Serious Undesirable Effects (SUE) Reporting
What is Serious Undesirable Effects (SUE) Reporting?
Serious Undesirable Effects (SUE) reporting is the obligation under Regulation (EC) No 1223/2009 for Responsible Persons and distributors to notify the competent authority of the member state where the serious undesirable effect occurred when a cosmetic product is linked to a serious adverse reaction in a consumer. A serious undesirable effect is defined under the regulation as an undesirable effect that results in temporary or permanent functional incapacity, disability, hospitalisation, congenital abnormalities, an immediate vital risk, or death.
Why It Matters
SUE reporting is a critical post-market safety obligation under the EU Cosmetics Regulation. It ensures that competent authorities are informed promptly when a cosmetic product causes serious harm to a consumer, enabling them to investigate, take corrective action, and share information with other member states where necessary.
For Responsible Persons, failing to report a serious undesirable effect is a breach of the regulation and can result in enforcement action. Beyond the regulatory consequences, failure to act on safety signals can expose consumers to continued harm and result in significant reputational and legal consequences for the brand.
For cosmetic brands, manufacturers, and ecommerce sellers, having a clear process in place for identifying, documenting, and reporting serious undesirable effects is an essential part of responsible post-market compliance.
Key Requirements
Who Is Required to Report Serious Undesirable Effects?
SUE reporting obligations apply to:
- Responsible Persons who become aware of a serious undesirable effect linked to their product
- Distributors who become aware of a serious undesirable effect linked to a product they make available on the market
This requirement applies under:
- Regulation (EC) No 1223/2009 — EU Cosmetics Regulation, Article 23
Reports must be submitted to the competent authority of the member state where the serious undesirable effect occurred. Where the effect occurs in multiple member states, reports must be submitted to the competent authority in each relevant member state.
Responsibilities Relating to SUE Reporting
While specific obligations depend on the role in the supply chain, responsibilities commonly include:
- Notifying the competent authority of the member state where the SUE occurred without undue delay upon becoming aware of it
- Providing the product name, the nature of the serious undesirable effect, and the corrective measures taken or planned
- Keeping records of all serious undesirable effects and non-serious undesirable effects reported to the Responsible Person or distributor
- Making records of undesirable effects available to competent authorities upon request
- Cooperating with competent authority investigations into reported serious undesirable effects
- Taking appropriate corrective action where a product is found to be linked to a serious undesirable effect
SUE Reporting and the Responsible Person
These are distinct categories under the EU Cosmetics Regulation. Prohibited substances listed in Annex II may not be used in cosmetic products under any circumstances. Restricted substances listed in Annex III may be used but only within the specific conditions set out in the annex, such as maximum permitted concentrations or mandatory labelling warnings. Where a substance appears in Annex II, no conditions of use can make its inclusion in a cosmetic product lawful.
Need EU cosmetics compliance support?
Euverify provides Responsible Person services for cosmetic brands and manufacturers placing products on the EU market under the EU Cosmetics Regulation. Our team supports CPNP notification, product information file management, regulatory communication, and ongoing compliance management.
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Further Reading
