Ad-Hoc Meeting of Competent Authorities for REACH

Helsinki, 19/06/2013

CA-July13-Doc.5.1.e

Ad-hoc Meeting of Competent Authorities for REACH

Open session

2-3 July 2013

ECHA Conference Centre, Guido Sacconi Room

Helsinki, Finland

and

Competent Authorities for biocides

10-12 July 2013

Concerns:ED expert group

Agenda Item:Point5.2

Action requested:The REACH and BPR Competent Authorities are requested to provide comments on the draft mandate proposed forthe ED expert group,and the Competent Authorities and stakeholder organisations are invited to nominate experts to the ED expert group by 15 September.

ED Expert Group

1. Background

The most widely accepted definition for endocrine disruptors is the one by the International Programme for Chemical Safety (IPCS): “Endocrine disruptors have been defined as exogenous substances that alter function(s) of the endocrine system and consequently cause adverse health effects in an intact organism or its progeny, or (sub)populations”. (IPCS 2002)

As a response to public concerns on hormonal active substances and their effects on humans and wildlife the "Community Strategy for Endocrine Disruptors" was adopted in 1999; (COM (1999) 706). The Strategy is currently being updated. In the EU, endocrine disruptors (EDs) are addressed by a number of legal instruments, e.g. REACH, Plant Protection Products Regulation, Biocidal Products Regulation (BPR). The European Commission (COM) is currently developing criteria – to be finalised by the end of 2013 - for the identification of such ED-substances that require regulatory action.

Endocrine disruptors are also addressed on an international level. The OECD is developing test methods and guidance for the assessment of Endocrine disruptors. UNEP/WHO have in February 2013 published an updated Global assessment on the state of the science of endocrine disruptors. The Strategic Approach to International Chemicals Management (SAICM) in ICCM3 identified endocrine disrupting chemicals as emerging policy issues and agreed to implement cooperative actions with the overall objective of increasing awareness and understanding amongst policymakers and other stakeholders.

2. EDs in REACH

Under substance evaluation the potential for ED properties is an important factor in the prioritisation of substances to be included in the CoRAP, and may lead to requests for further information to conclude on the ED properties. ECHA, as part of its activities underdossier evaluation, can also consider ED properties while assessing information in the registration dossiers. The possibility to request additional information specifically on ED properties under dossier evaluation is however limited by the fact that they are not standard information requirements.

In relation to risk management, substances – such as those having endocrine disrupting properties – may be identified on a case-by-case basis as Substances of Very High Concern (SVHC), where there is scientific evidence of probable serious effects to human health or the environment, which give rise to an equivalent level of concern to CMR or PBT/vPvB substances (Art 57(f)). These substances may subsequently be added to the authorisation list. If appropriate, authorisation for the use of SVHCs with ED properties may be granted via the adequate control route or the socio-economic route, depending on whether a threshold can be determined (Art 60). However, the Commission is currently reviewing this latter aspect under Art 138(7) of REACH.

So far only a small number (4) of substances have been formally identified as SVHCs according to article 57(f) with reference to their ED properties. In relation to dossier and substance evaluation, assessment of ED properties can be complex, triggering specific questions on what kind of further testing would be required to clarify concerns. Therefore, it is envisaged that establishment of an ED Expert Group which can contribute to efficient assessment of substances with (potential) ED properties, would bean important step forward in the implementation of REACH and achievement of the SVHC Roadmap aims.

3. EDs and the SVHC Roadmap

The SVHC Roadmap to 2020 aims to have all currently known relevant SVHCs included in the Candidate List by 2020. In relation to EDs the Roadmap provides a brief overview of the screening and assessment activities which need to be carried out and states that it should be considered if an ED Expert Group needs to be established (as done for PBTs).

Subsequent to publication of the Roadmap, ECHA held a Roadmap Implementation Workshop (17-18 April 2013) with the primary aim of gathering input to the development of a Roadmap Implementation Plan. At the workshop there were detailed discussions on the activities required to ensure that all relevant SVHCs with ED properties were included in the Candidate List by 2020.The workshop clearly supported the establishment of an ED Expert Group to advise on these activities.

