Report on the meeting in the European Ombudsman's own-initiative inquiry OI/2/2016/RA regarding delays under the REACH Regulation
Correspondence - Case OI/2/2016/RH - Opened on Tuesday | 16 February 2016 - Decision on Tuesday | 18 July 2017
on the meeting in the European Ombudsman's own-initiative inquiry OI/2/2016/RA regarding delays under the REACH Regulation
Institution or body concerned: European Commission
Date and time: 26 September 2016, 11:00-12:30
Location: Avenue de Beaulieu 5, 1160 - Auderghem, BU-5 0/A
The Ombudsman's services represented by:
- Ms Rosita Hickey, Strategic Inquiries Unit
- Mr Tuomas Lihr, Strategic Inquiries Unit
1. Introduction and procedural aspects
The Ombudsman representatives introduced themselves and presented the purpose of the own-initiative inquiry concerning delays in the handling, under the REACH Regulation, of compliance check files and proposals aimed at testing the reproductive toxicity effects of over 200 chemicals. The inquiry was opened to help ensure that the decisions on the pending cases are taken as rapidly as possible.
The Ombudsman representatives explained that the purpose of the meeting was to provide for an opportunity to clarify issues falling within the scope of the inquiry in order to help the Ombudsman fully understand the ongoing processes before deciding on the next step in the inquiry. The intention is to publish the present report on the Ombudsman’s website.
The Ombudsman representatives outlined the legal framework applicable to the meeting, notably that the Ombudsman will not disclose any information or documents identified by the Commission as confidential without the prior agreement of the institution.
2. Exchange of views
The Commission representatives shared a copy of their written replies to the questions sent by the Ombudsman representatives before the meeting. Those questions sought to clarify points made in the Commission’s reply dated 27 June 2016 to the Ombudsman’s letter opening the inquiry.
The Commission representatives provided general information on the pending cases and the Extended One-Generation Reproductive Toxicity Study (EOGRTS), which is the new information requirement on reproductive toxicity (following the update of the respective Annexes to the REACH Regulation in February 2015). They outlined the respective roles of the European Chemicals Agency (ECHA), Member State representatives and the Commission in the regime for evaluating testing proposals and compliance of registration dossiers. They underlined in particular the protracted difficulties in finding common ground among the Member States in relation to replacing the Two-Generation Reproductive Toxicity Study with the EOGRTS and during the ensuing development of guidance by ECHA.
The Commission representatives provided an update on the most recent developments in processing the pending cases and outlined the expected timeline for adopting the decisions. The Commission representatives explained that all the pending cases will be dealt with via 16 decisions, most of which will require the registrants to submit an updated REACH registration dossier for the concerned substance to ECHA based on the amended information requirements. This means, in practical terms, starting the evaluation process over, since the update of the Annexes to the REACH Regulation has led to a situation where the original registration dossiers are no longer in line with the legal requirements. The Commission decisions rejecting the pending proposals will enable registrants to update their registration dossiers on the basis of the amended information requirements. Moreover, the guidance developed by ECHA for registrants on how to satisfy the modified information requirements, should expedite matters.
Both the Commission and Ombudsman representatives expressed the view that the meeting was extremely useful in clarifying issues falling within the scope of the inquiry.
To further the Ombudsman’s understanding of the process, the Commission shared the following documents:
(i) Replies to questions from the European Ombudsman in the context of own-initiative inquiry OI/2/2016/RA regarding delays under the REACH Regulation.
(ii) Power point presentation for the meeting of the REACH Committee of 20 September 2016: Dossier evaluation decisions addressing EOGRTS referred by ECHA under Article 51(7) of the REACH Regulation.
(iii) Inter-service consultation on draft Commission Implementing Decisions on the examination of testing proposals and compliance checks pursuant to Article 51(7) of the REACH Regulation (confidential).
(iv) Draft Commission Implementing Decision on the examination of testing proposals for reproductive toxicity referred by ECHA to the Commission pursuant to Article 51(7) of the REACH Regulation: Group 1 of generic decisions addressing EOGRTS (confidential).
(v) Draft Commission Implementing Decision on the examination of testing proposals for reproductive toxicity referred by ECHA to the Commission pursuant to Article 51(7) of the REACH Regulation: Group 3 of generic decisions addressing EOGRTS (confidential).
