# 62017TJ0125

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

20 September 2019 (
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(REACH — Evaluation of substances — Triclosan — ECHA decision requesting further information — Article 51(6) of Regulation (EC) No 1907/2006 — Action brought before the Board of Appeal — Task of the Board of Appeal — Adversarial nature of the procedure — Scope of the review — Intensity of the review — Powers of the Board of Appeal — Article 93(3) of Regulation No 1907/2006 — First sentence of Article 47(1) of Regulation No 1907/2006 — Relevant information — Proportionality — Article 25 of Regulation No 1907/2006 — Annex XIII to Regulation No 1907/2006 — Data obtained under relevant circumstances — Persistence — Neurotoxicity — Reproductive toxicity — Article 12(1) of Regulation (EC) No 771/2008 — Delay in the submission of a scientific opinion)

In Case T‐125/17,

BASF Grenzach GmbH, established in Grenzach-Wyhlen (Germany), represented initially by K. Nordlander and M. Abenhaïm, lawyers, and subsequently by K. Nordlander and K. Le Croy, Solicitor,

BASF Grenzach GmbH

applicant,

v

European Chemicals Agency (ECHA), represented initially by M. Heikkilä, W. Broere and T. Röcke, and subsequently by M. Heikkilä, W Broere and C. Jacquet, acting as Agents,

European Chemicals Agency (ECHA)

defendant,

supported by

Kingdom of Denmark, represented initially by C. Thorning and M. Wolff, and subsequently by M. Wolff, J. Nymann-Lindegren and P. Ngo, acting as Agents,

Kingdom of Denmark

by

Federal Republic of Germany, represented initially by T. Henze and D. Klebs, and subsequently by D. Klebs, acting as Agents,

Federal Republic of Germany

and by

Kingdom of the Netherlands, represented by M. Bulterman and C. Schillemans, acting as Agents,

Kingdom of the Netherlands

interveners,

ACTION under Article 263 TFEU for the partial annulment of Decision A‐018‐2014 of the Board of Appeal of the ECHA of 19 December 2016 in so far as it partially dismissed the applicant’s appeal against the ECHA decision of 19 September 2014 to request further information about the substance Triclosan (CAS 3380‐34‐5) and in which it fixed the deadline for presenting that information as 26 December 2018,

THE GENERAL COURT (Fifth Chamber, Extended Composition),

composed of D. Gratsias, President, I. Labucka, S. Papasavvas, A. Dittrich (Rapporteur) and I. Ulloa Rubio, Judges,

Registrar: N. Schall, Administrator,

having regard to the written part of the procedure and further to the hearing on 12 December 2018,

gives the following

Judgment

Judgment

I. Background to the dispute and the contested decision

I.

Background to the dispute and the contested decision

| 1 | Triclosan (CAS 3380‐34‐5) is a broad-spectrum antibacterial that is approved for use as a preservative in certain types of cosmetic products. It is registered solely for cosmetic use under Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, corrigendum OJ 2007 L 136, p. 3). |
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1

Triclosan (CAS 3380‐34‐5) is a broad-spectrum antibacterial that is approved for use as a preservative in certain types of cosmetic products. It is registered solely for cosmetic use under Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, corrigendum OJ 2007 L 136, p. 3).

| 2 | The applicant, BASF Grenzach GmbH, manufacturer of Triclosan, is the sole registrant of that substance within the meaning of Article 3(7) of Regulation No 1907/2006. |
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2

The applicant, BASF Grenzach GmbH, manufacturer of Triclosan, is the sole registrant of that substance within the meaning of Article 3(7) of Regulation No 1907/2006.

| 3 | In 2012, Triclosan was included in the Community rolling action plan for evaluation within the meaning of Article 44 of Regulation No 1907/2006 due to grounds for concern relating to its persistent, bioaccumulative and toxic properties as well as its potential for endocrine disruption. |
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3

In 2012, Triclosan was included in the Community rolling action plan for evaluation within the meaning of Article 44 of Regulation No 1907/2006 due to grounds for concern relating to its persistent, bioaccumulative and toxic properties as well as its potential for endocrine disruption.

| 4 | In accordance with Article 45 of Regulation No 1907/2006, the competent authority of the Kingdom of the Netherlands was appointed to carry out the evaluation of Triclosan, in cooperation with the competent authority of the Kingdom of Denmark. Together, pursuant to Article 46(1) of Regulation No 1907/2006, those authorities prepared a draft decision for the applicant, in which requests for further information about Triclosan were made. |
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4

In accordance with Article 45 of Regulation No 1907/2006, the competent authority of the Kingdom of the Netherlands was appointed to carry out the evaluation of Triclosan, in cooperation with the competent authority of the Kingdom of Denmark. Together, pursuant to Article 46(1) of Regulation No 1907/2006, those authorities prepared a draft decision for the applicant, in which requests for further information about Triclosan were made.

| 5 | On 20 March 2013, pursuant to Article 50(1) of Regulation No 1907/2006, the draft decision was notified to the applicant. |
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5

On 20 March 2013, pursuant to Article 50(1) of Regulation No 1907/2006, the draft decision was notified to the applicant.

| 6 | On 23 April 2013, the applicant provided its comments on the draft decision. |
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6

On 23 April 2013, the applicant provided its comments on the draft decision.

| 7 | The competent authority of the Kingdom of the Netherlands took account of the applicant’s comments and revised the draft decision, in accordance with Article 50(1) of Regulation No 1907/2006. |
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7

The competent authority of the Kingdom of the Netherlands took account of the applicant’s comments and revised the draft decision, in accordance with Article 50(1) of Regulation No 1907/2006.

| 8 | On 6 March 2014, in accordance with Article 52(1) of Regulation No 1907/2006, the revised draft decision and the applicant’s comments were notified to the competent authorities of the other Member States and to the European Chemicals Agency (ECHA). |
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8

On 6 March 2014, in accordance with Article 52(1) of Regulation No 1907/2006, the revised draft decision and the applicant’s comments were notified to the competent authorities of the other Member States and to the European Chemicals Agency (ECHA).

| 9 | Four competent authorities of those other Member States and the ECHA submitted proposals for amendment, pursuant to Article 51(2) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation. |
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9

Four competent authorities of those other Member States and the ECHA submitted proposals for amendment, pursuant to Article 51(2) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation.

mutatis mutandis

| 10 | After having reviewed those proposals, the competent authority of the Kingdom of the Netherlands amended the draft decision, pursuant to the first sentence of Article 51(4) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation. |
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10

After having reviewed those proposals, the competent authority of the Kingdom of the Netherlands amended the draft decision, pursuant to the first sentence of Article 51(4) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation.

mutatis mutandis

| 11 | On 22 April 2014, the amended draft decision was referred to the Member State Committee, pursuant to the second sentence of Article 51(4) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation. |
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11

On 22 April 2014, the amended draft decision was referred to the Member State Committee, pursuant to the second sentence of Article 51(4) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation.

mutatis mutandis

| 12 | The applicant provided comments on those proposals for amendment, which were taken into account by the Member State Committee (Article 51(5) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation). |
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12

The applicant provided comments on those proposals for amendment, which were taken into account by the Member State Committee (Article 51(5) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation).

mutatis mutandis

| 13 | On 12 June 2014, pursuant to Article 51(6) of Regulation No 1907/2006, applicable mutatis
  mutandis in accordance with Article 52(2) of that regulation, the Member State Committee reached a unanimous agreement on the amended draft decision. |
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13

On 12 June 2014, pursuant to Article 51(6) of Regulation No 1907/2006, applicable mutatis
  mutandis in accordance with Article 52(2) of that regulation, the Member State Committee reached a unanimous agreement on the amended draft decision.

mutatis

mutandis

| 14 | On 19 September 2014, the ECHA adopted Decision SEV-D-2114285478-33-01/F on the evaluation of Triclosan (‘the ECHA decision’) on the basis of Article 51(6) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation. By that decision, it requested the applicant to produce in particular the following information:





  – | simulation testing of Triclosan on ultimate degradation in fresh surface water (lake or river) and sea water, performed as a pelagic test, that is to say in water only, without addition of suspended solids, at an environmentally relevant temperature of at most 12 degrees centigrade, in accordance with EU test method C.25 and Organisation for Economic Cooperation and Development (OECD) test guidelines 309 for the Testing of Chemicals (‘the persistence test’); |
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14

On 19 September 2014, the ECHA adopted Decision SEV-D-2114285478-33-01/F on the evaluation of Triclosan (‘the ECHA decision’) on the basis of Article 51(6) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation. By that decision, it requested the applicant to produce in particular the following information:

mutatis mutandis

–

simulation testing of Triclosan on ultimate degradation in fresh surface water (lake or river) and sea water, performed as a pelagic test, that is to say in water only, without addition of suspended solids, at an environmentally relevant temperature of at most 12 degrees centigrade, in accordance with EU test method C.25 and Organisation for Economic Cooperation and Development (OECD) test guidelines 309 for the Testing of Chemicals (‘the persistence test’);

| – | an enhanced developmental neurotoxicity study, in accordance with OECD test guidelines 426 for the Testing of Chemicals, with relevant elements of the extended one-generation reproductive toxicity study, in accordance with OECD test guidelines 433 for the Testing of Chemicals, which involved testing on rats (‘the enhanced neurotoxicity rat study’); |
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–

an enhanced developmental neurotoxicity study, in accordance with OECD test guidelines 426 for the Testing of Chemicals, with relevant elements of the extended one-generation reproductive toxicity study, in accordance with OECD test guidelines 433 for the Testing of Chemicals, which involved testing on rats (‘the enhanced neurotoxicity rat study’);

| – | a fish sexual development test, in accordance with OECD test guidelines 234 for the Testing of Chemicals, on zebrafish or Japanese medaka (‘the fish test’). |
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–

a fish sexual development test, in accordance with OECD test guidelines 234 for the Testing of Chemicals, on zebrafish or Japanese medaka (‘the fish test’).

| 15 | By its decision, the ECHA also asked the applicant to provide the information available on the effects of Triclosan on the cardiovascular system of certain laboratory animals and humans as well as further information on the ‘wide dispersive indoor use of reactive substances in open systems’ emission scenario. |
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15

By its decision, the ECHA also asked the applicant to provide the information available on the effects of Triclosan on the cardiovascular system of certain laboratory animals and humans as well as further information on the ‘wide dispersive indoor use of reactive substances in open systems’ emission scenario.

| 16 | The ECHA decision fixed 26 September 2016 as the deadline for providing the information requested. |
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16

The ECHA decision fixed 26 September 2016 as the deadline for providing the information requested.

| 17 | On 17 December 2014, the applicant brought an action against the ECHA decision before the Board of Appeal of that agency, pursuant to Article 51(8) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, and with Article 91(1) of that regulation. |
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17

On 17 December 2014, the applicant brought an action against the ECHA decision before the Board of Appeal of that agency, pursuant to Article 51(8) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, and with Article 91(1) of that regulation.

mutatis mutandis

| 18 | In accordance with Article 91(2) of Regulation No 1907/2006, the action against the ECHA decision had suspensory effect. |
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18

In accordance with Article 91(2) of Regulation No 1907/2006, the action against the ECHA decision had suspensory effect.

| 19 | On 2 April 2015, the ECHA lodged the defence before the Board of Appeal. |
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19

On 2 April 2015, the ECHA lodged the defence before the Board of Appeal.

| 20 | On 6 October 2015, PETA International Science Consortium Ltd was granted leave to intervene before the Board of Appeal in support of the form of order sought by the applicant. |
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20

On 6 October 2015, PETA International Science Consortium Ltd was granted leave to intervene before the Board of Appeal in support of the form of order sought by the applicant.

| 21 | On 12 January 2016, PETA International Science Consortium lodged its statement in intervention before the Board of Appeal. On 22 February 2016, the ECHA and the applicant submitted their observations on that statement. The applicant enclosed an expert opinion as an annex to its observations. |
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21

On 12 January 2016, PETA International Science Consortium lodged its statement in intervention before the Board of Appeal. On 22 February 2016, the ECHA and the applicant submitted their observations on that statement. The applicant enclosed an expert opinion as an annex to its observations.

| 22 | A hearing before the Board of Appeal was held on 9 June 2016. At that hearing, the ECHA submitted three studies by which it sought to refute the expert opinion submitted by the applicant as part of its observations on the statement in intervention. That board allowed the parties to submit their observations on that opinion and on the three studies submitted by the ECHA after the hearing. |
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22

A hearing before the Board of Appeal was held on 9 June 2016. At that hearing, the ECHA submitted three studies by which it sought to refute the expert opinion submitted by the applicant as part of its observations on the statement in intervention. That board allowed the parties to submit their observations on that opinion and on the three studies submitted by the ECHA after the hearing.

| 23 | On 19 December 2016, the Board of Appeal adopted Decision A‐018‐2014 (‘the contested decision’). By that decision, it annulled the ECHA decision in so far as the latter had obliged the applicant to provide information about the effects of Triclosan on the cardiovascular system (see paragraph 15 above) and dismissed the action as to the remainder. In addition, it fixed 26 December 2018 as the deadline for the submission of the information referred to in paragraph 14 above. |
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23

On 19 December 2016, the Board of Appeal adopted Decision A‐018‐2014 (‘the contested decision’). By that decision, it annulled the ECHA decision in so far as the latter had obliged the applicant to provide information about the effects of Triclosan on the cardiovascular system (see paragraph 15 above) and dismissed the action as to the remainder. In addition, it fixed 26 December 2018 as the deadline for the submission of the information referred to in paragraph 14 above.

II. Procedure before the Court and forms of order sought

II.

Procedure before the Court and forms of order sought

| 24 | By application lodged at the Registry of the Court on 28 February 2017, the applicant brought this action. |
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24

By application lodged at the Registry of the Court on 28 February 2017, the applicant brought this action.

| 25 | By a separate document lodged at the Court Registry on the same day, the applicant brought an application for interim measures, by which it claimed, in essence, that the President of the General Court should order the immediate suspension of the implementation of the contested decision, pending a decision on the application for interim measures, suspend the implementation of the contested decision in so far as it concerns the persistence test, the enhanced neurotoxicity rat study and the fish test, and order, consequently, the extension of the prescribed period to provide the results of the tests and of the study for the duration of the suspension. The application for interim measures was dismissed by order of 13 July 2017, BASF Grenzach v ECHA (T‐125/17 R, not published, EU:T:2017:496), because the applicant had failed to establish urgency, and the costs of that procedure were reserved. The appeal against that order was dismissed by order of 28 May 2018, BASF Grenzach v ECHA (C‐565/17 P(R), not published, EU:C:2018:340). |
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25

By a separate document lodged at the Court Registry on the same day, the applicant brought an application for interim measures, by which it claimed, in essence, that the President of the General Court should order the immediate suspension of the implementation of the contested decision, pending a decision on the application for interim measures, suspend the implementation of the contested decision in so far as it concerns the persistence test, the enhanced neurotoxicity rat study and the fish test, and order, consequently, the extension of the prescribed period to provide the results of the tests and of the study for the duration of the suspension. The application for interim measures was dismissed by order of 13 July 2017, BASF Grenzach v ECHA (T‐125/17 R, not published, EU:T:2017:496), because the applicant had failed to establish urgency, and the costs of that procedure were reserved. The appeal against that order was dismissed by order of 28 May 2018, BASF Grenzach v ECHA (C‐565/17 P(R), not published, EU:C:2018:340).

| 26 | By a document lodged at the Court Registry on 18 April 2017, PETA International Science Consortium sought leave to intervene in the present case in support of the form of order sought by the applicant. By order of 12 December 2017, BASF Grenzach v ECHA (T‐125/17, not published, EU:T:2017:931), that application was rejected. |
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26

By a document lodged at the Court Registry on 18 April 2017, PETA International Science Consortium sought leave to intervene in the present case in support of the form of order sought by the applicant. By order of 12 December 2017, BASF Grenzach v ECHA (T‐125/17, not published, EU:T:2017:931), that application was rejected.

| 27 | By documents lodged at the Court Registry on 16, 18 and 31 May 2017, the Federal Republic of Germany, the Kingdom of the Netherlands and the Kingdom of Denmark sought leave to intervene in the present proceedings in support of the form of order sought by the ECHA. By decisions of the President of the Chamber of 21 June 2017, those Member States were granted leave to intervene. |
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27

By documents lodged at the Court Registry on 16, 18 and 31 May 2017, the Federal Republic of Germany, the Kingdom of the Netherlands and the Kingdom of Denmark sought leave to intervene in the present proceedings in support of the form of order sought by the ECHA. By decisions of the President of the Chamber of 21 June 2017, those Member States were granted leave to intervene.

| 28 | On 1 June 2017 the ECHA lodged the defence. |
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28

On 1 June 2017 the ECHA lodged the defence.

| 29 | On 20 July 2017 the applicant lodged the reply. |
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29

On 20 July 2017 the applicant lodged the reply.

| 30 | On 7 September 2017 the ECHA lodged the rejoinder. |
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30

On 7 September 2017 the ECHA lodged the rejoinder.

| 31 | On 1 September 2017, the Kingdom of Denmark and the Kingdom of the Netherlands lodged their statements in intervention. On 4 September 2017, the Federal Republic of Germany lodged its statement in intervention. On 31 October 2017, the ECHA and the applicant submitted their observations on those statements. |
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31

On 1 September 2017, the Kingdom of Denmark and the Kingdom of the Netherlands lodged their statements in intervention. On 4 September 2017, the Federal Republic of Germany lodged its statement in intervention. On 31 October 2017, the ECHA and the applicant submitted their observations on those statements.

| 32 | On a proposal from the Second Chamber, the Court decided, pursuant to Article 28 of its Rules of Procedure, to assign the case to a Chamber sitting in extended composition. |
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32

On a proposal from the Second Chamber, the Court decided, pursuant to Article 28 of its Rules of Procedure, to assign the case to a Chamber sitting in extended composition.

| 33 | On a proposal from the Judge-Rapporteur, the Court (Fifth Chamber) decided to open the oral part of the procedure and, by way of measures of organisation of procedure pursuant to Article 89 of the Rules of Procedure, to submit written questions to the ECHA, and to request it to produce the administrative file. The ECHA responded to those questions and that request within the period specified. |
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33

On a proposal from the Judge-Rapporteur, the Court (Fifth Chamber) decided to open the oral part of the procedure and, by way of measures of organisation of procedure pursuant to Article 89 of the Rules of Procedure, to submit written questions to the ECHA, and to request it to produce the administrative file. The ECHA responded to those questions and that request within the period specified.

| 34 | The applicant, the ECHA, the Kingdom of Denmark, the Federal Republic of Germany and the Kingdom of the Netherlands presented oral argument and replied to questions put by the Court at the hearing on 12 December 2018. |
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34

The applicant, the ECHA, the Kingdom of Denmark, the Federal Republic of Germany and the Kingdom of the Netherlands presented oral argument and replied to questions put by the Court at the hearing on 12 December 2018.

| 35 | In its pleadings, the applicant presented an argument alleging that the requests for information on carrying out studies involving tests on animals did not comply with the principle of proportionality, due to the fact that the conduct of those studies could entail a prohibition on the marketing of products in which Triclosan is used, in accordance with the provisions of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ 2009 L 342, p. 59). |
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35

In its pleadings, the applicant presented an argument alleging that the requests for information on carrying out studies involving tests on animals did not comply with the principle of proportionality, due to the fact that the conduct of those studies could entail a prohibition on the marketing of products in which Triclosan is used, in accordance with the provisions of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ 2009 L 342, p. 59).

| 36 | For its part, during the hearing, the ECHA withdrew part of its arguments which it had put forward in relation to the first plea in law. |
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36

For its part, during the hearing, the ECHA withdrew part of its arguments which it had put forward in relation to the first plea in law.

| 37 | The applicant claims that the Court should:





  – | annul the contested decision, in so far as the Board of Appeal partially dismissed the action brought against the ECHA decision, and fixed 26 December 2018 as the deadline for presenting further information about the substance Triclosan; |
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37

The applicant claims that the Court should:

–

annul the contested decision, in so far as the Board of Appeal partially dismissed the action brought against the ECHA decision, and fixed 26 December 2018 as the deadline for presenting further information about the substance Triclosan;

| – | order the ECHA and the interveners to bear its costs, in addition to their own costs. |
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–

order the ECHA and the interveners to bear its costs, in addition to their own costs.

| 38 | The ECHA and the Kingdom of the Netherlands contend that the Court should:





  – | dismiss the application; |
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38

The ECHA and the Kingdom of the Netherlands contend that the Court should:

–

dismiss the application;

| – | order the applicant to pay the costs. |
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–

order the applicant to pay the costs.

| 39 | The Kingdom of Denmark and the Federal Republic of Germany contend that the Court should dismiss the application. |
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39

The Kingdom of Denmark and the Federal Republic of Germany contend that the Court should dismiss the application.

III. Law

III.

Law

| 40 | In the contested decision, the Board of Appeal examined, in the first place, the pleas developed by the applicant in the context of the action before it which referred to the request to conduct the persistence test, in the second place, those referring to the request to conduct the enhanced neurotoxicity rat test, in the third place, those referring to the request to conduct the fish test and, in the fourth place, those referring to the request to submit available information concerning the effects of Triclosan on the cardiovascular system. |
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40

In the contested decision, the Board of Appeal examined, in the first place, the pleas developed by the applicant in the context of the action before it which referred to the request to conduct the persistence test, in the second place, those referring to the request to conduct the enhanced neurotoxicity rat test, in the third place, those referring to the request to conduct the fish test and, in the fourth place, those referring to the request to submit available information concerning the effects of Triclosan on the cardiovascular system.

| 41 | In support of the present action, the applicant puts forward two pleas in law. |
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41

In support of the present action, the applicant puts forward two pleas in law.

| 42 | The first plea alleges that the Board of Appeal breached essential procedural requirements. It is based on two parts, the first alleging that that board applied an erroneous standard of review of the ECHA decision and the second alleging that that board failed to examine key studies and scientific dossiers which were included in the ECHA dossier and which the applicant had sent it. |
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42

The first plea alleges that the Board of Appeal breached essential procedural requirements. It is based on two parts, the first alleging that that board applied an erroneous standard of review of the ECHA decision and the second alleging that that board failed to examine key studies and scientific dossiers which were included in the ECHA dossier and which the applicant had sent it.

| 43 | The second plea alleges that the Board of Appeal failed to take into account animal welfare and breached the principle of proportionality. It consists of three parts. The first concerns the request to conduct the enhanced neurotoxicity rat study, the second to conduct the fish test and the third to conduct the persistence test. |
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43

The second plea alleges that the Board of Appeal failed to take into account animal welfare and breached the principle of proportionality. It consists of three parts. The first concerns the request to conduct the enhanced neurotoxicity rat study, the second to conduct the fish test and the third to conduct the persistence test.

| 44 | The applicant’s arguments are examined according to the order of the considerations of the contested decision to which they refer. Therefore, as a first step, the arguments put forward in the context of the first plea and the third part of the second plea will be examined. Those arguments concern the dismissal of the action before the Board of Appeal in so far as it related to the request to conduct the persistence test. As a second step, the arguments put forward in the context of the first plea and the first part of the second plea will be analysed. Those arguments concern the dismissal of that action in so far as it related to the request to conduct the enhanced neurotoxicity rat study. As a third step, the arguments put forward in the context of the first plea and the second part of the second plea will be examined. Those arguments concern the dismissal of that action in so far as it related to the request to conduct the fish rest. |
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44

The applicant’s arguments are examined according to the order of the considerations of the contested decision to which they refer. Therefore, as a first step, the arguments put forward in the context of the first plea and the third part of the second plea will be examined. Those arguments concern the dismissal of the action before the Board of Appeal in so far as it related to the request to conduct the persistence test. As a second step, the arguments put forward in the context of the first plea and the first part of the second plea will be analysed. Those arguments concern the dismissal of that action in so far as it related to the request to conduct the enhanced neurotoxicity rat study. As a third step, the arguments put forward in the context of the first plea and the second part of the second plea will be examined. Those arguments concern the dismissal of that action in so far as it related to the request to conduct the fish rest.

| 45 | As a fourth step, the argument alleging that the Board of Appeal did not apply a consistent standard of review in the entirety of the contested decision, that the applicant puts forward in the context of the first part of the first plea, will be analysed. As a fifth step, the argument alleging a breach of the rights of the defence which the applicant puts forward in the context of the first plea will be examined. Finally, as a sixth step, account will be taken of the argument relating to the provisions of Regulation No 1223/2009 which the applicant puts forward in the context of its pleadings during the hearing (paragraph 35 above). |
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45

As a fourth step, the argument alleging that the Board of Appeal did not apply a consistent standard of review in the entirety of the contested decision, that the applicant puts forward in the context of the first part of the first plea, will be analysed. As a fifth step, the argument alleging a breach of the rights of the defence which the applicant puts forward in the context of the first plea will be examined. Finally, as a sixth step, account will be taken of the argument relating to the provisions of Regulation No 1223/2009 which the applicant puts forward in the context of its pleadings during the hearing (paragraph 35 above).

A. The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the persistence test

A.

The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the persistence test

| 46 | In its decision, the ECHA requested the applicant to conduct the persistence test. According to the considerations in that decision, that request to provide further information about Triclosan was justified by the fact that there existed a potential risk of Triclosan being persistent in marine or fresh water environments, that that question should be clarified, that it was not possible to clarify it on the basis of available information and that the persistence test would allow useful information to be obtained in that regard. |
| --- | --- |

46

In its decision, the ECHA requested the applicant to conduct the persistence test. According to the considerations in that decision, that request to provide further information about Triclosan was justified by the fact that there existed a potential risk of Triclosan being persistent in marine or fresh water environments, that that question should be clarified, that it was not possible to clarify it on the basis of available information and that the persistence test would allow useful information to be obtained in that regard.

| 47 | In the context of the action before the Board of Appeal, the applicant claimed that the ECHA was not entitled to request the persistence test to be conducted. In that regard, it puts forward five pleas, alleging, firstly, inter alia an infringement of Annex XIII to Regulation No 1907/2006, secondly, an infringement of the first sentence of Article 47(1) of that regulation, thirdly, an infringement of Article 130 thereof, fourthly, a breach of the principle of proportionality and, fifthly, a breach of the principle of sound administration, which were rejected in their entirety for the reasons set out in paragraphs 28 to 115 of the contested decision. |
| --- | --- |

47

In the context of the action before the Board of Appeal, the applicant claimed that the ECHA was not entitled to request the persistence test to be conducted. In that regard, it puts forward five pleas, alleging, firstly, inter alia an infringement of Annex XIII to Regulation No 1907/2006, secondly, an infringement of the first sentence of Article 47(1) of that regulation, thirdly, an infringement of Article 130 thereof, fourthly, a breach of the principle of proportionality and, fifthly, a breach of the principle of sound administration, which were rejected in their entirety for the reasons set out in paragraphs 28 to 115 of the contested decision.

| 48 | In the context of the present action, the applicant contests the findings on which the Board of Appeal based the dismissal of the action before it in so far as it referred to the request to conduct the persistence test. As a first step, the applicant’s arguments calling into question the findings on which the Board of Appeal based the rejection of the second plea in the action before it, alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006 will be examined. As a second step, the applicant’s arguments calling into question the findings on which the Board of Appeal based the rejection of the first plea in the action before it, alleging, in particular, an infringement of Annex XIII to Regulation No 1907/2006 will be examined. As a third step, the applicant’s arguments alleging that the Canadian authorities reached the conclusion that Triclosan lacked both the persistence property and the bioaccumulation property will be examined. |
| --- | --- |

48

In the context of the present action, the applicant contests the findings on which the Board of Appeal based the dismissal of the action before it in so far as it referred to the request to conduct the persistence test. As a first step, the applicant’s arguments calling into question the findings on which the Board of Appeal based the rejection of the second plea in the action before it, alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006 will be examined. As a second step, the applicant’s arguments calling into question the findings on which the Board of Appeal based the rejection of the first plea in the action before it, alleging, in particular, an infringement of Annex XIII to Regulation No 1907/2006 will be examined. As a third step, the applicant’s arguments alleging that the Canadian authorities reached the conclusion that Triclosan lacked both the persistence property and the bioaccumulation property will be examined.

1.
   
  The arguments calling into question the rejection, by the Board of Appeal, of the second plea in the action before it

1.

The arguments calling into question the rejection, by the Board of Appeal, of the second plea in the action before it

| 49 | In the context of the second plea in the action before the Board of Appeal, the applicant claimed that the ECHA had infringed the first sentence of Article 47(1) of Regulation No 1907/2006. In that context, it claimed in particular that the ECHA had failed to take account of relevant information showing that Triclosan was largely eliminated from water leaving sewage treatment plants, not only due to its absorption, but also to its mineralisation. That substance is quickly eliminated from the water phase and absorbed in sediment, which suggests a potentially relatively significant elimination in the aquatic environment. In the context of that plea, the applicant also put forward arguments relating to the weight of evidence determination of the available data. |
| --- | --- |

49

In the context of the second plea in the action before the Board of Appeal, the applicant claimed that the ECHA had infringed the first sentence of Article 47(1) of Regulation No 1907/2006. In that context, it claimed in particular that the ECHA had failed to take account of relevant information showing that Triclosan was largely eliminated from water leaving sewage treatment plants, not only due to its absorption, but also to its mineralisation. That substance is quickly eliminated from the water phase and absorbed in sediment, which suggests a potentially relatively significant elimination in the aquatic environment. In the context of that plea, the applicant also put forward arguments relating to the weight of evidence determination of the available data.

| 50 | In paragraphs 57 to 65 of the contested decision, the Board of Appeal examined those arguments. |
| --- | --- |

50

In paragraphs 57 to 65 of the contested decision, the Board of Appeal examined those arguments.

| 51 | First of all, in paragraph 58 of the contested decision, the Board of Appeal stated that, although, under the first sentence of Article 47(1) of Regulation No 1907/2006, the ECHA was required to take into account all the relevant information submitted, that did not imply that that agency would necessarily arrive at the same conclusions as the applicant. |
| --- | --- |

51

First of all, in paragraph 58 of the contested decision, the Board of Appeal stated that, although, under the first sentence of Article 47(1) of Regulation No 1907/2006, the ECHA was required to take into account all the relevant information submitted, that did not imply that that agency would necessarily arrive at the same conclusions as the applicant.

| 52 | In paragraphs 59 to 61 of the contested decision, concerning, firstly, the applicant’s argument alleging that the ECHA had not taken account of information indicating that Triclosan would largely be eliminated from wastewater by sewage treatment plants, the Board of Appeal held that, although, according to the findings in the ECHA decision, Triclosan was largely eliminated from wastewater by sewage treatment plants, that was not the case with respect to all of that substance, which seemed to be ubiquitous in certain fresh surface water and the concentration of that substance in the maritime environment remained relatively high. It concluded that, contrary to what was submitted by the applicant, the relevant information had been taken into account but that, in the ECHA decision, a conclusion other than that supported by the applicant was drawn from that information. |
| --- | --- |

52

In paragraphs 59 to 61 of the contested decision, concerning, firstly, the applicant’s argument alleging that the ECHA had not taken account of information indicating that Triclosan would largely be eliminated from wastewater by sewage treatment plants, the Board of Appeal held that, although, according to the findings in the ECHA decision, Triclosan was largely eliminated from wastewater by sewage treatment plants, that was not the case with respect to all of that substance, which seemed to be ubiquitous in certain fresh surface water and the concentration of that substance in the maritime environment remained relatively high. It concluded that, contrary to what was submitted by the applicant, the relevant information had been taken into account but that, in the ECHA decision, a conclusion other than that supported by the applicant was drawn from that information.

| 53 | Regarding, secondly, the applicant’s argument alleging that the ECHA had not taken account of the fact that Triclosan rapidly binds with suspended particulate matter and was, consequently, eliminated from the water phase to a large extent, the Board of Appeal held, in paragraphs 62 and 63 of the contested decision, that it concerned comments relating to the dissipation of Triclosan already put forward during the proceedings before the ECHA and that, in that agency’s decision, an explicit and extensive response had already been given to those comments. In paragraph 64 of the contested decision, in response to the applicant’s argument alleging that there should have been an answer to the question whether Triclosan was persistent in determining the evidential weight of the information available, it held that, in accordance with Annex XI to Regulation No 1907/2006, the determination by means of the weight of evidence approach could be used to adapt standard information requirements for registration purposes. However, according to it, even where such an approach has been applied for the purposes of registering a substance, in the context of the evaluation of that substance, further information could be requested in order to clarify whether there are any concerns in that regard, on condition that the ECHA correctly exercised its discretion, by taking account, in particular, of all of the relevant information which had been submitted concerning the substance at issue. |
| --- | --- |

53

Regarding, secondly, the applicant’s argument alleging that the ECHA had not taken account of the fact that Triclosan rapidly binds with suspended particulate matter and was, consequently, eliminated from the water phase to a large extent, the Board of Appeal held, in paragraphs 62 and 63 of the contested decision, that it concerned comments relating to the dissipation of Triclosan already put forward during the proceedings before the ECHA and that, in that agency’s decision, an explicit and extensive response had already been given to those comments. In paragraph 64 of the contested decision, in response to the applicant’s argument alleging that there should have been an answer to the question whether Triclosan was persistent in determining the evidential weight of the information available, it held that, in accordance with Annex XI to Regulation No 1907/2006, the determination by means of the weight of evidence approach could be used to adapt standard information requirements for registration purposes. However, according to it, even where such an approach has been applied for the purposes of registering a substance, in the context of the evaluation of that substance, further information could be requested in order to clarify whether there are any concerns in that regard, on condition that the ECHA correctly exercised its discretion, by taking account, in particular, of all of the relevant information which had been submitted concerning the substance at issue.

| 54 | The applicant contests those assessments by claiming, as a first step, that the Board of Appeal failed to fulfil the task imposed on it in the context of an action before it, as a second step, that it failed to take into account the fact that, in the evaluation of substances, it is necessary to carry out the weight of evidence determination of the available information and, finally, as a third step, that the intensity of the review conducted by that board was insufficient. |
| --- | --- |

54

The applicant contests those assessments by claiming, as a first step, that the Board of Appeal failed to fulfil the task imposed on it in the context of an action before it, as a second step, that it failed to take into account the fact that, in the evaluation of substances, it is necessary to carry out the weight of evidence determination of the available information and, finally, as a third step, that the intensity of the review conducted by that board was insufficient.

(a)
   
  The arguments alleging that the Board of Appeal disregarded the task imposed on it in the context of an action before it

(a)

The arguments alleging that the Board of Appeal disregarded the task imposed on it in the context of an action before it

| 55 | In the context of the first part of the first plea in law, the applicant claims that, in paragraph 64 of the contested decision, the Board of Appeal disregarded its review task. It claims that that board merely reviewed the lawfulness of the ECHA decision, restricted to the manifest error of assessment. In particular, it refused to examine the scientific data which it had invoked and to take their relevance into account. According to it, that board should have itself carried out a full administrative review. Such a review would have involved not only a legal review of the ECHA decision, but also a re-examination of the scientific assessments underlying that decision, in the light of the most relevant data and, where appropriate, data which became apparent during the appeal proceedings. Moreover, according to the applicant, under the principle of functional continuity, that board, which may exercise any power which lies within the competence of the ECHA, was required to examine whether, in the light of all the relevant matters of law and fact, a new decision with the same operative part as the ECHA decision could be lawfully adopted. In the context of such an examination, the board in question is subject to the same substantive obligations and the same burden of proof to which the ECHA had been subject in the context of its review. The review carried out by the Board of Appeal should therefore have been based also on the elements which had been submitted during the proceedings before it. |
| --- | --- |

55

In the context of the first part of the first plea in law, the applicant claims that, in paragraph 64 of the contested decision, the Board of Appeal disregarded its review task. It claims that that board merely reviewed the lawfulness of the ECHA decision, restricted to the manifest error of assessment. In particular, it refused to examine the scientific data which it had invoked and to take their relevance into account. According to it, that board should have itself carried out a full administrative review. Such a review would have involved not only a legal review of the ECHA decision, but also a re-examination of the scientific assessments underlying that decision, in the light of the most relevant data and, where appropriate, data which became apparent during the appeal proceedings. Moreover, according to the applicant, under the principle of functional continuity, that board, which may exercise any power which lies within the competence of the ECHA, was required to examine whether, in the light of all the relevant matters of law and fact, a new decision with the same operative part as the ECHA decision could be lawfully adopted. In the context of such an examination, the board in question is subject to the same substantive obligations and the same burden of proof to which the ECHA had been subject in the context of its review. The review carried out by the Board of Appeal should therefore have been based also on the elements which had been submitted during the proceedings before it.

| 56 | In support of its arguments, the applicant claims that, firstly, under Article 76(1)(h) of Regulation No 1907/2006, the Board of Appeal is part of the ECHA. Secondly, the rationale for the internal review mechanism is to ensure the scientific quality and regulatory legitimacy of the ECHA decisions. Thirdly, that board is responsible for examining the appeal as effectively and efficiently as possible. Fourthly, such an approach would allow that board to carefully and impartially examine all the relevant elements of the present case, on the basis of the most relevant scientific data and in accordance with the principles of excellence, independence and transparency. Fifthly, that board has the same capacity to investigate as the Board of Appeal of the European Union Intellectual Property Office (EUIPO). Under Article 12(1) and (2) of Commission Regulation (EC) No 771/2008 of 1 August 2008 laying down the rules of organisation and procedure of the Board of Appeal of the ECHA (OJ 2008 L 206, p. 5), the latter is allowed to take account of scientific facts post-dating the ECHA decision. That allows it to adapt its review and to take into account the most recent scientific research in the field. Sixthly, the appeals against the decisions requesting further information in the context of the evaluation of substances are governed by the same rules as appeals against other ECHA decisions. Seventhly, in accordance with Article 93(3) of Regulation No 1907/2006 and the principle of functional continuity, the Board of Appeal may exercise any power that lies within ECHA’s competence. It could thus have modified the ECHA decision or replaced it with its own decision. Eighthly, appeals before the Board of Appeal have suspensory effect. Ninthly, the approach followed in the contested decision creates a gap in the decision-making process which the EU Courts and the EU legislature sought to avoid. |
| --- | --- |

56

In support of its arguments, the applicant claims that, firstly, under Article 76(1)(h) of Regulation No 1907/2006, the Board of Appeal is part of the ECHA. Secondly, the rationale for the internal review mechanism is to ensure the scientific quality and regulatory legitimacy of the ECHA decisions. Thirdly, that board is responsible for examining the appeal as effectively and efficiently as possible. Fourthly, such an approach would allow that board to carefully and impartially examine all the relevant elements of the present case, on the basis of the most relevant scientific data and in accordance with the principles of excellence, independence and transparency. Fifthly, that board has the same capacity to investigate as the Board of Appeal of the European Union Intellectual Property Office (EUIPO). Under Article 12(1) and (2) of Commission Regulation (EC) No 771/2008 of 1 August 2008 laying down the rules of organisation and procedure of the Board of Appeal of the ECHA (OJ 2008 L 206, p. 5), the latter is allowed to take account of scientific facts post-dating the ECHA decision. That allows it to adapt its review and to take into account the most recent scientific research in the field. Sixthly, the appeals against the decisions requesting further information in the context of the evaluation of substances are governed by the same rules as appeals against other ECHA decisions. Seventhly, in accordance with Article 93(3) of Regulation No 1907/2006 and the principle of functional continuity, the Board of Appeal may exercise any power that lies within ECHA’s competence. It could thus have modified the ECHA decision or replaced it with its own decision. Eighthly, appeals before the Board of Appeal have suspensory effect. Ninthly, the approach followed in the contested decision creates a gap in the decision-making process which the EU Courts and the EU legislature sought to avoid.

| 57 | The ECHA and the interveners contest those arguments. |
| --- | --- |

57

The ECHA and the interveners contest those arguments.

| 58 | First of all, before responding to the applicant’s arguments, it is necessary to analyse the scope and intensity of the review that the Board of Appeal is required to carry out of ECHA decisions and, in particular, of decisions requesting further information in the context of the evaluation of substances. |
| --- | --- |

58

First of all, before responding to the applicant’s arguments, it is necessary to analyse the scope and intensity of the review that the Board of Appeal is required to carry out of ECHA decisions and, in particular, of decisions requesting further information in the context of the evaluation of substances.

(1) The scope and intensity of the review conducted by the Board of Appeal

(1)

The scope and intensity of the review conducted by the Board of Appeal

(i) The scope of the review

(i)

The scope of the review

| 59 | It should be noted, at the outset, that none of the provisions of Regulation No 1907/2006, or of Regulation No 771/2008, expressly provide that, in the context of an action before it against a decision of the ECHA requesting further information in the evaluation of a substance, the Board of Appeal is to conduct a ‘de novo’ evaluation as envisaged by the applicant, that is to say an evaluation of the question whether, at the time when it rules on the action, in the light of all the relevant elements of fact and law, in particular scientific issues, a new decision with the same operative part as the decision contested before it may be lawfully adopted. |
| --- | --- |

59

It should be noted, at the outset, that none of the provisions of Regulation No 1907/2006, or of Regulation No 771/2008, expressly provide that, in the context of an action before it against a decision of the ECHA requesting further information in the evaluation of a substance, the Board of Appeal is to conduct a ‘de novo’ evaluation as envisaged by the applicant, that is to say an evaluation of the question whether, at the time when it rules on the action, in the light of all the relevant elements of fact and law, in particular scientific issues, a new decision with the same operative part as the decision contested before it may be lawfully adopted.

| 60 | By contrast, it follows from the provisions of Regulation No 1907/2006 and of Regulation No 771/2008 that, in the context of such an action, the Board of Appeal is to confine itself to examining whether the arguments put forward by the applicant are such as to demonstrate the existence of an error vitiating the contested decision. |
| --- | --- |

60

By contrast, it follows from the provisions of Regulation No 1907/2006 and of Regulation No 771/2008 that, in the context of such an action, the Board of Appeal is to confine itself to examining whether the arguments put forward by the applicant are such as to demonstrate the existence of an error vitiating the contested decision.

| 61 | In the first place, it must be noted that the procedure before the Board of Appeal has an adversarial nature. |
| --- | --- |

61

In the first place, it must be noted that the procedure before the Board of Appeal has an adversarial nature.

| 62 | Article 93(4) of Regulation No 1907/2006 provides that the rules on procedures before the Board of Appeal are fixed by the European Commission in accordance with the procedure referred to in Article 133(4) of that regulation. Therefore, it is the rules included in Regulation No 771/2008 which govern the procedure before that board. |
| --- | --- |

62

Article 93(4) of Regulation No 1907/2006 provides that the rules on procedures before the Board of Appeal are fixed by the European Commission in accordance with the procedure referred to in Article 133(4) of that regulation. Therefore, it is the rules included in Regulation No 771/2008 which govern the procedure before that board.

| 63 | As regards the rules on procedures before the Board of Appeal, it must be noted, in particular, that, under Article 6(1)(e) and (f) of Regulation No 771/2008, the notice of appeal must include the pleas in law and the arguments of fact and law relied on and, where relevant, production of evidence and a statement explaining the facts for which the evidence is offered in support. Under Article 7(1) and (2)(b) and (c) of that regulation, the ECHA must lodge a defence which fulfils those requirements. Finally, Article 12 of that regulation, entitled ‘Examination of appeals’, provides, in paragraphs 1 and 2 thereof, that no further evidence may be introduced after the first exchange of written pleadings, unless the delay is duly justified, and that no new plea in law may be introduced after the first exchange of written pleadings unless the Board of Appeal decides that it is based on new matters of law or of fact that come to light in the course of the proceedings. |
| --- | --- |

63

As regards the rules on procedures before the Board of Appeal, it must be noted, in particular, that, under Article 6(1)(e) and (f) of Regulation No 771/2008, the notice of appeal must include the pleas in law and the arguments of fact and law relied on and, where relevant, production of evidence and a statement explaining the facts for which the evidence is offered in support. Under Article 7(1) and (2)(b) and (c) of that regulation, the ECHA must lodge a defence which fulfils those requirements. Finally, Article 12 of that regulation, entitled ‘Examination of appeals’, provides, in paragraphs 1 and 2 thereof, that no further evidence may be introduced after the first exchange of written pleadings, unless the delay is duly justified, and that no new plea in law may be introduced after the first exchange of written pleadings unless the Board of Appeal decides that it is based on new matters of law or of fact that come to light in the course of the proceedings.

| 64 | The rules of procedure laid down in Regulation No 771/2008 provide therefore for the organisation, before the Board of Appeal, of an inter partes hearing between the applicant, which contests an ECHA decision, and the latter as defendant, on the basis of pleas, arguments and evidence produced, in principle, during the first round of written pleadings. Those provisions of that regulation are general provisions which apply to all decisions of the Board of Appeal, regardless of the nature of the decision contested before it. |
| --- | --- |

64

The rules of procedure laid down in Regulation No 771/2008 provide therefore for the organisation, before the Board of Appeal, of an inter partes hearing between the applicant, which contests an ECHA decision, and the latter as defendant, on the basis of pleas, arguments and evidence produced, in principle, during the first round of written pleadings. Those provisions of that regulation are general provisions which apply to all decisions of the Board of Appeal, regardless of the nature of the decision contested before it.

inter partes

| 65 | As an interim conclusion, it must thus be noted that the subject of the procedure before the Board of Appeal of the ECHA is determined by the pleas put forward by the applicant in the context of the action before that board. In the examination of the merits of such an action, that board confines itself therefore to an examination of whether the pleas put forward by the applicant are capable of demonstrating that the decision contested before it is vitiated by an error, and the pleas which must be raised of its own motion. |
| --- | --- |

65

As an interim conclusion, it must thus be noted that the subject of the procedure before the Board of Appeal of the ECHA is determined by the pleas put forward by the applicant in the context of the action before that board. In the examination of the merits of such an action, that board confines itself therefore to an examination of whether the pleas put forward by the applicant are capable of demonstrating that the decision contested before it is vitiated by an error, and the pleas which must be raised of its own motion.

| 66 | The adversarial nature of the proceedings before the Board of Appeal is not called into question by Article 93(3) of Regulation No 1907/2006, which provides that the Board of Appeal may exercise any power which lies within the competence of the Agency or remit the case to the competent body of the Agency for further action. That provision governs solely the Board of Appeal’s powers after having held that an action before it was well founded. By contrast, it does not govern the review carried out by that board in relation to the merits of an action before it. |
| --- | --- |

66

The adversarial nature of the proceedings before the Board of Appeal is not called into question by Article 93(3) of Regulation No 1907/2006, which provides that the Board of Appeal may exercise any power which lies within the competence of the Agency or remit the case to the competent body of the Agency for further action. That provision governs solely the Board of Appeal’s powers after having held that an action before it was well founded. By contrast, it does not govern the review carried out by that board in relation to the merits of an action before it.

| 67 | Moreover, it cannot be deduced from the fact that, under Article 76(1)(h) of Regulation No 1907/2006, the Board of Appeal is an integral part of the ECHA and that the provisions on which the ECHA relies when it rules at first instance refer to the ‘Agency’, that that board is required to follow the same procedure as the ECHA where the latter rules at first instance, in accordance with the same rules of procedure. |
| --- | --- |

67

Moreover, it cannot be deduced from the fact that, under Article 76(1)(h) of Regulation No 1907/2006, the Board of Appeal is an integral part of the ECHA and that the provisions on which the ECHA relies when it rules at first instance refer to the ‘Agency’, that that board is required to follow the same procedure as the ECHA where the latter rules at first instance, in accordance with the same rules of procedure.

| 68 | It follows from the scheme of Regulation No 1907/2006 that the rules of procedure addressing the ‘Agency’, which apply to the ECHA where it adopts a decision at first instance, are not intended to apply directly to the Board of Appeal. |
| --- | --- |

68

It follows from the scheme of Regulation No 1907/2006 that the rules of procedure addressing the ‘Agency’, which apply to the ECHA where it adopts a decision at first instance, are not intended to apply directly to the Board of Appeal.

| 69 | As is shown by the example of the rules of procedure governing the adoption of a decision requesting further information in the context of the evaluation of a substance, a direct application of those procedural rules to the Board of Appeal would produce results contrary to the objectives pursued by Regulation No 1907/2006. |
| --- | --- |

69

As is shown by the example of the rules of procedure governing the adoption of a decision requesting further information in the context of the evaluation of a substance, a direct application of those procedural rules to the Board of Appeal would produce results contrary to the objectives pursued by Regulation No 1907/2006.

| 70 | In that context, it should be recalled that, where a competent authority of a Member State, which was designated in order to implement the procedure for assessing a substance indicated in the Community rolling action plan as a result of concerns relating to its persistence, bioaccumulation and toxicity properties (‘the designated authority’), considers that further information is necessary, in accordance with Article 46(1) of Regulation No 1907/2006, it is to establish a draft decision within 12 months of the publication of the Community rolling action plan on the ECHA’s website for substances to be evaluated that year. The decision is then to be taken in accordance with the procedure laid down in Articles 50 and 52 of that regulation. |
| --- | --- |

70

In that context, it should be recalled that, where a competent authority of a Member State, which was designated in order to implement the procedure for assessing a substance indicated in the Community rolling action plan as a result of concerns relating to its persistence, bioaccumulation and toxicity properties (‘the designated authority’), considers that further information is necessary, in accordance with Article 46(1) of Regulation No 1907/2006, it is to establish a draft decision within 12 months of the publication of the Community rolling action plan on the ECHA’s website for substances to be evaluated that year. The decision is then to be taken in accordance with the procedure laid down in Articles 50 and 52 of that regulation.

| 71 | Article 50 of Regulation No 1907/2006 governs the rights of registrants and downstream users. Article 50(1) thereof provides that the ECHA is to submit the draft decision to the registrants or downstream users concerned. If the registrants or downstream users wish to present comments, they are to submit them to the ECHA within 30 days of receipt. The latter is in turn to inform the designated authority of the submission of the comments without delay. That authority is to take into account all comments received and may amend the draft decision as a result. |
| --- | --- |

71

Article 50 of Regulation No 1907/2006 governs the rights of registrants and downstream users. Article 50(1) thereof provides that the ECHA is to submit the draft decision to the registrants or downstream users concerned. If the registrants or downstream users wish to present comments, they are to submit them to the ECHA within 30 days of receipt. The latter is in turn to inform the designated authority of the submission of the comments without delay. That authority is to take into account all comments received and may amend the draft decision as a result.

| 72 | Under Article 52(1) of Regulation No 1907/2006, the designated authority is to circulate its draft decision, together with any comments by the registrant or downstream user, to the ECHA and to the competent authorities of the Member States. |
| --- | --- |

72

Under Article 52(1) of Regulation No 1907/2006, the designated authority is to circulate its draft decision, together with any comments by the registrant or downstream user, to the ECHA and to the competent authorities of the Member States.

| 73 | According to Article 52(2) of Regulation No 1907/2006, the provisions of Article 51(2) to (8) of that regulation, concerning the decision-making process for dossier evaluation, apply mutatis mutandis to the adoption of decisions requesting further information in the context of the evaluation of a substance. |
| --- | --- |

73

According to Article 52(2) of Regulation No 1907/2006, the provisions of Article 51(2) to (8) of that regulation, concerning the decision-making process for dossier evaluation, apply mutatis mutandis to the adoption of decisions requesting further information in the context of the evaluation of a substance.

mutatis mutandis

| 74 | Under Article 51(2) of Regulation No 1907/2006, the Member States may propose amendments to the draft decision within 30 days of circulation. If no proposed amendment is sent to the designated authority, under Article 51(3) of that regulation, as applicable in accordance with Article 52(2) of that regulation, the ECHA is to take the decision in the version notified. |
| --- | --- |

74

Under Article 51(2) of Regulation No 1907/2006, the Member States may propose amendments to the draft decision within 30 days of circulation. If no proposed amendment is sent to the designated authority, under Article 51(3) of that regulation, as applicable in accordance with Article 52(2) of that regulation, the ECHA is to take the decision in the version notified.

| 75 | When the designated authority receives proposals for amendment it may amend the draft decision in accordance with the first sentence of Article 51(4) of Regulation No 1907/2006, as applicable in accordance with Article 52(2) of that regulation. Within 15 days after the 30-day period provided for the submission of comments, that authority is to refer a draft decision, together with any amendments proposed, to the Member State Committee and to the ECHA, in accordance with the second sentence of Article 51(4) of that regulation. Under Article 51(5) of the regulation in question, as applicable in accordance with Article 52(2) of that regulation, it is to also send it to registrants or downstream users concerned, who may submit comments. If, within 60 days of the referral, the Member State Committee reaches a unanimous agreement on the draft decision, in accordance with Article 51(6) of the regulation concerned, as applicable in accordance with Article 52(2) of that regulation, the ECHA is to take its decision accordingly. |
| --- | --- |

75

When the designated authority receives proposals for amendment it may amend the draft decision in accordance with the first sentence of Article 51(4) of Regulation No 1907/2006, as applicable in accordance with Article 52(2) of that regulation. Within 15 days after the 30-day period provided for the submission of comments, that authority is to refer a draft decision, together with any amendments proposed, to the Member State Committee and to the ECHA, in accordance with the second sentence of Article 51(4) of that regulation. Under Article 51(5) of the regulation in question, as applicable in accordance with Article 52(2) of that regulation, it is to also send it to registrants or downstream users concerned, who may submit comments. If, within 60 days of the referral, the Member State Committee reaches a unanimous agreement on the draft decision, in accordance with Article 51(6) of the regulation concerned, as applicable in accordance with Article 52(2) of that regulation, the ECHA is to take its decision accordingly.

| 76 | By contrast, if the Member State Committee does not reach a unanimous agreement, under Article 51(7) of Regulation No 1907/2006, as applicable in accordance with Article 52(2) of that regulation, the Commission is to prepare a draft decision to be taken in accordance with the procedure referred to in Article 133(3) of that regulation. |
| --- | --- |

76

By contrast, if the Member State Committee does not reach a unanimous agreement, under Article 51(7) of Regulation No 1907/2006, as applicable in accordance with Article 52(2) of that regulation, the Commission is to prepare a draft decision to be taken in accordance with the procedure referred to in Article 133(3) of that regulation.

| 77 | Therefore, if, in an action against a decision requesting further information in the context of the evaluation of a substance, the Board of Appeal was required to follow the same procedure as the ECHA where the latter rules at first instance, due to the fact that it is part of the ‘Agency’, that would mean that that board could adopt a decision only in the event of prior unanimous agreement within the Member State Committee for the purposes of Article 51(6) of Regulation No 1907/2006. |
| --- | --- |

77

Therefore, if, in an action against a decision requesting further information in the context of the evaluation of a substance, the Board of Appeal was required to follow the same procedure as the ECHA where the latter rules at first instance, due to the fact that it is part of the ‘Agency’, that would mean that that board could adopt a decision only in the event of prior unanimous agreement within the Member State Committee for the purposes of Article 51(6) of Regulation No 1907/2006.

| 78 | Such an approach is not compatible with the legislator’s objective to allow a review, by the Board of Appeal, of decisions requesting further information in the context of the evaluation of a substance. |
| --- | --- |

78

Such an approach is not compatible with the legislator’s objective to allow a review, by the Board of Appeal, of decisions requesting further information in the context of the evaluation of a substance.

| 79 | Similar considerations apply to the procedure governing the adoption of decisions taken in accordance with the dossier evaluation, with respect to which Article 51 of Regulation No 1907/2006 applies directly. |
| --- | --- |

79

Similar considerations apply to the procedure governing the adoption of decisions taken in accordance with the dossier evaluation, with respect to which Article 51 of Regulation No 1907/2006 applies directly.

| 80 | In that context, it should also be noted that, contrary to what is provided in relation to the boards of appeal of other agencies, such as the Board of Appeal of the EUIPO, the rules applicable to the Board of Appeal of the ECHA do not contain any provisions providing that the provisions relating to procedures before the unit which adopted the decision subject to appeal apply mutatis mutandis to appeal proceedings (concerning the rules applicable to the Board of Appeal of EUIPO, see paragraph 96 below). |
| --- | --- |

80

In that context, it should also be noted that, contrary to what is provided in relation to the boards of appeal of other agencies, such as the Board of Appeal of the EUIPO, the rules applicable to the Board of Appeal of the ECHA do not contain any provisions providing that the provisions relating to procedures before the unit which adopted the decision subject to appeal apply mutatis mutandis to appeal proceedings (concerning the rules applicable to the Board of Appeal of EUIPO, see paragraph 96 below).

mutatis mutandis

| 81 | In the second place and in any event, it should be noted that an action before the Board of Appeal against an ECHA decision requesting further information in the context of the evaluation of a substance may only aim to examine whether the evidence submitted by the applicant is capable of demonstrating that that decision is vitiated by error. |
| --- | --- |

81

In the second place and in any event, it should be noted that an action before the Board of Appeal against an ECHA decision requesting further information in the context of the evaluation of a substance may only aim to examine whether the evidence submitted by the applicant is capable of demonstrating that that decision is vitiated by error.

| 82 | An ECHA decision requesting further information in the context of the evaluation of a substance is to be adopted on the basis of Article 46(1) of Regulation No 1907/2006, which is included in chapter 2 of Title VI of that regulation concerning the evaluation of substances, and of Article 50(1), Article 52 and Article 51(2) to (6) of that regulation, as applicable mutatis mutandis in accordance with Article 51(2) of that regulation. |
| --- | --- |

82

An ECHA decision requesting further information in the context of the evaluation of a substance is to be adopted on the basis of Article 46(1) of Regulation No 1907/2006, which is included in chapter 2 of Title VI of that regulation concerning the evaluation of substances, and of Article 50(1), Article 52 and Article 51(2) to (6) of that regulation, as applicable mutatis mutandis in accordance with Article 51(2) of that regulation.

mutatis mutandis

| 83 | As is apparent from Articles 44 to 48 of Regulation No 1907/2006, read in the light of recitals 66 to 68 of that regulation, the process for assessing substances, which encompasses the adoption of a decision requesting further information in the evaluation of a substance, is intended to achieve a more detailed evaluation of substances which are considered to be priority in the light of the risks they are likely to pose for human health and for the environment. Such an evaluation, which is conducted by the designated authority taking into account the precautionary principle (the second sentence of Article 1(3) of that regulation), must be entrusted to scientific experts. |
| --- | --- |

83

As is apparent from Articles 44 to 48 of Regulation No 1907/2006, read in the light of recitals 66 to 68 of that regulation, the process for assessing substances, which encompasses the adoption of a decision requesting further information in the evaluation of a substance, is intended to achieve a more detailed evaluation of substances which are considered to be priority in the light of the risks they are likely to pose for human health and for the environment. Such an evaluation, which is conducted by the designated authority taking into account the precautionary principle (the second sentence of Article 1(3) of that regulation), must be entrusted to scientific experts.

| 84 | As is apparent from Article 46(1) and Article 52 of Regulation No 1907/2006, read in conjunction with Article 51(2) to (8) of that regulation, the procedure for the adoption of a decision requesting further information is initiated on the basis of a draft established by the designated authority, if the latter considers that further information is necessary. As stated in paragraph 75 above, that proposal culminates in a decision of the ECHA in the event of agreement for the purposes of Article 51(3) or (6) of that regulation, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, namely where no comments are made about the proposal for a decision by the Member States or by the ECHA, or, where such a comment is made, in the event of unanimous agreement within the Member State Committee. |
| --- | --- |

84

As is apparent from Article 46(1) and Article 52 of Regulation No 1907/2006, read in conjunction with Article 51(2) to (8) of that regulation, the procedure for the adoption of a decision requesting further information is initiated on the basis of a draft established by the designated authority, if the latter considers that further information is necessary. As stated in paragraph 75 above, that proposal culminates in a decision of the ECHA in the event of agreement for the purposes of Article 51(3) or (6) of that regulation, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, namely where no comments are made about the proposal for a decision by the Member States or by the ECHA, or, where such a comment is made, in the event of unanimous agreement within the Member State Committee.

mutatis mutandis

| 85 | Such a decision is therefore developed in a context of uncertainty and based on the scientific assessments of scientific experts of a Member State’s designated authority and of the competent authorities of the other Member States. It must be noted that it does not follow from the provisions of Regulation No 1907/2006, or from those of Regulation No 771/2008, that it is necessary to repeat that scientific assessment in the context of the appeal proceedings before the Board of Appeal. On the contrary, as stated in paragraphs 68 to 79 above, it follows from the scheme of the procedural provisions governing the adoption of decisions requesting further information that Articles 46 and 50 to 52 of Regulation No 1907/2006 are not directly applicable to proceedings before the Board of Appeal. |
| --- | --- |

85

Such a decision is therefore developed in a context of uncertainty and based on the scientific assessments of scientific experts of a Member State’s designated authority and of the competent authorities of the other Member States. It must be noted that it does not follow from the provisions of Regulation No 1907/2006, or from those of Regulation No 771/2008, that it is necessary to repeat that scientific assessment in the context of the appeal proceedings before the Board of Appeal. On the contrary, as stated in paragraphs 68 to 79 above, it follows from the scheme of the procedural provisions governing the adoption of decisions requesting further information that Articles 46 and 50 to 52 of Regulation No 1907/2006 are not directly applicable to proceedings before the Board of Appeal.

| 86 | Consequently, an action before the Board of Appeal against an ECHA decision requesting further information in the context of the evaluation of a substance may only seek to examine whether the evidence submitted by the applicant is capable of showing that that decision is vitiated by error. Therefore, in the context of such an action, the applicant may not confine itself to claiming that the result of the assessment on which that decision is based should have been different, but it must put forward arguments to show the existence of errors vitiating the scientific assessment on which the decision in question is based. |
| --- | --- |

86

Consequently, an action before the Board of Appeal against an ECHA decision requesting further information in the context of the evaluation of a substance may only seek to examine whether the evidence submitted by the applicant is capable of showing that that decision is vitiated by error. Therefore, in the context of such an action, the applicant may not confine itself to claiming that the result of the assessment on which that decision is based should have been different, but it must put forward arguments to show the existence of errors vitiating the scientific assessment on which the decision in question is based.

(ii) The intensity of the review

(ii)

The intensity of the review

| 87 | As regards the intensity of the review carried out by the Board of Appeal, it should be noted that, admittedly, in an action for annulment under Article 263 TFEU, the review carried out by the EU Courts is limited where it involves the assessment of highly complex scientific and technical facts. Regarding such assessments, the EU Courts are limited to reviewing whether they are vitiated by a manifest error, a misuse of powers or whether the author of the decision clearly exceeded the limits of its discretion (see judgment of 21 July 2011, Etimine, C‐15/10, EU:C:2011:504, paragraph 60 and the case-law cited). |
| --- | --- |

87

As regards the intensity of the review carried out by the Board of Appeal, it should be noted that, admittedly, in an action for annulment under Article 263 TFEU, the review carried out by the EU Courts is limited where it involves the assessment of highly complex scientific and technical facts. Regarding such assessments, the EU Courts are limited to reviewing whether they are vitiated by a manifest error, a misuse of powers or whether the author of the decision clearly exceeded the limits of its discretion (see judgment of 21 July 2011, Etimine, C‐15/10, EU:C:2011:504, paragraph 60 and the case-law cited).

| 88 | However, that case-law does not apply to the review carried out by the Board of Appeal of the ECHA. In that regard, concerning the members of that agency, it should be noted that, under the second subparagraph of Article 1(1) of Regulation No 771/2008, at least one of its members is to be legally qualified and at least one member to be technically qualified, in accordance with Commission Regulation (EC) No 1238/2007 of 23 October 2007 on laying down rules on the qualifications of the members of the Board of Appeal of the ECHA (OJ 2007 L 280, p. 10). Under Article 1(2) of that regulation, the technically qualified members are to hold a university degree or an equivalent qualification and to have substantial professional experience in hazard assessment, exposure assessment or risk management with regard to human health or environment risks of chemical substances or in related fields. It must be deduced from those provisions that the legislature intended to provide the ECHA with the necessary expertise to allow it to itself carry out assessments of highly complex scientific facts. |
| --- | --- |

88

However, that case-law does not apply to the review carried out by the Board of Appeal of the ECHA. In that regard, concerning the members of that agency, it should be noted that, under the second subparagraph of Article 1(1) of Regulation No 771/2008, at least one of its members is to be legally qualified and at least one member to be technically qualified, in accordance with Commission Regulation (EC) No 1238/2007 of 23 October 2007 on laying down rules on the qualifications of the members of the Board of Appeal of the ECHA (OJ 2007 L 280, p. 10). Under Article 1(2) of that regulation, the technically qualified members are to hold a university degree or an equivalent qualification and to have substantial professional experience in hazard assessment, exposure assessment or risk management with regard to human health or environment risks of chemical substances or in related fields. It must be deduced from those provisions that the legislature intended to provide the ECHA with the necessary expertise to allow it to itself carry out assessments of highly complex scientific facts.

| 89 | Therefore, the review, by the Board of Appeal, of scientific assessments in an ECHA decision is not limited to verifying the existence of manifest errors. On the contrary, in that regard, by relying on the legal and scientific competences of its members, that board must examine whether the arguments put forward by the applicant are capable of demonstrating that the considerations on which that decision of the ECHA is based are vitiated by error. |
| --- | --- |

89

Therefore, the review, by the Board of Appeal, of scientific assessments in an ECHA decision is not limited to verifying the existence of manifest errors. On the contrary, in that regard, by relying on the legal and scientific competences of its members, that board must examine whether the arguments put forward by the applicant are capable of demonstrating that the considerations on which that decision of the ECHA is based are vitiated by error.

(2) The arguments put forward by the applicant

(2)

The arguments put forward by the applicant

| 90 | It is necessary to examine the arguments put forward by the applicant by taking into account the previous considerations relating to the scope and intensity of the review carried out by the Board of Appeal. |
| --- | --- |

90

It is necessary to examine the arguments put forward by the applicant by taking into account the previous considerations relating to the scope and intensity of the review carried out by the Board of Appeal.

| 91 | In the first place, the applicant claims that, under Article 93(3) of Regulation No 1907/2006, functional continuity exists between the Board of Appeal and the ECHA where that agency rules at first instance which is comparable to that existing between the Boards of Appeal of the EUIPO and the units of that office, and that, as a result of that functional continuity, in the context of an action before it against a decision of the ECHA, the Board of Appeal of that agency is required to conduct a full re-examination of all the questions, in particular scientific questions, addressed in the decision contested before it. |
| --- | --- |

91

In the first place, the applicant claims that, under Article 93(3) of Regulation No 1907/2006, functional continuity exists between the Board of Appeal and the ECHA where that agency rules at first instance which is comparable to that existing between the Boards of Appeal of the EUIPO and the units of that office, and that, as a result of that functional continuity, in the context of an action before it against a decision of the ECHA, the Board of Appeal of that agency is required to conduct a full re-examination of all the questions, in particular scientific questions, addressed in the decision contested before it.

| 92 | In that regard, firstly, it should be recalled, as was stated in paragraphs 60 to 80 above, that in the context of the examination of the merits of the action before the Board of Appeal, the procedural rules for the adoption of an ECHA decision where that agency is ruling at first instance are not directly applicable. By contrast, that board applies rules of procedure provided for by Regulation No 1907/2006 and Regulation No 771/2008, which are designed specifically for proceedings before it, and is thus limited to examining, in adversarial proceedings, whether that decision is vitiated by error. In any event, as stated in paragraphs 81 to 86 above, at least in an appeal against an ECHA decision requesting further information in the context of the evaluation of a substance, the Board of Appeal is limited to such an examination. |
| --- | --- |

92

In that regard, firstly, it should be recalled, as was stated in paragraphs 60 to 80 above, that in the context of the examination of the merits of the action before the Board of Appeal, the procedural rules for the adoption of an ECHA decision where that agency is ruling at first instance are not directly applicable. By contrast, that board applies rules of procedure provided for by Regulation No 1907/2006 and Regulation No 771/2008, which are designed specifically for proceedings before it, and is thus limited to examining, in adversarial proceedings, whether that decision is vitiated by error. In any event, as stated in paragraphs 81 to 86 above, at least in an appeal against an ECHA decision requesting further information in the context of the evaluation of a substance, the Board of Appeal is limited to such an examination.

| 93 | Secondly, it should be noted that, as was stated in paragraph 66 above, Article 93(3) of Regulation No 1907/2006 governs solely the Board of Appeal’s powers after having concluded that an action before it was well founded, and not the scope of the review carried out by that board with regard to the merits of an action brought before it. |
| --- | --- |

93

Secondly, it should be noted that, as was stated in paragraph 66 above, Article 93(3) of Regulation No 1907/2006 governs solely the Board of Appeal’s powers after having concluded that an action before it was well founded, and not the scope of the review carried out by that board with regard to the merits of an action brought before it.

| 94 | Thirdly, as regards the applicant’s arguments based on the case-law concerning the Boards of Appeal of the EUIPO, it should be noted that, admittedly, according to the case-law, as a result of the appeal before it, the Board of Appeal of the EUIPO is called upon to carry out a new, full examination, in terms of both law and fact, of the merits of the request or of the dispute brought before the department hearing the application at first instance (see, to that effect, judgment of 13 March 2007, OHIM v Kaul, C‐29/05 P, EU:C:2007:162, paragraph 57). A Board of Appeal of the EUIPO may therefore not confine itself to examining whether, in the light of the arguments put forward by the applicant, the decision of the department of the EUIPO hearing the application at first instance is vitiated by error, but it is required to examine whether a new decision with the same operative part as the decision subject to appeal before it may be lawfully adopted at the time of the appeal ruling. Therefore, the extent of the examination which the Board of Appeal must conduct in respect of the decision under appeal is not, in principle, determined by the grounds relied on by the party who has brought the appeal (judgments of 23 September 2003, Henkel v OHIM — LHS (UK) (KLEENCARE), T‐308/01, EU:T:2003:241, paragraphs 26 and 29, and of 16 March 2005, L’Oréal v OHIM — Revlon (FLEXI AIR), T‐112/03, EU:T:2005:102, paragraph 36). |
| --- | --- |

94

Thirdly, as regards the applicant’s arguments based on the case-law concerning the Boards of Appeal of the EUIPO, it should be noted that, admittedly, according to the case-law, as a result of the appeal before it, the Board of Appeal of the EUIPO is called upon to carry out a new, full examination, in terms of both law and fact, of the merits of the request or of the dispute brought before the department hearing the application at first instance (see, to that effect, judgment of 13 March 2007, OHIM v Kaul, C‐29/05 P, EU:C:2007:162, paragraph 57). A Board of Appeal of the EUIPO may therefore not confine itself to examining whether, in the light of the arguments put forward by the applicant, the decision of the department of the EUIPO hearing the application at first instance is vitiated by error, but it is required to examine whether a new decision with the same operative part as the decision subject to appeal before it may be lawfully adopted at the time of the appeal ruling. Therefore, the extent of the examination which the Board of Appeal must conduct in respect of the decision under appeal is not, in principle, determined by the grounds relied on by the party who has brought the appeal (judgments of 23 September 2003, Henkel v OHIM — LHS (UK) (KLEENCARE), T‐308/01, EU:T:2003:241, paragraphs 26 and 29, and of 16 March 2005, L’Oréal v OHIM — Revlon (FLEXI AIR), T‐112/03, EU:T:2005:102, paragraph 36).

| 95 | However, contrary to what is claimed by the applicant, that case-law cannot be transposed to the Board of Appeal of the ECHA. The nature and scope of the examination carried out by the boards of appeal of EUIPO are highly dependent on the legislative and regulatory context in which it takes place, which is very different from that of the Board of Appeal of the ECHA. |
| --- | --- |

95

However, contrary to what is claimed by the applicant, that case-law cannot be transposed to the Board of Appeal of the ECHA. The nature and scope of the examination carried out by the boards of appeal of EUIPO are highly dependent on the legislative and regulatory context in which it takes place, which is very different from that of the Board of Appeal of the ECHA.

| 96 | In that context, first of all, it should be noted that, in the system established by Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ 2017 L 154, p. 1), the provisions governing proceedings before the units and divisions of the EUIPO apply mutatis mutandis to appeal proceedings before the Board of Appeal. That applies to the general provisions provided for in Chapter IX, Section 1 of Regulation 2017/1001, and in particular to Article 95 of that regulation, which provides that the EUIPO is to examine the facts of its own motion, except in proceedings relating to relative grounds for refusal and invalidity proceedings pursuant to Article 59 of that regulation. Likewise, it should be noted that Article 48 of Commission Delegated Regulation (EU) 2018/625 of 5 March 2018 supplementing Regulation (EU) 2017/1001 of the European Parliament and of the Council on the European Union trade mark, and repealing Delegated Regulation (EU) 2017/1430 (OJ 2018 L 104, p. 1) provides that, unless otherwise provided, the provisions relating to proceedings before the instance of the EUIPO which adopted the decision subject to appeal are to be applicable to appeal proceedings mutatis
  mutandis. |
| --- | --- |

96

In that context, first of all, it should be noted that, in the system established by Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ 2017 L 154, p. 1), the provisions governing proceedings before the units and divisions of the EUIPO apply mutatis mutandis to appeal proceedings before the Board of Appeal. That applies to the general provisions provided for in Chapter IX, Section 1 of Regulation 2017/1001, and in particular to Article 95 of that regulation, which provides that the EUIPO is to examine the facts of its own motion, except in proceedings relating to relative grounds for refusal and invalidity proceedings pursuant to Article 59 of that regulation. Likewise, it should be noted that Article 48 of Commission Delegated Regulation (EU) 2018/625 of 5 March 2018 supplementing Regulation (EU) 2017/1001 of the European Parliament and of the Council on the European Union trade mark, and repealing Delegated Regulation (EU) 2017/1430 (OJ 2018 L 104, p. 1) provides that, unless otherwise provided, the provisions relating to proceedings before the instance of the EUIPO which adopted the decision subject to appeal are to be applicable to appeal proceedings mutatis
  mutandis.

mutatis mutandis

mutatis

mutandis

| 97 | By contrast, as regards the ECHA, not only must it be noted that, as was stated in paragraphs 68 to 79 above, the provisions governing the procedure for the adoption of decisions by that agency at first instance are not applicable to appeal proceedings before the Board of Appeal, but it should also be noted that the rules applicable to that board do not contain a provision comparable to Article 48 of Delegated Regulation 2018/625, which provides that the rules of procedure governing the adoption of a decision by the ECHA where the latter rules at first instance are applicable mutatis mutandis to proceedings before that board. |
| --- | --- |

97

By contrast, as regards the ECHA, not only must it be noted that, as was stated in paragraphs 68 to 79 above, the provisions governing the procedure for the adoption of decisions by that agency at first instance are not applicable to appeal proceedings before the Board of Appeal, but it should also be noted that the rules applicable to that board do not contain a provision comparable to Article 48 of Delegated Regulation 2018/625, which provides that the rules of procedure governing the adoption of a decision by the ECHA where the latter rules at first instance are applicable mutatis mutandis to proceedings before that board.

mutatis mutandis

| 98 | Next, it is true that the case-law concerning the Board of Appeal of the EUIPO cited in paragraph 94 above is based in particular on the second sentence of Article 71(1) of Regulation 2017/1001, according to which that board may either exercise any power within the competence of the department which was responsible for the decision appealed or remit the case to that department for further prosecution. According to that case-law, that provision contains an indication not only as to the possible content of a decision of the Board of Appeal of the EUIPO, but also as to the extent of the examination which it must conduct of the decision under appeal (judgment of 23 September 2003, KLEENCARE, T‐308/01, EU:T:2003:241, paragraph 24). |
| --- | --- |

98

Next, it is true that the case-law concerning the Board of Appeal of the EUIPO cited in paragraph 94 above is based in particular on the second sentence of Article 71(1) of Regulation 2017/1001, according to which that board may either exercise any power within the competence of the department which was responsible for the decision appealed or remit the case to that department for further prosecution. According to that case-law, that provision contains an indication not only as to the possible content of a decision of the Board of Appeal of the EUIPO, but also as to the extent of the examination which it must conduct of the decision under appeal (judgment of 23 September 2003, KLEENCARE, T‐308/01, EU:T:2003:241, paragraph 24).

| 99 | However, contrary to what is claimed by the applicant, the mere fact that the wording of the second sentence of Article 71(1) of Regulation 2017/1001 is similar to that of Article 93(3) of Regulation No 1907/2006 does not permit that case-law to be transposed to the Board of Appeal of the ECHA. |
| --- | --- |

99

However, contrary to what is claimed by the applicant, the mere fact that the wording of the second sentence of Article 71(1) of Regulation 2017/1001 is similar to that of Article 93(3) of Regulation No 1907/2006 does not permit that case-law to be transposed to the Board of Appeal of the ECHA.

| 100 | In that context, it should be noted that the second sentence of Article 71(1) of Regulation 2017/1001 is preceded by a first sentence from which it follows that the Board of Appeal of the EUIPO is to exercise the powers provided for in the second sentence of that paragraph ‘following the examination as to the allowability of the appeal’. According to its wording, Article 71(1) of that regulation refers therefore to the question of which powers that board has after having found that an action before it was well founded. |
| --- | --- |

100

In that context, it should be noted that the second sentence of Article 71(1) of Regulation 2017/1001 is preceded by a first sentence from which it follows that the Board of Appeal of the EUIPO is to exercise the powers provided for in the second sentence of that paragraph ‘following the examination as to the allowability of the appeal’. According to its wording, Article 71(1) of that regulation refers therefore to the question of which powers that board has after having found that an action before it was well founded.

| 101 | However, it follows from the regulatory context of Article 71(1) of Regulation 2017/1001 that, in proceedings before the Board of Appeal of the EUIPO, the provisions governing proceedings before the units and divisions of the EUIPO apply (see paragraph 96 above) and that that board is thus required to examine whether a new decision with the same operative part as the decision under appeal before it may be lawfully adopted at the time of the appeal ruling. Therefore, the case-law referred to in paragraph 98 above must be read in the light of the regulatory context of Article 71(1) of Regulation 2017/1001. It cannot therefore be deduced from that case-law that Article 93(3) of Regulation No 1907/2006, which is in a different regulatory context, must be interpreted as determining in itself the scope of the review which must be conducted by the Board of Appeal of the ECHA in the context of the examination of the merits of an action before it. |
| --- | --- |

101

However, it follows from the regulatory context of Article 71(1) of Regulation 2017/1001 that, in proceedings before the Board of Appeal of the EUIPO, the provisions governing proceedings before the units and divisions of the EUIPO apply (see paragraph 96 above) and that that board is thus required to examine whether a new decision with the same operative part as the decision under appeal before it may be lawfully adopted at the time of the appeal ruling. Therefore, the case-law referred to in paragraph 98 above must be read in the light of the regulatory context of Article 71(1) of Regulation 2017/1001. It cannot therefore be deduced from that case-law that Article 93(3) of Regulation No 1907/2006, which is in a different regulatory context, must be interpreted as determining in itself the scope of the review which must be conducted by the Board of Appeal of the ECHA in the context of the examination of the merits of an action before it.

| 102 | Finally, it should be noted that the nature of the tasks of the EUIPO and of the decisions of that office is not comparable to that of the tasks and decisions of the ECHA. As is apparent from recital 27 of Regulation 2017/1001, it is for the EUIPO to take administrative implementation measures at Union level that trade mark law requires for each trade mark. As can be deduced from recitals 40 and 41 of that regulation, those implementation measures imply, in particular, that the EUIPO decides on applications for registration of a European Union trade mark and on cases initiated by third parties to oppose such registration or have it cancelled. As regards the ECHA, it is required, according to recital 15 of Regulation No 1907/2006, to centrally ensure effective management of the technical, administrative and scientific aspects of the system of protection of human health and the environment established by that regulation against risks connected with the manufacture, distribution and use of chemical substances. In particular, it results from recitals 16 to 21 of that regulation that one of the core principles of that system, which is to be implemented by the ECHA, is the obligation for producers and importers of chemical substances to provide all the relevant and available information on the dangers posed by those substances and to promote appropriate risk management measures. It is in the context of those obligations that decisions requesting further information adopted by the ECHA should be considered. |
| --- | --- |

102

Finally, it should be noted that the nature of the tasks of the EUIPO and of the decisions of that office is not comparable to that of the tasks and decisions of the ECHA. As is apparent from recital 27 of Regulation 2017/1001, it is for the EUIPO to take administrative implementation measures at Union level that trade mark law requires for each trade mark. As can be deduced from recitals 40 and 41 of that regulation, those implementation measures imply, in particular, that the EUIPO decides on applications for registration of a European Union trade mark and on cases initiated by third parties to oppose such registration or have it cancelled. As regards the ECHA, it is required, according to recital 15 of Regulation No 1907/2006, to centrally ensure effective management of the technical, administrative and scientific aspects of the system of protection of human health and the environment established by that regulation against risks connected with the manufacture, distribution and use of chemical substances. In particular, it results from recitals 16 to 21 of that regulation that one of the core principles of that system, which is to be implemented by the ECHA, is the obligation for producers and importers of chemical substances to provide all the relevant and available information on the dangers posed by those substances and to promote appropriate risk management measures. It is in the context of those obligations that decisions requesting further information adopted by the ECHA should be considered.

| 103 | In the light of those differences, adequate legal protection against such decisions is not necessarily ensured by making the review thereof by the Board of Appeal of the ECHA subject to the requirements applicable to the review conducted by the Boards of Appeal of the EUIPO. As can be deduced from recital 42 of Regulation 2017/1001, in order to guarantee effective and efficient treatment of applications and disputes to be ruled on by the EUIPO, it can be justified to consider that it is for the Boards of Appeal of that office to re-examine, on their merits, those applications and disputes, substituting, in that regard, the first instance of the EUIPO. By contrast, where an administrative decision imposes obligations on individuals, such as a decision of the ECHA based on Article 46(1) and Article 52 of Regulation No 1907/2006, read in conjunction with Article 51(2) to (8) of that regulation, the legal protection of those individuals vis-à-vis that decision does not justify such a substitution, but merely requires that the Board of Appeal verify whether the decision at issue is vitiated by an error. |
| --- | --- |

103

In the light of those differences, adequate legal protection against such decisions is not necessarily ensured by making the review thereof by the Board of Appeal of the ECHA subject to the requirements applicable to the review conducted by the Boards of Appeal of the EUIPO. As can be deduced from recital 42 of Regulation 2017/1001, in order to guarantee effective and efficient treatment of applications and disputes to be ruled on by the EUIPO, it can be justified to consider that it is for the Boards of Appeal of that office to re-examine, on their merits, those applications and disputes, substituting, in that regard, the first instance of the EUIPO. By contrast, where an administrative decision imposes obligations on individuals, such as a decision of the ECHA based on Article 46(1) and Article 52 of Regulation No 1907/2006, read in conjunction with Article 51(2) to (8) of that regulation, the legal protection of those individuals vis-à-vis that decision does not justify such a substitution, but merely requires that the Board of Appeal verify whether the decision at issue is vitiated by an error.

| 104 | In the second place, it is necessary to reject the applicant’s argument alleging that, under Article 76(1)(h) of Regulation No 1907/2006, the Board of Appeal is an integral part of the ECHA. As is set out in paragraphs 59 to 86 above, the fact that that board is a body of the ECHA and not a body separate from that agency cannot, in itself, prejudge the nature and scope of the examination it is to conduct, regardless of the provisions defining the competences of that body and the rules of procedure applicable to it, of the nature of decisions subject to its review and the objectives of legal protection which it upholds. |
| --- | --- |

104

In the second place, it is necessary to reject the applicant’s argument alleging that, under Article 76(1)(h) of Regulation No 1907/2006, the Board of Appeal is an integral part of the ECHA. As is set out in paragraphs 59 to 86 above, the fact that that board is a body of the ECHA and not a body separate from that agency cannot, in itself, prejudge the nature and scope of the examination it is to conduct, regardless of the provisions defining the competences of that body and the rules of procedure applicable to it, of the nature of decisions subject to its review and the objectives of legal protection which it upholds.

| 105 | In the third place, it is necessary to examine the applicant’s arguments alleging that the Board of Appeal has capacity to investigate allowing it to adopt a decision based on a review on both facts and points of law of questions addressed by the ECHA where that agency rules at first instance. |
| --- | --- |

105

In the third place, it is necessary to examine the applicant’s arguments alleging that the Board of Appeal has capacity to investigate allowing it to adopt a decision based on a review on both facts and points of law of questions addressed by the ECHA where that agency rules at first instance.

| 106 | Firstly, it is necessary to reject the applicant’s argument alleging that the Board of Appeal has the same capacity to investigate as the ECHA where that agency rules at first instance. In that regard, it suffices to note that, as is apparent from paragraphs 59 to 86 above, in the light of the adversarial nature of the proceedings before that board and the fact that, in the context of the examination of the merits of the action before it, the rules of procedure applicable to the ECHA where that agency rules at first instance do not apply, it cannot be concluded that that board has the same capacity to investigate as the ECHA where that agency rules at first instance. |
| --- | --- |

106

Firstly, it is necessary to reject the applicant’s argument alleging that the Board of Appeal has the same capacity to investigate as the ECHA where that agency rules at first instance. In that regard, it suffices to note that, as is apparent from paragraphs 59 to 86 above, in the light of the adversarial nature of the proceedings before that board and the fact that, in the context of the examination of the merits of the action before it, the rules of procedure applicable to the ECHA where that agency rules at first instance do not apply, it cannot be concluded that that board has the same capacity to investigate as the ECHA where that agency rules at first instance.

| 107 | Secondly, the applicant claims that Article 12(1) of Regulation No 771/2008, which permits the Board of Appeal to take account of evidence which was presented for the first time during the appeal proceedings, confirms that that board is required to itself carry out a re-examination of the scientific assessments justifying the request for further information. |
| --- | --- |

107

Secondly, the applicant claims that Article 12(1) of Regulation No 771/2008, which permits the Board of Appeal to take account of evidence which was presented for the first time during the appeal proceedings, confirms that that board is required to itself carry out a re-examination of the scientific assessments justifying the request for further information.

| 108 | That interpretation of Article 12(1) of Regulation No 771/2008 cannot be accepted. |
| --- | --- |

108

That interpretation of Article 12(1) of Regulation No 771/2008 cannot be accepted.

| 109 | Firstly, Article 12(1) of Regulation No 771/2008 must be read in conjunction with Article 6(1)(f) of that regulation. Under Article 6(1)(f) of that regulation, in principle, the nature of any evidence offered and the facts for which the evidence is offered in support must already be included in the notice of appeal. As is apparent from a combined reading of Article 6(1)(f) and Article 12(1) of the regulation at issue, in principle, the parties may not submit further evidence after the first exchange of pleadings. An exception is however provided for the submission of new evidence in respect of which the delay is duly justified. Article 12(1) of that regulation is thus restricted to deciding in which circumstances, in adversarial proceedings before the Board of Appeal, an offer of evidence which was not already in the notice of appeal may still be submitted at a later stage of those proceedings. |
| --- | --- |

109

Firstly, Article 12(1) of Regulation No 771/2008 must be read in conjunction with Article 6(1)(f) of that regulation. Under Article 6(1)(f) of that regulation, in principle, the nature of any evidence offered and the facts for which the evidence is offered in support must already be included in the notice of appeal. As is apparent from a combined reading of Article 6(1)(f) and Article 12(1) of the regulation at issue, in principle, the parties may not submit further evidence after the first exchange of pleadings. An exception is however provided for the submission of new evidence in respect of which the delay is duly justified. Article 12(1) of that regulation is thus restricted to deciding in which circumstances, in adversarial proceedings before the Board of Appeal, an offer of evidence which was not already in the notice of appeal may still be submitted at a later stage of those proceedings.

| 110 | Secondly, it should be pointed out that Article 12(1) of Regulation No 771/2008 cannot be regarded as a rule like Article 95(2) of Regulation 2017/1001 concerning the EUIPO, which provides that that ‘office may disregard facts or evidence which are not submitted in due time by the parties concerned’. |
| --- | --- |

110

Secondly, it should be pointed out that Article 12(1) of Regulation No 771/2008 cannot be regarded as a rule like Article 95(2) of Regulation 2017/1001 concerning the EUIPO, which provides that that ‘office may disregard facts or evidence which are not submitted in due time by the parties concerned’.

| 111 | Article 95(2) of Regulation 2017/1001 is one of the rules of procedure which are applicable not only to the department of the EUIPO ruling at first instance, but also to the board of appeal of that agency. By contrast, Article 12(1) of Regulation No 771/2008 concerns only the procedure before the Board of Appeal, and is limited to specifying the cases in which an offer of evidence not included in the notice of appeal may still be considered to be admissible. |
| --- | --- |

111

Article 95(2) of Regulation 2017/1001 is one of the rules of procedure which are applicable not only to the department of the EUIPO ruling at first instance, but also to the board of appeal of that agency. By contrast, Article 12(1) of Regulation No 771/2008 concerns only the procedure before the Board of Appeal, and is limited to specifying the cases in which an offer of evidence not included in the notice of appeal may still be considered to be admissible.

| 112 | Therefore, in the light of the wording of Article 12(1) of Regulation No 771/2008, and of the context of that provision, contrary to what is claimed by the applicant, it cannot be deduced that the Board of Appeal is required, in an action before it, to re-examine the scientific assessments which justified the request to provide further information. |
| --- | --- |

112

Therefore, in the light of the wording of Article 12(1) of Regulation No 771/2008, and of the context of that provision, contrary to what is claimed by the applicant, it cannot be deduced that the Board of Appeal is required, in an action before it, to re-examine the scientific assessments which justified the request to provide further information.

| 113 | The applicant’s argument relating to Article 12(1) of Regulation No 771/2008 must therefore be rejected. |
| --- | --- |

113

The applicant’s argument relating to Article 12(1) of Regulation No 771/2008 must therefore be rejected.

| 114 | Thirdly, it must be noted that the approach advocated by the applicant, according to which, in an action before it, the Board of Appeal must conduct its own inquiry, is not, in any event, compatible with the provisions of Regulation No 1907/2006 and with the objectives pursued by the provisions of that regulation relating to the evaluation of substances. |
| --- | --- |

114

Thirdly, it must be noted that the approach advocated by the applicant, according to which, in an action before it, the Board of Appeal must conduct its own inquiry, is not, in any event, compatible with the provisions of Regulation No 1907/2006 and with the objectives pursued by the provisions of that regulation relating to the evaluation of substances.

| 115 | As is apparent from paragraphs 81 to 86 above, a decision requesting further information is adopted, in a context of uncertainty about the risks posed by the substance in question, on the basis of a draft prepared by the designated authority of a Member State. As was stated in paragraphs 70 to 76 above, the rules of Regulation No 1907/2006 on the procedure for adopting such an ECHA decision grants a significant role to the competent authorities of the Member States. They seek to involve Member State experts in the decision-making process, in order to make use of the available expertise at Member State level concerning the different scientific questions raised during the evaluation of a substance. Furthermore, as follows from the provisions at issue and from recital 67 of that regulation, the procedure laid down for substance and dossier evaluation is based on the principle that a unanimous agreement within the Member State Committee concerning draft decisions (or an agreement between the Member States and the ECHA) should provide the basis for an efficient system that respects the principle of subsidiarity. In that context, it is useful to note that, under Article 51(7) of that regulation, which is directly applicable to decisions taken for dossier evaluation and is applicable mutatis mutandis to decisions on substance evaluation under Article 52(2) of that regulation, in the absence of such an agreement, the decision on dossier or substance evaluation may not be adopted at ECHA level, but must be adopted by the Commission. |
| --- | --- |

115

As is apparent from paragraphs 81 to 86 above, a decision requesting further information is adopted, in a context of uncertainty about the risks posed by the substance in question, on the basis of a draft prepared by the designated authority of a Member State. As was stated in paragraphs 70 to 76 above, the rules of Regulation No 1907/2006 on the procedure for adopting such an ECHA decision grants a significant role to the competent authorities of the Member States. They seek to involve Member State experts in the decision-making process, in order to make use of the available expertise at Member State level concerning the different scientific questions raised during the evaluation of a substance. Furthermore, as follows from the provisions at issue and from recital 67 of that regulation, the procedure laid down for substance and dossier evaluation is based on the principle that a unanimous agreement within the Member State Committee concerning draft decisions (or an agreement between the Member States and the ECHA) should provide the basis for an efficient system that respects the principle of subsidiarity. In that context, it is useful to note that, under Article 51(7) of that regulation, which is directly applicable to decisions taken for dossier evaluation and is applicable mutatis mutandis to decisions on substance evaluation under Article 52(2) of that regulation, in the absence of such an agreement, the decision on dossier or substance evaluation may not be adopted at ECHA level, but must be adopted by the Commission.

mutatis mutandis

| 116 | The approach advocated by the applicant, which would involve the Board of Appeal itself conducting an examination of the scientific assessments on which a request for further information is based, by carrying out its own investigation, does not take sufficient account of the objectives of that procedure. By contrast, the approach followed by the Board of Appeal, which consists in confining itself, in the context of the examination of the merits of an action before it, to reviewing whether, in the light of the arguments put forward by the applicant, the considerations on which the decision contested before it is based are vitiated by errors, is compatible with those objectives. |
| --- | --- |

