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EC Publishes 12th Amendment to the Plastics Regulation

Machine wrapping packages in plastic

The European Commission published the 12th amendment to the Plastics Regulation (EU) No 10/2011 on January 11, 2019, in the Official Journal of the European Union.  This amendment, Commission Regulation (EU) 2019/37, adds new substances to the list of substances that may be used in food contact materials (also referred to as the positive list or the Union list), makes corrections to pre-existing substances on the positive list, and clarifies what food simulants should be used for the overall migration testing of milk products.

Based on favorable scientific opinions from the European Food Safety Authority (EFSA), the Commission added the following substances to the positive list in Annex 1 of the Plastics Regulation:

  • Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate), which is a biodegradable (co)polymer obtained from microbial fermentation used in the manufacture of packaging articles intended to be in contact with whole fruit and vegetables;
  • Dimethyl carbonate as a monomer; and
  • Isobutane as a foaming/blowing agent only.

Commission Regulation (EU) 2019/37 will enter into force 20 days after publication in the Official Journal of the European Union (i.e., on January 31, 2019) and it includes an exhaustion of stocks clause.