# 62017TO0621(01)

ORDER OF THE PRESIDENT OF THE GENERAL COURT

12 October 2018 (
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(Application for interim measures — Plant protection products — Regulation (EC) No 1107/2009 — Publication of the conclusion of the examination carried out by EFSA on the review of the approval of the active substance thiram — Claim for confidential treatment of certain sections — Refusal to grant confidentiality — Application for interim measures — Lack of urgency)

In Case T‐621/17 R,

Taminco BVBA, established in Ghent (Belgium), represented by C. Mereu and M. Grunchard, lawyers,

Taminco BVBA

applicant,

v

European Food Safety Authority (EFSA), represented by D. Detken and S. Gabbi, acting as Agents, and by R. van der Hout and C. Wagner, lawyers,

European Food Safety Authority (EFSA)

defendant,

supported by

European Commission, represented by G. Koleva and I. Naglis, acting as Agents,

European Commission

intervener,

APPLICATION based on Articles 278 and 279 TFEU, seeking suspension of the operation of the decision of EFSA of 18 July 2017 rejecting the claims for confidential treatment made in the context of the application for the renewal of the approval of the active substance thiram,

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order (
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Order (
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[omissis]

omissis

Law

Law

[omissis]

omissis

Subject matter of the application for interim measures and the nature of the information concerned

Subject matter of the application for interim measures and the nature of the information concerned

| 25 | By its application for interim measures, in order to avoid damage to its commercial interests, the applicant seeks to prevent the publication of the information concerned. |
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25

By its application for interim measures, in order to avoid damage to its commercial interests, the applicant seeks to prevent the publication of the information concerned.

| 26 | In that regard, in the first place, it is appropriate to note that, in its order of 12 June 2018, Nexans France and Nexans v Commission (C‐65/18 P(R), EU:C:2018:426), the Vice-President of the Court of Justice underlined that it is insufficient, for the purposes of being granted interim measures, to have claimed that the information which is to be disclosed is confidential where such a claim does not satisfy the condition relating to the establishment of a prima facie case (order of 12 June 2018, Nexans France and Nexans v Commission, C‐65/18 P(R), EU:C:2018:426, paragraph 22). |
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26

In that regard, in the first place, it is appropriate to note that, in its order of 12 June 2018, Nexans France and Nexans v Commission (C‐65/18 P(R), EU:C:2018:426), the Vice-President of the Court of Justice underlined that it is insufficient, for the purposes of being granted interim measures, to have claimed that the information which is to be disclosed is confidential where such a claim does not satisfy the condition relating to the establishment of a prima facie case (order of 12 June 2018, Nexans France and Nexans v Commission, C‐65/18 P(R), EU:C:2018:426, paragraph 22).

| 27 | In the present case, in demonstrating the fulfilment of that condition, the applicant relies on four pleas in law, namely (i) the lack of legal basis justifying EFSA’s publication of the information concerned under Regulations No 1107/2009 and No 178/2002 and Implementing Regulation No 844/2012, (ii) the commission by EFSA of an act ultra vires to the extent that 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) does not confer any competence on EFSA for the classification of substances, (iii) violation of its rights of defence, the applicant not having, in its view, been given a full, proper and effective opportunity to submit comments on the proposed reclassification of its substance, and (iv) infringement of Article 63 of Regulation No 1107/2009 concerning the possibility to assert the confidentiality of certain information submitted under that regulation. |
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27

In the present case, in demonstrating the fulfilment of that condition, the applicant relies on four pleas in law, namely (i) the lack of legal basis justifying EFSA’s publication of the information concerned under Regulations No 1107/2009 and No 178/2002 and Implementing Regulation No 844/2012, (ii) the commission by EFSA of an act ultra vires to the extent that 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) does not confer any competence on EFSA for the classification of substances, (iii) violation of its rights of defence, the applicant not having, in its view, been given a full, proper and effective opportunity to submit comments on the proposed reclassification of its substance, and (iv) infringement of Article 63 of Regulation No 1107/2009 concerning the possibility to assert the confidentiality of certain information submitted under that regulation.

ultra vires

| 28 | It is thus apparent from the foregoing that the first three pleas raise questions of procedure that do not pertain to the nature of the information concerned. Only the last plea, relating to the alleged infringement of Article 63 of Regulation No 1107/2009, concerns, indirectly, the determination of the confidentiality of the information concerned. |
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28

It is thus apparent from the foregoing that the first three pleas raise questions of procedure that do not pertain to the nature of the information concerned. Only the last plea, relating to the alleged infringement of Article 63 of Regulation No 1107/2009, concerns, indirectly, the determination of the confidentiality of the information concerned.

