(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list 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) establishing a Union list of authorised novel foods was adopted.

(3)

On 4 June 2020, the company Pharmanutra S.p.A. (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 to place cetylated fatty acids on the Union market as a novel food. The applicant requested cetylated fatty acids to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3). The application specified that the food supplements are intended for use by the adult population at the maximum use level of 2,1 g per day.

(4)

The applicant also submitted a request to the Commission for the protection of proprietary data for a number of data submitted in support of the application. Namely, bacterial reverse mutation assay (4); in vitro micronucleus test (5); 14-day toxicity study in rats (6); 13-week toxicity study in rats (7); summary table of statistically significant observations in toxicity studies (8); certificates of analysis, batch testing and methods of analysis (9); stability data (10).

(5)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 20 July 2020, requesting it to provide a scientific opinion by carrying out an assessment of cetylated fatty acids as a novel food.

(6)

On 26 May 2021, the Authority adopted its scientific opinions on the ‘Safety of Cetylated Fatty Acids as a Novel Food pursuant to Regulation (EU) 2015/2283’ (11). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

(7)

In that opinion, the Authority concluded that the novel food, cetylated fatty acids, is safe at an intake level of 1,6 g per day for the adult population. This safe intake level is lower than the maximum intake level of 2,1 g per day proposed by the applicant. As indicated by the Authority, the highest dose tested in a subchronic toxicity study in rats was considered as the no-observed-adverse effect level (NOAEL). By applying the default uncertainty factor and a default body weight for the adult population, that results in an intake of 1,6 g per day.

(8)

Therefore, the opinion of the Authority gives sufficient grounds to establish that cetylated fatty acids when used in food supplements for the adult population with maximum level of 1,6 g per day fulfil the conditions for placing on the market in accordance Article 12(1) of Regulation (EU) 2015/2283.

(9)

The food supplements containing cetylated fatty acids should not be consumed by persons under 18 years of age and therefore, a labelling requirement should be provided in order to properly inform the consumers about that.

(10)

In its opinion, the Authority also concluded that the bacterial reverse mutation assay; in vitro micronucleus test; 13-week toxicity study in rats; summary table of statistically significant observations in toxicity studies; certificates of analysis, batch testing and methods of analysis; and stability data served as a basis to establish the safety of the novel food. The Authority also noted that it could not have reached that conclusion without those data, claimed by the applicant as proprietary.

(11)

The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those data and to clarify their claim to an exclusive right of reference to those data, as required under Article 26(2)(b) of Regulation (EU) 2015/2283.

(12)

The applicant declared that, at the time of the submission of the application, they held proprietary and exclusive rights of reference to those data under national law, and that therefore third parties cannot lawfully access or use those data or refer to those data.

(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, the bacterial reverse mutation assay (12); in vitro micronucleus test (13); 13-week toxicity study in rats (14); summary table of statistically significant observations in toxicity studies (15); certificates of analysis, batch testing and methods of analysis (16); stability data (17) contained in the applicant’s file should not be used by the Authority for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of cetylated fatty acids should be restricted to the applicant for that period.

(14)

However, restricting the authorisation of cetylated fatty acids and of the reference to the data contained in the applicant’s file for the sole use of the applicant, does not prevent other 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 authorisation under Regulation (EU) 2015/2283.

(15)

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,