Our Verdict: RATING UNKNOWN

Massaranduba Balata, Solvent-free Resin Extract

CAS977044-53-3

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

Massaranduba Balata, Solvent-free Resin Extract — food additive

Massaranduba Balata, Solvent-free Resin Extract is a natural resin derived from the Massaranduba tree used as a masticatory substance in chewing gum and similar products. It functions as a gum base component that provides elasticity and texture to chewable confections.

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
Not EvaluatedUK FSA
Canada
Not EvaluatedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
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 Massaranduba Balata, Solvent-free Resin Extract?

Massaranduba Balata, Solvent-free Resin Extract (CAS Number 977044-53-3) is a naturally derived resin obtained from the Massaranduba tree, scientifically known as Manilkara bidentata, which is native to Central and South America. The solvent-free extraction process means the resin is isolated without using chemical solvents, preserving its natural composition. This ingredient belongs to the category of masticatory substances—materials specifically designed to be chewed but not swallowed.

Common Uses

Massaranduba Balata is primarily used in the confectionery industry as a component of chewing gum base formulations. In this application, it contributes to the texture, elasticity, and overall chewing properties of gum products. Natural resin bases like Massaranduba Balata are valued by manufacturers seeking alternatives to synthetic gum bases, appealing to consumers interested in more naturally sourced ingredients. The ingredient helps maintain consistent chewability and flavor release throughout the gum's useful life.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with Massaranduba Balata, Solvent-free Resin Extract, and no product recalls have been linked to this ingredient. This lack of adverse event reporting suggests a favorable safety profile in practical use. However, it is important to note that this ingredient does not currently hold FDA GRAS (Generally Recognized As Safe) status, which means it has not undergone the formal GRAS affirmation process or notification procedure with the FDA.

The absence of GRAS status does not necessarily indicate safety concerns; rather, it reflects that formal regulatory review through the GRAS pathway has not been completed. Ingredients used in food products must comply with FDA regulations either through GRAS status, food additive approval, or other regulatory pathways. Manufacturers using this ingredient in the United States must ensure compliance with applicable regulations.

As a masticatory substance, Massaranduba Balata is designed to be chewed and spit out rather than ingested, which limits systemic exposure. The solvent-free extraction method may reduce potential concerns associated with residual solvents that could be present in solvent-extracted versions.

Regulatory Status

Massaranduba Balata, Solvent-free Resin Extract currently lacks FDA GRAS designation. This means its regulatory pathway in the United States may be through food additive petition approval or other compliance mechanisms. The ingredient's regulatory status should be verified for specific jurisdictions, as regulations vary internationally. The European Food Safety Authority (EFSA) maintains separate approval processes and food additive databases. Manufacturers and importers should consult current regulations and maintain appropriate documentation regarding the legal status of this ingredient in their target markets.

Key Studies

Scientific literature specifically addressing Massaranduba Balata, Solvent-free Resin Extract is limited in publicly available databases. Most safety data derives from its use history in traditional applications and general knowledge of natural resin compounds. Broader research on masticatory substances and gum base ingredients provides relevant context, though substance-specific toxicological or clinical studies would strengthen the safety database. The zero adverse events reported to the FDA over the ingredient's use period suggests practical safety in commercial applications, though additional independent research could further characterize its safety profile.

Frequently Asked Questions

What is Massaranduba Balata, Solvent-free Resin Extract?

Massaranduba Balata, Solvent-free Resin Extract is a natural resin derived from the Massaranduba tree used as a masticatory substance in chewing gum and similar products. It functions as a gum base component that provides elasticity and texture to chewable confections.

Is Massaranduba Balata, Solvent-free Resin Extract safe?

Massaranduba Balata, Solvent-free Resin Extract 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 Massaranduba Balata, Solvent-free Resin Extract banned in any country?

Massaranduba Balata, Solvent-free Resin Extract 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.