EU Safety Assessment of Calcium Fructoborate as a Novel Food

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On July 05, 2021, the European Food Safety Authority’s scientific opinions of Nutrition, Novel Foods and Food Allergens (NDA) evaluated the “Safety of calcium fructoborate as a novel food (NF) pursuant to Regulation (EU) 2015/2283”.

The scope of the scientific assessment is summarized as follows:

  • The Novel food (NF), produced by chemical synthesis, contains a maximum of 2.9% of boron and on average 4.7% calcium and 84.2% fructose.
  • It is intended to be marketed as a food supplement targeting the general adult population, excluding pregnant and lactating women, at a maximum level of 220 mg/day (maximum boron intake of 6.4 mg per day).
  • The combined intake of boron from the background diet and the NF is in the range of 9.6–9.9 mg/day.
  • Range of the acceptable daily intake (ADI) of 0.16 mg/kg bw per day.
  • Under the given conditions of the gastrointestinal (GI) environment, the NF is fully hydrolyzed and boron toxicity was considered relevant for the safety assessment.
  • No concerns related to genotoxicity and toxicological studies.
  • The conclusion was considered appropriate on the NF, calcium fructoborate, is safe under the proposed uses and use levels.

To view the complete document, check out the Food News Monitoring System.

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