Scientific Opinion on the food additives E 315 and E 316

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of erythorbic acid (E 315) and sodium erythorbate (E 316) as food additives.

The use of these food additives was previously evaluated by the Scientific Committee on Food (SCF), which established an acceptable daily intake (ADI) of 6 mg/kg body weight (bw) per day.

Intestinal absorption of erythorbate was reported in a mouse study, and near-complete excretion within 24 hours was observed in a guinea pig study.

The Panel noted that the acute toxicity of erythorbic acid and sodium erythorbate is low. No indications of adverse effects were identified in the available subchronic toxicity studies, and there were no concerns regarding their genotoxicity or carcinogenicity.

A no observed adverse effect level (NOAEL) of 650 mg/kg bw per day was identified, based on a decrease in body weight observed in a carcinogenicity study.

No maternal or developmental effects were observed in a prenatal developmental toxicity study conducted with sodium erythorbate.

The Panel acknowledged limitations in the overall toxicological database, including the absence of reproductive and chronic toxicity studies, but did not consider it necessary to increase the standard uncertainty factor of 100 when deriving the ADI. Therefore, the Panel concluded that there is no reason to revise the current ADI of 6 mg/kg bw per day.

Combined dietary exposure to erythorbic acid and sodium erythorbate from their use as food additives was calculated. As the ADI was not exceeded in any population group, the Panel also concluded that the use of erythorbic acid (E 315) and sodium erythorbate (E 316) as food additives at the permitted or reported use levels does not raise safety concerns.