Cosmetovigilance and tattoovigilance
Cosmetovigilance and tattoovigilance are two schemes for collecting reports of undesirable effects caused by the use of cosmetics and tattoo products, respectively.
Cosmetovigilance
The aim of cosmetovigilance is to identify undesirable effects in humans associated with 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 its Article 23, as well as Articles L.5131-5, L.5431-8 and R.5131-6 to R.5131-15 of the French Public Health Code (CSP).
What is meant by cosmetic products?
These products are defined as any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.
What is the cosmetovigilance scheme?
Cosmetovigilance is based on the reporting by healthcare professionals, manufacturers or users of undesirable effects associated with the use of a cosmetic product. ANSES collects, records, assesses and analyses these reports. If necessary, it informs the competent authorities to enable the necessary measures to be taken.
How to report an undesirable effect
If you are a distributor of cosmetic products or the "responsible person" for the product, i.e. manufacturers, representatives or importers working within the European Union, you have an obligation to report any serious undesirable effects in humans occurring under normal or reasonably foreseeable conditions of use of a cosmetic product: an effect leading to hospitalisation, permanent or temporary functional incapacity, disability, congenital anomalies, an immediate vital risk or death.
To report a serious undesirable effect, complete the serious undesirable effect (SUE) reporting form:
- French version Formulaire EIG A (Word): notification d'un EIG à l'autorité compétente par la personne responsable ou le distributeur
- English version: SUE form A (Word): notification of SUE by responsible person or distributor to competent authority
- With the help of the European Commission's SUE reporting guidelines (PDF)
- Reports should be sent by e-mail to cosmetovigilance@anses.fr
You can also report any other undesirable effects of which you are aware, as well as effects likely to result from misuse:
- Complete the form for reporting undesirable effects following the use of a cosmetic product (Word) – in French
- Read the guidance on reporting (PDF) – in French
- Reports should be sent by e-mail to cosmetovigilance@anses.fr
If you are a healthcare professional or a user, hairdresser or beautician, you can also report an undesirable effect associated with a cosmetic product:
- Use the undesirable effect reporting portal: signalement.social-sante.gouv.fr
Tattoovigilance
The goal of tattoovigilance is to monitor the undesirable effects caused by the use of tattoo products. It applies to all tattoo products placed on the market. ANSES records, assesses and analyses information to prevent the occurrence of undesirable effects associated with the use of these products. It implements corrective measures and monitors their application in coordination with the DGCCRF.
How to report an undesirable effect
Tattoo artists, manufacturers and healthcare professionals are obliged to report without delay any serious undesirable effects – i.e. effects leading to hospitalisation, permanent or temporary functional incapacity, disability, congenital anomalies, immediate vital risk or death – and any other undesirable effects of which they are aware, or any undesirable effects that could be caused by misuse.
For serious undesirable effects:
- Complete the form for reporting undesirable effects following application of a tattoo (Word) – in French
- Reports should be sent by e-mail to tatouvigilance@anses.fr
Consumers and healthcare professionals can also report any undesirable effect or misuse, describing the conditions under which the tattoo was applied:
- Use the undesirable effect reporting portal: signalement.social-sante.gouv.fr