Commission Implementing Regulation (EU) 2022/168 of 8 February 2022 authorising the placing on the market of pasteurised Akkermansia muciniphila 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 24 October 2019, the company A-Mansia Biotech S.A. (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place pasteurised Akkermansia muciniphila on the Union market as a novel food. The applicant requested for pasteurised Akkermansia muciniphila bacteria to be used as a novel food at levels not exceeding 5 × 10¹⁰ cells per day in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council ³ and in foods for special medical purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council ⁴, intended for the adult population, excluding pregnant and lactating women.

• (4) On 24 October 2019, the applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application, namely, a bacterial reverse mutation test ⁵, an in vitro mammalian cell micronucleus test ⁶, a 14-day dose ranging oral toxicity study in rats ⁷, a 90-day oral toxicity study in rats ⁸, the published toxicity data ⁹, a flow cytometry validation study ¹⁰, and an antimicrobial resistance study ¹¹.

• (5) On 19 May 2020, the Commission requested, in accordance with Article 10(3) of Regulation (EU) 2015/2283, the European Food Safety Authority (‘the Authority’) to carry out an assessment of pasteurised Akkermansia muciniphila as a novel food.

• (6) On 7 July 2021, the Authority adopted its scientific opinion on the safety of pasteurised Akkermansia muciniphila as a novel food pursuant to Regulation (EU) 2015/2283 ¹².

• (7) In its scientific opinion, the Authority concluded that pasteurised Akkermansia muciniphila is safe under the proposed conditions of use for the proposed target populations at levels not exceeding 3,4 × 10¹⁰ cells/day. Therefore, that scientific opinion gives sufficient grounds to establish that pasteurised Akkermansia muciniphila, when used at levels not exceeding 3,4 × 10¹⁰ cells/day in food supplements and in foods for special medical purposes intended for the adult population, excluding pregnant and lactating women, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

• (8) In its scientific opinion, the Authority noted that its conclusion on the safety of the novel food was based on the data from the bacterial reverse mutation test, the in vitro mammalian cell micronucleus test, the 14-day dose ranging oral toxicity study in rats, the 90-day oral toxicity study in rats, the method validation study for the formulation analysis for the 90-day oral toxicity study in rats, and the antimicrobial resistance study.

• (9) The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those data and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2)(b) of Regulation (EU) 2015/2283.

• (10) The applicant declared that they held proprietary and exclusive rights of reference to the data from the bacterial reverse mutation test, the in vitro mammalian cell micronucleus test, the 14-day dose ranging oral toxicity study in rats, the 90-day oral toxicity study in rats, the published toxicity data, the flow cytometry validation study, and the antimicrobial resistance study at the time they submitted the application and therefore third parties could not lawfully have access to or use those studies.

• (11) 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 data from the bacterial reverse mutation test, the in vitro mammalian cell micronucleus test, the 14-day dose ranging oral toxicity study in rats, the 90-day oral toxicity study in rats, the published toxicity data, the flow cytometry validation study, and the antimicrobial resistance study contained in the applicant’s file on which the Authority based its conclusion on the safety of the novel food and without which it could have not assessed the novel food, 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, only the applicant should be authorised to place pasteurised Akkermansia muciniphila on the market within the Union during that period.

• (12) However, restricting the authorisation of pasteurised Akkermansia muciniphila and the reference to the data contained in the applicant’s file for the sole use by 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.

• (13) The Annex to Regulation (EU) 2017/2470 should therefore be amended accordingly.

• (14) 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: A-Mansia Biotech S.A.;

address: rue Granbonpré, 11 Bâtiment H 1435 Mont-Saint-Guibert, Belgium,

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 or with the agreement of A-Mansia Biotech S.A.

Article 2

The scientific data contained in the application file on the basis of which the novel food referred to in Article 1 have 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 a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of A-Mansia Biotech S.A.

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, 8 February 2022.

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: