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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Etimine [2011] EUECJ C-15/10 (24 March 2011)
URL: http://www.bailii.org/eu/cases/EUECJ/2011/C1510_O.html
Cite as: ECLI:EU:C:2011:504, EU:C:2011:504, [2011] EUECJ C-15/10
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OPINION OF ADVOCATE GENERAL
BOT
delivered on 24 March 2011 (1)
Case C-15/10
Étimine SA
v
Secretary of State for Work and Pensions
(Reference for a preliminary ruling from the High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) (United Kingdom))
(Environment and protection of human health – Directive 67/548/EEC – Directive 2008/58/EC – Regulation (EC) No 1272/2008 – Regulation (EC) No 790/2009 – Adaptation to technical and scientific progress – Classification of borate substances as toxic to reproduction – Compliance with procedural rules – Legal basis – Rules governing consultation of the Committee for Adaptation to Technical Progress – Review of manifest error of assessment – Methods adopted for the purpose of evaluating the intrinsic properties of the substances at issue – Obligation to state reasons – Compliance with the principle of proportionality)
1. By this reference for a preliminary ruling, the High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) (United Kingdom) asks the Court to assess whether the classifications adopted by the European Commission in relation to certain substances containing borates (2) are valid. These substances are currently classified as toxic to reproduction, entailing new responsibilities and obligations for industrial operators as regards management of the risks involved, which may affect their economic interests. In particular, those operators must affix a special label to packaging which must include phrases R60 ‘May impair fertility’ and R61 ‘May cause harm to the unborn child’.
2. Two regulatory frameworks are relevant in this case. The first is laid down in Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. (3) The contested classifications were introduced by Commission Directive 2008/58/EC of 21 August 2008 amending, for the purpose of its adaptation to technical progress, for the 30th time, Directive 67/548. (4)
3. The second regulatory framework is established by Regulation (EC) No 1272/2008, (5) which partially repeals, amends and replaces Directive 67/548 in order to implement the Globally Harmonised System of Classification and Labelling of Chemicals developed within the United Nations (‘the GHS’). Bearing in mind that the classifications harmonised on the basis of Directive 67/548 were still relevant, the Commission decided to include those classifications in that new regulatory framework. Thus, the contested classifications were reproduced in Commission Regulation (EC) No 790/2009 of 10 August 2009 amending, for the purposes of its adaptation to technical and scientific progress, Regulation No 1272/2008. (6)
4. By its questions, the referring court asks the Court whether the 30th ATP Directive and the 1st ATP Regulation are valid. In particular, it entertains doubts as to whether, in making the contested classifications in the 30th ATP Directive and the 1st ATP Regulation, the Commission complied with the substantive and procedural rules laid down, inter alia, by Directive 67/548 and Regulation No 1272/2008.
5. It should be noted at the outset that this reference for a preliminary ruling raises certain issues, some of which are identical to, or closely connected with, those raised in the Nickel Institute case (C-14/10) currently pending before the Court, in connection with which I shall also deliver an Opinion.
I – European Union law
A – Legislation on the classification, labelling and packaging of dangerous substances
1. Directive 67/548
6. The object of classification is to identify all the physicochemical, toxicological and ecotoxicological properties of substances which may constitute a risk during normal handling or use. Once hazardous properties have been identified, the substance or preparation must be labelled to indicate the hazard(s) in order to protect the user, the general public and the environment. Annex I to Directive 67/548 therefore contains a list harmonising the classification and labelling of over 8 000 substances and groups of substances.
2. Procedure for adapting Directive 67/548 to technical progress
7. Under Articles 28 and 29 of Directive 67/548, the Commission may adapt the annexes to the directive to technical progress by having recourse to the regulatory procedure with scrutiny. That procedure is laid down in Article 5a of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission. (7) That provision is worded as follows:
‘1. The Commission shall be assisted by a Regulatory Procedure with Scrutiny Committee composed of the representatives of the Member States and chaired by the representative of the Commission.
2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time-limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 205(2) and (4) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
…’
8. The majority referred to in Article 205(2) EC is a qualified majority.
9. If the measures envisaged are in accordance with the opinion of the Committee, the Commission must without delay submit the draft measures for scrutiny by the European Parliament and the Council and may adopt those measures only if, upon expiry of a three-month period, neither the Parliament nor the Council has opposed the draft measures. However, if the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission must, without delay, submit to the Council a proposal relating to the measures to be taken and forward it to the Parliament at the same time.
10. Annex I to Directive 67/548 was amended by the 30th ATP Directive and, most recently, by Commission Directive 2009/2/EC of 15 January 2009 amending, for the purpose of its adaptation to technical progress, for the 31st time, Directive 67/548, (8) the legality of which is not challenged in this case.
3. Partial repeal, amendment and replacement of Directive 67/548 by Regulation No 1272/2008
11. With effect from 20 January 2009, Directive 67/548 was partially repealed, amended and replaced by Regulation No 1272/2008. One of the aims of that regulation is to implement the GHS. (9)
12. As is apparent from recital 53 in the preamble to Regulation No 1272/2008, all existing harmonised classifications were converted into new harmonised classifications based on the new criteria laid down by that regulation. For that purpose, a conversion table is included in Annex VII to the regulation.
13. Those new classifications are set out in Annex VI, Part 3, to Regulation No 1272/2008, in particular in Table 3.1.
14. Furthermore, Article 55(11) of Regulation No 1272/2008 provides that Annex I to Directive 67/548, containing the list of harmonised classifications, is to be deleted. Since application of that regulation is deferred, the classifications harmonised in accordance with the criteria established in Directive 67/548 are still relevant. They are therefore now set out in Table 3.2 in Part 3 of Annex VI to Regulation No 1272/2008.
15. However, it should be pointed out that when that regulation entered into force, Annex VI thereto contained all the classifications from Annex I to Directive 67/548, as amended by Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth time Directive 67/548. (10) That annex therefore did not contain the contested classifications incorporated by the 30th ATP Directive.
16. The content of the 30th ATP Directive was therefore added to Annex VI to Regulation No 1272/2008 when the 1st ATP Regulation was adopted.
17. For the purpose of incorporating the content of that directive, the Commission relied on Articles 53 and 54(3) of Regulation No 1272/2008. Under those provisions, Annexes I to VII to that regulation may be adjusted and adapted to technical and scientific progress in accordance with the regulatory procedure with scrutiny referred to in Article 5a of Decision 1999/468.
B – Evaluation and control of the risks of existing substances
18. Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (11) provides, as set out in the fourth recital in the preamble thereto, for the sharing and coordination of responsibilities between Member States, the Commission and industrial operators in assessing the risks of substances produced, imported and/or used by those operators. Accordingly, Articles 3 and 4 of the regulation require manufacturers and importers of those substances to report certain relevant information, depending on the volume of production and import.
19. Under Article 8(1) of Regulation No 793/93, the Commission is to draw up lists of substances requiring priority risk evaluation. For each of those substances, the competent authority of a Member State is to be designated as rapporteur, in accordance with Article 10(1) of the regulation.
20. Articles 9, 10(2) and 12 of Regulation No 793/93 require manufacturers and importers to forward, where necessary, further information or carry out testing to obtain any information that is lacking and needed for evaluating the risks. In that regard, manufacturers and importers may request of the rapporteur, giving reasons, that they be exempted from some or all of the additional testing on the grounds that a given piece of information is either unnecessary for risk evaluation or impossible to obtain. They may also request a longer period where circumstances so require.
21. Following the risk evaluation, the rapporteur may, where appropriate, suggest a strategy and control measures for limiting the risks identified (Article 10(3) of Regulation No 793/93). On the basis of the risk evaluation and the strategy recommended by the rapporteur, the Commission is required to submit a proposal concerning the results of the risk evaluation of the priority substances and, if necessary, a recommendation for an appropriate strategy for limiting those risks for adoption in accordance with the committee procedure referred to in Article 15 of Regulation No 793/93. On the basis of the risk evaluation and the recommended strategy thus adopted, the Commission is to decide, where necessary, to propose Community measures.
22. That regulatory framework was updated by Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 (REACH). (12)
23. REACH is an integrated system for registration, evaluation, authorisation and restriction of chemicals, managed by the European Chemicals Agency (ECHA). One of the objectives of the REACH Regulation, (13) laid down in Article 13 thereof, is to promote the development of alternative methods for the assessment of hazards associated with chemical substances.
24. In accordance with the obligations laid down in Articles 6 and 7 of the REACH Regulation, manufacturers and importers whose production or importation of the substance in question exceeds one tonne per year are required to notify and submit a registration for that substance to the ECHA. To that end, pursuant to Articles 10 and 13 of the REACH Regulation, they must draw up a detailed technical dossier containing information on the substance in question, including information on its manufacture and uses, its classifications and intrinsic properties, which must, where necessary, be demonstrated by appropriate tests or the results of relevant studies.
II – Facts and main proceedings
A – Procedure leading to the contested classifications (14)
25. On 28 January 1999, the French Republic submitted to the Commission a proposal for classifying boric acid under Directive 67/548 as category 2 for reproductive toxicity and developmental toxicity, that substance not having previously been covered by Annex I to that directive. That was followed on 10 February 1999 by a proposal from the Kingdom of Denmark for classifying boric acid and borax decahydrate under that directive as category 2 for reproductive toxicity and category 3 for developmental toxicity. (15)
26. At its meeting of 15 to 17 November 2000, the Commission’s working group on the classification and labelling of dangerous substances at the European Chemicals Bureau (which was replaced by the ECHA) recommended that boric acid should be classified under Directive 67/548 as toxic to reproduction category 3 for both fertility and development. For borax decahydrate and anhydrous disodium tetraborate, the working group recommended classification under that directive as toxic to reproduction category 3.
27. At the request of the Commission’s Directorate-General for the Environment, the European Chemicals Bureau called a meeting of specialised experts in order to reconsider the classification of the borates under Directive 67/548 with reference to their reproductive toxicity. At its meeting of 5 and 6 October 2004, the Commission’s working group of specialised experts on reproductive toxicity considered various borate substances, including borax pentahydrate, boric oxide, boric acid, borax decahydrate and anhydrous disodium tetraborate, and concluded that they should be classified under Directive 67/548 as toxic to reproduction category 2 on the basis of animal studies.
28. A meeting took place on 4 April 2005 between the Commission, Étimine SA (16) and the Turkish authorities (the Republic of Turkey being the world’s second largest producer of boric acid after the State of California in the United States) at which the Turkish authorities opposed the proposed classification of the borate substances as toxic to reproduction category 2. By letter to the Environment Directorate-General of 8 April 2005, Étimine objected to the conclusions of the working group of specialised experts and asked the Commission to disregard those conclusions.
29. At its meeting of 8 September 2005, the working group on classification and labelling of dangerous substances, with the participation of representatives of the Turkish authorities, Éti Mine Works General Management (the parent company of Étimine) and Turkish toxicologists, further discussed the proposed classification of the borate substances under Directive 67/548 and decided to follow the opinion of the working group of specialised experts and recommend that those substances be classified as toxic to reproduction category 2.
30. By letter of 30 September 2005, the Turkish authorities asked the Commission to postpone the decision on the classification of the borate substances under Directive 67/548 until inter alia several studies being carried out in that respect were completed.
31. By letter to the Environment Directorate-General of 17 October 2005, Étimine repeated its request that the borate substances should not be classified as toxic to reproduction category 2 under the 30th adaptation to technical progress of Directive 67/548.
32. By letter of 18 November 2005, the Environment Directorate-General stated that it had taken due account of Étimine’s comments and replied to certain points raised by Étimine in its letter of 8 April 2005.
