The European Commission published the 11th Amendment to the Plastics Regulation (EU) No 10/2011 (Commission Regulation (EU) 2018/831) in the Official Journal of the European Union on June 5, 2018. This amendment follows publication of scientific opinions from the European Food Safety Authority (EFSA) on new substances that may be used in food contact materials and on the re-evaluation of substances that have been authorized for food contact use previously.

Specifically, the 11th Amendment revises the listing in Annex I for the additive/polymer production aid, perchloric acid, salts, to lower the specific migration limit (SML) from 0.05 mg/kg to 0.002 mg/kg. The move follows EFSA’s re-evaluation of perchlorate contamination in foods and the resulting dietary exposure, where EFSA concluded that the short and long term exposure to perchlorate for young population groups from all food sources exceed the tolerable daily intake (TDI). The Commission stated that the lower SML is necessary to ensure that migration of perchlorate from plastic food contact materials does not pose a human health hazard.

The Commission also listed the following new substances in Annex I, permitting their use in plastic food contact materials and articles, and increased the SML for another previously listed compound, based on three favorable scientific opinions from EFSA:

  • Phosphorus acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters, (SML increased from 5 mg/kg to 10 mg/kg)
  • Use of 1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid,dimethyl ester
  • Use of [3-(2,3-epoxypropoxy)propyl] trimethoxy silane

Commission Regulation (EU) 2018/831 will enter into force on June 26, 2018 and includes the following exhaustion of stocks clause: “Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, may be placed on the market until 26 June 2019 and may remain on the market until exhaustion of stocks.”