116

The approach advocated by the applicant, which would involve the Board of Appeal itself conducting an examination of the scientific assessments on which a request for further information is based, by carrying out its own investigation, does not take sufficient account of the objectives of that procedure. By contrast, the approach followed by the Board of Appeal, which consists in confining itself, in the context of the examination of the merits of an action before it, to reviewing whether, in the light of the arguments put forward by the applicant, the considerations on which the decision contested before it is based are vitiated by errors, is compatible with those objectives.

| 117 | That conclusion is not called into question by the fact that, where the examination of pleas put forward by the applicant in adversarial proceedings provided for by Regulation No 771/2008 shows that an ECHA decision is vitiated by error, under Article 93(3) of Regulation No 1907/2006, it is for the Board of Appeal to decide whether to refer the case to the competent body of that agency or whether it adopts a final decision itself. |
| --- | --- |

117

That conclusion is not called into question by the fact that, where the examination of pleas put forward by the applicant in adversarial proceedings provided for by Regulation No 771/2008 shows that an ECHA decision is vitiated by error, under Article 93(3) of Regulation No 1907/2006, it is for the Board of Appeal to decide whether to refer the case to the competent body of that agency or whether it adopts a final decision itself.

| 118 | In the event that the action before the Board of Appeal is well founded, Article 93(3) of Regulation No 1907/2006 confers a power of discretion on that board. In the exercise of that power, that board must assess whether the evidence it disposes of following the examination of the action allow it to adopt its own decision. Furthermore, it must take into account rules governing the procedure for the adoption of the ECHA decision where that agency rules at first instance. If that procedure grants an important role to certain actors, such as the procedure for the adoption of decisions relating to dossier and substance evaluation provides for the Member States and the Member State Committee, it must examine whether the adoption of a final decision at its level is compatible with the objectives pursued by that regulation or whether respect for the rules governing the procedure before the ECHA, where the latter rules at first instance, and the objectives pursued by those rules requires that the case be referred back to the competent body of that agency. |
| --- | --- |

118

In the event that the action before the Board of Appeal is well founded, Article 93(3) of Regulation No 1907/2006 confers a power of discretion on that board. In the exercise of that power, that board must assess whether the evidence it disposes of following the examination of the action allow it to adopt its own decision. Furthermore, it must take into account rules governing the procedure for the adoption of the ECHA decision where that agency rules at first instance. If that procedure grants an important role to certain actors, such as the procedure for the adoption of decisions relating to dossier and substance evaluation provides for the Member States and the Member State Committee, it must examine whether the adoption of a final decision at its level is compatible with the objectives pursued by that regulation or whether respect for the rules governing the procedure before the ECHA, where the latter rules at first instance, and the objectives pursued by those rules requires that the case be referred back to the competent body of that agency.

| 119 | In view of the above considerations, it is necessary to reject the applicant’s arguments relating to the Board of Appeal’s capacity to investigate. |
| --- | --- |

119

In view of the above considerations, it is necessary to reject the applicant’s arguments relating to the Board of Appeal’s capacity to investigate.

| 120 | In the fourth place, the applicant claims that it follows from the practice of the Board of Appeal that the latter considers itself to be a functional continuation of the ECHA ruling at first instance. In that regard, it suffices to note that the findings set out in paragraphs 59 to 86 above are based directly on the relevant provisions of Regulation No 1907/2006 and of Regulation No 771/2008 and cannot therefore be called into question by the practice of that board. |
| --- | --- |

120

In the fourth place, the applicant claims that it follows from the practice of the Board of Appeal that the latter considers itself to be a functional continuation of the ECHA ruling at first instance. In that regard, it suffices to note that the findings set out in paragraphs 59 to 86 above are based directly on the relevant provisions of Regulation No 1907/2006 and of Regulation No 771/2008 and cannot therefore be called into question by the practice of that board.

| 121 | In the fifth place, the applicant claims that Regulation No 1907/2006 and Regulation No 771/2008 make provision for identical rules for the actions against all of the ECHA decisions mentioned in Article 91(1) of Regulation No 1907/2006. In that regard, it suffices to note, as was stated in paragraph 59 above, that none of the provisions of the abovementioned regulations provides for the obligation to carry out a ‘de novo’ examination of an ECHA decision. In any event, for the reasons set out in paragraphs 81 to 86 above, such an obligation does not exist in relation to decisions requesting further information in the evaluation of a substance. |
| --- | --- |

121

In the fifth place, the applicant claims that Regulation No 1907/2006 and Regulation No 771/2008 make provision for identical rules for the actions against all of the ECHA decisions mentioned in Article 91(1) of Regulation No 1907/2006. In that regard, it suffices to note, as was stated in paragraph 59 above, that none of the provisions of the abovementioned regulations provides for the obligation to carry out a ‘de novo’ examination of an ECHA decision. In any event, for the reasons set out in paragraphs 81 to 86 above, such an obligation does not exist in relation to decisions requesting further information in the evaluation of a substance.

| 122 | In the sixth place, the applicant claims that the objective of an action before the Board of Appeal is not to conduct a limited review of the lawfulness of an ECHA decision identical to that exercised by the Union Courts. |
| --- | --- |

122

In the sixth place, the applicant claims that the objective of an action before the Board of Appeal is not to conduct a limited review of the lawfulness of an ECHA decision identical to that exercised by the Union Courts.

| 123 | That argument must also be rejected as irrelevant. |
| --- | --- |

123

That argument must also be rejected as irrelevant.

| 124 | As was stated in paragraphs 87 to 89 above, as regards the assessment of highly complex scientific and technical facts, the intensity of the review carried out by the Board of Appeal is greater than that of the review carried out by the Union Courts. |
| --- | --- |

124

As was stated in paragraphs 87 to 89 above, as regards the assessment of highly complex scientific and technical facts, the intensity of the review carried out by the Board of Appeal is greater than that of the review carried out by the Union Courts.

| 125 | In the seventh place, the applicant claims that, under Article 91(2) of Regulation No 1907/2006, an action before the Board of Appeal has suspensory effect, like actions before the Board of Appeal of the EUIPO. |
| --- | --- |

125

In the seventh place, the applicant claims that, under Article 91(2) of Regulation No 1907/2006, an action before the Board of Appeal has suspensory effect, like actions before the Board of Appeal of the EUIPO.

| 126 | In the light of the considerations set out in paragraphs 59 to 86 above, the mere fact that actions before the Board of Appeal of ECHA have suspensory effect cannot mean that the Board of Appeal must itself carry out a new examination of the assessments of scientific and technical facts justifying a request for further information. |
| --- | --- |

126

In the light of the considerations set out in paragraphs 59 to 86 above, the mere fact that actions before the Board of Appeal of ECHA have suspensory effect cannot mean that the Board of Appeal must itself carry out a new examination of the assessments of scientific and technical facts justifying a request for further information.

| 127 | By contrast, the suspensory effect of the action before the Board of Appeal militates against such an approach. |
| --- | --- |

127

By contrast, the suspensory effect of the action before the Board of Appeal militates against such an approach.

| 128 | In that context, it should be noted that one of the objectives pursued by Regulation No 1907/2006 is the exclusion or limitation of the manufacture and use of substances which have harmful effects on human health and the environment. The evaluation of a substance seeks therefore to determine whether it is persistent, bioaccumulative or toxic or very persistent or very bioaccumulative. The ECHA decisions requesting further information are thus necessary in order to conduct such an assessment. |
| --- | --- |

128

In that context, it should be noted that one of the objectives pursued by Regulation No 1907/2006 is the exclusion or limitation of the manufacture and use of substances which have harmful effects on human health and the environment. The evaluation of a substance seeks therefore to determine whether it is persistent, bioaccumulative or toxic or very persistent or very bioaccumulative. The ECHA decisions requesting further information are thus necessary in order to conduct such an assessment.

| 129 | If, as the applicant claims, the Board of Appeal should systematically conduct itself a new review of the assessments of scientific and technical facts justifying a request for further information, the length of the procedure before that board would risk being extended, which is likely to delay the establishment of the studies containing the further information which is thus necessary in order to conduct the evaluation of the substance at issue. |
| --- | --- |

129

If, as the applicant claims, the Board of Appeal should systematically conduct itself a new review of the assessments of scientific and technical facts justifying a request for further information, the length of the procedure before that board would risk being extended, which is likely to delay the establishment of the studies containing the further information which is thus necessary in order to conduct the evaluation of the substance at issue.

| 130 | In the light of those considerations, the applicant’s argument relating to the suspensory effect of the action before the Board of Appeal must also be rejected. |
| --- | --- |

130

In the light of those considerations, the applicant’s argument relating to the suspensory effect of the action before the Board of Appeal must also be rejected.

| 131 | Therefore, it is necessary to reject all of the applicant’s arguments seeking to demonstrate that, in paragraph 64 of the contested decision, the Board of Appeal failed to fulfil the task imposed on it in the context of an action against an ECHA decision. |
| --- | --- |

131

Therefore, it is necessary to reject all of the applicant’s arguments seeking to demonstrate that, in paragraph 64 of the contested decision, the Board of Appeal failed to fulfil the task imposed on it in the context of an action against an ECHA decision.

(b)
   
  The arguments alleging that the Board of Appeal did not take into account the evidential weight of the available information

(b)

The arguments alleging that the Board of Appeal did not take into account the evidential weight of the available information

| 132 | In the context of the third part of the second plea in law, the applicant claims that, in paragraph 64 of the contested decision, the Board of Appeal infringed Annex XIII to Regulation No 1907/2006. In that paragraph, that board wrongly considered that the weight of evidence determination of the information available did not apply to the evaluation of a substance. That approach is applicable both to the registration of a substance and the assessment thereof. Therefore, according to the applicant, before requesting the conduct of the persistence test, that board should have examined whether the weight of evidence determination of the information available allowed conclusions to be drawn concerning the risk that Triclosan is persistent. It is only in the event that such an approach did not produce conclusive results that the conduct of a further test could have been requested. The board in question did not carry out such an examination. Moreover, that annex does not indicate that the weight of evidence determination of the information available is required solely of registrants. |
| --- | --- |

132

In the context of the third part of the second plea in law, the applicant claims that, in paragraph 64 of the contested decision, the Board of Appeal infringed Annex XIII to Regulation No 1907/2006. In that paragraph, that board wrongly considered that the weight of evidence determination of the information available did not apply to the evaluation of a substance. That approach is applicable both to the registration of a substance and the assessment thereof. Therefore, according to the applicant, before requesting the conduct of the persistence test, that board should have examined whether the weight of evidence determination of the information available allowed conclusions to be drawn concerning the risk that Triclosan is persistent. It is only in the event that such an approach did not produce conclusive results that the conduct of a further test could have been requested. The board in question did not carry out such an examination. Moreover, that annex does not indicate that the weight of evidence determination of the information available is required solely of registrants.

| 133 | The ECHA and the interveners dispute those arguments. |
| --- | --- |

133

The ECHA and the interveners dispute those arguments.

| 134 | As a first step, it is necessary to reject the arguments put forward by the applicant in so far as they seek to demonstrate that the Board of Appeal should have itself conducted a new examination by itself carrying out a weight of evidence determination of the available information. As has already been stated in paragraphs 55 to 131 above, in the context of an action before it, that board merely examines whether the arguments put forward by the applicant are capable of showing the existence of an error vitiating the decision contested before it. |
| --- | --- |

134

As a first step, it is necessary to reject the arguments put forward by the applicant in so far as they seek to demonstrate that the Board of Appeal should have itself conducted a new examination by itself carrying out a weight of evidence determination of the available information. As has already been stated in paragraphs 55 to 131 above, in the context of an action before it, that board merely examines whether the arguments put forward by the applicant are capable of showing the existence of an error vitiating the decision contested before it.

| 135 | As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review it conducted relating to the ECHA decision. |
| --- | --- |

135

As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review it conducted relating to the ECHA decision.

| 136 | In that regard, in the first place, it should be noted that, in itself, the Board of Appeal’s finding in the first sentence of paragraph 64 of the contested decision, according to which, in application of Annex XI to Regulation No 1907/2006, a weight of evidence approach may be adopted in order to adapt standard information requirements for the registration of a substance, is not incorrect. As is apparent from point 1.2 of that annex, in the context of the registration of a substance, if such an approach allows the existence or absence of a particular dangerous property to be confirmed, further testing on vertebrate animals for the property at issue is to be omitted and further testing not involving vertebrate animals may be omitted. |
| --- | --- |

136

In that regard, in the first place, it should be noted that, in itself, the Board of Appeal’s finding in the first sentence of paragraph 64 of the contested decision, according to which, in application of Annex XI to Regulation No 1907/2006, a weight of evidence approach may be adopted in order to adapt standard information requirements for the registration of a substance, is not incorrect. As is apparent from point 1.2 of that annex, in the context of the registration of a substance, if such an approach allows the existence or absence of a particular dangerous property to be confirmed, further testing on vertebrate animals for the property at issue is to be omitted and further testing not involving vertebrate animals may be omitted.

| 137 | In the second place, in so far as the applicant claims that the Board of Appeal infringed Annex XIII to Regulation No 1907/2006, it must be noted that the second paragraph of that annex merely indicates that a weight of evidence determination based on an expert opinion is to be applied to the identification of persistent, bioaccumulative and toxic substances, and to the identification of very persistent and very bioaccumulative substances. By contrast, no express reference is made to the stage of the evaluation of substances. Therefore, the applicant’s arguments alleging an infringement of that annex must be rejected. |
| --- | --- |

137

In the second place, in so far as the applicant claims that the Board of Appeal infringed Annex XIII to Regulation No 1907/2006, it must be noted that the second paragraph of that annex merely indicates that a weight of evidence determination based on an expert opinion is to be applied to the identification of persistent, bioaccumulative and toxic substances, and to the identification of very persistent and very bioaccumulative substances. By contrast, no express reference is made to the stage of the evaluation of substances. Therefore, the applicant’s arguments alleging an infringement of that annex must be rejected.

| 138 | In the third place, it is necessary to examine the applicant’s arguments claiming that, if a weight of evidence approach to the available information had been applied, it would have been possible to evaluate whether Triclosan was persistent, and that, therefore, the principle of proportionality precluded the ECHA from requesting further information. |
| --- | --- |

138

In the third place, it is necessary to examine the applicant’s arguments claiming that, if a weight of evidence approach to the available information had been applied, it would have been possible to evaluate whether Triclosan was persistent, and that, therefore, the principle of proportionality precluded the ECHA from requesting further information.

| 139 | In that regard, firstly, it should be noted that, in the second sentence of paragraph 64 of the contested decision, the Board of Appeal took care to state that, in the evaluation of a substance, the ECHA was entitled to request further information in addition to the information required in the context of its registration, where, after having taken into account all the relevant information which had been submitted concerning the substance, that agency concluded that that additional information was necessary in order to carry out the evaluation of the substance at issue. By that sentence, it thus noted that the ECHA should take into account all the relevant information in its possession before requesting further information. |
| --- | --- |

139

In that regard, firstly, it should be noted that, in the second sentence of paragraph 64 of the contested decision, the Board of Appeal took care to state that, in the evaluation of a substance, the ECHA was entitled to request further information in addition to the information required in the context of its registration, where, after having taken into account all the relevant information which had been submitted concerning the substance, that agency concluded that that additional information was necessary in order to carry out the evaluation of the substance at issue. By that sentence, it thus noted that the ECHA should take into account all the relevant information in its possession before requesting further information.

| 140 | Secondly, it should be noted that, as has already been stated in paragraphs 59 to 86 above, proceedings before the Board of Appeal are adversarial and the scope of the examination conducted by that board is thus limited by the arguments put forward by the applicant. Therefore, supposing that, at the stage of the evaluation of a substance, the ECHA had been required to take into account the evidential weight of the available information during those proceedings, the applicant would have had to set out the reasons why the application of such an approach would have allowed a conclusion to be drawn concerning the existence or lack thereof of a risk of persistence. |
| --- | --- |

140

Secondly, it should be noted that, as has already been stated in paragraphs 59 to 86 above, proceedings before the Board of Appeal are adversarial and the scope of the examination conducted by that board is thus limited by the arguments put forward by the applicant. Therefore, supposing that, at the stage of the evaluation of a substance, the ECHA had been required to take into account the evidential weight of the available information during those proceedings, the applicant would have had to set out the reasons why the application of such an approach would have allowed a conclusion to be drawn concerning the existence or lack thereof of a risk of persistence.

| 141 | However, in the context of the second plea in the action before the Board of Appeal, the applicant had not put forward detailed arguments to show the existence of errors affecting the ECHA’s findings justifying its conclusion that further information was necessary. That plea alleged principally an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, according to which, in the evaluation of a substance, it is necessary to take into account, in particular, all the relevant information submitted on the substance in question. As was stated in paragraph 52 above, in paragraphs 59 to 61 of the contested decision, the Board of Appeal had responded to that principal argument. In that context, it stated that the ECHA had taken the information at issue into account, but that it had drawn a conclusion different from that drawn by the applicant. |
| --- | --- |

141

However, in the context of the second plea in the action before the Board of Appeal, the applicant had not put forward detailed arguments to show the existence of errors affecting the ECHA’s findings justifying its conclusion that further information was necessary. That plea alleged principally an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, according to which, in the evaluation of a substance, it is necessary to take into account, in particular, all the relevant information submitted on the substance in question. As was stated in paragraph 52 above, in paragraphs 59 to 61 of the contested decision, the Board of Appeal had responded to that principal argument. In that context, it stated that the ECHA had taken the information at issue into account, but that it had drawn a conclusion different from that drawn by the applicant.

| 142 | Admittedly, in the context of the second plea in the action before the Board of Appeal, the applicant also invoked an argument alleging that, if the ECHA had carried out a weight of evidence determination of the available information, it would not have been able to consider it necessary to conduct the persistence test. However, in that context, it should be noted that, as that board stated in paragraphs 57 to 63 of the contested decision, in its decision, the ECHA had comprehensively set out the reasons why it considered that the information invoked by the applicant did not allow it to be concluded that there was no risk of persistence. It must be noted that, in the context of that action, the applicant did not develop arguments seeking to call into question the grounds set out in that decision, but it merely invoked that a weight of evidence determination of the available information should have been carried out. |
| --- | --- |

142

Admittedly, in the context of the second plea in the action before the Board of Appeal, the applicant also invoked an argument alleging that, if the ECHA had carried out a weight of evidence determination of the available information, it would not have been able to consider it necessary to conduct the persistence test. However, in that context, it should be noted that, as that board stated in paragraphs 57 to 63 of the contested decision, in its decision, the ECHA had comprehensively set out the reasons why it considered that the information invoked by the applicant did not allow it to be concluded that there was no risk of persistence. It must be noted that, in the context of that action, the applicant did not develop arguments seeking to call into question the grounds set out in that decision, but it merely invoked that a weight of evidence determination of the available information should have been carried out.

| 143 | In the light of the arguments put forward by the applicant in the action before the Board of Appeal, irrespective of the question whether there is an obligation to apply the weight of evidence approach to the available information in the evaluation of a substance, in any event, that board cannot be criticised for confining itself to noting, in paragraph 64 of the contested decision, that, before adopting a decision requesting further information, the ECHA should take into account all the relevant information in its possession. |
| --- | --- |

143

In the light of the arguments put forward by the applicant in the action before the Board of Appeal, irrespective of the question whether there is an obligation to apply the weight of evidence approach to the available information in the evaluation of a substance, in any event, that board cannot be criticised for confining itself to noting, in paragraph 64 of the contested decision, that, before adopting a decision requesting further information, the ECHA should take into account all the relevant information in its possession.

| 144 | In the fourth place, it is necessary to reject the applicant’s argument alleging that it was not for it to show that, in the light of the available information, a request for further information was not necessary. Firstly, it in no way follows from paragraph 64 of the contested decision that the Board of Appeal considered that, during the procedure leading to the adoption of the ECHA decision, it is for the registrant to show the need for the request for information. Secondly, and in any event, it should be noted that it is apparent from page 5, the second paragraph of point III.I.1 of the ECHA decision that, in the examination of whether further information on the persistence of Triclosan was necessary, that agency carried out the weight of evidence determination of the available information. |
| --- | --- |

144

In the fourth place, it is necessary to reject the applicant’s argument alleging that it was not for it to show that, in the light of the available information, a request for further information was not necessary. Firstly, it in no way follows from paragraph 64 of the contested decision that the Board of Appeal considered that, during the procedure leading to the adoption of the ECHA decision, it is for the registrant to show the need for the request for information. Secondly, and in any event, it should be noted that it is apparent from page 5, the second paragraph of point III.I.1 of the ECHA decision that, in the examination of whether further information on the persistence of Triclosan was necessary, that agency carried out the weight of evidence determination of the available information.

| 145 | Therefore, it is necessary to reject the applicant’s arguments claiming that, in paragraph 64 of the contested decision, the Board of Appeal failed to take into account the evidential weight of the available information. |
| --- | --- |

145

Therefore, it is necessary to reject the applicant’s arguments claiming that, in paragraph 64 of the contested decision, the Board of Appeal failed to take into account the evidential weight of the available information.

(c)
   
  The arguments alleging that the intensity of the review conducted by the Board of Appeal was not sufficient

(c)

The arguments alleging that the intensity of the review conducted by the Board of Appeal was not sufficient

| 146 | In the context of the first part of the first plea, the applicant claims that, in paragraph 64 of the contested decision, the Board of Appeal committed an error by relying on the ECHA concerning the differences of scientific opinion, in so far as the latter properly exercised its discretion. In that paragraph, the Board of Appeal merely verified the absence of manifest errors of assessment on the part of the ECHA. |
| --- | --- |

146

In the context of the first part of the first plea, the applicant claims that, in paragraph 64 of the contested decision, the Board of Appeal committed an error by relying on the ECHA concerning the differences of scientific opinion, in so far as the latter properly exercised its discretion. In that paragraph, the Board of Appeal merely verified the absence of manifest errors of assessment on the part of the ECHA.

| 147 | The ECHA and the interveners dispute those arguments. |
| --- | --- |

147

The ECHA and the interveners dispute those arguments.

| 148 | As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should not have merely examined whether the ECHA decision was vitiated by error, but should have examined itself whether it was necessary to adopt the request to conduct the persistence test, they must be rejected for the same reasons as those set out in paragraphs 55 to 131 above. |
| --- | --- |

148

As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should not have merely examined whether the ECHA decision was vitiated by error, but should have examined itself whether it was necessary to adopt the request to conduct the persistence test, they must be rejected for the same reasons as those set out in paragraphs 55 to 131 above.

| 149 | As a second step, in so far as that argument seeks to demonstrate that, in the second sentence of paragraph 64 of the contested decision, the Board of Appeal unduly limited the intensity of the review that it conducted of the scientific findings in the ECHA decision, it must also be rejected. |
| --- | --- |

149

As a second step, in so far as that argument seeks to demonstrate that, in the second sentence of paragraph 64 of the contested decision, the Board of Appeal unduly limited the intensity of the review that it conducted of the scientific findings in the ECHA decision, it must also be rejected.

| 150 | In the context of the action before the Board of Appeal, the applicant claimed that, if the ECHA had followed an approach based on the weight of evidence determination of the available information, it would not have been able to conclude that it was necessary to request the persistence test to be conducted. |
| --- | --- |

150

In the context of the action before the Board of Appeal, the applicant claimed that, if the ECHA had followed an approach based on the weight of evidence determination of the available information, it would not have been able to conclude that it was necessary to request the persistence test to be conducted.

| 151 | In the second sentence of paragraph 64 of the contested decision, the Board of Appeal set out that, in the evaluation of a substance, further information could be requested in order to clarify potential concerns, on condition that the ECHA correctly exercised its discretion by taking account, in particular, of all of the relevant information which had been submitted in relation to that substance. However, it cannot be deduced from that sentence that that board rejected the applicant’s argument on the ground that that argument was not capable of showing the existence of a manifest error affecting the ECHA decision. As was stated in paragraphs 140 to 143 above, in that sentence, that board did not further examine that argument of the applicant on the ground that it was not sufficiently substantiated. In those circumstances, it cannot be deduced from that sentence that an inappropriate limitation of the intensity of the review conducted by that board led to the rejection of an argument of the applicant. |
| --- | --- |

151

In the second sentence of paragraph 64 of the contested decision, the Board of Appeal set out that, in the evaluation of a substance, further information could be requested in order to clarify potential concerns, on condition that the ECHA correctly exercised its discretion by taking account, in particular, of all of the relevant information which had been submitted in relation to that substance. However, it cannot be deduced from that sentence that that board rejected the applicant’s argument on the ground that that argument was not capable of showing the existence of a manifest error affecting the ECHA decision. As was stated in paragraphs 140 to 143 above, in that sentence, that board did not further examine that argument of the applicant on the ground that it was not sufficiently substantiated. In those circumstances, it cannot be deduced from that sentence that an inappropriate limitation of the intensity of the review conducted by that board led to the rejection of an argument of the applicant.

| 152 | Therefore, the arguments alleging that, in paragraph 64 of the contested decision, the Board of Appeal committed an error by deferring to the ECHA on matters of scientific dispute and by merely verifying the absence of manifest errors of assessment cannot succeed. Therefore, all of the arguments calling into question the considerations on which the Board of Appeal based the rejection of the second plea in the action against the ECHA decision must be rejected. |
| --- | --- |

152

Therefore, the arguments alleging that, in paragraph 64 of the contested decision, the Board of Appeal committed an error by deferring to the ECHA on matters of scientific dispute and by merely verifying the absence of manifest errors of assessment cannot succeed. Therefore, all of the arguments calling into question the considerations on which the Board of Appeal based the rejection of the second plea in the action against the ECHA decision must be rejected.

2.
   
  The arguments calling into question the rejection, by the Board of Appeal, of the first plea in the action before it

2.

The arguments calling into question the rejection, by the Board of Appeal, of the first plea in the action before it

| 153 | In the context of the first plea in the action before the Board of Appeal, the applicant alleged, in particular, an infringement of the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006, according to which the information used for the evaluation of the persistent, bioaccumulative and toxic properties of a substance and for the evaluation of very persistent and very bioaccumulative properties thereof must be based on data obtained under relevant conditions. |
| --- | --- |

153

In the context of the first plea in the action before the Board of Appeal, the applicant alleged, in particular, an infringement of the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006, according to which the information used for the evaluation of the persistent, bioaccumulative and toxic properties of a substance and for the evaluation of very persistent and very bioaccumulative properties thereof must be based on data obtained under relevant conditions.

| 154 | In paragraphs 40 to 51 of the contested decision, the Board of Appeal examined and rejected those arguments. In paragraph 41 of that decision, it stated that, in the light of the applicant’s arguments, it was necessary for it to examine whether the testing conditions described in the ECHA decision, namely the requirement that the testing be conducted in pelagic waters without additional suspended particulate matter, constituted relevant conditions for the purposes of the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006. In paragraphs 42 to 45 of the contested decision, it stated that, according to the findings made in the ECHA decision, Triclosan was present in certain fresh and marine pelagic waters which did not contain large quantities of the suspended particulate matter with which it readily bound, that it was potentially persistent in such waters and that the results of testing in water-sediment systems did not allow a conclusion to be drawn as to the half-life of that substance in pelagic water. In paragraph 46 of that decision, it noted the applicant’s argument alleging that the most significant source of environmental emissions of Triclosan is the direct emission of effluent from water treatment plants into surface water, which may or may not contain high levels of solid matter and sediment. It also stated that, for that reason, the applicant considered that testing in pelagic water without the addition of suspended solids is not conducted under relevant conditions within the meaning of the fourth paragraph of the preamble to that annex. In paragraphs 47 to 50 of that decision, it responded to that argument. Firstly, it noted the definition of persistence and the fact that, under Section 1.1.1 of that annex, the persistence property of a substance depended, in particular, on its degradation in pelagic water. Secondly, it noted that, even if it was indicated in that section that the testing must be conducted in the relevant conditions, that does not mean that it was necessary to limit itself to the most frequent patterns of distribution of a substance in the environment. It noted that the request to conduct the persistence test did not pursue the objective of assessing the behaviour of Triclosan in waters containing a high content of suspended solids or sediment, but its behaviour in the specific environment mentioned in Section 1.1.1 of that annex, which includes fresh and marine pelagic waters, without large amounts of bound residue. In paragraph 51 of that decision, it concluded that, in the light of those considerations, the first plea in the action against the ECHA decision had to be rejected. |
| --- | --- |

154

In paragraphs 40 to 51 of the contested decision, the Board of Appeal examined and rejected those arguments. In paragraph 41 of that decision, it stated that, in the light of the applicant’s arguments, it was necessary for it to examine whether the testing conditions described in the ECHA decision, namely the requirement that the testing be conducted in pelagic waters without additional suspended particulate matter, constituted relevant conditions for the purposes of the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006. In paragraphs 42 to 45 of the contested decision, it stated that, according to the findings made in the ECHA decision, Triclosan was present in certain fresh and marine pelagic waters which did not contain large quantities of the suspended particulate matter with which it readily bound, that it was potentially persistent in such waters and that the results of testing in water-sediment systems did not allow a conclusion to be drawn as to the half-life of that substance in pelagic water. In paragraph 46 of that decision, it noted the applicant’s argument alleging that the most significant source of environmental emissions of Triclosan is the direct emission of effluent from water treatment plants into surface water, which may or may not contain high levels of solid matter and sediment. It also stated that, for that reason, the applicant considered that testing in pelagic water without the addition of suspended solids is not conducted under relevant conditions within the meaning of the fourth paragraph of the preamble to that annex. In paragraphs 47 to 50 of that decision, it responded to that argument. Firstly, it noted the definition of persistence and the fact that, under Section 1.1.1 of that annex, the persistence property of a substance depended, in particular, on its degradation in pelagic water. Secondly, it noted that, even if it was indicated in that section that the testing must be conducted in the relevant conditions, that does not mean that it was necessary to limit itself to the most frequent patterns of distribution of a substance in the environment. It noted that the request to conduct the persistence test did not pursue the objective of assessing the behaviour of Triclosan in waters containing a high content of suspended solids or sediment, but its behaviour in the specific environment mentioned in Section 1.1.1 of that annex, which includes fresh and marine pelagic waters, without large amounts of bound residue. In paragraph 51 of that decision, it concluded that, in the light of those considerations, the first plea in the action against the ECHA decision had to be rejected.

| 155 | The applicant claims that those findings are wrong. In the context of the third part of the second plea, alleging an infringement of the principle of proportionality, it claims that, by requiring that the persistence test be conducted in pelagic water, which is contrary to the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006, the ECHA and the Board of Appeal failed to take account of data which reflected environmentally relevant conditions. The objective of a request for information is to obtain data allowing the environmental risks to be identified and to define appropriate risk management measures. By contrast, the determination in the abstract of an intrinsic property of a substance which has an effect on the possibility of it degrading is not relevant in that context. The most significant source of environmental emissions of Triclosan is the direct emission of effluent from water treatment plants into surface water, which may or may not contain high levels of solid matter and sediment. For that reason, testing in pelagic water without the addition of suspended solids is not conducted under relevant conditions within the meaning of the fourth paragraph of the preamble to that annex. |
| --- | --- |

155

The applicant claims that those findings are wrong. In the context of the third part of the second plea, alleging an infringement of the principle of proportionality, it claims that, by requiring that the persistence test be conducted in pelagic water, which is contrary to the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006, the ECHA and the Board of Appeal failed to take account of data which reflected environmentally relevant conditions. The objective of a request for information is to obtain data allowing the environmental risks to be identified and to define appropriate risk management measures. By contrast, the determination in the abstract of an intrinsic property of a substance which has an effect on the possibility of it degrading is not relevant in that context. The most significant source of environmental emissions of Triclosan is the direct emission of effluent from water treatment plants into surface water, which may or may not contain high levels of solid matter and sediment. For that reason, testing in pelagic water without the addition of suspended solids is not conducted under relevant conditions within the meaning of the fourth paragraph of the preamble to that annex.

| 156 | The ECHA and the interveners dispute those arguments. |
| --- | --- |

156

The ECHA and the interveners dispute those arguments.

| 157 | As a first step, in so far as the applicant’s arguments seek to demonstrate that, in a ‘de novo’ examination of the ECHA decision, the Board of Appeal should itself have applied the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006, they must be rejected for the same reasons as those set out in paragraphs 55 to 131 above. |
| --- | --- |

157

As a first step, in so far as the applicant’s arguments seek to demonstrate that, in a ‘de novo’ examination of the ECHA decision, the Board of Appeal should itself have applied the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006, they must be rejected for the same reasons as those set out in paragraphs 55 to 131 above.

| 158 | As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that, in the context of its review of the ECHA decision, the Board of Appeal misconstrued the scope of the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006. |
| --- | --- |

158

As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that, in the context of its review of the ECHA decision, the Board of Appeal misconstrued the scope of the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006.

| 159 | In that regard, it should be noted that, as is apparent from the first sentence of paragraph 12.2 of Annex II to Regulation 1907/2006, the persistence and degradability of a substance corresponds to its environmental degradation potential, either by biodegradation, or by other processes, such as oxidation or hydrolysis. |
| --- | --- |

159

In that regard, it should be noted that, as is apparent from the first sentence of paragraph 12.2 of Annex II to Regulation 1907/2006, the persistence and degradability of a substance corresponds to its environmental degradation potential, either by biodegradation, or by other processes, such as oxidation or hydrolysis.

| 160 | According to paragraph 1.1.1 of Annex XIII to Regulation No 1907/2006, a substance fulfils the persistence criterion in any of the following situations:





  (a) | the degradation half-life in marine water is higher than 60 days; |
| --- | --- | --- |

160

According to paragraph 1.1.1 of Annex XIII to Regulation No 1907/2006, a substance fulfils the persistence criterion in any of the following situations:

(a)

the degradation half-life in marine water is higher than 60 days;

| (b) | the degradation half-life in fresh or estuarine water is higher than 40 days; |
| --- | --- |

(b)

the degradation half-life in fresh or estuarine water is higher than 40 days;

| (c) | the degradation half-life in marine sediment is higher than 180 days; |
| --- | --- |

(c)

the degradation half-life in marine sediment is higher than 180 days;

| (d) | the degradation half-life in fresh or estuarine water sediment is higher than 120 days; |
| --- | --- |

(d)

the degradation half-life in fresh or estuarine water sediment is higher than 120 days;

| (e) | the degradation half-life in soil is higher than 120 days. |
| --- | --- |

(e)

the degradation half-life in soil is higher than 120 days.

| 161 | It follows that a substance must be considered to be persistent where its half-life in one of the five environments mentioned in paragraph 1.1.1 of Annex XIII to Regulation No 1907/2006 exceeds the duration stated in that paragraph. As is apparent from paragraphs (a) and (b) of that provision, some of those environments consist of fresh waters or of marine pelagic waters. |
| --- | --- |

161

It follows that a substance must be considered to be persistent where its half-life in one of the five environments mentioned in paragraph 1.1.1 of Annex XIII to Regulation No 1907/2006 exceeds the duration stated in that paragraph. As is apparent from paragraphs (a) and (b) of that provision, some of those environments consist of fresh waters or of marine pelagic waters.

| 162 | In that context, it must also be noted that, in the contested decision, the Board of Appeal recalled that, according to statements in the ECHA decision that the applicant had not contested, Triclosan was present in fresh and marine pelagic waters and those environments did not contain a large quantity of suspended particulate matter with which it easily bound. |
| --- | --- |

162

In that context, it must also be noted that, in the contested decision, the Board of Appeal recalled that, according to statements in the ECHA decision that the applicant had not contested, Triclosan was present in fresh and marine pelagic waters and those environments did not contain a large quantity of suspended particulate matter with which it easily bound.

| 163 | In those circumstances, the Board of Appeal did not commit an error, in paragraphs 40 to 51 of the contested decision, when it concluded that the persistence test, which relates to the behaviour of Triclosan in fresh and marine pelagic waters, was conducted in conditions which are appropriate for the purposes of the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006. |
| --- | --- |

163

In those circumstances, the Board of Appeal did not commit an error, in paragraphs 40 to 51 of the contested decision, when it concluded that the persistence test, which relates to the behaviour of Triclosan in fresh and marine pelagic waters, was conducted in conditions which are appropriate for the purposes of the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006.

| 164 | Since a substance must be considered to be persistent if its degradation half-life exceeds the period indicated in one of the five environments mentioned in point 1.1.1 of Annex XIII to Regulation No 1907/2006 (see paragraph 160 above), the examination of the persistence of Triclosan could not be limited to the environment in which the majority of its emissions take place, if there existed information that Triclosan was also present in other relevant environments such as fresh and marine pelagic waters. Therefore, the Board of Appeal was correct to reject the argument alleging that the requirement that the persistence test be conducted in pelagic water was not compatible with the fourth paragraph of the preamble to that annex. |
| --- | --- |

164

Since a substance must be considered to be persistent if its degradation half-life exceeds the period indicated in one of the five environments mentioned in point 1.1.1 of Annex XIII to Regulation No 1907/2006 (see paragraph 160 above), the examination of the persistence of Triclosan could not be limited to the environment in which the majority of its emissions take place, if there existed information that Triclosan was also present in other relevant environments such as fresh and marine pelagic waters. Therefore, the Board of Appeal was correct to reject the argument alleging that the requirement that the persistence test be conducted in pelagic water was not compatible with the fourth paragraph of the preamble to that annex.

| 165 | Therefore, all of the applicant’s arguments calling into question the rejection, by the Board of Appeal, of the first plea in the action against the ECHA decision must be rejected. |
| --- | --- |

165

Therefore, all of the applicant’s arguments calling into question the rejection, by the Board of Appeal, of the first plea in the action against the ECHA decision must be rejected.

3.
   
  The arguments relating to the Canadian authorities’ conclusions

3.

The arguments relating to the Canadian authorities’ conclusions

| 166 | In the context of third part of the second plea, the applicant claims that the ECHA and the Board of Appeal did not take into account the evidence relating to the persistence of Triclosan. On the basis of the available information, the Canadian authorities came to the conclusion that Triclosan did not demonstrate either persistence or bioaccumulation properties. Firstly, the criteria applied by the ECHA and by the Canadian authorities for identifying persistent, bioaccumulative and toxic substances are similar in so far as they pursue the same objective of protecting the environment from adverse effects of such substances. Secondly, the scientific method used by the Canadian authorities is similar to the weight of evidence approach. |
| --- | --- |

166

In the context of third part of the second plea, the applicant claims that the ECHA and the Board of Appeal did not take into account the evidence relating to the persistence of Triclosan. On the basis of the available information, the Canadian authorities came to the conclusion that Triclosan did not demonstrate either persistence or bioaccumulation properties. Firstly, the criteria applied by the ECHA and by the Canadian authorities for identifying persistent, bioaccumulative and toxic substances are similar in so far as they pursue the same objective of protecting the environment from adverse effects of such substances. Secondly, the scientific method used by the Canadian authorities is similar to the weight of evidence approach.

| 167 | The ECHA and the interveners dispute those arguments. |
| --- | --- |

167

The ECHA and the interveners dispute those arguments.

| 168 | As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should have taken account of the Canadian authorities’ conclusions in the ‘de novo’ examination of the ECHA decision that it was required to conduct in the context of the action before it, they should be rejected for the same reasons as those set out in paragraphs 55 to 131 above. |
| --- | --- |

168

As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should have taken account of the Canadian authorities’ conclusions in the ‘de novo’ examination of the ECHA decision that it was required to conduct in the context of the action before it, they should be rejected for the same reasons as those set out in paragraphs 55 to 131 above.

| 169 | As a second step, it is necessary to examine the applicant’s arguments relating to the Canadian authorities’ conclusions in so far as they seek to demonstrate that, in the context of the review conducted by the Board of Appeal of the ECHA decision, that board committed an error. |
| --- | --- |

169

As a second step, it is necessary to examine the applicant’s arguments relating to the Canadian authorities’ conclusions in so far as they seek to demonstrate that, in the context of the review conducted by the Board of Appeal of the ECHA decision, that board committed an error.

| 170 | In the first place, in so far as, by its arguments, the applicant intends to demonstrate that the Board of Appeal should have found that the ECHA had infringed the first sentence of Article 47(1) of Regulation No 1907/2006 or that, in the light of the Canadian authorities’ conclusions, that agency was not entitled to request the persistence test to be conducted, they must be rejected. As was stated in paragraphs 59 to 86 above, the scope of the review conducted by that board depends on the pleas put forward by the applicant. It must be noted that, in the context of the first plea in the action before that board, the applicant did not put forward any pleas relating to the Canadian authorities’ conclusions. |
| --- | --- |

170

In the first place, in so far as, by its arguments, the applicant intends to demonstrate that the Board of Appeal should have found that the ECHA had infringed the first sentence of Article 47(1) of Regulation No 1907/2006 or that, in the light of the Canadian authorities’ conclusions, that agency was not entitled to request the persistence test to be conducted, they must be rejected. As was stated in paragraphs 59 to 86 above, the scope of the review conducted by that board depends on the pleas put forward by the applicant. It must be noted that, in the context of the first plea in the action before that board, the applicant did not put forward any pleas relating to the Canadian authorities’ conclusions.

| 171 | In the second place, in so far as, by its arguments, the applicant claims that the Canadian authorities’ conclusions demonstrate that the Board of Appeal’s findings are vitiated by error, it should be noted that the applicant merely invokes the existence of those conclusions, but does not state the reasons why those conclusions are capable of calling into question the lawfulness of that board’s findings, which are based on the rules provided for by Regulation No 1907/2006. Therefore, such arguments must be rejected as not sufficiently substantiated. |
| --- | --- |

171

In the second place, in so far as, by its arguments, the applicant claims that the Canadian authorities’ conclusions demonstrate that the Board of Appeal’s findings are vitiated by error, it should be noted that the applicant merely invokes the existence of those conclusions, but does not state the reasons why those conclusions are capable of calling into question the lawfulness of that board’s findings, which are based on the rules provided for by Regulation No 1907/2006. Therefore, such arguments must be rejected as not sufficiently substantiated.

| 172 | Therefore, it is also necessary to reject the applicant’s arguments relating to the Canadian authorities’ conclusions and, therefore, the entirety of the arguments concerning the dismissal of the action before the Board of Appeal in so far as it related to the request to conduct the persistence test. |
| --- | --- |

172

Therefore, it is also necessary to reject the applicant’s arguments relating to the Canadian authorities’ conclusions and, therefore, the entirety of the arguments concerning the dismissal of the action before the Board of Appeal in so far as it related to the request to conduct the persistence test.

B. The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the enhanced neurotoxicity rat study

B.

The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the enhanced neurotoxicity rat study

| 173 | In its decision, the ECHA requested the applicant to conduct the enhanced neurotoxicity rat study. According to the considerations in that decision, that request to provide further information is justified by the fact that there were concerns concerning the potential risk of Triclosan being neurotoxic and reproductive toxic and that it was not possible to dispense with them or confirm them on the basis of available information. |
| --- | --- |

173

In its decision, the ECHA requested the applicant to conduct the enhanced neurotoxicity rat study. According to the considerations in that decision, that request to provide further information is justified by the fact that there were concerns concerning the potential risk of Triclosan being neurotoxic and reproductive toxic and that it was not possible to dispense with them or confirm them on the basis of available information.

| 174 | In the context of the action against the ECHA decision before the Board of Appeal, the applicant claimed that there should have been no request to conduct that study. In that regard, it put forward four pleas, namely, the sixth plea alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, the seventh plea alleging an infringement of Article 25 of that regulation, the eighth plea alleging a breach of the principle of proportionality, and the ninth plea alleging an infringement of Article 130 of that regulation. |
| --- | --- |

174

In the context of the action against the ECHA decision before the Board of Appeal, the applicant claimed that there should have been no request to conduct that study. In that regard, it put forward four pleas, namely, the sixth plea alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, the seventh plea alleging an infringement of Article 25 of that regulation, the eighth plea alleging a breach of the principle of proportionality, and the ninth plea alleging an infringement of Article 130 of that regulation.

| 175 | In the contested decision, the Board of Appeal examined those arguments. It examined questions of admissibility (paragraphs 117 to 131). It made several introductory remarks (paragraphs 132 to 136). It examined and rejected the seventh and eighth pleas (paragraphs 137 to 168), the sixth plea (paragraphs 169 to 203) and the ninth plea (paragraphs 204 to 220). |
| --- | --- |

175

In the contested decision, the Board of Appeal examined those arguments. It examined questions of admissibility (paragraphs 117 to 131). It made several introductory remarks (paragraphs 132 to 136). It examined and rejected the seventh and eighth pleas (paragraphs 137 to 168), the sixth plea (paragraphs 169 to 203) and the ninth plea (paragraphs 204 to 220).

| 176 | In the context of the present action, the applicant claims that certain of the considerations that the Board of Appeal advanced in those parts of the contested decision are incorrect. As a first step, the arguments relating to the rejection of the sixth plea in the action against the ECHA decision will be analysed. Those arguments allege an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006. As a second step, the arguments relating to the rejection of the seventh and eighth pleas of that action will be examined. Those arguments allege an infringement of Article 25 of that regulation and of the principle of proportionality. As a third step, the arguments calling into question that board’s findings relating to issues of admissibility will be assessed. As a fourth step, the arguments calling into question that board’s introductory comments will be analysed. |
| --- | --- |

176

In the context of the present action, the applicant claims that certain of the considerations that the Board of Appeal advanced in those parts of the contested decision are incorrect. As a first step, the arguments relating to the rejection of the sixth plea in the action against the ECHA decision will be analysed. Those arguments allege an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006. As a second step, the arguments relating to the rejection of the seventh and eighth pleas of that action will be examined. Those arguments allege an infringement of Article 25 of that regulation and of the principle of proportionality. As a third step, the arguments calling into question that board’s findings relating to issues of admissibility will be assessed. As a fourth step, the arguments calling into question that board’s introductory comments will be analysed.

1.
   
  The arguments calling into question the rejection, by the Board of Appeal, of the sixth plea in the action before it

1.

