SUE and safeguarding notifications for cosmetics
Information on how to report a serious undesirable effect (SUE) or safeguarding issue for cosmetic products.
Reporting serious undesirable effects in cosmetics
A ‘serious undesirable effect’ (SUE) is one in which the normal or reasonably foreseeable use of a cosmetic results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death.
A SUE notification does not necessarily mean that a product is unsafe or noncompliant with the regulations. An undesirable effect from a cosmetic product can arise as a result of an individual allergy or sensitivity.
You should use this form to notify the Office for Product Safety and Standards (OPSS) about serious undesirable effects reported to you by health professionals or end users in Great Britain:
SUE form for Trading Standards
For serious undesirable effects reported to District Councils by health professionals or end users in Northern Ireland, Form C must be submitted to OPSS:
All SUE forms should be submitted to: seriousundesirableeffects@businessandtrade.gov.uk.
Notifying safety risks identified in technically compliant cosmetics products (safeguarding)
If you identify a cosmetic product which is technically compliant with the legislation but you consider could still pose a serious risk to human health and are intending to take action (as required by Regulation 9, the Cosmetic Products Enforcement Regulations 2013), you must consult OPSS before taking action.
In the first instance please contact opss.enquiries@businessandtrade.gov.uk.
You will need to set out:
- information about the identity of the cosmetic product
- a description of the product risk, including a summary of any test results or analysis
- the nature and duration of any measures proposed (e.g. recall)
- information on supply chains and distribution of the product