(1)

Annex I to Commission Regulation (EU) No 10/2011 (2) establishes a Union list of authorised substances which may be used in the manufacture of plastic materials and articles intended to come into contact with food.

(2)

Since the last amendment to Regulation (EU) No 10/2011, the European Food Safety Authority (‘the Authority’) has published a scientific opinion on the permitted uses of an already authorised substance that may be used in food contact materials (‘FCM’). In order to ensure that Regulation (EU) No 10/2011 reflects the most recent findings of the Authority, that Regulation should be amended.

(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) 2019/37 (3) 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 opinions (4) (5) published by the Authority. The Authority has adopted a new favourable scientific opinion (6) 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 1 000 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 1 000 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.

(4)

The authorisation of the FCM substance No 1059 provided for in this Regulation, 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. As analytical methods to determine the migration of these oligomers are complex, a description of those methods is not necessarily available to competent authorities. Without that description, it is not possible for the competent authority to verify that the migration of oligomers from the material or article complies with the migration limit for these oligomers. Therefore, business operators placing on the market the final article or material containing that substance should be required to include in the supporting documentation referred to in Article 16 of Regulation (EU) No 10/2011 a description of the method and a calibration sample if required by the method.

(5)

Annex I to Regulation (EU) No 10/2011 should therefore be amended accordingly.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,