Safety in cosmetic products is a priority in the industry, and cosmetovigilance has emerged as a key mechanism to ensure it. This system, implemented in both the European Union (EU) and the United Kingdom (UK), ensures the detection, assessment and prevention of risks associated with the use of cosmetics. In this article, we will explore the crucial role of cosmetovigilance and its impact in both regions.
Table of contents
What is cosmetovigilance?
Cosmetovigilance is a system that monitors and evaluates undesirable effects associated with the normal use of cosmetic products. Its aim is to detect potential risks, establish corrective measures and ensure consumer safety. This ranges from the initial evaluation of the product to the monitoring of possible incidents after it has been placed on the market.
Regulatory framework in the European Union
In the European Union , cosmetovigilance is regulated by Regulation (EC) No 1223/2009 , a comprehensive regulation that sets strict standards to ensure the safety of cosmetic products.
Key points of the regulation
Responsible Person (RP): Each cosmetic product must have a responsible person or entity within the EU to ensure its compliance with the regulations.
Safety Assessment: Before being placed on the market, all products must undergo a comprehensive safety assessment documented in a Product Information File (PIF).
Reporting of serious adverse events: Article 23 requires companies to report any serious adverse events to the competent authorities, together with all relevant information.
The notification procedure
The cosmetovigilance system in the EU is based on:
Data collection: Detailed information on adverse events, including the nature of the incident and the history of the product.
Causality assessment: Determination of the relationship between the observed effect and the cosmetic product.
Corrective actions: Product reformulation, labeling changes or even withdrawal from the market.
Cosmetovigilance in the UK
Following Brexit, the UK adopted its own legislation for cosmetic products, although it is largely based on the European regulation. The UK Cosmetics Regulation sets the standards to ensure the safety of products in this territory.
Key differences with the EU
Registration with SCPN: All products must be notified to the UK Submit Cosmetic Product Notification (SCPN) before being placed on the market.
Responsible Person in the UK: Companies must appoint a Responsible Person within the UK to ensure the compliance of their products.
Specific labelling: Labelling must include the PR's UK address and, if applicable, the country of origin of the product.
Incident reporting
Serious adverse events should be reported to the Office for Product Safety and Standards (OPSS), which assesses the situation and recommends action as necessary.
Importance of cosmetovigilance
Benefits for the industry
Proactive risk management: Companies can identify problems before they become major crises.
Regulatory Compliance: Compliance with regulations avoids legal penalties and protects brand reputation.
Advantages for consumers
Increased confidence: Consumers are confident that products meet high safety standards.
Effective protection: Continuous monitoring reduces the risk of exposure to unsafe products.
Challenges and future prospects
The future of cosmetovigilance is linked to technological progress and the globalization of trade. The main challenges include:
International Data Management: As businesses operate in global markets, they must comply with multiple regulatory frameworks.
Products in e-commerce: Ensuring the security of products sold online requires more sophisticated monitoring systems.
Conclusion
Cosmetovigilance is essential to ensure the safety of cosmetic products in the European Union and the United Kingdom. This system protects both consumers and the industry, ensuring that products meet the strictest standards. In a constantly evolving environment , companies must be prepared to adapt to new regulations and take advantage of emerging technologies to strengthen their surveillance systems.
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