Date: Tuesday, 19 September 2023

Remote meeting via WebEx

Present

European Commission

Two members of the Secretariat-General (SG)

Four members of the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (‘DG GROW’)

Four members of the Directorate-General for Environment (‘DG ENV’)

European Ombudsman (Directorate of Inquiries)

Mr KRAJEWSKI Michał, Inquiries Officer

Ms KING Jennifer, Legal Expert

Ms EHNERT Tanja, Inquiries Coordinator

Ms KOSMOPOULOU Maria Eleni, Inquiries Trainee

Mr WAWRZYCZEK-SEIFERT Krzesimir, Inquiries Trainee

Purpose of the meeting

The purpose of the meeting was for the Ombudsman inquiry team to understand the nature of the contents of files relating to inclusions in Annex XIV, individual authorisations and restrictions under the REACH Regulation,[1] and to clarify certain aspects of the Commission’s written reply in this inquiry.

More specifically, the meeting aimed to understand better the administrative organisation of the risk management process, the Commission’s role therein and the transparency of that process.

Introduction and procedural information

The Ombudsman inquiry team introduced themselves, thanked the Commission representatives for meeting with them and set out the purpose of the meeting. They outlined the legal framework that applies to meetings held by the Ombudsman, in particular, that the Ombudsman would not disclose any information identified by the Commission as confidential to any other person outside the Ombudsman’s Office, without the Commission’s prior consent.^[2]

The inquiry team explained that they would draw up a draft report on the meeting to be sent to the Commission to ensure that the contents were factually accurate and complete. The meeting report would then be finalised and included in the file. No confidential information would be included in the report or otherwise be made public.

Information exchanged

Documents produced in the course of the risk management process within the Commission

In reply to a question from the Ombudsman inquiry team, the Commission representatives outlined the different steps of the risk management process within the Commission and the types of documents that are produced during this process.

· Drafting of the measure: The lead DG for authorisation and restrictions - DG GROW - produces a first draft of the measure, which is then discussed with the other lead DG – DG ENV. The exchanges between DG GROW and DG ENV are not usually registered in Ares. They include initial informal contacts and discussions between desk officers, who report on them to their respective hierarchies. At this stage, early working drafts are created, modified and commented on, in the case of authorisation decisions in shared folders recently.

The first document that is registered in the file is the draft measure, accompanied by a cover note addressed to other DGs, submitted for inter-service consultation.

· Inter-service consultation: Consultations take place with the Secretariat General, the Legal Service, DG AGRI,[3] DG JUST,[4] DG SANTE, DG TRADE, DG EMPL, DG ENER, DG MOVE, DG TAXUD, JRC, RTD, and the European External Action Service, which is a standard list of services consulted in this kind of REACH process. Documents produced during the inter-service consultation also include notes sent to the respective cabinets of the Commissioners responsible for the two lead DGs, a draft notification form to the World Trade Organisation (‘WTO’) under the terms of the Agreement on Technical Barriers to Trade (in cases of inclusions in Annex XIV or restrictions), and an explanatory note in case of restrictions as foreseen by Article 73 of the REACH Regulation.

Subsequently, based on replies from the consulted services, the final draft measure to be presented to the Member States in the REACH Committee[5] is prepared.

The Commission representatives confirmed that prior to the conclusion of the inter-service consultation, in general there are no exchanges within the REACH Committee on the draft measure.

· Discussions within the REACH Committee: The Commission representatives said that the documents exchanged with the REACH Committee include an invitation to the meeting and a draft agenda, the final draft measure, the explanatory note in case of restrictions, any positions expressed by stakeholders, comments received on the notification to the WTO, invitations to vote and information on the outcome of votes, minutes of the meetings and requests to REACH Committee members to provide linguistic suggestions for their respective language versions.

Before the meetings of the REACH Committee, Member States often submit written comments on draft measures. These comments are circulated to all members of the REACH Committee. However, Member States may also comment on a measure during the meeting only, without having previously submitted their views in writing.

Administrative organisation of the risk management process

In reply to a series of questions posed by the Ombudsman inquiry team, the Commission representatives provided further details of the administrative organisation of the risk management process.

1) How does the fact that Commission staff attends the meetings of the ECHA committees for risk assessment (‘RAC’) and socio-economic analysis (‘SEAC’) facilitate the Commission’s risk management process?

