Made in accordance with Article 4(1) of the Statute of the European Ombudsman^[1].

Background

Public consultation

1. In September 2022, the European Ombudsman organised a public consultation on transparency and participation in EU environmental decision-making.[2] One of the issues brought to the Ombudsman’s attention concerned delays and limited transparency in the risk management of dangerous chemical substances by the European Commission.[3]

The risk regulation of chemical substances in the EU

2. The production, marketing and use of chemical substances in the EU is governed by the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (the ‘REACH Regulation’).[4] The REACH Regulation aims to ensure a high level of protection of human health and the environment from chemical substances, while ensuring their free movement in the EU.

3. The REACH Regulation was designed to shift the burden of proof from regulators to industry. It obliges companies to generate information on the chemicals they produce or import to the EU, in line with its principle of ‘no data, no market’.[5] Companies must register information on chemicals with the European Chemicals Agency (ECHA). Based on this information, the Commission can decide to restrict certain uses of dangerous substances or subject certain substances to prior authorisation. ECHA and national authorities take part in the decision-making process concerning these issues. In particular, substances subject to prior authorisation[6] are first identified by ECHA as ‘substances of very high concern’. This designation requires a thorough scientific assessment and a unanimous agreement of the members of ECHA’s ‘Member State Committee’.[7]

Individual authorisations of particularly dangerous chemical substances

4. Companies that wish to use ‘substances of very high concern’ must apply to the Commission for authorisation. They must demonstrate either that the risks to public health and the environment resulting from the use of the relevant substance are adequately controlled (the ‘adequate control route’)[8] or that the socio-economic benefits of the continuous use outweigh the risks and that there are no suitable alternative substances or technologies (the ‘socio-economic route’).[9]

5. Two expert committees of ECHA, composed of independent experts,[10] provide the Commission with scientific and technical advice as to whether an application fulfils the conditions for authorisation: the Risk Assessment Committee (RAC) and the Socio-Economic Assessment Committee (SEAC). Based on that advice, the Commission presents a draft decision on the application for authorisation to the ‘REACH Committee’,[11] composed of Member State representatives, which votes on the draft decision.

6. In this context, the European Parliament and a Member State recently brought two cases before the EU Courts, in which they disagreed with the assessment of the Commission and the majority of members of the REACH Committee that applications for authorisation had fulfilled the conditions.

7. In the relevant judgments, the EU Courts held that the conditions must be interpreted in a restrictive way. They annulled two decisions in which the Commission had authorised the use of certain substances via the socio-economic route. In one case, the Court found that the Commission had not properly taken into account the uncertainty about risks stemming from the use of the relevant substance. This uncertainty was due to the fact that the applicant had failed to provide sufficient information.[12] In the other case, the Court found that the Commission had not properly considered available reliable information about the existence of suitable alternatives to the use of the relevant substance. This information had been made available to the Commission by third parties and Member States.[13]

8. The EU Courts noted  that applicants are responsible for providing the relevant information in their applications. This is because a company that submits an application within a deadline specified in accordance with the REACH Regulation may continue using the substance covered by the application as long as the decision-making process is ongoing.[14] During this time, additional conditions and monitoring arrangements that the Commission may determine in its final decision are not yet applicable.[15] This is why it is particularly important that the Commission decides on applications for authorisation promptly.

Delays and lack of transparency of the decision-making procedures

9. In reply to the public consultation, concerns were brought to the Ombudsman’s attention about the time that it takes the Commission to complete the risk management processes under the REACH Regulation. In particular, while the Commission should prepare draft decisions granting or refusing authorisation to use substances of very high concern within a three-month deadline of receiving the opinions of RAC and SEAC,[16] in practice it may take the Commission several years. Specific files were brought to the Ombudsman’s attention in that regard. It was considered that such time frames are excessive in light of the urgency of the matter and the fact that the Commission decides based on comprehensive expert advice.

