COMMISSION IMPLEMENTING REGULATION (EU) 2022/672

of 22 April 2022

amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food trans-resveratrol (from microbial source)

(3) The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes trans-resveratrol from synthetic and microbial sources as an authorised novel food.

(5) Commission Implementing Decision (EU) 2016/1190 (5) authorised the placing on the Union market of synthetic trans-resveratrol as a novel food ingredient under Regulation (EC) No 258/97, also to be used in food supplements as defined in Directive 2002/46/EC in capsule or tablet form, for the adult population

(7) On 29 July 2021, the company Evolva AG (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the specifications of trans-resveratrol from a microbial source. The applicant requested to remove the requirement that 100 % of the particles of the novel food produced by S. cerevisiae should be of a size less than 62,23 micrometres (< 62,23 μm).

(8) The applicant justifies the request by indicating that the change is necessary in order to take account of the variation in the particle sizes of trans-resveratrol from a microbial source in the course of its production process and processing for use in food supplements. In support of the request, the applicant provided analytical data demonstrating that the particle size profile of trans-resveratrol from a microbial source is comparable to the particle size profile of the chemically synthesised trans-resveratrol that was evaluated by the European Food Safety Authority (‘the Authority’) (7), and for which no particle size requirements are included in the Union list of novel foods.

(9)

The Commission considers that the requested update of the Union list is not liable to have an effect on human health and that a safety evaluation by the Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary as the requested removal of the particle size requirement for trans-resveratrol from a microbial source does not alter its safety profile because the analytical evidence submitted by the applicant demonstrates that its particle size distribution profile is comparable to that of the chemically synthesised trans-resveratrol which was evaluated by the Authority.