(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)

On 17 March 2020, the company Chr. Hansen 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 one genetically modified strain of E. coli BL21(DE3), on the Union market as a novel food. The applicant requested for 3-fucosyllactose 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 (4), processed cereal-based food for infants and young children and baby food for infants and young children as defined in Regulation (EU) No 609/2013, foods for infants and young children for special medical purposes as defined in Regulation (EU) No 609/2013, foods for special medical purposes as defined in Regulation (EU) No 609/2013 excluding foods for infants and young children, in milk-based drinks and similar products intended for young children, and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5) intended for the general population. Subsequently, on 17 June 2022, the applicant modified the initial request in the application on the use of 3-FL in food supplements to exclude infants and young children. The applicant also proposed that food supplements containing 3-FL should not be used if other foods with added 3-fucosyllactose are consumed the same day.

(5)

On 17 March 2020, 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, the mass spectrometry (‘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 and carbohydrate by-products (6); a description of the genetically modified 3-FL production strain (7); a certificate of deposition of the genetically modified 3-FL production strain (8); real time quantitative polymerase chain reaction (‘qPCR’) system and method validation reports for the genetically modified 3-FL production strain (9); a bacterial reverse mutation test with 3-FL (10); an in vitro mammalian cell micronucleus test with 3-FL (11); a 7-day dose range finding oral toxicity study in rats with 3-FL (12); and, a 90-day oral toxicity study in rats with 3-FL (13).

(6)

On 23 September 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of 3-Fucosyllactose obtained by microbial fermentation using a genetically modified production strain derived from the host strain E. coli BL21(DE3), as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.

(7)

On 29 April 2022, the Authority adopted its scientific opinion on the ‘Safety of 3-fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3) as a novel food pursuant to Regulation (EU) 2015/2283’ (14) in accordance with Article 11 of Regulation (EU) 2015/2283.

(8)

In its scientific opinion, the Authority concluded that 3-FL 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, when used in infant formula and follow-on formula as defined in Regulation (EU) No 609/2013, processed cereal-based food for infants and young children and baby food for infants and young children as defined in Regulation (EU) No 609/2013, foods for infants and young children for special medical purposes as defined in Regulation (EU) No 609/2013, foods for special medical purposes as defined in Regulation (EU) No 609/2013 excluding foods for infants and young children, in milk-based drinks and similar products intended for young children, 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.

(9)

In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 3-FL without the scientific studies and data on the MS, NMR and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL and of the carbohydrate by-products present in the novel food; the description of the genetically modified 3-FL production strain; the certificate of deposition of the genetically modified 3-fucosyllactose production strain; the qPCR system and method validation report for the genetically modified 3-FL production strain; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 7-day dose range finding oral toxicity study in rats with 3-FL; and, the 90-day oral toxicity study in rats with 3-FL.

(10)

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.

(11)

The applicant declared that they held proprietary and exclusive rights of reference to the scientific studies and data on MS, NMR and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL and of the carbohydrate by-products present in the novel food; the description of the genetically modified 3-FL production strain; the certificate of deposition of the genetically modified 3-FL production strain; the qPCR system and method validation report for the genetically modified 3-FL production strain; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 7-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 they submitted the application, and that third parties cannot lawfully access, use or refer to those data and 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 scientific studies and data on MS, NMR and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL and of the carbohydrate by-products present in the novel food; the description of the genetically modified 3-FL production strain; the certificate of deposition of the genetically modified 3-FL production strain; the qPCR system and method validation report for the genetically modified 3-FL production strain; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 7-day dose range finding oral toxicity study in the rat with 3-FL; and, the 90-day oral toxicity study in the rat 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-fucosyllactose produced with a derivative strain of E. coli BL21(DE3) on the market within the Union during a period of five years from the entry into force of this Regulation.

(13)

However, restricting the authorisation of 3-FL produced with a derivative strain of E. coli BL21(DE3) and the reference to the scientific studies and data contained in the applicant’s file for the sole use by them 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.

(14)

In line with the conditions of use of food supplements containing 3-FL as proposed by the applicant and assessed by the Authority, it is necessary to inform consumers with an appropriate label that food supplements containing 3-FL 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.

(15)

It is appropriate that the inclusion of 3-FL produced with a derivative strain of E. coli BL21(DE3) as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283.

(16)

3-FL produced with a derivative strain of E. coli BL21(DE3) 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.

(17)

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