On June 5, 2018, the European Commission (EC) published the 11th amendment to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. The EU had notified the World Trade Organization (WTO) of the foreseen amendment in February 2018 (FPF reported).
Two new substances are authorized for use in plastic FCMs and included in the Union List: 1) 1,2,3,4-tetrahydronaphtalene-2,6-dicarboxylic acid, dimethyl ester (CAS 23985-75-3) and [3-(2,3-epoxypropoxy) propyl]trimethoxy silane (CAS 2530-83-8). The entries for two other food contact substances are changed: The specific migration limit (SML) for perchloric acid and its salts (‘perchlorates’) is lowered from 0.05 mg/kg to 0.002 mg/kg. The SML for phosphorous acid, mixed 2,4-bis(1,1- dimethylpropyl)phenyl and 4-(1,1- dimethylpropyl)phenyl triesters (CAS 939402-02-5) is increased from 5 to 10 mg/kg.
The amendment will enter into force on the 20th day after its publication in the Official Journal of the European Union. However, “[p]lastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, may be placed on the market until 26 June 2019 and may remain on the market until exhaustion of stocks.”