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
Date: 2011-01-14
Institutions: European Commission
Subjects: adjuvant, food safety, foodstuff, health risk, market approval, packaging product, plastics, toxic substance




L_2011012EN.01000101.xml










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


 


 


 


 




527


14411


0008001-79-4


castor oil


yes


yes


no


 


 


 


 




42880




528


63760


0008002-43-5


lecithin


yes


no


no


 


 


 


 




529


67850


0008002-53-7


montan wax


yes


no


no


 


 


 


 




530


41760


0008006-44-8


candelilla wax


yes


no


no


 


 


 


 




531


36880


0008012-89-3


beeswax


yes


no


no


 


 


 


 




532


88640


0008013-07-8


soybean oil, epoxidised


yes


no


no


60
30(*)


(32)








(*)


In the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 2006/141/EC or processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC, the SML is lowered to 30 mg/kg.
Oxirane < 8 %, iodine number < 6.






 




533


42720


0008015-86-9


carnauba wax


yes


no


no


 


 


 


 




534


80720


0008017-16-1


polyphosphoric acids


yes


no


no


 


 


 


 




535


24100


0008050-09-7


rosin


yes


yes


no


 


 


 


 




24130




24190




83840




536


84320


0008050-15-5


rosin, hydrogenated, ester with methanol


yes


no


no


 


 


 


 




537


84080


0008050-26-8


rosin, ester with pentaerythritol


yes


no


no


 


 


 


 




538


84000


0008050-31-5


rosin, ester with glycerol


yes


no


no


 


 


 


 




539


24160


0008052-10-6


rosin tall oil


no


yes


no


 


 


 


 




540


63940


0008062-15-5


lignosulphonic acid


yes


no


no


0,24


 


Only to be used as dispersant for plastics dispersions


 




541


58480


0009000-01-5


gum arabic


yes


no


no


 


 


 


 




542


42640


0009000-11-7


carboxymethylcellulose


yes


no


no


 


 


 


 




543


45920


0009000-16-2


dammar


yes


no


no


 


 


 


 




544


58400


0009000-30-0


guar gum


yes


no


no


 


 


 


 




545


93680


0009000-65-1


tragacanth gum


yes


no


no


 


 


 


 




546


71440


0009000-69-5


pectin


yes


no


no


 


 


 


 




547


55440


0009000-70-8


gelatin


yes


no


no


 


 


 


 




548


42800


0009000-71-9


casein


yes


no


no


 


 


 


 




549


80000


0009002-88-4


polyethylene wax


yes


no


no


 


 


 


 




550


81060


0009003-07-0


polypropylene wax


yes


no


no


 


 


 


 




551


79920


0009003-11-6
0106392-12-5


poly(ethylene propylene) glycol


yes


no


no


 


 


 


 




552


81500


0009003-39-8


polyvinylpyrrolidone


yes


no


no


 


 


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



 




553


14500


0009004-34-6


cellulose


yes


yes


no


 


 


 


 




43280




554


43300


0009004-36-8


cellulose acetate butyrate


yes


no


no


 


 


 


 




555


53280


0009004-57-3


ethylcellulose


yes


no


no


 


 


 


 




556


54260


0009004-58-4


ethylhydroxyethylcellulose


yes


no


no


 


 


 


 




557


66640


0009004-59-5


methylethylcellulose


yes


no


no


 


 


 


 




558


60560


0009004-62-0


hydroxyethylcellulose


yes


no


no


 


 


 


 




559


61680


0009004-64-2


hydroxypropylcellulose


yes


no


no


 


 


 


 




560


66700


0009004-65-3


methylhydroxypropylcellulose


yes


no


no


 


 


 


 




561


66240


0009004-67-5


methylcellulose


yes


no


no


 


 


 


 




562


22450


0009004-70-0


nitrocellulose


no


yes


no


 


 


 


 




563


78320


0009004-97-1


polyethyleneglycol monoricinoleate


yes


no


yes


42


 


 


 




564


24540


0009005-25-8


starch, edible


yes


yes


no


 


 


 


 




88800




565


61120


0009005-27-0


hydroxyethyl starch


yes


no


no


 


 


 


 




566


33350


0009005-32-7


alginic acid


yes


no


no


 


 


 


 




567


82080


0009005-37-2


1,2-propyleneglycol alginate


yes


no


no


 


 


 


 




568


79040


0009005-64-5


polyethyleneglycol sorbitan monolaurate


yes


no


no


 


 


 


 




569


79120


0009005-65-6


polyethyleneglycol sorbitan monooleate


yes


no


no


 


 


 


 




570


79200


0009005-66-7


polyethyleneglycol sorbitan monopalmitate


yes


no


no


 


 


 


 




571


79280


0009005-67-8


polyethyleneglycol sorbitan monostearate


yes


no


no


 


 


 


 




572


79360


0009005-70-3


polyethyleneglycol sorbitan trioleate


yes


no


no


 


 


 


 




573


79440


0009005-71-4


polyethyleneglycol sorbitan tristearate


yes


no


no


 


 


 


 




574


24250


0009006-04-6


rubber, natural


yes


yes


no


 


 


 


 




84560




575


76721


0063148-62-9


polydimethylsiloxane (Mw > 6 800  Da)


yes


no


no


 


 


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


 




576


60880


0009032-42-2


hydroxyethylmethylcellulose


yes


no


no


 


 


 


 




577


62280


0009044-17-1


isobutylene-butene copolymer


yes


no


no


 


 


 


 




578


79600


0009046-01-9


polyethyleneglycol tridecyl ether phosphate


yes


no


no


5


 


For materials and articles intended for contact with aqueous foods only.
Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether.


 




579


61800


0009049-76-7


hydroxypropyl starch


yes


no


no


 


 


 


 




580


46070


0010016-20-3


α-dextrin


yes


no


no


 


 


 


 




581


36800


0010022-31-8


barium nitrate


yes


no


no


 


 


 


 




582


50240


0010039-33-5


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


yes


no


no


 


(10)


 


 




583


40400


0010043-11-5


boron nitride


yes


no


no


 


(16)


 


 




584


13620


0010043-35-3


boric acid


yes


yes


no


 


(16)


 


 




40320




585


41120


0010043-52-4


calcium chloride


yes


no


no


 


 


 


 




586


65280


0010043-84-2


manganese hypophosphite


yes


no


no


 


 


 


 




587


68400


0010094-45-8


octadecylerucamide


yes


no


yes


5


 


 


 




588


64320


0010377-51-2


lithium iodide


yes


no


no


 


(6)


 


 




589


52645


0010436-08-5


cis-11-eicosenamide


yes


no


no


 


 


 


 




590


21370


0010595-80-9


methacrylic acid, 2-sulphoethyl ester


no


yes


no


ND


 


 


(1)




591


36160


0010605-09-1


ascorbyl stearate


yes


no


no


 


 


 


 




592


34690


0011097-59-9


aluminium magnesium carbonate hydroxide


yes


no


no


 


 


 


 




593


44960


0011104-61-3


cobalt oxide


yes


no


no


 


 


 


 




594


65360


0011129-60-5


manganese oxide


yes


no


no


 


 


 


 




595


19510


0011132-73-3


lignocellulose


no


yes


no


 


 


 


 




596


95935


0011138-66-2


xanthan gum


yes


no


no


 


 


 


 




597


67120


0012001-26-2


mica


yes


no


no


 


 


 


 




598


41600


0012004-14-7
0037293-22-4


calcium sulphoaluminate


yes


no


no


 


 


 


 




599


36840


0012007-55-5


barium tetraborate


yes


no


no


 


(16)


 


 




600


60030


0012072-90-1


hydromagnesite


yes


no


no


 


 


 


 




601


35440


0012124-97-9


ammonium bromide


yes


no


no


 


 


 


 




602


70240


0012198-93-5


ozokerite


yes


no


no


 


 


 


 




603


83460


0012269-78-2


pyrophyllite


yes


no


no


 


 


 


 




