Our Verdict: RATING UNKNOWN

Stearyl Monoglyceridyl Citrate

CAS55840-13-6

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Stearyl Monoglyceridyl Citrate — food additive

Stearyl monoglyceridyl citrate (SMGC) is an ester-based food additive derived from stearic acid, glycerol, and citric acid. It functions as a stabilizer and thickener in food formulations, helping maintain emulsion stability and improve product texture.

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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 Stearyl Monoglyceridyl Citrate?

Stearyl monoglyceridyl citrate (SMGC), identified by CAS number 55840-13-6, is a synthetic compound belonging to the class of citrate esters. It is chemically derived from three components: stearic acid (a saturated fatty acid), glycerol (a humectant and thickener), and citric acid (an organic acid). This combination creates a molecule designed to function at the interface between water and oil phases in food systems.

The additive appears in food ingredient lists and technical specifications but remains relatively specialized in its application compared to more common emulsifiers like lecithin or mono- and diglycerides.

Common Uses

Stearyl monoglyceridyl citrate is primarily employed as a stabilizer in food products where maintaining consistent texture and preventing separation is critical. Common applications include:

- Bakery products and cake mixes

- Margarine and fat-based spreads

- Confectionery items requiring stable emulsions

- Processed cheese products

- Whipped cream and dairy-based desserts

- Certain beverage emulsions

In these applications, SMGC works by positioning itself at oil-water interfaces, reducing interfacial tension and preventing coalescence of dispersed droplets. This stabilization function extends shelf life and maintains sensory quality throughout product distribution and storage.

Safety Assessment

Stearyl monoglyceridyl citrate has not been granted GRAS (Generally Recognized as Safe) status by the FDA, indicating it has not undergone the formal FDA review process for self-affirmation or petition approval in the United States. However, this absence of GRAS designation does not inherently indicate safety concerns.

According to FDA records, there are zero reported adverse events associated with this additive and zero product recalls attributable to SMGC. This absence of incidents suggests either minimal exposure in the U.S. food supply, a favorable safety profile in actual use, or both.

The additive belongs to a chemical family (citrate esters and glyceride derivatives) with generally established safety precedent. Similar compounds in this class have undergone toxicological evaluation, though SMGC specifically may have more limited direct study data publicly available.

As a synthetic food additive, its safety profile depends on purity standards, production methods, and maximum usage levels in formulations, which vary by jurisdiction and product category.

Regulatory Status

Stearyl monoglyceridyl citrate occupies an interesting regulatory position. While not FDA GRAS-listed in the United States, it may be approved under different regulatory pathways in other countries or permitted as a food additive in specific jurisdictions with established usage levels.

The European Food Safety Authority (EFSA) and other regional regulatory bodies maintain separate approval lists and specifications. Manufacturers seeking to use SMGC in products distributed in different markets must comply with the specific regulations of each jurisdiction.

The lack of FDA GRAS status means products containing SMGC for U.S. distribution would typically require either a Food Additive Petition or approval under an alternative regulatory framework, though actual market availability may reflect established use under grandfather provisions or regional approvals.

Key Studies

Publicly available toxicological data specifically on stearyl monoglyceridyl citrate is limited in peer-reviewed literature. The additive's safety assessment relies partially on read-across data from similar compounds—mono- and diglycerides, citric acid esters, and glycerol derivatives—which have more extensive toxicological studies.

General safety data on citrate esters and glyceride-based stabilizers indicates low acute toxicity in animal models and minimal systemic absorption when used as food additives. The structural components (stearic acid, glycerol, and citric acid) are common food ingredients with established safety histories.

Conclusive human safety data from controlled trials specific to SMGC is not widely published, reflecting both its specialized use and regulatory status. Risk assessment would typically proceed through manufacturer-conducted studies and regulatory submission when seeking approval in major markets.

Frequently Asked Questions

What is Stearyl Monoglyceridyl Citrate?

Stearyl monoglyceridyl citrate (SMGC) is an ester-based food additive derived from stearic acid, glycerol, and citric acid. It functions as a stabilizer and thickener in food formulations, helping maintain emulsion stability and improve product texture.

Is Stearyl Monoglyceridyl Citrate safe?

Stearyl Monoglyceridyl Citrate is currently rated "unknown" 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 Stearyl Monoglyceridyl Citrate banned in any country?

Stearyl Monoglyceridyl Citrate 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.