In an article published on February 27, 2018, regulatory news provider Chemical Watch informed that the EU has notified the World Trade Organization (WTO) of several amendments to Regulation (EU) No 10/2011 on plastic food contact materials (FCMs).
These amendments authorize two new substances, namely 1,2,3,4-tetrahydronaphthalene 2,6-dicarboxylic acid, dimethyl ester (CAS 23985-75-3) and [3-(2,3-epoxypropoxy)propyl]trimethoxy silane (CAS 2530-83-8). The sum of the former substance and its dimers should not migrate above 0.05 mg/kg food. The latter substance should not be detectable in the treated glass fibers at 10 µg/kg detection limit, and each of its reaction products (hydrolyzed monomers and epoxy-containing cyclic dimer, trimer and tetramer) at 60 µg/kg limit.
Further, the specific migration limit (SML) is changed for two substances. For the salts of perchloric acid (so-called ‘perchlorates’), the SML is lowered to 0.002 mg/kg from the current 0.05 mg/kg. This is done “to protect younger population groups.” On the contrary, for phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters (CAS 939402-02-5), the SML is increased to 10 mg/kg from the current 5 mg/kg. This is justified by “new scientific evidence that this substance is not of a safety concern for the consumer.”
These amendments will enter into force 20 days after publication in the Official Journal of the European Union. Plastic materials and articles complying with the regulation before the amendments “may be placed on the market in the next 12 months and can be sold until exhaustion of stocks.”
Chemical Watch (February 27, 2018). “EU notifies WTO of two new authorizations for plastic FCMs.”