Date: Wednesday, 29 May 2024

Remote arrangements

Webex meeting

Present

European Commission

DG GROW

Head of Unit GROW.DDG2.F.1 - REACH

Legal and Policy Officer - Chemicals GROW.DDG2.F.1 - REACH

Legal Officer - Chemicals GROW.DDG2.F.1 - REACH

Senior Expert GROW.DDG2.F.1 - REACH

Head of Sector - Inter-institutional relations GROW.D.4.001 - Inter-Institutional Relations

DG ENVI

Deputy Head of Unit - Chemicals ENV.B.2 - Safe & Sustainable Chemicals

Policy Officer - Chemicals in particular REACH - ENV.B.2 - Safe & Sustainable Chemicals

Legal Officer - Chemicals in particular REACH and Use of animals for scientific purposes - ENV.B.2 - Safe & Sustainable Chemicals

SG

Senior Expert - Coordinator for inter-institutional Relations - relations with the European Ombudsman - SG.DSG1.C.2 - Ethics, Good Administration & Relations with the European Ombudsman

European Ombudsman

Jennifer King - Legal Expert

Tanja Ehnert - Inquiries Coordinator

Michał Krajewski - Inquiries Officer

Anežka Hlinovská - Inquiries Trainee

Purpose of the meeting

The purpose of the meeting was for the Ombudsman inquiry team to discuss preliminary findings of the inquiry. The inquiry team had identified three broad issues and a number of specific questions on which it requested further clarifications.

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, notably to any person outside the Ombudsman’s Office, without the Commission’s prior consent.^[1]

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 made public or provided to any third party.

Information exchanged

Whether the Commission has put in place administrative arrangements for promptly drafting proposals based on the expert advice it receives from the European Chemicals Agency

The Ombudsman inquiry team clarified that the questions focus primarily on individual authorisations, as it understood that those are the most numerous files, affecting the efficiency of the entire decision-making system under the REACH Regulation.[2]

It further noted that, from the inspection of files, it appeared that the Commission does not depart from the opinions of the committees of the European Chemicals Agency (ECHA) - the Committee for Socio-Economic Analysis (SEAC) and the Committee for Risk Assessment (RAC) - regarding whether the conditions for granting authorisations under the REACH Regulation are met. Rather, the Commission summarises the opinions of the ECHA committees and broadly concurs with them. The inquiry team referred to one of the written replies provided by the Commission in the context of this inquiry, namely that ECHA opinions “are conceived as to provide the Commission with all the necessary technical and scientific support for the decision-making, thus there is usually no need of additional information to be provided”. Therefore, the inquiry team asked why it is not possible for the Commission to comply with the time limit of three months, as set out in the REACH Regulation, to present a draft authorisation decision to the REACH Committee. Moreover, the inquiry team asked what measures had been put in place to enable the Commission to meet the statutory time limit of three months.

The Commission representatives stated that the Commission has put in place specific Working Arrangements in 2018, which define the workflow and include relevant deadlines for each step in the process. These deadlines were designed to respect the three-month time limit imposed by the REACH Regulation on the Commission for presenting a draft decision to the REACH Committee.

However, in relation to processing proposals for restrictions upon hazardous chemical substances, these deadlines have proven to be unrealistic in light of the increasing complexity of the proposals.[3] Proposals for restrictions covering broad scope of substances have been emerging.[4] There have also been proposals including new kinds of regulatory duties, such as training requirements,[5] and proposals for restrictions upon a wide range of uses of substances[6]. Such complex files require more thorough analyses and discussions. Also, in some cases, stakeholders raise concerns based on new information that the ECHA committees have not considered in the opinions submitted to the Commission. In such situations, more discussion within and among the Commission departments is needed. Moreover, it has not been possible to speed up the process of obtaining formal agreements to launch the inter-service consultation of draft acts prepared by the Commission’s Directorate-General for the Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) and the Directorate General for the Environment (DG ENV). This process of obtaining formal agreements to launch the inter-service consultation usually takes 4 to 6 weeks. Finally, the Commission staff responsible for restriction files has recently been heavily involved in the revision of the REACH Regulation. Nonetheless, this revision should allow some of the substantive and procedural issues encountered in processing restriction files to be resolved.

