Calcium fructoborate: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food supplements as defined in Directive 2002/46/EC for the adult population, excluding food supplements for pregnant and lactating women: 220 mg/day

Additional specific labelling requirements

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.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

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

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

Want the whole list as one table?

If we publish the Union list as one table (name, food category, maximum level), we write to you once. We use the email for nothing else.