604


60080


0012304-65-3


hydrotalcite


yes


no


no


 


 


 


 




605


11005


0012542-30-2


acrylic acid, dicyclopentenyl ester


no


yes


no


0,05


 


 


(1)




606


65200


0012626-88-9


manganese hydroxide


yes


no


no


 


 


 


 




607


62245


0012751-22-3


iron phosphide


yes


no


no


 


 


Only to be used in PET polymers and copolymers


 




608


40800


0013003-12-8


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


yes


no


yes


6


 


 


 




609


83455


0013445-56-2


pyrophosphorous acid


yes


no


no


 


 


 


 




610


93440


0013463-67-7


titanium dioxide


yes


no


no


 


 


 


 




611


35120


0013560-49-1


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


yes


no


no


 


 


 


 




612


16694


0013811-50-2


N,N′-divinyl-2-imidazolidinone


no


yes


no


0,05


 


 


(10)




613


95905


0013983-17-0


wollastonite


yes


no


no


 


 


 


 




614


45560


0014464-46-1


cristobalite


yes


no


no


 


 


 


 




615


92080


0014807-96-6


talc


yes


no


no


 


 


 


 




616


83470


0014808-60-7


quartz


yes


no


no


 


 


 


 




617


10660


0015214-89-8


2-acrylamido-2-methylpropanesulphonic acid


no


yes


no


0,05


 


 


 




618


51040


0015535-79-2


di-n-octyltin mercaptoacetate


yes


no


no


 


(10)


 


 




619


50320


0015571-58-1


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


yes


no


no


 


(10)


 


 




620


50720


0015571-60-5


di-n-octyltin dimaleate


yes


no


no


 


(10)


 


 




621


17110


0016219-75-3


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


no


yes


no


0,05


 


 


(9)




622


69840


0016260-09-6


oleylpalmitamide


yes


no


yes


5


 


 


 




623


52640


0016389-88-1


dolomite


yes


no


no


 


 


 


 




624


18897


0016712-64-4


6-hydroxy-2-naphthalenecarboxylic acid


no


yes


no


0,05


 


 


 




625


36720


0017194-00-2


barium hydroxide


yes


no


no


 


 


 


 




626


57800


0018641-57-1


glycerol tribehenate


yes


no


no


 


 


 


 




627


59760


0019569-21-2


huntite


yes


no


no


 


 


 


 




628


96190


0020427-58-1


zinc hydroxide


yes


no


no


 


 


 


 




629


34560


0021645-51-2


aluminium hydroxide


yes


no


no


 


 


 


 




630


82240


0022788-19-8


1,2-propyleneglycol dilaurate


yes


no


no


 


 


 


 




631


59120


0023128-74-7


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


yes


no


yes


45


 


 


 




632


52880


0023676-09-7


4-ethoxybenzoic acid, ethyl ester


yes


no


no


3,6


 


 


 




633


53200


0023949-66-8


2-ethoxy-2′-ethyloxanilide


yes


no


yes


30


 


 


 




634


25910


0024800-44-0


tripropyleneglycol


no


yes


no


 


 


 


 




635


40720


0025013-16-5


tert-butyl-4-hydroxyanisole


yes


no


no


30


 


 


 




636


31500


0025134-51-4


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


yes


no


no


0,05


(22)


SML expressed as acrylic acid, 2-ethylhexyl ester


 




637


71635


0025151-96-6


pentaerythritol dioleate


yes


no


no


0,05


 


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


 




638


23590


0025322-68-3


polyethyleneglycol


yes


yes


no


 


 


 


 




76960




639


23651


0025322-69-4


polypropyleneglycol


yes


yes


no


 


 


 


 




80800




640


54930


0025359-91-5


formaldehyde-1-naphthol, copolymer


yes


no


no


0,05


 


 


 




641


22331


0025513-64-8


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


no


yes


no


0,05


 


 


(10)




642


64990


0025736-61-2


maleic anhydride-styrene, copolymer, sodium salt


yes


no


no


 


 


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


 




643


87760


0026266-57-9


sorbitan monopalmitate


yes


no


no


 


 


 


 




644


88080


0026266-58-0


sorbitan trioleate


yes


no


no


 


 


 


 




645


67760


0026401-86-5


mono-n-octyltin tris(isooctyl mercaptoacetate)


yes


no


no


 


(11)


 


 




646


50480


0026401-97-8


di-n-octyltin bis(isooctyl mercaptoacetate)


yes


no


no


 


(10)


 


 




647


56720


0026402-23-3


glycerol monohexanoate


yes


no


no


 


 


 


 




648


56880


0026402-26-6


glycerol monooctanoate


yes


no


no


 


 


 


 




649


47210


0026427-07-6


dibutylthiostannoic acid polymer


yes


no


no


 


 


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


 




650


49600


0026636-01-1


dimethyltin bis(isooctyl mercaptoacetate)


yes


no


no


 


(9)


 


 




651


88240


0026658-19-5


sorbitan tristearate


yes


no


no


 


 


 


 




652


38820


0026741-53-7


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


yes


no


yes


0,6


 


 


 




653


25270


0026747-90-0


2,4-toluene diisocyanate dimer


no


yes


no


 


(17)


1 mg/kg in final product expressed as isocyanate moiety


(10)




654


88600


0026836-47-5


sorbitol monostearate


yes


no


no


 


 


 


 




655


25450


0026896-48-0


tricyclodecanedimethanol


no


yes


no


0,05


 


 


 




656


24760


0026914-43-2


styrenesuphonic acid


no


yes


no


0,05


 


 


 




657


67680


0027107-89-7


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


yes


no


no


 


(11)


 


 




658


52000


0027176-87-0


dodecylbenzenesulphonic acid


yes


no


no


30


 


 


 




659


82800


0027194-74-7


1,2-propyleneglycol monolaurate


yes


no


no


 


 


 


 




660


47540


0027458-90-8


di-tert-dodecyl disulphide


yes


no


yes


0,05


 


 


 




661


95360


0027676-62-6


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


yes


no


yes


5


 


 


 




662


25927


0027955-94-8


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


no


yes


no


0,005


 


Only to be used in polycarbonates


(1)




663


64150


0028290-79-1


linolenic acid


yes


no


no


 


 


 


 




664


95000


0028931-67-1


trimethylolpropane trimethacrylate-methyl methacrylate copolymer


yes


no


no


 


 


 


 




665


83120


0029013-28-3


1,2-propyleneglycol monopalmitate


yes


no


no


 


 


 


 




666


87280


0029116-98-1


sorbitan dioleate


yes


no


no


 


 


 


 




667


55190


0029204-02-2


gadoleic acid


yes


no


no


 


 


 


 




668


80240


0029894-35-7


polyglycerol ricinoleate


yes


no


no


 


 


 


 




669


56610


0030233-64-8


glycerol monobehenate


yes


no


no


 


 


 


 




670


56800


0030899-62-8


glycerol monolaurate diacetate


yes


no


no


 


(32)


 


 




671


74240


0031570-04-4


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


yes


no


no


 


 


 


 




672


76845


0031831-53-5


polyester of 1,4-butanediol with caprolactone


yes


no


no


 


(29)
(30)


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


 




673


53670


0032509-66-3


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


yes


no


yes


6


 


 


 




674


46480


0032647-67-9


dibenzylidene sorbitol


yes


no


no


 


 


 


 




675


38800


0032687-78-8


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


yes


no


yes


15


 


 


 




676


50400


0033568-99-9


di-n-octyltin bis(isooctyl maleate)


yes


no


no


 


(10)


 


 




677


82560


0033587-20-1


1,2-propyleneglycol dipalmitate


yes


no


no


 


 


 


 




678


59200


0035074-77-2


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


yes


no


yes


6


 


 


 




679


39060


0035958-30-6


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


yes


no


yes


5


 


 


 




680


94400


0036443-68-2


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


yes


no


no


9


 


 


 




681


18310


0036653-82-4


1-hexadecanol


no


yes


no


 


 


 


 




