Safety of calcium fructoborate as a novel food pursuant to Regulation (EU) 2015/2283.
Résumé
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on calcium fructoborate as a novel food (NF)pursuant to Regulation (EU) 2015/2283. The NF, produced by chemical synthesis, contains a maximumof 2.9% of boron and on average 4.7% calcium and 84.2% fructose. It is intended to be marketed asfood supplements targeting the general adult population, excluding pregnant and lactating women, ata maximum level of 220 mg/day (maximum boron intake of 6.4 mg per day). The combined intake ofboron from the background diet and the NF is in the range of 9.6–9.9 mg/day (corresponding to up to0.14 mg/kg body weight (bw) per day given a default bw of 70 kg). This is in the range of theacceptable daily intake (ADI) of 0.16 mg/kg bw per day. Under conditions mimicking thegastrointestinal (GI) environment, the NF is fully hydrolysed and the Panel considered boron toxicityrelevant for the safety assessment. The Panel considers that there is no concern with respect togenotoxicity of the NF. The effect induced by the NF in a 13-week rat study is consistent withtoxicologicalfindings induced by treatment with boron compounds in animal studies. Epididymides-to-brain weight ratio was identified as the most relevant endpoint and the reference point derived wasthe lowest model averaged BMDL10value of 529 mg/kg bw per day. This corresponds to 14.8 mg/kgbw per day of boron, which is higher than the critical no observed adverse effect level (NOAEL)(9.6 mg boron/kg bw per day) used for establishing the ADI of 0.16 mg/kg bw per day for boron. ThePanel therefore applied the present ADI for boron in the assessment of the NF. The Panel concludesthat the NF, calcium fructoborate, is safe under the proposed uses and use levels.
Domaines
Sciences du Vivant [q-bio]
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EFSA Journal - 2021 - - Safety of calcium fructoborate as a novel food pursuant to Regulation EU 2015 2283.pdf (2.56 Mo)
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