(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 28 February 2019, the company Glycom A/S (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place 3'-sialyllactose (‘3'-SL’) sodium salt, 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 3'-SL sodium salt to be used as a novel food in unflavoured pasteurised and unflavoured sterilised milk products, flavoured and unflavoured fermented milk based products including heat-treated products, beverages (flavoured drinks excluding drinks with a pH less than 5), cereal bars, infant formula and follow-on formula, processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (3), milk-based drinks and similar products intended for young children, 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, 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 and young children. The applicant also proposed that food supplements containing 3'-SL sodium salt should not be used if other foods with added 3'-SL sodium salt, are consumed on the same day.

(4)

On 28 February 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 proprietary analytical reports on the structure comparison via nuclear magnetic resonance (‘NMR’) of 3'-SL produced by bacterial fermentation with 3'-SL naturally present in human milk (5); the detailed characterisation data on the production bacterial strains (6) and their certificates (7); the specifications for the raw materials and processing aids (8); the certificates of analyses of the various 3'-SL sodium salt batches (9); the analytical methods and validation reports (10); the 3'-SL sodium salt stability reports (11); the detailed description of the production process (12); the laboratory accreditation certificates (13); the 3'-SL intake assessment reports (14); an in vitro mammalian cell micronucleus test with 3'-SL sodium salt (15); an in vitro mammalian cell micronucleus test with the related compound 6'-sialyllactose (‘6'-SL’) sodium salt (16); a bacterial reverse mutation test with 3'-SL sodium salt (17); a bacterial reverse mutation test with 6'-SL sodium salt (18); a 14-day oral toxicity study in the neonatal rat with 3'-SL sodium salt (19); a 90-day oral toxicity study in the neonatal rat with 3'-SL sodium salt including the summary table of the statistically significant observations (20), a 14-day oral toxicity study in the neonatal rat with 6'-SL sodium salt (21), and a 90-day oral toxicity study in the neonatal rat with 6'-SL sodium salt, including the summary table of the statistically significant observations (22).

(5)

On 12 June 2019, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of 3'-SL sodium salt as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.

(6)

On 25 March 2020, the Authority adopted its scientific opinion ‘Safety of 3'-Sialyllactose (3'-SL) sodium salt as a novel food pursuant to Regulation (EU) 2015/2283’ (23).

(7)

In its scientific opinion, the Authority concluded that 3'-SL sodium salt is safe under the proposed conditions of use for the proposed target populations. Therefore, that scientific opinion gives sufficient grounds to establish that 3'-SL sodium salt, when used in unflavoured pasteurised and unflavoured sterilised milk products, flavoured and unflavoured fermented milk based products including heat-treated products, beverages (flavoured drinks excluding drinks with a pH less than 5), cereal bars, infant formula and follow-on formula, processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013, milk-based drinks and similar products intended for young children, 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, and in food supplements as defined in Directive 2002/46/EC, 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'-SL sodium salt without the data from the proprietary analytical reports on the structure comparison via NMR of 3'-SL produced by bacterial fermentation with 3'-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids, the certificates of analyses of the various 3'-SL sodium salt batches; the analytical methods and validation reports; the 3'-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates; the 3'-SL intake assessment reports; the in vitro mammalian cell micronucleus test with 3'-SL sodium salt; the bacterial reverse mutation test with 3'-SL sodium salt; the 14-day oral toxicity study in the neonatal rat with 3'-SL sodium salt; and the 90-day oral toxicity study in the neonatal rat with 3'-SL sodium salt, including the summary table of the statistically significant observations.

(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 analytical reports on the structure comparison via nuclear magnetic resonance (‘NMR’) of 3'-SL produced by bacterial fermentation with 3'-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids; the certificates of analyses of the various 3'-SL sodium salt batches; the analytical methods and validation reports; the 3'-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates; the 3'-SL intake assessment reports; the in vitro mammalian cell micronucleus test with 3'-SL sodium salt; the bacterial reverse mutation test with 3'-SL sodium salt; the 14-day oral toxicity study in the neonatal rat with 3'-SL sodium salt; and the 90-day oral toxicity study in the neonatal rat with 3'-SL sodium salt, including the summary table of the statistically significant observations, and to clarify their claim to an exclusive right of reference to these studies, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

(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'-SL sodium salt, 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 3'-SL sodium salt should be restricted to the applicant for that period.

(12)

However, restricting the authorisation of 3'-SL sodium salt 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'-SL sodium salt 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'-SL sodium salt should not be consumed the same day if other foods with added 3'-SL sodium salt are consumed on the same day.

(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,