CWS Powder Coatings GmbH v European Commission.

JurisdictionEuropean Union
CourtGeneral Court (European Union)
ECLIECLI:EU:T:2022:725
Docket NumberT-279/20
Celex Number62020TJ0279
Date23 November 2022

JUDGMENT OF THE GENERAL COURT (Ninth Chamber, Extended Composition)

23 November 2022 (*)

(Environment and protection of human health – Regulation (EC) No 1272/2008 – Classification, labelling and packaging of substances and mixtures – Delegated Regulation (EU) 2020/217 – Classification of titanium dioxide in powder form containing 1% or more of particles of a diameter equal to or below 10 μm – Criteria for classification of a substance as carcinogenic – Reliability and acceptability of studies – Substance that has the intrinsic property to cause cancer – Calculation of lung overload in particles – Manifest errors of assessment)

In Joined Cases T‑279/20 and T‑288/20 and in Case T‑283/20,

CWS Powder Coatings GmbH, established in Düren (Germany), represented by R. van der Hout, C. Wagner and V. Lemonnier, lawyers,

applicant in Case T‑279/20,

supported by

Billions Europe Ltd, established in Stockton-on-Tees (United Kingdom), and the other interveners whose names are listed in the annex, (1) represented by J.‑P. Montfort, T. Delille and P. Chopova-Leprêtre, lawyers,

by

Ettengruber GmbH Abbruch und Tiefbau, established in Dachau (Germany),

Ettengruber GmbH Recycling und Verwertung, established in Dachau,

represented by R. van der Hout, C. Wagner and V. Lemonnier, lawyers,

and by

TIGER Coatings GmbH & Co. KG, established in Wels (Austria), represented by R. van der Hout, C. Wagner and V. Lemonnier, lawyers,

interveners in Case T‑279/20,

Billions Europe Ltd, established in Stockton-on-Tees, and the other applicants whose names are listed in the annex, (2) represented by J.-P. Montfort, T. Delille and P. Chopova-Leprêtre, lawyers,

applicants in Case T‑283/20,

supported by

Conseil européen de l’industrie chimique – European Chemical Industry Council (Cefic), established in Brussels (Belgium), represented by D. Abrahams, Z. Romata and H. Widemann, lawyers,

by

Conseil européen de l’industrie des peintures, des encres d’imprimerie et des couleurs d’art (CEPE), established in Brussels,

British Coatings Federation Ltd (BCF), established in Coventry (United Kingdom),

American Coatings Association, Inc. (ACA), established in Washington, DC (United States),

represented by D. Waelbroeck and I. Antypas, lawyers,

and by

Mytilineos SA, established in Maroussi (Greece),

Delfi-Distomon Anonymos Metalleftiki Etaireia, established in Maroussi,

represented by J.-P. Montfort, T. Delille and P. Chopova-Leprêtre, lawyers,

interveners in Case T‑283/20,

Brillux GmbH & Co. KG, established in Münster (Germany),

Daw SE, established in Ober-Ramstadt (Germany),

represented by R. van der Hout, C. Wagner and V. Lemonnier, lawyers,

applicants in Case T‑288/20,

supported by

Billions Europe Ltd, established in Stockton-on-Tees, and the other interveners whose names are listed in the annex, (3) represented by J.-P. Montfort, T. Delille and P. Chopova-Leprêtre, lawyers,

by

Sto SE & Co. KGaA, established in Stühlingen (Germany), represented by R. van der Hout, C. Wagner and V. Lemonnier, lawyers,

and by

Rembrandtin Coatings GmbH, established in Vienna (Austria), represented by R. van der Hout, C. Wagner and V. Lemonnier, lawyers,

interveners in Case T‑288/20,

v

European Commission, represented in Joined Cases T‑279/20 and T‑288/20 by S. Delaude, R. Lindenthal and M. Noll-Ehlers and, in Case T‑283/20, by A. Dawes, S. Delaude and R. Lindenthal, acting as Agents,

defendant,

supported by

Kingdom of Denmark, represented by M. Søndahl Wolff, acting as Agent,

by

French Republic, represented in Joined Cases T‑279/20 and T‑288/20 by T. Stéhelin, W. Zemamta, G. Bain and J.-L. Carré and, in Case T‑283/20, by E. de Moustier and W. Zemamta, acting as Agents,

by

Kingdom of the Netherlands, represented in Case T‑279/20 by M. Bulterman and C. Schillemans, in Case T‑283/20 by M. Bulterman and J. Langer, and in Case T‑288/20 by M. Bulterman, J. Langer and C. Schillemans, acting as Agents,

by

Kingdom of Sweden, represented in Joined Cases T‑279/20 and T‑288/20 by C. Meyer-Seitz and, in Case T‑283/20, by O. Simonsson, C. Meyer-Seitz, A. Runeskjöld, M. Salborn Hodgson, H. Shev, H. Eklinder and R. Shahsavan Eriksson, acting as Agents,

