(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 (2) has established a Union list of novel foods.

(3)

On 7 September 2022, the company Eggnovo SL (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place egg membrane collagen peptides on the Union market as a novel food. The applicant requested the egg membrane collagen peptides to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3), at levels not exceeding 500 mg/day for the general adult population, excluding pregnant and lactating women.

(4)

On 7 September 2022, 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 (4), production process (5), compositional data (6), absorption, distribution, metabolism and excretion information (7), toxicological information (8), and allergenicity (9).

(5)

On 29 February 2024, the Commission, requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of egg membrane collagen peptides as a novel food.

(6)

On 29 September 2025, the Authority adopted its scientific opinion ‘Safety of egg membrane collagen peptides as a novel food pursuant to Regulation (EU) 2015/2283’ (10) in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)

In its scientific opinion, the Authority concluded that the novel food ‘egg membrane collagen peptides’ is safe under the proposed conditions of use for the proposed target population. Therefore, that scientific opinion gives sufficient grounds to establish that the novel food ‘egg membrane collagen peptides’, when used in food supplements as defined in Directive 2002/46/EC at levels not exceeding 500 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, production process, and allergenicity (11) 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, production process, and allergenicity should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place the novel food ‘egg membrane collagen peptides’ 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 egg membrane collagen peptides and the reference to the protected 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)

The designation ‘egg membrane collagen peptides’ does not reflect the actual composition of the novel food, because the collagen content of the novel food is only 15-30 %w/w. The use of the term ‘egg membrane collagen peptides’ in the designation of the novel food could therefore mislead consumers as to its nutritional properties and composition. Therefore, it is appropriate to replace the term ‘egg membrane collagen peptides’ with a name that accurately reflects the novel food’s true nature and composition. The applicant accepted the proposed designation ‘egg membrane hydrolysate (enzymatically produced)’ which is produced by enzymatic hydrolysis as compared to the authorised novel food egg membrane hydrolysate obtained by a different production process.

(13)

As the source of the novel food comes from eggs, which is listed in Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council (12), as one of the substances or products causing allergies or intolerances, food supplements containing egg membrane hydrolysate (enzymatically produced) should be appropriately labelled following the requirements of Article 21 of that Regulation.

(14)

Directive 2002/46/EC lays down requirements on food supplements. The use of egg membrane hydrolysate (enzymatically produced) should be authorised without prejudice to that Directive.

(15)

It is appropriate that the inclusion of egg membrane hydrolysate (enzymatically produced) 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.

(16)

Egg membrane hydrolysate (enzymatically produced) 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.

(17)

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