L 30/2 Official Journal of the European Union 6.2.2015 REGULATIONS 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) 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 ('), and in particular points (a), (c), (d) and (e) of Article 5(1), Article 11(3) and Article 12(6) thereof, Whereas: (1)  Annex I to Commission Regulation (EU) No 10/2011 (? establishes a Union list of authorised substances (‘the Union list’) which may be used in the manufacture of plastic materials and articles. (2)  Tartaric acid (food contact material (FCM) substance No 161) was assessed by the Scientific Committee for Foods (SCF) in 1991 (). The SCF gave a favourable opinion only to the natural occurring form of tartaric acid (L-(+)-tartaric acid). It explicitly excluded the DL form of tartaric acid. It followed from the SCF assessment that only L-(+)-tartaric acid does not endanger human health, while this has not been shown for all other forms of that substance. Therefore, it should be clear from the name of the substance as included in Table 1 of Annex I to Regulation (EU) No 10/2011 that it refers only to L-(+)-tartaric acid. Therefore, the name of FCM substance No 161 should be amended accordingly. (3)  The European Food Safety Authority (the Authority) adopted an opinion re-evaluating the tolerable daily intake (TD]) of phenol (*). Phenol (FCM No 241) is included as a starting substance in Table 1 of Annex I to Regulation (EU) No 10/2011. The generic specific migration limit (SML) of 60 mg/kg set out in Article 11(2) of Regulation (EU) No 10/2011 applies to that substance. In the re-evaluation of phenol, the Authority reduced the TDI from 1,5 mg/kg body weight (bw’)/day to 0,5 mg/kg bw/day. The Authority noted that the exposure from all sources was above the TDI, while exposure from food contact materials was likely to be in the range of the TDL In addition to the TDI, an allocation factor of 10 % for the exposure from food contact materials should be used to achieve a sufficient reduction in phenol exposure. The setting of the migration limit takes into account a conventional exposure assumption that 1 kg of food is consumed daily by a person of 60 kg body weight. Therefore, on the basis of the TDI, the allocation factor and the exposure assumption a specific migration limit of 3 mg/kg for phenol should be set to ensure that phenol does not endanger human health. (4) 1,4-Butanediol formal (FCM No 344) was evaluated by the SCF in 2000 (°). The SCF concluded that a SML of 0,05 mg/kg should be set for that substance. Column 8 of Table 1 of Annex I to Regulation (EU) No 10/2011 incorrectly states that migration of the substance shall be non-detectable and should therefore be corrected. (5)  The SCF proposed to determine the residual content of the substance 1,4-butanediol formal (FCM No 344) in the material instead of verifying compliance against the SML, because no suitable method to determine the substance in a food or simulant was available. Suitable methods to determine the substance in a food or simulant () OJL338,13.11.2004, p. 4. (*) Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJL12,15.1.2011,p. 1). (®) Report of the Scientific Committee for foods, 25% series, EUR 13416, 1991. (*) EFSA Journal 2013;11(4):3189. (’) Opinion of the Scientific Committee on Food on the 11th additional list of monomers and additives for food contact materials, SCF/CS/PM/GEN/M8313, November 2000.