On August 8, 2019, the European Commission (EC) amended EU Regulation No. 10/2011 on plastic materials and articles intended to come into contact with food. The amendment authorizes the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (CAS 147398-31-0) to be used either alone or blended with other polymers that come into contact with dry or solid foods for less than 6 months at room temperature or below. This includes hot filling and short heating phases. The authorization corresponds to migration testing that makes use of simulant E in Table 2 of Annex III of the EU No. 10/2011 regulation. The amendment also “requires that the total migration of all oligomers with a molecular weight below 1 000 Da does not exceed 5.0 mg/kg food or food simulant.” The EC notified the World Trade Organization (WTO) of the planned amendment in May 2019 (FPF reported), and the new regulation is set to enter into force on August 28, 2019.
EC (August 8, 2019). “Commission Regulation (EU) 2019/1338 of 8 August 2019 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance.)”
Chemical Watch (August 15, 2019). “European Commission amends FCM regulation.”
IBE-BVI (August 2019). “FCM: 13th amendment to regulation EU/10/2011.“