Speeding up the supply of disinfectants
Corrigendum 3 April 2020: Following recent discussions with the Commission and the national authorities, it has been decided that the centralised submission to ECHA for applications covering several countries will not be developed.
To increase the manufacture and supply of disinfectants on the European market, ECHA is supporting EU/EEA authorities to apply derogations from the normal authorisation requirement for biocidal products.
Helsinki, 24 March 2020 – As the COVID-19 pandemic grows, it is essential for healthcare professionals and European citizens to have access to more disinfectants. To improve this access, there is a need to increase the manufacture and supply of these products.
Companies looking to quickly access the market with their disinfectants that contain an already approved active substance, can apply for permission to the relevant national authority by relying on Article 55(1) of the Biocidal Products Regulation (BPR). This provision allows national authorities to give time-limited derogations from the standard product authorisation requirements in situations where there is a threat to public health.
Several EU/EEA countries have already granted such permissions to companies that have the capacity to manufacture disinfectants.
ECHA is also recommending certain compositional requirements for the two approved active substances, propan-1-ol and propan-2-ol, for their use in disinfectants. These recommendations will enable national authorities to swiftly check the quality of the incoming applications before deciding on a derogation.
Furthermore, to ease the work of authorities and for companies looking for information, ECHA is making three lists available with information on:
- biocidal active substances approved or being reviewed for their use in disinfectant products;
- disinfectant products that are authorised under the Biocidal Products Regulation (BPR); and
- disinfectant products authorised under national regimes in Spain, the Netherlands and Switzerland.
The European Commission has also prepared a document about the measures that national authorities could use (or have already used) to permit the sale of disinfectant products and help to reduce the spread of the novel coronavirus.
A new dedicated web page on COVID-19 collects information on the Agency’s supportive actions during the pandemic. It will be updated as new arrangements are agreed.