33. On 21 August 2008, the Commission adopted the 30th ATP Directive. That directive was adopted in accordance with the regulatory procedure with scrutiny referred to in Articles 28 and 29 of Directive 67/548.
34. Finally, on 10 August 2009 the Commission adopted the 1st ATP Regulation on the basis of Article 53 of Regulation No 1272/2008. The contested classifications were therefore inserted into Annex VI to that regulation with effect from 25 September 2009.
B – The main proceedings
35. Étimine, a company governed by Luxembourg law, is the exclusive sales agent and distributor in the United Kingdom of the borate substances which are produced by its parent company, Éti Mine Works General Management, in Turkey. The intervener, Borax Europe Ltd, (17) is owned by Rio Tinto plc, a US group conducting borates mining operations in California and Argentina.
36. On 5 December 2008, Étimine and Éti Ab Étiproducts Oy, a company governed by Finnish law, brought an action before the General Court for annulment of the 30th ATP Directive in so far as concerns the classification of the borates. By order of 7 July 2009, Borax was granted leave to intervene in the proceedings in support of the applicants. By its order in Étimine and Étiproducts v Commission, the General Court dismissed that application since the applicants were not individually concerned by the contested legislation within the meaning of Article 230 EC.
37. At the same time, Étimine brought an action before the referring court against the Secretary of State for Work and Pensions for judicial review of the ‘intention and/or obligation’ of the United Kingdom Government to transpose the 30th ATP Directive.
III – The reference for a preliminary ruling
38. The High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court), decided to stay the proceedings and refer the following questions to the Court for a preliminary ruling:
‘1. Are the challenged borate classifications in [the 30th ATP] Directive … and/or [the 1st ATP Regulation] … invalid on one or more of the following grounds:
(a) The classifications were included in the 30th ATP Directive in breach of essential procedural requirements?
(b) The classifications were included in the 30th ATP Directive in breach of Directive 67/548 … and/or as a result of manifest errors of assessment, in that:
(i) The Commission did not apply or failed properly to apply the “normal handling and use” principle contained in Annex VI to … Directive [67/548]?
(ii) There was an unlawful application of risk assessment criteria?
(iii) The Commission failed to apply or misapplied the “appropriateness” criterion in breach of section 4.2.3.3 of Annex VI to … [Directive 67/548]?
(iv) The Commission failed to have proper regard to the need for epidemiological/human data?
and/or
(v) The Commission unlawfully extrapolated data relating to one of the borate substances for the purposes of classifying the other borate substances and/or gave inadequate reasoning for that extrapolation contrary to Article 253 EC?
(c) The classifications were included in the 30th ATP Directive in breach of the fundamental Community law principle of proportionality?
2. Are the challenged borate classifications in the 1st ATP Regulation invalid, in that:
(a) The 1st ATP Regulation was wrongly adopted using the procedure set out in Article 53 as its legal basis?
(b) The criteria for a new harmonised classification under Annex I to Regulation … No 1272/2008 … were not applied, and instead Annex VII to [that] Regulation was wrongly applied?’
39. Observations were submitted by the parties to the main proceedings and the intervener as well as by the Austrian, Danish, French, German and United Kingdom Governments and by the Commission.
IV – My analysis
A – Whether the first question is admissible
40. At the hearing, the Commission stated that it was withdrawing the plea of inadmissibility that it had raised in relation to the first question. Since that issue is raised in the written pleadings, I should nevertheless like to refer to it.
41. In its observations, the Commission submitted that the first question is inadmissible in so far as it concerns the legality of the 30th ATP Directive. To that end, it has put forward the same arguments as those already relied on in the Nickel Institute case, cited above, claiming in particular that the directive was repealed by the 1st ATP Regulation with effect from 20 January 2009, that is to say, some months before this reference for a preliminary ruling was made. It also stated that the United Kingdom of Great Britain and Northern Ireland, like the majority of the Member States, failed to transpose that directive into domestic law and has inferred from this that the answers given by the Court would not be capable of influencing the outcome of the case.
42. For the same reasons as those set out in my Opinion in Nickel Institute, that line of argument is, in my view, irrelevant.
43. In particular, I do not share the Commission’s view that the European Union legislature repealed the 30th ATP Directive by deleting Annex I to Directive 67/548 under Regulation No 1272/2008.
44. While the sole purpose of the 30th ATP Directive was to amend Annex I to Directive 67/548, (18) that does not allow such a conclusion to be drawn. Indeed, the 30th ATP Directive entails legal effects for the Member States and its repeal can be effected, to my mind, only by means of a formal repeal procedure. (19) That is justified by the principle of legal certainty. Although the 30th ATP Directive has now become obsolete, the fact remains that it was not expressly repealed under Regulation No 1272/2008, as amended by the 1st ATP Regulation.
45. In addition, the 30th ATP Directive is an instrument amending Directive 67/548. Consequently, its fate is closely connected to the fate of that directive. The European Union legislature expressly provided in Article 60 of Regulation No 1272/2008, as amended by the 1st ATP Regulation, that ‘Directive 67/584 … shall be repealed with effect from 1 June 2015’. The reference to ‘Directive 67/548’ includes, a fortiori, all the amending directives adopted since 27 June 1967, including the 30th ATP Directive. The 1st ATP Regulation and Directive 67/548 have coexisted since entry into force of Regulation No 1272/2008 and will continue to coexist until 1 June 2015. The classifications adopted in accordance with the harmonised criteria laid down by Directive 67/548 continue to be relevant and are included, as they stand, in Table 3.2 in Annex VI to Regulation No 1272/2008, Table 3.1 in that annex setting out the new classification established in accordance with the GHS. (20)
46. Lastly, the Commission made an error of assessment in maintaining that the 30th ATP Directive was repealed with effect from 20 January 2009.
