OPINION OF ADVOCATE GENERAL

SHARPSTON

delivered on 6 July 2017 ( 1 )

Case C‑650/15 P

Polyelectrolyte Producers Group GEIE (PPG)

SNF SAS

v

European Chemicals Agency

‛Appeal — Regulation (EC) No 1907/2006 (REACH Regulation) — Substances of very high concern — Establishment of a list of substances identified for eventual inclusion in Annex XIV (list of substances subject to authorisation) — Decision identifying acrylamide as a substance fulfilling the criteria for inclusion on the list — Article 2(8)(b) — Exemption — Concept of ‘intermediate’ — Duty to state reasons — Principle of proportionality’

1. This is an appeal brought against the judgment of the General Court of 25 September 2015, PPG and SNF v ECHA ( 2 ) (‘the judgment under appeal’). In that judgment, the General Court dismissed the action brought by Polyelectrolyte Producers Group GEIE (‘PPG’) and SNF SAS (‘SNF’) seeking annulment of the decision of the European Chemicals Agency (‘the ECHA’ or ‘the Agency’) (ED/68/2009) identifying acrylamide (EC No 201-173-7) as a substance of very high concern (‘an SVHC’) fulfilling the criteria set out in Article 57 of the REACH Regulation ( 3 ) and including it in the candidate list of substances for eventual inclusion in Annex XIV of that regulation (‘the decision at issue’).

2. The appeal provides the Court with the opportunity to interpret Article 2(8)(b) of the REACH Regulation, which exempts on-site and transported isolated intermediates from Title VII of that regulation. That title concerns SVHCs and sets out the rules and procedures applicable, first, to their identification and eventual inclusion in the list of substances subject to authorisation and, second, to their authorisation once included in that list. Such an analysis will require the Court to define the concept of ‘intermediate’ and determine whether the intermediate uses of substances should be taken into consideration when identifying an SVHC.

The REACH Regulation

3. The purpose of the REACH Regulation is to ensure a high level of protection of human health and the environment. That includes promoting alternative methods for assessment of substances’ hazards and their free movement on the internal market, while enhancing competitiveness and innovation. ( 4 )

4. Recital 12 states that the REACH Regulation seeks ‘to encourage and in certain cases to ensure that [SVHCs] are eventually replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available’.

5. Recital 22 notes that the authorisation provisions ‘should ensure the good functioning of the internal market while assuring that the risks from [SVHCs] are properly controlled’.

6. According to recital 41, ‘for reasons of workability and because of their special nature, specific registration requirements should be laid down for intermediates’.

7. Article 2 sets out the exemptions from the scope of the REACH Regulation. Article 2(1)(c) provides that the regulation is not to apply to non-isolated intermediates. Article 2(8) provides that ‘on-site isolated intermediates and transported isolated intermediates shall be exempted from: (a) Chapter 1 of Title II, with the exception of Articles 8 and 9; and (b) Title VII.’

8. Article 3 contains the following definitions: ‘1. substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition; … 15. intermediate: means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis): (a) non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture; (b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities; (c) transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites; 16. site: means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared; ...’

9. Title VII concerns the authorisation procedure. According to Article 55, the aim of that title is to ‘ensure the good functioning of the internal market while assuring that the risks from [SVHCs] are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable’. Article 56(1)(a) sets out the general principle that manufacturers, importers or downstream users may not place a substance that has been included in Annex XIV (entitled ‘List of substances subject to authorisation’) on the market for use, or use it themselves, unless its uses have been authorised.

10. According to Article 57, the substances that may be included in Annex XIV are as follows: ‘(a) substances meeting the criteria for classification as carcinogenic category 1 or 2 in accordance with Directive 67/548/EEC; [ ( 5 )] (b) substances meeting the criteria for classification as mutagenic category 1 or 2 in accordance with Directive 67/548/EEC; (c) substances meeting the criteria for classification as toxic for reproduction category 1 or 2 in accordance with Directive 67/548/EEC; (d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation; (e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation; (f) substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.’

11. Article 59(2) to (10) lays down the procedure for identifying substances meeting the criteria referred to in Article 57 and establishing a candidate list for eventual inclusion in Annex XIV: ‘2. The [European] Commission may ask the Agency to prepare a dossier in accordance with relevant Sections of Annex XV for substances which in its opinion meet the criteria set out in Article 57. The dossier may be limited, if appropriate, to a reference to an entry in Part 3 of Annex VI to Regulation (EC) No 1272/2008. The Agency shall make this dossier available to the Member States. 3. Any Member State may prepare a dossier in accordance with Annex XV for substances which in its opinion meet the criteria set out in Article 57 and forward it to the Agency. The dossier may be limited, if appropriate, to a reference to an entry in Part 3 of Annex VI to Regulation (EC) No 1272/2008. The Agency shall make this dossier available within 30 days of receipt to the other Member States. 4. The Agency shall publish on its website a notice that an Annex XV dossier has been prepared for a substance. The Agency shall invite all interested parties to submit comments within a specified deadline to the Agency. 5. Within 60 days of circulation, the other Member States or the Agency may comment on the identification of the substance in relation to the criteria in Article 57 in the dossier to the Agency. 6. If the Agency does not receive or make any comments, it shall include this substance on the list referred to in paragraph 1. The Agency may include this substance in its recommendations under Article 58(3). 7. When comments are made or received, the Agency shall refer the dossier to the Member State Committee within 15 days of the end of the 60-day period referred to in paragraph 5. 8. If, within 30 days of the referral, the Member State Committee reaches a unanimous agreement on the identification, the Agency shall include the substance in the list referred to in paragraph 1. The Agency may include that substance in its recommendations under Article 58(3). 9. If the Member State Committee fails to reach a unanimous agreement, the Commission shall prepare a draft proposal on the identification of the substance within three months of receipt of the opinion of the Member State Committee. A final decision on the identification of the substance shall be taken in accordance with the procedure referred to in Article 133(3). 10. The Agency shall publish and update the list referred to in paragraph 1 on its website without delay after a decision on inclusion of a substance has been taken.’

Background to the dispute

The decision at issue

12. PPG is a European economic interest grouping which represents the interests of companies that are producers or importers of polyelectrolytes, polyacrylamide or other polymers containing acrylamide. SNF is one of its member companies.

13. Acrylamide is a monomer substance used to form polyacrylamide by polymerisation. ( 6 ) Polyacrylamide is most commonly used in water treatment, the paper industry, the mining industry, the oil industry, in agriculture, as a textile additive and in the cosmetics and personal-care sectors.

14. On 25 August 2009, the Kingdom of the Netherlands submitted to the ECHA a dossier concerning the identification of acrylamide as a carcinogenic and mutagenic substance, fulfilling the criteria set out in Article 57(a) and (b) of the REACH Regulation with a view to that substance being placed on the candidate list of substances for inclusion in Annex XIV of that regulation (‘the candidate list’). On 31 August 2009, the ECHA published a notice on its website inviting interested parties to submit comments on that dossier. It also invited the competent authorities of other Member States to submit comments on the matter.

15. On 27 November 2009, the Member State Committee, to which the dossier was referred pursuant to Article 59(7) of the REACH Regulation, unanimously agreed on the identification of acrylamide as an SVHC, since it fulfilled the criteria set out in Article 57(a) and (b) of that regulation.

16. On 22 December 2009, the Executive Director of the ECHA adopted the decision at issue. On 30 March 2010, the ECHA published the candidate list including acrylamide.

Proceedings before the General Court and the Court of Justice

17. By application lodged at the Registry of the General Court on 10 June 2010, PPG and SNF brought an action for annulment of the decision at issue.

18. By order of 21 September 2011 in PPG and SNF v ECHA, ( 7 ) the General Court dismissed the action as inadmissible.

19. By judgment of 26 September 2013 in PPG and SNF v ECHA, ( 8 ) the Court of Justice set aside that order, referred the case back to the General Court and reserved the costs.

The judgment under appeal

20. Following the Court’s judgment, the General Court rejected the objection of inadmissibility raised by the ECHA and addressed the merits of the case. ( 9 )

21. By their first plea, PPG and SNF submitted that the decision at issue infringed Articles 2(8)(b) and 59 of the REACH Regulation. They argued that acrylamide is an intermediate exempted from identification as an SVHC under Article 59. The General Court rejected that argument. It found that according to the definition of an intermediate, laid down in Article 3(15), the classification of a substance as an intermediate depends on the intended purpose of its manufacture and use. The fact that a substance has, in a specific case, the status of an intermediate does not mean that it should be exempted from the identification procedure provided for by Article 59.

22. By their second plea, PPG and SNF submitted that the ECHA committed a manifest error of assessment by accepting that not all uses of acrylamide are intermediate. The General Court found that the ECHA has a broad discretion as to the assessment of highly complex scientific and technical facts. The dossier drawn up by the Kingdom of the Netherlands in accordance with Annex XV to the REACH Regulation indicates that 99% of acrylamide in the European Union was used as an intermediate in the production of polyacrylamides for a number of applications; that there were other uses as an agent in grouting products and for on-site preparation of polyacrylamide gels; and that it could not be concluded that all uses of acrylamide referred to by the Kingdom of the Netherlands in its dossier were intermediate in nature.

23. With regard to the third plea (alleged breach of the principle of proportionality), the General Court found that (i) omission to act; (ii) adoption of restrictions under Title VIII of the REACH Regulation; and (iii) legislation on the protection of workers could not be considered as appropriate and/or less onerous measures compared to identifying acrylamide as an SVHC.

24. By their fourth plea, PPG and SNF submitted that the ECHA breached the principle of equal treatment by treating acrylamide less favourably than other substances in an identical situation that had not been identified as SVHCs. The General Court found that, under Article 59(2) and (3), it was the Commission and the Member States who chose the substances to be included in Annex XIV. The ECHA could not, without exceeding its powers, proceed to the identification of a substance in the absence of a dossier prepared by a Member State or requested by the Commission. It follows that by identifying acrylamide as an SVHC, and not other allegedly comparable substances, the ECHA did not breach the principle of equal treatment. No further reasoning was necessary to that effect.

25. In its judgment of 25 September 2015 the General Court therefore dismissed the action in its entirety.

The appeal before the Court of Justice and forms of order sought by the parties

26. By an appeal lodged with the Court Registry on 4 December 2015, PPG and SNF ask the Court to set aside the judgment under appeal, to give final judgment and annul the decision at issue or, alternatively, to refer the case back to the General Court. They also ask this Court to order the ECHA to pay the costs of the proceedings, including the costs of the proceedings before the General Court.

27. PPG and SNF put forward six grounds of appeal, which may be summarised as follows. The first ground of appeal alleges an error in law in the interpretation of the definition of ‘intermediate’ in Article 3(15) of the REACH Regulation. The second ground of appeal alleges a breach of the duty to state reasons by the General Court insofar as it failed to address the argument that Article 2(8)(b) exempts on-site isolated intermediates and transported isolated intermediates from Title VII in its entirety. The third ground of appeal complains that the General Court erred in law in finding that intermediates are not exempt from Article 59 of the REACH Regulation. The fourth ground of appeal alleges an error in law by the General Court in finding that the ECHA did not commit a manifest error of assessment by failing to take into consideration the information in Annex XV. The fifth ground of appeal complains of an error in assessing the proportionality of the decision at issue. The sixth ground of appeal alleges a breach of the duty to state reasons inasmuch as the General Court failed to address the less onerous measures put forward by PPG and SNF.

28. The ECHA asks the Court to dismiss the appeal as unfounded, to confirm the judgment under appeal and to order PPG and SNF to pay the costs of the proceedings, including the costs of the proceedings before the General Court. The European Commission asks the Court to dismiss the grounds of appeal. The Netherlands supports the ECHA in the appeal.

29. PPG and SNF, the ECHA and the European Commission presented oral argument at the hearing on 11 January 2017.

Preliminary observations

30. This appeal essentially concerns the scope of the exemption of isolated intermediates from the authorisation procedure for SVHCs laid down by Title VII of the REACH Regulation.

31. The REACH Regulation introduces an integrated system for monitoring chemical substances, including registration, evaluation and authorisation. ( 10 ) According to the Commission’s Proposal for a Regulation, (i) registration ‘requires industry to obtain relevant information on their substances and to use that data to manage them safely’; (ii) evaluation ‘provides confidence that industry is meeting its obligations …’; (iii) authorisation concerns SVHCs whose ‘risks associated with uses … will be reviewed and, if they are adequately controlled, or if the socio-economic benefits outweigh the risks and there are no suitable alternative substitute substances or technologies, then the uses will be granted an authorisation’; and (iv) restrictions provide ‘a safety net to manage risks that have not been adequately addressed by another part of the REACH system’. ( 11 )

32. The REACH Regulation is based on the precautionary principle as enshrined in Article 191 TFEU. ( 12 ) In accordance with that principle and in order to ensure a sufficiently high level of protection for human health and the environment, SVHCs must be subject to careful attention. ( 13 )

33. Title VII of the REACH Regulation sets out the authorisation process for SVHCs.

34. The first stage consists in identifying the SVHCs in accordance with Article 57. SVHCs are those substances listed in either Article 57(a) to (e) due to their carcinogenic, mutagenic or reproductive toxic properties, or because they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative, or in Article 57(f), which includes all other substances ‘for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e)’. ( 14 )

