COVID-19 & Article 55

With the aim to address shortages with the supply of disinfectants, which has become a critical issue in several EU Member States, ECHA, together with the European Commission, announced to support Member States and industry.

Currently ECHA advises to apply for permission from the relevant national authority using the public health danger provision of the BPR (Article 55(1)) if your company would like to quickly place products on the EU market using already approved active substances (e.g. propan-1-ol, propan-2-ol). Several Member States, such as AT, BE, DE, DK, EE, FR, LV, MT, PL, ES and SE, recently have already granted permissions to pharmacies or companies that are producing disinfectants. While, at the moment, being handled differently from Member State to Member State, most of the permissions are covering the WHO recommended formulations and are based on alcoholic disinfectants for the Product Types 1, 2 and 4.

Deadlines for certain processes will 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.

For applications that cover several countries, a centralized submission to ECHA is being developed and more information about this will be available in the coming days.