| 29 | However, the arguments put forward concern the possibility of requesting confidential treatment and not the assessment of the confidentiality of that information as such. Moreover, it is not apparent, at first sight, from the examination of the arguments on the alleged infringement of Article 63 of Regulation No 1107/2009 that those arguments are such as to convince the judge hearing the application for interim measures as to the existence of a prima facie case in that regard. |
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29

However, the arguments put forward concern the possibility of requesting confidential treatment and not the assessment of the confidentiality of that information as such. Moreover, it is not apparent, at first sight, from the examination of the arguments on the alleged infringement of Article 63 of Regulation No 1107/2009 that those arguments are such as to convince the judge hearing the application for interim measures as to the existence of a prima facie case in that regard.

| 30 | First, it should be noted, first of all, that, pursuant to Article 63(1) of Regulation No 1107/2009, confidential treatment can be requested for information submitted under that regulation. It does not seem, a priori, possible to categorise the information concerned in the case at hand as such in so far as it was prepared by EFSA in the context of the assessment of the application for the renewal of the approval of the substance at issue. In the English-language version of that regulation (annexes included), the verb ‘submit’ and derivations thereof (‘submitted’, ‘submitting’ and ‘submission’), understood in the same sense as that of Article 63 of Regulation No 1107/2009, appear 92 times, and are used 72 of those times in reference to the production by interested parties (applicants, third parties) of the dossier for applying for approval of an active substance or for an amendment to the conditions of an approval or of the list of tests and studies. The other instances concern for the most part the Member State Rapporteur, the other Member States and, very rarely, the Commission. |
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30

First, it should be noted, first of all, that, pursuant to Article 63(1) of Regulation No 1107/2009, confidential treatment can be requested for information submitted under that regulation. It does not seem, a priori, possible to categorise the information concerned in the case at hand as such in so far as it was prepared by EFSA in the context of the assessment of the application for the renewal of the approval of the substance at issue. In the English-language version of that regulation (annexes included), the verb ‘submit’ and derivations thereof (‘submitted’, ‘submitting’ and ‘submission’), understood in the same sense as that of Article 63 of Regulation No 1107/2009, appear 92 times, and are used 72 of those times in reference to the production by interested parties (applicants, third parties) of the dossier for applying for approval of an active substance or for an amendment to the conditions of an approval or of the list of tests and studies. The other instances concern for the most part the Member State Rapporteur, the other Member States and, very rarely, the Commission.

| 31 | Next, contrary to what the applicant claims in the application for interim measures and in its observations on the Commission’s statement in intervention, it appears, at first sight, that Article 63(2)(b) of Regulation No 1107/2009 mentions a possible assessment by EFSA not to show that it can be granted confidential treatment, but to exclude the application of confidential treatment to information submitted by interested parties. |
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31

Next, contrary to what the applicant claims in the application for interim measures and in its observations on the Commission’s statement in intervention, it appears, at first sight, that Article 63(2)(b) of Regulation No 1107/2009 mentions a possible assessment by EFSA not to show that it can be granted confidential treatment, but to exclude the application of confidential treatment to information submitted by interested parties.

| 32 | Last, in its observations on the Commission’s statement in intervention, the applicant states that a combined reading of the relevant provisions should be adopted and, to that end, refers to Article 13(2) of Implementing Regulation No 844/2012. |
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32

Last, in its observations on the Commission’s statement in intervention, the applicant states that a combined reading of the relevant provisions should be adopted and, to that end, refers to Article 13(2) of Implementing Regulation No 844/2012.

| 33 | Article 13(2) of Implementing Regulation No 844/2012 provides that, after giving the applicant two weeks to request, pursuant to Article 63 of Regulation No 1107/2009, that certain parts of the conclusion be kept confidential, EFSA is to make its conclusion available to the public, excluding any information in respect of which confidentiality has been granted by EFSA, unless there is an overriding public interest in its disclosure. |
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33

Article 13(2) of Implementing Regulation No 844/2012 provides that, after giving the applicant two weeks to request, pursuant to Article 63 of Regulation No 1107/2009, that certain parts of the conclusion be kept confidential, EFSA is to make its conclusion available to the public, excluding any information in respect of which confidentiality has been granted by EFSA, unless there is an overriding public interest in its disclosure.

| 34 | The applicant considers it apparent from a reading of Article 13(2) of Implementing Regulation No 844/2012 that the legislation allows the parties to request confidentiality for conclusions such as the one at issue in the present case. However, it appears, at first sight, that Article 13(2) of Implementing Regulation No 844/2012 merely refers to Article 63 of Regulation No 1107/2009 which allows, in line with what has been noted in paragraphs 30 and 31 above, confidential treatment to be requested for information submitted by interested parties which, in the case referred to in Article 13(2) of Implementing Regulation No 844/2012, appears in the conclusion referred to and not, as the applicant claims, that treatment to be applied to the conclusion itself. In other words, only ‘certain parts’ of that conclusion, namely, ‘any information in respect of which confidentiality has been granted’, under the understanding accorded to it in paragraphs 30 and 31 above, are covered by that provision. |
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34

