ECHA's biocides committee agrees its rules

ECHA's Biocidal Products Committee (BPC) reached agreement on its rules of procedure at its meeting last week. The rules are expected to be adopted by the agency's Management Board later this month and then they will be published. The BPC also made progress on its working procedures. The first one, on applications for approval of active substances, is expected to be agreed at the Committee's October meeting.

Following on from discussions at its first meeting, the Committee will have four permanent working groups. These will cover: human health; environment; efficacy; physical chemical properties and analytical methods.

It will also have two ad hoc groups covering: dietary risk assessment and human exposure assessment.

The permanent working groups will meet five times a year, like the BPC, as they will do the groundwork for the main committee.

The BPC disagreed with ECHA’s proposal to prevent applicants from attending its meetings where their applications are discussed. Under the agency's proposal applicants will only be permitted to attend preparatory working group meetings. Applicants will have to adhere to a code of conduct, which will oblige them to introduce critical information well in advance of the Committee meeting. “Applicants are there to clarify minor points,” BPC chairman Erik Van de Plassche says. He adds that ECHA is concerned about the efficiency of the process if applicants submit key information at the single meeting that the BPC will hold on any application. He said the agency was reassured by the code.

However, ECHA remains concerned about the administrative burden of organising applicants’ attendance at BPC meetings, especially when a large consortium is involved and plans to limit attendance to one or two representatives through the code of conduct. Relevant stakeholders will be invited to meetings according to their area of interest.

The BPC further agreed stakeholders, including animal welfare or other non-governmental organisations, will also be able to attend discussions on biocide applications, provided the applicant has not proved the need for business confidentiality. “This is in line with the way we work under other processes in the agency,” Mr Van de Plassche says.

There was also some discussion at the meeting on a disagreement between the European Commission and EU member states on a Commission proposal which could result in evaluations of certain biocidal active substances being put on hold for several years. This plan was discussed during the Biocides Competent Authorities meeting on 16 May and at last week’s Biocidal Products Committee meeting.

The Commission wants active substances to undergo an assessment of their persistent, bioaccumulative and toxic (PBT) properties, where relevant, and a harmonised classification and labelling process to take place before the evaluation under the biocidal products Regulation is submitted to ECHA by a member state Competent Authority. These processes can take up to two years in the Risk Assessment Committee and/or the PBT Expert Group. The proposed working procedure will be a key item on the agenda of next month’s Competent Authorities meeting under the BPR, where the Commission is aiming for agreement on the establishment of a work programme to meet the 2024 deadline for the Review Programme.

Mr Van de Plassche stated that member states are concerned that national biocides officials will start the work on an active substance, then the CLH people would have to take over and the biocides work will be halted. Biocides officials would then lose time getting back up to speed, member states argue. They are pushing to do the biocides work in parallel with the CLH and PBT Expert Group assessments.

Since a CMR category 1a or 1b or a PBT classification means the exclusion criteria are met for an active substance, this needs to be addressed first before the dossier arrives at the BPC, Mr Van de Plassche underlined. “So for us this is an efficient way to structure the future workload of the Committee,” he said.