经过评估，专家小组得出结论，在提议的用途和使用水平下，果糖硼酸钙作为新型食品是安全的。部分原文报道如下：
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food 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, co
ntains a maximum of 2.9% of boron and on average 4.7% calcium and 84.2% fructose. It is intended to be marketed as food supplements 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 9.6C9.9 mg/day (correspo
nding to up to 0.14 mg/kg body weight (bw) per day given a default bw of 70 kg). This is in the range of the acceptable daily intake (ADI) of 0.16 mg/kg bw per day. Under co
nditions mimicking the gastrointestinal (GI) environment, the NF is fully hydrolysed and the Panel co
nsidered boron toxicity relevant for the safety assessment. The Panel co
nsiders that there is no co
ncern with respect to genotoxicity of the NF. The effect induced by the NF in a 13-week rat study is co
nsistent with toxicological findings 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 was the lowest model averaged BMDL10 value of 529 mg/kg bw per day. This correspo
nds to 14.8 mg/kg bw 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. The Panel therefore applied the present ADI for boron in the assessment of the NF. The Panel co
ncludes that the NF, calcium fructoborate, is safe under the proposed uses and use levels.
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