The Commission representatives confirmed that Commission staff attends meetings of RAC and SEAC as observers. This allows the Commission to be up-to-speed with the files under assessment and the development of the draft opinion. The Commission representatives stated that the Commission only provides input to make sure that the committees’ conclusions and justifications supporting those conclusions are sufficiently complete, clear and robust for the sake of the decision making process that follows.

The Commission representatives explained that the Commission cannot initiate its own risk management process before receiving the final opinions of RAC and SEAC as there are often significant differences between the draft opinions discussed and the final opinions adopted. Nevertheless, the role as observer can save some time in that the Commission can start working on the file once an opinion has been adopted even before it has been formally received from ECHA.

2) How are tasks divided between DG GROW and DG ENV? Is there any procedure or guidance on how they arrive at a joint position?

The Commission representatives clarified that both DG GROW and DG ENV are lead services responsible for REACH. For organisational purposes, however, DG GROW takes the lead for inclusions into Annex XIV, restrictions and authorisations. DG GROW is hence in charge of producing the various first drafts (of the measure, the cover note to other DGs, the explanatory note etc., except for the note addressed to the cabinet of the commissioner responsible for DG ENV), based on pre-agreed templates in the case of authorisation decisions. Discussions between the two lead DGs continue as the drafts circulate between the responsible desk officers from the two DGs. In response to a follow-up question as to how these exchanges are coordinated, the Commission representatives confirmed that working arrangements exist in practice between the two DGs. 

The Ombudsman inquiry team asked whether there are any challenges in this cooperation. The Commission representatives said that it is difficult to provide a general reply to this question and to identify specific challenges. The Commission representatives explained that, because of the different political objectives of  DGs, and the variety of interests that need to be taken into account, there are, legitimately, divergences between the views expressed by different DGs on specific files. Thus, although normally DG ENV and DG GROW have similar views on the REACH files (e.g. the need for a certain restriction), there is usually a need to discuss certain details, and issues may arise in individual cases.

While the Commission representatives explained that it is an unusual arrangement within the Commission that there are two lead DGs responsible for the same files, it is speculative whether, and how much, this arrangement adds to the time needed to process these files. They noted that the points of divergence would likely arise irrespective of the organisational structure of the risk management process, at the latest during the inter-service consultation.

3) How does the Commission handle overlaps between proposals for restrictions and recommendations for inclusion in Annex XIV?

The Commission representatives stated that, when overlaps occur, the Commission assesses the relevant files and looks for the appropriate way forward on a case-by-case basis. In the cases so far where there was an ongoing restriction process for a substance recommended by ECHA for prioritisation for inclusion in Annex XIV, the Commission has postponed its decision on the inclusion of a substance into Annex XIV. The Commission representatives referred to two examples: one concerning the substance “Dechlorane Plus”, which figured in ECHA’s recommendation of 2019 of priority substances for inclusion into Annex XIV, and another one concerning seven lead compounds which figured in the same recommendation and are mainly present in recycled PVC.

The Commission representatives stated that the Commission cannot prevent Member States from proposing restrictions under the REACH Regulation, and this may cause an overlap in the regulatory tools for restriction and authorisation of the same substance. However, the Commission has encouraged Member States, prior to submitting a restriction proposal or a proposal for identification of a substance as Substance of Very High Concern (which are the ones subject to listing in Annex XIV), to include a Regulatory Management Option analysis (RMOA). This analysis allows to identify whether e.g. a restriction could be the most appropriate regulatory tool in each individual case. The Commission representatives noted that each regulatory tool has its own advantages and disadvantages. So far, however, postponing the procedure for the inclusion of a substance into Annex XIV has produced positive results.

Role of the Commission in the risk management process

4) The Commission stated in its written reply that “the opinions of RAC and SEAC did not always provide all the elements necessary for efficient decision-making by the Commission or did not always do so with sufficient clarity”. What were the reasons for insufficient clarity/absence of all necessary elements?

The Commission representatives emphasised that ECHA is an independent agency and that the Commission cannot influence ECHA’s opinion-making process. However, the Commission may revert to ECHA when it considers that its opinions are incomplete or not sufficiently clear.

The Commission representatives explained that this may happen if an opinion lacks clarity or if there is insufficient argumentation to support the conclusions by the scientific committees. The Commission representatives referred to a number of examples where it was considered that the opinions by ECHA were lacking clarity or did not contain all necessary elements for an efficient decision-making.

