Retinol is the primary naturally occurring form of vitamin A. It is a pale yellow crystalline material or a thick liquid. Retinyl Palmitate is a yellow to yellow-red solid or oily substance. Retinyl Palmitate is the ester of Retinol and palmitic acid. In cosmetics and personal care products, Retinol and Retinyl Palmitate are used primarily in the formulation of hair, facial makeup and skin care products.
The safety of Retinol and Retinyl Palmitate has been assessed by the Cosmetic Ingredient Review (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=...
Research completed by the FDA also supports limited skin penetration of Retinol.
http://www.accessdata.fda.gov/scripts/oc/scienceforum/sf2006...
FDA: Link to Code of Federal Regulations for Retinol and Retinyl Palmitate http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Retinyl Palmitate and Retinol may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...
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/hotlist-liste_3...
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 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 65 warning.