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annul Commission Delegated Regulation (EU) 2020/217 (1) (‘the contested Regulation’) insofar as it concerns Titanium Dioxide, i.e. Recital (5) of the contested Regulation, Annexes I and II to the contested Regulation, the amendments to Part 1 of Annex VI to Regulation (EC) No 1272/2008 (2) in Annex III to the contested Regulation, and the entry for Titanium Dioxide in Part 3 of Annex VI to Regulation No 1272/2008 introduced by Annex III to the contested Regulation;

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order the defendant to pay the costs of these proceedings

1.

First plea in law, alleging that the contested Regulation was adopted in breach of several mandatory provisions of Regulation (EC) No 1272/2008 regulating the classification of substances in the human health hazard ‘carcinogenicity’, including, in particular, Article 36 and Section 3.6 of Annex I to Regulation (EC) No 1272/2008.

2.

Second plea in law, alleging the contested Regulation breaches the principle of legal certainty. The economic operators, including the applicants, are prevented from knowing the exact extent of their obligations and taking appropriate legal steps accordingly. This uncertainty is present, with respect to the scope of the harmonised classification, the intended use of the Notes, and the impact of the contested Regulation on the legal and regulatory status of the products made with or containing TiO2 and the hazard classification of the waste of such products.

3.

Third plea in law, alleging that the contested Regulation was adopted in breach of the principle of proportionality, in that it is unnecessary (as carcinogenic effects were only observed in animal studies conducted under such extreme lung overload conditions that could never be achieved in worst-case real life conditions) and that the disadvantages caused by the harmonised classification of TiO2 are disproportionate to the aims it pursues.

4.

Fourth plea in law, alleging that, in adopting the contested Regulation, the Commission incorrectly exercised its margin of discretion and breached its duty of care. To justify the contested Regulation, the Commission simply relied upon the RAC Opinion on TiO2 without making a sufficient assessment of the probative value of such RAC Opinion, in breach of its duties in that regard.

5.

Fitfh plea in law, alleging that, in adopting the contested Regulation, the Commission breached Article 37(4) of Regulation (EC) No 1272/2008, its duty of sound administration, and the right of the applicants to be heard. In particular, the applicants have been denied an adequate opportunity to comment meaningfully on the RAC Opinion itself, which significantly deviated from the original classification proposal both with regard to the scientific rationale used and to the final conclusion on the classification of TiO2. By contrast, had the applicants been given a sufficient and formal opportunity to comment on the RAC Opinion in the course of its adoption, such comments would have likely led to another outcome in the decision-making process.

6.

Sixth plea in law, alleging that, in adopting the contested Regulation without the prior conduct and documentation of an Impact Assessment, the Commission breached its commitments under the Interinstitutional Agreement on better-law-making, (3) and the principle of sound administration.