At ORY®, we believe you should know what’s in your products and why. This page lists the published research behind what we say about annatto. Each section starts with our claim, then tells you how well the research supports it, then lists the sources so you can read them yourself.
How to read this page Supported — backed by peer-reviewed research or official safety reviews. Supported, with caveats — the research points this way, but mostly from laboratory or animal studies, or at different strengths than ORY® uses. Limited evidence — little or no published research yet. We say so openly. |
1. General Description and Role
Claim: Annatto comes from the red-orange coating of the seeds of the achiote tree (Bixa orellana). In ORY® products, it gives a natural warm orange color and provides antioxidant support. |
Verification: Supported. Annatto is an FDA-approved color additive for cosmetics, including products used around the eyes. Reviews document its carotenoid pigments and tocotrienol content. We found no CIR safety assessment for annatto.
Citations:
- U.S. Food and Drug Administration. 21 CFR 73.2030 — Annatto (color additive exempt from certification, permitted in cosmetics generally, including the eye area). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-C/section-73.2030
- What it shows: FDA color additive listing for annatto.
- Vilar, D. A., et al. (2014). Traditional uses, chemical constituents, and biological activities of Bixa orellana L.: A review. The Scientific World Journal, 2014, 857292. https://doi.org/10.1155/2014/857292
- What it shows: Review of annatto’s uses and chemistry.
- U.S. Food and Drug Administration. 21 CFR 73.2030 — Annatto (color additive exempt from certification, permitted in cosmetics generally, including the eye area). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-C/section-73.2030
2. Composition and Production
Claim: Annatto extract is made from the seed coat with oil (rich in bixin), alkaline water (rich in norbixin), or alcohol. Annatto is also one of the richest natural sources of tocotrienols, a form of vitamin E. |
Verification: Supported. Annatto’s pigments and vitamin E content are well documented.
Citations:
- Raddatz-Mota, D., Pérez-Flores, L. J., Carrari, F., et al. (2017). Achiote (Bixa orellana L.): A natural source of pigment and vitamin E. Journal of Food Science and Technology, 54(6), 1729–1741. https://doi.org/10.1007/s13197-017-2579-7
- What it shows: Review of annatto pigments and vitamin E.
- Raddatz-Mota, D., Pérez-Flores, L. J., Carrari, F., et al. (2017). Achiote (Bixa orellana L.): A natural source of pigment and vitamin E. Journal of Food Science and Technology, 54(6), 1729–1741. https://doi.org/10.1007/s13197-017-2579-7
3. Skin Type Suitability
Claim: Annatto suits most skin types. Sensitive skin should patch test. |
Verification: Limited evidence. We found no cosmetic clinical studies of annatto by skin type. Allergy to annatto is rare and has been reported mainly from food.
Citations:
- Vilar, D. A., et al. (2014). Traditional uses, chemical constituents, and biological activities of Bixa orellana L.: A review. The Scientific World Journal, 2014, 857292. https://doi.org/10.1155/2014/857292
- What it shows: General review.
- Vilar, D. A., et al. (2014). Traditional uses, chemical constituents, and biological activities of Bixa orellana L.: A review. The Scientific World Journal, 2014, 857292. https://doi.org/10.1155/2014/857292
4. Hair and Scalp Suitability
Claim: In haircare, annatto is used in small amounts in hair oils for antioxidant support and to warm the look of copper and auburn shades. |
Verification: Limited evidence. We found no clinical studies of annatto on hair. It can tint light hair. ORY® haircare products are not intended to grow hair or treat scalp conditions.
Citations:
- U.S. Food and Drug Administration. 21 CFR 73.2030 — Annatto (color additive exempt from certification, permitted in cosmetics generally, including the eye area). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-C/section-73.2030
- What it shows: Color additive listing.
- U.S. Food and Drug Administration. 21 CFR 73.2030 — Annatto (color additive exempt from certification, permitted in cosmetics generally, including the eye area). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-C/section-73.2030
5. Benefits
Claim: Annatto gives products a natural warm color and provides antioxidant support. |
Verification: Supported, with caveats. Color use is approved by FDA. Antioxidant benefits are supported by research on annatto pigments and on tocotrienols, mostly from lab studies. Annatto is not an FDA sunscreen ingredient, and ORY® does not make sun-protection, wound, or antimicrobial claims.
Citations:
- U.S. Food and Drug Administration. 21 CFR 73.2030 — Annatto (color additive exempt from certification, permitted in cosmetics generally, including the eye area). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-C/section-73.2030
- What it shows: Approved color use.
- Sen, C. K., Khanna, S., & Roy, S. (2006). Tocotrienols: Vitamin E beyond tocopherols. Life Sciences, 78(18), 2088–2098. https://pubmed.ncbi.nlm.nih.gov/16458936/
- What it shows: Review of tocotrienol research.
- U.S. Food and Drug Administration. (2019, February 26). Sunscreen drug products for over-the-counter human use (proposed rule), 84 FR 6204. https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
- What it shows: FDA regulates sun-protection claims as sunscreen drugs.