Furthermore, the Commission representatives noted that, concerning restriction files, some of the deadlines set by the REACH Regulation may have been feasible at the time when this regulation was adopted but, in view of the current internal procedures, they are not feasible anymore. The complexity of the cases and the impact of restrictions on stakeholders have become far greater than before. In addition, restrictions often have a political dimension and the College of Commissioners must agree on the approach taken, which can take time.

With regard to the individual authorisations of uses of chemical substances ‘of very high concern’[7], the Working Arrangements have proven effective for most non-controversial files. They have helped structure and rationalise the drafting process and exchanges between DG GROW, DG ENV and other Commission departments, especially the Legal Service, as well as with Member States. They have enabled agreements to be reached on draft decisions in all but one file, in which there were exceptional internal disagreements and diverging views. However, they have not speeded up the process of obtaining formal agreements to launch the inter-service consultation, which still takes between 4 to 6 weeks, just like in the case of restrictions. Also in the case of authorisations, the deadline of three months to draft a decision based on the ECHA opinions, as laid down in the REACH Regulation, is inadequate and should be extended significantly.[8]

Moreover, the Commission representatives explained that delays in drafting authorisation decisions have been caused by several factors.

First, the Commission was awaiting important judgments of the Court in two cases.[9] Subsequently, the Court’s stricter interpretation of the REACH Regulation required extensive discussions between the Commission departments. All pending files had to be put on hold until a common understanding of the judgments was established among the Commission departments and members of the REACH Committee. Also, in a number of cases it was necessary to contact the companies applying for authorisation to obtain additional information. That information then needed to be first assessed by the ECHA committees before the Commission could take it into account in its decisions.

Second, as a knock-on effect of the Court’s recent case law, which provided a stricter interpretation of the conditions for authorisations under the REACH Regulation for applications submitted by operators up the supply chain, the Commission has received, starting from 2022, an increased number of applications from operators down the supply chain for the use of chromium(VI) substances (over 130 applications received, and more applications is expected). This is currently the most serious challenge for the authorisation process, both for the Commission and ECHA.

Third, the European Parliament adopted four resolutions objecting to draft authorisations, which resulted in further discussions among the Commission departments and members of the REACH Committee. These discussions slowed down the process because there were other files similar to those addressed by the Parliament. Those other files needed to be discussed as well.

Third, as of 2019, ECHA and the Commission have unexpectedly received large batches of applications for authorisation for uses of OPE[10] and NPE[11] (around 80 or 90 applications), which exceeded the capacity of both ECHA and the Commission. Those applications have created significant delays.

The Commission has tried to address the large number of applications concerning chromium(VI) proactively. It has mandated ECHA to initiate a restriction process to cover the relevant substances, so that these substances could be handled within a single restriction (with potential derogations) rather than multiple authorisations.[12] This approach would address the challenge that the Commission is facing in a structural manner.

The Commission representatives also mentioned that there is an internal discussion, in the context of the revision of the REACH Regulation, regarding what timeframe would be realistic for the Commission to draft and process decisions regarding restrictions or authorisations.

As regards whether the ECHA committees provide the Commission with all the necessary elements for its decision making, the Commission representatives confirmed that the Commission decision is based on the opinions of the ECHA committees. However, those opinions contain scientific and technical assessments, whereas the Commission needs to take a broader view, including legal and political aspects. The Commission is to conclude on whether the legal conditions for granting authorisations are met and, where it decides to grant authorisations,[13] it must also decide on the length of the review period and on the conditions and monitoring arrangements. The Commission does not just “copy-paste” ECHA opinions in its authorisation decisions. Rather, the Commission must elaborate on its reasoning and verify the consistency, robustness and completeness of the reasoning presented in the opinions of the ECHA committees. These tasks require time from economists, lawyers, and technical experts. Any deviations from what the ECHA committees have recommended must be thoroughly explained in the recitals of the Commission decisions. Often, the Commission must ‘fine-tune’ or adjust the relevant recommendations made by the ECHA committees. Crucially, the Commission must ensure that the decision is legally sound as it is challengeable before the Court. The Commission representatives highlighted that it is the Commission’s sole responsibility to decide if the conditions for authorisation are met.

