Annatto

What Is It?

Annato is a coloring agent made from the seeds of the plant Bixa orellana. In cosmetics and personal care products, Annatto is used in the formulation of face and neck products, lipsticks, permanent waves, shampoos, and skin care products.

Why Is It Used?

Annatto imparts a red or orange color to cosmetics and personal care products.

Scientific Facts

Annatto is the coloring matter made from from the seeds of the tree, Bixa orellana, commonly called the lipstick tree. Annatto is used in coloring cheeses, margarine, butterAny of various fatty oils remaining nearly solid at room temperature. and custard powder and is commonly found in Latin American and Caribbean cuisines.

Safety Information

The Food and Drug Administration (FDA) lists Annatto as a color additive exempt from certification and it may be safely used in coloring foods, as well as cosmetics and drugs including products intended for use in the area of the eye. Annatto used in food, cosmetics and drugs must conform to FDA specifications. Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.

All color additives used in foods, drugs and cosmetics in the United States must be approved by FDA and listed in the Code of Federal Regulations. In some cases, FDA requires that each batch of color produced for use in regulated products can be used only if it is certified by the agency to meet strict specifications. FDA maintains a laboratory especially for this purpose and color manufacturers must pay a fee to support this activity. FDA only approves colors after extensive review of all safety data and publication of the basis for its approval in the Federal Register.

You can find out more about FDA regulation of colors at: http://www.cfsan.fda.gov/~dms/cos-col.html

Link to FDA Code of Federal Regulations for Annatto

Annatto is listed as CI 75120 in the Cosmetics Directive of the European Union and may be used as a coloring agent in all cosmetics and personal care products (see Annex IV). When used in cosmetic products in the European Union, Annatto must be listed as CI 75120.

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

You can learn more about the regulation and labeling of colors at:
http://www.personalcarecouncil.org/colors-cosmetics-regulation-and-nomen…

More Scientific Information

Annatto is obtained from the reddish pulp which surrounds the seed of Bixa orellana, a small tree or shrub from the tropical regions of the Americas. In cosmetics and personal care products, Annatto functions as a colorantIngredients that impart color to cosmetic products. In the United States, the FDA regulates which colorants may be used in cosmetics..

Resources

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/