Commission Implementing Regulation (EU) 2021/2129 of 2 December 2021 authorising the placing on the market of calcium fructoborate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/2129
• Articles: 5

Article 1

1.   Calcium fructoborate as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

2.   For a period of 5 years from 23 December 2021 only the initial applicant,

Company: VDF FutureCeuticals, Inc.,

Address: 300 West 6th Street Momence, Illinois 60954, the United States,

is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for that novel food without reference to the data protected pursuant to Article 2 or with the agreement of VDF FutureCeuticals, Inc.

3.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.

Article 2

The data contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of 5 years from 23 December 2021 without the agreement of VDF FutureCeuticals, Inc.

Article 3

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted:

‘Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

Calcium fructoborate

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘calcium fructoborate’.

2.

The labelling of food supplements containing calcium fructoborate shall bear a statement that those food supplements should not be consumed by population under 18 years of age and by pregnant and lactating women.

Authorised on 23 December 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: VDF FutureCeuticals, Inc., 300 West 6th Street Momence, Illinois 60954, the United States.

During the period of data protection, the novel food calcium fructoborate is authorised for placing on the market within the Union only by VDF FutureCeuticals, Inc., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of VDF FutureCeuticals, Inc.

End date of the date protection: 23 December 2026’

Food supplements as defined in Directive 2002/46/EC for the adult population, excluding food supplements for pregnant and lactating women

220 mg/day

(2)

in Table 2 (Specifications), the following entry is inserted:

‘Authorised Novel Food

Specifications

Calcium fructoborate

Description/Definition

The novel food is calcium fructoborate, a calcium salt tetrahydrate of a bis(fructose) ester of boric acid in the form of a powder, represented by Ca[(C6H10O6)2B]2•4H2O, with a molecular mass of 846 Da.

The novel food is produced by chemical synthesis whereby fructose is combined with boric acid in water to produce a bis(fructose) ester of boric acid through various heating and mixing processes. Calcium carbonate is then added to produce a solution containing the calcium salt of fructoborate (tetrahydrate). The solution is freeze-dried, ground to produce the final powdered product, and then packaged and stored under representative storage conditions (22 ± 1°C RH 55-60 %).

Characteristics/composition

Free moisture: < 5,0 %

Calcium: 4,5-5 %

Boron: 2,5-2,9 %

Fructose: 80-85 %

Ash: 15-16 %

Heavy metals

Arsenic: ≤ 1 mg/kg

Microbiological criteria

Total plate count: ≤ 1 000 CFU/g (a)

Yeast and mould: < 100 CFU/g

Coliforms: ≤ 10 CFU/g

Escherichia coli : < 10 CFU/g

Salmonella spp.: Absence in 25 g

Coagulase-positive staphylococci: Absence in 1 g

(a)

CFU: colony forming units’