BAKGRUNN (fra kommisjonsforordningen)

(1) Commission Regulation (EU) No 10/20112 lays down specific rules as regards plastic materials and articles intended to come into contact with foods. In particular Chapter II thereof sets out compositional requirements for plastic materials and articles that are to ensure that final plastic materials intended to come into contact with food are sufficiently safe, in order to meet the requirements of Article 3 of Regulation (EC) No 1935/2004. 

(2) In its Chapter II, the compositional requirements for substances that can be used to manufacture plastic materials and articles are specifically referring to ‘plastic layers’ in plastic materials and articles. However, in many cases, plastic materials and articles do not conform to a layer structure but consist of a single homogenous material with a complex shape, leading to ambiguity. Therefore, Chapter II of Regulation (EU) No 10/2011 should refer to plastic materials and articles instead of to plastic layers. Since the new wording could raise doubts as to whether the compositional requirements laid down in Regulation (EU) No 10/2011 apply to non-plastic layers of plastic materials and articles, such as adhesives, printing inks, varnishes and coatings, it should be clarified that the compositional requirements do not apply to those layers. However, the reference to ‘plastic layers’ in Chapter III of Regulation (EU) No 10/2011 should be maintained since it allows, in relation to multi-layer materials and articles, for some of the provisions of that Chapter to apply to some layers and not to others. In particular, the plastic layer which is separated from the food by a functional barrier in multi-layer materials may be manufactured with substances not listed in the Union list. It should also remain possible to verify compliance with the migration limits in accordance with Regulation (EU) 10/2011 of materials and articles falling within its scope that are held together by adhesives or that are printed and/or covered by a coating. 

(3) According to the definition of ‘plastic’ in Regulation (EU) No 10/2011, ‘plastic’ consists of polymers to which additives or other substances may have been added, in order to achieve a physical or chemical effect in the plastic. That Regulation authorises additives and starting substances as two different categories. Therefore, an additive cannot be used as a starting substance if not authorised as such and vice versa. Typically, additives are not chemically bonded to the polymers. However certain particles, fibres, or other solid materials used in plastics to achieve a physical effect are bonded with or without the aid of a bonding agent to the polymer to ensure the overall integrity of the material. Given the definitions of plastic, additives, polymers and starting substances in Regulation (EU) No 10/2011 where this bond is a chemical bond there may be doubts as to whether such a solid material is to be regarded as an additive or as a starting substance. Therefore, uncertainty ensues over whether that solid material is to be authorised as an additive or as a starting substance. Consequently, it is appropriate to clarify the definition of additives. In particular, since the nature of starting substances makes them suitable for polymerisation, a process that involves significant chemical change, while solid materials used as additives remain substantially in the form in which they have been added, it should be considered that a solid material that is chemically bonded to the polymer to which it is added functions as an additive and not as a starting substance, even though its surface may still react with the polymers in the plastic. 

(4) Certain authorised substances listed in Annex I to Regulation (EU) No 10/2011 are derived from materials of natural origin, including minerals and living organisms, which are also used as additives in plastics, as fibres or as small particles. These materials have historically been considered substances used for the manufacture of plastics and therefore as falling within the scope of that Regulation. However, the composition of those substances is complex, variable, and may not be fully known. As a result, it is difficult to define those substances’ identities and this creates difficulties, since clearly defining those substances is important to distinguish each of them from other substances. These substances are referred to in Regulation (EC) No 1907/2006 of the European Parliament and the Council3 as substances of unknown or variable composition, complex reaction products or biological materials (‘UVCB’). To ensure better alignment of Regulation (EU) No 10/2011 with Regulation (EC) No 1907/2006 and, in particular, to facilitate the future alignment of the risk assessment and authorisation of such substances, it is therefore appropriate to apply this concept of UVCB substances also under Regulation (EU) No 10/2011. 

(5) Pursuant to Article 5 of Regulation (EU) No 10/2011, the Union list of substances laid down in Annex I to that Regulation contains the substances authorised to be ‘intentionally’ used in the manufacture of plastic materials and articles. In certain cases Annex I also includes specifications on the impurities that may be present in the substance, provided they are relevant for the risk assessment and have the potential to affect human health. The same applies for any substance-related reaction and degradation products that can be formed during the manufacturing of the plastic material or article. However, those impurities, reaction and degradation products are not intentionally present in the plastic material or article. Therefore, it is appropriate to delete the word ‘intentionally’ in Article 5 of Regulation (EU) No 10/2011. 