The Commission must also ensure the equal treatment of applicants, who oftentimes submit similar applications. This is why a consistent approach across applications is necessary. An issue or a change occurring in one file requires a check for that issue in other files.[14] It is then necessary to find a common solution to those issues in order to be consistent.

The Ombudsman inquiry team asked about examples of cases in which the ECHA committees have already provided substantial input, but that still has required further elaboration by the Commission.

The Commission representatives explained that one of the most debated issues in the REACH Committee (especially for chromium(VI) cases) is the analysis of alternatives, notably the level of granularity required for the definition of a use and the corresponding analysis of alternatives.

Also, sometimes new, non-mandatory information has been requested from applicants, e.g. reduction figures of the volumes of the substance used over time, requiring additional work by the Commission.

The Commission representatives also mentioned that the length of the review period is another point that causes lengthy discussions. There are no criteria in the legislation for determining the review period. Article 60(4) requires that the duration of the review period is determined on a case-by-case basis taking into account all relevant information  including the elements listed in article 60(4)(a) to (d), as appropriate. The Commission sets the review period considering various elements taking into account RAC and SEAC opinions, such as whether a suitable alternative is available in the EU and what the actual level of risk is. Due to frequent disagreements among the Member States, these discussions have been very challenging.

The Ombudsman inquiry team referred to the judgment in case T-837/16 Sweden v Commission, in which the General Court found that, if the Commission opts to depart from or substitute the opinion of ECHA, it must provide a statement of reasons “of a scientific level at least commensurate with that of the opinion in question”.[15] As the decisions of the Commission only refer to ECHA assessments, the inquiry team asked if other opinions were ever taken into account. The inquiry team also asked whether delays were also due to disagreements between the lead DG GROW and DG ENV.

The Commission representatives confirmed that the main basis for the Commission’s assessment are the ECHA scientific opinions. However, other elements of political or legal nature may also be taken into account and it is the Commission who decides if the conditions for granting an authorisation are met. Furthermore, the Commission decision is not only about whether the conditions for granting an authorisation are met. The Commission decides on each element of the authorisation decision, which includes the review period, and potentially conditions and monitoring arrangements. Although a number of services is consulted in the inter-service consultations, the discussions take place mainly between the two lead DG GROW and DG ENV, but also with the Legal Service and, in some instances, with other relevant services. In any case, it is exceptional that the decision making would takes several years. These cases are often linked to the particularity and sensitivity of the subject matter.

The Commission representatives further specified that, specifically for authorisation cases, in certain applications obtaining a qualified majority in the REACH Committee has proven to be very difficult.[16] For that reason, additional time is necessary before presenting a draft text to the following REACH Committee meeting, also taking into account that substantial changes to the draft require a new inter-service consultation or at least a new informal consultation with the Legal Service. Moreover, according to the rules of procedure of the REACH Committee, draft decisions need to be made available at least 20 days prior to the meeting in order to be able to organise a voting.

The Ombudsman inquiry team asked if the Commission shares the preliminary draft decisions with the Member States before they are submitted to the REACH Committee.

The Commission representatives explained the process for the authorisation files. As soon as the drafts are ready after the inter-service consultation, they are shared with the Member States, at the latest 20 days before a meeting. If the drafts are ready long before that deadline, for example 2 months ahead of the meeting, the Commission shares the files for a ‘preliminary’ written commenting period to gather early orientations from the Member States.

The Commission representatives explained that its practice has not always been the same. Before 2021, some preliminary drafts would have been discussed with Member States before the launch of inter-service consultations (which today would be unmanageable, due to the number of files, changes, and comments).

The Commission also mentioned other examples of difficult discussions following the judgment Sweden v Commission.[17] While before the judgment it was considered that an alternative was suitable if it provided the same level of quality and performance, the Court took the view that also solutions with worse performance must be considered. Therefore, it now has to be determined how much ‘worse’ is acceptable and this can add to the delays in decision making.[18]

The Ombudsman inquiry team asked whether the Commission tries to resolve similar issues with the REACH Committee at an early stage of its decision making.

