(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 1 October 2019, the company DuPont Nutrition & Biosciences ApS (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place 3-Fucosyllactose (3-FL), obtained by microbial fermentation with a genetically modified strain of Escherichia coli, strain K12 MG1655, on the Union market as a novel food. The applicant requested for 3-FL to be used as a novel food in unflavoured pasteurised and unflavoured sterilised (including Ultra High Temperature, ‘UHT’) milk products, flavoured and unflavoured fermented milk based products including heat-treated products, cereal bars, dairy analogues and non-dairy yoghurts, beverages (flavoured drinks, energy drinks, sports drinks), infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (3), processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013, total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013, foods for special medical purposes as defined in Regulation (EU) No 609/2013, 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 (4) intended for the general population, excluding infants. During the application process, the applicant agreed to also exclude young children (under 3 years of age) from the scope of the request for authorisation of the novel food in food supplements. The applicant also proposed that food supplements containing 3-FL should not be used if other foods with added 3-FL are consumed on the same day.

(4)

On 1 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, the detailed characterisation data on the production bacterial strain (5); the novel food production process (6); the analyses of the various 3-FL batches (7); the analytical reports on the characterisation via nuclear magnetic resonance (‘NMR’) of 3-FL and of the 3-FL naturally present in human milk (8); the 3-FL stability reports (9); the 3-FL intake assessment reports (10); a bacterial reverse mutation test (11); an in vitro mouse micronucleus test (12); an in vitro micronucleus test with Chinese hamster ovary cells (13); an in vitro mammalian cell chromosomal aberration test in human lymphocytes (14); an acute oral toxicity test in rats (15); a 90-day oral toxicity study in the rat including serum and urine analysis (16); a 6-day oral toxicity study in piglets (17); and a 3-week oral toxicity study in neonatal piglets (18).

(5)

On 29 January 2020, the Commission, in accordance with Article 10(3) of Regulation (EU) 2015/2283 requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of 3-FL as a novel food.

(6)

On 25 May 2021, the Authority adopted its scientific opinion on the safety of 3-FL as a novel food pursuant to Regulation (EU) 2015/2283 (19).

(7)

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 unflavoured pasteurised and unflavoured sterilised (including UHT) milk products, flavoured and unflavoured fermented milk based products including heat-treated products, cereal bars, dairy analogues and non-dairy yoghurts, beverages (flavoured drinks, energy drinks, sports drinks), infant formula and follow-on formula as defined in Regulation (EU) No 609/2013, processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013, total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013, foods for special medical purposes as defined in Regulation (EU) No 609/2013, milk based drinks and similar products intended for young children, and in food supplements as defined in Directive 2002/46/EC intended for the general population, with limitations for infants and young children complies with Article 12(1) of Regulation (EU) 2015/2283.

(8)

In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 3-FL without the data from the detailed characterisation data on the production bacterial strain; the novel food production process; the analyses of the various 3-FL batches; the analytical reports on the characterisation via NMR of 3-FL and of the 3-FL naturally present in human milk; the 3-FL stability reports; the 3-FL intake assessment reports; a bacterial reverse mutation test; an in vitro mouse micronucleus test; an in vitro micronucleus test with Chinese hamster ovary cells; an in vitro mammalian cell chromosomal aberration test in human lymphocytes; an acute oral toxicity test in rats; a 90-day oral toxicity study in the rat including serum and urine analysis; a 6-day oral toxicity study in piglets; and a 3-week oral toxicity study in neonatal piglets.

(9)

Following the receipt of the Authority’s scientific opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the data from the detailed characterisation data on the production bacterial strain; the novel food production process; the analyses of the various 3-FL batches; the analytical reports on the characterisation via NMR of 3-FL and of the 3-FL naturally present in human milk; the 3-FL stability reports; the 3-FL intake assessment reports; a bacterial reverse mutation test; an in vitro mouse micronucleus test; an in vitro micronucleus test with Chinese hamster ovary cells; an in vitro mammalian cell chromosomal aberration test in human lymphocytes; an acute oral toxicity test in rats; a 90-day oral toxicity study in the rat including serum and urine analysis; a 6-day oral toxicity study in piglets; and a 3-week oral toxicity study in neonatal piglets.

(10)

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 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 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 3-FL, 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 5 years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of 3-FL should be restricted to the applicant for that period.

(12)

However, restricting the authorisation of 3-FL and of 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 under Regulation (EU) 2015/2283.

(13)

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 through the use of an appropriate label that food supplements containing 3-FL should not be consumed on the same day with other foods containing added 3-FL.

(14)

The Annex to Implementing Regulation (EU) 2017/2470 should therefore be 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,