47. That date is incorrect: it corresponds to the date of entry into force of Regulation No 1272/2008. In accordance with Article 55(11) thereof, that regulation deletes Annex I to Directive 67/548 with immediate effect. (21) That is Annex I as amended by Directive 2004/73, which, it should be recalled, adapts Directive 67/548 for the twenty-ninth time to technical progress. As the Commission pointed out in its observations, the European Union legislature could not take account of the amendments made to that annex by the 30th ATP Directive as the text of Regulation No 1272/2008 had been ‘frozen’, when that directive was adopted, in the course of the codecision procedure.
48. Those amendments were therefore incorporated by the Commission on 10 August 2009 under the 1st ATP Regulation. (22) As is apparent from recital 2 in the preamble to that regulation, the Commission took the view that ‘[i]t [was] necessary to amend Annex VI to Regulation … No 1272/2008 in order to reflect the recently adopted amendments to Annex I to Directive 67/548 … introduced by [the 30th ATP Directive]’. (23) It is therefore clear that, prior to entry into force of the 1st ATP Regulation on 10 August 2009, the 30th ATP Directive was in force.
49. In the light of those factors, I therefore take the view that the 30th ATP Directive was in force on the date on which the referring court made this reference for a preliminary ruling.
50. Contrary to the Commission’s submission, I do not consider that an assessment of the validity of the 30th ATP Directive is manifestly irrelevant to the outcome of the main proceedings. As I have stated, in Table 3.2 in Part 3 of Annex VI to Regulation No 1272/2008 that regulation, as amended by the 1st ATP Regulation, reproduces the classification established in accordance with Directive 67/548, as amended most recently by the 30th and 31st ATP Directives. Consequently, assessment of the validity of Regulation No 1272/2008 cannot be dissociated from assessment of the validity of the 30th ATP Directive.
51. In the light of those factors, I am of the view that the first question is admissible in so far as it concerns the validity of the 30th ATP Directive.
B – The first question
52. By its first question, the referring court asks the Court to consider whether the contested classifications are lawful in three respects. First, it is uncertain whether the Commission complied with the procedural rules referred to in Article 29 of Directive 67/548 and Article 5 of Decision 1999/468. Second, it asks the Court to assess whether the Commission made various errors of assessment in its evaluation of the intrinsic properties of the substances at issue. Third, it asks the Court whether, in the course of that evaluation, the Commission complied with the principle of proportionality.
1. Compliance with the procedural rules
53. The referring court first asks the Court whether the validity of the 30th ATP Directive is vitiated by infringement of the procedural rules laid down in Article 29 of Directive 67/548 and in Article 5 of Decision 1999/468.
54. It will be recalled that, under those provisions, the Commission must submit to the ‘Adaptation to Technical Progress’ Committee (24) a draft of the measures it deems necessary for the purposes of adaptation to technical progress. The ATP Committee must deliver an opinion by qualified majority, the votes of the Member States being weighted as provided for in Article 205(2) EC.
55. The applicant in the main proceedings maintains that that procedure was disregarded in so far as the ATP Committee was not able to take a decision specifically on the contested classifications but was required instead to vote on all the proposed classifications, amendments and deletions set out in the draft 30th adaptation to technical progress. Acting in that manner, it claims, the Commission ignored the reservations expressed by seven Member States regarding the classification of the substances at issue as toxic to reproduction category 2.
56. I do not consider this to be a valid criticism or that it can render the 30th ATP Directive invalid.
57. As the applicant in the main proceedings points out, at the vote on the draft 30th adaptation to technical progress, seven Member States did indeed express reservations vis-à-vis the classification of the borate substances proposed by the Commission. Those reservations are recorded in the minutes of the meeting of 16 February 2007. (25) None the less, on reading those minutes it is apparent from the outset that the ATP Committee delivered a qualified majority opinion in favour of the Commission’s proposal. Although the Republic of Estonia was not represented and the Italian Republic and the Republic of Poland abstained, it should be noted that no other Member State opposed that proposal.
58. In those circumstances and having regard to the reservations expressed by some, was the Commission required to put the proposed borates classification to a separate vote?
59. Unlike the applicant in the main proceedings, I do not consider that to be the case.
60. There is no legal basis on which such a conclusion could be drawn. As the Danish, French and United Kingdom Governments point out, Article 29 of Directive 67/548, like Article 5 of Decision 1999/468 to which it refers, does not require the Commission to put each of its proposed classifications to a separate vote.
61. Nor is there any such requirement in the committee’s Rules of Procedure. (26) In particular, the conditions laid down in Article 5(2) of those rules, which were referred to on a number of occasions at the hearing, are not met. That provision reads as follows:
‘The Chairman, on his own initiative or at the request of a committee member, may postpone the vote on a particular agenda point until the end of the meeting or a later meeting in the following cases:
(a) if a substantive change is made to the proposal during the meeting,
(b) if the text of the proposal has been submitted to the committee during the meeting,
(c) if a new point has been added to the agenda, in accordance with Article 3(3).
If there are specific difficulties, the Chairman, in agreement with the Committee members, may extend the meeting until the following day.’
62. Although the ATP Committee members are therefore able to extend the discussion, they do not seem to be able to demand a separate vote in circumstances such as those in question.
63. In those circumstances, in the absence of any legal basis, and short of its acting as the legislature, I cannot conclude that the Commission manifestly infringed the procedural rules under Article 29 of Directive 67/548 and Article 5 of Decision 1999/468 when adopting the 30th ATP Directive.
2. Whether the assessment of the intrinsic properties of the borates is lawful
64. Substances which are toxic for reproduction are defined in Article 2(2)(n) of Directive 67/548. They are ‘substances … which, if they are inhaled or ingested or if they penetrate the skin, may produce, or increase the incidence of, non-heritable adverse effects in the progeny and/or an impairment of male or female reproductive functions or capacity‘.
65. In accordance with Article 4(1) of that directive, such substances are to be classified on the basis of their intrinsic properties and assessed on the basis of the principles set out in Annex VI to the directive.
