Lexploria

15.1.2011

EN

Official Journal of the European Union

L 12/1

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,

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,

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

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

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

(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.

Done at Brussels, 14 January 2011.

For the Commission

The President

José Manuel BARROSO

(1) OJ L 338, 13.11.2004, p. 4.

(2) OJ L 220, 15.8.2002, p. 18.

(3) OJ L 44, 15.2.1978, p. 15.

(4) OJ L 135, 30.5.2009, p. 3.

(5) OJ L 354, 31.12.2008, p. 16.

(6) OJ L 354, 31.12.2008, p. 34.

(7) OJ L 31, 1.2.2002, p. 1.

(8) SCF opinion of 4 December 2002 on the introduction of a Fat (Consumption) Reduction Factor (FRF) in the estimation of the exposure to a migrant from food contact materials.

http://ec.europa.eu/food/fs/sc/scf/out149_en.pdf

(9) Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on a request from the Commission related to the introduction of a Fat (consumption) Reduction Factor for infants and children, The EFSA Journal (2004) 103, 1-8.

(10) OJ L 297, 23.10.1982, p. 26.

(11) OJ L 213, 16.8.1980, p. 42.

(12) OJ L 167, 24.6.1981, p. 6.

(13) OJ L 165, 30.4.2004, p. 1.

(14) OJ L 384, 29.12.2006, p. 75.

(15) OJ L 401, 30.12.2006, p. 1.

(16) OJ L 339, 6.12.2006, p. 16.

(17) OJ L 353, 31.12.2008, p. 1.

(18) OJ L 372, 31.12.1985, p. 14.

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

8

30401

—

acetylated mono- and diglycerides of fatty acids

yes

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

10

30612

—

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

yes

no

11

30960

—

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

yes

no

12

31328

—

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

yes

no

13

33120

—

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

yes

no

14

33801

—

n-alkyl(C10-C13)benzenesulphonic acid

yes

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

6

17

34281

—

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

yes

no

18

34475

—

aluminium calcium hydroxide phosphite, hydrate

yes

no

19

39090

—

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

yes

no

(7)

20

39120

—

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

yes

no

(7)

SML(T) expressed excluding HCl

21

42500

—

carbonic acid, salts

yes

no

22

43200

—

castor oil, mono- and diglycerides

yes

no

23

43515

—

chlorides of choline esters of coconut oil fatty acids

yes

no

0,9

(1)

24

45280

—

cotton fibers

yes

no

25

45440

—

cresols, butylated, styrenated

yes

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

5

27

48960

—

9,10-dihydroxy stearic acid and its oligomers

yes

no

5

28

50160

—

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

yes

no

(10)

29

50360

—

di-n-octyltin bis(ethyl maleate)

yes

no

(10)

30

50560

—

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

yes

no

(10)

31

50800

—

di-n-octyltin dimaleate, esterified

yes

no

(10)

32

50880

—

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

yes

no

(10)

33

51120

—

di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate

yes

no

(10)

34

54270

—

ethylhydroxymethylcellulose

yes

no

35

54280

—

ethylhydroxypropylcellulose

yes

no

36

54450

—

fats and oils, from animal or vegetable food sources

yes

no

37

54480

—

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

yes

no

38

55520

—

glass fibers

yes

no

39

55600

—

glass microballs

yes

no

40

56360

—

glycerol, esters with acetic acid

yes

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

42

56487

—

glycerol, esters with butyric acid

yes

no

43

56490

—

glycerol, esters with erucic acid

yes

no

44

56495

—

glycerol, esters with 12-hydroxystearic acid

yes

no

45

56500

—

glycerol, esters with lauric acid

yes

no

46

56510

—

glycerol, esters with linoleic acid

yes

no

47

56520

—

glycerol, esters with myristic acid

yes

no

48

56535

—

glycerol, esters with nonanoic acid

yes

no

49

56540

—

glycerol, esters with oleic acid

yes

no

50

56550

—

glycerol, esters with palmitic acid

yes

no

51

56570

—

glycerol, esters with propionic acid

yes

no

52

56580

—

glycerol, esters with ricinoleic acid

yes

no

53

56585

—

glycerol, esters with stearic acid

yes

no

54

57040

—

glycerol monooleate, ester with ascorbic acid

yes

no

55

57120

—

glycerol monooleate, ester with citric acid

yes

no

56

57200

—

glycerol monopalmitate, ester with ascorbic acid

yes

no

57

57280

—

glycerol monopalmitate, ester with citric acid

yes

no

58

57600

—

glycerol monostearate, ester with ascorbic acid

yes

no

59

57680

—

glycerol monostearate, ester with citric acid

yes

no

60

58300

—

glycine, salts

yes

no

62

64500

—

lysine, salts

yes

no

63

65440

—

manganese pyrophosphite

yes

no

64

66695

—

methylhydroxymethylcellulose

yes

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

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

(11)

67

67840

—

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

yes

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

(22)

71

76730

—

polydimethylsiloxane, γ-hydroxypropylated

yes

no

6

72

76815

—

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

yes

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

76

77732

—

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

yes

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

0,05

Only for use in PET

78

77897

—

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

yes

no

5

79

80640

—

polyoxyalkyl (C2-C4) dimethylpolysiloxane

yes

no

80

81760

—

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

yes

no

81

83320

—

propylhydroxyethylcellulose

yes

no

82

83325

—

propylhydroxymethylcellulose

yes

no

83

83330

—

propylhydroxypropylcellulose

yes

no

84

85601

—

silicates, natural (with the exception of asbestos)

yes

no

85

85610

—

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

yes

no

86

86000

—

silicic acid, silylated

yes

no

87

86285

—

silicon dioxide, silanated

yes

no

88

86880

—

sodium monoalkyl dialkylphenoxybenzenedisulphonate

yes

no

9

89

89440

—

stearic acid, esters with ethyleneglycol

yes

no

(2)

90

92195

—

taurine, salts

yes

no

91

92320

—

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

yes

no

yes

15

92

93970

—

tricyclodecanedimethanol bis(hexahydrophthalate)

yes

no

0,05

93

95858

—

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

yes

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

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

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

97

72081/10

—

petroleum hydrocarbon resins (hydrogenated)

yes

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

no

(15)

54880

99

19460

0000050-21-5

lactic acid

yes

no

62960

100

24490

0000050-70-4

sorbitol

yes

no

88320

101

36000

0000050-81-7

ascorbic acid

yes

no

102

17530

0000050-99-7

glucose

no

yes

no

103

18100

0000056-81-5

glycerol

yes

no

55920

104

58960

0000057-09-0

hexadecyltrimethylammonium bromide

yes

no

6

105

22780

0000057-10-3

palmitic acid

yes

no

70400

106

24550

0000057-11-4

stearic acid

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

no

81840

110

93520

0000059-02-9

0010191-41-0

α-tocopherol

yes

no

111

53600

0000060-00-4

ethylenediaminetetraacetic acid

yes

no

112

64015

0000060-33-3

linoleic acid

yes

no

113

16780

0000064-17-5

ethanol

yes

no

52800

114

55040

0000064-18-6

formic acid

yes

no

115

10090

0000064-19-7

acetic acid

yes

no

30000

116

13090

0000065-85-0

benzoic acid

yes

no

37600

117

21550

0000067-56-1

methanol

no

yes

no

118

23830

0000067-63-0

2-propanol

yes

no

81882

119

30295

0000067-64-1

acetone

yes

no

120

49540

0000067-68-5

dimethyl sulphoxide

yes

no

121

24270

0000069-72-7

salicylic acid

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

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

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

(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

(32)

139

14680

0000077-92-9

citric acid

yes

no

44160

140

44640

0000077-93-0

citric acid, triethyl ester

yes

no

(32)

