EU Safety Assessment of Calcium Fructoborate as a Novel Food

Posted By: Trace One

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.

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