682


53270


0037205-99-5


ethylcarboxymethylcellulose


yes


no


no


 


 


 


 




683


66200


0037206-01-2


methylcarboxymethylcellulose


yes


no


no


 


 


 


 




684


68125


0037244-96-5


nepheline syenite


yes


no


no


 


 


 


 




685


85950


0037296-97-2


silicic acid, magnesium-sodium-fluoride salt


yes


no


no


0,15


 


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


 




686


61390


0037353-59-6


hydroxymethylcellulose


yes


no


no


 


 


 


 




687


13530


0038103-06-9


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


no


yes


no


0,05


 


 


 




13614




688


92560


0038613-77-3


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


yes


no


yes


18


 


 


 




689


95280


0040601-76-1


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


yes


no


yes


6


 


 


 




690


92880


0041484-35-9


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


yes


no


yes


2,4


 


 


 




691


13600


0047465-97-4


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


no


yes


no


1,8


 


 


 




692


52320


0052047-59-3


2-(4-dodecylphenyl)indole


yes


no


yes


0,06


 


 


 




693


88160


0054140-20-4


sorbitan tripalmitate


yes


no


no


 


 


 


 




694


21400


0054276-35-6


methacrylic acid, sulphopropyl ester


no


yes


no


0,05


 


 


(1)




695


67520


0054849-38-6


monomethyltin tris(isooctyl mercaptoacetate)


yes


no


no


 


(9)


 


 




696


92205


0057569-40-1


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


yes


no


no


 


 


 


 




697


67515


0057583-34-3


monomethyltin tris(ethylhexyl mercaptoacetate)


yes


no


no


 


(9)


 


 




698


49595


0057583-35-4


dimethyltin bis(ethylhexyl mercaptoacetate)


yes


no


no


 


(9)


 


 




699


90720


0058446-52-9


stearoylbenzoylmethane


yes


no


no


 


 


 


 




700


31520


0061167-58-6


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


yes


no


yes


6


 


 


 




701


40160


0061269-61-2


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


yes


no


no


2,4


 


 


 




702


87920


0061752-68-9


sorbitan tetrastearate


yes


no


no


 


 


 


 




703


17170


0061788-47-4


fatty acids, coco


no


yes


no


 


 


 


 




704


77600


0061788-85-0


polyethyleneglycol ester of hydrogenated castor oil


yes


no


no


 


 


 


 




705


10599/90A


0061788-89-4


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


no


yes


no


 


(18)


 


(1)




10599/91




706


17230


0061790-12-3


fatty acids, tall oil


no


yes


no


 


 


 


 




707


46375


0061790-53-2


diatomaceous earth


yes


no


no


 


 


 


 




708


77520


0061791-12-6


polyethyleneglycol ester of castor oil


yes


no


no


42


 


 


 




709


87520


0062568-11-0


sorbitan monobehenate


yes


no


no


 


 


 


 




710


38700


0063397-60-4


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


yes


no


yes


18


 


 


 




711


42000


0063438-80-2


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


yes


no


yes


30


 


 


 




712


42960


0064147-40-6


castor oil, dehydrated


yes


no


no


 


 


 


 




713


43480


0064365-11-3


charcoal, activated


yes


no


no


 


 


Only for use in PET at maximum 10 mg/kg of polymer.
Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Directive 95/45/EC (4) with exception of ash content which can be up to 10 % (w/w).


 




714


84400


0064365-17-9


rosin, hydrogenated, ester with pentaerythritol


yes


no


no


 


 


 


 




715


46880


0065140-91-2


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


yes


no


no


6


 


 


 




716


60800


0065447-77-0


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


yes


no


no


30


 


 


 




717


84210


0065997-06-0


rosin, hydrogenated


yes


no


no


 


 


 


 




718


84240


0065997-13-9


rosin, hydrogenated, ester with glycerol


yes


no


no


 


 


 


 




719


65920


0066822-60-4


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


yes


no


no


 


 


 


 




720


67360


0067649-65-4


mono-n-dodecyltin tris(isooctyl mercaptoacetate)


yes


no


no


 


(25)


 


 




721


46800


0067845-93-6


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


yes


no


no


 


 


 


 




722


17200


0068308-53-2


fatty acids, soya


no


yes


no


 


 


 


 




723


88880


0068412-29-3


starch, hydrolysed


yes


no


no


 


 


 


 




724


24903


0068425-17-2


syrups, hydrolysed starch, hydrogenated


no


yes


no


 


 


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



 




725


77895


0068439-49-6


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


yes


no


no


0,05


 


The composition of this mixture is as follows:






—


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










—


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










—


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






 




726


83599


0068442-12-6


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


yes


no


yes


 


(9)


 


 




727


43360


0068442-85-3


cellulose, regenerated


yes


no


no


 


 


 


 




728


75100


0068515-48-0
0028553-12-0


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



yes


no


no


 


(26)
(32)


Only to be used as:






(a)


plasticiser in repeated use materials and articles;










(b)


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










(c)


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






(7)




729


75105


0068515-49-1
0026761-40-0


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



yes


no


no


 


(26)
(32)


Only to be used as:






(a)


plasticiser in repeated use materials and articles;










(b)


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










(c)


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






(7)




730


66930


0068554-70-1


methylsilsesquioxane


yes


no


no


 


 


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


 




731


18220


0068564-88-5


N-heptylaminoundecanoic acid


no


yes


no


0,05


 


 


(2)




732


45450


0068610-51-5



p-cresol-dicyclopentadiene-isobutylene, copolymer


yes


no


yes


5


 


 


 




733


10599/92A


0068783-41-5


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


no


yes


no


 


(18)


 


(1)




10599/93




734


46380


0068855-54-9


diatomaceous earth, soda ash flux-calcined


yes


no


no


 


 


 


 




735


40120


0068951-50-8


bis(polyethyleneglycol)hydroxymethylphosphonate


yes


no


no


0,6


 


 


 




736


50960


0069226-44-4


di-n-octyltin ethyleneglycol bis(mercaptoacetate)


yes


no


no


 


(10)


 


 




737


77370


0070142-34-6


polyethyleneglycol-30 dipolyhydroxystearate


yes


no


no


 


 


 


 




738


60320


0070321-86-7


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


yes


no


yes


1,5


 


 


 




739


70000


0070331-94-1


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


yes


no


no


 


 


 


 




740


81200


0071878-19-8


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


yes


no


yes


3


 


 


 




741


24070


0073138-82-6


resin acids and rosin acids


yes


yes


no


 


 


 


 




83610




742


92700


0078301-43-6


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


yes


no


yes


5


 


 


 




743


38950


0079072-96-1


bis(4-ethylbenzylidene)sorbitol


yes


no


no


 


 


 


 




744


18888


0080181-31-3


3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer


no


yes


no


 


 


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


 




745


68145


0080410-33-9


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


yes


no


yes


5


 


SML expressed as sum of phosphite and phosphate


 




746


38810


0080693-00-1


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


yes


no


yes


5


 


SML expressed as sum of phosphite and phosphate


 




747


47600


0084030-61-5


di-n-dodecyltin bis(isooctyl mercaptoacetate)


yes


no


yes


 


(25)


 


 




748


12765


0084434-12-8


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


no


yes


no


0,05


 


 


 




749


66360


0085209-91-2


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


yes


no


yes


5


 


 


 




750


66350


0085209-93-4


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


yes


no


no


5


 


 


 




751


81515


0087189-25-1


poly(zinc glycerolate)


yes


no


no


 


 


 


 




752


39890


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


bis(methylbenzylidene)sorbitol


yes


no


no


 


 


 


 




753


62800


0092704-41-1


kaolin, calcined


yes


no


no


 


 


 


 




754


56020


0099880-64-5


glycerol dibehenate


yes


no


no


 


 


 


 




755


21765


0106246-33-7


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


no


yes


no


0,05


 


 


(1)




756


40020


0110553-27-0


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


yes


no


yes


 


(24)


 


 




757


95725


0110638-71-6


vermiculite, reaction product with citric acid, lithium salt


yes


no


no


 


 


 


 




758


38940


0110675-26-8


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


yes


no


yes


 


(24)


 


 




759


54300


0118337-09-0


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


yes


no


yes


6


 


 


 




760


83595


0119345-01-6


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


yes


no


no


18


 


Composition:






—


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










—


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










—


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










—


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










—


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










—


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










(*)


Quantity of substance used/quantity of formulation




Other specifications:






—


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










—


Acid value of max. 10 mg KOH per gram,










—


Melt range of 85– 110 °C,






 




761


92930


0120218-34-0


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


yes


no


no


6


 


 


 




762


31530


0123968-25-2


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


yes


no


yes


5


 


 


 




763


39925


0129228-21-3


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


yes


no


yes


0,05


 


 


 




764


13317


0132459-54-2


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


no


yes


no


0,05


 


Purity > 98,1 % (w/w).
Only to be used as co-monomer (max 4 %) for polyesters (PET, PBT).