10. Concerns were also expressed that there is insufficient information in the public domain that would allow the public to understand the causes of the delays.

11. The Ombudsman takes this matter very seriously. In one of her previous cases, she called on the Commission to demonstrate “a greater sense of urgency” and to complete its decision-making processes concerning the risk management of dangerous chemicals more rapidly.[17] To achieve the fundamental goals of the REACH Regulation, that is, to protect human health and the environment from chemical substances, it is in the public interest that this regulation be implemented in full and in a timely way.

12. Against this background, the Ombudsman decided to open an own-initiative inquiry to examine the delays in the Commission’s procedures for managing particularly dangerous chemical substances. As the procedures for granting or refusing individual authorisations constitute the biggest share of procedures under the REACH Regulation, the Ombudsman focused the inquiry on this procedure. In particular, the Ombudsman aimed to assess whether the Commission seeks to complete the decision-making processes with the requisite urgency. Moreover, she sought to assess the transparency of these processes, including whether the public can follow the decision-making process and understand the reasons for any delays.

The inquiry

The steps taken by the Ombudsman

13. The Ombudsman first asked the Commission to provide statistical data regarding the time it takes to complete the authorisation procedure.[18] The Ombudsman also asked the Commission for information on the process it follows when deciding on authorisation applications and what information it makes available concerning that process in the ‘Comitology Register’[19].

14. The Ombudsman inquiry team held two meetings with representatives of the Commission to discuss these issues.[20]

15.  The Ombudsman inquiry team also inspected the files concerning a sample of 12 applications for authorisation submitted to the Commission.[21]

Commission’s replies to the Ombudsman

Statistical data provided by the Commission

16. The Commission provided the Ombudsman with the following information regarding the time it takes to complete the authorisation procedure since the REACH Regulation has entered into force.

17. It took the Commission, on average, 14.5 months to present a draft decision to the REACH Committee[22], whereas the statutory time limit is three months. The delays in some cases were much longer.^[23]

18. Overall, after receiving the opinions of RAC and SEAC, it may take up to twelve months to adopt the decision, whereas in other cases it has taken more than 30 and up to 54 months to complete the authorisation procedure. This is illustrated in the following table.

Causes for delays encountered by the Commission in the authorisation procedure

19. The Commission said that the three-month time limit set out in the REACH Regulation to draft decisions after receiving RAC and SEAC opinions is unrealistic to attain in practice, given the complexity and number of applications it receives. In addition, delays in the authorisation procedure are caused by the following factors:

• Two directorates-general of the Commission are jointly responsible for processing the files under the REACH Regulation, including drafting authorisation decisions, that is, the Directorate-General for the Environment (‘DG ENV’) and the Directorate-General for the Internal Market, Industry, Entrepreneurship and SMEs (‘DG GROW’). The Commission acknowledged that this is an unusual arrangement, which generates the need for internal discussion between the two DGs. While the Commission put in place internal measures in 2018 to respect the three-month statutory deadline, these arrangements have proved effective only for non-controversial files.
• The Commission must take a broader view on applications than RAC and SEAC, which focus on scientific and technical issues. The Commission does not just “copy-paste” their opinions in its decisions. Rather, it must verify the consistency, robustness and completeness of these opinions, and elaborate on the reasoning of RAC and SEAC. It must sometimes explore why RAC and SEAC treat similar applications differently. Also, some additional elements such as the review period, conditions and monitoring arrangements often require further discussions.

The Commission added that, according to case law, it must gather and assess all relevant evidence and information on its own motion, whereas the applications are not always sufficiently complete and, consequently, RAC and SEAC opinions may not be clear regarding, for instance, the existence of alternatives.

• In a number of cases, the Commission had to contact the companies applying for authorisation to obtain additional information. In this context, the Commission explained that the application’s ‘conformity’ check conducted by ECHA only involves a verification of whether “all the boxes have been ticked”, that is, whether the application contains all the required elements, but this check does not concern the sufficiency or quality of the information provided. In some cases, the Commission therefore had to go back to RAC and SEAC and await supplementary opinions, in light of the additional information it obtained.
• In recent years, ECHA and the Commission have unexpectedly received large batches of applications in relation to certain substances, which have exceeded their capacity.
• The Commission had to put on hold all pending files, while awaiting important judgments in the two cases mentioned above.[24] Subsequently, additional time was needed to establish a common understanding of the rulings among the Commission departments and members of the REACH Committee.
• The European Parliament adopted several resolutions calling on the Commission to withdraw its draft authorisation decisions, which resulted in further discussions, thereby slowing down the process.
• There are lengthy deliberations within the REACH Committee, which contribute to the overall delays in the authorisation procedure. The Commission mentioned several elements that prolong the discussions within the REACH Committee, such as the late submission of comments by Member States. The Commission shared measures it has undertaken to address these elements with the Ombudsman on a confidential basis.

Transparency of ‘comitology’ procedures

20. The Commission stressed that, according to the rules of procedure of the REACH Committee, the deliberations of the REACH Committee are confidential.^[25] In the past, the Commission was criticised for delays in publishing the summary records of its meetings, whereas current summary records can be validated and published in a short time frame. However, the Commission is willing to examine a new format, provided that this new format respects the confidential nature of the Committee’s meetings.

21. The Commission added that it has received few requests for public access to documents related to the REACH Committee, which it interprets as meaning that the existing transparency standard is sufficient. It further added that it refused to grant public access to the results of a vote by the REACH Committee, including how specific Member States voted, and to its correspondence with a particular Member State. In replying to those requests, the Commission invoked the exception to public access, which concerns the protection of an ongoing decision-making process.^[26]

The Ombudsman's assessment leading to a recommendation

22. Applications for authorisation concern ‘substances of very high concern’, which may be carcinogenic, mutagenic, toxic for reproduction, or have endocrine disrupting properties. They may also be persistent, bioaccumulative and toxic. Not only the Commission itself, but also ECHA and national authorities, including scientific experts, jointly contribute to the procedure in which specific ‘substances of very high concern’ are subjected to authorisation under the REACH Regulation. This procedure usually requires many years to complete.

23. A company that submits an application for the authorisation of a particularly dangerous substance within a deadline specified in accordance with the REACH Regulation may continue to use this substance as long as the decision-making process is ongoing. During this time, additional conditions and monitoring arrangements that the Commission may define in its final decision are not yet applicable.

24. In view of this, the Commission must do its utmost to ensure that the authorisation procedure is conducted as swiftly as possible, so that particularly dangerous substances are not used in the EU without a prior verification of the requirements established by the REACH Regulation, as well as without applying appropriate conditions and monitoring arrangements.

Delays encountered by the Commission in the authorisation procedure

25. The Commission is encountering significant delays in drafting decisions on applications for authorisation, after receiving the opinions of RAC and SEAC. While the REACH Regulation sets a time limit of three months for the Commission to prepare a draft decision granting or refusing authorisation,^[27] it takes the Commission on average 14.5 months. This is almost five times the statutory time limit. The Ombudsman is very concerned about these delays.

26. The Ombudsman is not convinced by the Commission’s position that it cannot comply with the statutory time limit of three months to draft a decision. She will deal, in turn, with the arguments put forward by the Commission.

1. Internal organisation

27. The Commission cannot justify non-compliance with mandatory statutory time limits, by reference to its internal organisation, the need to hold lengthy internal discussions or by the fact that its procedure for launching the inter-service consultation takes in practice several weeks. The Commission must organise its internal procedures in a way that ensures compliance with statutory time limits.