35. Article 59 lays down the procedure for identifying those substances.

36. First, an Annex XV dossier is prepared by a Member State or the ECHA (in the latter case, after a request by the Commission). That dossier must include the identity of the substance concerned, a justification of the proposed qualification of the substance concerned and the available use and exposure information as well as information on alternative substances and techniques. The ECHA makes this dossier available to the Member States. ( 15 ) Second, the ECHA publishes on its website a notice that an Annex XV dossier has been prepared for a substance and invites all interested parties to submit comments within a deadline that it specifies. ( 16 ) If there are no comments, the third step is the inclusion of the substance in the candidate list, pursuant to Article 59(6). If the ECHA receives comments, it must refer the dossier to the Member State Committee. The ECHA will then include the substance in the candidate list only after that Committee has reached unanimous agreement or the Commission has prepared a draft proposal and a final decision has been taken in accordance with the comitology procedure referred to in Article 133(3). ( 17 )

37. It is clear from Article 59(1) of the REACH Regulation that the objective of the first stage is to identify SVHCs and to establish the candidate list for possible inclusion in Annex XIV.

38. The second stage of the procedure consists in including certain candidate substances in Annex XIV, entitled ‘List of substances subject to authorisation’. First, the ECHA issues recommendations on priority SVHCs to be included in Annex XIV. ( 18 ) Then, based on the ECHA’s recommendation, the Commission may decide to include a substance from the candidate list in the authorisation list of Annex XIV. That decision is taken according to the procedure laid down in Articles 5a(1) to (4) and 7 of Decision 1999/468/EC. ( 19 ) It must specify for each substance its identity, its intrinsic property or properties that justified its identification according to Article 57, any transitional arrangements that may apply, review periods for certain uses (if appropriate) and any uses or categories of uses exempted from the authorisation requirement together with the conditions for applying for such exemptions, if any. ( 20 )

39. The third stage of the authorisation procedure consists in granting authorisations for the substances included in Annex XIV. Applications for authorisation are to be made to the ECHA by the manufacturer(s), importer(s) or downstream user(s) of the substance. ( 21 ) It is the Commission that adopts authorisation decisions, on the basis of the procedure laid down in Article 64.

40. SVHCs that have been included in Annex XIV may not be placed on the market for a use or be used by manufacturers, importers, or downstream users unless they have been authorised or fall into certain limited categories set out in the regulation. ( 22 ) However, medicinal products, food or feedingstuffs and on-site and transported isolated intermediates are exempted from Title VII pursuant to Article 2(5) and (8) of the REACH Regulation.

41. It is the interaction between the first stage of the identification procedure, set out in points 35 to 37 above, and the exemption of isolated intermediates from authorisation laid down in Article 2(8)(b) of the REACH Regulation that lies at the heart of this appeal.

42. Against that background, I shall now examine the present appeal. Of the six grounds of appeal it seems to me that the first and third should be examined first, since they concern the scope of the exemption of intermediates from Title VII of the REACH Regulation.

First ground of appeal: error in law in the interpretation of the definition of ‘intermediates’

Summary of the relevant passages of the judgment under appeal

43. The General Court ruled that the fact that a substance may have an intermediate status does not mean that it is exempt from identification as being of very high concern in accordance with the procedure referred to in Article 59 of the REACH Regulation. ( 23 )

44. The General Court examined the uses of acrylamide as a grouting agent through polymerisation and for the preparation of polyacrylamide electrophoresis gels. As regards grouting, it found that the use of acrylamide is not an intermediate use but rather an end-use of the substance. ( 24 ) Sections 2 and 4 of the ‘Definition of intermediates as agreed by Commission, Member States and ECHA on4 May 2010’ ( 25 ) support that conclusion. ( 26 ) As regards the preparation of polyacrylamide electrophoresis gels, the intention behind the handcast preparation, which is one of the steps in the electrophoresis protocol, is not the manufacturing of polyacrylamide as such but the analytical separation of molecules by electrophoresis. ( 27 ) In any case, the fact that the three registration dossiers for acrylamide on the ECHA database all identify acrylamide as an intermediate does not mean that that substance was used exclusively as an intermediate. ( 28 )

45. The General Court pointed out that, under the REACH Regulation, a substance is defined by its intrinsic properties, whereas the concept of an intermediate is defined according to the intended purpose of the manufacture and use of the substance. ( 29 ) The fact that a substance may have an intermediate status therefore does not mean that it is exempt from identification as being of very high concern in accordance with the procedure referred to in Article 59 of the REACH Regulation. ( 30 )

The parties’ submissions

46. By their first ground of appeal, PPG and SNF submit that the General Court erred in law in its interpretation of the definition of ‘intermediate’, as set out in Article 3(15) of the REACH Regulation. That ground of appeal is divided into three parts.

47. First, PPG and SNF argue that the General Court’s interpretation of intermediates is contrary to the clear wording of the provisions on intermediates set out in the REACH Regulation. Acrylamide satisfies the definition of intermediates since it is manufactured for and consumed in a chemical reaction with the intention of being transformed into polyacrylamide. Therefore, its use in order to form polyacrylamide subsequently used as a grouting agent or for the preparation of electrophoresis gels should not be excluded from that definition. The end use of the synthesised substance or the chemical process subsequent to synthesis is not relevant for the definition of intermediates.

48. Second, the interpretation of intermediates by the General Court is contrary to the purpose of the provisions on intermediates of the REACH Regulation. Intermediates are a specific category of substances that are covered by the exemptions provided for in Article 2(8) of the REACH Regulation because they do not represent the same level of risk as substances to which there is significant exposure.

49. Third, PPG and SNF contend that the General Court erred in law when it relied on Appendix 4 of the ECHA Guidance on intermediates to support its interpretation of the definition of ‘intermediate’.

50. The ECHA responds that the definition of ‘intermediate’ must be interpreted strictly since it is the starting point for exempting those substances from the scope of certain provisions of the REACH Regulation. For a substance to qualify as an intermediate within the meaning of Article 3(15), the main aim of transforming that substance must be to contribute to the structure of a different substance whose manufacture is intended. Furthermore, intermediates are subject to lighter registration requirements when used under strictly controlled conditions on a ‘site’ as defined by Article 3(16). Therefore, where a substance is used for a specific end-use, in the place where that end-use is supposed to occur (for instance, the use of acrylamide in grouting), that use is not intermediate. Furthermore, the ECHA Guidance on intermediates was merely used by the General Court to buttress its conclusions.

