Cosmetovigilance: definition, regulation and use "in practice"

Area of Science:

• Pharmacovigilance
• Cosmetic Science
• Public Health Surveillance

Background:

• Cosmetovigilance is an emerging field focused on monitoring cosmetic product safety.
• Existing systems include industrial surveillance (commercial focus) and peer surveillance (medical focus).
• European regulations (2006 resolution, 2013 regulation) established a framework for cosmetovigilance based on case notifications and data sharing.

Purpose of the Study:

• To define cosmetovigilance as a distinct form of public health surveillance for cosmetic products.
• To highlight the role of cosmetovigilance in ensuring cosmetic product safety and regulatory compliance.
• To identify ongoing challenges in causality assessment and reporting categories within cosmetovigilance systems.

Main Methods:

• Analysis of the concept and evolution of cosmetovigilance.
• Review of European regulations governing cosmetic product safety surveillance.
• Examination of the notification and data transmission processes for undesirable effects.

Main Results:

• Cosmetovigilance serves a public health objective, differentiating it from commercial or medical surveillance.
• European regulations mandate reporting of serious undesirable effects to competent authorities and stakeholders.
• Key challenges remain in establishing causality and standardizing reporting categories.

Conclusions:

• Cosmetovigilance systems provide crucial data for assessing the safety of cosmetic products and ingredients.
• These systems are vital for verifying the effectiveness of European directives in ensuring high safety standards.
• Cosmetovigilance enables the identification and control of potentially hazardous ingredients, enhancing consumer confidence in marketed products.