(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 25 March 2019, the company VDF FutureCeuticals, Inc. (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 to place calcium fructoborate on the Union market as a novel food. The applicant requested calcium fructoborate to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3), for the adult population, excluding pregnant and lactating women.

(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, detailed description of the production process (4); methods of analysis (5); certificates of analysis (6); stability report (7); dietary boron intake assessment (8); toxicokinetic study (9); bacterial reverse mutation test (10); in vitro mammalian micronucleus assay (11); 90-day toxicity study in rats (12); particle size analysis (13); particle size method of analysis (14); fructose analysis (15); amino acid analysis (16); microorganisms analysis (17); physiochemical stability (18); stability of fructose in the novel food (19); background dietary boron intakes (20); boron dissociation under varying pH (21).

(5)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 10 July 2019, requesting it to provide a scientific opinion by carrying out a safety assessment of calcium fructoborate as a novel food.

(6)

On 25 May 2021, the Authority adopted its scientific opinion on the ‘Safety of calcium fructoborate as a novel food pursuant to Regulation (EU) 2015/2283’ (22). This 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, calcium fructoborate, is safe for the adult population, excluding pregnant and lactating women, at intake levels up to 220 mg/day (3,14 mg/kg bw per day). Therefore, the opinion of the Authority gives sufficient grounds to establish that calcium fructoborate under the specific conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.

(8)

Since few data are available regarding the safety of calcium fructoborate in the population under 18 years of age and by pregnant and lactating women, a labelling should be provided in order to properly inform the consumers that the food supplements containing calcium fructoborate should not be consumed by those population groups.

(9)

In its opinion, the Authority considered that all the data for which the applicant requested data protection, except for the dietary boron intake assessment and background dietary boron intakes, served as a basis to establish the safety of the novel food. On this basis, the Commission considers that the conclusions on the safety of calcium fructoborate could not have been reached without the data from the reports of those studies.

(10)

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.

(11)

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.

(12)

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, detailed description of the production process; methods of analysis; certificates of analysis; stability report; toxicokinetic study; bacterial reverse mutation test; in vitro mammalian micronucleus assay; 90-day toxicity study in rats; particle size analysis; particle size method of analysis; fructose analysis; amino acid analysis; microorganisms analysis; physiochemical stability; stability of fructose in the novel food; boron dissociation under varying pH contained in the applicant’s file, on which the Authority based its conclusion on the safety of the novel food and without which it could not have assessed the novel food, should not be used by the Authority for the benefit of any subsequent applicant for a period of 5 years from the date of entry into force of this Regulation. Accordingly, only the applicant should be authorised to place calcium fructoborate on the market within the Union during that period.

(13)

However, restricting the authorisation of calcium fructoborate 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.

(14)

Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,