On April 29, 2017 the European Commission (EC) published Regulation (EU) 2017/752 amending the regulation on plastic materials and articles intended for food contact ((EU) No 10/2011) in the Official Journal of the European Union.
Six new food contact substances have been added to the Union List (Annex I) of substances authorized for use in the manufacture of plastic food contact materials (FCMs), based on favorable Scientific Opinions by the European Food Safety Authority (EFSA): Diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate (CAS 976-56-7) used in the polymerization process to manufacture polyethylene terephthalate (PET) (FPF reported); (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform used as an additive in rigid non-plasticized polyvinylchloride (PVC) (FPF reported); montmorillonite clay modified by dimethyldialkyl(C16-C18)ammonium chloride used as an additive in in ethylene-based polymers (FPF reported); α-tocopherol acetate (CAS 7695-91-2 and 58-95-7) used as an antioxidant in polyolefins (FPF reported); ground sunflower seed hulls used as an additive in plastics such as polypropylene (PP) (FPF reported); and the defined mixture of 97% tetraethyl orthosilicate (TEOS, CAS 78-10-4) and 3% hexamethyldisilazane (HMDS, CAS 999-97-3) used as a chain extender in recycled PET (FPF reported).
Further, a specific migration limit (SML) for nickel of 0.02 mg/kg food or food simulant has been added to Annex II. The food simulant assignment for testing overall migration has been updated in Annex III. Lastly, the provision on the ratio of food contact surface area to volume to be specified in the Declaration of Compliance (DOC) (Annex IV) has been clarified.
EC (April 29, 2017). “Commission Regulation (EU) 2017/752 of 28 April 2017 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.” (pdf)
Chemical Watch (May 3, 2017). “EU Commission amends plastic FCM regulation.”