12Th Meeting of Competent Authorities for REACH and CLP (CARACAL)

Helsinki, 27/02/2013

Doc. CA/18/2013

12th Meeting of Competent Authorities for REACH and CLP (CARACAL)

13 - 14March 2013

Centre A. Borschette, Room1D

Brussels, Belgium

Concerns:Report on Dossier Submitter Workshop 2013

Agenda Item:Point 21

Action requested:For information and discussion.

Summary[1]

The workshop “quality dossiers – sound opinions” (hosted by ECHA in Helsinki on 16 January 2013)emphasised the important role of the CLH dossier in the opinion forming process.A quality CLH dossier provides RAC with a solid information base for its opinion and focusses the public consultation (PC), such that relevant information is submitted, generally ensuring that the opinion forming process is efficient and transparent.

At the workshop, ECHA presented analysis ofissues that required attention inCLH dossiers after submission, including those relating tosubstance identity (SID). Member States shared their experiences on drafting CLH proposals, and a RAC member discussed the role of quality of dossiers in opinion development. Group discussion focussedon dossier format and content, alignment of the CLH and PPP/BP processes, assessment of hazard classes and what ECHA could do to support the dossier submitter.

Outcomes from the workshop include better understanding of the issues associated with both the compilation and subsequent processing of CLH dossiers and an improved mutual understanding of the role of the various actors in the process. On various topics options for improvement or further action were offered. ECHA is considering how these can be taken further.

CARACAL is asked to consider the analysis of the accordance check data and the feedback from RAC and their implications for compiling dossiers, as well as any improvements to the accordance check process. CARACAL comment is specifically sought on the revised dossier format template (circulated to participating MS).Input on the prioritisation of other specific processes or documents (or parts thereof) which might need updatingand advice onfurther defining specific technical and scientific support that ECHA could offer to the DS would also be welcome, includingany role as a facilitator of communication and collaboration between the parties. Consideration could be given to potential benefits of greater collaboration among MS in prioritisation of substances and hazard classes for CLH. Improved communication between ECHA and the DS would also enhance the predictability of submission and resubmission of dossiers into the process. In addition, it is recommended that the MSCAs for the CLH and PPP processes coordinate (and keep ECHA informed of) their plans for submissions to maximise the opportunities for alignment of these processes.

It is envisaged that in the long term, as issues raised at the workshop are addressed, a larger proportion of proposals would be adopted unchanged, and within shorter time-frames.

Introduction: Workshop objectives and attendance

ECHA organised and hosted a one-day workshop at its premises in Helsinki for dossier submitter member states on 16th January 2013 titled “quality dossiers – sound opinions”. The main objective of the workshop was to find ways for ensuring that high quality harmonised classification and labelling (CLH) dossiers are provided to ECHA, with a view to improving the overall efficiency of the CLH opinion forming process. The workshop was chaired by Jack de Bruijn (Director - Risk Management, ECHA).

The event was attended by 42 delegates from outside of ECHA. Most delegates (35) represented competent authorities of 22 member states of the European Economic Area, their experience in submitting CLH dossiers to date ranging from nil to extensive. In addition, 3 delegates represented industry stakeholder organisations and 3 members represented EU organisations (DG Environment, DG Enterprise and EFSA). In addition, over 20 ECHA staff (from various directorates) attended the event.

The presentations to the workshop as well as the summaries of discussions at the break out groups were made available to the participants after the event.

Dossier statusand analysis of accordance check (AC) outcomes

ECHA presented a quantitative process analysis focusing on the annual cumulative number of dossiers at key stages of the process, which showed that recentlythe number of dossiers that would eventually need to be processed to public consultation (PC) surpassed by more than 3-fold the number of dossiers that had completed PC (and for which the RAC opinion was yet to be finalised). Since most of the dossiers in the pre-PC phase are awaiting resubmission following the accordance check, there is potential for a rush of resubmissions which cannot be adequately allowed for in planning.Because the process needs to be completed within legal deadlines, the reduced processing time could potentially increase the risk of lower quality dossiers and/or opinions. ECHA seeks improved communication with the DS concerning submission and resubmission of dossiers, with a view to increasing the predictability and therefore the manageability of the process.

The accordance check (AC) report provided to the dossier submitter (DS) by ECHA after a dossier has been submitted focuses on specific issues which need to be addressed in order that the CLH dossier meets the requirements of the CLP regulation. It also makes recommendations on issues which ECHA and/or the rapporteur consider would improve the quality of the dossier, with the objective of ensuring that the arguments are scientifically robust. Analysis was presented which explored the reasons why a high proportion of dossiers fail the AC, currently resulting in 62 dossiers in the process which are awaiting resubmission. Of 27 AC reports analysed (all from 2012), the greatest number of amendments to dossiers (approximately 60%) were required because the CLH report did not clearly specify the proposed classification and labelling in accordance with the CLP and DSD criteria and/or did not provide a systematic evaluation of the relevant available information for the proposed classification. Other issues which needed attention in 30% or greater number of dossiers included documenting assessment of information from registration dossiers, not conforming to the CLH report format, absence of a comparison of the available information with relevant CLP (and DSD) criteria and/or absence of classification information in IUCLID. A presentation from the SID team from ECHA provided information specifically intended to assist with compliance with SID requirements.

The AC report was considered tocontribute to consistent and complete CLH reports being submitted to PC, thereby contributing to the efficiency and transparency of the opinion development process. However,additional action is still often required during opinion development, including, for example, consultation of original study reports or clarification of hazard classes/endpoints. Therefore, while it may not always be possible to predict the issues that will arise during later stages of the process, the AC procedure can still be improved.