66. Section 1.1 of Annex VI states that ‘[t]he object of classification is to identify all the physicochemical, toxicological and ecotoxicological properties of substances … which may constitute a risk during normal handling or use’.
67. In particular, section 1.6.1(b) of Annex VI (27) states that the data required for classification of the substances in question may, if necessary, by obtained from a number of different sources, including not only the results of previous tests, information taken from reference works and the literature and information derived from practical experience but also the results of validated structure-activity relationships and expert judgment.
68. As regards substances toxic to reproduction, assessments are to be carried out essentially on the basis of animal data in accordance with section 4.2.3 of Annex VI to Directive 67/548.
69. In the main proceedings, Étimine argues that the Commission made a number of errors of assessment, thereby vitiating the legality of the contested classifications: first, the Commission failed to assess correctly the hazards connected with the normal handling or use of the borate substances and wrongly proceeded to assess the risks posed by those substances. Secondly, it claims that the Commission made a manifest error of assessment when it assessed the appropriateness of the route of administration by which the animal testing was carried out. Similarly, it failed to give sufficient weight to the epidemiological data. Finally, the applicant in the main proceedings complains that the Commission assessed the intrinsic properties of the substances at issue using the read-across method.
70. The referring court raises questions concerning all of those matters.
a) Preliminary observations on the Commission’s discretion
71. In order to answer the questions referred by the national court, it is appropriate at the outset to note that, in accordance with settled case-law, (28) the European Union judicature confers on the Commission a broad discretion, in particular as to the assessment of highly complex scientific and technical facts, in order to determine, with full knowledge of the facts, the measures that are necessary and appropriate for the protection of public health. That approach is necessary where action by the Commission is in an area of evolving and complex technology such as that in the main proceedings, and where the matter involves a dangerous substance such as a borate, the classification and labelling of which raise delicate and controversial issues from a scientific point of view. Directive 67/548 thus grants the Commission considerable discretion as to the extent of the measures to be taken in order to adapt the annexes to that directive to technical progress.
72. Review by the European Union judicature must be confined to verifying whether the exercise of such powers has been vitiated by a manifest error of assessment or misuse of powers, or whether the legislature has manifestly exceeded the bounds of its discretion. In such a context, the Court has ruled that it cannot substitute its assessment of scientific and technical facts for that of the legislature on which the Treaty conferred that task. (29)
b) Whether there are manifest errors of assessment
i) Assessment of the hazards connected with normal handling or use of the substances concerned
73. First, Étimine claims that the Commission failed to assess correctly the risks associated with ‘normal handling or use’ of the borates within the meaning of section 1.1 of Annex VI to Directive 67/548. The Commission erred by relying on tests carried out on animals to which boric acid had been administered orally. According to the applicant in the main proceedings, normal handling or use of those substances in humans does not involve a risk of exposure by ingestion. First, normal handling or use of products containing borates (30) could not lead to ingestion in quantities liable to give rise to concern. Second, to reach the levels of exposure to which the animals were subjected, humans would have to ingest deliberately large quantities of borates on a repeated basis, which would automatically trigger a vomiting reflex.
74. In support of those claims, the intervener also submits that the Commission has failed to define the normal conditions for the handling and use of the borates. In particular, the Commission has failed to identify the conditions under which workers may be exposed to those substances in the European Union, since its only point of reference was the studies carried out in the context of occupational exposure in Turkey.
75. I do not consider those criticisms valid or capable of establishing that the Commission manifestly exceeded the bounds of its discretion or that it made a manifest error of assessment.
76. As I have pointed out in my Opinion in the Nickel Institute case, the system for classifying and labelling substances established by Directive 67/548 and reproduced in Regulation No 1272/2008 is based on the reporting of information relating to the hazards associated with the intrinsic properties of substances.
77. That is apparent from Article 4(1) of Directive 67/548 and the wording of Annex VI to that directive. In accordance with sections 1.1 and 1.7 of that annex, the object of classification is to identify all the physicochemical, toxicological and ecotoxicological properties of substances which may constitute a risk during normal handling or use. (31) Under section 1.4 of that annex, the label must therefore take account of all potential hazards which are likely to be faced in such handling or use.
78. That is also apparent from the wording of Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Directive 67/548. (32) Under Article 2(2) of Directive 93/67, ‘“hazard identification”’ [of a substance] is defined as ‘the identification of the adverse effects which [that] substance has an inherent [(33)] capacity to cause’.
79. Consequently, assessment of the hazards associated with a substance must not be confused with assessment of the risks that its handling or use may create.
80. Risk assessment is concerned with the likelihood that one of the hazards associated with a substance will occur as a result of human or environmental exposure to that substance. Classification and labelling based on risk are therefore linked to specific use and specific conditions of exposure. That is the case, for example, as regards workers in the Turkish and Californian boron mines or those working in a glass or detergent factory. They therefore do not reflect the actual exposure situation; nor do they make it possible to adopt risk management measures.
81. Classification and labelling based on the hazards associated with normal handling or use of a substance make it possible for the same information to be provided in an appropriate manner to all users of chemicals, irrespective of the location and methods of use. Information on the hazards thus enables the competent authorities to adopt independent decisions on the risk management measures to be taken, which may vary considerably depending on the conditions and types of use. Hazards must therefore be classified independently of the manner or location in which the substance is used – whether in a laboratory or outside a laboratory – independently of the means by which exposure occurs, whether orally, by dermal exposure or by inhalation, and of the levels of exposure to the substance.
82. Thus, under Directive 67/548 and Regulation No 1272/2008 the Commission must have regard only to the assessment of the intrinsic properties of the substances concerned in its evaluation of the hazards.
83. At this stage, the question arises as to how the expression ‘normal handling or use’ of a substance is to be construed?
