What is E203?
Complete guide to understanding E203 (Calcium Sorbate) in your food
The Quick Answer
E203 is calcium sorbate—the calcium salt of sorbic acid, a preservative that inhibits growth of molds, yeasts, and fungi in foods by extending shelf-life.
CRITICAL REGULATORY STATUS: E203 (Calcium Sorbate) has been WITHDRAWN from the EU list of approved food additives as of January 22, 2018 (Commission Regulation EU 2018/98). It is NO LONGER PERMITTED in the European Union. However, it remains permitted in the United States (GRAS-approved) and some other countries. The reason for EU withdrawal was insufficient genotoxicity data when requested during re-evaluation—EFSA could not confirm safety without additional studies that were not provided by manufacturers, so it was removed on the precautionary principle.
📌 Quick Facts
- Category: Synthetic preservative (antimicrobial); calcium salt of sorbic acid
- Chemical Name: Calcium di[(2E,4E)-hexa-2,4-dienoate] or calcium sorbate
- Chemical Formula: Ca(C₆H₇O₂)₂ or C₁₂H₁₄CaO₄
- Appearance: White crystalline powder; water-soluble
- EU Status: WITHDRAWN SINCE JANUARY 22, 2018 – NO LONGER PERMITTED in European Union
- USA Status: GRAS approved; still permitted
- Global Status: Approved in some countries; not universally permitted
- Found in (Outside EU): Dairy products, some processed foods (USA, other non-EU countries)
- Key Reason for EU Withdrawal: Insufficient genotoxicity data provided during re-evaluation; precautionary withdrawal pending additional safety studies
What Exactly Is It?
E203 is calcium sorbate—the calcium salt of sorbic acid, created by neutralizing sorbic acid with calcium hydroxide or other calcium-containing compounds.
Chemical formula: Ca(C₆H₇O₂)₂ or C₁₂H₁₄CaO₄; molecular weight 258.30.
E203 appears as white crystalline powder. It is water-soluble and sparingly soluble in ethanol.
Production: Calcium sorbate is produced commercially by neutralizing sorbic acid (itself synthesized from crotonaldehyde and ketene) with calcium hydroxide, calcium oxide, or calcium carbonate.
Mechanism: Like sorbic acid and its salts, calcium sorbate functions as a preservative by inhibiting growth of molds, yeasts, and fungi (but not bacteria). Most effective at pH below 6.5 (acidic conditions). Used primarily in dairy products.
Geographic Regulatory Status – CRITICAL DISTINCTION
E203’s regulatory status represents a dramatic split driven by different data sufficiency requirements:
European Union: WITHDRAWN AND PROHIBITED as of January 22, 2018 (Commission Regulation EU 2018/98). No longer permitted in any EU member state. The withdrawal occurred because during re-evaluation, EFSA requested genotoxicity data for calcium sorbate. Manufacturers did not submit this data, so EFSA could not complete the re-evaluation. Under EU’s precautionary principle, substances cannot continue use if safety cannot be confirmed, so E203 was removed from the approved list.
United States: GRAS (Generally Recognized As Safe) approved; still permitted for certain applications (primarily dairy products).
Other Countries: Approved in some countries outside EU; regulatory status varies. Not universally permitted.
Where You’ll Find It (Outside EU)
In countries where E203 is still permitted (USA, etc.):
• Dairy products (primary use; cheese, yogurt)
• Some processed foods
• Wine (in some regions)
• Beverages (limited use)
• Cosmetics and pharmaceuticals
• Pet food (in some countries)
E203 is much less common than E200 (sorbic acid) or E202 (potassium sorbate) because it was withdrawn from the EU and is no longer available in Europe’s large market.
🛑 RED SAFETY RATING – EU WITHDRAWAL FOR DATA INSUFFICIENCY: E203 has:
• WITHDRAWN from EU as of January 22, 2018 – no longer permitted
• Reason for withdrawal: Insufficient genotoxicity data during re-evaluation
• Manufacturers did not submit requested genotoxicity studies when re-evaluation requested them
• Precautionary principle applied: Without confirmed safety, substance cannot continue use
• FDA GRAS approved in USA (still permitted)
• Regulatory disagreement: EU withdrew due to data gaps; USA maintains GRAS
• Similar safety concerns to E202 (potassium sorbate) but specifically E203 failed data requirement
• Not genotoxic itself (like E202), but specific data for E203 form not provided
This is markedly different from E200/E202 which are approved with adequate data. E203 withdrawal reflects regulatory requirement for sufficient safety evidence, not necessarily proven harm.
Is It Safe?
E203’s safety status is fundamentally uncertain due to EU withdrawal: The EU concluded there was insufficient data to confirm safety and withdrew approval; the USA maintains GRAS approval despite insufficient data in the EU. This represents a regulatory split on data sufficiency requirements rather than proven toxicity.
Available safety data mirrors E202 (potassium sorbate)—the sorbate component is the same:
Sorbic acid and potassium sorbate (E200, E202) have been extensively studied and show no genotoxicity in comprehensive testing. However, calcium sorbate (E203) specifically was not studied as thoroughly. When EFSA requested genotoxicity data specifically for E203 during re-evaluation, manufacturers did not submit these studies.
