Kommisjonsrekommandasjon (EU) 2019/794 av 15. mai 2019 om en koordinert kontrollplan med sikte på å fastslå utbredelsen av visse stoffer som migrerer fra materialer og gjenstander som er beregnet på å komme i kontakt med mat
Commission Recommendation (EU) 2019/794 of 15 May 2019 on a coordinated control plan with a view to establishing the prevalence of certain substances migrating from materials and articles intended to come into contact with food
Kommisjonsrekommandasjon publisert i EU-tidende 17.5.2019
BAKGRUNN (fra kommisjonsrekommandasjonen, engelsk utgave)
(1) Article 53 of Regulation (EC) No 882/2004 of the European Parliament and of the Council empowers the Commission to recommend coordinated control plans where considered necessary, organised on an ad hoc basis, with a view to establishing the prevalence of hazards in feed, food and animals.
(2) Regulation (EC) No 1935/2004 of the European Parliament and of the Council lays down general requirements on the safety of materials and articles intended to come into contact with food (‘food contact materials’), specifically regarding the transfer of the constituents of food contact materials into food. In addition, specific measures for groups of food contact materials have been established in accordance with Article 5(1) of that Regulation. In particular, for plastic food contact materials, an authorised list of substances has been established under Commission Regulation (EU) No 10/2011 . Some of these authorised substances are also subject to restrictions, including Specific Migration Limits (SML), which restrict their migration into or onto food.
(3) Information available from the Rapid Alert System for Food and Feed (‘RASFF’, reported pursuant to Article 50 of Regulation (EC) No 178/2002 of the European Parliament and of the Council indicates various non-compliances as regards migration of certain substances from food contact materials. However, at present there is inadequate information to sufficiently determine the prevalence of these substances in food migrating from food contact materials.
(4) Primary aromatic amines (‘PAA’) are a family of compounds, some of which are carcinogenic, while others are suspected carcinogens. PAA may arise in food contact materials from authorised substances, or the presence of impurities or breakdown products. Annex II of Regulation (EU) No 10/2011 sets out that such PAA shall not migrate from plastic materials and articles into food or food simulant. Work undertaken by the Joint Research Centre of the European Commission has also determined that PAA occur at concentrations in coloured paper napkins that are relevant for monitoring.
(5) Formaldehyde (FCM No 98) is a substance authorised at Union level for use in the manufacture of plastic food contact materials. However, it is subject to an SML of 15 mg/kg of formaldehyde (expressed as total formaldehyde and hexamethylenetetramine).
(6) Commission Regulation (EU) No 284/2011 lays down specific conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from the People's Republic of China and Hong Kong, including 10% mandatory physical controls by Member States. The Regulation was introduced on the basis of elevated numbers of non-compliances due to the release of high levels of PAA from polyamide and formaldehyde from melamine plastic food contact materials.
(7) Recent analysis of data reported in accordance with Article 9 of Regulation (EU) No 284/2011 indicates a decrease in non-compliance of these products, based on the controls carried out at the point of import into the European Union. Nevertheless, RASFF data shows that some of these products are still non-compliant from samples taken on the market. Information also shows that the origin of such products is not restricted to China and Hong Kong. It is therefore appropriate to control levels of PAA and formaldehyde in addition to the controls carried out under Regulation (EU) No 284/2011.
(8) Melamine (FCM No 239) is a substance also authorised in the manufacture of plastic food contact materials and subject to an SML of 2,5 mg/kg. In addition to formaldehyde, migration of melamine from melamine plastic kitchenware has also been reported. It is therefore appropriate to control levels of melamine migrating from the same samples.
(9) Phenol (FCM No 241) is a substance authorised for use as a monomer to manufacture plastic food contact materials and may also be used to manufacture other types of materials that come into contact with food, including epoxy resins used in varnishes and coatings. An SML of 3 mg/kg applies to plastic food contact materials, which was introduced by Commission Regulation (EU) No 2015/174 on the basis of a re-evaluation by the European Food Safety Authority ('the Authority'). In its opinion, the Authority reduced the Tolerable Daily Intake (TDI) from 1,5 mg/kg bw to 0,5 mg/kg bodyweight (bw), noting that there are many sources of exposure to phenol in addition to food contact materials, which may contribute to levels of exposure at or above the TDI. It is therefore appropriate to control levels of phenol in light of potential exceedances of the TDI.
(10) The substance 2,2-bis(4-hydroxyphenyl)propane (FCM No 151), commonly known as bisphenol A ('BPA') is a substance authorised for use as a monomer to manufacture plastic food contact materials but is also used to manufacture other materials and articles which come into contact with food, including epoxy resins used in varnishes and coatings. Recently, a new SML of 0,05 mg/kg was introduced by Commission Regulation (EU) No. 2018/213 for plastic food contact materials and in addition the SML applies to varnishes and coatings, on the basis of a re-evaluation by the Authority, who concluded on a lower temporary Tolerable Daily Intake (tTDI) compared to the previous TDI. It is therefore appropriate to control these food contact materials to determine compliance of BPA migration in light of this new SML.
(11) In addition to BPA, other bisphenols may be used in or migrate from food contact materials. In particular, 4,4′-dihydroxydiphenyl sulphone, commonly known as bisphenol S ('BPS', FCM No 154) is used as a monomer to manufacture polyethersulphone plastic and is authorised to be used for manufacturing plastic food contact materials in the Union with an SML of 0,05 mg/kg. There is no recent information available on its possible migration into food and information on its possible use or migration from varnished or coated food contact materials is incomplete. It is therefore appropriate to control materials from which BPS potentially migrates to check for the prevalence of BPS migrating into food.
