BAKGRUNN (fra kommisjonsforordningen)

(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 has established a Union list of novel foods.
 

(3) On 25 March 2021, the company Kyowa Hakko Bio Co., Ltd. (‘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′-Sialyllactose (ʽ3′-SLʼ) sodium salt, obtained by microbial fermentation using a genetically modified strain (Escherichia coli NEO3) derived from the host strain Escherichia coli (E. coli) W (ATCC 9637), on the Union market as a novel food. The applicant requested for the so produced 3′-SL sodium salt to be used in unflavoured pasteurised and unflavoured sterilised milk products, unflavoured fermented milk-based products, flavoured 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 as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council, processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) 609/2013, milk-based drinks and similar products, total diet replacement foods for weight control as defined in Regulation (EU) 609/2013, foods for special medical purposes as defined in Regulation (EU) 609/2013, and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council intended for the general population. With regard to conditions of use, the applicant also proposed that food supplements containing 3′-SL sodium salt produced with the derivative strain of E. coli W (ATCC 9637) should not be consumed if other foods with added 3′-SL sodium salt are consumed on the same day. Subsequently, on 19 October 2023, the applicant modified the initial request in the application for the use of 3′-SL sodium salt produced using the derivative strain of E. coli W (ATCC 9637) in food supplements to exclude infants and children under three years of age.
 

(4) On 26 March 2021, the applicant also made a request to the Commission for the protection of proprietary scientific studies and data, namely, a liquid chromatography-mass spectrometry (‘LC-MS/MS’), a nuclear magnetic resonance (‘NMR’) and a high-performance liquid chromatography – charged aerosol detection (‘HPLC-CAD’) study for the determination of the identity of 3′-SL; a description of the genetically modified 3′-SL sodium salt production strain; a detailed description of the production process; a bacterial reverse mutation test with 3′-SL sodium salt; an in vitro mammalian cell micronucleus test with 3′-SL sodium salt; an in vivo mammalian cell micronucleus test with 3′-SL sodium salt; an in vivo mammalian cell micronucleus test with 6′-Sialyllactose (‘6′-SL’) sodium salt; a bacterial reverse mutation test with 6′-SL sodium salt; a 90-day oral toxicity study in rats with 3′-SL sodium salt; a bioinformatics analysis study on the genome of the E. coli W (ATCC 9637) to detect heterologous sequences that could encode possible allergens; and, a 90-day oral toxicity study in rats with 6′-SL sodium salt, submitted in support of the application.
 

(5) In accordance with Article 10(3) of Regulation (EU) 2015/2283, on 7 December 2021, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to carry out an assessment of 3′-SL sodium salt obtained by microbial fermentation using a genetically modified strain of E. coli W (ATCC 9637), as a novel food.
 

(6) On 3 August 2023, the Authority adopted its scientific opinion on the ʽSafety of 3′-sialyllactose (‘3′-SL’) sodium salt produced by a derivative strain (Escherichia coli NEO3) of Escherichia coli W (ATCC 9637) as a novel food pursuant to Regulation (EU) 2015/2283ʼ, in accordance with Article 11 of Regulation (EU) 2015/2283.
 

(7) In its scientific opinion, the Authority concluded that 3′-SL sodium salt is safe under the proposed conditions of use and for the proposed target populations. Therefore, that scientific opinion gives sufficient grounds to establish that 3′-SL sodium salt produced with derivative strain of E. coli W (ATCC 9637), when used in unflavoured pasteurised and unflavoured sterilised milk products, unflavoured fermented milk-based products, flavoured 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, milk-based drinks and similar products, total diet replacement foods for weight control, foods for special medical purposes, and in food supplements, complies with the authorisation requirements laid down Article 12(1) of Regulation (EU) 2015/2283.
 

(8) In its scientific opinion, the Authority noted that its conclusion on the safety of the novel food was based on scientific studies and data from the LC-MS/MS, the NMR and the HPLC-CAD study for the determination of the identity of 3′-SL; the description of the genetically modified 3′-SL sodium salt production strain; the detailed description of the production process; the bacterial reverse mutation test with 3′-SL sodium salt; the in vitro mammalian cell micronucleus test with 3′-SL sodium salt; the in vivo mammalian cell micronucleus test with 3′-SL sodium salt; the bioinformatics analysis study on the genome of the E. coli W (ATCC 9637) to detect heterologous sequences that could encode possible allergens; and the 90-day oral toxicity study in rats with 3′-SL sodium salt, contained in the applicant’s file, without which it could not have assessed the novel food and reached its conclusion.
 

(9) The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those scientific studies and data, and to clarify its claim to an exclusive right of reference to them in accordance with Article 26(2), point (b) of Regulation (EU) 2015/2283.
 

(10) The applicant declared that it held proprietary and exclusive rights of reference to the scientific studies and data, namely, the LC-MS/MS, the NMR and the HPLC-CAD study for the determination of the identity of 3′-SL; the description of the genetically modified 3′-SL sodium salt production strain; the detailed description of the production process; the bacterial reverse mutation test with 3′-SL sodium salt; the in vitro mammalian cell micronucleus test with 3′-SL sodium salt; the in vivo mammalian cell micronucleus test with 3′-SL sodium salt; a bioinformatics analysis study on the genome of the E. coli W (ATCC 9637) to detect heterologous sequences that could encode possible allergens; and the 90-day oral toxicity study in rats with 3′-SL sodium salt, under national law at the time of submission of the application and that third parties cannot lawfully access, use or refer to those data and 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 scientific studies and data submitted in support of the application, namely, the LC-MS/MS, the NMR and the HPLC-CAD study for the determination of the identity of 3′-SL; the description of the genetically modified 3′-SL sodium salt production strain; the detailed description of the production process; the bacterial reverse mutation test with 3′-SL sodium salt; the in vitro mammalian cell micronucleus test with 3′-SL sodium salt; the in vivo mammalian cell micronucleus test with 3′-SL sodium salt; the bioinformatics analysis study on the genome of the E. coli W (ATCC 9637) to detect heterologous sequences that could encode possible allergens; and the 90-day oral toxicity study in rats with 3′-SL sodium salt, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place 3′-SL sodium salt produced using a derivative strain of E. coli W (ATCC 9637) on the market within the Union during a period of five years from the entry into force of this Regulation.
 

(12) However, restricting the authorisation of 3′-SL sodium salt produced using a derivative strain of E. coli W (ATCC 9637) 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.
 

(13) In line with the conditions of use of food supplements containing 3′-SL sodium salt produced using a derivative strain of E. coli W (ATCC 9637), as proposed by the applicant, it is necessary to inform consumers by appropriate labelling that food supplements containing 3′-SL sodium salt, produced with a derivative strain of E. coli W (ATCC 9637), should not be consumed by infants and children under three years of age and should not be used if other foods with added 3′-SL sodium salt are consumed on the same day.
 

(14) It is appropriate that the inclusion of 3′-SL sodium salt produced using a derivative strain of E. coli W (ATCC 9637) as a novel food in the Union list of novel foods contains also the information referred to in Article 9(3) of Regulation (EU) 2015/2283.
 

(15) 3′-SL sodium salt produced using a derivative strain of E. coli W (ATCC 9637) 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.
 

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