Commission Regulation (EU) 2026/245 of 2 February 2026 amending Annex I to Regulation (EU) No 10/2011 as regards the authorisation or the conditions of use of several substances — Full Text

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

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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) entry 768 is replaced by the following: ‘768 34850 0143925-92-2 amines, di-C14-C20-alkyl, oxidised, from hydrogenated tallow yes no no Only to be used in contact with non-fatty foods: (a) at 0,1 % w/w in polyolefins (b) at 0,25 % w/w in PET’ (b) the following entries are added: ‘1084 1821217-71-3 phosphorous acid, triphenyl ester, polymer with 1,4-cyclohexanedimethanol and polypropylene glycol, C10-16 alkyl esters yes no yes 5 Only to be used as an additive at up to 0,15 % w/w in polyolefins intended for contact with food at room temperature and below, including hot-fill and/or heating up to 100 °C for up to 2 hours. Not to be used in the manufacture of articles intended for contact with infant formula ( 7 ), and human milk. The fraction with a molecular weight below 1 000 Da shall not exceed 13 % w/w of the substance. The SML applies to the total of phosphite and phosphate species. (2) 1089 81607-35-4 calcium tert -butylphosphonate yes no no Only to be used as a nucleating agent at up to 0,15 % w/w in polyolefins intended for contact with food at room temperature and below, including temperatures up to 100 °C for maximum 2 hours and up to 130 °C for less than 15 minutes. Not to be used in materials and articles intended for contact with infant formula ( 7 ), and human milk. 1092 1801863-42-2 amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil yes no no Only to be used as an additive at up to 0,1 % w/w in polyolefins, which are to be used only in contact with non-fatty foods at room temperature and below, including hot-fill and/or heating up to 100 °C for up to 2 hours. Not to be used in the manufacture of materials and articles intended for contact with infant formula ( 7 ), and human milk. 1093 1883583-80-9 wax, rice bran, oxidised yes no no Only to be used as an additive at up to 0,3 % w/w in polyethylene terephthalate, polylactic acid and rigid poly(vinyl chloride) materials and articles intended for contact with non-fatty foods, at room temperature and below, including hot-fill and/or heating up to 100 °C for up to 2 hours. 1094 2752-17-2 2,2′-oxydiethylamine no yes no 0,05 Only to be used as a comonomer at up to 14 % w/w with adipic acid and caprolactam, or with authorised homologues of these two substances with a longer C chain, to manufacture polyamide films with a thickness of up to 25 μm. The migration of oligomers containing the substance with a molecular weight below 1 000 Da shall not exceed 5 mg/kg food. Not to be used in the manufacture of materials and articles intended for contact with infant formula ( 7 ), and human milk. (31)’ 1096 1850357-57-1 wax, rice bran, oxidised, calcium salt yes no no Only to be used as an additive at up to 0,3 % w/w in polyethylene terephthalate, polylactic acid and rigid poly(vinyl chloride) materials and articles intended for contact with non-fatty foods, at room temperature and below, including hot-fill and/or heating up to 100 °C for up to 2 hours. (2) in point 3, Table 3, the following entry is added: ‘(31) Water shall be used for verification of compliance instead of food simulants listed in Table 1 of Annex III.’

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