(3)The substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (FCM substance No 1059, CAS number 147398-31-0) has been authorised by Commission Regulation (EU) 2019/37note to be used either alone or blended with other polymers in contact with dry or solid foods for which food simulant E is assigned in Table 2 of Annex III to Regulation (EU) No 10/2011 on the basis of two scientific opinionsnotenote published by the Authority. The Authority has adopted a new favourable scientific opinionnote extending the use of this substance alone or blended with other polymers in the manufacture of plastics intended to come into contact with all foods. In the later opinion, the Authority concluded that this substance is not of a safety concern for the consumer if it is used either alone or blended with other polymers in 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 5,0 mg/kg food or food simulant. The Authority's conclusion is based on the worst-case migration testing conditions set out in point 2.1.4 of Chapter 2 of Annex V to Regulation (EU) No 10/2011 for long term contact conditions (6 months or more) with food at room temperature or below. In accordance with the provisions of point 2.1.5 of Chapter 2, of Annex V to that Regulation, these worst-case migration testing conditions also address contact conditions of less than 6 months at room temperature or below. Therefore, 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 less than 6 months at room temperature or below, including hot fill or short heating-up phases will also be of no safety concern, provided that the migration of all oligomers with a molecular weight below 1000 Da does not exceed 5,0 mg/kg food or food simulant. In addition, the Authority also confirmed in this opinion that the specific migration limit of 0,05 mg/kg food set for the degradation product crotonic acid in the previous authorisation of FCM substance No 1059, should also apply under this extended use. The entry for this substance in Table 1 of point 1 of Annex I to Regulation (EU) No 10/2011 should therefore include the uses of this substance with all foods and in all conditions, in column 10 of that Table.
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.