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CELEX-02011R0010-20150226-EN-TXT.pdf
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.
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.
