Our Verdict: RATING UNKNOWN

Rosin, Adduct With Fumaric Acid, Pentaerythritol Ester

E-numberE297CAS65997-11-7

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, Adduct With Fumaric Acid, Pentaerythritol Ester — food additive

Rosin, Adduct With Fumaric Acid, Pentaerythritol Ester (CAS 65997-11-7) is a synthetic compound derived from rosin and fumaric acid. Its specific function in food applications remains undocumented in available regulatory databases, and it does not currently hold FDA GRAS (Generally Recognized as Safe) status.

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, Adduct With Fumaric Acid, Pentaerythritol Ester?

Rosin, Adduct With Fumaric Acid, Pentaerythritol Ester is a complex organic compound synthesized through chemical reactions between rosin (a natural resin derived from pine trees), fumaric acid (a naturally occurring organic acid), and pentaerythritol (a synthetic polyol). The resulting compound is identified by CAS Number 65997-11-7. This additive belongs to a category of miscellaneous food substances whose specific applications in food manufacturing are not clearly defined in current regulatory literature.

Common Uses

Despite its chemical characterization in regulatory databases, the specific food applications for this compound are not well-documented in publicly available sources. Unlike many food additives with clearly defined functions (such as preservatives, emulsifiers, or colorants), the intended use of this rosin derivative in food products is not explicitly stated in FDA or industry documentation. This lack of documented application may reflect limited commercial use or possible applications in specialized food formulations not widely disclosed in regulatory filings.

Safety Assessment

Current safety data on this additive is limited. The FDA has received zero adverse event reports associated with this substance, and no recalls have been issued. However, the absence of reported adverse events does not constitute a comprehensive safety approval. The compound does not hold FDA GRAS status, meaning it has not been formally recognized as safe for use in food through the standard GRAS notification process. For food additives lacking GRAS status and with limited documented use, safety information typically remains sparse unless specific toxicological studies have been commissioned by manufacturers or regulatory agencies.

Rosin derivatives generally have a long history of use in food applications (rosin itself is approved in certain limited uses), but each chemical modification creates a distinct compound requiring its own safety evaluation. The addition of fumaric acid and pentaerythritol moieties alters the chemical structure and potential biological activity, necessitating separate assessment.

Regulatory Status

This additive is not listed as a GRAS substance by the FDA, which means it cannot be legally used in food products in the United States without specific FDA approval or authorization. Its regulatory status in other jurisdictions, including the European Union, is unclear from available public databases. The lack of GRAS status combined with minimal documented commercial use suggests this compound may be investigational, obsolete, or used only in very limited specialized applications with appropriate regulatory authorization on a case-by-case basis.

Any manufacturer seeking to use this additive in food would need to either obtain GRAS affirmation through the formal notification process (which requires comprehensive safety data) or petition the FDA for food additive approval, a process requiring significant toxicological and safety documentation.

Key Studies

Publicly available peer-reviewed literature specifically examining this compound in food safety contexts is limited. The scientific community's knowledge base regarding this particular rosin-fumaric acid-pentaerythritol ester appears minimal, suggesting either very limited research attention or restricted access to proprietary safety data held by potential manufacturers. Most available toxicological information on rosin derivatives comes from general rosin safety assessments rather than specific evaluations of this particular chemical adduct.

Regulatory agencies typically only generate or commission detailed safety studies when additives are actively being proposed for food use. The absence of such studies in this case may indicate this compound has not been submitted for formal food additive approval or GRAS notification.

Frequently Asked Questions

What is Rosin, Adduct With Fumaric Acid, Pentaerythritol Ester?

Rosin, Adduct With Fumaric Acid, Pentaerythritol Ester (CAS 65997-11-7) is a synthetic compound derived from rosin and fumaric acid. Its specific function in food applications remains undocumented in available regulatory databases, and it does not currently hold FDA GRAS (Generally Recognized as Safe) status.

Is Rosin, Adduct With Fumaric Acid, Pentaerythritol Ester safe?

Rosin, Adduct With Fumaric Acid, Pentaerythritol 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, Adduct With Fumaric Acid, Pentaerythritol Ester banned in any country?

Rosin, Adduct With Fumaric Acid, Pentaerythritol 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.