(fra kommisjonsforordningen)

(1) Commission Regulation (EU) No 10/2011 lays down specific rules as regards plastic materials and articles intended to come into contact with food. In particular, Annex I to that Regulation establishes a Union list of authorised substances that may be intentionally used in the manufacture of plastic materials and articles intended to come into contact with food. 

(2) On 6 March 2024, the European Food Safety Authority (‘the Authority’) adopted a scientific opinion on the use of the substance phosphorous acid, triphenyl ester, polymer with 1,4-cyclohexanedimethanol and polypropylene glycol, C10–16 alkyl esters. The Authority concluded that the substance is not of safety concern for the consumer if used as an additive at up to 0,15% w/w in polyolefin materials and articles intended for contact with all food types except for infant formula and human milk, for long-term storage at room temperature and below, including hot-fill and/or heating up to 100 °C for up to 2 hours, if the migration of the total of phosphite and phosphate species does not exceed 5 mg/kg food, and if its low molecular weight fraction (LMWF) (<1000 Da) is not higher than 13% w/w. The Authority also indicated that the fat consumption reduction factor applies. 

(3) It is therefore appropriate to authorise the substance phosphorous acid, triphenyl ester, polymer with 1,4-cyclohexanedimethanol and polypropylene glycol, C10–16 alkyl esters (CAS No 1821217-71-3, FCM No 1084) accordingly.

(4) On 13 March 2024, the Authority adopted a scientific opinion4 on the use of the substance calcium tert-butylphosphonate. The Authority concluded that the substance is not of a safety concern for the consumer if it is used as a nucleating agent up to 0,15% w/w in polyolefin materials and articles intended for contact with all types of food for storage above 6 months at room temperature and below, including at temperatures up to 100 °C for maximum 2 hours and up to 130 °C for short durations, except for infant formula and human milk. 

(5) It is therefore appropriate to authorise the substance calcium tert-butylphosphonate (CAS No 81607-35-4, FCM No 1089) accordingly. 

(6) On 16 April 2024, the Authority adopted a scientific opinion5 on the use of the substance amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil. The Authority concluded that the substance is not of safety concern for the consumer if it is used as an additive at 0,1% w/w in the manufacture of polyolefin food contact materials intended to be in contact with foods simulated by food simulants A, B, C and E, except for infant formula and human milk, for storage above 6 months at room temperature and below, including hot-fill conditions and heating up to 100 °C for 2 hours. 

(7) It is therefore appropriate to authorise the substance amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil (CAS No 1801863-42-2, FCM No 1092) accordingly. 

(8) In its opinion on the substance amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil, the Authority proposed renaming the substance amines, bis(hydrogenated tallow alkyl) oxidised, by including the precision ‘di-C14-C20- alkyl’. This change of name was suggested as this substance contains C14- and C20- alkyl chains. Moreover, the authority recommended removing the note of verification of compliance in column 11 of Table 1 of Annex I for this substance as no substance’s specific value exists to verify its compliance. 

(9) It is therefore appropriate to change the name of the substance amines, bis(hydrogenated tallow alkyl) oxidised (FCM No 768) and remove the reference to the note on the verification of compliance accordingly. In addition, the restriction for the uses of this substance should be made consistent with the definition of ‘non-fatty foods’ in Regulation (EU) No 10/2011. 

(10) On 3 July 2024, the Authority adopted a scientific opinion on the use of the substances wax, rice bran, oxidised, and wax, rice bran, oxidised, calcium salt. The Authority concluded that these two substances are not of safety concern for the consumer if used as additives up to 0,3% w/w in polyethylene terephthalate (PET), polylactic acid (PLA) and rigid poly(vinyl chloride) (PVC) materials and articles intended for contact with all food types except for fatty foods, for long-term storage at