Commission Implementing Regulation (EU) 2021/670 of 23 April 2021 authorising the placing on the market of Schizochytrium sp. (WZU477) oil 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 (Text with EEA relevance)

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 1852/2001 ¹, and in particular Article 12 thereof,

Whereas:

• (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 14 March 2019, the company Progress Biotech bv (‘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 application requested to extend the use of Schizochytrium sp. oil to infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council ³ intended for infants and young children. The strain of Schizochytrium sp. used by the applicant and concerned by this application is specified as strain WZU477.

• (4) The applicant also submitted a request to the Commission for the protection of proprietary data for a number of original data submitted in support of its application, being data submitted in support of the initial application of 14 March 2019 namely, application 2012 ⁴; detailed description of the production process ⁵; chemical characteristics ⁶; fatty acid analysis ⁷; sterol analysis ⁸; heavy metals analysis ⁹; PAH analysis ¹⁰; mycotoxin analysis ¹¹; dioxin, dioxin like, PCB, pesticides analysis ¹²; microbiological analysis ¹³; retrospective stability study ¹⁴; analytical lab certificates ¹⁵; compositional data ¹⁶. The applicant also requested data protection for the additional data submitted in the course of the safety assessment carried out by the Authority: protein analysis ¹⁷; 3 MCPD & glycidyl ester analyses ¹⁸; physicochemical analysis ¹⁹; microbiological analysis ²⁰; heavy metals analysis ²¹; mycotoxin analysis ²²; PAH, dioxin and dioxin-like contaminants analysis ²³; fatty acid profile analysis ²⁴; sterol composition analysis ²⁵; hydrolytic rancidity analysis over time ²⁶; marine biotoxin analysis ²⁷; stability study ²⁸; certificate of analysis ²⁹.

• (5) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 24 June 2019, requesting it to provide a scientific opinion by carrying out an assessment for an extension of use of Schizochytrium sp. oil as a novel food in infant formula and follow-on formula.

• (6) On 31 August 2020, the Authority adopted its scientific opinion on the “Safety of Schizochytrium sp. oil as a novel food pursuant to Regulation (EU) 2015/2283” ³⁰. That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

• (7) In that opinion, the Authority confirmed that the identity of the strain WZU477 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 ³¹. In its opinion, the Authority concluded that Schizochytrium sp. oil produced from the strain WZU477 belonging to species Schizochytrium limacinum is safe under the proposed conditions of use. 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. The opinion of the Authority gives sufficient grounds to establish that Schizochytrium sp. (WZU477) oil under the proposed uses and use levels complies with the requirements of Article 12(1) of Regulation (EU) 2015/2283.

• (8) Therefore, the opinion of the Authority does not give sufficient grounds to establish that oil produced from other strains of the Schizochytrium microalgae genus when used in infant formula and follow on formula, complies with Article 12(1) of Regulation (EU) 2015/2283. Following the Authority’s opinion and taking into account that the 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 WZU477 of Schizochytrium sp., and not an extension of use of oil from all strains of the Schizochytrium genus as requested by the applicant.

• (9) In its opinion, the Authority considered that the data from the application 2012, detailed description of the production process, chemical characteristics, fatty acid analysis, sterol analysis, heavy metals analysis, PAH analysis, mycotoxin analysis, dioxin, dioxin like, PCB, pesticides analysis, microbiological analysis, retrospective stability study, analytical lab certificates, compositional data, 3 MCPD & glycidyl ester analyses, physicochemical analysis, microbiological analysis, heavy metals analysis, mycotoxin analysis, PAH, dioxin and dioxin-like contaminants analysis, fatty acid profile analysis, sterol composition analysis, hydrolytic rancidity analysis over time, marine biotoxin analysis, stability study and certificate of analysis served as a basis to establish the safety of the novel food. On this basis, the Commission considers that the conclusions on the safety of Schizochytrium sp. (WZU477) oil could not have been reached without the data from the reports of those studies.

• (10) Following the authority’s opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the application 2012, detailed description of the production process, chemical characteristics, fatty acid analysis, sterol analysis, heavy metals analysis, PAH analysis, mycotoxin analysis, dioxin, dioxin like, PCB, pesticides analysis, microbiological analysis, retrospective stability study, analytical lab certificates, compositional data, 3 MCPD & glycidyl ester analyses, physicochemical analysis, microbiological analysis, heavy metals analysis, mycotoxin analysis, PAH, dioxin and dioxin-like contaminants analysis, fatty acid profile analysis, sterol composition analysis, hydrolytic rancidity analysis over time, marine biotoxin analysis, stability study and certificate of analysis, and to clarify their claim to an exclusive right of reference to that data, as required under Article 26(2)(b) of Regulation (EU) 2015/2283.

• (11) The applicant declared that, at the time of the submission of the application, they held proprietary and exclusive rights of reference to that data under national law, and that therefore third parties cannot lawfully access or use those studies or refer to that data.

• (12) The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the application 2012, detailed description of the production process, chemical characteristics, fatty acid analysis, sterol analysis, heavy metals analysis, PAH analysis, mycotoxin analysis, dioxin, dioxin like, PCB, pesticides analysis, microbiological analysis, retrospective stability study, analytical lab certificates, compositional data, 3 MCPD & glycidyl ester analyses, physicochemical analysis, microbiological analysis, heavy metals analysis, mycotoxin analysis, PAH, dioxin and dioxin-like contaminants analysis, fatty acid profile analysis, sterol composition analysis, hydrolytic rancidity analysis over time, marine biotoxin analysis, stability study and certificate of analysis contained in the applicant’s file should not be used by the Authority for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of Schizochytrium sp. (WZU477) oil should be restricted to the applicant for that period.

• (13) However, restricting the authorisation of Schizochytrium sp. (WZU477) oil and of the reference to the data contained in the applicant’s file for the sole use of the applicant, does not prevent other applicants from applying for an authorisation to place on the market the same novel food, provided that their application is based on legally obtained information supporting such authorisation under Regulation (EU) 2015/2283.

• (14) Implementing Regulation (EU) 2017/2470 should be therefore 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,

HAS ADOPTED THIS REGULATION:

Article 1

• — Company: Progress Biotech bv,

• — Address: Canaalstaete, Kanaalweg 33, 2903LR Capelle aan den Ijssel, the Netherlands,

is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for that novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Progress Biotech bv.

Article 2

The data contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation, without the agreement of Progress Biotech bv.

Article 3

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 23 April 2021.

For the Commission

The President

Ursula VON DER LEYEN

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

• (1) in Table 1 (Authorised novel foods), the following entry is inserted:

• (2) in Table 2 (Specifications), the following entry is inserted: