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Friday, April 24, 2015Authorities

Brief - Some figures on cosmetovigilance 2014

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In its"Vigilances" bulletin of April 2015, the ANSM (Agence nationale des médicaments et produits de santé) reveals some cosmetovigilance data (based on adverse reaction reports due to cosmetic products) for the year 2014. without however saying too much, nor revealing the French figures…

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After recalling which adverse reactions due to cosmetic products must be reported to the authorities (serious adverse reactions or SAEs, which cause temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies, immediate vital risk or death), the ANSM gives a short assessment of European cosmetovigilance for the year 2014. There he is.

Data for 2014 The European database gathered 266 ISGs, registered mainly in Germany, France and the United Kingdom, which together represent 64% of the declarations. In most cases, the initial registrant is a consumer who informs the manufacturer of the incident, which in turn notifies the Competent Authority. The consumer is 90% a consumer for personal use. The main products concerned are those intended for hair colouring and skin care. The reported effects are mainly contact dermatitis or allergic dermatitis type skin manifestations. The severity criterion that ranks the adverse reaction as a serious adverse reaction is disability in 68% of cases. The imputability estimated by the competent authority is similar to that of the manufacturer in 86% of cases.

To go further - See the Vigilances report n° 65 of April 2015 on the ANSM website.



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