Safety of Acute Exposure to the Food Additive Glycerol (E 422) from Beverages

The European Commission requested EFSA to assess the acute exposure to glycerol (E 422) from slush ice drinks and de-alcoholised wine.

The acute exposure assessment was conducted on a single‑consumption‑event basis considering the reported use levels and analytical data of glycerol in slush ice drinks and the proposed maximum level of 50,000 mg glycerol/L in de-alcoholised wine. The Panel considered that a conservative dose above which unintended pharmacological effects would occur should be used for the determination of the acute reference dose (ARfD). Based on Wald and McLaurin (1982) study, the Panel derived an ARfD of 125 mg glycerol/kg body weight for a single consumption event.

The Panel concluded that the acute exposure to glycerol per single consumption event from slush ice drinks, assuming a consumption of 250 mL and 500 mL for children and other population groups, respectively, would exceed the ARfD for all population groups. The Panel also concluded that the P95 acute exposure estimates for glycerol, at the proposed maximum level, from the potential use of de‑alcoholised wine, assumed to be consumed by children and adolescents as a substitute for flavoured drinks and by other population groups as a substitute for wine and wine-like drinks, would exceed the ARfD for all population groups.

As requested by the European Commission, the Panel calculated the maximum single consumption event volume of beverages containing glycerol (E 422) that can be consumed by different populations groups without exceeding the ARfD. For slush ice drinks, the corresponding volumes are 29, 57, 127, 179 and 181 mL in toddlers, children, adolescents, adults and the elderly, respectively, based on the 90th percentile concentration (UB P90, i.e. 52,900 mg/L). For de-alcoholised wine, the corresponding volumes are 31, 60, 134, 190 and 191 mL, in toddlers, children, adolescents, adults and the elderly, respectively, considering the proposed maximum level of 50,000 mg/kg of glycerol.

The theoretical maximum levels of glycerol (E 422) when used as a food additive in beverages, including slush ice drinks and de-alcoholised wine, at which exposure does not exceed the ARfD are 6200, 12,000, 13,400, 19,000 and 19,100 mg/L in toddlers, children, adolescents, adults and the elderly, respectively.

CIRS Group believes that high-consumption scenarios are becoming a key focus in the EU’s risk assessment and regulatory scrutiny of food additives. The recent opinion issued by the European Food Safety Authority (EFSA) may further drive the EU to reconsider the conditions of use and maximum permitted levels of glycerol (E 422). CIRS Group will continue to closely monitor subsequent discussions by the European Commission and updates to EFSA’s final opinion. For companies, proactively conducting exposure assessments, optimizing product formulations, and strengthening compliance strategies will become increasingly important for accessing the EU market.

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