2. Serious uncertainty and insufficient information in applications

28. While the Ombudsman acknowledges that the assessment of applications in the authorisation process can be complex and uncertain, the case law does not require “absolute certainty” from the Commission.[28] In any case, serious uncertainty should result in the dismissal of the respective application, rather than in delays. Serious uncertainty means that applicants have failed to convince the decision maker that they have met the conditions under the REACH Regulation. In accordance with case law, the Commission can accept only ‘negligible’ uncertainty in the information provided by the applicants when granting an authorisation.[29] That uncertainty is ‘negligible’ should be evident to the decision makers. Persistent doubts in this regard mean that the uncertainty is not negligible.   

29. As the Commission acknowledged itself, it cannot seek additional information “aimed at remedying incomplete applications where the conditions for authorisations are not met”, given that the burden of proof rests with the applicants.[30] Indeed, it is not clear to the Ombudsman that the Commission can, under the REACH Regulation, request additional information from applicants after the deadline for submitting the applications has elapsed and, in any case, after RAC and SEAC have finalised their opinions. The Commission itself took this view in one of its decisions, examined in the context of this inquiry. Accepting late information, according to the Commission, would result in a substance of very high concern remaining on the market for longer or without conditions, which would amount to “an abuse of process”.^[31]

30. When faced with a significant surge in the number of applications, as happened in the past, the Commission should strictly adhere to the principle that it is up to the applicant to demonstrate that they have fulfilled the conditions for authorisation under the REACH Regulation.^[32] As the EU Courts made clear, the applicant “bears the risk of any impossibility of establishing” that the conditions are fulfilled.^[33]

31. However, at present, the initial check of applications by ECHA consists only of checking whether “all the boxes have been ticked”. It therefore cannot be ruled out that some applicants exploit the possibility to continue using dangerous substances by submitting applications containing information that is insufficient to conclude whether the legal conditions for authorisation are met. The Ombudsman inspected the files concerning twelve authorisation procedures. Based on that, she is concerned that serious doubts as to whether the applicants have discharged their burden of proof dragged on in some of these procedures rather than being solved at the outset.

32. The Ombudsman understands that it may not be easy to draw a clear distinction between applications containing insufficient information and applications containing complete information that may nonetheless lead to doubts at a later stage among decision makers. However, the Commission should take stock of its existing experience and seek to determine which applications should be considered as containing insufficient information and, as such, promptly dismissed.

33. In practice, the Commission, which bears the overall responsibility for compliance of the authorisation procedure with the REACH Regulation, could consider asking RAC and SEAC to flag to it any applications containing insufficient information at an early stage, so as to allow the Commission promptly to dismiss these applications. This approach would not require any amendment of the REACH Regulation.[34] On the contrary, the REACH Regulation already requires RAC and SEAC to check that “the application includes all the information specified in Article 62 that is relevant to its remit”.[35] RAC and SEAC should thus verify that applications include “all the information”, which is more than checking whether “all the boxes have been ticked”.

34. This approach appears in line with recent case law. The reason for annulling the Commission decision in one of the recent cases was that the Commission had not taken into account that the application had too many shortcomings to allow the level of risk to be assessed, as clearly flagged by RAC in its opinion.[36] Identifying such cases at an early stage would allow the Commission to avoid lengthy discussions first among its departments and then within the REACH Committee.

3. The requirement to take into account all relevant information on its own motion

35. The Commission receives comprehensive expert opinions from RAC and SEAC, which, as the Commission acknowledged, in principle provide it with all the necessary scientific and technical support. The Commission shared its internal guidelines for drafting the decisions by DG GROW and DG ENVI, according to which they should in principle follow the opinions of RAC and SEAC. In this context, there should be no place for systemic disagreements between the Commission departments lasting for months, let alone years.

36. Although the Commission is not legally bound by the opinions of RAC and SEAC, it cannot depart from them arbitrarily. It must first obtain a “supplementary opinion from the same committee or other evidence, whose probative value is at least commensurate with that of the opinion concerned”.[37] The Ombudsman understands that the Commission has not yet made use of this possibility.

