(Utkast) Kommisjonens gjennomføringsforordning om tillatelse til bringe gjærbiomasse (Yarrowia lipolytica) som inneholder selen i omsetning som et nytt næringsmiddel i henhold til europaparlaments- og rådsforordning (EU) 2015/2283, og om endring av Kommisjonens gjennomføringsforordning (EU) 2017/2470
(Draft) Commission Implementing Regulation authorising the placing on the market of selenium-containing yeast (Yarrowia lipolytica) biomass as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 13.10.2020
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 establishing a Union list of authorised novel foods was adopted.
(3) Commission Implementing Regulation (EU) 2019/760 authorised, in accordance with Regulation (EU) 2015/2283, the placing on the market of Yarrowia lipolytica yeast biomass as a novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council , excluding food supplements for infants and young children.
(4) On 21 September 2018, the company Skotan S.A. (‘the applicant’) introduced an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 to place selenium-enriched biomass of the yeast Yarrowia lipolytica on the Union market as a novel food. The applicant requested for selenium-enriched biomass of the yeast Yarrowia lipolytica to be used in food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council . The maximum use levels proposed by the applicant are 0,2 g per day for children from 3 to 9 years of age, and 1 g per day for adolescents and adults.
(5) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority ('Authority') on 18 February 2019, asking it to provide a scientific opinion by carrying out an assessment for selenium-containing yeast (Yarrowia lipolytica) biomass as a novel food.
(6) On 18 December 2019, the Authority adopted the scientific opinion “Safety of selenium-enriched biomass of Yarrowia lipolytica as a novel food pursuant to Regulation (EU) 2015/2283” . That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
(7) In that opinion, the Authority concluded that selenium-containing yeast (Yarrowia lipolytica) biomass is not of safety concern at the proposed use levels. The Authority also considered that the selenium provided by selenium-containing yeast (Yarrowia lipolytica) biomass is as safe as selenium from other dietary sources.
(8) The Authority also noted that, at the use levels proposed by the applicant, the intake of the novel food in combination with a background diet high in selenium could lead to total selenium intakes exceeding the Tolerable Upper Intake Level (‘UL’) for selenium established by the Scientific Committee on Food , in all target population groups, except for children from 7 to 9 years of age.
(9) In light of the observation made by the Authority relating to the combined intake of selenium, the applicant submitted a modified request to the Commission with regard to the conditions of use of selenium-containing yeast (Yarrowia lipolytica) biomass, in particular concerning the maximum levels of the novel food in food supplements and the population groups for which food supplements are intended. The applicant proposed the novel food to be used in food supplements intended for the general population from 4 years of age, at levels ranging from 50 mg/day to 800 mg/day, that would result in selenium intakes which, combined with the selenium intakes from a background diet high in selenium, would not exceed the UL for selenium.
(10) The Commission considers that the Authority’s opinion and the modified conditions of use requested by the applicant give sufficient grounds to establish that selenium-containing yeast (Yarrowia lipolytica) biomass at the proposed uses and use levels when used in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.
(11) Regulation (EU) 2017/2470 should be therefore 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
Helse- og omsorgsdepartementet