(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 21 December 2018, the company BK Giulini GmbH, member of ICL Group, (‘the applicant’), submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place potassium magnesium trichloride hexahydrate on the Union market as a novel food. The applicant requested the novel food to be used as a salt substitute in leavened bread or similar, raw cured meat, cooked cured or seasoned meat, preserved or partly preserved sausages, as well as in deep-frozen pizza dishes intended for the adult population.

(4)

On 11 September 2019, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of potassium magnesium trichloride hexahydrate as a novel food.

(5)

During the assessment, on 19 April 2023, the applicant made a request for the protection of proprietary scientific studies and data submitted in support of the application, namely on the production process (3) and compositional data (4).

(6)

Due to the level of bromide in the novel food and given the ongoing work of the Authority’s Scientific Committee on the risks to human and animal health from the presence of bromide in food and feed (5), the Authority on 13 September 2024 requested the applicant to revise the proposed uses and use levels of the novel food. On 26 November 2024, the applicant agreed to revise the proposed uses and use levels for potassium magnesium trichloride hexahydrate accordingly. As a result, the novel food is intended to be used in raw cured or seasoned meat, cooked cured or seasoned meat, cereal-based dishes and preserved or partly preserved sausages, intended for the adult population.

(7)

On 17 December 2024, the Authority adopted its scientific opinion on the ‘safety of mineral salt containing potassium and magnesium as a novel food pursuant to Article 10 of Regulation (EU) 2015/2283’ (6) in accordance with Article 11 of Regulation (EU) 2015/2283.

(8)

In its scientific opinion, the Authority concluded that potassium magnesium trichloride hexahydrate is safe under the proposed conditions of use. Therefore, the Authority’s scientific opinion gives sufficient grounds to establish that potassium magnesium trichloride hexahydrate, when used under the proposed conditions of use, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(9)

In that opinion, the Authority also noted that the additional intake of magnesium and potassium from the novel food does not represent a safety concern for the general population. Nevertheless, taking into consideration that foods containing the novel food may end up containing an amount of magnesium and/or potassium that is considered significant under Point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011 of the European Parliament and of the Council (7), it is appropriate to inform consumers about that fact. In such cases, the nutrition declaration shall contain the amount of potassium and/or magnesium.

(10)

In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on proprietary scientific studies and data submitted in support of the application, namely on data concerning the production process and compositional data. without which it could not have assessed the novel food and reached its conclusion.

(11)

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

(12)

The applicant declared that they held proprietary and exclusive rights of reference to those proprietary scientific studies and data at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data and studies.

(13)

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, those proprietary scientific studies and data should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place potassium magnesium trichloride hexahydrate on the market within the Union during a period of five years from the entry into force of this Regulation.

(14)

However, restricting the authorisation of potassium magnesium trichloride hexahydrate 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.

(15)

It is appropriate that the inclusion of potassium magnesium trichloride hexahydrate 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)

Potassium magnesium trichloride hexahydrate 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,