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Tuesday, March 14, 2017Authorities

A portal to report adverse effects

© CosmeticOBS-L'Observatoire des Cosmétiques

On March 13, the French Minister of Social Affairs and Health launched a new online portal to declare adverse effects with a negative impact on health. Open to the general public and professionals, it comprises a section dedicated to cosmetic products.

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Provided for by the French health system modernization legislation, the website is designed for both professionals and users to report any adverse event or unusual effect with a negative impact on health to health authorities in a few clicks.
On the website, it is specified that an adverse effect may be triggered by the exposure to a product bought in a pharmacy, off-the-shelf, or online. It may be a product (drugs, foodstuffs, cleaning or DIY products… and of course, cosmetics), or a substance found in the natural environment. The adverse effect may result from its handling, consumption, or conditions of use.

More specifically, the products concerned are:
• Drugs
• Medical devices
• Convenience or environmental goods
• Food supplements
• Tattoo products
• Cosmetic products
• Blood products
• Products or substances with a psychoactive effect
• Care procedures (including related infections)
Every product type has a specific dedicated space.

The Cosmetics section

As a preamble, it is reminded in this space that ‘cosmetics monitoring (cosmetovigilance) helps identify effects which were not observed during the safety studies conducted by the manufacturers before they marketed their products. By declaring the adverse effects related to their use, you contribute to improving the safety of all users and to implementing adapted preventive or corrective measures: modification of the product composition, precautions for use.’

The products concerned may be creams, makeup products, sunscreen products, toothpaste, toilet soap, deodorants, bath salts, perfumes, or nail varnish…

Everyone can notify any abnormal reaction, serious or not, which has an impact on health: allergy, intoxication, inflammation, abnormal body reaction… whether the problem appears after using a cosmetic product under normal conditions or following its use without complying with the instructions: mistake while making the mixture, wrong quantity delivered, product left on the skin too long…
However, the portal is not designed to report a product’s inefficacy, since it does not fall under the scope of the communication of adverse effects. In this case, it is recommended to directly inform the manufacturer.

It is also reiterated that health professionals, cosmetics industries, and distributors must immediately declare the serious adverse effects that occurred or are likely to occur under the normal conditions of use of a cosmetic product. In addition, they may report any other adverse effect they know about, as well as the effects likely to result from the improper use of the product at stake.

Ten minutes are enough to fill in the declaration form, and it is guaranteed that all the information provided will be processed, respecting confidentiality of personal data, medical and professional secrecy.

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