The arguments calling into question the rejection, by the Board of Appeal, of the sixth plea in the action before it

| 177 | The sixth plea in the action against the ECHA decision alleged an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006. That plea was divided into two parts. The first part, which called into question the request to conduct a neurotoxicity study in its entirety, was examined and rejected by the Board of Appeal in paragraphs 186 to 199 of the contested decision. The second part, which sought more specifically to call into question the requirement to provide further evidence, namely the one-generation reproductive toxicity study, was examined and rejected by that board in paragraphs 200 to 203 of that decision. |
| --- | --- |

177

The sixth plea in the action against the ECHA decision alleged an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006. That plea was divided into two parts. The first part, which called into question the request to conduct a neurotoxicity study in its entirety, was examined and rejected by the Board of Appeal in paragraphs 186 to 199 of the contested decision. The second part, which sought more specifically to call into question the requirement to provide further evidence, namely the one-generation reproductive toxicity study, was examined and rejected by that board in paragraphs 200 to 203 of that decision.

| 178 | The applicant considers that the Board of Appeal committed errors in the context of the examination of the two parts of the sixth plea in the action against the ECHA decision. |
| --- | --- |

178

The applicant considers that the Board of Appeal committed errors in the context of the examination of the two parts of the sixth plea in the action against the ECHA decision.

(a)
   
  The arguments calling into question the considerations on which the Board of Appeal based the rejection of the first part of the sixth plea in the action before it

(a)

The arguments calling into question the considerations on which the Board of Appeal based the rejection of the first part of the sixth plea in the action before it

| 179 | The first part of the sixth plea in the action before the Board of Appeal concerned the findings of the ECHA justifying the request to conduct the neurotoxicity study in accordance with the OECD TG 426 method. In the context of that part, the applicant alleges, in particular, an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, on the ground that account had not been taken of all the relevant information concerning Triclosan. That part was structured around several complaints. The first alleged that the rat studies were not relevant and the second that, as regards the effects of Triclosan on the thyroid functions of humans, in particular, account had not been taken of the Allmyr, Cullinan and Koeppe studies or of the Witorsch report. |
| --- | --- |

179

The first part of the sixth plea in the action before the Board of Appeal concerned the findings of the ECHA justifying the request to conduct the neurotoxicity study in accordance with the OECD TG 426 method. In the context of that part, the applicant alleges, in particular, an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, on the ground that account had not been taken of all the relevant information concerning Triclosan. That part was structured around several complaints. The first alleged that the rat studies were not relevant and the second that, as regards the effects of Triclosan on the thyroid functions of humans, in particular, account had not been taken of the Allmyr, Cullinan and Koeppe studies or of the Witorsch report.

| 180 | In paragraphs 187 to 199 of the contested decision, the Board of Appeal examined the first part of the sixth plea in the action against the ECHA decision. |
| --- | --- |

180

In paragraphs 187 to 199 of the contested decision, the Board of Appeal examined the first part of the sixth plea in the action against the ECHA decision.

| 181 | In that context, in paragraph 187 of the contested decision, the Board of Appeal stated that the first complaint alleging the lack of relevance of the rat studies and certain of the arguments put forward in the context of the sixth plea in the action before it overlapped and that account was taken thereof in the context of the examination of the sixth plea. |
| --- | --- |

181

In that context, in paragraph 187 of the contested decision, the Board of Appeal stated that the first complaint alleging the lack of relevance of the rat studies and certain of the arguments put forward in the context of the sixth plea in the action before it overlapped and that account was taken thereof in the context of the examination of the sixth plea.

| 182 | In paragraphs 188 to 193 of the contested decision, the Board of Appeal rejected the arguments relating to the Allmyr, Cullinan and Koeppe studies and the Witorsch report that the applicant had developed in the context of the second complaint. |
| --- | --- |

182

In paragraphs 188 to 193 of the contested decision, the Board of Appeal rejected the arguments relating to the Allmyr, Cullinan and Koeppe studies and the Witorsch report that the applicant had developed in the context of the second complaint.

| 183 | In the context of the present action, the applicant puts forward arguments calling into question, firstly, the Board of Appeal’s findings concerning the Allmyr, Cullinan and Koeppe studies and, secondly, its considerations concerning the Witorsch report. |
| --- | --- |

183

In the context of the present action, the applicant puts forward arguments calling into question, firstly, the Board of Appeal’s findings concerning the Allmyr, Cullinan and Koeppe studies and, secondly, its considerations concerning the Witorsch report.

(1) The arguments relating to the Board of Appeal’s findings concerning the Allmyr, Cullinan and Koeppe studies

(1)

The arguments relating to the Board of Appeal’s findings concerning the Allmyr, Cullinan and Koeppe studies

| 184 | In paragraph 188 of the contested decision, the Board of Appeal rejected the applicant’s argument alleging that, during the adoption of the ECHA decision, the Allmyr, Cullinan and Koeppe studies had not been taken into account, which, according to it, demonstrate that, at the relevant doses, Triclosan does not affect humans. In that regard, the Board of Appeal noted that those studies were included in the bibliography attached to the studies which was annexed to that decision, which had stated that those studies had been taken into account. By referring to its comments set out in paragraph 135 of the contested decision, the Board of Appeal stated that, in those circumstances, it should be considered that those studies had been taken into account during the adoption of the ECHA decision. In paragraph 135 of the contested decision, it had stated in particular that the ECHA was not required due to its obligation to state reasons to address, in a decision requesting further information in the context of the evaluation of a substance, every point contained in all existing or submitted studies and that, therefore, it should be considered that the ECHA had taken into account the studies mentioned in the bibliography annexed to its decision. |
| --- | --- |

184

In paragraph 188 of the contested decision, the Board of Appeal rejected the applicant’s argument alleging that, during the adoption of the ECHA decision, the Allmyr, Cullinan and Koeppe studies had not been taken into account, which, according to it, demonstrate that, at the relevant doses, Triclosan does not affect humans. In that regard, the Board of Appeal noted that those studies were included in the bibliography attached to the studies which was annexed to that decision, which had stated that those studies had been taken into account. By referring to its comments set out in paragraph 135 of the contested decision, the Board of Appeal stated that, in those circumstances, it should be considered that those studies had been taken into account during the adoption of the ECHA decision. In paragraph 135 of the contested decision, it had stated in particular that the ECHA was not required due to its obligation to state reasons to address, in a decision requesting further information in the context of the evaluation of a substance, every point contained in all existing or submitted studies and that, therefore, it should be considered that the ECHA had taken into account the studies mentioned in the bibliography annexed to its decision.

| 185 | The applicant claims that the Board of Appeal’s findings developed in paragraphs 135 and 188 of the contested decision are incorrect. According to it, that board should not have confined itself to holding that the scientific studies providing data on Triclosan exposure in humans were included in the bibliography annexed to the ECHA decision. The applicant claims that that board was not entitled to merely assume that the data indicated in those studies had been taken into account or to reject its argument that Triclosan did not have effects on human health at the doses required in the enhanced neurotoxicity rat study, by relying on that sole ground. |
| --- | --- |

185

The applicant claims that the Board of Appeal’s findings developed in paragraphs 135 and 188 of the contested decision are incorrect. According to it, that board should not have confined itself to holding that the scientific studies providing data on Triclosan exposure in humans were included in the bibliography annexed to the ECHA decision. The applicant claims that that board was not entitled to merely assume that the data indicated in those studies had been taken into account or to reject its argument that Triclosan did not have effects on human health at the doses required in the enhanced neurotoxicity rat study, by relying on that sole ground.

| 186 | The ECHA and the interveners dispute that argument. |
| --- | --- |

186

The ECHA and the interveners dispute that argument.

| 187 | As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should not have confined itself to examining whether the ECHA decision was vitiated by error, but should have examined itself whether, in the light of the information contained in the Allmyr, Cullinan and Koeppe studies, it was necessary to request a neurotoxicity rat study to be conducted, those arguments should be rejected for the same reasons as those set out in paragraphs 55 to 131 above. |
| --- | --- |

187

As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should not have confined itself to examining whether the ECHA decision was vitiated by error, but should have examined itself whether, in the light of the information contained in the Allmyr, Cullinan and Koeppe studies, it was necessary to request a neurotoxicity rat study to be conducted, those arguments should be rejected for the same reasons as those set out in paragraphs 55 to 131 above.

| 188 | As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision carried out by it. |
| --- | --- |

188

As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision carried out by it.

| 189 | Firstly, it is necessary to reject the applicant’s argument claiming that, in paragraph 188 of the contested decision, the Board of Appeal should have examined its argument according to which Triclosan had no effects on human health at the doses required in the enhanced neurotoxicity rat study. In that regard, it suffices to note that, as is clearly apparent from paragraph 187 of the contested decision (see paragraph 181 above), the Board of Appeal examined that argument in the context of the examination of the sixth plea in the action, since that argument and those put forward in the context of the sixth plea overlapped. |
| --- | --- |

189

Firstly, it is necessary to reject the applicant’s argument claiming that, in paragraph 188 of the contested decision, the Board of Appeal should have examined its argument according to which Triclosan had no effects on human health at the doses required in the enhanced neurotoxicity rat study. In that regard, it suffices to note that, as is clearly apparent from paragraph 187 of the contested decision (see paragraph 181 above), the Board of Appeal examined that argument in the context of the examination of the sixth plea in the action, since that argument and those put forward in the context of the sixth plea overlapped.

| 190 | Secondly, the applicant claims that the Board of Appeal infringed the first sentence of Article 47(1) of Regulation No 1907/2006. According to it, that board could not confine itself to finding, in paragraph 188 of the contested decision, that the Allmyr, Cullinan and Koeppe studies were mentioned in the bibliography annexed to the ECHA decision. |
| --- | --- |

190

Secondly, the applicant claims that the Board of Appeal infringed the first sentence of Article 47(1) of Regulation No 1907/2006. According to it, that board could not confine itself to finding, in paragraph 188 of the contested decision, that the Allmyr, Cullinan and Koeppe studies were mentioned in the bibliography annexed to the ECHA decision.

| 191 | In that regard, it should be noted that, in the context of the action before it, it was for the Board of Appeal to review whether, in the course of the procedure leading to the adoption of the ECHA decision, account had been taken of all of the relevant information which had been communicated concerning Triclosan. |
| --- | --- |

191

In that regard, it should be noted that, in the context of the action before it, it was for the Board of Appeal to review whether, in the course of the procedure leading to the adoption of the ECHA decision, account had been taken of all of the relevant information which had been communicated concerning Triclosan.

| 192 | Firstly, it should be noted that the Board of Appeal did not commit an error, in paragraph 135 of the contested decision, where it found that the ECHA had not failed to satisfy the obligation to state reasons by not addressing in its decision each point contained in all the existing or submitted studies. In any event, on page 20 of its decision, the ECHA took account of the Allmyr and Cullinan studies. |
| --- | --- |

192

Firstly, it should be noted that the Board of Appeal did not commit an error, in paragraph 135 of the contested decision, where it found that the ECHA had not failed to satisfy the obligation to state reasons by not addressing in its decision each point contained in all the existing or submitted studies. In any event, on page 20 of its decision, the ECHA took account of the Allmyr and Cullinan studies.

| 193 | Secondly, it must be noted that the arguments put forward by the applicant in the action before the Board of Appeal in support of its complaint alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006 was not adequately substantiated. In support of the complaint that account was not taken of the Allmyr, Cullinan and Koeppe studies during the procedure which led to the adoption of the ECHA decision, the applicant merely claimed that, if account had been taken of those studies, it could not have been concluded that it was necessary to provide further information about a risk that Triclosan is neurotoxic. As the Board of Appeal has already indicated in another context, in paragraph 61 of the contested decision, the mere fact that the ECHA reached a different conclusion than the applicant was not capable of demonstrating that the contents of certain studies had not been taken into account. That could also result from the fact that, on the basis of the same information, the ECHA reached a different conclusion than that reached by the applicant. In those circumstances, it cannot be complained that the Board of Appeal merely noted, in paragraph 188 of the contested decision, that the Allmyr, Cullinan and Koeppe studies were mentioned in the bibliography annexed to the ECHA decision. |
| --- | --- |

193

Secondly, it must be noted that the arguments put forward by the applicant in the action before the Board of Appeal in support of its complaint alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006 was not adequately substantiated. In support of the complaint that account was not taken of the Allmyr, Cullinan and Koeppe studies during the procedure which led to the adoption of the ECHA decision, the applicant merely claimed that, if account had been taken of those studies, it could not have been concluded that it was necessary to provide further information about a risk that Triclosan is neurotoxic. As the Board of Appeal has already indicated in another context, in paragraph 61 of the contested decision, the mere fact that the ECHA reached a different conclusion than the applicant was not capable of demonstrating that the contents of certain studies had not been taken into account. That could also result from the fact that, on the basis of the same information, the ECHA reached a different conclusion than that reached by the applicant. In those circumstances, it cannot be complained that the Board of Appeal merely noted, in paragraph 188 of the contested decision, that the Allmyr, Cullinan and Koeppe studies were mentioned in the bibliography annexed to the ECHA decision.

| 194 | Therefore, the complaint alleging that the Board of Appeal infringed the first sentence of Article 47(1) of Regulation No 1907/2006 by failing to adequately respond to the arguments relating to the Allmyr, Cullinan and Koeppe studies must be rejected. |
| --- | --- |

194

Therefore, the complaint alleging that the Board of Appeal infringed the first sentence of Article 47(1) of Regulation No 1907/2006 by failing to adequately respond to the arguments relating to the Allmyr, Cullinan and Koeppe studies must be rejected.

| 195 | Therefore, the arguments relating to the Allmyr, Cullinan and Koeppe studies and seeking to demonstrate that, in paragraphs 135 and 188 of the contested decision, the Board of Appeal committed an error, must be rejected in their entirety. |
| --- | --- |

195

Therefore, the arguments relating to the Allmyr, Cullinan and Koeppe studies and seeking to demonstrate that, in paragraphs 135 and 188 of the contested decision, the Board of Appeal committed an error, must be rejected in their entirety.

(2) The arguments relating to the Board of Appeal’s findings concerning the Witorsch report

(2)

The arguments relating to the Board of Appeal’s findings concerning the Witorsch report

| 196 | In paragraphs 189 to 191 of the contested decision, the Board of Appeal ruled on the applicant’s arguments alleging that, during the procedure which led to the adoption of the ECHA decision, account had not been taken of the Witorsch report. In those paragraphs, it relied, in essence, on three considerations. In the first place, in paragraph 190 of the contested decision, it relied on the consideration that that report had not been submitted in the action before it and that, for that reason, it had been unable to evaluate its relevance. In the second place, in paragraph 189 and the first sentence of paragraph 191 of the contested decision, it relied on the consideration that the report at issue was not available during the evaluation of Triclosan and that it could thus not be complained that the ECHA failed to take it into account. In the third place, in the second to fourth sentences of paragraph 191 of the contested decision, it notes that the applicant did not claim that that report was such as to dispel the concerns identified by the ECHA. |
| --- | --- |

196

In paragraphs 189 to 191 of the contested decision, the Board of Appeal ruled on the applicant’s arguments alleging that, during the procedure which led to the adoption of the ECHA decision, account had not been taken of the Witorsch report. In those paragraphs, it relied, in essence, on three considerations. In the first place, in paragraph 190 of the contested decision, it relied on the consideration that that report had not been submitted in the action before it and that, for that reason, it had been unable to evaluate its relevance. In the second place, in paragraph 189 and the first sentence of paragraph 191 of the contested decision, it relied on the consideration that the report at issue was not available during the evaluation of Triclosan and that it could thus not be complained that the ECHA failed to take it into account. In the third place, in the second to fourth sentences of paragraph 191 of the contested decision, it notes that the applicant did not claim that that report was such as to dispel the concerns identified by the ECHA.

| 197 | The applicant claims that the Board of Appeal’s findings concerning the Witorsch report are vitiated by errors. The Board of Appeal’s finding that that report had not been presented as evidence in the notice of appeal or subsequently is incorrect. That report was already published in a scientific journal and it was relevant. The Canadian authorities directly relied on that report in order to conclude that the available information did not allow Triclosan to be identified as a concern for human health. By failing to take it into account, that board thus infringed the first sentence of Article 47(1) of Regulation No 1907/2006. |
| --- | --- |

197

The applicant claims that the Board of Appeal’s findings concerning the Witorsch report are vitiated by errors. The Board of Appeal’s finding that that report had not been presented as evidence in the notice of appeal or subsequently is incorrect. That report was already published in a scientific journal and it was relevant. The Canadian authorities directly relied on that report in order to conclude that the available information did not allow Triclosan to be identified as a concern for human health. By failing to take it into account, that board thus infringed the first sentence of Article 47(1) of Regulation No 1907/2006.

| 198 | As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should not have confined itself to examining whether the ECHA decision was vitiated by error, but should have conducted a ‘de novo’ examination of that decision in the context of which the Witorsch report should be taken into account, they must be rejected, for the same reasons as those set out in paragraphs 55 to 131 above. |
| --- | --- |

198

As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should not have confined itself to examining whether the ECHA decision was vitiated by error, but should have conducted a ‘de novo’ examination of that decision in the context of which the Witorsch report should be taken into account, they must be rejected, for the same reasons as those set out in paragraphs 55 to 131 above.

| 199 | As regards the argument alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, it should be pointed out that, in the context of the action before it, the Board of Appeal is not required to carry out a new evaluation of the substance at issue and that that provision is therefore not directly applicable to it. By contrast, in the context of the review conducted by the Board of Appeal of the ECHA decisions where that agency rules at first instance, when the applicant has put forward an argument alleging an infringement of that provision, it is for that board to review whether, during the procedure that led to the adoption of the decision contested before it, that provision was complied with. |
| --- | --- |

199

As regards the argument alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, it should be pointed out that, in the context of the action before it, the Board of Appeal is not required to carry out a new evaluation of the substance at issue and that that provision is therefore not directly applicable to it. By contrast, in the context of the review conducted by the Board of Appeal of the ECHA decisions where that agency rules at first instance, when the applicant has put forward an argument alleging an infringement of that provision, it is for that board to review whether, during the procedure that led to the adoption of the decision contested before it, that provision was complied with.

| 200 | As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision. |
| --- | --- |

200

As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision.

| 201 | In the first place, in so far as, by its arguments, the applicant claims that, during the procedure which led to the adoption of the ECHA decision, the first sentence of Article 47(1) of Regulation No 1907/2006 was infringed due to the fact that the Witorsch report was not taken into account, it is necessary to reject that argument. In that regard, it suffices to note that, as the Board of Appeal stated in paragraph 189 and the first sentence of paragraph 191 of the contested decision, that report was not available during that procedure. Therefore, as that board correctly concluded, any infringement of the first sentence of Article 47(1) of Regulation No 1907/2006 is excluded in that regard. |
| --- | --- |

201

In the first place, in so far as, by its arguments, the applicant claims that, during the procedure which led to the adoption of the ECHA decision, the first sentence of Article 47(1) of Regulation No 1907/2006 was infringed due to the fact that the Witorsch report was not taken into account, it is necessary to reject that argument. In that regard, it suffices to note that, as the Board of Appeal stated in paragraph 189 and the first sentence of paragraph 191 of the contested decision, that report was not available during that procedure. Therefore, as that board correctly concluded, any infringement of the first sentence of Article 47(1) of Regulation No 1907/2006 is excluded in that regard.

| 202 | In the second place, in so far as, by its arguments, the applicant claims that, in the context of its review of the ECHA decision, the Board of Appeal should have taken the Witorsch report into account, it should be noted that, as is apparent from Articles 6(1)(f) and 12(1) of Regulation No 771/2008, it was for the applicant to submit that report during the adversarial proceedings before that board. However, as the latter noted in paragraph 190 of the contested decision, the applicant did not do so. |
| --- | --- |

202

In the second place, in so far as, by its arguments, the applicant claims that, in the context of its review of the ECHA decision, the Board of Appeal should have taken the Witorsch report into account, it should be noted that, as is apparent from Articles 6(1)(f) and 12(1) of Regulation No 771/2008, it was for the applicant to submit that report during the adversarial proceedings before that board. However, as the latter noted in paragraph 190 of the contested decision, the applicant did not do so.

| 203 | Moreover, the mere fact that the Canadian authorities relied on the Witorsch report in order to conclude that, on the basis of existing data on rats, Triclosan could not be identified as a concern for human health, could not call into question the merits of the Board of Appeal’s findings with regard to the arguments relating to that report. |
| --- | --- |

203

Moreover, the mere fact that the Canadian authorities relied on the Witorsch report in order to conclude that, on the basis of existing data on rats, Triclosan could not be identified as a concern for human health, could not call into question the merits of the Board of Appeal’s findings with regard to the arguments relating to that report.

| 204 | In the light of those considerations, it must be concluded that the applicant’s arguments relating to the Witorsch report are not capable of demonstrating that, in paragraphs 189 to 191 of the contested decision, the Board of Appeal committed an error. |
| --- | --- |

204

In the light of those considerations, it must be concluded that the applicant’s arguments relating to the Witorsch report are not capable of demonstrating that, in paragraphs 189 to 191 of the contested decision, the Board of Appeal committed an error.

| 205 | Therefore, it is necessary to reject the entirety of the arguments calling into question the considerations on which the Board of Appeal based the rejection of the first part of the sixth plea in the action before it. |
| --- | --- |

205

Therefore, it is necessary to reject the entirety of the arguments calling into question the considerations on which the Board of Appeal based the rejection of the first part of the sixth plea in the action before it.

(b)
   
  The arguments calling into question the consideration on which the Board of Appeal based the rejection of the second part of the sixth plea in the action before it

(b)

The arguments calling into question the consideration on which the Board of Appeal based the rejection of the second part of the sixth plea in the action before it

| 206 | In the context of the second part of the sixth plea in the action before the Board of Appeal, the applicant put forward arguments relating to the considerations on which the ECHA had based its request to conduct a neurotoxicity rat study enhanced by the relevant evidence from the one-generation reproductive toxicity study, in accordance with OECD guidelines 443. In that context, firstly, it claimed that the ECHA decision had been adopted in breach of Article 47 of Regulation No 1907/2006, since account was not taken of the Ciba-Geigy (1983), Ciba-Geigy (1986) and Ciba-Geigy (1994) studies. In support of that claim, it maintained that the finding of the designated authority included in that decision, according to which there were no results on the weight or morphology of male reproductive organs in the registration dossier was incorrect. Those studies included such results. Secondly, it claimed that no weight of evidence determination of the available information had been carried out. |
| --- | --- |

206

In the context of the second part of the sixth plea in the action before the Board of Appeal, the applicant put forward arguments relating to the considerations on which the ECHA had based its request to conduct a neurotoxicity rat study enhanced by the relevant evidence from the one-generation reproductive toxicity study, in accordance with OECD guidelines 443. In that context, firstly, it claimed that the ECHA decision had been adopted in breach of Article 47 of Regulation No 1907/2006, since account was not taken of the Ciba-Geigy (1983), Ciba-Geigy (1986) and Ciba-Geigy (1994) studies. In support of that claim, it maintained that the finding of the designated authority included in that decision, according to which there were no results on the weight or morphology of male reproductive organs in the registration dossier was incorrect. Those studies included such results. Secondly, it claimed that no weight of evidence determination of the available information had been carried out.

| 207 | In paragraphs 201 to 203 of the contested decision, the Board of Appeal examined and rejected those arguments. |
| --- | --- |

207

In paragraphs 201 to 203 of the contested decision, the Board of Appeal examined and rejected those arguments.

| 208 | In the second sentence of paragraph 201 of the contested decision, the Board of Appeal noted that the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies were listed in the bibliography of that decision. In the third sentence of that paragraph, it stated that the Ciba-Geigy (1994) study had been mentioned ‘in passing’ in the arguments advanced by the applicant in support of the action before it, but that that study did not appear in the list of studies submitted during the evaluation of the substance which was annexed to that decision. In the fourth and fifth sentences of that paragraph, it noted that none of those studies had been filed during the course of the appeal proceedings. Therefore, it would have been impossible for it to determine whether those studies were relevant for the evaluation of Triclosan for the purposes of the first sentence of Article 47(1) of Regulation No 1907/2006. |
| --- | --- |

208

In the second sentence of paragraph 201 of the contested decision, the Board of Appeal noted that the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies were listed in the bibliography of that decision. In the third sentence of that paragraph, it stated that the Ciba-Geigy (1994) study had been mentioned ‘in passing’ in the arguments advanced by the applicant in support of the action before it, but that that study did not appear in the list of studies submitted during the evaluation of the substance which was annexed to that decision. In the fourth and fifth sentences of that paragraph, it noted that none of those studies had been filed during the course of the appeal proceedings. Therefore, it would have been impossible for it to determine whether those studies were relevant for the evaluation of Triclosan for the purposes of the first sentence of Article 47(1) of Regulation No 1907/2006.

| 209 | In paragraph 202 of the contested decision, the Board of Appeal examined the argument alleging that no weight of evidence determination of the available information was conducted. In the first place, in the first sentence of that paragraph, it noted, referring to its findings in paragraph 64 of that decision, that the ECHA was not required to follow a weight of evidence approach in relation to the available information in order to reach a conclusion regarding a particular property in the evaluation of a substance. According to it, the relevant question was instead whether the ECHA had taken into account all the relevant information. In the second place, in the second to fourth sentences of that paragraph, it stated that, in so far as the applicant had submitted comments concerning the available information, those comments had been rejected in the ECHA decision. For the remainder, according to it, it could not be expected of the ECHA that it rebut complaints which had not been specifically raised by the applicant. |
| --- | --- |

209

In paragraph 202 of the contested decision, the Board of Appeal examined the argument alleging that no weight of evidence determination of the available information was conducted. In the first place, in the first sentence of that paragraph, it noted, referring to its findings in paragraph 64 of that decision, that the ECHA was not required to follow a weight of evidence approach in relation to the available information in order to reach a conclusion regarding a particular property in the evaluation of a substance. According to it, the relevant question was instead whether the ECHA had taken into account all the relevant information. In the second place, in the second to fourth sentences of that paragraph, it stated that, in so far as the applicant had submitted comments concerning the available information, those comments had been rejected in the ECHA decision. For the remainder, according to it, it could not be expected of the ECHA that it rebut complaints which had not been specifically raised by the applicant.

| 210 | The applicant claims that some of those findings of the Board of Appeal are incorrect. |
| --- | --- |

210

The applicant claims that some of those findings of the Board of Appeal are incorrect.

| 211 | In the first place, in the context of the second part of the first plea, the applicant claims that the Board of Appeal infringed the first sentence of Article 47(1) of Regulation No 1907/2006 by ignoring the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, which, firstly, corroborated its argument that no potential risk of reproductive toxicity could justify the request to conduct the enhanced neurotoxicity rat study, secondly, contain histopathological analyses relating to reproductive organ weights and histopathology in rats and thirdly, were included in the assessment file relating to the substance and invoked in the notice of appeal before that board. |
| --- | --- |

211

In the first place, in the context of the second part of the first plea, the applicant claims that the Board of Appeal infringed the first sentence of Article 47(1) of Regulation No 1907/2006 by ignoring the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, which, firstly, corroborated its argument that no potential risk of reproductive toxicity could justify the request to conduct the enhanced neurotoxicity rat study, secondly, contain histopathological analyses relating to reproductive organ weights and histopathology in rats and thirdly, were included in the assessment file relating to the substance and invoked in the notice of appeal before that board.

| 212 | In that context, the applicant also claims that the Board of Appeal’s finding that, since it had not re-submitted the studies as an annex to the notice of appeal, that board had been unable to determine whether they would be useful for the evaluation of Triclosan for the purposes of the first sentence of Article 47(1) of Regulation No 1907/2006, is incorrect. According to it, that board could easily have gained access to those reports which were available through the International Uniform Chemical Information Database and which were mentioned in Annex 3 to the ECHA decision. It considers that that board could also have requested production of those documents in accordance with Article 15(3) of Regulation No 771/2008. Consequently, by refusing to examine the relevance of the studies at issue, the board in question unlawfully excluded important scientific evidence and did not take into account all the relevant information. |
| --- | --- |

212

In that context, the applicant also claims that the Board of Appeal’s finding that, since it had not re-submitted the studies as an annex to the notice of appeal, that board had been unable to determine whether they would be useful for the evaluation of Triclosan for the purposes of the first sentence of Article 47(1) of Regulation No 1907/2006, is incorrect. According to it, that board could easily have gained access to those reports which were available through the International Uniform Chemical Information Database and which were mentioned in Annex 3 to the ECHA decision. It considers that that board could also have requested production of those documents in accordance with Article 15(3) of Regulation No 771/2008. Consequently, by refusing to examine the relevance of the studies at issue, the board in question unlawfully excluded important scientific evidence and did not take into account all the relevant information.

| 213 | In the second place, in the context of the first part of the second plea, the applicant claims that the Board of Appeal failed to recognise that the weight of evidence approach is applicable to the evaluation of substances and allowed the ECHA to exercise its discretion in relation to complex scientific and technical assessments by taking into consideration all the relevant evidence. |
| --- | --- |

213

In the second place, in the context of the first part of the second plea, the applicant claims that the Board of Appeal failed to recognise that the weight of evidence approach is applicable to the evaluation of substances and allowed the ECHA to exercise its discretion in relation to complex scientific and technical assessments by taking into consideration all the relevant evidence.

| 214 | In the third place, in the context of the second part of the first plea, the applicant claims that the Board of Appeal distorted the content of the notice of appeal. According to it, that board held that it had not presented arguments concerning the weight of evidence determination, although, in that notice, it developed such an argument. That board in particular ignored the contents of the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies. |
| --- | --- |

214

In the third place, in the context of the second part of the first plea, the applicant claims that the Board of Appeal distorted the content of the notice of appeal. According to it, that board held that it had not presented arguments concerning the weight of evidence determination, although, in that notice, it developed such an argument. That board in particular ignored the contents of the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies.

| 215 | The ECHA and the interveners dispute those arguments. |
| --- | --- |

215

The ECHA and the interveners dispute those arguments.

| 216 | As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should not have merely examined whether the ECHA decision was vitiated by error, but should have examined itself, taking account of the contents of the Ciba-Geigy studies, whether it was necessary to request the enhanced neurotoxicity rat study to be conducted, they should be rejected for the same reasons as those set out in paragraphs 55 to 131 above. In that context, it is necessary also to reject the arguments alleging that the first sentence of Article 47(1) of Regulation No 1907/2006 was directly applicable to the Board of Appeal, for the same reasons as those set out in paragraph 199 above. |
| --- | --- |

216

As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should not have merely examined whether the ECHA decision was vitiated by error, but should have examined itself, taking account of the contents of the Ciba-Geigy studies, whether it was necessary to request the enhanced neurotoxicity rat study to be conducted, they should be rejected for the same reasons as those set out in paragraphs 55 to 131 above. In that context, it is necessary also to reject the arguments alleging that the first sentence of Article 47(1) of Regulation No 1907/2006 was directly applicable to the Board of Appeal, for the same reasons as those set out in paragraph 199 above.

| 217 | As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that, in the context of the review of the ECHA decision, the Board of Appeal committed an error. |
| --- | --- |

217

As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that, in the context of the review of the ECHA decision, the Board of Appeal committed an error.

| 218 | In that context, it is necessary to make a distinction between the arguments that the Board of Appeal should have found that the ECHA decision had been adopted in breach of the first sentence of Article 47(1) of Regulation No 1907/2006, on the one hand, and the arguments alleging that that board should not have rejected the arguments concerning the weight of evidence determination, on the other hand. |
| --- | --- |

218

In that context, it is necessary to make a distinction between the arguments that the Board of Appeal should have found that the ECHA decision had been adopted in breach of the first sentence of Article 47(1) of Regulation No 1907/2006, on the one hand, and the arguments alleging that that board should not have rejected the arguments concerning the weight of evidence determination, on the other hand.

(1) The arguments according to which the Board of Appeal should have found an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006

(1)

The arguments according to which the Board of Appeal should have found an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006

| 219 | The applicant claims that the Board of Appeal should have found that the ECHA had infringed the first sentence of Article 47(1) of Regulation No 1907/2006. |
| --- | --- |

219

The applicant claims that the Board of Appeal should have found that the ECHA had infringed the first sentence of Article 47(1) of Regulation No 1907/2006.

| 220 | In that context, it should be noted that, in response to an argument alleging that the ECHA decision had been adopted in breach of the first sentence of Article 47(1) of Regulation No 1907/2006, because account had not been taken of the Ciba-Geigy studies, the Board of Appeal should have examined whether it concerned information about Triclosan which was relevant and which had been submitted for the purposes of that provision and whether it had been taken into account during the procedure which led to the adoption of that decision. |
| --- | --- |

220

In that context, it should be noted that, in response to an argument alleging that the ECHA decision had been adopted in breach of the first sentence of Article 47(1) of Regulation No 1907/2006, because account had not been taken of the Ciba-Geigy studies, the Board of Appeal should have examined whether it concerned information about Triclosan which was relevant and which had been submitted for the purposes of that provision and whether it had been taken into account during the procedure which led to the adoption of that decision.

| 221 | In the first place, it should be noted that, in its pleadings before the Court, the applicant merely put forward arguments relating to the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies. The term ‘Ciba-Geigy studies’ that the applicant used in its pleadings indeed covers the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, but not the Ciba-Geigy (1994) study. Therefore, it must be concluded that the arguments raised before the Court do not refer to the Ciba-Geigy (1994) study. |
| --- | --- |

221

In the first place, it should be noted that, in its pleadings before the Court, the applicant merely put forward arguments relating to the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies. The term ‘Ciba-Geigy studies’ that the applicant used in its pleadings indeed covers the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, but not the Ciba-Geigy (1994) study. Therefore, it must be concluded that the arguments raised before the Court do not refer to the Ciba-Geigy (1994) study.

| 222 | Admittedly, in its comments made during the hearing, the applicant stated that its written observations concerned also the Ciba-Geigy (1994) study. However, under Article 84(1) of the Rules of Procedure, no new plea in law may be introduced unless based on matters of law or of fact which came to light in the course of the procedure. Since the applicant does not invoke the presence of such elements, its comments made during the hearing must be rejected as being out of time. |
| --- | --- |

222

Admittedly, in its comments made during the hearing, the applicant stated that its written observations concerned also the Ciba-Geigy (1994) study. However, under Article 84(1) of the Rules of Procedure, no new plea in law may be introduced unless based on matters of law or of fact which came to light in the course of the procedure. Since the applicant does not invoke the presence of such elements, its comments made during the hearing must be rejected as being out of time.

| 223 | In any event, the Board of Appeal was correct to reject the argument alleging that the ECHA decision had been adopted in breach of the first sentence of Article 47(1) of Regulation No 1907/2006, due to the fact that the Ciba-Geigy (1994) study had not been taken into account. According to the third sentence of paragraph 201 of the contested decision, which the applicant does not contest, that study was not submitted during the evaluation procedure. Therefore, the ECHA cannot be criticised for infringing the abovementioned provision in relation to that study. |
| --- | --- |

223

In any event, the Board of Appeal was correct to reject the argument alleging that the ECHA decision had been adopted in breach of the first sentence of Article 47(1) of Regulation No 1907/2006, due to the fact that the Ciba-Geigy (1994) study had not been taken into account. According to the third sentence of paragraph 201 of the contested decision, which the applicant does not contest, that study was not submitted during the evaluation procedure. Therefore, the ECHA cannot be criticised for infringing the abovementioned provision in relation to that study.

| 224 | In the second place, it is necessary to examine the applicant’s arguments alleging that the Board of Appeal should have found an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006 concerning the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies. |
| --- | --- |

224

In the second place, it is necessary to examine the applicant’s arguments alleging that the Board of Appeal should have found an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006 concerning the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies.

| 225 | In that context, it should be noted that, as the Board of Appeal stated in paragraph 201 of the contested decision, the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies were mentioned in the bibliography annexed to the ECHA decision. |
| --- | --- |

225

In that context, it should be noted that, as the Board of Appeal stated in paragraph 201 of the contested decision, the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies were mentioned in the bibliography annexed to the ECHA decision.

| 226 | In those circumstances, in the context of the adversarial proceedings before the Board of Appeal, it was for the applicant to put forward arguments capable of demonstrating that, despite their mention in the bibliography annexed to the ECHA decision, the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies had not been taken into account in the context of the procedure leading to the adoption of that decision. |
| --- | --- |

226

In those circumstances, in the context of the adversarial proceedings before the Board of Appeal, it was for the applicant to put forward arguments capable of demonstrating that, despite their mention in the bibliography annexed to the ECHA decision, the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies had not been taken into account in the context of the procedure leading to the adoption of that decision.

| 227 | As was stated in paragraphs 190 to 194 above, in itself, the fact that the ECHA reached a conclusion different from that reached by the applicant concerning the necessity to conduct the enhanced neurotoxicity rat study was not capable of demonstrating that the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies had not been taken into account. |
| --- | --- |

227

As was stated in paragraphs 190 to 194 above, in itself, the fact that the ECHA reached a conclusion different from that reached by the applicant concerning the necessity to conduct the enhanced neurotoxicity rat study was not capable of demonstrating that the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies had not been taken into account.

| 228 | However, before the Board of Appeal, the applicant had also claimed that the finding of the designated authority summarised on page 15 of the ECHA decision, according to which there were no results concerning the weight or morphology of male reproductive organs in the registration dossier, was contradicted by the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, which, according to it, contained such results. It is thus necessary to examine whether, in the light of the contents of the ECHA decision, that argument was capable of raising a doubt in relation to whether those studies were taken into account. |
| --- | --- |

228

However, before the Board of Appeal, the applicant had also claimed that the finding of the designated authority summarised on page 15 of the ECHA decision, according to which there were no results concerning the weight or morphology of male reproductive organs in the registration dossier, was contradicted by the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, which, according to it, contained such results. It is thus necessary to examine whether, in the light of the contents of the ECHA decision, that argument was capable of raising a doubt in relation to whether those studies were taken into account.

| 229 | In that regard, first of all, it should be noted that, as is apparent from pages 8 and 19 of Annex N to the notice of appeal, in the context of its comments on the proposals for amendment of the draft ECHA decision (see paragraph 12 above), the applicant had observed that the studies in the technical registration dossier had not identified any histopathological or weight changes in relation to testicles or reproductive organs. In that context, reference had in particular been made to the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies. On page 8 of that annex, reference is made in particular to studies Nos 18 and 19 and, on page 19 of that annex, it is indicated that it concerned the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies. |
| --- | --- |

229

In that regard, first of all, it should be noted that, as is apparent from pages 8 and 19 of Annex N to the notice of appeal, in the context of its comments on the proposals for amendment of the draft ECHA decision (see paragraph 12 above), the applicant had observed that the studies in the technical registration dossier had not identified any histopathological or weight changes in relation to testicles or reproductive organs. In that context, reference had in particular been made to the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies. On page 8 of that annex, reference is made in particular to studies Nos 18 and 19 and, on page 19 of that annex, it is indicated that it concerned the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies.

| 230 | Next, it should be noted that, on pages 26 and 27 of the ECHA decision, the applicant’s comments on the draft decision were summarised and, on page 27 of that decision, the comment mentioned in paragraph 229 above was reproduced verbatim. In that context, it should also be noted that it is apparent from Annex 3 to that decision that that comment referred in particular to the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies. |
| --- | --- |

230

Next, it should be noted that, on pages 26 and 27 of the ECHA decision, the applicant’s comments on the draft decision were summarised and, on page 27 of that decision, the comment mentioned in paragraph 229 above was reproduced verbatim. In that context, it should also be noted that it is apparent from Annex 3 to that decision that that comment referred in particular to the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies.

| 231 | Finally, it must be noted that, on pages 27 and 28 of the ECHA decision, it was examined whether, as a result, in particular, of information contained in the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, the potential risk that Triclosan is reproductive toxic could be excluded. Firstly, on those pages, and more particularly in point 2 of the designated authority’s replies, it was in particular stated that the registrants had already previously submitted comments on the absence of effects on reproduction in certain of the studies conducted on Triclosan and that the designated authority had already indicated previously that, in those studies, the dosing of Triclosan had not been conducted during critical prenatal and postnatal periods of development of the reproductive system and that, consequently, they did not provide sufficient information to allow the absence of effects on reproduction to be reliably assessed. As regards the Ciba-Geigy (1983) study, which is a subchronic study, it was also stated, on page 28 of that decision, that, in a retrospective analysis of the added value of a two-generation study, it had been concluded that the fact that no effect on reproduction is observed in a subchronic study does not prevent the substance from having effects on reproduction. |
| --- | --- |

231

Finally, it must be noted that, on pages 27 and 28 of the ECHA decision, it was examined whether, as a result, in particular, of information contained in the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, the potential risk that Triclosan is reproductive toxic could be excluded. Firstly, on those pages, and more particularly in point 2 of the designated authority’s replies, it was in particular stated that the registrants had already previously submitted comments on the absence of effects on reproduction in certain of the studies conducted on Triclosan and that the designated authority had already indicated previously that, in those studies, the dosing of Triclosan had not been conducted during critical prenatal and postnatal periods of development of the reproductive system and that, consequently, they did not provide sufficient information to allow the absence of effects on reproduction to be reliably assessed. As regards the Ciba-Geigy (1983) study, which is a subchronic study, it was also stated, on page 28 of that decision, that, in a retrospective analysis of the added value of a two-generation study, it had been concluded that the fact that no effect on reproduction is observed in a subchronic study does not prevent the substance from having effects on reproduction.

| 232 | In the light of those elements, in itself, the reference to the designated authority’s finding included on page 15 of the ECHA decision, according to which there were no results on the weight or morphology of male reproductive organs in the applicant’s registration dossier, was not capable of demonstrating that, during the procedure leading to the adoption of that decision, the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies had not been taken into account. |
| --- | --- |

232

In the light of those elements, in itself, the reference to the designated authority’s finding included on page 15 of the ECHA decision, according to which there were no results on the weight or morphology of male reproductive organs in the applicant’s registration dossier, was not capable of demonstrating that, during the procedure leading to the adoption of that decision, the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies had not been taken into account.

| 233 | Therefore, it should be noted that, in the action before the Board of Appeal, the applicant did not put forward arguments capable of demonstrating an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006 due to the fact that the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies were not taken into account. In those circumstances, that board cannot be criticised for failing to find such an infringement in the contested decision. |
| --- | --- |

233

Therefore, it should be noted that, in the action before the Board of Appeal, the applicant did not put forward arguments capable of demonstrating an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006 due to the fact that the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies were not taken into account. In those circumstances, that board cannot be criticised for failing to find such an infringement in the contested decision.

| 234 | In that context, it should be pointed out that that conclusion is not liable to be called into question by a possible error vitiating the Board of Appeal’s finding in the fourth sentence of paragraph 201 of the contested decision, according to which it was also entitled to reject the argument alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, on the ground that the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies had not been submitted by the applicant during the procedure before it. As set out in paragraphs 219 to 233 above, even assuming that that finding is incorrect, the fact remains that the arguments put forward by the applicant were not capable of calling into question the rejection, by that board, of the argument alleging an infringement of the first sentence of Article 47(1) of that regulation. The applicant had not put forward an argument to show that those studies had not been taken into account. |
| --- | --- |

234

In that context, it should be pointed out that that conclusion is not liable to be called into question by a possible error vitiating the Board of Appeal’s finding in the fourth sentence of paragraph 201 of the contested decision, according to which it was also entitled to reject the argument alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, on the ground that the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies had not been submitted by the applicant during the procedure before it. As set out in paragraphs 219 to 233 above, even assuming that that finding is incorrect, the fact remains that the arguments put forward by the applicant were not capable of calling into question the rejection, by that board, of the argument alleging an infringement of the first sentence of Article 47(1) of that regulation. The applicant had not put forward an argument to show that those studies had not been taken into account.

