MOCRA – Data to support the safety of cosmetic products placed on sale in the U.S. market

The person responsible for selling a cosmetic product in America [the responsible party under MOCRA regulations] must collect and maintain data to support the consumer safety of that cosmetic product.

"Data supporting the safety of cosmetic products" refers to tests or studies, research, analysis, or other evidence or information that is considered among experts qualified by scientific training and/or professional experience to evaluate the safety of cosmetic products and their ingredients, to be sufficient to support a reasonable certainty that the use of a cosmetic product for sale in the U.S. market can be considered safe.

Also, under MOCRA regulations, the term "safe" means that the cosmetic product to be imported into the U.S., including the ingredients, is not harmful to consumers under the conditions of use provided on the label or under the conditions of use that are usual or customary for that particular cosmetic product. FDA will not consider a cosmetic ingredient or product harmful to consumers merely because it may cause minor and temporary reactions or minor and temporary skin irritation in some consumers. In determining for purposes of this section whether a cosmetic product is safe, FDA may consider, where appropriate and available, data on cumulative exposure to the cosmetic product or its ingredients.