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

OJ L 12, 15.1.2011, p. 1–89 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
Special edition in Croatian: Chapter 13 Volume 045 P. 42 - 130

ELI: http://data.europa.eu/eli/reg/2011/10/oj
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Text

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

no

 

 

 

 

8

30401

acetylated mono- and diglycerides of fatty acids

yes

no

no

 

(32)

 

 

9

30610

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

yes

no

no

 

 

 

 

10

30612

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

yes

no

no

 

 

 

 

11

30960

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

yes

no

no

 

 

 

 

12

31328

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

yes

no

no

 

 

 

 

13

33120

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

yes

no

no

 

 

 

 

14

33801

n-alkyl(C10-C13)benzenesulphonic acid

yes

no

no

30

 

 

 

15

34130

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

yes

no

yes

30

 

 

 

16

34230

alkyl(C8-C22)sulphonic acids

yes

no

no

6

 

 

 

17

34281

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

yes

no

no

 

 

 

 

18

34475

aluminium calcium hydroxide phosphite, hydrate

yes

no

no

 

 

 

 

19

39090

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

yes

no

no

 

(7)

 

 

20

39120

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

yes

no

no

 

(7)

SML(T) expressed excluding HCl

 

21

42500

carbonic acid, salts

yes

no

no

 

 

 

 

22

43200

castor oil, mono- and diglycerides

yes

no

no

 

 

 

 

23

43515

chlorides of choline esters of coconut oil fatty acids

yes

no

no

0,9

 

 

(1)

24

45280

cotton fibers

yes

no

no

 

 

 

 

25

45440

cresols, butylated, styrenated

yes

no

no

12

 

 

 

26

46700

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

yes

no

no

5

 

 

 

27

48960

9,10-dihydroxy stearic acid and its oligomers

yes

no

no

5

 

 

 

28

50160

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

yes

no

no

 

(10)

 

 

29

50360

di-n-octyltin bis(ethyl maleate)

yes

no

no

 

(10)

 

 

30

50560

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

yes

no

no

 

(10)

 

 

31

50800

di-n-octyltin dimaleate, esterified

yes

no

no

 

(10)

 

 

32

50880

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

yes

no

no

 

(10)

 

 

33

51120

di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate

yes

no

no

 

(10)

 

 

34

54270

ethylhydroxymethylcellulose

yes

no

no

 

 

 

 

35

54280

ethylhydroxypropylcellulose

yes

no

no

 

 

 

 

36

54450

fats and oils, from animal or vegetable food sources

yes

no

no

 

 

 

 

37

54480

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

yes

no

no

 

 

 

 

38

55520

glass fibers

yes

no

no

 

 

 

 

39

55600

glass microballs

yes

no

no

 

 

 

 

40

56360

glycerol, esters with acetic acid

yes

no

no

 

 

 

 

41

56486

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

yes

no

no

 

 

 

 

42

56487

glycerol, esters with butyric acid

yes

no

no

 

 

 

 

43

56490

glycerol, esters with erucic acid

yes

no

no

 

 

 

 

44

56495

glycerol, esters with 12-hydroxystearic acid

yes

no

no

 

 

 

 

45

56500

glycerol, esters with lauric acid

yes

no

no

 

 

 

 

46

56510

glycerol, esters with linoleic acid

yes

no

no

 

 

 

 

47

56520

glycerol, esters with myristic acid

yes

no

no

 

 

 

 

48

56535

glycerol, esters with nonanoic acid

yes

no

no

 

 

 

 

49

56540

glycerol, esters with oleic acid

yes

no

no

 

 

 

 

50

56550

glycerol, esters with palmitic acid

yes

no

no

 

 

 

 

51

56570

glycerol, esters with propionic acid

yes

no

no

 

 

 

 

52

56580

glycerol, esters with ricinoleic acid

yes

no

no

 

 

 

 

53

56585

glycerol, esters with stearic acid

yes

no

no

 

 

 

 

54

57040

glycerol monooleate, ester with ascorbic acid

yes

no

no

 

 

 

 

55

57120

glycerol monooleate, ester with citric acid

yes

no

no

 

 

 

 

56

57200

glycerol monopalmitate, ester with ascorbic acid

yes

no

no

 

 

 

 

57

57280

glycerol monopalmitate, ester with citric acid

yes

no

no

 

 

 

 

58

57600

glycerol monostearate, ester with ascorbic acid

yes

no

no

 

 

 

 

59

57680

glycerol monostearate, ester with citric acid

yes

no

no

 

 

 

 

60

58300

glycine, salts

yes

no

no

 

 

 

 

62

64500

lysine, salts

yes

no

no

 

 

 

 

63

65440

manganese pyrophosphite

yes

no

no

 

 

 

 

64

66695

methylhydroxymethylcellulose

yes

no

no

 

 

 

 

65

67155

mixture of 4-(2-benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl)stilbene, 4,4′-bis(2-benzoxazolyl) stilbene and 4,4′-bis(5-methyl-2-benzoxazolyl)stilbene

yes

no

no

 

 

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

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

 

66

67600

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

yes

no

no

 

(11)

 

 

67

67840

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

yes

no

no

 

 

 

 

68

73160

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

yes

no

yes

0,05

 

 

 

69

74400

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

yes

no

yes

30

 

 

 

70

76463

polyacrylic acid, salts

yes

no

no

 

(22)

 

 

71

76730

polydimethylsiloxane, γ-hydroxypropylated

yes

no

no

6

 

 

 

72

76815

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

yes

no

no

 

(32)

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

 

73

76866

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

yes

no

yes

 

(31)

(32)

 

 

74

77440

polyethyleneglycol diricinoleate

yes

no

yes

42

 

 

 

75

77702

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

yes

no

no

 

 

 

 

76

77732

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

yes

no

no

0,05

 

Only for use in PET

 

77

77733

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

yes

no

no

0,05

 

Only for use in PET

 

78

77897

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

yes

no

no

5

 

 

 

79

80640

polyoxyalkyl (C2-C4) dimethylpolysiloxane

yes

no

no

 

 

 

 

80

81760

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

yes

no

no

 

 

 

 

81

83320

propylhydroxyethylcellulose

yes

no

no

 

 

 

 