(6) Substances listed in table 1 of Annex I to Regulation (EU) No 10/2011 are denoted by their FCM substance number, reference number and their chemical name and, where available, by their respective Chemical Abstracts Service (CAS) registry number. However, experience shows that there may remain doubts as to the precise identity of the substances authorised. Since the application for an authorisation of a substance is to contain information on the identity of the substance, such as the chemical name, chemical composition, level of purity, molecular weight and spectroscopic data, and this information is verified by the European Food Safety Authority (‘the Authority’), the designated identity of the substances listed in table 1 of Annex I to Regulation (EU) No 10/2011 should be considered in relation to the identity of the substance specified in the opinion of the Authority. Therefore, if a level of doubt over the designation of a substance remains, the Authority should be consulted. 

(7) Biocidal products containing active substances may be incorporated into various materials, including plastics, which may enter into contact with food. Regulation (EU) No 10/2011 provides that, in order to be used in the manufacturing of plastic food contact materials and articles, substances which are intended to be present in the final plastic materials or articles and having a biocidal function must have been authorised by the Commission or, pending such authorisation, be one of the substances included in the provisional list referred to in Article 7 of that Regulation. However, Regulation (EU) No 528/2012 of the European Parliament and of the Council lays down rules for the authorisation of the types of biocidal products listed in its Annex V, including those intended to be incorporated into food contact materials and articles, and the placing on the market of treated articles containing such products, such as food contact materials and articles. In accordance with that Regulation, a biocidal product containing an active substance may be incorporated into food contact materials provided that both the substance and the product containing that substance are approved and authorised respectively under Regulation (EU) No 528/2012 for that use. Therefore, Regulation (EU) No 10/2011 should refer to Regulation (EU) No 528/2012 as to the biocidal active substances and biocidal products that may be used in the manufacturing of and intentionally present in plastic food contact materials. 

(8) Regulation (EU) No 10/2011 presently lays down that substances used in the manufacture of plastic layers in plastic materials and articles are to be of a purity suitable for the intended and foreseeable use of the materials or articles. Experience shows that in order to ensure a high level of protection of human health and help business operators to assess the compliance of materials and articles with the Regulation (EU) No 10/2011, the concept of purity of substances used to manufacture food contact materials and articles should be defined. Given the current scientific information and regulatory provisions for the authorisation of substances used in the manufacturing of food contact materials and articles, it is appropriate to define the high degree of purity for substances used in the manufacturing of food contact materials or articles in relation to their identity and, as relevant, to the specifications or restrictions laid down in Annex I to Regulation (EU) No 10/2011, to a risk assessment in accordance with Article 19 or to the relevant guidance of the Authority. In this regard, in its Note for Guidance for the preparation of an application for the safety assessment of a substance to be used in plastic food contact materials, the Authority has established the principle that the higher the exposure of consumers through migration of substances in food contact materials or articles into food, the more toxicological data would be needed. In particular, the Authority considers that, where a substance used in the manufacturing of a food contact materials or article has a migration level into food below of 0.00015 mg substance/kg food (0.15µg/kg), the risk of genotoxicity is unlikely and no toxicity testing of the migrating substance is needed, and that, where it has a migration level of more than 0.15µg/kg but less than 0.05 mg/kg only data on genotoxicity tests is needed. However, at the early stages in the manufacturing process of plastic materials and articles, the next manufacturing steps and/or the final use of the materials and articles may not be sufficiently known to calculate the migration levels of a substance into food. Therefore, to evaluate whether a substance used in the manufacturing of a food contact material or article complies with these threshold levels, it is appropriate to take into account factors that affect their concentration in and migration from the final materials and articles into food. Furthermore, where the assessment of genotoxicity of an individual substance is required, it should be possible to substitute it with an assessment of genotoxicity of a group of substances, but only under specific requirements. 

(9) Regulation (EU) No 10/2011 does not impose restrictions on the source of substances that can be used in the manufacture of plastic materials and articles and, therefore, such substances may be manufactured from waste. Substances manufactured from waste may however contain incidental contamination. In order to protect human health and considering that certain manufacturing processes of substances can eliminate the presence of incidental contaminants or reduce it so as to ensure that contamination in the final plastic material does not result in a risk to human health, it should be required that substances produced from waste should also be of a high level of purity. 

(10) Specific rules need to be laid down as regards the purity of substances of natural origin, so-called UVCB substances. In some cases, a substance originates from a portion of an organism that has not had any of its components removed, or it originates from a natural material that has only been partially purified and, consequently, its full composition may be unknown or variable. However, in other cases, where the natural substance can be extracted from the natural material and further purified, a substance with a known chemical composition may be obtained. Therefore, as regards substances of natural origin, it is appropriate to specify how their identity is to be determined in order to apply the requirement of high degree of purity. Based on the latest knowledge, the Authority describes the identity of such substances as detailed as possible, including its composition, its source, the process used to obtain it, and specifies the uncharacterized fraction as far as possible. However, where historically such a detailed designation was not provided, the name of the substance should be the determining factor for its identification. 

