62022TJ0453_INF
Judgment of the General Court (Sixth Chamber) of 27 November 2024 –BASF and Others v Commission
(Case T‑453/22) (
1
)
(Environment and protection of human health – Regulation (EC) No 1272/2008 – Classification, labelling and packaging of certain substances and mixtures – Delegated Regulation (EU) 2022/692 – Classification and labelling of the substance N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) and its pentasodium and pentapotassium salts (DTPA) – Criteria for classification of a substance as a reproductive toxicant Category 1B – Intrinsic property to specifically harm reproduction – Non-specific secondary consequence of other toxic effects – Possible influence of maternal toxicity – Appropriateness of the classification – Absence of public consultation on the opinions of ECHA’s Committee for Risk Assessment – Interinstitutional Agreement on Better Law-Making – Absence of impact assessment)
1.
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) and its pentasodium and pentapotassium salts (DTPA) as a presumed reproductive toxicant – Discretion of the Commission – Judicial review – Scope – Limits
(European Parliament and Council Regulation No 1272/2008, as amended by Regulation 2022/692, Arts 5, 9, 13, 36(1), 37(1), (2), (4) and (5), and 53a, and Annexes I, Part 3, Section 3.7, and VI, Part 3, Table 3)
(see paragraphs 25-36)
2.
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) and its pentasodium and pentapotassium salts (DTPA) as a presumed reproductive toxicant – Criteria – Intrinsic property of a substance to specifically harm reproduction – Concept – Property of a substance which has the effect of specifically harming the development of the offspring – Included – Adverse effects on development of the offspring – Limitation solely to primary effects on reproduction – Not permissible
(European Parliament and Council Regulation No 1272/2008, as amended by Regulation 2022/692, Art. 36 and Annex I, Sections 1.1.1.6(b), 1.1.3.1.1, 3.6.2.2.1, 3.7.1.1, first and second paras., point (b), 3.7.1.4, 3.7.2.2, 3.7.2.3.4, 3.7.2.3.5 and 3.7.2.4.3 and Table 3.7.1(a))
(see paragraphs 46-50, 52-60, 62-69)
3.
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) and its pentasodium and pentapotassium salts (DTPA) as a presumed reproductive toxicant – Criteria – Infringement of those criteria and of the principle of legal certainty – Absence
(European Parliament and Council Regulation No 1272/2008, as amended by Regulation 2022/692, Arts 36(1) and 37, and Annex I, Section 3.7.2.2.1)
(see paragraphs 72-81, 83, 84, 86-88, 90-94)
4.
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) and its pentasodium and pentapotassium salts (DTPA) as a presumed reproductive toxicant – Assessment by the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA) of the possible influence of maternal toxicity on the development of the offspring – Taking into account the severity of that toxicity – Manifest error of assessment – Absence
(European Parliament and Council Regulation No 1272/2008, as amended by Regulation 2022/692, Annex I, Sections 3.7.2.2.2, 3.7.2.3.5, 3.7.2.4.2 and 3.7.2.4.3)
(see paragraphs 97-108)
5.
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) and its pentasodium and pentapotassium salts (DTPA) as a presumed reproductive toxicant – Broad discretion of the Commission – Classification based on scientific data from animal studies indicating the capacity of DTPA to interfere with reproduction – Available data capable of clearly demonstrating the adverse effects of the substance on the development of the foetus – Manifest error of assessment – Absence
(European Parliament and Council Regulation No 1272/2008, as amended by Regulation 2022/692, Art. 36(1) and Annex I, Sections 3.7.2.1.1, 3.7.2.2.1, 3.7.2.2.2 and 3.7.2.3.2 and Table 3.7.1(a); Commission Regulation 2022/692, recitals 3 and 4)
(see paragraphs 118-126, 128-136, 138-141, 144-146)
6.
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) and its pentasodium and pentapotassium salts (DTPA) as a presumed reproductive toxicant – Obligation of the Commission to examine the appropriateness of that classification – Infringement – Absence – Breach of the principles of proportionality and sound administration – Absence
(European Parliament and Council Regulation No 1272/2008, as amended by Regulation 2022/692, Art. 37(1), (2), (3) and (5) and Annex VI; Commission Regulation 2022/692, recitals 2, 16th indent, 3 and 4)
(see paragraphs 150-161)
7.
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) and its pentasodium and pentapotassium salts (DTPA) as a presumed reproductive toxicant – Obligation of the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA) to organise public consultations concerning classification proposals – Right of the parties concerned to comment on RAC opinions– Absence – Infringement of that obligation and of the right to be heard – Absence
(Charter of Fundamental Rights of the European Union, Art. 41(2)(a); European Parliament and Council Regulation No 1272/2008, as amended by Regulation 2022/692, Arts 1 and 37(4) and Annex VI, Part 3, Table 3)
(see paragraphs 165-176)
8.
Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 1272/2008 – Adaption to scientific and technical progress – Harmonised classification and labelling of the substance N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) and its pentasodium and pentapotassium salts (DTPA) as a presumed reproductive toxicant – Obligation for the Commission to carry out an impact assessment before adopting the regulation introducing that classification – Absence – Breach of the principle of sound administration – Absence
(European Parliament and Council Regulations No 1907/2006, Art. 76(1)(c) and (d), and No 1272/2008, as amended by Regulation 2022/692, Art. 37)
(see paragraphs 180-190)
Operative part
The Court:
1.
Dismisses the action;
2.
Orders BASF SE, Dow Europe GmbH and Nouryon Functional Chemicals BV to bear their own costs and to pay those incurred by the European Commission;
3.
Orders the French Republic and the European Chemicals Agency (ECHA) to each bear their own costs.
(
1
)	OJ C 389, 10.10.2022.