Sodium Sorbate E201
organic acid salt — Primarily synthetic.
Sodium (2E,4E)-hexa-2,4-dienoate
CAS: 7757-81-5
Factual Regulatory Reference
This database provides factual regulatory information compiled from official government sources. It does not constitute medical, nutritional, or safety advice. Regulatory status varies by country and is subject to change. Always refer to your local regulatory authority for the most current information.
? Did You Know?
Sodium Sorbate occurs naturally in Rowan berries (Sorbus aucuparia) and Sea buckthorn berries. Many people consume it daily without realizing it's also a listed food additive.
Beyond food, Sodium Sorbate is also used in cosmetics, medicine. Its versatility makes it one of the most multi-purpose chemical compounds in everyday life.
Regulatory opinions differ: Sodium Sorbate is approved in USA, JAPAN, CANADA but banned in EU. This reflects different risk assessment philosophies between regions.
Regulatory Analysis
Sodium sorbate presents a striking case of salt-form specificity in regulatory toxicology: sorbic acid (E200) and potassium sorbate (E202) are universally approved preservatives, yet the sodium salt was banned in the EU in 1998 due to genotoxicity concerns specific to this form. The in vitro evidence of DNA damage to human peripheral blood lymphocytes raises questions about whether the genotoxic potential is an artifact of the sodium counterion, test conditions, or a genuine structural concern that should logically extend to other sorbate salts. The continued GRAS status in the USA and approval in Japan and Canada, despite the EU ban, exemplifies how different jurisdictions weigh in vitro genotoxicity findings when they conflict with decades of apparently safe use of chemically related compounds.
Detailed Regulatory Assessment
European Union (EFSA)
BANNED in EU since 1998 due to genotoxic concerns. Previously approved in Germany until 1998.
Official EFSA LinkUnited States (FDA)
Permitted for use in cheese, fruit butter, fruit jelly, fruit preserves and jams, margarine
Japan (MHLW)
Part of sorbic acid group with usage standards
Acceptable Daily Intake (ADI)
International Standard (JECFA)
mg/kg body weight per day
European Standard (EFSA)
Everyday Perspective
For a 60kg adult, this limit is roughly equivalent to consuming:
Natural Occurrence
The sodium salt of sorbic acid. Sorbic acid was first isolated in 1859 from rowan berries, though today all commercial production is synthetic. Unlike potassium and calcium sorbates, sodium sorbate is banned in the EU due to genotoxicity concerns.
Manufacturing
Produced by neutralizing synthetically manufactured sorbic acid with sodium hydroxide or sodium carbonate. Sorbic acid is synthesized through the condensation of crotonaldehyde with ketene.
Applications Beyond Food
Limited use due to safety concerns
Not commonly used due to EU ban