ECHA is currently drafting the Roadmap Implementation Plan and this will set out the activities required to meet the Roadmap targets, including activities in relation to screening and assessment of EDs. The activities required for EDs include development of screening algorithms, screening of the EU database (Endocrine Active Substances Information System) and of registered substances (with priority on those substances which areregistered for uses within the scope of authorisation), and assessment of ED properties of relevant substances to determine if they meet the forthcoming Commission ED criteria. It can be anticipated that there will be a need for additional information to be collected on EDs via dossier or substance evaluation and this will require activities such as screening of substances for the CoRAP and interpretation of test data. It is envisaged that the ED Expert Group would support these activities.

4. EDs in the BPR

Active substances having ED properties are considered to meet the exclusion criteria included in the BRP. These active substances shall not be approved unless a derogation is granted based on the conditions in Article 5(2), for example evidence that the active substance is essential to prevent or control a serious danger to human health. Criteria for the determination of ED properties based on the classification for carcinogenicity and reproduction are incorporated in the BPR which can be applied until the Commission has adopted a delegated act specifying scientific criteria for the determination of ED properties.

Following the application for an active substance the evaluating Competent Authority (eCA) has to evaluate if the exclusion criteria are met. During the evaluation additional data can be requested by the eCA. Following the submission of the conclusions of the eCA to ECHA, the Biocidal Products Committee (BPC) has to deliver an opinion which shall also contain an opinion on whether the exclusion criteria are met.

As the assessment of ED properties can be complex, triggering specific questions on what kind of further testing would be required to clarify concerns, it is envisaged that efficient identification of substances with (potential) ED properties would be important in the implementation of the BPR and that an expert group will be helpful to achieve this efficiency.

5. The role of the ED expert group

It is envisaged that the organisation and tasks of the ED Expert Group would be very similar to those of the PBT Expert Group which was set up by ECHA in 2012. It is expected that the majority of the scientific questions will relate to whether a substance fulfils the ED criteria that the Commission is specifying. In addition, it will be necessary to discuss whether there is a specific piece of (testing) information needed that can clarify the concern for substances that have been identified as potentialEDs since they fulfil (certain) screening criteria or have been identified otherwise (e.g. through modelling activities). Hence, in terms of scope, the work of the expert group would be closely related to certain MSC tasks under SVHC identification(i.e. assessment whether the (forthcoming) COM EDcriteria are met, but not equivalent level of concern assessment), dossier evaluation and substance evaluation (defining testing needs and strategies, possibly beyond standard information requirements).

The expert group should of course not provide any advice that would pre-empt, dispute or go beyond the actual ECHA decisions that have been agreed by the MSCA’s or MSC which has its own specific mandate according to the REACH Regulation. On the other hand, expert input (prior to decision making) regarding evaluation dossiers could support the development of consensus among ECHA and MSCAs on how to assess ED properties and, should specific cases be referred to the MSC, lead to more efficient MSC discussions. In other words, the expert group would not be directly involved in the discussion on specific cases e.g. from the Committees, but could provide scientific advice on questions arising from these cases. The group could also be consulted before such cases would potentially end up in the Committees, i.e. in the preparatory phase.This would apply also when MSCAs are drafting substance evaluation decisions.

Therefore, the expert group would have an advisory and feedback function towards different parties but function independently from the ECHA MSC. Such an expert group should be addressing specific scientific questions on the identification of ED properties of substances that may come from the Member States, as well as directly from ECHA. This would support the preparatory work on identifying potential SVHCs orin defining additional information to be requested under the dossier or substance evaluation process.

Also for the BPR it is envisaged that the organisation and tasks of the ED Expert Group would be similar to those of the PBT Expert Group: the questions will relate to seeking scientific advice by the eCA on whether an active substance fulfils the forthcoming COM ED criteria before the submission of their conclusions to ECHA.

6. Draft mandate

The following overall mandate is suggested for this expert group:

The expert group will provide informal and non-binding scientific advice on questions related to the identification of endocrine disrupting properties of chemicals and, in particular, on:

Questions related to screening methods/activities to identify potential EDs (e.g. for the CoRAP and/or candidate list)
Questions related to the development of integrated approaches to testing and assessment of ED properties
Feedback and recommendations on complex (specific/generic) scientific issues related to information and (tiered) testing needs for potential EDs (e.g. under dossier or substance evaluation or under the evaluation by the eCA of a biocides active substance application)
Specific questions on the interpretation of test data as well as other relevant information in relation to the identification of ED properties (e.g. during the development of an SVHC dossier or a biocides active substance evaluation)

ECHA will act as secretariat for the ED Expert Group and is also co-ordinating the Roadmap implementation. Thus, ECHA will ensure that the work of the ED Expert Group is co-ordinated effectivelywith relevant REACH and CLP processes and other Roadmap activities, on the basis of advice provided by the expert group.

