Cosmetovigilance is the process of collecting, evaluating and monitoring reports of undesirable events following normal or reasonably foreseeable use of a cosmetic product.
The EU and the UK Cosmetics Regulations require that any adverse effects attributable to a cosmetic product are recorded in the Product Information File (PIF). Additionally, the Responsible Person and Distributors must report a Serious Undesirable Effect (SUE) to the Competent Authority.
Article 2 of both the Regulations provides definitions of both undesirable effects and serious undesirable effects.
'an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product'.
Serious Undesirable Effect
'an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death'.
UK (including Northern Ireland)
On 1 January 2021, the Office for Product Safety and Standards (OPSS), the Competent Authority for cosmetics in the UK, published the new UK Serious Undesirable Effects (SUE) reporting form 1. This form allows the UK Responsible Person (RP) to notify SUEs to the Competent Authority.
Under this new system, RPs and/or distributors should send SUE reports received from UK consumers directly to OPSS via the email address [email protected]. This replaces the previous process by which SUE reports were sent to Trading Standards.
The RP or a distributor should complete SUE report Form A to transmit the information on the SUE to the Competent Authority of the Member State where the SUE has occurred. When an SUE is reported to a Competent Authority, the authority then has to alert the authorities in all other EU Member States.
SUE reporting guidelines and reporting forms are available on the European Commission's Market Surveillance webpage.
Any undesirable effect (UE), whether it is deemed to be 'serious' or not, does need to be investigated to make sure it is attributable to the cosmetic product in question. In order to determine this, it is important that a causality assessment is performed. Although the reporting aspect of the SUE reporting guidelines by the European Commission is not relevant to the UK, the causality assessment process is the same in the UK and EU.