(2) The arguments relating to the Board of Appeal’s findings concerning the weight of evidence determination of the available information

(2)

The arguments relating to the Board of Appeal’s findings concerning the weight of evidence determination of the available information

| 235 | The applicant claims that the Board of Appeal’s findings concerning the evidential weight of the available information are wrong. |
| --- | --- |

235

The applicant claims that the Board of Appeal’s findings concerning the evidential weight of the available information are wrong.

| 236 | In the first place, the applicant claims that, in paragraph 202 of the contested decision, by holding that the ECHA was not required to follow a weight of evidence approach in relation to the available information in order to reach a conclusion concerning a particular characteristic of a substance in the evaluation of a substance, the Board of Appeal failed to recognise that the weight of evidence determination applied also to the evaluation of a substance. |
| --- | --- |

236

In the first place, the applicant claims that, in paragraph 202 of the contested decision, by holding that the ECHA was not required to follow a weight of evidence approach in relation to the available information in order to reach a conclusion concerning a particular characteristic of a substance in the evaluation of a substance, the Board of Appeal failed to recognise that the weight of evidence determination applied also to the evaluation of a substance.

| 237 | In that regard, firstly, it should be noted that, as was set out in paragraphs 136 and 137 above, admittedly, in the first place, it follows from point 1.2 of Annex XI to Regulation No 1907/2006 that, in the context of the registration of a substance, if a weight of evidence approach allows the existence or absence of a particular dangerous property to be confirmed, it is necessary to omit further testing on vertebrate animals in relation to the substance at issue and further testing not using vertebrate animals may be omitted, and, in the second place, it follows from the second paragraph of Annex XIII to that regulation that a weight of evidence determination based on an expert opinion is applied for the identification of persistent, bioaccumulative and toxic substances, as well as for the identification of very persistent and very bioaccumulative substances. However, it does not expressly follow from those provisions that the weight of evidence determination applies in the evaluation of a substance. |
| --- | --- |

237

In that regard, firstly, it should be noted that, as was set out in paragraphs 136 and 137 above, admittedly, in the first place, it follows from point 1.2 of Annex XI to Regulation No 1907/2006 that, in the context of the registration of a substance, if a weight of evidence approach allows the existence or absence of a particular dangerous property to be confirmed, it is necessary to omit further testing on vertebrate animals in relation to the substance at issue and further testing not using vertebrate animals may be omitted, and, in the second place, it follows from the second paragraph of Annex XIII to that regulation that a weight of evidence determination based on an expert opinion is applied for the identification of persistent, bioaccumulative and toxic substances, as well as for the identification of very persistent and very bioaccumulative substances. However, it does not expressly follow from those provisions that the weight of evidence determination applies in the evaluation of a substance.

| 238 | Secondly, assuming that, in the evaluation of a substance, in view of the principle of proportionality, the ECHA is not entitled to request further information concerning the existence of a potential risk posed by a substance where the evidential weight of the available information allows a conclusion to be drawn about whether or not that risk exists, given the adversarial nature of the proceedings before the Board of Appeal (see paragraphs 59 to 86 above), it is nevertheless for the applicant in an action before the Board of Appeal to set out the reasons why the findings in the ECHA decision are incorrect. |
| --- | --- |

238

Secondly, assuming that, in the evaluation of a substance, in view of the principle of proportionality, the ECHA is not entitled to request further information concerning the existence of a potential risk posed by a substance where the evidential weight of the available information allows a conclusion to be drawn about whether or not that risk exists, given the adversarial nature of the proceedings before the Board of Appeal (see paragraphs 59 to 86 above), it is nevertheless for the applicant in an action before the Board of Appeal to set out the reasons why the findings in the ECHA decision are incorrect.

| 239 | In the second sentence of paragraph 202 of the contested decision, the Board of Appeal stated that, in the context of the second part of the sixth plea in the action before it, the applicant had not put forward detailed arguments calling into question the ECHA’s conclusion that the available information did not suffice for the purposes of completing the evaluation of Triclosan with respect to the potential risk of reproductive toxicity. |
| --- | --- |

239

In the second sentence of paragraph 202 of the contested decision, the Board of Appeal stated that, in the context of the second part of the sixth plea in the action before it, the applicant had not put forward detailed arguments calling into question the ECHA’s conclusion that the available information did not suffice for the purposes of completing the evaluation of Triclosan with respect to the potential risk of reproductive toxicity.

| 240 | In so far as those arguments of the applicant seek to contest that finding, it suffices to note that, as was set out in paragraph 231 above, on pages 27 and 28 of the ECHA decision it was stated that, in the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, dosing of Triclosan had not been conducted during the critical prenatal and postnatal periods of the development of the reproductive system and that, for that reason, the information provided by those studies was not sufficient to allow a reliable assessment of the absence of effects on reproduction. As regards the Ciba-Geigy (1983) study, which is a subchronic study, it was indicated that, in a retrospective analysis of the added value of a two-generation study, it had been concluded that the fact that no effect on reproduction is observed in a subchronic study did not prevent the substance from potentially having effects on reproduction. |
| --- | --- |

240

In so far as those arguments of the applicant seek to contest that finding, it suffices to note that, as was set out in paragraph 231 above, on pages 27 and 28 of the ECHA decision it was stated that, in the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, dosing of Triclosan had not been conducted during the critical prenatal and postnatal periods of the development of the reproductive system and that, for that reason, the information provided by those studies was not sufficient to allow a reliable assessment of the absence of effects on reproduction. As regards the Ciba-Geigy (1983) study, which is a subchronic study, it was indicated that, in a retrospective analysis of the added value of a two-generation study, it had been concluded that the fact that no effect on reproduction is observed in a subchronic study did not prevent the substance from potentially having effects on reproduction.

| 241 | It must be noted that, in the context of the second part of the sixth plea in the action before the Board of Appeal, concerning the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, the applicant merely claimed that a weight of evidence determination of the available information would have allowed it to be concluded that there existed no risk relating to reproductive toxicity. The applicant therefore merely invoked the fact that those studies existed, without putting forward arguments capable of calling into question the reason stated in the ECHA decision, as a result of which the information in those studies could not be considered to be sufficient. |
| --- | --- |

241

It must be noted that, in the context of the second part of the sixth plea in the action before the Board of Appeal, concerning the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, the applicant merely claimed that a weight of evidence determination of the available information would have allowed it to be concluded that there existed no risk relating to reproductive toxicity. The applicant therefore merely invoked the fact that those studies existed, without putting forward arguments capable of calling into question the reason stated in the ECHA decision, as a result of which the information in those studies could not be considered to be sufficient.

| 242 | In those circumstances, the Board of Appeal cannot be criticised for having considered that the arguments that the applicant had put forward with respect to the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies were not sufficiently substantiated. |
| --- | --- |

242

In those circumstances, the Board of Appeal cannot be criticised for having considered that the arguments that the applicant had put forward with respect to the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies were not sufficiently substantiated.

| 243 | As regards the Ciba-Geigy (1994) study, it should be recalled that, as was stated in paragraph 222 above, in its written observations before the Court, the applicant did not develop arguments in relation to that study and its oral comments made for the first time during the hearing must be rejected as inadmissible. In any event, it must be noted that, before the Board of Appeal, the applicant did not develop any detailed arguments concerning that study. For the sake of completeness, it must be noted that that study had not been submitted before the ECHA. |
| --- | --- |

243

As regards the Ciba-Geigy (1994) study, it should be recalled that, as was stated in paragraph 222 above, in its written observations before the Court, the applicant did not develop arguments in relation to that study and its oral comments made for the first time during the hearing must be rejected as inadmissible. In any event, it must be noted that, before the Board of Appeal, the applicant did not develop any detailed arguments concerning that study. For the sake of completeness, it must be noted that that study had not been submitted before the ECHA.

| 244 | Therefore, the arguments alleging that the Board of Appeal failed to take into account the evidential weight of the available information must be rejected. |
| --- | --- |

244

Therefore, the arguments alleging that the Board of Appeal failed to take into account the evidential weight of the available information must be rejected.

| 245 | In the second place, where, by its arguments, the applicant seeks to claim that the Board of Appeal should have held that the designated authority’s finding on page 15 of the ECHA decision, according to which there were no results relating to the weight or morphology of male reproductive organs in the registration dossier was incorrect, those arguments must also be rejected. |
| --- | --- |

245

In the second place, where, by its arguments, the applicant seeks to claim that the Board of Appeal should have held that the designated authority’s finding on page 15 of the ECHA decision, according to which there were no results relating to the weight or morphology of male reproductive organs in the registration dossier was incorrect, those arguments must also be rejected.

| 246 | Admittedly, in the event that, contrary to what was concluded by the designated authority, results concerning the weight or morphology of male reproductive organs were included in the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, that authority’s finding summarised on page 15 of the ECHA decision, according to which there were no results concerning the weight or morphology of male reproductive organs in the applicant’s registration dossier, was incorrect. |
| --- | --- |

246

Admittedly, in the event that, contrary to what was concluded by the designated authority, results concerning the weight or morphology of male reproductive organs were included in the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, that authority’s finding summarised on page 15 of the ECHA decision, according to which there were no results concerning the weight or morphology of male reproductive organs in the applicant’s registration dossier, was incorrect.

| 247 | However, in the light of the grounds set out on pages 27 and 28 of the ECHA decision (see paragraph 231 above), according to which, in the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, the dosing of Triclosan had not been conducted during critical prenatal and postnatal periods of development of the reproductive system and according to which, for that reason, the information provided by those studies was not sufficient to allow the absence of effects on reproduction to be reliably assessed, those results would not have been sufficient to exclude the possibility that Triclosan could have reproductive toxic effects. |
| --- | --- |

247

However, in the light of the grounds set out on pages 27 and 28 of the ECHA decision (see paragraph 231 above), according to which, in the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies, the dosing of Triclosan had not been conducted during critical prenatal and postnatal periods of development of the reproductive system and according to which, for that reason, the information provided by those studies was not sufficient to allow the absence of effects on reproduction to be reliably assessed, those results would not have been sufficient to exclude the possibility that Triclosan could have reproductive toxic effects.

| 248 | In those circumstances, a potential error vitiating the designated authority’s finding on page 15 of the ECHA decision was not capable of calling into question its decision to request the enhanced neurotoxicity rat study to be conducted. |
| --- | --- |

248

In those circumstances, a potential error vitiating the designated authority’s finding on page 15 of the ECHA decision was not capable of calling into question its decision to request the enhanced neurotoxicity rat study to be conducted.

| 249 | It follows that it is necessary to reject all of the arguments calling into question the considerations on which the Board of Appeal based the rejection of the second part of the sixth plea in the action against the ECHA decision and, therefore, the entirety of the arguments calling into question the considerations on which the Board of Appeal based the rejection of that plea. |
| --- | --- |

249

It follows that it is necessary to reject all of the arguments calling into question the considerations on which the Board of Appeal based the rejection of the second part of the sixth plea in the action against the ECHA decision and, therefore, the entirety of the arguments calling into question the considerations on which the Board of Appeal based the rejection of that plea.

2.
   
  The arguments calling into question the rejection, by the Board of Appeal, of the seventh and eighth pleas in the action before it

2.

The arguments calling into question the rejection, by the Board of Appeal, of the seventh and eighth pleas in the action before it

| 250 | In paragraphs 137 to 168 of the contested decision, the Board of Appeal examined the arguments which the applicant had developed in the seventh and eighth pleas in the administrative appeal, alleging an infringement of Article 25 of Regulation No 1907/2006 and a breach of the principle of proportionality. In the context of those pleas, the applicant had claimed, in essence, that it was not possible, on the basis of the available data, to identify the existence of a potential risk of Triclosan having neurotoxic or reproductive toxic effects. It had in particular claimed that that conclusions relating to the absence of such a risk could have been drawn from existing data. It had also indicated that, as a result of differences between rats and humans, it was not possible to draw conclusions relating to humans from the enhanced neurotoxicity rat study. |
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250

In paragraphs 137 to 168 of the contested decision, the Board of Appeal examined the arguments which the applicant had developed in the seventh and eighth pleas in the administrative appeal, alleging an infringement of Article 25 of Regulation No 1907/2006 and a breach of the principle of proportionality. In the context of those pleas, the applicant had claimed, in essence, that it was not possible, on the basis of the available data, to identify the existence of a potential risk of Triclosan having neurotoxic or reproductive toxic effects. It had in particular claimed that that conclusions relating to the absence of such a risk could have been drawn from existing data. It had also indicated that, as a result of differences between rats and humans, it was not possible to draw conclusions relating to humans from the enhanced neurotoxicity rat study.

| 251 | In paragraph 149 of the contested decision, the Board of Appeal held that, in the action before it, the applicant merely put forward arguments calling into question the necessity and appropriateness of the request to conduct the enhanced neurotoxicity rat study and stated that it would limit itself to examining those elements. In paragraphs 150 to 160 of that decision, it examined and rejected the applicant’s arguments calling into question the necessity of that request. In paragraphs 161 to 168 of that decision, it examined and rejected the applicant’s arguments calling into question the appropriateness of that request. |
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251

In paragraph 149 of the contested decision, the Board of Appeal held that, in the action before it, the applicant merely put forward arguments calling into question the necessity and appropriateness of the request to conduct the enhanced neurotoxicity rat study and stated that it would limit itself to examining those elements. In paragraphs 150 to 160 of that decision, it examined and rejected the applicant’s arguments calling into question the necessity of that request. In paragraphs 161 to 168 of that decision, it examined and rejected the applicant’s arguments calling into question the appropriateness of that request.

| 252 | The applicant claims that those considerations of the Board of Appeal are incorrect. As a first step, its arguments calling into question that boards’ findings concerning the necessity of the request to conduct the enhanced neurotoxicity rat study will be examined. As a second step, the arguments calling into question that board’s findings concerning the appropriateness of that request will be examined. |
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252

The applicant claims that those considerations of the Board of Appeal are incorrect. As a first step, its arguments calling into question that boards’ findings concerning the necessity of the request to conduct the enhanced neurotoxicity rat study will be examined. As a second step, the arguments calling into question that board’s findings concerning the appropriateness of that request will be examined.

(a)
   
  The arguments calling into question the Board of Appeal’s findings concerning the necessity of the request to conduct the enhanced neurotoxicity rat study

(a)

The arguments calling into question the Board of Appeal’s findings concerning the necessity of the request to conduct the enhanced neurotoxicity rat study

| 253 | In paragraph 150 of the contested decision, the Board of Appeal stated that, in order to establish the necessity of a request for further information in the context of the evaluation of a substance, the ECHA should be able to demonstrate the existence of a potential risk for human health and the environment, the need to clarify that risk and the realistic possibility that the information requested will allow improved risk management measures to be taken. |
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253

In paragraph 150 of the contested decision, the Board of Appeal stated that, in order to establish the necessity of a request for further information in the context of the evaluation of a substance, the ECHA should be able to demonstrate the existence of a potential risk for human health and the environment, the need to clarify that risk and the realistic possibility that the information requested will allow improved risk management measures to be taken.

| 254 | In paragraph 151 of the contested decision, the Board of Appeal noted that the applicant had claimed that the ECHA had not demonstrated that there was a risk which should be clarified, because the evidential weight of the available information was not sufficient for the purposes of identifying a risk of endocrine disruption in humans. |
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254

In paragraph 151 of the contested decision, the Board of Appeal noted that the applicant had claimed that the ECHA had not demonstrated that there was a risk which should be clarified, because the evidential weight of the available information was not sufficient for the purposes of identifying a risk of endocrine disruption in humans.

| 255 | In paragraph 152 of the contested decision, the Board of Appeal noted that, even where, in accordance with Annex XI to Regulation No 1907/2006, a weight of evidence approach had been adopted in order to adjust the information requirements to the needs of a registration, the ECHA was not obliged to adopt such an approach in the evaluation of a substance, on condition that that agency correctly exercised its discretion, in particular by establishing the existence of a potential risk. In that context, it referred to the considerations which it developed in paragraph 64 of that decision. |
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255

In paragraph 152 of the contested decision, the Board of Appeal noted that, even where, in accordance with Annex XI to Regulation No 1907/2006, a weight of evidence approach had been adopted in order to adjust the information requirements to the needs of a registration, the ECHA was not obliged to adopt such an approach in the evaluation of a substance, on condition that that agency correctly exercised its discretion, in particular by establishing the existence of a potential risk. In that context, it referred to the considerations which it developed in paragraph 64 of that decision.

| 256 | In paragraph 153 of the contested decision, the Board of Appeal stated that, in its decision, the ECHA had identified two potential risks concerning Triclosan, namely, in the first place, the potential risk of reproductive toxicity and, in the second place, the potential risk of neurotoxic effects. |
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256

In paragraph 153 of the contested decision, the Board of Appeal stated that, in its decision, the ECHA had identified two potential risks concerning Triclosan, namely, in the first place, the potential risk of reproductive toxicity and, in the second place, the potential risk of neurotoxic effects.

| 257 | In paragraph 154 of the contested decision, the Board of Appeal stated that, in the notice of appeal, the applicant had not put forward detailed arguments capable of calling into question the ground for concern relating to the risk of reproductive toxicity effects. |
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257

In paragraph 154 of the contested decision, the Board of Appeal stated that, in the notice of appeal, the applicant had not put forward detailed arguments capable of calling into question the ground for concern relating to the risk of reproductive toxicity effects.

| 258 | In paragraphs 155 to 158 of the contested decision, the Board of Appeal stated the reasons why, despite the arguments put forward by the applicant, the ECHA had been entitled to conclude that Triclosan was capable, in particular, of having an inhibiting effect on thyroxine in humans, causing adverse neurological effects for offspring. |
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258

In paragraphs 155 to 158 of the contested decision, the Board of Appeal stated the reasons why, despite the arguments put forward by the applicant, the ECHA had been entitled to conclude that Triclosan was capable, in particular, of having an inhibiting effect on thyroxine in humans, causing adverse neurological effects for offspring.

| 259 | The applicant claims that those findings of the Board of Appeal are incorrect. As a first step, it puts forward arguments relating specifically to that board’s findings concerning the risk of neurotoxicity presented by Triclosan, and, as a second step arguments relating specifically to that board’s findings concerning the risk of reproductive toxicity presented by that substance. As a third step, it submits arguments relating to the conclusions of the Canadian authorities concerning Triclosan. As a fourth step, it maintains that, in paragraph 152 of the contested decision, that board disregarded the fact that the weight of evidence determination of the available information was applicable in the evaluation of a substance. As a fifth step, it claims that the board in question confined itself to verifying the absence of manifest errors of assessment. |
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259

The applicant claims that those findings of the Board of Appeal are incorrect. As a first step, it puts forward arguments relating specifically to that board’s findings concerning the risk of neurotoxicity presented by Triclosan, and, as a second step arguments relating specifically to that board’s findings concerning the risk of reproductive toxicity presented by that substance. As a third step, it submits arguments relating to the conclusions of the Canadian authorities concerning Triclosan. As a fourth step, it maintains that, in paragraph 152 of the contested decision, that board disregarded the fact that the weight of evidence determination of the available information was applicable in the evaluation of a substance. As a fifth step, it claims that the board in question confined itself to verifying the absence of manifest errors of assessment.

(1) The arguments relating specifically to the Board of Appeal’s findings concerning the potential risk posed by Triclosan

(1)

The arguments relating specifically to the Board of Appeal’s findings concerning the potential risk posed by Triclosan

| 260 | In paragraphs 153 and 155 to 158 of the contested decision, the Board of Appeal examined the applicant’s arguments seeking to show that the ECHA had not demonstrated the existence of a potential risk that Triclosan has neurotoxic effects. In paragraph 153 of that decision, it held that, in its decision, the ECHA referred to a wealth of information, and in particular to in vitro and in vivo studies carried out on rats and humans. It is on the basis of that information that the ECHA concluded that the substance at issue was likely, inter alia, to act as a thyroxine inhibitor in humans, causing adverse neurological effects in the offspring. In paragraphs 155 to 158 of that decision, that board examined and rejected the applicant’s arguments which seek to call into question the conclusions based on the potential risk of neurotoxic effects created by Triclosan. In that context, it held, in essence, that the applicant confined itself to expressing its disagreement with the conclusions that the ECHA had drawn from the available data, which amounts to a difference in scientific opinion, and noted, by referring to its considerations set out in paragraph 134 of that decision, that such arguments were not capable of establishing the existence of an error vitiating the contested decision. It also rejected an argument based on the Axelstad study (2013), noting in particular that the applicant had not established that the ECHA conclusions were mistaken, but merely expressed that it was not in agreement with the interpretation given by that agency to the existing data. Such arguments would not have been capable of calling into question the lawfulness of the request to conduct the enhanced neurotoxicity rat study. As regards the applicant’s arguments alleging that, in the light of differences between rats and humans, the ECHA should not have found the existence of a potential risk that Triclosan has neurotoxic effects by relying on the results of studies on rats, that board stated that those arguments should be rejected due to the considerations set out in paragraphs 163 to 165 of the decision at issue, in which the arguments calling into question the ECHA conclusions concerning the appropriateness of the enhanced neurotoxicity rat study were examined. |
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260

In paragraphs 153 and 155 to 158 of the contested decision, the Board of Appeal examined the applicant’s arguments seeking to show that the ECHA had not demonstrated the existence of a potential risk that Triclosan has neurotoxic effects. In paragraph 153 of that decision, it held that, in its decision, the ECHA referred to a wealth of information, and in particular to in vitro and in vivo studies carried out on rats and humans. It is on the basis of that information that the ECHA concluded that the substance at issue was likely, inter alia, to act as a thyroxine inhibitor in humans, causing adverse neurological effects in the offspring. In paragraphs 155 to 158 of that decision, that board examined and rejected the applicant’s arguments which seek to call into question the conclusions based on the potential risk of neurotoxic effects created by Triclosan. In that context, it held, in essence, that the applicant confined itself to expressing its disagreement with the conclusions that the ECHA had drawn from the available data, which amounts to a difference in scientific opinion, and noted, by referring to its considerations set out in paragraph 134 of that decision, that such arguments were not capable of establishing the existence of an error vitiating the contested decision. It also rejected an argument based on the Axelstad study (2013), noting in particular that the applicant had not established that the ECHA conclusions were mistaken, but merely expressed that it was not in agreement with the interpretation given by that agency to the existing data. Such arguments would not have been capable of calling into question the lawfulness of the request to conduct the enhanced neurotoxicity rat study. As regards the applicant’s arguments alleging that, in the light of differences between rats and humans, the ECHA should not have found the existence of a potential risk that Triclosan has neurotoxic effects by relying on the results of studies on rats, that board stated that those arguments should be rejected due to the considerations set out in paragraphs 163 to 165 of the decision at issue, in which the arguments calling into question the ECHA conclusions concerning the appropriateness of the enhanced neurotoxicity rat study were examined.

in vitro

in vivo

| 261 | The applicant claims that some of those findings of the Board of Appeal are incorrect. |
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261

The applicant claims that some of those findings of the Board of Appeal are incorrect.

| 262 | In the first place, in the context of the first part of the first plea, the applicant claims that the Board of Appeal did not conduct an adequate examination of the scientific studies it had invoked. According to it, in the light of the functional continuity between the ECHA and that board, the latter should have conducted a ‘de novo’ examination of the ECHA decision, which would have covered the scientific assessments included in that decision. If not, that board would create a lacuna in the procedural protection guaranteed to registrants such as itself. |
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262

In the first place, in the context of the first part of the first plea, the applicant claims that the Board of Appeal did not conduct an adequate examination of the scientific studies it had invoked. According to it, in the light of the functional continuity between the ECHA and that board, the latter should have conducted a ‘de novo’ examination of the ECHA decision, which would have covered the scientific assessments included in that decision. If not, that board would create a lacuna in the procedural protection guaranteed to registrants such as itself.

| 263 | In the second place, in the context of the first part of the second plea, the applicant claims that, in paragraph 156 of the contested decision, the Board of Appeal unduly reversed the burden of proof. It was for the ECHA and that board to demonstrate that there existed a risk, which needed to be clarified and that further information could genuinely improve the risk management measures. However, neither the ECHA nor that board demonstrated those elements. Therefore, according to the applicant, that board should not have concluded in that paragraph that it had not established that the ECHA had reached incorrect conclusions. |
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263

In the second place, in the context of the first part of the second plea, the applicant claims that, in paragraph 156 of the contested decision, the Board of Appeal unduly reversed the burden of proof. It was for the ECHA and that board to demonstrate that there existed a risk, which needed to be clarified and that further information could genuinely improve the risk management measures. However, neither the ECHA nor that board demonstrated those elements. Therefore, according to the applicant, that board should not have concluded in that paragraph that it had not established that the ECHA had reached incorrect conclusions.

| 264 | In the third place, in the context of the second part of the first plea, the applicant claims that, in paragraphs 134, 155 and 156 of the contested decision, the Board of Appeal should not have relied on the consideration according to which a difference in scientific opinions did not show any breach of the law. By doing so, that board failed to take account of the existence of functional continuity between it and the ECHA and applied an erroneous standard of review. |
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264

In the third place, in the context of the second part of the first plea, the applicant claims that, in paragraphs 134, 155 and 156 of the contested decision, the Board of Appeal should not have relied on the consideration according to which a difference in scientific opinions did not show any breach of the law. By doing so, that board failed to take account of the existence of functional continuity between it and the ECHA and applied an erroneous standard of review.

| 265 | In the fourth place, in the context of the second part of the first plea and the second part of the second plea, the applicant claims that the Board of Appeal was unable to explain how the evidence invoked, namely the existing rat studies, could substantiate the conclusions that the ECHA had drawn therefrom. Firstly, that board’s conclusion, set out in paragraph 153 of the contested decision, according to which the ECHA had examined a large number of studies was not sufficient. Factors such as the quality of the data, the consistency of the results, the nature and severity of the effects and the relevance of the information are important for the weight given to evidence in order to support or disprove a given hypothesis. Secondly, that decision is vitiated by a contradiction and is based on evidence which lacks consistency, in so far as, regarding the potential risk of neurotoxic effects in humans, that board relied exclusively on data derived from studies conducted on rats. Thirdly, the ECHA and that board did not take in account studies on humans and other species which showed the absence of neurotoxic effects and of endocrine disruption. According to the applicant, if the Board of Appeal had taken those studies into account, it would have concluded that, in the light of the interspecies differences of Triclosan, extrapolation of data was not possible. Fourthly, the board in question did not take account of its arguments based on the Witorsch report which showed the absence of neurotoxic effects and of endocrine disruption on the part of Triclosan. That report compiled the relevant evidence and also described it in detail and documents and explains how the evidence was used to reach the final conclusion in a reliable, robust and transparent manner. |
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265

In the fourth place, in the context of the second part of the first plea and the second part of the second plea, the applicant claims that the Board of Appeal was unable to explain how the evidence invoked, namely the existing rat studies, could substantiate the conclusions that the ECHA had drawn therefrom. Firstly, that board’s conclusion, set out in paragraph 153 of the contested decision, according to which the ECHA had examined a large number of studies was not sufficient. Factors such as the quality of the data, the consistency of the results, the nature and severity of the effects and the relevance of the information are important for the weight given to evidence in order to support or disprove a given hypothesis. Secondly, that decision is vitiated by a contradiction and is based on evidence which lacks consistency, in so far as, regarding the potential risk of neurotoxic effects in humans, that board relied exclusively on data derived from studies conducted on rats. Thirdly, the ECHA and that board did not take in account studies on humans and other species which showed the absence of neurotoxic effects and of endocrine disruption. According to the applicant, if the Board of Appeal had taken those studies into account, it would have concluded that, in the light of the interspecies differences of Triclosan, extrapolation of data was not possible. Fourthly, the board in question did not take account of its arguments based on the Witorsch report which showed the absence of neurotoxic effects and of endocrine disruption on the part of Triclosan. That report compiled the relevant evidence and also described it in detail and documents and explains how the evidence was used to reach the final conclusion in a reliable, robust and transparent manner.

| 266 | The ECHA and the interveners dispute those arguments. |
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266

The ECHA and the interveners dispute those arguments.

| 267 | As a first step, it is necessary to reject the applicant’s arguments in so far as they allege that the Board of Appeal should have itself conducted an evaluation of the relevant information, in order to decide whether there existed a potential risk of Triclosan being neurotoxic. In that regard, it suffices to note that, as was stated in paragraphs 55 to 131 above, in an action before it, that board merely examines whether, in the light of the arguments put forward by the applicant, the ECHA decision is vitiated by error. |
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267

As a first step, it is necessary to reject the applicant’s arguments in so far as they allege that the Board of Appeal should have itself conducted an evaluation of the relevant information, in order to decide whether there existed a potential risk of Triclosan being neurotoxic. In that regard, it suffices to note that, as was stated in paragraphs 55 to 131 above, in an action before it, that board merely examines whether, in the light of the arguments put forward by the applicant, the ECHA decision is vitiated by error.

| 268 | As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision. |
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268

As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision.

| 269 | In the first place, in so far as, by its arguments, the applicant alleges that the Board of Appeal should have found that, on the basis of the available information, the ECHA was not entitled to have concluded that Triclosan was neurotoxic, they must be rejected. |
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269

In the first place, in so far as, by its arguments, the applicant alleges that the Board of Appeal should have found that, on the basis of the available information, the ECHA was not entitled to have concluded that Triclosan was neurotoxic, they must be rejected.

| 270 | The allegation referred to in paragraph 269 above is based on the false premiss according to which, in order to be able to request further information seeking to clarify whether Triclosan has neurotoxic effects, the ECHA should have demonstrated that that substance was neurotoxic. |
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270

The allegation referred to in paragraph 269 above is based on the false premiss according to which, in order to be able to request further information seeking to clarify whether Triclosan has neurotoxic effects, the ECHA should have demonstrated that that substance was neurotoxic.

| 271 | According to the system introduced by Regulation No 1907/2006, where there are concerns concerning potential risks for human health and the environment caused by a substance and it is not possible to dispense with them or to confirm them on the basis of available information, a decision relating to the evaluation of that substance may be adopted with a view to requesting further information allowing that risk to be clarified. |
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271

According to the system introduced by Regulation No 1907/2006, where there are concerns concerning potential risks for human health and the environment caused by a substance and it is not possible to dispense with them or to confirm them on the basis of available information, a decision relating to the evaluation of that substance may be adopted with a view to requesting further information allowing that risk to be clarified.

| 272 | Under Article 1(1) of Regulation No 1907/2006, the latter seeks to ensure a high level of protection of human health and the environment. Moreover, it follows from the second sentence of Article 1(3) of that regulation that those provisions are underpinned by the precautionary principle. As is apparent from recital 66 of that regulation, in the evaluation of a substance, if a substance is suspected of posing a risk to health or the environment, the ECHA is entitled to request further information about that substance. |
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272

Under Article 1(1) of Regulation No 1907/2006, the latter seeks to ensure a high level of protection of human health and the environment. Moreover, it follows from the second sentence of Article 1(3) of that regulation that those provisions are underpinned by the precautionary principle. As is apparent from recital 66 of that regulation, in the evaluation of a substance, if a substance is suspected of posing a risk to health or the environment, the ECHA is entitled to request further information about that substance.

| 273 | In order to establish that the neurotoxicity rat study was necessary, the ECHA was therefore not required to demonstrate that, on the basis of the information at its disposal, Triclosan should be considered to be neurotoxic. It was sufficient for it to establish that there was a potential risk of neurotoxicity. |
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273

In order to establish that the neurotoxicity rat study was necessary, the ECHA was therefore not required to demonstrate that, on the basis of the information at its disposal, Triclosan should be considered to be neurotoxic. It was sufficient for it to establish that there was a potential risk of neurotoxicity.

| 274 | In the second place, it is necessary to examine the applicant’s argument alleging that, in paragraph 156 of the contested decision, the Board of Appeal unduly reversed the burden of proof. |
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274

In the second place, it is necessary to examine the applicant’s argument alleging that, in paragraph 156 of the contested decision, the Board of Appeal unduly reversed the burden of proof.

| 275 | Firstly, in so far as the argument mentioned in paragraph 274 above refers to the allocation of the burden of proof during the procedure before the Board of Appeal, it should be noted that the Board of Appeal did not commit an error when it considered, in the fourth sentence of paragraph 156 of the contested decision, that it was for the applicant to demonstrate that the ECHA’s conclusions were vitiated by error. That allocation of the burden of proof results from the adversarial nature of the procedure before that board. Therefore, the applicant’s argument must be rejected in so far as it refers to the allocation of the burden of proof during that procedure. |
| --- | --- |

275

Firstly, in so far as the argument mentioned in paragraph 274 above refers to the allocation of the burden of proof during the procedure before the Board of Appeal, it should be noted that the Board of Appeal did not commit an error when it considered, in the fourth sentence of paragraph 156 of the contested decision, that it was for the applicant to demonstrate that the ECHA’s conclusions were vitiated by error. That allocation of the burden of proof results from the adversarial nature of the procedure before that board. Therefore, the applicant’s argument must be rejected in so far as it refers to the allocation of the burden of proof during that procedure.

| 276 | Secondly, in so far as the argument mentioned in paragraph 274 above refers to the burden of proof during the procedure before the ECHA, it should be noted that, in order to demonstrate that a request is necessary, it is for the ECHA to establish that the substance at issue poses a potential risk for human health and the environment, that it is necessary to clarify that risk and that there is a realistic possibility that the information requested allows improved risk management measures to be taken. |
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276

Secondly, in so far as the argument mentioned in paragraph 274 above refers to the burden of proof during the procedure before the ECHA, it should be noted that, in order to demonstrate that a request is necessary, it is for the ECHA to establish that the substance at issue poses a potential risk for human health and the environment, that it is necessary to clarify that risk and that there is a realistic possibility that the information requested allows improved risk management measures to be taken.

| 277 | However, it must be pointed out that the Board of Appeal did not disregard the rules on the burden of proof applying to the procedure before the ECHA. That board’s finding in the fourth sentence of paragraph 156 of the contested decision refers solely to the allocation of the burden of proof during the procedure before that board. By contrast, as is apparent from paragraph 150 of that decision, concerning the procedure before the ECHA, the board in question followed an approach which is compatible with the rule referred to in paragraph 276 above. |
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277

However, it must be pointed out that the Board of Appeal did not disregard the rules on the burden of proof applying to the procedure before the ECHA. That board’s finding in the fourth sentence of paragraph 156 of the contested decision refers solely to the allocation of the burden of proof during the procedure before that board. By contrast, as is apparent from paragraph 150 of that decision, concerning the procedure before the ECHA, the board in question followed an approach which is compatible with the rule referred to in paragraph 276 above.

| 278 | In the light of those considerations, it is necessary to reject the argument referred to in paragraph 274 above. |
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278

In the light of those considerations, it is necessary to reject the argument referred to in paragraph 274 above.

| 279 | In the third place, the applicant claims that, in paragraphs 134, 155 and 156 of the contested decision, the Board of Appeal should not have relied on the consideration that a difference of scientific opinion did not indicate a legal violation. It should not have limited its review due to the ECHA’s discretion. |
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279

In the third place, the applicant claims that, in paragraphs 134, 155 and 156 of the contested decision, the Board of Appeal should not have relied on the consideration that a difference of scientific opinion did not indicate a legal violation. It should not have limited its review due to the ECHA’s discretion.

| 280 | First of all, it should be noted that, in the light of the adversarial nature of the proceedings before the Board of Appeal, in such proceedings, the applicant must put forward detailed arguments calling into question the ECHA’s findings. Therefore, where, during the procedure which led to the adoption of the ECHA decision, the applicant puts forward arguments alleging that the available information does not allow a finding that there is a potential risk to human health or the environment or alleging that some of the information allows the absence of adverse effects of a substance on human health of the environment to be demonstrated and that, as a result, in its decision, the ECHA examines and rejects those arguments, in the context of proceedings before the Board of Appeal, it is for the applicant to put forward detailed arguments to show that the considerations relied on by the ECHA are incorrect. In that case, any argument of the applicant before that board which merely evokes the existence of studies taken into account by the ECHA, but which does not set out the reasons why the ECHA’s considerations are allegedly incorrect, cannot be considered to be sufficiently substantiated. |
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280

First of all, it should be noted that, in the light of the adversarial nature of the proceedings before the Board of Appeal, in such proceedings, the applicant must put forward detailed arguments calling into question the ECHA’s findings. Therefore, where, during the procedure which led to the adoption of the ECHA decision, the applicant puts forward arguments alleging that the available information does not allow a finding that there is a potential risk to human health or the environment or alleging that some of the information allows the absence of adverse effects of a substance on human health of the environment to be demonstrated and that, as a result, in its decision, the ECHA examines and rejects those arguments, in the context of proceedings before the Board of Appeal, it is for the applicant to put forward detailed arguments to show that the considerations relied on by the ECHA are incorrect. In that case, any argument of the applicant before that board which merely evokes the existence of studies taken into account by the ECHA, but which does not set out the reasons why the ECHA’s considerations are allegedly incorrect, cannot be considered to be sufficiently substantiated.

| 281 | It is in the light of the foregoing that it is necessary to examine the applicant’s arguments relating to the Board of Appeal’s findings in paragraphs 134, 155 and 156 of the contested decision. |
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281

It is in the light of the foregoing that it is necessary to examine the applicant’s arguments relating to the Board of Appeal’s findings in paragraphs 134, 155 and 156 of the contested decision.

| 282 | Firstly, in paragraph 155 of the contested decision, in essence, the Board of Appeal held that the applicant’s arguments concerning the conclusions to be drawn from the available information were limited to noting that the applicant was not in agreement with the conclusions reached by the ECHA. In that context, it referred to the fourth sentence of paragraph 134 of that decision, where it stated that the fact that the applicant did not share a scientific conclusion of the ECHA did not suffice in order to demonstrate the existence of an error vitiating that conclusion. |
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282

Firstly, in paragraph 155 of the contested decision, in essence, the Board of Appeal held that the applicant’s arguments concerning the conclusions to be drawn from the available information were limited to noting that the applicant was not in agreement with the conclusions reached by the ECHA. In that context, it referred to the fourth sentence of paragraph 134 of that decision, where it stated that the fact that the applicant did not share a scientific conclusion of the ECHA did not suffice in order to demonstrate the existence of an error vitiating that conclusion.

| 283 | Secondly, in paragraph 156 of the contested decision, the Board of Appeal noted that, in the context of the action, the applicant had claimed that, according to the Axelstad study (2013), it was unlikely that Triclosan has the relevant adverse effects. In that regard, it noted that, in that study, it was also stated that it could be necessary to conduct a further evaluation of Triclosan as a potentially neurotoxic substance. It also noted that the ECHA had claimed that the study at issue was not sufficient to dispel the concern that Triclosan may affect the brain development of offspring by reducing the level of thyroxine in the mother. In that context, it held that the applicant had not established that that finding by the ECHA was incorrect, but merely indicated that it did not agree with the ECHA’s interpretation of the available information. Therefore, it again referred to the fourth sentence of paragraph 134 of that decision, where it stated that the fact that the applicant did not share a conclusion on a scientific point expressed by the ECHA was not sufficient to show the existence of an error affecting that conclusion. |
| --- | --- |

283

Secondly, in paragraph 156 of the contested decision, the Board of Appeal noted that, in the context of the action, the applicant had claimed that, according to the Axelstad study (2013), it was unlikely that Triclosan has the relevant adverse effects. In that regard, it noted that, in that study, it was also stated that it could be necessary to conduct a further evaluation of Triclosan as a potentially neurotoxic substance. It also noted that the ECHA had claimed that the study at issue was not sufficient to dispel the concern that Triclosan may affect the brain development of offspring by reducing the level of thyroxine in the mother. In that context, it held that the applicant had not established that that finding by the ECHA was incorrect, but merely indicated that it did not agree with the ECHA’s interpretation of the available information. Therefore, it again referred to the fourth sentence of paragraph 134 of that decision, where it stated that the fact that the applicant did not share a conclusion on a scientific point expressed by the ECHA was not sufficient to show the existence of an error affecting that conclusion.

| 284 | In the light of the considerations set out in paragraph 280 above, the Board of Appeal cannot be criticised for having rejected the arguments by which the applicant merely indicated its disagreement with the ECHA’s conclusion as not sufficiently substantiated for the reasons set out in paragraphs 155 and 156 of the contested decision. |
| --- | --- |

284

In the light of the considerations set out in paragraph 280 above, the Board of Appeal cannot be criticised for having rejected the arguments by which the applicant merely indicated its disagreement with the ECHA’s conclusion as not sufficiently substantiated for the reasons set out in paragraphs 155 and 156 of the contested decision.

| 285 | In that context, it should also be noted that, in paragraphs 155 and 156 of the contested decision, the Board of Appeal rejected the applicant’s arguments either because they were not sufficiently substantiated or because they were unfounded. By contrast, it is not because those arguments were not capable of demonstrating the existence of a manifest error vitiating the ECHA’s findings that it rejected them. Therefore, contrary to what is claimed by the applicant, it cannot be deduced from those paragraphs that that board limited the intensity of its review due to the ECHA’s discretion. |
| --- | --- |

285

In that context, it should also be noted that, in paragraphs 155 and 156 of the contested decision, the Board of Appeal rejected the applicant’s arguments either because they were not sufficiently substantiated or because they were unfounded. By contrast, it is not because those arguments were not capable of demonstrating the existence of a manifest error vitiating the ECHA’s findings that it rejected them. Therefore, contrary to what is claimed by the applicant, it cannot be deduced from those paragraphs that that board limited the intensity of its review due to the ECHA’s discretion.

| 286 | Therefore, the argument referring to paragraphs 134, 155 and 156 of the contested decision must also be rejected. |
| --- | --- |

286

Therefore, the argument referring to paragraphs 134, 155 and 156 of the contested decision must also be rejected.

| 287 | In the fourth place, concerning the applicant’s arguments based on the Witorsch report, firstly, it should be noted that, in so far as the applicant invoked that report in the context of the sixth plea in the action, alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, its arguments must be rejected on the same grounds as those set out in paragraphs 200 to 205 above. Secondly, it must be noted that, in the context of the seventh and eighth pleas in the action before the Board of Appeal, which alleged an infringement of Article 25 of Regulation No 1907/2006 and a breach of the principle of proportionality, the applicant did not invoke that report. In the light of the adversarial nature of the proceedings before that board, it cannot therefore be complained that that board failed to take into account the report in question in the examination of those grounds. In any event, it must be noted that, in the context of that action, the applicant did not comprehensively set out the reasons why, according to it, in view of the contents of that report, the findings included in the ECHA decision had to be regarded as mistaken. Thirdly, in so far as the applicant claims that, in the light of those contents, the Board of Appeal’s findings should be regarded as mistaken, it suffices to note that it did not comprehensively set out the reasons why, in view of those contents, the Board of Appeal’s findings should be regarded as mistaken. Therefore, the entirety of the arguments based on the report concerned must be rejected. |
| --- | --- |

287

In the fourth place, concerning the applicant’s arguments based on the Witorsch report, firstly, it should be noted that, in so far as the applicant invoked that report in the context of the sixth plea in the action, alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, its arguments must be rejected on the same grounds as those set out in paragraphs 200 to 205 above. Secondly, it must be noted that, in the context of the seventh and eighth pleas in the action before the Board of Appeal, which alleged an infringement of Article 25 of Regulation No 1907/2006 and a breach of the principle of proportionality, the applicant did not invoke that report. In the light of the adversarial nature of the proceedings before that board, it cannot therefore be complained that that board failed to take into account the report in question in the examination of those grounds. In any event, it must be noted that, in the context of that action, the applicant did not comprehensively set out the reasons why, according to it, in view of the contents of that report, the findings included in the ECHA decision had to be regarded as mistaken. Thirdly, in so far as the applicant claims that, in the light of those contents, the Board of Appeal’s findings should be regarded as mistaken, it suffices to note that it did not comprehensively set out the reasons why, in view of those contents, the Board of Appeal’s findings should be regarded as mistaken. Therefore, the entirety of the arguments based on the report concerned must be rejected.

| 288 | In the fifth place, in so far as the applicant claims that the Board of Appeal failed to take into account differences between the effects of Triclosan on rats, on the one hand, and on humans, on the other hand, and that the findings in the contested decision are contradictory, since, in order to identify a potential risk of neurotoxicity in humans, that board relied exclusively on data from studies on rats, it should be noted that those arguments refer to paragraph 157 of that decision, which concerns arguments alleging differences between the effects of Triclosan on rats and on humans. It must be noted that, in that paragraph, that board referred to its conclusions set out in paragraphs 163 to 165 of that decision. The applicant’s arguments are therefore taken into account in the context of the examination of the arguments concerning that board’s findings (see paragraphs 365 to 383 below). |
| --- | --- |

288

In the fifth place, in so far as the applicant claims that the Board of Appeal failed to take into account differences between the effects of Triclosan on rats, on the one hand, and on humans, on the other hand, and that the findings in the contested decision are contradictory, since, in order to identify a potential risk of neurotoxicity in humans, that board relied exclusively on data from studies on rats, it should be noted that those arguments refer to paragraph 157 of that decision, which concerns arguments alleging differences between the effects of Triclosan on rats and on humans. It must be noted that, in that paragraph, that board referred to its conclusions set out in paragraphs 163 to 165 of that decision. The applicant’s arguments are therefore taken into account in the context of the examination of the arguments concerning that board’s findings (see paragraphs 365 to 383 below).

| 289 | In the sixth place, in so far as the applicant claims that, in paragraph 153 of the contested decision, the Board of Appeal should not have confined itself to noting that the ECHA had examined a large number of studies, but should have examined itself whether, on the basis of the available information, it could have excluded the potential risk of neurotoxicity, it should be pointed out that, as was set out in paragraphs 59 to 86 above, in the context of an action before it, that board merely examines the pleas put forward by the applicant. Therefore, that board cannot be criticised for having stated, in paragraph 153 of that decision, that the ECHA had examined a large number of studies or for having confined itself, in paragraphs 154 to 159 of that decision, to examining the arguments which were developed by the applicant in the context of the administrative appeal. |
| --- | --- |

289

In the sixth place, in so far as the applicant claims that, in paragraph 153 of the contested decision, the Board of Appeal should not have confined itself to noting that the ECHA had examined a large number of studies, but should have examined itself whether, on the basis of the available information, it could have excluded the potential risk of neurotoxicity, it should be pointed out that, as was set out in paragraphs 59 to 86 above, in the context of an action before it, that board merely examines the pleas put forward by the applicant. Therefore, that board cannot be criticised for having stated, in paragraph 153 of that decision, that the ECHA had examined a large number of studies or for having confined itself, in paragraphs 154 to 159 of that decision, to examining the arguments which were developed by the applicant in the context of the administrative appeal.

| 290 | In the light of those considerations, the arguments relating specifically to the Board of Appeal’s considerations concerning the potential risk of neurotoxicity posed by Triclosan must be rejected, subject to the arguments relating to the differences between the effects of Triclosan on rats, on the one hand, and on humans, on the other hand, which will be examined in paragraphs 339 to 386 below. |
| --- | --- |

290

In the light of those considerations, the arguments relating specifically to the Board of Appeal’s considerations concerning the potential risk of neurotoxicity posed by Triclosan must be rejected, subject to the arguments relating to the differences between the effects of Triclosan on rats, on the one hand, and on humans, on the other hand, which will be examined in paragraphs 339 to 386 below.

(2) The arguments relating specifically to the Board of Appeal’s findings concerning the potential risk of reproductive toxicity posed by Triclosan

(2)

The arguments relating specifically to the Board of Appeal’s findings concerning the potential risk of reproductive toxicity posed by Triclosan

| 291 | In paragraph 154 of the contested decision, in the context of the examination of the applicant’s arguments seeking to demonstrate that the request to conduct the enhanced neurotoxicity rat study was not necessary, the Board of Appeal considered that those arguments were not sufficiently substantiated. |
| --- | --- |

291

In paragraph 154 of the contested decision, in the context of the examination of the applicant’s arguments seeking to demonstrate that the request to conduct the enhanced neurotoxicity rat study was not necessary, the Board of Appeal considered that those arguments were not sufficiently substantiated.

| 292 | The applicant claims that that conclusion is wrong. As a first step, it maintains that the Board of Appeal distorted the arguments that it had put forward in the context of the notice of appeal. As a second step, it claims that, in the light of the existing studies, that board should have found that there was no risk of reproductive toxicity connected with Triclosan. |
| --- | --- |

292

The applicant claims that that conclusion is wrong. As a first step, it maintains that the Board of Appeal distorted the arguments that it had put forward in the context of the notice of appeal. As a second step, it claims that, in the light of the existing studies, that board should have found that there was no risk of reproductive toxicity connected with Triclosan.

