JUDGMENT OF THE GENERAL COURT (Tenth Chamber)
11 September 2024 (*)
( REACH – Compliance check of registrations – Substance 1,3-dioxo-2-benzofuran-5-carboxylic acid with nonan-1-ol – Articles 42 and 50 of Regulation (EC) No 1907/2006 – Principle of good administration – Proportionality )
In Case T‑29/22,
Polynt SpA, established in Scanzorosciate (Italy), represented by C. Mereu and I. Zonca, lawyers,
applicant,
v
European Chemicals Agency (ECHA), represented by L. Lourenço, W. Broere, F. Becker and L. Bolzonello, acting as Agents,
defendant,
THE GENERAL COURT (Tenth Chamber),
composed of O. Porchia, President, M. Jaeger (Rapporteur) and S. Verschuur, Judges,
Registrar: M. Zwozdziak-Carbonne, Administrator,
having regard to the written part of the procedure,
further to the hearing on 24 October 2023,
gives the following
Judgment
1        By its action under Article 263 TFEU, the applicant, Polynt SpA, seeks the annulment of the decision of the Board of Appeal of the European Chemicals Agency (ECHA) (‘the Board of Appeal’) of 9 November 2021 (‘the contested decision’) on the compliance check of the applicant’s registration dossier for the substance 1,3-dioxo-2-benzofuran-5-carboxylic acid with nonan-1-ol (‘the substance at issue’), dismissing its appeal against the follow-up decision of 30 June 2020 on the compliance check (‘the follow-up decision of 30 June 2020’), adopted following the compliance check decision of 18 December 2017 (‘the initial compliance decision of 18 December 2017’).
Background to the dispute
2        On 15 December 2014, the applicant submitted to ECHA a registration dossier for the substance at issue in the tonnage band of more than 1 000 tonnes.
3        On 19 December 2014, ECHA adopted a decision according to which, from a procedural perspective, the registration dossier was complete and, therefore, the applicant could manufacture the substance at issue. However, ECHA reserved the right to carry out a compliance check at a later stage as to the quality of the data submitted by the applicant in its registration dossier.
4        On 3 October 2016, in the context of a ‘Substance Information Exchange Forum’, the applicant and another company (‘the other registrant’) concluded an agreement, the prerequisite for which was the recognition of the sameness of the substance, registered with ECHA, which they produced.
5        On 30 November 2016, ECHA carried out a compliance check as to the quality of the data submitted by the applicant in its registration dossier.
6        On 20 December 2016, ECHA sent the applicant a draft decision on that compliance check, under Article 41(3) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, and corrigendum OJ 2007 L 136, p. 3; ‘the REACH Regulation’).
7        In accordance with Article 41(3) of the REACH Regulation, ECHA adopted the initial compliance decision of 18 December 2017, in which it considered that the applicant’s registration dossier did not contain adequate information and asked the applicant to carry out a series of studies and to submit the results thereof to it.
8        The initial compliance decision of 18 December 2017 required the applicant to submit a 90-day sub-chronic toxicity study by 3 January 2019 (‘the 90-day study’) as well as a number of other studies by 25 June 2021 at the latest. Appendix 3 to that decision stated that the sample used for the requested studies had to be suitable for use by ‘all the joint registrants’.
9        By letter of 19 December 2018, the applicant’s supplier informed the applicant that there had been a fire at a manufacturing plant in which it produced a component which it supplied to the applicant for the manufacture of the substance at issue, namely Linevol9 (that supplier’s trade name for alcohol C9), and that it had ceased production of that component.
10      On 3 January 2019, on expiry of the deadline for carrying out the 90-day study, the applicant, instead of submitting the results of that study to ECHA, submitted an adaptation of its registration dossier under Section 1.5 of Annex XI to the REACH Regulation, in the form of a read-across justification (‘the read-across justification’).
11      On 28 February 2019, after evaluating the read-across justification, ECHA informed the applicant, first, that that justification was not sufficient and, secondly, that it intended to adopt a follow-up decision, in accordance with Article 42(1) of the REACH Regulation.
12      On 3 May 2019, the applicant notified ECHA, by means of an update to its digital dossier, that it had ceased production of the substance at issue.
13      On 19 July 2019, ECHA sent a draft follow-up decision to the applicant under Article 42(1) of the REACH Regulation.
14      By letter of 27 August 2019, the applicant informed ECHA that it had ceased production of the substance at issue in May 2019, as it had indicated in the update to its digital dossier on 3 May 2019. Moreover, the applicant stated that the decision to cease production had been made as a result of a situation of force majeure, as its supplier had ceased the production of Linevol9, a component used in the manufacture of the substance at issue, due to a fire at one of its manufacturing plants. The applicant added that, although there were alternative components available on the market from other suppliers, none of them was technically equivalent to Linevol9 and that, therefore, any substance manufactured using an alternatively sourced component would be a new substance requiring registration. The applicant concluded by stating that production of the substance had ceased in accordance with Article 50(3) of the REACH Regulation and that, therefore, no further information could be requested from it in the context of its registration dossier update.
15      On 6 September 2019, the applicant submitted its comments on ECHA’s draft follow-up decision of 19 July 2019. In those comments, the applicant informed ECHA, first, that it had ceased manufacturing the substance at issue, in accordance with Article 50 of the REACH Regulation, and, secondly, that, following that cessation of manufacture, it had entered into negotiations with the other registrant to transfer the role of lead registrant to the latter in the registration of the substance at issue.
16      On 18 October 2019, in response to its letter of 27 August 2019, the applicant received an email from ECHA stating that Article 50(2) of the REACH Regulation concerning the cessation of production or import of a substance did not apply to the draft follow-up decision which had been sent to the applicant on 19 July 2019, in so far as it did not contain a request for further information but merely stated that, after examining the information provided under Article 42(1) of that regulation, ECHA considered that its registration still did not comply with the information requirements and that the Italian enforcement authorities would be informed of the decision (‘the email of 18 October 2019’). The email of 18 October 2019 stated that the requirements set out in the initial compliance decision of 18 December 2017 continued to apply.
17      By letter of 4 November 2019, the applicant complained that ECHA had misinterpreted Articles 41, 42 and 50 of the REACH Regulation.
18      On 27 November 2019, the other registrant informed the applicant that ECHA had accepted the change of lead registrant.
19      ECHA adopted the follow-up decision of 30 June 2020 on the basis of Article 42(1) of the REACH Regulation. In that decision, first, it confirmed that the applicant’s registration dossier still did not comply with the information requirements and, secondly, it notified the applicant that the competent national authorities, namely the Italian authorities, had been informed of that non-compliance and that, consequently, those authorities could consider enforcement actions to secure implementation of the decision.
20      On 28 September 2020, the applicant lodged an appeal with the Board of Appeal, challenging the legality of the follow-up decision of 30 June 2020 and requesting that it be annulled.
21      On 9 November 2021, the Board of Appeal adopted the contested decision dismissing the applicant’s appeal.
Forms of order sought
22      The applicant, in the final form of its pleadings, claims that the Court should:
–        annul the contested decision;
–        give directions and guidance allowing ECHA to give full effect to the judgment to be given, relying on the judgment of 14 June 2016, Commission v McBride and Others (C‑361/14 P, EU:C:2016:434);
–        order ECHA to pay the costs.
23      ECHA contends that the Court should:
–        dismiss the action as partly inadmissible and partly unfounded or, in any event, wholly unfounded;
–        order the applicant to pay the costs.
Law
24      In support of its action for annulment, the applicant raises seven pleas in law, alleging, first, in essence, failure to comply with the principle of force majeure; secondly, distortion of evidence; thirdly, misinterpretation and misapplication of Article 42(1) and Article 50(2) of the REACH Regulation; fourthly, misinterpretation and misapplication of Articles 5 and 6 of that regulation; fifthly, failure to comply with the principles of legal certainty and the protection of legitimate expectations; sixthly, misinterpretation and misapplication of the principles of proportionality and good administration; and, seventhly, illegality of Article 50(2) of that regulation as interpreted by the Board of Appeal.
25      It is appropriate to examine, first of all, the third plea, then the fifth plea, then the first, second and fourth pleas together, followed by the sixth plea and, lastly, the seventh plea.
The third plea in law, alleging misinterpretation and misapplication of Article 42(1) and Article 50(2) of the REACH Regulation
26      The applicant’s third plea is divided into three parts, alleging, first, that there is no time limit for notifying the cessation of manufacture of a substance under Article 50(2) of the REACH Regulation, secondly, misinterpretation of the expression ‘further information’ contained in the English-language version of that provision and, thirdly, incorrect evaluation of substantial new information.
The first part of the third plea, alleging that there is no time limit for notifying the cessation of manufacture under Article 50(2) of the REACH Regulation
27      The applicant asserts that the Board of Appeal’s conclusions in paragraphs 34 to 55 of the contested decision are not consistent with Article 50(2) of the REACH Regulation, which does not set any time limit for notifying the cessation of production of a substance. According to the applicant, a registrant can, at any time, cease the manufacture or import of a substance and notify that cessation to ECHA, with the consequence that the registered volume of the substance in question is put to zero and that no further information can be requested with respect to that substance.
28      By contrast, Article 50(3) of that regulation sets a time limit for informing ECHA of the cessation of production of a substance, namely ‘upon receipt of the draft decision’.
29      Furthermore, the applicant observes that the Board of Appeal’s interpretation to the effect that the exercise of the right provided for in Article 50(2) of the REACH Regulation is limited to cases in which the dossier evaluation procedure has not started or is not concluded is contrary to the general legal principle ‘ubi lex non distinguit, nec nos distinguere debemus’. According to the applicant, the Board of Appeal has introduced a distinction not provided for by the legislature and, in so doing, has misinterpreted and misapplied Article 42(1) and Article 50(2) of the REACH Regulation.
30      Lastly, the applicant submits that the reference to the judgment of 21 January 2021, Germany v Esso Raffinage (C‑471/18 P, EU:C:2021:48), in paragraph 47 of the contested decision is irrelevant in the present case.
31      ECHA disputes the applicant’s arguments.
The second part of the third plea, alleging misinterpretation of the expression ‘further information’ contained in the English-language version of Article 50(2) of the REACH Regulation
32      The applicant submits that, in paragraphs 34 to 56 of the contested decision, the Board of Appeal misinterpreted the expression ‘further information’ contained in the English-language version of Article 50(2) of the REACH Regulation, in so far as it found that that expression referred to information not already requested in the initial compliance decision of 18 December 2017.
33      In the first place, the applicant submits, first, that the Board of Appeal’s interpretation has no basis in the wording of Article 50(2) of the REACH Regulation since, as it explained at the hearing before that board, the expression ‘further information’ is wider in scope. According to the applicant, the English word ‘further’ relates necessarily to ‘any’ information on the substance, that is to say, it is not limited to ‘additional’ information that ECHA might request in the future, but refers, in essence, to ‘any’ information which may need to be submitted to fulfil the applicable information requirements, including information that has already been requested. Therefore, according to the applicant, once a registrant notifies the cessation of manufacture of a substance, the information obligations are ‘put to zero’, just like the registered volume.
34      The applicant submits, secondly, that its own interpretation is in line with the other language versions of the REACH Regulation, in particular the French- and Italian-language versions.
35      In the second place, the applicant submits that its interpretation is also borne out by the wording of Article 50(2) of the REACH Regulation, in so far as, in the French-language version, the expression ‘plus aucune information’ (‘no further information’) is followed by the words ‘au sujet de la substance en cause’ (‘with respect to that substance’), which suggests that there is nothing else to be done other than to draw the appropriate conclusions from the cessation of manufacture of a substance, namely that the registered volume of that substance is put to zero.
36      ECHA disputes the applicant’s arguments.
The third part of the third plea, alleging incorrect evaluation of substantial new information
37      The applicant submits that, as it argued before the Board of Appeal, the read-across justification constituted substantial new information. In that regard, the applicant does not dispute the fact that ECHA adopted a new decision following a new decision-making process, but submits that the initiation of that new decision-making process afforded it the right to benefit from the possibility of notifying the cessation of manufacture due to the situation of force majeure, in accordance with Article 50(2) of the REACH Regulation. Therefore, according to the applicant, it was no longer subject to new decisions adopted under Article 42(1) of the REACH Regulation after having notified the cessation of manufacture of the substance at issue.
38      ECHA disputes the applicant’s arguments.
The relevant passages of the contested decision
39      In paragraphs 34 to 38 of the contested decision, the Board of Appeal recalled the consequences of the cessation of manufacture or import of a substance regulated by Article 50(2) and (3) of the REACH Regulation. According to the Board of Appeal, Article 50(2) of the REACH Regulation contains a general rule that does not take account of the moment when the cessation occurs, whereas Article 50(3) of that regulation refers to a specific moment, namely when the registrant has already received an initial draft decision, in accordance with Articles 40, 41 or 46 of that regulation. Furthermore, the Board of Appeal observed that Article 50(2) and (3) of the REACH Regulation made use of the same expression to define the consequences of cessation, namely ‘no further information may be requested with respect to that substance’.
40      The Board of Appeal also observed that, where the cessation of manufacture took place in an evaluation process on the basis of Article 46 of the REACH Regulation, Article 50(4) thereof set out an exception to the rules established in Article 50(2) and (3) of that regulation, so that, in certain circumstances, namely when a potential long-term risk to human health or the environment was detected or if exposure to the substance contributed significantly to that risk, despite cessation of manufacture or import, additional information could be requested from the registrant.
41      The Board of Appeal thus concluded that a registrant that had ceased production of a substance in accordance with Article 50(2) or (3) of the REACH Regulation was no longer required to provide further information, unless the specific conditions set out in Article 50(4) thereof were fulfilled.
42      In paragraphs 39 to 48 of the contested decision, the Board of Appeal examined the objectives of a follow-up decision adopted on the basis of Article 42 of the REACH Regulation.
43      First, the Board of Appeal stated that the applicant had ceased manufacturing the substance at issue after the adoption of the initial compliance decision of 18 December 2017 but before receipt of the draft follow-up decision. Secondly, the Board of Appeal found that the parties did not agree that the applicant was under an obligation to provide the information requested by the initial compliance decision of 18 December 2017.
44      In that regard, the Board of Appeal stated that an initial compliance check decision adopted under Article 41 of the REACH Regulation identified one or more gaps in a registration dossier and required a registrant to fill those gaps by submitting a study or an acceptable adaptation, but that, by contrast, in a follow-up procedure on the basis of Article 42 of the REACH Regulation, ECHA prepared a follow-up decision that did not identify any additional gaps because those gaps had already been identified in the initial compliance check decision. Accordingly, the Board of Appeal held that, in that context, ECHA did not request any ‘further information’, within the meaning of Article 41(3) of the REACH Regulation. First, according to the Board of Appeal, a follow-up decision adopted under Article 42 of the REACH Regulation is intended to determine whether the information provided by the registrant corresponds to what is requested in an initial compliance check decision. Secondly, the Board of Appeal established, referring to the judgment of 21 January 2021, Germany v Esso Raffinage (C‑471/18 P, EU:C:2021:48), that a registrant whose registration dossier had been subject to an initial compliance check decision continued to be bound by all the information obligations set out in the REACH Regulation. The Board of Appeal found that, in the context of the same registration dossier, ECHA could find other gaps at a later stage and that, in that event, it would have to start a new compliance check process under Article 41 of the REACH Regulation, in so far as it could not examine any additional gaps in the context of a follow-up process on the basis of Article 42 of that regulation.
45      In the light of those considerations, the Board of Appeal concluded that, first, the follow-up process provided for in Article 42 of the REACH Regulation pursued the objective of verifying whether the gaps in an initial compliance check decision had been filled, secondly, ‘further information’ could not be requested by ECHA in a follow-up decision adopted under that article and, thirdly, any request for further information had to be based on a new compliance check process under Article 41 of that regulation.
46      In paragraphs 49 to 55 of the contested decision, the Board of Appeal examined the consequences of the cessation of manufacture of a substance after the adoption of an initial compliance check decision.
47      In that regard, the Board of Appeal found that, if a registrant ceased the manufacture of a substance, ECHA could not initiate a compliance check process or would have to discontinue it if it had already started, as such a process could lead to a request for further information from that registrant.
48      By contrast, according to the Board of Appeal, a registrant continues to be bound by any initial compliance check decision adopted by ECHA if that decision was adopted before it ceased production of the substance and, in accordance with Article 42 of the REACH Regulation, ECHA must check whether the registrant has complied with that initial compliance check decision.
49      In the present case, the Board of Appeal found that the initial compliance decision of 18 December 2017 had identified several gaps in the applicant’s registration dossier, one of which concerned the
request for information relating to the 90-day study. The Board of Appeal found, first, that the applicant had tried to fill that gap by an adaptation (namely the read-across justification) and, next, that it had ceased manufacturing the substance at issue before receipt of the draft follow-up decision. The Board of Appeal added that, in the course of the follow-up process, ECHA had found that the adaptation proposed to fill the gap relating to the 90-day study was not valid and, therefore, the applicant’s registration dossier still did not comply with the REACH Regulation. Furthermore, the Board of Appeal found that the follow-up decision of 30 June 2020 did not contain any request for further information, within the meaning of Article 50(2) of the REACH Regulation, but merely concluded that the gap relating to the 90-day study, identified in the initial compliance decision of 18 December 2017, had still not been filled. Taking into account the fact that the cessation of manufacture of the substance at issue did not fill that gap, the Board of Appeal found that the applicant was not relieved of its obligation to provide the information requested in the initial compliance decision of 18 December 2017. The Board of Appeal stated, however, that the cessation of manufacture of the substance at issue led to ECHA not being able to request of the applicant further information that was not requested in the initial compliance decision of 18 December 2017.
The merits of the first and second parts of the third plea
50      As regards the first and second parts of the third plea, which it is appropriate to examine together, the applicant submits, in essence, that Article 50(2) and (3) of the REACH Regulation must be interpreted as meaning that a registrant that ceases the manufacture or import of a substance, irrespective of when that cessation occurs, and notifies ECHA of that cessation is relieved of any obligation to provide information, whatever it may be, concerning that substance.
51      In the first place, it should be recalled that Article 50 of the REACH Regulation, on ‘registrants’ and downstream users’ rights’, provides as follows:
‘1.      [ECHA] shall notify any draft decision under Articles 40, 41 or 46 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt. …
2.      If a registrant has ceased the manufacture or import of the substance, or the production or import of an article, or the downstream user the use, he shall inform [ECHA] of this fact with the consequence that the registered volume in his registration, if appropriate, shall be put to zero and no further information may be requested with respect to that substance, unless the registrant notifies the restart of the manufacture or import of the substance or the production or import of the article, or the downstream user notifies the restart of the use. [ECHA] shall inform the competent authority of the Member State in which the registrant or downstream user is located.
3.      The registrant may cease the manufacture or import of the substance or the production or import of the article, or the downstream user the use, upon receipt of the draft decision. In such cases, the registrant, or downstream user, shall inform [ECHA] of this fact with the consequence that his registration, or report, shall no longer be valid, and no further information may be requested with respect to that substance, unless he submits a new registration or report. [ECHA] shall inform the competent authority of the Member State in which the registrant or downstream user is located.
4.      Notwithstanding paragraphs 2 and 3, further information may be required in accordance with Article 46 in either or both of the following cases:
(a)      where the competent authority prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information;
(b)      where the exposure to the substance manufactured or imported by the registrant(s), or to the substance in the article produced or imported by the registrant(s), or to the substance used by the downstream user(s) contributes significantly to that risk.
…’
52      Thus, it must be held that Article 50(1) of the REACH Regulation, first, limits its scope to draft decisions and does not refer to adopted decisions and, secondly, expressly mentions only Articles 40, 41 and 46 of that regulation. Article 50(1) of the REACH Regulation does not refer to Article 42 of that regulation or, therefore, to draft decisions adopted in a follow-up process.
53      In view of the scope of Article 50(1) of the REACH Regulation, it follows that, as the Board of Appeal stated in paragraph 35 of the contested decision, the relationship between paragraph 2 and paragraph 3 of that article must be understood as meaning that paragraph 2 lays down the rule of general application that no further information may be requested on the substance, that rule being valid during the course of any of the procedures initiated for the purposes of Articles 40, 41 and 46 of that regulation, and that paragraph 3 provides a clarification intended to make it clear that, even upon receipt of a draft decision and until the definitive adoption of that draft, that general rule is applicable.
54      Thus, contrary to what the applicant claims, Article 50(2) of the REACH Regulation imposes a time limit for notification of the cessation of manufacture of a substance, a time limit that corresponds to the adoption of a compliance check decision.
55      In the second place, as regards the expression ‘no further information’ in Article 50 of the REACH Regulation, the applicant maintains that its own interpretation is confirmed by the French- and Italian-language versions of that regulation, whereas ECHA disputes that interpretation on the basis of the wording of the English-, German-, Spanish- and Dutch-language versions of that regulation.
56      In that regard, it should be noted that, according to settled case-law, the different language versions of the provisions of EU law must be interpreted uniformly (judgment of 6 October 2021, Consorzio Italian Management and Catania Multiservizi, C‑561/19, EU:C:2021:799, paragraph 43), since no language version can have primacy over the others (see, to that effect, judgment of 26 January 2021, Hessischer Rundfunk, C‑422/19 and C‑423/19, EU:C:2021:63, paragraph 65), so, where there is divergence between the various language versions of an EU legislative text, the provision in question must be interpreted by reference to the purpose and general scheme of the rules of which it forms part (judgment of 24 February 2022, Tiketa, C‑536/20, EU:C:2022:112, paragraph 27).
57      In that context, in order to rule on the applicant’s argument relating to the expression ‘no further information’, it is necessary to examine Article 50(4) of the REACH Regulation, to which the Board of Appeal refers in the contested decision.
58      Although Article 50(4) of the REACH Regulation refers to the evaluation procedure initiated on the basis of Article 46 of that regulation and not to the procedures launched on the basis of Articles 40 and 41 thereof, referred to in Article 50(1), it nonetheless allows the expression ‘no further information’, in paragraphs 2 and 3 thereof, to be regarded as targeting all the ongoing procedures referred to in paragraph 1 that lead to the adoption of a decision by which ECHA requests information from the registrant, namely the procedures referred to in Articles 40, 41 and 46 of the REACH Regulation, but not the follow-up procedure provided for in Article 42 of that regulation.
59      It follows, first of all, that, contrary to what the applicant claims, Article 50 of the REACH Regulation does not refer to the procedure based on Article 42 of that regulation. Next, the time horizon of Article 50 of the REACH Regulation is between the initiation of a procedure, the draft decision and the adoption of the decision closing the procedure. Lastly, in the light of the systemic interpretation of Article 50(2) to (4) of the REACH Regulation, the expression ‘no further information’ refers to information that may be requested for the first time after the cessation of manufacture or import of a substance, and not to information previously requested in a compliance check decision adopted before that cessation of manufacture and which has not yet been provided by the registrant.
60      Moreover, it should be noted that, from 19 December 2014, the applicant was able to manufacture and market the substance at issue, which is used in the composition of cables used in vehicles for the purpose of ensuring their flexibility. Subsequently, on 30 November 2016, ECHA initiated a compliance check procedure which was closed by the initial compliance decision of 18 December 2017 finding gaps in the registration dossier for the substance at issue and requiring studies to be carried out. Following that decision, the applicant submitted, on 3 January 2019, the read-across justification to fill the gap relating to the 90-day study. Since that justification was not accepted by ECHA, the existence of that gap in the registration dossier between the date of adoption of the initial compliance decision of 18 December 2017 and the date of cessation of manufacture of the substance at issue justifies the applicant’s obligation to comply with that decision despite the cessation of manufacture.
61      If that were not the case, that would mean, first of all, that a registrant that has not complied with a compliance check decision could manufacture a substance by evading the obligations under the REACH Regulation to the detriment, first, of the objective of ensuring a high level of protection of human health and the environment and, secondly, of other registrants whose registration dossier complies with those obligations.
62      In addition, that registrant could circumvent the obligations under the REACH Regulation by arguing that it has ceased manufacturing said substance. In that regard, in addition to the reasons explained in paragraph 61 above, the basis for the continued obligation to carry out a study which had been requested before the manufacture of a substance had been ceased is to be found in the fact that that cessation may not automatically correspond to the disappearance of that substance from circulation. In the present case, the substance at issue is used to ensure the flexibility of car cables. Thus, the substance at issue continues to circulate and to be in contact with humans and the environment, which justifies the continued obligation to provide the studies requested in the initial compliance decision of 18 December 2017, in accordance with Article 1 of the REACH Regulation, even though the applicant ceased its manufacture.
63      In the third place, the applicant’s argument that the Board of Appeal made a distinction not provided for by the legislature contrary to the general legal principle ‘ubi lex non distinguit, nec nos distinguere debemus’ cannot succeed. Contrary to what the applicant submits, that distinction, drawn by ECHA and confirmed by the Board of Appeal, has a textual basis in Article 50(1) of the REACH Regulation. Furthermore, the Board of Appeal did not introduce a new distinction not provided for by the legislature, in so far as it did not err in law in considering that Article 50 of the REACH Regulation did not refer to decisions adopted under Article 42 of that regulation, but only to procedures initiated in accordance with Articles 40, 41 and 46 of that regulation. Information is requested in those latter procedures, whereas, in the procedure laid down in Article 42 of the REACH Regulation, ECHA merely assesses whether the registrant has complied with the obligation to provide information contained in an initial compliance check decision.
