COVID-19: Fast track authorisation in the EU for hand sanitisers and surface disinfectants

Following the WHO (World Health Organisation) declaration that the new coronavirus (COVID-19) is a pandemic, the most recommended method to prevent COVID-19 spreading is the frequent handwashing and disinfection. This induced an increasing demand for hand hydroalcoholic gels and disinfectant products that are currently in very limited supply.

In the EU, there is the possibility for fast track authorisations for disinfectants and hand sanitizers:

  •    Transitional period: if your product contains active substances such as ethanol, chlorine, or quaternary ammonium compounds, as these are still not approved under the Biocidal Products Regulation (BPR) then the transitional period will apply. The transitional period will make it possible to immediately market your product after notification in some EU countries, and within a few weeks to a few months in others.
  •    Exceptional authorisation under Art. 55(1) of the BPR: due to the very limited supply and the sanitary emergency, the EU countries can currently allow the placing on the market of disinfectant products under specific conditions according to Art. 55 (1) of the BPR:

‘By way of derogation from Articles 17 and 19, a competent authority may permit, for a period not exceeding 180 days, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means.’ 

ECHA provides some information here: https://echa.europa.eu/covid-19

Our regulatory team at Staphyt can help you choose the best approach for yours products and provide support for a successful exceptional authorisation in EU countries. 

So please do not hesitate to contact us for further information!

Contact:
Sara Monteiro
smonteiro@staphyt.com