Product safety substantiation

MoCRA requires the Responsible Person of a cosmetic product to maintain records justifying the safety of the product. While the Amendment is non-prescriptive about the method to adequately substantiate the safety of cosmetic products, it clarifies that “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.”

Product safety substantiation documentation should be demonstrated according to current industry standards, and within the industry it is widely accepted that a similar approach should be followed to that of EU Regulation 1223/2009, which is commonly used in many countries around the world.

In addition, it’s worth noting that an official method for detecting the presence of asbestos in products containing talc will soon be published. Furthermore, the FDA will be involved in evaluating the use and safety of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products, including assessing any associated risks. Following these evaluations, the Responsible Persons will need to adjust cosmetic products as necessary in line with these assessments.

With more than decade of expertise with safety substantiation documentation preparation, CE.way’s team of highly qualified safety assessors is able to support you with every step to ensure your cosmetic product is safe and compliant before entering the US market.