How is this bergamot oil treated under US FDA regulations?
Under US FDA rules, this bergamot oil is a GRAS flavor substance for food-flavor use and a cosmetic ingredient under the FD&C Act, handled per current good manufacturing practices.
US FDA Compliance
| Aspect | Status | Reference |
|---|---|---|
| Food flavoring | GRAS | FEMA 2153 (1965), CAS 8007-75-8, FCC 1996 |
| Cosmetic ingredient | Permitted | FD&C Act; INCI: Citrus Aurantium Bergamia (Bergamot) Fruit Oil |
| cGMP | Compliant | 21 CFR 110/117 food cGMP; cosmetic cGMP 21 CFR 700 |
| Facilitating entry | No FDA pre-approval needed for flavor/cosmetic use | FDA food facility registration recommended for commercial importers |
- FEMA GRAS listing 2153 means the substance is Generally Recognized As Safe for flavor use; FEMA limits range from 7.9 to 43 ppm depending on food category
- For cosmetics, the undiluted oil's furocoumarin content is regulated by FDA labeling/consumer-safety rules (photo-irritation warnings on finished labels when applicable); using the FCF grade avoids this concern
- Importers of food flavoring materials should register the facility with the FDA (if US) and maintain records per FSMA
- We supply an FDA-relevant technical dossier: FCC monograph compliance data, FEMA GRAS reference, MSDS and allergen-free statement
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