82

83325

propylhydroxymethylcellulose

yes

no

no

 

 

 

 

83

83330

propylhydroxypropylcellulose

yes

no

no

 

 

 

 

84

85601

silicates, natural (with the exception of asbestos)

yes

no

no

 

 

 

 

85

85610

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

yes

no

no

 

 

 

 

86

86000

silicic acid, silylated

yes

no

no

 

 

 

 

87

86285

silicon dioxide, silanated

yes

no

no

 

 

 

 

88

86880

sodium monoalkyl dialkylphenoxybenzenedisulphonate

yes

no

no

9

 

 

 

89

89440

stearic acid, esters with ethyleneglycol

yes

no

no

 

(2)

 

 

90

92195

taurine, salts

yes

no

no

 

 

 

 

91

92320

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

yes

no

yes

15

 

 

 

92

93970

tricyclodecanedimethanol bis(hexahydrophthalate)

yes

no

no

0,05

 

 

 

93

95858

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

yes

no

no

0,05

 

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

Average molecular weight not less than 350 Da.

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

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

 

94

95859

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

yes

no

no

 

 

Average molecular weight not less than 500 Da.

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

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

 

95

95883

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

yes

no

no

 

 

Average molecular weight not less than 480 Da.

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

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

 

96

95920

wood flour and fibers, untreated

yes

no

no

 

 

 

 

97

72081/10

petroleum hydrocarbon resins (hydrogenated)

yes

no

no

 

 

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

Properties:

Viscosity at 120 °C: > 3 Pa.s,

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

Bromine number: < 40 (ASTM D1159),

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

Residual aromatic monomer ≤ 50 ppm,

 

98

17260

0000050-00-0

formaldehyde

yes

yes

no

 

(15)

 

 

54880

99

19460

0000050-21-5

lactic acid

yes

yes

no

 

 

 

 

62960

100

24490

0000050-70-4

sorbitol

yes

yes

no

 

 

 

 

88320

101

36000

0000050-81-7

ascorbic acid

yes

no

no

 

 

 

 

102

17530

0000050-99-7

glucose

no

yes

no

 

 

 

 

103

18100

0000056-81-5

glycerol

yes

yes

no

 

 

 

 

55920

104

58960

0000057-09-0

hexadecyltrimethylammonium bromide

yes

no

no

6

 

 

 

105

22780

0000057-10-3

palmitic acid

yes

yes

no

 

 

 

 

70400

106

24550

0000057-11-4

stearic acid

yes

yes

no

 

 

 

 

89040

107

25960

0000057-13-6

urea

no

yes

no

 

 

 

 

108

24880

0000057-50-1

sucrose

no

yes

no

 

 

 

 

109

23740

0000057-55-6

1,2-propanediol

yes

yes

no

 

 

 

 

81840

110

93520

0000059-02-9

0010191-41-0

α-tocopherol

yes

no

no

 

 

 

 

111

53600

0000060-00-4

ethylenediaminetetraacetic acid

yes

no

no

 

 

 

 

112

64015

0000060-33-3

linoleic acid

yes

no

no

 

 

 

 

113

16780

0000064-17-5

ethanol

yes

yes

no

 

 

 

 

52800

114

55040

0000064-18-6

formic acid

yes

no

no

 

 

 

 

115

10090

0000064-19-7

acetic acid

yes

yes

no

 

 

 

 

30000

116

13090

0000065-85-0

benzoic acid

yes

yes

no

 

 

 

 

37600

117

21550

0000067-56-1

methanol

no

yes

no

 

 

 

 

118

23830

0000067-63-0

2-propanol

yes

yes

no

 

 

 

 

81882

119

30295

0000067-64-1

acetone

yes

no

no

 

 

 

 

120

49540

0000067-68-5

dimethyl sulphoxide

yes

no

no

 

 

 

 

121

24270

0000069-72-7

salicylic acid

yes

yes

no

 

 

 

 

84640

122

23800

0000071-23-8

1-propanol

no

yes

no

 

 

 

 

123

13840

0000071-36-3

1-butanol

no

yes

no

 

 

 

 

124

22870

0000071-41-0

1-pentanol

no

yes

no

 

 

 

 

125

16950

0000074-85-1

ethylene

no

yes

no

 

 

 

 

126

10210

0000074-86-2

acetylene

no

yes

no

 

 

 

 

127

26050

0000075-01-4

vinyl chloride

no

yes

no

ND

 

1 mg/kg in final product

 

128

10060

0000075-07-0

acetaldehyde

no

yes

no

 

(1)

 

 

129

17020

0000075-21-8

ethylene oxide

no

yes

no

ND

 

1 mg/kg in final product

(10)

130

26110

0000075-35-4

vinylidene chloride

no

yes

no

ND

 

 

(1)

131

48460

0000075-37-6

1,1-difluoroethane

yes

no

no

 

 

 

 

132

26140

0000075-38-7

vinylidene fluoride

no

yes

no

5

 

 

 

133

14380

0000075-44-5

carbonyl chloride

no

yes

no

ND

 

1 mg/kg in final product

(10)

23155

134

43680

0000075-45-6

chlorodifluoromethane

yes

no

no

6

 

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

 

135

24010

0000075-56-9

propylene oxide

no

yes

no

ND

 

1 mg/kg in final product

 

136

41680

0000076-22-2

camphor

yes

no

no

 

 

 

(3)

137

66580

0000077-62-3

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

yes

no

yes

 

(5)

 

 

138

93760

0000077-90-7

tri-n-butyl acetyl citrate

yes

no

no

 

(32)

 

 

139

14680

0000077-92-9

citric acid

yes

yes

no

 

 

 

 

44160

140

44640

0000077-93-0

citric acid, triethyl ester

yes

no

no

 

(32)

 

 

141

13380

0000077-99-6

1,1,1-trimethylolpropane

yes

yes

no

6

 

 

 

25600

94960

142

26305

0000078-08-0

vinyltriethoxysilane

no

yes

no

0,05

 

Only to be used as a surface treatment agent

(1)

143

62450

0000078-78-4

isopentane

yes

no

no

 

 

 

 

144

19243

0000078-79-5

2-methyl-1,3-butadiene

no

yes

no

ND

 