141

13380

0000077-99-6

1,1,1-trimethylolpropane

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

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

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

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

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

no

76320

159

74560

0000085-68-7

phthalic acid, benzyl butyl ester

yes

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

162

65520

0000087-78-5

mannitol

yes

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

0,05

Only for use in PET for water and beverages

165

23200

0000088-99-3

o-phthalic acid

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

172

37840

0000093-89-0

benzoic acid, ethyl ester

yes

no

173

60240

0000094-13-3

4-hydroxybenzoic acid, propyl ester

yes

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

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

(3)

196

18670

0000100-97-0

hexamethylenetetramine

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

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

no

(4)

41840

213

82400

0000105-62-4

1,2-propyleneglycol dioleate

yes

no

214

61840

0000106-14-9

12-hydroxystearic acid

yes

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

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

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

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

239

19975

0000108-78-1

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

yes

no

30

25420

93720

240

45760

0000108-91-8

cyclohexylamine

yes

no

241

22960

0000108-95-2

phenol

no

yes

no

242

85360

0000109-43-3

sebacic acid, dibutyl ester

yes

no

(32)

243

19060

0000109-53-5

isobutyl vinyl ether

no

yes

no

0,05

(10)

244

71720

0000109-66-0

pentane

yes

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

no

90960

248

19540

0000110-16-7

maleic acid

yes

no

(3)

64800

249

17290

0000110-17-8

fumaric acid

yes

no

55120

250

53520

0000110-30-5

N,N′-ethylenebisstearamide

yes

no

251

53360

0000110-31-6

N,N′-ethylenebisoleamide

yes

no

252

87200

0000110-44-1

sorbic acid

yes

no

253

15250

0000110-60-1

1,4-diaminobutane

no

yes

no

254

13720

0000110-63-4

1,4-butanediol

yes

no

(30)

40580

255

25900

0000110-88-3

trioxane

no

yes

no

5

256

18010

0000110-94-1

glutaric acid

yes

no

55680

257

13550

0000110-98-5

dipropyleneglycol

yes

no

16660

51760

258

70480

0000111-06-8

palmitic acid, butyl ester

yes

no

259

58720

0000111-14-8

heptanoic acid

yes

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

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

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

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

no

92350

270

22763

0000112-80-1

oleic acid

yes

no

69040

271

52720

0000112-84-5

erucamide

yes

no

272

37040

0000112-85-6

behenic acid

yes

no

273

52730

0000112-86-7

erucic acid

yes

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

no

71600

280

73720

0000115-96-8

phosphoric acid, trichloroethyl ester

yes

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

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

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

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

(20)

291

19150

0000121-91-5

isophthalic acid

no

yes

no

(27)

292

94560

0000122-20-3

triisopropanolamine

yes

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

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

300

30045

0000123-86-4

acetic acid, butyl ester

yes

no

301

89120

0000123-95-5

stearic acid, butyl ester

yes

no

302

12820

0000123-99-9

azelaic acid

no

yes

no

303

12130

0000124-04-9

adipic acid

yes

no

31730

304

14320

0000124-07-2

caprylic acid

yes

no

41960

305

15274

0000124-09-4

hexamethylenediamine

no

yes

no

2,4

18460

306

88960

0000124-26-5

stearamide

yes

no

307

42160

0000124-38-9

carbon dioxide

yes

no

308

91200

0000126-13-6

sucrose acetate isobutyrate

yes

no

309

91360

0000126-14-7

sucrose octaacetate

yes

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

no

51200

312

21490

0000126-98-7

methacrylonitrile

no

yes

no

ND

313

16650

0000127-63-9

diphenyl sulphone

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

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

(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

321

36080

0000137-66-6

ascorbyl palmitate

yes

no

322

63040

0000138-22-7

lactic acid, butyl ester

yes

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

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

328

65040

0000141-82-2

malonic acid

yes

no

329

59360

0000142-62-1

hexanoic acid

yes

no

330

19470

0000143-07-7

lauric acid

yes

no

63280

331

22480

0000143-08-8

1-nonanol

no

yes

no

332

69760

0000143-28-2

oleyl alcohol

yes

no

333

22775

0000144-62-7

oxalic acid

yes

no

6

69920

334

17005

0000151-56-4

ethyleneimine

no

yes

no

ND

335

68960

0000301-02-0

oleamide

yes

no

336

15095

0000334-48-5

n-decanoic acid

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

339

86160

0000409-21-2

silicon carbide

yes

no

340

47440

0000461-58-5

dicyanodiamide

yes

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

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

no

67891

349

25550

0000552-30-7

trimellitic anhydride

no

yes

no

(21)

350

63920

0000557-59-5

lignoceric acid

yes

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

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

no

(8)

48720

360

57920

0000620-67-7

glycerol triheptanoate

yes

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

376

66905

0000872-50-4

N-methylpyrrolidone

yes

no

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

(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

(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

394

41280

0001305-62-0

calcium hydroxide

yes

no

395

41520

0001305-78-8

calcium oxide

yes

no

396

64640

0001309-42-8

magnesium hydroxide

yes

no

397

64720

0001309-48-4

magnesium oxide

yes

no

398

35760

0001309-64-4

antimony trioxide

yes

no

0,04

SML expressed as antimony

(6)

399

81600

0001310-58-3

potassium hydroxide

yes

no

400

86720

0001310-73-2

sodium hydroxide

yes

no

401

24475

0001313-82-2

sodium sulphide

no

yes

no

402

96240

0001314-13-2

zinc oxide

yes

no

403

96320

0001314-98-3

zinc sulphide

yes

no

404

67200

0001317-33-5

molybdenum disulphide

yes

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

407

87040

0001330-43-4

sodium tetraborate

yes

no

(16)

408

82960

0001330-80-9

1,2-propyleneglycol monooleate

yes

no

409

62240

0001332-37-2

iron oxide

yes

no

410

62720

0001332-58-7

kaolin

yes

no

411

42080

0001333-86-4

carbon black

yes

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

(6)

413

35600

0001336-21-6

ammonium hydroxide

yes

no

414

87600

0001338-39-2

sorbitan monolaurate

yes

no

415

87840

0001338-41-6

sorbitan monostearate

yes

no

416

87680

0001338-43-8

sorbitan monooleate

yes

no

417

85680

0001343-98-2

silicic acid

yes

no

418

34720

0001344-28-1

aluminium oxide

yes

no

419

92150

0001401-55-4

tannic acids

yes

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

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)

438

38875

0002162-74-5

bis(2,6-diisopropylphenyl) carbodiimide

yes

no

0,05

For indirect food contact only, behind a PET layer

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

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

(12)

445

83440

0002466-09-3

pyrophosphoric acid

yes

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

0,5

Only to be used in aqueous polymer dispersions and emulsions

452

38885

0002725-22-6

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

yes

no

0,05

Only to be used in aqueous foods

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

459

46870

0003135-18-0

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

yes

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

466

50640

0003648-18-8

di-n-octyltin dilaurate

yes

no

(10)

467

14800

0003724-65-0

crotonic acid

yes

no

0,05

(1)

45600

468

71960

0003825-26-1

perfluorooctanoic acid, ammonium salt

yes

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

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

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

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

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

487

45640

0005232-99-5

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

yes

no

0,05

488

53440

0005518-18-3

N,N′-ethylenebispalmitamide

yes

no

489

41040

0005743-36-2

calcium butyrate

yes

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

492

45650

0006197-30-4

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

yes

no

0,05

493

39200

0006200-40-4

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

yes

no

1,8

494

62140

0006303-21-5

hypophosphorous acid

yes

no

495

35160

0006642-31-5

6-amino-1,3-dimethyluracil

yes

no

5

496

71680

0006683-19-8

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

yes

no

497

95020

0006846-50-0

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

yes

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

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

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

504

86240

0007631-86-9

silicon dioxide

yes

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

(19)

506

86920

0007632-00-0

sodium nitrite

yes

no

0,6

507

59990

0007647-01-0

hydrochloric acid

yes

no

508

86560

0007647-15-6

sodium bromide

yes

no

509

23170

0007664-38-2

phosphoric acid

yes

no

72640

510

12789

0007664-41-7

ammonia

yes

no

35320

511

91920

0007664-93-9

sulphuric acid

yes

no

512

81680

0007681-11-0

potassium iodide

yes

no

(6)

513

86800

0007681-82-5

sodium iodide

yes

no

(6)

514

91840

0007704-34-9

sulphur

yes

no

515

26360

0007732-18-5

water

yes

no

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

95855

516

86960

0007757-83-7

sodium sulphite

yes

no

(19)

517

81520

0007758-02-3

potassium bromide

yes

no

518

35845

0007771-44-0

arachidonic acid

yes

no

519

87120

0007772-98-7

sodium thiosulphate

yes

no

(19)

520

65120

0007773-01-5

manganese chloride

yes

no

521

58320

0007782-42-5

graphite

yes

no

522

14530

0007782-50-5

chlorine

no

yes

no

523

45195

0007787-70-4

copper bromide

yes

no

524

24520

0008001-22-7

soybean oil

no

yes

no

525

62640

0008001-39-6

japan wax

yes

no

526

43440

0008001-75-0

ceresin

yes

no

527

14411

0008001-79-4

castor oil

yes

no

42880

528

63760

0008002-43-5

lecithin

yes

no

529

67850

0008002-53-7

montan wax

yes

no

530

41760

0008006-44-8

candelilla wax

yes

no

531

36880

0008012-89-3

beeswax

yes

no

532

88640

0008013-07-8

soybean oil, epoxidised

yes

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

534

80720

0008017-16-1

polyphosphoric acids

yes

no

535

24100

0008050-09-7

rosin

yes

no

24130

24190

83840

536

84320

0008050-15-5

rosin, hydrogenated, ester with methanol

yes

no

537

84080

0008050-26-8

rosin, ester with pentaerythritol

yes

no

538

84000

0008050-31-5

rosin, ester with glycerol

yes

no

539

24160

0008052-10-6

rosin tall oil

no

yes

no

540

63940

0008062-15-5

lignosulphonic acid

yes

no

0,24

Only to be used as dispersant for plastics dispersions

541

58480

0009000-01-5

gum arabic

yes

no

542

42640

0009000-11-7

carboxymethylcellulose

yes

no

543

45920

0009000-16-2

dammar

yes

no

544

58400

0009000-30-0

guar gum

yes

no

545

93680

0009000-65-1

tragacanth gum

yes

no

546

71440

0009000-69-5

pectin

yes

no

547

55440

0009000-70-8

gelatin

yes

no

548

42800

0009000-71-9

casein

yes

no

549

80000

0009002-88-4

polyethylene wax

yes

no

550

81060

0009003-07-0

polypropylene wax

yes

no

551

79920

0009003-11-6

0106392-12-5

poly(ethylene propylene) glycol

yes

no

552

81500

0009003-39-8

polyvinylpyrrolidone

yes

no

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

553

14500

0009004-34-6

cellulose

yes

no

43280

554

43300

0009004-36-8

cellulose acetate butyrate

yes

no

555

53280

0009004-57-3

ethylcellulose

yes

no

556

54260

0009004-58-4

ethylhydroxyethylcellulose

yes

no

557

66640

0009004-59-5

methylethylcellulose

yes

no

558

60560

0009004-62-0

hydroxyethylcellulose

yes

no

559

61680

0009004-64-2

hydroxypropylcellulose

yes

no

560

66700

0009004-65-3

methylhydroxypropylcellulose

yes

no

561

66240

0009004-67-5

methylcellulose

yes

no

562

22450

0009004-70-0

nitrocellulose

no

yes

no

563

78320

0009004-97-1

polyethyleneglycol monoricinoleate

yes

no

yes

42

564

24540

0009005-25-8

starch, edible

yes

no

88800

565

61120

0009005-27-0

hydroxyethyl starch

yes

no

566

33350

0009005-32-7

alginic acid

yes

no

567

82080

0009005-37-2

1,2-propyleneglycol alginate

yes

no

568

79040

0009005-64-5

polyethyleneglycol sorbitan monolaurate

yes

no

569

79120

0009005-65-6

polyethyleneglycol sorbitan monooleate

yes

no

570

79200

0009005-66-7

polyethyleneglycol sorbitan monopalmitate

yes

no

571

79280

0009005-67-8

polyethyleneglycol sorbitan monostearate

yes

no

572

79360

0009005-70-3

polyethyleneglycol sorbitan trioleate

yes

no

573

79440

0009005-71-4

polyethyleneglycol sorbitan tristearate

yes

no

574

24250

0009006-04-6

rubber, natural

yes

no

84560

575

76721

0063148-62-9

polydimethylsiloxane (Mw > 6 800 Da)

yes

no

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

576

60880

0009032-42-2

hydroxyethylmethylcellulose

yes

no

577

62280

0009044-17-1

isobutylene-butene copolymer

yes

no

578

79600

0009046-01-9

polyethyleneglycol tridecyl ether phosphate

yes

no

5

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

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

579

61800

0009049-76-7

hydroxypropyl starch

yes

no

580

46070

0010016-20-3

α-dextrin

yes

no

581

36800

0010022-31-8

barium nitrate

yes

no

582

50240

0010039-33-5

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

yes

no

(10)

583

40400

0010043-11-5

boron nitride

yes

no

(16)

584

13620

0010043-35-3

boric acid

yes

no

(16)

40320

585

41120

0010043-52-4

calcium chloride

yes

no

586

65280

0010043-84-2

manganese hypophosphite

yes

no

587

68400

0010094-45-8

octadecylerucamide

yes

no

yes

5

588

64320

0010377-51-2

lithium iodide

yes

no

(6)

589

52645

0010436-08-5

cis-11-eicosenamide

yes

no

590

21370

0010595-80-9

methacrylic acid, 2-sulphoethyl ester

no

yes

no

ND

(1)

591

36160

0010605-09-1

ascorbyl stearate

yes

no

592

34690

0011097-59-9

aluminium magnesium carbonate hydroxide

yes

no

593

44960

0011104-61-3

cobalt oxide

yes

no

594

65360

0011129-60-5

manganese oxide

yes

no

595

19510

0011132-73-3

lignocellulose

no

yes

no

596

95935

0011138-66-2

xanthan gum

yes

no

597

67120

0012001-26-2

mica

yes

no

598

41600

0012004-14-7

0037293-22-4

calcium sulphoaluminate

yes

no

599

36840

0012007-55-5

barium tetraborate

yes

no

(16)

600

60030

0012072-90-1

hydromagnesite

yes

no

601

35440

0012124-97-9

ammonium bromide

yes

no

602

70240

0012198-93-5

ozokerite

yes

no

603

83460

0012269-78-2

pyrophyllite

yes

no

604

60080

0012304-65-3

hydrotalcite

yes

no

605

11005

0012542-30-2

acrylic acid, dicyclopentenyl ester

no

yes

no

0,05

(1)

606

65200

0012626-88-9

manganese hydroxide

yes

no

607

62245

0012751-22-3

iron phosphide

yes

no

Only to be used in PET polymers and copolymers

608

40800

0013003-12-8

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

yes

no

yes

6

609

83455

0013445-56-2

pyrophosphorous acid

yes

no

610

93440

0013463-67-7

titanium dioxide

yes

no

611

35120

0013560-49-1

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

yes

no

612

16694

0013811-50-2

N,N′-divinyl-2-imidazolidinone

no

yes

no

0,05

(10)

613

95905

0013983-17-0

wollastonite

yes

no

614

45560

0014464-46-1

cristobalite

yes

no

615

92080

0014807-96-6

talc

yes

no

616

83470

0014808-60-7

quartz

yes

no

617

10660

0015214-89-8

2-acrylamido-2-methylpropanesulphonic acid

no

yes

no

0,05

618

51040

0015535-79-2

di-n-octyltin mercaptoacetate

yes

no

(10)

