ECHA makes exceptions for authorisation of biocidal products

The European Chemicals Agency has agreed to work with EU/EEA authorities to increase the manufacture and supply of disinfectants, targeting isopropanol, 1-propanol and ethanol

ECHA's office building. Source: European Chemicals Agency 2020

ECHA is taking measures to support EU action to fight the pandemic caused by the coronavirus disease (COVID-19).

The Agency, together with the European Commission, will support Member States and industry to address shortages with the supply of disinfectants, which has become a critical issue in several EU Member States.

Bjorn Hansen, ECHA’s Executive Director said: “It is essential to ensure that there are enough disinfectants available for health professionals and European citizens. The main limiting factor seems to be the availability of active substances used in these biocidal products – in particular isopropanol, 1-propanol and ethanol.”

Explaining what was being done, Hansen said: “We are working, together with the Commission, on special arrangements to help Member States and companies get more disinfectants on the market as soon as possible.” More details about concrete actions will follow soon.

The main limiting factor seems to be the availability of active substances – in particular isopropanol, 1-propanol and ethanol

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. For applications that target several countries, a centralised submission to ECHA is being developed. More information about that will follow in the coming days.

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)
  • 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.

Deadlines

Deadlines for certain processes will also be handled flexibly, including the payment of invoices. For certain deadlines that fall between now and the end of May 2020, companies will receive an extension of two months. This applies to cases where companies have initially failed to provide a complete registration for their chemicals and were granted a final deadline between March and May 2020, as well as for requests for further information related to confidentiality claims.

An extension of 30 days will also apply for companies to comment on ECHA’s draft decisions in cases where a registration has been considered incompliant with legal requirements.

More information on these arrangements will be published soon and duty holders will also be informed directly through ECHA’s IT systems.