(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 (2) establishing a Union list of authorised novel foods was adopted.

(3)

On 23 January 2019, the company Fermentalg (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 for an extension of use of the novel food Schizochytrium sp. oil. The applicant requested to extend the use of Schizochytrium sp. oil to infant formula and follow-on formula intended for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (3). The strain of Schizochytrium sp. used by the applicant and concerned by that application is specified as strain FCC-3204.

(4)

On 15 April 2019, the applicant submitted another application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 requesting to change the conditions of use of the novel food Schizochytrium sp. oil. The applicant requested to increase the maximum level of Schizochytrium sp. oil in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4) for the adult population, excluding pregnant and lactating women. The strain of Schizochytrium sp. used by the applicant and concerned by that application is the same strain FCC-3204 as above.

(5)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 13 May 2019, requesting it to provide a scientific opinion by carrying out an assessment for an extension of the use of Schizochytrium sp. oil as a novel food in infant formula and follow-on formula.

(6)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the Authority on 10 July 2019, requesting it to provide a scientific opinion by carrying out an assessment for the change of the conditions of use of Schizochytrium sp. oil as a novel food in food supplements.

(7)

On 24 November 2020, the Authority adopted its scientific opinions on the ‘Safety of oil from Schizochytrium limacinum (strain FCC-3204) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283’ (5) and ‘Safety of oil from Schizochytrium limacinum (strain FCC-3204) for use in food supplements as a novel food pursuant to Regulation (EU) 2015/2283’ (6). These opinions are in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

(8)

In these opinions, the Authority confirmed that the strain FCC-3204 belongs to the species Schizochytrium limacinum, which was attributed the qualified presumption of safety (‘QPS’) status and included in 2020 in the list of QPS-recommended biological agents intentionally added to food or feed (7).

(9)

The Authority concluded that Schizochytrium sp. oil produced from the strain FCC-3204, belonging to the species Schizochytrium limacinum, is safe under the proposed conditions of use in infant formula and in follow-on formula and at the maximum level of 1 g/day in food supplements.

(10)

With regard to the application concerning the food supplements, the Authority considered that the data provided by the applicant were not sufficient to conclude on the safety of the novel food at the proposed uses (3 g DHA/day in food supplements for adults, excluding pregnant and lactating women). However, the Authority in its 2012 scientific opinion on the ‘Tolerable Upper Intake Level of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA)’ (8) concluded that supplemental intakes of DHA alone up to about 1 g/day do not raise safety concerns for the general population. In line with the conclusions made by the Authority, and taking into account the Member States views, the Commission is of the view that this authorisation should concern general population above 3 years of age.

(11)

A labelling requirement should be provided in order to properly inform the consumers that the food supplements containing Schizochytrium sp. (FCC-3204) oil should not be consumed by infants and children under 3 years of age.

(12)

Data submitted by the applicant did not allow for a conclusion on the safety of oil produced from other strains of the Schizochytrium microalgae genus. Therefore, the opinions of the Authority do not give sufficient grounds to establish that oil produced from other strains of Schizochytrium microalgae genus when used in infant formula and follow-on formula and with increased levels in food supplements fulfil the requirements of Article 12(1) of Regulation (EU) 2015/2283.

(13)

Following the Authority’s opinions and taking into account that authorised Schizochytrium sp. oil for which an extension of use was requested is neither species-specific nor strain-specific, it is therefore necessary to authorise the placing on the market of oil from strain FCC-3204 of Schizochytrium sp. under the assessed conditions of use, and not an extension of use of oil from all strains of the Schizochytrium genus as requested by the applicant.

(14)

Regulation (EU) 2017/2470 should therefore be amended accordingly.

(15)

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