Potassium sorbate

Because the label says 'synthetic preservative', this is one of the additives people most often try to avoid. What is interesting is that its intake limit recently went up rather than down. In 2015 EFSA set a temporary limit because of data gaps; once an extended one-generation reproductive toxicity study was submitted, the panel evaluated it in 2019, derived a benchmark dose lower confidence limit of 1,110 mg/kg, applied the default uncertainty factor of 100, and set a group intake limit of 11 mg of sorbic acid per kg of body weight per day. New data can change an assessment, and not always for the worse.

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Claimed harm

Reproductive toxicity

D / None

General population

The European Commission asked EFSA whether an extended one-generation reproductive toxicity study would allow reconsideration of the temporary group intake limit set in 2015. From that study the panel identified a benchmark dose lower confidence limit of 1,110 mg of sorbic acid per kg of body weight per day and, applying the default uncertainty factor of 100, established a group intake limit of 11 mg per kg per day for sorbic acid (E 200) and its potassium salt (E 202). What had been a temporary figure became a settled one, and the number rose. This is a case of a conservatively set limit being adjusted once the data gap was filled.

PMID: 32626251

Acceptable Daily Intake (ADI): 11 mg/kg 체중/일 (소브산으로 환산, E 200·E 202 그룹 ADI)

Set in 2019 by applying an uncertainty factor of 100 to a benchmark dose lower confidence limit of 1,110 mg/kg from an extended one-generation reproductive toxicity study, replacing the temporary figure from 2015.

Journal quotations are checked character by character against the original. Quotations from Korean MFDS documents are outside that automated check and were verified by hand.

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Sources

Each source shows its one-line summary and key summary up front. Expand the collapsed section to read the original abstract. Every citation is verified by re-resolving through the API.

PMID 32626251 Opinion on the follow-up of the re-evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives Agency follow-up opinion · EFSA Journal, 2019 From an extended one-generation reproductive toxicity study, BMDL 1,110 mg/kg gave a settled group intake limit of 11 mg/kg, replacing the 2015 temporary figure.

Key summary

An EFSA Panel opinion, requested by the European Commission, evaluating an extended one-generation reproductive toxicity study. The question was whether it would allow reconsideration of the temporary group intake limit for sorbic acid (E 200) and potassium sorbate (E 202) set in 2015. From that study the panel identified a benchmark dose lower confidence limit of 1,110 mg of sorbic acid per kg per day and, applying the default uncertainty factor of 100, established a group limit of 11 mg per kg per day. It also reviewed an industry report on the stability of sorbates during food processing and storage, but as no new information was provided it did not re-assess the 2015 conclusions on stability.

Show original abstract

In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one-generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2015. From the EOGTRS, the FAF Panel identified a lower confidence limit of the benchmark dose (BMDL) of 1,110 mg sorbic acid/kg body weight (bw) per day. By applying a default uncertainty factor of 100, the Panel established a group ADI expressed as 11 mg sorbic acid/kg bw per day for sorbic acid (E 200) and its potassium salt (E 202). In addition, European Commission asked EFSA to review a report on the 'Stability of sorbic acid (E 200) and its potassium salt (E 202) during food processing and storage' provided by industry. No new information was provided in this report, and therefore, in this opinion, there was no re-assessment of the EFSA ANS opinion conclusions from 2015 regarding the stability of sorbates in food. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.

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Revision history

The full history of when and how this ingredient's evidence changed (git commits = proof of trust).

2026-08-18 First edition - one assessment (reproductive toxicity D/none; EOGRTS BMDL 1,110 mg/kg giving a group limit of 11 mg/kg). No-concern badge. Source: the EFSA follow-up opinion (2019). Abstract extracted mechanically. The frame is that limits move with data in both directions - this one went up from the 2015 temporary figure.