The European Commission (EC) has been reported to be developing the next (15th) amendment to EU Regulation No. 10/2011 on plastic materials and articles intended to come into contact with food. Law firm Keller and Heckman LLP (KH) informed about the developments in an article published on September 3, 2019. KH describes the current draft form of the amendment as including the following:

  • Adding three substances to the Union List of substances authorized for use in the manufacture of plastic food contact materials (FCMs):
    • “montmorillonite clay modified with hexadecyltrimethylammonium bromide
    • phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl ester
    • titanium dioxide surface-treated with fluoride-modified alumina, including the nano form”;
  • Decreasing the non-detect limit for specific migration of (i) 1,3-phenylenediamine (CAS 108-45-2) from 0.01 mg/kg to 0.002 mg/kg food or food simulant and of (ii) primary aromatic amines from 0.01 mg/kg to 0.002 mg/kg food or food simulant;
  • Adding specific migration limits for certain elements/metals into Annex II based on new scientific opinions from the European Food Safety Authority (EFSA);
  • Moving a list of permitted salts of authorized acids, phenols, and alcohols from Article 6.3(a) to Annex II;
  • Updating compliance testing requirements in Annex V.

The draft has not yet been published publicly on the EC’s website, and it might be further edited. The amendment is expected to be adopted no sooner than early 2020.

The most recent, 13th, amendment to the EU plastic FCM regulation extended permitted uses of a previously authorized substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (CAS 147398-31-0) (FPF reported).


Keller and Heckman LLP (September 3, 2019). “Work on the 15th Amendment to the Plastics Regulation Underway.”