(11) During the manufacture of plastic materials and articles, it is not possible to fully avoid the production of off-cuts, scraps and other by-products. Allowing the reprocessing of these by-products for manufacturing plastic materials and articles can contribute to the reduction of the occurrence of unusable manufacturing materials. If by-products can be used directly in the manufacturing of plastics without any further operations than normal industrial practices such as shredding and re-granulation, they are not considered waste. As Regulation (EU) No 2022/16169 does not apply to these by-products and clarity is required over which by-products can be considered safe for reprocessing, rules should be laid down to ensure the safety of their use. It is therefore appropriate to include a definition of reprocessing to have a clear delineation between the products to which Regulation (EU) No 10/2011 apply and those to which Regulation (EU) No 2022/1616 applies, and to lay down rules for the safe reprocessing of these by-products. 

(12) Since Directive (EU) 2019/90410 discourages the use of single use plastic food contact materials due to their environmental impact, increasingly plastic materials and articles in contact with food are designed for repeated use. However, repeated use may lead to deterioration of the plastic material or article, leading to an increase of migration of constituents into food that may endanger human health. Such deterioration of plastic materials and articles is indicated by various signs, for example, by surface cracks and crazes, blisters, delamination, shrinkage or other deformation, and yellowing or other permanent discoloration or loss of gloss or transparency. However, usage related changes such as tainting from colorants from foods, including from lycopene and curcumin, is not in principle a deterioration of the material or article. To prevent the use of deteriorated plastic articles, the manufacturer or other operator responsible for placing on the market of the final plastic food contact article should provide users of plastic food contact articles with information about how to prevent or slow down deterioration and the changes that indicate the deterioration by repeated use. 

(13) Article 15 of Regulation (EC) No 1935/2004 provides that materials and articles which are not yet in contact with food when placed on the market, if necessary, are to be accompanied by special instructions to be observed for safe and appropriate use. It is appropriate to consider that, where Regulation (EC) No 10/2011 sets out restrictions to the use of plastic articles, it is always necessary that such special instructions are provided to consumers. 

(14) Article 14(4) of Regulation (EU) No 10/2011 sets out that the rules on migration limits laid down in Articles 11 and 12 do not apply to plastic layers in multi-material multilayer materials and articles. However, since final multi-material multi-layer materials or articles, in which the layer in direct contact with food is a plastic layer, may raise the same potential health risks as plastic material or articles, this layer should comply with the provisions concerning migration set out in Regulation (EU) No 10/2011. On the contrary, Articles 11 and 12 of Regulation (EU) No 10/2011 should still not apply to non-plastic layers in multi-material multi-layer materials. Other Union legislation or national rules may apply. Nonetheless, the migration limits set out in Regulation (EU) No 10/2011 continue to apply to plastic layers in materials and articles that are printed, coated or held together by adhesives. 

(15) In order to further specify the obligations of business operators in relation to the information they are to supply to competent authorities, it should be required that business operators make available to competent authorities information on the composition of starting substances and supporting documents at each stage of the manufacturing process. This documentation should also demonstrate compliance with the rules regarding the high level of purity introduced by this Regulation. 

(16) In order to ensure compliance with Regulation (EU) No 10/2011, Member States are to have in place effective control measures, including the sampling of plastic materials and articles, as well as products from intermediate stages of the manufacturing process of plastic materials and articles. However, experience shows that inspectors may encounter practical challenges taking samples at certain stages of the manufacturing process on manufacturing sites. Therefore, it is appropriate to require that manufacturers facilitate inspections by ensuring that inspectors can take samples at relevant stages of the manufacturing process and they can take samples of substances and (intermediate) materials used for the manufacturing that are present on the manufacturing site. 

(17) The real surface-to-volume ratio of the plastic final food contact article serves as the basis for the rules on migration testing laid down in Regulation (EU) No 10/2011. However, that Regulation establishes also that as regards certain materials and articles a fixed surface-to-volume ratio is to be applied, in order to facilitate the determination of the level of migration, in particular when testing articles not yet in contact with food, for which it is not feasible to determine the surface area that is in contact with food or to compensate for the expected level of over- or underestimation of the exposure of consumers to constituents in those materials and articles. However, in certain cases applying a fixed surface-to-volume ratio may lead to an underestimation of the exposure of consumers to constituents in those materials and articles that may endanger human health. Therefore, it is appropriate that business operators have the possibility to opt for the real surface-to-volume ratio instead of being obliged to use the fixed surface-to-volume ratio established for these exceptions. 

