Retinol and Retinyl Palmitate

The Food and Drug Administration (FDA) includes Retinol and Retinyl Palamitate on its list of substances affirmed as 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.) for direct addition to food as a nutrient supplement. The safety of Retinol and Retinyl Palmitate has been assessed by the 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) Expert Panel. The CIR Expert Panel evaluated scientific data and concluded that Retinol and Retinyl Palmitate were safe as cosmetic ingredients. In 2005, the CIR Expert Panel considered available new data on Retinol and Retinyl Palmitate and reaffirmed the above conclusion.

CIR Review:

The CIR Expert Panel noted that vitamin A is an essential nutrient with a Recommended Daily Allowance orally that varies for different groups: 5000 and 4000 International Units (IU) daily for male and female adults, respectively; lesser amounts for infants and children; and 5000 and 6000 IU daily for pregnant and lactating women, respectively. The CIR Expert Panel reviewed the safety data on Retinol and Retinyl Palmitate and concluded that these ingredients were not mutagenic or carcinogenic. Cosmetics and personal care products containing 0.1-1% of these ingredients were at most slightly irritating. These products did not result in skin sensitization.

A recent publication demonstrated that topically-applied Retinol and Retinyl Palmitate did not result in measurable increases in the amount of vitamin A in the blood. Blood levels of vitamin A were increased when similar amounts of Retinol or Retinyl Palmitate were taken orally.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dop…

Research completed by the FDA also supports limited skin penetration of Retinol. http://www.accessdata.fda.gov/scripts/oc/scienceforum/sf2006/search/prev…

FDA:

Link to Code of Federal Regulations for Retinol and Retinyl Palmitate

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Retinyl Palmitate and Retinol may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm

Health Canada permits the use of Retinyl Palmitate and Retinol in cosmetics and personal care products at concentrations equal to or less than 1%.

http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-cri…

The state of California lists Retinol and retinyl esters, including Retinyl Palmitate, as Proposition 65 chemicals “known to the state” to cause reproductive toxicity at daily dosages in excess of 10,000 IU. It is noted that retinol/retinyl esters are required and essential for maintenance of normal reproductive function, and the recommended daily level during pregnancy is 8,000 IU.

http://www.oehha.ca.gov/prop65.html

Cosmetics and personal care products do not contain large amounts of Retinol and retinyl esters, including Retinyl Palmitate, and these ingredients dermally applied do not substantially contribute to the amount of vitamin A in the blood (more than 10,000 IU). Therefore, cosmetics and personal care products containing Retinol and Retinyl Palmitate do not need to be labeled with a Proposition 65Proposition 65 is a California citizens initiative that was enacted as “The Safe Drinking Water and Toxic Enforcement Act of 1986.” Proposition 65 requires the State to publish a list of chemicals known to the state of California to cause cancer or birth defects or other reproductive harm. Businesses are then required to notify Californians about these chemicals if they are present in the products they purchase, in their homes or workplaces, or that are released into the environment. warning.