619

50320

0015571-58-1

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

yes

no

(10)

620

50720

0015571-60-5

di-n-octyltin dimaleate

yes

no

(10)

621

17110

0016219-75-3

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

no

yes

no

0,05

(9)

622

69840

0016260-09-6

oleylpalmitamide

yes

no

yes

5

623

52640

0016389-88-1

dolomite

yes

no

624

18897

0016712-64-4

6-hydroxy-2-naphthalenecarboxylic acid

no

yes

no

0,05

625

36720

0017194-00-2

barium hydroxide

yes

no

626

57800

0018641-57-1

glycerol tribehenate

yes

no

627

59760

0019569-21-2

huntite

yes

no

628

96190

0020427-58-1

zinc hydroxide

yes

no

629

34560

0021645-51-2

aluminium hydroxide

yes

no

630

82240

0022788-19-8

1,2-propyleneglycol dilaurate

yes

no

631

59120

0023128-74-7

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

yes

no

yes

45

632

52880

0023676-09-7

4-ethoxybenzoic acid, ethyl ester

yes

no

3,6

633

53200

0023949-66-8

2-ethoxy-2′-ethyloxanilide

yes

no

yes

30

634

25910

0024800-44-0

tripropyleneglycol

no

yes

no

635

40720

0025013-16-5

tert-butyl-4-hydroxyanisole

yes

no

30

636

31500

0025134-51-4

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

yes

no

0,05

(22)

SML expressed as acrylic acid, 2-ethylhexyl ester

637

71635

0025151-96-6

pentaerythritol dioleate

yes

no

0,05

Not to be used for articles in contact with fatty foods for which simulant D is laid down

638

23590

0025322-68-3

polyethyleneglycol

yes

no

76960

639

23651

0025322-69-4

polypropyleneglycol

yes

no

80800

640

54930

0025359-91-5

formaldehyde-1-naphthol, copolymer

yes

no

0,05

641

22331

0025513-64-8

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

no

yes

no

0,05

(10)

642

64990

0025736-61-2

maleic anhydride-styrene, copolymer, sodium salt

yes

no

The fraction with molecular weight below 1 000 Da should not exceed 0,05 % (w/w)

643

87760

0026266-57-9

sorbitan monopalmitate

yes

no

644

88080

0026266-58-0

sorbitan trioleate

yes

no

645

67760

0026401-86-5

mono-n-octyltin tris(isooctyl mercaptoacetate)

yes

no

(11)

646

50480

0026401-97-8

di-n-octyltin bis(isooctyl mercaptoacetate)

yes

no

(10)

647

56720

0026402-23-3

glycerol monohexanoate

yes

no

648

56880

0026402-26-6

glycerol monooctanoate

yes

no

649

47210

0026427-07-6

dibutylthiostannoic acid polymer

yes

no

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

650

49600

0026636-01-1

dimethyltin bis(isooctyl mercaptoacetate)

yes

no

(9)

651

88240

0026658-19-5

sorbitan tristearate

yes

no

652

38820

0026741-53-7

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

yes

no

yes

0,6

653

25270

0026747-90-0

2,4-toluene diisocyanate dimer

no

yes

no

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

654

88600

0026836-47-5

sorbitol monostearate

yes

no

655

25450

0026896-48-0

tricyclodecanedimethanol

no

yes

no

0,05

656

24760

0026914-43-2

styrenesuphonic acid

no

yes

no

0,05

657

67680

0027107-89-7

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

yes

no

(11)

658

52000

0027176-87-0

dodecylbenzenesulphonic acid

yes

no

30

659

82800

0027194-74-7

1,2-propyleneglycol monolaurate

yes

no

660

47540

0027458-90-8

di-tert-dodecyl disulphide

yes

no

yes

0,05

661

95360

0027676-62-6

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

yes

no

yes

5

662

25927

0027955-94-8

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

no

yes

no

0,005

Only to be used in polycarbonates

(1)

663

64150

0028290-79-1

linolenic acid

yes

no

664

95000

0028931-67-1

trimethylolpropane trimethacrylate-methyl methacrylate copolymer

yes

no

665

83120

0029013-28-3

1,2-propyleneglycol monopalmitate

yes

no

666

87280

0029116-98-1

sorbitan dioleate

yes

no

667

55190

0029204-02-2

gadoleic acid

yes

no

668

80240

0029894-35-7

polyglycerol ricinoleate

yes

no

669

56610

0030233-64-8

glycerol monobehenate

yes

no

670

56800

0030899-62-8

glycerol monolaurate diacetate

yes

no

(32)

671

74240

0031570-04-4

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

yes

no

672

76845

0031831-53-5

polyester of 1,4-butanediol with caprolactone

yes

no

(29)

(30)

The fraction with molecular weight below 1 000 Da should not exceed 0,5 % (w/w)

673

53670

0032509-66-3

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

yes

no

yes

6

674

46480

0032647-67-9

dibenzylidene sorbitol

yes

no

675

38800

0032687-78-8

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

yes

no

yes

15

676

50400

0033568-99-9

di-n-octyltin bis(isooctyl maleate)

yes

no

(10)

677

82560

0033587-20-1

1,2-propyleneglycol dipalmitate

yes

no

678

59200

0035074-77-2

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

yes

no

yes

6

679

39060

0035958-30-6

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

yes

no

yes

5

680

94400

0036443-68-2

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

yes

no

9

681

18310

0036653-82-4

1-hexadecanol

no

yes

no

682

53270

0037205-99-5

ethylcarboxymethylcellulose

yes

no

683

66200

0037206-01-2

methylcarboxymethylcellulose

yes

no

684

68125

0037244-96-5

nepheline syenite

yes

no

685

85950

0037296-97-2

silicic acid, magnesium-sodium-fluoride salt

yes

no

0,15

SML expressed as fluoride.

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

686

61390

0037353-59-6

hydroxymethylcellulose

yes

no

687

13530

0038103-06-9

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

no

yes

no

0,05

13614

688

92560

0038613-77-3

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

yes

no

yes

18

689

95280

0040601-76-1

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

yes

no

yes

6

690

92880

0041484-35-9

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

yes

no

yes

2,4

691

13600

0047465-97-4

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

no

yes

no

1,8

692

52320

0052047-59-3

2-(4-dodecylphenyl)indole

yes

no

yes

0,06

693

88160

0054140-20-4

sorbitan tripalmitate

yes

no

694

21400

0054276-35-6

methacrylic acid, sulphopropyl ester

no

yes

no

0,05

(1)

695

67520

0054849-38-6

monomethyltin tris(isooctyl mercaptoacetate)

yes

no

(9)

696

92205

0057569-40-1

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

yes

no

697

67515

0057583-34-3

monomethyltin tris(ethylhexyl mercaptoacetate)

yes

no

(9)

698

49595

0057583-35-4

dimethyltin bis(ethylhexyl mercaptoacetate)

yes

no

(9)

699

90720

0058446-52-9

stearoylbenzoylmethane

yes

no

700

31520

0061167-58-6

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

yes

no

yes

6

701

40160

0061269-61-2

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

yes

no

2,4

702

87920

0061752-68-9

sorbitan tetrastearate

yes

no

703

17170

0061788-47-4

fatty acids, coco

no

yes

no

704

77600

0061788-85-0

polyethyleneglycol ester of hydrogenated castor oil

yes

no

705

10599/90A

0061788-89-4

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

no

yes

no

(18)

(1)

10599/91

706

17230

0061790-12-3

fatty acids, tall oil

no

yes

no

707

46375

0061790-53-2

diatomaceous earth

yes

no

708

77520

0061791-12-6

polyethyleneglycol ester of castor oil

yes

no

42

709

87520

0062568-11-0

sorbitan monobehenate

yes

no

710

38700

0063397-60-4

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

yes

no

yes

18

711

42000

0063438-80-2

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

yes

no

yes

30

712

42960

0064147-40-6

castor oil, dehydrated

yes

no

713

43480

0064365-11-3

charcoal, activated

yes

no

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

Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Directive 95/45/EC (4) with exception of ash content which can be up to 10 % (w/w).

