Safety of calcium fructoborate as a novel food pursuant to Regulation (EU) 2015/2283

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http://hdl.handle.net/10138/340214

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EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) , Turck , D & Heinonen , M 2021 , ' Safety of calcium fructoborate as a novel food pursuant to Regulation (EU) 2015/2283 ' , EFSA Journal , vol. 19 , no. 7 , 06661 . https://doi.org/10.2903/j.efsa.2021.6661

Title: Safety of calcium fructoborate as a novel food pursuant to Regulation (EU) 2015/2283
Author: EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA); Turck, Dominique; Heinonen, Marina
Contributor organization: Department of Food and Nutrition
Helsinki One Health (HOH)
Food Quality & Safety
Date: 2021-07
Language: eng
Number of pages: 22
Belongs to series: EFSA Journal
ISSN: 2314-9396
DOI: https://doi.org/10.2903/j.efsa.2021.6661
URI: http://hdl.handle.net/10138/340214
Abstract: 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, 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 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 9.6-9.9 mg/day (corresponding 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 conditions mimicking the gastrointestinal (GI) environment, the NF is fully hydrolysed and the Panel considered boron toxicity relevant for the safety assessment. The Panel considers that there is no concern with respect to genotoxicity of the NF. The effect induced by the NF in a 13-week rat study is consistent 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 corresponds 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 concludes that the NF, calcium fructoborate, is safe under the proposed uses and use levels. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
Subject: Calcium fructoborate
novel foods
food supplement
boron
safety
BORIC-ACID
BORON
TOXICITY
416 Food Science
Peer reviewed: Yes
Rights: cc_by_nd
Usage restriction: openAccess
Self-archived version: publishedVersion


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