2The Drivers for the Proposed Approach

CA-Dec12-Doc.5.1.k

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Biocides Competent Authorities Meeting
(12-14December 2012)
Proposal for establishing the Coordination Group
Draft: 27 November 2012 / Classification: RESTRICTED

1Introduction

The Coordination Group (CG)is expected to play a contributing role to the overall efficiency of the regulation of biocides. The Biocidal Products Regulation[1] (BPR) formally provides for the establishment of the CG. This follows the operation of the informal body, the Product Authorisation and Mutual Recognition Facilitation Group (PAMRFG)or the ‘PA Group’, under the former BPD[2] legislation.

The scope of the CG as set out in the BPR is much more limited than that of the PA Group as it currently operates. The CG has the specific remit to resolve disagreements within 60 days between national authorities in relation to the mutual recognition of national authorisations for biocidal products. If the CG cannot broker a resolution, the dispute may escalate to the Commission which then in turn may ask the Biocidal Products Committee (BPC) for an opinion on a scientific or technical issue in relation to the case.

The PA Group has been operating for five years. In contrast to the CG, the PA Group has evolved to deal, not only with disagreements in mutual recognition, but also with wider issues e.g. procedural, IT (development of R4BP), regulatory and more general scientific and technical questions in relation to product authorisation. In addition, the secretariat of the PA Group has been able to ‘look upstream’ to identify at an early stage, disagreements as they arise and reportedly has been able to broker a resolution before the need to consider the disagreements formally within the context of the PA Group.

The BPR does not specify how the CG will function. Instead the BPR divides the responsibility in broad terms: ECHA is required to provide the Secretariat, whilst the Member States are to use ‘best endeavours to reach an agreement on the action to be taken[3]’. This paper therefore proposes a strategy to establish the CG which is intended take as a starting point the wishes of the Member States who will be key players in the functioning of the CG.

2The drivers for the proposed approach

The BPR will apply from 1 September 2013. It is therefore the intention to have the CG operational by this date.

In the absence of detailed legal provisions on how to organise the work of the CG, a number of different approaches are possible. The choice of approaches will depend very much upon the expected ambition level of the body, the type of cases it will deal with and the numbers of cases. On each of these aspects there is a significant information gap.

The ambition level of the CG will, at least in part, be determined by the commitment and resources of the participants. it should be noted that in the financial fiche for the purposes of the CG a specific budget for meetings has not been allocated to ECHA and foreseen human resource allocations are limited. In addition there are currently uncertainties over the available resources for biocides at ECHA in the first years of operation and as a result, other activities are considered to have higher priority than the support to the CG.

The BPR allocates responsibility for resolving disagreements with the Member States and ECHA provides the secretariat. In the light of the current resource constraints it is proposed that at the outset the CG will restrict itself to legal requirements as set out in the BPR. The CG will therefore only tackle formal disagreements that arrive at the Group. In addition, it is proposed to ensure that the scope of the CG does not overlap with other biocide bodies such as the Biocidal Products Committee and its working groups. In parallel to this approach, we would like to explore with the Member States the extent to which they can resolve developing disagreements upstream of the CG.

The Commission has estimated that it expects relatively low numbers of cases going through the CG, in a manner similar to the PA Group which has dealt with less than 10formal disagreements in mutual recognition (notifications in accordance with Article 4(4) of the Biocidal Products Directive) in the last two years. Nevertheless, the number of cases that may arise in the future is uncertain and cannot necessarily be deducted from the past figures. A larger number of cases combined with the short legal deadlines for resolving them would necessitate a considerably different approach to be taken by the CG, perhaps similar to that proposed for the Biocidal Products Committee.

With such uncertainty about the demands to be placed upon the CG and with the current resource constraints, a detailed proposal from ECHA for the function of the CG is considered to be premature. Instead it is therefore proposed that the functioning of the CG is jointly prepared by MemberStates and ECHA.

The approach and timing of the establishment of the CG would need to be commensurate with the level of involvement that can realistically be achieved with the foreseen resources from ECHA and those of the Member States. To construct the CG, a consultation process is set out below in which we would seek to gather from the Member States the missing information highlighted above and then construct the CG according to available resources.

3Support of ECHA

In the light of the resource constraints described above, ECHA will assist the Member States to construct and ensure the CG becomes operational by the application date. Once the CG is up and running ECHA will provide the Secretariat functions (i.e. preparing agendas, minutes and coordinating documents for the meetings).

