Cosmetics Europe Conference 2022
Monday, December 17, 2012Congresses

Cosmetovigilance in Europe and in the World


Do not look for the term "Cosmetovigilance" in the text of the Regulation on cosmetics, which will be fully applicable as of 11 July 2013: it does not exist, as it did not in the Directive that it will replace. However, in its Article 23, the "Communication of serious undesirable effects" is required, detailing the process. This survey system has its equivalents everywhere in the world, which come with specificities that it is better to manage as soon as a product is exported. This was the topic of a conference during the 10th Cosmetic Valley Regulatory Convention, held in Chartres (France) on November 28 and 29.

Reading time
~ 12 minutes

Report of the common paper by Nedjwa Abbadi and Emmanuelle Amsler, Centre de Vigilance IRIS (IRIS Survey Centre), Chartres, 28 November.

Under the Serious Undesirable Effects (SUE) Reporting Guidelines published by the European Commission in August 2012, "Cosmetovigilance is defined by the collection, evaluation and monitoring of spontaneous reports of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product. Together with other tools, cosmetovigilance contributes to post market surveillance. "

This means specific requirements for the manufacturers and for the distributors of cosmetic products, in a process that involves the health professionals, as well as the consumers, obviously, though differently, depending on the countries.

Cosmetovigilance in non-European countries


• Federal Food, Drug and Cosmetic (FD&C) Act
• Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462)
• Guidance for Industry Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application (July 2009)

Health professionals
They are encouraged by the FDA to report the undesirable effects and quality problems, via the MedWatch portal: ( FDA Form 3500 – Voluntary reporting ) or a hotline.

They are encouraged by the FDA to report the undesirable effects and …

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