# Alkanet Root, Extract (alkanna Tinctoria Tausch)

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**Safety rating:** UNKNOWN
**CAS number:** 23444-65-7
**Category:** other
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

Alkanet root extract is a natural colorant derived from the Alkanna tinctoria plant, traditionally used in cosmetics and textiles. Its function in food applications remains poorly documented, and it is not approved by the FDA as a food additive.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | not_evaluated |
| Canada | not_evaluated |
| Australia | not_evaluated |
| Japan | not_evaluated |
| South Korea | not_evaluated |
| Brazil | not_evaluated |
| China | not_evaluated |
| India | not_evaluated |

## Detailed analysis

## What is Alkanet Root, Extract?

Alkanet root extract (Alkanna tinctoria Tausch) is derived from the roots of the alkanet plant, a member of the Boraginaceae family native to the Mediterranean region. The extract contains alkannin and related naphthoquinone compounds that impart a deep red to purple coloration. Historically, alkanet has been used in traditional medicine and as a natural dye in textile and cosmetic industries for centuries. The extract is obtained through solvent extraction of dried plant roots, concentrating the pigmented compounds responsible for its color properties.

## Common Uses

Alkanet root extract is primarily recognized for applications in cosmetics, pharmaceuticals, and textile dyeing rather than food production. In cosmetic formulations, it has been used as a natural colorant in lipsticks, creams, and other personal care products. Its use in food applications is not well-established or documented in mainstream food manufacturing. Limited information suggests potential interest in natural food coloring, but commercial food use appears minimal or non-existent in regulated markets. The lack of FDA approval and documented food applications indicates this ingredient has not achieved significant acceptance in the food industry.

## Safety Assessment

Alkanet root extract presents a complex safety profile due to limited toxicological data specific to food consumption. The plant contains pyrrolizidine alkaloids (PAs), compounds that have raised safety concerns in herbal medicine contexts. These alkaloids can accumulate in liver tissue and have demonstrated hepatotoxic potential in some studies. However, the concentration and bioavailability of PAs in processed alkanet extract versus whole plant material remains unclear.

The FDA has not established this ingredient as Generally Recognized as Safe (GRAS) for food use, and no adverse events related to alkanet root extract in food have been reported to the FDA database. Additionally, no food-related recalls involving this additive exist in FDA records. This absence of reported incidents may reflect minimal food industry use rather than conclusive safety evidence.

The European Food Safety Authority (EFSA) has not issued a comprehensive safety assessment for alkanet root extract as a food additive. Its use in the European Union is not clearly established under the approved food colorant regulations. The lack of extensive human consumption data and toxicological studies specific to food applications creates significant uncertainty regarding safe exposure levels.

## Regulatory Status

Alkanet root extract is not approved by the FDA as a food additive or color additive for use in foods intended for human consumption in the United States. It does not appear on the FDA's GRAS list, meaning manufacturers cannot legally market it as a food ingredient in the U.S. without prior FDA approval or a successful GRAS notification.

In the European Union, natural colorants are regulated under Regulation (EC) No 1333/2008. Alkanet root extract does not appear on the approved list of food colorants for EU member states, though regulations vary by individual country. Some countries may permit limited use in traditional or herbal products under less stringent regulations.

Globally, regulatory acceptance of alkanet root extract as a food ingredient remains inconsistent, with most major food markets either prohibiting or not clearly permitting its use in food products.

## Key Studies

Limited peer-reviewed research addresses alkanet root extract specifically in food safety contexts. Most available literature focuses on its traditional medicinal use and cosmetic applications. Studies on alkannin and related compounds have examined their antimicrobial and antioxidant properties, but these investigations typically use isolated compounds rather than commercial extracts.

Research on pyrrolizidine alkaloids in Boraginaceae plants suggests potential hepatotoxic concerns, but direct applicability to processed alkanet extract in food doses remains undetermined. The absence of clinical trials or controlled human studies examining alkanet root extract as a food additive limits evidence-based safety conclusions. Further toxicological evaluation, including studies on extract composition, bioavailability, and long-term safety in food matrices, would be necessary to inform regulatory decisions.

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "Alkanet Root, Extract (alkanna Tinctoria Tausch) — Safety, regulation, and evidence." https://additivefacts.com/additives/alkanet-root-extract-alkanna-tinctoria-tausch-nlfg. Accessed 2026-05-17.