Commission implementing Regulation (EU) 2019/1979 of 26 November 2019 authorising the placing on the market of 2'-Fucosyllactose/Difucosyllactose mixture 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 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 was adopted, which establishes a Union list of authorised novel foods.

• (3) Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on updating the Union list.

• (4) On 30 April 2018, the company Glycom A/S (‘the Applicant’) made a request to the Commission within the meaning of Article 10(1) of Regulation (EU) 2015/2283 to place 2'-Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’), obtained by microbial fermentation with a genetically modified strain of Escherichia coli strain K12 DH1, on the Union market as a novel food. The Applicant requested for 2'-FL/DFL to be used in unflavoured pasteurised and unflavoured sterilised milk products, flavoured and unflavoured fermented milk based products including heat-treated products, cereal bars, flavoured drinks, infant formula and follow-on formula and processed cereal-based food and baby food for infants and young children, foods for special medical purposes, and total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council ³, and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council ⁴ intended for the general population excluding infants.

• (5) On 30 April 2018, the Applicant also made a request to the Commission for protection of proprietary data for a number of studies submitted in support of the application, namely, the proprietary analytical reports on the structure comparison via nuclear magnetic resonance (‘NMR’) of 2'-fucosyllactose and of difucosyllactose produced by bacterial fermentation with 2'-fucosyllactose and difucosyllactose naturally present in human milk ⁵, the detailed characterisation data on the production bacterial strains and their certificates ⁶, ⁷, the specifications for the raw materials and processing aids ⁸, the certificates of analyses of the various 2'-FL/DFL batches ⁹, the analytical methods and validation reports ¹⁰, the 2'-FL/DFL stability reports ¹¹, the laboratory accreditation certificates ¹², the 2'-FL/DFL intake assessment reports ¹³, the summary table of the statistically significant observations in the toxicity studies ¹⁴, a bacterial reverse mutation test with 2'-FL/DFL ¹⁵, an in vitro mammalian cell micronucleus test with 2'-FL/DFL ¹⁶, a 14-day oral toxicity study in the neonatal rat with 2'-FL/DFL ¹⁷, a 90-day oral toxicity study in the neonatal rat with 2'-FL/DFL ¹⁸, a bacterial reverse mutation test with 2'-Fucosyllactose (‘2'-FL’) ¹⁹ two in vitro mammalian cell micronucleus tests with 2'-FL ²⁰, ²¹, and a 90-day oral toxicity study in the neonatal rat with 2'-FL ²².

• (6) On 29 June 2018, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of 2'-FL/DFL as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.

• (7) On 15 May 2019, the Authority adopted its scientific opinion ‘Safety of 2'-Fucosyllactose/Difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283’ ²³. That scientific opinion is in accordance with the requirements of Article 11 of Regulation (EU) 2015/2283.

• (8) In its opinion, the Authority concluded that 2'-FL/DFL is safe under the proposed conditions of use for the proposed target population. Therefore that scientific opinion gives sufficient grounds to establish that 2'-FL/DFL, when used in unflavoured pasteurised and unflavoured sterilised milk products, flavoured and unflavoured fermented milk based products including heat treated products, cereal bars, flavoured drinks, infant formula and follow-on formula and processed cereal-based food and baby food for infants and young children, foods for special medical purposes, and total diet replacement foods for weight control, and in food supplements intended for the general population, excluding infants, complies with the requirements of Article 12(1) of Regulation (EU) 2015/2283.

• (9) In its opinion, the Authority considered that the data from the analytical NMR reports on the structure comparison of 2'-fucosyllactose and of difucosyllactose produced by bacterial fermentation with 2'-fucosyllactose and difucosyllactose naturally present in human milk, the detailed characterisation data on the production bacterial strains, the specifications for the raw materials and processing aids, the certificates of analyses of the various 2'-FL/DFL batches, the bacterial reverse mutation test with 2'-FL/DFL, the in vitro mammalian cell micronucleus test with 2'-FL/DFL, the 90-day oral toxicity study in the neonatal rat with 2'-FL/DFL, and the summary table of the statistically significant observations in the 90-day toxicity study, served as a basis to establish the safety of the novel food. Therefore, it is considered that the conclusions on the safety of 2'-FL/DFL could not have been reached without the data from the reports of these studies.

• (10) Following the receipt of the Authority’s considerations, the Commission requested the Applicant to further clarify the justification provided with regard to their proprietary analytical NMR reports on the structure comparison of 2'-fucosyllactose and of difucosyllactose produced by bacterial fermentation with 2'-fucosyllactose and difucosyllactose naturally present in human milk, the detailed characterisation data on the production bacterial strains, the specifications for the raw materials and processing aids, the certificates of analyses of the various 2'-FL/DFL batches, the bacterial reverse mutation test with 2'-FL/DFL, the in vitro mammalian cell micronucleus test with 2'-FL/DFL, the 90-day oral toxicity study in the neonatal rat with 2'-FL/DFL, and the summary table of the statistically significant observations in the 90-day toxicity study, and to clarify their claim to an exclusive right of reference to those reports and studies, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

• (11) The Applicant declared that, at the time the application was made, they held proprietary and exclusive rights of reference to the studies under national law and that therefore third parties could not lawfully access or use these studies.

• (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 data from the studies contained in the Applicant’s file which served as a basis for the Authority to establish the safety of the novel food and to reach its conclusions on the safety of 2'-FL/DFL, and without which the novel food could not have been assessed by the Authority, 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 2'-FL/DFL should be restricted to the Applicant for that period.

• (13) However, restricting the authorisation of 2'-FL/DFL and of the reference to the studies 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) The use of 2'-FL/DFL should be authorised without prejudice to Regulation (EU) No 609/2013 laying down requirements on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control.

• (15) The use of 2'-FL/DFL should also be authorised without prejudice to Directive 2002/46/EC laying down requirements on food supplements.

• (16) The use of 2'-FL/DFL should be authorised without prejudice to Regulation (EU) No 1308/2013 of the European Parliament and Council of 17 December 2013 establishing a common organisation of the markets in agricultural products ²⁴ laying down requirements for agricultural products, in particular on milk and milk products.

• (17) 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

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 the novel food without reference to the data protected pursuant to Article 2 to this Regulation or with the agreement of Glycom A/S.

Article 2

The studies and reports contained in the application file on the basis of which 2'-FL/DFL has been assessed by the Authority, claimed by the Applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EC) 2015/2283, 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 Glycom A/S.

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, 26 November 2019.

For the Commission

The President

Jean-Claude JUNCKER

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 in alphabetical order:

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