What is E483?

Complete guide to stearyl tartrate—a banned food additive

The Quick Answer

E483 is stearyl tartrate, a food emulsifier and stabilizer that WAS used in fermented milk products, bread, cakes, and desserts—but is now BANNED in the EU as of April 23, 2024.

The EU removed E483 from its approved additives list because the European Food Safety Authority (EFSA) could not confirm its safety due to inadequate toxicological data.

Important distinction: It was NOT proven to be unsafe; rather, the safety could NOT be confirmed due to missing research data.

What Was E483?

E483 (stearyl tartrate) was an emulsifier and stabilizer created by chemically combining tartaric acid with stearyl alcohol.

Specifically, E483 was produced through esterification of tartaric acid with commercial stearyl alcohol, which is a mixture of stearyl and palmityl alcohols. The resulting product consisted mainly of diesters, with minor amounts of monoester and unchanged starting materials.

E483 appeared as an odorless and colorless substance. It functioned as a surfactant—a molecule with both oil-attracting and water-attracting properties—that allowed fats and water to mix stably in foods.

Where E483 Was Found

Before its ban on April 23, 2024, E483 appeared in only limited food categories:

– Fermented milk products (including heat-treated products): 4,000-5,000 mg/kg
– Bread and rolls: 4,000 mg/kg
– Fine bakery wares (cakes, pastries): 5,000 mg/kg
– Desserts: 5,000 mg/kg

Important note: E483 was very rarely used. Between 1996 and 2020, only two food products were labeled with E483 in the Mintel Global New Products Database. This suggests minimal market penetration even before the ban.

How E483 Worked in Food

E483 served as an emulsifier and stabilizer in the few products that contained it.

As an emulsifier: E483 allowed oil and water phases to remain mixed in stable emulsions, preventing separation in fermented milk products and other products where oil and water needed to coexist.

As a stabilizer: E483 prevented component separation and maintained uniform texture, extending shelf life of products.

Why Was E483 Banned?

On March 10, 2020, the EFSA issued a critical decision: it could not confirm the safety of E483 as a food additive due to inadequate data.

The key findings were:

– Inadequate toxicity data: The original toxicological studies reviewed by regulators in 1978 were no longer available
– No genotoxicity data: No genetic safety data was ever generated
– Incomplete hydrolysis data: Lack of proof that E483 completely breaks down in the gastrointestinal tract
– Cannot assess from constituents: Cannot assume safety based on tartaric acid or stearyl alcohol alone
– Safety cannot be confirmed: Without data, EFSA cannot confirm safe use

Important Distinction: Unproven ≠ Proven Unsafe

This is a critical distinction that often causes confusion.

E483 was NOT banned because it was proven to cause harm. Rather, it was banned because:

– The scientific data needed to confirm its safety was unavailable
– EU regulatory principle requires positive evidence of safety
– When such evidence cannot be provided, the substance cannot remain approved
– The EU Commission requested toxicological data from industry in January 2021
– No company submitted the required data
– Without data, EFSA could not permit continued use

In other words: Lack of safety confirmation ≠ Proven to be dangerous. Regulatory agencies must err on the side of caution when confirming safety is impossible.

Timeline of E483’s Authorization and Removal

1978: Scientific Committee on Food (SCF) set ADI (Acceptable Daily Intake) at 20 mg/kg body weight/day, though noted original studies should be made available or new hydrolysis data submitted for future re-evaluation.

2006: JECFA set limits of use at 4 g/kg for bakery wares and 5 g/kg for dessert products.

2020 (March 10): EFSA concluded it could not confirm safety of E483 due to inadequate toxicological data and lack of hydrolysis information.

2021 (January): European Commission requested toxicological data from industry. No data was submitted.

2023 (October): EU formally announced removal of E483 from approved additives list via Implementing Regulation (EU) 2023/2379.

2024 (April 23): Effective date when E483 became prohibited in new food products in the EU. Existing stock with lawful placement before this date may be sold until expiry.