The Commission representatives said that it occasionally holds early consultations on challenging files. However, it explained that, at present, the Commission deals mostly with single-use downstream applications rather than broad upstream applications like in the past. Therefore, the current decision-making practice is different, as it involves a large amount of broad cross-cutting issues, given the similarities across files.

The Ombudsman inquiry team noted that, based on the inspected documents only, it is difficult to understand the exact working arrangements between the two Commission DGs. It would therefore be useful if the Commission could provide the Ombudsman inquiry team with documents setting out the internal procedure followed in any files concerning the implementation of the REACH Regulation, such as the 2018 Working Arrangements and the standard operating procedure for making drafts available to the REACH Committee, to better under the Commission’s workflow in practice.

Whether the Commission has put in place administrative arrangements for dealing with applications containing insufficient information

The Ombudsman inquiry team asked if there is a specific procedure for an initial check of applications, to ensure that they contain all the information required under Article 62 of the REACH Regulation and whether this information is of sufficient detail to enable a substantive assessment by the ECHA committees.

The Commission representatives explained that upstream applicants who submitted very broad applications in the past do not have the detailed information required under the REACH Regulation to demonstrate fulfilment of the conditions for granting an authorisation for the broad scope of such applications to the standard requested by the EU courts. Recent case law accepts only ‘negligible uncertainty’ as to the lack of alternatives. As a consequence, the Commission is now dealing mostly with much narrower but also much more numerous downstream applications, which have caused a significant backlog.

The Ombudsman inquiry team asked whether the case-law helps the Commission to dismiss insufficiently substantiated applications by operators up in the supply chain in a timely manner.

The Commission representatives clarified that this depends on each individual application. In a few cases, the recent case law has led to a swift refusal, but in many other cases, as mentioned above, the case-law triggered extensive discussions and delays. The discussions concerned, for example, how to address the level of performance, the level of granularity in the description of use, etc.).

The Ombudsman inquiry team asked whether the Commission would consider introducing a ‘fast-track’ procedure to dismiss applications that are clearly insufficiently substantiated, in order to reduce the workload of the Commission and of the REACH Committee.

The Commission representatives stated that this may require an amendment of the REACH Regulation. In any event, such an approach may not solve the problem, as it may only be apparent at a later stage of the decision making that certain Member States consider the applications too broad in scope or unsubstantiated. The conformity check conducted by ECHA only involves a verification of whether ‘all the boxes have been ticked’. However, even if the application conforms to all the formal requirements, it may not contain all the information necessary for a robust risk or socio-economic/alternatives assessment. It is thus the Commission’s sole responsibility to decide whether the information provided by the applicants is sufficient in light of the REACH requirements.

The Ombudsman inquiry team asked whether there have been any cases in which the evidence that the applicant provided in its application turned out to be manifestly insufficient and yet the application was considered ‘in conformity’, thereby giving to the applicant the benefit of continuous use during the Commission decision making.

The Commission representatives noted that there had only been one case of non-conformity so far. The ECHA committees and the Commission dealt with that application quickly, as, evidently, the required information was not provided.

As regards the discussions within the REACH Committee, the Commission representatives also said that the assessment of whether the uncertainty in the submitted scientific information is ‘negligible’ is not trivial. In any case, the Commission has always called upon ECHA to be as clear as possible in their opinions. Uncertainties concern in principle the existence of alternatives. The Commission representatives acknowledged that, although the threshold for refusing an authorisation might have ‘moved’ in view of recent judgments, a thorough assessment is still required.

Furthermore, they noted that a stricter approach may not necessarily relieve the decision-making process. On the contrary, the strict approach required by recent case-law has led to high numbers of granular downstream applications (instead of fewer broader upstream applications).

The Ombudsman inquiry team asked whether the Commission has estimated how many authorisations already granted may be affected by the deficiencies identified by the Court in the recent judgments,[19] and whether there is a need to re-assess these authorisations.

