16th Amendment to the EU Plastics Regulation Published

The 16^th amendment to the Plastics Regulation, (EU) No 10/2011, was published on July 12, 2023, in the Official Journal of the European Union: Commission Regulation (EU) 2023/1442 of 11 July 2023 amending Annex I to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, as regards changes to substance authorisations and addition of new substances.

The 16^th amendment revokes the authorization of wood flour and fibers, untreated and salicylic acid, and adds the following substances to the positive list of Annex I:

• tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate 
• (triethanolamine-perchlorate, sodium salt) dimer 
• N, N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids 
• phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate 
• benzophenone-3,3’,4,4’-tetracarboxylic dianhydride (BTDA) 

Other changes to the Plastics Regulation include amending the specific migration levels (SMLs) and/or restrictions and specifications for four phthalates, namely: 

• phthalic acid, dibutyl ester (DBP)
• phthalic acid, benzyl butyl ester (BBP)
• phthalic acid, bis(2-ethylhexyl) ester (DEHP)
• phthalic acid, diesters with primary, saturated C₈-C₁₀ branched alcohols, more than 60% C₉ (DINP) 

In addition, the 16^th amendment amends the restrictions and specifications for Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (PHBH) and extends the permitted use for diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate and phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2- ethanediyl)], C10-16 alkyl ester.

The 16^th amendment will enter into force on August 1, 2023. However, it does include an exhaustion of stocks provision and several other transitional measures. (Background information on the EU’s Plastics Regulation can be found here.)