Companies can now apply to include active substances in Annex I of the BPR
ECHA has implemented the new EU procedure to amend the list of active substances.
Helsinki, 21 February 2014 – Following the publication of the Commission Implementing Regulation (EU) No 88/2014, ECHA has developed a new procedure using the register for biocidal products (R4BP 3), which allows industry to submit requests to amend the current list of active substances in Annex I of the Biocidal Products Regulation (BPR).
The regulation defines the data requirements for applications for inclusion in Annex I dossiers and establishes the relevant evaluation procedure. Applicants need to conclusively demonstrate that the substance falls into the description of the relevant category for which the authorisation is sought and that there is a robust consensus of expert opinion that the substance does not give rise to concern.
In some cases, it is necessary to submit a data package allowing a full risk assessment of the substance. The evaluation of applications is made by the evaluating competent authority (eCA) which prepares the draft assessment report and the conclusions of its evaluation. ECHA's Biocidal Products Committee adopts and submits it's opinion to the EU Commission based on the conclusions of the eCA. The Commission takes the final decision on the amendment of Annex I.
Companies that want to make available on the EU market biocidal products containing exclusively active substances listed in Annex I of the BPR will benefit from a simplified authorisation procedure.
The Agency provides information and support on the new process established by the Implementing Regulation (EU) 88/2014 on its website and through the ECHA Helpdesk.