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

Abstract

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. JECFA evaluated sorbic acid and its salts in 1961, 1965 and, most recently, in 1973. A group Acceptable Daily Intake (ADI) of 25 mg/kg body weight (bw)/day expressed as sorbic acid was allocated, covering sorbic acid, sodium sorbate, potassium sorbate and calcium sorbate (JECFA, 1974). This ADI was based on a no observed adverse effect level (NOAEL) of 5 % in the diet of rats in a long-term study, equivalent to 2 500 mg/kg bw/day. © EuropeanBased on studies originally evaluated by JECFA (1974), as well as more recent studies, the SCF endorsed the group ADI of 25 mg/kg bw/day for sorbic acid, potassium sorbate and calcium sorbate allocated by JECFA. The SCF noted that there were no toxicological studies on calcium sorbate, but nevertheless included this substance in the group ADI (SCF, 1996).The Panel considered that data available on the absorption, distribution, metabolism and excretion of sorbic acid show that sorbic acid is absorbed and mainly excreted as expired carbon dioxide. As no data on bioavailability were available on potassium sorbate and calcium sorbate, the Panel considered that, owing to the ionisation properties of sorbic acid (pK a = 4.76), the unionised forms of these sorbates are absorbed by a diffusion process in the stomach. Potassium and calcium sorbate might dissociate into their constituents-potassium, calcium and so...

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

“…In the present dietary EOGRTS, the effect on anogenital distance in pups observed in a twogeneration reproductive toxicity study assessed previously (EFSA ANS Panel, 2015) was not confirmed and therefore not considered relevant for the risk assessment. The delay in functional development in F1 pups of the high-dose group (3,000 mg/kg bw per day administered by gavage), also observed previously, was not tested in the present EOGRTS.…”

“…In this report, the available published studies on the stability, and possible degradation products, of sorbic acid and potassium sorbate in model food systems and in foods during storage were summarised. The Panel considered that no new relevant information was provided on the occurrence and toxicity of breakdown and reaction products of sorbic acid and its potassium salt in food under realistic conditions of processing and storage, as compared to the information evaluated in the previous opinion (EFSA ANS Panel, 2015) and therefore did not re-assess previous conclusions of the 2015 ANS Panel opinion.…”

“…The FAF Panel considered that the most realistic approach using reported use levels and analytical data was in the non-brand-loyal scenario as already stated in the previous opinion (EFSA ANS Panel, 2015). In the non-brand loyal scenario, the highest estimates of the exposure resulting from the use of sorbic acid (E 200), potassium sorbate (E 202) including calcium sorbate (E 203) as calculated by the ANS Panel (EFSA ANS Panel, 2015) were 1.7 mg sorbic acid-sorbates/kg bw per day at the mean and 3.7 mg sorbic acid-sorbates/kg bw per day at the highest (95th) levels for children (3-9 years old).…”

Outcome of the consultation with Member States and EFSA on the basic substance application for potassium sorbate for use in plant protection as fungicide on citrus, stone and pome fruits

“…Given the attested consumer exposure related to the use of sorbic acid and its salts (including potassium sorbate) as a food additive (EFSA ANS Panel, 2015) and the requested use as a postharvest pesticide on fruit, a chronic dietary exposure assessment considering the different possible dietary exposure routes should be conducted to exclude an unacceptable consumer risk, specifically for the most vulnerable consumer groups. In this context it is noteworthy that the ANS Panel stated that the most realistic approach using reported use levels and analytical data in the non-brand-loyal scenario lead to an exceedance of the temporary ADI for toddlers and for children in one Member State.…”

“…Altogether the quality of the residue trial data has to be considered poor, specifically in view of contradictory or missing information with regard to the most pertinent parameters such as the explicit application rate, the determined residue levels in some samples as well as important analytical information. Therefore the residue levels on oranges, lemons, peaches, nectarines, apricots, plums, apples and pears treated according to the intended GAP and the consumer exposure resulting from these residues are uncertain, and therefore a reliable consumer risk assessment cannot be conducted for the requested uses.Outcome of the consultation on the basic substance application for potassium sorbate www.efsa.europa.eu/publications 4 EFSA Supporting publication 2017:EN-1232Given the attested consumer exposure related to the use of sorbic acid and its salts (including potassium sorbate) as a food additive (EFSA ANS Panel, 2015) and the requested use as a postharvest pesticide on fruit, a chronic dietary exposure assessment considering the different possible dietary exposure routes should be conducted to exclude an unacceptable consumer risk, specifically for the most vulnerable consumer groups. In this context it is noteworthy that the ANS Panel stated that the most realistic approach using reported use levels and analytical data in the non-brand-loyal scenario lead to an exceedance of the temporary ADI for toddlers and for children in one Member State.…”