(18) Point 07.04 of Table 2 of Annex III to Regulation (EU) No 10/2011 assigns food simulants to categories of cheese. However, the present assignments, in particular categories 07.04.B and 07.04.C, do not correspond to the common interpretation and usage of the expressions ‘natural cheese’ and ‘processed cheese’. More specifically, melting cheese is usually considered as a processed cheese, while cheeses similar to cottage cheese are commonly considered unprocessed natural cheeses. The present assignments also do not follow the terminology used in the ‘FoodEx2 classification’ established by the Authority, in particular regarding unripened (fresh) and ripened cheese. Therefore, it is appropriate to amend the respective categories in order to classify in a better manner natural and processed cheeses and ripened and unripened cheese, while setting out simulant assignments appropriate for these new categories of cheese on the basis of the existing assignments. 

(19) In order to ensure safety, business operators need to receive all information relevant for the safety of the plastic materials and articles they manufacture or use. However, Regulation (EU) No 10/2011 only requires that the written declaration of compliance contains information on the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to that Regulation. To further increase safety, it is appropriate to require that the declaration of compliance contains information also on non-intentionally added substances, such as impurities and reaction intermediates, decomposition, or reaction products formed during the manufacturing process of the plastic material or article and that could be present in the final food contact material or article. 

(20) Even though substances manufactured from waste may contain contaminants derived from waste that could endanger human health, the current rules as regards the written declaration of compliance do not require specifying whether the plastic material has been manufactured with substances manufactured from waste. It is therefore necessary to amend the provisions for the declaration of compliance, so that the manufacturer of the final plastic article gets adequate information that would enable it to ensure compliance with the requirement laid down in Article 3(1) of Regulation (EC) No 1935/2004 that plastic materials and articles are not to endanger human health. 

(21) To achieve results that are comparable, laboratories need to conduct compliance testing under standardised test conditions. In addition, analysis of the test results needs to be carried out consistently. It is therefore appropriate to further specify the rules on the verification of compliance testing in Annex V to Regulation (EU) No 10/2011. 

(22) Regulation (EU) 2022/1616 requires that recycled plastic materials and articles comply with Chapters II and III and Chapter V of Regulation (EU) No 10/2011. The high purity requirement laid down by this Regulation in Chapter II of Regulation (EU) No 10/2011 applies to substances used in the manufacture of plastic materials and articles. However, there is no need that the high purity requirement applies to as regards substances contained in the input and remaining in the output of the decontamination process of plastic waste since Regulation (EU) 2022/1616 ensures that incidental contamination is removed from the material during the manufacture of recycled plastic materials intended to come into contact with food to an extent that the requirements of Article 3 of Regulation (EC) No 1935/2004 are met. Therefore, concerning the manufacturing of recycled plastic materials and articles, the high purity requirement should apply only to any substance added during the recycling process and to any reaction intermediate, decomposition or reaction product resulting from that substance. It is therefore appropriate to further specify in Regulation which provisions apply of Regulation (EU) No 10/2011 to recycled plastic materials and articles. 

(23) Regulation (EU) 2022/1616 lays down rules regarding quality assurance systems for collection, pre-processing, decontamination and recycling of plastic waste material. This Regulation introduces rules for the reprocessing of plastic by-products of plastic manufacturing. To further increase food safety, detailed rules on good manufacturing practices should be laid down in Regulation (EC) No 2023/2006 as regards reprocessing and recycling. 

(24) Plastic by-products intended for reprocessing might be reprocessed at a manufacturing location other than the one from which they originally came. However, if it is not clear for what purpose these by-products would be suitable, or if they are contaminated during storage or transport from the production facility from which they originate, their reprocessing could pose risks. Therefore, in order to prevent any use of plastic by-products for purposes for which they are not suitable and contamination of plastic by-products from the point where they are produced until their point of reprocessing, rules should be laid down in Commission Regulation (EC) No 2023/2006. In addition, when such by-products are placed on the market, the declaration of compliance referred to in Article 15 of Regulation (EU) No 10/2011 should provide the information required for their reprocessing, in particular as regards their suitability for particular uses. 

(25) In order to allow operators to adapt to the changes provided for in this Regulation, it is appropriate to provide that plastic materials and articles complying with Regulation (EU) No 10/2011, as applicable before the date of the entry into force of this Regulation, and any other relevant Union legislation are allowed to be first placed on the market for a period of 18 months after the entry into force of this Regulation and remain on the market until the exhaustion of stocks. However, the production of final plastic materials and articles typically involves the supply of several products and substances from intermediate manufacturing stages by other operators. For the sake of consumer safety, the transition to full compliance with this Regulation should be achieved as efficiently as possible, and with minimum delay. Therefore, operators placing on the market, as of nine months before expiry of the 18-months transition period, intermediate products and substances that do not yet comply with this Regulation, should be required to inform the users of those products that they cannot be used to manufacture plastic materials and articles to be placed on the market after the transition period expires. 

(26) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,