Cosmetovigilance

Cosmetovigilance refers to the surveillance and monitoring of cosmetic products to ensure their safety and to identify potential risks or adverse effects on human health. It is a field of regulatory and scientific activities focused on the post-market surveillance of cosmetics. This involves the systematic collection, assessment, and analysis of data regarding the safety of cosmetics and their potential risks to human health.

The primary goal of cosmetovigilance is to protect consumers from potential hazards associated with the use of cosmetic products. This includes monitoring the safety profile of cosmetics, detecting any adverse reactions or side effects reported by consumers or healthcare professionals, and taking appropriate measures to minimise risks. These incidents can range from mild skin irritations to severe allergic reactions or other health concerns.

Similar to pharmacovigilance, which focuses on monitoring the safety of pharmaceutical drugs, cosmetovigilance involves various stakeholders, including regulatory authorities, cosmetic manufacturers, healthcare professionals, and consumers. These stakeholders collaborate to collect and analyse information on adverse events or safety concerns related to cosmetics. This information can be obtained through consumer complaints, healthcare provider reports, literature reviews, and other sources.

Once potential risks or safety issues are identified, cosmetovigilance activities may include product recalls, formulation changes, labelling modifications, or even the removal of a product from the market if necessary. Cosmetovigilance aims to ensure that cosmetic products are safe, effective, and in compliance with regulatory requirements, providing consumers with confidence in the products they use.
Cosmetovigilance plays a crucial role in ensuring the continuous safety of cosmetic products on the market. It helps in identifying potential issues, taking appropriate actions to mitigate risks, and implementing measures to prevent future incidents. By monitoring and addressing adverse effects associated with cosmetics, cosmetovigilance contributes to consumer protection and the overall quality of cosmetic products.

It’s important to note that cosmetovigilance focuses on the safety aspects of cosmetics, whereas the efficacy and performance of cosmetics are typically addressed through other regulatory frameworks and testing methods.

Moreover, cosmetovigilance is mandatory in all countries where cosmetics are regulated around the world, and its organisation with cosmetics manufacturers, importers and/or distributors, is part of any local regulation.
For products that may have different regulatory statuses according to local constraints, cosmetovigilance can transition to pharmacovigilance or materiovigilance. Regardless of the regulatory status, knowing the risks, even if minor, of a product is always essential and mandatory. Implementing cosmetovigilance procedures is part of any quality system regardless of the company size and the number of marketed products. Cosmetovigilance can be outsourced if necessary.