1 mg/kg in final product

 

21640

145

10630

0000079-06-1

acrylamide

no

yes

no

ND

 

 

 

146

23890

0000079-09-4

propionic acid

yes

yes

no

 

 

 

 

82000

147

10690

0000079-10-7

acrylic acid

no

yes

no

 

(22)

 

 

148

14650

0000079-38-9

chlorotrifluoroethylene

no

yes

no

ND

 

 

(1)

149

19990

0000079-39-0

methacrylamide

no

yes

no

ND

 

 

 

150

20020

0000079-41-4

methacrylic acid

no

yes

no

 

(23)

 

 

151

13480

0000080-05-7

2,2-bis(4-hydroxyphenyl)propane

no

yes

no

0,6

 

 

 

13607

152

15610

0000080-07-9

4,4′-dichlorodiphenyl sulphone

no

yes

no

0,05

 

 

 

153

15267

0000080-08-0

4,4′-diaminodiphenyl sulphone

no

yes

no

5

 

 

 

154

13617

0000080-09-1

4,4′-dihydroxydiphenyl sulphone

no

yes

no

0,05

 

 

 

16090

155

23470

0000080-56-8

α-pinene

no

yes

no

 

 

 

 

156

21130

0000080-62-6

methacrylic acid, methyl ester

no

yes

no

 

(23)

 

 

157

74880

0000084-74-2

phthalic acid, dibutyl ester

yes

no

no

0,3

(32)

Only to be used as:

(a)

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

(b)

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

(7)

158

23380

0000085-44-9

phthalic anhydride

yes

yes

no

 

 

 

 

76320

159

74560

0000085-68-7

phthalic acid, benzyl butyl ester

yes

no

no

30

(32)

Only to be used as:

(a)

plasticiser in repeated use materials and articles;

(b)

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

(c)

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

(7)

160

84800

0000087-18-3

salicylic acid, 4-tert-butylphenyl ester

yes

no

yes

12

 

 

 

161

92160

0000087-69-4

tartaric acid

yes

no

no

 

 

 

 

162

65520

0000087-78-5

mannitol

yes

no

no

 

 

 

 

163

66400

0000088-24-4

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

yes

no

yes

 

(13)

 

 

164

34895

0000088-68-6

2-aminobenzamide

yes

no

no

0,05

 

Only for use in PET for water and beverages

 

165

23200

0000088-99-3

o-phthalic acid

yes

yes

no

 

 

 

 

74480

166

24057

0000089-32-7

pyromellitic anhydride

no

yes

no

0,05

 

 

 

167

25240

0000091-08-7

2,6-toluene diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

168

13075

0000091-76-9

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

no

yes

no

5

 

 

(1)

15310

169

16240

0000091-97-4

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

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

170

16000

0000092-88-6

4,4′-dihydroxybiphenyl

no

yes

no

6

 

 

 

171

38080

0000093-58-3

benzoic acid, methyl ester

yes

no

no

 

 

 

 

172

37840

0000093-89-0

benzoic acid, ethyl ester

yes

no

no

 

 

 

 

173

60240

0000094-13-3

4-hydroxybenzoic acid, propyl ester

yes

no

no

 

 

 

 

174

14740

0000095-48-7

o-cresol

no

yes

no

 

 

 

 

175

20050

0000096-05-9

methacrylic acid, allyl ester

no

yes

no

0,05

 

 

 

176

11710

0000096-33-3

acrylic acid, methyl ester

no

yes

no

 

(22)

 

 

177

16955

0000096-49-1

ethylene carbonate

no

yes

no

30

 

SML expressed as ethyleneglycol.

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

 

178

92800

0000096-69-5

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

yes

no

yes

0,48

 

 

 

179

48800

0000097-23-4

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

yes

no

yes

12

 

 

 

180

17160

0000097-53-0

eugenol

no

yes

no

ND

 

 

 

181

20890

0000097-63-2

methacrylic acid, ethyl ester

no

yes

no

 

(23)

 

 

182

19270

0000097-65-4

itaconic acid

no

yes

no

 

 

 

 

183

21010

0000097-86-9

methacrylic acid, isobutyl ester

no

yes

no

 

(23)

 

 

184

20110

0000097-88-1

methacrylic acid, butyl ester

no

yes

no

 

(23)

 

 

185

20440

0000097-90-5

methacrylic acid, diester with ethyleneglycol

no

yes

no

0,05

 

 

 

186

14020

0000098-54-4

4-tert-butylphenol

no

yes

no

0,05

 

 

 

187

22210

0000098-83-9

α-methylstyrene

no

yes

no

0,05

 

 

 

188

19180

0000099-63-8

isophthalic acid dichloride

no

yes

no

 

(27)

 

 

189

60200

0000099-76-3

4-hydroxybenzoic acid, methyl ester

yes

no

no

 

 

 

 

190

18880

0000099-96-7

p-hydroxybenzoic acid

no

yes

no

 

 

 

 

191

24940

0000100-20-9

terephthalic acid dichloride

no

yes

no

 

(28)

 

 

192

23187

phthalic acid

no

yes

no

 

(28)

 

 

193

24610

0000100-42-5

styrene

no

yes

no

 

 

 

 

194

13150

0000100-51-6

benzyl alcohol

no

yes

no

 

 

 

 

195

37360

0000100-52-7

benzaldehyde

yes

no

no

 

 

 

(3)

196

18670

0000100-97-0

hexamethylenetetramine

yes

yes

no

 

(15)

 

 

59280

197

20260

0000101-43-9

methacrylic acid, cyclohexyl ester

no

yes

no

0,05

 

 

 

198

16630

0000101-68-8

diphenylmethane-4,4′-diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

199

24073

0000101-90-6

resorcinol diglycidyl ether

no

yes

no

ND

 

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

For indirect food contact only, behind a PET layer.

