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Parliamentary question - P-005729/2021(ASW)Parliamentary question
P-005729/2021(ASW)
European Parliament

Answer given by Mr Breton on behalf of the European Commission

18.2.2022

Written question

In the context of the COVID-19 pandemic, the Commission services have published detailed Guidance[1] to clarify the applicable EU legislation for alcohol-based solutions, gels, hand-cleaners, hand-disinfectants, namely Regulation (EC) No 1223/2009 on cosmetic products[2] and Regulation (EU) No 528/2012 on biocidal products[3].

In general, products containing an active substance and supplied with a primary biocidal purpose would in principle fall under the biocides legislation.

However, a personal health product, such as the ones to which the Honourable Member refers, presenting itself as ‘antiseptic’ or ‘antibacterial’ may, depending on the specific product, be a biocidal product, a cosmetic product, a medicinal product[4] or a medical device[5].

The decision on the classification of a specific product is to be taken on a case-by-case basis, taking into account all characteristics of the product, such as its presentation, ingredients, claims, and mode of action.

The Commission services have published general guidance on the demarcation of those products[6]. O nce classified, products should follow the requirements set out in the relevant EU legislation.

Manufacturers and other businesses may take contact with the appropriate national competent authorities in their Member State for further information and guidance, including on the classification of a product, where relevant.

In particular, they can consult the European Chemical Agency (ECHA) website[7] and/or the national authorities listed on the Commission’s website and being competent, for example, for cosmetics[8], medical devices[9], medicinal products[10] or biocidal products[11].

Last updated: 18 February 2022
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