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.)

• Published date: 09 August 2019
• Subject Matter: Consumer protection,Foodstuffs
• Official Gazette Publication: Official Journal of the European Union, L 209, 9 August 2019

9.8.2019 EN Official Journal of the European Union L 209/5

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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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular points (a), (d), (e), and (i) of Article 5(1), Article 11(3) and Article 12(3) and (6) thereof,

Whereas:

(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

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