(vi) Draft Commission Implementing Decision on the examination of testing proposals for reproductive toxicity referred by ECHA to the Commission pursuant to Article 51(7) of the REACH Regulation: Group 15 of generic decisions addressing EOGRTS (confidential).
(vii) Sample ECHA Draft Decision communicated pursuant to Article 51(1) of the REACH Regulation (confidential).
As indicated in the above list, the Commission representatives identified some of the documents made available to the Ombudsman as ‘confidential’, in accordance with Article 4(8) of the European Ombudsman's Implementing Provisions. The copies of the relevant documents were marked ‘confidential’ and signed by a representative of the Commission and a representative of the Ombudsman.
Ms Rosita Hickey
Head of Strategic Inquiries Unit
 The letter opening the inquiry is available here: http://www.ombudsman.europa.eu/en/cases/correspondence.faces/en/64026/html.bookmark.
 Article 4(8) of the European Ombudsman's Implementing Provisions.
 See annex.
 The Commission’s reply is available here: http://www.ombudsman.europa.eu/en/cases/correspondence.faces/en/68996/html.bookmark.
Own-initiative inquiry 01/2/2016/RA regarding delays under the REACH Regulation
QUESTIONS FROM THE EUROPEAN OMBUDSMAN 1
Q1: Do each of the compliance check files and testing proposals concern a different chemical substance (i.e. do they concern over 200 chemical substances and over 200 different registrants?)
The compliance check files and testing proposals indeed concern over 200 substances. A number of registrants are concerned by more than 1 substance (especially the large companies), but for each of their substances there is a specific registration dossier.
Q2: How long is a typical "draft dossier evaluation decision"?
Most Commission draft dossier evaluation decisions regarding the current cases are five pages long (up to seven pages). ECHA draft decisions referred to the Commission followed another format and included other elements; their size could extend to 15 pages or more.
Q3: Do the same MS representatives tend to be on the MSC of ECHA and in the REACH Committee?
For most Member States that is not the case.
Q4: The decisions have been pending before the REACH Committee, a comitology committee which operates under the joint responsibility of DG Environment and DG Internal Market, Industry, Entrepreneurship and SMEs. Could you please explain how this shared responsibility functions in practice?
Both DGs are indeed co-responsible for REACH. In practice, and in view of efficiency and high workload within both services, it has been agreed that each of the DGs is 'lead DG' for one of the main parts of REACH: DG Environment is in the lead for registration (Title II) and evaluation (Title VI), whereas DG Internal Market, Industry, Entrepreneurship and SMEs is in the lead for authorisations (Title VII) and restrictions (Title VIII). The lead DG is usually in charge of drafting the first version of any document (whether draft decision, note to legal service etc.) and for the administrative and legislative process. The other DG provides comments and suggestions on the documents drafted by the lead DG and both DGs try to find an agreement on the final text. Sometimes, meetings or teleconferences are organised, including discussions with ECHA in most cases. The documents have to be approved or signed by the hierarchy of both DGs, usually starting with the one from the lead DG.
Q5: Could you please explain in more detail the timeline for adopting the decisions after the EOGRTS regulatory update was finalised and ECHA 's guidance on the new test method was produced (July 2015)? For instance, how long did the Commission give applicants to update their applications? When did the Commission receive all the updated files from applicants? How long did it take for the Commission to review all the updated files and prepare the 'draft dossier evaluation decisions' for adoption by the REACH Committee?
The registrants had been informed on the referral of the ECHA draft decisions to the Commission. Via ECHA's Newsletter of April 2015, they had also been informed of the amended information requirements2 for reproductive toxicity of REACH and they had been invited to check that the information in the registration dossier complies with the amended information requirement.
Registrants are by themselves required to update their registration 'with relevant new information' and 'without undue delay' (Article 22 of REACH) and submit this information to the Agency (ECHA). This obligation is provided in Article 22 of REACH.
Updates are identified when a registration dossier is individually assessed, probing the ECHA registration database (REACH-IT). The Commission services started these assessments as soon as they had agreed on the way to deal with them and following the discussions with the MS Competent Authorities in the expert group CARACAL (i.e. by bundling the Commission implementing decisions as much as possible, 'omnibus approach'). But as registrants can update their dossier at any time, the status in each individual case needs to be verified prior to drafting the Commission implementing decision.