 




765


49485


0134701-20-5


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


yes


no


yes


1


 


 


 




766


38879


0135861-56-2


bis(3,4-dimethylbenzylidene)sorbitol


yes


no


no


 


 


 


 




767


38510


0136504-96-6


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


yes


no


no


5


 


 


 




768


34850


0143925-92-2


amines, bis(hydrogenated tallow alkyl) oxidised


yes


no


no


 


 


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






(a)


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










(b)


PET at 0,25 % (w/w) concentration.






(1)




769


74010


0145650-60-8


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


yes


no


yes


5


 


SML expressed as sum of phosphite and phosphate


 




770


51700


0147315-50-2


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


yes


no


no


0,05


 


 


 




771


34650


0151841-65-5


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


yes


no


no


5


 


 


 




772


47500


0153250-52-3


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


yes


no


no


5


 


 


 




773


38840


0154862-43-8


bis(2,4-dicumylphenyl)pentaerythritol-diphosphite


yes


no


yes


5


 


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


 




774


95270


0161717-32-4


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


yes


no


yes


2


 


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


 




775


45705


0166412-78-8


1,2-cyclohexanedicarboxylic acid, diisononyl ester


yes


no


no


 


(32)


 


 




776


76723


0167883-16-1


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


yes


no


no


 


 


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


 




777


31542


0174254-23-0


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


yes


no


no


 


 


0,5 % in final product


(1)




778


71670


0178671-58-4


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


yes


no


yes


0,05


 


 


 




779


39815


0182121-12-6


9,9-bis(methoxymethyl)fluorene


yes


no


yes


0,05


 


 


(1)




780


81220


0192268-64-7


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


yes


no


no


5


 


 


 




781


95265


0227099-60-7


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


yes


no


no


0,05


 


 


 




782


76725


0661476-41-1


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


yes


no


no


 


 


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


 




783


55910


0736150-63-3


glycerides, castor-oil mono-, hydrogenated, acetates


yes


no


no


 


(32)


 


 




784


95420


0745070-61-5


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


yes


no


no


0,05


 


 


 




785


24910


0000100-21-0


terephthalic acid


no


yes


no


 


(28)


 


 




786


14627


0000117-21-5


3-chlorophthalic anhydride


no


yes


no


0,05


 


SML expressed as 3-chlorophthalic acid


 




787


14628


0000118-45-6


4-chlorophthalic anhydride


no


yes


no


0,05


 


SML expressed as 4-chlorophthalic acid


 




788


21498


0002530-85-0


[3-(methacryloxy)propyl]trimethoxysilane


no


yes


no


0,05


 


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


(1)
(11)




789


60027


—


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


yes


no


no


 


 


Average molecular weight not less than 440 Da.
Viscosity at 100 °C not less than 3,8 cSt (3,8 × 10-6 m2/s).


(2)




790


80480


0090751-07-8
0082451-48-7


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


yes


no


no


5


 


Average molecular weight not less than 2 400  Da.
Residual content of morpholine ≤ 30 mg/kg, of N,N′-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine < 15 000  mg/kg, and of 2,4-dichloro-6-morpholino-1,3,5-triazine ≤ 20 mg/kg.


(16)




791


92470


0106990-43-6


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


yes


no


no


0,05


 


 


 




792


92475


0203255-81-6


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


yes


no


yes


5


 


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


 




793


94000


0000102-71-6


triethanolamine


yes


no


no


0,05


 


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


 




794


18117


0000079-14-1


glycolic acid


no


yes


no


 


 


For indirect food contact only, behind a PET layer


 




795


40155


0124172-53-8


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


yes


no


no


0,05


 


 


(2)
(12)




796


72141


0018600-59-4


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


yes


no


yes


0,05


 


SML including the sum of its hydrolysis products


 




797


76807


0007328-26-5


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


yes


no


yes


 


(31)
(32)


 


 




798


92200


0006422-86-2


terephthalic acid, bis(2-ethylhexyl)ester


yes


no


no


60


(32)


 


 




799


77708


—


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


yes


no


no


1,8


 


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


 




800


94425


0000867-13-0


triethyl phosphonoacetate


yes


no


no


 


 


Only for use in PET


 




801


30607


—


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


yes


no


no


 


 


 


 




802


33105


0146340-15-0


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


yes


no


no


5


 


 


(12)




803


33535


0152261-33-1


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


yes


no


no


 


 


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


(13)




804


80510


1010121-89-7


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


yes


no


no


 


 


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


 




805


93450


—


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


yes


no


no


 


 


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


 




806


14876


0001076-97-7


1,4-cyclohexanedicarboxylic acid


no


yes


no


5


 


Only to be used for manufacture of polyesters


 




807


93485


—


titanium nitride, nanoparticles


yes


no


no


 


 


No migration of titanium nitride nanoparticles.
Only to be used in PET bottles up to 20 mg/kg.
In the PET, the agglomerates have a diameter of 100 – 500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.


 




808


38550


0882073-43-0


bis(4-propylbenzylidene)propylsorbitol


yes


no


no


5


 


SML including the sum of its hydrolysis products


 




809


49080


0852282-89-4


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


yes


no


yes


0,05


 


Only for use in PET


(6)
(14)
(15)




810


68119


 


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


yes


no


no


5


(32)


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


 




811


80077


0068441-17-8


polyethylene waxes, oxidised


yes


no


no


60


 


 


 




812


80350


0124578-12-7


poly(12-hydroxystearic acid)-polyethyleneimine copolymer


yes


no


no


 


 


Only to be used in polyethylene terephthalate (PET), polystyrene (PS), high impact polystyrene (HIPS) and polyamide (PA) up to 0,1 % w/w.
Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.


 




813


91530


—


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


yes


no


no


5


 


 


 




814


91815


—


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


yes


no


no


2


 


 


 




815


94985


—


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


yes


no


no


5


(32)


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


 




816


45704


—


cis-1,2-cyclohexanedicarboxylic acid, salts


yes


no


no


5


 


 


 




817


38507


—


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


yes


no


no


5


 


Not to be used with polyethylene in contact with acidic foods.
Purity ≥ 96 %.


 




818


21530


—


methallylsulphonic acid, salts


no


yes


no


5


 


 


 




819


68110


—


neodecanoic acid, salts


yes


no


no


0,05


 


Not to be used in polymers contacting fatty foods.
Not to be used for articles in contact with fatty foods for which simulant D is laid down.
SML expressed as neodecanoic acid.


 




820


76420


—


pimelic acid, salts


yes


no


no


 


 


 


 




821


90810


—


stearoyl-2-lactylic acid, salts


yes


no


no


 


 


 


 




822


71938


—


perchloric acid, salts


yes


no


no


0,05


 


 


(4)




823


24889


—


5-Sulphoisophthalic acid, salts


no


yes


no


5


 


 


 




854


71943


0329238-24-6


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


yes


no


no


 


 


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


 




860


71980


0051798-33-5


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


yes


no


no


 


 


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


 




861


71990


0013252-13-6


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


yes


no


no


 


 


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


 




862


15180


0018085-02-4


3,4-diacetoxy-1-butene


no


yes


no


0,05


 


SML including the hydrolysis product 3,4-dihydroxy-1-butene.
Only for use as a co-monomer for ethyl vinyl alcohol copolymers.