84. Admittedly, that expression is not defined anywhere. However, contrary to what is claimed by the applicant in the main proceedings and the intervener, the Commission’s Legal Service drew up guidelines for members of the Technical Committee on Classification and Labelling of Dangerous Substances (‘TCCL’). They are, in part, reproduced in the minutes of the TCCL meeting of 8 September 2005: (34)
‘In order to identify the potentially dangerous intrinsic properties of a substance, one shall take into account (at least) the following elements:
– The form under which the substance is normally used or may be used: if it is liquid, then it could be drinkable even though it is not intended to be drunk; it could also be spilled on the hands/body even though it’s not a body lotion; this covers all physical forms in which the substance is manufactured and placed on the market or all physical forms into which it might be transformed.
– The normal behaviour of the persons that are handling/using the substance: if it is intended to be used by general consumers, the normal/foreseeable behaviour of adults and children shall be taken into account. But one shall not assess this behaviour taking into account the instruction of the manufacturer; instructions of manufacturers are risk reduction measures that shall be drafted with regard to the intrinsic properties of the product. Under directive 67/548 what shall be identified are the intrinsic properties of a substance without taking into account any risk reduction measure. If a substance is marketed and used in a liquid form but is not intended for oral consumption (for instance washing liquid), the instruction of the manufacturer would be ‘not for oral consumption’ and ‘take away from children’. However in identifying the intrinsic properties of the said substance we should consider what would happen if the said substance was accidentally swallowed.
– Foreseeable and realistic accidents (young children eating/drinking a bit of a product not intended for oral consumption …)
While identifying the intrinsic properties of a substance, we shall not take into account unrealistic scenario:
– We shall not consider as an intrinsic property a property that occurs when the substance is deliberately used in an unintended way with an intention to kill/harm: whereas the effect on the human body of one single absorption of a substance that is not intended to be drunk shall be considered (this is a foreseeable accident), the effect of a regular daily absorption of the product shall not be taken into account because this would correspond to an unrealistic scenario/a gross abuse.
– The effect of concentrations that are far above the maximum physically possible concentration in humans.’
85. To my mind, it is clear that the expression used in section 1.1 of Annex VI to Directive 67/548 must therefore refer to situations in which the substance is handled and used under the conditions and for the purposes for which it was designed. As required by the precautionary principle, the expression must, in my opinion, also cover everyday acts, in particular accidents in the home. I cannot exclude situations in which a child, evading parental supervision, eats washing powder or knocks over detergent. Account must therefore be taken of all possible handling and uses of a substance occurring in normal circumstances, which does not therefore rule out cases in which a person runs the risk of ingesting a borate.
86. Moreover, as regards substances that are toxic to reproduction, Article 2(2)(n) of Directive 67/548 relates to substances which may have adverse effects on fertility not only if inhaled or if they penetrate the skin but also if ingested.
87. In the light of those factors, I do not therefore consider that the Commission could have made a manifest error of assessment by basing its analysis on data collected following oral administration of the substances at issue.
ii) Assessment of risks
88. Secondly, the applicant in the main proceedings criticises the Commission for carrying out a risk assessment in accordance with Regulation (EC) No 1488/94. (35) That is apparent, it claims, from point 1.1.5 of the explanatory memorandum to its proposal for the 30th adaptation to technical progress. (36)
89. That point, entitled ‘Normal Handling and Use’, reads as follows:
‘…
Several of the available epidemiology studies indicate an average repeated daily occupational exposure of 5 mg/m³ with average daily exposures reaching even 10 mg/m³. Applying the principles of Regulation (EEC) 1488/94 using a Margin of Safety … of 60 for occupational exposure, an exposure to 5 mg/m³ would give rise to the conclusion that there is a need for limiting the risks and that additional risk management measures, beyond those already in place, are needed. In this context it should be noted that under the implementation of Regulation (EEC) 1488/94 a [Margin of Safety] of 100 or lower generally gives rise to the identification of a risk which needs limiting and in specific cases even a [Margin of Safety] higher than 100 may be considered insufficient [(37)]. Furthermore, the available evidence does not demonstrate that at these inhalation exposure levels (e.g. around 5 mg/m³) humans would be prevented from taking up the substance due to vomiting. The available information therefore demonstrates that under normal handling and use conditions, inhalation exposures can occur which, when applying the principles of Regulation (EEC) 1488/94, would give rise to concern and therefore may constitute a risk [(38)]’.
90. It seems clear to me from reading that point that it cannot be argued that the Commission made a manifest error of assessment in its evaluation of the hazards posed by the borates.
91. In my view, the evidence adduced by the applicant in the main proceedings is insufficient by some margin.
92. First, it is not possible as a result of the reference to point 1.1.5 of the Commission’s explanatory memorandum alone to establish that the Commission did in fact base its analysis on a risk assessment carried out pursuant to Regulation No 1488/94. In view of public nature of the proceedings and the detail in which the experts’ discussions are recorded, I take the view that the applicant in the main proceedings could have provided further evidence if the Commission had actually acted in the manner claimed. However, that is not the case.
93. Second, that point must not be read out of context. Earlier in its explanatory memorandum, the Commission set out the methods and studies on which it relied for the purpose of evaluating the intrinsic properties of the substances at issue and states the pros and cons of each of them. The ‘available information’ to which the Commission then refers in the last sentence of that point relates, to my mind, to all the data collected in applying Directive 67/548 and, in my view, forms part of its conclusion.
94. As to the reference to Regulation No 1488/94, the use of the conditional tense should be noted. The Commission claims that its objective was to point out that the risks created by the borates were a real source of concern. As the Danish, French and United Kingdom Governments point out, the Commission was seeking to reply to the arguments raised by industry concerning the seriousness of the risks created by the borates. Whatever the Commission’s intention, the wording that it uses does not, in any event, show that it carried out a risk assessment of that nature.