64      In the fourth place, the applicant’s argument relating to the irrelevance, in the present case, of the judgment of 21 January 2021, Germany v Esso Raffinage (C‑471/18 P, EU:C:2021:48), cited in paragraph 47 of the contested decision, must be rejected. Suffice it to note that the Board of Appeal referred to that judgment in order to clarify the scope of the relationship between the conformity check procedure and the follow-up procedure on which it bases its interpretation of Article 50 of the REACH Regulation. Thus, the reference to that judgment was relevant in the context of the examination carried out by the Board of Appeal and the Board of Appeal did not err in law in referring to it.
65      It follows from the foregoing that the first and second parts of the third plea cannot succeed.
The merits of the third part of the third plea
66      As regards the third part of the third plea, the applicant submits that the adaptation it provided on 3 January 2019 to respond to the initial compliance decision of 18 December 2017, namely the read-across justification, constituted new information enabling it to benefit from the possibility of notifying the cessation of manufacture of the substance at issue due to a situation of force majeure, in accordance with Article 50(2) of the REACH Regulation.
67      In that regard, in the first place, suffice it to note that the decision of 28 February 2019, adopted prior to the communication of the cessation of manufacture of the substance at issue, is not challenged before the Court, so the conclusion it contains regarding the lack of novelty of the information contained in the adaptation submitted on 3 January 2019 is not called into question. In the second place, by that decision, ECHA informed the applicant that a follow-up decision, for the purposes of Article 42 of the REACH Regulation, would be adopted. Accordingly, the decision of 28 February 2019 essentially confirmed the initial compliance decision of 18 December 2017 and initiated the follow-up procedure relating to the substance at issue.
68      Thus, in so far as it is apparent from the examination set out above that the Board of Appeal did not err in law in finding that Article 50(2) of the REACH Regulation did not apply to follow-up procedures initiated in accordance with Article 42 of that regulation, the third part of the third plea in law cannot succeed either. The third plea must therefore be rejected in its entirety.
The fifth plea, alleging failure to comply with the principles of legal certainty and the protection of legitimate expectations
69      The applicant submits that the Board of Appeal erred in law in concluding, in paragraphs 61 to 72 of the contested decision, that ECHA had not failed to comply with the principles of legal certainty and the protection of legitimate expectations.
70      The applicant submits that the Board of Appeal failed to comply with those two principles when it held, on the basis of the Practical Guide ‘How to act in dossier evaluation’ adopted in January 2019 (‘the Practical Guide’) and on the basis of similar guidance given to registrants under entry number 1580 of ECHA’s website section on ‘Questions and Answers’ (‘the Q&As’), that a registrant continued to be bound to provide the information requested in an initial compliance check decision even if it ceased to manufacture a substance after the adoption of that decision.
71      In that context, the applicant maintains, first, that it complied with the initial compliance decision of 18 December 2017 by submitting the read-across justification, since that adaptation was one of the possibilities expressly provided for in that decision, and, secondly, that it notified the cessation of manufacture of the substance at issue before receipt of the draft follow-up decision and before receipt of the follow-up decision of 30 June 2020. The applicant states that this is not a new argument but merely a factual consideration.
72      The applicant observes that, throughout the proceedings, it relied on the Practical Guide and the Q&As. In that regard, it claims that it could not foresee that ECHA would consider that the expression ‘draft decision’ in Section 5.4 of the Practical Guide and in the Q&As referred only to the draft compliance check decision, given that those documents, in the applicant’s view, do not make a distinction between draft decisions issued in the context of a compliance check procedure and those issued in the context of a follow-up procedure.
73      The applicant adds that the Practical Guide and the Q&As are not formally legally binding acts, such that, first, they are not normally capable of producing ‘external’ legal effects and, secondly, they are binding only on their author.
74      Furthermore, the applicant submits that it communicated the cessation of manufacture of the substance at issue in its letter of 27 August 2019 and in its comments on the draft follow-up decision of 30 June 2020, submitted on 6 September 2019. In that regard, according to the applicant, ECHA did not notify the applicant of its interpretation of Article 42(1) and Article 50(2) of the REACH Regulation until 18 October 2019. That late notification does not satisfy the fundamental requirement of the principle of legal certainty.
75      In the light of all those factors, the applicant argues that it could not unambiguously know what its rights and obligations were in a situation where it was obliged to cease manufacturing the substance at issue due to a situation of force majeure.
76      ECHA disputes the applicant’s arguments.
The relevant passages of the contested decision
77      In paragraphs 61 to 68 of the contested decision, after recalling the essence of the principles of legal certainty and the protection of legitimate expectations, the Board of Appeal found, in essence, that the Practical Guide and the Q&As informed a registrant in a clear and precise manner that it was required to provide the information requested in an adopted initial compliance check decision, in the event that that registrant ceases the manufacture or import of a substance after the receipt of that decision.
78      The Board of Appeal therefore concluded, in the contested decision, that, with the help of the Practical Guide and the Q&As, the applicant could have known without ambiguity what its rights and obligations were; it thus found that there had been no failure to comply with either the principle of legal certainty or the principle of the protection of legitimate expectations.
The merits of the fifth plea
79      As a preliminary point, it should be noted that, according to settled case-law, the right to rely on the principle of the protection of legitimate expectations, which is one of the fundamental principles of the European Union, assumes that three conditions are satisfied. First, precise, unconditional and consistent assurances from authorised and reliable sources must have been given to the person concerned by the administration. Secondly, those assurances must be such as to give rise to a legitimate expectation on the part of the person to whom they are addressed. Thirdly, the assurances given must comply with the applicable rules (see judgment of 19 December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph 109 and the case-law cited).
80      Furthermore, the principle of legal certainty requires, on the one hand, that the rules of law be clear and precise and, on the other, that their application be foreseeable for those subject to the law, in particular, where they may have adverse consequences. That principle requires, inter alia, that legislation must enable those concerned to know precisely the extent of the obligations imposed on them, and those persons must be able to ascertain unequivocally their rights and obligations and take steps accordingly (judgments of 29 April 2021, Banco de Portugal and Others, C‑504/19, EU:C:2021:335, paragraph 51, and of 16 February 2022, Poland v Parliament and Council, C‑157/21, EU:C:2022:98, paragraph 319).
81      Next, in the first place, as regards the argument by which the applicant claims that the Practical Guide and the Q&As are not legally binding acts, it must be borne in mind that since the scope of the review conducted by the Board of Appeal is determined by the pleas put forward by the applicant before it, an argument that was not put forward before that board must be rejected as inadmissible (see, to that effect, judgment of 20 September 2019, BASF Grenzach v ECHA, T‑125/17, EU:T:2019:638, paragraph 475).
82      Thus, suffice it to note that the applicant did not claim before the Board of Appeal that the Practical Guide and the Q&As were not legally binding acts. That argument is therefore inadmissible.
83      In the second place, as regards the applicant’s argument that the Practical Guide and the Q&As do not make a distinction between draft decisions issued in the context of a compliance check procedure and those issued in the context of a follow-up procedure, the following should be noted.
84      That argument runs counter to the Board of Appeal’s finding, in paragraphs 67 and 68 of the contested decision, that Section 5.4 of the Practical Guide and the Q&As state that, if a registrant were to cease the manufacture of a substance upon receipt of an adopted decision, it would have to comply with the content of that decision.
85      As regards the Practical Guide, reproduced in Annex A2 to the application, contrary to what the applicant claims, it does make a distinction between draft decisions issued in the context of a compliance check procedure and those issued in the context of a follow-up procedure.
86      It is true that Section 5 of the Practical Guide, on steps to be taken following receipt of a draft decision, includes Section 5.4, in which the expression ‘draft decision’ appears without further clarification. The fact remains that, first, Section 5.4 must be placed in the context of the sequence of titles in the Practical Guide, Section 4.2 et seq. being devoted to the compliance check procedure, with the result that Section 5, which contains Section 5.4, forms part of the logic behind that procedure and, secondly, that Section 6, on the follow-up procedure after the adoption of a decision, contains a Section 6.6 on the follow-up procedure.
87      It follows that the applicant cannot validly claim that the Board of Appeal erred in law in considering that Section 5.4 of the Practical Guide concerned the steps to be taken by a registrant following receipt of a draft compliance check decision and not of a draft follow-up decision.
88      The same is true of the Q&As, referred to in paragraph 68 of the contested decision, which reproduce the content of Section 5.4 of the Practical Guide.
89      Thus, in so far as the applicant bases its argument on a partial and incorrect interpretation of the Practical Guide and of the Q&As, that argument must be rejected.
90      In the third place, as regards the argument by which the applicant submits that, first, it complied with the initial compliance decision of 18 December 2017 by submitting the read-across justification, that adaptation being one of the possibilities expressly offered by that decision, and, secondly, it notified the cessation of manufacture of the substance at issue before the receipt of the draft follow-up decision and therefore, a fortiori, the follow-up decision of 30 June 2020, the following should be noted.
91      As regards the presentation of the read-across justification, it is sufficient to note that, as stated in paragraph 67 above, the applicant cannot validly claim that it complied with the initial compliance decision of 18 December 2017, in so far as, by its decision of 28 February 2019, ECHA informed it that that adaptation was not valid and that it was going to adopt a follow-up decision for the purposes of Article 42 of the REACH Regulation. Furthermore, it should be noted that, although the applicant challenged ECHA’s rejection of the read-across justification before the Board of Appeal, it does not dispute, before the Court, paragraphs 124 to 140 of the contested decision rejecting that challenge. Accordingly, its argument relating to the read-across justification is unfounded.
92      As regards the applicant’s argument that it notified the cessation of manufacture of the substance at issue before receipt of the draft follow-up decision and the follow-up decision of 30 June 2020, suffice it to state that it is based on a partial and incorrect interpretation of the Practical Guide and that it cannot therefore succeed.
93      In the fourth place, as regards the applicant’s argument that ECHA did not communicate its interpretation of Article 42(1) and Article 50(2) of the REACH Regulation to the applicant until 18 October 2019, that is to say, belatedly, the following should be noted.
94      First, the Practical Guide did indeed contain the distinction set out in the email of 18 October 2019, as is apparent from paragraphs 85 and 86 above.
95      Secondly, in any event, on the one hand, it is apparent from paragraph 13 of the contested decision that, on 4 November 2019, the applicant had the opportunity to comment on the interpretation contained in the email of 18 October 2019, which it does not dispute in the present action, and, on the other, the follow-up decision of 30 June 2020 was adopted almost eight months after that email.
96      Thus, since there has been no failure to comply with the principles of legal certainty and the protection of legitimate expectations, that argument and, therefore, the fifth plea in its entirety must be rejected.
The first, second and fourth pleas, alleging failure to comply with the principle of force majeure, distortion of evidence and misinterpretation and misapplication of Articles 5 and 6 of the REACH Regulation
97      In its first plea, the applicant puts forward, in essence, three arguments, alleging, first, an error on the part of the Board of Appeal in finding that the applicant had not demonstrated that it was impossible to carry out the 90-day study on the substance at issue, secondly, failure to comply with the principle of force majeure and, thirdly, unreasonable consequences arising from the Board of Appeal’s interpretation in paragraphs 110 to 112 of the contested decision.
98      As regards its first argument, the applicant claims that, after its supplier notified it that production of Linevol9 had ceased due to force majeure, it diligently researched whether other comparable components were available on the market, and identified two other theoretical suppliers of components which could be a potential substitute for Linevol9. The applicant states that it therefore carried out market research on raw materials which showed that those components were not chemically equivalent to Linevol9 (‘the market research’). According to the applicant, none of those components met the requirements defined in its registration dossier. Thus, the applicant submits that the Board of Appeal erred in stating, in paragraph 116 of the contested decision, that the applicant had not demonstrated that it was impossible to carry out the 90-day study on the substance at issue as registered. Furthermore, the applicant submits that carrying out that study on a different substance from the substance at issue would not generate relevant data for the substance at issue as registered by the applicant.
99      As regards its second argument, the applicant submits that, in paragraph 112 of the contested decision, the Board of Appeal clearly failed to comply with the principle of force majeure.
100    In that regard, in the first place, the applicant asserts that the principle of force majeure must be understood as covering the ‘abnormal and unforeseeable circumstances which were outside the control of the party by whom it is pleaded and the consequences of which could not have been avoided in spite of the exercise of all due care’.
101    In the second place, the applicant argues that the fact that the REACH Regulation does not contain a provision governing potential situations of force majeure does not mean that force majeure does not apply.
102    Thus, according to the applicant, in the present case, the elements constituting force majeure are present.
103    As regards its third argument, first, the applicant submits that it is required to carry out a study concerning a substance which is not registered by it, and which was not registered when the follow-up decision of 30 June 2020 was adopted. Secondly, the applicant would be subject to a perpetual risk of enforcement actions on the part of Member States because, even if it were to submit the requested information, that information would relate to a substance that is different from the one initially registered. Thirdly, the contested decision places the applicant in the impossible situation of having to carry out a study on a substance that does not exist and cannot be produced, which therefore requires the applicant to bring a probatio diabolica.
104    In its second plea, the applicant asserts that, in paragraph 116 of the contested decision, the Board of Appeal distorted the evidence by finding, first, that the applicant had not established that it would be impossible to carry out the 90-day study and, secondly, that its argument that the raw materials differed in their composition did not suffice to demonstrate that a 90-day study would not provide relevant data for the applicant’s registration dossier.
105    In the first place, the distortion of evidence, in the applicant’s view, stems from the fact that it proved that Linevol9 could not be replaced by other components.
106    The applicant adds that, contrary to what ECHA contends, the applicant not only carried out the market research, but also consulted the ECHA database of substances registered in the European Union in order to find a suitable new supplier.
107    In the second place, the applicant submits that the Board of Appeal also distorted the evidence by stating that its argument that the raw materials differ in their composition did not suffice to demonstrate that the 90-day study would not provide relevant data for the applicant’s registration dossier.
108    In that regard, the applicant submits that it is not just the difference in the composition of the raw materials which led to the generation of data that are irrelevant to its registration dossier, but the fact that the substance produced using those various components is different from the substance at issue, in so far as Linevol9 has been replaced by a different component, which makes any study on that substance irrelevant for the registration of the substance at issue.
109    In addition, the applicant argues that the Board of Appeal relied on an unsubstantiated hypothesis in finding that other potential manufacturers might – at some point – register the substance at issue as it was previously registered by the applicant, and submits that the question whether other manufacturers would register the substance at issue is, first, hypothetical and, secondly, immaterial.
110    In that context, the applicant asserts that the existence of two active registrants of the substance at issue does not call into question its arguments, given that it has demonstrated that, unless a raw material with the same composition as that of Linevol9 is used, any other substance will be different from the substance at issue.
111    In addition, the applicant observes that it argued that the compliance check procedure should have been conducted on the substance produced by the other registrant because the latter had taken on the role of lead registrant, and not because the applicant considers the substance produced by the other registrant and the substance at issue to be the same.
112    Lastly, the applicant concludes by stating that carrying out the 90-day study on the substance manufactured by the other registrant or other manufacturers would neither have an impact on its inactive registration dossier nor contribute to achieving the objectives of the REACH Regulation, since the substance at issue is no longer being produced or placed on the market.
113    As part of its fourth plea, alleging misinterpretation and misapplication of Articles 5 and 6 of the REACH Regulation, the applicant states that the principle ‘one substance, one registration’ requires that several registrants of the same substance agree that the substances they manufacture are sufficiently similar to allow joint submission to ECHA.
114    In that context, the applicant states that, on 3 October 2016, it entered into an agreement concerning the substance at issue with the other registrant without any chemical assessment having been carried out. The applicant adds that it did not know the chemical composition and sources of supply of the raw materials used by the other registrant, since that was confidential business information.
115    However, the applicant submits that, as a result of the unavailability of a C9 alcohol chemically similar to Linevol9, the initial assumption on the sameness of the substance made by the other registrant and that made by the applicant itself is no longer valid. Thus, according to the applicant, the substance at issue can no longer exist, and therefore, first, the substance manufactured by the other registrant is necessarily different from the one manufactured by the applicant and, secondly, the use of any commercially available C9 alcohol as a substitute for Linevol9 would involve the manufacture of a new substance different from the substance at issue, which would require a new registration.
116    In the light of that premiss, the applicant concludes that, as neither ECHA nor the Board of Appeal assessed whether the substance made by the other registrant was indeed the same as the substance at issue, paragraph 116 of the contested decision is unsubstantiated.
117    In addition, the applicant submits that, contrary to the Board of Appeal’s conclusion in paragraph 117 of the contested decision, the fact that the applicant had suggested that the compliance check procedure be redirected to the other registrant’s registration dossier did not constitute an acknowledgement that the latter could provide the applicant with a sample to test the substance at issue and, therefore, submit the requested information.
118    ECHA disputes the applicant’s arguments.
The relevant passages of the contested decision
119    In paragraphs 106 to 112 of the contested decision, the Board of Appeal concluded that the applicant’s argument that it could no longer manufacture the substance at issue in the absence of Linevol9 and, therefore, in accordance with Articles 5 and 6 of the REACH Regulation, it was no longer possible to request information from it on that substance could not succeed. First, it found that it was not disputed that, on the date on which the initial compliance decision of 18 December 2017 was adopted, the applicant was required, in accordance with Articles 5 and 6 of the REACH Regulation, to comply with the standard information obligations. Secondly, it noted that ECHA had not erred in law in finding that the applicant continued to be bound to comply with the initial compliance decision of 18 December 2017, despite the fact that it had ceased producing the substance at issue. Thirdly, it observed that those two findings were independent from the reasons for the cessation of manufacture of the substance at issue. The Board of Appeal concluded that the cessation of manufacture of a substance, whatever the cause and even in the event of force majeure, did not relieve the registrant of the obligation to comply with an initial compliance check decision.
120    In paragraphs 115 to 117 of the contested decision, the Board of Appeal concluded that the applicant’s argument that no other company was able to produce the substance at issue due to the absence of Linevol9 and that the differences between Linevol9 and the other components available on the market meant that it was impossible to obtain an appropriate sample of the relevant test material to carry out the 90-day study could not succeed either.
121    First, in paragraph 115 of the contested decision, the Board of Appeal noted that Section 4 of Appendix 3 to the initial compliance decision of 18 December 2017 stated that, in the case of several registrants of a substance, it was their responsibility to agree on the appropriate composition of the test material and to document the necessary information on the composition of the substance they wished to register.
122    Secondly, in paragraph 116 of the contested decision, the Board of Appeal established that the applicant had not proved that it was impossible to carry out the 90-day study due to the unavailability of a suitable sample of relevant test material. According to the Board of Appeal, the applicant’s argument that the components differed in their composition did not suffice to demonstrate that the 90-day study, even carried out on test material provided by the other registrant, or by another potential manufacturer of the substance at issue, would not provide relevant data for the applicant’s registration dossier.
123    Thirdly, in paragraph 117 of the contested decision, the Board of Appeal found that the applicant’s argument was contradictory, given that, in its plea alleging failure to comply with the principle of proportionality, the applicant
itself argued that ECHA could have addressed the other registrant, which had not ceased manufacturing the substance at issue. The Board of Appeal concluded that the applicant itself had considered that the other registrant could provide the information requested by the initial compliance decision of 18 December 2017 and that it was therefore able to provide a suitable sample for the study requested in that decision.
Preliminary observations
124    As a preliminary point, in the first place, it should be borne in mind that, according to settled case-law, the EU Courts conduct, in respect of a decision of the Board of Appeal concerning an action against a decision taken as part of the evaluation of a substance, a review of lawfulness. That review is limited where it concerns highly complex scientific and technical facts. Concerning such assessments, the EU Courts are limited to checking whether they are vitiated by a manifest error, a misuse of powers or whether the decision-maker manifestly exceeded the limits of its power of review (see judgment of 20 September 2019, Germany v ECHA, T‑755/17, EU:T:2019:647, paragraph 120 and the case-law cited).
125    Furthermore, according to the case-law, first, an action before the Board of Appeal against an ECHA decision may only seek to examine whether the evidence submitted by the applicant is capable of showing that that decision is vitiated by error and, secondly, the burden of proof during the procedure before the Board of Appeal lies with the applicant, so it is for the latter to demonstrate that ECHA’s conclusions are vitiated by error, that allocation of the burden of proof resulting from the adversarial nature of the procedure before that board (see, to that effect, judgment of 20 September 2019, BASF Grenzach v ECHA, T‑125/17, EU:T:2019:638, paragraphs 86 and 275).
126    In the second place, it should also be borne in mind that the registration of a substance is the responsibility of the registrant(s), in accordance with Article 1(3) of the REACH Regulation.
127    In that regard, first, it is noteworthy that the applicant itself argues that, in the agreement it entered into with the other registrant on 3 October 2016, the sameness of the substance produced by the latter and that produced by the applicant itself had been acknowledged. It is true that the applicant puts forward that argument to demonstrate that the disappearance of Linevol9 had certain consequences, but the fact remains that it leads to the conclusion that there was at least one other company that produced the same substance for the purposes of its registration with ECHA.
128    Secondly, it is apparent from the file that the applicant transferred the role of lead registrant to the other registrant. That fact supports the conclusion that the substance at issue continues to be registered by the other registrant, with the result that, when the Board of Appeal adopted the contested decision, the other registrant had an active registration dossier concerning the substance at issue.
129    Thirdly, the applicant claims that ECHA should have addressed the other registrant and not it in order to obtain information about the substance at issue. Even though the applicant disputes the Board of Appeal’s interpretation of that argument put forward before it, it makes it possible to establish the factual context in which the Board of Appeal delivered the contested decision, namely that it could consider that, if the role of lead registrant had passed from the applicant to the other registrant, the latter continued to manufacture the substance at issue.
130    Fourthly, it should be noted that, in Appendix 3 to the initial compliance decision of 18 December 2017, ECHA noted that the 90-day study had to be carried out using a sample of the substance at issue suitable for use by all the joint registrants and that it was the responsibility of those registrants, which manufactured or imported the same substance, to agree on the appropriate composition of the test material and to document the necessary information on their substance composition. That means that, where several registrants or importers register a substance jointly, the substance in question must fall within the limits of the common description and that it is possible, by definition, that the substances manufactured by the various registrants differ in their precise composition, so that there are many variations in composition within a single substance.
131    Thus, first, it was for the applicant, during the proceedings before the Board of Appeal, to adduce evidence that it was no longer in a position to carry out the 90-day study.
132    Secondly, in the context in which the Board of Appeal was called upon to review the follow-up decision of 30 June 2020, the initial compliance decision of 18 December 2017 stated that, for the purposes of registering the substance at issue, there were at least two registrants, namely the applicant and the other registrant, producing the same substance.
The merits of the first, second and fourth pleas
133    It is appropriate to examine the first, second and fourth pleas together, having regard, on the one hand, to the fact that the concept of ‘force majeure’ was dealt with by the Board of Appeal in its examination of the alleged infringement of Articles 5 and 6 of the REACH Regulation, in paragraphs 103 to 117 of the contested decision, and, on the other hand, to the existence of certain overlaps within those pleas.
134    As regards the arguments put forward contesting the Board of Appeal’s assessment of force majeure, the applicant concentrates its criticism on paragraphs 116 and 117 of the contested decision. However, paragraph 115 of the contested decision contains the premiss of the Board of Appeal’s reasoning, namely the fact that Appendix 3 to the initial compliance decision of 18 December 2017 stated that it was the responsibility of the joint registrants of a substance to agree on the appropriate composition of the material for the requested studies and to provide the necessary documents with regard to the composition of that substance.
135    In paragraph 116 of the contested decision, the Board of Appeal focused on the probative value of the applicant’s argument relating to the difference between the components. Nevertheless, in order to reject that argument, the Board of Appeal found that the applicant’s argument that the components differed in their composition did not suffice to demonstrate that the 90-day study, even carried out on test material provided by the other registrant or by another potential manufacturer of the substance at issue, would not provide relevant data for the applicant’s registration dossier. Thus, the Board of Appeal had to carry out an assessment of highly complex scientific and technical facts in respect of which, in accordance with the case-law cited in paragraph 124 above, the Court carries out a review limited to manifest error.
136    Based on that premiss and on paragraph 115 of the contested decision, it must be held that the Board of Appeal did not commit a manifest error in stating that the applicant had not proved that it was impossible to carry out the 90-day study due to the unavailability of a suitable sample of the relevant test material, since the Board of Appeal considered that the applicant’s argument relating to the fact that the components differed in their composition was not sufficient to demonstrate that the performance of the requested study, carried out with a sample provided by the other registrant or any other potential registrant, would not have provided relevant data for the registration dossier for the substance at issue.
137    In the context of the obligations arising from Appendix 3 to the initial compliance decision of 18 December 2017 for the joint registrants of the substance at issue, the fact that the applicant claimed that Linevol9 had disappeared from the market does not prove that the 90-day study could not be carried out using a sample provided by the other registrant or by any other potential registrant.
138    Furthermore, the probative value of the market research that, according to the applicant, shows that Linevol9 cannot be replaced must be put into perspective.
139    In the first place, it should be noted that the market research dates from 2 September 2020, that is to say, after the follow-up decision of 30 June 2020 and 26 days before the applicant brought its appeal against that decision before the Board of Appeal.
140    In the second place, the market research was carried out by the applicant itself. Accordingly, it is not capable, in itself, of proving the assertion that the disappearance of Linevol9 made it impossible to carry out the 90-day study and may, at most, be regarded as an indication that must be supported by additional evidence contained in the file (see, by analogy, judgment of 5 October 2022, Aldi Einkauf v EUIPO – Cantina sociale Tollo (ALDIANO), T‑429/21, not published, EU:T:2022:601, paragraph 53).
