Case T‑868/19

Nouryon Industrial Chemicals BV and Others

v

European Commission

Judgment of the General Court (Fourth Chamber), 29 March 2023

(REACH – Evaluation of registration dossiers and compliance check of information provided by registrants – Request for further studies for the purposes of the registration dossier for dimethyl ether – Pre-natal developmental toxicity study – Extended one-generation reproductive toxicity study – Preliminary dose-range finding study – Article 51(7) of Regulation (EC) No 1907/2006 – Animal testing – Article 25 of Regulation No 1907/2006 – Manifest error of assessment – Proportionality)

1. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Evaluation procedure – Compliance check of registrations – Lack of a unanimous agreement of the Member State Committee on the draft decision of the European Chemicals Agency (ECHA) – Transfer to the Commission of the power to prepare a draft decision – Scope of the Commission’s power – Restriction to the aspects of the decision of ECHA upon which the Member State Committee did not reach a unanimous agreement – Not included

   (European Parliament and Council Regulation No 1907/2006, Art. 51(7))

   (see paragraphs 27-33)

2. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Evaluation procedure – Compliance check of registration dossiers – Decision of the European Chemicals Agency (ECHA) requesting additional information – Appeal brought before the Board of Appeal of ECHA – Task of the Board of Appeal – Intensity of the review – Assessment of highly complex scientific and technical facts – Restriction of the review to the assessment of manifest errors of assessment by ECHA – Precluded – Right to review ECHA’s assessments – Included

   (European Parliament and Council Regulation No 1907/2006)

   (see paragraph 38)

3. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Evaluation procedure – Compliance check of registration dossiers – Decision of the European Chemicals Agency (ECHA) requesting additional information – Action brought before the EU Courts – Intensity of the review – Assessment of highly complex scientific and technical facts – Restriction of the review to the assessment of manifest errors of assessment by ECHA – Included

   (Art. 263 TFEU; European Parliament and Council Regulation No 1907/2006)

   (see paragraph 38)

4. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Obligation to register with the European Chemicals Agency (ECHA) – Subject matter of the registration – Guarantee of the non-hazardous use of a substance in its normal applications – Necessary knowledge in respect of the intrinsic characteristics of the substance, in particular its effects on living organisms and on the environment

   (European Parliament and Council Regulation No 1907/2006, Annexes VII to X)

   (see paragraph 83)

5. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Evaluation procedure – Concept of particular concern – Conditions – Existence of information that could reasonably give rise to fears as to the neurotoxic effects of the substance – Included

   (European Parliament and Council Regulation No 1907/2006, Annex X, Section 8.7.3., column 2, 2nd para.)

   (see paragraph 103)

6. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Evaluation procedure – Compliance check of registration dossiers – Commission’s power – Scope – Right to request a dose-range finding study prior to an extended one-generation reproductive toxicity study – Included

   (European Parliament and Council Regulation No 1907/2006, Annex X, Section 8.7.3.)

   (see paragraph 133)

7. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Evaluation procedure – Compliance check of registration dossiers – Decision to request that the registration dossier be supplemented on the basis of a study involving animal testing – Right to respond by proposing adaptations of the requested studies – Whether permissible

   (European Parliament and Council Regulation No 1907/2006, Annex X, Section 8.7.3., column 2, 2nd para.)

   (see paragraphs 144-148)

8. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Evaluation procedure – Compliance check of registration dossiers – Standard information requirements in respect of substances manufactured or imported in quantities of 1000 tonnes or more – Request that a pre-natal developmental toxicity study be carried out on a second species under Annex X – Mandatory scope

   (European Parliament and Council Regulation No 1907/2006, Annex X, Section 8.7.2.)

   (see paragraph 164)

Résumé

The applicants are manufacturers or importers of dimethyl ether established in the European Union or exclusive representatives acting on behalf of manufacturers of that chemical substance established outside the European Union. In accordance with the principle of ‘no data, no market’, ( 1 ) they filed with the European Chemicals Agency (ECHA) an application for registration of dimethyl ether for manufactured or imported quantities of 1000 tonnes or more per year per manufacturer or per importer.

In the context of a procedure for a compliance check of the registration, ( 2 ) as the ECHA Member State Committee had not reached a unanimous agreement on a draft ECHA decision, ECHA sent the dossier to the European Commission for it to adopt a final decision. ( 3 ) In that decision (‘the contested decision’), the Commission concluded that the registration of dimethyl ether did not comply with the information requirements as regards two different effects relating to reproductive toxicity, namely the effects on pre-natal development and the effects on one-generation reproduction. Consequently, in the contested decision, the Commission required the registrants to provide information in that regard after the carrying out of additional testing on rabbits and rats.

Hearing an action for annulment, which it dismisses, the General Court provides important clarifications, in the light of the provisions of the REACH Regulation and its annexes, as regards, in particular, the Commission’s power in respect of a compliance check of a registration dossier, laboratory testing on animals which it is compulsory to carry out or which may be required, and the conditions for carrying out such testing, the conditions for adaptation of the requirements set out in a decision adopted following such a compliance check and the role of the court before which an action is brought against that decision.

