Our Verdict: SAFE

Grape Skin Extract

CAS11029-12-2

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

1

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Grape Skin Extract — food additive

Grape Skin Extract (CAS 11029-12-2) is a natural colorant derived from grape skins containing anthocyanins and other polyphenols. It is used in food products as a color additive and flavor enhancer to impart red, purple, or blue hues and enhance flavor profiles.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

1

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 Grape Skin Extract?

Grape Skin Extract is a concentrated preparation derived from the skins of grapes, primarily Vitis vinifera species. The extract contains naturally occurring anthocyanins, which are water-soluble pigments responsible for red, purple, and blue coloration in plants. These compounds are obtained through solvent extraction processes and are valued in the food industry for their dual functionality as both colorants and flavor enhancers. The extract may be processed into liquid, powder, or concentrate forms depending on intended applications.

Common Uses

Grape Skin Extract is utilized across multiple beverage and food categories. Primary applications include:

- Fruit juices, nectars, and juice drinks

- Wine and wine-based beverages

- Flavored water and sports drinks

- Yogurt and cultured dairy products

- Confectionery items including hard candies and gummies

- Baked goods and desserts

- Jams, jellies, and fruit preserves

The extract serves as a natural alternative to synthetic colorants such as FD&C Red No. 40 or FD&C Blue No. 1, appealing to consumers seeking label-friendly, plant-derived ingredients. Beyond coloration, the polyphenol content contributes subtle flavor characteristics aligned with natural fruit profiles.

Safety Assessment

Grape Skin Extract has generated no reported adverse events in FDA databases, indicating a favorable safety profile under normal conditions of use. The extract's safety profile is supported by the long history of grape consumption and the well-characterized nature of grape polyphenols in human nutrition.

Anthocyanins and other phenolic compounds in grape skin extract have been extensively studied in scientific literature. These compounds are readily metabolized and eliminated by the body. No acute toxicity concerns have been identified at typical dietary exposure levels. The extract contains no inherent allergens beyond the universal concern regarding grape allergies, which are rare.

One FDA recall was associated with this additive, though specific details regarding causality or contamination versus formulation issues are not specified in available databases. This single recall does not indicate a systemic safety concern with the ingredient itself.

Individuals with grape allergies should avoid products containing this extract. Additionally, those taking certain medications affecting blood clotting should consult healthcare providers, as high polyphenol intake theoretically may interact with anticoagulants, though this risk is generally minimal at typical food use levels.

Regulatory Status

Grape Skin Extract has not received GRAS (Generally Recognized as Safe) status from the FDA, meaning it has not undergone formal FDA affirmation for this designation. However, this classification does not indicate safety concerns; rather, it reflects that manufacturers have not submitted or received formal GRAS determination through the established petition process.

In the European Union, grape skin extract is permitted as a food colorant under specific regulations governing natural colorants. Its use is subject to maximum permitted levels in specific food categories. The extract is compliant with international food standards where permitted and is increasingly recognized in global food safety frameworks.

The additive is permitted in various other jurisdictions including Australia, Canada, and Japan, typically under natural colorant classifications. Regulatory approaches reflect the ingredient's natural origin and safety profile.

Key Studies

Scientific literature supports the safety of grape polyphenols at dietary levels. Research published in food chemistry and toxicology journals demonstrates that anthocyanins from grape sources undergo extensive hepatic metabolism. Bioavailability studies show minimal systemic accumulation. In vitro and animal studies have shown no genotoxic or teratogenic potential.

Nutritional research has examined potential health benefits of grape polyphenols, including antioxidant activity, though such claims fall outside the scope of food safety assessment. Safety margins between typical dietary exposure and any observed adverse effect levels in animal studies remain substantial.

Frequently Asked Questions

What is Grape Skin Extract?

Grape Skin Extract (CAS 11029-12-2) is a natural colorant derived from grape skins containing anthocyanins and other polyphenols. It is used in food products as a color additive and flavor enhancer to impart red, purple, or blue hues and enhance flavor profiles.

Is Grape Skin Extract safe?

Grape Skin Extract is currently rated "safe" 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 Grape Skin Extract banned in any country?

Grape Skin 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.