(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)

The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes partially defatted chia seed (Salvia hispanica) powders as authorised novel foods.

(4)

Commission Implementing Regulation (EU) 2020/500 (3) authorised the placing on the market of partially defatted chia seed (Salvia hispanica) powders as novel foods for use in a number of foods intended for the general population.

(5)

On 26 July 2021, the company Functional Products Trading Arica S.A./BENEXIA (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the conditions of use of the novel foods partially defatted chia seed (Salvia hispanica) powders. In particular, the applicant requested to extend the use of partially defatted chia seed (Salvia hispanica) powder with a high fibre content to a number of foods intended for the general population, namely: cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products.

(6)

On 26 July 2021, the applicant also made a request to the Commission for the protection of proprietary data for an acute toxicity study (4), a human study (5), a process contaminants formation assessment study (6) and the certificates of analysis (7).

(7)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 23 March 2022, requesting it to provide a scientific opinion on the change of conditions of use of partially defatted chia seed powders with a high fibre content as a novel food.

(8)

On 27 February 2023, the Authority adopted its scientific opinion on the ‘Safety of the extension of use of partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content as a novel food pursuant to Regulation (EU) 2015/2283’ (8) in accordance with Article 11 of Regulation (EU) 2015/2283.

(9)

In its scientific opinion, the Authority concluded that the proposed change is safe under the proposed conditions of use, and therefore it is appropriate to amend the conditions of use of partially defatted chia seed (Salvia hispanica) powder with a high fibre content.

(10)

In its scientific opinion, the Authority noted the incorrect reporting of the specification for Listeria monocytogenes (‘Absence/g’) and Escherichia coli (‘< 10 MPN/g’) in the novel food as authorised in Implementing Regulation (EU) 2020/500. Therefore, the specification of the novel foods should be amended accordingly by indicating correct maximum levels of Listeria monocytogenes as ‘Not detected in 25 g’ and of Escherichia coli as ‘Not detected in 10 g’.

(11)

In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the human study, the process contaminants formation assessment study and the certificates of analysis submitted by the applicant without which it could not have assessed the novel food and reached its conclusion.

(12)

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)(b) of Regulation (EU) 2015/2283.

(13)

The applicant declared that it held proprietary and exclusive rights of reference to the human study, the process contaminants formation assessment study and the certificates of analysis at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data.

(14)

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 human study, the process contaminants formation assessment study and certificates of analysis should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place partially defatted chia seed powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products, on the market within the Union during a period of five years from the entry into force of this Regulation.

(15)

However, such a restriction of the authorisation 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.

(16)

The information provided in the application and the opinion of the Authority give sufficient grounds to establish that the changes to the conditions of use and the specifications of the novel food are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.

(17)

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,