Open AccessSafety of calcium fructoborate as a novel food pursuant to Regulation (EU) 2015/2283
Author(s) -
Turck Dominique,
Castenmiller Jacqueline,
De Henauw Stefaan,
HirschErnst Karen Ildico,
Kearney John,
Maciuk Alexandre,
Mangelsdorf Inge,
McArdle Harry J,
Naska Androniki,
Peláez Carmen,
Pentieva Kristina,
Siani Alfonso,
Thies Frank,
Tsabouri Sophia,
Vinceti Marco,
Cubadda Francesco,
Frenzel Thomas,
Hein Marina,
Marchelli Rosangela,
NeuhauserBerthold Monika,
Poulsen Morten,
Maradona Miguel Prieto,
Schlatter Josef Rudolf,
van Loveren Henk,
Rossi Annamaria,
Knutsen Helle Katrine
Publication year - 2021
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2021.6661
Subject(s) - european commission , zoology , toxicity , population , calcium , genotoxicity , body weight , toxicology , medicine , european union , tolerable daily intake , food safety , food science , chemistry , biology , environmental health , business , economic policy
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 BMDL 10 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.