Because EFSA could not confirm E203’s safety without this specific data, and because EU’s precautionary principle requires substances to be removed if safety cannot be confirmed, E203 was withdrawn from the approved list in 2018.
Why Was E203 Withdrawn from the EU?
The 2018 EU withdrawal reflects a regulatory policy question rather than proven toxicity:
• Re-evaluation process: EFSA began re-evaluation of all sorbates (E200, E201, E202, E203) in 2015. Data sufficiency requirements are set for each substance/salt form.
• Genotoxicity data gaps: For calcium sorbate specifically, EFSA requested genotoxicity studies to confirm safety of this particular salt form.
• No data submitted: No business operator submitted the requested genotoxicity data for E203.
• Precautionary principle applied: EU policy requires that if sufficient safety data cannot be obtained, the substance must be removed from approved lists rather than remaining on lists with data gaps.
• E202 retained: Potassium sorbate (E202) was retained because adequate data was submitted and reviewed.
• E201 status: Sodium sorbate (E201) was previously withdrawn in 1998 for different reasons (suspected mutagenicity), not due to data gaps.
Why Does USA Still Approve It?
FDA’s GRAS maintenance reflects a different regulatory philosophy:
• Different data standards: FDA focuses on demonstrated adverse events in humans rather than absence of comprehensive animal study data.
• Long history of use: Decades of use in USA without documented health incidents supports GRAS status.
• Similar to approved E202: Since potassium sorbate (E202) is approved and similar in chemistry, FDA maintains GRAS for calcium sorbate as well.
• Burden of proof differs: USA does not require as extensive pre-market testing as EU for substances with long history of use.
Comparison to E200 (Sorbic Acid) and E202 (Potassium Sorbate)
• E200 (Sorbic Acid): Free acid form; approved globally including EU with comprehensive safety data.
• E202 (Potassium Sorbate): Potassium salt; approved globally including EU with adequate safety data.
• E203 (Calcium Sorbate): Calcium salt; WITHDRAWN from EU 2018 due to insufficient genotoxicity data; still GRAS in USA.
• E201 (Sodium Sorbate): Sodium salt; BANNED from EU 1998 due to suspected mutagenicity; approved in USA.
Health Concerns & Data Gaps
The issue with E203 is not proven toxicity but rather insufficient data:
No documented toxicity (at food levels): Like all sorbates, E203 is not believed to be toxic at food-use levels. No documented adverse events in humans exist.
Data gap—specific genotoxicity studies for E203 not performed: EFSA required genotoxicity data specifically for calcium sorbate during re-evaluation. These studies were not submitted.
Sorbate form consideration: While sorbic acid itself (E200) and potassium sorbate (E202) show no genotoxicity, it cannot be assumed all salt forms are identical. Different salts can have different bioavailability and metabolism.
Precautionary approach applied: Rather than assume E203 is safe (like E200/E202), EU’s precautionary principle requires proof of safety. Without data, approval was withdrawn.
Not a proven hazard: The withdrawal does not mean E203 is hazardous—it means safety cannot be confirmed without additional studies.
Natural Alternatives (E200 or E202)
Want to avoid E203?
• Sorbic acid (E200) – EU-approved; comprehensive safety data available
• Potassium sorbate (E202) – EU-approved; comprehensive safety data available
• Benzoic acid (E210) – Alternative synthetic preservative
• Ascorbic acid (E300/Vitamin C) – Natural antioxidant (less effective)
• Rosemary extract – Natural antioxidant
• Refrigeration/Freezing – Alternative preservation
The Bottom Line
E203 (Calcium Sorbate) has been WITHDRAWN from the European Union as of January 22, 2018, and is NO LONGER PERMITTED in any EU member state. It remains GRAS-approved in the USA but is less commonly used than E200 (sorbic acid) or E202 (potassium sorbate). The EU withdrawal occurred because manufacturers did not submit requested genotoxicity data during re-evaluation, and EU precautionary principle requires substances to be removed if sufficient safety data cannot be confirmed.
EU Regulatory Status (Critical): WITHDRAWN January 22, 2018 (Commission Regulation EU 2018/98); no longer permitted in any EU member state.
Reason for EU Withdrawal (Not Toxicity, But Data Gaps): Insufficient genotoxicity data; manufacturers did not submit requested studies; precautionary principle applied.
USA Regulatory Status: Still GRAS-approved; continues to be used in some applications.
Regulatory Split Reflects Different Standards: EU requires proof of safety via specific studies; USA focuses on long history of use without documented harm.
Not Proven Hazardous: Withdrawal reflects data gaps, not proven toxicity. Similar sorbates (E200, E202) show no genotoxicity; assumption exists E203 similar, but specific data not submitted.
Comparison to Other Sorbates: E200/E202 approved with data; E203 withdrawn for data insufficiency; E201 banned for suspected mutagenicity.
Recommendation: In the EU, E203 is prohibited—consumers cannot find it. Outside the EU (USA, etc.), those concerned about the regulatory withdrawal and data gaps should prefer E200 (sorbic acid) or E202 (potassium sorbate), both of which have comprehensive safety data supporting their approval. The EU’s withdrawal decision reflects a legitimate regulatory principle—when safety data cannot be confirmed, substances should not remain approved. This is one of the clearest examples of how different regulatory systems (EU vs USA) apply different standards to the same additive.