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EU: Commission proposes revisions to food contact plastic regulation

FEBRUARY 2023 - ELECTRICAL AND ELECTRONICS, HARDLINES, TOYS AND CHILDREN'S PRODUCTS

The European Commission (EC) has proposed¹ the 16th amendment to Annex I of the Regulation (EU) No 10/2011², which lays down specific rules for plastic materials and articles intended to come into contact with food. The proposed changes are based on recent scientific opinions from the European Food Safety Authority (EFSA) on new substances that may be used in food contact materials, as well as on the use of already authorized substances.

The public consultation on the proposed amendment is open until 31 March 2023, after which the EC will consider any feedback received before finalising the changes.

This draft Regulation contains several important changes to Annex I of the Plastic Regulation (EU) No 10/2011 which includes:

• Deletion of FCM 96 (wood) and FCM 121 (salicylic acid)
• New limits/group restrictions for the authorised phthalates:
  • FCM 157 (phthalic acid, dibutyl ester, DBP)
  • FCM 159 (phthalic acid, benzyl butyl ester, BBP)
  • FCM 283 (phthalic acid, bis(2- ethylhexyl) ester, DEHP)
  • FCM 728 (phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60 % C9, DINP)
• Adjustment specification of FCM 1059 (Poly((R)-3- hydroxybutyrate-co-(R)-3-hydroxyhexanoate, PHBH)
• Addition of 5 new substances:
  • FCM 1078 (tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate)
  • FCM 1080 (triethanolamine-perchlorate, sodium salt) dimer)
  • FCM 1081 (N, N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids)
  • FCM 1082 (Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate)
  • FCM 1083 (Benzophenone-3,3’,4,4’-tetracarboxylic dianhydride)
• Extension of use from poly(ethylene terephthalate) (PET) to poly(ethylene 2,5-furandicarboxylate) (PEF) of FCM 1007 (diethyl[[3,5‐bis(1,1‐dimethylethyl)‐4‐hydroxyphenyl]methyl] phosphonate)

The Commission has also proposed that plastic materials and articles complying with the Plastic Regulation (EC) No.10/2011 before the entry of this amendment, are allowed to be first placed on the market for a transition period of eighteen (18) months after the entry into force of this amendment and may remain on the market until stocks are exhausted. Operators manufacturing intermediate products and substances that do not yet comply with this Regulation should inform the users of these products already within nine (9) months following the entry into force of this Regulation that these products, as provided, cannot be used to manufacture plastic materials and articles to be placed on the market after the transition period ends.

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[1] G/SPS/N/EU/611

[2] Regulation (EU) No 10/2011 (consolidated version to 23 September 2020)