• The first example concerned three RAC opinions on individual authorisations for the substance “trichloroethylene”. RAC’s initial opinions contained some unclear statements concerning the risk and recommendations to improve risk management measures and operational conditions to reduce worker’s exposure. As such, the Commission asked ECHA to clarify the opinions. In this case, ECHA provided addenda to the opinions with clarifications as to the evaluation and conclusions on the appropriateness and effectiveness of the risk management measures and operational conditions in the applications. The addenda also explained RAC limitations in these cases as to the possibility to further specify the recommendations but, where possible, it indicated same aspects that could be considered to address them.
• The second example provided by the Commission representatives concerned wide-scope applications for individual authorisation of chromium trioxide, where there was a lack of clarity in the opinions because the applications themselves lacked detail and granularity. In those cases, both RAC and SEAC had presented an, overall, positive opinion, but with caveats that there were remaining uncertainties. The Commission had concerns given the uncertainties in the applications and these cases have required more lengthy assessments by the Commission as the Commission representatives stressed that the Commission has to ensure that only negligible uncertainties remain in case it is to propose a measure to grant an authorisation under REACH.
• The third example concerned a proposed restriction of formaldehyde, on which SEAC’s opinion had to rely on insufficient data, due to the RAC proposal for a lower emission limit compared to the one in the dossier prepared by ECHA. Even though SEAC is not obliged to search for more data, it took into account information on impacts submitted during the third-party consultations so as to fill in the gap and assess the impacts associated with lowering the limit value, including other limits considered by RAC. Thus, RAC and SEAC opinions did not clearly point at a specific emission limit to be considered as the most appropriate to address the risk, taking also into account its socioeconomic impacts, and thus the Commission had to carry out its own extensive assessment in order to draft a proportionate measure to restrict formaldehyde.

The Ombudsman inquiry team asked what a common reason for a lack of clarity in ECHA’s opinions is. The Commission representatives replied that sometimes there is a lack of data provided by the applicant. They referred to wide upstream applications for authorisation, which have been the subject of Court cases.[6] Up-stream applicants often have insufficient data and/or understanding of the precise exposure scenarios at each downstream user site as well as possible alternative substances and technologies to replace the substance of very high concern for the specific utilisations covered by the application for authorisation; applications made by down-stream users are generally more precise and better substantiated.

5) How does the Commission handle applications for individual authorisations of insufficient quality? How does the Commission implement the recent case law clarifying that the burden of proof in the process for granting individual authorisations rests with the applicants?

The Commission representatives noted that an authorisation can be granted based on the ‘adequate control’ route (where the risks stemming from the use of the substance are shown to be adequately controlled) or the ‘socio-economic’ route (where the benefits stemming from the use of the substance are shown to outweigh the risks and there are no suitable alternatives). The Commission representatives explained that, according to previous guidance of ECHA, a substitution plan was only deemed to be necessary in the context of the ‘adequate control’ route. However, the Court clarified that applicants must also submit a substitution plan in the context of the ‘socio-economic’ route in the event that there are suitable alternatives available in general but that those alternatives are not yet feasible for the applicant.[7] As regards the latter, the Commission invited several applicants in February 2020 to submit a substitution plan to complete their applications. SEAC assessed those substitution plans and issued addenda to the affected opinions in summer of 2021.

The Ombudsman inquiry team asked why, in view of the recent court judgment, the Commission did not reject applications for authorisation via the ‘socio-economic’ route that did not contain a substitution plan. The inquiry team also queried whether rejecting such applications not containing a substitution plan would result in the suspension of the use of the harmful substance in question and whether applicants would have the possibility to submit a new application in such cases.

The Commission representatives explained that the Court judgment considered alternatives available in general, while the Commission and SEAC assessment had been focusing on alternatives feasible for the applicant. The Court clarified that if alternatives are available in general but they are not feasible yet for the applicant an authorisation may be granted if the applicant submits a substitution plan. As this requirement to submit a substitution plan in the context of applications for individual authorisations via the ‘socio-economic’ route arose from the Court judgment and the applications were submitted before that judgement, the dossier was not complete for Commission assessment and decision on the concerned applications and afforded the respective applicants an opportunity to provide the missing plans. Such plans would be assessed by ECHA. Furthermore, in their view, rejecting applications that did not contain a substitution plan because they followed ECHA’s guidance document would be unfair for the applicants considering ECHA’s guidance document.