Findings of the Court

In the first place, the Court rejects the plea alleging that the Commission infringed the REACH Regulation by adopting the contested decision which, in part, covers aspects on which the Member State Committee reached a unanimous agreement.

In that regard, first, the Court finds that, contrary to what is claimed by the applicants, it is not apparent from Article 51(7) of the REACH Regulation that if a disagreement within the Member State Committee concerns only part of ECHA’s draft decision, ECHA must divide the final decision into one part, the subject matter of the agreement, which would be adopted by it on the basis of paragraph 6 of that article, and into another part, the subject matter of the disagreement, which would be adopted by the Commission in accordance with paragraph 7 of that article. The Court concludes, following a literal, contextual and teleological approach, that paragraph 7 of that article, which is the legal basis for the contested decision, can be understood only as meaning that any disagreement within the Member State Committee on an aspect of a draft ECHA decision examined in the context of a compliance check of registrations constitutes a disagreement on that draft considered as a whole, which confers on the Commission the power to prepare a new draft decision evaluating a registration dossier and then to adopt a final decision in that regard.

Secondly, the Court states that that conclusion is not called into question by the argument that the applicants would have benefited from more guarantees if the final decision, as regards the aspects on which the Member State Committee had reached a unanimous agreement, had been adopted by ECHA, since the review carried out by the Board of Appeal of ECHA is not limited, as in the case of the General Court, to verifying whether there are manifest errors. That difference is a result of the legislature’s choice to establish, in certain cases, a review of an administrative nature and, in other cases, a review of a judicial nature.

In the second place, the Court rejects the plea alleging that the Commission infringed the REACH Regulation ( 4 ) and made a manifest error of assessment by requesting tests that run counter to the applicable legal requirements and are not technically feasible without presenting hazards. The Court finds that the arguments set out in support of that plea have no factual basis and that the applicants have not demonstrated in any way that, in the contested decision, the Commission required, contrary to the legally applicable provisions, that dangerous concentrations be reached for acute inhalation toxicity tests. The Court also finds that it is apparent from the case file that some laboratories consider that they are capable of carrying out the tests in question.

In the third place, the Court rejects the plea alleging that the Commission made a manifest error of assessment by requiring tests that do not produce any relevant information on dimethyl ether.

After noting the layout and role of the annexes to the REACH Regulation, the Court states, inter alia, that the information which must, in principle, be provided, concerns chemical substances and is intended, as set out in Article 1 of the REACH Regulation, to ensure that the hazards associated with those substances, when manufactured, placed on the market and used, are known and that those substances, when used, do not adversely affect human health or the environment. The Court infers from that that, in the light of the potential hazards of chemical substances and applying the precautionary principle, but also taking into account the objective of preventing unnecessary testing on vertebrate animals, the legislature has already made choices in order to request registrants to carry out studies on vertebrate animals only if those studies appear relevant in view of the relevant quantities of substance. Accordingly, since they do not challenge the legality of those annexes, the applicants cannot validly claim that they are exempt from carrying out studies which must in all cases be carried out according to the provisions of those annexes, on the ground that those studies are irrelevant.

Next, the Court examines the arguments put forward in support of the third plea seeking to call into question the Commission’s assessment as to the usefulness of the various requested studies, in so far as those studies are not in any event mandatory. The Court states that, since such an assessment falls within the category of assessments of highly complex scientific and technical facts by an administrative authority, it must confine itself to ascertaining whether that assessment is vitiated by a manifest error or by a misuse of powers, or whether that authority has manifestly exceeded the limits of its discretion. After rejecting the applicants’ request that an independent expert be used, due to that being unnecessary in order to rule on the present action, the Court finds, as regards the arguments relating to specific uses in humans and relating to the assessment and management of risks in that regard, which seek to demonstrate that, where the substance is used in its industrial, professional or domestic applications, it cannot lead to narcotic effects in humans, that registration of a substance is not intended solely to ensure its non-hazardous use in its normal applications, but also to know about the substance and its effects on living organisms and on the environment as such, in other words, to know its intrinsic characteristics, which may require tests recreating conditions that differ from those in its normal applications. It concludes that the Commission did not make a manifest error of assessment by requesting the tests listed in the contested decision.

In the fourth place, the Court rejects the argument that the Commission erred in law by distorting the scope of the wording ‘particular concerns’ set out in an annex to the REACH Regulation. ( 5 ) It holds that, despite the lack of a precise definition as to what is a particular concern on developmental neurotoxicity, it follows from the very wording used in the provision in question that, for such a concern to exist, information of a certain nature held by the registrants or by the competent authority must establish that the substance in question has developmental neurotoxic effects, or even merely gives reasonable grounds for fearing that that substance might have those effects. Where there is such information, the purpose of the extended one-generation reproductive toxicity study including cohorts 2A and 2B is then to clarify, confirm or disprove the developmental neurotoxic effects of the substance. It is therefore for the competent authority, in the absence of a spontaneous initiative to that effect by the registrants, to consider whether concerns on developmental neurotoxicity exist. Thus, in the present case, the Commission was not required to put forward evidence, at that stage, that dimethyl ether has serious and severe neurotoxicity effects.

