes no no 508 86560 0007647-15-6 sodium bromide yes no no 509 23170 0007664-38-2 phosphoric acid yes yes no 72640 510 12789 0007664-41-7 ammonia yes yes no 35320 511 91920 0007664-93-9 sulphuric acid yes no no 512 81680 0007681-11-0 potassium iodide yes no no (6) 513 86800 0007681-82-5 sodium iodide yes no no (6) 514 91840 0007704-34-9 sulphur yes no no 515 26360 0007732-18-5 water yes yes no In compliance with Directive 98/83/EC (2) 95855 516 86960 0007757-83-7 sodium sulphite yes no no (19) 517 81520 0007758-02-3 potassium bromide yes no no 518 35845 0007771-44-0 arachidonic acid yes no no 519 87120 0007772-98-7 sodium thiosulphate yes no no (19) 520 65120 0007773-01-5 manganese chloride yes no no 521 58320 0007782-42-5 graphite yes no no 522 14530 0007782-50-5 chlorine no yes no 523 45195 0007787-70-4 copper bromide yes no no 524 24520 0008001-22-7 soybean oil no yes no 525 62640 0008001-39-6 japan wax yes no no 526 43440 0008001-75-0 ceresin yes no no 527 14411 0008001-79-4 castor oil yes yes no 42880 528 63760 0008002-43-5 lecithin yes no no 529 67850 0008002-53-7 montan wax yes no no 530 41760 0008006-44-8 candelilla wax yes no no 531 36880 0008012-89-3 beeswax yes no no 532 88640 0008013-07-8 soybean oil, epoxidised yes no no 60 30(*) (32) (*) In the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC, the SML is lowered to 30 mg/kg. Oxirane < 8 %, iodine number < 6. 533 42720 0008015-86-9 carnauba wax yes no no 534 80720 0008017-16-1 polyphosphoric acids yes no no 535 24100 0008050-09-7 rosin yes yes no 24130 24190 83840 536 84320 0008050-15-5 rosin, hydrogenated, ester with methanol yes no no 537 84080 0008050-26-8 rosin, ester with pentaerythritol yes no no 538 84000 0008050-31-5 rosin, ester with glycerol yes no no 539 24160 0008052-10-6 rosin tall oil no yes no 540 63940 0008062-15-5 lignosulphonic acid yes no no 0,24 Only to be used as dispersant for plastics dispersions 541 58480 0009000-01-5 gum arabic yes no no 542 42640 0009000-11-7 carboxymethylcellulose yes no no 543 45920 0009000-16-2 dammar yes no no 544 58400 0009000-30-0 guar gum ye