# C_2021263EN.01003301.xml

| 5.7.2021 | EN | Official Journal of the European Union | C 263/33 |
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5.7.2021

EN

Official Journal of the European Union

C 263/33

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Action brought on 19 May 2021 — Ortis v Commission

(Case T-271/21)

(2021/C 263/44)

Language of the case: French

Parties

Applicant: Ortis (Bütgenbach, Belgium) (represented by: A. de Brosses, lawyer)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

| — | rule that Commission Regulation (EU) 2021/468 infringes Article 6 of Regulation (EC) No 178/2002 and Article 8 of Regulation (EC) No 1925/2006; that it is therefore vitiated by errors of law; |
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rule that Commission Regulation (EU) 2021/468 infringes Article 6 of Regulation (EC) No 178/2002 and Article 8 of Regulation (EC) No 1925/2006; that it is therefore vitiated by errors of law;

| — | rule that Regulation (EU) 2021/468 is vitiated by misuse of powers; |
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rule that Regulation (EU) 2021/468 is vitiated by misuse of powers;

| — | rule that Regulation (EU) 2021/468 and its scientific basis, the EFSA opinion of 22 November 2017, are vitiated by manifest errors of assessment; |
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rule that Regulation (EU) 2021/468 and its scientific basis, the EFSA opinion of 22 November 2017, are vitiated by manifest errors of assessment;

| — | rule that Regulation (EU) 2021/468 infringes the principle of legal certainty; |
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rule that Regulation (EU) 2021/468 infringes the principle of legal certainty;

| — | rule that Regulation (EU) 2021/468 infringes the principle of proportionality; |
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rule that Regulation (EU) 2021/468 infringes the principle of proportionality;

consequently,

| — | annul Commission Regulation (EU) 2021/468 of 18 March 2021 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives; |
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annul Commission Regulation (EU) 2021/468 of 18 March 2021 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives;

| — | order the European Commission to pay all of the costs. |
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order the European Commission to pay all of the costs.

Pleas in law and main arguments

In support of the action, the applicant relies on five pleas in law.

| 1. | First plea in law, alleging errors of law. The applicant claims in that regard that the contested regulation infringes Article 8 of Regulation (EC) No 1925/2006, (1) which requires an identified risk, by classifying in Part A of Annex III to that regulation the substances and preparations referred to even though there are scientific uncertainties and by classifying in Part C of Annex III products other than substances, and infringes Article 6 of Regulation (EC) No 178/2002, (2) on the ground that it is based on an incomplete and non-compliant risk assessment. |
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1.

First plea in law, alleging errors of law. The applicant claims in that regard that the contested regulation infringes Article 8 of Regulation (EC) No 1925/2006, (1) which requires an identified risk, by classifying in Part A of Annex III to that regulation the substances and preparations referred to even though there are scientific uncertainties and by classifying in Part C of Annex III products other than substances, and infringes Article 6 of Regulation (EC) No 178/2002, (2) on the ground that it is based on an incomplete and non-compliant risk assessment.

| 2. | Second plea in law, alleging misuse of powers, on the ground that a body of precise, plausible and consistent evidence shows that the objective of consumer health protection alleged by the Commission does not reflect the reality. The applicant claims that the contested regulation has in particular the effect of reserving to medicines alone the right to use the preparations and substances containing hydroxyanthracene derivatives (‘HADs’) inserted into Part A of Annex III to Regulation (EC) No 1925/2006, although that is not the objective pursued. |
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2.

Second plea in law, alleging misuse of powers, on the ground that a body of precise, plausible and consistent evidence shows that the objective of consumer health protection alleged by the Commission does not reflect the reality. The applicant claims that the contested regulation has in particular the effect of reserving to medicines alone the right to use the preparations and substances containing hydroxyanthracene derivatives (‘HADs’) inserted into Part A of Annex III to Regulation (EC) No 1925/2006, although that is not the objective pursued.

| 3. | Third plea in law, alleging manifest errors of assessment. According to the applicant, the opinion of the European Food Safety Authority (EFSA) of 22 November 2017, on which the contested regulation is based, is vitiated by several manifest errors of assessment, since the EFSA assessed the genotoxic and carcinogenic risk of HADs without complying either with its own risk evaluation methods or the risk evaluation methods of the OECD and by drawing conclusions that are inconsistent with the conclusions of the European Medicines Agency. The contested regulation is therefore vitiated by manifest errors of assessment, since, first, the Commission inserted substances and preparations into Part A of Annex III to Regulation (EC) No 1925/2006 even though the EFSA opinion of 22 November 2017 highlights scientific uncertainties, secondly, it did not apply the ALARA principle to the risk management measures and, lastly, it did not take into account the development of scientific knowledge that has taken place after the EFSA opinion of 22 November 2017. |
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3.

Third plea in law, alleging manifest errors of assessment. According to the applicant, the opinion of the European Food Safety Authority (EFSA) of 22 November 2017, on which the contested regulation is based, is vitiated by several manifest errors of assessment, since the EFSA assessed the genotoxic and carcinogenic risk of HADs without complying either with its own risk evaluation methods or the risk evaluation methods of the OECD and by drawing conclusions that are inconsistent with the conclusions of the European Medicines Agency. The contested regulation is therefore vitiated by manifest errors of assessment, since, first, the Commission inserted substances and preparations into Part A of Annex III to Regulation (EC) No 1925/2006 even though the EFSA opinion of 22 November 2017 highlights scientific uncertainties, secondly, it did not apply the ALARA principle to the risk management measures and, lastly, it did not take into account the development of scientific knowledge that has taken place after the EFSA opinion of 22 November 2017.

| 4. | Fourth plea in law, alleging infringement of the principle of legal certainty, on the ground that the wording of the contested regulation is inconsistent since, first, it refers to the term ‘preparations’ while that term is not defined in any text, secondly, certain HADs substances appear to be simultaneously prohibited and authorised, but under control, and, lastly, the Standing Committee on Plants, Animals, Food and Feed had to add clarifications to the text. |
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4.

Fourth plea in law, alleging infringement of the principle of legal certainty, on the ground that the wording of the contested regulation is inconsistent since, first, it refers to the term ‘preparations’ while that term is not defined in any text, secondly, certain HADs substances appear to be simultaneously prohibited and authorised, but under control, and, lastly, the Standing Committee on Plants, Animals, Food and Feed had to add clarifications to the text.

| 5. | Fifth plea in law, alleging infringement of the principle of proportionality, in so far as the contested regulation classifies substances in Part A of Annex III to Regulation (EC) No 1925/2006 without setting any threshold whatsoever, which results in those substances being prohibited, even though that prohibition is not necessary in order to achieve the sought objective of consumer health protection. |
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5.

Fifth plea in law, alleging infringement of the principle of proportionality, in so far as the contested regulation classifies substances in Part A of Annex III to Regulation (EC) No 1925/2006 without setting any threshold whatsoever, which results in those substances being prohibited, even though that prohibition is not necessary in order to achieve the sought objective of consumer health protection.

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(1)  Regulation (EC) No 1925/2006 of the European Parliament and Council of 20 December 2006 concerning the addition of vitamins, minerals and certain other substances to foodstuffs (OJ 2006 L 404, p. 26).

(2)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1).

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