Alcohol-based hand sanitizers in times of COVID-19: Legal Situation in the EU

As a result of the COVID-19 pandemic, disinfectants and cleansers of various kinds, e.g. washing gels, lotions, soaps and similar products have been introduced to the market throughout Europe in an increasing number. This applies in particular to leave-on hand gels (hand sanitizers) on the basis of ethanol. The demand is expected to increase even further during the “second wave” which will most likely continue through the autumn and upcoming winter.

Cosmetic or biocide?

Hand sanitizers on the basis of ethanol as active ingredient have been marketed as biocidal products by many producers for a long time before the pandemic, in accordance with requirements of the EU Biocide Regulation 528/2012[1].

Since the start of the pandemic in early 2020, many products of this type were notified via the Cosmetic Product Notification Portal (CPNP) and placed on the market as cosmetic products according to the EU Cosmetics Regulation 1223/2009[2].

A matter of definition

The definition of cosmetic products as outlined in Article 2 of the Cosmetics Regulation includes cleaning as cosmetic purpose. The definition of biocidal products on the other side (Article 3 of the Biocide Regulation) outlines that biocidal products imply the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

Thus, even though clear biocidal claims, e.g. “Kills 99.9% of germs”, etc. are avoided for the product label, high amounts of ethanol may be clearly recognized for the purposes of the above-mentioned destroying effects on microorganisms.

What means cleaning your hands in legal terms?

Furthermore, according to the Detergents Regulation 648/2004[3], cleaning means the process by which an undesirable deposit is dislodged from a substrate (…) and brought into a state of solution or dispersion. The intended purpose of leave on hand gels intended does not included dislodging substances (since it is not washed off) and therefore does not fulfil the cleaning function. This drops the products from the scope of the cosmetic definition.

The situation remains unclear

Taking the above into account and considering the general consumer perception for alcohol-based leave-on gels, the classification as a biocide should be the only applicable one within the meaning of the current EU legislation. Hand gels with ethanol concentrations clear above 70% (which is often highlighted on the label), cannot not be considered as cosmetic products per definition.

Most certainly, all products must be still assessed individually considering all applicable characteristics and its presentation. However, the official statements issued by the European Commission, including the currently applicable guideline for borderline products, do not allow any other conclusion[4].

It is nevertheless expected that during the ongoing pandemic, more products will be marketed under the scope of the Cosmetics Regulation. Considering the public high demand and possible supply shortages in European countries, this may be accepted by many national authorities. However, the rules may vary in the Member States and it should be clarified whether and how products may be accepted, in particular considering labelling and marketing claims.

Simplified Biocide routes

Depending on the exact product composition and intended use, different registration procedures for biocides on European and national level may be applicable. During the COVID 19 pandemic, many EU countries simplified their national registration procedures. For example, the nation al competent authority of Germany published a general decision[5]on the authorisation of biocidal products. This decision is pursuant to Article 55 of the Biocide Regulation and has been recently renewed until April 2021[6]. Notwithstanding national rules in terms of registration, the legal requirements according to the European Biocide Regulation will be applicable for all EU countries.

[1] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32012R0528

[2] https://eur-lex.europa.eu/legal-content/de/ALL/?uri=CELEX:32009R1223

[3] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02004R0648-20150601&from=EN

[4] https://ec.europa.eu/growth/sectors/cosmetics/products/borderline-products_en

[5] https://www.reach-clp-biozid-helpdesk.de/EN/Home/Covid19/Covid19_node.html

[6] https://www.baua.de/DE/Angebote/Aktuelles/Meldungen/2020/pdf/Allgemeinverfuegung-Haendedesinfektion-neu.pdf?__blob=publicationFile&v=2 (in German language only)

 

The above article is based on the legal situation in the European Union at the time of its publication and is for information purposes only. It does not replace professional legal advice before you act in accordance with the regulations and guidelines mentioned in this article.



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