Re-evaluation of hydrochloric acid (E 507), potassium chloride (E 508), calcium chloride (E 509) and magnesium chloride (E 511) as food additives

Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Peter Fürst, Rainer Gürtler, Ursula Gundert-Remy, Trine Husøy, Wim Mennes, Peter Moldeus, Agneta Oskarsson, Romina Shah, Ine Waalkens-Berendsen, Detlef Wölfle, Polly Boon, Riccardo Crebelli, Alessandro Di Domenico, Metka Filipič, Alicja MortensenHenk Van Loveren, Ruud Woutersen, Alessandra Giarola, Federica Lodi, Francesca Riolo, Maria Jose Frutos Fernandez, EFSA Panel on Food Additives and Flavourings (FAF)

Research output: Contribution to specialist publicationArticle

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Abstract

The Panel on Food Additives and Flavourings added to Food (FAF) provided a scientific opinion re-evaluating the safety of chlorides (E 507–509, E 511) as food additives. Chlorides are authorised food additives in the EU in accordance with Annex II and III to Regulation (EC) No 1333/2008. In the non- brand-loyal scenario, mean exposure to chlorides (E 507–509, E 511) as food additives ranged from 2 mg/kg body weight (bw) per day in the elderly to 42 mg/kg bw per day in toddlers. The 95th percentile of exposure ranged from 5 mg/kg bw per day in the elderly to 71 mg/kg bw per day in toddlers. Chloride is an essential nutrient and after absorption is distributed to organs and tissues. The Panel considered chlorides to be of low acute oral toxicity and there is no concern with respect to genotoxicity and carcinogenicity. No effects were reported in developmental toxicity studies in rats following administration of magnesium chloride hexahydrate at 800 mg/kg bw per day. Some animal studies suggested a role of chloride in increasing blood pressure but based on the toxicological database available the Panel considered human data more appropriate to identify a level of chloride intake which does not raise a safety concern. The Panel identified a human dose of 40 mg chloride/kg bw per day as a reference value for the assessment. Mean levels of exposure in all age groups were below or at this reference value, which indicates no safety concern. In some age groups (toddlers, children and adolescents), the 95th percentile exposure estimates were slightly above this reference value. The Panel concluded that the exposure to chloride from hydrochloric acid and its potassium, calcium and magnesium salts (E 507, E 508, E 509 and E 511) does not raise a safety concern at the reported use and use levels.
Original languageEnglish
Pagese05751
Number of pages51
Volume17
No.7
Specialist publicationEFSA Journal
DOIs
Publication statusPublished - Jul 2019

Bibliographical note

Acknowledgements: The Panel wishes to thank: Agnes De Sesmaisons-Lecarr e of the NUTRI EFSA Unit for the support provided to this scientific output and Dimitrios Chrysafidis for the preparatory work on this scientific output. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.

Keywords

  • chloride
  • hydrochloric acid
  • food additive
  • safety
  • risk assessment
  • dietary exposure

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