(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 22 July 2020, the company Arla Foods Ingredients Group P/S (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place bovine milk beta-lactoglobulin (β-lactoglobulin), isolated from bovine whey under acidic or neutral conditions, on the Union market as a novel food. The applicant requested for bovine milk beta-lactoglobulin to be used in soft drinks marketed in relation to physical exercise, whey powder, milk based drinks and similar products, and in foods for special medical purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (3) intended for the general population older than three years of age excluding pregnant and lactating women.

(4)

On 22 July 2020, the applicant also made a request to the Commission for the protection of proprietary scientific studies and data and submitted in support of the application, namely, a bacterial reverse mutation test (4); an in vitro micronucleus assay with human lymphocytes (5); a 14-day range-finding oral toxicity study in rodents (6); a 90-day oral sub-chronic toxicity study in rodents (7); the results of compositional analyses and the analytical certificates for 23 additional batches of the novel food and 20 batches of commercial whey protein isolate (8); and, the results of total microbial plate count analyses of the novel food and their certificates (9).

(5)

On 5 November 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of beta-lactoglobulin as a novel food.

(6)

On 28 February 2022, the Authority adopted its scientific opinion on the ‘Safety of beta-lactoglobulin 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 bovine milk beta-lactoglobulin is safe under the proposed conditions of use. Therefore, that scientific opinion gives sufficient grounds to establish that bovine milk beta-lactoglobulin, when used in soft drinks marketed in relation to physical exercise, whey powder, milk based drinks and similar products, and in foods for special medical purposes as defined in Regulation (EU) No 609/2013, intended for the general population older than three years of age 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 the scientific studies and data on the bacterial reverse mutation test; the in vitro micronucleus assay with human lymphocytes; the 14-day range-finding oral toxicity study in rodents; the 90-day oral sub-chronic toxicity study in rodents; the results of compositional analyses; and, the analytical certificates for 23 additional batches of the novel food and the 20 batches of commercial whey protein isolate and the results of total microbial plate count analyses of the novel food and their certificates, contained in the applicant’s file, without which it could not have assessed the novel food and reached its conclusion.

(9)

The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those scientific studies and data 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.

(10)

The applicant declared that they held proprietary and exclusive rights of reference to the scientific studies and data on the bacterial reverse mutation test; the in vitro micronucleus assay with human lymphocytes; the 14-day range-finding oral toxicity study in rodents; the 90-day oral sub-chronic toxicity study in rodents; the results of compositional analyses and the analytical certificates for 23 additional batches of the novel food and the 20 batches of commercial whey protein isolate; and, the results of total microbial plate count analyses of the novel food and their certificates, at the time they submitted the application and that third parties cannot lawfully access, use or refer to those data.

(11)

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 studies and data on the bacterial reverse mutation test; the in vitro micronucleus assay with human lymphocytes; the 14-day range-finding oral toxicity study in rodents; the 90-day oral sub-chronic toxicity study in rodents; the results of compositional analyses and the analytical certificates for 23 additional batches of the novel food and the 20 batches of commercial whey protein isolate; and, the results of total microbial plate count analyses of the novel food and their certificates, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place bovine milk beta-lactoglobulin on the market within the Union during a period of five years from the entry into force of this Regulation.

(12)

However, restricting the authorisation of bovine milk beta-lactoglobulin and the reference to the scientific studies 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.

(13)

As the source of the novel food comes from bovine milk, which is listed in Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council (11) as one of a number of substances or products which cause allergies or intolerances, foods containing beta-lactoglobulin, should be appropriately labelled following the requirements of Article 21 of that Regulation.

(14)

It is appropriate that the inclusion of bovine milk beta-lactoglobulin 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.

(15)

Bovine milk beta-lactoglobulin 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,