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 – Failure to respond to the compliance check decision – Article 50 of Regulation (EC) No 1907/2006 – Proportionality )
In Case T‑192/22,
Polynt SpA, established in Scanzorosciate (Italy), represented by C. Mereu and I. Zonca, lawyers,
applicant,
v
European Chemicals Agency (ECHA), represented by M. Heikkilä, L. Lourenço, and W. Broere, 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 based on Article 263 TFEU, the applicant, Polynt SpA, seeks the annulment of the letter sent to the Italian authorities by the European Chemicals Agency (ECHA) on 4 February 2022 (‘the contested act’), by which ECHA, first, found that the applicant had failed to respond to its compliance check decision of 18 December 2017 (‘the initial compliance decision of 18 December 2017’), adopted under 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’), and, secondly, requested those authorities to take all the necessary measures to secure implementation of that decision.
Background to the dispute
2        On 15 December 2014, the applicant submitted to ECHA a registration dossier for substance 1,3-dioxo-2-benzofuran-5-carboxylic acid with nonan-1-ol (‘the substance at issue’). The application sought registration of the substance at issue as a ‘substance of Unknown or Variable composition, Complex reaction products or Biological materials’.
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 the REACH Regulation. ECHA subsequently received comments on that draft from the applicant and the competent authorities of the Member States.
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 (‘the 90-day study’) by 3 January 2019, as well as four other studies (‘the other four studies’) by 25 June 2021 at the latest.
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 that 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 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.
11      On 19 July 2019, ECHA sent a draft follow-up decision to the applicant under Article 42(1) of the REACH Regulation.
12      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 stopped 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.
13      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 the manufacture of 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.
14      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 that 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. That email stated that the requirements set out in the initial compliance decision of 18 December 2017 continued to apply.
15      By letter of 4 November 2019, the applicant complained that ECHA had misinterpreted Articles 41, 42 and 50 of the REACH Regulation.
16      On 27 November 2019, the other registrant informed the applicant that ECHA had accepted the change of lead registrant.
17      On 30 June 2020, ECHA adopted a follow-up decision on the basis of Article 42(1) of the REACH Regulation (‘the follow-up decision of 30 June 2020’). 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.
18      On 28 September 2020, the applicant lodged an appeal with the Board of Appeal of ECHA (‘the Board of Appeal’), challenging the legality of the follow-up decision of 30 June 2020 and requesting that it be annulled.
19      On 9 November 2021, the Board of Appeal dismissed the applicant’s appeal in its entirety.
20      On 18 January 2022, the applicant brought an action under Article 263 TFEU, registered as Case T‑29/22, seeking the annulment of the decision of the Board of Appeal of 9 November 2021. That action was dismissed by the Court by judgment delivered today in Polynt v ECHA (T‑29/22, not published).
21      On 4 February 2022, ECHA sent the contested act to the competent Italian authorities. In that act, in the first place, ECHA recalled the obligations imposed on the applicant by the initial compliance decision of 18 December 2017. In the second place, ECHA informed the Italian authorities that, by the time the deadline of 25 June 2021 had passed, the applicant had not submitted any information corresponding to the other four studies, with the exception of an adaptation that was assessed as manifestly unreasonable. In the third place, ECHA requested the Italian authorities to take appropriate actions to address the non-compliance of the applicant’s dossier and to ensure full implementation of the initial compliance decision of 18 December 2017. In the fourth place, ECHA informed the Italian authorities of the fact that the applicant had ceased manufacturing the substance at issue, while reminding them of the Board of Appeal’s decision of 9 November 2021 establishing that that cessation of manufacture was subsequent to the initial compliance decision of 18 December 2017 and therefore had no effect on the information requirements imposed on the applicant.
Forms of order sought
22      The applicant claims that the Court should:
–        annul the contested act;
–        order ECHA to adopt a new measure declaring that the applicant is released from the obligation to provide any information to ECHA following the cessation of manufacture of the substance at issue due to force majeure;
–        order ECHA to pay the costs.
