# 62015TJ0115

JUDGMENT OF THE GENERAL COURT (Fifth Chamber)

11 May 2017 (
  *1
  )

*1

‛Reach — Establishment of a list of substances identified for eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 — Supplement to the entry of the substance bis(2-ethylhexyl)phthalate (DEHP) on that list — Articles 57 and 59 of Regulation No 1907/2006’

In Case T‐115/15,

Deza, a.s., established in Valašské Meziříčí (Czech Republic), represented by P. Dejl, lawyer,

Deza, a.s

applicant,

v

European Chemicals Agency (ECHA), represented initially by M. Heikkilä, W. Broere and T. Zbihlej, and subsequently by M. Heikkilä, W. Broere and C. Buchanan, acting as Agents, and by M. Procházka et M. Mašková, lawyers,

European Chemicals Agency (ECHA)

defendant,

supported by

Kingdom of Denmark, represented by C. Thorning and N. Lyshøj Malte, acting as Agents,

Kingdom of Denmark

Kingdom of the Netherlands, represented by M. Bulterman, B. Koopman and H. Stergiou, acting as Agents,

Kingdom of the Netherlands

Kingdom of Sweden, represented by E. Karlsson, L. Swedenborg, A. Falk, C. Meyer-Seitz, U. Persson and N. Otte Widgren, acting as Agents,

Kingdom of Sweden

and by

Kingdom of Norway, represented by K. Moen and K. Moe Winther, acting as Agents,

Kingdom of Norway

interveners,

APPLICATION pursuant to Article 263 TFEU seeking the annulment of a decision of 12 December 2014 by the Executive Director of the ECHA by which the existing entry relating to the substance DEHP on the list of identified substances with a view to their eventual inclusion in Annex XIV to 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), was supplemented to the effect that that substance is also identified as a substance with endocrine-disrupting properties that may have serious effects on the environment, within the meaning of Article 57(f) of that Regulation,

THE GENERAL COURT (Fifth Chamber),

composed of D. Gratsias, President, A. Dittrich (Rapporteur) and P.G. Xuereb, Judges,

Registrar: M. Marescaux, Administrator,

having regard to the written part of the procedure and further to the hearing on 15 December 2016,

gives the following

Judgment

Background to the dispute

| 1 | The applicant, Deza, a.s., a limited company incorporated under Czech law, is active in the chemical sector. It produces, markets and uses, inter alia, the chemical substance bis(2-ethylhexyl)phthalate (EC No 204-211-0, CAS No 117‐81-7) (‘DEHP’ or ‘DEHP substance’). |
| --- | --- |

1

The applicant, Deza, a.s., a limited company incorporated under Czech law, is active in the chemical sector. It produces, markets and uses, inter alia, the chemical substance bis(2-ethylhexyl)phthalate (EC No 204-211-0, CAS No 117‐81-7) (‘DEHP’ or ‘DEHP substance’).

| 2 | By a decision of 28 October 2008, bearing reference ED/67/2008, the Executive Director of the European Chemicals Agency (ECHA) included DEHP in the ‘Candidate list’ of substances identified for inclusion in Annex XIV to 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), on the ground that DEHP had been identified as toxic for reproduction, category 1B, within the meaning of Article 57(c) of Regulation No 1907/2006. |
| --- | --- |

2

By a decision of 28 October 2008, bearing reference ED/67/2008, the Executive Director of the European Chemicals Agency (ECHA) included DEHP in the ‘Candidate list’ of substances identified for inclusion in Annex XIV to 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), on the ground that DEHP had been identified as toxic for reproduction, category 1B, within the meaning of Article 57(c) of Regulation No 1907/2006.

| 3 | By adopting Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation No 1907/2006 (OJ 2011 L 44, p. 2), the European Commission included DEHP in Annex XIV. Annex XIV indicates an intrinsic property of this substance, namely that it is ‘toxic for reproduction (category 1B)’, which corresponds to the wording of Article 57(c) of Regulation No 1907/2006. In addition, Annex XIV lays down a deadline for the submission of applications for authorisation within the meaning of Article 58(1)(c)(ii) of Regulation No 1907/2006, namely 21 August 2013 and an expiry date within the meaning of Article 58(1)(c)(i) of Regulation No 1907/2006, namely 21 February 2015. |
| --- | --- |

3

By adopting Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation No 1907/2006 (OJ 2011 L 44, p. 2), the European Commission included DEHP in Annex XIV. Annex XIV indicates an intrinsic property of this substance, namely that it is ‘toxic for reproduction (category 1B)’, which corresponds to the wording of Article 57(c) of Regulation No 1907/2006. In addition, Annex XIV lays down a deadline for the submission of applications for authorisation within the meaning of Article 58(1)(c)(ii) of Regulation No 1907/2006, namely 21 August 2013 and an expiry date within the meaning of Article 58(1)(c)(i) of Regulation No 1907/2006, namely 21 February 2015.

| 4 | On 12 August 2013 the applicant filed an application for authorisation pursuant to Article 62 of Regulation No 1907/2006 for the use of DEHP. The applicant attached to that application a series of studies and detailed documents, including a chemical safety report, an analysis of alternatives and a socio-economic analysis. On the date the hearing was held, no decision had been taken on that application. |
| --- | --- |

4

On 12 August 2013 the applicant filed an application for authorisation pursuant to Article 62 of Regulation No 1907/2006 for the use of DEHP. The applicant attached to that application a series of studies and detailed documents, including a chemical safety report, an analysis of alternatives and a socio-economic analysis. On the date the hearing was held, no decision had been taken on that application.

| 5 | On 26 August 2014, pursuant to Article 59(3) of Regulation No 1907/2006, the Kingdom of Denmark submitted four dossiers in accordance with Annex XV to that regulation, proposing, first, that DEHP and three other chemical substances, namely Dibutyl phthalate (‘DBP’), Benzyl butyl phthalate (‘BBP’) and Diisobutyl phthalate (‘DIBP’), which had already been identified as toxic for reproduction within the meaning of Article 57(c) of Regulation No 1907/2006 and included for that reason in the candidate list of substances, be also identified as endocrine-disrupting substances for which there is scientific evidence of probable serious effects on human health and the environment within the meaning of Article 57(f) of Regulation No 1907/2006 and, second, that they be added to the candidate list of substances (‘the Kingdom of Denmark’s initial proposal’) |
| --- | --- |

5

On 26 August 2014, pursuant to Article 59(3) of Regulation No 1907/2006, the Kingdom of Denmark submitted four dossiers in accordance with Annex XV to that regulation, proposing, first, that DEHP and three other chemical substances, namely Dibutyl phthalate (‘DBP’), Benzyl butyl phthalate (‘BBP’) and Diisobutyl phthalate (‘DIBP’), which had already been identified as toxic for reproduction within the meaning of Article 57(c) of Regulation No 1907/2006 and included for that reason in the candidate list of substances, be also identified as endocrine-disrupting substances for which there is scientific evidence of probable serious effects on human health and the environment within the meaning of Article 57(f) of Regulation No 1907/2006 and, second, that they be added to the candidate list of substances (‘the Kingdom of Denmark’s initial proposal’)

| 6 | Interested parties were invited to comment on the Kingdom of Denmark’s initial proposal in accordance with the requirement laid down in Article 59(4) and (5) of Regulation No 1907/2006. Several Member States and some non-State entities, including the applicant, submitted comments on the proposal. |
| --- | --- |

6

Interested parties were invited to comment on the Kingdom of Denmark’s initial proposal in accordance with the requirement laid down in Article 59(4) and (5) of Regulation No 1907/2006. Several Member States and some non-State entities, including the applicant, submitted comments on the proposal.

| 7 | Subsequently, in accordance with Article 59(7) of Regulation No 1907/2006, the ECHA referred the four dossiers to the Member State Committee. The Kingdom of Denmark’s initial proposal was accordingly included in the agenda of the 39th meeting of the Member State Committee, held from 8 to 11 December 2014. |
| --- | --- |

7

Subsequently, in accordance with Article 59(7) of Regulation No 1907/2006, the ECHA referred the four dossiers to the Member State Committee. The Kingdom of Denmark’s initial proposal was accordingly included in the agenda of the 39th meeting of the Member State Committee, held from 8 to 11 December 2014.

| 8 | In the examination of those dossiers at the meeting, it transpired that, due to the opposition of several representatives of the Member States, the Kingdom of Denmark’s initial proposal was not going to be approved unanimously. Only the identification of DEHP as an endocrine-disrupting substance that may have serious effects on the environment was not opposed by the members of the Committee. |
| --- | --- |

8

In the examination of those dossiers at the meeting, it transpired that, due to the opposition of several representatives of the Member States, the Kingdom of Denmark’s initial proposal was not going to be approved unanimously. Only the identification of DEHP as an endocrine-disrupting substance that may have serious effects on the environment was not opposed by the members of the Committee.

| 9 | In view of this result, the Kingdom of Denmark divided its original proposal into eight parts as follows:





  — | four parts aimed at identifying the four chemical substances DBP, BBP, DIBP and DEHP as endocrine-disrupting substances that may have serious effects on human health within the meaning of Article 57(f) of Regulation No 1907/2006 and to supplement, by that new identification, the existing entry of those four substances in the candidate list of substances pursuant to Article 57(c) of Regulation No 1907/2006; |
| --- | --- | --- |

9

In view of this result, the Kingdom of Denmark divided its original proposal into eight parts as follows:

—

four parts aimed at identifying the four chemical substances DBP, BBP, DIBP and DEHP as endocrine-disrupting substances that may have serious effects on human health within the meaning of Article 57(f) of Regulation No 1907/2006 and to supplement, by that new identification, the existing entry of those four substances in the candidate list of substances pursuant to Article 57(c) of Regulation No 1907/2006;

| — | four parts aimed at identifying those four chemical substances as endocrine-disrupting substances that may have serious effects on the environment within the meaning of Article 57(f) of Regulation No 1907/2006 and to supplement, by that new identification, the existing entry of those four substances in the candidate list of substances pursuant to Article 57(c) of Regulation No 1907/2006. |
| --- | --- |

—

four parts aimed at identifying those four chemical substances as endocrine-disrupting substances that may have serious effects on the environment within the meaning of Article 57(f) of Regulation No 1907/2006 and to supplement, by that new identification, the existing entry of those four substances in the candidate list of substances pursuant to Article 57(c) of Regulation No 1907/2006.

| 10 | The representatives of the Kingdom of Denmark further requested that each of the eight parts of its proposal be submitted to a separate vote. |
| --- | --- |

10

The representatives of the Kingdom of Denmark further requested that each of the eight parts of its proposal be submitted to a separate vote.

| 11 | Subsequently, the representatives of the Kingdom of Denmark withdrew their proposal in so far as it aimed to include the substances DBP, BBP and DIBP in the candidate list of substances, on the ground that they were endocrine-disrupting substances that may have serious effects on the environment within the meaning of Article 57(f) of Regulation No 1907/2006. |
| --- | --- |

11

Subsequently, the representatives of the Kingdom of Denmark withdrew their proposal in so far as it aimed to include the substances DBP, BBP and DIBP in the candidate list of substances, on the ground that they were endocrine-disrupting substances that may have serious effects on the environment within the meaning of Article 57(f) of Regulation No 1907/2006.

| 12 | The Member State Committee did not reach unanimous agreement on the parts of the Kingdom of Denmark’s initial proposal aimed at identifying the substances DEHP, DBP, BBP and DIBP as endocrine-disrupting substances for which there was scientific evidence of probable serious effects on human health within the meaning of Article 57(f) of Regulation No 1907/2006. |
| --- | --- |

12

The Member State Committee did not reach unanimous agreement on the parts of the Kingdom of Denmark’s initial proposal aimed at identifying the substances DEHP, DBP, BBP and DIBP as endocrine-disrupting substances for which there was scientific evidence of probable serious effects on human health within the meaning of Article 57(f) of Regulation No 1907/2006.

| 13 | However, that committee did unanimously approve that part of the proposal aimed at identifying DEHP as an endocrine-disrupting substance for which there was scientific evidence of probable serious effects on the environment within the meaning of Article 57(f) of Regulation No 1907/2006. |
| --- | --- |

13

However, that committee did unanimously approve that part of the proposal aimed at identifying DEHP as an endocrine-disrupting substance for which there was scientific evidence of probable serious effects on the environment within the meaning of Article 57(f) of Regulation No 1907/2006.

| 14 | On 12 December 2014, the Executive Director of the ECHA adopted Decision ED/108/2014, updating and supplementing the existing entry for DEHP in the candidate list of substances and identifying that substance as a substance with endocrine-disrupting properties for which there was scientific evidence of probable serious effects on the environment which gave rise to an equivalent level of concern to that of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006 within the meaning of Article 57(f) of the regulation (‘the contested decision’). |
| --- | --- |

14

On 12 December 2014, the Executive Director of the ECHA adopted Decision ED/108/2014, updating and supplementing the existing entry for DEHP in the candidate list of substances and identifying that substance as a substance with endocrine-disrupting properties for which there was scientific evidence of probable serious effects on the environment which gave rise to an equivalent level of concern to that of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006 within the meaning of Article 57(f) of the regulation (‘the contested decision’).

Procedure and forms of order sought

| 15 | By application lodged at the Registry of the General Court on 5 March 2015, the applicant brought the present action. By a separate document lodged at the Court Registry on the same day, the applicant brought an application for interim measures pursuant to Article 104 et seq. of the Rules of Procedure of the General Court of 2 May 1991 to stay the operation of the decision until the Court had ruled on the main action. By order of 6 May 2015 in Deza v ECHA (T‐115/15 R, not published, EU:T:2015:263), the President of the Court dismissed the application for interim measures. The ECHA lodged a statement in defence at the Court Registry on 27 May 2015. |
| --- | --- |

15

By application lodged at the Registry of the General Court on 5 March 2015, the applicant brought the present action. By a separate document lodged at the Court Registry on the same day, the applicant brought an application for interim measures pursuant to Article 104 et seq. of the Rules of Procedure of the General Court of 2 May 1991 to stay the operation of the decision until the Court had ruled on the main action. By order of 6 May 2015 in Deza v ECHA (T‐115/15 R, not published, EU:T:2015:263), the President of the Court dismissed the application for interim measures. The ECHA lodged a statement in defence at the Court Registry on 27 May 2015.

| 16 | By documents lodged at the Court Registry on 3, 9 13 and 21 July 2015 respectively, the Kingdom of Norway, the Kingdom of Sweden, the Kingdom of the Netherlands and the Kingdom of Denmark applied for leave to intervene in support of the form of order sought by the ECHA. After the views of the principal parties on this issue were heard, leave was granted. |
| --- | --- |

16

By documents lodged at the Court Registry on 3, 9 13 and 21 July 2015 respectively, the Kingdom of Norway, the Kingdom of Sweden, the Kingdom of the Netherlands and the Kingdom of Denmark applied for leave to intervene in support of the form of order sought by the ECHA. After the views of the principal parties on this issue were heard, leave was granted.

| 17 | The reply and the rejoinder were lodged at the Court Registry on 20 July and 10 September 2015, respectively. |
| --- | --- |

17

The reply and the rejoinder were lodged at the Court Registry on 20 July and 10 September 2015, respectively.

| 18 | The Kingdom of the Netherlands and the Kingdom of Sweden lodged their statements in intervention on 3 and 16 December 2015, respectively. The Kingdom of Denmark and the Kingdom of Norway lodged their statements in intervention on 17 December 2015. |
| --- | --- |

18

The Kingdom of the Netherlands and the Kingdom of Sweden lodged their statements in intervention on 3 and 16 December 2015, respectively. The Kingdom of Denmark and the Kingdom of Norway lodged their statements in intervention on 17 December 2015.

| 19 | By documents lodged at the Court Registry on 4 April 2016, the ECHA submitted its observations on the statements in intervention. The applicant did not submit observations on those statements. |
| --- | --- |

19

By documents lodged at the Court Registry on 4 April 2016, the ECHA submitted its observations on the statements in intervention. The applicant did not submit observations on those statements.

| 20 | By way of measure of organisation of procedure under Article 89 of its Rules of Procedure, the Court ordered the ECHA to produce a copy of the Guidance on Information Requirements and Chemical Safety Assessment, to which it had referred in the rejoinder. On 30 November 2016, the ECHA lodged a copy of that document at the Court Registry. |
| --- | --- |

20

By way of measure of organisation of procedure under Article 89 of its Rules of Procedure, the Court ordered the ECHA to produce a copy of the Guidance on Information Requirements and Chemical Safety Assessment, to which it had referred in the rejoinder. On 30 November 2016, the ECHA lodged a copy of that document at the Court Registry.

| 21 | The applicant claims that the Court should:





  — | annul the contested decision in so far as it updates and supplements the existing entry for DEHP in the candidate list of substances for eventual inclusion in Annex XIV to Regulation No 1907/2006; |
| --- | --- | --- |

21

The applicant claims that the Court should:

—

annul the contested decision in so far as it updates and supplements the existing entry for DEHP in the candidate list of substances for eventual inclusion in Annex XIV to Regulation No 1907/2006;

| — | order the ECHA to pay the costs. |
| --- | --- |

—

order the ECHA to pay the costs.

| 22 | The ECHA contends that the Court should:





  — | dismiss the application; |
| --- | --- | --- |

22

The ECHA contends that the Court should:

—

dismiss the application;

| — | order the applicant to bear the costs. |
| --- | --- |

—

order the applicant to bear the costs.

| 23 | The Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway contend that the Court should uphold the ECHA’s claim that the present action should be dismissed. |
| --- | --- |

23

The Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway contend that the Court should uphold the ECHA’s claim that the present action should be dismissed.

| 24 | The Kingdom of the Netherlands further contends that the Court should order the applicant to pay the costs. |
| --- | --- |

24

The Kingdom of the Netherlands further contends that the Court should order the applicant to pay the costs.

Law

Admissibility

Admissibility

| 25 | The applicant claims that it has locus standi. Referring, inter alia, to the judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA (T‐93/10, EU:T:2013:106), the applicant considers in essence that the contested decision referred to in Article 59(8) of Regulation No 1907/2006 constitutes an act of the European Union which concerns it directly, even if it is not the addressee thereof. The contested decision is therefore a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU. |
| --- | --- |

25

The applicant claims that it has locus standi. Referring, inter alia, to the judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA (T‐93/10, EU:T:2013:106), the applicant considers in essence that the contested decision referred to in Article 59(8) of Regulation No 1907/2006 constitutes an act of the European Union which concerns it directly, even if it is not the addressee thereof. The contested decision is therefore a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU.

locus standi

| 26 | The ECHA and the Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway have not taken a position on the admissibility of the application. |
| --- | --- |

26

The ECHA and the Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway have not taken a position on the admissibility of the application.

| 27 | In that regard, it should be recalled that, under the terms of the fourth paragraph of Article 263 TFEU, any natural or legal person may, under the conditions laid down in the first and second paragraphs of that article, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures. |
| --- | --- |

27

In that regard, it should be recalled that, under the terms of the fourth paragraph of Article 263 TFEU, any natural or legal person may, under the conditions laid down in the first and second paragraphs of that article, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures.

| 28 | In the present case, the applicant is not the addressee of the contested decision. In those circumstances, the present action for annulment is admissible under the fourth paragraph of Article 263 TFEU only if the contested decision is of direct and individual concern to the applicant (the second situation provided for in the fourth paragraph of Article 263 TFEU) or if the contested decision is of direct concern to the applicant and is a regulatory act which does not entail implementing measures (the third situation provided for in the fourth paragraph of Article 263 TFEU). |
| --- | --- |

28

In the present case, the applicant is not the addressee of the contested decision. In those circumstances, the present action for annulment is admissible under the fourth paragraph of Article 263 TFEU only if the contested decision is of direct and individual concern to the applicant (the second situation provided for in the fourth paragraph of Article 263 TFEU) or if the contested decision is of direct concern to the applicant and is a regulatory act which does not entail implementing measures (the third situation provided for in the fourth paragraph of Article 263 TFEU).

| 29 | In that regard and as a preliminary point it should be noted that, irrespective of the question raised by the parties to the dispute as to whether the contested decision supplements an entry already in the candidate list of substances, that decision in essence and in any event identifies DEHP as a substance of very high concern (SVHC) within the meaning of Article 57(f) of Regulation No 1907/2006. As is apparent from recital 11 of the preamble to and point 2 of its operative part, that decision was adopted on the basis of Article 59(8) of Regulation No 1907/2006 and in accordance with the procedure referred to in Article 59(3) to (5) and (7) of that regulation. |
| --- | --- |

29

In that regard and as a preliminary point it should be noted that, irrespective of the question raised by the parties to the dispute as to whether the contested decision supplements an entry already in the candidate list of substances, that decision in essence and in any event identifies DEHP as a substance of very high concern (SVHC) within the meaning of Article 57(f) of Regulation No 1907/2006. As is apparent from recital 11 of the preamble to and point 2 of its operative part, that decision was adopted on the basis of Article 59(8) of Regulation No 1907/2006 and in accordance with the procedure referred to in Article 59(3) to (5) and (7) of that regulation.

| 30 | In the context of an action for annulment of an ECHA decision identifying a substance of very high concern on the ground that it fulfils the criteria laid down in Article 57(f) of Regulation No 1907/2006, it has been held that such a decision directly affects the legal situation of the supplier of the substance concerned. This is because the identification of a substance under Article 57(f) of Regulation No 1907/2006 constitutes new information obliging the supplier to update the safety data sheet for the substance concerned in accordance with Article 31(9)(a) of that regulation (see, to that effect, judgment of 30 April 2015, Polynt and Sitre v ECHA, T‐134/13, not published, EU:T:2015:254, paragraphs 30, 36 and 37). |
| --- | --- |

30

In the context of an action for annulment of an ECHA decision identifying a substance of very high concern on the ground that it fulfils the criteria laid down in Article 57(f) of Regulation No 1907/2006, it has been held that such a decision directly affects the legal situation of the supplier of the substance concerned. This is because the identification of a substance under Article 57(f) of Regulation No 1907/2006 constitutes new information obliging the supplier to update the safety data sheet for the substance concerned in accordance with Article 31(9)(a) of that regulation (see, to that effect, judgment of 30 April 2015, Polynt and Sitre v ECHA, T‐134/13, not published, EU:T:2015:254, paragraphs 30, 36 and 37).

| 31 | In the present case, it follows from the two-fold fact that, first, the applicant is a supplier of DEHP and, second, as observed in paragraph 29 above, the contested decision identifies that substance as a substance referred to in Article 57(f) of Regulation No 1907/2006, that the contested decision directly affects the applicant’s legal situation, more specifically due to the obligation laid down in Article 31(9)(a) of that regulation. |
| --- | --- |

31

In the present case, it follows from the two-fold fact that, first, the applicant is a supplier of DEHP and, second, as observed in paragraph 29 above, the contested decision identifies that substance as a substance referred to in Article 57(f) of Regulation No 1907/2006, that the contested decision directly affects the applicant’s legal situation, more specifically due to the obligation laid down in Article 31(9)(a) of that regulation.

| 32 | As regards the other conditions laid down in the fourth paragraph of Article 263 TFEU, suffice it to recall that, according to the case-law of the General Court, a decision identifying a substance as a substance of very high concern under Article 57(f) of Regulation No 1907/2006 constitutes a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU (judgment of 30 April 2015, Polynt and Sitre v ECHA, T‐134/13, not published, EU:T:2015:254, paragraph 40). |
| --- | --- |

32

As regards the other conditions laid down in the fourth paragraph of Article 263 TFEU, suffice it to recall that, according to the case-law of the General Court, a decision identifying a substance as a substance of very high concern under Article 57(f) of Regulation No 1907/2006 constitutes a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU (judgment of 30 April 2015, Polynt and Sitre v ECHA, T‐134/13, not published, EU:T:2015:254, paragraph 40).

| 33 | Such a decision is of general application inasmuch as it applies to situations which have been determined objectively and have legal effects as regards a category of persons viewed in a general and abstract manner, that is to say with regard to every natural or legal person falling within the scope of Article 31(9)(a) of Regulation No 1907/2006. Moreover, it does not constitute a legislative act, since it was not adopted either under the ordinary legislative procedure or under a special legislative procedure within the meaning of Article 289(1) to (3) TFEU but under Article 59 of Regulation No 1907/2006 (see to that effect, judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‐93/10, EU:T:2013:106, paragraphs 55 to 58). |
| --- | --- |

33

Such a decision is of general application inasmuch as it applies to situations which have been determined objectively and have legal effects as regards a category of persons viewed in a general and abstract manner, that is to say with regard to every natural or legal person falling within the scope of Article 31(9)(a) of Regulation No 1907/2006. Moreover, it does not constitute a legislative act, since it was not adopted either under the ordinary legislative procedure or under a special legislative procedure within the meaning of Article 289(1) to (3) TFEU but under Article 59 of Regulation No 1907/2006 (see to that effect, judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‐93/10, EU:T:2013:106, paragraphs 55 to 58).

| 34 | The contested decision therefore constitutes a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU. |
| --- | --- |

34

The contested decision therefore constitutes a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU.

| 35 | Furthermore, the identification of a substance as of very high concern resulting from the procedure referred to in Article 59 of Regulation No 1907/2006 gives rise to information obligations without any further measures being necessary. In particular, the next stage of the authorisation procedure, which consists of the inclusion in order of priority of the candidate substances in Annex XIV to Regulation No 1907/2006, that is to say, in the list of substances subject to authorisation, is not a measure implementing a decision to include a substance in the candidate list (see to that effect, judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‐93/10, EU:T:2013:106, paragraphs 63 and 64). |
| --- | --- |

35

Furthermore, the identification of a substance as of very high concern resulting from the procedure referred to in Article 59 of Regulation No 1907/2006 gives rise to information obligations without any further measures being necessary. In particular, the next stage of the authorisation procedure, which consists of the inclusion in order of priority of the candidate substances in Annex XIV to Regulation No 1907/2006, that is to say, in the list of substances subject to authorisation, is not a measure implementing a decision to include a substance in the candidate list (see to that effect, judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‐93/10, EU:T:2013:106, paragraphs 63 and 64).

| 36 | In the light of all the foregoing, the conclusion is that the applicant is directly concerned by the contested decision, which constitutes a regulatory act not entailing implementing measures, with the result that the applicant has locus standi. |
| --- | --- |

36

In the light of all the foregoing, the conclusion is that the applicant is directly concerned by the contested decision, which constitutes a regulatory act not entailing implementing measures, with the result that the applicant has locus standi.

locus standi

| 37 | As the other relevant requirements for admissibility of the action are met, the present action must be held to be admissible. |
| --- | --- |

37

As the other relevant requirements for admissibility of the action are met, the present action must be held to be admissible.

Substance

Substance

| 38 | The applicant puts forward four pleas in law in support of its application. |
| --- | --- |

38

The applicant puts forward four pleas in law in support of its application.

| 39 | By its first plea, the applicant criticises the ECHA for having taken an ultra vires decision, without however defining those terms. The second plea alleges infringement of the principles of foreseeability, legal certainty and the protection of legitimate expectations, whilst the third alleges that there were no convincing and objective scientific findings and also non-compliance with the ECHA’s instructions. By its fourth plea, the applicant alleges infringement of the rights and principles enshrined in the Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’), and in the Charter of Fundamental Rights of the European Union (‘the Charter’), being more specifically the principle of legal certainty, the right to a fair hearing within the meaning of Article 6 ECHR and Article 47 of the Charter and its right to peaceful enjoyment of its property within the meaning of Article 1 of Additional Protocol No 1 to the ECHR and Article 17 of the Charter. |
| --- | --- |

39

By its first plea, the applicant criticises the ECHA for having taken an ultra vires decision, without however defining those terms. The second plea alleges infringement of the principles of foreseeability, legal certainty and the protection of legitimate expectations, whilst the third alleges that there were no convincing and objective scientific findings and also non-compliance with the ECHA’s instructions. By its fourth plea, the applicant alleges infringement of the rights and principles enshrined in the Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’), and in the Charter of Fundamental Rights of the European Union (‘the Charter’), being more specifically the principle of legal certainty, the right to a fair hearing within the meaning of Article 6 ECHR and Article 47 of the Charter and its right to peaceful enjoyment of its property within the meaning of Article 1 of Additional Protocol No 1 to the ECHR and Article 17 of the Charter.

The first plea: an ultra vires decision was taken

| 40 | It is apparent from the applicant’s observations as a whole that the first plea comprises three distinct aspects: (i) the absence in Regulation No 1907/2006 of a provision empowering the ECHA to supplement an existing entry for a chemical substance in the candidate list of substances; (ii) alleged infringement of the procedural provisions laid down in Article 59 of Regulation No 1907/2006; and (iii) a circumvention of the procedures provided for by the Council of the European Union and the European Parliament for the identification of substances as endocrine disruptors of very high concern within the meaning of Article 57(f) of Regulation No 1907/2006. These three aspects should be treated as three separate parts. |
| --- | --- |

40

It is apparent from the applicant’s observations as a whole that the first plea comprises three distinct aspects: (i) the absence in Regulation No 1907/2006 of a provision empowering the ECHA to supplement an existing entry for a chemical substance in the candidate list of substances; (ii) alleged infringement of the procedural provisions laid down in Article 59 of Regulation No 1907/2006; and (iii) a circumvention of the procedures provided for by the Council of the European Union and the European Parliament for the identification of substances as endocrine disruptors of very high concern within the meaning of Article 57(f) of Regulation No 1907/2006. These three aspects should be treated as three separate parts.

– The first part of the first plea: whether the ECHA was empowered to supplement an existing entry for a chemical substance in the candidate list of substances

| 41 | In the applicant’s submission, it follows from the wording of Article 59(10) of Regulation No 1907/2006 that the ECHA may publish and update the candidate list of substances only if a substance which is not yet included or has not yet been identified as a substance referred to in Article 57 of Regulation No 1907/2006 is included in that list. |
| --- | --- |

41

In the applicant’s submission, it follows from the wording of Article 59(10) of Regulation No 1907/2006 that the ECHA may publish and update the candidate list of substances only if a substance which is not yet included or has not yet been identified as a substance referred to in Article 57 of Regulation No 1907/2006 is included in that list.

| 42 | By contrast, there is no provision in Regulation No 1907/2006 providing that the ECHA is empowered to update the candidate list of substances by supplementing an existing entry for a substance identified pursuant to one of the paragraphs of Article 57 of Regulation No 1907/2006 through a new identification of that substance pursuant to another paragraph of the same article. The applicant submits that the ECHA cannot rely on Article 61(2) of Regulation No 1907/2006 for that purpose. That provision concerns the Commission’s powers, not the ECHA’s, to review authorisations granted previously for the use of a chemical substance listed in Annex XIV to Regulation No 1907/2006. The applicant adds that if the legislature had intended to empower the ECHA to supplement an existing entry, it would have done so by making express provision to that effect in Regulation No 1907/2006, as it precisely did in Article 58(8) thereof by expressly granting the Commission the power to amend an entry relating to a chemical substance in Annex XIV. |
| --- | --- |

42

By contrast, there is no provision in Regulation No 1907/2006 providing that the ECHA is empowered to update the candidate list of substances by supplementing an existing entry for a substance identified pursuant to one of the paragraphs of Article 57 of Regulation No 1907/2006 through a new identification of that substance pursuant to another paragraph of the same article. The applicant submits that the ECHA cannot rely on Article 61(2) of Regulation No 1907/2006 for that purpose. That provision concerns the Commission’s powers, not the ECHA’s, to review authorisations granted previously for the use of a chemical substance listed in Annex XIV to Regulation No 1907/2006. The applicant adds that if the legislature had intended to empower the ECHA to supplement an existing entry, it would have done so by making express provision to that effect in Regulation No 1907/2006, as it precisely did in Article 58(8) thereof by expressly granting the Commission the power to amend an entry relating to a chemical substance in Annex XIV.

| 43 | The Kingdom of Denmark itself expressly supported the abovementioned position by stating in its observations on the comments on the dossier it submitted in accordance with Annex XV that ‘the procedure to supplement the candidate list and Annex XIV [was] not provided for by Regulation No 1907/2006’, but that ‘[it was] based on the principle that the Commission [supplemented] that Annex in an appropriate manner’. As part of the discussion at the meeting of the Member State Committee, a number of participants also voiced objections to the proposal to supplement the existing entry for DEHP, DBP, BBP and DIBP in the candidate list of substances. In any event, the ECHA’s lack of powers under the regulation itself cannot be offset by the fact that the Member State Committee ultimately expressed its agreement with the new proposal. |
| --- | --- |

43

The Kingdom of Denmark itself expressly supported the abovementioned position by stating in its observations on the comments on the dossier it submitted in accordance with Annex XV that ‘the procedure to supplement the candidate list and Annex XIV [was] not provided for by Regulation No 1907/2006’, but that ‘[it was] based on the principle that the Commission [supplemented] that Annex in an appropriate manner’. As part of the discussion at the meeting of the Member State Committee, a number of participants also voiced objections to the proposal to supplement the existing entry for DEHP, DBP, BBP and DIBP in the candidate list of substances. In any event, the ECHA’s lack of powers under the regulation itself cannot be offset by the fact that the Member State Committee ultimately expressed its agreement with the new proposal.

| 44 | The applicant adds that, contrary to the ECHA’s contention, the latter’s powers to supplement an existing entry for a chemical substance in the candidate list of substances cannot be derived from the doctrine of ‘implied powers’. Under Article 13(2) of the EU Treaty, the fundamental principle regulating the scope of the powers of the Union institutions is not that of ‘implied powers’, but that of ‘attribution of powers’. The doctrine of implied powers is an exception to this principle. The derogation from the principle in the form of implied powers should be strictly assessed since this derogation can be applied only exceptionally. |
| --- | --- |

44

The applicant adds that, contrary to the ECHA’s contention, the latter’s powers to supplement an existing entry for a chemical substance in the candidate list of substances cannot be derived from the doctrine of ‘implied powers’. Under Article 13(2) of the EU Treaty, the fundamental principle regulating the scope of the powers of the Union institutions is not that of ‘implied powers’, but that of ‘attribution of powers’. The doctrine of implied powers is an exception to this principle. The derogation from the principle in the form of implied powers should be strictly assessed since this derogation can be applied only exceptionally.

| 45 | Contrary to what the ECHA suggests, the ECHA’s powers to supplement an existing entry for a chemical substance in the candidate list of substances are not necessary to achieve the objectives of Regulation No 1907/2006. In the applicant’s submission, that regulation also allows for the possibility of adopting restrictions under Title VIII. The majority of substances in the candidate list of substances were not subjected to the authorisation procedure. The ECHA itself opted for another method of regulation for most of these chemicals, being the restriction procedure referred to in Title VIII of Regulation No 1907/2006. |
| --- | --- |

45

Contrary to what the ECHA suggests, the ECHA’s powers to supplement an existing entry for a chemical substance in the candidate list of substances are not necessary to achieve the objectives of Regulation No 1907/2006. In the applicant’s submission, that regulation also allows for the possibility of adopting restrictions under Title VIII. The majority of substances in the candidate list of substances were not subjected to the authorisation procedure. The ECHA itself opted for another method of regulation for most of these chemicals, being the restriction procedure referred to in Title VIII of Regulation No 1907/2006.

| 46 | Lastly, the applicant submits that under Article 69(2) of Regulation No 1907/2006 a substance included in Annex XIV may be re-examined by the ECHA only after the date referred to in Article 58(1)(c)(i) of Regulation No 1907/2006, which in the present case was 21 February 2015, in other words, on a date subsequent to the adoption of the contested decision. In the present case, the ECHA re-examined DEHP before that date on the basis of a dossier which it had not itself prepared. |
| --- | --- |

46

Lastly, the applicant submits that under Article 69(2) of Regulation No 1907/2006 a substance included in Annex XIV may be re-examined by the ECHA only after the date referred to in Article 58(1)(c)(i) of Regulation No 1907/2006, which in the present case was 21 February 2015, in other words, on a date subsequent to the adoption of the contested decision. In the present case, the ECHA re-examined DEHP before that date on the basis of a dossier which it had not itself prepared.

| 47 | The ECHA, supported by the Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway, disputes those arguments. |
| --- | --- |

47

The ECHA, supported by the Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway, disputes those arguments.

| 48 | In that regard, in summary the applicant is, in essence, disputing the ECHA’s powers to identify DEHP as an endocrine disruptor of very high concern under Article 57(f) of Regulation No 1907/2006 in view of the fact that DEHP had already been identified as a substance of very high concern within the meaning of Article 57(c) of that regulation. |
| --- | --- |

48

In that regard, in summary the applicant is, in essence, disputing the ECHA’s powers to identify DEHP as an endocrine disruptor of very high concern under Article 57(f) of Regulation No 1907/2006 in view of the fact that DEHP had already been identified as a substance of very high concern within the meaning of Article 57(c) of that regulation.

| 49 | In that context, it must be borne in mind that, as observed in paragraph 29 above, the contested decision was adopted on the basis of Article 59(8) of Regulation No 1907/2006. |
| --- | --- |

49

In that context, it must be borne in mind that, as observed in paragraph 29 above, the contested decision was adopted on the basis of Article 59(8) of Regulation No 1907/2006.

| 50 | The first sentence thereof provides that, if within 30 days of referral of a dossier submitted to the attention of the Member State Committee, that committee reaches unanimous agreement on the identification of a substance as a substance referred to in Article 57 of that Regulation, the ECHA is to include that substance in the candidate list of substances. |
| --- | --- |

50

The first sentence thereof provides that, if within 30 days of referral of a dossier submitted to the attention of the Member State Committee, that committee reaches unanimous agreement on the identification of a substance as a substance referred to in Article 57 of that Regulation, the ECHA is to include that substance in the candidate list of substances.

| 51 | It follows from the wording of Article 59(8) of Regulation No 1907/2006 that such a decision is therefore justified if a substance can be identified as being of very high concern under Article 57 thereof, with the identification of a substance always being carried out, as specified in Article 58(1)(b) of that same regulation, by indicating the intrinsic property or properties of the substance referred to in Article 57 thereof. The name of the substance included in the candidate list of substances and the reason for inclusion therein constitute a whole, with the identification decision being therefore limited to the reasons given. |
| --- | --- |

51

It follows from the wording of Article 59(8) of Regulation No 1907/2006 that such a decision is therefore justified if a substance can be identified as being of very high concern under Article 57 thereof, with the identification of a substance always being carried out, as specified in Article 58(1)(b) of that same regulation, by indicating the intrinsic property or properties of the substance referred to in Article 57 thereof. The name of the substance included in the candidate list of substances and the reason for inclusion therein constitute a whole, with the identification decision being therefore limited to the reasons given.

| 52 | It is true that the words ‘the Agency shall include that substance on the list’ set out in Article 59(8) of Regulation No 1907/2006 prima facie concern the situation in which a dossier drawn up in accordance with Annex XV to that Regulation, which relates to a substance which has not yet been brought to the Member State Committee’s attention, is referred to that committee. If the committee reaches unanimous agreement on the identification of such a substance as a substance referred to in Article 57 of that Regulation, the ECHA is required to include this substance in the candidate list. |
| --- | --- |

52

It is true that the words ‘the Agency shall include that substance on the list’ set out in Article 59(8) of Regulation No 1907/2006 prima facie concern the situation in which a dossier drawn up in accordance with Annex XV to that Regulation, which relates to a substance which has not yet been brought to the Member State Committee’s attention, is referred to that committee. If the committee reaches unanimous agreement on the identification of such a substance as a substance referred to in Article 57 of that Regulation, the ECHA is required to include this substance in the candidate list.

| 53 | However, it cannot be inferred from those terms that the Member State Committee is competent only for the identification of substances which have not yet been included in the candidate list. |
| --- | --- |

53

However, it cannot be inferred from those terms that the Member State Committee is competent only for the identification of substances which have not yet been included in the candidate list.

| 54 | In a situation where, because it has intrinsic properties within the meaning of one of the points of Article 57(a) to (f) of Regulation No 1907/2006, a certain substance is included in the candidate list of substances as a substance of very high concern, neither the wording of Article 57 of Regulation No 1907/2006 and Article 59(8) of that regulation nor the wording of any other provision of that regulation prohibits the ECHA from verifying whether that substance has intrinsic properties other than those which led to the initial inclusion of the substance in the list. |
| --- | --- |

54

In a situation where, because it has intrinsic properties within the meaning of one of the points of Article 57(a) to (f) of Regulation No 1907/2006, a certain substance is included in the candidate list of substances as a substance of very high concern, neither the wording of Article 57 of Regulation No 1907/2006 and Article 59(8) of that regulation nor the wording of any other provision of that regulation prohibits the ECHA from verifying whether that substance has intrinsic properties other than those which led to the initial inclusion of the substance in the list.

| 55 | Accordingly, from a technical point of view, the identification of a substance as fulfilling the conditions of one of the points of Article 57 of Regulation No 1907/2006 other than the one that led to the initial inclusion in the candidate list of substances is the form of a supplement to the existing entry. It is, moreover, in this sense that the ECHA’s argument that it has an ‘implied power’ to supplement an existing entry must be understood. |
| --- | --- |

55

Accordingly, from a technical point of view, the identification of a substance as fulfilling the conditions of one of the points of Article 57 of Regulation No 1907/2006 other than the one that led to the initial inclusion in the candidate list of substances is the form of a supplement to the existing entry. It is, moreover, in this sense that the ECHA’s argument that it has an ‘implied power’ to supplement an existing entry must be understood.

| 56 | This is how Article 59(8) of Regulation No 1907/2006 must be interpreted, in the light of the purpose of the provisions governing the identification of a substance as a substance of very high concern. |
| --- | --- |

56

This is how Article 59(8) of Regulation No 1907/2006 must be interpreted, in the light of the purpose of the provisions governing the identification of a substance as a substance of very high concern.

| 57 | In that regard, it must be borne in mind that Regulation No 1907/2006 introduced a system for the registration, evaluation, authorisation and restriction of chemicals aimed at ensuring in particular, according to recital 1 to the preamble thereto and Article 1(1) thereof, a high level of protection of human health and the environment. Recital 69 of the preamble thereto states that, in order to ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention. |
| --- | --- |

57

In that regard, it must be borne in mind that Regulation No 1907/2006 introduced a system for the registration, evaluation, authorisation and restriction of chemicals aimed at ensuring in particular, according to recital 1 to the preamble thereto and Article 1(1) thereof, a high level of protection of human health and the environment. Recital 69 of the preamble thereto states that, in order to ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention.

| 58 | In view of the fact that the different properties of a substance may give rise to risks of a different nature and given that the possibility cannot therefore be ruled out that the intrinsic properties of a substance may come under several of the grounds set out in Article 57(a) to (f) of Regulation No 1907/2006, the only interpretation of Article 59(8) of Regulation No 1907/2006 that is likely effectively to serve all of the aforementioned objectives is one that allows, within the framework of the candidate list of substances, all intrinsic properties of a substance to be taken into account. |
| --- | --- |

58

In view of the fact that the different properties of a substance may give rise to risks of a different nature and given that the possibility cannot therefore be ruled out that the intrinsic properties of a substance may come under several of the grounds set out in Article 57(a) to (f) of Regulation No 1907/2006, the only interpretation of Article 59(8) of Regulation No 1907/2006 that is likely effectively to serve all of the aforementioned objectives is one that allows, within the framework of the candidate list of substances, all intrinsic properties of a substance to be taken into account.

| 59 | The considerations set out in paragraphs 53 to 55 above must also be endorsed given the stages of the authorisation procedure, particularly the stages following the inclusion of a substance in the candidate list of substances. |
| --- | --- |

59

The considerations set out in paragraphs 53 to 55 above must also be endorsed given the stages of the authorisation procedure, particularly the stages following the inclusion of a substance in the candidate list of substances.

| 60 | It must be remembered in that regard that Article 59 of Regulation No 1907/2006 describes the procedure for identifying substances fulfilling the criteria set out in Article 57 of Regulation No 1907/2006 with a view to their inclusion in the candidate list of substances, which serves as a basis for drawing up Annex XIV. |
| --- | --- |

60

It must be remembered in that regard that Article 59 of Regulation No 1907/2006 describes the procedure for identifying substances fulfilling the criteria set out in Article 57 of Regulation No 1907/2006 with a view to their inclusion in the candidate list of substances, which serves as a basis for drawing up Annex XIV.

| 61 | It follows from the wording of Article 56(1)(a) of Regulation No 1907/2006 that, once the substance in question is included in Annex XIV, that substance can no longer be used or placed on the market, except where an authorisation for a specific use has been granted under Article 60 of that regulation. |
| --- | --- |

61

It follows from the wording of Article 56(1)(a) of Regulation No 1907/2006 that, once the substance in question is included in Annex XIV, that substance can no longer be used or placed on the market, except where an authorisation for a specific use has been granted under Article 60 of that regulation.

| 62 | It is only if all the properties of a substance under Article 57 of Regulation No 1907/2006 are entered in the candidate list of substances that their inclusion in the list in Annex XIV to that regulation will be guaranteed to have any practical effect. Thus, the only interpretation of Article 59(8) of Regulation No 1907/2006 that will ensure that any authorisation granted to use a substance has a scope that adequately serves the objectives of the regulation is one that takes into account all the properties of a substance within the meaning of Article 57 of that regulation and permits the inclusion of all those properties in the candidate list of substances. |
| --- | --- |

62

It is only if all the properties of a substance under Article 57 of Regulation No 1907/2006 are entered in the candidate list of substances that their inclusion in the list in Annex XIV to that regulation will be guaranteed to have any practical effect. Thus, the only interpretation of Article 59(8) of Regulation No 1907/2006 that will ensure that any authorisation granted to use a substance has a scope that adequately serves the objectives of the regulation is one that takes into account all the properties of a substance within the meaning of Article 57 of that regulation and permits the inclusion of all those properties in the candidate list of substances.

| 63 | The finding set out in paragraphs 53 to 55 above is further supported by the legislative context of which Article 59(8) of Regulation No 1907/2006 forms a part. |
| --- | --- |

63

The finding set out in paragraphs 53 to 55 above is further supported by the legislative context of which Article 59(8) of Regulation No 1907/2006 forms a part.

| 64 | It must be pointed out that, under Article 61(2)(a) of that regulation, the Commission may at any time review an authorisation granted and, more specifically, if the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment. As rightly pointed out by the ECHA, this may be so specifically where new hazardous properties of a substance already included in Annex XIV have been identified. |
| --- | --- |

64

It must be pointed out that, under Article 61(2)(a) of that regulation, the Commission may at any time review an authorisation granted and, more specifically, if the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment. As rightly pointed out by the ECHA, this may be so specifically where new hazardous properties of a substance already included in Annex XIV have been identified.

| 65 | The exercise of the Commission’s power to review an authorisation is closely linked to and directly dependent on the ECHA’s power to include new grounds such as those referred to in Article 57 of Regulation No 1907/2006, in the candidate list for substances already included therein. If it does not take account of a new ground under one of the points in Article 57 thereof which has emerged as a result of new information and include that ground in the candidate list of substances in accordance with the procedure laid down in Article 59 of Regulation No 1907/2006, then the Commission may not include the substance in Annex XIV or authorise or modify an authorisation on the basis of Article 61(2)(a) of Regulation No 1907/2006. Consequently, if the ECHA were not competent to examine whether a substance is subject to a supplementary ground of identification as set out in Article 57 of Regulation No 1907/2006 because of a newly identified hazardous property, the procedure for reviewing an authorisation would be impeded. |
| --- | --- |

65

The exercise of the Commission’s power to review an authorisation is closely linked to and directly dependent on the ECHA’s power to include new grounds such as those referred to in Article 57 of Regulation No 1907/2006, in the candidate list for substances already included therein. If it does not take account of a new ground under one of the points in Article 57 thereof which has emerged as a result of new information and include that ground in the candidate list of substances in accordance with the procedure laid down in Article 59 of Regulation No 1907/2006, then the Commission may not include the substance in Annex XIV or authorise or modify an authorisation on the basis of Article 61(2)(a) of Regulation No 1907/2006. Consequently, if the ECHA were not competent to examine whether a substance is subject to a supplementary ground of identification as set out in Article 57 of Regulation No 1907/2006 because of a newly identified hazardous property, the procedure for reviewing an authorisation would be impeded.

| 66 | Article 59(10) of Regulation No 1907/2006, referred to by the parties, merely allows the ECHA to update the candidate list of substances following a decision taken on the basis of Article 59(8), read in conjunction with Article 57 of Regulation No 1907/2006. |
| --- | --- |

66

Article 59(10) of Regulation No 1907/2006, referred to by the parties, merely allows the ECHA to update the candidate list of substances following a decision taken on the basis of Article 59(8), read in conjunction with Article 57 of Regulation No 1907/2006.

| 67 | The finding that the ECHA has the power to supplement an existing entry in the candidate list with another ground within the meaning of one of the points of Article 57 of Regulation No 1907/2006 cannot be called into question by the applicant’s other arguments. |
| --- | --- |

67

The finding that the ECHA has the power to supplement an existing entry in the candidate list with another ground within the meaning of one of the points of Article 57 of Regulation No 1907/2006 cannot be called into question by the applicant’s other arguments.

| 68 | Thus, first and contrary to what the applicant claims, the fact that the Member State Committee expressed its agreement with the Kingdom of Denmark’s ‘new proposal’ did not, in this case, ‘correct’ the absence of an ‘authorisation’ granted to the ECHA by Regulation No 1907/2006. It is for the Member State Committee to identify substances as substances of very high concern under Article 57(f) of Regulation No 1907/2006, since the decisions of the Executive Director of the ECHA are adopted, as in the present case, only following unanimous agreement by that committee. |
| --- | --- |

68

Thus, first and contrary to what the applicant claims, the fact that the Member State Committee expressed its agreement with the Kingdom of Denmark’s ‘new proposal’ did not, in this case, ‘correct’ the absence of an ‘authorisation’ granted to the ECHA by Regulation No 1907/2006. It is for the Member State Committee to identify substances as substances of very high concern under Article 57(f) of Regulation No 1907/2006, since the decisions of the Executive Director of the ECHA are adopted, as in the present case, only following unanimous agreement by that committee.

| 69 | Second, nor can the applicant’s argument to the effect that if the legislature had intended to give the ECHA the power to supplement an existing entry it would have done so expressly by providing for that competence in Regulation No 1907/2006, as it did in Article 58(8) of Regulation No 1907/2006, by specifically granting the Commission the power to amend an entry relating to a chemical substance in Annex XIV, be upheld. |
| --- | --- |

69

Second, nor can the applicant’s argument to the effect that if the legislature had intended to give the ECHA the power to supplement an existing entry it would have done so expressly by providing for that competence in Regulation No 1907/2006, as it did in Article 58(8) of Regulation No 1907/2006, by specifically granting the Commission the power to amend an entry relating to a chemical substance in Annex XIV, be upheld.

| 70 | In that regard, although it is true that there is no provision expressly and formally providing that the ECHA is empowered to supplement existing entries in the candidate list of substances with new grounds within the meaning of Article 57 of Regulation No 1907/2006, such express authority for the ECHA cannot be regarded as indispensable, inasmuch as its competence to do so already derives from Article 59(8) of Regulation No 1907/2006, read in the light of the overall scheme of the provisions of that regulation and the purpose underlying the identification of a substance as a substance of very high concern, as demonstrated in paragraphs 56 to 65 above. |
| --- | --- |

70

In that regard, although it is true that there is no provision expressly and formally providing that the ECHA is empowered to supplement existing entries in the candidate list of substances with new grounds within the meaning of Article 57 of Regulation No 1907/2006, such express authority for the ECHA cannot be regarded as indispensable, inasmuch as its competence to do so already derives from Article 59(8) of Regulation No 1907/2006, read in the light of the overall scheme of the provisions of that regulation and the purpose underlying the identification of a substance as a substance of very high concern, as demonstrated in paragraphs 56 to 65 above.

| 71 | Third, the applicant’s argument that the ECHA’s power to supplement an existing entry for a chemical substance in the candidate list of substances is not necessary to achieve the objectives of Regulation No 1907/2006, since there is also the possibility of adopting restrictions under Title VIII of that regulation, must also be rejected. |
| --- | --- |

71

Third, the applicant’s argument that the ECHA’s power to supplement an existing entry for a chemical substance in the candidate list of substances is not necessary to achieve the objectives of Regulation No 1907/2006, since there is also the possibility of adopting restrictions under Title VIII of that regulation, must also be rejected.

| 72 | In that regard, it must be observed that the mere fact that a substance appears in the candidate list of substances does not prevent that substance from being subject to restrictions in certain conditions rather than an authorisation. As is apparent from Article 58(5) and Article 69 of Regulation No 1907/2006, the Commission or a Member State may still propose that the manufacture, the placing on the market or the use of a substance on its own, in a mixture or in an article be managed by restrictions rather than by an authorisation (see, to that effect, judgment in 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‐135/13, EU:T:2015:253 paragraph 124). |
| --- | --- |

72

In that regard, it must be observed that the mere fact that a substance appears in the candidate list of substances does not prevent that substance from being subject to restrictions in certain conditions rather than an authorisation. As is apparent from Article 58(5) and Article 69 of Regulation No 1907/2006, the Commission or a Member State may still propose that the manufacture, the placing on the market or the use of a substance on its own, in a mixture or in an article be managed by restrictions rather than by an authorisation (see, to that effect, judgment in 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‐135/13, EU:T:2015:253 paragraph 124).

| 73 | Furthermore, as is apparent from Annex XVII to Regulation No 1907/2006, restrictions applicable to the manufacture, the placing on the market and the use of certain dangerous substances and certain preparations and dangerous articles, adopted in accordance with the procedure set out in Title VIII of that regulation, may range from specific conditions imposed on the manufacture or the placing on the market of a substance to a total ban on the use of a substance (see, to that effect, judgment in 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‐135/13, EU:T:2015:253 paragraph 125). |
| --- | --- |

73

Furthermore, as is apparent from Annex XVII to Regulation No 1907/2006, restrictions applicable to the manufacture, the placing on the market and the use of certain dangerous substances and certain preparations and dangerous articles, adopted in accordance with the procedure set out in Title VIII of that regulation, may range from specific conditions imposed on the manufacture or the placing on the market of a substance to a total ban on the use of a substance (see, to that effect, judgment in 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‐135/13, EU:T:2015:253 paragraph 125).

| 74 | However, the restriction procedure, as referred to in Title VIII of Regulation No 1907/2006, is a different instrument from the authorisation procedure referred to in Title VII of that regulation (judgment of 7 March 2013, Rütgers Germany and Others v ECHA, T‐94/10, EU:T:2013:107, paragraph 149). |
| --- | --- |

74

However, the restriction procedure, as referred to in Title VIII of Regulation No 1907/2006, is a different instrument from the authorisation procedure referred to in Title VII of that regulation (judgment of 7 March 2013, Rütgers Germany and Others v ECHA, T‐94/10, EU:T:2013:107, paragraph 149).

| 75 | Therefore, the identification procedure set out in Article 59 of Regulation No 1907/2006, read in conjunction with Article 57 thereof, including the procedure for updating the candidate list of substances, cannot be called into question by the mere fact that in some cases it would also be possible to resort to restrictions. |
| --- | --- |

75

Therefore, the identification procedure set out in Article 59 of Regulation No 1907/2006, read in conjunction with Article 57 thereof, including the procedure for updating the candidate list of substances, cannot be called into question by the mere fact that in some cases it would also be possible to resort to restrictions.

| 76 | Fourth, as regards the applicant’s argument that the ECHA makes use of the restriction procedure for the majority of substances in the candidate list of substances that would not otherwise be included in Annex XIV, it should be remembered that recital 77 of Regulation No 1907/2006 states that, in view of workability and practicality considerations, only a limited number of substances should be subjected to the authorisation procedure at the same time (judgment of 7 March 2013, Rütgers Germany and Others v ECHA, T‐96/10, EU:T:2013:109, paragraph 93). Furthermore, the identification of the substances referred to in Article 57 of Regulation No 1907/2006 and the establishment of the candidate list of substances are only a precursor to the decision to include a substance in Annex XIV. Such decisions can be taken only gradually, depending on the administrative capacities of the ECHA and the Commission. |
| --- | --- |

76

Fourth, as regards the applicant’s argument that the ECHA makes use of the restriction procedure for the majority of substances in the candidate list of substances that would not otherwise be included in Annex XIV, it should be remembered that recital 77 of Regulation No 1907/2006 states that, in view of workability and practicality considerations, only a limited number of substances should be subjected to the authorisation procedure at the same time (judgment of 7 March 2013, Rütgers Germany and Others v ECHA, T‐96/10, EU:T:2013:109, paragraph 93). Furthermore, the identification of the substances referred to in Article 57 of Regulation No 1907/2006 and the establishment of the candidate list of substances are only a precursor to the decision to include a substance in Annex XIV. Such decisions can be taken only gradually, depending on the administrative capacities of the ECHA and the Commission.

| 77 | Fifth, the applicant’s argument that it follows from Article 69(2) of Regulation No 1907/2006 that a substance included in Annex XIV to that regulation can be reviewed by the ECHA only after the date referred to in Article 58(1)(c)(i) of that regulation — meaning that the ECHA would not have complied with that date in that case — must also be rejected as ineffective. |
| --- | --- |

77

Fifth, the applicant’s argument that it follows from Article 69(2) of Regulation No 1907/2006 that a substance included in Annex XIV to that regulation can be reviewed by the ECHA only after the date referred to in Article 58(1)(c)(i) of that regulation — meaning that the ECHA would not have complied with that date in that case — must also be rejected as ineffective.

| 78 | The question of whether to conduct a review pursuant to Article 69(2) of Regulation No 1907/2006 after the date referred to in Article 58(1)(c)(i) of that regulation can arise only in respect of the properties of a substance which are already listed in Annex XIV. However, that question is not relevant in the case of the addition of a new ground in Article 57 of that regulation to the candidate list of substances. |
| --- | --- |

78

The question of whether to conduct a review pursuant to Article 69(2) of Regulation No 1907/2006 after the date referred to in Article 58(1)(c)(i) of that regulation can arise only in respect of the properties of a substance which are already listed in Annex XIV. However, that question is not relevant in the case of the addition of a new ground in Article 57 of that regulation to the candidate list of substances.

| 79 | Sixth, the Court cannot accept the applicant’s argument that the Kingdom of Denmark itself stated in its observations on the comments on the dossier submitted in accordance with Annex XV, to the effect that ‘the procedure for supplementing the candidate list of substances and Annex XIV [was] not provided for by Regulation No 1907/2006’, but that ‘[it was] based on the principle that the Commission [supplemented] the Annex in an appropriate manner’. Such observations on the part of the participants in the proceedings before the Member State Committee are devoid of any binding legal effect and therefore cannot legitimately affect the interpretation of Article 59(8) of Regulation No 1907/2006. |
| --- | --- |

79

Sixth, the Court cannot accept the applicant’s argument that the Kingdom of Denmark itself stated in its observations on the comments on the dossier submitted in accordance with Annex XV, to the effect that ‘the procedure for supplementing the candidate list of substances and Annex XIV [was] not provided for by Regulation No 1907/2006’, but that ‘[it was] based on the principle that the Commission [supplemented] the Annex in an appropriate manner’. Such observations on the part of the participants in the proceedings before the Member State Committee are devoid of any binding legal effect and therefore cannot legitimately affect the interpretation of Article 59(8) of Regulation No 1907/2006.

| 80 | Seventh, the same holds true for the applicant’s argument that several participants in the Member State Committee also put forward objections to the proposal to ‘supplement’ the existing entry concerning DEHP on the candidate list of substances. |
| --- | --- |

80

Seventh, the same holds true for the applicant’s argument that several participants in the Member State Committee also put forward objections to the proposal to ‘supplement’ the existing entry concerning DEHP on the candidate list of substances.

| 81 | Having regard to all the foregoing, it must be concluded that the ECHA was empowered to adopt the contested decision. |
| --- | --- |

81

Having regard to all the foregoing, it must be concluded that the ECHA was empowered to adopt the contested decision.

| 82 | Accordingly, the first part of the first plea must be rejected. |
| --- | --- |

82

Accordingly, the first part of the first plea must be rejected.

– The second part of the first plea: infringement of the procedure provided for in Article 59 of Regulation No 1907/2006

| 83 | The applicant submits that the specific parameters defined for a dossier submitted in accordance with Annex XV are absolutely decisive for the comments procedure provided for in Article 59(3) to (5) of Regulation No 1907/2006 and for the evaluation and decision of the Member State Committee. In the present case, due to the Kingdom of Denmark’s conduct, the Member State Committee, which was unable to reach agreement on the fact that the four chemicals referred to in the Kingdom of Denmark’s initial proposal fulfilled the conditions for inclusion in the candidate list of substances under Article 57(f) of Regulation No 1907/2006, in terms of both their impact on human health and their impact on the environment, nevertheless managed to adopt a common position on that part of the new proposal that dealt with DEHP as an endocrine disruptor that may have serious effects on the environment. In the applicant’s submission, without the Kingdom of Denmark’s ‘intentional and unlawful’ substitution of the original proposal with another proposal while the Member State Committee’s discussions were already under way at the meeting held from 8 to 11 December 2014, that committee would not have decided unanimously to identify DEHP as a substance of very serious concern due to its alleged effects on the environment and the contested decision therefore would have had a substantially different content or would not have been adopted at all. Moreover, the ‘new proposal’ was not presented in accordance with the procedure for submitting comments provided for in Article 59(3) to (5) of Regulation No 1907/2006. This ‘new proposal’ was not even placed on the agenda of the meeting of the Member State Committee. Furthermore, there was no mention of ‘certain new facts’ relating to the assessment of the four chemicals concerned by the ECHA’s Risk Assessment Committee until after the vote on the ‘new proposal’. The Member State Committee therefore was not able to organise an in-depth scientific debate on these new developments. |
| --- | --- |

83

The applicant submits that the specific parameters defined for a dossier submitted in accordance with Annex XV are absolutely decisive for the comments procedure provided for in Article 59(3) to (5) of Regulation No 1907/2006 and for the evaluation and decision of the Member State Committee. In the present case, due to the Kingdom of Denmark’s conduct, the Member State Committee, which was unable to reach agreement on the fact that the four chemicals referred to in the Kingdom of Denmark’s initial proposal fulfilled the conditions for inclusion in the candidate list of substances under Article 57(f) of Regulation No 1907/2006, in terms of both their impact on human health and their impact on the environment, nevertheless managed to adopt a common position on that part of the new proposal that dealt with DEHP as an endocrine disruptor that may have serious effects on the environment. In the applicant’s submission, without the Kingdom of Denmark’s ‘intentional and unlawful’ substitution of the original proposal with another proposal while the Member State Committee’s discussions were already under way at the meeting held from 8 to 11 December 2014, that committee would not have decided unanimously to identify DEHP as a substance of very serious concern due to its alleged effects on the environment and the contested decision therefore would have had a substantially different content or would not have been adopted at all. Moreover, the ‘new proposal’ was not presented in accordance with the procedure for submitting comments provided for in Article 59(3) to (5) of Regulation No 1907/2006. This ‘new proposal’ was not even placed on the agenda of the meeting of the Member State Committee. Furthermore, there was no mention of ‘certain new facts’ relating to the assessment of the four chemicals concerned by the ECHA’s Risk Assessment Committee until after the vote on the ‘new proposal’. The Member State Committee therefore was not able to organise an in-depth scientific debate on these new developments.

| 84 | The ECHA, supported by the Kingdom of Denmark and the Kingdom of Norway, disputes those arguments. |
| --- | --- |

84

The ECHA, supported by the Kingdom of Denmark and the Kingdom of Norway, disputes those arguments.

| 85 | It must be stated as a preliminary point that it follows from the wording of Article 59(2) to (5) of Regulation No 1907/2006 that the purpose of the identification procedure for the substances referred to in Article 57 of that regulation is to ensure that Member States and interested parties to that procedure can be heard before the drafting of a decision to include a substance in the candidate list of substances. |
| --- | --- |

85

It must be stated as a preliminary point that it follows from the wording of Article 59(2) to (5) of Regulation No 1907/2006 that the purpose of the identification procedure for the substances referred to in Article 57 of that regulation is to ensure that Member States and interested parties to that procedure can be heard before the drafting of a decision to include a substance in the candidate list of substances.

| 86 | Article 59 of Regulation No 1907/2006 does not, however, specify the manner in which several proposals for identifying a substance as a substance of very high concern within the meaning of Article 57 of that Regulation should be presented, be they different substances or different properties of the same substance referred to in that article. In particular, it is not clear whether each proposal relating to one of the grounds laid down in Article 57 of that regulation must be submitted separately or whether several such proposals may be submitted in a single document. In any event, there is nothing in those two provisions establishing that there is an obligation to group proposals into one and the same document when those proposals are submitted from the same source at the same time. Nor is there any provision prohibiting the withdrawal of one or more proposals in the course of the procedure, even where those proposals were originally submitted as part of a single document. |
| --- | --- |

86

Article 59 of Regulation No 1907/2006 does not, however, specify the manner in which several proposals for identifying a substance as a substance of very high concern within the meaning of Article 57 of that Regulation should be presented, be they different substances or different properties of the same substance referred to in that article. In particular, it is not clear whether each proposal relating to one of the grounds laid down in Article 57 of that regulation must be submitted separately or whether several such proposals may be submitted in a single document. In any event, there is nothing in those two provisions establishing that there is an obligation to group proposals into one and the same document when those proposals are submitted from the same source at the same time. Nor is there any provision prohibiting the withdrawal of one or more proposals in the course of the procedure, even where those proposals were originally submitted as part of a single document.

| 87 | In the present case it is common ground that a separate dossier complying with Annex XV was submitted to the ECHA for each of the substances included in the Kingdom of Denmark’s initial proposal: DEHP, DBP, BBP and DIBP. |
| --- | --- |

87

In the present case it is common ground that a separate dossier complying with Annex XV was submitted to the ECHA for each of the substances included in the Kingdom of Denmark’s initial proposal: DEHP, DBP, BBP and DIBP.

| 88 | Contrary to the applicant’s assertions, it is not clear from the documents before the Court that the Kingdom of Denmark completely withdrew its original proposal and that it was necessary to introduce a new proposal. On the contrary, the Kingdom of Denmark merely divided its original proposal into eight separate parts. This dividing-up was followed by a partial withdrawal of the proposals relating to DBP, BBP and DIBP in so far as these proposals concerned the serious effects on the environment, whilst the proposal relating to DEHP was maintained. |
| --- | --- |

88

Contrary to the applicant’s assertions, it is not clear from the documents before the Court that the Kingdom of Denmark completely withdrew its original proposal and that it was necessary to introduce a new proposal. On the contrary, the Kingdom of Denmark merely divided its original proposal into eight separate parts. This dividing-up was followed by a partial withdrawal of the proposals relating to DBP, BBP and DIBP in so far as these proposals concerned the serious effects on the environment, whilst the proposal relating to DEHP was maintained.

| 89 | As regards the part of the proposal relating to DEHP, it is clear, first, that the applicant has not demonstrated how the substantive content of the Kingdom of Denmark’s initial proposal differed from that of the proposal which was voted on at the meeting of the Member State Committee held from 8 to 11 December 2014. |
| --- | --- |

89

As regards the part of the proposal relating to DEHP, it is clear, first, that the applicant has not demonstrated how the substantive content of the Kingdom of Denmark’s initial proposal differed from that of the proposal which was voted on at the meeting of the Member State Committee held from 8 to 11 December 2014.

| 90 | Second, the applicant does not call into question the fact that the DEHP dossier was indeed the subject of the comments procedure provided for in Article 59(4) and (5) of Regulation No 1907/2006. It is therefore not disputed that all interested parties, including the applicant, did in fact have an opportunity to submit their comments on DEHP before the Kingdom of Denmark’s initial proposal was divided up. |
| --- | --- |

90

Second, the applicant does not call into question the fact that the DEHP dossier was indeed the subject of the comments procedure provided for in Article 59(4) and (5) of Regulation No 1907/2006. It is therefore not disputed that all interested parties, including the applicant, did in fact have an opportunity to submit their comments on DEHP before the Kingdom of Denmark’s initial proposal was divided up.

| 91 | It follows that, in the vote on DEHP that took place within the debates of the Member State Committee, which occurred after the Kingdom of Denmark separated its observations on that substance, as contained in the dossier submitted in accordance with Article 59(3) and (5) of Regulation No 1907/2006, from its observations on the three other proposals, namely those on DBP, BBP and DIBP, there has been no infringement of Article 59(8) and (9) of Regulation No 1907/2006 or even of the applicant’s right to be heard. |
| --- | --- |

91

It follows that, in the vote on DEHP that took place within the debates of the Member State Committee, which occurred after the Kingdom of Denmark separated its observations on that substance, as contained in the dossier submitted in accordance with Article 59(3) and (5) of Regulation No 1907/2006, from its observations on the three other proposals, namely those on DBP, BBP and DIBP, there has been no infringement of Article 59(8) and (9) of Regulation No 1907/2006 or even of the applicant’s right to be heard.

| 92 | The applicant’s other arguments cast no doubt on this conclusion. |
| --- | --- |

92

The applicant’s other arguments cast no doubt on this conclusion.

| 93 | First, contrary to the applicant’s assertions, the unanimous agreement of the Member State Committee on DEHP is not vitiated by irregularity because it relied solely on ‘serious effects on the environment’ whereas the original identification proposal and the dossier submitted in accordance with Annex XV are grounded on ‘serious effects on human health and the environment’. |
| --- | --- |

93

First, contrary to the applicant’s assertions, the unanimous agreement of the Member State Committee on DEHP is not vitiated by irregularity because it relied solely on ‘serious effects on the environment’ whereas the original identification proposal and the dossier submitted in accordance with Annex XV are grounded on ‘serious effects on human health and the environment’.

| 94 | Under Article 57(f) of Regulation No 1907/2006, the properties concerned are those that may have serious effects on human health or the environment. As those criteria are alternative, only one of them need be fulfilled in order for Article 57(f) of that regulation to apply. The Kingdom of Denmark’s initial proposal also included the criterion relating to environmental effects, a criterion which led to the unanimous vote of the Member State Committee. |
| --- | --- |

94

Under Article 57(f) of Regulation No 1907/2006, the properties concerned are those that may have serious effects on human health or the environment. As those criteria are alternative, only one of them need be fulfilled in order for Article 57(f) of that regulation to apply. The Kingdom of Denmark’s initial proposal also included the criterion relating to environmental effects, a criterion which led to the unanimous vote of the Member State Committee.

| 95 | Second, as regards the applicant’s argument that the DEHP-related part of the proposal was not included on the agenda of the meeting of the Member State Committee, suffice it to note that point 9(b) of the agenda stated specifically that agreement was to be sought on the proposal to identify DEHP as an endocrine disruptor of very high concern. Consequently, since the Kingdom of Denmark’s original proposal on DEHP has not been replaced by a different type of proposal, this argument put forward by the applicant cannot be upheld. |
| --- | --- |

95

Second, as regards the applicant’s argument that the DEHP-related part of the proposal was not included on the agenda of the meeting of the Member State Committee, suffice it to note that point 9(b) of the agenda stated specifically that agreement was to be sought on the proposal to identify DEHP as an endocrine disruptor of very high concern. Consequently, since the Kingdom of Denmark’s original proposal on DEHP has not been replaced by a different type of proposal, this argument put forward by the applicant cannot be upheld.

| 96 | Third, regarding the applicant’s claim that, following the vote on the Kingdom of Denmark’s proposal, ‘certain new facts’ came to light, being more specifically facts about which the Member State Committee had been unable to hold an in-depth discussion, the applicant does not specify either what those new facts were or how they might have had any relevance for the contested decision. |
| --- | --- |

96

Third, regarding the applicant’s claim that, following the vote on the Kingdom of Denmark’s proposal, ‘certain new facts’ came to light, being more specifically facts about which the Member State Committee had been unable to hold an in-depth discussion, the applicant does not specify either what those new facts were or how they might have had any relevance for the contested decision.

| 97 | Nor does the applicant dispute the ECHA’s argument that those ‘new facts’ concerned serious effects on human health and not the serious effects on the environment referred to in the contested decision. It follows that this argument cannot be accepted. |
| --- | --- |

97

Nor does the applicant dispute the ECHA’s argument that those ‘new facts’ concerned serious effects on human health and not the serious effects on the environment referred to in the contested decision. It follows that this argument cannot be accepted.

| 98 | In the light of the foregoing, the second part of the first plea must be rejected. |
| --- | --- |

98

In the light of the foregoing, the second part of the first plea must be rejected.

– The third part of the first plea: circumvention of the procedure laid down by the Council and the Parliament

| 99 | By a series of arguments put forward in support of both the third part of the first plea and the second plea, the applicant submits that the contested decision is vitiated by a misuse of powers. The Council and the Parliament instructed the Commission to lay down criteria of general application in all Union legal texts for the identification of endocrine-disrupting substances so that they could be applied horizontally in all areas of Union legislation concerning those substances, including Article 57(f) of Regulation No 1907/2006. The Commission’s obligation derives, first, from Article 5(3), read in conjunction with Article 83 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1), as amended, and point 3.6.5 of Annex II to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1), as amended. Such an obligation of the Commission results moreover from Decision No 1386/2013/EU of the European Parliament and of the Council of 20 November 2013 on a General Union Environment Action Programme to 2020 ‘Living well, within the limits of our planet’ (OJ 2013 L 354, p. 171). Lastly, the need to adopt harmonised criteria is apparent from the Commission’s roadmap of June 2014 on the definition of criteria for the identification of endocrine disruptors in the field of plant protection products and biocides. Despite that obligation, the Commission has not yet adopted harmonised criteria. Furthermore, Regulation No 1907/2006 lays down no transitional criteria for the identification of endocrine-disrupting substances and the transitional criteria referred to in the second and third subparagraphs of Article 5(3) of Regulation No 528/2012 do not apply to cases governed by Regulation No 1907/2006. |
| --- | --- |

99

By a series of arguments put forward in support of both the third part of the first plea and the second plea, the applicant submits that the contested decision is vitiated by a misuse of powers. The Council and the Parliament instructed the Commission to lay down criteria of general application in all Union legal texts for the identification of endocrine-disrupting substances so that they could be applied horizontally in all areas of Union legislation concerning those substances, including Article 57(f) of Regulation No 1907/2006. The Commission’s obligation derives, first, from Article 5(3), read in conjunction with Article 83 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1), as amended, and point 3.6.5 of Annex II to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1), as amended. Such an obligation of the Commission results moreover from Decision No 1386/2013/EU of the European Parliament and of the Council of 20 November 2013 on a General Union Environment Action Programme to 2020 ‘Living well, within the limits of our planet’ (OJ 2013 L 354, p. 171). Lastly, the need to adopt harmonised criteria is apparent from the Commission’s roadmap of June 2014 on the definition of criteria for the identification of endocrine disruptors in the field of plant protection products and biocides. Despite that obligation, the Commission has not yet adopted harmonised criteria. Furthermore, Regulation No 1907/2006 lays down no transitional criteria for the identification of endocrine-disrupting substances and the transitional criteria referred to in the second and third subparagraphs of Article 5(3) of Regulation No 528/2012 do not apply to cases governed by Regulation No 1907/2006.

| 100 | In identifying DEHP as an endocrine-disrupting substance within the meaning of Article 57(f) of Regulation No 1907/2006 on the basis of its own criteria, which in turn are based on unconvincing and not particularly objective scientific findings, the ECHA clearly circumvented the legally binding procedure provided for by the Council and the Parliament in order to establish the harmonised criteria referred to above. |
| --- | --- |

100

In identifying DEHP as an endocrine-disrupting substance within the meaning of Article 57(f) of Regulation No 1907/2006 on the basis of its own criteria, which in turn are based on unconvincing and not particularly objective scientific findings, the ECHA clearly circumvented the legally binding procedure provided for by the Council and the Parliament in order to establish the harmonised criteria referred to above.

| 101 | The need to apply such harmonised criteria has been recognised, at least implicitly, by certain Member States and a number of other bodies who provided their opinions during the comments submission procedure and by the Commission itself. In fact, the Commission waited until such criteria had been drawn up before formulating its proposal on the identification of DEHP, DBP, BBP and DIBP as substances that may have serious effects on human health within the meaning of Article 57(f) of Regulation No 1907/2006. In the present case, the Commission should be asked to explain why it failed to prepare a proposal on the identification of DEHP, DBP, BBP and DIBP as endocrine-disrupting substances that may have serious effects on human health within the meaning of Article 59(9) [sic] of Regulation No 1907/2006 within three months of receipt of the opinion of the Member State Committee. |
| --- | --- |

101

The need to apply such harmonised criteria has been recognised, at least implicitly, by certain Member States and a number of other bodies who provided their opinions during the comments submission procedure and by the Commission itself. In fact, the Commission waited until such criteria had been drawn up before formulating its proposal on the identification of DEHP, DBP, BBP and DIBP as substances that may have serious effects on human health within the meaning of Article 57(f) of Regulation No 1907/2006. In the present case, the Commission should be asked to explain why it failed to prepare a proposal on the identification of DEHP, DBP, BBP and DIBP as endocrine-disrupting substances that may have serious effects on human health within the meaning of Article 59(9) [sic] of Regulation No 1907/2006 within three months of receipt of the opinion of the Member State Committee.

| 102 | The applicant further argues that the Kingdom of Denmark has attempted previously to circumvent the procedures and provisions of Regulation No 1907/2006 by unilaterally prohibiting the use of those substances on its territory by means of national legislation. Following a warning sent by the Commission on 4 June 2012, it withdrew that prohibition. |
| --- | --- |

102

The applicant further argues that the Kingdom of Denmark has attempted previously to circumvent the procedures and provisions of Regulation No 1907/2006 by unilaterally prohibiting the use of those substances on its territory by means of national legislation. Following a warning sent by the Commission on 4 June 2012, it withdrew that prohibition.

| 103 | Lastly, in the applicant’s submission, the ECHA’s approach is contrary to Article 95 of Regulation No 1907/2006, which sets out the procedure for resolving conflicts between the opinions of the ECHA and those of other bodies established under Union law. |
| --- | --- |

103

Lastly, in the applicant’s submission, the ECHA’s approach is contrary to Article 95 of Regulation No 1907/2006, which sets out the procedure for resolving conflicts between the opinions of the ECHA and those of other bodies established under Union law.

| 104 | The ECHA, supported by the Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway, disputes that argument of the applicant. |
| --- | --- |

104

The ECHA, supported by the Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway, disputes that argument of the applicant.

| 105 | In that regard, and as a preliminary point, as regards, specifically, the conditions which lead to the conclusion that a decision is vitiated by misuse of powers, it must be borne in mind that, according to settled case-law, a decision may amount to a misuse of powers only if it appears, on the basis of objective, relevant and consistent factors, to have been taken with the exclusive purpose, or at any rate the main purpose, for purposes others than those for which the power in question was conferred or for the purpose of evading a procedure specifically prescribed in the FEU Treaty to deal with the circumstances of the case (judgments of 13 November 1990, Fedesa and Others, C‐331/88, EU:C:1990:391, paragraph 24, and of 16 April 2013, Spain and Italy v Council, C‐274/11 and C‐295/11, EU:C:2013:240, paragraph 33 and the case-law cited). |
| --- | --- |

105

In that regard, and as a preliminary point, as regards, specifically, the conditions which lead to the conclusion that a decision is vitiated by misuse of powers, it must be borne in mind that, according to settled case-law, a decision may amount to a misuse of powers only if it appears, on the basis of objective, relevant and consistent factors, to have been taken with the exclusive purpose, or at any rate the main purpose, for purposes others than those for which the power in question was conferred or for the purpose of evading a procedure specifically prescribed in the FEU Treaty to deal with the circumstances of the case (judgments of 13 November 1990, Fedesa and Others, C‐331/88, EU:C:1990:391, paragraph 24, and of 16 April 2013, Spain and Italy v Council, C‐274/11 and C‐295/11, EU:C:2013:240, paragraph 33 and the case-law cited).

| 106 | There is no basis for concluding that the ECHA engaged in a misuse of powers in the present case. |
| --- | --- |

106

There is no basis for concluding that the ECHA engaged in a misuse of powers in the present case.

| 107 | First, the applicant has not provided any objective evidence from which it could be inferred that the contested decision was taken solely or at least decisively for purposes other than those for which the power in question was conferred on the ECHA. |
| --- | --- |

107

First, the applicant has not provided any objective evidence from which it could be inferred that the contested decision was taken solely or at least decisively for purposes other than those for which the power in question was conferred on the ECHA.

| 108 | Nor can it be held that the ECHA acted in order to circumvent a procedure specifically provided for in the FEU Treaty for dealing with the circumstances of the case. |
| --- | --- |

108

Nor can it be held that the ECHA acted in order to circumvent a procedure specifically provided for in the FEU Treaty for dealing with the circumstances of the case.

| 109 | In that regard, in the first place, with regards to Regulation No 528/2012, it should be noted first that, as is apparent from Article 2(3)(j) thereof, that regulation applies without prejudice to Regulation No 1907/2006. It follows that Regulation No 1907/2006, in particular Article 57(f) thereof, does not preclude the application of Regulation No 528/2012. The reverse is also true. |
| --- | --- |

109

In that regard, in the first place, with regards to Regulation No 528/2012, it should be noted first that, as is apparent from Article 2(3)(j) thereof, that regulation applies without prejudice to Regulation No 1907/2006. It follows that Regulation No 1907/2006, in particular Article 57(f) thereof, does not preclude the application of Regulation No 528/2012. The reverse is also true.

| 110 | Second, Regulation No 528/2012 does not expressly provide that the identification of a substance with intrinsic properties, such as those referred to in Article 57(f) of Regulation No 1907/2006, is not possible before the Commission has adopted the harmonised criteria for the determination of substances with endocrine-disrupting properties. |
| --- | --- |

110

Second, Regulation No 528/2012 does not expressly provide that the identification of a substance with intrinsic properties, such as those referred to in Article 57(f) of Regulation No 1907/2006, is not possible before the Commission has adopted the harmonised criteria for the determination of substances with endocrine-disrupting properties.

| 111 | Third, the applicant’s argument is clearly based on a combined reading of Article 5(1)(d) and Article 5(3) of Regulation No 528/2012, to the effect that the Commission’s adoption of the harmonised scientific criteria for the determination of endocrine-disrupting properties would replace the identification of such properties in certain substances under the procedure provided for in Article 59 of Regulation No 1907/2006. |
| --- | --- |

111

Third, the applicant’s argument is clearly based on a combined reading of Article 5(1)(d) and Article 5(3) of Regulation No 528/2012, to the effect that the Commission’s adoption of the harmonised scientific criteria for the determination of endocrine-disrupting properties would replace the identification of such properties in certain substances under the procedure provided for in Article 59 of Regulation No 1907/2006.

| 112 | It is apparent from the wording of Article 5(1)(d) of Regulation No 528/2012 that the substances covered by that provision can be identified as endocrine disruptors through two alternative and independent mechanisms: on the one hand, on the basis of the harmonised scientific criteria referred to in the first subparagraph of Article 5(3) of Regulation No 528/2012 or, pending the adoption of those criteria, on the basis of the second and third subparagraphs of Article 5(3) of that regulation; or, on the other, as substances with intrinsic properties as referred to in Article 57(f) of Regulation No 1907/2006, pursuant to Article 59(1) thereof. |
| --- | --- |

112

It is apparent from the wording of Article 5(1)(d) of Regulation No 528/2012 that the substances covered by that provision can be identified as endocrine disruptors through two alternative and independent mechanisms: on the one hand, on the basis of the harmonised scientific criteria referred to in the first subparagraph of Article 5(3) of Regulation No 528/2012 or, pending the adoption of those criteria, on the basis of the second and third subparagraphs of Article 5(3) of that regulation; or, on the other, as substances with intrinsic properties as referred to in Article 57(f) of Regulation No 1907/2006, pursuant to Article 59(1) thereof.

| 113 | Consequently, the Commission’s obligation to adopt harmonised scientific criteria concerns only the first scenario mentioned in Article 5(1)(d) of Regulation No 528/2012, without that obligation having any bearing on the application of the second scenario covered by that provision, being the application of Article 57(f) and Article 59(1) of Regulation No 1907/2006. |
| --- | --- |

113

Consequently, the Commission’s obligation to adopt harmonised scientific criteria concerns only the first scenario mentioned in Article 5(1)(d) of Regulation No 528/2012, without that obligation having any bearing on the application of the second scenario covered by that provision, being the application of Article 57(f) and Article 59(1) of Regulation No 1907/2006.

| 114 | In other words, the Commission’s obligation under the first subparagraph of Article 5(3) of Regulation No 528/2012 to adopt harmonised scientific criteria has no bearing on the identification on a case-by-case basis of the substances referred to in Article 57(f) of Regulation No 1907/2006. |
| --- | --- |

114

In other words, the Commission’s obligation under the first subparagraph of Article 5(3) of Regulation No 528/2012 to adopt harmonised scientific criteria has no bearing on the identification on a case-by-case basis of the substances referred to in Article 57(f) of Regulation No 1907/2006.

| 115 | Consequently, the applicant’s argument that Regulation No 1907/2006 lays down no transitional criterion for the identification of endocrine-disrupting substances and the argument that the transitional criteria referred to in the second and third subparagraphs of Article 5(3) of Regulation No 528/2012 do not apply to Regulation No 1907/2006 are ineffective. The identification of the substances referred to in Article 57(f) of Regulation No 1907/2006 may be carried out on a case-by-case basis independently of the criteria to be drawn up on the basis of Regulation No 528/2012, since any transitional criteria deriving from the latter regulation have no bearing on the application of Article 57(f) of Regulation No 1907/2006. |
| --- | --- |

115

Consequently, the applicant’s argument that Regulation No 1907/2006 lays down no transitional criterion for the identification of endocrine-disrupting substances and the argument that the transitional criteria referred to in the second and third subparagraphs of Article 5(3) of Regulation No 528/2012 do not apply to Regulation No 1907/2006 are ineffective. The identification of the substances referred to in Article 57(f) of Regulation No 1907/2006 may be carried out on a case-by-case basis independently of the criteria to be drawn up on the basis of Regulation No 528/2012, since any transitional criteria deriving from the latter regulation have no bearing on the application of Article 57(f) of Regulation No 1907/2006.

| 116 | In the second place, as regards the applicant’s argument relating to point 3.6.5 of Annex II to Regulation No 1107/2009, it should be noted at the outset that it does not expressly preclude the application of Regulation No 1907/2006, in particular Articles 57 and 59 thereof. |
| --- | --- |

116

In the second place, as regards the applicant’s argument relating to point 3.6.5 of Annex II to Regulation No 1107/2009, it should be noted at the outset that it does not expressly preclude the application of Regulation No 1907/2006, in particular Articles 57 and 59 thereof.

| 117 | Moreover, under point 3.6.5 it is permissible to ascertain whether a substance has endocrine-disrupting and potentially adverse effects, not only ‘on the basis of the assessment of [EU] or internationally agreed test guidelines’, but also on the basis of ‘other available data and information, including a review of the scientific literature reviewed by the [European Food Safety Authority]’. |
| --- | --- |

117

Moreover, under point 3.6.5 it is permissible to ascertain whether a substance has endocrine-disrupting and potentially adverse effects, not only ‘on the basis of the assessment of [EU] or internationally agreed test guidelines’, but also on the basis of ‘other available data and information, including a review of the scientific literature reviewed by the [European Food Safety Authority]’.

| 118 | The word ‘including’ in point 3.6.5 indicates that the example of the European Food Safety Authority (EFSA) review is illustrative only, and that other data and information may be used as a basis for considering whether a substance has adverse effects on the endocrine system. An ECHA opinion based on a case-by-case examination constitutes such a source of information. |
| --- | --- |

118

The word ‘including’ in point 3.6.5 indicates that the example of the European Food Safety Authority (EFSA) review is illustrative only, and that other data and information may be used as a basis for considering whether a substance has adverse effects on the endocrine system. An ECHA opinion based on a case-by-case examination constitutes such a source of information.

| 119 | Accordingly, point 3.6.5 of Annex II to Regulation No 1107/2009 does not preclude the ECHA from undertaking a case-by-case analysis for the identification of a substance as an endocrine disruptor within the meaning of Article 57(f) of Regulation No 1907/2006. |
| --- | --- |

119

Accordingly, point 3.6.5 of Annex II to Regulation No 1107/2009 does not preclude the ECHA from undertaking a case-by-case analysis for the identification of a substance as an endocrine disruptor within the meaning of Article 57(f) of Regulation No 1907/2006.

| 120 | In the third place, as regards Decision No 1386/2013, it must be held that no provision in that decision permits the inference that it is not permissible for the ECHA to draw up its own criteria for the identification of a substance as an endocrine-disrupting substance within the meaning of Article 57(f) of Regulation No 1907/2006. |
| --- | --- |

120

In the third place, as regards Decision No 1386/2013, it must be held that no provision in that decision permits the inference that it is not permissible for the ECHA to draw up its own criteria for the identification of a substance as an endocrine-disrupting substance within the meaning of Article 57(f) of Regulation No 1907/2006.

| 121 | Admittedly, in the second sentence of the third subparagraph of point 50 of the Annex to that Decision, in order to examine the combined effects of chemicals and the safety problems linked to endocrine disruptors, the Union ‘will develop harmonised hazard-based criteria for the identification of endocrine disruptors’. However, there is nothing in that decision to suggest that only harmonised scientific criteria would make it possible to identify endocrine disruptors for the purposes of Article 57(f) of Regulation No 1907/2006. In other words, Decision No 1386/2013 does not affect in any way the application of Article 57(f) of Regulation No 1907/2006, the purpose of which is to enable the ECHA to identify those substances on a case-by-case basis. |
| --- | --- |

121

Admittedly, in the second sentence of the third subparagraph of point 50 of the Annex to that Decision, in order to examine the combined effects of chemicals and the safety problems linked to endocrine disruptors, the Union ‘will develop harmonised hazard-based criteria for the identification of endocrine disruptors’. However, there is nothing in that decision to suggest that only harmonised scientific criteria would make it possible to identify endocrine disruptors for the purposes of Article 57(f) of Regulation No 1907/2006. In other words, Decision No 1386/2013 does not affect in any way the application of Article 57(f) of Regulation No 1907/2006, the purpose of which is to enable the ECHA to identify those substances on a case-by-case basis.

| 122 | In the fourth place, as regards the Commission’s roadmap of June 2014, it should first be noted that this document has no binding legal force. As is clear from the disclaimer which appears on it ‘[t]his indicative roadmap is provided for information purposes only and is subject to change’. It ‘does not prejudge the final decision of the Commission on whether this initiative will be pursued or on its final content and structure’. |
| --- | --- |

122

In the fourth place, as regards the Commission’s roadmap of June 2014, it should first be noted that this document has no binding legal force. As is clear from the disclaimer which appears on it ‘[t]his indicative roadmap is provided for information purposes only and is subject to change’. It ‘does not prejudge the final decision of the Commission on whether this initiative will be pursued or on its final content and structure’.

| 123 | Nor is there anything in that document to support the conclusion that the identification of endocrine disruptors under Article 57(f) and Article 59 of Regulation No 1907/2006 should be suspended until the Commission has adopted harmonised scientific criteria. |
| --- | --- |

123

Nor is there anything in that document to support the conclusion that the identification of endocrine disruptors under Article 57(f) and Article 59 of Regulation No 1907/2006 should be suspended until the Commission has adopted harmonised scientific criteria.

| 124 | In the fifth place, as regards the argument that, in the opinion of certain Member States and other entities involved in the comments submission procedure, the existence of harmonised criteria for the identification of substances under Article 57(f) of Regulation No 1907/2006 is necessary, suffice it to note that such opinions have no binding legal force and therefore cannot have a decisive influence on the interpretation of that regulation. |
| --- | --- |

124

In the fifth place, as regards the argument that, in the opinion of certain Member States and other entities involved in the comments submission procedure, the existence of harmonised criteria for the identification of substances under Article 57(f) of Regulation No 1907/2006 is necessary, suffice it to note that such opinions have no binding legal force and therefore cannot have a decisive influence on the interpretation of that regulation.

| 125 | In the sixth place, as regards the applicant’s argument that even the Commission waited for the adoption of the harmonised scientific criteria before proceeding with its proposal for the identification of DEHP, DBP, BBP and DIBP as substances that may have serious effects on human health within the meaning of Article 57(f) of Regulation No 1907/2006, it must be held that the Commission’s alleged wait cannot serve as a basis for the interpretation of the provisions of Regulation No 1907/2006 or the other provisions applicable in the present case. Moreover, as observed by the Kingdom of Norway, the Commission has in the meantime submitted the proposal for the identification of DEHP, DBP, BBP and DIBP as substances that may have serious effects on human health without harmonised scientific criteria being adopted — a point not disputed by the applicant. |
| --- | --- |

125

In the sixth place, as regards the applicant’s argument that even the Commission waited for the adoption of the harmonised scientific criteria before proceeding with its proposal for the identification of DEHP, DBP, BBP and DIBP as substances that may have serious effects on human health within the meaning of Article 57(f) of Regulation No 1907/2006, it must be held that the Commission’s alleged wait cannot serve as a basis for the interpretation of the provisions of Regulation No 1907/2006 or the other provisions applicable in the present case. Moreover, as observed by the Kingdom of Norway, the Commission has in the meantime submitted the proposal for the identification of DEHP, DBP, BBP and DIBP as substances that may have serious effects on human health without harmonised scientific criteria being adopted — a point not disputed by the applicant.

| 126 | In the light of the foregoing, the applicant’s request that the Commission be asked to explain why it failed to prepare a proposal on the identification of DEHP, DBP, BBP and DIBP as endocrine-disrupting substances that may have serious effects on human health within the meaning of Article 59(9) of Regulation No 1907/2006 within three months of receipt of the opinion of the Member State Committee cannot be upheld. |
| --- | --- |

126

In the light of the foregoing, the applicant’s request that the Commission be asked to explain why it failed to prepare a proposal on the identification of DEHP, DBP, BBP and DIBP as endocrine-disrupting substances that may have serious effects on human health within the meaning of Article 59(9) of Regulation No 1907/2006 within three months of receipt of the opinion of the Member State Committee cannot be upheld.

| 127 | In the seventh place, even if it were established that the Kingdom of Denmark has in the past attempted to employ national measures to prevent the use of DEHP in its territory, that is irrelevant to the question whether the ECHA could identify DEHP as a substance within the meaning of Article 57(f) of Regulation No 1907/2006 on the basis of its own criteria or whether it should have waited for the Commission to adopt harmonised criteria. |
| --- | --- |

127

In the seventh place, even if it were established that the Kingdom of Denmark has in the past attempted to employ national measures to prevent the use of DEHP in its territory, that is irrelevant to the question whether the ECHA could identify DEHP as a substance within the meaning of Article 57(f) of Regulation No 1907/2006 on the basis of its own criteria or whether it should have waited for the Commission to adopt harmonised criteria.

| 128 | In the eighth place, as regards the applicant’s argument that the contested decision is contrary to Article 95 of Regulation No 1907/2006, suffice it to note that that provision requires the ECHA to avoid and, where necessary, to resolve conflicts and divergences between it and other Union bodies. Those other bodies include the European Medicines Agency (EMA) and the EFSA. Those agencies have powers similar to those of the ECHA and may, in principle, adopt different opinions on a substance than the ECHA. |
| --- | --- |

128

In the eighth place, as regards the applicant’s argument that the contested decision is contrary to Article 95 of Regulation No 1907/2006, suffice it to note that that provision requires the ECHA to avoid and, where necessary, to resolve conflicts and divergences between it and other Union bodies. Those other bodies include the European Medicines Agency (EMA) and the EFSA. Those agencies have powers similar to those of the ECHA and may, in principle, adopt different opinions on a substance than the ECHA.

| 129 | Under Article 95(3) of Regulation 1907/2006, where there is a fundamental conflict over scientific or technical points and the body concerned is a Union agency or a scientific committee, the ECHA and the body concerned are to work together either to resolve the conflict or to submit a joint document to the Commission clarifying the scientific and/or technical points of conflict. |
| --- | --- |

129

Under Article 95(3) of Regulation 1907/2006, where there is a fundamental conflict over scientific or technical points and the body concerned is a Union agency or a scientific committee, the ECHA and the body concerned are to work together either to resolve the conflict or to submit a joint document to the Commission clarifying the scientific and/or technical points of conflict.

| 130 | In the present case, the applicant does not specify which other Union body had a different scientific opinion than that expressed by the ECHA with regards to DEHP. |
| --- | --- |

130

In the present case, the applicant does not specify which other Union body had a different scientific opinion than that expressed by the ECHA with regards to DEHP.

| 131 | In the light of the foregoing considerations, the arguments put forward in the third part of the first plea must be rejected. |
| --- | --- |

131

In the light of the foregoing considerations, the arguments put forward in the third part of the first plea must be rejected.

| 132 | Consequently, the first plea must be rejected in its entirety. |
| --- | --- |

132

Consequently, the first plea must be rejected in its entirety.

The second plea: infringement of the principles of foreseeability and the protection of legitimate expectations

| 133 | In support of its second plea, the applicant submits that the contested decision infringes the principles of foreseeability, legal certainty and the protection of legitimate expectations in that, first, the ECHA identified DEHP as an endocrine-disrupting substance, even though Union law did not define such a substance or provide for a legally binding criterion for the identification of that substance. Second, the ECHA was not empowered to supplement an existing entry for a chemical substance in the candidate list of substances. Third, the contested decision is likely to compromise the authorisation procedure for DEHP identified as toxic for reproduction within the meaning of Article 57(c) of Regulation No 1907/2006, a procedure which has been under way since 12 August 2013, the date when the applicant’s application for authorisation was lodged. Fourth, the contested decision does not address the legal consequences that would ensue if the Commission, working within the framework of its mandate, were to draw up criteria of general application for the identification of endocrine-disturbing substances differing from those applied by the ECHA in the present case. Fifth, the applicant could not foresee the ECHA’s regulatory activity or make advance preparations for the obligations imposed by the contested decision in the context of other Union regulatory procedures, or adapted its corporate activity. The contested decision calls into question and casts uncertainty on how the substances are to be identified in terms of their endocrine effects and completely clouds the regulatory relationship between the inclusion of a substance in the candidate list of substances, the addition of a substance in Annex XIV to Regulation No 1907/2006 and the grant of the authorisation referred to in Title VII of that regulation. |
| --- | --- |

133

In support of its second plea, the applicant submits that the contested decision infringes the principles of foreseeability, legal certainty and the protection of legitimate expectations in that, first, the ECHA identified DEHP as an endocrine-disrupting substance, even though Union law did not define such a substance or provide for a legally binding criterion for the identification of that substance. Second, the ECHA was not empowered to supplement an existing entry for a chemical substance in the candidate list of substances. Third, the contested decision is likely to compromise the authorisation procedure for DEHP identified as toxic for reproduction within the meaning of Article 57(c) of Regulation No 1907/2006, a procedure which has been under way since 12 August 2013, the date when the applicant’s application for authorisation was lodged. Fourth, the contested decision does not address the legal consequences that would ensue if the Commission, working within the framework of its mandate, were to draw up criteria of general application for the identification of endocrine-disturbing substances differing from those applied by the ECHA in the present case. Fifth, the applicant could not foresee the ECHA’s regulatory activity or make advance preparations for the obligations imposed by the contested decision in the context of other Union regulatory procedures, or adapted its corporate activity. The contested decision calls into question and casts uncertainty on how the substances are to be identified in terms of their endocrine effects and completely clouds the regulatory relationship between the inclusion of a substance in the candidate list of substances, the addition of a substance in Annex XIV to Regulation No 1907/2006 and the grant of the authorisation referred to in Title VII of that regulation.

| 134 | The ECHA disputes those arguments. |
| --- | --- |

134

The ECHA disputes those arguments.

| 135 | In that respect, in the first place, it must be recalled, according to settled case-law, the principle of legal certainty — which is a general principle of EU law — requires, particularly, that rules of law be clear, precise and foreseeable in their effects, in particular where they may have adverse effects on individuals and undertakings (judgment of 16 July 2014, National Iranian Oil Company v Council, T‐578/12, not published, EU:T:2014:678, paragraph 112). As a result of that requirement for legal certainty, the binding nature of any act intended to have legal effects must be derived from a provision of EU law which prescribes the legal form to be taken by that act and which must be expressly indicated therein as its legal basis (see judgment of 19 June 2015, Italy v Commission, T‐358/11, EU:T:2015:394, paragraph 123 and the case-law cited). The principle of foreseeability is an integral part of the principle of legal certainty (see, to that effect, judgment of 16 July 2014, National Iranian Oil Company v Council, T‐578/12, not published, EU:T:2014:678, paragraphs 111 and 112). |
| --- | --- |

135

In that respect, in the first place, it must be recalled, according to settled case-law, the principle of legal certainty — which is a general principle of EU law — requires, particularly, that rules of law be clear, precise and foreseeable in their effects, in particular where they may have adverse effects on individuals and undertakings (judgment of 16 July 2014, National Iranian Oil Company v Council, T‐578/12, not published, EU:T:2014:678, paragraph 112). As a result of that requirement for legal certainty, the binding nature of any act intended to have legal effects must be derived from a provision of EU law which prescribes the legal form to be taken by that act and which must be expressly indicated therein as its legal basis (see judgment of 19 June 2015, Italy v Commission, T‐358/11, EU:T:2015:394, paragraph 123 and the case-law cited). The principle of foreseeability is an integral part of the principle of legal certainty (see, to that effect, judgment of 16 July 2014, National Iranian Oil Company v Council, T‐578/12, not published, EU:T:2014:678, paragraphs 111 and 112).

| 136 | In the present case, the contested decision lays down not only the legal basis, namely Article 59(8) of Regulation No 1907/2006, but also all the necessary parameters for identifying its legal effects, in a clear and precise manner, thus enabling the applicant to be unambiguously aware of its scope. It is clear from that decision that it is intended to supplement the existing entry relating to DEHP on the candidate list of substances pursuant to Article 57(c) of Regulation No 1907/2006 by an identification as an endocrine-disrupting substance for which there is scientific evidence of probable serious effects on the environment within the meaning of Article 57(f) of Regulation No 1907/2006. |
| --- | --- |

136

In the present case, the contested decision lays down not only the legal basis, namely Article 59(8) of Regulation No 1907/2006, but also all the necessary parameters for identifying its legal effects, in a clear and precise manner, thus enabling the applicant to be unambiguously aware of its scope. It is clear from that decision that it is intended to supplement the existing entry relating to DEHP on the candidate list of substances pursuant to Article 57(c) of Regulation No 1907/2006 by an identification as an endocrine-disrupting substance for which there is scientific evidence of probable serious effects on the environment within the meaning of Article 57(f) of Regulation No 1907/2006.

| 137 | In the second place, as regards the principle of the protection of legitimate expectations, it is clear from settled case-law that the right to rely on that principle extends to any person with regard to whom an institution of the Union has given rise to justified hopes and that a person may not plead a breach of that principle unless the administration has given him precise assurances (see, order of 4 July 2013, Menidzherski biznes reshenia, C‐572/11, not published, EU:C:2013:456, paragraph 30 and the case-law cited). |
| --- | --- |

137

In the second place, as regards the principle of the protection of legitimate expectations, it is clear from settled case-law that the right to rely on that principle extends to any person with regard to whom an institution of the Union has given rise to justified hopes and that a person may not plead a breach of that principle unless the administration has given him precise assurances (see, order of 4 July 2013, Menidzherski biznes reshenia, C‐572/11, not published, EU:C:2013:456, paragraph 30 and the case-law cited).

| 138 | In whatever form it is given, information which is precise, unconditional and consistent and comes from authorised and reliable sources constitutes assurances capable of giving rise to such expectations (see judgment of 14 March 2013, Agrargenossenschaft Neuzelle, C‐545/11, EU:C:2013:169, paragraph 25 and the case-law cited). |
| --- | --- |

138

In whatever form it is given, information which is precise, unconditional and consistent and comes from authorised and reliable sources constitutes assurances capable of giving rise to such expectations (see judgment of 14 March 2013, Agrargenossenschaft Neuzelle, C‐545/11, EU:C:2013:169, paragraph 25 and the case-law cited).

| 139 | In the present case, the applicant has neither demonstrated nor even maintained that the ECHA has provided precise assurances to it, either with regards to the inclusion of any substance in the candidate list of substances or the criteria to be applied to that effect. |
| --- | --- |

139

In the present case, the applicant has neither demonstrated nor even maintained that the ECHA has provided precise assurances to it, either with regards to the inclusion of any substance in the candidate list of substances or the criteria to be applied to that effect.

| 140 | The above conclusions are not called into question by the applicant’s other arguments. |
| --- | --- |

140

The above conclusions are not called into question by the applicant’s other arguments.

| 141 | First, as regards the argument that the ECHA identified DEHP as an endocrine-disrupting substance even though EU law did not define such a substance, or provide for a legally binding criterion for the identification of that substance, it should be borne in mind that, as is clear from paragraphs 105 to 114 above, in the absence of harmonised criteria for the identification of substances with endocrine-disrupting properties, under Article 57(f) of Regulation No 1907/2006 the ECHA was empowered to carry out an identification of DEHP on a case-by-case basis, even on the basis of its own criteria. |
| --- | --- |

141

First, as regards the argument that the ECHA identified DEHP as an endocrine-disrupting substance even though EU law did not define such a substance, or provide for a legally binding criterion for the identification of that substance, it should be borne in mind that, as is clear from paragraphs 105 to 114 above, in the absence of harmonised criteria for the identification of substances with endocrine-disrupting properties, under Article 57(f) of Regulation No 1907/2006 the ECHA was empowered to carry out an identification of DEHP on a case-by-case basis, even on the basis of its own criteria.

| 142 | Furthermore, in view of the explanations made in paragraphs 137 and 138 above, as regards the principle of the protection of legitimate expectations, the mere fact that the applicant had expected that the application of Article 57(f) of Regulation No 1907/2006 was to be suspended in respect of endocrine disruptors until the Commission had established uniform criteria for the identification of such substances cannot serve as a basis for successfully relying on that principle. By definition, the principle of the protection of legitimate expectations does not cover such an expectation. Nor has the applicant established that the ECHA acted in such a way as to lead it to believe that the ECHA would not identify DEHP as an endocrine disruptor of very high concern for the purposes of Article 57(f) of Regulation No 1907/2006. On the contrary, as observed by the Kingdom of the Netherlands, there are a number of precedents involving substances identified as being of very high concern on the basis of more than one property under Article 57 of that regulation, such as cadmium fluoride (identified on the basis of four properties as referred to in Article 57(a) to (c) and (f) of that regulation). Anthracene oil, a substance identified as a substance of very high concern meeting the criteria set out in Article 57(a), (d) and (e) of Regulation No 1907/2006, also constitutes a precedent in that regard (judgment of 7 March 2013, Rütgers Germany and Others v ECHA, T‐94/10, EU:T:2013:107, paragraphs 7 and 77). |
| --- | --- |

142

Furthermore, in view of the explanations made in paragraphs 137 and 138 above, as regards the principle of the protection of legitimate expectations, the mere fact that the applicant had expected that the application of Article 57(f) of Regulation No 1907/2006 was to be suspended in respect of endocrine disruptors until the Commission had established uniform criteria for the identification of such substances cannot serve as a basis for successfully relying on that principle. By definition, the principle of the protection of legitimate expectations does not cover such an expectation. Nor has the applicant established that the ECHA acted in such a way as to lead it to believe that the ECHA would not identify DEHP as an endocrine disruptor of very high concern for the purposes of Article 57(f) of Regulation No 1907/2006. On the contrary, as observed by the Kingdom of the Netherlands, there are a number of precedents involving substances identified as being of very high concern on the basis of more than one property under Article 57 of that regulation, such as cadmium fluoride (identified on the basis of four properties as referred to in Article 57(a) to (c) and (f) of that regulation). Anthracene oil, a substance identified as a substance of very high concern meeting the criteria set out in Article 57(a), (d) and (e) of Regulation No 1907/2006, also constitutes a precedent in that regard (judgment of 7 March 2013, Rütgers Germany and Others v ECHA, T‐94/10, EU:T:2013:107, paragraphs 7 and 77).

| 143 | Second, with regard to the applicant’s argument that the contested decision was adopted without the ECHA being empowered to supplement an existing entry for a chemical substance in the candidate list of substances, which would also constitute infringement of the principles of legal certainty and the protection of legitimate expectations, it should be remembered that, as is clear from the conclusion in paragraph 81 above, the ECHA was empowered on the basis of Article 59(8) of Regulation No 1907/2006 to supplement the existing DEHP entry in the candidate list of substances. That argument must accordingly be rejected. |
| --- | --- |

143

Second, with regard to the applicant’s argument that the contested decision was adopted without the ECHA being empowered to supplement an existing entry for a chemical substance in the candidate list of substances, which would also constitute infringement of the principles of legal certainty and the protection of legitimate expectations, it should be remembered that, as is clear from the conclusion in paragraph 81 above, the ECHA was empowered on the basis of Article 59(8) of Regulation No 1907/2006 to supplement the existing DEHP entry in the candidate list of substances. That argument must accordingly be rejected.

| 144 | Third, the following can be stated with regard to the applicant’s argument that the contested decision may compromise the authorisation procedure for DEHP identified as toxic for reproduction within the meaning of Article 57(c) of Regulation No 1907/2006, a procedure which had been under way since 12 August 2013, the date when the applicant’s application for authorisation was lodged. |
| --- | --- |

144

Third, the following can be stated with regard to the applicant’s argument that the contested decision may compromise the authorisation procedure for DEHP identified as toxic for reproduction within the meaning of Article 57(c) of Regulation No 1907/2006, a procedure which had been under way since 12 August 2013, the date when the applicant’s application for authorisation was lodged.

| 145 | Even if additional intrinsic properties such as those referred to in Article 57(f) of Regulation No 1907/2006, have been added to the DEHP entry in the candidate list of substances, the authorisation procedure, which is currently still under way, is not ‘compromised’. As rightly pointed out by the ECHA, the applicant for authorisation must take into account, in its application, only hazardous properties for which the substance has been included in Annex XIV. An intrinsic property of a substance in the candidate list that is not included in the entry for that substance in Annex XIV therefore has no influence on the authorisation procedure. |
| --- | --- |

145

Even if additional intrinsic properties such as those referred to in Article 57(f) of Regulation No 1907/2006, have been added to the DEHP entry in the candidate list of substances, the authorisation procedure, which is currently still under way, is not ‘compromised’. As rightly pointed out by the ECHA, the applicant for authorisation must take into account, in its application, only hazardous properties for which the substance has been included in Annex XIV. An intrinsic property of a substance in the candidate list that is not included in the entry for that substance in Annex XIV therefore has no influence on the authorisation procedure.

| 146 | It is true that, as provided in Article 62(4)(d) of Regulation No 1907/2006, where an existing entry concerning a substance in Annex XIV is supplemented the application for authorisation must be amended to take account of that development. In other words, if the Commission adds the endocrine-disrupting property of very high concern referred to in Article 57(f) of that regulation to the DEHP entry in Annex XIV, the applicant will have to take account of that amendment to Annex XIV. |
| --- | --- |

146

It is true that, as provided in Article 62(4)(d) of Regulation No 1907/2006, where an existing entry concerning a substance in Annex XIV is supplemented the application for authorisation must be amended to take account of that development. In other words, if the Commission adds the endocrine-disrupting property of very high concern referred to in Article 57(f) of that regulation to the DEHP entry in Annex XIV, the applicant will have to take account of that amendment to Annex XIV.

| 147 | However, in that event, the applicant would find itself in the same situation as if all the intrinsic properties of DEHP referred to in Article 57 of Regulation No 1907/2006 had been identified and included in Annex XIV at the same time. |
| --- | --- |

147

However, in that event, the applicant would find itself in the same situation as if all the intrinsic properties of DEHP referred to in Article 57 of Regulation No 1907/2006 had been identified and included in Annex XIV at the same time.

| 148 | Fourth, with regard to the argument that the contested decision does not address the legal consequences that would ensue if the Commission, working within the framework of its mandate, were to draw up criteria of general application for the identification of endocrine-disturbing substances differing from those applied by the ECHA in the present case, it should be noted that, as is apparent from paragraphs 112 to 114 above, the identification of a substance as endocrine-disrupting and of very high concern on the basis of a case-by-case examination in accordance with Article 57(f) of Regulation No 1907/2006 cannot be ruled out on the ground that the Commission must adopt harmonised criteria for determining endocrine-disrupting properties. |
| --- | --- |

148

Fourth, with regard to the argument that the contested decision does not address the legal consequences that would ensue if the Commission, working within the framework of its mandate, were to draw up criteria of general application for the identification of endocrine-disturbing substances differing from those applied by the ECHA in the present case, it should be noted that, as is apparent from paragraphs 112 to 114 above, the identification of a substance as endocrine-disrupting and of very high concern on the basis of a case-by-case examination in accordance with Article 57(f) of Regulation No 1907/2006 cannot be ruled out on the ground that the Commission must adopt harmonised criteria for determining endocrine-disrupting properties.

| 149 | Fifth, regarding the applicant’s argument that, by calling into question and casting uncertainty on ‘how the substances are to be identified in terms of their endocrine effects’, the contested decision completely clouds the regulatory relationship between the inclusion of DEHP in the candidate list of substances, the addition of it in Annex XIV and the grant of authorisation for it, it must be remembered at the outset that it is the legislation in force, and in particular Article 59(8) of Regulation No 1907/2006, read in conjunction with Article 57(f) of that regulation, which was the basis for the adoption of the contested decision. |
| --- | --- |

149

Fifth, regarding the applicant’s argument that, by calling into question and casting uncertainty on ‘how the substances are to be identified in terms of their endocrine effects’, the contested decision completely clouds the regulatory relationship between the inclusion of DEHP in the candidate list of substances, the addition of it in Annex XIV and the grant of authorisation for it, it must be remembered at the outset that it is the legislation in force, and in particular Article 59(8) of Regulation No 1907/2006, read in conjunction with Article 57(f) of that regulation, which was the basis for the adoption of the contested decision.

| 150 | The applicant’s complaint alleging that it could not foresee the contested decision or make advance preparations for the obligations imposed by it or adapt its corporate activity must be construed as an argument alleging, in essence, breach of the principle of the protection of legitimate expectations. |
| --- | --- |

150

The applicant’s complaint alleging that it could not foresee the contested decision or make advance preparations for the obligations imposed by it or adapt its corporate activity must be construed as an argument alleging, in essence, breach of the principle of the protection of legitimate expectations.

| 151 | According to settled case-law, whilst the principle of the protection of legitimate expectations is one of the fundamental principles of the Union, economic operators are not justified in having a legitimate expectation that an existing situation which is capable of being altered by the Union institutions in the exercise of their discretionary power will be maintained (judgment of 26 June 2012, Poland v Commission, C‐335/09 P, EU:C:2012:385, paragraph 180). Therefore, the applicant was not justified in placing its legitimate expectations on the assumption that the ECHA would not identify DEHP as an endocrine disruptor of very high concern under Article 57(f) of Regulation No 1907/2006. |
| --- | --- |

151

According to settled case-law, whilst the principle of the protection of legitimate expectations is one of the fundamental principles of the Union, economic operators are not justified in having a legitimate expectation that an existing situation which is capable of being altered by the Union institutions in the exercise of their discretionary power will be maintained (judgment of 26 June 2012, Poland v Commission, C‐335/09 P, EU:C:2012:385, paragraph 180). Therefore, the applicant was not justified in placing its legitimate expectations on the assumption that the ECHA would not identify DEHP as an endocrine disruptor of very high concern under Article 57(f) of Regulation No 1907/2006.

| 152 | In the light of the foregoing, the arguments alleging infringement of the principles of foreseeability, legal certainty and the protection of legitimate expectations must be rejected. |
| --- | --- |

152

In the light of the foregoing, the arguments alleging infringement of the principles of foreseeability, legal certainty and the protection of legitimate expectations must be rejected.

| 153 | Accordingly, the second plea must be rejected as unfounded in its entirety. |
| --- | --- |

153

Accordingly, the second plea must be rejected as unfounded in its entirety.

The third plea: no convincing and objective scientific findings and non-compliance with the ECHA’s instructions

| 154 | The third plea is divided into two parts. |
| --- | --- |

154

The third plea is divided into two parts.

| 155 | In the first part the applicant argues that the contested decision is vitiated by a manifest error of assessment which could even be described as misuse of powers, as it is not based on scientific findings which establish objectively and convincingly that DEHP fulfils all the criteria laid down in Article 57(f) of Regulation No 1907/2006. |
| --- | --- |

155

In the first part the applicant argues that the contested decision is vitiated by a manifest error of assessment which could even be described as misuse of powers, as it is not based on scientific findings which establish objectively and convincingly that DEHP fulfils all the criteria laid down in Article 57(f) of Regulation No 1907/2006.

| 156 | The second part alleges that the ECHA did not comply with its own technical instructions. |
| --- | --- |

156

The second part alleges that the ECHA did not comply with its own technical instructions.

– The first part of the third plea: manifest error, or even a misuse of powers, due to there being no objective and sufficiently convincing scientific evidence

| 157 | In the first place, the applicant submits that, from a scientific point of view, the finding that a substance is endocrine-disturbing is not sufficient for concluding that the substance fulfils the criteria laid down in Article 57(f) of Regulation No 1907/2006. The endocrine disruption does not in itself constitute a danger; rather, it is merely a pattern of behaviour, and yet the contested decision is based on this erroneous assumption. By contrast, the scientific evaluation of the effects of DEHP on the environment should have made it possible to establish a causal link between the pattern of behaviour of DEHP and the effects on the environment. The DEHP dossier fails to fulfil this fundamental requirement because the alleged adverse effects of DEHP were considered to be only ‘possible’. |
| --- | --- |

157

In the first place, the applicant submits that, from a scientific point of view, the finding that a substance is endocrine-disturbing is not sufficient for concluding that the substance fulfils the criteria laid down in Article 57(f) of Regulation No 1907/2006. The endocrine disruption does not in itself constitute a danger; rather, it is merely a pattern of behaviour, and yet the contested decision is based on this erroneous assumption. By contrast, the scientific evaluation of the effects of DEHP on the environment should have made it possible to establish a causal link between the pattern of behaviour of DEHP and the effects on the environment. The DEHP dossier fails to fulfil this fundamental requirement because the alleged adverse effects of DEHP were considered to be only ‘possible’.

| 158 | In the second place, as several Member States and several other participants have noted in the context of the comments submission procedure, the arguments in the DEHP dossier do not satisfy one of the decidedly most essential criteria for identifying a substance under Article 57(f) of Regulation No 1907/2006 and including it in the candidate list of substances: that the substance concerned must also give rise to an equivalent level of concern to that of other substances listed in Article 57(a) to (e) of that regulation. |
| --- | --- |

158

In the second place, as several Member States and several other participants have noted in the context of the comments submission procedure, the arguments in the DEHP dossier do not satisfy one of the decidedly most essential criteria for identifying a substance under Article 57(f) of Regulation No 1907/2006 and including it in the candidate list of substances: that the substance concerned must also give rise to an equivalent level of concern to that of other substances listed in Article 57(a) to (e) of that regulation.

| 159 | In the third place, the scientific reliability of the studies forming the basis of the DEHP dossier, the supporting document and, consequently, the contested decision, is falsely and intentionally overestimated. Nor are those specialised studies convincing. |
| --- | --- |

159

In the third place, the scientific reliability of the studies forming the basis of the DEHP dossier, the supporting document and, consequently, the contested decision, is falsely and intentionally overestimated. Nor are those specialised studies convincing.

| 160 | Take, for example, the studies on fish, forming the basis of both the supporting document and the DEHP dossier. It is apparent from a 2008 scientific report entitled ‘European Union Risk Assessment Report’ issued by the Commission’s Joint Research Centre (JRC) that it ‘is not possible to definitively conclude whether DEHP is an endocrine disruptor in fish’. The nine studies drawn up after 2008 on the influence of DEHP on fish constitute only ‘non-guideline studies’, namely studies which have not been carried out in accordance with the standards of the Organisation for Economic Cooperation and Development (OECD). Those studies should be appraised on the basis of an internationally recognised methodology called the Klimisch scoring system (Klimisch, H.J., Andreae, M. and Tillmann. U., A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data’, Regulatory Toxicology and Pharmacology, 1997, Vol 25, pp 1–5,). Even if, in the context of the Klimisch scoring system, ‘non-guideline’ studies are given a score of 3, corresponding to ‘not reliable’ studies (Klimisch score 3), in the supporting document the abovementioned studies are at odds with the Klimisch scoring system, classified as category 2, corresponding to ‘reliable with restriction’ studies (Klimisch score 2). The author of the supporting document himself questions the reliability of the Carnevali et al. (2010) and Corradetti et al. (2013) studies, calling them ‘essentially not reliable’ studies (Klimisch score 2/4). In some studies referred to in the supporting document, the adverse endocrine influence of DEHP has not been demonstrated at all. This is particularly true of the studies by Zanotelli et al. (2010), Wang et al. (2013) or Uhren-Webster et al. (2010). In addition, the results of the Zanotelli et al. (2010) study concluding that ‘reduction in growth’ in fish following treatment with DEHP could be considered a manifestation of an ‘endocrine action effect’ of this substance but not evidence of its ‘adverse effect’ have been called into question by other specialised studies, including the Norman et al. (2007) study. |
| --- | --- |

160

Take, for example, the studies on fish, forming the basis of both the supporting document and the DEHP dossier. It is apparent from a 2008 scientific report entitled ‘European Union Risk Assessment Report’ issued by the Commission’s Joint Research Centre (JRC) that it ‘is not possible to definitively conclude whether DEHP is an endocrine disruptor in fish’. The nine studies drawn up after 2008 on the influence of DEHP on fish constitute only ‘non-guideline studies’, namely studies which have not been carried out in accordance with the standards of the Organisation for Economic Cooperation and Development (OECD). Those studies should be appraised on the basis of an internationally recognised methodology called the Klimisch scoring system (Klimisch, H.J., Andreae, M. and Tillmann. U., A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data’, Regulatory Toxicology and Pharmacology, 1997, Vol 25, pp 1–5,). Even if, in the context of the Klimisch scoring system, ‘non-guideline’ studies are given a score of 3, corresponding to ‘not reliable’ studies (Klimisch score 3), in the supporting document the abovementioned studies are at odds with the Klimisch scoring system, classified as category 2, corresponding to ‘reliable with restriction’ studies (Klimisch score 2). The author of the supporting document himself questions the reliability of the Carnevali et al. (2010) and Corradetti et al. (2013) studies, calling them ‘essentially not reliable’ studies (Klimisch score 2/4). In some studies referred to in the supporting document, the adverse endocrine influence of DEHP has not been demonstrated at all. This is particularly true of the studies by Zanotelli et al. (2010), Wang et al. (2013) or Uhren-Webster et al. (2010). In addition, the results of the Zanotelli et al. (2010) study concluding that ‘reduction in growth’ in fish following treatment with DEHP could be considered a manifestation of an ‘endocrine action effect’ of this substance but not evidence of its ‘adverse effect’ have been called into question by other specialised studies, including the Norman et al. (2007) study.

Regulatory Toxicology and Pharmacology

| 161 | The studies on rats, in the applicant’s submission, were designed to examine the effects on human health and not on the environment. Their reliability is also questionable, since in those studies DEHP was administered directly and in very high doses, which would not occur in nature, where its presence is at levels a thousand times, even tens of thousands of times, lower. |
| --- | --- |

161

The studies on rats, in the applicant’s submission, were designed to examine the effects on human health and not on the environment. Their reliability is also questionable, since in those studies DEHP was administered directly and in very high doses, which would not occur in nature, where its presence is at levels a thousand times, even tens of thousands of times, lower.

| 162 | The ECHA, supported by the Kingdom of Norway, disputes these arguments. |
| --- | --- |

162

The ECHA, supported by the Kingdom of Norway, disputes these arguments.

| 163 | First of all, it should be pointed out that, in accordance with settled case-law, where the authorities of the European Union have a broad discretion, in particular as to the assessment of highly complex scientific and technical facts in order to determine the nature and scope of the measures which they adopt, review by the European Union judicature is limited to verifying whether there has been a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion. In such a context, the European Union judicature cannot substitute its assessment of scientific and technical facts for that of the authorities of the European Union on which alone the FEU Treaty has placed that task (see judgment of 30 April 2015, Polynt and Sitre v ECHA, T‐134/13, not published, EU:T:2015:254, paragraph 52 and the case-law cited). |
| --- | --- |

163

First of all, it should be pointed out that, in accordance with settled case-law, where the authorities of the European Union have a broad discretion, in particular as to the assessment of highly complex scientific and technical facts in order to determine the nature and scope of the measures which they adopt, review by the European Union judicature is limited to verifying whether there has been a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion. In such a context, the European Union judicature cannot substitute its assessment of scientific and technical facts for that of the authorities of the European Union on which alone the FEU Treaty has placed that task (see judgment of 30 April 2015, Polynt and Sitre v ECHA, T‐134/13, not published, EU:T:2015:254, paragraph 52 and the case-law cited).

| 164 | Nevertheless, the broad discretion of the authorities of the European Union, which implies limited judicial review of its exercise, applies not only to the nature and scope of the measures to be taken but also, to some extent, to the finding of the basic facts. However, even though such judicial review is of limited scope, it requires that the European Union authorities which have adopted the act in question must be able to show before the European Union judicature that in adopting the act they actually exercised their discretion, which presupposes that they took into consideration all the relevant factors and circumstances of the situation the act was intended to regulate (see judgment of 30 April 2015, Polynt and Sitre v ECHA, T‐134/13, not published, EU:T:2015:254, paragraph 53 and the case-law cited). |
| --- | --- |

164

Nevertheless, the broad discretion of the authorities of the European Union, which implies limited judicial review of its exercise, applies not only to the nature and scope of the measures to be taken but also, to some extent, to the finding of the basic facts. However, even though such judicial review is of limited scope, it requires that the European Union authorities which have adopted the act in question must be able to show before the European Union judicature that in adopting the act they actually exercised their discretion, which presupposes that they took into consideration all the relevant factors and circumstances of the situation the act was intended to regulate (see judgment of 30 April 2015, Polynt and Sitre v ECHA, T‐134/13, not published, EU:T:2015:254, paragraph 53 and the case-law cited).

| 165 | It is in the light of those considerations that it is necessary to consider whether the ECHA’s assessment of DEHP’s properties as a substance fulfilling the provisions of Article 57(f) of Regulation No 1907/2006 is vitiated by a manifest error of assessment or even misuse of powers. |
| --- | --- |

165

It is in the light of those considerations that it is necessary to consider whether the ECHA’s assessment of DEHP’s properties as a substance fulfilling the provisions of Article 57(f) of Regulation No 1907/2006 is vitiated by a manifest error of assessment or even misuse of powers.

| 166 | Point 6.3 of the supporting document states that the conclusion may be drawn that it is probable that the endocrine-disrupting mechanism of DEHP has adverse effects on the environment. The Member State Committee reached this conclusion by evaluating several studies on fish and rats. In particular, point 5.1.6 of the supporting document indicates that, on an overall assessment of a part of the studies used, it is highly probable that the estrogenic pattern of behaviour of DEHP has adverse effects on the sexual and reproductive phenotypic features of male and female fish. This fact, together with the effects of DEHP as observed in the studies on rats referred to in Chapter 4 of the supporting document, suffice for a conclusion that DEHP may have adverse effects on the environment. |
| --- | --- |

166

Point 6.3 of the supporting document states that the conclusion may be drawn that it is probable that the endocrine-disrupting mechanism of DEHP has adverse effects on the environment. The Member State Committee reached this conclusion by evaluating several studies on fish and rats. In particular, point 5.1.6 of the supporting document indicates that, on an overall assessment of a part of the studies used, it is highly probable that the estrogenic pattern of behaviour of DEHP has adverse effects on the sexual and reproductive phenotypic features of male and female fish. This fact, together with the effects of DEHP as observed in the studies on rats referred to in Chapter 4 of the supporting document, suffice for a conclusion that DEHP may have adverse effects on the environment.

| 167 | The applicant’s arguments do not have the effect of calling into question the assessment of all the scientific studies referred to in Chapters 4 and 5 of the supporting document. |
| --- | --- |

167

The applicant’s arguments do not have the effect of calling into question the assessment of all the scientific studies referred to in Chapters 4 and 5 of the supporting document.

| 168 | In the first place, contrary to what the applicant claims, the contested decision is not based on the argument that the mere impact of a substance on the endocrine system of an isolated individual would necessarily have adverse effects on the environment. |
| --- | --- |

168

In the first place, contrary to what the applicant claims, the contested decision is not based on the argument that the mere impact of a substance on the endocrine system of an isolated individual would necessarily have adverse effects on the environment.

| 169 | As is apparent from point 5.1.1 of the supporting document, read in conjunction with point 4.2.1 thereof, the scientific approach on the basis of which the ECHA concluded that DEHP possessed intrinsic properties such as those referred to in Article 57(f) of Regulation No 1907/2006 was that proposed by an expert advisory group. Under that approach, a substance may be identified as an endocrine disruptor that may have adverse effects on the environment where: first, it has adverse health effects; second, it has an endocrine-disrupting mechanism; third, there is a ‘plausible’ connection between those adverse effects and the endocrine-disrupting mechanism; and fourth, that causal connection is also relevant to the environment. As indicated in point 4.2.1 of the supporting document, this approach is based on a definition that is broadly accepted and promoted by the World Health Organisation (WHO) programme on endocrine disruptors. |
| --- | --- |

169

As is apparent from point 5.1.1 of the supporting document, read in conjunction with point 4.2.1 thereof, the scientific approach on the basis of which the ECHA concluded that DEHP possessed intrinsic properties such as those referred to in Article 57(f) of Regulation No 1907/2006 was that proposed by an expert advisory group. Under that approach, a substance may be identified as an endocrine disruptor that may have adverse effects on the environment where: first, it has adverse health effects; second, it has an endocrine-disrupting mechanism; third, there is a ‘plausible’ connection between those adverse effects and the endocrine-disrupting mechanism; and fourth, that causal connection is also relevant to the environment. As indicated in point 4.2.1 of the supporting document, this approach is based on a definition that is broadly accepted and promoted by the World Health Organisation (WHO) programme on endocrine disruptors.

| 170 | Consequently, the applicant’s argument, to the effect that the contested decision is based on the assumption that when a chemical substance disrupts the endocrine system the necessary implication is that it is a substance that may have adverse effects on the environment, must be rejected. |
| --- | --- |

170

Consequently, the applicant’s argument, to the effect that the contested decision is based on the assumption that when a chemical substance disrupts the endocrine system the necessary implication is that it is a substance that may have adverse effects on the environment, must be rejected.

| 171 | The following may be stated with respect to the applicant’s argument that the scientific assessment of the effects of DEHP on the environment ought to have enabled a causal link to be established between the pattern of behaviour of DEHP and its effects on the environment, in that it would be precisely DEHP, to the exclusion of all other substances, that would have serious adverse effects on the environment, leading to the conclusion that DEHP constitutes an endocrine disruptor of very high concern within the meaning of Article 57(f) of Regulation No 1907/2006. |
| --- | --- |

171

The following may be stated with respect to the applicant’s argument that the scientific assessment of the effects of DEHP on the environment ought to have enabled a causal link to be established between the pattern of behaviour of DEHP and its effects on the environment, in that it would be precisely DEHP, to the exclusion of all other substances, that would have serious adverse effects on the environment, leading to the conclusion that DEHP constitutes an endocrine disruptor of very high concern within the meaning of Article 57(f) of Regulation No 1907/2006.

| 172 | By that argument, the applicant must be understood as intending, in essence, to cast doubt on the standard of proof applied by the author of the supporting document to establish the causal link. |
| --- | --- |

172

By that argument, the applicant must be understood as intending, in essence, to cast doubt on the standard of proof applied by the author of the supporting document to establish the causal link.

| 173 | In that regard, as regards the applicable standard of proof under Article 57(f) of Regulation No 1907/2006, it must first be noted that, according to the wording of that provision, inter alia endocrine disruptors of very high concern for which there is scientific evidence of ‘probable’ serious effects on the environment may be included in Annex XIV. It should be pointed out that, in certain language versions of that provision, including the English, German, Italian and Romanian versions, the effects on the environment must be ‘probable’, whereas in other language versions substances must ‘be able to’ have effects on the environment. It follows that the probability that an endocrine disruptor may have adverse effects on the environment is sufficient to establish a causal link within the meaning of that provision. The Union legislature’s approach on this point is also in line with the precautionary principle referred to, inter alia, in Article 1(3) of Regulation No 1907/2006. |
| --- | --- |

173

In that regard, as regards the applicable standard of proof under Article 57(f) of Regulation No 1907/2006, it must first be noted that, according to the wording of that provision, inter alia endocrine disruptors of very high concern for which there is scientific evidence of ‘probable’ serious effects on the environment may be included in Annex XIV. It should be pointed out that, in certain language versions of that provision, including the English, German, Italian and Romanian versions, the effects on the environment must be ‘probable’, whereas in other language versions substances must ‘be able to’ have effects on the environment. It follows that the probability that an endocrine disruptor may have adverse effects on the environment is sufficient to establish a causal link within the meaning of that provision. The Union legislature’s approach on this point is also in line with the precautionary principle referred to, inter alia, in Article 1(3) of Regulation No 1907/2006.

| 174 | As is apparent inter alia from the first sentence of point 6.3 of the supporting document, the scientific reasoning of the author of the document meets the standard of proof referred to in Article 57(f) of Regulation No 1907/2006, referring to the probability that DEHP may have adverse effects on the environment. |
| --- | --- |

174

As is apparent inter alia from the first sentence of point 6.3 of the supporting document, the scientific reasoning of the author of the document meets the standard of proof referred to in Article 57(f) of Regulation No 1907/2006, referring to the probability that DEHP may have adverse effects on the environment.

| 175 | In view of the statements in paragraphs 105, 163 and 164 above with regard to review of acts for manifest errors of assessment or misuse of powers, it must be concluded that the contested decision is not vitiated because the author of the supporting document established only that it was ‘highly plausible’ that the endocrine-disrupting mechanism of DEHP would have adverse effects on the environment. |
| --- | --- |

175

In view of the statements in paragraphs 105, 163 and 164 above with regard to review of acts for manifest errors of assessment or misuse of powers, it must be concluded that the contested decision is not vitiated because the author of the supporting document established only that it was ‘highly plausible’ that the endocrine-disrupting mechanism of DEHP would have adverse effects on the environment.

| 176 | In the second place, with regard to the applicant’s argument that the DEHP dossier does not provide a basis for DEHP to be considered a substance giving rise to an equivalent level of concern to that of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006, suffice it to refer to the supporting document. |
| --- | --- |

176

In the second place, with regard to the applicant’s argument that the DEHP dossier does not provide a basis for DEHP to be considered a substance giving rise to an equivalent level of concern to that of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006, suffice it to refer to the supporting document.

| 177 | In point 6.2, the author of the supporting document examines not only the intrinsic properties, scientific evidence and serious effects of DEHP, but also the equivalent level of concern within the meaning of Article 57(f) of Regulation No 1907/2006. In summary, the four paragraphs of point 6.2 state inter alia that the ecotoxicological effects of DEHP are potentially severe and irreversible and that they have a significant impact on the environment. |
| --- | --- |

177

In point 6.2, the author of the supporting document examines not only the intrinsic properties, scientific evidence and serious effects of DEHP, but also the equivalent level of concern within the meaning of Article 57(f) of Regulation No 1907/2006. In summary, the four paragraphs of point 6.2 state inter alia that the ecotoxicological effects of DEHP are potentially severe and irreversible and that they have a significant impact on the environment.

| 178 | It follows that, in view of the explanations given in paragraphs 102, 164 and 165 above, there can be no finding of a manifest error of assessment or misuse of powers on the ground that the ECHA allegedly disregarded one of the essential criteria of Article 57(f) of Regulation No 1907/2006. |
| --- | --- |

178

It follows that, in view of the explanations given in paragraphs 102, 164 and 165 above, there can be no finding of a manifest error of assessment or misuse of powers on the ground that the ECHA allegedly disregarded one of the essential criteria of Article 57(f) of Regulation No 1907/2006.

| 179 | In the third place, the following remarks can be made with respect to the applicant’s argument that the studies used in the DEHP dossier were not reliable. |
| --- | --- |

179

In the third place, the following remarks can be made with respect to the applicant’s argument that the studies used in the DEHP dossier were not reliable.

| 180 | The scientific justifications underpinning the contested decision included studies on fish that were carried out, in part, before 2008. These studies have been reproduced and described in the 2008 JRC report. As is apparent from point 5.1.2 of the supporting document, it is true that, according to that report, it was not possible to conclude definitively that DEHP is an endocrine disruptor in fish. |
| --- | --- |

180

The scientific justifications underpinning the contested decision included studies on fish that were carried out, in part, before 2008. These studies have been reproduced and described in the 2008 JRC report. As is apparent from point 5.1.2 of the supporting document, it is true that, according to that report, it was not possible to conclude definitively that DEHP is an endocrine disruptor in fish.

| 181 | A number of studies carried out after 2008 supplement those findings, however. |
| --- | --- |

181

A number of studies carried out after 2008 supplement those findings, however.

| 182 | As indicated in point 5.1.2.1 of the supporting document, the ECHA assessed the reliability of those studies using the Klimisch scoring system because Chapter R.4.2 of the ECHA Guidance on Information Requirements and Chemical Safety Assessment states that the Klimisch scoring system should also be applied to the evaluation of studies on the effects and behaviour of a substance in the environment. |
| --- | --- |

182

As indicated in point 5.1.2.1 of the supporting document, the ECHA assessed the reliability of those studies using the Klimisch scoring system because Chapter R.4.2 of the ECHA Guidance on Information Requirements and Chemical Safety Assessment states that the Klimisch scoring system should also be applied to the evaluation of studies on the effects and behaviour of a substance in the environment.

| 183 | In particular, in that scoring system, the ‘2 = reliable with restriction’ rating (Klimisch score 2) is given to ‘studies or data ... (mostly not performed according to GLP [Good Laboratory Practice]), in which the test parameters documented do not totally comply with the specific testing guideline, but are sufficient to accept the data or in which investigations are described which cannot be subsumed under a testing guideline, but which are nevertheless well documented and scientifically acceptable’. |
| --- | --- |

183

In particular, in that scoring system, the ‘2 = reliable with restriction’ rating (Klimisch score 2) is given to ‘studies or data ... (mostly not performed according to GLP [Good Laboratory Practice]), in which the test parameters documented do not totally comply with the specific testing guideline, but are sufficient to accept the data or in which investigations are described which cannot be subsumed under a testing guideline, but which are nevertheless well documented and scientifically acceptable’.

| 184 | By contrast, the ‘3 = not reliable’ rating (Klimisch score 3) is given to ‘studies or data ... in which there are interferences between the measuring system and the test substance or in which organisms/test systems were used which are not relevant in relation to the exposure (e.g., unphysiologic pathways of application) or which were carried out or generated according to a method which is not acceptable, the documentation of which is not sufficient for an assessment and which is not convincing for an expert judgment’. |
| --- | --- |

184

By contrast, the ‘3 = not reliable’ rating (Klimisch score 3) is given to ‘studies or data ... in which there are interferences between the measuring system and the test substance or in which organisms/test systems were used which are not relevant in relation to the exposure (e.g., unphysiologic pathways of application) or which were carried out or generated according to a method which is not acceptable, the documentation of which is not sufficient for an assessment and which is not convincing for an expert judgment’.

| 185 | Contrary to the applicant’s argument that a study which does not comply with OECD standards constitutes a ‘non-guideline’ study, there is nothing in the Klimisch scoring system to indicate that all ‘non-guideline’ studies should receive a ‘3 = not reliable’ rating. In fact, the ‘2 = reliable with restriction’ rating can be given precisely to studies for which the documented test parameters do not fully comply with a specific guideline. Consequently, in contrast to what the applicant suggests, the mere fact that an expert’s report is described as a ‘non-guideline’ study does not imply that that study is not reliable. |
| --- | --- |

185

Contrary to the applicant’s argument that a study which does not comply with OECD standards constitutes a ‘non-guideline’ study, there is nothing in the Klimisch scoring system to indicate that all ‘non-guideline’ studies should receive a ‘3 = not reliable’ rating. In fact, the ‘2 = reliable with restriction’ rating can be given precisely to studies for which the documented test parameters do not fully comply with a specific guideline. Consequently, in contrast to what the applicant suggests, the mere fact that an expert’s report is described as a ‘non-guideline’ study does not imply that that study is not reliable.

| 186 | Nor has the applicant provided any specific evidence calling into question, in a substantiated manner and on the basis of an individual examination of the studies, the rating given to the various studies referred to in Chapter 5 of the supporting document. |
| --- | --- |

186

Nor has the applicant provided any specific evidence calling into question, in a substantiated manner and on the basis of an individual examination of the studies, the rating given to the various studies referred to in Chapter 5 of the supporting document.

| 187 | The applicant has not specified, either, which of the ratings given to the studies on fish is incorrect and may have influenced the outcome of the Member State Committee’s overall assessment. |
| --- | --- |

187

The applicant has not specified, either, which of the ratings given to the studies on fish is incorrect and may have influenced the outcome of the Member State Committee’s overall assessment.

| 188 | Moreover, the applicant’s argument that, first, the author of the supporting document called into question the reliability of the Carnevali et al. (2010) and Corradetti et al. (2013) studies and, second, the adverse endocrine effects of DEHP were not demonstrated in the Zanotelli et al. (2010), Wang et al. (2013) or Uhren-Webster et al. (2010) studies, is not convincing. |
| --- | --- |

188

Moreover, the applicant’s argument that, first, the author of the supporting document called into question the reliability of the Carnevali et al. (2010) and Corradetti et al. (2013) studies and, second, the adverse endocrine effects of DEHP were not demonstrated in the Zanotelli et al. (2010), Wang et al. (2013) or Uhren-Webster et al. (2010) studies, is not convincing.

| 189 | Admittedly, it follows from point 5.1.2.1.2 of the supporting document that the Zanotelli et al. (2010) study was not conclusive as to whether DEHP should be classified as an endocrine disruptor. It is not clear from that study whether the ‘reduction in growth’ observed in fish as an effect of DEHP was endocrine mediated or not. Similarly, according to the Wang et al. (2013) study, no endocrine related or systemic adverse effects were investigated nor observed. |
| --- | --- |

189

Admittedly, it follows from point 5.1.2.1.2 of the supporting document that the Zanotelli et al. (2010) study was not conclusive as to whether DEHP should be classified as an endocrine disruptor. It is not clear from that study whether the ‘reduction in growth’ observed in fish as an effect of DEHP was endocrine mediated or not. Similarly, according to the Wang et al. (2013) study, no endocrine related or systemic adverse effects were investigated nor observed.

