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Editor-in-chief: Maurizio Roncaccia

Editors: Paul Trouth and Päivi Jokiniemi

Article related to: Biocides

Biocidal Products Committee Working Groups start their journey

The Environmental Working Group of the Biocidal Products Committee was the first of the Working Groups to kick off its meetings at the end of January. There are altogether four permanent and two Ad hoc Working Groups to support the Biocidal Products Committee.

The Working Groups under the Biocidal Products Regulation continue the work of the Technical Meetings that took place under the Biocidal Products Directive. In addition to the permanent Working Groups – Efficacy; Analytical methods and Physico-chemical Properties; Human health; and Environment – there are currently also two Ad hoc Working Groups – Human Exposure and the Assessment of Residue Transfer to Food. A third Ad hoc Working Group for Environmental exposure is being discussed.

The permanent Working Groups support the work of the Biocidal Products Committee by discussing the open scientific and technical issues identified during the peer review of the Competent Authority Report. The Competent Authority Report is drafted by the evaluating competent authority and it is based on the information given in the application dossier.

The discussions in the permanent Working Groups focus on whether the proposed use of the specific active substance or biocidal product is safe for the environment and human health. When requested by the permanent groups, the Ad hoc Working Groups find scientific consensus between the Member States for creating the scientific basis, for example by developing emission scenarios and tools to support human or environmental exposure assessment.

The permanent Groups meet five times a year in Helsinki. These meetings take place before the Biocidal Products Committee meetings so that open issues are solved and the Competent Authority Report can be revised before the Committee forms its opinion. In general, all of the permanent Groups have their meetings during the same week. The work of the Ad hoc Working Groups will be carried out more continuously and therefore no regular physical meetings are scheduled.

Collaboration between the Member States and ECHA

The Working Groups are composed of representatives from the Member States and the EEA and are chaired by ECHA. Each Member State can nominate core members, who will attend all meetings, and/or flexible members, who can choose which meetings to attend.

ECHA provides a chairperson for all permanent and Ad hoc Working Groups. Additionally, a dossier manager, supported by other experts on the case and the active substance in question, represents ECHA in the meetings. The meetings of the Working Groups are open to observers, such as applicants whose dossier is discussed in the meeting and the nominated representatives of ECHA's accredited stakeholder organisations.

ECHA has appointed chairpersons for all the Working Groups. ECHA Newsletter met with the chairpersons of the four permanent Working Groups to find out their expectations for 2014. Heike Schimmelpfennig is the Chairperson of the Environment Working Group; Antero Airaksinen of the Human health Working Group; Bernhard Krebs of the Analytical methods and Physico-chemical Properties Working Group and Ann Thuvander of the Efficacy Working Group.

What are the biggest challenges for 2014?

Heike Schimmelpfennig: I think that the biggest challenge in our work is to cope with the new legal deadlines that are very tight. Earlier the substance could be discussed in several Technical Meetings but now we only have one Working Group meeting before the Biocidal Products Committee meeting, in exceptional cases maybe two. Therefore, we have to make sure that we are very efficient. I also think that it will be challenging and very interesting every time a product-type comes to the Working Group for the first time.

Antero Airaksinen: Stabilising the new processes within the tight legal deadlines requires very good coordination and cooperation between all the players – it is essential that we are all on the same page. We will have a lot to do since the Biocidal Products Committee aims to give 50 opinions during 2014. It means that we have to take the deadlines very seriously to be able to keep them.

Berhard Krebs: I feel that one of my tasks is to make sure that the meetings are conducted in a good spirit and that the cooperation between all parties involved is continuously developed. I see that the Member States are the drivers in the discussion and my job is to make sure that these discussions run smoothly and the tight deadlines are kept.

Ann Thuvander: It is always challenging to set up the procedures for a new Working Group and to make them work in a smooth and efficient way. As part of that, it is important that all members share a common understanding of the tasks that we have and agree on the principles and criteria for the work that should be carried out. We also plan to devote most of the Efficacy Working Group's time on finalising guidance documents in 2014.

What advice would you give to new applicants who are preparing their applications?

Heike Schimmelpfennig: I think the key is to make sure that the application is prepared properly. This means that, if relevant for the application, the uses are clearly described and an appropriate risk assessment is presented and well explained. I would also encourage the applicants to contact the rapporteur in the evaluating competent authority in good time to agree on the outlines.

Antero Airaksinen: My advice for new applicants is to make use of all the available material to get to know the Biocidal Products Regulation and its processes. Therefore, I would encourage any new applicants to familiarise themselves with the regulation and ECHA's website to understand their responsibilities. Some industry stakeholder organisations are also well aware of the new regulation and might be able to support new applicants.

Bernhard Krebs: To be able to meet the tight deadlines, the applicants need to understand the changes that the regulation has brought along, as Antero points out. Compared to the former biocidal products directive, there is also a new submission system (R4BP 3) and the applications must be prepared in IUCLID 5 format. Therefore, any new applicant needs to learn how to use the new tools. We at ECHA are here to support the applicants and they are welcome to send their questions to the ECHA Helpdesk.

Ann Thuvander: I would like to remind applicants to keep themselves up-to-date on the latest guidance and information as there is more material to come. Our aim is to help applicants to prepare high-quality applications. The discussions in the Working Groups will also be more focused when the applications include all the necessary information which in turn will lead to timely and efficient opinion-making in the Biocidal Products Committee.