Cosmetovigilance

from Wikipedia, the free encyclopedia

Under cosmetovigilance (German also Kosmeto vigilance ) is based on the concept of pharmacovigilance , the ongoing and systematic monitoring of the safety of a cosmetic product understood in terms of human health. The aim is to discover, assess and understand the undesirable effects of cosmetic products, and to take appropriate measures to prevent them.

EC Cosmetics Regulation

The need to monitor cosmetics results from the EC Cosmetics Regulation . The person responsible for safety (safety assessor) of the marketing company maintains a product information file in electronic or other format which is easily accessible to the competent authority of the Member State. The central element of this product information is the safety report. For this, the safety-related information must be checked and, if necessary, updated even after the cosmetic products have been placed on the market.

unwanted effects

The practical consequence of the legislation is an obligation to continuously monitor the product after it has been launched on the market. This applies in particular to "undesirable effects" and "serious undesirable effects". Legislation defines “undesirable effects” as a negative impact on human health that is attributable to the normal or reasonably foreseeable use of a cosmetic product. A "serious undesirable effect" leads to temporary or permanent functional impairment, disability, hospitalization, congenital anomalies, immediate danger to life or even death.

Data on adverse effects and serious adverse effects caused by the cosmetic product when it is used must be made easily available to the public. In the case of serious adverse effects from cosmetic products, the responsible persons report this immediately to the competent authority of the Member State in which the serious adverse effects occurred. Other member states will be informed immediately and appropriate measures will be initiated.

Web links