51. For the Commission, the mere fact that one substance is transformed into another does not suffice to classify it as an intermediate. Without implying that there is a subjective criterion, the Commission argues that the purpose of the manufacturing and use of the substance and the aim of the chemical process should be taken into consideration when assessing whether that substance qualifies as an intermediate. It adds that the use of a substance as intermediate is irrelevant in relation to its identification as an SVHC under Article 59 of the REACH Regulation. Furthermore, PPG’s and SNF’s assertions regarding the General Court’s use of the ECHA Guidance are incorrect.

Assessment

52. In essence, the first ground of appeal raises the question of the definition of ‘intermediates’ under the REACH Regulation and the relationship of that term to ‘substances’.

53. ‘Substance’ is the main concept used to define the scope of the REACH Regulation. Recital 1 states that the regulation’s objectives are to ensure ‘a high level of protection of human health and the environment as well as the free movement of substances … while enhancing competitiveness and innovation’. Both the high level of protection of human health and the efficient functioning of the internal market for substances are to be achieved by the approximation of legislation on substances. ( 31 ) The core of the definition of ‘substance’ under Article 3(1) (‘a chemical element and its compounds in the natural state or obtained by any manufacturing process’), has remained unaltered since the earlier texts that were amended or repealed by that regulation ( 32 ) and the first directive on dangerous substances. ( 33 ) That definition is the ‘cornerstone of REACH, as substances are the main subject of REACH provisions’. ( 34 ) Furthermore, the definitions of most of the terms of the REACH Regulation, such as ‘polymer’, ‘monomer’ and ‘intermediate’, are directly based on the concept of ‘substance’.

54. When a substance is considered to be of very high concern, which means that it is particularly dangerous because of its intrinsic properties, it can be included in Annex XIV of the REACH Regulation, ‘List of substances subject to authorisation’, under the procedure described in points 33 to 38 above. The identification of SVHCs in terms of Article 57 does not address the intended uses of substances, but only their intrinsic properties.

55. ‘Intermediate’ is defined in Article 3(15). It is clear from the wording of that provision that an intermediate is (i) a substance; (ii) that is manufactured for chemical processing; (iii) that is consumed in or used for that processing; (iv) in order to be transformed into another substance. When it comes to isolated intermediates, such as acrylamide in the present case, a further condition applies before the substance will qualify as an intermediate under the REACH Regulation: the procedure must take place at a ‘site’, as defined by Article 3(16), or the substance must be transported between or supplied to other ‘sites’. The ratio legis here is to avoid risks for human health and the environment by ensuring that intermediates are only used under controlled conditions.

56. The difference between the concept of substance and the concept of intermediate is that the latter are manufactured for chemical processing and are used in order to create another substance. The latter definition thus encompasses both (i) the purpose of manufacturing intermediate substances as well as of their consumption or use, namely chemical processing, and (ii) the purpose of the chemical processing itself, which is the creation of another substance. For isolated intermediates, the definition also includes the concept of ‘site’.

57. The examination that requires to be conducted here is twofold: (i) whether or not there is a substance and (ii) whether or not the purpose and conditions of the manufacture, use and chemical processing of that substance correspond to those of the definition of an intermediate under the REACH Regulation. As PPG and SNF accepted at the hearing, the starting point for the analysis must be the concept of ‘substance’; first, the substance should be identified and then one should look at the ways it is used in order to verify if it corresponds to the definition of ‘intermediate’. I shall use a syllogism here: all intermediates are uses of substances, but only some substances’ uses are intermediate; therefore, a substance may have both intermediate and non-intermediate uses.

58. It follows from the above that the definition of intermediates adopted by the REACH Regulation is based on the purpose of the manufacture and use of the substance concerned. That is reflected both in the text of the regulation and in its purpose.

59. Thus, the text of Article 3(15) defines an ‘intermediate’ using the expressions ‘manufactured for’ and ‘in order to’. The purpose of the provisions on intermediates within the context of the authorisation procedure is to exempt certain uses of substances from the authorisation requirement in order to concentrate on the uses that pose the greatest risk. ( 35 ) That purpose should be interpreted according to the overall aim of the REACH Regulation and of the authorisation procedure, that is to say, the control of risks from SVHCs in the context of assuring a high level of protection of human health and the environment. ( 36 )

60. I therefore consider that the General Court correctly found, in paragraph 67 of the judgment under appeal, that the REACH Regulation defines an intermediate ‘according to the intended purpose of the manufacture and use of a substance’. That approach is in line both with the wording and the purpose of that regulation.

61. PPG and SNF also contend that the General Court erred in law when it categorised the use of acrylamide in grouting and for the preparation of electrophoresis gels as end uses and not intermediate uses of acrylamide.

62. The General Court’s reasoning regarding grouting applications and preparation of electrophoresis gels (paragraphs 54 to 58 of the judgment under appeal) rejects the intermediate nature of those uses. That reasoning is based on the argument that the main purpose of the chemical process is not the creation of polyacrylamide but the sealing function or the analytical separation of molecules by electrophoresis.

63. As I read the judgment under appeal, the General Court did not extend the scope of the definition in Article 3(15) nor did it introduce the absence of an end-use of the synthesised substance as an additional criterion into the definition of intermediates, as PPG and SNF maintain. On the contrary, the General Court applied the definition of intermediates, having regard to the intended purpose of the manufacture and use of a substance, to the letter. Indeed, as the General Court correctly pointed out, the purpose of using acrylamide in those two instances is not manufacturing polyacrylamide, but grouting or electrophoresis. The General Court therefore found as a fact that those two uses were not intermediate uses but end-uses.

64. It is true that some terminological variations in the judgment under appeal, such as the use of the words ‘intention’, ‘intended purpose’ or ‘intended objective’, could lead one to think that the General Court sought to introduce a subjective element of evaluation of intent in the definition of ‘intermediates’. However, in my view, an overall reading of the disputed passages shows that not to be the case. The occasional presence of those words does not therefore invalidate that Court’s reasoning.

65. Whether or not grouting applications and preparation of electrophoresis gels are uses of acrylamide, and if so what kind of uses, is a question of fact. On one view, the appellants are here asking this Court to reach different findings of fact. However, absent a distortion of facts (which is not alleged) the General Court’s findings of fact cannot be challenged on appeal. Even if one takes the view — more favourable to the appellants — that they are, rather, seeking to challenge the legal characterisation of those facts by the General Court and the legal conclusions it has drawn from them, it follows from the analysis that I have just set out that I consider that the General Court made a correct application of the law. ( 37 )

66. I therefore reject PPG’s and SNF’s arguments.

67. Regarding the reference at paragraph 55 of the judgment under appeal to Appendix 4 of the ECHA Guidance on intermediates, PPG and SNF maintain that the General Court should have assessed independently the legal soundness of that document and that it relies on sections that are irrelevant to the present case.