714

84400

0064365-17-9

rosin, hydrogenated, ester with pentaerythritol

yes

no

715

46880

0065140-91-2

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

yes

no

6

716

60800

0065447-77-0

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

yes

no

30

717

84210

0065997-06-0

rosin, hydrogenated

yes

no

718

84240

0065997-13-9

rosin, hydrogenated, ester with glycerol

yes

no

719

65920

0066822-60-4

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

yes

no

720

67360

0067649-65-4

mono-n-dodecyltin tris(isooctyl mercaptoacetate)

yes

no

(25)

721

46800

0067845-93-6

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

yes

no

722

17200

0068308-53-2

fatty acids, soya

no

yes

no

723

88880

0068412-29-3

starch, hydrolysed

yes

no

724

24903

0068425-17-2

syrups, hydrolysed starch, hydrogenated

no

yes

no

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

725

77895

0068439-49-6

polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether

yes

no

0,05

The composition of this mixture is as follows:

—

polyethyleneglycol (EO = 2-6)monoalkyl (C16-C18) ether (approximately 28 %),

—

fatty alcohols (C16-C18) (approximately 48 %),

—

ethyleneglycol monoalkyl (C16-C18) ether (approximately 24 %),

726

83599

0068442-12-6

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

yes

no

yes

(9)

727

43360

0068442-85-3

cellulose, regenerated

yes

no

728

75100

0068515-48-0

0028553-12-0

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

yes

no

(26)

(32)

Only to be used as:

(a)

plasticiser in repeated use materials and articles;

(b)

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

(c)

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

(7)

729

75105

0068515-49-1

0026761-40-0

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

yes

no

(26)

(32)

Only to be used as:

(a)

plasticiser in repeated use materials and articles;

(b)

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

(c)

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

(7)

730

66930

0068554-70-1

methylsilsesquioxane

yes

no

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

731

18220

0068564-88-5

N-heptylaminoundecanoic acid

no

yes

no

0,05

(2)

732

45450

0068610-51-5

p-cresol-dicyclopentadiene-isobutylene, copolymer

yes

no

yes

5

733

10599/92A

0068783-41-5

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

no

yes

no

(18)

(1)

10599/93

734

46380

0068855-54-9

diatomaceous earth, soda ash flux-calcined

yes

no

735

40120

0068951-50-8

bis(polyethyleneglycol)hydroxymethylphosphonate

yes

no

0,6

736

50960

0069226-44-4

di-n-octyltin ethyleneglycol bis(mercaptoacetate)

yes

no

(10)

737

77370

0070142-34-6

polyethyleneglycol-30 dipolyhydroxystearate

yes

no

738

60320

0070321-86-7

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

yes

no

yes

1,5

739

70000

0070331-94-1

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

yes

no

740

81200

0071878-19-8

poly[6-[(1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl) imino]

yes

no

yes

3

741

24070

0073138-82-6

resin acids and rosin acids

yes

no

83610

742

92700

0078301-43-6

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

yes

no

yes

5

743

38950

0079072-96-1

bis(4-ethylbenzylidene)sorbitol

yes

no

744

18888

0080181-31-3

3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer

no

yes

no

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

745

68145

0080410-33-9

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

yes

no

yes

5

SML expressed as sum of phosphite and phosphate

746

38810

0080693-00-1

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

yes

no

yes

5

SML expressed as sum of phosphite and phosphate

747

47600

0084030-61-5

di-n-dodecyltin bis(isooctyl mercaptoacetate)

yes

no

yes

(25)

748

12765

0084434-12-8

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

no

yes

no

0,05

749

66360

0085209-91-2

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

yes

no

yes

5

750

66350

0085209-93-4

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

yes

no

5

751

81515

0087189-25-1

poly(zinc glycerolate)

yes

no

752

39890

0087826-41 – 30069158-41 – 40054686-97 – 40081541-12-0

bis(methylbenzylidene)sorbitol

yes

no

753

62800

0092704-41-1

kaolin, calcined

yes

no

754

56020

0099880-64-5

glycerol dibehenate

yes

no

755

21765

0106246-33-7

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

no

yes

no

0,05

(1)

756

40020

0110553-27-0

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

yes

no

yes

(24)

757

95725

0110638-71-6

vermiculite, reaction product with citric acid, lithium salt

yes

no

758

38940

0110675-26-8

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

yes

no

yes

(24)

759

54300

0118337-09-0

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

yes

no

yes

6

760

83595

0119345-01-6

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

yes

no

18

Composition:

—

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

—

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

—

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

—

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

—

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

—

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

(*)

Quantity of substance used/quantity of formulation

Other specifications:

—

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

—

Acid value of max. 10 mg KOH per gram,

—

Melt range of 85– 110 °C,

761

92930

0120218-34-0

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

yes

no

6

762

31530

0123968-25-2

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

yes

no

yes

5

763

39925

0129228-21-3

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

yes

no

yes

0,05

764

13317

0132459-54-2

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

no

yes

no

0,05

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

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

765

49485

0134701-20-5

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

yes

no

yes

1

766

38879

0135861-56-2

bis(3,4-dimethylbenzylidene)sorbitol

yes

no

767

38510

0136504-96-6

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

yes

no

5

768

34850

0143925-92-2

amines, bis(hydrogenated tallow alkyl) oxidised

yes

no

Not to be used for articles in contact with fatty foods for which simulant D is laid down.

Only to be used in:

(a)

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

(b)

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

(1)

769

74010

0145650-60-8

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

yes

no

yes

5

SML expressed as sum of phosphite and phosphate

770

51700

0147315-50-2

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

yes

no

0,05

771

34650

0151841-65-5

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

yes

no

5

772

47500

0153250-52-3

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

yes

no

5

773

38840

0154862-43-8

bis(2,4-dicumylphenyl)pentaerythritol-diphosphite

yes

no

yes

5

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

774

95270

0161717-32-4

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

yes

no

yes

2

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

775

45705

0166412-78-8

1,2-cyclohexanedicarboxylic acid, diisononyl ester

yes

no

(32)

776

76723

0167883-16-1

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

yes

no

The fraction with molecular weight below 1 000 Da should not exceed 1,5 % (w/w)

777

31542

0174254-23-0

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

yes

no

0,5 % in final product

(1)

778

71670

0178671-58-4

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

yes

no

yes

0,05

779

39815

0182121-12-6

9,9-bis(methoxymethyl)fluorene

yes

no

yes

0,05

(1)

780

81220

0192268-64-7

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

yes

no

5

781

95265

0227099-60-7

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

yes

no

0,05

782

76725

0661476-41-1

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

yes

no

The fraction with molecular weight below 1 000 Da should not exceed 1 % (w/w)

783

55910

0736150-63-3

glycerides, castor-oil mono-, hydrogenated, acetates

yes

no

(32)

784

95420

0745070-61-5

1,3,5-tris (2,2-dimethylpropanamido)benzene

yes

no

0,05

785

24910

0000100-21-0

terephthalic acid

no

yes

no

(28)

786

14627

0000117-21-5

3-chlorophthalic anhydride

no

yes

no

0,05

SML expressed as 3-chlorophthalic acid

787

14628

0000118-45-6

4-chlorophthalic anhydride

no

yes

no

0,05

SML expressed as 4-chlorophthalic acid

788

21498

0002530-85-0

[3-(methacryloxy)propyl]trimethoxysilane

no

yes

no

0,05

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

(1)

(11)

789

60027

—

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

yes

no

Average molecular weight not less than 440 Da.

