The European Chemicals Agency has highlighted how European companies can bypass the normal authorization requirement for biocidal products in order to speed up the manufacture and supply of disinfectants.
As the agency reported, with the COVID-19 pandemic growing, it is essential for health care 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.
Apply for Permission Under Article 55(1)
To quickly access the market with disinfectants that contain already-approved actives, companies can apply for permission to the relevant national authority based on Article 55(1) of the Biocidal Products Regulation (BPR). This provision allows national authorities to give time-limited derogations from the standard product authorization 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. For applications that target several countries, a centralized submission to ECHA is being developed. More information about this will follow.
Recommended Compositions, Approved Ingredients
The ECHA is also recommending compositional requirements for the two approved active substances in disinfectants:
These recommendations will enable national authorities to swiftly check the quality of the incoming applications before deciding on a derogation. In addition, to ease the work of authorities and companies, the ECHA is creating three lists with information on:
- Biocidal active substances approved or being reviewed for their use in disinfectant products;
- Disinfectant products that are authorized under the Biocidal Products Regulation (BPR); and
- Disinfectant products authorized 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.
For more information, visit the ECHA COVID-19 web page.