68. I consider that this argument should be rejected. In my view, the General Court’s interpretation of intermediates is correct and the fact that it invokes an extract of the ECHA Guidance on intermediates to support its conclusions concerning the use of acrylamide for grouting has no consequence as regards the operative part of the judgment under appeal. It cannot therefore justify its being set aside. ( 38 )

69. I therefore reject that argument and the first ground of appeal.

Third ground of appeal: error in law in the interpretation of the exemption of intermediates from Article 59 of the REACH Regulation

Summary of the relevant passages of the judgment under appeal

70. The General Court ruled that acrylamide, as a ‘substance’ under Article 3(1) of the REACH Regulation, can be subjected to the identification procedure provided for by Article 59. ( 39 ) Even though Article 2(8)(b) of that regulation exempts on-site isolated and transported isolated intermediates from Title VII, the fact that a substance may have the status of an intermediate does not mean that it is exempted from the identification procedure. ( 40 ) The fact that the dossier submitted by the Netherlands concerning the identification of acrylamide as a carcinogenic and mutagenic substance refers only to examples using that substance as an intermediate is not relevant for the purposes of identifying that substance as an SVHC meeting the criteria referred to in Article 57. That fact might, however, become relevant later in the authorisation procedure. ( 41 )

The parties’ submissions

71. By their third ground of appeal, PPG and SNF submit that the General Court erred in law in its interpretation of the exemption of intermediates from Title VII of the REACH Regulation on authorisation. That ground of appeal is composed of three parts.

72. First, PPG and SNF submit that the General Court’s finding that intermediates are not exempted from Article 59 is contrary to the clear intention of the legislature and the express wording of Article 2(8)(b) that excludes intermediates from Title VII in its entirety.

73. Second, they argue that the General Court erred in its interpretation of Article 59, since the general reference to ‘substances’ in that article cannot preclude the application of the specific exemptions for intermediates. Since the General Court acknowledged that intermediates are not subject to authorisation, it erred in law by not then concluding that intermediate uses are also not subject to Article 59. Furthermore, whether a substance benefits from an exemption from certain provisions must be verified before, not after, those provisions are applied to it. The appellants also argue that the procedure set out in Article 59 is not intended merely to identify substances having the properties listed in Article 57, but also establishes a list of substances that will eventually be included in Annex XIV.

74. Third, PPG and SNF contend that the General Court erred in law by ruling that intermediates are not exempted from Article 57. The fact that a substance has intrinsic properties of concern listed in Article 57 does not mean that the express exemption set out in Article 2(8)(b) can be ignored. Furthermore, the purpose of identifying substances having the intrinsic properties listed in Article 57 is not to identify all such substances but only those subject to inclusion in Annex XIV.

75. The ECHA argues that the General Court was correct in finding that Article 2(8)(b) of the REACH Regulation cannot prevent it from identifying acrylamide as an SVHC. The legislative background, the meaning and the application of that article in practice support this view. Moreover, Article 2(8)(b) is an exception to the requirement to apply for authorisation and should therefore be interpreted strictly.

76. Concerning Articles 57 and 59, the ECHA submits that the General Court was right to conclude that acrylamide constitutes a substance that can be subject to the identification procedure, irrespective of whether it is used only as an intermediate. Furthermore, the wording of those articles indicates that identifying and including a substance in the candidate list does not necessarily result in its inclusion in Annex XIV.

77. The Commission submits that the exemption in Article 2(8)(b) of the REACH Regulation must be understood as an exemption from all the provisions in Title VII which refer to the use of a substance as an intermediate. It adds that other uses, such as in medicinal products and in food and feedstuffs, are exempted from Title VII by virtue of Article 2(5) but do not prevent a substance from being identified and included in the candidate list. According to the Commission, PPG and SNF have not explained how a substance which is used as both an intermediate and a non-intermediate should be treated if their interpretation of Article 2(8)(b) were to be upheld.

Assessment

78. The third ground of appeal concerns the scope and effect of the exemption laid down in Article 2(8)(b) of the REACH Regulation. The three branches of the third ground of appeal all essentially concern that issue and I shall therefore consider them together.

79. First, it is necessary to bear in mind that exceptions to a principle must, according to settled case-law, be interpreted strictly. ( 42 ) That conclusion is valid a fortiori, when the principle is of a protective nature. Here, the authorisation procedure aims to control risks from SVHCs to human health and the environment. In that context, the precautionary principle which underpins the REACH Regulation is particularly relevant.

80. Second, the exemption set out in Article 2(8) is a partial exemption. It merely exempts on-site and transported isolated intermediates from Chapter 1 of Title II (except for Articles 8 and 9) and Title VII of the REACH Regulation. It therefore differs from the general exemptions from the scope of that regulation for radioactive substances, substances, mixtures and articles under customs supervision, non-isolated intermediates, the carriage of dangerous substances and waste contained in Article 2(1) and (2).

81. Third, in my view the exemption in Article 2(8)(a) and (b) concerns particular uses of substances, for the following reasons.

82. As I have already explained, the definition of intermediates adopted by the REACH Regulation must be construed having regard to the purpose of the manufacture and use of the substance in question. ( 43 ) It follows that the exemption from Title VII (on-site and transported isolated) for intermediates must be construed in the same way. It is use related and should be read as concerning intermediate uses of substances.

83. The legislative history of that exemption points in that direction. Thus, the White Paper that preceded the procedure promulgating the REACH Regulation states, in section 2.3 entitled ‘key elements of the proposed strategy’, that uses of substances which do not give rise to concern may be subject to general exemptions from the authorisation procedure for SVHCs. ( 44 ) The Commission’s Proposal for a Regulation repeats that principle and states that ‘certain uses may be exempted from the requirement to be authorised’ in order to ‘allow the authorisation process to concentrate on the uses of substances that are likely to pose the greatest risk’. ( 45 ) Both documents clearly indicate that the exemptions from authorisation concern uses of substances.

84. Furthermore, the initial draft of the REACH Regulation placed the exemption of intermediates from authorisation within Title VII. Article 53(5)(g) of the proposed regulation provided that (only) the first two paragraphs of that article, concerning authorisation, did not apply to ‘uses as an on-site isolated intermediate or as a transported isolated intermediate’. ( 46 ) It was the European Parliament which, with the stated intention of grouping all the exemptions affecting the scope of the REACH Regulation in one article at the beginning of the document for the sake of clarity, moved the exemption concerning intermediates to join the other exemptions from the scope of that regulation in Article 2. ( 47 ) On the other hand, Articles 57 and 59 have remained unaltered since the initial drafting of the proposed regulation. ( 48 ) They concern substances, as defined in Article 3(1).

85. It follows that a combined reading of Articles 2(8)(b), 3(1), 3(15)(b) and (c) and Title VII of the REACH Regulation leads to the conclusion that the exemption of on-site and transported isolated intermediates from Title VII is a use related exemption, that covers a substance’s specific intended use.