(i) The arguments alleging a distortion of the applicant’s arguments

(i)

The arguments alleging a distortion of the applicant’s arguments

| 293 | In the context of the second part of the first plea and the first part of the second plea, the applicant claims that, in paragraph 154 of the contested decision, the Board of Appeal distorted the arguments it had put forward in the notice of appeal. According to it, that board stated that, in the context of the seventh and eighth grounds of the administrative appeal, it had failed to put forward an argument capable of calling into question the need to conduct the enhanced neurotoxicity rat study given the concerns relating to the reproductive toxicity of Triclosan. It alleges however that, in the notice of appeal, it put forward arguments calling into question the ECHA’s conclusion that Triclosan presented a potential risk of reproductive toxicity. It states that it claimed that the finding, in the ECHA decision, that no results on the weight or morphology of male reproductive organs had been presented in its registration dossier, was incorrect, because, according to it, the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies contained such information. |
| --- | --- |

293

In the context of the second part of the first plea and the first part of the second plea, the applicant claims that, in paragraph 154 of the contested decision, the Board of Appeal distorted the arguments it had put forward in the notice of appeal. According to it, that board stated that, in the context of the seventh and eighth grounds of the administrative appeal, it had failed to put forward an argument capable of calling into question the need to conduct the enhanced neurotoxicity rat study given the concerns relating to the reproductive toxicity of Triclosan. It alleges however that, in the notice of appeal, it put forward arguments calling into question the ECHA’s conclusion that Triclosan presented a potential risk of reproductive toxicity. It states that it claimed that the finding, in the ECHA decision, that no results on the weight or morphology of male reproductive organs had been presented in its registration dossier, was incorrect, because, according to it, the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies contained such information.

| 294 | The ECHA disputes those arguments. |
| --- | --- |

294

The ECHA disputes those arguments.

| 295 | First of all, it should be noted that, in the context of the action against the ECHA decision, the applicant developed arguments concerning the enhanced neurotoxicity rat study (paragraphs 47 to 106 of the notice of appeal). The arguments developed by the applicant in that context were presented in the form of an introductory section (paragraphs 48 to 51 of that notice), and three parts, the first of which referred specifically to concerns in relation to the neurotoxicity of Triclosan (paragraphs 52 to 85 of that notice) and the second specifically to the concerns in relation to the reproductive toxicity of that substance (paragraphs 86 to 97 of that notice). The third part alleged an infringement of Article 25(1) of Regulation No 1907/2006 and of the principle of proportionality (paragraphs 98 to 106 of the notice in question). |
| --- | --- |

295

First of all, it should be noted that, in the context of the action against the ECHA decision, the applicant developed arguments concerning the enhanced neurotoxicity rat study (paragraphs 47 to 106 of the notice of appeal). The arguments developed by the applicant in that context were presented in the form of an introductory section (paragraphs 48 to 51 of that notice), and three parts, the first of which referred specifically to concerns in relation to the neurotoxicity of Triclosan (paragraphs 52 to 85 of that notice) and the second specifically to the concerns in relation to the reproductive toxicity of that substance (paragraphs 86 to 97 of that notice). The third part alleged an infringement of Article 25(1) of Regulation No 1907/2006 and of the principle of proportionality (paragraphs 98 to 106 of the notice in question).

| 296 | In that regard, it should be noted that, admittedly, in the context of the part of the notice of appeal which refers specifically to a breach of the principle of proportionality, namely in paragraphs 98 to 106 of that notice, the applicant did not develop detailed arguments calling into question the ECHA’s findings relating to the necessity of requesting the enhanced neurotoxicity rat study in the light of the potential risk of reproductive toxicity posed by Triclosan. |
| --- | --- |

296

In that regard, it should be noted that, admittedly, in the context of the part of the notice of appeal which refers specifically to a breach of the principle of proportionality, namely in paragraphs 98 to 106 of that notice, the applicant did not develop detailed arguments calling into question the ECHA’s findings relating to the necessity of requesting the enhanced neurotoxicity rat study in the light of the potential risk of reproductive toxicity posed by Triclosan.

| 297 | However, it must be noted that, in paragraph 106 of the notice of appeal, the applicant indicated that the request to conduct that study was not necessarily for the ‘reasons set out above’. Contrary to what is put forward by the ECHA, it is sufficiently clear from that reference to that paragraph and from its context that, in that paragraph, the applicant refers to its arguments developed in paragraphs 86 to 97 of that notice, concerning the potential risk of reproductive toxicity posed by Triclosan. In that context, the applicant had put forward in particular that the finding in the ECHA decision, according to which there were no results on the weight or morphology of male reproductive organs in the registration dossier was incorrect. |
| --- | --- |

297

However, it must be noted that, in paragraph 106 of the notice of appeal, the applicant indicated that the request to conduct that study was not necessarily for the ‘reasons set out above’. Contrary to what is put forward by the ECHA, it is sufficiently clear from that reference to that paragraph and from its context that, in that paragraph, the applicant refers to its arguments developed in paragraphs 86 to 97 of that notice, concerning the potential risk of reproductive toxicity posed by Triclosan. In that context, the applicant had put forward in particular that the finding in the ECHA decision, according to which there were no results on the weight or morphology of male reproductive organs in the registration dossier was incorrect.

| 298 | Therefore, the applicant correctly claims that, in paragraph 106 of the notice of appeal, in the context of the part alleging an infringement of Article 25(1) of Regulation No 1907/2006 and of the principle of proportionality, it put forward an argument calling into question the ECHA’s conclusion that Triclosan posed a potential risk of reproductive toxicity, namely the argument alleging that, contrary to the finding in that decision, there were results on the weight or morphology of male reproductive organs in the registration dossier. |
| --- | --- |

298

Therefore, the applicant correctly claims that, in paragraph 106 of the notice of appeal, in the context of the part alleging an infringement of Article 25(1) of Regulation No 1907/2006 and of the principle of proportionality, it put forward an argument calling into question the ECHA’s conclusion that Triclosan posed a potential risk of reproductive toxicity, namely the argument alleging that, contrary to the finding in that decision, there were results on the weight or morphology of male reproductive organs in the registration dossier.

| 299 | In that context, it should also be noted that, in the context of its response to the seventh and eighth pleas, the Board of Appeal did not expressly respond to that argument. |
| --- | --- |

299

In that context, it should also be noted that, in the context of its response to the seventh and eighth pleas, the Board of Appeal did not expressly respond to that argument.

| 300 | However, since the applicant had developed the argument relating to the erroneous nature of the finding according to which the results on the weight or morphology of male reproductive organs were not present in the registration dossier, in paragraphs 86 to 97 of the notice of appeal, and thus in the context of the second part of sixth plea, it is necessary to examine whether, in the examination of that part, the Board of Appeal did indeed respond to that argument. |
| --- | --- |

300

However, since the applicant had developed the argument relating to the erroneous nature of the finding according to which the results on the weight or morphology of male reproductive organs were not present in the registration dossier, in paragraphs 86 to 97 of the notice of appeal, and thus in the context of the second part of sixth plea, it is necessary to examine whether, in the examination of that part, the Board of Appeal did indeed respond to that argument.

| 301 | In that context, it should be recalled that, as was stated in paragraphs 238 to 242 above, in the context of the examination of the second part of the sixth plea in the action before it, the Board of Appeal did not confine itself to examining the arguments alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, but also examined, in paragraph 202 of the contested decision, the argument alleging that a weight of evidence determination of the available information would have allowed the existence of a potential risk that Triclosan is reproductive toxic to be excluded. As was stated in paragraphs 238 to 242 above, in paragraph 202 of that decision, it, in essence, relied on the finding that indications concerning the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies included in the ECHA decision explained the reasons why those studies did not provide sufficient information enabling a reliable evaluation of the absence of effects on reproduction and that the applicant had not put forward detailed arguments calling those findings into question. |
| --- | --- |

301

In that context, it should be recalled that, as was stated in paragraphs 238 to 242 above, in the context of the examination of the second part of the sixth plea in the action before it, the Board of Appeal did not confine itself to examining the arguments alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, but also examined, in paragraph 202 of the contested decision, the argument alleging that a weight of evidence determination of the available information would have allowed the existence of a potential risk that Triclosan is reproductive toxic to be excluded. As was stated in paragraphs 238 to 242 above, in paragraph 202 of that decision, it, in essence, relied on the finding that indications concerning the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies included in the ECHA decision explained the reasons why those studies did not provide sufficient information enabling a reliable evaluation of the absence of effects on reproduction and that the applicant had not put forward detailed arguments calling those findings into question.

| 302 | It is by taking that response of the Board of Appeal into account that it is necessary to understand the latter’s consideration in paragraph 154 of the contested decision, according to which, in the context of the seventh and eighth pleas in the administrative appeal, the applicant had not put forward arguments calling into question the necessity to conduct the enhanced neurotoxicity rat study in the light of the potential risk posed by Triclosan. |
| --- | --- |

302

It is by taking that response of the Board of Appeal into account that it is necessary to understand the latter’s consideration in paragraph 154 of the contested decision, according to which, in the context of the seventh and eighth pleas in the administrative appeal, the applicant had not put forward arguments calling into question the necessity to conduct the enhanced neurotoxicity rat study in the light of the potential risk posed by Triclosan.

| 303 | As was stated above, the Board of Appeal had already responded to the argument that the applicant had put forward in the context of the second part of the sixth plea in the examination of that part. It cannot therefore be accused of failing to examine it again in the context of the examination of the eighth plea, where the applicant merely referred to that argument. |
| --- | --- |

303

As was stated above, the Board of Appeal had already responded to the argument that the applicant had put forward in the context of the second part of the sixth plea in the examination of that part. It cannot therefore be accused of failing to examine it again in the context of the examination of the eighth plea, where the applicant merely referred to that argument.

| 304 | Therefore, in paragraph 154 of the contested decision, the Board of Appeal did not distort the applicant’s arguments. |
| --- | --- |

304

Therefore, in paragraph 154 of the contested decision, the Board of Appeal did not distort the applicant’s arguments.

| 305 | In any event, even assuming that, in paragraph 154 of the contested decision, the Board of Appeal distorted the applicant’s arguments, such an error could not lead to the annulment of that decision. The reasons why the ECHA had considered that the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies did not provide sufficient information allowing the absence of effects on reproduction to be reliably assessed justified in themselves the conclusion that the contents of those studies did not oppose the request for the enhanced neurotoxicity rat study to be conducted and, in the notice of appeal before that board, the applicant had not put forward arguments calling into question those considerations. |
| --- | --- |

305

In any event, even assuming that, in paragraph 154 of the contested decision, the Board of Appeal distorted the applicant’s arguments, such an error could not lead to the annulment of that decision. The reasons why the ECHA had considered that the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies did not provide sufficient information allowing the absence of effects on reproduction to be reliably assessed justified in themselves the conclusion that the contents of those studies did not oppose the request for the enhanced neurotoxicity rat study to be conducted and, in the notice of appeal before that board, the applicant had not put forward arguments calling into question those considerations.

| 306 | Therefore, the argument alleging that, in paragraph 154 of the contested decision, the Board of Appeal distorted the arguments which the applicant had put forward in the notice of appeal must be rejected. |
| --- | --- |

306

Therefore, the argument alleging that, in paragraph 154 of the contested decision, the Board of Appeal distorted the arguments which the applicant had put forward in the notice of appeal must be rejected.

(ii) The arguments alleging the existence of studies confirming that Triclosan does not have reproductive toxic effects

(ii)

The arguments alleging the existence of studies confirming that Triclosan does not have reproductive toxic effects

| 307 | In the context of the first part of the second plea, the applicant claims that the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies as well as the Witorsch report confirm that Triclosan does not have reproductive toxic effects. It maintains that the ECHA and the Board of Appeal should have carried out a weight of evidence determination of the evidence. According to it, the ECHA and that board acknowledged that the samples studied could have been contaminated by dioxins which could have produced the results observed. |
| --- | --- |

307

In the context of the first part of the second plea, the applicant claims that the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies as well as the Witorsch report confirm that Triclosan does not have reproductive toxic effects. It maintains that the ECHA and the Board of Appeal should have carried out a weight of evidence determination of the evidence. According to it, the ECHA and that board acknowledged that the samples studied could have been contaminated by dioxins which could have produced the results observed.

| 308 | The ECHA and the interveners dispute those arguments. |
| --- | --- |

308

The ECHA and the interveners dispute those arguments.

| 309 | As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should have examined whether it was necessary to request the enhanced neurotoxicity rat study to be conducted, by itself again evaluating the relevant information, it is necessary to reject them for the same reasons as those set out in paragraphs 55 to 131 above. |
| --- | --- |

309

As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should have examined whether it was necessary to request the enhanced neurotoxicity rat study to be conducted, by itself again evaluating the relevant information, it is necessary to reject them for the same reasons as those set out in paragraphs 55 to 131 above.

| 310 | As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision. |
| --- | --- |

310

As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision.

| 311 | In that context, in the first place, it is necessary to reject the applicant’s arguments concerning the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies. As was stated in paragraph 305 above, in its decision, the ECHA set out the reasons why, according to it, those studies did not provide sufficient information so as to reliably asses the absence of effects on reproduction and, in the action before the Board of Appeal, the applicant did not put forward arguments capable of calling those findings into question. |
| --- | --- |

311

In that context, in the first place, it is necessary to reject the applicant’s arguments concerning the Ciba-Geigy (1983) and Ciba-Geigy (1986) studies. As was stated in paragraph 305 above, in its decision, the ECHA set out the reasons why, according to it, those studies did not provide sufficient information so as to reliably asses the absence of effects on reproduction and, in the action before the Board of Appeal, the applicant did not put forward arguments capable of calling those findings into question.

| 312 | In the second place, as regards the arguments according to which the Board of Appeal did not sufficiently take into account the Witorsch report, it is necessary to reject them for the same reasons as those set out in paragraph 287 above. |
| --- | --- |

312

In the second place, as regards the arguments according to which the Board of Appeal did not sufficiently take into account the Witorsch report, it is necessary to reject them for the same reasons as those set out in paragraph 287 above.

| 313 | In the third place, as regards the argument alleging that the study samples may have been contaminated by dioxins, which would have been capable of having produced the observed results, firstly, it should be noted that the applicant did not put forward an argument to that effect in the context of the seventh and eighth pleas in the action before the Board of Appeal. Secondly and in any event, it must be stated that, in so far as the applicant put forward arguments in that regard in the context of the first part of the sixth plea in that action, that board responded to them in paragraph 197 of the contested decision. However, it must be noted that, in the present action, the applicant does not put any detailed arguments forward calling that response into question. |
| --- | --- |

313

In the third place, as regards the argument alleging that the study samples may have been contaminated by dioxins, which would have been capable of having produced the observed results, firstly, it should be noted that the applicant did not put forward an argument to that effect in the context of the seventh and eighth pleas in the action before the Board of Appeal. Secondly and in any event, it must be stated that, in so far as the applicant put forward arguments in that regard in the context of the first part of the sixth plea in that action, that board responded to them in paragraph 197 of the contested decision. However, it must be noted that, in the present action, the applicant does not put any detailed arguments forward calling that response into question.

| 314 | Therefore, it is necessary to reject the arguments relating to the existence of studies confirming that Triclosan does not have reproductive toxic effects and, therefore, all of the arguments relating specifically to the Board of Appeal’s findings concerning the potential risk of reproductive toxicity posed by Triclosan. |
| --- | --- |

314

Therefore, it is necessary to reject the arguments relating to the existence of studies confirming that Triclosan does not have reproductive toxic effects and, therefore, all of the arguments relating specifically to the Board of Appeal’s findings concerning the potential risk of reproductive toxicity posed by Triclosan.

(3) The arguments relating to the evaluation carried out by the Canadian authorities

(3)

The arguments relating to the evaluation carried out by the Canadian authorities

| 315 | In the context of the first part of the second plea, the applicant claims that, on the basis of a weight of evidence approach, without requesting further tests, the Canadian authorities concluded that Triclosan did not have neurotoxic or reproductive toxic effects. Those authorities in particular expressed doubts concerning the appropriateness of the extrapolation to humans of the results of tests on rats. In that context, the applicant refers to a report by those authorities of 26 November 2016. |
| --- | --- |

315

In the context of the first part of the second plea, the applicant claims that, on the basis of a weight of evidence approach, without requesting further tests, the Canadian authorities concluded that Triclosan did not have neurotoxic or reproductive toxic effects. Those authorities in particular expressed doubts concerning the appropriateness of the extrapolation to humans of the results of tests on rats. In that context, the applicant refers to a report by those authorities of 26 November 2016.

| 316 | The ECHA and the interveners dispute those arguments. |
| --- | --- |

316

The ECHA and the interveners dispute those arguments.

| 317 | As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should have decided itself whether it was necessary to request the enhanced neurotoxicity rat study to be conducted, by taking into account, in the context of its own evaluation, the Canadian authorities’ evaluation, they should be rejected for the same reasons as those set out in paragraphs 55 to 131 above. |
| --- | --- |

317

As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should have decided itself whether it was necessary to request the enhanced neurotoxicity rat study to be conducted, by taking into account, in the context of its own evaluation, the Canadian authorities’ evaluation, they should be rejected for the same reasons as those set out in paragraphs 55 to 131 above.

| 318 | As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that, in the context of the review of the ECHA decision, the Board of Appeal committed an error. |
| --- | --- |

318

As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that, in the context of the review of the ECHA decision, the Board of Appeal committed an error.

| 319 | In that context, it should be noted that, in paragraphs 150 to 160 of the contested decision, the Board of Appeal examined the applicant’s arguments seeking to demonstrate that the ECHA should not have concluded that the request to conduct the enhanced neurotoxicity rat study was necessary. |
| --- | --- |

319

In that context, it should be noted that, in paragraphs 150 to 160 of the contested decision, the Board of Appeal examined the applicant’s arguments seeking to demonstrate that the ECHA should not have concluded that the request to conduct the enhanced neurotoxicity rat study was necessary.

| 320 | Firstly, in so far as, by its arguments, the applicant claims that, in the context of its examination, the Board of Appeal should have taken into account the report of the Canadian authorities, it should be noted that, as a result of the adversarial nature of the proceedings before that board, it was for the applicant to produce that report during those proceedings. However, the applicant does not claim that it submitted it during those proceedings. In that context it should be noted that the report in question was published on 26 November 2016, namely after the hearing before that board which took place on 9 June 2016 (see paragraph 22 above), and that the applicant does not claim that that report was submitted to that board after the hearing. |
| --- | --- |

320

Firstly, in so far as, by its arguments, the applicant claims that, in the context of its examination, the Board of Appeal should have taken into account the report of the Canadian authorities, it should be noted that, as a result of the adversarial nature of the proceedings before that board, it was for the applicant to produce that report during those proceedings. However, the applicant does not claim that it submitted it during those proceedings. In that context it should be noted that the report in question was published on 26 November 2016, namely after the hearing before that board which took place on 9 June 2016 (see paragraph 22 above), and that the applicant does not claim that that report was submitted to that board after the hearing.

| 321 | Secondly, in so far as, by its arguments, the applicant claims that the Canadian authorities’ evaluation shows that the Board of Appeal’s considerations in paragraphs 150 to 160 of the contested decision are incorrect, it should be noted that it merely invokes the existence of that evaluation, but does not set out the reasons why those conclusions are capable of calling into question the lawfulness of that board’s findings, which are based on the rules provided for by Regulation No 1907/2006. Therefore, the arguments drawn by the applicant from that evaluation must be rejected as insufficiently substantiated. |
| --- | --- |

321

Secondly, in so far as, by its arguments, the applicant claims that the Canadian authorities’ evaluation shows that the Board of Appeal’s considerations in paragraphs 150 to 160 of the contested decision are incorrect, it should be noted that it merely invokes the existence of that evaluation, but does not set out the reasons why those conclusions are capable of calling into question the lawfulness of that board’s findings, which are based on the rules provided for by Regulation No 1907/2006. Therefore, the arguments drawn by the applicant from that evaluation must be rejected as insufficiently substantiated.

| 322 | Therefore, it is necessary also to reject the arguments referring to the evaluation by the Canadian authorities. |
| --- | --- |

322

Therefore, it is necessary also to reject the arguments referring to the evaluation by the Canadian authorities.

(4) The arguments alleging that the Board of Appeal disregarded the fact that the weight of evidence determination applied in the context of the evaluation of substances

(4)

The arguments alleging that the Board of Appeal disregarded the fact that the weight of evidence determination applied in the context of the evaluation of substances

| 323 | In the context of the first part of the second plea, the applicant claims that, in paragraph 152 of the contested decision, the Board of Appeal disregarded the fact that the weight of evidence determination applied in the context of the evaluation of substances and thus allowed it to exercise its discretion in relation to complex scientific and technical assessments by taking into account all the relevant evidence. |
| --- | --- |

323

In the context of the first part of the second plea, the applicant claims that, in paragraph 152 of the contested decision, the Board of Appeal disregarded the fact that the weight of evidence determination applied in the context of the evaluation of substances and thus allowed it to exercise its discretion in relation to complex scientific and technical assessments by taking into account all the relevant evidence.

| 324 | The ECHA and the interveners dispute those arguments. |
| --- | --- |

324

The ECHA and the interveners dispute those arguments.

| 325 | As a first step, it is necessary to reject the arguments put forward by the applicant in so far as they seek to demonstrate that the Board of Appeal should have itself conducted a new examination by determining itself the evidential weight of the available information. As was stated in paragraphs 55 to 131 above, in the action before it, that board merely examines whether, in the light of the arguments put forward by the applicant, the ECHA decision was vitiated by error. |
| --- | --- |

325

As a first step, it is necessary to reject the arguments put forward by the applicant in so far as they seek to demonstrate that the Board of Appeal should have itself conducted a new examination by determining itself the evidential weight of the available information. As was stated in paragraphs 55 to 131 above, in the action before it, that board merely examines whether, in the light of the arguments put forward by the applicant, the ECHA decision was vitiated by error.

| 326 | As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision. |
| --- | --- |

326

As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision.

| 327 | In that regard, firstly, it should be noted that, as was stated in paragraphs 136 and 137 above, admittedly, first, it follows from point 1.2 of Annex XI to Regulation No 1907/2006 that, in the context of the registration of a substance, if an approach based on the weight of evidence determination allows the presence or absence of a dangerous property to be confirmed, it is necessary to omit further testing on vertebrate animals for the property at issue and further testing not involving vertebrate animals may be omitted, and, secondly, it is apparent from the second paragraph of Annex XIII to that regulation, that a weight of evidence determination based on an expert opinion is to be applied for the identification of persistent, bioaccumulative and toxic substances, and for the identification of very persistent and very bioaccumulative substances. However, it is not expressly apparent from those provisions that the weight of evidence determination applies to the evaluation of a substance. |
| --- | --- |

327

In that regard, firstly, it should be noted that, as was stated in paragraphs 136 and 137 above, admittedly, first, it follows from point 1.2 of Annex XI to Regulation No 1907/2006 that, in the context of the registration of a substance, if an approach based on the weight of evidence determination allows the presence or absence of a dangerous property to be confirmed, it is necessary to omit further testing on vertebrate animals for the property at issue and further testing not involving vertebrate animals may be omitted, and, secondly, it is apparent from the second paragraph of Annex XIII to that regulation, that a weight of evidence determination based on an expert opinion is to be applied for the identification of persistent, bioaccumulative and toxic substances, and for the identification of very persistent and very bioaccumulative substances. However, it is not expressly apparent from those provisions that the weight of evidence determination applies to the evaluation of a substance.

| 328 | Secondly, assuming that, in the evaluation of a substance, the ECHA was not entitled, in view of the principle of proportionality, to request further information concerning the existence of a potential risk resulting from that substance in cases in which the evidential weight of the available information allows a conclusion to be drawn regarding the existence of such a risk, in the light of the adversarial nature of proceedings before the Board of Appeal (see paragraphs 59 to 86 above), it is nevertheless for the applicant to set out the reasons why it considers that the findings in the ECHA decision are incorrect. |
| --- | --- |

328

Secondly, assuming that, in the evaluation of a substance, the ECHA was not entitled, in view of the principle of proportionality, to request further information concerning the existence of a potential risk resulting from that substance in cases in which the evidential weight of the available information allows a conclusion to be drawn regarding the existence of such a risk, in the light of the adversarial nature of proceedings before the Board of Appeal (see paragraphs 59 to 86 above), it is nevertheless for the applicant to set out the reasons why it considers that the findings in the ECHA decision are incorrect.

| 329 | It must be noted that, in paragraphs 150 to 160 of the contested decision, the Board of Appeal examined certain of the applicant’s arguments calling into question the necessity of the request to conduct the enhanced neurotoxicity rat study and that the arguments put forward by the applicant in the context of the present action, which were examined in paragraphs 260 to 322 above, are not capable of demonstrating that that board failed to take into account a detailed argument presented by the applicant in the action before that board. |
| --- | --- |

329

It must be noted that, in paragraphs 150 to 160 of the contested decision, the Board of Appeal examined certain of the applicant’s arguments calling into question the necessity of the request to conduct the enhanced neurotoxicity rat study and that the arguments put forward by the applicant in the context of the present action, which were examined in paragraphs 260 to 322 above, are not capable of demonstrating that that board failed to take into account a detailed argument presented by the applicant in the action before that board.

| 330 | Therefore, that argument of the applicant should be rejected. |
| --- | --- |

330

Therefore, that argument of the applicant should be rejected.

(5) The argument alleging that the Board of Appeal confined itself to verifying the absence of manifest errors of assessment

(5)

The argument alleging that the Board of Appeal confined itself to verifying the absence of manifest errors of assessment

| 331 | In the context of the first part of the first plea, the applicant claims that, in paragraph 152 of the contested decision, the Board of Appeal committed an error by deferring to the ECHA concerning scientific differences of opinion, in so far as the latter properly exercised its discretion. In that paragraph, that board merely verified the absence of manifest errors of assessment on the part of the ECHA. |
| --- | --- |

331

In the context of the first part of the first plea, the applicant claims that, in paragraph 152 of the contested decision, the Board of Appeal committed an error by deferring to the ECHA concerning scientific differences of opinion, in so far as the latter properly exercised its discretion. In that paragraph, that board merely verified the absence of manifest errors of assessment on the part of the ECHA.

| 332 | The ECHA and the interveners dispute those arguments. |
| --- | --- |

332

The ECHA and the interveners dispute those arguments.

| 333 | In that regard, it should be noted that it follows neither from paragraph 152 of the contested decision, nor from the other paragraphs of the part of that decision in which the Board of Appeal examined the necessity of the request to conduct the enhanced neurotoxicity rat study that that board confined itself to verifying the absence of manifest errors of assessment on the part of the ECHA. |
| --- | --- |

333

In that regard, it should be noted that it follows neither from paragraph 152 of the contested decision, nor from the other paragraphs of the part of that decision in which the Board of Appeal examined the necessity of the request to conduct the enhanced neurotoxicity rat study that that board confined itself to verifying the absence of manifest errors of assessment on the part of the ECHA.

| 334 | As was stated in paragraphs 323 to 330 above, in paragraph 152 of the contested decision, in essence, the Board of Appeal confined itself to noting that, in the action before it, it was for the applicant to show that the ECHA’s conclusion relating to the necessity of the request to conduct the enhanced neurotoxicity rat study was incorrect. Moreover, as was set out in paragraphs 279 to 285 above, in paragraphs 155 and 156 of that decision, it stated, in essence, that an argument by which an applicant merely expressed its disagreement with the conclusions drawn by the ECHA was not sufficiently substantiated. |
| --- | --- |

334

As was stated in paragraphs 323 to 330 above, in paragraph 152 of the contested decision, in essence, the Board of Appeal confined itself to noting that, in the action before it, it was for the applicant to show that the ECHA’s conclusion relating to the necessity of the request to conduct the enhanced neurotoxicity rat study was incorrect. Moreover, as was set out in paragraphs 279 to 285 above, in paragraphs 155 and 156 of that decision, it stated, in essence, that an argument by which an applicant merely expressed its disagreement with the conclusions drawn by the ECHA was not sufficiently substantiated.

| 335 | By contrast, contrary to what is claimed by the applicant, in paragraphs 152, 155 and 156 of the contested decision, the Board of Appeal did not reject the arguments put forward by the applicant because they were not capable of demonstrating the existence of a manifest error vitiating the ECHA’s findings. |
| --- | --- |

335

By contrast, contrary to what is claimed by the applicant, in paragraphs 152, 155 and 156 of the contested decision, the Board of Appeal did not reject the arguments put forward by the applicant because they were not capable of demonstrating the existence of a manifest error vitiating the ECHA’s findings.

| 336 | It follows that that argument must also be rejected, as well as all of the arguments calling into question the Board of Appeal’s findings concerning the necessity of the request to conduct the enhanced neurotoxicity rat study, subject to the arguments relating to the interspecies differences of Triclosan, which will be examined in paragraphs 339 to 386 below. |
| --- | --- |

336

It follows that that argument must also be rejected, as well as all of the arguments calling into question the Board of Appeal’s findings concerning the necessity of the request to conduct the enhanced neurotoxicity rat study, subject to the arguments relating to the interspecies differences of Triclosan, which will be examined in paragraphs 339 to 386 below.

(b)
   
  The arguments calling into question the Board of Appeal’s findings concerning the appropriateness of the request to conduct the enhanced neurotoxicity rat study

(b)

The arguments calling into question the Board of Appeal’s findings concerning the appropriateness of the request to conduct the enhanced neurotoxicity rat study

| 337 | In paragraphs 161 to 167 of the contested decision, the Board of Appeal examined the applicant’s arguments calling into question the ECHA’s finding that the request to conduct the enhanced neurotoxicity rat study provides useful information concerning the effects of Triclosan on humans. In that context, it ruled on the applicant’s arguments criticising the extrapolation of the results of rat studies to humans in the light of the differences between rats and humans. By those arguments, the applicant calls into question not only the appropriateness of the request to conduct that study, but also the necessity of that request. In paragraph 167 of that decision, that board concluded that the sixth plea in law, alleging an infringement of the principle of proportionality should be rejected. In paragraph 168 of that decision, it noted that, as all of the arguments calling into question the necessity of that request should be rejected and as, beyond the arguments examined and rejected, neither the applicant nor the PETA International Science Consortium had claimed that there were alternatives to vertebrate animal testing, the seventh plea, alleging an infringement of Article 25 of Regulation No 1907/2006 should also be rejected. |
| --- | --- |

337

In paragraphs 161 to 167 of the contested decision, the Board of Appeal examined the applicant’s arguments calling into question the ECHA’s finding that the request to conduct the enhanced neurotoxicity rat study provides useful information concerning the effects of Triclosan on humans. In that context, it ruled on the applicant’s arguments criticising the extrapolation of the results of rat studies to humans in the light of the differences between rats and humans. By those arguments, the applicant calls into question not only the appropriateness of the request to conduct that study, but also the necessity of that request. In paragraph 167 of that decision, that board concluded that the sixth plea in law, alleging an infringement of the principle of proportionality should be rejected. In paragraph 168 of that decision, it noted that, as all of the arguments calling into question the necessity of that request should be rejected and as, beyond the arguments examined and rejected, neither the applicant nor the PETA International Science Consortium had claimed that there were alternatives to vertebrate animal testing, the seventh plea, alleging an infringement of Article 25 of Regulation No 1907/2006 should also be rejected.

| 338 | The applicant puts forward arguments calling those findings into question. As a first step, it is necessary to examine the applicant’s arguments concerning the Board of Appeal’s findings developed in paragraphs 162 to 167 of the contested decision. As a second step, the arguments alleging that, in paragraph 168 of that decision, that board failed to examine whether there existed less onerous measures will be examined. |
| --- | --- |

338

The applicant puts forward arguments calling those findings into question. As a first step, it is necessary to examine the applicant’s arguments concerning the Board of Appeal’s findings developed in paragraphs 162 to 167 of the contested decision. As a second step, the arguments alleging that, in paragraph 168 of that decision, that board failed to examine whether there existed less onerous measures will be examined.

(1) The arguments relating to the Board of Appeal’s considerations developed in paragraphs 161 to 167 of the contested decision

(1)

The arguments relating to the Board of Appeal’s considerations developed in paragraphs 161 to 167 of the contested decision

| 339 | In paragraph 161 of the contested decision, the Board of Appeal noted that, by its arguments concerning the differences between rats and humans, the applicant called into question the appropriateness of the request to conduct the enhanced neurotoxicity rat study. In the second sentence of paragraph 162 of that decision, it stated that it was for the applicant to establish that the ECHA’s conclusion concerning the appropriateness of that request was incorrect. |
| --- | --- |

339

In paragraph 161 of the contested decision, the Board of Appeal noted that, by its arguments concerning the differences between rats and humans, the applicant called into question the appropriateness of the request to conduct the enhanced neurotoxicity rat study. In the second sentence of paragraph 162 of that decision, it stated that it was for the applicant to establish that the ECHA’s conclusion concerning the appropriateness of that request was incorrect.

| 340 | In paragraphs 163 to 166 of the contested decision, the Board of Appeal examined and rejected the applicant’s arguments alleging that the request to conduct the enhanced neurotoxicity rat study was not appropriate due to differences between rats and humans which preclude that results of rat studies could be extrapolated to humans. In those paragraphs, it stated that the arguments put forward by the applicant were not capable of calling into question the ECHA’s findings according to which, despite the differences between rats and humans, firstly, it was possible to identify a potential risk of neurotoxicity in humans on the basis of studies conducted on rats and, secondly, testing on rats would provide useful information about the effects of Triclosan on humans. |
| --- | --- |

340

In paragraphs 163 to 166 of the contested decision, the Board of Appeal examined and rejected the applicant’s arguments alleging that the request to conduct the enhanced neurotoxicity rat study was not appropriate due to differences between rats and humans which preclude that results of rat studies could be extrapolated to humans. In those paragraphs, it stated that the arguments put forward by the applicant were not capable of calling into question the ECHA’s findings according to which, despite the differences between rats and humans, firstly, it was possible to identify a potential risk of neurotoxicity in humans on the basis of studies conducted on rats and, secondly, testing on rats would provide useful information about the effects of Triclosan on humans.

| 341 | In that context, in paragraph 163 of the contested decision, the Board of Appeal stated that, in its decision, the ECHA had identified problems relating to the extrapolation to humans of results concerning rats and had thus taken into account the problems raised by the applicant. It also stated that the ECHA had examined the arguments put forward by the applicant in that regard and had justified the relevance of rat studies. |
| --- | --- |

341

In that context, in paragraph 163 of the contested decision, the Board of Appeal stated that, in its decision, the ECHA had identified problems relating to the extrapolation to humans of results concerning rats and had thus taken into account the problems raised by the applicant. It also stated that the ECHA had examined the arguments put forward by the applicant in that regard and had justified the relevance of rat studies.

| 342 | In paragraph 164 of the contested decision, the Board of Appeal concluded that it followed from the ECHA decision and the arguments submitted before it that, during the procedure leading to the adoption of that decision, account had been carefully taken of the differences between rats and humans. According to it, the applicant’s arguments repeated the arguments which had already been raised and addressed during that procedure, merely claimed that there were diverging scientific opinions and therefore had to be rejected. In that context, it referred to its considerations set out in paragraph 134 of the contested decision, according to which the fact that the applicant did not share the point of view of the ECHA concerning a scientific issue was not, in itself, sufficient to show that that agency had exercised its discretion incorrectly. According to it, the mere fact that the applicant had a scientific opinion different from that of the ECHA was therefore not capable of calling into question the lawfulness of the contested decision. |
| --- | --- |

342

In paragraph 164 of the contested decision, the Board of Appeal concluded that it followed from the ECHA decision and the arguments submitted before it that, during the procedure leading to the adoption of that decision, account had been carefully taken of the differences between rats and humans. According to it, the applicant’s arguments repeated the arguments which had already been raised and addressed during that procedure, merely claimed that there were diverging scientific opinions and therefore had to be rejected. In that context, it referred to its considerations set out in paragraph 134 of the contested decision, according to which the fact that the applicant did not share the point of view of the ECHA concerning a scientific issue was not, in itself, sufficient to show that that agency had exercised its discretion incorrectly. According to it, the mere fact that the applicant had a scientific opinion different from that of the ECHA was therefore not capable of calling into question the lawfulness of the contested decision.

| 343 | In paragraph 165 of the contested decision, the Board of Appeal acknowledged the existence of problems concerning the conduct of toxicity testing on vertebrate animals producing reliable information about the effects of a given substance on humans. The extrapolation of results from one species to another is complex. However, according to that board, at that stage, the testing methods provided for by the ECHA decision were in accordance with the state of the art. The existence of differences relating to the reaction of rats and humans to exposure to Triclosan does therefore not suffice in order to establish that the study requested does not provide useful information about the effects of that substance on humans who are exposed to it. In the opinion of that board, the applicant had moreover not suggested an appropriate alternative to the enhanced neurotoxicity rat study. |
| --- | --- |

343

In paragraph 165 of the contested decision, the Board of Appeal acknowledged the existence of problems concerning the conduct of toxicity testing on vertebrate animals producing reliable information about the effects of a given substance on humans. The extrapolation of results from one species to another is complex. However, according to that board, at that stage, the testing methods provided for by the ECHA decision were in accordance with the state of the art. The existence of differences relating to the reaction of rats and humans to exposure to Triclosan does therefore not suffice in order to establish that the study requested does not provide useful information about the effects of that substance on humans who are exposed to it. In the opinion of that board, the applicant had moreover not suggested an appropriate alternative to the enhanced neurotoxicity rat study.

| 344 | In paragraph 166 of the contested decision, the Board of Appeal concluded that the arguments put forward by the applicant had to be rejected. |
| --- | --- |

344

In paragraph 166 of the contested decision, the Board of Appeal concluded that the arguments put forward by the applicant had to be rejected.

| 345 | The applicant claims that certain of the Board of Appeal’s findings in paragraphs 134 and 162 to 166 of the contested decision are wrong. |
| --- | --- |

345

The applicant claims that certain of the Board of Appeal’s findings in paragraphs 134 and 162 to 166 of the contested decision are wrong.

| 346 | In the first place, in the context of the first part of the second plea, the applicant claims that, in paragraphs 162 to 165 of the contested decision, the Board of Appeal unduly reversed the burden of proof. |
| --- | --- |

346

In the first place, in the context of the first part of the second plea, the applicant claims that, in paragraphs 162 to 165 of the contested decision, the Board of Appeal unduly reversed the burden of proof.

| 347 | In the second place, in the context of the first and second parts of the first plea, the applicant claims that the Board of Appeal’s finding set out in paragraphs 134 and 164 of the contested decision, which is based on the consideration that a difference of scientific opinion did not indicate a legal violation, is incorrect. According to it, in the light of the functional continuity between the ECHA and that board, the latter should not have confined itself to carrying out a review of lawfulness and should not have deferred to the ECHA on matters of scientific dispute, as long as the latter exercised its discretion properly. That board’s role consists precisely in carefully examining the different scientific opinions in order to determine whether the ECHA’s opinion was justified in the light of the relevant evidence. According to the applicant, that board should thus not have confined itself to noting that the ECHA had carefully examined its argument and should not have rejected it on the ground that it was based on a difference in scientific opinions. According to it, on the contrary, the board in question should have conducted a ‘de novo’ examination of the ECHA decision covering the scientific assessments included in that decision. Otherwise, it would create a lacuna in the procedural protection guaranteed to registrants like itself. |
| --- | --- |

347

In the second place, in the context of the first and second parts of the first plea, the applicant claims that the Board of Appeal’s finding set out in paragraphs 134 and 164 of the contested decision, which is based on the consideration that a difference of scientific opinion did not indicate a legal violation, is incorrect. According to it, in the light of the functional continuity between the ECHA and that board, the latter should not have confined itself to carrying out a review of lawfulness and should not have deferred to the ECHA on matters of scientific dispute, as long as the latter exercised its discretion properly. That board’s role consists precisely in carefully examining the different scientific opinions in order to determine whether the ECHA’s opinion was justified in the light of the relevant evidence. According to the applicant, that board should thus not have confined itself to noting that the ECHA had carefully examined its argument and should not have rejected it on the ground that it was based on a difference in scientific opinions. According to it, on the contrary, the board in question should have conducted a ‘de novo’ examination of the ECHA decision covering the scientific assessments included in that decision. Otherwise, it would create a lacuna in the procedural protection guaranteed to registrants like itself.

| 348 | In the third place, in the context of the first part of the second plea, the applicant claims that there is no certainty relating to the application of the results of the rat studies to humans, as a result of the differences concerning the mode of action of Triclosan in rats, on the one hand, and in humans, on the other hand. There are significant differences between the endocrine functions of rats and humans and therefore concerning the very mode of action through which Triclosan is alleged to produce neurotoxic effects. There are known differences in the thyroid functions of humans and rats, and those differences significantly impact the conclusions to be drawn from the results of rat studies for the assessment of a potential risk to human health. The Board of Appeal’s finding that the differences between humans and rats in terms of sensitivity to Triclosan are qualitative rather than quantitative is not convincing and is contradictory. Qualitative differences concern the very mode through which Triclosan is alleged to produce adverse effects in humans and rats. That finding demonstrates a lack of understanding of the scientific arguments presented to it. In that context, it is also necessary to take into account the applicant’s arguments summarised in paragraph 265 above, in so far as they relate to differences between humans and rats. |
| --- | --- |

348

In the third place, in the context of the first part of the second plea, the applicant claims that there is no certainty relating to the application of the results of the rat studies to humans, as a result of the differences concerning the mode of action of Triclosan in rats, on the one hand, and in humans, on the other hand. There are significant differences between the endocrine functions of rats and humans and therefore concerning the very mode of action through which Triclosan is alleged to produce neurotoxic effects. There are known differences in the thyroid functions of humans and rats, and those differences significantly impact the conclusions to be drawn from the results of rat studies for the assessment of a potential risk to human health. The Board of Appeal’s finding that the differences between humans and rats in terms of sensitivity to Triclosan are qualitative rather than quantitative is not convincing and is contradictory. Qualitative differences concern the very mode through which Triclosan is alleged to produce adverse effects in humans and rats. That finding demonstrates a lack of understanding of the scientific arguments presented to it. In that context, it is also necessary to take into account the applicant’s arguments summarised in paragraph 265 above, in so far as they relate to differences between humans and rats.

| 349 | The ECHA and the interveners dispute those arguments. |
| --- | --- |

349

The ECHA and the interveners dispute those arguments.

| 350 | As a first step, it is necessary to reject the applicant’s arguments in so far as they allege that the Board of Appeal should itself have assessed the relevant information and decided whether Triclosan posed a potential risk of neurotoxicity or of reproductive toxicity. In that regard, it suffices to note that, as was stated in paragraphs 55 to 131 above, the proceedings before that board are adversarial and, in the examination of the merits of an action before it, that board therefore merely examines whether the arguments put forward by the applicant are capable of demonstrating that the ECHA decision is vitiated by error. |
| --- | --- |

350

As a first step, it is necessary to reject the applicant’s arguments in so far as they allege that the Board of Appeal should itself have assessed the relevant information and decided whether Triclosan posed a potential risk of neurotoxicity or of reproductive toxicity. In that regard, it suffices to note that, as was stated in paragraphs 55 to 131 above, the proceedings before that board are adversarial and, in the examination of the merits of an action before it, that board therefore merely examines whether the arguments put forward by the applicant are capable of demonstrating that the ECHA decision is vitiated by error.

| 351 | As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision. |
| --- | --- |

351

As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision.

| 352 | In the first place, the applicant claims that, in the second sentence of paragraph 162 and in paragraph 165 of the contested decision, the Board of Appeal unduly reversed the burden of proof. |
| --- | --- |

352

In the first place, the applicant claims that, in the second sentence of paragraph 162 and in paragraph 165 of the contested decision, the Board of Appeal unduly reversed the burden of proof.

| 353 | Firstly, in so far as the argument mentioned in paragraph 352 above relates to the allocation of the burden of proof during proceedings before the Board of Appeal, it should be noted that the Board of Appeal did not commit an error when it found, in the second sentence of paragraph 162 and the third sentence of paragraph 165 of the contested decision, that it was for the applicant to demonstrate that the ECHA’s conclusions were vitiated by error. That allocation of the burden of proof results from the adversarial nature of the proceedings before that board. Therefore, the applicant’s argument must be rejected in so far as it relates to the allocation of the burden of proof during those proceedings. |
| --- | --- |

353

Firstly, in so far as the argument mentioned in paragraph 352 above relates to the allocation of the burden of proof during proceedings before the Board of Appeal, it should be noted that the Board of Appeal did not commit an error when it found, in the second sentence of paragraph 162 and the third sentence of paragraph 165 of the contested decision, that it was for the applicant to demonstrate that the ECHA’s conclusions were vitiated by error. That allocation of the burden of proof results from the adversarial nature of the proceedings before that board. Therefore, the applicant’s argument must be rejected in so far as it relates to the allocation of the burden of proof during those proceedings.

| 354 | Secondly, in so far as the argument mentioned in paragraph 352 above relates to the allocation of the burden of proof during the procedure before the ECHA, it should be noted that, in order to demonstrate that the request to conduct the enhanced neurotoxicity rat study was appropriate, it was for the ECHA to establish that it would provide useful information about the effects of Triclosan on humans. |
| --- | --- |

354

Secondly, in so far as the argument mentioned in paragraph 352 above relates to the allocation of the burden of proof during the procedure before the ECHA, it should be noted that, in order to demonstrate that the request to conduct the enhanced neurotoxicity rat study was appropriate, it was for the ECHA to establish that it would provide useful information about the effects of Triclosan on humans.

| 355 | However, it must be noted that the Board of Appeal did not breach the rules on the allocation of the burden of proof during the procedure before the ECHA. That board’s findings in the second sentence of paragraph 162 and the third sentence of paragraph 165 of the contested decision related solely to the allocation of the burden of proof during the procedure before that board. |
| --- | --- |

355

However, it must be noted that the Board of Appeal did not breach the rules on the allocation of the burden of proof during the procedure before the ECHA. That board’s findings in the second sentence of paragraph 162 and the third sentence of paragraph 165 of the contested decision related solely to the allocation of the burden of proof during the procedure before that board.

| 356 | In light of those considerations, it is necessary to reject the argument referred to in paragraph 352 above. |
| --- | --- |

356

In light of those considerations, it is necessary to reject the argument referred to in paragraph 352 above.

| 357 | In the second place, the applicant claims that, in paragraphs 134 and 164 of the contested decision, the Board of Appeal should not have relied on the consideration according to which a difference of scientific opinions did not reveal any violation of the law. It should not have limited its review in the light of the ECHA’s discretion. |
| --- | --- |

357

In the second place, the applicant claims that, in paragraphs 134 and 164 of the contested decision, the Board of Appeal should not have relied on the consideration according to which a difference of scientific opinions did not reveal any violation of the law. It should not have limited its review in the light of the ECHA’s discretion.

| 358 | In that regard, it should be noted that, in paragraphs 134 and 164 of the contested decision, the Board of Appeal examined the applicant’s arguments seeking to demonstrate the incorrectness of the ECHA’s conclusion according to which, despite differences between rats and humans, it was possible to extrapolate the results of rat studies, such as those of the enhanced neurotoxicity rat study, to humans. |
| --- | --- |

358

In that regard, it should be noted that, in paragraphs 134 and 164 of the contested decision, the Board of Appeal examined the applicant’s arguments seeking to demonstrate the incorrectness of the ECHA’s conclusion according to which, despite differences between rats and humans, it was possible to extrapolate the results of rat studies, such as those of the enhanced neurotoxicity rat study, to humans.