95. In view of the information available and bearing in mind the weakness of the evidence relied on by the applicant in the main proceedings, I find it difficult to conclude that the Commission could have manifestly exceeded the bounds of its discretion and made a manifest error in its assessment of the hazards posed by the borates.
iii) Assessment of the appropriateness of the route of administration used
96. Thirdly, the referring court asks the Court whether the Commission correctly applied the principles laid down in the fourth subparagraph of section 4.2.3.3 of Annex VI to Directive 67/548 in extrapolating animal data to man. In particular, it is uncertain whether the Commission made a manifest error of assessment by refraining from assessing or assessing incorrectly the appropriateness of the route of administration used in carrying out the animal tests.
97. The applicant in the main proceedings takes the view that oral administration of boric acid was inappropriate because, during normal handling or use, humans are unlikely to ingest it. In those circumstances, the Commission should have classified the substances concerned as toxic to reproduction category 3.
98. I do not consider that criticism valid or capable of establishing that the Commission has manifestly exceeded the bounds of its discretion or made a manifest error of assessment.
99. The third and fourth subparagraphs of section 4.2.3.3 of Annex VI to Directive 67/548 read as follows:
‘The placing of a compound in Category 1 for effects on fertility and/or developmental toxicity is done on the basis of epidemiological data. Placing in Categories 2 or 3 is done primarily on the basis of animal data …
… Even when clear effects have been demonstrated in animal studies the relevance for humans may be doubtful because of the doses administered, for example, where effects have been demonstrated only at high doses, or where marked toxicokinetic differences exist, or the route of administration is inappropriate. [(39)] For these or similar reasons it may be that classification in Category 3, or even no classification, will be warranted.’
100. First, contrary to what is claimed by the applicant in the main proceedings, the Commission did in fact assess the appropriateness of the route of administration. That is clear from point 1.1.4 of the explanatory memorandum to its proposal for the 30th adaptation to technical progress. (40)
101. In that point, under the heading ‘Human Data and Toxico-kinetic Information’, the Commission considered whether, in accordance with the third and fourth subparagraphs of section 4.2.3.3 of Annex VI to Directive 67/548, it was appropriate to extrapolate animal data to man. It therefore looked at the level of the doses administered in the tests on animals. The Commission went on to state that the toxicokinetic data available did not indicate major differences between laboratory animals and humans. Lastly, having pointed out that animal testing had been carried out using the oral route of administration, it concluded that that was an appropriate route of administration in accordance with Article 2(2)(n) of Directive 67/548. It should be recalled that, under that provision, a substance which is toxic for reproduction is a substance which may produce adverse effects on fertility or development if it is inhaled or ingested or if it penetrates the skin.
102. Second, it is not, to my mind, for the Court to examine the merits of the Commission’s assessment of the appropriateness of the route of administration used in carrying out the animal tests. That is not a matter for legal assessment but for expert scientific opinion in a relatively complex field.
103. In any event, while I am aware that other routes of administration were possible, I none the less consider that the choice of one route of administration over another does not depend on the likely route of human exposure alone. There are other factors that the experts must consider, including the physical properties of the substance being tested and the aim pursued. However, as regards the teratogencity studies and reproduction tests, it is also expressly stated in Part B of Annex V to Directive 67/548, entitled ‘Methods for the Determination of Toxicity and other Health Effects’, that the test method is primarily directed to administration by the oral route. (41) Furthermore, as I have pointed out, I cannot rule out that human beings may be exposed to that risk by swallowing the substance directly or by inhaling it, in which case some compounds that are initially inhaled are capable of being absorbed, subsequently, by digestion.
104. In the light of those factors and bearing in mind the limits of the Court’s power of review, I take the view that the Commission did not manifestly exceed the bounds of its discretion or make a manifest error of assessment when it considered that the route of administration used in carrying out the animal tests was appropriate.
iv) The absence of epidemiological data
105. Fourthly, the referring court asks the Court to consider whether the Commission made a manifest error of assessment in failing to accord sufficient importance to epidemiological data. According to the applicant in the main proceedings, the Commission incorrectly assumed that animal data could be extrapolated to humans.
106. In that regard, the Commission’s analysis cannot, to my mind, be criticised. I am basing my assessment on the broad logic of the system on which the classification of substances toxic to reproduction is based.
107. The assessment of the toxicological properties of substances, in particular assessment of the effects on fertility and development, is carried out in tests on animals. (42) The Commission must therefore assess the hazards which humans may face on the basis of presumptions or extrapolations. In section 4.2.3.1 and the sixth and eighth subparagraphs of section 4.2.3.3 of Annex VI to Directive 67/548, the European Union legislature provided that those presumptions must, first, be based on clear evidence in animals studies of impaired fertility and of toxic effects on development. They must then be based on supporting evidence enabling the Commission to conclude that comparable effects are likely to be observed in humans. (43)
108. Consequently, it is clear from those factors that evaluation of the toxicity of a substance is necessarily and primarily based on animal data. Epidemiological studies seem to constitute supporting evidence and it is for the experts to assess the weight and relevance to be accorded to it in their discussions.
109. The Commission appears to have adopted this approach in this case.
110. As is clear from the minutes of 22 November 2004 and 20 February 2006 and from the explanatory memorandum to the proposal for the 30th adaptation to technical progress, the experts meeting within the TCCL first established the adverse effects of ingesting boric acid on the fertility of rats, mice and dogs and on the development of rats, mice and rabbits. As the Commission states in its observations, from those results ‘clear evidence’ could be established of impaired fertility and development in those species, for the purpose of section 4.2.3.1 of Annex VI to Directive 67/548. The experts went on to examine whether epidemiological studies conducted on humans could give rise to a different conclusion. In that regard, they noted that the studies conducted thus far in connection with the occupational exposure of borate miners were insufficient to show that the substances concerned did not have adverse effects on human fertility and were insufficient to warrant amending the conclusions from the animal tests.