23      ECHA contends that the Court should:
–        dismiss the action as inadmissible or, in the alternative, as unfounded;
–        order the applicant to pay the costs.
Law
24      It should be borne in mind that the Courts of the European Union are entitled to assess, according to the circumstances of each case, whether the proper administration of justice justifies the dismissal of an action on the substance without a prior ruling on its admissibility (see, to that effect, judgments of 26 February 2002, Council v Boehringer, C‑23/00 P, EU:C:2002:118, paragraphs 51 and 52, and of 14 September 2016, Trajektna luka Split v Commission, T‑57/15, not published, EU:T:2016:470, paragraph 84). In the present case, it is appropriate, in the interests of procedural economy, to examine at the outset the merits of the action, without first ruling on its admissibility, since, for the reasons set out below, it is unfounded.
25      In support of its action, the applicant raises four pleas in law, alleging, first, failure to comply with the principle of force majeure, secondly, infringement of Article 50(2) of the REACH Regulation, thirdly, infringement of Articles 5 and 6 of that regulation and, fourthly, failure to comply with the principle of proportionality.
26      It is appropriate to examine, first of all, the second plea, then the first and third pleas together and, lastly, the fourth plea.
The second plea, alleging infringement of Article 50(2) of the REACH Regulation
27      The applicant’s second plea is divided into two 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 and, secondly, misinterpretation of the expression ‘further information’ contained in the English-language version of that provision.
28      As regards the first part, the applicant submits that Article 50(2) of the REACH Regulation does not set any time limit for notifying the cessation of manufacture 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.
29      The applicant observes that ECHA’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, ECHA 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      As regards the second part, the applicant submits that ECHA 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.
31      In the first place, the applicant submits, first, that ECHA’s interpretation has no basis in the wording of Article 50(2) of the REACH Regulation since 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.
32      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.
33      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.
34      ECHA disputes the applicant’s arguments.
35      The applicant, in essence, as in its action that gave rise to the judgment delivered today in Polynt v ECHA (T‑29/22, not published), submits 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.
36      In the first place, in paragraph 59 of the judgment delivered today in Polynt v ECHA (T‑29/22, not published), the Court held as follows. First, 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. Secondly, 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. Thirdly, 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.
37      In the second place, first, in paragraphs 60 and 61 of the judgment delivered today in Polynt v ECHA (T‑29/22, not published), the Court held that the continued obligation to provide the information requested in a compliance check decision adopted before the cessation of manufacture of a substance was justified by the fact that, if that were not the case, a registrant that had not complied with such a decision could manufacture a substance by evading the obligations under the REACH Regulation, to the detriment, on the one hand, of the objective of ensuring a high level of protection of human health and the environment and, on the other hand, of other registrants whose registration dossier complies with those obligations.
38      Secondly, in paragraph 62 of the judgment delivered today in Polynt v ECHA (T‑29/22, not published), the Court held that the continued obligation to provide the information requested in a compliance check decision adopted before the cessation of manufacture of a substance was, moreover, justified by the fact that that cessation could not automatically correspond, as in the present case, to the disappearance of that substance from circulation.
39      In the third place, in paragraph 63 of the judgment delivered today in Polynt v ECHA (T‑29/22, not published), the Court held that the applicant’s argument that ECHA had made a distinction not provided for by the legislature contrary to the general legal principle ‘ubi lex non distinguit, nec nos distinguere debemus’ could not succeed, since, contrary to what the applicant submitted, that distinction has a textual basis in Article 50(1) of the REACH Regulation.
40      Accordingly, since the arguments raised by the applicant in its second plea correspond to the arguments rejected in the judgment delivered today in Polynt v ECHA (T‑29/22, not published), that plea must also be rejected.
