# C_2020255EN.01002001.xml

| 3.8.2020 | EN | Official Journal of the European Union | C 255/20 |
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3.8.2020

EN

Official Journal of the European Union

C 255/20

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Action brought on 13 May 2020 — Billions Europe and Others v Commission

(Case T-283/20)

(2020/C 255/26)

Language of the case: English

Parties

Applicants: Billions Europe Ltd (Stockton-on-Tees, United Kingdom), and seven other applicants (represented by: J. Montfort, T. Delille, and P. Chopova-Leprêtre, lawyers)

Defendant: European Commission

Form of order sought

The applicants claim that the Court should:

| — | 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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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;

| — | order the defendant to pay the costs of these proceedings |
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order the defendant to pay the costs of these proceedings

Pleas in law and main arguments

In support of the action, the applicants rely on six pleas in law.

| 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.






  — | The Committee for Risk Assessment (‘RAC’) committed several serious factual errors in assessing the available information and failed to satisfactorily establish that the available data are ‘reliable and acceptable’ and suggest that TiO2 has the intrinsic property to cause cancer. Had the RAC not committed such errors, it would necessarily have issued an opinion supporting ‘no classification’ of TiO2. Therefore, TiO2 could not be lawfully classified. |
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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.

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The Committee for Risk Assessment (‘RAC’) committed several serious factual errors in assessing the available information and failed to satisfactorily establish that the available data are ‘reliable and acceptable’ and suggest that TiO2 has the intrinsic property to cause cancer. Had the RAC not committed such errors, it would necessarily have issued an opinion supporting ‘no classification’ of TiO2. Therefore, TiO2 could not be lawfully classified.

| 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. |
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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. |
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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.






  — | The Commission opted for a broad interpretation of the classification, labelling and packaging requirements regulating the human health hazard ‘carcinogenicity’ and what could constitute an ‘intrinsic property’ of a substance. It merely relied on the RAC, without assessing the scope and impact of such broad interpretation or setting appropriate boundaries that would allow a proper implementation. Doing so, the Commission based the contested Regulation on materially inaccurate facts and failed to take into consideration all the relevant factors and circumstances of the situation. |
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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.

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The Commission opted for a broad interpretation of the classification, labelling and packaging requirements regulating the human health hazard ‘carcinogenicity’ and what could constitute an ‘intrinsic property’ of a substance. It merely relied on the RAC, without assessing the scope and impact of such broad interpretation or setting appropriate boundaries that would allow a proper implementation. Doing so, the Commission based the contested Regulation on materially inaccurate facts and failed to take into consideration all the relevant factors and circumstances of the situation.

| 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. |
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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. |
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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.

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(1)  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)

(2)  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).

(3)  Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making of 13 April 2016 (OJ 2016 L 123, p. 1).

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