Stay Ahead of Risk and Protect your Business
Legal background
Global cosmetics regulations require manufacturers and their designated regulatory partners to actively track and report serious incidents. These include adverse reactions, contamination, or safety concerns that could pose a health risk to consumers.
Failing to comply with incident reporting obligations can result in:
- Regulatory investigations and potential product recalls
- Market withdrawal or distribution bans
- Legal penalties and enforcement actions
- Loss of consumer trust and brand credibility
- Negative publicity and damage to reputation
Our services
How Obelis Manages Incident Reporting
Obelis acts as your global compliance partner, helping you manage cosmetic incident reporting across the EU, UK, US, and Canada.
- Incident Monitoring & Intake
- Risk Assessment & Classification
- Regulatory Submission
- Corrective Actions & Follow‑Up
- PIF & Safety Documentation Updates
- Ongoing Regulatory Monitoring
With Obelis as your partner, you gain a compliant, proactive incident management system that reduces risk and demonstrates your brand’s dedication to safety. Let us help you stay ahead of incident reporting obligations and protect your consumers and brand reputation.
FAQ
Frequently Asked Questions
Serious adverse events refer to significant incidents involving cosmetic products that result in harmful effects, safety concerns, or consumer complaints. These events must be monitored, documented, and reported to regulatory authorities to ensure ongoing product safety and protect public health.
Reporting serious adverse events is a legal obligation in key markets such as the EU, UK, US, and Canada. Timely and accurate reporting helps regulatory bodies assess risks, initiate corrective actions if needed, and maintain consumer trust. Failure to report can lead to regulatory penalties, product recalls, market withdrawals, and damage to brand reputation.
Obelis acts as your global compliance partner, managing the entire incident reporting process. We collect and assess incident reports, perform risk classification, submit required notifications to authorities across multiple regions, and advise on necessary corrective measures such as recalls or label changes. We also update your Product Information File (PIF) and safety assessments to reflect new findings and monitor regulatory changes to keep you compliant.
Depending on the severity and nature of the incident, corrective actions may include product recalls, labelling updates, formula modifications, or enhanced quality controls. Obelis provides expert guidance to implement these actions promptly to minimize risk and regulatory exposure.
