(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 27 March 2020, the company Arla Foods Ingredients Group P/S (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place bovine milk osteopontin (‘bmOPN’) on the Union market as a novel food. The applicant requested for bovine milk osteopontin to be used in infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (3) and in milk-based drinks intended for young children, at levels not exceeding 151 mg/L in the final product.

(4)

On 27 March 2020, the applicant also made a request to the Commission for the protection of proprietary data for certificates of analyses and batch testing, stability reports and unpublished study (4) reports.

(5)

On 9 October 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of bovine milk osteopontin as a novel food.

(6)

On 26 January 2022, the Authority adopted its scientific opinion on Safety of bovine milk osteopontin as a Novel food (5) in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)

In its scientific opinion, the Authority concluded that bovine milk osteopontin is safe under the proposed conditions of use for infants and young children up to 35 months of age at levels not exceeding 151 mg/L. Therefore, that scientific opinion gives sufficient grounds to establish that bovine milk osteopontin, when used at levels not exceeding 151 mg/L, intended for use in infant formula (IF), follow-on formula and milk-based drinks intended for young children, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(8)

The opinion of the Authority follows the assessment of the safety of novel foods, in accordance with Regulation (EU) 2015/2283, and does not consider whether all other Union requirements for the placement of a food in the EU market are met. Therefore, infant formula and follow-on formula containing bovine milk osteopontin on the EU market must comply with the requirements of Regulation (EU) No 609/2013 and Commission Delegated Regulation (EU) 2016/127 (6).

(9)

In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the scientific data from the certificates of analyses and batch testing, stability reports and unpublished study reports without which it could not have assessed the novel food and reached its conclusion.

(10)

The applicant declared that they held proprietary and exclusive rights of reference to the scientific data from the certificates of analyses and batch testing, stability reports and unpublished study reports at the time they submitted the application and that the third parties cannot lawfully use or refer to those data

(11)

The Commission assessed all the information provided by the applicant and considered that it has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the previously mentioned scientific data 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 osteopontin 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 osteopontin and the reference to the scientific data contained in the applicant’s file for the sole use by it 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 (7) as one of a number of substances or products which may cause allergies or intolerances, foods containing bovine milk basic protein isolate, such as bovine milk osteopontin, should be appropriately labelled following the requirements laid down in Article 21 of that Regulation.

(14)

It is appropriate that the inclusion of bovine milk osteopontin 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 osteopontin 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,