Flavor ingredient regulatory record
3,4-Xylenol
3,4-Xylenol is a phenol in the woody family, FEMA GRAS under FEMA number 3596 (CAS 95-65-8). Its odor is sweet, medicinal, woody, earthy.
- FEMA
- 3596
- CAS
- 95-65-8
- JECFA
- 708
- EU FL
- 04.048
- Formula
- C8H10O
- EC
- 202-439-5
GRAS status: FEMA GRAS, publication 11. Recorded by FDA in the Substances Added to Food inventory under CAS 95-65-8.
Structure
Identity
Also known as: Phenol, 3,4-dimethyl-, 3,4-Dimethylphenol, 4,5-Dimethylphenol, 4-Hydroxy-1,2-dimethylbenzene, 1,3,4-Xylenol, 1-Hydroxy-3,4-dimethylbenzene, NSC 1549, 3,4-DMP, 3,4-dimethylphenol, 4,5-dimethylphenol, phenol, 3,4-dimethyl-, 1,3,4-xylenol.
Can 3,4-Xylenol be labeled natural?
Nature occurrence: Not yet found in nature (provisional).
Nature occurrence has not been settled for this substance, so the natural or artificial class is not stated here. The FEMA GRAS status does not depend on it.
Regulatory status, with citations
United States
3,4-Xylenol is FEMA GRAS under FEMA number 3596. 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 04.048, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 708, evaluated at the 55th meeting in 2000. no safety concern at current levels of intake.
Other US flags
Not on the California Proposition 65 list.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. 3,4-Xylenol appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 95-65-8, where EPA names it Phenol, 3,4-dimethyl-.
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: Sweet, medicinal, woody, earthy.
Taste: Bitter, medicinal, slightly sweet.
Where it is used
3,4-Xylenol is used in beverage, flavoring, fragrance and cosmetics, typically as a woody note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to 3,4-Xylenol by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| p-Cresol | 2337 | 86% | In nature |
| 1-Hydroxy-2,5-dimethylbenzene | 3595 | 83% | In nature |
| 2,3,6-Trimethylphenol | 3963 | 81% | In nature |
| o-Cresol | 3480 | 76% | In nature |
| Benzyl alcohol | 2137 | 75% | In nature |
More phenols in this index
2-Methoxy-4-propylphenol · o-Cresol · p-Propylphenol · Diphenyl · Diphenyl ether · o-Propylphenol
3,4-Xylenol FAQ
Is 3,4-Xylenol on the FEMA GRAS list?
It is. FEMA number 3596 covers 3,4-Xylenol. It is also codified at 21 CFR 172.515.
What is the FEMA number for 3,4-Xylenol?
The FEMA number for 3,4-Xylenol is 3596 and its CAS registry number is 95-65-8. FEMA files it in the woody flavor category.
Is 3,4-Xylenol approved in the EU?
3,4-Xylenol is on the EU Union List of flavouring substances as FL 04.048 (Annex I Part A) under Regulation 1334/2008.
Has JECFA evaluated 3,4-Xylenol?
Yes. JECFA number 708, evaluated at the 55th meeting in 2000. Conclusion: no safety concern at current levels of intake.
What is 3,4-Xylenol used for?
3,4-Xylenol is described as sweet, medicinal, woody, earthy. On the palate it is bitter, medicinal, slightly sweet. It shows up in beverage, flavoring, 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 3,4-XYLENOL under CAS 95-65-8 and carries its FEMA number, its JECFA flavor number. 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.