In the fifth place, the Court rejects the plea alleging that the Commission erred in law ( 6 ) by requiring that the extended one-generation reproductive toxicity study be preceded by a preliminary dose-range finding study. First of all, the Court rules that the Commission is authorised to request that a preliminary dose-range finding study be carried out prior to an extended one-generation reproductive toxicity study. Next, in so far as, in view of the quantities declared in the present case, the level of the substances manufactured or imported per year per manufacturer or per importer in quantities of 1000 tonnes or more has been reached, the applicants cannot rely on the adaptation possibilities the application of which concerns substances manufactured or imported in quantities of 10 tonnes or more. Lastly, as regards the line of argument that the carrying out of a preliminary dose-range finding study disregards the objective ( 7 ) of carrying out tests on vertebrate animals only if there is no other solution, the Court finds, in the present case, that the fact that that study was requested in the context of the carrying out of an extended one-generation reproductive toxicity study enabled the precautionary principle to be reconciled with the requirement to reduce animal testing.

In the sixth place, the Court rejects the plea alleging that the Commission erred in law ( 8 ) on the ground that the contested decision does not allow the applicants to remedy the non-compliance of the registration of dimethyl ether by submitting adaptations of the studies requested in that decision. The Court states that the relevant general provisions of the REACH Regulation and the objective of limiting animal testing mean that a registrant whom ECHA has requested to supplement its registration dossier on the basis of a study involving animal testing has, in so far as possible from a scientific and technical perspective, the option and even the obligation to respond to that request by providing appropriate information in the light of the grounds justifying that request, but from sources other than that study. Furthermore, ECHA is under a corresponding obligation to check the compliance of such alternative information with the applicable requirements and, more specifically, to determine whether it is to be classified as adaptations in accordance with the rules laid down in the relevant annexes to the REACH Regulation. According to the Court, there is no reason why a different solution should be used where, as in the present case, the decision requesting the registrant to supplement its registration dossier on the basis of a study involving animal testing is adopted ( 9 ) not by ECHA, but by the Commission because of the lack of unanimity in the Member State Committee on the draft ECHA decision. The Court therefore concludes that the contested decision cannot be interpreted as prohibiting the applicants from responding to it by proposing adaptations and, therefore, in the technical file, appropriate information in the light of the grounds which justified the requests for studies on animals set out in that decision, but from sources other than those studies.

As regards the plea alleging that, by requesting that a pre-natal developmental toxicity study be carried out on rabbits, the Commission made in particular an error in law and a manifest error of assessment, ( 10 ) the Court rejects that plea. It holds that the error of law is not established, since the provision of Annex IX according to which ‘the study shall be initially performed on one species’ and ‘a decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available data’, ( 11 ) highlighted by the applicants, means only that the requirement for a study on a second species for a substance manufactured or imported in quantities between 100 tonnes and 999 tonnes per year per manufacturer or per importer may, where the conditions for carrying out such a study are met, possibly be postponed until such time as the substance comes under the ‘next level’, namely when the substance is manufactured or imported in quantities of 1000 tonnes or more per year per manufacturer or per importer. However, that provision of Annex IX is not itself transposed to the latter level, which is the subject of Annex X. Therefore, as regards the manifest error of assessment that was allegedly made by requesting that a pre-natal developmental toxicity study be carried out on a second species when the conditions were not met, the Court rules that the requirement in column 1 of Section 8.7.2. of Annex X to have a ‘toxicity study … single species’ carried out must be interpreted as differing from the requirement set out in similar terms in column 1 of Annex IX for the same section, which means that both studies in question must each concern a different species. As no adaptation is provided for in that regard in Section 8.7.2. of Annex X, the pre-natal developmental toxicity study carried out on a second species is mandatory where the substance is produced or imported at the levels referred to in Annex X, unless adaptations are possible under the provisions set out elsewhere.

( 1 ) Principle set out in Article 5 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; ‘the REACH regulation’).

( 2 ) On the basis of Article 41 of the REACH Regulation.

( 3 ) Article 51(7) of the REACH Regulation.

( 4 ) Article 13(3) of the REACH Regulation.

( 5 ) Second paragraph of column 2 of Section 8.7.3. of Annex X to the REACH Regulation.

( 6 ) Infringement of column 1 of Section 8.7.3. of Annex X to, and of Article 25 of, the REACH Regulation.

( 7 ) Set out in Article 25(1) of the REACH Regulation.

( 8 ) Infringement of Article 41 of, and of Annex XI to, the REACH Regulation.

( 9 ) In the context of the procedure laid down in Article 51 of the REACH Regulation on the adoption of decisions under dossier evaluation.

( 10 ) Infringement of column 2 of Section 8.7.2. of Annex IX to the REACH Regulation.

( 11 ) Provision set out in column 2 of Section 8.7.2. of Annex IX to the REACH Regulation.