(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) 2017/24702 has established a Union list of novel foods. 

(3) On 18 March 2023, the company Caregen 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 nonapeptide-pentapeptide mixture on the Union market as a novel food. The applicant requested the nonapeptide-pentapeptide mixture to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council, at levels not exceeding 30 mg/day for the general adult population, excluding pregnant and lactating women. 

(4) On 18 March 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 food, compositional data, absorption, distribution, metabolism and excretion information, and toxicological information. 

(5) On 14 November 2023, the Commission, requested the European Food Safety Authority (ʽthe Authorityʼ) to carry out an assessment of nonapeptide-pentapeptide mixture as a novel food 

(6) On 17 April 2026, the Authority adopted its scientific opinion “Safety of nonapeptide-pentapeptide mixture as a novel food pursuant to Regulation (EU) 2015/2283 ” in accordance with Article 11 of Regulation (EU) 2015/2283. 

(7) In its scientific opinion, the Authority did not establish the safety of nonapeptide-pentapeptide mixture used in food supplements intended for adults, excluding pregnant and lactating women at the maximum dose of 30 mg/day as proposed by the applicant because the intake would exceed the level which is considered safe (0,2 mg/kg bw per day). However, the Authority concluded that the nonapeptidepentapeptide mixture is safe for adults, excluding pregnant and lactating women when added to food supplements at a maximum daily dose of 14 mg, which corresponds to the safe level of intake for an adult person with a default body weight of 70 kg. Therefore, the scientific opinion gives sufficient grounds to establish that nonapeptide-pentapeptide mixture, when used in food supplements as defined in Directive 2002/46/EC at levels not exceeding 14 mg/day for the general adult population, excluding pregnant and lactating women, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283. 

(8) In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on analytical reports for the identity of the novel food, compositional data, absorption, distribution, metabolism and excretion information, and toxicological information without which it could not have assessed the novel food and reached its conclusion. 

(9) 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. 

(10) The Commission assessed all the information provided by the applicant and considered that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the scientific evidence and data, namely, identity of the novel food, compositional data, absorption, distribution, metabolism and excretion information, and toxicological information should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place nonapeptide-pentapeptide mixture on the market within the Union during a period of five years from the entry into force of this Regulation. 

(11) However, restricting the authorisation of nonapeptide-pentapeptide mixture and the reference to the scientific evidence 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. 

(12) It is appropriate that the inclusion of nonapeptide-pentapeptide mixture 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. 

(13) Nonapeptide-pentapeptide mixture 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. 

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