 




864


46330


0000056-06-4


2,4-diamino-6-hydroxypyrimidine


yes


no


no


5


 


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


 




865


40619


0025322-99-0


(butyl acrylate, methyl methacrylate, butyl methacrylate) copolymer


yes


no


no


 


 


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


 




866


40620


—


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


yes


no


no


 


 


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


 




867


40815


0040471-03-2


(butyl methacrylate, ethyl acrylate, methyl methacrylate) copolymer


yes


no


no


 


 


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


 




868


53245


0009010-88-2


(ethyl acrylate, methyl methacrylate) copolymer


yes


no


no


 


 


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


 




869


66763


0027136-15-8


(butyl acrylate, methyl methacrylate, styrene) copolymer


yes


no


no


 


 


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


 




870


95500


0160535-46-6


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


yes


no


no


5


 


 


 




875


80345


0058128-22-6


poly(12-hydroxystearic acid) stearate


yes


no


yes


5


 


 


 




878


31335


—


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


yes


no


no


 


 


 


 




879


31336


—


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


yes


no


no


 


 


 


 




880


31348


0085116-93-4


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


yes


no


no


 


 


 


 




881


25187


0003010-96-6


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


no


yes


no


5


 


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


 




882


25872


0002416-94-6


2,3,6-trimethylphenol


no


yes


no


0,05


 


 


 




883


22074


0004457-71-0


3-methyl-1,5-pentanediol


no


yes


no


0,05


 


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


 




884


34240


0091082-17-6


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


yes


no


no


0,05


 


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


 




885


45676


0263244-54-8


cyclic oligomers of (butylene terephthalate)


yes


no


no


 


 


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


 




2.   Group restriction of substances
Table 2 on Group restrictions contains the following information:
Column 1 (Group restriction No): contains the identification number of the group of substances for which the group restriction applies. It is the number referred to in Column 9 in Table 1 of this Annex.
Column 2 (FCM substance No): contains the unique identification numbers of the substances for which the group restriction applies. It is the number referred to in Column 1 in Table 1 of this Annex.
Column 3 (SML (T) [mg/kg]): contains the total specific migration limit for the sum of substances applicable to this group. It is expressed in mg substance per kg food. It is indicated ND if the substance shall not migrate in detectable quantities.
Column 4 (Group restriction specification): contains an indication of the substance whose molecular weight forms the basis for expression of the result.
Table 2








(1)


(2)


(3)


(4)




Group Restriction No


FCM substance No


SML (T)
[mg/kg]


Group restriction specification




1


128
211


6


expressed as acetaldehyde




2


89
227
263


30


expressed as ethyleneglycol




3


234
248


30


expressed as maleic acid




4


212
435


15


expressed as caprolactam




5


137
472


3


expressed as the sum of the substances




6


412
512
513
588


1


expressed as iodine




7


19
20


1,2


expressed as tertiary amine




8


317
318
319
359
431
464


6


expressed as the sum of the substances




9


650
695
697
698
726


0,18


expressed as tin




10


28
29
30
31
32
33
466
582
618
619
620
646
676
736


0,006


expressed as tin




11


66
645
657


1,2


expressed as tin




12


444
469
470


30


expressed as the sum of the substances




13


163
285


1,5


expressed as the sum of the substances




14


294
368


5


expressed as the sum of the substances




15


98
196


15


expressed as formaldehyde




16


407
583
584
599


6


expressed as boron
Without prejudice to the provisions of Directive 98/83/EC




17


4
167
169
198
274
354
372
460
461
475
476
485
490
653


ND


expressed as isocyanate moiety




18


705
733


0,05


expressed as the sum of the substances




19


505
516
519


10


expressed as SO2





20


290
386
390


30


expressed as the sum of the substances




21


347
349


5


expressed as trimellitic acid




22


70
147
176
218
323
325
365
371
380
425
446
448
456
636


6


expressed as acrylic acid




23


150
156
181
183
184
355
370
374
439
440
447
457
482


6


expressed as methacrylic acid




24


756
758


5


expressed as the sum of the substances




25


720
747


0,05


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




26


728
729


9


expressed as the sum of the substances




27


188
291


5


expressed as isophthalic acid




28


191
192
785


7,5


expressed as terephthalic acid




29


342
672


0,05


expressed as the sum of 6-hydroxyhexanoic acid and caprolactone




30


254
672


5


expressed as 1,4-butanediol




31


73
797


30


expressed as the sum of the substances




32


8
72
73
138
140
157
159
207
242
283
532
670
728
729
775
783
797
798
810
815


60


expressed as the sum of the substances




3.   Notes on verification of compliance
Table 3 on notes on verification of compliance contains the following information:
Column 1 (Note No): contains the identification number of the Note. It is the number referred to in Column 11 in Table 1 of this Annex.
Column 2 (Notes on verification of compliance): contains rules that shall be respected when testing for compliance of the substance with specific migration limits or other restrictions or it contains remarks on situations where there is a risk of non-compliance.
Table 3






(1)


(2)




Note No


Notes on verification of compliance




(1)


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




(2)


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




(3)


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




(4)


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




(5)


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




(6)


Migration limit might be exceeded at very high temperature.




(7)


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




(8)


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




(9)


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




(10)


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




(11)


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




(12)


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




(13)


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




(14)


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




(15)


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




(16)


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




(17)


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




4.   Detailed specification on substances
Table 4 on detailed specifications on substances contains the following information
Column 1 (FCM substance No): contains the unique identification number of the substances referred to in Column 1 in Table 1 of Annex I to which the specification applies.
Column 2 (Detailed specification on the substance): contains the specification on the substance.
Table 4







(1)


(2)




FCM substance No


Detailed specification on the substance




744


Definition


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




 


Chemical name


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




 


CAS number


0080181-31-3




 


Structural formula







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




 


Average molecular weight


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




 


Assay


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




 


Description


White to off-white powder after isolation




 


Characteristics


 




 


Identification tests:


 




 


Solubility


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




 


Restriction


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





 


Purity


Prior to granulation the raw material copolymer powder must contain:




 








—


nitrogen,






Not more than 2 500  mg/kg of plastic




 








—


zinc,






Not more than 100 mg/kg of plastic




 








—


copper,






Not more than 5 mg/kg of plastic




 








—


lead,






Not more than 2 mg/kg of plastic




 








—


arsenic,






Not more than 1 mg/kg of plastic




 








—


chromium,






Not more than 1 mg/kg of plastic






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

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

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

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

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





ANNEX II
Restrictions on materials and articles
1.   Plastic materials and articles shall not release the following substances in quantities exceeding the specific migration limits below:
Barium = 1 mg/kg food or food simulant.
Cobalt = 0,05 mg/kg food or food simulant.
Copper = 5 mg/kg food or food simulant.
Iron = 48 mg/kg food or food simulant.
Lithium = 0,6 mg/kg food or food simulant.
Manganese = 0,6 mg/kg food or food simulant.
Zinc = 25 mg/kg food or food simulant.
2.   Plastic materials and articles shall not release primary aromatic amines, excluding those appearing in Table 1 of Annex I, in a detectable quantity into food or food simulant. The detection limit is 0,01 mg of substance per kg of food or food simulant. The detection limit applies to the sum of primary aromatic amines released.