86. When it comes to applying the exemption in Article 2(8)(b) the line of reasoning should therefore be as follows: (i) the authorisation procedure concerns substances; (ii) the application of that procedure presupposes that the criteria for identification as an SVHC set out in Article 57 have already been fulfilled; ( 49 ) (iii) that identification depends only on the intrinsic properties of substances and not on their intended use; (iv) once a substance has been identified as an SVHC, it falls within the scope of the authorisation procedure, although its formal inclusion in the list of substances subject to authorisation may be deferred depending on the degree of priority granted by the ECHA; ( 50 ) however (v) when the identified SVHCs have intermediate uses, those uses are exempted from the scope of Title VII of that regulation; and finally (vi) if a substance has multiple uses, only one of which is exempt, the exemption will apply only to the quantity that is intended for the exempted use. ( 51 )

87. It follows from all the above considerations that Articles 57 and 59 of the REACH Regulation concern substances with certain intrinsic properties and not uses of substances. In contrast, Article 2(8)(b) merely exempts specific uses of substances (as an isolated intermediate) from Title VII. The effect of that exemption cannot be larger than its scope. Thus Article 2(8)(b) can only exempt intermediates from the articles of that title that concern uses of substances, not from the articles that concern intrinsic properties of substances.

88. I therefore conclude that the General Court did not err in law when it held that the fact that a substance may have intermediate status for certain uses does not mean that it is exempt from identification as an SVHC in accordance with the procedure in Article 59. ( 52 )

89. I consider therefore that the third ground of appeal should be dismissed.

Second ground of appeal: breach of the duty to state reasons

Summary of the relevant passages of the judgment under appeal

90. In paragraph 64 of the judgment under appeal, the General Court recalled that, under Article 2(8)(b) of the REACH Regulation, on-site isolated intermediates and transported isolated intermediates are exempted from Title VII. It therefore proceeded to examine whether, as a result of that exemption, the decision at issue was lawful insofar as it identified acrylamide as an SVHC. ( 53 )

91. The General Court held that the fact that a substance has, in a specific case, the status of an intermediate cannot exempt it from the identification procedure laid down in Article 59. ( 54 )

The parties’ submissions

92. In support of their second ground of appeal, PPG and SNF argue that the General Court breached the duty to state reasons by failing to address their arguments concerning Article 2(8)(b) of the REACH Regulation. They contend that the judgment under appeal failed to state why the clear and unambiguous exemption of on-site isolated intermediates and transported isolated intermediates from Title VII did not thereby also exclude the application of Article 59.

93. The ECHA submits that the reasoning of the General Court is straightforward and enables the appellants to know why their arguments were rejected. In this respect, it refers to paragraphs 65 to 70 of the judgment under appeal.

94. The Commission considers that the General Court sufficiently explained why a substance that is used as an intermediate may nevertheless be identified under Article 59 of the REACH Regulation.

Assessment

95. The obligation to state the reasons on which a judgment is based arises under Article 36 of the Statute of the Court of Justice, which applies to the General Court by virtue of the first paragraph of Article 53 thereof. It has consistently been held that the statement of the reasons on which a judgment of the General Court is based must clearly and unequivocally disclose that court’s reasoning in such a way as to enable the persons concerned to ascertain the reasons for the decision taken and the Court of Justice to exercise its power of review. ( 55 )

96. As I read the judgment under appeal, the General Court directly addressed the scope of the exemption laid down by Article 2(8)(b) of the REACH Regulation.

97. The General Court clearly explained its reasoning in paragraphs 65 to 70 of the judgment under appeal. It found that acrylamide is a substance under Article 3(1) of the REACH Regulation and that the fact that it has, in a specific case, the status of an intermediate cannot exempt it from the identification procedure.

98. In my view, the General Court’s reasoning is clear and expressed with sufficient detail to enable PPG and SNF to lodge their appeal and for the Court to make a ruling on appeal.

99. I therefore conclude that the General Court gave sufficient reasons for its decision and that the second ground of appeal is unfounded.

Fourth ground of appeal: error in law in the assessment of the obligation of the ECHA to consider the information in the Annex XV dossier

Summary of the relevant passages of the judgment under appeal

100. The fourth ground of appeal is aimed at the General Court’s rejection of the appellants’ claim that under Article 59, the identification of acrylamide should have been based on all the information contained in the Annex XV dossier prepared by the Netherlands, including the information concerning uses and exposure. The General Court held that even if that dossier referred only to examples of the use of acrylamide as an intermediate, that was not relevant for the purposes of identifying acrylamide as an SVHC, given that that information did not concern the intrinsic properties of acrylamide. The information on the uses of acrylamide could become relevant in the later stages of the procedure, namely the procedure for granting authorisations for specific uses. In any event, it cannot be concluded that all uses of acrylamide referred in that dossier are intermediate in nature.

The parties’ submissions

101. PPG and SNF argue that the General Court’s conclusion is based on an error in law. The information on the uses of a substance is a regulatory requirement for the Annex XV dossier and the ECHA is required to take that information into account. In the case of acrylamide, the information showed that that substance was only used as an intermediate, a fact relevant for the application of the exemption laid down in Article 2(8)(b) of the REACH Regulation.

102. The ECHA submits that the General Court was right to conclude that during the first stage of the authorisation process, which concerns the identification of a substance, it is not required to consider information about the use of a substance. In any event, the Annex XV dossier noted that there were two uses of acrylamide that were not intermediate.

Assessment

103. The preparation of an Annex XV dossier is a formal requirement of the procedure under Article 59 of the REACH Regulation. The purpose of that procedure is to identify substances that have the intrinsic properties referred to in Article 57 and that may, therefore, be subject to authorisation.

104. The obligatory content of an Annex XV dossier is laid down by the REACH Regulation itself. It comprises three parts: (i) the proposal; (ii) the justification and (iii) the information on use, exposure, alternative substances, and risks. The proposal is the essential part of the dossier, since it includes the identity of the substance concerned and its proposed identification according to the criteria laid down in Article 57. The justification is also fundamental, since it gives the reasons for the identification of substances.

105. The information on use, exposure, alternative substances and risks is also obligatory but it seems to me that its role is complementary. First, only the ‘available’ use and exposure information is required to be provided. ( 56 ) There is no duty to conduct research going beyond the information that is available in order to prepare an Annex XV dossier. Second, the term ‘use and exposure category’, defined in Article 3(38), ( 57 ) is used several times by that regulation. For instance, it is relevant to Title II, concerning the registration of substances, when it comes to the information to be submitted for general registration purposes (Article 10; see also Annex VI) and to Annex I, laying down general provisions for assessing substances and preparing chemical safety reports. In my view, it follows from the complementary nature of that information and from the fact that it is not supposed to be exhaustive that its role in Annex XV is only at the stage when exemptions of certain uses are being considered. It plays no part in the (prior) assessment of whether a particular substance should be identified as an SVHC.