ECHA will carefully monitor that the discussion items for the expert group will not interfere with the specific tasks of the MSC in identifying Substances of Very High Concern or under the Evaluation title. The expert group should be organised in such a way that its output enhances the scientific level, efficiency and consistency of the decision making under evaluation and SVHC identification. The same applies for the BPC, where ECHA will monitor that the discussion items for the expert group will not interfere with the specific tasks of the BPC in providing an opinion on whether an active substance meets the exclusion criteria.

7. Invitation to Nominate Experts to the ED Expert Group

ECHA hereby invites Member State Competent Authorities and stakeholder organisations to nominate experts to the ED expert group.

ECHA proposes to set up this group as a self-standing ECHA expert groupand not directly as a sub-group of any of the ECHA Committees or any other existing group. It is however in our interest that the extensive expertise that is available at Member State level will become available for this group and that these experts are supported by their Competent Authorities for REACH and the BPR. For workability reasons the size of the expert group will be limited to one or as a maximum two experts per Member State. The possibility to nominate two experts per Member State is to allow for the situation where a Member State may wish to nominatedifferent ED experts for human health and the environment. Otherwise one nomination is requested.

Experts from Industry and NGOs are also invited to participate in the expert group. It is anticipated that a maximum number of four experts from industry and four from NGO’s can participate in the group. The experts should preferably have experience in assessing ED properties of substances.

On a case-by-case basis, depending on the agenda items covered, the expert group may agree to the participation of additional experts or observers.

ECHA will reimburse the travel expenses of the experts according to its normal practice.

In accordance with ECHA’s policy on conflict of interest, participants in the expert group meetings will be requested to fill in a Conflict of Interest declaration.

8. Organisation of the meetings

The ECHA secretariat will provide the chair for the meeting and will also take care of developing the minutes and their appropriate distribution. Communication on the activities of the Expert Group will be discussed and developed as part of the SVHC Roadmap to 2020 communication plan.

ECHA’s current planning is to organise these meetings 2-3 times per year with a duration of 1,5 to 2 days.

ECHA will organise, and develop the agenda for, the meetings in consultation with the members of the expert group. Suggestions for agenda items can be submitted by the participating experts, the MSCAs, ECHA secretariat, the Commission, Industry or NGOs.

It is suggested that the mandate and functioning of the expert group will be reviewed after one year (or after three meetings have been held).

9. Dealing with confidential information

Discussions in the expert group should normally not be based on confidential information. Where this cannot be avoided (e.g. for some tasks confidential information from registration dossiers may be needed) participation will need to be limited to experts from MSCAs only that fall under the specific data security arrangements.Therefore, it can be anticipated that open and closed sessions of the meetings willmost probably be needed.

10. Next steps

Based on the discussion at the Ad-Hoc Meeting of Competent Authorities for REACH and at the meeting of the Competent Authority for biocides, ECHA will finalise the mandate forthe expert group.

ECHA would be grateful to be informed of the nominated experts no later than 15September.We would appreciate if you used the form in Annex 1 for nominating experts and send it by e-mail to Ms Sanna Suomela ().

As soon as ECHAhas received all nominations, the experts will be informed by the ECHA secretariat about the date of the first meeting of the ED expert group, with the aim of organising this meeting early in 2014 in ECHA’s premises.

Action requested:

The REACHand biocidesCompetent Authorities are requested to provide comments on the draft mandate proposed for the ED expert group, and the Competent Authorities and stakeholder organisations are invited to nominate experts to the ED expert group.

Annex 1

Competent Authority/Stakeholder Organisation:
Contact details and experience of nominated expert:
Contact Name:
Contact Tel:
Contact Email :
Brief description of the ED related experience (please specify if this relates to human health, environment or both):

Please, send this form to Ms Sanna Suomela () by 15 September.

Data protection note:

Your personal data are solely processed for the purpose of establishing the ED Expert Group and will only be accessible to the secretariat. Please note that the European Chemicals Agency will ensure on its part that your personal data is processed as required by Regulation (EC) No 45/2001 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data. You have the right to access and rectify that data. To exercise these rights, please contact the data controller .