Commission Regulation (EU) 2015/174 of 5 February 2015 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Text with EEA relevance

Regulation (EU) 2015/174 · Regulation · 4 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

Annex I to Regulation (EU) No 10/2011 is amended in accordance with the Annex to this Regulation.

Article 2

Plastic materials and articles complying with the requirements of Regulation (EU) No 10/2011 as applicable before 26 February 2015 may be placed on the market until 26 February 2016. Those plastic materials and articles may remain on the market after that date until exhaustion of stocks.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEXSupplementary provisions

ANNEX Annex I to Regulation (EU) No 10/2011 is amended as follows: (1) Table 1 is amended as follows: (a) the entries concerning FCM substances Nos 161, 241, 344, 364, 410, 713, 784, 799, 880 and 881 are replaced by the following: ‘161 92160 000087-69-4 L-(+)-tartaric acid yes no no 241 22960 0000108-95-2 phenol no yes no 3 344 13810 0000505-65-7 1,4-butanediol formal no yes no 0,05 15 30 (21) 21821 364 15404 0000652-67-5 1,4:3,6-dianhydrosorbitol no yes no 5 Only to be used as: (a) a co-monomer in poly(ethylene-co-isosorbide terephthalate); (b) a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol. 410 62720 0001332-58-7 kaolin yes no no Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi-layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food. 713 43480 0064365-11-3 charcoal, activated yes no no Only for use in PET at maximum 10 mg/kg of polymer. Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 ( *1 ) with exception of ash content which can be up to 10 % (w/w). 0007440-44-0 784 95420 0745070-61-5 1,3,5-tris (2,2-di-methylpropanamido) benzene yes no no 5 799 77708 polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C 8 -C 22 ) alcohols yes no no 1,8 In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012. 880 31348 acids, fatty (C 8 -C 22 ), esters with pentaerythritol' yes no no 881 25187 0003010-96-6 2,2,4,4-tetramethylcyclobutane-1,3-diol no yes no 5 Only for: (a) repeated use articles for long term storage at room temperature or below and hotfill; (b) single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles. (b) the following entries are inserted in numerical order of the FCM substance numbers: ‘859 (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene, in nanoform yes no no Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage. When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm. 903 37486-69-4 2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether] yes no no Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for: (a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; (b) repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes. 969 24937-78-8 ethylene-vinyl acetate copolymer wax yes no no Only to be used as a polymeric additive up to 2 % w/w in polyolefins. The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food. 998 (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked, in nanoform yes no no Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm. 1017 25618-55-7 polyglycerol yes no no To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C. 1043 (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform yes no no Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage. When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances. The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.’ (c) The entry concerning FCM substance No 725 is deleted. (2) In Table 2, the entries concerning group restrictions Nos 15 and 30 are replaced by the following: ‘15 98 196 344 15 expressed as formaldehyde 30 254 344 672 5 expressed as 1,4-butanediol’ (3) In Table 3, the following entry is added: ‘(21) In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded.’ ( *1 ) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications of food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council ( OJ L 83, 22.3.2012, p. 1 ).’

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