Issues raised by dossier submitters (DS) and RAC

Presentations by representatives of Member States (DS) were based on their experiences with compiling and submitting CLH dossiers. One DS representative noted that they were seeking candidates for CLH from the registrations and notifications to the C&L inventory. It was suggested that a systematic approach to prioritising potential CLH candidates and the hazards for which CLH is proposed could be initiated, involving discussions with other MS. A role for ECHA as a facilitator of such a process could be foreseen and would be consistent with the CLP regulation[2]. Methods of data collection employed to ensure that the dossiers were as complete as possible were also outlined. Other challenges noted for this process included the compilation and use of robust study summaries (if available) which were originally prepared for another purpose and generally deciding on the level of detail to be included in a CLH report.

It was noted that because any authorisation or restriction measure for substances without existing CLH may be delayed by two years or more, consideration could be given to a RAC “fast-track processing” for “urgent cases” (both of which need to be defined).

Diverging interpretations regarding correct application of CLP classification criteria and formal requirements or documentation needs were also noted. It was suggested that the process be streamlined, best practice clarified, CLP criteria explained and that additional efforts be directed towards improving the quality of the content.

A RAC member presented the ‘end user’ perspective, which included the framework of the RAC opinion and how dossiers are discussed during opinion development. Issues highlighted included dossier clarity, sound use of the scientific data and the application of ‘weight of evidence’, how the DS contributes to efficiency of the process, the role of original scrutiny of the data by DS in preparation of adequate summaries and general avoidance of misunderstandings regarding borderline cases for classification and the consequence for RAC.

Support from ECHA[3] and the CLH report format

A break-out group discussion dedicated to seeking input from DS on where and how ECHA could support the DS considered that additional technical support could include (among others)

-assisting with ensuring completeness of the data package; and

-providing more extensive scientific support on SID issuesincludingintervention prior to registering an intention to potentially improve transparency with concerned parties and efficiency of the submission; and

-clarifying the use of selected CLP criteria based on e.g. RAC common practice, beyond what is offered in existing guidance documentation; and

-improving communication between ECHA and the DS prior to submission of a dossier, especially with less experienced MSCA; and

-facilitating communication and collaboration between MS and between the DS and RAC, including establishing common practice for information exchange during the compilation process.

Opportunities for implementation of the detail of the suggestions are being considered by ECHA.

In view of the central role of the CLH report in the process, a proposal for a revised CLH report format[4] was discussed in a break out group. Drafting of this revised template documentis envisaged to involve collaboration between the DS, RAC and ECHA-secretariat. The main principles driving the revision have been to increase efficiency and to reduce the overall workload for the whole process. To this end, it is intended that the format should facilitate a complete report which follows a clear, logical structure for the all necessary information to be included by the dossier submitter and found by the end-user, and which minimises any duplication of work (e.g by simplifying transfer of data between different processes).To increase transparency, it was suggested that the CLH format template could include a specific part for sources consulted during data collection. The revised dossier format has been provided to participants of the workshop and comments and suggestions for improving this template document generally as well as specific practical solutions for implementing the principles outlined above in the format document are sought.

Alignment of the CLH process with the plant protection products approval process.

An EFSA/ECHA cooperation looking into the alignment of the assessment of active substances (plant protection products(PPP)) that are regulated under both the ECHA (CLH) and EFSA processes is on-going.Currently, for substances covered by the previous pesticides legislation (Directive 91/414/EEC), ECHA receives CLH proposals only after they have entered the PPP approval process (which is administered by EFSA). Alignment of the RAC opinion development process with the EFSA peer review process could be possible, if the CLH report was submitted to ECHA well in advance of the draft assessment report (DAR) being submitted to EFSA (to allow the AC on the CLH report to be conducted), as this would enable the launch of the PC on both the DAR and on the CLH report to occur in parallel.

It was suggested that the formats of the CLH report and the DAR should be made more consistent with each other, to alleviate anyneed to prepare two different reports for the same substance. This would, however, require more extensive coordination between the MSCAs for PPPs and for CLH during the compilation process.

It is recommended that the MSCAs for the CLH and PPP processes coordinate (and keep ECHA informed of) their plans for submissions, both with respect to new substances and those on the renewal programme, beginning with those covered by Regulation (EC) No 1141/2010, for which the decision on the renewal will be taken according to Reg. (EC) No 1107/2009.

Assessment of hazard classes

ECHA also presented a paper on the content of the with regard to the hazard classes to be addressedin the CLH proposal (based on a paper submitted to CARACAL in November 2012, and responses to this paper). This issue was also further discussed at the workshop in a break out group specifically established for this purpose. A revised paperis scheduled to be discussed at this meeting of CARACAL.

1

[1] Abbreviations used throughout this document: Committee for Risk Assessment (RAC); Directorate General (DG); Public Consultation (PC); Dossier Submitter (DS); Dossier Submitter Competent Authority (MSCA); Harmonised Classification and Labelling (CLH); Classification, Labelling and Packaging (CLP).

[2] Recital 61 of Regulation (EC) 1272/2008 (the CLP regulation) states that “In order for the system established by this Regulation to operate effectively, it is important that there should be good cooperation and coordination between the Member States, the Agency and the Commission.”

[3] The tasks of the Agency in relation to providing technical and scientific advice are described in Article 50 of the CLP regulation.

[4]The general principles for preparing dossiers to propose and justify harmonised classification and labelling are described in Annex VI Part 2 of the CLP regulation. A template which sets out the format of the CLH report is currently available from the ECHA website (at