(12) Phthalate esters (‘phthalates’) are a group of substances widely used as plasticisers and technical support agents. Five phthalates have been authorised for use in plastic food contact materials, including di-butylphthalate (‘DBP’, FCM No 157), butyl-benzyl-phthalate (‘BBP’, FCM No 159), bis(2-ethylhexyl)phthalate (‘DEHP’, FCM No 283), diisononyl phthalate (‘DINP’, FCM No 728) and diisodecyl phthalate (‘DIDP’, FCM No 729). These phthalates are included in a group restriction SML (T) of 60 mg/kg, along with a number of other substances. Individual SMLs are also applicable to DBP, BBP and DEHP, whereas a group restriction exists for DINP and DIDP of 9 mg/kg. The concentration of these five phthalates is also restricted in childcare articles for feeding, as set out in Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council . In addition to results from the RASFF indicating non-compliance with the SMLs, phthalates that are not authorised for use in plastic food contact materials may still be found in plastic food contact materials and migrate into food. It is therefore appropriate to control levels of phthalates in light of possible non-compliance.
(13) In addition to the use of phthalates, other non-phthalate substances are also used in food contact materials as plasticisers. Epoxidized soybean oil (‘ESBO’, FCM No 532) as well as 1,2-Cyclohexane dicarboxylic acid diisononyl ester (‘DINCH’, FCM No 775) and terephthalic acid, bis(2-ethylhexyl)ester (‘DEHTP’ or ‘DOTP’, FCM No 798) are authorised for use in the manufacture of plastic food contact materials and are included in the group SML (T) of 60 mg/kg. In addition, both DEHTP and ESBO have individual SMLs of 60 mg/kg, except in the case of PVC gaskets used to seal glass jars containing infant and baby foods for infants and young children where, the SML for ESBO is 30 mg/kg. Previous work carried out by Member States and Switzerland has identified compliance issues with the migration of ESBO from jar lids. As there is also an indication that DINCH and DEHTP may be used as replacements for phthalates and there is little or no available information on their migration into food, it is appropriate to check for the prevalence of these substances migrating into food.
(14) Per- and polyfluoroalkyl substances (‘PFAS’) are a group of compounds that includes perfluorooctanoic acid (‘PFOA’) and perfluorooctane sulphonate (‘PFOS’). Due to their amphiphilic properties, these fluorinated compounds are used in the production of water and fat repellent coatings such as those used on paper and board based food packaging materials. Information from some Member States indicates possible concerns on the levels of these substances in coated paper and board based packaging materials. In addition, PFOA is restricted for use in the production and placing on the market of articles, including food contact materials and articles from 4 July 2020, as laid down in Commission Regulation (EU) No 2017/1000 . It is therefore appropriate to further investigate the prevalence of these substances in food contact materials.
(15) Metals and alloys are used in food contact materials and articles including kitchenware and tableware as well as food processing equipment. A number of SMLs are laid down at Union level for metals migrating from plastic food contact materials; however, information from the RASFF shows a number of non-compliances for metal kitchenware and tableware, based on risk assessments or moreover national legislation. As the hazards from certain metals such as lead and cadmium is well defined, it is appropriate to carry out controls on the migration of metals into food and to improve the understanding of the prevalence of migration of metals, including in particular from imported food contact materials and articles as well as traditional and artisanal products.
(16) In order to ensure the overall inertness and safety of plastic food contact materials, an overall migration limit (OML) is set to restrict the release of non-volatile constituents into food, including particles such as microfibres. As conventional plastic materials and articles are under pressure to be replaced due to environmental concerns, additives derived from natural sources are being used as fillers in combination with plastic in order to reduce environmental impacts. In order to verify that good manufacturing practices have been followed and that these plastic food contact materials and articles are sufficiently inert, it is appropriate to control for overall migration.
(17) To ensure uniform application of this Recommendation and in order to generate reliable and comparable results of the controls, the European Union Reference Laboratory (EU-RL) for Food Contact Materials should assist Member States in implementing this Recommendation where necessary.
(18) In order to maximise the available information on the prevalence of substances migrating from food contact materials, Member States should also be encouraged to submit relevant data that have been generated recently, prior to the application of this Recommendation. To ensure that these results are reliable and consistent with those generated as part of this control program, only those results that have been generated following relevant rules on the sampling and analysis of the food contact materials as well as legislation on official controls should be reported.
(19) The primary aim of this Recommendation is to establish the prevalence of substances migrating from food contact materials and articles into food or the presence of substances in the food contact material or article; it is not intended to contribute to the understanding of exposure levels. Data should therefore be submitted using a common format in order to ensure that they are coordinated and compiled in a consistent manner.
(20) Where appropriate, the competent authorities of the Member States should consider enforcement action in accordance with applicable legislation and procedures.
(21) The information generated on the prevalence of these substances resulting from this Recommendation should be used to determine whether any possible future action is necessary, in particular to secure a high level of human health and the interests of consumers. Such future action may include additional control measures for substances from plastic materials for which specific EU measures exist. In addition, the results may contribute towards an information base on which to consider future priorities in the context of the evaluation of food contact materials legislation, in particular for materials for which no specific EU measures exist.
(22) The implementation of this coordinated control plan is without prejudice to other official controls carried out by Member States in the framework of their national control programmes, as provided in Article 3 of Regulation (EC) No 882/2004.
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