by

European Chemicals Agency (ECHA), represented by A. Hautamäki and J.‑P. Trnka, acting as Agents,

interveners in Joined Cases T‑279/20 and T‑288/20 and in Case T‑283/20,

by

Republic of Slovenia, represented by V. Klemenc, acting as Agent,

intervener in Case T‑283/20,

by

European Parliament, represented by C. Ionescu Dima, W. Kuzmienko and B. Schäfer, acting as Agents,

and by

Council of the European Union, represented by A.-L. Meyer and T. Haas, acting as Agents,

interveners in Joined Cases T‑279/20 and T‑288/20,

THE GENERAL COURT (Ninth Chamber, Extended Composition),

composed, at the time of the deliberations, of M.J. Costeira (Rapporteur), President, M. Kancheva, T. Perišin, P. Zilgalvis and I. Dimitrakopoulos, Judges,

Registrar: S. Jund and I. Kurme, Administrators,

having regard to the written part of the procedure, in particular the order of 11 March 2022 joining Cases T‑279/20 and T‑288/20 for the purposes of the oral part of the procedure and the decision closing the proceedings,

further to the hearings on 12 May 2022, in Joined Cases T‑279/20 and T‑288/20, and on 18 May 2022, in Case T‑283/20,

gives the following

Judgment

1 By their actions based on Article 263 TFEU, the applicants, CWS Powder Coatings GmbH (‘the first applicant’), Billions Europe Ltd and the other applicants whose names are listed in the annex (‘the second applicants’) and Brillux GmbH & Co. KG and Daw SE (‘the third applicants’), seek annulment of Commission Delegated Regulation (EU) 2020/217 of 4 October 2019 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures and correcting that Regulation (OJ 2020 L 44, p. 1; ‘the contested regulation’), as regards the harmonised classification and labelling of titanium dioxide in powder form containing 1% or more of particles of a diameter equal to or below 10 μm.

I. Background to the dispute

2 The applicants are manufacturers, importers, downstream users and suppliers of titanium dioxide.

3 Titanium dioxide is an inorganic chemical substance with the molecular formula TiO2. It can be found in nature or produced industrially and it is used, in particular in the form of a white pigment, for its colourant and covering properties in various products, such as paints, coating materials, varnishes, plastics, laminated paper, cosmetics, medicinal products and toys.

4 In May 2016, the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES) (National Agency for Food, Environmental and Occupational Health and Safety (ANSES), France) (‘the competent French authority’) submitted to the European Chemicals Agency (ECHA), pursuant to Article 37(1) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1), a dossier proposing the harmonised classification and labelling of titanium dioxide as a category 1B carcinogen by inhalation (Carc. 1B, H350i) (‘the classification proposal’).

5 On 31 May 2016, the dossier submitted to ECHA by the competent French authority was published, in accordance with Article 37(4) of Regulation No 1272/2008. A number of parties concerned submitted their comments within the prescribed period.

6 On 14 September 2017, pursuant to Article 37(4) of Regulation No 1272/2008, ECHA’s Committee for Risk Assessment (‘the RAC’) adopted an opinion on titanium dioxide (‘the RAC Opinion’). The RAC Opinion, which was adopted by consensus, concluded that the classification of titanium dioxide as a category 2 carcinogen, including the hazard statement ‘H351 (inhalation)’, was justified.

7 On the basis of the RAC Opinion, the European Commission drew up a draft regulation on the harmonised classification and labelling of, inter alia, titanium dioxide, which was submitted for public consultation between 11 January and 8 February 2019.

8 On 18 February 2020, on the basis of the RAC Opinion, the Commission adopted the contested regulation, by which it proceeded, inter alia, with the harmonised classification and labelling of titanium dioxide (recitals 2 and 5 of the contested regulation).

9 In that regard, first, the contested regulation inserted into Table 3 of Part 3 of Annex VI to Regulation No 1272/2008, which contains the harmonised classification and labelling list, a new row with the chemical name ‘titanium dioxide (in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm)’, hazard class ‘carcinogenicity’, hazard category ‘2’, pictogram hazard code ‘GHS 08 Wng’ and hazard statement code ‘H351 (inhalation)’ (Article 1(3) of, and Section 2(c) of Annex III to, the contested regulation).

10 In addition, the contested regulation added, in point 1.1.3.1, of Part 1 of Annex VI to Regulation No 1272/2008, the following note (Article 1(3) of, and Section 1(a) of Annex III to, the contested regulation):

‘Note W:

It has been observed that the carcinogenic hazard of this substance arises when respirable dust is inhaled in quantities leading to significant impairment of particle clearance mechanisms in the lung.

This note aims to describe the particular toxicity of the substance; it does not constitute a criterion for classification according to this Regulation’ (‘Note W’).

11 Second, the contested regulation added, in Section 1.1.3.2, of Part 1 of Annex VI to Regulation No 1272/2008, the following note (Article 1(3) of, and Section 1(b) of Annex III to, the contested regulation):

‘Note 10:

The classification as a carcinogen by...

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