Re‐evaluation of sulphuric acid and its sodium, potassium, calcium and ammonium salts (E 513, 514 (i), 514 (ii), 515 (i), 515 (ii), 516 and 517) as food additive. (30th October 2019)

• Record Type: Journal Article
• Authors: Younes, Maged; Aquilina, Gabriele; Castle, Laurence; Engel, Karl‐Heinz; Fowler, Paul; Fürst, Peter; Gürtler, Rainer; Gundert‐Remy, Ursula; Husøy, Trine; Mennes, Wim; Moldeus, Peter; Oskarsson, Agneta; Shah, Romina; Waalkens‐Berendsen, Ine; Wölfle, Detlef; Boon, Polly; Crebelli, Riccardo; Di Domenico, Alessandro; Filipič, Metka; Mortensen, Alicja; Van Loveren, Henk; Woutersen, Ruud; Giarola, Alessandra; Lodi, Federica; Riolo, Francesca; Frutos Fernandez, Maria Jose
• Is Part Of: EFSA journal. Volume 17:Number 10(2019)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2019-10-30
• Subjects: sulphate -- sulphuric acid -- food additive -- safety -- risk assessment -- dietary exposure; Food -- Europe -- Safety measures -- Periodicals; Food Safety; Food -- Safety measures; Europe; Periodicals; Periodicals; Fulltext; Government Publications, International; Internet Resources; Periodicals; Periodicals; 363.19209405
• DOI: 10.2903/j.efsa.2019.5868
• Languages: English
• ISSNs: 1831-4732

Abstract

Abstract: 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).