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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001note, and in particular Article 12 thereof,Whereas:
(1)Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.
(2)Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470note has established a Union list of novel foods.
(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.
(4)The novel food trans-resveratrol from a microbial source has been authorised as a novel food ingredient under pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Councilnote to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Councilnote, in capsule or tablet form, for the adult population on the basis of its substantial equivalence to resveratrol with a history of consumption before 15 May 1997 extracted from the Japanese knotweed (Fallopia japonica).
(5)Commission Implementing Decision (EU) 2016/1190note 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.
(6)Commission Implementing Regulation (EU) 2021/51note amended the conditions of use of trans-resveratrol. In particular, the restrictions on the delivery formats of food supplements containing the novel food have been lifted.
(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’)note, 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.
(10)The information provided in the application gives sufficient grounds to establish that the requested changes to the specifications of trans-resveratrol are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.
(11)The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(12)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1#
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 2#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
In Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470 the entry for trans-resveratrol is replaced by the following:
Authorised Novel Food | SpecificationsTrans-resveratrol | Description/Definition:Synthetic: Trans-resveratrol is off-white to beige crystals.Chemical name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diolChemical formula: C14H12O3Molecular weight: 228,25 DaCAS No: 501-36-0Purity:Trans-resveratrol: ≥ 98 %-99 %Total by-products (related substances): ≤ 0,5 %Any single related substance: ≤ 0,1 %Sulphated ash: ≤ 0,1 %Loss on drying: ≤ 0,5 %Heavy metals:Lead: ≤ 1,0 ppmMercury: ≤ 0,1 ppmArsenic: ≤ 1,0 ppmImpurities:Diisopropylamine: ≤ 50 mg/kgMicrobial source: A genetically modified strain of Saccharomyces cerevisiaeAppearance: Off-white to slight yellow powderTrans-resveratrol content: Min. 98 % w/w (dry weight basis)Ash: Max. 0,5 % w/wMoisture: Max. 3 % w/w
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