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






Food simulant


Abbreviation




Ethanol 10 % (v/v)


Food simulant A




Acetic acid 3 % (w/v)


Food simulant B




Ethanol 20 % (v/v)


Food simulant C




Ethanol 50 % (v/v)


Food simulant D1




Vegetable oil (*1)



Food simulant D2




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


Food simulant E




2.   General assignment of food simulants to foods
Food simulants A, B and C are assigned for foods that have a hydrophilic character and are able to extract hydrophilic substances. Food simulant B shall be used for those foods which have a pH below 4.5. Food simulant C shall be used for alcoholic foods with an alcohol content of up to 20 % and those foods which contain a relevant amount of organic ingredients that render the food more lipophilic.
Food simulants D1 and D2 are assigned for foods that have a lipophilic character and are able to extract lipophilic substances. Food simulant D1 shall be used for alcoholic foods with an alcohol content of above 20 % and for oil in water emulsions. Food simulant D2 shall be used for foods which contain free fats at the surface.
Food simulant E is assigned for testing specific migration into dry foods.
3.   Specific assignment of food simulants to foods for migration testing of materials and articles not yet in contact with food
For testing migration from materials and articles not yet in contact with food the food simulants that corresponds to a certain food category shall be chosen according Table 2 below.
For testing overall migration from materials and articles intended to come into contact with different food categories or a combination of food categories the food simulant assignment in point 4 is applicable.
Table 2 contains the following information:
Column 1 (Reference number): contains the reference number of the food category.
Column 2 (Description of food): contains a description of the foods covered by the food category
Column 3 (Food simulants): contains sub-columns for each of the food simulants
The food simulant for which a cross is contained in the respective sub-column of column 3 shall be used when testing migration of materials and articles not yet in contact with food.
For food categories where in sub-column D2 the cross is followed by an oblique stroke and a figure, the migration test result shall be divided by this figure before comparing the result with the migration limit. The figure is the correction factor referred to in point 4.2 of Annex V to this Regulation.
For food category 01.04 food simulant D2 shall be replaced by 95 % ethanol.
For food categories where in sub-column B the cross is followed by (*) the testing in food simulant B can be omitted if the food has a pH of more than 4.5.
For food categories where in sub-column D2 the cross is followed by (**) the testing in food simulant D2 can be omitted if it can be demonstrated by means of an appropriate test that there is no ‘fatty contact’ with the plastic food contact material.
Table 2
food category specific assignment of food simulants












(1)


(2)


(3)




Reference number


Description of food


Food simulants




A


B


C


D1


D2


E




01



Beverages



 


 


 


 


 


 




01.01


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


 


 


 


 


 


 




 








A.


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






 


X(*)


X


 


 


 




 








B.


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






 


X(*)


 


X


 


 




01.02


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


 


 


X


 


 


 




01.03


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


 


 


 


X


 


 




01.04


Miscellaneous: undenaturated ethyl alcohol


 


X(*)


 


 


Substitute 95 % ethanol


 




02



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



 


 


 


 


 


 




02.01


Starches


 


 


 


 


 


X




02.02


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


 


 


 


 


 


X




02.03


Cereal flour and meal


 


 


 


 


 


X




02.04


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


 


 


 


 


 


X




02.05


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


 


 


 


 


 


 




 








A.


With fatty substances on the surface






 


 


 


 


X/3


 




 








B.


Other






 


 


 


 


 


X




02.06


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


 


 


 


 


 


 




 








A.


With fatty substances on the surface






 


 


 


 


X/3


 




 








B.


Other






 


 


 


 


 


X




03



Chocolate, sugar and products thereof


Confectionery products



 


 


 


 


 


 




03.01


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


 


 


 


 


X/3


 




03.02


Confectionery products:


 


 


 


 


 


 




 








A.


In solid form:






 


 


 


 


 


 




 








I.


With fatty substances on the surface






 


 


 


 


X/3


 




 








II.


Other






 


 


 


 


 


X




 








B.


In paste form:






 


 


 


 


 


 




 








I.


With fatty substances on the surface






 


 


 


 


X/2


 




 








II.


Moist






 


 


X


 


 


 




03.03


Sugar and sugar products


 


 


 


 


 


 




 








A.


In solid form: crystal or powder






 


 


 


 


 


X




 








B.


Molasses, sugar syrups, honey and the like






X


 


 


 


 


 




04



Fruit, vegetables and products thereof



 


 


 


 


 


 




04.01


Whole fruit, fresh or chilled, unpeeled


 


 


 


 


 


 




04.02


Processed fruit:


 


 


 


 


 


 




 








A.


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






 


 


 


 


 


X




 








B.


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






 


X(*)


X


 


 


 




 








C.


Fruit preserved in a liquid medium:






 


 


 


 


 


 




 








I.


In an oily medium






 


 


 


 


X


 




 








II.


In an alcoholic medium






 


 


 


X


 


 




04.03


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


 


 


 


 


 


 




 








A.


Shelled, dried, flaked or powdered






 


 


 


 


 


X




 








B.


Shelled and roasted






 


 


 


 


 


X




 








C.


In paste or cream form






X


 


 


 


X


 




04.04


Whole vegetables, fresh or chilled, unpeeled


 


 


 


 


 


 




04.05


Processed vegetables:


 


 


 


 


 


 




 








A.


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






 


 


 


 


 


X




 








B.


Fresh vegetables, peeled or cut






X


 


 


 


 


 




 








C.


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






 


X(*)


X


 


 


 




 








D.


Preserved vegetables:






 


 


 


 


 


 




 








I.


In an oily medium






X


 


 


 


X


 




 








II.


In an alcoholic medium






 


 


 


X


 


 




05



Fats and oils



 


 


 


 


 


 




05.01


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


 


 


 


 


X


 




05.02


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


 


 


 


 


X/2


 




06



Animal products and eggs



 


 


 


 


 


 




06.01


Fish:


 


 


 


 


 


 




 








A.


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






X


 


 


 


X/3(**)


 




 








B.


Preserved fish:






 


 


 


 


 


 




 








I.


In an oily medium






X


 


 


 


X


 




 








II.


In an aqueous medium






 


X(*)


X


 


 


 




06.02


Crustaceans and molluscs (including oysters, mussels, snails)


 


 


 


 


 


 




 








A.


Fresh within the shell






 


 


 


 


 


 




 








B.


Shell removed, processed, preserved or cooked with the shell






 


 


 


 


 


 




 








I.


In an oily medium






X


 


 


 


X


 




 








II.


In an aqueous medium






 


X(*)


X


 


 


 




06.03


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


 


 


 


 


 


 




 








A.


Fresh, chilled, salted, smoked






X


 


 


 


X/4(**)


 




 








B.


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






X


 


 


 


X/4(**)


 




 








C.


Marinated meat products in an oily medium






X


 


 


 


X


 




06.04


Preserved meat:


 


 


 


 


 


 




 








A.


In an fatty or oily medium






X


 


 


 


X/3


 




 








B.


In an aqueous medium






 


X(*)


 


X


 


 




06.05


Whole eggs, egg yolk, egg white


 


 


 


 


 


 




 








A.


Powdered or dried or frozen






 


 


 


 


 


X




 








B.


Liquid and cooked






 


 


 


X


 


 




07



Milk products



 


 


 


 


 


 




07.01


Milk


 


 


 


 


 


 




 








A.


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






 


 


 


X


 


 




 








B.


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






 


 


 


 


 


X




07.02


Fermented milk such as yoghurt, buttermilk and similar products


 


X(*)


 


X


 


 




07.03


Cream and sour cream


 


X(*)


 


X


 


 




07.04


Cheeses:


 


 


 


 


 


 




 








A.


Whole, with not edible rind






 


 


 


 


 


X




 








B.


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






 


 


 


 


X/3(**)


 




 








C.


Processed cheese (soft cheese, cottage cheese and similar)






 


X(*)


 


X


 


 




 








D.


Preserved cheese:






 


 


 


 


 


 




 








I.


In an oily medium






X


 


 


 


X


 




 








II.


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






 


X(*)


 


X


 


 




08



Miscellaneous products



 


 


 


 


 


 




08.01


Vinegar


 


X


 


 


 


 




08.02


Fried or roasted foods:


 


 


 


 


 


 




 








A.


Fried potatoes, fritters and the like






X


 


 


 


X/5


 




 








B.


