Flavor ingredient regulatory record
L-Malic Acid
L-Malic Acid is an acid in the acidic family, FEMA GRAS under FEMA number 2655 (CAS 97-67-6). Its odor is sour, fruity, tart, apple.
- FEMA
- 2655
- CAS
- 97-67-6
- JECFA
- 619
- EU FL
- 08.017
- Formula
- C4H6O5
- EC
- 201-196-2
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 97-67-6.
Structure
Identity
Also known as: Butanedioic acid, 2-hydroxy-, (2S)-, Malic acid, L-, Butanedioic acid, hydroxy-, (S)-, Butanedioic acid, hydroxy-, (2S)-, Malic acid, l-, (2S)-2-Hydroxybutanedioic acid, Apple acid, (-)-Hydroxysuccinic acid, (-)-Malic acid, L-(-)-Malic acid, (S)-Malic acid, S-(-)-Malic acid.
Can L-Malic Acid be labeled natural?
The process decides for L-Malic Acid. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic L-Malic Acid is artificial. 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
L-Malic Acid is FEMA GRAS under FEMA number 2655. It is cited in the Code of Federal Regulations at 21 CFR 184.1069.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 08.017, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (JECFA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 619, evaluated at the 53rd meeting in 1999. No safety concern at current levels of intake when used as a flavouring agent.
Other US flags
Not on the California Proposition 65 list. Listed on the EPA TSCA inventory.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. L-Malic Acid appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 97-67-6, where EPA names it Butanedioic acid, 2-hydroxy-, (2S)-.
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: Sour, fruity, tart, apple.
Where it is used
L-Malic Acid is used in beverage, confection, fruit flavors and sour candies, typically as a acidic note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to L-Malic Acid by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| L-Aspartic acid | 3656 | 95% | In nature |
| Tartaric acid (+)-, (-)-, (+/-)-, meso- | 3044 | 93% | In nature |
| Succinic acid | 4719 | 88% | In nature |
| Fumaric acid | 2488 | 86% | In nature |
| Levulinic acid | 2627 | 84% | In nature |
More acids in this index
Formic acid · Benzoic acid · Lactic acid · Fumaric acid · Adipic acid · Aconitic acid
L-Malic Acid FAQ
Is L-Malic Acid FEMA GRAS?
Yes. The FEMA Expert Panel lists L-Malic Acid as GRAS under FEMA number 2655. The Code of Federal Regulations lists it at 21 CFR 184.1069.
What are the FEMA and CAS numbers for L-Malic Acid?
L-Malic Acid is FEMA 2655, CAS 97-67-6. Its flavor category is acidic.
How is L-Malic Acid described, and where does it show up?
Flavorists describe L-Malic Acid as sour, fruity, tart, apple. It is used in beverage, confection, fruit flavors and sour candies.
What did JECFA conclude about L-Malic Acid?
JECFA evaluated L-Malic Acid at the 53rd meeting in 1999 under JECFA number 619. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is L-Malic Acid on the EU Union List?
Yes. FL 08.017 is the Union List entry for L-Malic Acid, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Does L-Malic Acid count as natural in the US and the EU?
Nature makes L-Malic Acid, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial L-Malic Acid, same molecule. 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.
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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
Check L-Malic Acid in a formula
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Sources and attribution. The identity and regulatory facts on this page are taken from the FDA Substances Added to Food inventory, a US government record, which lists this substance as L-MALIC ACID under CAS 97-67-6 and carries its FEMA number, its JECFA flavor number and its 21 CFR citations. The inventory is searchable at FDA. FDA records its technical effect as antimicrobial agent, flavor enhancer, flavoring agent or adjuvant, ph control agent, synergist.
A FEMA GRAS conclusion is reached by the Expert Panel of the Flavor and Extract Manufacturers Association of the United States, and the FEMA number names that conclusion. FEMA publishes its own entry for this substance in the FEMA Flavor Library, which is the authoritative record of what the Panel decided 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.