Flavor ingredient regulatory record
Gallic acid
Gallic acid is an acid in the bitter family, FEMA GRAS under FEMA number 4994 (CAS 149-91-7). Its odor is astringent, herbal, woody, slightly sweet.
- FEMA
- 4994
- CAS
- 149-91-7
- EU FL
- 08.080
- Formula
- C7H6O5
- EC
- 205-749-9
GRAS status: FEMA GRAS. Source: FEMA Flavor Ingredient Library.
Structure
Identity
Also known as: Benzoic acid, 3,4,5-trihydroxy-, 3,4,5-Trihydroxybenzoic acid, NSC 20103, NSC 674319, 3,4,5-Hydroxybenzoic acid, A 1925-04, MeSH ID: D005707, BL 20220429008, 3,4,5-trihydroxybenzoic acid, benzoic acid, 3,4,5-trihydroxy-, gallic acid, tech., pyrogallol-5-carboxylic acid.
Can Gallic acid be labeled natural?
Since gallic acid is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when gallic acid is synthesized. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
- United States
- Natural or artificial, by process
- European Union and UK
- Natural only from natural material
- Mercosur and Mexico
- Natural or identical-to-natural
How each market defines the classes: natural vs artificial flavor under 21 CFR 101.22.
Regulatory status, with citations
United States
Gallic acid is FEMA GRAS under FEMA number 4994. It is cited in the Code of Federal Regulations at 21 CFR 172.515.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 08.080, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
Gallic acid has not been evaluated by JECFA as a flavouring agent, or no evaluation is on file.
Other US flags
Not on the California Proposition 65 list.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. Gallic acid appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 149-91-7, where EPA names it Benzoic acid, 3,4,5-trihydroxy-.
Active in US commerce
EPA designates this substance active, so no Notice of Activity Form B is required before manufacturing. What active and inactive mean.
EPA publishes no regulatory flags on this listing. What the flags mean.
From the EPA non-confidential TSCA Inventory, July 2026 release. EPA also maintains a confidential portion it does not publish. Search the Inventory by CAS number.
Odor and taste
Odor: Astringent, herbal, woody, slightly sweet.
Taste: Bitter, astringent, tart.
Where it is used
Gallic acid is used in beverage, confection, herbal extracts and food preservatives, typically as a bitter note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Gallic acid by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 3,4-Dihydroxybenzoic acid | 4430 | 93% | In nature |
| Aconitic acid | 2010 | 79% | In nature |
| 4-Hydroxy-3-methoxy benzoic acid | 3988 | 78% | In nature |
| Ascorbic Acid | 2109 | 77% | In nature |
| Propyl Gallate | 2947 | 72% | In nature |
More acids in this index
cis-4-(2,2,3-Trimethylcyclopentyl)butanoic acid · N-Benzoylanthranilic acid · Aconitic acid · 2-Methyl-2-pentenoic acid · Phenoxyacetic acid · 2-Ethylbutyric acid
Gallic acid FAQ
Is gallic acid on the FEMA GRAS list?
It is. FEMA number 4994 covers gallic acid. It is also codified at 21 CFR 172.515.
What is the FEMA number for gallic acid?
The FEMA number for gallic acid is 4994 and its CAS registry number is 149-91-7. FEMA files it in the bitter flavor category.
Is gallic acid natural or artificial?
Gallic acid occurs in nature, so the label depends on the route: gallic acid won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized gallic acid is artificial. In the EU and UK the natural claim likewise needs the natural route, while Mercosur and Mexico keep a third class, identical-to-natural, for the synthetic material.
Is gallic acid approved in the EU?
Gallic acid is on the EU Union List of flavouring substances as FL 08.080 (Annex I Part A) under Regulation 1334/2008.
What is gallic acid used for?
Gallic acid is described as astringent, herbal, woody, slightly sweet. On the palate it is bitter, astringent, tart. It shows up in beverage, confection, herbal extracts and food preservatives.
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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
Check Gallic acid in a formula
Screened against FEMA GRAS, 21 CFR and EU rules as you build. Free to start.
Sources and attribution. The FEMA number and GRAS status on this page name a conclusion reached by the Expert Panel of the Flavor and Extract Manufacturers Association of the United States. FDA does not list this substance by FEMA number in its Substances Added to Food inventory. Its identity is attested by EU Union List of flavouring substances, EPA TSCA Chemical Substance Inventory, matched on CAS 149-91-7.
FEMA publishes its own entry for this substance in the FEMA Flavor Library, which is the authoritative record and is worth reading alongside this page.
Ambrose Compliance is not affiliated with, endorsed by, or sponsored by FEMA. FEMA and FEMA GRAS are used here as identifiers for a published regulatory determination, not as marks of any relationship between FEMA and Ambrose.
About this page. Facts come from the FDA Substances Added to Food inventory, the Code of Federal Regulations, the EPA TSCA Inventory, the EU Union List, JECFA and the Ambrose database, with FEMA's published determination cited where it applies; parts of the text are written by Ambrose AI, which can make mistakes. Check the cited source before relying on anything here. This is not regulatory or legal advice.