- U.S. Food and Drug Administration. 21 CFR 73.2030 — Annatto (color additive exempt from certification, permitted in cosmetics generally, including the eye area). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-C/section-73.2030
6. Use Across ORY® Product Lines
Claim: Annatto is used in all four ORY® product lines. |
Verification: Supported. Annatto is permitted as a color additive in cosmetics generally and is listed on labels as “Annatto.” It is one of the few natural colors that holds in cold-process soap.
| Product line | Typical level | How ORY® uses it |
| Skincare | 0.1–1% extract; 2–10% infused oil | Antioxidant serums, creams, face and body oils, and balms. |
| Haircare | 0.1–0.5% extract; 1–5% infused oil | Hair oils for warm shades. |
| Handmade Soap | 5–20% of oils as infusion | Annatto-infused oil for yellow-orange bars. |
| Cosmetics | 0.05–2% (by color) | Lip balms, tints, cream blush, and bronzers. |
Citations:
- U.S. Food and Drug Administration. 21 CFR 73.2030 — Annatto (color additive exempt from certification, permitted in cosmetics generally, including the eye area). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-C/section-73.2030
- What it shows: FDA color additive listing.
- U.S. Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap
- What it shows: FDA explains how soap is regulated.
- U.S. Food and Drug Administration. 21 CFR 73.2030 — Annatto (color additive exempt from certification, permitted in cosmetics generally, including the eye area). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-C/section-73.2030
7. Pros
Claim: An FDA-approved natural color with antioxidant tocotrienols. |
Verification: Supported. Color approval is clear; skin benefits are mainly from lab research.
Citations:
- U.S. Food and Drug Administration. 21 CFR 73.2030 — Annatto (color additive exempt from certification, permitted in cosmetics generally, including the eye area). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-C/section-73.2030
- What it shows: Color approval.
- Raddatz-Mota, D., Pérez-Flores, L. J., Carrari, F., et al. (2017). Achiote (Bixa orellana L.): A natural source of pigment and vitamin E. Journal of Food Science and Technology, 54(6), 1729–1741. https://doi.org/10.1007/s13197-017-2579-7
- What it shows: Composition.
- U.S. Food and Drug Administration. 21 CFR 73.2030 — Annatto (color additive exempt from certification, permitted in cosmetics generally, including the eye area). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-C/section-73.2030
8. Cons
Claim: Annatto stains, fades in light, and has limited topical skin research. |
Verification: Supported. We list these limits so you have the full picture:
- Staining. Can tint skin, fabric, and light hair.
- Light fading. Bixin fades in prolonged light.
- Limited evidence. Topical benefits are mostly preclinical.
- No CIR assessment. No independent cosmetic safety review found.
Citations:
- Vilar, D. A., et al. (2014). Traditional uses, chemical constituents, and biological activities of Bixa orellana L.: A review. The Scientific World Journal, 2014, 857292. https://doi.org/10.1155/2014/857292
- What it shows: Review.
- Vilar, D. A., et al. (2014). Traditional uses, chemical constituents, and biological activities of Bixa orellana L.: A review. The Scientific World Journal, 2014, 857292. https://doi.org/10.1155/2014/857292
9. Safety Notes
Claim: Patch test before use; for external use only. |
Verification: Supported. Follow these precautions:
- Patch test any new product on a small area for 24–48 hours before full use.
- Stop use if redness, burning, itching, or rash occurs, and talk to a healthcare provider.
- For external use only. Avoid the eyes. Do not use on broken or seriously damaged skin.
- If you are pregnant, nursing, have a medical condition, or are buying for a child, ask a healthcare provider before use.
Citations:
- Vilar, D. A., et al. (2014). Traditional uses, chemical constituents, and biological activities of Bixa orellana L.: A review. The Scientific World Journal, 2014, 857292. https://doi.org/10.1155/2014/857292
- What it shows: Review.
- Vilar, D. A., et al. (2014). Traditional uses, chemical constituents, and biological activities of Bixa orellana L.: A review. The Scientific World Journal, 2014, 857292. https://doi.org/10.1155/2014/857292
10. Product-line notes
- ORY® Skincare: For external use only. Not for deep or puncture wounds, animal bites, or serious burns.
- ORY® Haircare: Designed for scalp comfort and the look and feel of hair. Not intended to treat dandruff or scalp conditions, or to promote hair growth or prevent hair loss. If you notice sudden shedding or a persistent itchy, flaking scalp, see a dermatologist.
- ORY® Handmade Soap: Handmade soap is naturally alkaline, and each bar may vary slightly in color, scent, and texture. Not intended to treat eczema or any skin condition.
- ORY® Cosmetics: Lip products are not intended to treat or protect chapped or cracked lips. Do not share applicators, and replace any product that changes color, smell, or texture.
11. References
Peer-reviewed research
- Raddatz-Mota, D., Pérez-Flores, L. J., Carrari, F., et al. (2017). Achiote (Bixa orellana L.): A natural source of pigment and vitamin E. Journal of Food Science and Technology, 54(6), 1729–1741. https://doi.org/10.1007/s13197-017-2579-7
- Sen, C. K., Khanna, S., & Roy, S. (2006). Tocotrienols: Vitamin E beyond tocopherols. Life Sciences, 78(18), 2088–2098. https://pubmed.ncbi.nlm.nih.gov/16458936/
- Vilar, D. A., et al. (2014). Traditional uses, chemical constituents, and biological activities of Bixa orellana L.: A review. The Scientific World Journal, 2014, 857292. https://doi.org/10.1155/2014/857292
Government and regulatory sources
- U.S. Food and Drug Administration. 21 CFR 73.2030 — Annatto (color additive exempt from certification, permitted in cosmetics generally, including the eye area). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-73/subpart-C/section-73.2030
- U.S. Food and Drug Administration. (2019, February 26). Sunscreen drug products for over-the-counter human use (proposed rule), 84 FR 6204. https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
- U.S. Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap