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Judgment of the General Court (Fifth Chamber) of 20 September 2019.#Federal Republic of Germany v European Chemicals Agency.#REACH – Evaluation of substances – Benpat – Persistence – 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 procedure – Nature of review – Intensity of review – Powers of the Board of Appeal – Article 93(3) of Regulation No 1907/2006 – Conferral of powers on EU agencies – Principle of conferral – Principle of subsidiarity – Proportionality – Obligation to state reasons.#Case T-755/17.

ECLI:EU:T:2019:647

62017TJ0755

September 20, 2019
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Valentina R., lawyer

20 September 2019 (*1)

20 September 2019 (*1)

(REACH — Evaluation of substances — Benpat — Persistence — 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 procedure — Nature of review — Intensity of review — Powers of the Board of Appeal — Article 93(3) of Regulation No 1907/2006 — Conferral of powers on EU agencies — Principle of conferral — Principle of subsidiarity — Proportionality — Obligation to state reasons)

(REACH — Evaluation of substances — Benpat — Persistence — 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 procedure — Nature of review — Intensity of review — Powers of the Board of Appeal — Article 93(3) of Regulation No 1907/2006 — Conferral of powers on EU agencies — Principle of conferral — Principle of subsidiarity — Proportionality — Obligation to state reasons)

In Case T‑755/17,

In Case T‑755/17,

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

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

applicant,

applicant,

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

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

defendant,

defendant,

supported by

supported by

European Commission, represented by M. Konstantinidis, R. Lindenthal and M. Noll-Ehlers, acting as Agents,

European Commission, represented by M. Konstantinidis, R. Lindenthal and M. Noll-Ehlers, acting as Agents,

and by

and by

Envigo Consulting Ltd, established in Huntingdon (United Kingdom),

Envigo Consulting Ltd, established in Huntingdon (United Kingdom),

Djchem Chemicals Poland S.A., established in Wołomin (Poland),

Djchem Chemicals Poland S.A., established in Wołomin (Poland),

represented by R. Cana, É. Mullier and H. Widemann, lawyers,

represented by R. Cana, É. Mullier and H. Widemann, lawyers,

interveners,

interveners,

ACTION under Article 263 TFEU for the partial annulment of Decision A‑026‑2015 of the Board of Appeal of the ECHA of 8 September 2017, in so far as it partially annulled the decision of the ECHA of 1 October 2015 requiring the conduct of further testing concerning the substance benpat (CAS 68953‑84‑4),

ACTION under Article 263 TFEU for the partial annulment of Decision A‑026‑2015 of the Board of Appeal of the ECHA of 8 September 2017, in so far as it partially annulled the decision of the ECHA of 1 October 2015 requiring the conduct of further testing concerning the substance benpat (CAS 68953‑84‑4),

THE GENERAL COURT (Fifth Chamber),

THE GENERAL COURT (Fifth Chamber),

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

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

Registrar: E. Coulon,

Registrar: E. Coulon,

gives the following

gives the following

Benpat (CAS 68953‑84‑4) is a multicomponent substance consisting of three very similar chemical substances. It is used as a stabiliser in industrial and consumer products made of rubber, such as tyres and pipes. It delays the alteration of the physical properties and appearance of rubber-based products caused by light and atmospheric oxygen.

Benpat (CAS 68953‑84‑4) is a multicomponent substance consisting of three very similar chemical substances. It is used as a stabiliser in industrial and consumer products made of rubber, such as tyres and pipes. It delays the alteration of the physical properties and appearance of rubber-based products caused by light and atmospheric oxygen.

The intervening companies, Envigo Consulting Ltd and Djchem Chemicals Poland S.A., are part of a consortium which, in 2010, registered benpat with the European Chemicals Agency (ECHA), for a tonnage of between 1000 and 10000 tonnes per year.

The intervening companies, Envigo Consulting Ltd and Djchem Chemicals Poland S.A., are part of a consortium which, in 2010, registered benpat with the European Chemicals Agency (ECHA), for a tonnage of between 1000 and 10000 tonnes per year.

In 2013, benpat was included in the Community rolling action plan for evaluation within the meaning of Article 44 of 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), due to grounds for concern relating to its persistent, bioaccumulative and toxic properties, and due to its wide dispersive use, in particular by consumers.

In 2013, benpat was included in the Community rolling action plan for evaluation within the meaning of Article 44 of 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), due to grounds for concern relating to its persistent, bioaccumulative and toxic properties, and due to its wide dispersive use, in particular by consumers.

4.4

4.4

In accordance with Article 45 of Regulation No 1907/2006, the competent authority of the Federal Republic of Germany (‘the designated authority’) was appointed to conduct the evaluation of benpat.

In accordance with Article 45 of Regulation No 1907/2006, the competent authority of the Federal Republic of Germany (‘the designated authority’) was appointed to conduct the evaluation of benpat.

In accordance with Article 46(1) of Regulation No 1907/2006, the designated authority established a draft decision, providing for requests for further information about benpat. That draft was forwarded to the ECHA on 20 June 2014.

In accordance with Article 46(1) of Regulation No 1907/2006, the designated authority established a draft decision, providing for requests for further information about benpat. That draft was forwarded to the ECHA on 20 June 2014.

On 28 August 2014, in accordance with Article 50(1) of Regulation No 1907/2006, the draft decision was notified to the registrants, including the intervening companies.

On 28 August 2014, in accordance with Article 50(1) of Regulation No 1907/2006, the draft decision was notified to the registrants, including the intervening companies.

On 6 October 2014, the registrants submitted their observations on the draft decision.

On 6 October 2014, the registrants submitted their observations on the draft decision.

8.8

8.8

The designated authority took those observations into account and notified a revised draft decision to the competent authorities of the other Member States and to the ECHA on 5 March 2015.

The designated authority took those observations into account and notified a revised draft decision to the competent authorities of the other Member States and to the ECHA on 5 March 2015.

Three competent authorities of 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.

Three competent authorities of 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.

10.10

10.10

The designated authority examined those proposals and amended the draft decision. On 20 April 2015, the revised draft decision was sent to the Member State Committee.

The designated authority examined those proposals and amended the draft decision. On 20 April 2015, the revised draft decision was sent to the Member State Committee.

11.11

11.11

On 8 May 2015, the registrants were heard with regard to the proposals of the Member States.

On 8 May 2015, the registrants were heard with regard to the proposals of the Member States.

12.12

12.12

At the meeting which was held from 8 to 11 June 2015, the Member State Committee reached unanimous agreement for the purposes of Article 51(6) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, with regard to a revised proposal for a decision.

At the meeting which was held from 8 to 11 June 2015, the Member State Committee reached unanimous agreement for the purposes of Article 51(6) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, with regard to a revised proposal for a decision.

13.13

13.13

On 1 October 2015, on the basis of Article 51(6) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, the ECHA adopted a decision as part of the evaluation of benpat (‘the ECHA decision’).

On 1 October 2015, on the basis of Article 51(6) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, the ECHA adopted a decision as part of the evaluation of benpat (‘the ECHA decision’).

14.14

14.14

By its decision, the ECHA requests the registrants to submit in particular the following information:

By its decision, the ECHA requests the registrants to submit in particular the following information:

simulation testing on ultimate degradation in surface water (testing method: aerobic mineralisation in surface water — simulation testing of biodegradation, EU C.25/OECD 309 [‘method No 309’]) as specified by point III.3 of that decision, using the R-898 constituent instead of benpat;

simulation testing on ultimate degradation in surface water (testing method: aerobic mineralisation in surface water — simulation testing of biodegradation, EU C.25/OECD 309 [‘method No 309’]) as specified by point III.3 of that decision, using the R-898 constituent instead of benpat;

in the event that testing conducted according to method No 309 does not allow it to be determined whether benpat was persistent or very persistent in accordance with paragraphs 1.1.1 and 1.2.1 of Regulation No 1907/2006, further simulation testing of biodegradation in sediments (testing method: aerobic and anaerobic transformation in aquatic sediment systems, EU C.24/OECD 308 [‘method No 308’]), as specified by point III.4 of that decision, using the R-898 constituent instead of benpat.

in the event that testing conducted according to method No 309 does not allow it to be determined whether benpat was persistent or very persistent in accordance with paragraphs 1.1.1 and 1.2.1 of Regulation No 1907/2006, further simulation testing of biodegradation in sediments (testing method: aerobic and anaerobic transformation in aquatic sediment systems, EU C.24/OECD 308 [‘method No 308’]), as specified by point III.4 of that decision, using the R-898 constituent instead of benpat.

15.15

15.15

In the ECHA decision, the deadline for providing the information requested was fixed as 8 April 2018.

In the ECHA decision, the deadline for providing the information requested was fixed as 8 April 2018.

16.16

16.16

On 23 December 2015, the intervening companies 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 Article 91(1) of that regulation.

On 23 December 2015, the intervening companies 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 Article 91(1) of that regulation.

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

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

18.18

18.18

On 8 March 2016, the ECHA lodged its defence before the Board of Appeal.

On 8 March 2016, the ECHA lodged its defence before the Board of Appeal.

On 13 April 2016, the designated authority was granted leave to intervene before the Board of Appeal in support of the form of order sought by the ECHA.

On 13 April 2016, the designated authority was granted leave to intervene before the Board of Appeal in support of the form of order sought by the ECHA.

On 2 June 2016, the intervening companies submitted their reply to the Board of Appeal. On 8 July 2016, the ECHA submitted its observations on that reply.

On 2 June 2016, the intervening companies submitted their reply to the Board of Appeal. On 8 July 2016, the ECHA submitted its observations on that reply.

21.21

21.21

On 20 June 2016, the designated authority submitted the statement in intervention to the Board of Appeal. On 31 October 2016, the ECHA and the intervening companies submitted their observations on that statement.

On 20 June 2016, the designated authority submitted the statement in intervention to the Board of Appeal. On 31 October 2016, the ECHA and the intervening companies submitted their observations on that statement.

22.22

22.22

On 27 April 2017, a hearing took place before the Board of Appeal.

On 27 April 2017, a hearing took place before the Board of Appeal.

23.23

23.23

Before the Board of Appeal, the intervening companies, in particular, requested that board to annul the ECHA decision in so far as it requested the conduct of testing in accordance with method No 309 and testing in accordance with method No 308, and in so far as, in its statement of reasons, it had been stated that benpat was bioaccumulative in accordance with Annex XIII to Regulation No 1907/2006.

Before the Board of Appeal, the intervening companies, in particular, requested that board to annul the ECHA decision in so far as it requested the conduct of testing in accordance with method No 309 and testing in accordance with method No 308, and in so far as, in its statement of reasons, it had been stated that benpat was bioaccumulative in accordance with Annex XIII to Regulation No 1907/2006.

24.24

24.24

For its part, the ECHA, supported by the designated authority, applied for the action before the Board of Appeal to be dismissed.

For its part, the ECHA, supported by the designated authority, applied for the action before the Board of Appeal to be dismissed.

25.25

25.25

On 8 September 2017, the Board of Appeal adopted decision A‑026‑2015 (‘the contested decision’). By that decision, it:

On 8 September 2017, the Board of Appeal adopted decision A‑026‑2015 (‘the contested decision’). By that decision, it:

annulled the ECHA decision in so far as it requested the registrants:

annulled the ECHA decision in so far as it requested the registrants:

to identify, in the context of testing conducted in accordance with method No 309, metabolites of benpat;

to identify, in the context of testing conducted in accordance with method No 309, metabolites of benpat;

to conduct testing conducted in accordance with method No 308;

to conduct testing conducted in accordance with method No 308;

decided that the claim concerning bioaccumulation in the grounds for that decision should be deleted;

decided that the claim concerning bioaccumulation in the grounds for that decision should be deleted;

dismissed the action before it as to the remainder; and

dismissed the action before it as to the remainder; and

fixed 15 March 2020 as the deadline for the production of the remaining information derived from testing conducted in accordance with method No 309 required by that decision.

fixed 15 March 2020 as the deadline for the production of the remaining information derived from testing conducted in accordance with method No 309 required by that decision.

II. Procedure before the Court and forms of order sought by the parties

II. Procedure before the Court and forms of order sought by the parties

26.26

26.26

By application lodged at the Court Registry on 20 November 2017, the Federal Republic of Germany brought the present action.

By application lodged at the Court Registry on 20 November 2017, the Federal Republic of Germany brought the present action.

27.27

27.27

On 8 March 2018, the ECHA filed its statement of defence.

On 8 March 2018, the ECHA filed its statement of defence.

28.28

28.28

By document lodged at the Court Registry on 21 March 2018, the European Commission sought leave to intervene in the present proceedings in support of the form of order sought by the ECHA. By decision of the President of the Chamber of 23 April 2018, it was granted leave to intervene.

By document lodged at the Court Registry on 21 March 2018, the European Commission sought leave to intervene in the present proceedings in support of the form of order sought by the ECHA. By decision of the President of the Chamber of 23 April 2018, it was granted leave to intervene.

29.29

29.29

By document lodged at the Court Registry on 21 March 2018, the intervening companies sought leave to intervene in the present proceedings in support of the form of order sought by the ECHA. By order of the President of the Chamber of 7 May 2018, they were granted leave to intervene.

By document lodged at the Court Registry on 21 March 2018, the intervening companies sought leave to intervene in the present proceedings in support of the form of order sought by the ECHA. By order of the President of the Chamber of 7 May 2018, they were granted leave to intervene.

30.30

30.30

On 24 April 2018, the Federal Republic of Germany lodged its reply.

On 24 April 2018, the Federal Republic of Germany lodged its reply.

31.31

31.31

On 18 June 2018, the ECHA lodged the rejoinder.

On 18 June 2018, the ECHA lodged the rejoinder.

On 9 July 2018, the Commission lodged its statement in intervention. On 10 July 2018, the intervening companies lodged their statement in intervention. On 31 October 2018, the Federal Republic of Germany and the ECHA submitted their observations on those statements in intervention.

In the absence of a request for a hearing by the main parties within 3 weeks after service on the parties of notification of the close of the written part of the procedure, considering that it had sufficient information available to it from the material in the file, the Court (Fifth Chamber) decided to rule on the action without an oral part of the procedure in accordance with Article 106(3) of its Rules of Procedure.

The Federal Republic of Germany claims that the Court should:

annul the contested decision, in so far as the Board of Appeal

partially annulled the ECHA decision, and

decided that the claim relating to bioaccumulation should be deleted from the grounds for that decision;

order the ECHA to pay the costs.

The ECHA, the Commission and the intervening companies contend that the Court should:

dismiss the action;

order the Federal Republic of Germany to pay the costs.

III. Law

In support of the action, the Federal Republic of Germany puts forward six pleas. The first plea alleges that, by examining the pleas relating to the evaluation of benpat, the Board of Appeal acted outside the framework of its powers. In the context of the second plea, that Member State claims that, by acting that way, that board did not respect the case-law (judgments of 13 June 1958, Meroni v High Authority, 9/56, EU:C:1958:7, and of 13 June 1958, Meroni v High Authority, 10/56, EU:C:1958:8). By the third plea, it claims that, since European Union law does not contain a legal basis allowing that board to conduct such an examination, the latter infringed the rights of the Member States institutionalised through their decision-making power within the ECHA’s Member State Committee and thus infringed the principle of subsidiarity and the principle of limited conferral of powers. The fourth plea alleges an infringement of the provisions of Regulation No 1907/2006 and is divided into two parts. The first seeks to demonstrate that the Board of Appeal was not competent to examine the pleas in the action before it concerning the substantive assessments relating to the evaluation of benpat and the second to demonstrate that, in the context of the assessment of the pleas concerning the substantive assessments relating to the evaluation of benpat, the Board of Appeal committed errors. In the context of the fifth plea, the Federal Republic of Germany claims that that board violated the duty to state reasons by failing to establish its alleged power of review. In the context of the sixth plea, it claims that the Board of Appeal’s assessments at issue are wrong.

As a first step, it is necessary to examine the first to third pleas, and the first part of the fourth plea, which seek to demonstrate that the Board of Appeal was not competent to examine the pleas in the action before it concerning substantive assessments relating to the evaluation of benpat.

As a second step, the fifth plea, alleging that the Board of Appeal infringed the obligation to state reasons by not establishing its power of review will be examined.

As a third step, the second part of the fourth plea and the sixth plea will be examined, by which the Federal Republic of Germany alleges that, in the context of the examination of the pleas concerning substantive assessments relating to the evaluation of benpat, the Board of Appeal committed errors.

In the context of the first to third pleas and the first part of the fourth plea, the Federal Republic of Germany claims that the Board of Appeal should have dismissed the action before it as inadmissible in so far as the intervening companies had put forward pleas seeking to have the ECHA decision reviewed to the extent that it contained substantive assessments relating to the evaluation of benpat. According to it, that board was not competent to rule on such pleas, but solely to review the existence of formal errors vitiating that decision.

The ECHA, the Commission and the intervening companies dispute those arguments. They maintain that the Board of Appeal is competent to examine the pleas in the action before it seeking to contest the merits of a decision taken as part of the evaluation of a substance. That examination is however not a new evaluation of the substance at issue.

As a first step, it is necessary to examine the Federal Republic of Germany’s arguments relating to the respective roles of the Member State Committee, the ECHA and of the Board of Appeal. As a second step, the other arguments put forward by the Federal Republic of Germany will be examined.

In the context of the first plea and the first part of the fourth plea, the Federal Republic of Germany claims that, under Article 51(3) or (6) of Regulation No 1907/2006, as applicable mutatis mutandis in accordance with Article 52(2) of that regulation, it is the Member States or the Member State Committee which are competent concerning the substantive assessments contained in a decision taken as part of the evaluation of a substance. The substance evaluation procedure is characterised in particular by the important role of Member States and of that committee within the ECHA. That committee is a genuine group of experts. Even if it involved an ECHA body, it would nevertheless be functionally independent from that agency. The Member States directly appoint the members of the committee in question and each Member State could give instructions to members appointed by it. That committee serves to involve the Member States at European Union level, by combining the competences of the Member States and of the Union. Representatives of the ECHA and of the Commission could assist at the meetings of the committee at issue, but only as observers. The importance of such a committee is apparent from Article 76(1)(e) of that regulation. The importance of collective agreement within that committee is apparent from recital 67 of that regulation. Such a committee should thus not be regarded as a decision-making body separate from the Member States, capable of replacing them, but as an instrument designed to encourage agreement between the latter.

Under Article 51(6) of Regulation No 1907/2006, as applicable mutatis mutandis in accordance with Article 52(2) of that regulation, the role of the ECHA is limited to ensuring coordination between the procedure and the work preparing and monitoring the decision-making and to formally adopting the decision, the contents of which are determined by the Member State Committee. That role is limited to ensuring respect for the procedural rules. That agency is bound by the agreement of the Member States and has no discretion in that regard. In the absence of unanimous agreement between the Member States or within the Member State Committee, it loses any decision-making power in favour of the Commission.

According to the Federal Republic of Germany, the particular role of the Member States or of the Member State Committee within the ECHA in the context of the substance evaluation procedure should not be circumvented in the appeal proceedings. In the context of an action against a decision taken as part of the evaluation of a substance, the Board of Appeal does not have more powers than the ECHA. The latter have parallel competences. That board, which is part of that agency, is also bound by the agreement of the Member States and has only the power to adopt a decision in conformity with the agreement reached by the Member States. It does not, in the case of decisions taken as part of the evaluation of a substance, have autonomous legitimacy identical to or even equivalent to that enjoyed by the ECHA as a whole thanks to the participation of the Member States in the agreement process. It cannot disregard an agreement between all the Member States. It is thus solely competent to review aspects other than the substantive assessments relating to the evaluation of a substance, namely in particular potential breaches of the rules of procedure. It is not competent to take a decision on the merits of a decision adopted as part of the evaluation of a substance in the context of its examination of an action against such a decision. That interpretation is not called into question by Article 93(3) of Regulation No 1907/2006. That provision should be read in conjunction with Article 51 of that regulation, which provides for a ‘dualism’ between the ECHA and the Member States (outside of or within the Member State Committee).

Moreover, the Federal Republic of Germany states that, according to the approach it advocates, effective legal protection is ensured. There is a link between the Board of Appeal’s decision and the decision taken as part of the evaluation of a substance. Therefore, even if the merits of the latter decision could not be reviewed by the Board of Appeal, the EU Courts could, in the context of an action against a decision of the Board of Appeal, review the pleas relating to that evaluation, since a decision of that board upholding a decision taken as part of the evaluation of a substance would reproduce the findings of the latter decision on the merits.

The ECHA, the Commission and the intervening companies dispute those arguments.

First of all, it should be noted that, in accordance with Article 51(8) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, and in accordance with Article 91(1) of that regulation, ECHA decisions taken as part of the evaluation of a substance may be subject to an action before the Board of Appeal.

Moreover, neither the provisions of Regulation No 1907/2006, nor those 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) contain express rules providing that that board is not competent to examine pleas seeking to demonstrate the existence of substantive errors vitiating an ECHA decision.

On the contrary, in the light of the elements examined in paragraphs 51 to 63 below, it is necessary to establish the Board of Appeal’s competence to examine pleas seeking to demonstrate the existence of substantive errors vitiating an ECHA decision.

In the first place, it should be noted that, under the first indent of the second sentence of Article 89(3) of Regulation No 1907/2006, the Chairperson of the Board of Appeal, its other members and its alternate members are appointed on the basis of the experience and expertise they possess in the field of chemical safety, natural sciences or regulatory and judicial procedures. Furthermore, under the second paragraph of Article 1(1) of Regulation No 771/2008, at least one member is to be legally qualified and at least one member is 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 the latter regulation, the technically qualified members and their alternates are to hold a university degree or an equivalent qualification and are 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. That board thus has the necessary expertise at its disposal in order to itself carry out assessments of scientific evidence.

As is apparent in particular from recital 3 of Regulation No 771/2008, the Board of Appeal’s expertise seeks to ensure that a balanced assessment of both legal and technical aspects can be carried out by that board.

In the second place, in so far as the Federal Republic of Germany’s arguments relate to the particular characteristics of the procedure provided for the adoption of decisions as part of the evaluation of a substance, it must be noted that neither Regulation No 1907/2006 nor Regulation No 771/2008 provide for special rules concerning actions against such decisions.

In the third place, the objectives pursued by the possibility of bringing an action before the Board of Appeal against an ECHA decision plead in favour of an approach in accordance with which that board is competent to examine pleas seeking to demonstrate the existence of substantive errors vitiating such a decision.

Firstly, as is apparent from recital 3 of Regulation No 771/2008, one of the objectives pursued by the possibility to bring an action against ECHA decisions, in particular those adopted as part of the evaluation of substances, is to allow the addressees of such decisions to review those decisions not only concerning legal aspects, but also concerning technical aspects. Concerning those technical aspects, as a result of the competences of the members of the Board of Appeal, the intensity of the review conducted by that board is greater than that of a review carried out by the EU Courts.

Secondly, a limitation on the powers of the Board of Appeal such as that envisaged by the Federal Republic of Germany would have the result that that board could not fully perform its function, which is to limit litigation before the EU Courts, whilst guaranteeing a right to an effective remedy. In that context, it should also be noted that, as is apparent from recital 4 of Regulation (EU, Euratom) 2019/629 of the European Parliament and of the Council of 17 April 2019 amending Protocol No 3 on the Statute of the Court of Justice of the European Union (OJ 2019 L 111, p. 1), the introduction of rules concerning the admission of appeals in cases which have already been considered twice is based on the consideration that, in cases concerning decisions of the Board of Appeal of the ECHA, it is possible for them to be considered twice, namely initially by that board and, subsequently, by the Court.

In the fourth place, it should be noted that an approach in accordance with which the Board of Appeal is not competent to examine pleas which seek to demonstrate the existence of substantive errors vitiating an ECHA decision is not capable of ensuring an effective remedy for the purposes of Article 47(1) of the Charter of Fundamental Rights of the European Union.

It should be noted that, in accordance with the fifth paragraph of Article 263 TFEU, acts setting up bodies, offices and agencies of the Union may lay down specific conditions and arrangements concerning actions brought by natural or legal persons against acts of those bodies, offices or agencies intended to produce legal effects in relation to them. Article 94(1) of Regulation No 1907/2006 provides that, where there is a right of appeal before the Board of Appeal, the EU Courts could only rule on an action for annulment of the decision of that board.

An action for annulment of a Board of Appeal decision relates therefore to the lawfulness of such a decision.

In the context of an action against an ECHA decision requesting further information as part of the evaluation of a substance, the Board of Appeal is limited to examining, in adversarial proceedings, whether the arguments put forward before it are capable of demonstrating the existence of an error vitiating that decision (see, to that effect, judgment delivered today, BASF Grenzach v ECHA, T‑125/17, paragraphs 59 to 86).

Contrary to what is claimed by the Federal Republic of Germany, it cannot be considered that, in so far as the Board of Appeal did not rule on the findings in the ECHA decision, those findings are an integral part of that board’s decision and could thus be reviewed in the context of an action against that decision before the EU Courts.

It follows that, if the approach according to which the Board of Appeal is not competent to review pleas seeking to demonstrate the existence of substantive errors vitiating an ECHA decision were adopted, such pleas could not be usefully invoked in the context of an action against a decision of that board brought before the Court. Firstly, it would not be possible, before the Court, to validly criticise that board for failing to examine pleas, the examination of which lay outside its competence. Secondly, even assuming that the ECHA decision is vitiated by a substantive error, such an error is not capable of calling into question the lawfulness of the decision of the board at issue.

In any event, even assuming that, as the Federal Republic of Germany claims, considerations included in the ECHA decision and on which the Board of Appeal has not ruled form an integral part of that board’s decision, the approach advocated by that Member State could have the result that unnecessary actions must be brought before that board. As is apparent from the fifth paragraph of Article 263 TFEU and Article 94(1) of Regulation No 1907/2006, where it is possible to bring an action against an ECHA decision before the Board of Appeal, an action against that decision before the Court is inadmissible. Therefore, where an applicant wishes to have an ECHA decision annulled solely for reasons relating to substantive errors vitiating that decision, it would only have the option of bringing an action before the Board of Appeal, although such an action would, in such a case, be bound to fail.

In the light of the above considerations, it must be concluded that, contrary to what is claimed by the Federal Republic of Germany, the Board of Appeal was competent, in the present case, to examine the pleas seeking to demonstrate the existence of substantive errors vitiating the ECHA decision.

It is by taking account of the considerations developed in paragraphs 48 to 64 above that it is necessary to examine the other arguments put forward by the Federal Republic of Germany.

In the first place, in the context of the first part of the fourth plea, the Federal Republic of Germany claims that, in the context of the procedure leading to the adoption of a decision as part of the evaluation of a substance, the Member States or the Member State Committee play a prominent role. By contrast, the ECHA’s role is limited. In that context, the ECHA is limited to responding to legal questions or simple scientific questions. Since the ECHA is bound by the agreement between the Member States or within the Member State Committee, the Board of Appeal is not competent to review that agreement, but must respect it. Otherwise, the special role of the Member States or of the Member State Committee within the ECHA in the context of the procedure for evaluating substances would be undermined.

The ECHA, the Commission and the intervening companies dispute those arguments.

In that context, firstly, it should be noted that, where the designated authority considers that further information is not 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 website for substances to be evaluated that year. The decision is then taken in accordance with the procedure set out in Articles 50 and 52 of that regulation.

Article 50 of Regulation No 1907/2006 governs the rights of registrants and of downstream users. Article 50(1) thereof provides that the ECHA is to notify the draft decision to the registrants or to the downstream users concerned. If the registrants or the downstream users concerned wish to submit comments, they are to send them to the ECHA within 30 days of the receipt. The latter in turn is to immediately inform the designated authority about the communication of comments. That authority is to take into account any comments received and may amend the draft decision accordingly.

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

According to Article 52(2) of Regulation No 1907/2006, the provisions of Article 51(2) to (8) of that regulation, relating to the adoption of decisions under dossier evaluation, are applicable mutatis mutandis to the adoption of decisions as part of the evaluation of a substance.

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

Where the designated authority receives proposals for amendments, 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 of the end of the period of 30 days 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, as applicable in accordance with Article 52(2) of that regulation. Under Article 51(5) of the regulation at issue, as applicable in accordance with Article 52(2) of that regulation, it is to send it also to the registrants and downstream users concerned, who may submit their comments. If, within 60 days of the referral of the draft decision, the Member State Committee reaches unanimous agreement on that decision, in accordance with Article 51(6) of the regulation at issue, as applicable in accordance with Article 52(2) of the regulation at issue, the ECHA is to take the decision accordingly.

On the contrary, if the Member State Committee does not reach unanimous agreement, in accordance with Article 51(7) of Regulation No 1907/2006, as applicable under 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.

The Federal Republic of Germany thus correctly claims that the Member States and the Member State Committee play an important role in the context of the procedure for the adoption of a decision as part of the evaluation of a substance.

However, although the Member States and the Member State Committee intervene in the context of the procedure leading to the adoption of a decision as part of the evaluation of a substance, it must be noted that that decision is adopted by the ECHA. Such a decision, which was adopted under Article 51(3) or (6) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, is thus neither a Member State decision nor a decision of the Member State Committee.

Secondly, it must be noted that the subject matter of an action before the Board of Appeal is an ECHA decision and not solely the measures taken by the director of the ECHA or his secretariat in the context of the procedure which led to the adoption of that decision.

In the context of an action against an ECHA decision, the Board of Appeal’s review does not therefore relate solely to the measures taken by the director of the ECHA or by his secretariat, but may, on the contrary, relate to all the elements of that decision.

Therefore, contrary to what is claimed by the Federal Republic of Germany, in the context of an action against a decision taken as part of the evaluation of a substance, nothing prevents the Board of Appeal from examining pleas calling into question the findings in that decision and in respect of which unanimous agreement was found within the Member State Committee and which, under Article 51(6) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, constitutes the substantive basis of that decision. As is apparent from Article 76(1)(e) of that regulation, in that context, the Member State Committee intervenes as a body of the ECHA.

Those considerations are not called into question by the Federal Republic of Germany’s arguments concerning the relationship between the Member States and their members within the Member State Committee, alleging the importance of that committee and that, under Article 76(1)(e) of Regulation No 1907/2006, that committee is tasked with resolving possible divergences of opinions on draft decisions proposed in accordance with Title VI of that regulation.

In the light of the foregoing, it is necessary to reject the Federal Republic of Germany’s arguments relating to the important role played by the Member States and the Member State Committee during the procedure leading to the adoption of a decision as part of the evaluation of a substance.

Thirdly, it is necessary to examine the Federal Republic of Germany’s arguments alleging that the procedure provided for the adoption of decisions as part of the evaluation of substances, which confers an important role on the Member States outside of or within the Member State Committee, would risk being circumvented if the Board of Appeal was competent to review the findings in an ECHA decision which are based on unanimous agreement for the purposes of Article 51(3) or (6) of Regulation No 1907/2006 applicable mutatis mutandis in accordance with Article 52(2) of that regulation.

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