(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 authorised novel foods. 

(3) Commission Implementing Regulation (EU) 2021/96 authorised the placing on the Union market of 3’-Sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283. 

(4) Commission Implementing Regulation (EU) 2023/113 authorised the placing on the Union market of 3’-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3), as a novel food under Regulation (EU) 2015/2283. 

(5) Commission Implementing Regulation (EU) 2024/10475 authorised the placing on the Union market of 3′-Sialyllactose sodium salt produced by derivative strain of Escherichia coli W (ATCC 9637), as a novel food under Regulation (EU) 2015/2283. 

(6) On 23 June 2023, the company Inbiose N.V. (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 seeking authorisation to place 3’-Sialyllactose (‘3′-SL’) sodium salt obtained by microbial fermentation using a genetically modified strain Escherichia coli (‘E. coli’) K-12 MG1655 INB-3SL_01 derived from the host strain E. coli K12 MG1655 (ATCC 700926), on the Union market as a novel food. The applicant requested for the so produced 3′-SL sodium salt to be used in the same food categories and at the same maximum levels as the currently 3′-SL sodium salt authorised by Commission Implementing Regulation (EU) 2021/96. 

(7) On 23 June 2023, the applicant also made a request to the Commission for the protection of the proprietary scientific studies and data, namely, identity of the novel food6 , production process, including information on the genetically modified production strain, composition and stability of the novel food, Absorption, Distribution, Metabolism and Excretion (ADME), toxicological information, the bioinformatic study for allergenicity assessment, and other relevant scientific studies, in support of the application. 

(8) On 18 March 2024, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to carry out an assessment of 3′-SL sodium salt produced by a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926), as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283. 

(9) On 4 March 2026, the Authority, in accordance with Article 11 of Regulation (EU) 2015/2283, adopted its scientific opinion on the ‘Safety of 3′-SL sodium salt produced with a derivative strain (Escherichia coli K-12 MG1655 INB-3SL_01) of E. coli K-12 MG1655 (ATCC 700926), as a novel food pursuant to Regulation (EU) 2015/2283’,. 

(10) In its scientific opinion, the Authority concluded that 3′-SL sodium salt produced by a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926) is safe when used under the proposed conditions of use. Therefore, the scientific opinion gives sufficient grounds to establish that 3′-SL sodium salt produced by a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926), when used under the currently authorised conditions of use, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283. 

(11) In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the following data: identity of the novel food, production process, including information on the genetically modified production strain, composition and stability of the novel food, Absorption, Distribution, Metabolism and Excretion (ADME), toxicological information, the bioinformatic study for allergenicity assessment, and other relevant scientific studies, without which it could not have assessed the novel food and reached its conclusion. 

(12) The applicant declared that they held proprietary and exclusive rights of reference to the scientific studies and data at the time they submitted the application. 

(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, scientific studies and data, namely, identity of the novel food, production process, including information on the genetically modified production strain, composition and stability of the novel food, Absorption, Distribution, Metabolism and Excretion (ADME), toxicological information, the bioinformatic study for allergenicity assessment, and other relevant scientific studies, 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 by a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926) on the market within the Union for a period of five years from the entry into force of this Regulation. 

(14) However, restricting the authorisation of 3′-SL sodium salt produced by a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926) and the reference to the scientific 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. 

(15) In accordance with the conditions of use of food supplements containing 3′-SL sodium salt produced by a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926), 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 produced by a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926) should not be used if other foods with added 3′-SL sodium salt are consumed on the same day. 

(16) It is appropriate that the inclusion of 3′-SL sodium salt using a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926), 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. 

(17) 3′-SL sodium salt using a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926) 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,