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

(2)

790

80480

0090751-07-8

0082451-48-7

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

yes

no

5

Average molecular weight not less than 2 400 Da.

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

(16)

791

92470

0106990-43-6

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

yes

no

0,05

792

92475

0203255-81-6

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

yes

no

yes

5

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

793

94000

0000102-71-6

triethanolamine

yes

no

0,05

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

794

18117

0000079-14-1

glycolic acid

no

yes

no

For indirect food contact only, behind a PET layer

795

40155

0124172-53-8

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

yes

no

0,05

(2)

(12)

796

72141

0018600-59-4

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

yes

no

yes

0,05

SML including the sum of its hydrolysis products

797

76807

0007328-26-5

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

yes

no

yes

(31)

(32)

798

92200

0006422-86-2

terephthalic acid, bis(2-ethylhexyl)ester

yes

no

60

(32)

799

77708

—

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

yes

no

1,8

In compliance with the purity criteria for ethylene oxide as laid down in Directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners (OJ L 253, 20.9.2008, p. 1)

800

94425

0000867-13-0

triethyl phosphonoacetate

yes

no

Only for use in PET

801

30607

—

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

yes

no

802

33105

0146340-15-0

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

yes

no

5

(12)

803

33535

0152261-33-1

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

yes

no

Not to be used for articles in contact with fatty foods for which simulant D is laid down.

Not to be used in contact with alcoholic foods.

(13)

804

80510

1010121-89-7

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

yes

no

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

805

93450

—

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

yes

no

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

806

14876

0001076-97-7

1,4-cyclohexanedicarboxylic acid

no

yes

no

5

Only to be used for manufacture of polyesters

807

93485

—

titanium nitride, nanoparticles

yes

no

No migration of titanium nitride nanoparticles.

Only to be used in PET bottles up to 20 mg/kg.

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

808

38550

0882073-43-0

bis(4-propylbenzylidene)propylsorbitol

yes

no

5

SML including the sum of its hydrolysis products

809

49080

0852282-89-4

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

yes

no

yes

0,05

Only for use in PET

(6)

(14)

(15)

810

68119

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

yes

no

5

(32)

Not to be used for articles in contact with fatty foods for which simulant D is laid down.

811

80077

0068441-17-8

polyethylene waxes, oxidised

yes

no

60

812

80350

0124578-12-7

poly(12-hydroxystearic acid)-polyethyleneimine copolymer

yes

no

Only to be used in polyethylene terephthalate (PET), polystyrene (PS), high impact polystyrene (HIPS) and polyamide (PA) up to 0,1 % w/w.

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

813

91530

—

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

yes

no

5

814

91815

—

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

yes

no

2

815

94985

—

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

yes

no

5

(32)

Not to be used for articles in contact with fatty foods for which simulant D is laid down

816

45704

—

cis-1,2-cyclohexanedicarboxylic acid, salts

yes

no

5

817

38507

—

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

yes

no

5

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

Purity ≥ 96 %.

818

21530

—

methallylsulphonic acid, salts

no

yes

no

5

819

68110

—

neodecanoic acid, salts

yes

no

0,05

Not to be used in polymers contacting fatty foods.

Not to be used for articles in contact with fatty foods for which simulant D is laid down.

SML expressed as neodecanoic acid.

820

76420

—

pimelic acid, salts

yes

no

821

90810

—

stearoyl-2-lactylic acid, salts

yes

no

822

71938

—

perchloric acid, salts

yes

no

0,05

(4)

823

24889

—

5-Sulphoisophthalic acid, salts

no

yes

no

5

854

71943

0329238-24-6

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

yes

no

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

860

71980

0051798-33-5

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

yes

no

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

861

71990

0013252-13-6

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

yes

no

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

862

15180

0018085-02-4

3,4-diacetoxy-1-butene

no

yes

no

0,05

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

Only for use as a co-monomer for ethyl vinyl alcohol copolymers.

864

46330

0000056-06-4

2,4-diamino-6-hydroxypyrimidine

yes

no

5

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

865

40619

0025322-99-0

(butyl acrylate, methyl methacrylate, butyl methacrylate) copolymer

yes

no

Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 1 %

866

40620

—

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

yes

no

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

867

40815

0040471-03-2

(butyl methacrylate, ethyl acrylate, methyl methacrylate) copolymer

yes

no

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

868

53245

0009010-88-2

(ethyl acrylate, methyl methacrylate) copolymer

yes

no

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

869

66763

0027136-15-8

(butyl acrylate, methyl methacrylate, styrene) copolymer

yes

no

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

870

95500

0160535-46-6

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

yes

no

5

875

80345

0058128-22-6

poly(12-hydroxystearic acid) stearate

yes

no

yes

5

878

31335

—

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

yes

no

879

31336

—

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

yes

no

880

31348

0085116-93-4

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

yes

no

881

25187

0003010-96-6

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

no

yes

no

5

Only for repeated use articles for long term storage at room temperature or below and hotfill

882

25872

0002416-94-6

2,3,6-trimethylphenol

no

yes

no

0,05

883

22074

0004457-71-0

3-methyl-1,5-pentanediol

no

yes

no

0,05

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

884

34240

0091082-17-6

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

yes

no

0,05

Not to be used for articles in contact with fatty foods for which simulant D is laid down.

885

45676

0263244-54-8

cyclic oligomers of (butylene terephthalate)

yes

no

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

2. Group restriction of substances

Table 2 on Group restrictions contains the following information:

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

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

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

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

Table 2

(1)

(2)

(3)

(4)

Group Restriction No

FCM substance No

SML (T)

[mg/kg]

Group restriction specification

1

128

211

6

expressed as acetaldehyde

2

89

227

263

30

expressed as ethyleneglycol

3

234

248

30

expressed as maleic acid

4

212

435

15

expressed as caprolactam

5

137

472

3

expressed as the sum of the substances

6

412

512

513

588

1

expressed as iodine

7

19

20

1,2

expressed as tertiary amine

8

317

318

319

359

431

464

6

expressed as the sum of the substances

9

650

695

697

698

726

0,18

expressed as tin

10

28

29

30

31

32

33

466

582

618

619

620

646

676

736

0,006

expressed as tin

11

66

645

657

1,2

expressed as tin

12

444

469

470

30

expressed as the sum of the substances

13

163

285

1,5

expressed as the sum of the substances

14

294

368

5

expressed as the sum of the substances

15

98

196

15

expressed as formaldehyde

16

407

583

584

599

6

expressed as boron

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

17

4

167

169

198

274

354

372

460

461

475

476

485

490

653

ND

expressed as isocyanate moiety

18

705

733

0,05

expressed as the sum of the substances

19

505

516

519

10

expressed as SO2

20

290

386

390

30

expressed as the sum of the substances

21

347

349

5

expressed as trimellitic acid

22

70

147

176

218

323

325

365

371

380

425

446

448

456

636

6

expressed as acrylic acid

23

150

156

181

183

184

355

370

374

439

440

447

457

482

6

expressed as methacrylic acid

24

756

758

5

expressed as the sum of the substances

25

720

747

0,05

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

26

728

729

9

expressed as the sum of the substances

27

188

291

5

expressed as isophthalic acid

28

191

192

785

7,5

expressed as terephthalic acid

29

342

672

0,05

expressed as the sum of 6-hydroxyhexanoic acid and caprolactone

30

254

672

5

expressed as 1,4-butanediol

31

73

797

30

expressed as the sum of the substances

32

8

72

73

138

140

157

159

207

242

283

532

670

728

729

775

783

797

798

810

815

60

expressed as the sum of the substances

3. Notes on verification of compliance

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

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

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

Table 3

(1)

(2)

Note No

Notes on verification of compliance

(1)

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

(2)

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

(3)

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

(4)

Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as simulant D.

(5)

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

(6)

Migration limit might be exceeded at very high temperature.