The Commission representatives explained that the granted authorisations are time limited unless a review report is submitted and, in that case, subject to a review before their potential extension. Therefore, although Article 61(2) of REACH allows for it, the Commission considered, after a careful assessment, that an early review in view of the recent case law was not necessary. In any case, such an assessment would take place for the cases in which a review report is submitted. Nonetheless, the Commission needed to scrutinise all pending applications for authorisation (more than 140). The outcome was that around 13 cases were considered non-compliant with the stricter requirements established in the recent judgments of the EU courts. The Commission will ask additional questions to the relevant applicants, which will add to the delays. This will also impact on applications currently processed by ECHA.

The Ombudsman inquiry team asked about the Commission’s approach to applications that turn out to be incomplete during the process.[20]

The Commission clarified that the information relevant for the discharge of the burden of proof, regarding core elements for granting an authorisation, needs to be submitted by the applicant before the end of the ECHA opinion making process. Remedying any shortcomings after this process is complete would constitute an abuse of process.

Nevertheless, the recent case law of the Court introduced new elements. The Court did not support the Commission’s earlier interpretation of the REACH Regulation. In particular, the submission of a substitution plan, as interpreted by the Court in the ‘lead chromate’ case, was not required by the Commission at the time of lodging the application. Or, in the ‘Chemservice case’ the level of granularity of the analysis of alternatives was not supported by the Court. This is why the Commission gave to the concerned applicants an opportunity to provide the missing information instead of dismissing their applications as ‘not in conformity’ with the requirements of the REACH Regulation (i.e. incomplete). Dismissing such applications would not be fair. The Commission applies now the same approach to the above-mentioned 13 applications identified as being non-compliant following the recent judgments, in light of which it is necessary to obtain additional information on the functionality and the level of performance of alternatives.

The Ombudsman inquiry team asked whether the assessment of this additional information is then dealt with as a matter of priority. In this context, the inquiry team referred to the delay in assessing the substitution plans in a case (ultimately that application was withdrawn many years after it had been lodged).

The Commission representatives explained that, like for the other 13 applications, the case referred to by the Ombudsman team had been the first case in which the SEAC committee assessed a substitution plan. The SEAC was faced with challenging questions especially regarding large upstream applications, which required further discussion also at the Commission stage.

The Ombudsman inquiry team asked whether the ECHA guidance is being updated in light of the recent case-law.

The Commission representatives replied that, regarding the substitution plans, the relevant ECHA guidance had already been updated, as well as the application template and the related Q&A. As regards the findings of the Court in Parliament v Commission,[21]  an update is underway. The Commission is in contact with ECHA to ensure that the new stricter requirements are formally included in the updated guidance, also providing a Q&A on the Commission’s website.

How the Commission ensures that the decision making in ‘comitology’ is prompt and transparent

The Ombudsman inquiry team asked about the elements that affect the pace of decision making within the REACH Committee.

The Commission representatives explained that there are several factors. Usually, the Commission uploads the draft authorisation decision for discussion within the REACH Committee three weeks in advance to enable Member States to submit comments. Those comments, however, are often received at the very last moment. Since the discussion within the REACH Committee is based on those comments, a second meeting is often required, especially for substantial comments, in order to fully process them.

The Ombudsman inquiry team asked about the role of the Appeal Committee in deciding on authorisations under the REACH Regulation, in cases in which the REACH Committee fails to adopt an opinion within a reasonable time frame.

The Commission representatives noted that the authorisation decisions follow the examination procedure, under which the Appeal Committee can only play a role once there has been a vote in the REACH Committee which is either negative or neither positive nor negative (‘no opinion’).

The Comitology Regulation requires the chair of the Committee to seek the widest possible support within the Committee.[22] The Commission representatives explained that the Commission always seeks a qualified majority. As long as there is a possibility to achieve this goal, it will continue the discussion within the REACH Committee.

The Commission representatives further noted that, in one case, after long discussions, it was clear that a qualified majority could not be reached. Whilst in that case they considered referring the matter to the Appeal Committee, in practical terms it appeared unlikely that the Appeal Committee would come to a different conclusion than the REACH Committee. More generally, it appears unlikely that the Appeal Committee could speed up the process.

The Ombudsman inquiry team asked the Commission whether it could publish more detailed summaries of the REACH Committee’s meetings. In that context, it referred to the summaries of the SCOPAFF Committee,[23] which mention that certain Member States expressed an opinion without mentioning concretely which Member States.