Of animal origin






X


 


 


 


X/4


 




08.03


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


 


 


 


 


 


 




 








A.


Powdered or dried:






 


 


 


 


 


 




 








I.


With fatty character






 


 


 


 


X/5


 




 








II.


Other






 


 


 


 


 


X




 








B.


any other form than powdered or dried:






 


 


 


 


 


 




 








I.


With fatty character






X


X(*)


 


 


X/3


 




 








II.


Other






 


X(*)


X


 


 


 




08.04


Sauces:


 


 


 


 


 


 




 








A.


With aqueous character






 


X(*)


X


 


 


 




 








B.


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






X


X(*)


 


 


X


 




08.05


Mustard (except powdered mustard under heading 08.14)


X


X(*)


 


 


X/3(**)


 




08.06


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


 


 


 


 


 


 




 








A.


With fatty substances on the surface






X


 


 


 


X/5


 




 








B.


Other






 


 


 


 


 


X




08.07


Ice-creams


 


 


X


 


 


 




08.08


Dried foods:


 


 


 


 


 


 




 








A.


With fatty substances on the surface






 


 


 


 


X/5


 




 








B.


Other






 


 


 


 


 


X




08.09


Frozen or deep-frozen foods


 


 


 


 


 


X




08.10


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


 


X(*)


 


X


 


 




08.11


Cocoa:


 


 


 


 


 


 




 








A.


Cocoa powder, including fat-reduced and highly fat reduced






 


 


 


 


 


X




 








B.


Cocoa paste






 


 


 


 


X/3


 




08.12


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


 


 


 


 


 


X




08.13


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


 


 


 


 


 


X




08.14


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


 


 


 


 


 


X




08.15


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


 


 


 


 


X


 




4.   Food simulant assignment for testing overall migration
To demonstrate compliance with the overall migration limit for all type of foods testing in distilled water or water of equivalent quality or food simulant A and food simulant B and simulant D2 shall be performed.
To demonstrate compliance with the overall migration limit for all types of food except for acidic foods testing in distilled water or water of equivalent quality or food simulant A and food simulant D2 shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous and alcoholic foods and milk products testing in food simulant D1 shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous, acidic and alcoholic foods and milk products testing in food simulant D1 and food simulant B shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous foods and alcoholic foods up to an alcohol content of 20 % testing in food simulant C shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20 % testing in food simulant C and food simulant B shall be performed.


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












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


6-12


14


16


18:0


18:1


18:2


18:3




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


< 1


< 1


1,5-20


< 7


15-85


5-70


< 1,5









ANNEX IV
Declaration of compliance
The written declaration referred to in Article 15 shall contain the following information:






(1)


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










(2)


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










(3)


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










(4)


the date of the declaration;










(5)


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










(6)


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










(7)


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










(8)


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






(i)


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










(ii)


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










(iii)


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














(9)


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









ANNEX V
COMPLIANCE TESTING
For testing compliance of migration from plastic food contact materials and articles the following general rules apply.
CHAPTER 1
Testing for specific migration of materials and articles already in contact with food
1.1.   Sample preparation
The material or article shall be stored as indicated on the packaging label or under conditions adequate for the packaged food if no instructions are given. The food shall be removed from contact with the material or article before its expiration date or any date by which the manufacturer has indicated the product should be used for reasons of quality or safety.
1.2.   Conditions of testing
The food shall be treated in accordance with the cooking instructions on the package if the food is to be cooked in the package. Parts of the food which are not intended to be eaten shall be removed and discarded. The remainder shall be homogenised and analysed for migration. The analytical results shall always be expressed on the basis of the food mass that is intended to be eaten, in contact with the food contact material.
1.3.   Analysis of migrated substances
The specific migration is analysed in the food using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004.
1.4.   Special cases
When contamination occurs from sources other than food contact materials this has to be taken into account when testing for compliance of the food contact materials, in particular for phthalates (FCM substance 157, 159, 283, 728, 729) referred to in Annex I.
CHAPTER 2
Testing for specific migration of materials and articles not yet in contact with food
2.1.   Verification method
Verification of compliance of migration into foods with the migration limits shall be carried out under the most extreme conditions of time and temperature foreseeable in actual use taking into account paragraphs 1.4, 2.1.1, 2.1.6 and 2.1.7.
Verification of compliance of migration into food simulants with the migration limits shall be carried out using conventional migration tests according to the rules set out in paragraphs 2.1.1 to 2.1.7.
2.1.1.   Sample preparation
The material or article shall be treated as described by accompanying instructions or by provisions given in the declaration of compliance.
Migration is determined on the material or article or, if this is impractical, on a specimen taken from the material or article, or a specimen representative of this material or article. For each food simulant or food type, a new test specimen is used. Only those parts of the sample which are intended to come into contact with foods in actual use shall be placed in contact with the food simulant or the food.
2.1.2.   Choice of food simulant
Materials and articles intended for contact with all types of food shall be tested with food simulant A, B and D2. However, if substances that may react with acidic food simulant or foods are not present testing in food simulant B can be omitted.
Materials and articles intended only for specific types of foods shall be tested with the food simulants indicated for the food types in Annex III.
2.1.3.   Conditions of contact when using food simulants
The sample shall be placed in contact with the food simulant in a manner representing the worst of the foreseeable conditions of use as regard contact time in Table 1 and as regard contact temperature in Table 2.
If it is found that carrying out the tests under the combination of contact conditions specified in Tables 1 and 2 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place.
Table 1
Contact time






Contact time in worst foreseeable use


Test time




t ≤ 5 min


5 min




5 min < t ≤ 0,5 hour


0,5 hour




0,5 hours < t ≤ 1 hour


1 hour




1 hour < t ≤ 2 hours


2 hours




2 hours < t ≤ 6 hours


6 hours




6 hours < t ≤ 24 hours


24 hours




1 day < t ≤ 3 days


3 days




3 days < t ≤ 30 days


10 days




Above 30 days


See specific conditions







Table 2
Contact temperature






Conditions of contact in worst foreseeable use


Test conditions




Contact temperature


Test temperature




T ≤ 5 °C


5 °C




5 °C < T ≤ 20 °C


20 °C




20 °C < T ≤ 40 °C


40 °C




40 °C < T ≤ 70 °C


70 °C




70 °C < T ≤ 100 °C


100 °C or reflux temperature




100 °C < T ≤ 121 °C


121 °C (*1)





121 °C < T ≤ 130 °C


130 °C (*1)





130 °C < T ≤ 150 °C


150 °C (*1)





150 °C < T < 175 °C


175 °C (*1)