(7)

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

(8)

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

(9)

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

(10)

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

(11)

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

(12)

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

(13)

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

(14)

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

(15)

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

(16)

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

(17)

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

4. Detailed specification on substances

Table 4 on detailed specifications on substances contains the following information

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

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

Table 4

(1)

(2)

FCM substance No

Detailed specification on the substance

744

Definition

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

Chemical name

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

CAS number

0080181-31-3

Structural formula

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

Average molecular weight

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

Assay

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

Description

White to off-white powder after isolation

Characteristics

Identification tests:

Solubility

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

Restriction

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

Purity

Prior to granulation the raw material copolymer powder must contain:

—

nitrogen,

Not more than 2 500 mg/kg of plastic

—

zinc,

Not more than 100 mg/kg of plastic

—

copper,

Not more than 5 mg/kg of plastic

—

lead,

Not more than 2 mg/kg of plastic

—

arsenic,

Not more than 1 mg/kg of plastic

—

chromium,

Not more than 1 mg/kg of plastic

(1) OJ L 302, 19.11.2005, p. 28.

(2) OJ L 330, 5.12.1998, p. 32.

(3) OJ L 253, 20.9.2008, p. 1.

(4) OJ L 226, 22.9.1995, p. 1.

(5) OJ L 158, 18.6.2008, p. 17.

ANNEX II

Restrictions on materials and articles

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

Barium = 1 mg/kg food or food simulant.

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

Copper = 5 mg/kg food or food simulant.

Iron = 48 mg/kg food or food simulant.

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

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

Zinc = 25 mg/kg food or food simulant.

2. Plastic materials and articles shall not release primary aromatic amines, excluding those appearing in Table 1 of Annex I, in a detectable quantity into food or food simulant. The detection limit is 0,01 mg of substance per kg of food or food simulant. The detection limit applies to the sum of primary aromatic amines released.

ANNEX III

Food simulants

1. Food simulants

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

Table 1

List of food simulants

Food simulant

Abbreviation

Ethanol 10 % (v/v)

Food simulant A

Acetic acid 3 % (w/v)

Food simulant B

Ethanol 20 % (v/v)

Food simulant C

Ethanol 50 % (v/v)

Food simulant D1

Vegetable oil (1)

Food simulant D2

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

Food simulant E

2. General assignment of food simulants to foods

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

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

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

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

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

For testing overall migration from materials and articles intended to come into contact with different food categories or a combination of food categories the food simulant assignment in point 4 is applicable.

Table 2 contains the following information:

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

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

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

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

For food categories where in sub-column D2 the cross is followed by an oblique stroke and a figure, the migration test result shall be divided by this figure before comparing the result with the migration limit. The figure is the correction factor referred to in point 4.2 of Annex V to this Regulation.

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

For food categories where in sub-column B the cross is followed by (*) the testing in food simulant B can be omitted if the food has a pH of more than 4.5.

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

Table 2

food category specific assignment of food simulants

(1)

(2)

(3)

Reference number

Description of food

Food simulants

A

B

C

D1

D2

E

01

Beverages

01.01

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

A.

Clear drinks:

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

X(*)

X

B.

cloudy drinks:

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

X(*)

X

01.02

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

X

01.03

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

X

01.04

Miscellaneous: undenaturated ethyl alcohol

X(*)

Substitute 95 % ethanol

02

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

02.01

Starches

X

02.02

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

X

02.03

Cereal flour and meal

X

02.04

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

X

02.05

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

A.

With fatty substances on the surface

X/3

B.

Other

X

02.06

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

A.

With fatty substances on the surface

X/3

B.

Other

X

03

Chocolate, sugar and products thereof

Confectionery products

03.01

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

X/3

03.02

Confectionery products:

A.

In solid form:

I.

With fatty substances on the surface

X/3

II.

Other

X

B.

In paste form:

I.

With fatty substances on the surface

X/2

II.

Moist

X

03.03

Sugar and sugar products

A.

In solid form: crystal or powder

X

B.

Molasses, sugar syrups, honey and the like

X

04

Fruit, vegetables and products thereof

04.01

Whole fruit, fresh or chilled, unpeeled

04.02

Processed fruit:

A.

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

X

B.

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

X(*)

X

C.

Fruit preserved in a liquid medium:

I.

In an oily medium

X

II.

In an alcoholic medium

X

04.03

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

A.

Shelled, dried, flaked or powdered

X

B.

Shelled and roasted

X

C.

In paste or cream form

X

04.04

Whole vegetables, fresh or chilled, unpeeled

04.05

Processed vegetables:

A.

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

X

B.

Fresh vegetables, peeled or cut

X

C.

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

X(*)

X

D.

Preserved vegetables:

I.

In an oily medium

X

II.

In an alcoholic medium

X

05

Fats and oils

05.01

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

X

05.02

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

X/2

06

Animal products and eggs

06.01

Fish:

A.

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

X

X/3(**)

B.

Preserved fish:

I.

In an oily medium

X

II.

In an aqueous medium

X(*)

X

06.02

Crustaceans and molluscs (including oysters, mussels, snails)

A.

Fresh within the shell

B.

Shell removed, processed, preserved or cooked with the shell

I.

In an oily medium

X

II.

In an aqueous medium

X(*)

X

06.03

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

A.

Fresh, chilled, salted, smoked

X

X/4(**)

B.

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

X

X/4(**)

C.

Marinated meat products in an oily medium

X

06.04

Preserved meat:

A.

In an fatty or oily medium

X

X/3

B.

In an aqueous medium

X(*)

X

06.05

Whole eggs, egg yolk, egg white

A.

Powdered or dried or frozen

X

B.

Liquid and cooked

X

07

Milk products

07.01

Milk

A.

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

X

B.

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

X

07.02

Fermented milk such as yoghurt, buttermilk and similar products

X(*)

X

07.03

Cream and sour cream

X(*)

X

07.04

Cheeses:

A.

Whole, with not edible rind

X

B.

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

X/3(**)

C.

Processed cheese (soft cheese, cottage cheese and similar)

X(*)

X

D.

Preserved cheese:

I.

In an oily medium

X

II.

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

X(*)

X

08

Miscellaneous products

08.01

Vinegar

X

08.02

Fried or roasted foods:

A.

Fried potatoes, fritters and the like

X

X/5

B.

Of animal origin

X

X/4

08.03

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

A.

Powdered or dried:

I.

With fatty character

X/5

II.

Other

X

B.

any other form than powdered or dried:

I.

With fatty character

X

X(*)

X/3

II.

Other

X(*)

X

08.04

Sauces:

A.

With aqueous character

X(*)

X

B.

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

X

X(*)

X

08.05

Mustard (except powdered mustard under heading 08.14)

X

X(*)

X/3(**)

08.06

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

A.

With fatty substances on the surface

X

X/5

B.

Other

X

08.07

Ice-creams

X

08.08

Dried foods:

A.

With fatty substances on the surface

X/5

B.

Other

X

08.09

Frozen or deep-frozen foods

X

08.10

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

X(*)

X

08.11

Cocoa:

A.

Cocoa powder, including fat-reduced and highly fat reduced

X

B.

Cocoa paste

X/3

08.12

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

X

08.13

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

X

08.14

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

X

08.15

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

X

4. Food simulant assignment for testing overall migration

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

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

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

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

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

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

(1) This may be any vegetable oil with a fatty acid distribution of

No of carbon atoms in fatty acid chain: No of unsaturation

6-12

14

16

18:0

18:1

18:2

18:3

Range of fatty acid composition expressed % (w/w) of methyl esters by Gas chromatography

< 1

1,5-20

< 7

15-85

5-70

< 1,5

ANNEX IV

Declaration of compliance

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

(1)

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

(2)

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

(3)

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

(4)

the date of the declaration;

(5)

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

(6)

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

(7)

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

(8)

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

(i)

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

(ii)

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

(iii)

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

(9)

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

ANNEX V

COMPLIANCE TESTING

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

CHAPTER 1

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

1.1. Sample preparation

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

1.2. Conditions of testing

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

1.3. Analysis of migrated substances

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

1.4. Special cases

When contamination occurs from sources other than food contact materials this has to be taken into account when testing for compliance of the food contact materials, in particular for phthalates (FCM substance 157, 159, 283, 728, 729) referred to in Annex I.