37. The Commission further insisted that it needs additional time because, according to case-law, when assessing applications for authorisation it must take into account all relevant information on its own motion.[38] However, the EU Courts stressed this duty of the Commission when they annulled an authorisation granted by the Commission on insufficient grounds. In that case, the Commission validated the information provided by the applicant and assessed by RAC and SEAC, without taking into account other reliable information about the existence of suitable alternatives provided by third parties and Member States.[39] That the Commission must take into account all relevant information on its own motion does not mean that it must undertake supplementary scientific investigations, as the Commission itself acknowledged in the context of this inquiry. In practice, as noted above, the Commission relies on the opinions of RAC and SEAC, which is in line with the case law.[40]

38. The Commission says it needs to take a broader view on applications than RAC and SEAC. However, the delays in the Commission’s process defy the main purpose of the REACH Regulation, which is the protection of human health and the environment.[41] According to case law, “considerations relating solely to the competitiveness of EU industry cannot justify authorising the use of a substance of very high concern for human health and the environment which is not strictly necessary”.[42] In particular, the Commission should ensure a prompt handling of applications for authorisation by rigorously verifying whether the applicants have fulfilled their duty to provide the necessary information.

4. Pending court cases

39. Pending court cases cannot justify the significant and systemic delays encountered by the Commission in complying with the statutory time limit of three months for presenting a draft decision to the REACH Committee. Litigation and the implementation of case law is an ordinary activity for EU institutions and bodies. The fact that the EU Courts came to a stricter interpretation of the REACH Regulation than the one used by the Commission makes it an even more urgent task for the Commission to implement this approach to protect public health and the environment.

40. In view of the above, the Ombudsman considers that the systemic failure by the Commission to comply with the statutory three-month time limit to present draft decisions to the REACH Committee constitutes maladministration.

41. These delays seem largely due to the manner in which  the Commission has organised its internal procedures, how it has allocated the responsibilities to its departments, and that it has not put in place a mechanism for ensuring that it can systematically, and at an early stage, reject applications that contain insufficient information to prove that the legal conditions for authorisation under the REACH Regulation are satisfied (the burden of proof). The Ombudsman will make a corresponding recommendation below.

42. The Ombudsman is also concerned about the time that it takes to complete the authorisation procedure, that is, to adopt the decision, once the Commission has presented its draft decisions to the REACH Committee. The Ombudsman stresses that administrative procedures, in particular those that are paramount for the protection of the environment and public health, must be completed promptly.

43. According to the information provided by the Commission[43], only 20% of the authorisation procedures (38) were completed within 12 months of receiving the opinions of RAC and SEAC. The remaining 80% (151) took much longer, and up to 54 months. Moreover, in the same period, 31 procedures were open for more than 18 months already.

44. These timeframes in no way reflect the urgency of the matter and cannot be considered good administrative practice.

45. While the Commission cannot be held to account for delays occurring due to disagreements between Member States in the REACH Committee, the Commission must make every effort to support the efficiency of deliberations within the REACH Committee and reduce the likelihood of long-running disagreements to enable the REACH Committee to complete the procedure promptly.

46. The Ombudsman welcomes the specific steps undertaken to date by the Commission to make the deliberations within the REACH Committee more efficient and reduce the need for a second meeting on the same file. That said, she considers that a mechanism, which she recommends below, enabling the Commission to reject applications that contain insufficient information systemically and at an early stage, will also reduce the need for lengthy deliberations within the REACH Committee on applications raising serious uncertainties due to insufficient information.

Transparency of ‘comitology’ procedures

47. The Commission is responsible for making sure that the meetings of the REACH Committee are transparent. The public must be in a position to scrutinise the causes of the excessive time that it takes to complete the authorisation procedure and to hold the relevant actors to account, not only the Commission, but also the Member States in the REACH Committee.

