62021TJ0207_INF
Judgment of the General Court (Second Chamber) of 28 June 2023 –Polynt v ECHA
(Case T‑207/21) (
1
)
(REACH – Evaluation of substances – Hexahydro-4-methylphthalic anhydride – ECHA decision requesting one or more additional tests – Article 40 of Regulation (EC) No 1907/2006 – Appeal brought before the Board of Appeal – Error of law)
1.
Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Assessment procedure – Decision of the European Chemicals Agency requesting further information in the context of a substance evaluation – Appeal brought before the Board of Appeal of ECHA – Task of the Board of Appeal – Audi alteram partem – Intensity of the review – Assessment of highly complex scientific and technical facts – Review of legality limited to manifest errors of assessment – Not included
(European Parliament and Council Regulation No 1907/2006, Art. 93)
(see paragraphs 38, 83, 100)
2.
Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Assessment procedure – Compliance check of registration dossiers – Additional standard information requirements for substances manufactured or imported in quantities of 1000 tonnes or more – Exception for reproductive toxicity studies carried out under Annex X – Genotoxic carcinogen – Substance of very high concern with respiratory sensitising properties deemed equivalent to substances which are carcinogenic, mutagenic and toxic for reproduction – Not included
(European Parliament and Council Regulation No 1907/2006, Art. 57(f), and Annex X, column 2, Section 8.7)
(see paragraphs 48-57)
3.
Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Objectives – Generation of information necessary for the European Chemicals Agency (ECHA) to evaluate the dossier
(European Parliament and Council Regulation 1907/2006, recital 63)
(see paragraphs 63, 64)
4.
Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Assessment procedure – Compliance check of registration dossiers – Additional standard information requirements for substances manufactured or imported in quantities of 1000 tonnes or more – Application of column 2 of Section 8.7 to the examination of testing proposals and to the compliance check of registrations – Included
(European Parliament and Council Regulation No 1907/2006, Arts 40 and 41)
(see paragraph 66)
5.
Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Assessment procedure – Compliance check of registration dossiers – Additional standard information requirements for substances manufactured or imported in quantities of 1000 tonnes or more – Exception for reproductive toxicity studies carried out under Annex X – Scope of the examination
(European Parliament and Council Regulation No 1907/2006, Annex X, column 2, Section 8.7)
(see paragraph 71)
6.
Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Assessment procedure – Compliance check of registration dossiers – Additional standard information requirements for substances manufactured or imported in quantities of 1000 tonnes or more – Request for an extended one-generation reproductive toxicity test including a cohort 3 (developmental immunotoxicity) – Particular concerns specific to (developmental) inmunotoxicity – Requirement of a certain level of severity
(European Parliament and Council Regulation No 1907/2006, Annex X, column 2, Section 8.7.3.)
(see paragraph 80)
7.
Action for annulment – Judicial review – Limits – Assessment of highly complex scientific and technical facts – Review confined to manifest errors, misuse of power and whether the bounds of discretion have been exceeded
(Art. 263 TFEU)
(see paragraph 84)
8.
Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Principles – Precautionary principle
(European Parliament and Council Regulation No 1907/2006, Art. 1(3))
(see paragraph 92)
9.
EU law – General principles of law – Proportionality
(Article 5(4) TEU)
(see paragraph 105)
10.
Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Objectives – High level of protection of human health and the environment
(European Parliament and Council Regulation No 1907/2006, Art. 6)
(see paragraph 106)
11.
Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Objectives – Protection of animals
(Art. 13 TFEU; European Parliament and Council Regulation No 1907/2006, Arts 13(1) and 25(1), and Annexes VII to X)
(see paragraphs 107-109)
Operative part
The Court:
1.
Dismisses the action;
2.
Orders Polynt SpA to pay the costs, including those relating to the interim proceedings.
(
1
)	OJ C 228, 14.6.2021.