Flavor ingredient regulatory record
o-Cresol
o-Cresol is a phenol in the woody family, FEMA GRAS under FEMA number 3480 (CAS 95-48-7). Its odor is phenolic, medicinal, sweet, smoky.
- FEMA
- 3480
- CAS
- 95-48-7
- JECFA
- 691
- EU FL
- 04.027
- Formula
- C7H8O
- EC
- 202-423-8
GRAS status: FEMA GRAS, publication 10. Recorded by FDA in the Substances Added to Food inventory under CAS 95-48-7.
Structure
Identity
Also known as: Phenol, 2-methyl-, 2-Methylphenol, o-Hydroxytoluene, o-Methylphenol, o-Oxytoluene, 2-Cresol, o-Methylphenylol, 2-Hydroxytoluene, o-Toluol, 1-Hydroxy-2-methylbenzene, o-Cresylic acid, 1-Methyl-2-hydroxybenzene.
Can o-Cresol be labeled natural?
o-Cresol occurs in nature, so the label depends on the route: o-Cresol won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized o-Cresol 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
o-Cresol is FEMA GRAS under FEMA number 3480. 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 04.027, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 691, evaluated at the 55th meeting in 2000. No safety concern at current levels of intake when used as a flavouring agent.
Other US flags
Not on the California Proposition 65 list.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. o-Cresol appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 95-48-7, where EPA names it Phenol, 2-methyl-.
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: Phenolic, medicinal, sweet, smoky.
Where it is used
o-Cresol is used in beverage, flavoring agent, fragrance and cosmetics, typically as a woody note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to o-Cresol by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Phenol | 3223 | 92% | In nature |
| m-Cresol | 3530 | 87% | In nature |
| Maltol | 2656 | 83% | In nature |
| Benzyl alcohol | 2137 | 78% | In nature |
| 3,4-Xylenol | 3596 | 76% | Not determined |
More phenols in this index
Diphenyl · Magnolol · 3,4-Xylenol · 4-(1,1-Dimethylethyl)phenol · 2-Isopropylphenol · 2,4,6-Trimethylphenol
o-Cresol FAQ
Is o-Cresol FEMA GRAS?
Yes. The FEMA Expert Panel lists o-Cresol as GRAS under FEMA number 3480. It is also codified at 21 CFR 172.515.
What are the FEMA and CAS numbers for o-Cresol?
o-Cresol is FEMA 3480, CAS 95-48-7. FEMA files it in the woody flavor category.
Does o-Cresol count as natural in the US and the EU?
Since o-Cresol is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when o-Cresol is synthesized. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
Is o-Cresol on the EU Union List?
o-Cresol is on the EU Union List of flavouring substances as FL 04.027 (Annex I Part A) under Regulation 1334/2008.
Has JECFA evaluated o-Cresol?
Yes. JECFA number 691, evaluated at the 55th meeting in 2000. Conclusion: No safety concern at current levels of intake when used as a flavouring agent.
How is o-Cresol described, and where does it show up?
Flavorists describe o-Cresol as phenolic, medicinal, sweet, smoky. It is used in beverage, flavoring agent, fragrance and cosmetics.
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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 O-CRESOL under CAS 95-48-7 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 flavoring agent or adjuvant.
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.