October 14, 2019

October 14, 2019

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Work on the 15th Amendment to the Plastics Regulation Underway

The European Commission (EC) is currently working on the 15th amendment to the Plastics Regulation. In its present form, the draft proposes to:

  • Add the following substances to the Plastic Regulation’s positive list subject to specific restrictions:

    • 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

  • Lower the non-detect limit for the specific migration of 1,3-phenylenediamine from 0.01 mg/kg to 0.002 mg/kg food or food simulant

  • Expand the table in Annex II (Restrictions on materials and articles) listing elements/metals subject to specific migration limits based on recent scientific opinions issued by the European Food Safety Authority (EFSA)

  • Move the list of permitted salts of authorized acids, phenols and alcohols from Article 6.3(a) of the Plastics Regulation to Annex II of that Regulation (currently only elements subject to restrictions in the final plastic material or article are listed in Annex II)

  • Reduce the non-detect limit for the specific migration of primary aromatic amines from 0.01 mg/kg to 0.002 mg/kg food or food simulant

  • Make certain changes to compliance testing requirements in Annex V

Importantly, the draft has not been posted on the EC’s website yet and may be subject to further changes.  The earliest potential timeline for adoption of the draft is the beginning of 2020.

© 2019 Keller and Heckman LLP


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PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.