141    However, the applicant did not adduce, before the Board of Appeal, any evidence other than the market research to demonstrate that the disappearance of Linevol9 made it impossible to carry out the 90-day study. The only argument put forward by the applicant, in its reply, is linked to the fact that it consulted the ECHA database of substances registered in the European Union in order to find a supplier of Linevol9. However, that argument was already included in the market research and cannot therefore be regarded as separate and additional evidence submitted by the applicant.
142    As regards paragraph 117 of the contested decision, it should be noted that it does not contain any assessment of highly complex scientific and technical facts, so the Court must carry out a comprehensive review of it, which is not limited to ascertaining whether there has been a manifest error.
143    The applicant submits that its proposal to address the other registrant is not contradictory. However, before the Board of Appeal, in the context of its argument alleging failure to comply with the principle of proportionality, the applicant merely proposed that ECHA address the other registrant, which ‘had not ceased the manufacture of the [substance at issue]’.
144    Thus, having regard, first, to the context recalled in paragraphs 127 to 130 above and, secondly, to the findings in paragraphs 115 and 116 of the contested decision, it must be held that the Board of Appeal did not make an error of assessment in finding, in paragraph 117 of that decision, that the applicant’s claims were contradictory.
145    Therefore, since the applicant has not proved that the Board of Appeal erred in finding that the disappearance of Linevol9 was not sufficient to demonstrate that the 90-day study could not be carried out using a sample provided by the other registrant, the second and fourth pleas must be rejected.
146    As regards the first plea, the arguments alleging that the Board of Appeal erred in finding that the applicant had not proved that it was impossible to carry out the 90-day study on the substance at issue and that there were unreasonable consequences stemming from the Board of Appeal’s interpretation in paragraphs 110 to 112 of the contested decision overlap with the arguments put forward in connection with the second and fourth pleas, which have been rejected. Consequently, they must also be rejected.
147    The same is true for the argument alleging failure to comply with the principle of force majeure on the part of the Board of Appeal in paragraph 112 of the contested decision. It is apparent from the examination set out above that, even though the disappearance of Linevol9 is not disputed, the applicant did not prove that that disappearance made it impossible to carry out the 90-day study requested by ECHA and, therefore, that the principle of force majeure could apply in the present case. Consequently, the statement of principle in paragraph 112 of the contested decision, according to which force majeure is not applicable in the context of the system established by the REACH Regulation, regardless of whether or not it is vitiated by an error of law, is not capable of having any consequences in the present case.
148    Therefore, the first plea must also be rejected.
The sixth plea, alleging misinterpretation and misapplication of the principle of proportionality and of the principle of good administration
149    The applicant’s sixth plea is divided into two parts, alleging, first, failure to comply with the principle of proportionality and, secondly, failure to comply with the principle of good administration.
The first part of the sixth plea, alleging failure to comply with the principle of proportionality
150    The applicant notes that one of the objectives of the REACH Regulation is to ensure a high level of protection of human health and the environment, which is partly achieved by the obligation to register substances manufactured in quantities above one tonne per year. The applicant argues that, since the substance at issue can no longer be manufactured or placed on the market, it is no longer relevant to obtain information on its potential hazards. According to the applicant, that is borne out by the rationale behind Article 50(2) and (3) of the REACH Regulation, according to which, upon notification of the cessation of manufacture, the registered volume is to be put to zero and no further information may be requested.
151    The applicant adds that that assessment is not called into question by the Board of Appeal’s finding, in paragraph 81 of the contested decision, that the initial compliance decision of 18 December 2017 has not been appealed. Indeed, the applicant did comply with that decision by submitting the read-across justification by the deadline set.
152    On the basis of those considerations, the applicant submits that ECHA’s course of action was disproportionate. In its view, as the substance at issue is not being and can no longer be manufactured, the follow-up decision of 30 June 2020, first, is not suitable to attain the objective of achieving a high level of protection of human health and the environment, secondly, imposes an excessive burden on the applicant in relation to the objective sought and, thirdly, is not the least onerous measure.
153    In that regard, the applicant states that ECHA’s approach leads to a disproportionate and unreasonable situation, since the applicant is required to carry out the 90-day study on the substance at issue, which has not been registered by it and was likewise not registered when the follow-up decision of 30 June 2020 was adopted. Furthermore, the applicant’s inactive registration dossier is destined to be in a situation of perpetual non-compliance and the applicant subject to a perpetual risk of enforcement actions on the part of Member States because the only information it can provide would pertain to a substance that is different from the substance which the applicant had initially registered. Lastly, it would be forced to carry out a study on a substance that is different from the substance at issue, namely the one marketed by the other registrant.
154    The applicant adds that, contrary to what ECHA contends, the arguments relating to the failure to comply with the principle of proportionality set out in the application are not different from those raised before the Board of Appeal.
155    ECHA disputes the applicant’s arguments.
–       The relevant passages of the contested decision
156    In paragraphs 78 to 86 of the contested decision, the Board of Appeal examined the applicant’s arguments regarding the principle of proportionality.
157    In the first place, in paragraph 79 of the contested decision, the Board of Appeal rejected the applicant’s argument that ECHA failed to comply with the principle of proportionality by adopting the follow-up decision of 30 June 2020 in respect of the applicant, and not in respect of the other registrant. According to the Board of Appeal, in so far as the decision adopted under Article 42(1) of the REACH Regulation is merely the continuation of one and the same procedure initiated by a decision adopted under Article 41 of that regulation, the follow-up decision of 30 June 2020 had to be addressed to the registrant to whom the initial compliance decision of 18 December 2017 was addressed, that is to say, the applicant. The Board of Appeal found that, since the other registrant was not involved in the compliance check procedure, ECHA could not involve it in the follow-up procedure and that, since the other registrant was not the addressee of the initial compliance check decision, it could not be the addressee of the follow-up decision of 30 June 2020.
158    In the second place, the Board of Appeal rejected the applicant’s argument that the follow-up decision of 30 June 2020 could lead to sanctions, adopted by the competent national authorities, which would exceed the limits of proportionality. After recalling that, according to the case-law, ECHA alone was competent to assess the compliance of a dossier and that the national authorities retained the power to impose sanctions, the Board of Appeal stated that ECHA did not err in law in finding that the applicant continued to be bound to provide the information requested in the initial compliance decision of 18 December 2017 regardless of the fact that it had ceased manufacturing the substance at issue. According to the Board of Appeal, the assessment of the proportionality of a possible sanction imposed on the applicant is a matter for the national authorities imposing it, in so far as ECHA is neither required nor empowered to assess the need or the proportionality of such a sanction.
–       The merits of the first part of the sixth plea
159    As a preliminary point, it must be borne in mind that, according to settled case-law, the principle of proportionality, which is one of the general principles of EU law, requires that measures adopted by EU institutions do not exceed the limits of what is appropriate and necessary in order to attain the objectives legitimately pursued by the legislation in question; when there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (judgments of 4 May 2016, Philip Morris Brands and Others, C‑547/14, EU:C:2016:325, paragraph 165, and of 20 January 2021, ABLV Bank v SRB, T‑758/18, EU:T:2021:28, paragraph 142; see also, to that effect, judgment of 8 June 2010, Vodafone and Others, C‑58/08, EU:C:2010:321, paragraph 51).
160    Furthermore, in the first place, as regards the applicant’s argument that its inactive registration dossier is destined to be in a situation of perpetual non-compliance which makes it subject to an equally perpetual risk of enforcement actions on the part of Member States, first, as stated in paragraphs 136 to 145 above, the Board of Appeal rightly held that the applicant had not proved that the only information that it could provide would relate to a substance different from that which it had initially registered. Secondly and in any event, it must be held that the applicant provides no additional details capable of calling into question the Board of Appeal’s finding in paragraphs 85 and 86 of the contested decision. The question of the possible sanctions that a national authority might adopt is unfounded as regards the question of the lawfulness of the contested decision.
161    In the second place, as regards the applicant’s argument that it is disproportionate to ask it to carry out the 90-day study on the substance marketed by the other registrant, which is, in its view, different from the substance at issue, first, it should be noted that the applicant does not claim before the Court and therefore does not adduce evidence that the assertion, in the contested decision, that, since the other registrant was not involved in the compliance check procedure, ECHA could not involve it in the follow-up procedure is incorrect. Secondly, it is apparent from the examination carried out in paragraphs 134 to 145 above that the applicant did not adduce evidence that the substance produced by the other registrant was different from its own.
