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Cosmetovigilance

Cosmetovigilance aims to identify adverse effects in humans related to the use of cosmetics. Cosmetovigilance is governed by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Cosmetics Regulation), in particular Article 23 and Articles L.5131-5, L.5431-8 and R.5131-6 to R.5131-15 of the French Public Health Code (CSP).

1. Definitions

Cosmetovigilance is exercised on all cosmetic products after they have been placed on the market. It includes:

• The declaration of all adverse effects and the collection of information concerning them

• The recording, evaluation and use of information relating to these effects for the purpose of prevention

• The carrying out of all studies and all work concerning the safety of use of cosmetic products / food supplements

• The implementation and monitoring of corrective actions, if necessary. Adverse effect: An adverse effect is a harmful and unintended reaction occurring under normal conditions of use in humans, or during misuse of a cosmetic product. Misuse: Misuse refers to use that is not in accordance with the product's intended purpose, its usual use, its instructions for use, or any special precautions for use. Serious adverse effect: A serious adverse effect is defined as a reaction resulting in permanent or temporary functional incapacity, disability, hospitalization, immediate life-threatening consequences, death, or a congenital anomaly or malformation (Article L. 5131-9 of the French Public Health Code).

2. Responibilities:

a. Healthcare professionals (doctors, pharmacists, dentists, nurses, etc.) are obligated to report serious adverse effects without delay to the Director General of the ANSM. They are also required to report any adverse effect which, although not meeting the definition of a serious adverse effect, appears to be serious enough to warrant such a report.

b. The ANSM. Manufacturers and Distributors: Manufacturers are required to report to the Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) any effect contrary to the safety requirements of a cosmetic product (Article L. 221-1-3 of the French Consumer Code). In practice, they must list the adverse effects for each cosmetic product and make this information available to the ANSM (French National Agency for Medicines and Health Products Safety). Under certain conditions, they may also be required, in case of serious doubt about the safety of one or more substances, to provide the Director General of the ANSM, upon reasoned request, with a list of their cosmetic products containing the substance(s) in question (Article L. 5131-10 of the French Public Health Code). According to Article 23 of Regulation (EC) No 1223/2009, responsible persons and distributors of cosmetic products must also report without delay any serious adverse effects following the use of a product. cosmetic.

3. What to report to the authorities?

Serious adverse effects that occur under normal conditions of use of a product in humans or that result from misuse. That is to say, those that:

• Either would justify hospitalization,

• Or would lead to temporary or permanent functional incapacity, disability, an immediate threat to life, death or a congenital anomaly or malformation,

• Or which do not fall under these aforementioned situations but appear to be of a serious nature.

4. Who reports?

• Any healthcare professional who has observed an adverse effect.

• Any person wishing to make a report. How to report? By completing the adverse effect reporting form following the use of a cosmetic product on the ANSES website (https://www.anses.fr/fr/content/cosmetovigilance-et-tatouvigilance) or here. The reporting form allows for the standardized and rapid collection of adverse effects occurring after the use of cosmetic products. It gathers the information necessary for an initial assessment. The first part can be completed by any person wishing to make a report. It must include at least the following information: a notifier, a consumer, the product name, and a description of the adverse effect. The second part is reserved for healthcare professionals. It allows for further details regarding the adverse effect, the patient, and any allergy investigations. Send as soon as possible to ANSES:

• Email: cosmetovigilance@anses.fr

• Mail: ANSES, Directorate of Health Alerts and Vigilance, 14 rue Pierre et Marie Curie, 94701 Maisons Alfort Cedex

Adverse events (AEs) are serious by definition, or deemed serious by the practitioner.