The Commission representatives clarified that the Commission has rejected applications due to insufficient information provided by the applicant. The Commission representatives stressed, however, that, in order to reject an application, the REACH Committee needs to attain a qualified majority, noting that there are at times blocking minorities. They further noted that the quality of the submitted applications has been improving recently, following the Court’s case-law, which has clarified among others, that applicants must consider not only the technically and economically feasible alternatives for them, but also the ones that are generally available in the EU.[8]

The Ombudsman inquiry team asked about the form and quality of the opinions of ECHA in those cases in which the Commission rejected the application. The Commission representatives referred to the case of an upstream application, in which ECHA, prior to the Court judgement referred to above had, overall, concluded positively on an application for an individual authorisation, but with caveats due to uncertainties. Following the judgement, the Commission requested a substitution plan from the applicant which was then assessed by SEAC. In an addendum to the original opinion SEAC concluded that the substitution plan was not credible. Following its review, the Commission considered that the applicant had not discharged the burden of proof and it thus refused the authorisation. The Commission representatives clarified that, when the Commission asked for a substitution plan from the applicant, it did not allow it to update, complete or rectify other parts of the application and the SEAC addendum concerns only the substitution plan.

In general, the Commission representatives stressed that the authorisation system is currently overloaded. Although the Court gave certain clarifications concerning the procedure to be followed, this clarification has had a positive impact only on the applications that have been submitted since this ruling has been announced. Previously submitted applications which do not contain a substitution plan, based on the previous ECHA’s guidance, are now considered to be incomplete, which is affecting the time needed to complete the assessment process. The Commission representatives noted that ECHA has estimated its capacity to adopt approximately 60 opinions per year, while approx. 250 applications are currently pending.

Finally, the Ombudsman inquiry team asked to what extent the clarifications of the Court can facilitate ECHA’s assessment, as well as whether there have been discussions between the ECHA and the Commission on how to implement the Court’s most recent judgment. The Commission representatives replied that there have been discussions about the recent case law. In particular, the Commission has informed SEAC and RAC of its view on this case law and how it will impact the assessment by the committees. The Commission representatives also noted that the Commission will work with ECHA to update its guidance to applicants.

6) When has the Commission “[taken] into account information and aspects not contained in ECHA recommendations or opinions”?

In the area of authorisation decisions, the Commission representatives mentioned an exceptional case, in which the Commission took into account information and aspects not contained in the ECHA opinions concerning the substance 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (“4-tert-OPnEO”). RAC had in some applications recommended that all waste-water that had been contaminated by this substance should be collected for incineration. This would have affected thousands of hospitals and laboratories who discharged thousands of tonnes of waste water with a minimal concentration of the substance and require the transport and incineration of such large volumes of wastewater which requires large amounts of energy. In the context of its risk management, the Commission, taking into account information from Member States water waste management systems and the applicants, assessed other alternatives and took a broader view, and set specific intermediate use reduction targets for the applicants to comply with, as well as included obligations for the applicants to inform the relevant local authorities about the discharge. These cases, however, were more the exceptions than the rule.

Regarding the transparency of the risk management process

7) How does the Commission ensure the transparency of the process before it presents a draft measure to the REACH Committee?

The Commission representatives explained that the Commission regularly publishes the rolling work plan of the CARACAL[9] which looks ahead to the next three or four REACH Committee meetings. Each rolling work plan covers the draft measures already submitted to the REACH Committee, and shows when new draft measures are expected to be tabled. The Commission representatives confirmed that only those items listed on the work plan are discussed in the REACH Committee. In light of the above, the Commission representatives argued that a satisfactory level of transparency is achieved with the material that is already published.

The Commission representatives added that it has other transparency tools at its disposal. For example, concerning restrictions and inclusions in Annex XIV, the Commission notifies the draft measures to the WTO, which are then made available on the Commission’s publicly available Technical Barriers to Trade (TBT) database. The ECHA’s opinions and recommendations are also publicly available. Moreover, if the Commission needs supplementary opinions from the ECHA, the requests for such supplementary opinions and the resulting opinions are made public.

The Ombudsman inquiry team asked whether the Commission has considered adding the drafts to the Have Your Say portal in order to receive comments from the public. The Commission noted that inclusions of substances in Annex XIV are published in the ‘Have Your Say portal’, while public consultations are carried out by ECHA on each restriction dossier and application for authorisation. In addition, a lot of information is already made public following the inter-service consultation, such as the already mentioned WTO notification which includes the final draft measure.

The Commission representatives took the view that, as long as the Commission has not internally agreed on the final draft of a measure (i.e. closing of the inter-service consultation), publishing additional information might be misleading. They added that it is difficult to communicate information on the timing of the Commission’s decisions, given the unpredictability of some elements of the process.

8) How can the public be aware of the state of play of a file being discussed before the REACH Committee takes a vote?

