Oskarsson, Agneta
- Department of Animal Biosciences, Swedish University of Agricultural Sciences
Research article2019Peer reviewedOpen access
Younes, Maged; Aquilina, Gabriele; Castle, Laurence; Engel, Karl-Heinz; Fowler, Paul; Furst, Peter; Guertler, Rainer; Gundert-Remy, Ursula; Husoy, Trine; Mennes, Wim; Moldeus, Peter; Oskarsson, Agneta; Shah, Romina; Waalkens-Berendsen, Ine; Woeffle, Detlef; Boon, Polly; Crebelli, Riccardo; Di Domenico, Alessandro; Filipic, Metka; Mortensen, Alicja;
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The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of sulphuric acid (E 513) and its sodium (E 514), potassium (E 515), calcium (E 516) and ammonium (E 517) salts when used as a food additive. The Panel considered that adequate exposure and toxicity data were available. Sulphuric acid and its sodium, potassium, calcium and ammonium salts (E 513, E 514, E 515, E 516, E 517) are authorised food additives in the EU, in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008. In the refined estimated exposure non brand-loyal scenario, mean exposure ranged from 0.4 mg sulphate/kg body weight (bw) per day in infants to 35 mg sulphate/kg bw per day in toddlers. The high percentile of exposure ranged from 3 mg sulphate/kg bw per day in adolescents to 68 mg sulphate/kg bw per day in toddlers. The Panel considered sulphates of low acute toxicity and there is no concern with respect to genotoxicity and carcinogenicity. The Panel noted that the exposure to sulphates at mean and 95th percentile in the non brand-loyal scenario as well as in the other scenarios, is far below the 300 mg/kg a dose that induced laxative effect in humans. Based on the toxicological database available, the Panel concluded that the exposure to sulphuric acid (E 513), sodium sulphate (E 514), potassium sulphates (E 515), calcium sulphate (E 516) and ammonium sulphate (E 517) does not raise a safety concern at the reported uses and use levels and there is no need for a numerical acceptable daily intake (ADI). (C) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
sulphate; sulphuric acid; food additive; safety; risk assessment; dietary exposure
EFSA Journal
2019, Volume: 17, number: 10, article number: 5868
Public Health, Global Health, Social Medicine and Epidemiology
DOI: https://doi.org/10.2903/j.efsa.2019.5868
https://res.slu.se/id/publ/104738