(8)

200

51680

0000102-08-9

N,N′-diphenylthiourea

yes

no

yes

3

 

 

 

201

16540

0000102-09-0

diphenyl carbonate

no

yes

no

0,05

 

 

 

202

23070

0000102-39-6

(1,3-phenylenedioxy)diacetic acid

no

yes

no

0,05

 

 

(1)

203

13323

0000102-40-9

1,3-bis(2-hydroxyethoxy)benzene

no

yes

no

0,05

 

 

 

204

25180

0000102-60-3

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

yes

yes

no

 

 

 

 

92640

205

25385

0000102-70-5

triallylamine

no

yes

no

 

 

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

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

 

206

11500

0000103-11-7

acrylic acid, 2-ethylhexyl ester

no

yes

no

0,05

 

 

 

207

31920

0000103-23-1

adipic acid, bis(2-ethylhexyl) ester

yes

no

yes

18

(32)

 

(2)

208

18898

0000103-90-2

N-(4-hydroxyphenyl) acetamide

no

yes

no

0,05

 

 

 

209

17050

0000104-76-7

2-ethyl-1-hexanol

no

yes

no

30

 

 

 

210

13390

0000105-08-8

1,4-bis(hydroxymethyl)cyclohexane

no

yes

no

 

 

 

 

14880

211

23920

0000105-38-4

propionic acid, vinyl ester

no

yes

no

 

(1)

 

 

212

14200

0000105-60-2

caprolactam

yes

yes

no

 

(4)

 

 

41840

213

82400

0000105-62-4

1,2-propyleneglycol dioleate

yes

no

no

 

 

 

 

214

61840

0000106-14-9

12-hydroxystearic acid

yes

no

no

 

 

 

 

215

14170

0000106-31-0

butyric anhydride

no

yes

no

 

 

 

 

216

14770

0000106-44-5

p-cresol

no

yes

no

 

 

 

 

217

15565

0000106-46-7

1,4-dichlorobenzene

no

yes

no

12

 

 

 

218

11590

0000106-63-8

acrylic acid, isobutyl ester

no

yes

no

 

(22)

 

 

219

14570

0000106-89-8

epichlorohydrin

no

yes

no

ND

 

1 mg/kg in final product

(10)

16750

220

20590

0000106-91-2

methacrylic acid, 2,3-epoxypropyl ester

no

yes

no

0,02

 

 

(10)

221

40570

0000106-97-8

butane

yes

no

no

 

 

 

 

222

13870

0000106-98-9

1-butene

no

yes

no

 

 

 

 

223

13630

0000106-99-0

butadiene

no

yes

no

ND

 

1 mg/kg in final product

 

224

13900

0000107-01-7

2-butene

no

yes

no

 

 

 

 

225

12100

0000107-13-1

acrylonitrile

no

yes

no

ND

 

 

 

226

15272

0000107-15-3

ethylenediamine

no

yes

no

12

 

 

 

16960

227

16990

0000107-21-1

ethyleneglycol

yes

yes

no

 

(2)

 

 

53650

228

13690

0000107-88-0

1,3-butanediol

no

yes

no

 

 

 

 

229

14140

0000107-92-6

butyric acid

no

yes

no

 

 

 

 

230

16150

0000108-01-0

dimethylaminoethanol

no

yes

no

18

 

 

 

231

10120

0000108-05-4

acetic acid, vinyl ester

no

yes

no

12

 

 

 

232

10150

0000108-24-7

acetic anhydride

yes

yes

no

 

 

 

 

30280

233

24850

0000108-30-5

succinic anhydride

no

yes

no

 

 

 

 

234

19960

0000108-31-6

maleic anhydride

no

yes

no

 

(3)

 

 

235

14710

0000108-39-4

m-cresol

no

yes

no

 

 

 

 

236

23050

0000108-45-2

1,3-phenylenediamine

no

yes

no

ND

 

 

 

237

15910

0000108-46-3

1,3-dihydroxybenzene

no

yes

no

2,4

 

 

 

24072

238

18070

0000108-55-4

glutaric anhydride

no

yes

no

 

 

 

 

239

19975

0000108-78-1

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

yes

yes

no

30

 

 

 

25420

93720

240

45760

0000108-91-8

cyclohexylamine

yes

no

no

 

 

 

 

241

22960

0000108-95-2

phenol

no

yes

no

 

 

 

 

242

85360

0000109-43-3

sebacic acid, dibutyl ester

yes

no

no

 

(32)

 

 

243

19060

0000109-53-5

isobutyl vinyl ether

no

yes

no

0,05

 

 

(10)

244

71720

0000109-66-0

pentane

yes

no

no

 

 

 

 

245

22900

0000109-67-1

1-pentene

no

yes

no

5

 

 

 

246

25150

0000109-99-9

tetrahydrofuran

no

yes

no

0,6

 

 

 

247

24820

0000110-15-6

succinic acid

yes

yes

no

 

 

 

 

90960

248

19540

0000110-16-7

maleic acid

yes

yes

no

 

(3)

 

 

64800

249

17290

0000110-17-8

fumaric acid

yes

yes

no

 

 

 

 

55120

250

53520

0000110-30-5

N,N′-ethylenebisstearamide

yes

no

no

 

 

 

 

251

53360

0000110-31-6

N,N′-ethylenebisoleamide

yes

no

no

 

 

 

 

252

87200

0000110-44-1

sorbic acid

yes

no

no

 

 

 

 

253

15250

0000110-60-1

1,4-diaminobutane

no

yes

no

 

 

 

 

254

13720

0000110-63-4

1,4-butanediol

yes

yes

no

 

(30)

 

 

40580

255

25900

0000110-88-3

trioxane

no

yes

no

5

 

 

 

256

18010

0000110-94-1

glutaric acid

yes

yes

no

 

 

 

 

55680

257

13550

0000110-98-5

dipropyleneglycol

yes

yes

no

 

 

 

 

16660

51760

258

70480

0000111-06-8

palmitic acid, butyl ester

yes

no

no

 

 

 

 

259

58720

0000111-14-8

heptanoic acid

yes

no

no

 

 

 

 

260

24280

0000111-20-6

sebacic acid

no

yes

no

 

 

 

 

261

15790

0000111-40-0

diethylenetriamine

no

yes

no

5

 

 

 

262

35284

0000111-41-1

N-(2-aminoethyl)ethanolamine

yes

no

no

0,05

 

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

For indirect food contact only, behind a PET layer.