The Commission representatives reiterated that information on the state of play of a file is made public through the rolling work plan.

The Ombudsman inquiry team noted that informing the public about the state of play of a file through the rolling work plans only works if the file is actively discussed. Otherwise, the public is not updated.

The Commission representatives explained that also, each draft measure is published in its entirety in the comitology register prior to each REACH Committee meeting it will be discussed in. For example, as regards the restrictions on micro-plastics, the different versions of the draft measure are published, which the public can compare. Also, the summary record of the REACH Committee meetings is always made available shortly after each meeting and specifies if there was a discussion and/or vote.

The Commission representatives noted that there are no deadlines imposed on the REACH Committee to conclude its negotiations. They acknowledged that it is not possible to infer in detail the state of play of the negotiations within the REACH Committee.  

In that regard, the Commission representatives stated that the Commission provides updates to the public also by replying to requests for information and that it tries to be in its replies as transparent as possible. They further clarified that the Commission mostly receives requests for information from interested parties, often together with comments on specific files.

9) As regards the public access to documents cases referred to in the Commission’s written reply, how did the Commission handle these requests? Did it grant full or partial access?

With reference to the 3rd bullet point on page 19 of its written reply,[10] the Commission referred to a request for public access to the outcome of a REACH Committee vote on a particular restriction. The requester had specifically asked how the individual Member States had voted. The Commission representatives stated that the Commission denied access to the requested documents in accordance with Article 4(3) (second indent) of Regulation 1049/2001, as the document requested relates to a decision which had not yet been taken and the Commission considered that disclosure would seriously undermine its decision-making process and that there was no overriding public interest in disclosure.

With reference to the 4th bullet point on page 19 of its written reply, the Commission referred to two requests for public access to the Commission’s correspondence with a particular Member State on the same restriction. The Commission representatives clarified that the first request concerned a file for which no decision had been taken at the time, while at the time of the second request the decision had been taken, and noted that both requests were made by the same requester. Following the second request, the Commission denied full access to two documents in accordance with Article 4(3) (first indent) of Regulation 1049/2001, as it considered that disclosure would seriously undermine its ongoing decision-making process and there was no overriding public interest in disclosure. It did not identify an overriding public interest in disclosure. The Commission also took into consideration the position of the Member State from which certain documents originated, according to Article 4(5) of the above Regulation. However, it provided partial access to seven out of nine documents falling within the scope of the second request, redacting personal data and the Member State’s positions.

No confirmatory applications were submitted for these three requests.

Finally, in reply to a question from the Ombudsman inquiry team, the Commission representatives refrained from commenting on the General Court’s Pollinis judgment[11]. They said that the Commission reserves its position until the Court of Justice has decided on the Commission’s appeal of the judgment.

Conclusion of the meeting

The inquiry team thanked the Commission’s representatives for their time and for the explanations provided, and the meeting ended.

Brussels, 29 November 2023

 

Michał Krajewski                                                                                                                                      Jennifer King

Inquiries Officer                                                                                                                                        Legal Expert

 

[1] Regulation 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, OJ L 396/1, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02006R1907-20140410

[2] Article 4.8 of the European Ombudsman’s Implementing Provisions.

[3] Directorate General for Agriculture and Rural Development.

[4] Directorate General for Justice and Consumers.

[5] Composed of Member States representatives as part of the “comitology” procedure.

[6] Judgment of the General Court of 7 March 2019 Case T-837/16, and Judgment of the Court of Justice of 25 February 2021, Sweden v Commission, Case C-389/19,

https://curia.europa.eu/juris/document/document.jsf?text=&docid=211428&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=561546; Judgment of the Court of Justice of 20 April 2023, Parliament v Commission, Case C-144/21, https://curia.europa.eu/juris/document/document.jsf?text=&docid=272682&pageIndex=0&doclang=en&mode=req&dir=&occ=first&part=1&cid=480945

[7] Judgment of the General Court of 7 March 2019, Sweden v Commission, Case T-837/16, paras 74-76, https://curia.europa.eu/juris/document/document.jsf?text=&docid=211428&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=561546

[8] Ibid.

[9] A Group of Competent Authorities for Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) and Classification, Labelling and Packaging, https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&do=groupDetail.groupDetail&groupID=2385

[10] Available at https://www.ombudsman.europa.eu/en/case/en/63908

[11] Judgment of the General Court of 14 September 2022, Pollinis France v. European Commission, https://curia.europa.eu/juris/document/document.jsf?text=&docid=265442&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=566540