Our Verdict: RATING UNKNOWN

Starch, Food, Modified: Isoamylase Modified Starch

CAS977186-03-0

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

Starch, Food, Modified: Isoamylase Modified Starch — food additive

Isoamylase Modified Starch is a chemically modified food starch created through enzymatic treatment with isoamylase, an enzyme that alters starch's molecular structure. Its specific functional properties and primary applications in food manufacturing remain poorly documented in publicly available scientific literature.

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 Starch, Food, Modified: Isoamylase Modified Starch?

Isoamylase Modified Starch is a food-grade starch that has undergone enzymatic modification using isoamylase, an enzyme classified as a debranching enzyme. Isoamylase specifically cleaves alpha-1,6-glycosidic bonds in the starch molecule, which are the branch points in amylopectin. This enzymatic treatment alters the physical and chemical properties of the native starch, creating a modified ingredient with characteristics distinct from unmodified starch.

The CAS number 977186-03-0 identifies this specific modified starch formulation in chemical databases. Modified starches are commonly used throughout the food industry to improve texture, stability, and processing characteristics of various food products.

Common Uses

While the specific applications of isoamylase-modified starch are not extensively documented in public databases, modified starches in general serve multiple functions in food manufacturing. These applications typically include:

Thickening agents in sauces, gravies, and soups; stabilizers in dairy products and salad dressings; binders in processed meat products; texture improvers in baked goods; and film-forming agents in certain food applications. The debranching action of isoamylase treatment would theoretically create a starch with altered viscosity and gel properties compared to native starch.

The limited public information about this specific modification suggests it may be used in specialized applications or by a limited number of manufacturers, or its functional benefits may be proprietary knowledge.

Safety Assessment

According to the FDA database, there are zero recorded adverse events associated with this additive and zero product recalls linked to its use. This absence of reported safety incidents suggests either a strong safety profile or minimal market presence.

Starch-based ingredients, whether modified or unmodified, are generally recognized as safe by regulatory bodies when used appropriately. The enzymatic modification process using isoamylase does not introduce new chemical entities beyond what occurs naturally during starch digestion and metabolism. Isoamylase itself is derived from naturally occurring enzymes and is not a synthetic chemical.

Starch and modified starch products are among the most widely consumed food additives globally, with extensive historical use supporting their general safety when used as intended. However, the specific toxicological data for this particular isoamylase-modified formulation is not readily available in peer-reviewed literature or FDA databases.

Regulatory Status

This additive does not currently hold FDA GRAS (Generally Recognized As Safe) status. This designation does not necessarily indicate safety concerns; rather, it means formal GRAS notification or affirmation has not been completed or published for this specific modification.

Modified starches are regulated under FDA regulations 21 CFR Part 182 (indirect food additives) and Part 184 (direct food additives). The specific regulatory pathway and approval status for isoamylase-modified starch may vary by country and intended use.

The lack of GRAS status combined with zero recorded adverse events suggests this ingredient may have limited commercial use, may be in earlier stages of market development, or may be used in specific food applications subject to different regulatory frameworks.

Key Studies

Published peer-reviewed research specifically examining isoamylase-modified starch safety and functionality is limited in public databases. Most available scientific literature on isoamylase focuses on its enzymatic properties in laboratory and industrial starch processing contexts rather than consumer safety assessments.

Broader research on modified starches demonstrates that enzymatic modifications generally do not create safety concerns when the enzymes are inactivated during processing and the final product composition is established. Standard toxicological principles suggest that debranched starches would be readily digestible and unlikely to pose systemic toxicity risks.

Frequently Asked Questions

What is Starch, Food, Modified: Isoamylase Modified Starch?

Isoamylase Modified Starch is a chemically modified food starch created through enzymatic treatment with isoamylase, an enzyme that alters starch's molecular structure. Its specific functional properties and primary applications in food manufacturing remain poorly documented in publicly available scientific literature.

Is Starch, Food, Modified: Isoamylase Modified Starch safe?

Starch, Food, Modified: Isoamylase Modified Starch 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 Starch, Food, Modified: Isoamylase Modified Starch banned in any country?

Starch, Food, Modified: Isoamylase Modified Starch 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.