Our Verdict: SAFE

Glycerin, Synthetic

E-numberE422CAS977091-53-4

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Glycerin, Synthetic — food additive

Synthetic glycerin (also called glycerol) is a clear, viscous liquid used in food manufacturing as an emulsifier, humectant, and thickening agent. It functions to improve texture, retain moisture, and maintain product stability across a wide range of food applications.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
ApprovedUK FSA
Canada
ApprovedHealth Canada
Australia
ApprovedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
ApprovedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Synthetic Glycerin?

Synthetic glycerin, identified by CAS number 977091-53-4, is a three-carbon polyol (a type of sugar alcohol) produced through synthetic chemical processes rather than derived from natural sources like vegetable oils or animal fats. The compound is colorless, odorless, and has a sweet taste. It is chemically identical to naturally occurring glycerin, differing only in its manufacturing origin.

Common Uses

Synthetic glycerin serves multiple functional roles in food manufacturing. As an emulsifier, it helps blend water-based and oil-based ingredients that would otherwise separate. As a humectant, it absorbs and retains moisture, preventing products from drying out during storage and extending shelf life. The additive also functions as a thickener and stabilizer in sauces, dressings, and confectionery products. Additionally, glycerin is used as a solvent or vehicle for flavorings and colorings, as a texturizer in baked goods and candies, and as a drying agent in certain food processing applications. Due to its mild sweetness, it is sometimes used as a nutritive sweetener in reduced-calorie formulations.

Safety Assessment

Synthetic glycerin has been extensively studied and has a long history of use in food and pharmaceutical applications. It is readily absorbed and metabolized by the human body through normal metabolic pathways, primarily by the liver. The FDA has not approved synthetic glycerin as Generally Recognized as Safe (GRAS) under current regulations, though glycerin itself (from other sources) has GRAS status for specific food applications.

According to FDA records, there have been zero reported adverse events associated with synthetic glycerin and zero product recalls attributed to this specific additive. Toxicological studies in animal models have not demonstrated significant safety concerns at typical levels of food use. The European Food Safety Authority (EFSA) has evaluated glycerin and considers it safe for food applications at current usage levels. Oral toxicity studies indicate extremely low acute toxicity, with LD50 values in rodents typically exceeding 4,000 mg/kg body weight.

Regulatory Status

The regulatory status of synthetic glycerin varies by jurisdiction. While glycerin is approved for food use in the United States, European Union, and many other countries, the specific GRAS status depends on the source and intended use. Synthetic glycerin is permitted in food manufacturing in most developed nations but may require documentation of manufacturing process and purity specifications. Food manufacturers using this additive must comply with current Good Manufacturing Practices (cGMP) and include it on product ingredient labels.

Key Studies

Research on glycerin's safety has been conducted over decades. Studies examining glycerin's metabolism show rapid absorption and conversion to glucose or incorporation into normal metabolic pathways. Reproductive and developmental toxicity studies in animals at doses far exceeding food exposure levels have not identified significant concerns. Chronic exposure studies in rodents have established no-observed-adverse-effect levels (NOAELs) well above anticipated dietary intakes from food additive use.

The WHO Joint Expert Committee on Food Additives (JECFA) has evaluated glycerin and determined acceptable daily intake (ADI) levels. Because glycerin is a normal constituent of lipid metabolism and is produced endogenously in the body, establishing traditional ADI limits has been considered unnecessary by some regulatory bodies, indicating a high margin of safety.

Frequently Asked Questions

What is Glycerin, Synthetic?

Synthetic glycerin (also called glycerol) is a clear, viscous liquid used in food manufacturing as an emulsifier, humectant, and thickening agent. It functions to improve texture, retain moisture, and maintain product stability across a wide range of food applications.

Is Glycerin, Synthetic safe?

Glycerin, Synthetic is currently rated "safe" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Glycerin, Synthetic banned in any country?

Glycerin, Synthetic is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.