Many companies, going from the traditional players to breweries and distilleries, have seen an opportunity in making hand disinfectants,available on the market, and converting their production capacity to address EU’s shortage in hand disinfectants. The European Commission reports to have seen a steep increase in the submission of Cosmetic Product Notifications under the Cosmetics Regulation, but is this the correct legal framework for hand disinfectants?
In fact, depending on the claims made, composition and purpose of use, the Biocidal Product Regulation (BPR) might apply. As clear guidance is needed on the applicable legislation, a few rules of thumb are addressed in this story.
In case your hand disinfectant contains active substance(s) still under examination in the « Review Programme », such as ethanol, your hand disinfectant would have to be placed on the market subject to the national rules. Some Member States, in response to the COVID-19 crisis, have introduced derogations to the national rules to ease access to market.
Be aware however that all active substances still under examination will at some point in time become approved and hence will follow this BPR route, explained in more detail below.
For hand disinfectants containing an active substance which has been examined and approved, for example isopropanol, requires an authorisation under the BPR regulation before being placed on the market. Unfortunately, costs for the preparation of a BPR authorisation are significantly higher as compared to national registrations/notifications/authorisations, and require more time (> 1 year) prior approval. Authorisation is granted for maximally 10 years.
Luckily, as for the active substances still under examination, some Member States can grant you an ’emergency permit’ if they consider it necessary to allow your product on the market in response to the current crisis.
You can check the status of your active substance here.
Apeiron-Team can help you strategically in choosing the markets in scope, in preparing registrations/notifications/authorisations according to the national rules or prepare a BPR authorisation, and guide you through the derogations introduced per country.
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