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16th amendment to EU Regulation 10/2011 on plastic FCMs now in force

The 16th amendment to Regulation EU 10/2011 on plastic materials and articles intended to come into contact was published on July 11, 2023, in the Official Journal of the EU.

This Regulation EU 2023/1442 amends the list of authorized substances in Annex I of the EU 10/2011. In particular, it modifies the SML (Specific Migration Limit) for five phthalates (BBP, DBP, DEHP, DIDP, and DINP). The specific migration limits (SMLs) for these substances have been reduced as follows:

  • DEHP from 1.5 mg/kg to 0.6 mg/kg

  • DBP from 0.3 mg/kg to 0.12 mg/kg

  • BBP from 30 mg/kg to 6 mg/kg

  • The sum of DiNP and DiDP from 9 mg/kg to 1.8 mg/kg

This new regulation further removes the authorized use of salicylic acid (FCM no. 121) and untreated wood flours and fibers (FCM no. 96). In addition, it adds the following five new authorized substances to the EU’s list:

  • Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate (CAS no. 3319-31-1) with an SML of 1 mg/kg

  • Dimer (triethanolamine perchlorate, sodium salt) (CAS no. 156157-97-0) with a total SML of 0.05 mg/kg expressed as the sum of the triethanolamine and the hydrochloride compound expressed as triethanolamine and an additional total SML of 0.002 mg/kg expressed as perchlorate

  • N,N-Bis(2-hydroxyethyl) stearylamine partially esterified with C16/C18 saturated fatty acids (MCDA No. 1081) with a total SML of 1.2 mg/kg expressed as tertiary amine

  • Mixtures of phosphoric acid esters and 2-hydroxyethyl methacrylate (CAS no. 52628-03-2) with an SML of 0.05 mg/kg

  • Benzophenone 3,3',4,4'-tetracarboxylic dianhydride (BTDA) (CAS no. 2421-28-5), with an SML of 0.05 mg/kg

The new regulation came into force on August 1, 2023.

Transitional provisions are provided under this new regulation. Notably, plastic materials and articles that comply with the provisions of Regulation (EU) No 10/2011 applicable before August 1, 2023, and which were placed on the market for the first time before February 1, 2025, may remain on the market until stocks are exhausted. Additionally, plastic materials and articles made with salicylic acid or with flour or untreated wood fibers from a specific wood species may continue to be placed on the market, for the first time after February 1, 2025, provided that an authorization request has been submitted to the competent authority before August 1, 2024.



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