Flavor ingredient regulatory record
4-Methyl-1,1'-biphenyl
4-Methyl-1,1'-biphenyl is a phenol in the woody family, FEMA GRAS under FEMA number 3186 (CAS 644-08-6). Its odor is woody, sweet, balsamic, aromatic.
- FEMA
- 3186
- CAS
- 644-08-6
- JECFA
- 1334
- Formula
- C13H12
- EC
- 211-409-0
GRAS status: FEMA GRAS, publication 4. Recorded by FDA in the Substances Added to Food inventory under CAS 644-08-6.
Structure
Identity
Also known as: 1,1′-Biphenyl, 4-methyl-, Biphenyl, 4-methyl-, 4-Methyl-1,1′-biphenyl, 4-Methylbiphenyl, 4-Methyldiphenyl, p-Methylbiphenyl, p-Methyldiphenyl, p-Phenyltoluene, 4-Phenyltoluene, (4-Methylphenyl)benzene, 1-Methyl-4-phenylbenzene, NSC 407669.
Can 4-Methyl-1,1'-biphenyl be labeled natural?
Since 4-Methyl-1,1'-biphenyl is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when 4-Methyl-1,1'-biphenyl is synthesized. 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.
- 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
4-Methyl-1,1'-biphenyl is FEMA GRAS under FEMA number 3186. It is cited in the Code of Federal Regulations at 21 CFR 172.515.
European Union and United Kingdom
No EU FL number is on file for 4-Methyl-1,1'-biphenyl. That is not a finding either way. The Union List covers defined flavouring substances, so natural complex materials are handled as flavouring preparations under Parts B to F and never receive a number, and substances used as additives sit under Regulation 1333/2008 instead. Confirm the position before EU or UK use.
JECFA (WHO / FAO)
JECFA number 1334, evaluated at the 63rd meeting in 2004. 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. 4-Methyl-1,1'-biphenyl appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 644-08-6, where EPA names it 1,1'-Biphenyl, 4-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: Woody, sweet, balsamic, aromatic.
Taste: Bitter, slightly sweet, complex.
Where it is used
4-Methyl-1,1'-biphenyl is used in beverage, flavoring, fragrance and food additives, typically as a woody note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to 4-Methyl-1,1'-biphenyl by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Diphenyl | 3129 | 84% | In nature |
| Diphenyl ether | 3667 | 70% | In nature |
| 2-(3-Phenylpropyl)pyridine | 3751 | 68% | In nature |
| 3-(p-Isopropylphenyl)propionaldehyde | 2957 | 66% | In nature |
| Benzyl benzoate | 2138 | 66% | In nature |
More phenols in this index
o-Propylphenol · 2,3,6-Trimethylphenol · 2,4,6-Trimethylphenol · o-Cresol · 4-(1,1-Dimethylethyl)phenol · 2-Methoxy-4-propylphenol
4-Methyl-1,1'-biphenyl FAQ
Is 4-Methyl-1,1'-biphenyl FEMA GRAS?
Yes. The FEMA Expert Panel lists 4-Methyl-1,1'-biphenyl as GRAS under FEMA number 3186. It is also codified at 21 CFR 172.515.
What are the FEMA and CAS numbers for 4-Methyl-1,1'-biphenyl?
4-Methyl-1,1'-biphenyl is FEMA 3186, CAS 644-08-6. FEMA files it in the woody flavor category.
Does 4-Methyl-1,1'-biphenyl count as natural in the US and the EU?
4-Methyl-1,1'-biphenyl occurs in nature, so the label depends on the route: 4-Methyl-1,1'-biphenyl won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized 4-Methyl-1,1'-biphenyl is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic 4-Methyl-1,1'-biphenyl identical-to-natural.
Is 4-Methyl-1,1'-biphenyl approved in the EU?
No EU FL number is on file for 4-Methyl-1,1'-biphenyl. It has a JECFA evaluation (JECFA 1334), which the EU list draws on, but the Union List entry itself should be confirmed before EU use.
Has JECFA evaluated 4-Methyl-1,1'-biphenyl?
Yes. JECFA number 1334, evaluated at the 63rd meeting in 2004. Conclusion: No safety concern at current levels of intake when used as a flavouring agent.
How is 4-Methyl-1,1'-biphenyl described, and where does it show up?
Flavorists describe 4-Methyl-1,1'-biphenyl as woody, sweet, balsamic, aromatic. On the palate it is bitter, slightly sweet, complex. It is used in beverage, flavoring, fragrance and food additives.
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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 4-METHYLBIPHENYL under CAS 644-08-6 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.