Beta-Carotene

What Is It?

Beta-Carotene is a precursor of vitamin A. It is the pigment responsible for the orange color of carrots and it is found in many other fruits and vegetables. In cosmetics and personal care products, Beta-Carotene is used in the formulation of aftershave lotions, bath products, cleansing products, makeup, hair conditioners, shampoos, skin care products and suntan products.

Why Is It Used?

Beta-Carotene imparts an orange color to cosmetics and personal care products. It also enhances the appearance of dry or damaged skin by reducing flaking and restoring suppleness.

Scientific Facts

Beta-Carotene is a naturally occurring carotenoid pigment found in many fruits and vegetables. Beta-Carotene is a precursor of, and can be synthesized from, vitamin A. Beta-Carotene used in cosmetics and personal care products is prepared synthetically or obtained from natural sources.

Safety Information

The Food and Drug Adminimstration (FDA) lists Beta-Carotene as a color additive exempt from certification and it may be safely used for coloring foods, drugs and cosmetics, including those intended for use in the area of the eye. When used to color food, drugs and cosmetics, it must conform to FDA specifications. The FDA also includes Beta-Carotene on its list of direct food substances Generally Recognized as Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.). 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 Beta-Carotene

Beta-Carotene is listed as CI 40800 and CI 75130 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 cosmetics and personal care products in the European Union Beta-Carotene must be called CI 40800 or CI 75130.

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

Beta-Carotene is a carotenoid compound that important for photosynthesis in some plants. Beta-Carotene used to color food, drugs and cosmetic products is prepared synthetically or obtained from natural sources. In cosmetics and personal care products, Beta-Carotene functions as a colorantIngredients that impart color to cosmetic products. In the United States, the FDA regulates which colorants may be used in cosmetics. and as a skin conditioning agent – miscellaneous.

Resources

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…

Substances Generally Recognized As Safe (GRAS): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

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/