On 24 March 2020, the European Chemicals Agency (ECHA) expressed its support for the EU / EEA authorities to apply exceptions to the normal authorization requirement for biocidal products in order to increase the manufacture and supply of disinfectants in the European market. ECHA believes that it is essential that health professionals and European citizens have access to more disinfectants. For this reason, the European Commission has prepared a document on measures that national authorities could use (or have already used) to allow the sale of disinfectant products and help reduce the spread of the new coronavirus. Additionally, the Agency will also extend some of its deadlines to help chemicals companies.
ECHA, in conjunction with the European Commission, will help Member States and industry to tackle the shortage of disinfectants. The Agency will also extend some of its deadlines to help chemical companies.
Several EU / EEA countries have already granted such permits to companies that have the capacity to manufacture disinfectants. A centralized submission to ECHA is being developed for applications targeting multiple countries. ECHA will provide more information on this in the coming days.
Companies seeking to quickly access the market with their disinfectants that contain an already approved active substance, can request permission from the relevant national authority relying on Article 55 (1) of the Biocide Regulation (BPR, Regulation (EU) 528/2012). This provision allows national authorities to grant limited-time exceptions to standard product authorization requirements in situations where there is a threat to public health.
In addition, to facilitate the work of the authorities and for companies seeking information, ECHA makes three lists available with information on:
- biocidal active substances approved or revised for use in disinfectant products;
- disinfectant products that are authorized under the Biocide Regulation (BPR);
- disinfectant products authorized under national regimes in Spain, the Netherlands and Switzerland.
Extension of deadlines
A 30-day extension will apply to companies to comment on ECHA’s draft decisions in cases where a registry has been deemed to be non-compliant.
Timelines for certain processes will also be handled flexibly, including bill payment. For certain terms that fall between now and the end of May 2020, companies will receive a two-month extension. This applies to cases where companies did not initially provide a full record of their chemicals and were granted a final deadline between March and May 2020, as well as requests for additional information related to confidentiality statements.
More information on these agreements will be published soon on the ECHA official website.
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