Cosmetic adverse event reporting in the EU is governed by a harmonized regulatory framework designed to protect consumer health and ensure product safety across Member States. The EU achieves this primarily through Regulation (EC) No. 1223/2009 and the implementation of standardized Serious Undesirable Effect (SUE) Reporting Guidelines.
This article outlines what Responsible Persons and distributors need to know about Undesirable Effect (UE) and Serious Undesirable Effect (SUE) reporting, including obligations, timelines, and post-reporting actions.
Key Takeaways
What This Article Covers
This article explains how cosmetic adverse event reporting works in the EU, including who must report, what must be reported, how reporting is carried out, and what happens after submission. It also highlights key timelines, definitions, and best practices to support ongoing compliance.
How Cosmetic Adverse Event Reporting Works in Practice
Causality Assessment
A central element of cosmetic adverse event reporting is causality assessment. This process evaluates whether a reported event is likely attributable to the cosmetic product used by the consumer.
While Competent Authorities may conduct causality assessments themselves, Responsible Persons and distributors are expected to support this process by providing complete and timely information. If a distributor submits the initial report, they must promptly inform the Responsible Person so the assessment can be completed without delay.
Harmonized Reporting Forms
To ensure consistency across Member States, the EU uses standardized reporting forms:
This harmonized approach supports effective information sharing and coordinated market surveillance across the EU.
What Happens After an Adverse Event Is Reported?
The primary objective following reporting is to protect consumer health and prevent recurrence. Authorities and Responsible Persons may analyze trends based on severity, frequency, and user-related factors. If a potential safety concern is identified, further investigation is required to determine root causes.
Adverse event data becomes part of the CPSR and must be made available to the public upon request. Depending on the findings, corrective actions may include updating usage instructions, modifying labeling or warnings, reformulating the product, or initiating a recall. Any corrective action must be reported to the original Competent Authority, which then informs other Member States as part of coordinated market surveillance.
Key Definitions to Understand
An Undesirable Effect (UE) is any adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product.
A Serious Undesirable Effect (SUE) is an undesirable effect that results in temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies, immediate vital risk, or death.
It is important to note that “serious” refers to the outcome of the event, not its intensity. Severity describes how intense an effect is (mild, moderate, or severe), while seriousness describes the impact on health or required medical intervention.
Reporting Timelines
Serious Undesirable Effects must be reported within 20 calendar days from the date any employee of the company or the Competent Authority becomes aware of the event, regardless of their role or function.
Timely internal escalation procedures are essential to meeting this requirement.
Why Cosmetic Adverse Event Reporting Matters
Effective cosmetic adverse event reporting protects public health by enabling rapid identification and management of product-related risks. Failure to comply with reporting obligations can lead to regulatory enforcement actions, including product withdrawal from the EU market.
Expert Recommendations
To maintain compliance, companies should ensure that all staff involved in cosmetovigilance are trained on Regulation (EC) No. 1223/2009 and the SUE Reporting Guidelines. All UEs and SUEs should be reported without delay, and consumers and health professionals should be educated on how to submit adverse event information.
Maintaining detailed, well-organized records, including causality assessments, outcomes, and corrective measures, is essential. Internal procedures should be reviewed regularly to reflect evolving EU guidance and enforcement expectations.
How the Ithos Regulatory Team Can Support You
Ithos can act as a single point of contact for cosmetic adverse event reporting and post-market surveillance activities. Our Regulatory Team works closely with Responsible Persons across the EU to help establish and maintain robust UE and SUE reporting systems.
We continuously monitor regulatory updates and guidance to ensure our clients remain informed, compliant, and prepared for inspections and market surveillance activities.