| 190 | However, it follows from point 5.1.2.1.2 that the Carnevali et al. (2010) and Corradetti et al. (2013) studies demonstrated the adverse effects of DEHP on zebrafish reproduction and that, despite some doubts, those studies are considered of some relevance for the evaluation of these effects. |
| --- | --- |

190

However, it follows from point 5.1.2.1.2 that the Carnevali et al. (2010) and Corradetti et al. (2013) studies demonstrated the adverse effects of DEHP on zebrafish reproduction and that, despite some doubts, those studies are considered of some relevance for the evaluation of these effects.

| 191 | It is true that the Uhren-Webster et al. (2010) study is based on an experimental method involving exposure to the substance that does not occur in nature. However, whether or not that method is reliable, given that the response to this question must be the same as that given in paragraphs 198 to 200 below concerning the application of high doses of DEHP in trials on rats, the fact remains that the Uhren-Webster et al. (2010) study showed that exposure to high concentrations of DEHP disrupts spermatogenesis in zebrafish. |
| --- | --- |

191

It is true that the Uhren-Webster et al. (2010) study is based on an experimental method involving exposure to the substance that does not occur in nature. However, whether or not that method is reliable, given that the response to this question must be the same as that given in paragraphs 198 to 200 below concerning the application of high doses of DEHP in trials on rats, the fact remains that the Uhren-Webster et al. (2010) study showed that exposure to high concentrations of DEHP disrupts spermatogenesis in zebrafish.

| 192 | The studies criticised by the applicant constitute only part of the body of evidence which was examined by the Member State Committee. |
| --- | --- |

192

The studies criticised by the applicant constitute only part of the body of evidence which was examined by the Member State Committee.

| 193 | Further studies on fish, such as those referred to in section 5.1.2.1.2 of the supporting document, provide further evidence of the adverse effects of DEHP on the environment. |
| --- | --- |

193

Further studies on fish, such as those referred to in section 5.1.2.1.2 of the supporting document, provide further evidence of the adverse effects of DEHP on the environment.

| 194 | Those studies are supplemented by the trials on rats, referred to in point 4.2.2 of the supporting document. Those tests revealed various adverse effects of DEHP on the endocrine system of mammals. |
| --- | --- |

194

Those studies are supplemented by the trials on rats, referred to in point 4.2.2 of the supporting document. Those tests revealed various adverse effects of DEHP on the endocrine system of mammals.

| 195 | The applicant does not give any particular attention to those other studies. |
| --- | --- |

195

The applicant does not give any particular attention to those other studies.

| 196 | In particular, as is apparent from the second paragraph of point 4.2.2(b) of the supporting document, the studies on rats have even been described as ‘reliable’ studies for the purposes of a Klimisch score of 1 or 2. The applicant, who seems to acknowledge that the Klimisch scoring system is a convincing method of study evaluation, has provided no evidence casting doubt on the reliability of the studies referred to in point 4.2.2 of the supporting document. |
| --- | --- |

196

In particular, as is apparent from the second paragraph of point 4.2.2(b) of the supporting document, the studies on rats have even been described as ‘reliable’ studies for the purposes of a Klimisch score of 1 or 2. The applicant, who seems to acknowledge that the Klimisch scoring system is a convincing method of study evaluation, has provided no evidence casting doubt on the reliability of the studies referred to in point 4.2.2 of the supporting document.

| 197 | Nor does the applicant dispute in any way the assessment in the third paragraph of point 6.3 of the supporting document, to the effect that the effects of DEHP on mammalian reproduction are relevant to the environment. The applicant does not call into question the finding that, first, the undesirable effects observed in rats are of very high concern for wild mammals with a naturally low rate of reproductive success and, second, the adverse effects on reproduction may trigger long-term adverse effects on the population of the animal in question. |
| --- | --- |

197

Nor does the applicant dispute in any way the assessment in the third paragraph of point 6.3 of the supporting document, to the effect that the effects of DEHP on mammalian reproduction are relevant to the environment. The applicant does not call into question the finding that, first, the undesirable effects observed in rats are of very high concern for wild mammals with a naturally low rate of reproductive success and, second, the adverse effects on reproduction may trigger long-term adverse effects on the population of the animal in question.

| 198 | Moreover, the applicant’s argument that the DEHP assessment, as carried out in the studies on rats, was carried out using very high doses of DEHP acting directly on the animals, a situation which does not occur in nature, cannot be upheld. |
| --- | --- |

198

Moreover, the applicant’s argument that the DEHP assessment, as carried out in the studies on rats, was carried out using very high doses of DEHP acting directly on the animals, a situation which does not occur in nature, cannot be upheld.

| 199 | First, in that regard, it should be noted at the outset that the applicant has not established that the method of directly applying high quantities of any substance was not a recognised and established scientific method. In this respect, the applicant merely makes a general assertion without providing any specific evidence calling into question the reliability of the method of applying high doses of a certain substance to animals under laboratory conditions. |
| --- | --- |

199

First, in that regard, it should be noted at the outset that the applicant has not established that the method of directly applying high quantities of any substance was not a recognised and established scientific method. In this respect, the applicant merely makes a general assertion without providing any specific evidence calling into question the reliability of the method of applying high doses of a certain substance to animals under laboratory conditions.

| 200 | Second, according to the case-law, an assessment of the hazards linked to the intrinsic properties of substances must not be limited according to specific circumstances of use and may be properly carried out irrespective of the place where the substance is used, the route by which contact with the substance might arise and the possible levels of exposure to the substance (see, to that effect, judgment of 21 July 2011, Nickel Institute, C‐14/10, EU:C:2011:503, paragraph 82). |
| --- | --- |

200

Second, according to the case-law, an assessment of the hazards linked to the intrinsic properties of substances must not be limited according to specific circumstances of use and may be properly carried out irrespective of the place where the substance is used, the route by which contact with the substance might arise and the possible levels of exposure to the substance (see, to that effect, judgment of 21 July 2011, Nickel Institute, C‐14/10, EU:C:2011:503, paragraph 82).

| 201 | In the light of those considerations and the findings in paragraphs 105, 163 and 164 above, it cannot be concluded that the contested decision is vitiated by a manifest error or misuse of powers; the arguments to that effect must therefore be rejected. |
| --- | --- |

201

In the light of those considerations and the findings in paragraphs 105, 163 and 164 above, it cannot be concluded that the contested decision is vitiated by a manifest error or misuse of powers; the arguments to that effect must therefore be rejected.

| 202 | The first part of the third plea must therefore be rejected. |
| --- | --- |

202

The first part of the third plea must therefore be rejected.

– The second part of the third plea: non-compliance by the ECHA with its own technical instructions

| 203 | The applicant submits that, by adopting the contested decision, the ECHA failed to comply with its own instructions, being the document entitled ‘Identification of substances as SVHCs due to equivalent level of concern to CMRs (Article 57(f)) — sensitisers as an example), containing detailed instructions for parties submitting proposals for the inclusion of chemical substances in the candidate list of substances in accordance with Article 57(f) of Regulation No 1907/2006. According to those instructions, the ‘quality of life’ of those affected, namely, in the present case the animals concerned, the ‘societal concern’ and possibility of a ‘safe concentration’ for the environment are factors to be taken into account in determining whether a substance raises a level of concern equivalent to that of the substances identified in accordance with Article 57(a) to (e) of Regulation No 1907/2006. In the present case, those factors were not assessed by the ECHA. |
| --- | --- |

203

The applicant submits that, by adopting the contested decision, the ECHA failed to comply with its own instructions, being the document entitled ‘Identification of substances as SVHCs due to equivalent level of concern to CMRs (Article 57(f)) — sensitisers as an example), containing detailed instructions for parties submitting proposals for the inclusion of chemical substances in the candidate list of substances in accordance with Article 57(f) of Regulation No 1907/2006. According to those instructions, the ‘quality of life’ of those affected, namely, in the present case the animals concerned, the ‘societal concern’ and possibility of a ‘safe concentration’ for the environment are factors to be taken into account in determining whether a substance raises a level of concern equivalent to that of the substances identified in accordance with Article 57(a) to (e) of Regulation No 1907/2006. In the present case, those factors were not assessed by the ECHA.

| 204 | The ECHA disputes this argument. |
| --- | --- |

204

The ECHA disputes this argument.

| 205 | The applicant’s complaint about the ECHA’s instructions constitutes a supplementary claim put forward for the first time in paragraphs 72 to 74 of the reply. In other words, the applicant is in essence putting forward a new plea in the course of the proceedings. |
| --- | --- |

205

The applicant’s complaint about the ECHA’s instructions constitutes a supplementary claim put forward for the first time in paragraphs 72 to 74 of the reply. In other words, the applicant is in essence putting forward a new plea in the course of the proceedings.

| 206 | It is clear from Article 84 of the Rules of Procedure that 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. |
| --- | --- |

206

It is clear from Article 84 of the Rules of Procedure that 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.

| 207 | Since the applicant has introduced the plea relating to the ECHA guidelines only at the stage of the reply and since it is not based on evidence which emerged after the introduction of the application, it must be rejected as being out of time and, consequently, inadmissible. |
| --- | --- |

207

Since the applicant has introduced the plea relating to the ECHA guidelines only at the stage of the reply and since it is not based on evidence which emerged after the introduction of the application, it must be rejected as being out of time and, consequently, inadmissible.

| 208 | Therefore, the second part of the third plea must be dismissed as inadmissible. |
| --- | --- |

208

Therefore, the second part of the third plea must be dismissed as inadmissible.

The fourth plea: infringement of the applicant’s rights under the ECHR and the Charter

| 209 | By its fourth plea, the applicant alleges, first, breach of the principle of legal certainty; second, breach of the right to a fair hearing within the meaning of Article 47 of the Charter and Article 6 of the ECHR; and, third, breach of the right to peaceful enjoyment of its property within the meaning of Article 1 of Additional Protocol No 1 to the ECHR and of Article 17 of the Charter, in particular the principle of the protection of legitimate expectations. |
| --- | --- |

209

By its fourth plea, the applicant alleges, first, breach of the principle of legal certainty; second, breach of the right to a fair hearing within the meaning of Article 47 of the Charter and Article 6 of the ECHR; and, third, breach of the right to peaceful enjoyment of its property within the meaning of Article 1 of Additional Protocol No 1 to the ECHR and of Article 17 of the Charter, in particular the principle of the protection of legitimate expectations.

| 210 | The ECHA disputes those arguments. |
| --- | --- |

210

The ECHA disputes those arguments.

| 211 | It should be remembered as a preliminary point that, according to the case-law, in a review of restrictions the Courts of the European Union must, in accordance with the powers conferred on them, ensure the review, in principle the full review, of the lawfulness of all Union acts in the light of the fundamental rights forming an integral part of the EU legal order. That obligation is expressly laid down by the second paragraph of Article 275 TFEU (see judgment of 28 November 2013, Council v Fulmen and Mahmoudian, C‐280/12 P, EU:C:2013:775, paragraph 58 and the case-law cited). |
| --- | --- |

211

It should be remembered as a preliminary point that, according to the case-law, in a review of restrictions the Courts of the European Union must, in accordance with the powers conferred on them, ensure the review, in principle the full review, of the lawfulness of all Union acts in the light of the fundamental rights forming an integral part of the EU legal order. That obligation is expressly laid down by the second paragraph of Article 275 TFEU (see judgment of 28 November 2013, Council v Fulmen and Mahmoudian, C‐280/12 P, EU:C:2013:775, paragraph 58 and the case-law cited).

| 212 | Such fundamental rights include, inter alia, observance of the right to a fair trial before a court as set out in the second paragraph of Article 47 of the Charter and Article 6 of the ECHR and right to property, as referred to in Article 17 of the Charter and in Article 1 of Additional Protocol No 1 to the ECHR. |
| --- | --- |

212

Such fundamental rights include, inter alia, observance of the right to a fair trial before a court as set out in the second paragraph of Article 47 of the Charter and Article 6 of the ECHR and right to property, as referred to in Article 17 of the Charter and in Article 1 of Additional Protocol No 1 to the ECHR.

| 213 | Since the ECHA does not constitute a court within the meaning of Article 47 of the Charter and Article 6 of the ECHR and the latter provisions therefore do not apply in the present case, the applicant may not successfully assert the right to a fair trial against the contested decision. |
| --- | --- |

213

Since the ECHA does not constitute a court within the meaning of Article 47 of the Charter and Article 6 of the ECHR and the latter provisions therefore do not apply in the present case, the applicant may not successfully assert the right to a fair trial against the contested decision.

| 214 | If, on the other hand, the applicant’s reference to the right to a fair trial must be understood as referring to its right to have its case dealt with impartially and fairly by the ECHA, all within the meaning of Article 41(1) of the Charter, it must be pointed out that the applicant has in no way shown that the ECHA has not fulfilled its obligations under that provision. |
| --- | --- |

214

If, on the other hand, the applicant’s reference to the right to a fair trial must be understood as referring to its right to have its case dealt with impartially and fairly by the ECHA, all within the meaning of Article 41(1) of the Charter, it must be pointed out that the applicant has in no way shown that the ECHA has not fulfilled its obligations under that provision.

| 215 | As regards the right to peaceful enjoyment of its property, as enshrined in Article 17 of the Charter and in Article 1 of Additional Protocol No 1 to the ECHR, the applicant refers, first, to the financial means it allegedly invested in the procedure to have the application for authorisation for the use of DEHP processed, and, second, to the risk of not obtaining such an authorisation as a result of the adoption of the contested decision. Moreover, at the hearing the applicant stated that the other property rights it could not enjoy as a result of the adoption of the contested decision included the right of an undertaking that uses and produces DEHP to produce it. |
| --- | --- |

215

As regards the right to peaceful enjoyment of its property, as enshrined in Article 17 of the Charter and in Article 1 of Additional Protocol No 1 to the ECHR, the applicant refers, first, to the financial means it allegedly invested in the procedure to have the application for authorisation for the use of DEHP processed, and, second, to the risk of not obtaining such an authorisation as a result of the adoption of the contested decision. Moreover, at the hearing the applicant stated that the other property rights it could not enjoy as a result of the adoption of the contested decision included the right of an undertaking that uses and produces DEHP to produce it.

| 216 | As regards the financial means allegedly invested by the applicant in the procedure for processing the application for authorisation, suffice it to observe that the applicant has not established how exactly those investments would have been affected by the contested decision. Those alleged investments can only concern DEHP as a substance fulfilling the criterion set out in Article 57(c) of Regulation No 1907/2006. Such investments would have been incurred even without the identification of that substance as an endocrine disruptor of very high concern under Article 57(f) of that regulation. |
| --- | --- |

216

As regards the financial means allegedly invested by the applicant in the procedure for processing the application for authorisation, suffice it to observe that the applicant has not established how exactly those investments would have been affected by the contested decision. Those alleged investments can only concern DEHP as a substance fulfilling the criterion set out in Article 57(c) of Regulation No 1907/2006. Such investments would have been incurred even without the identification of that substance as an endocrine disruptor of very high concern under Article 57(f) of that regulation.

| 217 | As regards the applicant’s risk of not obtaining an authorisation under Article 60 of Regulation No 1907/2006, it is clear that the procedure for obtaining an authorisation undertaken by the applicant refers to DEHP as toxic for reproduction under Article 57(c) of Regulation No 1907/2006. This type of authorisation is not precluded due to the inclusion of DEHP as an endocrine disruptor of very high concern within the meaning of Article 57(f) of the same regulation in the candidate list of substances. |
| --- | --- |

217

As regards the applicant’s risk of not obtaining an authorisation under Article 60 of Regulation No 1907/2006, it is clear that the procedure for obtaining an authorisation undertaken by the applicant refers to DEHP as toxic for reproduction under Article 57(c) of Regulation No 1907/2006. This type of authorisation is not precluded due to the inclusion of DEHP as an endocrine disruptor of very high concern within the meaning of Article 57(f) of the same regulation in the candidate list of substances.

| 218 | Lastly, with regard to the rights to manufacture DEHP, it must be pointed out that the existence, scope or legal nature of those rights has not been established, so that it is not possible to conclude that there was any interference with them. |
| --- | --- |

218

Lastly, with regard to the rights to manufacture DEHP, it must be pointed out that the existence, scope or legal nature of those rights has not been established, so that it is not possible to conclude that there was any interference with them.

| 219 | Moreover, irrespective of the categorisation of the factors relied on by the applicant to demonstrate the existence of ‘property’ within the meaning of Article 17 of the Charter and Article 1 of Additional Protocol No 1 to the ECHR, it should be noted that, according to the explanations given by the applicant at the hearing, its arguments concerning property rights are not intended to have an autonomous scope in the present action, but rather constitute argument supplementing what the applicant has submitted in the context of the previous pleas. More specifically, in the applicant’s submission, the property rights could be compromised by the unlawfulness of the contested decision inasmuch as that unlawfulness derives from what the applicant has already set out in the context of the other pleas. |
| --- | --- |

219

Moreover, irrespective of the categorisation of the factors relied on by the applicant to demonstrate the existence of ‘property’ within the meaning of Article 17 of the Charter and Article 1 of Additional Protocol No 1 to the ECHR, it should be noted that, according to the explanations given by the applicant at the hearing, its arguments concerning property rights are not intended to have an autonomous scope in the present action, but rather constitute argument supplementing what the applicant has submitted in the context of the previous pleas. More specifically, in the applicant’s submission, the property rights could be compromised by the unlawfulness of the contested decision inasmuch as that unlawfulness derives from what the applicant has already set out in the context of the other pleas.

| 220 | The examination of the other pleas has not revealed any evidence capable of affecting the lawfulness of the contested decision, however. Consequently, the arguments relating to property rights must be rejected, as must the arguments relating to the rights arising under Articles 41(1) and 47 of the Charter and Article 6 of the ECHR. |
| --- | --- |

220

The examination of the other pleas has not revealed any evidence capable of affecting the lawfulness of the contested decision, however. Consequently, the arguments relating to property rights must be rejected, as must the arguments relating to the rights arising under Articles 41(1) and 47 of the Charter and Article 6 of the ECHR.

| 221 | As observed in paragraphs 135 to 153 above, the contested decision does not infringe the principles of legal certainty or the protection of legitimate expectations. |
| --- | --- |

221

As observed in paragraphs 135 to 153 above, the contested decision does not infringe the principles of legal certainty or the protection of legitimate expectations.

| 222 | Consequently, the fourth plea must also be rejected and the action must be dismissed in its entirety. |
| --- | --- |

222

Consequently, the fourth plea must also be rejected and the action must be dismissed in its entirety.

Costs

| 223 | 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. As the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by the ECHA, in accordance with the form of order sought by the ECHA, including the costs of the interlocutory proceedings. |
| --- | --- |

223

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. As the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by the ECHA, in accordance with the form of order sought by the ECHA, including the costs of the interlocutory proceedings.

| 224 | Under Article 138(1) and (2) of the Rules of Procedure, the Member States, and States other than the Member States which are parties to the Agreement on the European Economic Area (EEA) which intervened in the proceedings must bear their own costs. The Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway must accordingly bear their own costs. |
| --- | --- |

224

Under Article 138(1) and (2) of the Rules of Procedure, the Member States, and States other than the Member States which are parties to the Agreement on the European Economic Area (EEA) which intervened in the proceedings must bear their own costs. The Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway must accordingly bear their own costs.

| | On those grounds,
  THE GENERAL COURT (Fifth Chamber),
  hereby: |
| --- | --- |

On those grounds,

THE GENERAL COURT (Fifth Chamber),

hereby:

| | 1. | Dismisses the action; |
| --- | --- | --- |

1.

Dismisses the action;

Dismisses the action;

| | 2. | Orders Deza, a.s. to bear its own costs and to pay the costs incurred by the European Chemicals Agency (ECHA), including the costs of the interlocutory proceedings; |
| --- | --- | --- |

2.

Orders Deza, a.s. to bear its own costs and to pay the costs incurred by the European Chemicals Agency (ECHA), including the costs of the interlocutory proceedings;

Orders Deza, a.s. to bear its own costs and to pay the costs incurred by the European Chemicals Agency (ECHA), including the costs of the interlocutory proceedings;

| | 3. | Orders the Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway to bear their own costs. |
| --- | --- | --- |

3.

Orders the Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway to bear their own costs.

Orders the Kingdom of Denmark, the Kingdom of the Netherlands, the Kingdom of Sweden and the Kingdom of Norway to bear their own costs.

| | Gratsias
  Dittrich
  Xuereb
  Delivered in open court in Luxembourg on 11 May 2017.
  [Signatures] |
| --- | --- |

Gratsias

Dittrich

Xuereb

Delivered in open court in Luxembourg on 11 May 2017.

[Signatures]

---

(
  *1
  )	Language of the case: Czech.

*1