Reporting Undesirable Effects

What is an undesirable effect?

An undesirable effect is an adverse reaction to a cosmetic product under normal or foreseeable conditions of use. Examples of undesirable effects include irritant and allergic effects, sensitivity to light and itching. 

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. All serious undesirable effects must be reported to us by the company responsible for placing that product on the market.   

Consumers

How do I report an undesirable effect or serious undesirable effect?

To report an undesirable effect or serious undesirable effect to us you can use our report form. 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 cosmetics@hpra.ie.

Industry

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 the responsible person or distributor once 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.

Reporting of SUEs to the HPRA became mandatory with the implementation of Regulation (EC) No. 1223/2009 on cosmetic products on 11 July 2013.

To report an SUE, please complete and return SUE Form A to cosmetics@hpra.ie.