106. I therefore consider that the General Court did not err in law when it found that even if the Annex XV dossier ‘refers only to examples of the use of that substance as an intermediate, that is not relevant for the purposes of identifying acrylamide as an [SVHC] …, given that that information does not concern the intrinsic properties of acrylamide’. ( 58 ) Indeed, both Article 57 and Annex XV are clear on this point: substances are identified as of very high concern when they have the properties listed in Article 57. ( 59 ) That provision makes no reference to the uses of substances for the purposes of identification. On the contrary, uses of substances are considered elsewhere, namely by Article 56, which lays down the general principle that substances included in Annex XIV cannot be placed on the market or used, and exceptions to that principle. That stage concerns the inclusion of substances in Annex XIV (Article 58), or in Chapter 2 of Title VII, which concerns the granting of authorisations.

107. I therefore consider that the fourth ground of appeal should be rejected.

Fifth and sixth grounds of appeal: error in law and breach of duty to state reasons in the assessment of the proportionality of the contested decision

Summary of the relevant passages of the judgment under appeal

108. The General Court rejected PPG’s and SNF’s arguments that the decision at issue breached the principle of proportionality. First, it found that the identification of acrylamide as an SVHC was not manifestly inappropriate in relation to the aim of protecting human health and the environment. Second, it found that the contested decision did not exceed the limits of what was necessary to achieve those objectives. In particular, the exemption of intermediate uses from identification is not a less onerous measure suitable to achieve the same aims. Rather, the legislature had introduced specific rules governing intermediates in Article 2(1)(c) and Article 2(8)(b) of the REACH Regulation.

The parties’ submissions

109. In support of their fifth ground of appeal, which is pleaded in the alternative, PPG and SNF argue that the General Court erred in law in its assessment of the principle of proportionality. A less onerous measure would have been to state expressly in the contested act that ‘identification and inclusion on the candidate list has no impact whatsoever on the use of intermediates’, since that solution has the advantage of reconciling the exemption of intermediates under Article 2(8)(b) with the identification procedure under Article 59.

110. PPG and SNF also submit, by their sixth ground of appeal, that the General Court’s assessment, set out in the second sentence of paragraph 93, does not enable them to understand why that measure is not a less onerous measure which the ECHA should therefore have adopted.

111. The ECHA submits that the General Court did not err in law applying the principle of proportionality. It must be allowed a broad discretion in a field which entails political, economic and social choices on its part and which requires it to undertake complex assessments. Furthermore, the General Court complied with its duty to state reasons in that regard. The reference in paragraph 93 of the judgment under appeal to the specific rules relating to intermediates introduced by the EU legislature, namely Article 2(1)(c) and Article 2(8)(b), and the cross reference to paragraph 48 were sufficient.

112. The Commission argues that the General Court fully addressed the ECHA’s alleged breach of the principle of proportionality. Furthermore, the alternative put forward by PPG and SNF is redundant because the consequence that it spells out stems directly from Article 2(8)(b) of the REACH Regulation itself. The restatement in different words of what is already laid down in legislation is not a ‘measure’ nor is it a ‘less onerous’ one given that the suggested addition has no legal or practical effect.

Assessment

113. In paragraphs 81 to 94 of the judgment under appeal the General Court examined PPG’s and SNF’s plea alleging a breach of the principle of proportionality.

114. First the General Court correctly defined that principle and the limitations on judicial review arising from the broad discretion enjoyed by the ECHA in that matter. ( 60 ) The General Court then addressed the arguments that the decision at issue was not appropriate to achieve the objectives of the REACH Regulation. ( 61 ) Finally, it considered whether the contested decision exceeded the limits of what was necessary to achieve the objectives pursued and the less onerous alternative measures presented by PPG and SNF. ( 62 ) It concluded that the decision at issue did not breach the principle of proportionality.

115. PPG’s and SNF’s fifth ground of appeal concerns the assessment by the General Court of one of the allegedly less onerous measures that would nevertheless, they argue, have permitted the achievement of the objectives pursued by the REACH Regulation.

116. In the judgment under appeal, the General Court rejected that argument on the grounds that the exemption of intermediates is expressly addressed by Article 2(8)(b) of the REACH Regulation. I agree with both the General Court and the Commission that, since that is indeed the legal position, the supposedly ‘alternative measure’ would have had no practical or legal effect. It would therefore have been meaningless in terms of the proportionality test. It would, in short, have been entirely pointless.

117. It follows that the fifth ground of appeal is unfounded.

118. By the sixth ground of appeal, PPG and SNF contend that the General Court breached its duty to state reasons. They submit, in particular, that the second sentence of paragraph 93 of the judgment under appeal does not enable them to understand why the measure they propose is not a less onerous measure that the ECHA should have had recourse to.

119. I do not accept that submission.

120. As I have already indicated, the General Court did state its reasons for rejecting PPG’s and SNF’s plea. It is true that that reasoning is limited to one sentence. I note, however, that the argument to which the General Court was responding was also formulated in one sentence in point 92 of the application for annulment. It is settled case-law that ‘the requirement for the [General Court] to give reasons for its decisions cannot be interpreted as meaning that it is obliged to respond in detail to every single argument advanced by the appellant’. ( 63 ) The approach of the General Court enabled the persons concerned to ascertain the reasons for the decision taken, thereby allowing the Court of Justice to exercise its power of review, as required by this Court’s case-law. ( 64 )

121. The sixth ground of appeal should therefore be rejected.

122. I thus conclude that the appeal should be dismissed in its entirety.

Costs

123. In accordance with Articles 137, 138, 140 and 184 of the Rules of Procedure of the Court, read together, PPG and SNF as the unsuccessful parties on all grounds of appeal should be ordered to pay the costs of the proceedings.

Conclusion

124. In the light of all the above considerations, I am of the opinion that the Court should: — dismiss the appeal; — order Polyelectrolyte Producers Group GEIE and SNF SAS to bear their own costs and to pay those incurred by the European Chemicals Agency; — order the Kingdom of the Netherlands and the European Commission to bear their own costs.

( 1 ) Original language: English

( 2 ) T‑268/10 RENV, EU:T:2015:698.

( 3 ) 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). The version of the REACH Regulation relevant to the facts in the main proceedings is that last amended by Commission Regulation (EC) No 552/2009 of 22 June 2009 (OJ 2009 L 164, p. 7) and it is that version that I shall reproduce below.

( 4 ) Recital 1 and Article 1.

( 5 ) Council Directive of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ, English Special Edition, 1967(I), p. 324). This directive has since been repealed by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1).