The first and third pleas, alleging failure to comply with the principle of force majeure and infringement of Articles 5 and 6 of the REACH Regulation
41      As regards the first plea, first, 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 that could be a potential substitute for Linevol9. The applicant states that it therefore carried out market research on raw materials that showed that those components were not chemically equivalent to Linevol9. According to the applicant, none of those components meets the requirements defined in its registration dossier. Thus, the applicant submits that carrying out the other four studies on a substance that is different from the substance at issue would not generate relevant data for the substance at issue as registered by the applicant.
42      Consequently, the applicant submits that ECHA manifestly failed to comply with the principle of force majeure.
43      In that regard, 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’.
44      Next, 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.
45      Thus, according to the applicant, in the present case, the elements constituting force majeure are present.
46      Lastly, in the first place, the applicant submits that it is required to carry out studies concerning a substance that is not registered by it. In the second place, 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. In the third place, the contested decision places the applicant in the impossible situation of having to carry out studies on a substance that does not exist and cannot be produced, which therefore requires the applicant to bring a probatio diabolica.
47      As regards the third plea, 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.
48      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.
49      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.
50      ECHA disputes the applicant’s arguments.
51      The applicant, as in its action that gave rise to the judgment delivered today in Polynt v ECHA (T‑29/22, not published), submits that the situation of force majeure in which it finds itself results from the fact that the substance at issue can no longer exist because of the disappearance of Linevol9 and that the substance produced by the other registrant is different from the substance at issue.
52      Suffice it to note, first, that, in paragraph 136 of the judgment delivered today in Polynt v ECHA (T‑29/22, not published), the Court held that the Board of Appeal had not committed 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 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. Secondly, in paragraph 147 of that judgment, the Court held that the applicant had not proved that the principle of force majeure could apply in the present case.
53      Therefore, even though the arguments raised by the applicant in its first and third pleas relate to the other four studies and not the 90-day study, they correspond, in essence, to the arguments rejected in the judgment delivered today in Polynt v ECHA (T‑29/22, not published), with the result that those pleas must also be rejected.
The fourth plea, alleging failure to comply with the principle of proportionality
54      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.
55      The applicant submits that ECHA’s approach leads to a disproportionate and unreasonable situation, since the applicant is required to carry out studies on the substance at issue, which has not been registered by it under the REACH Regulation 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, the applicant would be forced to carry out studies on a substance that is different from the substance at issue, namely the one marketed by the other registrant.
56      ECHA disputes the applicant’s arguments.
57      The applicant, as in its action that gave rise to the judgment delivered today in Polynt v ECHA (T‑29/22, not published), submits that the contested act fails to comply with the principle of proportionality in so far as (i) it is subject to a perpetual risk of enforcement measures on the part of the Member States, (ii) it is asked to carry out studies on a substance that is different from the substance at issue, (iii) it is no longer relevant to request studies on the substance at issue, the manufacture of which has ceased, and (iv) it is no longer possible to manufacture that substance.
58      In the first place, in paragraph 160 of the judgment delivered today in Polynt v ECHA (T‑29/22, not published), the Court held that the applicant had not proved the fact on which it bases that argument, namely that the only information that it could provide would relate to a substance that is different from the substance which it had initially registered.
59      In the second place, in paragraph 161 of the judgment delivered today in Polynt v ECHA (T‑29/22, not published), the Court held that the applicant had not adduced evidence that the substance produced by the other registrant was different from its own.
60      In the third place, in paragraph 162 of the judgment delivered today in Polynt v ECHA (T‑29/22, not published), the Court held that the applicant’s arguments that it was no longer relevant to request a study on the substance at issue, the manufacture of which had ceased, and it was no longer possible to manufacture that substance were similar to the arguments put forward, in particular, in the context of the first, second and third pleas raised in that case, which had all been rejected, and that, therefore, they could not succeed.
61      Thus, even though the arguments raised by the applicant in its fourth plea relate to the other four studies and not the 90-day study, they correspond, in essence, to the arguments rejected in the judgment delivered today in Polynt v ECHA (T‑29/22, not published), with the result that that plea must also be rejected.
62      Accordingly, the action must be dismissed in its entirety.
Costs
63      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.
64      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.