Regulatory Compliance

Cosmetic regulations vary dramatically across global markets. An ingredient that is freely used in the European Union may be prohibited in China. A concentration limit that applies in Japan may not exist in Brazil. Navigating this regulatory patchwork manually — across 8 or more markets — is one of the most time-consuming and error-prone tasks in cosmetic product development.

COSMIC's Regulatory Compliance module automates this screening for every formula. The system checks each ingredient against the regulatory databases of the European Union (Regulation 1223/2009), United States (FDA 21 CFR), China (NMPA/IECIC), Japan, Korea, Canada, Brazil, and Australia. For each market, it reports whether each ingredient is allowed, restricted (with concentration limits), or prohibited.

The screening goes beyond simple allowed/prohibited status. It identifies concentration-dependent restrictions (e.g. 'allowed up to 1% in leave-on products'), category-specific rules (e.g. 'prohibited in products for children under 3'), and documentation requirements (e.g. 'requires CPNP notification in the EU'). When a regulatory conflict is detected, the platform suggests compliant alternatives.

The compliance report is included in every formula PDF and is automatically updated when you change the target market selection. This makes it straightforward for your regulatory affairs team to prepare market submissions and ensure that every product in your portfolio meets the requirements of every market you sell in.