EFSA’s Specific Concerns

The EFSA’s 2020 re-evaluation identified specific data gaps:

– Original toxicology studies unavailable: Studies referenced in 1978 could not be located or reviewed
– No modern toxicity studies: New toxicological studies had never been conducted
– No absorption/metabolism data: How the body processes E483 was unknown
– No genotoxicity data: Genetic safety had never been tested
– Incomplete hydrolysis demonstration: No proof E483 completely breaks down in the digestive system
– Very low actual use: Only 2 products used it in 24 years (1996-2020), making data collection difficult

Exposure Assessment Findings

When calculating exposure at maximum permitted levels, EFSA found:

– Adults: Very low exposure (near zero at 95th percentile)
– Toddlers: Highest exposure at 82.5 mg/kg bw/day mean or 192.7 mg/kg bw/day at 95th percentile
– Important caveat: These exposure levels assumed maximum permitted levels in ALL authorized foods simultaneously—unrealistic worst-case scenario

The actual exposure was likely far lower since E483 was hardly used in practice (only 2 products in 24 years).

What About Tartaric Acid—Is It Safe?

Tartaric acid itself (L(+)-tartaric acid) is widely recognized as safe and used in many foods.

The issue with E483 is that it’s an esterified derivative—chemically combined with stearyl alcohol. The safety of the combination cannot be assumed based solely on the safety of the individual components. This is why separate toxicological data on E483 specifically was required.

FDA Status: Never Approved

Importantly, E483 was NEVER approved by the FDA in the United States.

This means E483 never entered the U.S. food supply in any significant way. Only the EU, and certain other jurisdictions, ever authorized its use.

Current Status by Region

EU: BANNED as of April 23, 2024. No new products permitted; existing stock may be sold until expiry.

UK: Previously authorized under UK regulations. Post-Brexit status unclear—check current UK FSA (Food Standards Authority) guidance.

USA: Never approved by FDA. E483 has never been legally used in U.S. food supply.

Australia: Prohibited—stearyl palmityl tartrate has been banned from use.

Other countries: Status varies. Check country-specific food additive regulations.

Historical Safety Assessment

When E483 was originally reviewed in 1978, the Scientific Committee on Food noted:

“There exists little doubt concerning the safety and freedom from carcinogenic hazard of stearyl tartrate” but requested that original studies be made available or new hydrolysis demonstration studies be submitted.

However, as time passed and original studies became unavailable, the 1978 assessment could never be properly updated or confirmed with modern scientific standards.

EFSA’s Recommendations When Withdrawing

To potentially re-authorize E483 in the future, EFSA recommended:

1. Confirmation of current industry use and actual use levels
2. Comprehensive toxicological studies demonstrating safety
3. Data showing complete breakdown in the gastrointestinal tract
4. Specifications should require only L(+)-tartaric acid (not D-tartaric acid)
5. Lower maximum limits for toxic element contamination (lead, arsenic, cadmium)
6. Name revision, since E483 is actually a mixture of several esters

As of 2025, no such data has been submitted, and E483 remains banned.

The Bottom Line

E483 (stearyl tartrate) was an emulsifier and stabilizer used in limited food categories in the EU.

On April 23, 2024, the EU removed E483 from its approved additives list following the EFSA’s determination in 2020 that its safety could not be confirmed due to inadequate toxicological data.

This was a regulatory precautionary decision—not because E483 was proven to be harmful, but because the scientific evidence needed to confirm its safety was unavailable.

E483 was never approved by the FDA, so its ban does not affect the U.S. food supply.

Foods containing E483 that were lawfully placed on the EU market before April 23, 2024 may continue to be sold until their expiry date.

No new food products containing E483 may be manufactured or marketed in the EU after April 23, 2024.

If you have concerns about consumption of E483-containing products purchased before the ban, note that actual use was minimal (only 2 products in 24 years), and exposure at maximum levels was well below levels of significant concern for most population groups.