We can support cosmetics & personal care regulatory strategy development, through to market access.
Our team has experience working for Fortune 500 cosmetics & personal care companies. We offer:
- Ingredient Review – for EU, US FDA, Health Canada, etc. (EU Annex II, etc.)
- Safety Data Sheet & Label Review (INCI, California Prop 65, etc.)
- EU, US and Canadian Market Entry Strategy & timing
- Claims review
US Modernization of Cosmetics Regulation Act (MoCRA)
The cosmetics regulatory landscape changed fundamentally in 2022. The Modernization of Cosmetics Regulation Act (MoCRA) — the first major overhaul of US federal cosmetics law since 1938 — introduced mandatory FDA oversight, facility registration, product listing, adverse event reporting, and safety substantiation requirements for every brand and manufacturer selling into the US market, domestic and foreign alike.
We help cosmetics brands and manufacturers understand what these requirements mean for their specific products, get into compliance, and stay there as FDA continues rolling out new rules.
What is Required Under MoCRA
- Facility registration
- Product Listing
- Adverse event reporting
- Safety substantiation
- Labeling requirements
- Good manufacturing practices
We can support global manufacturers in developing and executing their compliance plan under MoCRA.