( 6 ) According to the ECHA’s Multilingual Chemical Terminology Database, polymerisation is the formation of polymers from simpler (monomer) molecules by addition.

( 7 ) T‑268/10, EU:T:2011:508.

( 8 ) C‑625/11 P, EU:C:2013:594.

( 9 ) The General Court’s analysis of the admissibility issue is set out at paragraphs 29 to 61 of the judgment under appeal.

( 10 ) Judgment of 10 September 2015, FCD and FMB, C‑106/14, EU:C:2015:576, paragraph 32.

( 11 ) Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) [on Persistent Organic Pollutants], COM(2003) 644 final, p. 12 (‘the Commission’s Proposal for a Regulation’).

( 12 ) Article 1(3) of the REACH Regulation.

( 13 ) Recital 69 of the REACH Regulation.

( 14 ) Judgment of 10 September 2015, FCD and FMB, C‑106/14, EU:C:2015:576, paragraph 35.

( 15 ) Article 59(2) and (3) and Annex XV of the REACH Regulation. Within 60 days of the circulation of the dossier, the other Member States or the ECHA may comment on the identification of the substance (Article 59(5)).

( 16 ) Article 59(4) of the REACH Regulation.

( 17 ) Article 59(7) to (9) of the REACH Regulation.

( 18 ) Article 58(3) of the REACH Regulation.

( 19 ) Council Decision of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23). See Articles 58(1) and 133(4) of the REACH Regulation. Article 5a of Decision 1999/468/EC was inserted by Council Decision 2006/512 of 17 July 2006 amending Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 2006 L 200, p. 11).

( 20 ) Article 58(1) and (2) of the REACH Regulation.

( 21 ) Article 62 of the REACH Regulation.

( 22 ) See Article 56(1)(b) to (e) and Article 56(2) to (5) of the REACH Regulation.

( 23 ) Paragraph 66 of the judgment under appeal.

( 24 ) Paragraph 54 of the judgment under appeal.

( 25 ) Appendix 4 of the ECHA Guidance on intermediates, 2010, ECHA-2010-G-17-EN (‘the ECHA Guidance on intermediates’).

( 26 ) Paragraph 55 of the judgment under appeal.

( 27 ) Paragraph 58 of the judgment under appeal.

( 28 ) Paragraph 59 of the judgment under appeal.

( 29 ) Paragraphs 66 and 67 of the judgment under appeal.

( 30 ) Paragraph 66 of the judgment under appeal.

( 31 ) Recitals 2 and 3.

( 32 ) Article 1(3)(a) of Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (OJ 1976 L 262, p. 201); Article 2(a) of Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (OJ 1993 L 84, p. 1); Article 2(1)(a) of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ 1999 L 200, p. 1).

( 33 ) Article 2(1)(a) of Directive 67/548.

( 34 ) Commission staff working document, General Report on REACH, SWD(2013) 25 final, p. 17.

( 35 ) See to that effect the Commission’s Proposal for a Regulation, p. 33.

( 36 ) Articles 1 and 55 of the REACH Regulation.

( 37 ) The General Court has exclusive jurisdiction, first, to find the facts, except where the substantive inaccuracy of its findings is apparent from the documents submitted to it, and, second, to assess those facts. When the General Court has found or assessed the facts, the Court of Justice has jurisdiction under Article 256 TFEU to review the legal characterisation of those facts by the General Court and the legal conclusions it has drawn from them (see judgments of 1 June 1994, Commission v Brazzelli Lualdi and Others, C‑136/92 P, EU:C:1994:211, paragraphs 48 and 49, and of 19 July 2012, Alliance One International and Standard Commercial Tobacco v Commission and Commission v Alliance One International and Others, C‑628/10 P and C‑14/11 P, EU:C:2012:479, paragraph 84).

( 38 ) See, to that effect, judgment of 29 April 2004, Commission v CAS Succhi di Frutta, C‑496/99 P, EU:C:2004:236, paragraph 68 and the case-law cited.

( 39 ) Paragraph 65 of the judgment under appeal.

( 40 ) Paragraphs 66 and 67 of the judgment under appeal.

( 41 ) Paragraph 69 of the judgment under appeal.

( 42 ) Judgments of 10 November 2016, Baštová, C‑432/15, EU:C:2016:855, paragraph 59 and the case-law cited, and of 29 March 2012, Commission v Poland, C‑185/10, EU:C:2012:181, paragraph 31 and the case-law cited.

( 43 ) See points 55 and 58 above.

( 44 ) Commission of the European Communities, Strategy for a future Chemicals Policy, COM(2001) 88 final, pp. 8 and 19.

( 45 ) See the Commission’s Proposal for a Regulation, p. 33.

( 46 ) See the Commission’s Proposal for a Regulation, p. 108.

( 47 ) See the Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) on Persistent Organic Pollutants (2003/0256(COD)), A6-0315/2005, pp. 523 and 524.

( 48 ) See Articles 54 and 56 of the Commission’s Proposal for a Regulation.

( 49 ) Judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 35.

( 50 ) Judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 35.

( 51 ) See Bergkamp, L., ‘Key concepts and scope’, The European Union REACH Regulation for chemicals, Oxford University Press, 2013, p. 59. Indeed, PPG and SNF accepted at the hearing that when a substance has both intermediate and non-intermediate uses ‘for example 50% intermediate uses and 50% other uses’ only the intermediate uses are exempted under Article 2(8)(b).

( 52 ) Paragraph 66 of the judgment under appeal.

( 53 ) Paragraph 64 of the judgment under appeal.

( 54 ) Paragraph 66 of the judgment under appeal.

( 55 ) See, inter alia, judgment of 11 April 2013, Mindo v Commission, C‑652/11 P, EU:C:2013:229, paragraph 29.

( 56 ) See to that effect, the order of 4 September 2014, Cindu Chemicals and Others v ECHA, C‑289/13 P, not published, EU:C:2014:2175, paragraph 51.

( 57 ) Article 3(24) provides a separate definition of the term ‘use’ and Article 3(37) of the term ‘exposure scenario’.

( 58 ) Paragraph 69 of the judgment under appeal.

( 59 ) See point 34 above.

( 60 ) Paragraphs 81 and 82 of the judgment under appeal. See also judgment of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraphs 60, 124 and 125.

( 61 ) Paragraphs 84 to 87 of the judgment under appeal.

( 62 ) Paragraphs 88 to 93 of the judgment under appeal.

( 63 ) Judgment of 9 September 2008, FIAMM and Others v Council and Commission, C‑120/06 P and C‑121/06 P, EU:C:2008:476, paragraph 91 and the case-law cited.

( 64 ) Judgment of 11 April 2013, Mindo v Commission, C‑652/11 P, EU:C:2013:229, paragraph 29.