Is this eucalyptus leaf oil compliant for the US market (FDA)?
Yes. Eucalyptus oil is listed by the FDA as GRAS (Generally Recognized As Safe) for use as a natural flavoring substance under 21 CFR §182.20, and the oil can also be used in OTC-type products following the applicable monographs.
US Regulatory Status
| Application | Status | Reference |
|---|---|---|
| Food flavoring | GRAS natural substance | FDA 21 CFR §182.20 (eucalyptus oil) |
| FEMA GRAS | Flavoring material | FEMA 2466 |
| Cosmetics | Permitted ingredient; INCI: Eucalyptus Globulus Leaf Oil | Cosmetic Ingredient Review — safe with restrictions |
| OTC drug (cough/cold rubs) | Possible use per active-ingredient monographs | Follow 21 CFR Part 341 (external analgesic / cold rub actives) with correct labeling |
| Dietary supplement | Not a typical use for this oil; consult regulatory counsel if intended | — |
- For food flavoring, use levels should follow good manufacturing practice; typical use is at low ppm
- For cosmetics, comply with IFRA guidance for fragrance allergens and keep dermal concentrations within safe limits (see the IFRA allergen FAQ)
- Eucalyptus oil is not restricted by California Proposition 65 for its primary constituents
- The FDA does not pre-approve essential oils; compliance is the responsibility of the finished-product manufacturer based on the intended use
- We provide the SDS, COA, and compositional data you need to build your US regulatory file
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This article was published on 2026-09-07, and last updated on 2026-09-07. The article will be continuously updated.
