Case T‑115/15

Deza, a.s.

v

European Chemicals Agency

(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)

Summary — Judgment of the General Court (Fifth Chamber), 11 May 2017

1. Actions for annulment — Natural or legal persons — Measures of direct and individual concern to them — Whether directly concerned — Criteria — Decision of the European Chemicals Agency (ECHA) identifying a substance as being of very high concern — Action brought by suppliers of the substance — Admissibility

   (Art. 263, fourth para., TFEU; European Parliament and Council Regulation No 1907/2006, Arts 31(9), 57(f), and 59)

2. Actions for annulment — Natural or legal persons — Meaning of ‘regulatory act’ in Article 263, fourth paragraph, TFEU — Any act of general scope other than legislative acts — Decision of the European Chemicals Agency (ECHA) identifying a substance as being of very high concern — Inclusion — Act not containing implementing measures within the meaning of that provision of the Treaty

   (Arts 263, fourth para., TFEU and 289 TFEU; European Parliament and Council Regulation No 1907/2006, Arts 31, 57(f), and 59 and Annex XIV)

3. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for inclusion in Annex XIV — Amendment of an existing entry — Competence of the European Chemicals Agency (ECHA)

   (European Parliament and Council Regulation No 1907/2006, Arts 57 and 59(8), and Annex XIV)

4. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for inclusion in Annex XIV — Simultaneous submission of several proposals for identifying the substance — Possibility of withdrawing one or more of the submissions in the course of the procedure — Proposals submitted in a single document — Irrelevant

   (European Parliament and Council Regulation No 1907/2006, Arts 57 and 59)

5. Actions for annulment — Grounds — Misuse of powers — Concept

   (Art. 263 TFEU)

6. EU law — Principles — Legal certainty — EU rules — Requirements of clarity and foreseeability

7. Actions for annulment — Grounds — Breach of legitimate expectations — Economic operators relying on legitimate expectation in the continuation of an existing situation — Dismissal

   (Art. 263 TFEU)

8. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — Discretion of the EU authorities — Scope — Judicial review — Limits — Manifest error, misuse of powers or manifest exceeding of the limits of the discretion

   (European Parliament and Council Regulation No 1907/2006, Arts 57 and 59)

9. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — Endocrine-disrupting substances capable of having serious effects on the environment — Burden of proof

   (European Parliament and Council Regulation No 1907/2006, Arts 1(3), and 57(f))

10. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — Assessment of hazards linked to the intrinsic properties of a substance — Criteria for assessment

    (European Parliament and Council Regulation No 1907/2006, Art. 57)

11. Judicial proceedings — Introduction of new pleas during the proceedings — Plea raised for the first time at the reply stage — Inadmissibility

    (Rules of Procedure of the General Court, Art. 84)

12. EU law — Principles — Fundamental rights — Compliance ensured by the EU judicature

    (Art. 6(3) TEU; Art. 275, second para., TFEU)

13. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Substances of very high concern — Procedure for inclusion in Annex XIV — Amendment of an existing entry — Article 47 of the Charter of Fundamental Rights inapplicable

    (European Parliament and Council Regulation No 1907/2006, Arts 57 and 59(8), and Annex XIV)

1.  See the text of the decision.

   (see para. 30)

2.  A decision of the European Chemicals Agency identifying a substance as a substance of very high concern under Article 57(f) of Regulation No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), constitutes a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU. 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.

   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 paras 32, 33, 35)

3.  The European Chemicals Agency (ECHA) has the power to supplement an existing entry in the Candidate list, that is to say the list of substances identified for inclusion in Annex XIV to Regulation No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), with another ground within the meaning of one of the points of Article 57 of Regulation No 1907/2006.

   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. 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.

   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.

   (see paras 54, 55, 67, 70)

4.  Article 59 of Regulation No 1907/2006 does not 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.

   It follows that, in the vote taking place within the debates of the Member State Committee, concerning a substance, which has occurred after a Member State has 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 other proposals, there is no infringement of Article 59(8) and (9) of Regulation No 1907/2006 or of the right of the supplier of the substance in question to be heard.

   (see paras 86, 91)

5.  See the text of the decision.

   (see para. 105)

6.  See the text of the decision.

   (see para. 135)

7.  See the text of the decision.

   (see paras 137, 138, 151)

8.  See the text of the decision.

   (see paras 163, 164)

9.  As regards the applicable standard of proof under Article 57(f) of Regulation No 1907/2006, according to the wording of that provision, 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 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.

   (see para. 173)

10.  An assessment of the hazards linked to the intrinsic properties of substances, as referred to in Article 57 of Regulation No 1907/2006, 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 para. 200)

11.  See the text of the decision.

    (see paras 206, 207)

12.  See the text of the decision.

    (see para. 211)

13.  Since the ECHA does not constitute a court within the meaning of Article 47 of the Charter of Fundamental Rights of the European Union and Article 6 of the European Convention on Human Rights, the latter provisions may not validly be invoked against an ECHA decision amending the entry of a substance on the list of substances identified with a view to inclusion in Annex XIV to Regulation No 1907/2006.

    (see para. 213)