T > 175 °C


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





2.1.4.   Specific conditions for contact times above 30 days at room temperature and below
For contact times above 30 days at room temperature and below the specimen shall be tested in an accelerated test at elevated temperature for a maximum of 10 days at 60 °C. Testing time and temperature conditions shall be based on the following formula.
t2 = t1 * Exp ((-Ea/R) * (1/T1-1/T2))
Ea is the worst case activation energy 80kJ/mol
R is a factor 8,31 J/Kelvin/mol
Exp -9627 * (1/T1-1/T2)
t1 is the contact time
t2 is the testing time
T1 is the contact temperature in Kelvin. For room temperature storage this is set at 298 K (25 °C). For refrigerated and frozen conditions it is set at 278 K (5 °C).
T2 is the testing temperature in Kelvin.
Testing for 10 days at 20 °C shall cover all storage times at frozen condition.
Testing for 10 days at 40 °C shall cover all storage times at refrigerated and frozen conditions including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes.
Testing for 10 days at 50 °C shall cover all storage time at refrigerated and frozen conditions including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes and storage times of up to 6 months at room temperature.
Testing for 10 days at 60 °C shall cover long term storage above 6 months at room temperature and below including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes.
The maximum testing temperature is governed by the phase transition temperature of the polymer. At the test temperature the test specimen should not undergo any physical changes.
For storage at room temperature testing time can be reduced to 10 days at 40 °C if there is scientific evidence that migration of the respective substance in the polymer has reached equilibration under this test condition.
2.1.5.   Specific conditions for combinations of contact times and temperature
If a material or article is intended for different applications covering different combinations of contact time and temperature the testing should be restricted to the test conditions which are recognised to be the most severe on the basis of scientific evidence.
If the material or article is intended for a food contact application where it is successively subject to a combination of two or more times and temperatures, the migration test shall be carried out subjecting the test specimen successively to all the applicable worst foreseeable conditions appropriate to the sample, using the same portion of food simulant.
2.1.6.   Repeated use articles
If the material or article is intended to come into repeated contact with foods, the migration test(s) shall be carried out three times on a single sample using another portion of food simulant on each occasion. Its compliance shall be checked on the basis of the level of the migration found in the third test.
However, if there is conclusive proof that the level of the migration does not increase in the second and third tests and if the migration limits are not exceeded on the first test, no further test is necessary.
The material or article shall respect the specific migration limit already in the first test for substances for which in Annex I Table 1 column 8 or Table 2 column 3 the specific migration limit is set as non-detectable and for non-listed substances used behind a plastic functional barrier covered by the rules of point (b) of Articles 13(2) which should not migrate in detectable amounts.
2.1.7.   Analysis of migrating substances
At the end of the prescribed contact time, the specific migration is analysed in the food or food simulant using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004.
2.1.8.   Verification of compliance by residual content per food contact surface area (QMA)
For substances which are unstable in food simulant or food or for which no adequate analytical method is available it is indicated in Annex I that verification of compliance shall be undertaken by verification of residual content per 6 dm2 of contact surface. For materials and articles between 500 ml and 10 l the real contact surface is applied. For materials and articles below 500 ml and above 10 l as well as for articles for which it is impractical to calculate the real contact surface the contact surface is assumed to be 6 dm2 per kg food.
2.2.   Screening approaches
To screen if a material or article complies with the migration limits any of the following approaches can be applied which are considered more severe than the verification method described in section 2.1.
2.2.1.   Replacing specific migration by overall migration
To screen for specific migration of non-volatile substances, determination of overall migration under test conditions at least as severe as for specific migration can be applied.
2.2.2.   Residual content
To screen for specific migration the migration potential can be calculated based on the residual content of the substance in the material or article assuming complete migration.
2.2.3.   Migration modelling
To screen for specific migration the migration potential can be calculated based on the residual content of the substance in the material or article applying generally recognised diffusion models based on scientific evidence that are constructed such as to overestimate real migration.
2.2.4.   Food simulant substitutes
To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants overestimate migration compared to the regulated food simulants.
CHAPTER 3
Testing for overall migration
Overall migration testing shall be performed under the standardised testing conditions set out in this chapter.
3.1.   Standardised testing conditions
The overall migration test for materials and articles intended for the food contact conditions described in column 3 of Table 3 shall be performed for the time specified and at the temperature specified in column 2. For test OM5 the test can be performed either for 2 hours at 100 °C (food simulant D2) or at reflux (food simulant A, B, C, D1) or for 1 hour at 121 °C. The food simulant shall be chosen in accordance with Annex III.
If it is found that carrying out the tests under the contact conditions specified in Table 3 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place.
Table 3
Standardised testing conditions







Column 1


Column 2


Column 3




Test number


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


Intended food contact conditions




OM1


10 d at 20 °C


Any food contact at frozen and refrigerated conditions.




OM2


10 d at 40 °C


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




OM3


2 h at 70 °C


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




OM4


1 h at 100 °C


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




OM5


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


High temperature applications up to 121 °C.




OM6


4 h at 100 °C or at reflux


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




OM7


2 h at 175 °C


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




Test OM 7 covers also food contact conditions described for OM1, OM2, OM3, OM4, OM5. It represents the worst case conditions for fatty food simulants in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in paragraph 3.2.
Test OM 6 covers also food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B and C in contact with non-polyolefins.
Test OM 5 covers also food contact conditions described for OM1, OM2, OM3, OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.
Test OM 2 covers also food contact conditions described for OM1 and OM3.
3.2.   Substitute test for OM7 with food simulant D2
In case it is technically NOT feasible to perform OM7 with food simulant D2 the test can be replaced by test OM 8 or OM9. Both test conditions described under the respective test shall be performed with a new test sample.








Test number


Test conditions


Intended food contact conditions


Covers the intended food contact conditions described in




OM 8


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


High temperature applications only


OM1, OM3, OM4, OM5, and OM6




OM 9


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


High temperature applications including long term storage at room temperature


OM1, OM2, OM3, OM4, OM5 and OM6




3.3.   Repeated use articles
Where a material or article is intended to come into repeated contact with foods, the migration test shall be carried out three times on a single sample using another sample of the food simulant on each occasion.
Its compliance shall be checked on the basis of the level of the migration found in the third test. However, if there is conclusive proof that the level of the migration does not increase in the second and third tests and if the overall migration limit is not exceeded on the first test, no further test is necessary.
3.4.   Screening approaches
To screen if a material or article complies with the migration limits any of the following approaches can be applied which are considered more severe than the verification method described in sections 3.1. and 3.2.
3.4.1.   Residual content
To screen for overall migration the migration potential can be calculated based on the residual content of migratable substances determined in a complete extraction of the material or article.
3.4.2.   Food simulant substitutes
To screen for overall migration food simulants can be replaced if based on scientific evidence the substitute food simulants overestimate migration compared to the regulated food simulants.
CHAPTER 4
Correction factors applied when comparing migration test results with migration limits
4.1.   Correction of specific migration in foods containing more than 20 % fat by the Fat Reduction Factor (FRF)
For lipophilic substances for which in Annex I it is indicated in column 7 that the FRF is applicable the specific migration can be corrected by the FRF. The FRF is determined according to the formula FRF = (g fat in food/kg of food)/200 = (% fat × 5)/100.
The FRF shall be applied according to the following rules.
The migration test results shall be divided by the FRF before comparing with the migration limits.
The correction by the FRF is not applicable in the following cases:






(a)


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










(b)


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




The application of the FRF shall not lead to a specific migration exceeding the overall migration limit.
4.2.   Correction of migration into food simulant D2
For the food categories where in sub-column D2 of column 3 of Table 2 of Annex III the cross is followed by a figure the migration test result into food simulant D2 shall be divided by this figure.
The migration test results shall be divided by the correction factor before comparing with the migration limits.
The correction is not applicable to the specific migration for substances in the Union list in Annex I for which the specific migration limit in column 8 is ‘not detectable’ and for non-listed substances used behind a plastic functional barrier covered by the rules of Article 13(2)(b) which should not migrate in detectable amounts.
4.3.   Combination of correction factors 4.1 and 4.2.
The correction factors described in 4.1 and 4.2 can be combined for migration of substances for which the FRF is applicable when testing is performed in food simulant D2 by multiplying both factors. The applied maximum factor shall not exceed 5.


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





ANNEX VI
Correlation tables






Directive 2002/72/EC


This Regulation




Article 1(1)


Article 1




Article 1(2), (3) and (4)


Article 2




Article 1a


Article 3




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


Article 5




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


Article 6




Article 4a(3) and (6)


Article 7




Annex II (4) and Annex III (4)


Article 8




Article 3(1) and Article 4(1)


Article 9




Article 6


Article 10




Article 5a(1) and Annex I (8)


Article 11




Article 2


Article 12




Article 7a


Article 13




Article 9(1) and (2)


Article 15




Article 9(3)


Article 16




Article 7 and Annex I (5a)


Article 17




Article 8


Article 18




Annex II (3) and Annex III (3)


Article 19




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


Annex I




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


Annex II




Article 8(5) and Annex VIa


Annex IV




Annex I


Annex V













Directive 93/8/EEC


This Regulation




Article 1


Article 11




Article 1


Article 12




Article 1


Article 18




Annex


Annex III




Annex


Annex V













Directive 97/48/EC


This Regulation




Annex


Annex III




Annex


Annex V