The Modernization of the Cosmetics Regulation Act (MoCRA), as detailed in Sec. 608, mandates that the responsible person for a cosmetic product maintain records substantiating the product’s safety. This substantiation can include tests, studies, research, and other evidence deemed sufficient by experts to ensure a product’s safety. While the method for this substantiation isn’t strictly defined, Cosmeservice has confirmed that a Cosmetic Product Safety Report (CPSR) in line with the European Cosmetics Regulation EC No 1223/2009 meets the criteria for the USA. Products not marketed in the EU or UK will need a Toxicological Risk Assessment, similar to the CPSR. MoCRA also emphasizes that records should be accessible to FDA personnel, especially if concerns arise about product safety. This poses challenges for smaller cosmetic companies, Cosmeservice, as regulatory expert, can guide you through the safety substantiation.