| 359 | In that context, it should be recalled that, in the light of the adversarial nature of the proceedings before the Board of Appeal, in the context of such proceedings, the applicant must put forward detailed arguments calling into question the ECHA’s findings. Therefore, where, in its decision, the ECHA set out the reasons why it considered that, despite differences between rats and humans, it was possible to extrapolate the results of the rat studies to humans, it was for the applicant to put forward detailed arguments demonstrating that the considerations on which the ECHA relied were incorrect. |
| --- | --- |

359

In that context, it should be recalled that, in the light of the adversarial nature of the proceedings before the Board of Appeal, in the context of such proceedings, the applicant must put forward detailed arguments calling into question the ECHA’s findings. Therefore, where, in its decision, the ECHA set out the reasons why it considered that, despite differences between rats and humans, it was possible to extrapolate the results of the rat studies to humans, it was for the applicant to put forward detailed arguments demonstrating that the considerations on which the ECHA relied were incorrect.

| 360 | It is in the light of the above that it is necessary to examine the applicant’s arguments relating to the Board of Appeal’s findings in paragraphs 134 and 164 of the contested decision. |
| --- | --- |

360

It is in the light of the above that it is necessary to examine the applicant’s arguments relating to the Board of Appeal’s findings in paragraphs 134 and 164 of the contested decision.

| 361 | In the second sentence of paragraph 164 of the contested decision, the Board of Appeal held that, in essence, the applicant’s arguments relating to the differences between rats and humans merely noted that the applicant did not agree with the conclusions reached by the ECHA. In that context, it referred to the fourth sentence of paragraph 134 of that decision, where it stated that the fact that the applicant did not share a scientific conclusion reached by the ECHA was not sufficient to demonstrate the existence of an error vitiating that conclusion. |
| --- | --- |

361

In the second sentence of paragraph 164 of the contested decision, the Board of Appeal held that, in essence, the applicant’s arguments relating to the differences between rats and humans merely noted that the applicant did not agree with the conclusions reached by the ECHA. In that context, it referred to the fourth sentence of paragraph 134 of that decision, where it stated that the fact that the applicant did not share a scientific conclusion reached by the ECHA was not sufficient to demonstrate the existence of an error vitiating that conclusion.

| 362 | In the light of what was stated in paragraph 359 above, the Board of Appeal cannot be criticised for having rejected, in paragraph 164 of the contested decision, as not sufficiently substantiated, the arguments by which the applicant limited itself to indicating its disagreement with that board’s conclusion. |
| --- | --- |

362

In the light of what was stated in paragraph 359 above, the Board of Appeal cannot be criticised for having rejected, in paragraph 164 of the contested decision, as not sufficiently substantiated, the arguments by which the applicant limited itself to indicating its disagreement with that board’s conclusion.

| 363 | In that context, it should also be noted that, in paragraphs 134 and 164 of the contested decision, the Board of Appeal rejected the applicant’s arguments on the ground that they were not sufficiently substantiated. By contrast, it is not because the arguments put forward by the applicant were not capable of demonstrating a manifest error vitiating the ECHA’s findings that that board rejected them. Therefore, contrary to what is claimed by the applicant, it cannot be deduced from those paragraphs that that board limited the intensity of its review on the ground that the ECHA had a margin of discretion. |
| --- | --- |

363

In that context, it should also be noted that, in paragraphs 134 and 164 of the contested decision, the Board of Appeal rejected the applicant’s arguments on the ground that they were not sufficiently substantiated. By contrast, it is not because the arguments put forward by the applicant were not capable of demonstrating a manifest error vitiating the ECHA’s findings that that board rejected them. Therefore, contrary to what is claimed by the applicant, it cannot be deduced from those paragraphs that that board limited the intensity of its review on the ground that the ECHA had a margin of discretion.

| 364 | Therefore, the applicant’s arguments relating to the Board of Appeal’s finding that a difference of scientific opinions did not reveal any violation of the law must also be rejected. |
| --- | --- |

364

Therefore, the applicant’s arguments relating to the Board of Appeal’s finding that a difference of scientific opinions did not reveal any violation of the law must also be rejected.

| 365 | In the third place, it is necessary to examine the applicant’s arguments calling into question the Board of Appeal’s findings concerning the differences between rats and humans. |
| --- | --- |

365

In the third place, it is necessary to examine the applicant’s arguments calling into question the Board of Appeal’s findings concerning the differences between rats and humans.

| 366 | As a preliminary point, it should be noted that, in paragraph 163 of the contested decision, the Board of Appeal stated that the ECHA had acknowledged that there were problems concerning the extrapolation to humans of relevant information obtained from studies on rats. That board also stated that the ECHA had examined the arguments put forward by the applicant in that regard and had justified the relevance of rat studies. In that context, it noted, by way of example, first, in the fifth sentence of that paragraph, that the results of those tests indicated that the mechanism by which Triclosan disrupted the thyroid could also be relevant for humans. Secondly, in the sixth sentence of that paragraph, it noted that, in its decision, the ECHA had found that the differences between rats and humans were qualitative rather than quantitative. |
| --- | --- |

366

As a preliminary point, it should be noted that, in paragraph 163 of the contested decision, the Board of Appeal stated that the ECHA had acknowledged that there were problems concerning the extrapolation to humans of relevant information obtained from studies on rats. That board also stated that the ECHA had examined the arguments put forward by the applicant in that regard and had justified the relevance of rat studies. In that context, it noted, by way of example, first, in the fifth sentence of that paragraph, that the results of those tests indicated that the mechanism by which Triclosan disrupted the thyroid could also be relevant for humans. Secondly, in the sixth sentence of that paragraph, it noted that, in its decision, the ECHA had found that the differences between rats and humans were qualitative rather than quantitative.

| 367 | The applicant claims that the Board of Appeal’s finding, in the sixth sentence of paragraph 163 of the contested decision, according to which differences between rats and humans are more qualitative than quantitative is wrong. |
| --- | --- |

367

The applicant claims that the Board of Appeal’s finding, in the sixth sentence of paragraph 163 of the contested decision, according to which differences between rats and humans are more qualitative than quantitative is wrong.

| 368 | In that regard, it should be noted that, although the applicant is justified in claiming that the Board of Appeal’s finding in paragraph 163 of the contested decision is vitiated by error, such an error cannot lead to the annulment of the contested decision. |
| --- | --- |

368

In that regard, it should be noted that, although the applicant is justified in claiming that the Board of Appeal’s finding in paragraph 163 of the contested decision is vitiated by error, such an error cannot lead to the annulment of the contested decision.

| 369 | In the sixth sentence of paragraph 163 of the contested decision, the Board of Appeal refers to the contents of the ECHA decision. However, it must be noted that, in its decision, that agency did not rely on the finding according to which differences between rats and humans were qualitative rather than quantitative. On page 19 of that decision, it indicated that, to the extent that it had not been shown that rats were an inappropriate model, due to the fact that differences between humans and rats in relation to the sensitivity of chemical effects on T4 clearance are qualitative rather than quantitative, the results obtained from rats with regard to T4 reduction could not be discarded and should be considered relevant for human health risk assessment. |
| --- | --- |

369

In the sixth sentence of paragraph 163 of the contested decision, the Board of Appeal refers to the contents of the ECHA decision. However, it must be noted that, in its decision, that agency did not rely on the finding according to which differences between rats and humans were qualitative rather than quantitative. On page 19 of that decision, it indicated that, to the extent that it had not been shown that rats were an inappropriate model, due to the fact that differences between humans and rats in relation to the sensitivity of chemical effects on T4 clearance are qualitative rather than quantitative, the results obtained from rats with regard to T4 reduction could not be discarded and should be considered relevant for human health risk assessment.

| 370 | Therefore, in the sixth sentence of paragraph 163 of the contested decision, the Board of Appeal inadequately reproduced the contents of the ECHA decision. The findings made by that agency were based on the consideration that it was not established that the differences between rats and humans concerning the reduction of the thyroid hormone T4 were more qualitative than quantitative. By contrast, in the contested decision, that board relied on the opposite finding according to which those differences were more qualitative than quantitative. |
| --- | --- |

370

Therefore, in the sixth sentence of paragraph 163 of the contested decision, the Board of Appeal inadequately reproduced the contents of the ECHA decision. The findings made by that agency were based on the consideration that it was not established that the differences between rats and humans concerning the reduction of the thyroid hormone T4 were more qualitative than quantitative. By contrast, in the contested decision, that board relied on the opposite finding according to which those differences were more qualitative than quantitative.

| 371 | However, the Board of Appeal’s error in the sixth sentence of paragraph 163 of the contested decision is not such as to lead to the annulment of that decision. |
| --- | --- |

371

However, the Board of Appeal’s error in the sixth sentence of paragraph 163 of the contested decision is not such as to lead to the annulment of that decision.

| 372 | In that context, it should be noted that, in paragraph 163 of the contested decision, that Board of Appeal did not rely solely on the incorrect finding in the sixth sentence of that paragraph, according to which the differences between rats and humans were more qualitative than quantitative. In the fifth sentence of that paragraph, it also took into account the ECHA’s finding according to which the mechanism by which Triclosan reduces the hormone level in blood is a mechanism which could also be relevant to humans. |
| --- | --- |

372

In that context, it should be noted that, in paragraph 163 of the contested decision, that Board of Appeal did not rely solely on the incorrect finding in the sixth sentence of that paragraph, according to which the differences between rats and humans were more qualitative than quantitative. In the fifth sentence of that paragraph, it also took into account the ECHA’s finding according to which the mechanism by which Triclosan reduces the hormone level in blood is a mechanism which could also be relevant to humans.

| 373 | In that regard, on page 18 of its decision, the ECHA had stated that, according to several tests on animals, Triclosan affected the thyroid hormone system T4 and that, according to studies on animals and observations in humans, a reduction in the levels of that hormone could have adverse effects on brain development in foetuses. According to those studies, in humans, decreased IQ and delayed mental skills were observed in children from mothers with low T4 levels during pregnancy. On page 19 of that decision, the ECHA had stated that, despite differences between rats and humans, Triclosan could cause the clearance of the thyroid hormone T4 in humans. |
| --- | --- |

373

In that regard, on page 18 of its decision, the ECHA had stated that, according to several tests on animals, Triclosan affected the thyroid hormone system T4 and that, according to studies on animals and observations in humans, a reduction in the levels of that hormone could have adverse effects on brain development in foetuses. According to those studies, in humans, decreased IQ and delayed mental skills were observed in children from mothers with low T4 levels during pregnancy. On page 19 of that decision, the ECHA had stated that, despite differences between rats and humans, Triclosan could cause the clearance of the thyroid hormone T4 in humans.

| 374 | As regards those findings, the applicant merely claims that there is no certainty with respect to the application of the results of the rat studies to humans, due to differences concerning the mode of action of Triclosan in rats, on the one hand, and in humans, on the other hand. There are large differences between the endocrine function of rats and that of humans and therefore concerning the mode of action itself by which Triclosan is alleged to produce neurotoxic effects. There are known differences between the thyroid functions of humans and rats, and those differences significantly impact the conclusions to be drawn from the results of rat studies for the assessment of a potential risk to human health. |
| --- | --- |

374

As regards those findings, the applicant merely claims that there is no certainty with respect to the application of the results of the rat studies to humans, due to differences concerning the mode of action of Triclosan in rats, on the one hand, and in humans, on the other hand. There are large differences between the endocrine function of rats and that of humans and therefore concerning the mode of action itself by which Triclosan is alleged to produce neurotoxic effects. There are known differences between the thyroid functions of humans and rats, and those differences significantly impact the conclusions to be drawn from the results of rat studies for the assessment of a potential risk to human health.

| 375 | In that context, it should be recalled that the question whether, in the light of differences between rats and humans, relevant information can be extrapolated to humans from rat studies, involves assessments of highly complex scientific and technical facts, in relation to which the ECHA has a broad discretion. Therefore, in that regard, the Court’s review is limited (see, to that effect, judgment of 21 July 2011, Etimine, C‐15/10, EU:C:2011:504, paragraph 60 and the case-law cited). It is therefore necessary to examine whether the applicant’s arguments are capable of showing that, as regards such assessments, the Board of Appeal committed a manifest error, a misuse of powers or whether it manifestly exceeded the limits of its discretion. |
| --- | --- |

375

In that context, it should be recalled that the question whether, in the light of differences between rats and humans, relevant information can be extrapolated to humans from rat studies, involves assessments of highly complex scientific and technical facts, in relation to which the ECHA has a broad discretion. Therefore, in that regard, the Court’s review is limited (see, to that effect, judgment of 21 July 2011, Etimine, C‐15/10, EU:C:2011:504, paragraph 60 and the case-law cited). It is therefore necessary to examine whether the applicant’s arguments are capable of showing that, as regards such assessments, the Board of Appeal committed a manifest error, a misuse of powers or whether it manifestly exceeded the limits of its discretion.

| 376 | In that regard, first of all, it must be pointed out that, even if Regulation No 1907/2006 seeks to avoid, as far as possible, testing on animals, in particular on vertebrate animals, it nevertheless recognises that testing on vertebrate animals is a method allowing the properties of chemical substances to be evaluated. Therefore, in itself, the fact that there are differences between rats and humans is not capable of demonstrating a manifest error on the part of the Board of Appeal. There will always be differences between humans and vertebrate animals. It is thus solely the differences between the vertebrate animals covered by the request for testing and humans, which are capable of calling into question the relevance to humans of the results of testing on animals and which could call into question the proportionality of the request to conduct the enhanced neurotoxicity rat study. |
| --- | --- |

376

In that regard, first of all, it must be pointed out that, even if Regulation No 1907/2006 seeks to avoid, as far as possible, testing on animals, in particular on vertebrate animals, it nevertheless recognises that testing on vertebrate animals is a method allowing the properties of chemical substances to be evaluated. Therefore, in itself, the fact that there are differences between rats and humans is not capable of demonstrating a manifest error on the part of the Board of Appeal. There will always be differences between humans and vertebrate animals. It is thus solely the differences between the vertebrate animals covered by the request for testing and humans, which are capable of calling into question the relevance to humans of the results of testing on animals and which could call into question the proportionality of the request to conduct the enhanced neurotoxicity rat study.

| 377 | Next, it must be noted that the applicant does not put forward any arguments capable of calling into question the Board of Appeal’s finding according to which a mechanism identical to the mechanism by which Triclosan reduces the thyroid hormone T4 level in the blood of rats was observed in humans or the finding according to which, if such a reduction in hormone levels takes place during pregnancy, brain development in foetuses risks being affected. |
| --- | --- |

377

Next, it must be noted that the applicant does not put forward any arguments capable of calling into question the Board of Appeal’s finding according to which a mechanism identical to the mechanism by which Triclosan reduces the thyroid hormone T4 level in the blood of rats was observed in humans or the finding according to which, if such a reduction in hormone levels takes place during pregnancy, brain development in foetuses risks being affected.

| 378 | Moreover, in the context of its action before the Board of Appeal, the applicant did not put forward any arguments capable of calling into question the findings on page 19 of the ECHA decision, relating to the situations in which Triclosan could cause an increase in the clearance of the thyroid hormone T4 in humans. |
| --- | --- |

378

Moreover, in the context of its action before the Board of Appeal, the applicant did not put forward any arguments capable of calling into question the findings on page 19 of the ECHA decision, relating to the situations in which Triclosan could cause an increase in the clearance of the thyroid hormone T4 in humans.

| 379 | Finally, as was stated by the Kingdom of Denmark during the hearing, the differences between the endocrine functions of rats and humans are well known, which allows them to be taken into account in the extrapolation to humans of relevant information derived from rat studies. |
| --- | --- |

379

Finally, as was stated by the Kingdom of Denmark during the hearing, the differences between the endocrine functions of rats and humans are well known, which allows them to be taken into account in the extrapolation to humans of relevant information derived from rat studies.

| 380 | In the light of those considerations, it should be noted that the arguments put forward by the applicant are not capable of undermining the plausibility of the Board of Appeal’s conclusions according to which the results of rat studies cannot be regarded as irrelevant for humans, in spite of the fact that the reduction of concentrations of the thyroid hormone T4 in rats does not allow an identical effect on the concentrations of T4 in humans to be anticipated. |
| --- | --- |

380

In the light of those considerations, it should be noted that the arguments put forward by the applicant are not capable of undermining the plausibility of the Board of Appeal’s conclusions according to which the results of rat studies cannot be regarded as irrelevant for humans, in spite of the fact that the reduction of concentrations of the thyroid hormone T4 in rats does not allow an identical effect on the concentrations of T4 in humans to be anticipated.

| 381 | Therefore, the applicant’s arguments must be rejected in so far as they call into question the finding in the fifth sentence of paragraph 163 of the contested decision, according to which the mechanism by which Triclosan reduces the level of hormones in the blood is a mechanism which could also be relevant to humans. |
| --- | --- |

381

Therefore, the applicant’s arguments must be rejected in so far as they call into question the finding in the fifth sentence of paragraph 163 of the contested decision, according to which the mechanism by which Triclosan reduces the level of hormones in the blood is a mechanism which could also be relevant to humans.

| 382 | It follows that the error vitiating the Board of Appeal’s finding in the sixth sentence of paragraph 163 of the contested decision is not such as to call into question that board’s conclusion according to which the ECHA was correct to consider that, despite differences between rats and humans, it was possible to extrapolate the results of tests on rats to humans. |
| --- | --- |

382

It follows that the error vitiating the Board of Appeal’s finding in the sixth sentence of paragraph 163 of the contested decision is not such as to call into question that board’s conclusion according to which the ECHA was correct to consider that, despite differences between rats and humans, it was possible to extrapolate the results of tests on rats to humans.

| 383 | In the light of those considerations, it is necessary also to reject the applicant’s argument alleging that the Board of Appeal’s reasoning is contradictory, due to the fact that it relied on data from rat studies despite differences between rats and humans. |
| --- | --- |

383

In the light of those considerations, it is necessary also to reject the applicant’s argument alleging that the Board of Appeal’s reasoning is contradictory, due to the fact that it relied on data from rat studies despite differences between rats and humans.

| 384 | Therefore, all of the applicant’s arguments relating to the differences between humans and rats must be rejected, both those relating to the Board of Appeal’s finding in relation to the necessity of the request to conduct the enhanced neurotoxicity rat study (see paragraph 288 above) and those relating to the appropriateness thereof. |
| --- | --- |

384

Therefore, all of the applicant’s arguments relating to the differences between humans and rats must be rejected, both those relating to the Board of Appeal’s finding in relation to the necessity of the request to conduct the enhanced neurotoxicity rat study (see paragraph 288 above) and those relating to the appropriateness thereof.

| 385 | In the fourth place, in so far as the applicant invokes the Witorsch report, it is necessary to reject that argument for the same reasons as those set out in paragraph 287 above. |
| --- | --- |

385

In the fourth place, in so far as the applicant invokes the Witorsch report, it is necessary to reject that argument for the same reasons as those set out in paragraph 287 above.

| 386 | Therefore, it is necessary to reject the arguments relating to the Board of Appeal’s findings developed in paragraphs 161 to 167 of the contested decision, as well as the arguments calling into question that board’s findings concerning the necessity of the request to conduct the enhanced neurotoxicity rat study. |
| --- | --- |

386

Therefore, it is necessary to reject the arguments relating to the Board of Appeal’s findings developed in paragraphs 161 to 167 of the contested decision, as well as the arguments calling into question that board’s findings concerning the necessity of the request to conduct the enhanced neurotoxicity rat study.

(2) The arguments alleging that the Board of Appeal did not examine whether there existed less onerous methods

(2)

The arguments alleging that the Board of Appeal did not examine whether there existed less onerous methods

| 387 | In paragraph 168 of the contested decision, the Board of Appeal concluded that, since all of the arguments calling into question the necessity of the request to conduct the enhanced neurotoxicity rat study should be rejected and since, beyond the arguments examined and rejected, neither the applicant nor the PETA International Science Consortium had claimed that there were alternatives to the tests on vertebrate animals, the seventh plea in the action before it, alleging an infringement of Article 25 of Regulation No 1907/2006, must also be rejected. |
| --- | --- |

387

In paragraph 168 of the contested decision, the Board of Appeal concluded that, since all of the arguments calling into question the necessity of the request to conduct the enhanced neurotoxicity rat study should be rejected and since, beyond the arguments examined and rejected, neither the applicant nor the PETA International Science Consortium had claimed that there were alternatives to the tests on vertebrate animals, the seventh plea in the action before it, alleging an infringement of Article 25 of Regulation No 1907/2006, must also be rejected.

| 388 | In the context of the first part of the second plea, the applicant claims that those findings of the Board of Appeal are incorrect. The ECHA did not demonstrate that there was an alternative to conducting tests on vertebrate animals. The Board of Appeal refused to check whether there were less onerous means. According to the applicant, although that board has the same powers as the ECHA, it did not carry out a complete examination of proportionality and did not examine whether there were less onerous means than the enhanced neurotoxicity rat study to provide clarification about the potential risks of neurotoxicity and reproductive toxicity posed by Triclosan. That board therefore infringed Article 25(1) of Regulation No 1907/2006. Moreover, in the applicant’s opinion, that board could have proceeded by way of the weight of evidence determination of the available information, by relying on the studies provided by the applicant, in particular the Witorsch report, instead of requesting that the enhanced neurotoxicity rat study be conducted, which is not relevant to humans. |
| --- | --- |

388

In the context of the first part of the second plea, the applicant claims that those findings of the Board of Appeal are incorrect. The ECHA did not demonstrate that there was an alternative to conducting tests on vertebrate animals. The Board of Appeal refused to check whether there were less onerous means. According to the applicant, although that board has the same powers as the ECHA, it did not carry out a complete examination of proportionality and did not examine whether there were less onerous means than the enhanced neurotoxicity rat study to provide clarification about the potential risks of neurotoxicity and reproductive toxicity posed by Triclosan. That board therefore infringed Article 25(1) of Regulation No 1907/2006. Moreover, in the applicant’s opinion, that board could have proceeded by way of the weight of evidence determination of the available information, by relying on the studies provided by the applicant, in particular the Witorsch report, instead of requesting that the enhanced neurotoxicity rat study be conducted, which is not relevant to humans.

| 389 | The ECHA disputes those arguments. |
| --- | --- |

389

The ECHA disputes those arguments.

| 390 | As a first step, in so far as, by its arguments, the applicant claims that the Board of Appeal should not have confined itself to reviewing the ECHA decision, but should have itself re-examined whether there existed less onerous measures, it is necessary to reject them for the same reasons as those set out in paragraphs 55 to 131 above. |
| --- | --- |

390

As a first step, in so far as, by its arguments, the applicant claims that the Board of Appeal should not have confined itself to reviewing the ECHA decision, but should have itself re-examined whether there existed less onerous measures, it is necessary to reject them for the same reasons as those set out in paragraphs 55 to 131 above.

| 391 | As a second step, in so far as the applicant’s arguments seeking to demonstrate that, in the review of the ECHA decision, the Board of Appeal committed an error, first of all, it should be recalled that, in accordance with the first sentence of Article 25(1) of Regulation No 1907/2006, in order to avoid testing on animals, tests on vertebrate animals carried out for the purposes of that regulation are conducted only where there is no other solution. |
| --- | --- |

391

As a second step, in so far as the applicant’s arguments seeking to demonstrate that, in the review of the ECHA decision, the Board of Appeal committed an error, first of all, it should be recalled that, in accordance with the first sentence of Article 25(1) of Regulation No 1907/2006, in order to avoid testing on animals, tests on vertebrate animals carried out for the purposes of that regulation are conducted only where there is no other solution.

| 392 | In the first place, in so far as the applicant claims that the rat studies are not relevant to humans, it should be noted that it does not raise any arguments except those which were already examined and rejected in paragraphs 339 to 384 above. |
| --- | --- |

392

In the first place, in so far as the applicant claims that the rat studies are not relevant to humans, it should be noted that it does not raise any arguments except those which were already examined and rejected in paragraphs 339 to 384 above.

| 393 | In the second place, in so far as the applicant invokes the Witorsch report, it is necessary to reject that argument for the same reasons as those set out in paragraph 287 above. |
| --- | --- |

393

In the second place, in so far as the applicant invokes the Witorsch report, it is necessary to reject that argument for the same reasons as those set out in paragraph 287 above.

| 394 | In the light of those considerations, it is necessary to reject the applicant’s arguments alleging that the Board of Appeal infringed Article 25(1) of Regulation No 1907/2006, by failing to examine whether there were less restrictive measures. |
| --- | --- |

394

In the light of those considerations, it is necessary to reject the applicant’s arguments alleging that the Board of Appeal infringed Article 25(1) of Regulation No 1907/2006, by failing to examine whether there were less restrictive measures.

| 395 | It follows that all of the applicant’s arguments calling into question the Board of Appeal’s findings concerning the necessity and appropriateness of the request to conduct the enhanced neurotoxicity rat study must be rejected. |
| --- | --- |

395

It follows that all of the applicant’s arguments calling into question the Board of Appeal’s findings concerning the necessity and appropriateness of the request to conduct the enhanced neurotoxicity rat study must be rejected.

3.
   
  The arguments relating to the rejection of Mrs Mihaich’s expert opinion as inadmissible

3.

The arguments relating to the rejection of Mrs Mihaich’s expert opinion as inadmissible

| 396 | In the contested decision, the Board of Appeal examined questions of admissibility (paragraphs 117 to 131). In particular, it ruled on the admissibility of certain evidence adduced by the applicant (paragraphs 122 to 131). In that context, it considered that the Mihaich report, which the applicant had produced in the context of its comments on the statement in intervention of the PETA International Science Consortium, was not admissible (paragraphs 125 to 130). In that regard, it stated that the applicant had not submitted that report with the notice of appeal (paragraph 125). It stated that, in accordance with Article 12(1) of Regulation No 771/2008, the parties could not introduce further evidence after the first exchange of pleadings, unless the Board of Appeal decides that the delay in offering the evidence was duly justified (paragraph 126). It notes that, since that report dates from 2015 and that it was therefore subsequent to the notice of appeal, in principle, the delay in the presentation of that document could potentially be justified and stated that it was possible to justify the delay in the presentation of an experimental study carried out on a substance after the expiry of the deadline for submitting an appeal where the results of such a study could constitute new facts which were not available at the time of the expiry of the deadline for filing an appeal (paragraph 127). It stated that that report was not an experimental study, but the opinion of an expert formed on the basis of existing experimental studies, concerning the endocrine disruptive properties of Triclosan, and acknowledged that the methodology applied in the ‘report’ at issue was new, but that the data on which it was based was not, already existed and had already been available to the ECHA at the time the contested decision was adopted (paragraph 128). It concluded that the report in question constituted an opinion of an expert, which should normally be produced in evidence upon filing a notice of appeal, in accordance with Article 6(1)(f) of Regulation No 771/2008, that nothing prevented the applicant from commissioning such an expert opinion in due time, which is to say before the expiry of the deadline for filing an administrative appeal and that, therefore, the fact that the expert at issue had not yet formed his opinion at an earlier stage was not capable of justifying the delay with which that report had been submitted (paragraph 129). |
| --- | --- |

396

In the contested decision, the Board of Appeal examined questions of admissibility (paragraphs 117 to 131). In particular, it ruled on the admissibility of certain evidence adduced by the applicant (paragraphs 122 to 131). In that context, it considered that the Mihaich report, which the applicant had produced in the context of its comments on the statement in intervention of the PETA International Science Consortium, was not admissible (paragraphs 125 to 130). In that regard, it stated that the applicant had not submitted that report with the notice of appeal (paragraph 125). It stated that, in accordance with Article 12(1) of Regulation No 771/2008, the parties could not introduce further evidence after the first exchange of pleadings, unless the Board of Appeal decides that the delay in offering the evidence was duly justified (paragraph 126). It notes that, since that report dates from 2015 and that it was therefore subsequent to the notice of appeal, in principle, the delay in the presentation of that document could potentially be justified and stated that it was possible to justify the delay in the presentation of an experimental study carried out on a substance after the expiry of the deadline for submitting an appeal where the results of such a study could constitute new facts which were not available at the time of the expiry of the deadline for filing an appeal (paragraph 127). It stated that that report was not an experimental study, but the opinion of an expert formed on the basis of existing experimental studies, concerning the endocrine disruptive properties of Triclosan, and acknowledged that the methodology applied in the ‘report’ at issue was new, but that the data on which it was based was not, already existed and had already been available to the ECHA at the time the contested decision was adopted (paragraph 128). It concluded that the report in question constituted an opinion of an expert, which should normally be produced in evidence upon filing a notice of appeal, in accordance with Article 6(1)(f) of Regulation No 771/2008, that nothing prevented the applicant from commissioning such an expert opinion in due time, which is to say before the expiry of the deadline for filing an administrative appeal and that, therefore, the fact that the expert at issue had not yet formed his opinion at an earlier stage was not capable of justifying the delay with which that report had been submitted (paragraph 129).

| 397 | In the context of the second part of the first plea, the applicant claims that those findings of the Board of Appeal are wrong. |
| --- | --- |

397

In the context of the second part of the first plea, the applicant claims that those findings of the Board of Appeal are wrong.

| 398 | In the first place, the applicant maintains that the Board of Appeal infringed Article 12(1) of Regulation No 771/2008 and Article 8(4)(f) of that regulation. The delay in the submission of the Mihaich report is justified for the purposes of those provisions. According to it, in the context of its examination, that board should take account of the most recent relevant scientific evidence. Moreover, that board did not take account of the fact that the PETA International Science Consortium had not been able to annex that complete report to its statement in intervention since that report was not available at the time. It was also unable to submit that document in annex to its notice of appeal. Furthermore, the first of the abovementioned provisions does not distinguish the difference between types of evidence and does not preclude the late submission of certain types of evidence. That report is not a mere expert opinion but should be regarded as a scientific study. It is based on a systematic and validated approach, concerning the alleged endocrine disruption concerns of Triclosan. Mrs Mihaich’s expert opinion not only pools the relevant evidence together, but provides a detailed description of it and explains how the evidence is used to reach the final conclusion in a reliable, robust and transparent manner. |
| --- | --- |

398

In the first place, the applicant maintains that the Board of Appeal infringed Article 12(1) of Regulation No 771/2008 and Article 8(4)(f) of that regulation. The delay in the submission of the Mihaich report is justified for the purposes of those provisions. According to it, in the context of its examination, that board should take account of the most recent relevant scientific evidence. Moreover, that board did not take account of the fact that the PETA International Science Consortium had not been able to annex that complete report to its statement in intervention since that report was not available at the time. It was also unable to submit that document in annex to its notice of appeal. Furthermore, the first of the abovementioned provisions does not distinguish the difference between types of evidence and does not preclude the late submission of certain types of evidence. That report is not a mere expert opinion but should be regarded as a scientific study. It is based on a systematic and validated approach, concerning the alleged endocrine disruption concerns of Triclosan. Mrs Mihaich’s expert opinion not only pools the relevant evidence together, but provides a detailed description of it and explains how the evidence is used to reach the final conclusion in a reliable, robust and transparent manner.

| 399 | In the second place, the applicant claims that taking the Mihaich report into account could have changed the result of the procedure. According to it, if the Board of Appeal had taken that report into account, it would have concluded that, in the light of the different effects that Triclosan has on different species, the extrapolation to humans of data concerning rats was not possible. The conclusions of that report confirm that Triclosan does not have adverse effects. |
| --- | --- |

399

In the second place, the applicant claims that taking the Mihaich report into account could have changed the result of the procedure. According to it, if the Board of Appeal had taken that report into account, it would have concluded that, in the light of the different effects that Triclosan has on different species, the extrapolation to humans of data concerning rats was not possible. The conclusions of that report confirm that Triclosan does not have adverse effects.

| 400 | The ECHA disputes those arguments. |
| --- | --- |

400

The ECHA disputes those arguments.

| 401 | First of all, it should be noted that, in the present context, three documents must be distinguished:





  – | the Mihaich report published on 27 January 2017 in a scientific review; |
| --- | --- | --- |

401

First of all, it should be noted that, in the present context, three documents must be distinguished:

–

the Mihaich report published on 27 January 2017 in a scientific review;

| – | the poster of the Mihaich report during a scientific conference which was submitted by PETA International Science Consortium on 12 January 2016 in its statement in intervention before the Board of Appeal; |
| --- | --- |

–

the poster of the Mihaich report during a scientific conference which was submitted by PETA International Science Consortium on 12 January 2016 in its statement in intervention before the Board of Appeal;

| – | the expert opinion drafted by Mrs Mihaich at the request of the applicant, which was not verified by a third party and which the applicant submitted in the context of its observations on the statement in intervention before the Board of Appeal. |
| --- | --- |

–

the expert opinion drafted by Mrs Mihaich at the request of the applicant, which was not verified by a third party and which the applicant submitted in the context of its observations on the statement in intervention before the Board of Appeal.

| 402 | The document that the Board of Appeal rejected as inadmissible in paragraphs 125 to 130 of the contested decision of 19 December 2016 is the expert opinion of Mrs Mihaich, which the applicant had submitted in the context of its observations on the statement in intervention before it, and not the Mihaich report, which was not published until 27 January 2017, after the adoption of the contested decision. |
| --- | --- |

402

The document that the Board of Appeal rejected as inadmissible in paragraphs 125 to 130 of the contested decision of 19 December 2016 is the expert opinion of Mrs Mihaich, which the applicant had submitted in the context of its observations on the statement in intervention before it, and not the Mihaich report, which was not published until 27 January 2017, after the adoption of the contested decision.

| 403 | In the first place, it is necessary to reject the applicant’s argument alleging that, by rejecting the opinion at issue as inadmissible, the Board of Appeal infringed Article 8(4)(f) of Regulation No 771/2008. That provision covers requests to intervene. However, paragraphs 125 to 130 of the contested decision do not relate to the request to intervene before that board, but to a document which had been submitted by the applicant. |
| --- | --- |

403

In the first place, it is necessary to reject the applicant’s argument alleging that, by rejecting the opinion at issue as inadmissible, the Board of Appeal infringed Article 8(4)(f) of Regulation No 771/2008. That provision covers requests to intervene. However, paragraphs 125 to 130 of the contested decision do not relate to the request to intervene before that board, but to a document which had been submitted by the applicant.

| 404 | In the second place, as regards the argument alleging an infringement of Article 12(1) of Regulation No 771/2008, it should be noted that, under that provision, after the first exchange of pleadings, the parties to a procedure before the Board of Appeal of the ECHA cannot introduce further evidence, unless the Board of Appeal decides that the delay in offering the evidence is duly justified. |
| --- | --- |

404

In the second place, as regards the argument alleging an infringement of Article 12(1) of Regulation No 771/2008, it should be noted that, under that provision, after the first exchange of pleadings, the parties to a procedure before the Board of Appeal of the ECHA cannot introduce further evidence, unless the Board of Appeal decides that the delay in offering the evidence is duly justified.

| 405 | It is thus necessary to examine whether, in the circumstances of the present case, the Board of Appeal should have found that the delay in the presentation of the opinion at issue was duly justified. |
| --- | --- |

405

It is thus necessary to examine whether, in the circumstances of the present case, the Board of Appeal should have found that the delay in the presentation of the opinion at issue was duly justified.

| 406 | In that context, it should be noted that the applicant had stated the reasons why it had submitted the opinion at issue in the context of its observations on the statement in intervention before the Board of Appeal. As is apparent from the applicant’s written pleadings, after having become aware of the fact that the Mihaich report would not be available in due time, the applicant contacted Mrs Mihaich and requested her to draft an opinion based on the draft of the report to appear. The applicant then produced that opinion in the context of those observations. |
| --- | --- |

406

In that context, it should be noted that the applicant had stated the reasons why it had submitted the opinion at issue in the context of its observations on the statement in intervention before the Board of Appeal. As is apparent from the applicant’s written pleadings, after having become aware of the fact that the Mihaich report would not be available in due time, the applicant contacted Mrs Mihaich and requested her to draft an opinion based on the draft of the report to appear. The applicant then produced that opinion in the context of those observations.

| 407 | Contrary to what is claimed by the applicant, it cannot be considered that those circumstances justify the late presentation of the opinion at issue. As the Board of Appeal correctly pointed out in paragraph 129 of the contested decision, that opinion was issued by an expert, who analysed the conclusions to be drawn from the available information, by the weight of evidence determination of that information. In so far as that analysis called into question the conclusions reached by the ECHA on the basis of that information, it was an analysis which could have been submitted at the same time as the notice of appeal. There is nothing to prevent the applicant from commissioning such an opinion in a timely manner. The fact that Mrs Mihaich had still not formally drafted the opinion in question at the time the notice of appeal was submitted therefore does not justify the delay in the presentation of that opinion. |
| --- | --- |

407

Contrary to what is claimed by the applicant, it cannot be considered that those circumstances justify the late presentation of the opinion at issue. As the Board of Appeal correctly pointed out in paragraph 129 of the contested decision, that opinion was issued by an expert, who analysed the conclusions to be drawn from the available information, by the weight of evidence determination of that information. In so far as that analysis called into question the conclusions reached by the ECHA on the basis of that information, it was an analysis which could have been submitted at the same time as the notice of appeal. There is nothing to prevent the applicant from commissioning such an opinion in a timely manner. The fact that Mrs Mihaich had still not formally drafted the opinion in question at the time the notice of appeal was submitted therefore does not justify the delay in the presentation of that opinion.

| 408 | Therefore, the argument alleging an infringement of Article 12(1) of Regulation No 771/2008 must also be rejected. |
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408

Therefore, the argument alleging an infringement of Article 12(1) of Regulation No 771/2008 must also be rejected.

| 409 | In the light of those considerations, it is also necessary to reject the arguments based on the opinion at issue. |
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409

In the light of those considerations, it is also necessary to reject the arguments based on the opinion at issue.

4.
   
  The arguments calling into question the Board of Appeal’s preliminary observations

4.

The arguments calling into question the Board of Appeal’s preliminary observations

| 410 | In the context of the first part of the first plea, the applicant claims that, in paragraph 134 of the contested decision, the Board of Appeal applied an erroneous standard of review. According to it, that board deferred to the ECHA regarding scientific differences of opinion and confined itself to verifying the absence of a manifest error of assessment on the part of the ECHA. |
| --- | --- |

410

In the context of the first part of the first plea, the applicant claims that, in paragraph 134 of the contested decision, the Board of Appeal applied an erroneous standard of review. According to it, that board deferred to the ECHA regarding scientific differences of opinion and confined itself to verifying the absence of a manifest error of assessment on the part of the ECHA.

| 411 | The ECHA and the interveners dispute those arguments. |
| --- | --- |

411

The ECHA and the interveners dispute those arguments.

| 412 | In that regard, it should be noted that paragraph 134 of the contested decision is included in a part of the contested decision in which the Board of Appeal made some preliminary observations. In that paragraph, that board thus neither examined nor rejected the applicant’s arguments calling into question the ECHA decision. |
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412

In that regard, it should be noted that paragraph 134 of the contested decision is included in a part of the contested decision in which the Board of Appeal made some preliminary observations. In that paragraph, that board thus neither examined nor rejected the applicant’s arguments calling into question the ECHA decision.

| 413 | It is true that, subsequently, in the context of the applicant’s arguments, in paragraphs 156, 157 and 164 of the contested decision, the Board of Appeal referred to paragraph 134 of that decision. It should also be noted that the grounds set out in paragraphs 156, 157 and 164 of that decision were contested by the applicant in the context of the present action. However, as was stated in paragraphs 279 to 285, 331 to 336 and 363 above, that Board of Appeal confined itself in paragraphs 156, 157 and 164 of that decision to holding that the applicant’s arguments should be rejected, because they were not sufficiently substantiated. It therefore cannot be deduced that that board limited itself to verifying the absence of a manifest error of assessment on the part of the ECHA. |
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413

It is true that, subsequently, in the context of the applicant’s arguments, in paragraphs 156, 157 and 164 of the contested decision, the Board of Appeal referred to paragraph 134 of that decision. It should also be noted that the grounds set out in paragraphs 156, 157 and 164 of that decision were contested by the applicant in the context of the present action. However, as was stated in paragraphs 279 to 285, 331 to 336 and 363 above, that Board of Appeal confined itself in paragraphs 156, 157 and 164 of that decision to holding that the applicant’s arguments should be rejected, because they were not sufficiently substantiated. It therefore cannot be deduced that that board limited itself to verifying the absence of a manifest error of assessment on the part of the ECHA.

| 414 | It follows that the argument alleging that the Board of Appeal confined itself to verifying the absence of manifest errors of assessment must also be rejected. In so far as, in paragraph 232 of the contested decision, in the context of the examination of the 10th plea, concerning the request to conduct the fish test, that board also referred to paragraph 134 of that decision, this will be taken into account in paragraph 451 below. |
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414

It follows that the argument alleging that the Board of Appeal confined itself to verifying the absence of manifest errors of assessment must also be rejected. In so far as, in paragraph 232 of the contested decision, in the context of the examination of the 10th plea, concerning the request to conduct the fish test, that board also referred to paragraph 134 of that decision, this will be taken into account in paragraph 451 below.

| 415 | Therefore, all of the applicant’s arguments calling into question the considerations on which the Board of Appeal based the dismissal of the administrative appeal in so far as it related to the request to conduct the enhanced neurotoxicity rat study must be rejected. |
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415

Therefore, all of the applicant’s arguments calling into question the considerations on which the Board of Appeal based the dismissal of the administrative appeal in so far as it related to the request to conduct the enhanced neurotoxicity rat study must be rejected.

C. The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the fish test

C.

