Echa has retracted its plans to introduce a centralised submission system for applications to authorise disinfectants across several EU member states, using the exemptions they have issued in light of the coronavirus Covid-19 pandemic.
The agency said it made this decision after talking to the European Commission and national authorities for biocides.
"In view of the fact that the national authorities have taken different approaches regarding the derogations ... it was considered more effective that companies address directly the contacts in the member states," Echa told Chemical Watch.
Many EU member states and the UK are using Article 55 of the biocidal products Regulation (BPR), which allows them to put aside the standard authorisation requirements for some products in a situation of public health emergency. But each country is applying the derogation differently.
Echa has published a list of contacts at the competent authorities for biocides in each country that are responsible for applying the biocidal products Regulation (BPR) during the pandemic.
Companies can use the email addresses and phone numbers to enquire about placing disinfectants on the market and how to make use of the derogations that the individual member states are implementing.
Agency help
Instead of working on a derogation submission system, Echa will help companies with guidance on the regulatory process for disinfectant products, and on the effectiveness of different biocidal active substances against the virus, it said.
Plans are in motion for official agency recommendations on the compositional requirements of chemicals, effective against enveloped viruses like coronavirus Covid-19, other than the propanols that are covered under most of the member state derogations. The agency has already issued such recommendations for propan-1-ol and propan-2-ol.
In the meantime, Echa is speeding up technical equivalence assessments (see box) for propan-1-ol and propan-2-ol and applications from disinfectant manufacturers for inclusion in the Article 95 list of approved substance suppliers.
Echa’s helpdesk is also available to assist companies looking to place disinfectants on the market. It has managed 185 coronavirus-related questions from companies so far, the agency said.
Background to the BPR
Article 55 derogations
Article 55 of the BPR allows member states to put aside the standard BPR authorisation requirements in public health emergency situations. A national competent authority notifies the derogation they have applied in their territory to the European Commission. These derogations are temporary and last for a maximum of 180 days, but may be extended, on request, for a further 550 days by the Commission.
As it stands, several EU member states and the UK have made use of this mechanism to make more disinfectants available to fight Covid-19. Some derogations permit the production and marketing of disinfectants following generic WHO formulations while others specifically identify certain products.
Article 95 list
The Article 95 list is a register of companies that have been approved as suppliers of specific biocidal active substances, for use in specific product-types. Article 95 of the BPR states that a biocidal product "shall not be made available on the market" if the product or active supplier isn't included in the list.
Some member states, such as Sweden and Denmark, have temporarily excluded the suppliers of certain disinfectant ingredients from this requirement.
Technical equivalence
This is the process of assessing the similarity, with regard to chemical composition and hazard profile, of two biocidal substances that have been produced by different sources.
Echa has to carry out such an assessment if a company changes the source of a substance that it uses in a biocidal product.
Normally, getting an alternative source recognised as technically equivalent can be a lengthy process and Echa's decisions on this are subject to Board of Appeal review.
Get in touch
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