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Wednesday, March 25, 2020France

Update on the placing on the market of hydro-alcoholic products (updated)

Point sur la mise sur le marché des produits hydro-alcooliques

In July 2018, Corinne Benoliel and Pauline Ferreira-Théret, from Institut Scientis, had already presented the Regulations on hydroalcoholic products intended for the skin. The fight against the spread of the coronavirus Covid-19 is now leading them to go further, in order to clarify the current specific measures and general rules.

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Article updated on March 31, 2020, after publication of the French Decrre of March 27, 2020

European regulations

As a reminder, hydro-alcoholic products (HAP) intended for hand antisepsis must comply with the regulation on biocidal products (Regulation No.528/2012). They belong to product type 1 (TP1) which refers to “biocidal products used for human hygiene with the main purpose of disinfecting the skin or scalp”.

The active substance is the ingredient used to obtain the expected biocidal efficacy, in this case antimicrobial. Ethanol (CAS number 64-17-5) is the clear majority on the TP1 product market and is currently under review.
This step consists of evaluating all active substances supported by the industry on the basis of the data provided, in order to conclude whether or not their safety and efficacy are guaranteed.
It should be noted that other active substances may be used, already approved (such as isopropanol, CAS number 67-63-0) or still under evaluation by the competent authorities.

If the active substance of interest is approved, the biocidal product containing it must be the subject of an application dossier for marketing authorisation (MA) with the competent authorities in order to remain on the market. This is in turn evaluated to …

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