The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the fish test

| 416 | In its decision, the ECHA requested the applicant to conduct a fish test. In the context of the administrative appeal, the applicant claimed that that agency had not been entitled to request that test to be conducted. In the context of the 10th plea in that action, it claimed that that request was not compatible with either Article 25 of Regulation No 1907/2006 or with the principle of proportionality. It would not have been necessary to conduct such a test due to the fact that the available information showed the absence of adverse endocrine effects on fish at concentrations which would not cause general toxicity. In that context, the applicant claimed that it followed from the BASF and Foran studies that Triclosan was not sufficiently strong to produce such in vivo effects and that, therefore, it was not necessary to sacrifice animals in order to obtain data which is not relevant. |
| --- | --- |

416

In its decision, the ECHA requested the applicant to conduct a fish test. In the context of the administrative appeal, the applicant claimed that that agency had not been entitled to request that test to be conducted. In the context of the 10th plea in that action, it claimed that that request was not compatible with either Article 25 of Regulation No 1907/2006 or with the principle of proportionality. It would not have been necessary to conduct such a test due to the fact that the available information showed the absence of adverse endocrine effects on fish at concentrations which would not cause general toxicity. In that context, the applicant claimed that it followed from the BASF and Foran studies that Triclosan was not sufficiently strong to produce such in vivo effects and that, therefore, it was not necessary to sacrifice animals in order to obtain data which is not relevant.

in vivo

| 417 | In the contested decision, the Board of Appeal examined and rejected those arguments. Firstly, it noted, making reference to paragraph 101 of that decision, that, in order to establish that a request for further information was necessary in the context of the evaluation of a substance, the ECHA had to establish the existence of a potential risk to human health and to the environment, that that risk had to be clarified and that there was a real possibility that the information requested would lead to improved risk management measures (paragraph 225). Next, it noted that the applicant claimed, in essence, that the ECHA had not established the existence of a potential risk to human health and to the environment and that, in order to show the absence of a potential risk, the applicant relied on several studies which were included in the registration dossier for Triclosan (paragraph 226). Moreover, it stated, as was apparent from paragraph 44 of that decision, that there was considerable environmental exposure to Triclosan and that, in its decision, the ECHA had clearly identified potential adverse effects on fish (paragraphs 227 and 228). According to it, the ECHA decision therefore clearly identified a potential risk of adverse effects connected with the endocrine function on fish, which could result in Triclosan being regarded as a substance of very high concern and was of such significance that it had to be clarified. Finally, it examined the applicant’s arguments based on the BASF and Foran studies (paragraphs 229 to 232). Firstly, it noted that, in so far as, by its arguments, the applicant sought to claim that the ECHA had failed to take account of the BASF and Foran studies, it was necessary to reject them, because the ECHA set out in its decision the reasons why it considered that the information contained in those studies did not suffice in order to assess the effects of Triclosan on the sexual development of fish. Secondly, it noted that, in so far as, by its arguments, the applicant sought to express its disagreement with the ECHA assessment, it was also necessary to reject them. According to it, as set out in paragraph 134 of that decision, a mere difference of scientific opinion is not capable of calling into question the legality of the ECHA decision. |
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417

In the contested decision, the Board of Appeal examined and rejected those arguments. Firstly, it noted, making reference to paragraph 101 of that decision, that, in order to establish that a request for further information was necessary in the context of the evaluation of a substance, the ECHA had to establish the existence of a potential risk to human health and to the environment, that that risk had to be clarified and that there was a real possibility that the information requested would lead to improved risk management measures (paragraph 225). Next, it noted that the applicant claimed, in essence, that the ECHA had not established the existence of a potential risk to human health and to the environment and that, in order to show the absence of a potential risk, the applicant relied on several studies which were included in the registration dossier for Triclosan (paragraph 226). Moreover, it stated, as was apparent from paragraph 44 of that decision, that there was considerable environmental exposure to Triclosan and that, in its decision, the ECHA had clearly identified potential adverse effects on fish (paragraphs 227 and 228). According to it, the ECHA decision therefore clearly identified a potential risk of adverse effects connected with the endocrine function on fish, which could result in Triclosan being regarded as a substance of very high concern and was of such significance that it had to be clarified. Finally, it examined the applicant’s arguments based on the BASF and Foran studies (paragraphs 229 to 232). Firstly, it noted that, in so far as, by its arguments, the applicant sought to claim that the ECHA had failed to take account of the BASF and Foran studies, it was necessary to reject them, because the ECHA set out in its decision the reasons why it considered that the information contained in those studies did not suffice in order to assess the effects of Triclosan on the sexual development of fish. Secondly, it noted that, in so far as, by its arguments, the applicant sought to express its disagreement with the ECHA assessment, it was also necessary to reject them. According to it, as set out in paragraph 134 of that decision, a mere difference of scientific opinion is not capable of calling into question the legality of the ECHA decision.

| 418 | On the basis of those considerations, the Board of Appeal concluded that both the applicant’s argument alleging an infringement of Article 25 of Regulation No 1907/2006 and the argument alleging a breach of the principle of proportionality should be rejected. |
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418

On the basis of those considerations, the Board of Appeal concluded that both the applicant’s argument alleging an infringement of Article 25 of Regulation No 1907/2006 and the argument alleging a breach of the principle of proportionality should be rejected.

| 419 | The applicant claims that those findings are incorrect. |
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419

The applicant claims that those findings are incorrect.

| 420 | In the first place, in the context of the second part of the second plea, the applicant claims that, in paragraphs 229 to 231 of the contested decision, the Board of Appeal committed an error by not properly exercising its discretion and by not establishing, on the basis of the available scientific data, whether there was a potential risk, which could justify the conduct of further tests. It confirms that it provided numerous evidence and scientific studies in the notice of appeal showing how unlikely it was for Triclosan to have the adverse effects alleged by the ECHA on fecundity or fertility in fish. That board confined itself to reproducing an entire section of the ECHA decision, rejected the applicant’s arguments without examining the merits thereof and did not properly exercise its discretion, which would have required all of the relevant evidence and circumstances of the situation to be taken into consideration. |
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420

In the first place, in the context of the second part of the second plea, the applicant claims that, in paragraphs 229 to 231 of the contested decision, the Board of Appeal committed an error by not properly exercising its discretion and by not establishing, on the basis of the available scientific data, whether there was a potential risk, which could justify the conduct of further tests. It confirms that it provided numerous evidence and scientific studies in the notice of appeal showing how unlikely it was for Triclosan to have the adverse effects alleged by the ECHA on fecundity or fertility in fish. That board confined itself to reproducing an entire section of the ECHA decision, rejected the applicant’s arguments without examining the merits thereof and did not properly exercise its discretion, which would have required all of the relevant evidence and circumstances of the situation to be taken into consideration.

| 421 | In the second place, in the context of the second part of the second plea, the applicant claims that the ECHA and the Board of Appeal reversed the burden of proof, which is not compatible with the applicable rules and infringed Article 25(1) of Regulation No 1907/2006. According to it, it was not for it to demonstrate the absence of any concern relating to Triclosan, but rather for the ECHA to demonstrate the existence of a potential risk of endocrine disruption in fish. |
| --- | --- |

421

In the second place, in the context of the second part of the second plea, the applicant claims that the ECHA and the Board of Appeal reversed the burden of proof, which is not compatible with the applicable rules and infringed Article 25(1) of Regulation No 1907/2006. According to it, it was not for it to demonstrate the absence of any concern relating to Triclosan, but rather for the ECHA to demonstrate the existence of a potential risk of endocrine disruption in fish.

| 422 | In the third place, in the context of the second part of the second plea, the applicant claims that the ECHA’s findings and those of the Board of Appeal were insufficient for the purposes of establishing that the request to conduct the fish test was necessary. It states that, according to those findings, the link between Triclosan and the adverse effects was not ‘fully conclusive’. None of the studies established the risk which was allegedly identified. Moreover, in order to establish the existence of a potential risk, it is necessary to determine the relevant hazard and the exposure to that hazard. In paragraph 227 of the contested decision, that board limited itself to presenting different evidence about the risk and the exposure, without establishing the connexion between them. That board in particular failed to examine whether the concentration levels used in the available studies corresponded to levels which were consistent with those that can realistically occur in real life conditions. |
| --- | --- |

422

In the third place, in the context of the second part of the second plea, the applicant claims that the ECHA’s findings and those of the Board of Appeal were insufficient for the purposes of establishing that the request to conduct the fish test was necessary. It states that, according to those findings, the link between Triclosan and the adverse effects was not ‘fully conclusive’. None of the studies established the risk which was allegedly identified. Moreover, in order to establish the existence of a potential risk, it is necessary to determine the relevant hazard and the exposure to that hazard. In paragraph 227 of the contested decision, that board limited itself to presenting different evidence about the risk and the exposure, without establishing the connexion between them. That board in particular failed to examine whether the concentration levels used in the available studies corresponded to levels which were consistent with those that can realistically occur in real life conditions.

| 423 | In the fourth place, in the context of the first and second parts of the first plea, the applicant claims that, in paragraph 232 of the contested decision, the Board of Appeal should not have relied on the finding that, in itself, a difference of scientific opinion was not sufficient to call into question the lawfulness of that decision. According to it, the role of that board consists precisely in carefully examining whether the ECHA’s opinion was justified in the light of the relevant evidence. It claims that that board refused to examine the evidence it had put forward. |
| --- | --- |

423

In the fourth place, in the context of the first and second parts of the first plea, the applicant claims that, in paragraph 232 of the contested decision, the Board of Appeal should not have relied on the finding that, in itself, a difference of scientific opinion was not sufficient to call into question the lawfulness of that decision. According to it, the role of that board consists precisely in carefully examining whether the ECHA’s opinion was justified in the light of the relevant evidence. It claims that that board refused to examine the evidence it had put forward.

| 424 | In the fifth place, in the context of the second part of the first plea, the applicant claims that, in paragraph 231 of the contested decision, the Board of Appeal should not have restricted itself to finding that the ECHA had taken the BASF and Foran studies into account. It indicates that, in the notice of appeal, it had stated that the BASF study it submitted was a level 3 study. According to it, where the results of such studies are negative, it is widely accepted that it is not necessary to conduct a further study of the effects analysed. That board should therefore not have ignored that study. |
| --- | --- |

424

In the fifth place, in the context of the second part of the first plea, the applicant claims that, in paragraph 231 of the contested decision, the Board of Appeal should not have restricted itself to finding that the ECHA had taken the BASF and Foran studies into account. It indicates that, in the notice of appeal, it had stated that the BASF study it submitted was a level 3 study. According to it, where the results of such studies are negative, it is widely accepted that it is not necessary to conduct a further study of the effects analysed. That board should therefore not have ignored that study.

| 425 | In the sixth place, in the context of the second part of the second plea, the applicant claims that the Board of Appeal should also have taken into account the expert opinion of Mrs Mihaich that she had submitted in the context of her observations on the statement in intervention before that board. |
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425

In the sixth place, in the context of the second part of the second plea, the applicant claims that the Board of Appeal should also have taken into account the expert opinion of Mrs Mihaich that she had submitted in the context of her observations on the statement in intervention before that board.

| 426 | In the seventh place, in the context of the second part of the second plea, the applicant claims that it provided numerous data and scientific studies in its notice of appeal, which show how unlikely it is for Triclosan to have the adverse effects alleged by the ECHA on fecundity or fertility in fish. |
| --- | --- |

426

In the seventh place, in the context of the second part of the second plea, the applicant claims that it provided numerous data and scientific studies in its notice of appeal, which show how unlikely it is for Triclosan to have the adverse effects alleged by the ECHA on fecundity or fertility in fish.

| 427 | The ECHA and the interveners dispute those arguments. |
| --- | --- |

427

The ECHA and the interveners dispute those arguments.

| 428 | As a first step, in so far as the applicant’s arguments seek to demonstrate that, in the context of the examination of the merits of the action before it, the Board of Appeal should not have merely examined whether the ECHA decision is vitiated by error, but should have itself examined whether it was necessary to request the conduct of the fish test, it is necessary to reject them for the same reasons as those set out in paragraphs 55 to 131 above. |
| --- | --- |

428

As a first step, in so far as the applicant’s arguments seek to demonstrate that, in the context of the examination of the merits of the action before it, the Board of Appeal should not have merely examined whether the ECHA decision is vitiated by error, but should have itself examined whether it was necessary to request the conduct of the fish test, it is necessary to reject them for the same reasons as those set out in paragraphs 55 to 131 above.

| 429 | As a second step, it is necessary to examine the applicant’s arguments, in so far as they seek to demonstrate that, in the context of the review of the ECHA decision, the Boards of Appeal committed an error. |
| --- | --- |

429

As a second step, it is necessary to examine the applicant’s arguments, in so far as they seek to demonstrate that, in the context of the review of the ECHA decision, the Boards of Appeal committed an error.

| 430 | In the first place, the applicant claims that, in paragraph 231 of the contested decision, the Board of Appeal unduly reversed the burden of proof. Under Article 25(1) of Regulation No 1907/2006, it is not for it to demonstrate the absence of any concern in relation to Triclosan, but it was rather for the ECHA to demonstrate the existence of a potential risk of endocrine disruption in fish. |
| --- | --- |

430

In the first place, the applicant claims that, in paragraph 231 of the contested decision, the Board of Appeal unduly reversed the burden of proof. Under Article 25(1) of Regulation No 1907/2006, it is not for it to demonstrate the absence of any concern in relation to Triclosan, but it was rather for the ECHA to demonstrate the existence of a potential risk of endocrine disruption in fish.

| 431 | Firstly, in so far as the argument mentioned in paragraph 430 above relates to the allocation of the burden of proof in the proceedings before the Board of Appeal, it should be noted that that board did not commit an error when it found, in paragraphs 232 and 233 of the contested decision, that it was for the applicant to demonstrate that the ECHA’s findings were vitiated by an error. That allocation of the burden of proof results from the adversarial nature of the proceedings before that board. Therefore, that argument must be rejected in so far as it refers to the burden of proof in those proceedings. |
| --- | --- |

431

Firstly, in so far as the argument mentioned in paragraph 430 above relates to the allocation of the burden of proof in the proceedings before the Board of Appeal, it should be noted that that board did not commit an error when it found, in paragraphs 232 and 233 of the contested decision, that it was for the applicant to demonstrate that the ECHA’s findings were vitiated by an error. That allocation of the burden of proof results from the adversarial nature of the proceedings before that board. Therefore, that argument must be rejected in so far as it refers to the burden of proof in those proceedings.

| 432 | Secondly, in so far as the argument mentioned in paragraph 430 above relates to the burden of proof in proceedings before the ECHA, it should be recalled that, in order to demonstrate that a request for further information is necessary, the ECHA is required to show that the substance at issue poses a potential risk to human health and the environment, that it is necessary to clarify that risk and that there is a realistic possibility that the information requested would allow improved risk management measures to be taken. |
| --- | --- |

432

Secondly, in so far as the argument mentioned in paragraph 430 above relates to the burden of proof in proceedings before the ECHA, it should be recalled that, in order to demonstrate that a request for further information is necessary, the ECHA is required to show that the substance at issue poses a potential risk to human health and the environment, that it is necessary to clarify that risk and that there is a realistic possibility that the information requested would allow improved risk management measures to be taken.

| 433 | It must be noted that the Board of Appeal did not breach the rules on the allocation of the burden of proof during the procedure before the ECHA. As is apparent from paragraphs 225, 227 and 228 of the contested decision, concerning the procedure before the ECHA, that board followed an approach which was compatible with the principle referred to in paragraph 432 above. |
| --- | --- |

433

It must be noted that the Board of Appeal did not breach the rules on the allocation of the burden of proof during the procedure before the ECHA. As is apparent from paragraphs 225, 227 and 228 of the contested decision, concerning the procedure before the ECHA, that board followed an approach which was compatible with the principle referred to in paragraph 432 above.

| 434 | In the light of those considerations, it is necessary to reject the argument mentioned in paragraph 430 above. |
| --- | --- |

434

In the light of those considerations, it is necessary to reject the argument mentioned in paragraph 430 above.

| 435 | In the second place, as regards the applicant’s argument that, in the contested decision, the Board of Appeal reproduced an entire section of the ECHA decision, it suffices to note that, in the context of the review that that board must conduct following an action against a decision of the ECHA, nothing prevents it from referring to the findings on which that decision is based and reviewing whether the arguments put forward by the applicant in the action before it are capable of demonstrating the existence of an error vitiating those findings. Therefore, that argument must be rejected. |
| --- | --- |

435

In the second place, as regards the applicant’s argument that, in the contested decision, the Board of Appeal reproduced an entire section of the ECHA decision, it suffices to note that, in the context of the review that that board must conduct following an action against a decision of the ECHA, nothing prevents it from referring to the findings on which that decision is based and reviewing whether the arguments put forward by the applicant in the action before it are capable of demonstrating the existence of an error vitiating those findings. Therefore, that argument must be rejected.

| 436 | In the third place, the applicant claims that the Board of Appeal should not have rejected its arguments seeking to demonstrate that the ECHA had not established a potential risk concerning the sexual development of fish. |
| --- | --- |

436

In the third place, the applicant claims that the Board of Appeal should not have rejected its arguments seeking to demonstrate that the ECHA had not established a potential risk concerning the sexual development of fish.

| 437 | Firstly, the applicant claims that, contrary to what was noted by the Board of Appeal in paragraph 227 of the contested decision, the evidence upon which the ECHA relied in its decision did not suffice in order to establish the existence of such a risk. |
| --- | --- |

437

Firstly, the applicant claims that, contrary to what was noted by the Board of Appeal in paragraph 227 of the contested decision, the evidence upon which the ECHA relied in its decision did not suffice in order to establish the existence of such a risk.

| 438 | As the Board of Appeal noted in paragraph 102 of the contested decision, the existence of a potential risk of adverse effects to human health and the environment depends, firstly, on the harmful properties of that substance and, secondly, on the exposure to that substance. |
| --- | --- |

438

As the Board of Appeal noted in paragraph 102 of the contested decision, the existence of a potential risk of adverse effects to human health and the environment depends, firstly, on the harmful properties of that substance and, secondly, on the exposure to that substance.

| 439 | In paragraphs 227 and 228 of the contested decision, the Board of Appeal concluded that, according to the ECHA’s findings, firstly, there existed indications that Triclosan had adverse effects on fish and, secondly, there was a considerable environmental exposure to Triclosan. |
| --- | --- |

439

In paragraphs 227 and 228 of the contested decision, the Board of Appeal concluded that, according to the ECHA’s findings, firstly, there existed indications that Triclosan had adverse effects on fish and, secondly, there was a considerable environmental exposure to Triclosan.

| 440 | The Board of Appeal did not commit an error when it considered that those elements allowed the ECHA to establish the existence of a potential risk for the environment, which should be clarified, and thus justified the request to conduct the fish test. |
| --- | --- |

440

The Board of Appeal did not commit an error when it considered that those elements allowed the ECHA to establish the existence of a potential risk for the environment, which should be clarified, and thus justified the request to conduct the fish test.

| 441 | As was stated in paragraphs 269 to 273 above, in order to demonstrate the existence of such a potential risk, the ECHA was not required to find that, on the basis of the information available to it, Triclosan should be considered to indeed possess dangerous properties. Therefore, contrary to what is claimed by the applicant, in order to adopt a decision requesting further information, the ECHA was not required to find the existence of a conclusive link between Triclosan and the identified adverse effects. To justify its request for further information, it was solely required to establish that there was a potential risk of such a link existing. |
| --- | --- |

441

As was stated in paragraphs 269 to 273 above, in order to demonstrate the existence of such a potential risk, the ECHA was not required to find that, on the basis of the information available to it, Triclosan should be considered to indeed possess dangerous properties. Therefore, contrary to what is claimed by the applicant, in order to adopt a decision requesting further information, the ECHA was not required to find the existence of a conclusive link between Triclosan and the identified adverse effects. To justify its request for further information, it was solely required to establish that there was a potential risk of such a link existing.

| 442 | As regards the applicant’s argument alleging that, in that context, the Board of Appeal failed to examine whether the levels of concentration used in the available studies were consistent with those that could realistically occur in real life conditions, it should be noted that, in the context of an action before it, that board confined itself to examining whether the arguments put forward by the applicant are capable of demonstrating the existence of an error vitiating the decision contested before it. However, it must be noted that, in the context of the 10th plea in the notice of appeal, the applicant did not put forward such an argument. That board cannot therefore be criticised for not having examined it. |
| --- | --- |

442

As regards the applicant’s argument alleging that, in that context, the Board of Appeal failed to examine whether the levels of concentration used in the available studies were consistent with those that could realistically occur in real life conditions, it should be noted that, in the context of an action before it, that board confined itself to examining whether the arguments put forward by the applicant are capable of demonstrating the existence of an error vitiating the decision contested before it. However, it must be noted that, in the context of the 10th plea in the notice of appeal, the applicant did not put forward such an argument. That board cannot therefore be criticised for not having examined it.

| 443 | It follows that the arguments relating to the Board of Appeal’s findings in paragraph 227 of the contested decision must be rejected. |
| --- | --- |

443

It follows that the arguments relating to the Board of Appeal’s findings in paragraph 227 of the contested decision must be rejected.

| 444 | Secondly, the applicant claims that, in paragraph 232 of the contested decision, the Board of Appeal should not have relied on the finding that, in itself, a difference of scientific opinion did not suffice in order to call into question the lawfulness of the ECHA decision. In that context, concerning the BASF study, it claims that that study was a level 3 study and that, where the results of such a study are negative, it is widely accepted that it is not necessary to conduct a further study of the effects analysed. |
| --- | --- |

444

Secondly, the applicant claims that, in paragraph 232 of the contested decision, the Board of Appeal should not have relied on the finding that, in itself, a difference of scientific opinion did not suffice in order to call into question the lawfulness of the ECHA decision. In that context, concerning the BASF study, it claims that that study was a level 3 study and that, where the results of such a study are negative, it is widely accepted that it is not necessary to conduct a further study of the effects analysed.

| 445 | In that regard, it should be noted that paragraph 232 of the contested decision is in the part of that decision in which the Board of Appeal examined the applicant’s arguments alleging that the BASF and Foran studies allowed the absence of a potential risk for the sexual development of fish to be demonstrated. In paragraphs 229 to 231 of that decision, that board found that the ECHA had taken those studies into account. In that context, it noted that, in its decision, the ECHA had set out the reasons why the information contained in those studies did not allow a possible risk with regard to the sexual development of fish to be excluded. In paragraph 232 of the contested decision, that board ruled on whether the applicant’s arguments relating to those studies were capable of calling into question those findings of the ECHA. |
| --- | --- |

445

In that regard, it should be noted that paragraph 232 of the contested decision is in the part of that decision in which the Board of Appeal examined the applicant’s arguments alleging that the BASF and Foran studies allowed the absence of a potential risk for the sexual development of fish to be demonstrated. In paragraphs 229 to 231 of that decision, that board found that the ECHA had taken those studies into account. In that context, it noted that, in its decision, the ECHA had set out the reasons why the information contained in those studies did not allow a possible risk with regard to the sexual development of fish to be excluded. In paragraph 232 of the contested decision, that board ruled on whether the applicant’s arguments relating to those studies were capable of calling into question those findings of the ECHA.

| 446 | As is apparent from paragraph 229 of the contested decision, the Board of Appeal noted that, in its decision, the ECHA had examined and rejected the applicant’s argument alleging that the BASF study was a level 3 study and that, where the results of such a study were negative, it was widely accepted that it was not necessary to conduct a further study of the effects analysed. In that regard, it had stated, in particular, that the studies of the same type as the BASF study could not be used as definitive tests and that, statistically, they were not adequate bases. |
| --- | --- |

446

As is apparent from paragraph 229 of the contested decision, the Board of Appeal noted that, in its decision, the ECHA had examined and rejected the applicant’s argument alleging that the BASF study was a level 3 study and that, where the results of such a study were negative, it was widely accepted that it was not necessary to conduct a further study of the effects analysed. In that regard, it had stated, in particular, that the studies of the same type as the BASF study could not be used as definitive tests and that, statistically, they were not adequate bases.

| 447 | Moreover, in paragraph 230 of the contested decision, the Board of Appeal examined and rejected the applicant’s arguments relating to the Foran study. |
| --- | --- |

447

Moreover, in paragraph 230 of the contested decision, the Board of Appeal examined and rejected the applicant’s arguments relating to the Foran study.

| 448 | In the light of the adversarial nature of the proceedings before the Board of Appeal, confronted with detailed grounds setting out why the BASF and the Foran studies did not suffice in order to exclude the existence of a potential risk to the sexual development of fish, the applicant could not merely claim that those studies existed and justified a conclusion different from that of the ECHA. Such arguments were not capable, in themselves, of demonstrating the existence of an error vitiating the ECHA’s findings. |
| --- | --- |

448

In the light of the adversarial nature of the proceedings before the Board of Appeal, confronted with detailed grounds setting out why the BASF and the Foran studies did not suffice in order to exclude the existence of a potential risk to the sexual development of fish, the applicant could not merely claim that those studies existed and justified a conclusion different from that of the ECHA. Such arguments were not capable, in themselves, of demonstrating the existence of an error vitiating the ECHA’s findings.

| 449 | It must be noted that, in the action before the Board of Appeal, the applicant merely claimed that, in the light of the information contained in the BASF and Foran studies, the ECHA should have concluded that there was no potential risk connected with Triclosan for the sexual development of fish. By contrast, it did not set out the reasons why the ECHA’s detailed findings, according to which the information contained in those studies was not sufficient, should be considered to be incorrect. In those circumstances, the arguments raised by the applicant in that action relating to the BASF and Foran studies cannot be considered to be sufficiently substantiated. |
| --- | --- |

449

It must be noted that, in the action before the Board of Appeal, the applicant merely claimed that, in the light of the information contained in the BASF and Foran studies, the ECHA should have concluded that there was no potential risk connected with Triclosan for the sexual development of fish. By contrast, it did not set out the reasons why the ECHA’s detailed findings, according to which the information contained in those studies was not sufficient, should be considered to be incorrect. In those circumstances, the arguments raised by the applicant in that action relating to the BASF and Foran studies cannot be considered to be sufficiently substantiated.

| 450 | In those circumstances, the Board of Appeal cannot be criticised for confining itself, in paragraph 232 of the contested decision, to noting that the mere existence of a divergent scientific opinion did not, as such, suffice for the purposes of demonstrating the existence of an error vitiating the ECHA decision, by referring to its findings set out in the fourth and fifth sentences of paragraph 134 of that decision. |
| --- | --- |

450

In those circumstances, the Board of Appeal cannot be criticised for confining itself, in paragraph 232 of the contested decision, to noting that the mere existence of a divergent scientific opinion did not, as such, suffice for the purposes of demonstrating the existence of an error vitiating the ECHA decision, by referring to its findings set out in the fourth and fifth sentences of paragraph 134 of that decision.

| 451 | In that context, it should also be noted that, in doing so, the Board of Appeal merely rejected the applicant’s arguments as insufficiently substantiated. By contrast, it cannot be deduced from paragraph 232 of the contested decision and from the reference made in paragraph 134 of the contested decision that that board limited the intensity of its review to verifying the existence of manifest errors committed by the ECHA. |
| --- | --- |

451

In that context, it should also be noted that, in doing so, the Board of Appeal merely rejected the applicant’s arguments as insufficiently substantiated. By contrast, it cannot be deduced from paragraph 232 of the contested decision and from the reference made in paragraph 134 of the contested decision that that board limited the intensity of its review to verifying the existence of manifest errors committed by the ECHA.

| 452 | Therefore, the arguments referring to paragraph 232 of the contested decision and concerning the BASF and Foran studies must also be rejected and, therefore, the entirety of the arguments alleging that the Board of Appeal should not have rejected the applicant’s arguments seeking to demonstrate that the ECHA had not established a potential risk concerning the sexual development of fish. |
| --- | --- |

452

Therefore, the arguments referring to paragraph 232 of the contested decision and concerning the BASF and Foran studies must also be rejected and, therefore, the entirety of the arguments alleging that the Board of Appeal should not have rejected the applicant’s arguments seeking to demonstrate that the ECHA had not established a potential risk concerning the sexual development of fish.

| 453 | In the fourth place, in so far as, in the second part of the second plea, the applicant claims that the Board of Appeal should also have taken into account Mrs Mihaich’s expert opinion which she had submitted in the context of its observations on the statement in intervention before that board, it is necessary to reject that argument for the same reasons as those set out in paragraphs 396 to 409 above. |
| --- | --- |

453

In the fourth place, in so far as, in the second part of the second plea, the applicant claims that the Board of Appeal should also have taken into account Mrs Mihaich’s expert opinion which she had submitted in the context of its observations on the statement in intervention before that board, it is necessary to reject that argument for the same reasons as those set out in paragraphs 396 to 409 above.

| 454 | In the fifth place, in the context of the second part of the second plea, the applicant claims that it annexed numerous data and scientific studies to the notice of appeal, which reveal how unlikely it is that Triclosan could have the adverse effects alleged by the ECHA on the fecundity or fertility of fish. |
| --- | --- |

454

In the fifth place, in the context of the second part of the second plea, the applicant claims that it annexed numerous data and scientific studies to the notice of appeal, which reveal how unlikely it is that Triclosan could have the adverse effects alleged by the ECHA on the fecundity or fertility of fish.

| 455 | Firstly, in so far as the applicant’s argument relates to the BASF and Foran studies, and the expert opinion of Mrs Mihaich which it had submitted in the context of its observations on the statement in intervention before that board, it is necessary to reject it for the same reasons as those set out in paragraphs 430 to 453 above. |
| --- | --- |

455

Firstly, in so far as the applicant’s argument relates to the BASF and Foran studies, and the expert opinion of Mrs Mihaich which it had submitted in the context of its observations on the statement in intervention before that board, it is necessary to reject it for the same reasons as those set out in paragraphs 430 to 453 above.

| 456 | Secondly, in so far as the applicant’s argument relates to other studies than those mentioned in paragraph 455 above, it should be noted that, as was stated in paragraphs 59 to 86 above, in principle the Board of Appeal confines itself, in the context of an action before it, to examining the pleas put forward by the applicant. |
| --- | --- |

456

Secondly, in so far as the applicant’s argument relates to other studies than those mentioned in paragraph 455 above, it should be noted that, as was stated in paragraphs 59 to 86 above, in principle the Board of Appeal confines itself, in the context of an action before it, to examining the pleas put forward by the applicant.

| 457 | It must be noted that, in the context of the 10th plea in the action before the Board of Appeal, the applicant did not develop detailed arguments capable of demonstrating that the findings in the ECHA decision were vitiated by error, but merely claimed that it was of the opinion that it was possible to deduce from available studies that Triclosan did not pose a potential risk for the sexual development of fish. |
| --- | --- |

457

It must be noted that, in the context of the 10th plea in the action before the Board of Appeal, the applicant did not develop detailed arguments capable of demonstrating that the findings in the ECHA decision were vitiated by error, but merely claimed that it was of the opinion that it was possible to deduce from available studies that Triclosan did not pose a potential risk for the sexual development of fish.

| 458 | In those circumstances, the Board of Appeal cannot be criticised for confining itself, in paragraph 232 of the contested decision, to noting that the mere existence of a diverging scientific opinion was not, in itself, sufficient for the purposes of demonstrating the existence of an error vitiating the ECHA decision. |
| --- | --- |

458

In those circumstances, the Board of Appeal cannot be criticised for confining itself, in paragraph 232 of the contested decision, to noting that the mere existence of a diverging scientific opinion was not, in itself, sufficient for the purposes of demonstrating the existence of an error vitiating the ECHA decision.

| 459 | In the light of the above considerations, it is necessary to reject the entirety of the arguments concerning the rejection of the plea in the action before the Board of Appeal relating to the request to conduct the fish test. |
| --- | --- |

459

In the light of the above considerations, it is necessary to reject the entirety of the arguments concerning the rejection of the plea in the action before the Board of Appeal relating to the request to conduct the fish test.

D. The argument alleging that the Board of Appeal’s approach is incoherent

D.

The argument alleging that the Board of Appeal’s approach is incoherent

| 460 | The applicant claims that the Board of Appeal did not apply a coherent standard of review in the entirety of the contested decision. In paragraph 241 of that decision, that board carried out a detailed examination of the necessity of the cardiotoxicity literature review. In that context, that board conducted its own review of the scientific relevance and reliability of the study invoked by the ECHA in order to demonstrate the existence of a potential risk. That board thus did not exercise its discretion consistently. |
| --- | --- |

460

The applicant claims that the Board of Appeal did not apply a coherent standard of review in the entirety of the contested decision. In paragraph 241 of that decision, that board carried out a detailed examination of the necessity of the cardiotoxicity literature review. In that context, that board conducted its own review of the scientific relevance and reliability of the study invoked by the ECHA in order to demonstrate the existence of a potential risk. That board thus did not exercise its discretion consistently.

| 461 | The ECHA contests those arguments. |
| --- | --- |

461

The ECHA contests those arguments.

| 462 | In that regard, in the first place, it should be recalled that, as was stated in paragraphs 46 to 459 above, the arguments put forward by the applicant in the action before the Court did not identify errors on the part of the Board of Appeal which would justify the contested decision being annulled in so far as it related to the requests to conduct the persistence test, the enhanced neurotoxicity rat study and the fish test. In so far as, by its arguments, the applicant refers to an error committed in paragraph 241 of that decision, it suffices to note that that paragraph is in a part of that decision in which the Board of Appeal set out the findings which led it to annul the ECHA decision in so far as it obliged the applicant to present information relating to the effects of Triclosan on the cardiovascular system. However, it must be noted that the applicant does not seek annulment of that part of the decision at issue. |
| --- | --- |

462

In that regard, in the first place, it should be recalled that, as was stated in paragraphs 46 to 459 above, the arguments put forward by the applicant in the action before the Court did not identify errors on the part of the Board of Appeal which would justify the contested decision being annulled in so far as it related to the requests to conduct the persistence test, the enhanced neurotoxicity rat study and the fish test. In so far as, by its arguments, the applicant refers to an error committed in paragraph 241 of that decision, it suffices to note that that paragraph is in a part of that decision in which the Board of Appeal set out the findings which led it to annul the ECHA decision in so far as it obliged the applicant to present information relating to the effects of Triclosan on the cardiovascular system. However, it must be noted that the applicant does not seek annulment of that part of the decision at issue.

| 463 | In the second place and in any event, it should be noted that, contrary to what is claimed by the applicant, the Board of Appeal did not adopt an inconsistent approach in the context of the examination it carried out. |
| --- | --- |

463

In the second place and in any event, it should be noted that, contrary to what is claimed by the applicant, the Board of Appeal did not adopt an inconsistent approach in the context of the examination it carried out.

| 464 | It must be noted that, as is apparent from paragraphs 235 to 238 and 241 of the contested decision, in the action before the Board of Appeal, the applicant had put forward detailed arguments alleging that the ECHA had not established the existence of a potential risk of Triclosan having effects on the cardiovascular system, due to the fact that it had relied solely on one study and that that study was not relevant to humans, since Triclosan had been administered in artificially high doses and by a route of exposure which was not relevant to the exposure of humans to Triclosan. |
| --- | --- |

464

It must be noted that, as is apparent from paragraphs 235 to 238 and 241 of the contested decision, in the action before the Board of Appeal, the applicant had put forward detailed arguments alleging that the ECHA had not established the existence of a potential risk of Triclosan having effects on the cardiovascular system, due to the fact that it had relied solely on one study and that that study was not relevant to humans, since Triclosan had been administered in artificially high doses and by a route of exposure which was not relevant to the exposure of humans to Triclosan.

| 465 | In paragraphs 241 and 242 of the contested decision, the Board of Appeal thus confined itself to examining and upholding the applicant’s detailed arguments. |
| --- | --- |

465

In paragraphs 241 and 242 of the contested decision, the Board of Appeal thus confined itself to examining and upholding the applicant’s detailed arguments.

| 466 | Contrary to what is claimed by the applicant, the fact that other of its arguments were rejected by the Board of Appeal on the ground that they were not sufficiently substantiated and were therefore not capable of calling into question the lawfulness of the ECHA decision cannot be considered to be contradictory. |
| --- | --- |

466

Contrary to what is claimed by the applicant, the fact that other of its arguments were rejected by the Board of Appeal on the ground that they were not sufficiently substantiated and were therefore not capable of calling into question the lawfulness of the ECHA decision cannot be considered to be contradictory.

| 467 | Therefore, the applicant’s arguments alleging that the Board of Appeal adopted an incoherent approach must be rejected. |
| --- | --- |

467

Therefore, the applicant’s arguments alleging that the Board of Appeal adopted an incoherent approach must be rejected.

E. The arguments alleging an infringement of the rights of the defence

E.

The arguments alleging an infringement of the rights of the defence

| 468 | The applicant claims that, by rejecting its key arguments and the scientific evidence without examining their merits, the Board of Appeal infringed its rights of defence. |
| --- | --- |

468

The applicant claims that, by rejecting its key arguments and the scientific evidence without examining their merits, the Board of Appeal infringed its rights of defence.

| 469 | That argument must be rejected. |
| --- | --- |

469

That argument must be rejected.

| 470 | In that regard, it should be noted that respect for the rights of the defence requires that all addressees of decisions appreciably affecting their interests should be placed in a position in which they may effectively make known their views on the evidence against them taken as the basis for such a decision (judgment of 10 December 2009, Cofac v Commission, T‐159/07, not published, EU:T:2009:490, paragraph 33). |
| --- | --- |

470

In that regard, it should be noted that respect for the rights of the defence requires that all addressees of decisions appreciably affecting their interests should be placed in a position in which they may effectively make known their views on the evidence against them taken as the basis for such a decision (judgment of 10 December 2009, Cofac v Commission, T‐159/07, not published, EU:T:2009:490, paragraph 33).

| 471 | Contrary to what is claimed by the applicant, the mere fact that, in the action before it, the Board of Appeal did not itself examine whether the requests to conduct the persistence test, the enhanced neurotoxicity rat study and the fish test were necessary, but correctly confined itself to reviewing whether the arguments put forward by the applicant were capable of demonstrating that the ECHA decision was vitiated by error, in no way prevented the applicant from effectively making known its views concerning elements of that decision. |
| --- | --- |

471

Contrary to what is claimed by the applicant, the mere fact that, in the action before it, the Board of Appeal did not itself examine whether the requests to conduct the persistence test, the enhanced neurotoxicity rat study and the fish test were necessary, but correctly confined itself to reviewing whether the arguments put forward by the applicant were capable of demonstrating that the ECHA decision was vitiated by error, in no way prevented the applicant from effectively making known its views concerning elements of that decision.

| 472 | Therefore, the applicant’s argument alleging an infringement of its rights of defence must also be rejected. |
| --- | --- |

472

Therefore, the applicant’s argument alleging an infringement of its rights of defence must also be rejected.

F. The argument relating to the provisions of Regulation No 1223/2009

F.

The argument relating to the provisions of Regulation No 1223/2009

| 473 | During the hearing, the applicant put forward an argument alleging that the requests for information were not compatible with the principle of proportionality, due to the fact that the conduct of studies involving animal testing could result in a prohibition on marketing in accordance with the provisions of Regulation No 1223/2009 (see paragraph 35 above). |
| --- | --- |

473

During the hearing, the applicant put forward an argument alleging that the requests for information were not compatible with the principle of proportionality, due to the fact that the conduct of studies involving animal testing could result in a prohibition on marketing in accordance with the provisions of Regulation No 1223/2009 (see paragraph 35 above).

| 474 | In so far as, by its arguments, the applicant wishes to put forward a plea alleging a failure to take into account the provisions of Regulation No 1223/2009, they must be rejected as inadmissible. Under Article 84(1) of the Rules of Procedure, no new plea in law may be introduced in the course of proceedings unless it is based on matters of law or of fact which come to light in the course of the procedure. Firstly, it should be noted that a new plea in law is at issue. Contrary to what is claimed by the applicant, that plea may thus not be attached to the arguments relating to the breach of the principle of proportionality which it developed in the context of the written phase of the procedure. Secondly, it must be noted that nothing prevents the applicant from developing that plea at the stage of the written phase. |
| --- | --- |

474

In so far as, by its arguments, the applicant wishes to put forward a plea alleging a failure to take into account the provisions of Regulation No 1223/2009, they must be rejected as inadmissible. Under Article 84(1) of the Rules of Procedure, no new plea in law may be introduced in the course of proceedings unless it is based on matters of law or of fact which come to light in the course of the procedure. Firstly, it should be noted that a new plea in law is at issue. Contrary to what is claimed by the applicant, that plea may thus not be attached to the arguments relating to the breach of the principle of proportionality which it developed in the context of the written phase of the procedure. Secondly, it must be noted that nothing prevents the applicant from developing that plea at the stage of the written phase.

| 475 | In any event, those arguments should be rejected as unfounded. As was stated in paragraphs 59 to 86 above, the scope of the review conducted by the Board of Appeal is determined by the pleas put forward by the applicant before it. However, during the procedure before that board, the applicant did not put forward arguments relating to Regulation No 1223/2009. |
| --- | --- |

475

In any event, those arguments should be rejected as unfounded. As was stated in paragraphs 59 to 86 above, the scope of the review conducted by the Board of Appeal is determined by the pleas put forward by the applicant before it. However, during the procedure before that board, the applicant did not put forward arguments relating to Regulation No 1223/2009.

| 476 | It follows that the argument relating to the provisions of Regulation No 1223/2009 must also be rejected. |
| --- | --- |

476

It follows that the argument relating to the provisions of Regulation No 1223/2009 must also be rejected.

| 477 | In the light of the above considerations, it is necessary to dismiss the action. |
| --- | --- |

477

In the light of the above considerations, it is necessary to dismiss the action.

IV. Costs

IV.

Costs

| 478 | Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicant has been unsuccessful, it must be ordered to pay ECHA’s costs, in accordance with the form of order sought by the latter. |
| --- | --- |

478

Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicant has been unsuccessful, it must be ordered to pay ECHA’s costs, in accordance with the form of order sought by the latter.

| 479 | Under Article 138(1) of the Rules of Procedure, the Member States which have intervened in the proceedings are to bear their own costs. Therefore, the Kingdom of Denmark, the Federal Republic of Germany and the Kingdom of the Netherlands are ordered to bear their own costs. |
| --- | --- |

479

Under Article 138(1) of the Rules of Procedure, the Member States which have intervened in the proceedings are to bear their own costs. Therefore, the Kingdom of Denmark, the Federal Republic of Germany and the Kingdom of the Netherlands are ordered to bear their own costs.

| 480 | Moreover, it is necessary to reject the applicant’s request to order the Member States which intervened in the proceedings to bear the costs incurred by it under Article 135(2) of the Rules of Procedure. Under that provision, the Court may order a party, even if successful, to pay some or all of the costs, if this appears justified by the conduct of that party, including before the proceedings were brought, especially if he has made the opposite party incur costs which the Court holds to be unreasonable or vexatious. However, contrary to what is claimed by the applicant, the attitude of the Member States which intervened in the proceedings cannot justify that they be ordered to pay its costs. |
| --- | --- |

480

Moreover, it is necessary to reject the applicant’s request to order the Member States which intervened in the proceedings to bear the costs incurred by it under Article 135(2) of the Rules of Procedure. Under that provision, the Court may order a party, even if successful, to pay some or all of the costs, if this appears justified by the conduct of that party, including before the proceedings were brought, especially if he has made the opposite party incur costs which the Court holds to be unreasonable or vexatious. However, contrary to what is claimed by the applicant, the attitude of the Member States which intervened in the proceedings cannot justify that they be ordered to pay its costs.

| | On those grounds,
  THE GENERAL COURT (Fifth Chamber, Extended Composition)
  hereby: |
| --- | --- |

On those grounds,

THE GENERAL COURT (Fifth Chamber, Extended Composition)

hereby:

| | 1. | Dismisses the action; |
| --- | --- | --- |

1.

1.

Dismisses the action;

Dismisses the action;

| | 2. | Orders BASF Grenzach GmbH to bear its own costs, as well as the costs incurred by the European Chemicals Agency (ECHA), including those incurred in the proceedings for interim measures; |
| --- | --- | --- |

2.

2.

Orders BASF Grenzach GmbH to bear its own costs, as well as the costs incurred by the European Chemicals Agency (ECHA), including those incurred in the proceedings for interim measures;

Orders BASF Grenzach GmbH to bear its own costs, as well as the costs incurred by the European Chemicals Agency (ECHA), including those incurred in the proceedings for interim measures;

| | 3. | Orders the Kingdom of Denmark, the Federal Republic of Germany and the Kingdom of the Netherlands to bear their own costs. |
| --- | --- | --- |

3.

3.

Orders the Kingdom of Denmark, the Federal Republic of Germany and the Kingdom of the Netherlands to bear their own costs.

Orders the Kingdom of Denmark, the Federal Republic of Germany and the Kingdom of the Netherlands to bear their own costs.

| | Gratsias


  Labucka


  Papasavvas




  Dittrich


  Ulloa Rubio


  Delivered in open court in Luxembourg on 20 September 2019.


  E. Coulon
  Registrar


  D. Gratsias
  President |
| --- | --- |

Gratsias

Labucka

Papasavvas

Dittrich

Ulloa Rubio

Delivered in open court in Luxembourg on 20 September 2019.

E. Coulon

Registrar

D. Gratsias

President

Table of contents

| | I. Background to the dispute and the contested decision |
| --- | --- |
| | II. Procedure before the Court and forms of order sought |
| | III. Law |
| | A. The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the persistence test |
| | 1. The arguments calling into question the rejection, by the Board of Appeal, of the second plea in the action before it |
| | (a) The arguments alleging that the Board of Appeal disregarded the task imposed on it in the context of an action before it |
| | (1) The scope and intensity of the review conducted by the Board of Appeal |
| | (i) The scope of the review |
| | (ii) The intensity of the review |
| | (2) The arguments put forward by the applicant |
| | (b) The arguments alleging that the Board of Appeal did not take into account the evidential weight of the available information |
| | (c) The arguments alleging that the intensity of the review conducted by the Board of Appeal was not sufficient |
| | 2. The arguments calling into question the rejection, by the Board of Appeal, of the first plea in the action before it |
| | 3. The arguments relating to the Canadian authorities’ conclusions |
| | B. The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the enhanced neurotoxicity rat study |
| | 1. The arguments calling into question the rejection, by the Board of Appeal, of the sixth plea in the action before it |
| | (a) The arguments calling into question the considerations on which the Board of Appeal based the rejection of the first part of the sixth plea in the action before it |
| | (1) The arguments relating to the Board of Appeal’s findings concerning the Allmyr, Cullinan and Koeppe studies |
| | (2) The arguments relating to the Board of Appeal’s findings concerning the Witorsch report |
| | (b) The arguments calling into question the consideration on which the Board of Appeal based the rejection of the second part of the sixth plea in the action before it |
| | (1) The arguments according to which the Board of Appeal should have found an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006 |
| | (2) The arguments relating to the Board of Appeal’s findings concerning the weight of evidence determination of the available information |
| | 2. The arguments calling into question the rejection, by the Board of Appeal, of the seventh and eighth pleas in the action before it |
| | (a) The arguments calling into question the Board of Appeal’s findings concerning the necessity of the request to conduct the enhanced neurotoxicity rat study |
| | (1) The arguments relating specifically to the Board of Appeal’s findings concerning the potential risk posed by Triclosan |
| | (2) The arguments relating specifically to the Board of Appeal’s findings concerning the potential risk of reproductive toxicity posed by Triclosan |
| | (i) The arguments alleging a distortion of the applicant’s arguments |
| | (ii) The arguments alleging the existence of studies confirming that Triclosan does not have reproductive toxic effects |
| | (3) The arguments relating to the evaluation carried out by the Canadian authorities |
| | (4) The arguments alleging that the Board of Appeal disregarded the fact that the weight of evidence determination applied in the context of the evaluation of substances |
| | (5) The argument alleging that the Board of Appeal confined itself to verifying the absence of manifest errors of assessment |
| | (b) The arguments calling into question the Board of Appeal’s findings concerning the appropriateness of the request to conduct the enhanced neurotoxicity rat study |
| | (1) The arguments relating to the Board of Appeal’s considerations developed in paragraphs 161 to 167 of the contested decision |
| | (2) The arguments alleging that the Board of Appeal did not examine whether there existed less onerous methods |
| | 3. The arguments relating to the rejection of Mrs Mihaich’s expert opinion as inadmissible |
| | 4. The arguments calling into question the Board of Appeal’s preliminary observations |
| | C. The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the fish test |
| | D. The argument alleging that the Board of Appeal’s approach is incoherent |
| | E. The arguments alleging an infringement of the rights of the defence |
| | F. The argument relating to the provisions of Regulation No 1223/2009 |
| | IV. Costs |

I. Background to the dispute and the contested decision

II. Procedure before the Court and forms of order sought

III. Law

A. The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the persistence test

1. The arguments calling into question the rejection, by the Board of Appeal, of the second plea in the action before it

(a) The arguments alleging that the Board of Appeal disregarded the task imposed on it in the context of an action before it

(1) The scope and intensity of the review conducted by the Board of Appeal

(i) The scope of the review

(ii) The intensity of the review

(2) The arguments put forward by the applicant

(b) The arguments alleging that the Board of Appeal did not take into account the evidential weight of the available information

(c) The arguments alleging that the intensity of the review conducted by the Board of Appeal was not sufficient

2. The arguments calling into question the rejection, by the Board of Appeal, of the first plea in the action before it

3. The arguments relating to the Canadian authorities’ conclusions

B. The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the enhanced neurotoxicity rat study

1. The arguments calling into question the rejection, by the Board of Appeal, of the sixth plea in the action before it

(a) The arguments calling into question the considerations on which the Board of Appeal based the rejection of the first part of the sixth plea in the action before it

(1) The arguments relating to the Board of Appeal’s findings concerning the Allmyr, Cullinan and Koeppe studies

(2) The arguments relating to the Board of Appeal’s findings concerning the Witorsch report

(b) The arguments calling into question the consideration on which the Board of Appeal based the rejection of the second part of the sixth plea in the action before it

(1) The arguments according to which the Board of Appeal should have found an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006

(2) The arguments relating to the Board of Appeal’s findings concerning the weight of evidence determination of the available information

2. The arguments calling into question the rejection, by the Board of Appeal, of the seventh and eighth pleas in the action before it

(a) The arguments calling into question the Board of Appeal’s findings concerning the necessity of the request to conduct the enhanced neurotoxicity rat study

(1) The arguments relating specifically to the Board of Appeal’s findings concerning the potential risk posed by Triclosan

(2) The arguments relating specifically to the Board of Appeal’s findings concerning the potential risk of reproductive toxicity posed by Triclosan

(i) The arguments alleging a distortion of the applicant’s arguments

(ii) The arguments alleging the existence of studies confirming that Triclosan does not have reproductive toxic effects

(3) The arguments relating to the evaluation carried out by the Canadian authorities

(4) The arguments alleging that the Board of Appeal disregarded the fact that the weight of evidence determination applied in the context of the evaluation of substances

(5) The argument alleging that the Board of Appeal confined itself to verifying the absence of manifest errors of assessment

(b) The arguments calling into question the Board of Appeal’s findings concerning the appropriateness of the request to conduct the enhanced neurotoxicity rat study

(1) The arguments relating to the Board of Appeal’s considerations developed in paragraphs 161 to 167 of the contested decision

(2) The arguments alleging that the Board of Appeal did not examine whether there existed less onerous methods

3. The arguments relating to the rejection of Mrs Mihaich’s expert opinion as inadmissible

4. The arguments calling into question the Board of Appeal’s preliminary observations

C. The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the fish test

D. The argument alleging that the Board of Appeal’s approach is incoherent

E. The arguments alleging an infringement of the rights of the defence

F. The argument relating to the provisions of Regulation No 1223/2009

IV. Costs

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  )	Language of the case: English.

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