TheDose

Sorbic Acid

Also known as 2,4-Hexadienoic acid, Hexa-2,4-dienoic acid, (2E,4E)-hexa-2,4-dienoic acid, E200

CIREU CosIngPubMed

Safe with conditions

EU CosIng says: restricted.”

Sorbic acid is a polyunsaturated organic acid preservative (E200) approved by CIR (1988, confirmed 2006) as safe in current cosmetic practice and listed in EU Annex V (Reference 4) at a maximum of 0.6% calculated as the free acid. Walker (1990) reviewed extensive toxicological data showing very low mammalian toxicity, no carcinogenicity, and metabolism via fatty-acid pathways, while noting rare idiosyncratic non-immunological contact urticaria and pseudo-allergy. Dendooven et al. (2021) report that allergic contact dermatitis from sorbic acid and potassium sorbate is uncommon but likely underestimated, with patch-test sensitization rates historically reported around 0–0.8% in repeat-insult patch tests.


Effective against yeasts and molds; useful adjunct preservative at acidic pH (active form: undissociated sorbic acid).

Long history of safe use in cosmetics and as food additive E200; metabolized like other dietary fatty acids.

Practically nontoxic in acute and subchronic mammalian studies; no evidence of carcinogenicity, mutagenicity, or teratogenicity at relevant exposures (Walker 1990; CIR 1988).

Approved at the same EU Annex V cap as its salts, allowing formulators to choose acid vs. salt form based on solubility and pH without changing the regulatory ceiling.


Concerns
  • · Allergic contact dermatitis — uncommon but documented (sensitization rates ~0–0.8% in repeat-insult patch tests; Dendooven 2021 notes likely underestimation; cross-reactivity with potassium sorbate).
  • · pH-dependent activity — antimicrobial efficacy drops sharply above pH ~6.5 (pKa 4.76), so finished products with higher pH may be under-preserved despite the ingredient being present.

Non-immunological contact urticaria — transient stinging or wheal reaction, particularly perioral; mechanism is non-IgE-mediated histamine release rather than true allergy (Walker 1990; PMID 7067435).

Oxidative discoloration — sorbic acid is prone to atmospheric oxidation, which can cause yellowing of the finished product; chelators or co-formulation with citric acid are commonly used to manage this.


EU CosIng
Restricted (max 0.6%)
Use limit: 0.6%
EU Annex V Reference 4: Hexa-2,4-dienoic acid and its salts (Sorbic acid, calcium sorbate, sodium sorbate, potassium sorbate). Maximum concentration in ready-for-use preparation: 0.6% (calculated as the free acid). No product-type restrictions or additional warnings specified.
CIR Expert Panel
Approved
[1]
CIR Expert Panel · Jul 1, 2018Live

CIR Quick Reference Table (12/2017, revised 07/2018) — SORBIC ACID row: Finding=S, Citation=JACT 7(6):837-80, 1988 confirmed 04/06

Sorbic AcidQRT-122017revised072018.pdf, p. 124
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[2]
EU CosIng · Nov 30, 2009Document match

EU Cosmetics Regulation (EC) No 1223/2009, Annex V (preservatives), Reference 4 — Hexa-2,4-dienoic acid and its salts (Sorbic acid, calci…

Hexa-2,4-dienoic acid and its saltsEU Reg 1223/2009 Annex V, Reference 4 (current consolidated)
Verificationweb_textView source
[3]
Peer-reviewed (PubMed) · Sep 1, 1990

Walker R. Toxicology of sorbic acid and sorbates. Food Additives and Contaminants. 1990;7(5):671-676. PMID 2253811

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[4]
Peer-reviewed (PubMed) · Mar 2, 2021

Dendooven E, Kerre S, Foubert K, et al. Allergic contact dermatitis from potassium sorbate and sorbic acid in topical pharmaceuticals and…

Verificationweb_textView on PubMed
Sources
4
PubMed citations
2
Evidence quality
moderate
Last verified
Re-reviewed when a new CIR / SCCS opinion publishes.