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"Undesirable effect" means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product.


"Serious undesirable effect" means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies or an immediate vital risk or death.


According to Article 23 of the Cosmetics Regulation, the responsible person or the distributor must notify all serious undesirable effects known to them without delay to the competent authority of the Member State where the serious undesirable effect occurred. In Slovenia, this SUE (Serious Undesirable Effect) notification should be made to Chemicals Office of the Republic of Slovenia. Further information about making a notification is available here: