Streamlined Safety Management for Cosmetic Brands, Distributors & Regulatory Teams
Cosmetovigilance Made Simple
SafetyEasy® Suite offers a dedicated module for cosmetovigilance, purpose-built to streamline the monitoring and reporting of adverse events related to cosmetic products. From skin test tracking to regulatory form generation, our platform ensures efficient, compliant, and centralized safety management—leveraging the same robust infrastructure and automation that powers our entire vigilance ecosystem.
Global Regulatory Readiness for Cosmetovigilance
Supporting EU, US & Canada Compliance with SafetyEasy® Cosmetovigilance
The cosmetics industry is undergoing significant regulatory transformation across major markets. SafetyEasy® Cosmetovigilance is designed to help organizations stay ahead of evolving compliance requirements in the EU, US, and Canada—through automated adverse event reporting, structured data capture, and configurable workflows that align with national and international standards.
European Union
Under Regulation (EC) No 1223/2009 and its recent amendments, cosmetovigilance obligations are expanding:
- Mandatory Reporting of Serious Undesirable Effects (SUE): Responsible persons must report SUEs to national authorities, who then share data across EU member states.
- Centralized Notification via CPNP: All cosmetic products placed on the EU market must be registered through the Cosmetic Products Notification Portal.
- Harmonized SUE Forms: Structured templates (Forms A & B) ensure consistent reporting and cross-border communication.
- Market Surveillance Coordination: National authorities collaborate through PEMSAC to monitor safety and enforce compliance.
United States
The Modernization of Cosmetics Regulation Act (MoCRA) introduces the most significant update to U.S. cosmetic regulation since 1938:
- Mandatory Adverse Event Reporting: Responsible persons must report serious adverse events to the FDA within 15 business days, including label documentation.
- Facility Registration & Product Listing: Manufacturers and processors must register facilities and list marketed products with the FDA, with biennial updates.
- Recordkeeping & Safety Substantiation: Companies must maintain safety data and provide it during inspections.
- Mandatory Recall Authority: FDA can enforce recalls if products pose serious health risks.
Canada
Health Canada enforces cosmetovigilance through the Cosmetic Regulations under the Food and Drugs Act:
- Cosmetic Notification Form (CNF): Manufacturers and importers must notify Health Canada within 10 days of first sale.
- Ongoing Updates: Any changes to formulation, branding, or company details require resubmission of the CNF.
- Post-Market Oversight: Health Canada monitors safety and classification, with authority to request additional documentation or take compliance action.
- Incident Reporting: Safety concerns must be reported promptly, supporting lifecycle vigilance and consumer protection.
Ready to Streamline Your Cosmetovigilance Operations?
Discover how SafetyEasy® can simplify your cosmetic safety workflows—from skin test tracking to SUE form generation.