Authorised Regulated Food and Feed Products for Great Britain

Use as monomer or other starting substance or macromolecule obtained from microbial fermentation (yes/no): yes

Restrictions and specifications: Only to be used either alone or blended with other polymers in contact with all foods under contact conditions of up to 6 months and/or 6 months and more, at room temperature or below, including hot fill or a short heating up phase. The migration of all oligomers with a molecular weight below 1 000 Da shall not exceed 5,0 mg/kg food.

Notes on verification of compliance: When a final material or article containing this substance is placed on the market, a well described method to determine whether the oligomer migration complies with the restrictions specified in column 10 of Table 1 shall form part of the supporting documentation referred to in Article 16. This method shall be suitable for use by a competent authority to verify compliance. If an adequate method is publicly available, reference shall be made to that method. If the method requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.

Group restrictions: Group restriction No. FCM substance Nos. in group restriction Total specific migration limit [mg/kg] Group restriction specification

35 467 crotonic acid
744 3-hydroxybutanoic acid-3- hydroxypentanoic acid...
1059 Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexa...
0.05 mg/kg expressed as crotonic acid

Group restriction No.	FCM substance Nos. in group restriction	Total specific migration limit [mg/kg]	Group restriction specification
35	467 crotonic acid 744 3-hydroxybutanoic acid-3- hydroxypentanoic acid... 1059 Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexa...	0.05 mg/kg	expressed as crotonic acid

Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate)