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Challenges of post-market surveillance activities related to cosmetics: Focus on Cosmetovigilance

Post-marketing surveillance is essential to the effective regulation of cosmetic products, and it is considered a key regulatory function. It refers to the set of surveillance activities that monitor the safety, quality, effectiveness, and use of cosmetic products that are on the market.

Nowadays, the scope of safety surveillance is complex because the safety of a cosmetic product, apart from its properties, is also related to how it is actually used in practice and to the integrity of the quality of the product throughout the supply chain.

All the cosmetic products on the European market must be safe according to the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Despite this, it is possible that undesirable effects can be verified when using them, even though they are usually well-tolerated.

Apart from inspections, quality control testing (physical and laboratory checks) that the national health authorities concentrate their major activities, another important component of the post-marketing surveillance activities, is also the communication/reporting of undesirable effects (UE) and serious undesirable effects (SUE) of cosmetic products (as they are defined on the EU Regulation on cosmetic products).

Cosmetovigilance, as a concept of monitoring the safety of cosmetic products, was first used in literature in 1997 by Vigan. Now it is recognized as an important component of public health activities that addresses the safety of these products. It is the set of activities for the collection and management of reports of undesirable effects attributable to the use of a cosmetic product, carried out with the aim of facilitating post-marketing surveillance and ensuring the protection of final users’ health. However, safety can be achieved when problems that are related to these cosmetic products can be identified and then solved.

According to different reports, undesirable effects of cosmetic products are underestimated and in order that the reporting of UEs/SUEs are not low, it is fundamental that cosmetovigilance systems continue to engage final users and practitioners/health professionals to report suspected UEs and SUEs.

Cosmetovigilance can be improved in practice by increasing the awareness of the National competent authorities reporting system among consumers and professionals. Healthcare professionals should take the responsibility to educate the consumer about the reporting options available, as they have a fundamental role to recognize UEs and SUEs induced by cosmetic products. In this way, an increase in reporting will bring awareness to possible safety issues with specific cosmetic products. As a result, it will encourage the National competent authorities to take all the necessary measures, launch investigations and also review the literature on specific ingredients of cosmetic products.

Apart from common challenges for implementing post-marketing surveillance programs in the legal, financing, human resources, management and planning, sampling and testing methodology areas, extra efforts are needed to strengthen the post-marketing surveillance. It is important to highlight the importance of quality of reports and implementation of a structured vigilance system in order to obtain reliable data and that these activities don’t lack appropriate planning and resources.

Cosmetovigilance systems and the national competent authorities that work with them, must empower their efforts to strengthen the communication with their stakeholders, healthcare practitioners and final users. The nature of these interactions will vary between countries and will depend on their local needs, the structure of the healthcare system, more than the scientific and technical and aspects of the cosmetovigilance. These partnerships must provide expertise, as well as capacity to accomplish relevant monitoring of the safety of cosmetic products.

As a conclusion, a global collaboration to advance the practice of cosmetovigilance in countries around the world would be useful in order to:

- Work nationally but also collaborate internationally;

- Monitor and identify the harm caused by cosmetic products;

- Reduce the risks to final users;

- Establish worldwide cosmetovigilance standards and systems.

This can be done by creating a global database similar to the WHO’s database VigiBase that is used to analyse reports of suspected/potential side effects of medicinal products. The benefit of these reports in a global database is that patterns of harm might emerge from the amount of worldwide data which sometimes might not be evident in the national databases.


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Hale Z. Toklu1 , Abigail Antigua2 , Vanessa Lewis3 , Mar’Tina Reynolds3 , Jennifer Jones1,3 1 Department of Clinical Sciences, University of Central Florida College of Medicine, Orlando, 2 Clinical Pharmacy and 3 Family Medicine, North Florida Regional Medical Center, Gainesville, FL, USA

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