MoCRA – Modernization of Cosmetics Regulation Act – is the new US law to ensure the safety of cosmetic products distributed in the United States. It entails significant expansion of the FDA’s authority to regulate cosmetic products that consumers use every day.
MoCRA impacts manufacturers and processors selling cosmetic products in the US. It includes new and redefined requirements for cosmetic products, manufacturing facilities and distributors. The regulation also sets certain responsibilities for the Responsible Person whose name appears on the label of the cosmetic product.
The main requirements of MoCRA include:
- Facility registration and product listing
• Good Manufacturing Practice (GMP)
• Mandatory reporting of adverse events
• Safety substantiation of products
• Labeling of fragrance allergens
• Testing methods for talc-containing cosmetics
