(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods 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) has established a Union list of novel foods.

(3)

Commission Implementing Regulation (EU) 2021/2029 (3) authorised the placing on the Union market of 3-Fucosyllactose obtained by microbial fermentation using the genetically modified strain K12 MG1655 of Escherichia coli (‘E. coli’) as a novel food under Regulation (EU) 2015/2283.

(4)

Commission Implementing Regulation (EU) 2023/52 (4) of 4 January 2023 authorised the placing on the market of 3-Fucosyllactose produced by a derivative strain of E. coli BL21(DE3) as a novel food under Regulation (EU) 2015/2283.

(5)

On 25 March 2021, the company Glycom A/S (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place 3-Fucosyllactose (‘3-FL’) obtained by microbial fermentation using a genetically modified strain of E. coli K-12 DH1, on the Union market as a novel food. The applicant requested for 3-FL to be used in infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (5), unflavoured pasteurised and unflavoured sterilised (including UHT) milk products, unflavoured and flavoured fermented milk-based products including heat-treated products, cereal bars, milk based drinks and similar products, foods for special medical purposes as defined in Regulation (EU) No 609/2013, beverages (flavoured drinks, excluding drinks with a pH less than 5), total diet replacement for weight control as defined in Regulation (EU) No 609/2013, and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (6) intended for the general population. Subsequently, on 15 June 2023, the applicant modified the initial request in the application on the use of 3-FL in food supplements to exclude infants and young children. Concerning the conditions of use, the applicant also proposed that food supplements containing 3-FL should not be used if other foods with added 3-FL are consumed the same day.

(6)

On 25 March 2021, the applicant also made a request to the Commission for the protection of proprietary scientific studies and data submitted in support of the application, namely, high performance liquid chromatography-electrospray ionisation-mass spectrometry (‘HPLC-ESI-MS/MS’), nuclear magnetic resonance (‘NMR’) spectroscopy, and high-performance anion-exchange chromatography with pulsed amperometric detection (‘HPAEC-PAD’) method validation and the results for the determination of the identity of 3-FL (7); a detailed description of the genetically modified 3-FL production strain (8); a detailed description of the production process (9); detailed composition analysis and stability test results (10); a bacterial reverse mutation test with 3-FL (11); an in vitro mammalian cell micronucleus test with 3-FL (12); a 14-day dose range finding oral toxicity study in rats with 3-FL (13); and, a 90-day oral toxicity study in rats with 3-FL (14).

(7)

On 4 October 2021, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of 3-FL obtained by microbial fermentation using a genetically modified production strain derived from the host strain E. coli K-12 DH1, as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.

(8)

On 27 April 2023, the Authority adopted its scientific opinion on the ‘Safety of 3-fucosyllactose (3-FL) produced by a derivative strain of Escherichia coli K-12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283’ (15) in accordance with Article 11 of Regulation (EU) 2015/2283.

(9)

In its scientific opinion, the Authority concluded that 3-FL produced by a derivative strain of E. coli K-12 DH1 is safe under the proposed conditions of use for the proposed target populations. Therefore, that scientific opinion gives sufficient grounds to establish that 3-FL produced by a derivative strain of E. coli K-12 DH1, when used in infant formula and follow-on formula as defined in Regulation (EU) No 609/2013, unflavoured pasteurised and unflavoured sterilised (including UHT) milk products, unflavoured and flavoured fermented milk-based products including heat-treated products, cereal bars, milk based drinks and similar products, foods for special medical purposes as defined in Regulation (EU) No 609/2013, beverages (flavoured drinks, excluding drinks with a pH less than 5), total diet replacement for weight control as defined in Regulation (EU) No 609/2013, and in food supplements as defined in Directive 2002/46/EC, complies with the authorisation requirements of Article 12(1) of Regulation (EU) 2015/2283.

(10)

In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 3-FL produced by a derivative strain of E. coli K-12 DH1 without the scientific studies and data on the HPLC-ESI-MS/MS, NMR spectroscopy, and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL; the detailed description of the genetically modified 3-FL production strain; the detailed description of the production process; the detailed composition analysis and stability test results; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 14-day dose range finding oral toxicity study in rats with 3-FL; and, the 90-day oral toxicity study in rats with 3-FL.

(11)

The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those scientific studies and 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.

(12)

The applicant declared that it held proprietary and exclusive rights of reference to the scientific studies and data on the HPLC-ESI-MS/MS, NMR spectroscopy, and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL; the detailed description of the genetically modified 3-FL production strain; the detailed description of the production process; the detailed composition analysis and stability test results; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 14-day dose range finding oral toxicity study in rats with 3-FL; and, the 90-day oral toxicity study in rats with 3-FL, under national law at the time it submitted the application, and that third parties cannot lawfully access, use or refer to those data and studies.

(13)

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 scientific studies and data on the HPLC-ESI-MS/MS, NMR spectroscopy, and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL; the detailed description of the genetically modified 3-FL production strain; the detailed description of the production process; the detailed composition analysis and stability test results; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 14-day dose range finding oral toxicity study in rats with 3-FL; and, the 90-day oral toxicity study in rats with 3-FL, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place 3-FL produced with a derivative strain of E. coli K-12 DH1 on the market within the Union during a period of five years from the entry into force of this Regulation.

(14)

However, restricting the authorisation of 3-FL produced with a derivative strain of E. coli K-12 DH1 and the reference to the scientific studies and data contained in the applicant’s file for its sole use does not prevent subsequent 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 an authorisation.

(15)

In line with the conditions of use of food supplements containing 3-FL produced with a derivative strain of E. coli K-12 DH1 as proposed by the applicant and assessed by the Authority, it is necessary to inform consumers with an appropriate label that food supplements containing that novel food should not be consumed by infants and children under 3 years of age and should not be used if other foods with added 3-FL are consumed the same day.

(16)

It is appropriate that the inclusion of 3-FL produced with a derivative strain of E. coli K-12 DH1 as a novel food in the Union list of novel foods contains also the required conditions of use, specifications and other information related to its authorisation, as referred to in Article 9(3) of Regulation (EU) 2015/2283.

(17)

3-FL produced with a derivative strain of E. coli K-12 DH1 should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(18)

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