 

263

13326

0000111-46-6

diethyleneglycol

yes

yes

no

 

(2)

 

 

15760

47680

264

22660

0000111-66-0

1-octene

no

yes

no

15

 

 

 

265

22600

0000111-87-5

1-octanol

no

yes

no

 

 

 

 

266

25510

0000112-27-6

triethyleneglycol

yes

yes

no

 

 

 

 

94320

267

15100

0000112-30-1

1-decanol

no

yes

no

 

 

 

 

268

16704

0000112-41-4

1-dodecene

no

yes

no

0,05

 

 

 

269

25090

0000112-60-7

tetraethyleneglycol

yes

yes

no

 

 

 

 

92350

270

22763

0000112-80-1

oleic acid

yes

yes

no

 

 

 

 

69040

271

52720

0000112-84-5

erucamide

yes

no

no

 

 

 

 

272

37040

0000112-85-6

behenic acid

yes

no

no

 

 

 

 

273

52730

0000112-86-7

erucic acid

yes

no

no

 

 

 

 

274

22570

0000112-96-9

octadecyl isocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

275

23980

0000115-07-1

propylene

no

yes

no

 

 

 

 

276

19000

0000115-11-7

isobutene

no

yes

no

 

 

 

 

277

18280

0000115-27-5

hexachloroendomethylenetetrahydrophthalic anhydride

no

yes

no

ND

 

 

 

278

18250

0000115-28-6

hexachloroendomethylenetetrahydrophthalic acid

no

yes

no

ND

 

 

 

279

22840

0000115-77-5

pentaerythritol

yes

yes

no

 

 

 

 

71600

280

73720

0000115-96-8

phosphoric acid, trichloroethyl ester

yes

no

no

ND

 

 

 

281

25120

0000116-14-3

tetrafluoroethylene

no

yes

no

0,05

 

 

 

282

18430

0000116-15-4

hexafluoropropylene

no

yes

no

ND

 

 

 

283

74640

0000117-81-7

phthalic acid, bis(2-ethylhexyl) ester

yes

no

no

1,5

(32)

Only to be used as:

(a)

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

(b)

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

(7)

284

84880

0000119-36-8

salicylic acid, methyl ester

yes

no

no

30

 

 

 

285

66480

0000119-47-1

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

yes

no

yes

 

(13)

 

 

286

38240

0000119-61-9

benzophenone

yes

no

yes

0,6

 

 

 

287

60160

0000120-47-8

4-hydroxybenzoic acid, ethyl ester

yes

no

no

 

 

 

 

288

24970

0000120-61-6

terephthalic acid, dimethyl ester

no

yes

no

 

 

 

 

289

15880

0000120-80-9

1,2-dihydroxybenzene

no

yes

no

6

 

 

 

24051

290

55360

0000121-79-9

gallic acid, propyl ester

yes

no

no

 

(20)

 

 

291

19150

0000121-91-5

isophthalic acid

no

yes

no

 

(27)

 

 

292

94560

0000122-20-3

triisopropanolamine

yes

no

no

5

 

 

 

293

23175

0000122-52-1

phosphorous acid, triethyl ester

no

yes

no

ND

 

1 mg/kg in final product

(1)

294

93120

0000123-28-4

thiodipropionic acid, didodecyl ester

yes

no

yes

 

(14)

 

 

295

15940

0000123-31-9

1,4-dihydroxybenzene

yes

yes

no

0,6

 

 

 

18867

48620

296

23860

0000123-38-6

propionaldehyde

no

yes

no

 

 

 

 

297

23950

0000123-62-6

propionic anhydride

no

yes

no

 

 

 

 

298

14110

0000123-72-8

butyraldehyde

no

yes

no

 

 

 

 

299

63840

0000123-76-2

levulinic acid

yes

no

no

 

 

 

 

300

30045

0000123-86-4

acetic acid, butyl ester

yes

no

no

 

 

 

 

301

89120

0000123-95-5

stearic acid, butyl ester

yes

no

no

 

 

 

 

302

12820

0000123-99-9

azelaic acid

no

yes

no

 

 

 

 

303

12130

0000124-04-9

adipic acid

yes

yes

no

 

 

 

 

31730

304

14320

0000124-07-2

caprylic acid

yes

yes

no

 

 

 

 

41960

305

15274

0000124-09-4

hexamethylenediamine

no

yes

no

2,4

 

 

 

18460

306

88960

0000124-26-5

stearamide

yes

no

no

 

 

 

 

307

42160

0000124-38-9

carbon dioxide

yes

no

no

 

 

 

 

308

91200

0000126-13-6

sucrose acetate isobutyrate

yes

no

no

 

 

 

 

309

91360

0000126-14-7

sucrose octaacetate

yes

no

no

 

 

 

 

310

16390

0000126-30-7

2,2-dimethyl-1,3-propanediol

no

yes

no

0,05

 

 

 

22437

311

16480

0000126-58-9

dipentaerythritol

yes

yes

no

 

 

 

 

51200

312

21490

0000126-98-7

methacrylonitrile

no

yes

no

ND

 

 

 

313

16650

0000127-63-9

diphenyl sulphone

yes

yes

no

3

 

 

 

51570

314

23500

0000127-91-3

β-pinene

no

yes

no

 

 

 

 

315

46640

0000128-37-0

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

yes

no

no

3

 

 

 

316

23230

0000131-17-9

phthalic acid, diallyl ester

no

yes

no

ND

 

 

 

317

48880

0000131-53-3

2,2′-dihydroxy-4-methoxybenzophenone

yes

no

yes

 

(8)

 

 

318

48640

0000131-56-6

2,4-dihydroxybenzophenone

yes

no

no

 

(8)

 

 

319

61360

0000131-57-7

2-hydroxy-4-methoxybenzophenone

yes

no

yes

 

(8)

 

 

320

37680

0000136-60-7

benzoic acid, butyl ester

yes

no

no

 

 

 

 

321

36080

0000137-66-6

ascorbyl palmitate

yes

no

no

 

 

 

 

322

63040

0000138-22-7

lactic acid, butyl ester

yes

no

no

 

 

 

 

323

11470

0000140-88-5

acrylic acid, ethyl ester

no

yes

no

 

(22)

 

 

324

83700

0000141-22-0

ricinoleic acid

yes

no

yes

42

 

 

 

325

10780

0000141-32-2

acrylic acid, n-butyl ester

no

yes

no

 

(22)

 

 

326

12763

0000141-43-5

2-aminoethanol

yes

yes

no

0,05

 

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

For indirect food contact only, behind a PET layer.

 

35170

327

30140

0000141-78-6

acetic acid, ethyl ester

yes

no

no

 

 

 

 

328

65040

0000141-82-2

malonic acid

yes

no

no

 

 

 

 

329

59360

0000142-62-1

hexanoic acid

yes

no

no

 

 

 

 

330

19470

0000143-07-7

lauric acid

yes

yes

no

 

 

 

 

63280

331

22480

0000143-08-8

1-nonanol

no

yes

no

 

 

 

 

332

69760

0000143-28-2

oleyl alcohol

yes

no

no

 

 

 

 

333

22775

0000144-62-7

oxalic acid

yes

yes

no

6

 

 

 

69920

334

17005

0000151-56-4

ethyleneimine

no

yes

no

ND

 

 

 

335

68960

0000301-02-0

oleamide

yes

no

no

 

 

 

 

336

15095

0000334-48-5

n-decanoic acid

yes

yes

no

 

 

 

 

45940

337

15820

0000345-92-6

4,4′-difluorobenzophenone

no

yes

no

0,05

 

 

 

338

71020

0000373-49-9

palmitoleic acid

yes

no

no

 

 

 

 

339

86160

0000409-21-2

silicon carbide

yes

no

no

 

 

 

 

340

47440

0000461-58-5

dicyanodiamide

yes

no

no

 

 

 

 

341

13180

0000498-66-8

bicyclo[2.2.1]hept-2-ene

no

yes

no

0,05

 

 

 

22550

342

14260

0000502-44-3

caprolactone

no

yes

no

 

(29)

 

 

343

23770

0000504-63-2

1,3-propanediol

no

yes

no

0,05

 

 

 

344

13810

0000505-65-7

1,4-butanediol formal

no

yes

no

ND

 

 

(10)

21821

345

35840

0000506-30-9

arachidic acid

yes

no

no

 

 

 

 

346

10030

0000514-10-3

abietic acid

no

yes

no

 

 

 

 

347

13050

0000528-44-9

trimellitic acid

no

yes

no

 

(21)

 

 

25540

348

22350

0000544-63-8

myristic acid

yes

yes

no

 

 

 

 

67891

349

25550

0000552-30-7

trimellitic anhydride

no

yes

no

 

(21)

 

 

350

63920

0000557-59-5

lignoceric acid

yes

no

no

 

 

 

 

351

21730

0000563-45-1

3-methyl-1-butene

no

yes

no

ND

 

Only to be used in polypropylene

(1)

352

16360

0000576-26-1

2,6-dimethylphenol

no

yes

no

0,05

 

 

 

353

42480

0000584-09-8

carbonic acid, rubidium salt

yes

no

no

12

 

 

 

354

25210

0000584-84-9

2,4-toluene diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

355

20170

0000585-07-9

methacrylic acid, tert-butyl ester

no

yes

no

 

(23)

 

 

356

18820

0000592-41-6

1-hexene

no

yes

no

3

 

 

 

357

13932

0000598-32-3

3-buten-2-ol

no

yes

no

ND

 

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

(1)

358

14841

0000599-64-4

4-cumylphenol

no

yes

no

0,05

 

 

 

359

15970

0000611-99-4

4,4′-dihydroxybenzophenone

yes

yes

no

 

(8)

 

 

48720

360

57920

0000620-67-7

glycerol triheptanoate

yes

no

no

 

 

 

 

361

18700

0000629-11-8

1,6-hexanediol

no

yes

no

0,05

 

 

 

362

14350

0000630-08-0

carbon monoxide

no

yes

no

 

 

 

 

363

16450

0000646-06-0

1,3-dioxolane

no

yes

no

5

 

 

 

364

15404

0000652-67-5

1,4:3,6-dianhydrosorbitol

no

yes

no

5

 

Only to be used as a co-monomer in poly(ethylene-co-isosorbide terephthalate)

 

365

11680

0000689-12-3

acrylic acid, isopropyl ester

no

yes

no

 

(22)

 

 

366

22150

0000691-37-2

4-methyl-1-pentene

no

yes

no

0,05

 

 

 

367

16697

0000693-23-2

n-dodecanedioic acid

no

yes

no

 

 

 

 

368

93280

0000693-36-7

thiodipropionic acid, dioctadecyl ester

yes

no

yes

 

(14)

 

 

369

12761

0000693-57-2

12-aminododecanoic acid

no

yes

no

0,05

 

 

 

370

21460

0000760-93-0

methacrylic anhydride

no

yes

no

 

(23)

 

 

371

11510

0000818-61-1

acrylic acid, monoester with ethyleneglycol

no

yes

no

 

(22)

 

 

11830

372

18640

0000822-06-0

hexamethylene diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

373

22390

0000840-65-3

2,6-naphthalenedicarboxylic acid, dimethyl ester

no

yes

no

0,05

 

 

 

374

21190

0000868-77-9

methacrylic acid, monoester with ethyleneglycol

no

yes

no

 

(23)

 

 

375

15130

0000872-05-9

1-decene

no

yes

no

0,05

 

 

 

376

66905

0000872-50-4

N-methylpyrrolidone

yes

no

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

no

 

(20)

 

 

387

26155

0001072-63-5

1-vinylimidazole

no

yes

no

0,05

 

 

(1)

388

25080

0001120-36-1

1-tetradecene

no

yes

no

0,05

 

 

 

389

22360

0001141-38-4

2,6-naphthalenedicarboxylic acid

no

yes

no

5

 

 

 

390

55200

0001166-52-5

gallic acid, dodecyl ester

yes

no

no

 

(20)

 

 

391

22932

0001187-93-5

perfluoromethyl perfluorovinyl ether

no

yes

no

0,05

 

Only to be used in anti-stick coatings

 

392

72800

0001241-94-7

phosphoric acid, diphenyl 2-ethylhexyl ester

yes

no

yes

2,4

 

 

 

393

37280

0001302-78-9

bentonite

yes

no

no

 

 

 

 

394

41280

0001305-62-0

calcium hydroxide

yes

no

no

 

 

 

 

395

41520

0001305-78-8

calcium oxide

yes

no

no

 

 

 

 

396

64640

0001309-42-8

magnesium hydroxide

yes

no

no

 

 

 

 

397

64720

0001309-48-4

magnesium oxide

yes

no

no

 

 

 

 

398

35760

0001309-64-4

antimony trioxide

yes

no

no

0,04

 

SML expressed as antimony

(6)

399

81600

0001310-58-3

potassium hydroxide

yes

no

no

 

 

 

 

400

86720

0001310-73-2

sodium hydroxide

yes

no

no

 

 

 

 

401

24475

0001313-82-2

sodium sulphide

no

yes

no

 

 

 

 

402

96240

0001314-13-2

zinc oxide

yes

no

no

 

 

 

 

403

96320

0001314-98-3

zinc sulphide

yes

no

no

 

 

 

 

404

67200

0001317-33-5

molybdenum disulphide

yes

no

no

 

 

 

 

405

16690

0001321-74-0

divinylbenzene

no

yes

no

ND

 

SML expressed as the sum of divinylbenzene and ethylvinylbenzene.

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

(1)

406

83300

0001323-39-3

1,2-propyleneglycol monostearate

yes

no

no

 

 

 

 

407

87040

0001330-43-4

sodium tetraborate

yes

no

no

 

(16)

 

 

408

82960

0001330-80-9

1,2-propyleneglycol monooleate

yes

no

no

 

 

 

 

409

62240

0001332-37-2

iron oxide

yes

no

no

 

 

 

 

410

62720

0001332-58-7

kaolin

yes

no

no

 

 

 

 

411

42080

0001333-86-4

carbon black

yes

no

no

 

 

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

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

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

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

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

 

412

45200

0001335-23-5

copper iodide

yes

no

no

 

(6)

 

 

413

35600

0001336-21-6

ammonium hydroxide

yes

no

no

 

 

 

 

414

87600

0001338-39-2

sorbitan monolaurate

yes

no

no

 

 

 

 

415

87840

0001338-41-6

sorbitan monostearate

yes

no

no

 

 

 

 

416

87680

0001338-43-8

sorbitan monooleate

yes

no

no

 

 

 

 

417

85680

0001343-98-2

silicic acid

yes

no

no

 

 

 

 

418

34720

0001344-28-1

aluminium oxide

yes

no

no

 

 

 

 

419

92150

0001401-55-4

tannic acids

yes

no

no

 

 

According to the JECFA specifications

 

420

19210

0001459-93-4

isophthalic acid, dimethyl ester

no

yes

no

0,05

 

 

 

421

13000

0001477-55-0

1,3-benzenedimethanamine

no

yes

no

0,05

 

 

 

422

38515

0001533-45-5

4,4′-bis(2-benzoxazolyl)stilbene

yes

no

yes

0,05

 

 

(2)

423

22937

0001623-05-8

perfluoropropylperfluorovinyl ether

no

yes

no

0,05

 

 

 

424

15070

0001647-16-1

1,9-decadiene

no

yes

no

0,05

 

 

 

425

10840

0001663-39-4

acrylic acid, tert-butyl ester

no

yes

no

 

(22)

 

 

426

13510

0001675-54-3

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

no

yes

no

 

 

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

 

13610

427

18896

0001679-51-2

4-(hydroxymethyl)-1-cyclohexene

no

yes

no

0,05

 

 

 

428

95200

0001709-70-2

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

yes

no

no

 

 

 

 

429

13210

0001761-71-3

bis(4-aminocyclohexyl)methane

no

yes

no

0,05

 

 

 

430

95600

0001843-03-4

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

yes

no

yes

5

 

 

 

431

61600

0001843-05-6

2-hydroxy-4-n-octyloxybenzophenone

yes

no

yes

 

(8)

 

 

432

12280

0002035-75-8

adipic anhydride

no

yes

no

 

 

 

 

433

68320

0002082-79-3

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

yes

no

yes

6

 

 

 

434

20410

0002082-81-7

methacrylic acid, diester with 1,4-butanediol

no

yes

no

0,05

 

 

 

435

14230

0002123-24-2

caprolactam, sodium salt

no

yes

no

 

(4)

 

 

436

19480

0002146-71-6

lauric acid, vinyl ester

no

yes

no

 

 

 

 

437

11245

0002156-97-0

acrylic acid, dodecyl ester

no

yes

no

0,05

 

 

(2)

438

38875

0002162-74-5

bis(2,6-diisopropylphenyl) carbodiimide

yes

no

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

no

 

 

 

 

442

13780

0002425-79-8

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

no

yes

no

ND

 

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

Molecular weight is 43 Da.

(10)

443

12788

0002432-99-7

11-aminoundecanoic acid

no

yes

no

5

 

 

 

444

61440

0002440-22-4

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

yes

no

no

 

(12)

 

 

445

83440

0002466-09-3

pyrophosphoric acid

yes

no

no

 

 

 

 

446

10750

0002495-35-4

acrylic acid, benzyl ester

no

yes

no

 

(22)

 

 

447

20080

0002495-37-6

methacrylic acid, benzyl ester

no

yes

no

 

(23)

 

 

448

11890

0002499-59-4

acrylic acid, n-octyl ester

no

yes

no

 

(22)

 

 

449

49840

0002500-88-1

dioctadecyl disulphide

yes

no

yes

3

 

 

 

450

24430

0002561-88-8

sebacic anhydride

no

yes

no

 

 

 

 

451

66755

0002682-20-4

2-methyl-4-isothiazolin-3-one

yes

no

no

0,5

 

Only to be used in aqueous polymer dispersions and emulsions

 

452

38885

0002725-22-6

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

yes

no

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

no

 

 

 

 

459

46870

0003135-18-0

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

yes

no

no

 

 

 

 

460

14950

0003173-53-3

cyclohexyl isocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

461

22420

0003173-72-6

1,5-naphthalene diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

462

26170

0003195-78-6

N-vinyl-N-methylacetamide

no

yes

no

0,02

 

 

(1)

463

25840

0003290-92-4

1,1,1-trimethylolpropane trimethacrylate

no

yes

no

0,05

 

 

 

464

61280

0003293-97-8

2-hydroxy-4-n-hexyloxybenzophenone

yes

no

yes

 

(8)

 

 

465

68040

0003333-62-8

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

yes

no

no

 

 

 

 

466

50640

0003648-18-8

di-n-octyltin dilaurate

yes

no

no

 

(10)

 

 

467

14800

0003724-65-0

crotonic acid

yes

yes

no

0,05

 

 

(1)

45600

468

71960

0003825-26-1

perfluorooctanoic acid, ammonium salt

yes

no

no

 

 

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

 

469

60480

0003864-99-1

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

yes

no

yes

 

(12)

 

 

470

60400

0003896-11-5

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

yes

no

yes

 

(12)

 

 

471

24888

0003965-55-7

5-sulphoisophthalic acid, monosodium salt, dimethyl ester

no

yes

no

0,05

 

 

 

472

66560

0004066-02-8

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

yes

no

yes

 

(5)

 

 

473

12265

0004074-90-2

adipic acid, divinyl ester

no

yes

no

ND

 

5 mg/kg in final product.

Only to be used as co-monomer.

(1)

474

43600

0004080-31-3

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

yes

no

no

0,3

 

 

 

475

19110

0004098-71-9

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

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

476

16570

0004128-73-8

diphenylether-4,4′-diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

477

46720

0004130-42-1

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

yes

no

yes

4,8

 

 

(1)

478

60180

0004191-73-5

4-hydroxybenzoic acid, isopropyl ester

yes

no

no

 

 

 

 

479

12970

0004196-95-6

azelaic anhydride

no

yes

no

 

 

 

 

480

46790

0004221-80-1

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

yes

no

no

 

 

 

 

481

13060

0004422-95-1

1,3,5-benzenetricarboxylic acid trichloride

no

yes

no

0,05

 

SML expressed as 1,3,5-benzenetricarboxylic acid

(1)

482

21100

0004655-34-9

methacrylic acid, isopropyl ester

no

yes

no

 

(23)

 

 

483

68860

0004724-48-5

n-octylphosphonic acid

yes

no

no

0,05

 

 

 

484

13395

0004767-03-7

2,2-bis(hydroxymethyl)propionic acid

no

yes

no

0,05

 

 

(1)

485

13560

0005124-30-1

dicyclohexylmethane-4,4′-diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

15700

486

54005

0005136-44-7

ethylene-N-palmitamide-N′-stearamide

yes

no

no

 

 

 

 

487

45640

0005232-99-5

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

yes

no

no

0,05

 

 

 

488

53440

0005518-18-3

N,N′-ethylenebispalmitamide

yes

no

no

 

 

 

 

489

41040

0005743-36-2

calcium butyrate

yes

no

no

 

 

 

 

490

16600

0005873-54-1

diphenylmethane-2,4′-diisocyanate

no

yes

no

 

(17)

1 mg/kg in final product expressed as isocyanate moiety

(10)

491

82720

0006182-11-2

1,2-propyleneglycol distearate

yes

no

no

 

 

 

 

492

45650

0006197-30-4

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

yes

no

no

0,05

 

 

 

493

39200

0006200-40-4

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

yes

no

no

1,8

 

 

 

494

62140

0006303-21-5

hypophosphorous acid

yes

no

no

 

 

 

 

495

35160

0006642-31-5

6-amino-1,3-dimethyluracil

yes

no

no

5

 

 

 

496

71680

0006683-19-8

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

yes

no

no

 

 

 

 

497

95020

0006846-50-0

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

yes

no

no

5

 

Only to be used in single-use gloves

 

498

16210

0006864-37-5

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

no

yes

no

0,05

 

Only to be used in polyamides

(5)

499

19965

0006915-15-7

malic acid

yes

yes

no

 

 

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

 

65020

500

38560

0007128-64-5

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

yes

no

yes

0,6

 

 

 

501

34480

aluminium fibers, flakes and powders

yes

no

no

 

 

 

 

502

22778

0007456-68-0

4,4′-oxybis(benzenesulphonyl azide)

no

yes

no

0,05

 

 

(1)

503

46080

0007585-39-9

β-dextrin

yes

no

no

 

 

 

 

504

86240

0007631-86-9

silicon dioxide

yes

no

no

 

 

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

 

505

86480

0007631-90-5

sodium bisulphite

yes

no

no

 

(19)

 

 

506

86920

0007632-00-0

sodium nitrite

yes

no

no

0,6

 

 

 

507

59990

0007647-01-0

hydrochloric acid

yes

no

no

 

 

 

 

508

86560

0007647-15-6

sodium bromide

yes

no

no

 

 

 

 

509

23170

0007664-38-2

phosphoric acid

yes

yes

no

 

 

 

 

72640

510

12789

0007664-41-7

ammonia

yes

yes

no

 

 

 

 

35320

511

91920

0007664-93-9

sulphuric acid

yes

no

no

 

 

 

 

512

81680

0007681-11-0

potassium iodide

yes

no

no

 

(6)

 

 

513

86800

0007681-82-5

sodium iodide

yes

no

no

 

(6)

 

 

514

91840

0007704-34-9

sulphur

yes

no

no

 

 

 

 

515

26360

0007732-18-5

water

yes

yes

no

 

 

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

 

95855

516

86960

0007757-83-7

sodium sulphite

yes

no

no

 

(19)

 

 

517

81520

0007758-02-3

potassium bromide

yes

no

no

 

 

 

 

518

35845

0007771-44-0

arachidonic acid

yes

no

no

 

 

 

 

519

87120

0007772-98-7

sodium thiosulphate

yes

no

no

 

(19)

 

 

520

65120

0007773-01-5

manganese chloride

yes

no

no

 

 

 

 

521

58320

0007782-42-5

graphite

yes

no

no

 

 

 

 

522

14530

0007782-50-5

chlorine

no

yes

no

 

 

 

 

523

45195

0007787-70-4

copper bromide

yes

no

no

 

 

 

 

524

24520

0008001-22-7

soybean oil

no

yes

no

 

 

 

 

525

62640

0008001-39-6

japan wax

yes

no

no

 

 

 

 

526

43440

0008001-75-0

ceresin

yes

no

no