HCPC Brands EuropeCosmetovigilance
Article 23 of Regulation (EC) No 1223/2009 requires the Responsible Person to notify serious undesirable effects without delay, and Article 10(1)(c) requires the safety report to be kept up to date once the product is on the market. Together these mean the Responsible Person must keep monitoring a cosmetic product for as long as it remains on the market, and act quickly if something goes wrong. HCPC Brands Europe B.V. runs this ongoing monitoring and handles the formal reporting duties that come with it.
What's Included
- Undesirable effect monitoring — ongoing tracking of consumer and healthcare-professional reports connected to your products.
- Severity assessment — determining whether a reported effect meets the threshold for a serious undesirable effect requiring mandatory notification.
- Competent authority notification — formal, timely reporting to the relevant Member State authority when required.
- Consumer complaint handling — a documented process for receiving and triaging product-related complaints.
- Corrective action coordination — support with bringing a product into conformity, withdrawal, or recall where necessary.
Why This Matters Beyond Compliance
Cosmetovigilance data doesn't just satisfy a legal obligation - it feeds back into the Cosmetic Product Safety Report, which must be kept up to date in light of any new safety-relevant information that emerges after launch. A well-run cosmetovigilance process keeps your CPSR defensible over the full life of the product, not just at the point of market entry.
Regulatory Framework
Our Process
- 1. Monitoring setup — we establish the intake channel for complaints and adverse-effect reports connected to your products.
- 2. Triage — each report is assessed against the undesirable effect / serious undesirable effect threshold.
- 3. Notification — serious undesirable effects are reported to the relevant competent authority without delay.
- 4. Feedback into PIF/CPSR — relevant findings are used to keep your safety report current.
Frequently Asked Questions
What is cosmetovigilance?
Cosmetovigilance is the Responsible Person's ongoing duty to monitor cosmetic products for undesirable effects after they reach the market, and specifically to notify serious undesirable effects to the competent national authority without delay.
What counts as an "undesirable effect" versus a "serious undesirable effect"?
An undesirable effect is any adverse reaction for human health attributable to normal or reasonably foreseeable use of a cosmetic product. A serious undesirable effect is a narrower, higher-severity category: one causing temporary or permanent loss of function, disability, hospitalisation, birth defects, or an immediate risk to life or death. Only the serious category triggers the notification duty under Article 23. That threshold governs notification alone: the Responsible Person's other duties - keeping the safety report up to date, and taking corrective action where it considers or has reason to believe that a product is not compliant - are not limited by it.
Who is responsible for reporting a serious undesirable effect - the brand, the Responsible Person, or the distributor?
Both the Responsible Person and distributors have a notification duty. Whichever party becomes aware of a serious undesirable effect must report it without delay to the competent authority in the Member State where the effect occurred, and that authority in turn shares the information with the Responsible Person and other Member States.
Does a single customer complaint automatically count as a serious undesirable effect?
Not necessarily. A complaint must meet the specific severity threshold - functional incapacity, disability, hospitalisation, congenital anomaly, immediate life risk, or death - to qualify as a serious undesirable effect requiring mandatory notification. Milder undesirable effects are still tracked, but do not trigger the same formal reporting duty.
What happens after a serious undesirable effect is reported?
The receiving competent authority shares the information with the authorities of other Member States. Where the Responsible Person considers, or has reason to believe, that the product is not compliant, it must act without waiting for a definitive conclusion, and take corrective action - bringing the product into conformity, withdrawing it, or recalling it, as appropriate to the risk.
See also our Responsible Person and CPSR pages, or our full Cosmetics Glossary & FAQ.
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