Our Verdict: RATING UNKNOWN

Rosin, Tall Oil, Glycerol Ester

E-numberE445CAS977019-97-8

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

Rosin, Tall Oil, Glycerol Ester — food additive

Rosin, Tall Oil, Glycerol Ester is a masticatory substance derived from tall oil and rosin combined with glycerol. It is used in chewing gum and related products to provide texture and consistency.

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 Rosin, Tall Oil, Glycerol Ester?

Rosin, Tall Oil, Glycerol Ester (CAS Number: 977019-97-8) is a synthetic compound created by chemically combining rosin (a natural resin derived from pine trees), tall oil (a byproduct of kraft pulping in paper manufacturing), and glycerol (a humectant and solvent). The resulting ester is a semi-solid or solid substance with properties suitable for food applications, particularly as a masticatory substance.

Rosin itself has been used in food production for decades, primarily as a glazing agent and masticatory substance. When combined with tall oil and glycerol, it creates a modified compound with different functional properties that manufacturers use to formulate chewing gum bases and similar products.

Common Uses

Rosin, Tall Oil, Glycerol Ester functions as a masticatory substance, meaning it is used in products intended to be chewed but not swallowed. Its primary application is in chewing gum formulations, where it contributes to the gum base structure, providing elasticity, texture, and chewability. The compound helps maintain the desired consistency and mouthfeel during chewing.

Manufacturers select this particular ester for its stability, resistance to oxidation, and compatibility with other gum base ingredients. It allows for the creation of formulations that maintain consistent quality across production batches and during product shelf life.

Safety Assessment

Rosin, Tall Oil, Glycerol Ester has not been granted GRAS (Generally Recognized as Safe) status by the FDA, meaning it has not undergone the formal GRAS notification process or received explicit FDA approval for use as a direct food additive. However, the individual components—rosin, tall oil, and glycerol—have established safety histories in food applications.

As of the latest available data, there are zero documented adverse events reported to the FDA associated with this additive, and zero product recalls have been issued. This absence of reported problems suggests that if the compound is being used in commercial food products, it has not generated safety concerns significant enough to warrant regulatory action or consumer reports of harm.

The lack of GRAS status does not necessarily indicate safety concerns; rather, it reflects that manufacturers may not have submitted formal safety documentation to the FDA, or the agency has not completed review of such submissions. Many food additives operate under different regulatory frameworks, including being approved as food contact substances or being subject to other regulatory pathways.

Regulatory Status

In the United States, rosin and rosin derivatives have been approved for use in chewing gum bases under 21 CFR 184.1257 (Rosin). The regulatory status of this specific glycerol ester derivative is less explicitly defined in the Code of Federal Regulations. Manufacturers using this ingredient would typically rely on either prior FDA approval of similar rosin-based ingredients or would need to demonstrate safety through appropriate toxicological and use studies.

International regulatory bodies, including those in the European Union, maintain their own approval processes for food additives. The specific approval status of this compound may vary by country and region.

Key Studies

Specific published toxicological studies on Rosin, Tall Oil, Glycerol Ester are limited in the publicly available scientific literature. Safety assessments for this compound would typically draw on:

- Historical safety data for rosin in food applications

- Toxicological profiles of tall oil and its derivatives

- General safety information on glycerol esters as food components

- Bioavailability and metabolism studies of similar compounds

Since this is a masticatory substance not intended for ingestion, exposure is limited to residual amounts that may be swallowed during chewing. This restricted exposure pathway affects the safety considerations compared to additives meant for systemic absorption.

Further research and safety documentation may be available through FDA submission files or manufacturer technical data, though not all such information is publicly accessible.

Frequently Asked Questions

What is Rosin, Tall Oil, Glycerol Ester?

Rosin, Tall Oil, Glycerol Ester is a masticatory substance derived from tall oil and rosin combined with glycerol. It is used in chewing gum and related products to provide texture and consistency.

Is Rosin, Tall Oil, Glycerol Ester safe?

Rosin, Tall Oil, Glycerol Ester 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 Rosin, Tall Oil, Glycerol Ester banned in any country?

Rosin, Tall Oil, Glycerol Ester 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.