48. The Ombudsman disagrees with the Commission’s view that the low number of requests for public access to documents related to the REACH Committee means that there is low public interest in the authorisation procedure and that current transparency practices are satisfactory. A low number of requests might also mean that procedures are so opaque that the public does not even know of the documents’ existence or that informed public access applicants are well aware of the Commission’s position that the documents related to the REACH Committee are deemed confidential.

49. The Ombudsman has consistently reminded the Commission[44] that the rules of procedure of the ‘comitology’ committees do not prevail over the EU legislation on public access to documents. This has been confirmed by the General Court[45]. In order to justify a refusal to disclose such documents, the Commission must present tangible evidence of a concrete risk to a specific decision-making process. The Commission cannot use generic arguments, such as that the decision-making within the REACH Committee is always particularly controversial. Moreover, the documents produced in the context of the authorisation process under the REACH Regulation should benefit from the wider public access granted to documents containing environmental information.[46]

50. The inquiry found that, currently, the Commission does not publish information which would allow the public to understand the causes of the excessive timeframes in the authorisation procedure, including when these are due to disagreements among the actors involved. In particular, the summary records of the REACH Committee meetings do not currently capture the state of play of individual files and the reasons for possible delays, such as disagreements among Member States. This prevents the public from holding those responsible to account. The Ombudsman considers that this constitutes maladministration and makes a corresponding recommendation below.

Recommendation

On the basis of the inquiry into this complaint, the Ombudsman makes the following recommendation to the Commission:

The Commission should comply with the statutory deadline of three months for preparing authorisation decisions concerning dangerous chemical substances under the REACH Regulation and presenting them to the REACH Committee. To attain this, the Commission should:

• review its internal procedures,
• apply the rule that it is up to applicants to demonstrate that they have satisfied the legal conditions for obtaining the authorisation by providing sufficient information,
• ensure that applications containing insufficient information are promptly dismissed, so that the companies that have submitted those applications can no longer use the dangerous substances in the EU.

The Commission should publish more substantial summary records of the REACH Committee meetings, so as to allow the public to follow the progress of each authorisation file, understand outstanding issues and any reasons for delays. A good example could be the summary records of the SCoPAFF Committee.^[47] These records should be published in a timely manner and in any case before the next meeting of the REACH Committee.

The Commission and the complainant will be informed of this recommendation. In accordance with Article 4(2) of the Statute of the European Ombudsman, the Commission shall send a detailed opinion by 17 January 2025.

 

Emily O'Reilly
European Ombudsman

Strasbourg, 17/10/2024

 

[1] Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.253.01.0001.01.ENG&toc=OJ%3AL%3A2021%3A253%3ATOC

[2] https://www.ombudsman.europa.eu/en/public-consultation/en/160313

[3] The reply to question no 5 in https://www.ombudsman.europa.eu/en/doc/correspondence/en/169594.

[4] 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.

[5] Article 5 of the REACH Regulation.

[6] Annex XIV to the REACH Regulation sets out the list of particularly dangerous substances subject to authorisation. See also, Article 56 of the REACH Regulation.

[7] Article 59 of the REACH Regulation.

[8] Article 60(2) of the REACH Regulation.

[9] Article 60(4) of the REACH Regulation.

[10] Article 85(7) of the REACH Regulation.

[11] Article 64(8) and 133(3) of the REACH Regulation.

[12] Case C-144/21, Parliament v Commission, paragraph 68, https://curia.europa.eu/juris/document/document.jsf?text=&docid=272682&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=4701.

[13] Judgment of 7 March 2019, 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.

Judgment of 25 February 2021, 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.

[14] Article 58(1)(c)(ii) of the REACH Regulation. The deadline is 18 months before the so-called ‘sunset date’, from which the placing on the market and the use of the substance is prohibited.

[15] Article 60(9)(d) and (f) of the REACH Regulation.

[16] Article 64(8) of the REACH Regulation.

