What is the difference between a serious and a non-serious undesirable effect?

A serious undesirable effect is one that results in temporary or permanent functional incapacity, disability, hospitalisation, congenital abnormalities, an immediate vital risk, or death. A non-serious undesirable effect is any adverse reaction that does not meet this threshold — for example, mild skin irritation or temporary redness. Both must be recorded, but only serious undesirable effects trigger the mandatory reporting obligation to competent authorities.

Is there a specific timeframe for reporting a SUE?

The EU Cosmetics Regulation requires reporting without undue delay upon becoming aware of a serious undesirable effect. Manufacturers and Responsible Persons should have internal processes in place to ensure reports are submitted promptly and that no unnecessary delays occur between becoming aware of an effect and notifying the relevant competent authority.

Does SUE reporting apply to the UK market?

The UK Cosmetics Regulation, which governs products placed on the Great Britain market following Brexit, contains equivalent provisions for reporting serious undesirable effects to the MHRA. Responsible Persons and distributors operating in both markets must meet the reporting obligations of each framework independently.

Cosmetic Product Safety Report (CPSR) Archives

Related Terms: Cosmetic Product Safety Report (CPSR)

Serious Undesirable Effects (SUE) Reporting

Prohibited Substances (Annex II)

Restricted Substances (Annex III)

INCI

Good Manufacturing Practice (ISO 22716)

Product Information File (PIF)

UK

EU