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)
Article 1
Article 2
Article 3
Article 4
ANNEX
‘Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
Data protection |
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Calcium fructoborate |
Specified food category |
Maximum levels |
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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’ |
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Food supplements as defined in Directive 2002/46/EC for the adult population, excluding food supplements for pregnant and lactating women |
220 mg/day |
‘Authorised Novel Food |
Specifications |
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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 |
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