[17] Decision of the European Ombudsman closing own-initiative inquiry OI/2/2016/RH concerning delays by the European Commission in processing files on the reproductive toxicity of chemical substances, paragraph 27, https://www.ombudsman.europa.eu/en/decision/en/81645.

[18] See the written replies of the Commission: https://www.ombudsman.europa.eu/en/doc/correspondence/en/174970 and https://www.ombudsman.europa.eu/en/doc/correspondence/en/189320.

[19] https://ec.europa.eu/transparency/comitology-register/screen/committees/C34200/consult?lang=en.

[20] See reports from these meetings: https://www.ombudsman.europa.eu/en/doc/inspection-report/en/178826 and https://www.ombudsman.europa.eu/en/doc/inspection-report/en/191331.

[21] See the request for inspection (Annex 1), https://www.ombudsman.europa.eu/en/doc/correspondence/en/178825.

[22] The information was provided in February 2024.

[23] https://www.ombudsman.europa.eu/en/doc/correspondence/en/189320, p. 2.

[24] Case T-837/16, Sweden v Commission; Case C-389/19 P, Commission v Sweden; Case C-144/21, Parliament v Commission.

[25] See Article 13 of the Rules of Procedure for the REACH Committee adopted on 19.11.2019 available here: https://ec.europa.eu/transparency/comitology-register/screen/committees/C34200/consult?lang=en.

[26] https://www.ombudsman.europa.eu/en/doc/inspection-report/en/178826, point 9.

[27] Article 64(8) of the REACH Regulation.

[28] Case C-389/19 P, Commission v Sweden, paragraph 32.

[29] Case C-389/19 P, Commission v Sweden, paragraph 35.

[30] https://www.ombudsman.europa.eu/en/doc/correspondence/en/189320, p. 4.

[31] Commission Implementing Decision of 3.2.2022, C(2022) 523 final, https://ec.europa.eu/docsroom/documents/48874, para 8.

[32] Case T-837/16, Sweden v Commission, paragraph 77; Case C-389/19 P, Commission v Sweden, paragraph 33.

[33] Case T-837/16, Sweden v Commission, paragraph 79.

[34] RAC has already adopted a procedure for dealing with certain applications in a ‘fast-track’ procedure, that is, without a plenary debate: https://echa.europa.eu/documents/10162/13580/afa_a_listing_criteria_en.pdf/ed59cbc5-b814-43ef-a6cb-0512e3ec4e36.

[35] Article 64(3) of the REACH Regulation.

[36] Case C-144/21, Parliament v Commission, in particular paragraph 68.

[37] Case T-837/16, Sweden v Commission, paragraph 69.

[38] Case T-837/16, Sweden v Commission, paragraph 64.

[39] As the Court held in that case, “the views of the third parties and Member States heard during the authorisation procedure [which] cast serious doubts on the analysis presented by the applicant for authorisation”. Case T-837/16, Sweden v Commission, paragraph 89.

[40] Case T-837/16, Sweden v Commission, paragraph 67.

[41] Judgment of 7 July 2009, Case C-558/07, S.P.C.M. and Others, https://curia.europa.eu/juris/document/document.jsf?text=&docid=77548&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=4122482, paragraph 45; judgment of the General Court of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, https://curia.europa.eu/juris/document/document.jsf?text=&docid=134564&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=4122664, paragraph 116.

[42] Case C-144/21, Parliament v Commission, paragraph 126.

[43] The information was provided in February 2024.

[44] Recommendation of the European Ombudsman in case 2142/2018/TE on the European Commission’s refusal to grant access to Member State positions on a guidance document concerning the risk assessment of pesticides on bees, https://www.ombudsman.europa.eu/en/recommendation/en/113624.

[45] Judgment of 14 September 2022, Joined Cases T-371/20 and T-554/20, Pollinis France v Commission, https://curia.europa.eu/juris/document/document.jsf?text=&docid=265442&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=4098652, paragraph 96.

[46] Article 6 of Regulation 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies, OJ L 264/13, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32006R1367.

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