Commission Implementing Regulation (EU) 2025/2233

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001^note, and in particular Article 12(1) thereof,Whereas:

(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^note has established a Union list of novel foods.

(3)On 10 November 2021, the company TOA Biopharma 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 Clostridium butyricum TO-A on the Union market as a novel food. The applicant requested for the novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council^note, for the general population above 3 months of age.

(4)On 10 November 2021, the applicant also made a request to the Commission for the protection of the following proprietary data: manufacturing process^note, nutritional analysis (part 1–5)^note, C. butyricum analysis (part 1–5)^note, purity analysis (part 1–5)^note, AMES study^note, micronucleus study^note, AMES supernatant study^note, micronucleus supernatant study^note, in vivo micronucleus comet supernatant study^note, Lysis efficiency French Press study^note, Appendix1 SEM images^note, AMES Lysate study^note, micronucleus Lysate study^note and subchronic toxicity study^note.

(5)On 8 June 2022, the Commission requested the European Food Safety Authority (‘the Authority’) to provide a scientific opinion on Clostridium butyricum TO-A as a novel food.

(6)On 25 March 2025, the Authority adopted its scientific opinion on the ‘Safety of Clostridium butyricum TO-A as a novel food pursuant to Regulation (EU) 2015/2283’^note in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)Taking into account that the applicant requested the novel food to be used in food supplements as defined in Directive 2002/46/EC, for the general population above 3 months of age, the Authority indicated in its opinion that the target population for the novel food should be restricted to children above 3 years of age, adolescents and adults, excluding pregnant and lactating women. This was based on the consideration that appropriate initial bacteria colonisation of the gastrointestinal tract in humans, in particular during the first 3 years of life, profoundly affects health during infancy and childhood, that little is known on how the maternal microbiota shapes the maternal-fetal immune system during pregnancy, that disruptions to the microbiota early in life can have lasting health effects into adulthood and taking into account that the 90-day oral toxicity study was conducted in adult rats, which hampers the extrapolation of the results to early life stages in humans.

(8)In its scientific opinion, the Authority concluded that Clostridium butyricum TO-A is safe at 1,0 × 10⁸ CFU/day for children (3 to < 10 years), 2,0 × 10⁸ CFU/day for adolescents from 10 to < 14 years, 2,8 × 10⁸ CFU/day for adolescents from 14 to < 18 years, and 3,2 × 10⁸ CFU/day for adults, excluding pregnant and lactating women. Therefore, that scientific opinion gives sufficient grounds to establish that Clostridium butyricum TO-A, when used not exceeding those levels in food supplements, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(9)In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the proprietary data on the manufacturing process, nutritional analysis (part 1–5), C. butyricum analysis (part 1–5), purity analysis (part 1–5), AMES study, micronucleus study, AMES supernatant study, micronucleus supernatant study, in vivo micronucleus comet supernatant study, Lysis efficiency French Press study, Appendix1 SEM images, AMES Lysate study, micronucleus Lysate study and subchronic toxicity study, without which it could not have assessed the novel food and reached its conclusion.

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

(11)The applicant declared that they held proprietary and exclusive rights of reference to the relevant studies, at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data.

(12)The Commission assessed all the information provided by the applicant and considers that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, data on the manufacturing process, nutritional analysis (part 1–5), C. butyricum analysis (part 1–5), purity analysis (part 1–5), AMES study, micronucleus study, AMES supernatant study, micronucleus supernatant study, in vivo micronucleus comet supernatant study, Lysis efficiency French Press study, Appendix1 SEM images, AMES Lysate study, micronucleus Lysate study and subchronic toxicity study, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place Clostridium butyricum TO-A on the market within the Union during a period of five years from the entry into force of this Regulation.

(13)However, such restriction of the authorisation and the reference to the data contained in the applicant’s file for their sole use 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)It is appropriate that the inclusion of Clostridium butyricum TO-A 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. In line with the conditions of use of food supplements containing Clostridium butyricum TO-A as proposed by the applicant, it is necessary to inform the consumers in that regard by appropriate labelling about the uses of food supplements containing Clostridium butyricum TO-A.

(15)Clostridium butyricum TO-A 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,

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