Scientific Opinion on the re-evaluation of sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate (E 203) as food additives

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate (E 203) when used as food additives. Sorbic acid is absorbed and mainly excreted as expired carbon dioxide. The Panel noted that there was no evidence of genotoxic activity for sorbic acid or potassium sorbate. Sub-acute, sub-chronic and chronic toxicity studies did not show any adverse effects at concentrations up to 9 200 mg/kg body weight (bw)/day in rats. Given the lack of genotoxicity data on calcium sorbate and the available positive genotoxicity data on sodium sorbate, the Panel concluded that calcium sorbate should be excluded from the group ADI. The Panel concluded that the present dataset on reproductive and developmental toxicity gives a reason to revise the group ADI of 25 mg/kg bw/day set by the Scientific Committee on Food in 1996. The Panel considered that the no observed adverse effect level of 300 mg sorbic acid/kg bw/day from the two-generation reproductive toxicity study in rats can be used to allocate a temporary group ADI for sorbic acid and its potassium salt. By applying an uncertainty factor of 100, the Panel established a new temporary group ADI expressed as 3 mg sorbic acid/kg bw/day for sorbic acid and its potassium salt. The Panel noted that the most realistic approach using reported use levels and analytical data in the non-brand-loyal scenario did not exceed the temporary group ADI in any population group at the mean or in adolescents, adults and the elderly at the high level, except in the toddler and children population groups in one country.