TY - JOUR
T1 - Re-evaluation of hydrochloric acid (E 507), potassium chloride (E 508), calcium chloride (E 509) and magnesium chloride (E 511) as food additives
AU - EFSA Panel on Food Additives and Flavourings (FAF)
AU - Younes, Maged
AU - Aquilina, Gabriele
AU - Castle, Laurence
AU - Engel, Karl Heinz
AU - Fowler, Paul
AU - Fürst, Peter
AU - Gürtler, Rainer
AU - Gundert-Remy, Ursula
AU - Husøy, Trine
AU - Mennes, Wim
AU - Moldeus, Peter
AU - Oskarsson, Agneta
AU - Shah, Romina
AU - Waalkens-Berendsen, Ine
AU - Wölfle, Detlef
AU - Boon, Polly
AU - Crebelli, Riccardo
AU - Di Domenico, Alessandro
AU - Filipič, Metka
AU - Mortensen, Alicja
AU - Van Loveren, Henk
AU - Woutersen, Ruud
AU - Giarola, Alessandra
AU - Lodi, Federica
AU - Riolo, Francesca
AU - Frutos Fernandez, Maria Jose
N1 - Publisher Copyright:
© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
PY - 2019
Y1 - 2019
N2 - 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.
AB - 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.
KW - chloride
KW - dietary exposure
KW - food additive
KW - hydrochloric acid
KW - risk assessment
KW - safety
UR - https://www.scopus.com/pages/publications/85070194703
U2 - 10.2903/j.efsa.2019.5751
DO - 10.2903/j.efsa.2019.5751
M3 - Article
AN - SCOPUS:85070194703
SN - 1831-4732
VL - 17
JO - EFSA Journal
JF - EFSA Journal
IS - 7
M1 - e05751
ER -