On May 8, 2019, the EU notified the World Trade Organization (WTO) of a planned amendment of the Regulation (EU) 10/2011 on food contact plastics. The amendment extends the authorization conditions for the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate (PHBH; CAS 147398-31-0). This is a “biodegradable copolymer . . . produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator),” a scientific opinion by the European Food Safety Authority (EFSA) explains. The substance has already been authorized in January 2019 for use in food contact plastics by the 12th amendment to Regulation (EU) No 10/2011 (FPF reported), on the condition that it is “to be used either alone or blended with other polymers in contact with dry or solid foods for which food simulant E is assigned.”
This initial authorization was based on two scientific opinions published by the EFSA in April 2016 (FPF reported) and July 2018 (FPF reported). However, in January 2019, these two opinions have been superseded by a third one (FPF reported). Accordingly, the authorization will now be extended to “the use of this substance alone or blended with other polymers in the manufacture of plastics intended to come into contact with all foods . . . under contact conditions of 6 months or more at room temperature or below, including hot fill or short heating-up phases, provided that the migration of all oligomers with a molecular weight below 1000 Da does not exceed 5 mg/kg food or food simulant.” The specific migration limit of 0.05 mg/kg food previously set for the degradation product crotonic acid (CAS 107-93-7) “should also apply under this extended use.”
Chemical Watch (May 14, 2019). “Commission to amend plastic food contact materials regulation.”
EFSA (2016). “SUPERSEDED: Safety assessment of the substances Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials.” EFSA Journal 14: e04464.
EFSA (2018). “SUPERSEDED: Safety assessment of the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials.” EFSA Journal 16: e05326.
EFSA (2019). “Safety assessment of the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials.” EFSA Journal 17: e05551.