CHAPTER 2

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

2.1. Verification method

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

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

2.1.1. Sample preparation

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

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

2.1.2. Choice of food simulant

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

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

2.1.3. Conditions of contact when using food simulants

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

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

Table 1

Contact time

Contact time in worst foreseeable use

Test time

t ≤ 5 min

5 min

5 min < t ≤ 0,5 hour

0,5 hour

0,5 hours < t ≤ 1 hour

1 hour

1 hour < t ≤ 2 hours

2 hours

2 hours < t ≤ 6 hours

6 hours

6 hours < t ≤ 24 hours

24 hours

1 day < t ≤ 3 days

3 days

3 days < t ≤ 30 days

10 days

Above 30 days

See specific conditions

Table 2

Contact temperature

Conditions of contact in worst foreseeable use

Test conditions

Contact temperature

Test temperature

T ≤ 5 °C

5 °C

5 °C < T ≤ 20 °C

20 °C

20 °C < T ≤ 40 °C

40 °C

40 °C < T ≤ 70 °C

70 °C

70 °C < T ≤ 100 °C

100 °C or reflux temperature

100 °C < T ≤ 121 °C

121 °C (1)

121 °C < T ≤ 130 °C

130 °C (1)

130 °C < T ≤ 150 °C

150 °C (1)

150 °C < T < 175 °C

175 °C (1)

T > 175 °C

Adjust the temperature to the real temperature at the interface with the food (1)

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

For contact times above 30 days at room temperature and below the specimen shall be tested in an accelerated test at elevated temperature for a maximum of 10 days at 60 °C. Testing time and temperature conditions shall be based on the following formula.

t2 = t1 * Exp ((-Ea/R) * (1/T1-1/T2))

Ea is the worst case activation energy 80kJ/mol

R is a factor 8,31 J/Kelvin/mol

Exp -9627 * (1/T1-1/T2)

t1 is the contact time

t2 is the testing time

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

T2 is the testing temperature in Kelvin.

Testing for 10 days at 20 °C shall cover all storage times at frozen condition.

Testing for 10 days at 40 °C shall cover all storage times at refrigerated and frozen conditions including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes.

Testing for 10 days at 50 °C shall cover all storage time at refrigerated and frozen conditions including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes and storage times of up to 6 months at room temperature.

Testing for 10 days at 60 °C shall cover long term storage above 6 months at room temperature and below including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes.

The maximum testing temperature is governed by the phase transition temperature of the polymer. At the test temperature the test specimen should not undergo any physical changes.

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

2.1.5. Specific conditions for combinations of contact times and temperature

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

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

2.1.6. Repeated use articles

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

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

The material or article shall respect the specific migration limit already in the first test for substances for which in Annex I Table 1 column 8 or Table 2 column 3 the specific migration limit is set as non-detectable and for non-listed substances used behind a plastic functional barrier covered by the rules of point (b) of Articles 13(2) which should not migrate in detectable amounts.

2.1.7. Analysis of migrating substances

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

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

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

2.2. Screening approaches

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

2.2.1. Replacing specific migration by overall migration

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

2.2.2. Residual content

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

2.2.3. Migration modelling

To screen for specific migration the migration potential can be calculated based on the residual content of the substance in the material or article applying generally recognised diffusion models based on scientific evidence that are constructed such as to overestimate real migration.

2.2.4. Food simulant substitutes

To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants overestimate migration compared to the regulated food simulants.

CHAPTER 3

Testing for overall migration

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

3.1. Standardised testing conditions

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

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

Table 3

Standardised testing conditions

Column 1

Column 2

Column 3

Test number

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

Intended food contact conditions

OM1

10 d at 20 °C

Any food contact at frozen and refrigerated conditions.

OM2

10 d at 40 °C

Any long term storage at room temperature or below, including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes.

OM3

2 h at 70 °C

Any contact conditions that include heating up to 70 °C for up to 2 hours, or up to 100 °C for up to 15 minutes, which are not followed by long term room or refrigerated temperature storage.

OM4

1 h at 100 °C

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

OM5

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

High temperature applications up to 121 °C.

OM6

4 h at 100 °C or at reflux

Any food contact conditions with food simulants A, B or C, at temperature exceeding 40 °C.

OM7

2 h at 175 °C

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

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

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

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

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

3.2. Substitute test for OM7 with food simulant D2

In case it is technically NOT feasible to perform OM7 with food simulant D2 the test can be replaced by test OM 8 or OM9. Both test conditions described under the respective test shall be performed with a new test sample.

Test number

Test conditions

Intended food contact conditions

Covers the intended food contact conditions described in

OM 8

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

High temperature applications only

OM1, OM3, OM4, OM5, and OM6

OM 9

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

High temperature applications including long term storage at room temperature

OM1, OM2, OM3, OM4, OM5 and OM6

3.3. Repeated use articles

Where a material or article is intended to come into repeated contact with foods, the migration test shall be carried out three times on a single sample using another sample of the food simulant on each occasion.

Its compliance shall be checked on the basis of the level of the migration found in the third test. However, if there is conclusive proof that the level of the migration does not increase in the second and third tests and if the overall migration limit is not exceeded on the first test, no further test is necessary.

3.4. Screening approaches

To screen if a material or article complies with the migration limits any of the following approaches can be applied which are considered more severe than the verification method described in sections 3.1. and 3.2.

3.4.1. Residual content

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

3.4.2. Food simulant substitutes

To screen for overall migration food simulants can be replaced if based on scientific evidence the substitute food simulants overestimate migration compared to the regulated food simulants.

CHAPTER 4

Correction factors applied when comparing migration test results with migration limits

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

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

The FRF shall be applied according to the following rules.

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

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

(a)

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

(b)

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

The application of the FRF shall not lead to a specific migration exceeding the overall migration limit.

4.2. Correction of migration into food simulant D2

For the food categories where in sub-column D2 of column 3 of Table 2 of Annex III the cross is followed by a figure the migration test result into food simulant D2 shall be divided by this figure.

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

The correction is not applicable to the specific migration for substances in the Union list in Annex I for which the specific migration limit in column 8 is ‘not detectable’ and for non-listed substances used behind a plastic functional barrier covered by the rules of Article 13(2)(b) which should not migrate in detectable amounts.

4.3. Combination of correction factors 4.1 and 4.2.

The correction factors described in 4.1 and 4.2 can be combined for migration of substances for which the FRF is applicable when testing is performed in food simulant D2 by multiplying both factors. The applied maximum factor shall not exceed 5.

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

ANNEX VI

Correlation tables

Directive 2002/72/EC

This Regulation

Article 1(1)

Article 1

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

Article 2

Article 1a

Article 3

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

Article 5

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

Article 6

Article 4a(3) and (6)

Article 7

Annex II (4) and Annex III (4)

Article 8

Article 3(1) and Article 4(1)

Article 9

Article 6

Article 10

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

Article 11

Article 2

Article 12

Article 7a

Article 13

Article 9(1) and (2)

Article 15

Article 9(3)

Article 16

Article 7 and Annex I (5a)

Article 17

Article 8

Article 18

Annex II (3) and Annex III (3)

Article 19

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

Annex I

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

Annex II

Article 8(5) and Annex VIa

Annex IV

Annex I

Annex V

Directive 93/8/EEC

This Regulation

Article 1

Article 11

Article 1

Article 12

Article 1

Article 18

Annex

Annex III

Annex

Annex V

Directive 97/48/EC

This Regulation

Annex

Annex III

Annex

Annex V

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

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