162    In the third place, as regards the applicant’s arguments that (i) it complied with the initial compliance decision of 18 December 2017 by submitting, on 3 January 2019, the read-across justification, (ii) it is no longer relevant to request a study on the substance at issue, the manufacture of which has ceased, and (iii) it is no longer possible to manufacture that substance, suffice it to note that they are similar to the arguments put forward in the context of the first, second, third, fourth and fifth pleas, which have all been rejected, and that, therefore, they cannot succeed.
163    The first part of the sixth plea must therefore be rejected.
The second part of the sixth plea, alleging failure to comply with the principle of good administration
164    The applicant submits that ECHA failed to comply with the principle of good administration, first, by failing to take into consideration the fact that the applicant had ceased manufacturing the substance at issue due to a situation of force majeure and, secondly, by informing the applicant of its interpretation of Article 50(2) of the REACH Regulation only in October 2019, so that the applicant was unable to make known its views on that interpretation.
165    In that regard, the applicant disputes the reasoning, set out in paragraphs 87 to 95 of the contested decision, by which the Board of Appeal held, first, that ECHA had explained that the follow-up decision of 30 June 2020 did not contain a request for further information, secondly, that the applicant was bound by the initial compliance decision of 18 December 2017 regardless of the cessation of manufacture of the substance at issue and the transfer of the lead registrant role and, thirdly, that the applicant’s involvement in the procedure and the reasoning contained in the follow-up decision of 30 June 2020 enabled the applicant to understand how ECHA arrived at its conclusions.
166    The applicant observes that Appendix 2 to the follow-up decision of 30 June 2020 states, inter alia, that ‘comments of [a] procedural nature (referring to a cease of manufacture and transfer of the lead registrant role) which do not relate to the content of this decision, [were] addressed in a separate communication to [it]’ and that, in that communication, ECHA considered that, since the applicant had ceased manufacturing the substance at issue more than one year after the receipt of the initial compliance decision of 18 December 2017, Article 50(2) of the REACH Regulation did not apply and that, therefore, the applicant remained bound by that initial decision.
167    According to the applicant, ECHA not only failed to take into account the situation of force majeure, but it also considered that the cessation of manufacture of the substance at issue did not relate to the content of the follow-up decision of 30 June 2020. Furthermore, the applicant argues that ECHA did not explain why the situation of force majeure was not relevant and why it could not discharge the applicant of the burden to fulfil the information requirement, which, moreover, the applicant sought to fulfil with the read-across justification.
168    ECHA disputes the applicant’s arguments.
–       The relevant passages of the contested decision
169    In paragraphs 87 to 95 of the contested decision, the Board of Appeal expressed its view on the alleged failure to comply with the principle of good administration, recalling that that principle is based on the right to be heard and on compliance with the obligation to state reasons.
170    The Board of Appeal found that, in its comments on the draft follow-up decision and in other letters sent to ECHA, the applicant had claimed that, following the cessation of manufacture of the substance at issue, it was no longer responsible for carrying out the 90-day study requested in the initial compliance decision of 18 December 2017 and that it was in the process of negotiating the transfer of the role of lead registrant. The Board of Appeal noted that ECHA had replied to the applicant, in the email of 18 October 2019, stating that the draft follow-up decision did not contain a request for further information and that the applicant continued to be required to comply with the initial compliance decision of 18 December 2017, since the cessation of manufacture of the substance at issue or the transfer of the role of lead registrant had no bearing on that obligation.
171    The Board of Appeal also found that the follow-up decision of 30 June 2020 had not directly addressed the arguments raised by the applicant regarding the cessation of manufacture of the substance at issue and the transfer of the role of lead registrant. However, according to the Board of Appeal, Appendix 2 to the follow-up decision of 30 June 2020 stated that comments of a procedural nature referring to the cessation of manufacture of the substance at issue and to the transfer of the role of lead registrant had been addressed in a separate communication. In that regard, the Board of Appeal found that the email of 18 October 2019, to which that appendix referred, had enabled the applicant to understand why it continued to be bound to comply with the initial compliance decision of 18 December 2017.
172    The Board of Appeal concluded that, first, the applicant’s involvement in the process that led to the follow-up decision of 30 June 2020 and, secondly, the reasoning in that decision enabled the applicant to understand the grounds for that decision. Thus, the Board of Appeal found that ECHA had taken account of the cessation of manufacture of the substance at issue and had not breached the right to be heard or its obligation to state reasons for its decisions, with the result that the argument alleging failure to comply with the principle of good administration had to be rejected.
–       The merits of the second part of the sixth plea
173    As a preliminary point, it should be recalled that, according to settled case-law, the principle of good administration requires, where, as in the present case, the institutions or bodies of the European Union have a power of appraisal, observance of the guarantees afforded by the legal order of the European Union in administrative procedures, which include, in particular, the duty of the competent institution or body to examine carefully and impartially all the relevant aspects of the individual case (judgments of 21 November 1991, Technische Universität München, C‑269/90, EU:C:1991:438, paragraph 14; of 30 September 2003, Atlantic Container Line and Others v Commission, T‑191/98 and T‑212/98 to T‑214/98, EU:T:2003:245, paragraph 404; and of 9 April 2019, Qualcomm and Qualcomm Europe v Commission, T‑371/17, not published, EU:T:2019:232, paragraph 200).
174    Furthermore, in the first place, as regards the applicant’s argument that, in essence, ECHA did not explain why it had not taken account of the situation of force majeure, suffice it to note that, contrary to what the applicant claims, ECHA referred, in the email of 18 October 2019, to the fact that the applicant had ceased manufacturing the substance at issue by referring to a situation of force majeure, but it found that that did not call into question its obligation to provide the information requested by the initial compliance decision of 18 December 2017.
175    In the second place, as regards the applicant’s argument that it was unable to take a position on ECHA’s interpretation, set out in the email of 18 October 2019, relating to the relationship between Article 42 and Article 50 of the REACH Regulation, it is sufficient to note that, contrary to what the applicant claims, it was able to take a position on the content of the email of 18 October 2019 by means of its letter of 4 November 2019, as it itself states in paragraph 30 of the application.
176    Therefore, the second part of the sixth plea cannot succeed.
177    Consequently, the sixth plea in law must be rejected.
The seventh plea, requesting that the Court declare Article 50(2) of the REACH Regulation, as interpreted by the Board of Appeal, to be unlawful
178    In the reply, the applicant submits for the first time that, should the Court consider, like ECHA, that Article 50(2) of the REACH Regulation must be interpreted as meaning that the cessation of manufacture of the substance at issue did not release the applicant from its obligations under that regulation, the applicant then intended to raise a plea of illegality. It adds that, in accordance with Article 277 TFEU, the Court should not apply Article 50(2) of the REACH Regulation in the present case. The applicant states that the grounds underlying that plea of illegality are based on the interpretation of Article 50(2) of the REACH Regulation set out in paragraphs 77 to 79 of the defence.
179    In that context, the applicant submits that ECHA’s interpretation of Article 50(2) of the REACH Regulation is contrary, in the first place, to the principle of force majeure, which is ranked as a general principle of EU law; in the second place, to the principle of proportionality, enshrined in Article 5(4) TEU; and, in the third place, to the general legal principle ‘ubi lex non distinguit nec nos distinguere debemus’.
180    ECHA raises a plea of inadmissibility against that plea on the ground that it is out of time, in so far as it was raised by the applicant in its reply and, in any event, disputes the merits of the arguments put forward by the applicant in support of that plea.
181    Without it being necessary to rule on the plea of inadmissibility raised by ECHA, it is sufficient to note that, by its seventh plea, the applicant does not raise a genuine plea of illegality against Article 50(2) of the REACH Regulation. It merely reiterates, without adding anything, the challenges that it has already made against the interpretation and application of that article that ECHA and the Board of Appeal have made and which were rejected in the context of the first, second, third, fourth and sixth pleas.
182    Consequently, the seventh plea must be rejected.
183    It is also necessary to reject the head of claim reformulated by the applicant at the reply stage, requesting the Court to apply, in the present case, the principles established in the judgment of 14 June 2016, Commission v McBride and Others (C‑361/14 P, EU:C:2016:434). It is sufficient to note that the application of those principles presupposes the annulment of the contested measure, which is not the case here.
184    In the light of all the foregoing, the action must be dismissed in its entirety.
Costs
185    Under Article 134(1) of the Rules of Procedure of the General Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.
186    Since the applicant has been unsuccessful, it must be ordered to pay the costs, in accordance with the form of order sought by ECHA.
On those grounds,
THE GENERAL COURT (Tenth Chamber)
hereby:
1.      Dismisses the action;
2.      Orders Polynt SpA to pay the costs.
Porchia
Jaeger
Verschuur
Delivered in open court in Luxembourg on 11 September 2024.
V. Di Bucci
D. Spielmann
Registrar
President
*      Language of the case: English.