As the 'omnibus approach' has been chosen, the status of all cases had to be checked simultaneously. A cut-off date of 31 January 2016 (except for 1 specific case when the relevant update regarding the ongoing testing was announced in the dossier so it was explicitly followed-up) was chosen and all cases were systematically checked for all updates to that date. When that latest information was assessed cases were processed accordingly. This final assessment took place between February-June 2016.
The Commission services concluded that only in relatively few cases the registrants had updated their dossiers in such way that no further information was needed any more. The final assessment enabled the allocation of the cases to one of the 16 'omnibus decisions'. This was performed with a view to administrative efficiency in order to allow for a swift internal processing and adoption of the decisions.
Q6: The Commission notes in its opinion that it expects the REACH Committee to come to a decision on the pending dossiers in summer 2016. Has this turned out to be the case? If so, why does the Commission expect that the final decisions will be adopted only in 2017? If not, could you please give an update on the most recent developments?
After the 2 responsible DGs and their Cabinets had agreed on the draft Commission Decisions, they were submitted to inter-service consultation (involving a number of other Commission services) for comments until 13 September. The draft Commission decisions were swiftly made available to the Members of the REACH Committee on 15 September, in view of holding an initial discussion at the REACH Committee meeting of 20 September. At this meeting there was a general agreement by Member States to proceed rapidly with the batches of the draft Commission decisions, once these have been updated following the consultation with the registrants. It is envisaged that the draft Commission decisions will be discussed and voted in several batches within the coming months. Written procedure will be used as a default for all cases, unless one or more Member States request discussion and vote in Committee. After the discussion in the REACH Committee of 20 September, all but three draft Commission Implementing Decisions will be submitted for comments to the registrants concerned for a period of 30 days. It is to be noted that the Commission has no legal obligation to consult the registrants. However, since this is a complex matter and as a 'good administrative practice', it has been decided to provide the registrants with the opportunity to comment, except in cases were no further information was required. This practice mirrors ECHA's obligation to provide registrants the right to comment, as provided by Article 50 of REACH. The Commission services will have to analyse the comments, if any, and decide whether to take them into account in their final decisions while informing the registrants of this. Some case-specific comments may require that initially 'grouped' addressees of one same generic decision have to be taken out from the list of addressees of this decision and that further "individual" decisions need to be drafted. It is difficult to predict how many comments registrants will provide.
Member States will be allowed to comment on the draft decisions in parallel to the registrants. Once finalised, the draft decisions (EN version) will be submitted to the vote by the Members of the REACH Committee, scheduled to take place by written procedure ending at the latest in December 2016 or at the meeting of the REACH Committee in December 2016. (no meeting is scheduled in November). They will be sent in parallel to the translation service of the Commission for translation into the official language(s) of the Member State of the address of the registrant (in casu up to 8 languages per decision). Once voted by the REACH Committee, the draft decisions will need to be adopted by the Commission, by written procedure, which takes approximately 2 months. Therefore, adoption is expected in the first quarter of 2017, at least for most decisions. For the cases requiring no further information, for which the decisions will not be submitted to comments from registrants, Member States have been given a two week commenting period, after which the Commission will finalise the decisions and put them for a vote in written procedure. Adoption by December 2016 is still possible.
The final decisions will be notified directly by mail to the registrants in their own language. They will not be published in the Official Journal of the European Union since REACH does not require to do so. Following the adoption, a non-confidential version of the Commission decisions will be published on ECHA's website.
Q7: Has the Commission received complaints or other feedback from relevant stakeholders such as the companies concerned by the delays on their experience in the entire process?
No. There were a few informal enquiries by the industry associations which have been kept informed on the situation and progress. In a similar way, stakeholders were kept informed via the REACH Competent Authorities meeting (CARACAL), through which the competent authorities also provided feedback as the general approach was developed by the Commission. The Commission services in charge have not received any complaint, neither from registrants, nor from other stakeholders. They have endeavoured to perform this huge and complex task swiftly and in the best possible way. In the meantime, the registrants concerned were able to continue their operations, while being required to take the necessary precautionary measures.
2 Commission Regulation (EU) 2015/282 of20 February 2015 amending Annexes VIII, IX and X to Regulation
(EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH) as regards the Extended One-Generation Reproductive
Toxicity Study, OJ L 50 of 21.02.2015, p.l.
'3 In accordance with Article 51 (7) of REACH, which refers to Article 133(3) of REACH (examination