Division 3.9 Undesirable effects and serious undesirable effects

The aim of that section of the cosmetic product safety report is to monitor the safety of the product after it has been placed on the market and to take corrective action, where necessary. To this end, the responsible person (in collaboration with the distributors) is required to set up a system to collect, document, establish the causality of and manage the undesirable effects caused by the product after its use in the Union ^f1. When the undesirable effects are serious, the responsible person (and the distributors) are to notify the competent authority of the Member State where the effects occurred ^f2.

Information on undesirable effects and serious undesirable effects is to be included in the cosmetic product safety report, kept up-to-date and made available to the safety assessor, who may revise their assessment or take the information into account when assessing similar products.

The cosmetic product safety report is to include all the available data, including statistical data, on the undesirable effects and serious undesirable effects of the cosmetic product or, where relevant, other cosmetic products.

In particular, information on undesirable effects which, according to the causality assessment, are found to be very likely, likely, not clearly attributable or unlikely to be attributable^f3 to the cosmetic product in question are to be included in the safety report.

Data on undesirable effects may be included in this part of the safety report in the form of statistical data such as the number and type of undesirable effects per year.

Information on serious undesirable effects which, according to the causality assessment, are found to be very likely, likely, not clearly attributable or unlikely to be attributable to the cosmetic product in question are to be included in the safety report in accordance with section 9 of Part A of Annex I to Regulation (EC) No 1223/2009, and notified to the national competent authorities, in accordance with Article 23 of the same Regulation^f4. The notification forms sent to the competent authorities are therefore to be attached to the cosmetic product safety report.

The responsible person’s reaction to and handling of the reported serious undesirable effects is to be stated. The corrective and preventive measures taken, if any, should be described.

The information on undesirable effects is to be kept up-to-date and regularly made available to the safety assessor^f5, who may consider it necessary to revise the safety assessment, suggest improvements to the formulation or use the information to establish the safety assessment for similar products.

Additional cosmetovigilance data, such as serious undesirable effects of a non-intended use may also provide helpful information that the safety assessor should consider.