CELEX: 32011R0010
Language: en
Date: 2011-01-14 00:00:00
Title: 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

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