In addition ECHA foresees a hand-over of the relevant issues from the current PAGroup to the CG. This will entail not only unresolved agenda items of the PA Group but also on how to prepare for the future meetings of the CG. ECHA proposes to closely work with the Commission and the Chair of the PA Group from the beginning of 2013. A dedicated staff member will be identified for these purposes within ECHA.

4Proposed approach

It is proposed to construct a model for the CG in a stepwise process which will allow both the MemberStates and ECHA the opportunity to carefully consider the resources that can be invested in the CG when it becomes operational.

The main objectivesof this approach will be to determine the:

• Anticipated content and numbers of cases annually;
• Possible approaches for early identification of disagreements (i.e. pre-CG);
• Possible approach to resolving disagreements at the CG;
• Desired profile and level of involvement of participants;

One element that we would invite the CAs to carefully consider is the approach to chairing the CG meetings. The current PA Group has a rotating Chair of the members of the Group based upon the current EU Presidency. This system has been reported to have run into difficulties because of a lack of continuity. There have been no legal or resource provisions made for ECHA to Chair the CG. In this background, it is proposed that the Chair of the CG originates in the membership of the Group but is fixed for a three year term and elected by the members of the CG. Vice-Chair(s) may also be considered.

In order to work with the Member States to establish a model for the CG it is proposed that the time available before the application date is used both at BiocideCA meetings, and if necessary, between meetings in a written commenting round. Before the application date three CA meetings are scheduled. The model will be developed in the first half of 2013 and then implemented in the second half.Within this framework ECHA will assist the Member States to decide their preferred approach by offering possibilities for the structure and functioning of the CG that are commensurate with the available resources.

Taking into account the lead time from invitations going out to invite Member States to appoint members of a Committee and having them in place, and then subsequently the time for invitations to a specific meeting, plus the summer break, the likelihood is that a first meeting of the CG would take place in September or early October 2013.This first meeting could be a combined preparatory meeting (to agree rules of procedure etc.) and operational meeting to process the first cases if necessary.

As a first step, ECHA has developed a brief questionnaire (see annex) which we would invite Member States to complete and return to ECHA by Friday 11 January 2013 to the following email address:

.

ECHA, together with one or several Member States, will then develop a first paper setting out proposals for prevention and resolution of disagreements for the next CA meeting, scheduled for end February. If necessary, the paper can be revised in the light of the discussion at the CA meeting and subsequent comments.

5Planning

The proposed milestones are set out in the table below.

Milestone / Timing
Collect feedback from Member States / Dec 2012 – Jan 2013
Draw up proposals for prevention and resolution of disagreements / Feb 2013
Present proposals to Biocides CA meeting. / 27 Feb – 1 March 2013
Revise proposals if necessary / Mar – Apr 2013
Revised paper presented to Biocides CA meeting, if necessary. / 16-18 May 2013
Invitations to Member States to appoint members of CG / end May 2013
Members of CG in place by / end July 2013
Invitations for first meeting CG / Aug 2013
First meeting CG (preparatory and operational meeting) / Sep-Oct 2013
Second meeting CG (optional) / Nov-Dec 2013

6Action required

The Biocides CA meeting is invited to agree to the proposed approach.

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Annex - questions on the Coordination Group

AIssues related to Article 35 of the BPR

1. What are the main issues on which disagreements as defined under Article 35 have occurred under the BPD? For example in relation to the product:

- Interpretation of risk assessments;

- Interpretation of exposure assessments;

- Further testing needs;

- Risk management measures;

- Labelling inconsistencies.

1. What differed between the cases where the disagreement was solved before the PA Group was formally involved and those where the PA Group had to be formally consulted?

1. What were the critical elements that contributed to solving the disagreement, for example:

-Identification of a misunderstanding;

-Providing additional information;

-Mediation from a third party.

1. How many disagreement cases do you foresee per year?

As a reference, it is estimated there will be 300-500 first applications for national authorisations per year in the EU and on average 7 mutual recognitions per first national authorisation.

1. Given the short time available for settlements of disagreements (60 days), what mechanism(s) would you suggest to facilitate the process?

1. Member States need to use their best endeavours to reach agreement in the CG? What role should the disagreeing Member States play in the CG? What role should the reference, other concerned and also other Member States play?

1. How many resources would you be ready to make available to contribute to the CG?

1. What would constitute critical success factors for the CG?

BOther issues

1. What elements of the current PA MRF Group would you envisage could (or should not) be applied to the CG?

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Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu

[1]Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products

[2] EC Directive 98/8

[3]Article 35 of the BPR.