On August 25, 2016 the European Commission (EC) published Regulation (EU) 2016/1416 amending the regulation on plastic materials and articles intended for food contact ((EU) No 10/2011) in the Official Journal of the European Union. Ten new food contact substances have been added to the Union List of substances authorized for use in the manufacture of plastic food contact materials (FCMs). Their inclusion in the Union List is based on Scientific Opinions by the European Food Safety Authority (EFSA). Examples for newly authorized substances include the polymer production aid perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt (CAS 1190931-27-1) used in the manufacture of fluoropolymers (FPF reported). Also, two nanomaterials, zinc oxide uncoated (no CAS available; FCM No 1050) and coated with [3-(methacryloxy)propyl] trimethoxysilane (no CAS available; FCM No 1046), used as additives in polyolefins (FPF reported) and unplasticized polymers (FPF reported), have been included in the Union List.
For three of the ten newly authorized substances, a new provision requires that the migration of the low molecular weight oligomeric fraction less than 1,000 Da shall not in total exceed a migration limit of 50 μg/kg food. This applies to substances dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene (CAS 287916-86-3; FPF reported), 2,4,8,10-tetraoxaspiro[5,5] undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl- (CAS 1455-42-1; FPF reported), and furan-2,5-dicarboxylic acid (CAS 3238-40-2). The latter shall be used as a monomer in the production of polyethylene furanoate (PEF) polymer (FPF reported). In addition, specific provisions have been included for compliance testing of PEF plastic in contact with non-alcoholic foods.
Further, specifications are made for six food contact substances that are already on the Union List. For example, for silicon dioxide, silanated (no CAS available; FCM No 87) and its sub-category synthetic amorphous silicon dioxide, silanated, which is produced using primary particles in nanoform, specifications have been included for explicitly authorizing the nanoform. Also, for perfluoromethyl perfluorovinylether (CAS 1187-93-5) the authorization has been extended to use as monomer for fluoro- and perfluoropolymers intended for repeated use applications (FPF reported).
In order to reduce the contribution from FCMs to the general public’s overall exposure to chemicals, the migration limit for aluminum has been set at 1 mg/kg food and the migration limit for zinc has been lowered to 5 mg/kg food. The new regulation also makes several specifications for migration testing, in particular regarding food simulants and testing conditions.
The amendment enters into force on the 20th day after its publication in the EU Official Journal (September 14, 2016). The EC notes that the provisions on the specific migration limits for aluminum and zinc shall apply from September 14, 2018.
Read more
EC (August 25, 2016). “Commission Regulation (EU) 2016/1416 of 24 August 2016 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.” (pdf)
Smithers Pira (November 2, 2016). “EU publishes significant revision of plastics regulation.“
