Case T‑125/17
BASF Grenzach GmbH
v
European Chemicals Agency
Judgment of the General Court (Fifth Chamber, Extended Composition), 20 September 2019
(REACH – Evaluation of substances – Triclosan – ECHA decision requesting further information – Article 51(6) of Regulation (EC) No 1907/2006 – Action brought before the Board of Appeal – Task of the Board of Appeal – Adversarial nature of the procedure – Scope of the review – Intensity of the review – Powers of the Board of Appeal – Article 93(3) of Regulation No 1907/2006 – First sentence of Article 47(1) of Regulation No 1907/2006 – Relevant information – Proportionality – Article 25 of Regulation No 1907/2006 – Annex XIII to Regulation No 1907/2006 – Data obtained under relevant circumstances – Persistence – Neurotoxicity – Reproductive toxicity – Article 12(1) of Regulation (EC) No 771/2008 – Delay in the submission of a scientific opinion)
1. Approximation of laws – Registration, evaluation, and authorisation of chemicals – REACH Regulation – Evaluation procedure – Decision of the European Chemicals Agency (ECHA) requesting further information in the context of the evaluation of a substance – Action brought before the Board of Appeal of ECHA – Task of the Board of Appeal – Adversarial nature of the procedure – Scope of the review – No obligation on the Board of Appeal to carry out a ‘de novo’ examination of the scientific data evaluated by ECHA at first instance – Review, determined by the pleas put forward by the applicant, of the existence of errors vitiating the ECHA decision
(Regulation No 1907/2006 of the European Parliament and of the Council, Arts 46(1), 50, 51(2) to (8), 52(1) and (2), 93(3) and (4), 133(3) and (4); Commission Regulation No 771/2008, Arts 6(1)(e) and (f), 7(1) and (2)(b) and (c,) and 12(1) and (2))
(see paragraphs 59-61, 63-86, 92, 97, 104, 106, 112, 115, 120, 126, 129, 226, 280, 334, 448)
2. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Evaluation procedure – Decision of the European Chemicals Agency (ECHA) requesting further information in the context of the evaluation of a substance – Action brought before the Board of Appeal of ECHA – Task of the Board of Appeal – Adversarial nature of the procedure – Intensity of the review – Assessment of highly complex scientific and technical facts – Review of lawfulness restricted to an assessment of the manifest errors of assessment – Precluded
(Regulation No 1907/2006 of the European Parliament and of the Council; Commission Regulations No 1238/2007, Art. 1(2) and No 771/2008, Art.1(1), second para.)
(see paragraphs 87-89, 124)
Résumé
On 20 September 2019, in the judgment in BASF Grenzach v ECHA (T‑125/17), delivered in a chamber sitting in extended composition, the General Court ruled for the first time on the task and powers of the Board of Appeal of the European Chemicals Agency (ECHA) and, in particular, on the scope and intensity of the review carried out by that board, in the context of an action brought before it against a decision of the ECHA requesting additional information regarding the evaluation of the substance Triclosan, in accordance with Regulation No 1907/2006. (1)
The applicant company, the manufacturer of Triclosan, is the sole registrant of that substance within the meaning of that regulation. Following the adoption by ECHA of a decision requesting further information from the applicant, the latter brought an appeal before that agency’s Board of Appeal, which was dismissed in part. By its appeal before the General Court, the applicant requested the annulment of the decision of the Board of Appeal of ECHA, on the basis of pleas alleging that the Board of Appeal had failed to understand its review task since it did not carry out a ‘de novo’ examination of the scientific assessments on which the initial ECHA decision was based. The applicant’s arguments were unsuccessful and the General Court dismissed the appeal on the following grounds.
In the first place, as regards the scope of the review task of the Board of Appeal of ECHA, the General Court noted at the outset that none of the provisions of Regulation No 1907/2006 or of Regulation No 771/2008 (2) expressly provide that, in the context of an action before it against a decision of the ECHA requesting further information in the evaluation of a substance, the Board of Appeal is to conduct a ‘de novo’ evaluation as envisaged by the applicant, that is to say an evaluation of the question whether, at the time when it rules on the action, in the light of all the relevant matters of law and fact, in particular scientific issues, a new decision with the same operative part as the decision before it may be lawfully adopted. By contrast, it follows from the provisions of those two regulations that, in the context of such an action, the Board of Appeal is to confine itself to examining whether the arguments put forward by the applicant are such as to demonstrate the existence of an error vitiating the contested decision. The General Court ruled that, because of the adversarial nature of the procedure before the Board of Appeal of ECHA, as provided for by the general procedural rules of Regulation No 771/2008, the subject of that procedure is determined by the pleas put forward by the applicant in the context of the action before that board and that this type of action may therefore only aim to examine whether the evidence submitted by the applicant is capable of demonstrating that the decision contested before it is vitiated by error.
Moreover, the Court noted that it is clear from the scheme of Regulation No 1907/2006 that the rules of procedure which apply to ECHA where it adopts a decision at first instance are not intended to apply directly to the Board of Appeal. The Court therefore considered that the Board of Appeal was not required to carry out a new evaluation comparable to that carried out by ECHA at first instance. In particular, the Court considered that it is not for the Board of Appeal to repeat the scientific examination conducted in the initial ECHA decision, as, first, that examination, to be carried out in accordance with the precautionary principle, must be entrusted only to scientific experts and, second, there is no provision in Regulation No 1907/2006 or Regulation No 771/2008 providing for such a new scientific evaluation in the context of appeal proceedings before the Board of Appeal.
In the second place, as regards the intensity of the review by the Board of Appeal of ECHA, the Court ruled that, unlike the review of the EU courts, the review carried out by the Board of Appeal of assessments of highly complex scientific facts in an ECHA decision is not limited to verifying the existence of manifest errors. Having regard to the respective legal and scientific qualifications of the members of the Board of Appeal of ECHA, the board has the necessary expertise to allow it to carry out this type of assessment itself. Therefore, it is in reliance on the legal and scientific competences of its members, that that board must examine whether the arguments put forward by the applicant are capable of demonstrating that the considerations on which that decision is based are vitiated by error.