The applicant considers it apparent from a reading of Article 13(2) of Implementing Regulation No 844/2012 that the legislation allows the parties to request confidentiality for conclusions such as the one at issue in the present case. However, it appears, at first sight, that Article 13(2) of Implementing Regulation No 844/2012 merely refers to Article 63 of Regulation No 1107/2009 which allows, in line with what has been noted in paragraphs 30 and 31 above, confidential treatment to be requested for information submitted by interested parties which, in the case referred to in Article 13(2) of Implementing Regulation No 844/2012, appears in the conclusion referred to and not, as the applicant claims, that treatment to be applied to the conclusion itself. In other words, only ‘certain parts’ of that conclusion, namely, ‘any information in respect of which confidentiality has been granted’, under the understanding accorded to it in paragraphs 30 and 31 above, are covered by that provision.

| 35 | Second, in its observations on the application for interim measures, EFSA indicates that it has nevertheless analysed the potential for the applicant’s commercial interests to be undermined following the disclosure of the information referred to — a prerequisite for being granted confidential treatment under Article 63 of Regulation No 1107/2009 — and concluded that it was not sufficient to impede the publication of the information concerned, especially in the light of the overriding factor of public health, in accordance with Article 39(3) of Regulation No 178/2002. |
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35

Second, in its observations on the application for interim measures, EFSA indicates that it has nevertheless analysed the potential for the applicant’s commercial interests to be undermined following the disclosure of the information referred to — a prerequisite for being granted confidential treatment under Article 63 of Regulation No 1107/2009 — and concluded that it was not sufficient to impede the publication of the information concerned, especially in the light of the overriding factor of public health, in accordance with Article 39(3) of Regulation No 178/2002.

| 36 | It must be pointed out that, in its observations on the Commission’s statement in intervention submitted in support of the EFSA’s conclusion, highlighting inter alia the relevance of Article 63 of Regulation No 1107/2009 in the context of this case, the applicant elected not to address that argument, merely stating that the fact that certain parts of that statement had not been refuted or commented on did not mean that it accepted them. |
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36

It must be pointed out that, in its observations on the Commission’s statement in intervention submitted in support of the EFSA’s conclusion, highlighting inter alia the relevance of Article 63 of Regulation No 1107/2009 in the context of this case, the applicant elected not to address that argument, merely stating that the fact that certain parts of that statement had not been refuted or commented on did not mean that it accepted them.

| 37 | In the second place, and in any event, supposing that, first, the information concerned could have been subject to a request for confidentiality under Article 63 of Regulation No 1107/2009 and, second, EFSA had considered that information not to be of a confidential nature following its analysis in the context of the procedure established by that provision, the fact remains that the nature of the information concerned does not correspond to that for which the judge hearing the application for interim measures granted interim protection on numerous occasions in the context of requests relating to the disclosure of scientific data (see, to that effect, orders of 1 March 2017, EMA v PTC Therapeutics International, C‐513/16 P(R), not published, EU:C:2017:148; of 1 March 2017, EMA v MSD Animal Health Innovation and Intervet international, C‐512/16 P(R), not published, EU:C:2017:149; of 13 February 2014, Luxembourg Pamol (Cyprus) and Luxembourg Industries v Commission, T‐578/13 R, not published, EU:T:2014:103; and of 25 July 2014, Deza v ECHA, T‐189/14 R, not published, EU:T:2014:686). |
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37

In the second place, and in any event, supposing that, first, the information concerned could have been subject to a request for confidentiality under Article 63 of Regulation No 1107/2009 and, second, EFSA had considered that information not to be of a confidential nature following its analysis in the context of the procedure established by that provision, the fact remains that the nature of the information concerned does not correspond to that for which the judge hearing the application for interim measures granted interim protection on numerous occasions in the context of requests relating to the disclosure of scientific data (see, to that effect, orders of 1 March 2017, EMA v PTC Therapeutics International, C‐513/16 P(R), not published, EU:C:2017:148; of 1 March 2017, EMA v MSD Animal Health Innovation and Intervet international, C‐512/16 P(R), not published, EU:C:2017:149; of 13 February 2014, Luxembourg Pamol (Cyprus) and Luxembourg Industries v Commission, T‐578/13 R, not published, EU:T:2014:103; and of 25 July 2014, Deza v ECHA, T‐189/14 R, not published, EU:T:2014:686).