The Commission representatives noted that the advantage of the current summary records is that they can be drafted, validated and published in a short time frame. In the past, the Commission was criticised for delays in publishing the summary records. However, the Commission is willing to examine a new format, provided that it respects the confidential nature of the Committee meetings (as stated in its rules of procedure). The associated drafting and validation process would necessarily imply longer timeframes in which such summary records are published, compared to the current timeframes.

Conclusion of the meeting

It was agreed that the Commission will share with the Ombudsman inquiry team documents setting out the internal procedure followed in any files concerning the implementation of the REACH Regulation, such as the 2018 Working Arrangements and the standard operating procedure for making drafts available to the REACH Committee for the inquiry team to better understand the Commission’s decision-making process.

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

 

Brussels, 29/05/2024

JENNIFER KING                                                                                                                     MICHAŁ KRAJEWSKI

Legal Expert                                                                                                                            Inquiries Officer

 

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

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

[3] For example, during the first public consultation of the restriction concerning PFAS, ECHA received more than 5600 comments (as compared to circa. 600 comments on the similarly broad restriction on microplastics).

[4] For example, a restriction covering some 4000 substances in tattoo inks. See https://echa.europa.eu/hot-topics/tattoo-inks#:~:text=The%20use%20of%20more%20than,inks%20or%20permanent%20make%2Dup. See also https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/restrictions_en.

[5] For example, in the case of diisocyanates. See https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.252.01.0024.01.ENG&toc=OJ:L:2020:252:TOC.

[6] For example, the recent broad restriction on microplastics, covering many sectors. See https://ec.europa.eu/commission/presscorner/detail/en/ip_23_4581. See also https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/restrictions_en.

[7] Annex XIV to the REACH Regulation.

[8] Formal agreement for launching the inter-service consultations already takes 4-6 weeks, plus the inter-service consultation itself usually takes 4-6 weeks.

[9] Case T-837/16, Sweden v Commission, https://curia.europa.eu/juris/document/document.jsf?text=&docid=211428&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=4702  

Case C-389/19 P, Commission v Sweden, https://curia.europa.eu/juris/document/document.jsf?text=&docid=238162&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=4702

Case C-144/21, Parliament v Commission, https://curia.europa.eu/juris/document/document.jsf?text=&docid=272682&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=4701

[10] Octylphenol Ethoxylates.

[11] Nonylphenol Ethoxylates.

[13] In the so-called socio-economic route, it has broad discretion.

[14] For example, this occurred in the case of ECHA opinions on OPE/NPE.

[15] Case T-837/16, Sweden v Commission, https://curia.europa.eu/juris/document/document.jsf?text=&docid=211428&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=4702 , paragraph 69

[16] For example, for decorative uses of CrVI for the automotive sector.

[17] Case T-837/16 Sweden v Commission https://curia.europa.eu/juris/document/document.jsf?text=&docid=211428&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=4702

[18] This can be particularly challenging for substances used for decorative uses.

[19] See footnote 9.

[20] The Ombudsman inquiry team noted that, in one of its decisions, the Commission said: “Where an applicant has failed to discharge its burden of proof before the committees, the fact of the Commission sending additional information submitted to it after the opinion-making phase back to RAC and SEAC for additional opinions, or of otherwise taking that information into account, would allow an applicant to interrupt or delay (even repeatedly) a decision making procedure with the result that an SVHC remains on the market for longer, or without the conditions and measures that may be established under an authorisation decision, in case it is granted, with possible consequent risks to public health and/or the environment. Given that it was for the applicant to submit all relevant information as part of its application, this would also constitute an abuse of process”. See https://ec.europa.eu/transparency/comitology-register/core/api/integration/ers/225107/070377/4/attachment (recital 8).

[21] Case 144/21 Parliament v Commission https://curia.europa.eu/juris/document/document.jsf?text=&docid=272682&pageIndex=0&doclang=en&mode=req&dir=&occ=first&part=1&cid=480945

[22] Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers, Article 3(4)

[23] The Standing Committee on Plants, Animals, Food and Feed.