What is an undesirable effect?
An undesirable effect is an adverse reaction to a cosmetic product under normal or foreseeable conditions of use.
What is a serious undesirable effect?
A serious undesirable effect is an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies, an immediate vital risk or death. With the implementation of Regulation (EC) No. 1223/2009 all serious undesirable effects must be reported to the IMB.
I am a consumer or a healthcare professional, how do I report an undesirable effect or serious undesirable effect?
To report an undesirable effect or serious undesirable effect, please complete the form on our website. We may need to contact you in order to gather more information to help in our investigation. All the information relating to you is treated confidentially.
To report a risk associated with a cosmetic product, please e-mail firstname.lastname@example.org
I am the responsible person (RP) or distributor (including retailers) of a cosmetic product, how do I report a serious undesirable effect?
In order to facilitate the implementation of Article 23 of the Cosmetics Regulation and to establish a harmonised communication and management system on serious undesirable effects (SUE) throughout the EEA, the European Commission, in conjunction with Member States and industry, established the SUE Reporting Guidelines describing the system.
SUE Form A is designed to be filled in by responsible persons or distributors that are made aware of an SUE in order to transmit it to the competent authority of the country where the SUE occurred. To assist completion of SUE form A general instruction is available.
Regulation (EC) No. 1223/2009 will become mandatory on 11 July 2013. For the time being, the new system is being tested on a voluntary basis.