| 38 | In the cases that gave rise to the orders cited in paragraph 37 above, the judge hearing the application for interim measures was careful to recall that, where an undertaking seeks interim measures in order to prevent the publication of information allegedly covered by the obligation of professional secrecy, the extent to which disclosure of such information will cause serious and irreparable harm depends on a combination of factors, such as, inter alia, how significant the information is in commercial and professional terms for the undertaking providing the information and its usefulness for other market participants which are liable to examine and use it subsequently (order of 29 February 2016, Chemtura Netherlands v EFSA, T‐725/15 R, not published, EU:T:2016:128, paragraph 30). |
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38

In the cases that gave rise to the orders cited in paragraph 37 above, the judge hearing the application for interim measures was careful to recall that, where an undertaking seeks interim measures in order to prevent the publication of information allegedly covered by the obligation of professional secrecy, the extent to which disclosure of such information will cause serious and irreparable harm depends on a combination of factors, such as, inter alia, how significant the information is in commercial and professional terms for the undertaking providing the information and its usefulness for other market participants which are liable to examine and use it subsequently (order of 29 February 2016, Chemtura Netherlands v EFSA, T‐725/15 R, not published, EU:T:2016:128, paragraph 30).

| 39 | However, the solutions adopted in the cases that gave rise to those orders in view, inter alia, of the non-quantifiable and therefore irreparable nature of the financial loss caused by a publication of allegedly confidential information does not apply where the applicant fails to identify, in the application for interim measures, information which, if the documents at issue were published in their entirety, could be especially useful for its current or future competitors, in that it could be used for commercial and competitive purposes, and that, in particular, the applicant does not refer to any specific element which constitutes, for the applicant, an intangible asset that may be used for competitive purposes, whose value could be seriously reduced, or even eliminated, if it did not remain secret (order of 29 February 2016, Chemtura Netherlands v EFSA, T‐725/15 R, not published, EU:T:2016:128, paragraphs 34 and 35). |
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39

However, the solutions adopted in the cases that gave rise to those orders in view, inter alia, of the non-quantifiable and therefore irreparable nature of the financial loss caused by a publication of allegedly confidential information does not apply where the applicant fails to identify, in the application for interim measures, information which, if the documents at issue were published in their entirety, could be especially useful for its current or future competitors, in that it could be used for commercial and competitive purposes, and that, in particular, the applicant does not refer to any specific element which constitutes, for the applicant, an intangible asset that may be used for competitive purposes, whose value could be seriously reduced, or even eliminated, if it did not remain secret (order of 29 February 2016, Chemtura Netherlands v EFSA, T‐725/15 R, not published, EU:T:2016:128, paragraphs 34 and 35).

| 40 | Such is the case here, with the applicant merely arguing that full publication of the documents in question would be liable to harm its reputation, its market share and its turnover, in so far as the substance at issue is characterised — erroneously in its view — as presenting a health risk, with regards to its customers, users of that substance, the general public and regulatory authorities (see, to that effect, order of 29 February 2016, Chemtura Netherlands v EFSA, T‐725/15 R, not published, EU:T:2016:128, paragraph 34). |
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40

Such is the case here, with the applicant merely arguing that full publication of the documents in question would be liable to harm its reputation, its market share and its turnover, in so far as the substance at issue is characterised — erroneously in its view — as presenting a health risk, with regards to its customers, users of that substance, the general public and regulatory authorities (see, to that effect, order of 29 February 2016, Chemtura Netherlands v EFSA, T‐725/15 R, not published, EU:T:2016:128, paragraph 34).

| 41 | Consequently, in accordance with the principles set out in paragraphs 26, 38 and 39 above, it is appropriate to examine the arguments of the applicant aimed at establishing the urgency of the interim measures requested without starting from the premiss that the information concerned is confidential.
  [omissis] |
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41

Consequently, in accordance with the principles set out in paragraphs 26, 38 and 39 above, it is appropriate to examine the arguments of the applicant aimed at establishing the urgency of the interim measures requested without starting from the premiss that the information concerned is confidential.

[omissis]

omissis

| | On those grounds,
  THE PRESIDENT OF THE GENERAL COURT
  hereby orders: |
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On those grounds,

THE PRESIDENT OF THE GENERAL COURT

hereby orders:

| | 1. | The application for interim measures is dismissed. |
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1.

1.

The application for interim measures is dismissed.

The application for interim measures is dismissed.

| | 2. | The order of 19 September 2017 delivered in Case T‐621/17 R is cancelled. |
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2.

2.

The order of 19 September 2017 delivered in Case T‐621/17 R is cancelled.

The order of 19 September 2017 delivered in Case T‐621/17 R is cancelled.

| | 3. | The costs are reserved. |
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3.

3.

The costs are reserved.

The costs are reserved.

| | Luxembourg, 12 October 2018.


  E. Coulon
  Registrar


  M. Jaeger
  President |
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Luxembourg, 12 October 2018.

E. Coulon

Registrar

M. Jaeger

President

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(
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