The Brazilian Health Regulatory Agency (Anvisa) recently introduced RDC 894/2024, a new regulation aimed at enhancing post-market monitoring of cosmetic products in Brazil. This regulation, which comes into effect in 12 months, outlines stringent guidelines for ensuring consumer safety through a systematic process known as cosmetovigilance. The Anvisa RDC 894/2024 is designed to modernize the regulatory framework, replacing the older RDC 332/2005, and aligning Brazil’s practices with international standards.
Understanding Cosmetovigilance
The term cosmetovigilance refers to the surveillance and monitoring of cosmetic products after they have been commercialized. Under Anvisa RDC 894/2024, this involves a series of activities such as identifying, reporting, investigating, and mitigating any adverse reactions resulting from the use of cosmetics. The ultimate goal is to ensure timely identification and management of potential risks, protecting the health and safety of consumers.
Key Elements of Anvisa RDC 894/2024
- Clear Responsibilities for Companies: The regulation requires cosmetic companies to actively monitor their products post-market, ensuring that any adverse effects are promptly addressed.
- Mandatory Cosmetovigilance System: Companies must implement a robust cosmetovigilance system with at least six mandatory requirements. This includes procedures for collecting, investigating, and reporting serious adverse events.
- Appointment of a Responsible Professional: Anvisa RDC 894/2024 requires each company to designate a professional responsible for overseeing cosmetovigilance activities.
- Timely Notification of Serious Adverse Events: In cases of serious adverse reactions, companies must report incidents to Anvisa within a specified timeframe, allowing for quick intervention if necessary.
- Comprehensive Terminology: To ensure clarity, the regulation provides definitions for key terms like “serious adverse event” and “cosmetovigilance system.”
- Risk Minimization: If safety issues are detected, companies must implement risk-reduction measures, such as modifying product formulations or providing updated usage instructions.
Replacing RDC 332/2005 and What’s Next
By replacing RDC 332/2005, Anvisa RDC 894/2024 reflects the evolving nature of the cosmetic industry, introducing modernized practices and technological advancements. Moreover, Anvisa will release a Manual of Inspection in Cosmetovigilance by the end of 2024. This manual will guide health surveillance authorities across the country, providing clear, actionable steps for inspecting cosmetic products.