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On March 5th, 2020, the European Commission (EC) submitted a notification to the World Trade Organization regarding the proposed amendments and corrections to Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food.

This draft regulation amends Annex I of Regulation (EU) No 10/2011 and adds the following to the list of authorized substances that may be used in the manufacture of plastic layers in plastic materials and articles:

  • Montmorillonite clay modified with hexadecyltrimethyl ammonium bromide
  • Phosphorous acid, triphenyl ester, polymer with alpha-hydroomegahydroxypoly[oxy( methyl‑1,2- ethanediyl)], C10- 16 alkyl ester
  • Titanium dioxide surface-treated with fluoride modified alumina.

Furthermore, it authorizes “all salts of substances for which ‘yes’ is indicated in column 2 in table 1 of Annex II of authorized acids, phenols or alcohols, and subject to the restrictions set out in column 3 and 4 of that table” subject to the rules of Articles 8,9, 10, 11, and 12 of the regulation.

Annex II is amended in its entirety and specifies migration limits for more substances migrating from plastic materials and articles, including lead, cadmium and mercury which should not be detected.

Other changes concern lower detection limits for primary aromatic amines, stronger information requirement sunder point 6 of Annex IV, new testing rules for food processing equipment and appliances, a new standard testing condition for overall migration, and corrections on the wording related to overall migration testing.

The amendments and corrections are expected to be adopted by June 2020.