111. It is clear from the above that the Commission did take account of the epidemiological data. Although it considered them to be of secondary importance, it cannot be criticised for doing so, to my mind, since the data available were insufficient to disprove the predictions deriving from the tests carried out on animals and the results obtained from those tests were, according to the experts, particularly clear. Moreover, it is appropriate to point out that the Commission paid special attention to the further results of ongoing epidemiological studies. (44)
112. In view of the above, I consider that the Commission complied with the principles of classification set out in section 4.2.3.1 and the sixth and eighth subparagraphs of section 4.2.3.3 of Annex VI to Directive 67/548.
v) Using the read-across method
113. According to the applicant in the main proceedings, in carrying out the contested classifications in the 30th ATP Directive the Commission failed to comply with the general principles of classification set out in Annex VI to Directive 67/548. First, the applicant criticises the competent authorities for basing their assessment on the read-across method rather than evaluating the intrinsic properties of the substances at issue. Secondly, it claims that the Commission did not state the reasons for using that method of evaluation.
– Whether using the read-across method is lawful
114. Unlike the applicant in the main proceedings, I take the view that the Commission did not exceed the bounds of its discretion in using the read-across method for the purposes of its analysis. The reasons underlying my assessment are the same as those already set out in my Opinion in Nickel Institute.
115. First, the Commission did not, to my mind, deviate in this instance from the principles laid down in section 1.6.1(b) of Annex VI to Directive 67/548 by using the read-across method for the purposes of the contested classification.(45)
116. While use of that method is expressly provided for under the REACH Regulation, its use is also valid under Directive 67/548, a fact which is, moreover, recognised across the scientific community. In 2007, the Commission therefore produced a lengthy study on the use of the read-across method in the context of that directive, referring, by way of illustration, to many examples of classifications based on that method. Those examples include the classifications for the nickel and borate substances. (46) Also, in 2007, the OECD (Organisation for Economic Cooperation and Development) referred expressly to that method as a method provided for in Directive 67/548 for assessing the intrinsic properties of substances. (47) Lastly, use of the read-across method in the classification and labelling of dangerous substances has been the subject of many reports by legal commentators. (48)
117. Clearly, therefore, use of the read-across method is broadly accepted and widely publicised in the scientific community.
118. How does that method actually work?
119. The read-across method is one of prediction, based on the similarity of the chemical molecules. Scientists make use of the available data on substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern due to their structural similarity (the substances may be regarded as a group, or ‘category’ of substances (49)). Endpoint information relating to one chemical substance is therefore used to predict the same endpoint for another chemical substance which is regarded as similar. (50) Thus, that method avoids the need to test every substance for every hazard endpoint.
120. The Danish Government maintains that the read-across method is the same as the method of drawing on data from the structure-activity relationships referred to in section 1.6.1(b) of Annex VI to Directive 67/548. The United Kingdom Government submits that, by authorising the use of ‘the results of previous tests’ and data from structure-activity relationships, the European Union legislature implicitly authorised in that section the use of that method for the purposes of classifying a substance.
121. Unlike the Danish Government, I am not persuaded that the read-across method is the same as the model based on the structure-activity relationship. Nevertheless, those methods must not, to my mind, be regarded as separate and mutually independent. Based on common principles, they form part of the same overall scheme and I am therefore inclined to the view that reference to one of them does not preclude recourse to the other.
122. The structure-activity relationship model seeks to predict the intrinsic properties of chemicals by using various databases and theoretical models, instead of conducting tests. Based on knowledge of chemical structure, that model relates characteristics of the chemical to a measure of a particular activity. It allows qualitative conclusions to be drawn concerning the presence or absence of a property of a substance, based on a structural feature of the substance. (51)
123. Therefore, provided that data exist relating to a validated structure-activity relationship of a substance that has already been classified, an expert can extrapolate from those data to classify a substance with similar structures and properties. The read-across method always involves the use of data relating to other substances.
124. I therefore consider that the principles laid down in section 1.6.1(b) of Annex VI to Directive 67/548 do not preclude the Commission from having recourse to the read-across method for the purposes of its assessment.
125. Secondly, the REACH Regulation promotes the use of that technique (52) to avoid recourse to further tests on animals.
126. In accordance with Article 13 of that regulation, information on intrinsic properties of chemicals, in particular on their human toxicity, is to be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, qualitative or quantitative structure-activity relationship models or information from structurally related substances (grouping or read-across). As the European Union legislature states at section 1.3 of Annex XI to that regulation, the results of those assessments are adequate for the purpose of classification and labelling (53) and/or for the risk assessment of those substances.
127. Moreover, that method, like the method based on the structure-activity relationship, is promoted in Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes,(54) to which Annex VI to Directive 67/548 expressly refers.
128. Lastly, predictions made using the read-across method are currently expressly permitted under Regulation No 1272/2008. Section 1.1.1.3 of Annex I to that regulation points out inter alia that all available information having a bearing on the determination of hazard, such as information from the application of the category approach (grouping, read-across), must be considered in order to determine the weight of evidence.
129. Thirdly, whether recourse should be had to the read-across method is a matter for expert scientific opinion; it is not for the Court to assess its merits. As minutes of certain TCCL meetings show, that issue was discussed over several years by a broad range of scientific experts (55) and representatives from the borates industry were heard. In this instance, as is clear from the observations submitted by the Governments of the Member States, the experts found that assessment of the toxicity risk of the substances at issue, namely monohydrated sodium perborate and tetrahydrated sodium perborate, had to be based on the toxicity of boric acid, which borates are composed of. It is apparent from the documents before the Court that, in aqueous solution at physiological (7.4) and environmental pH, borates exist primarily as undissociated boric acid. The experts therefore decided to predict the physicochemical properties and the effects on human health of the substances concerned on the basis of data relating to borates compounds in the same group.
130. Consequently, in the light of the foregoing considerations, it seems to me that the Commission did not manifestly exceed the bounds of its discretion in using the read-across method for the purposes of assessing the intrinsic properties of the substances in question.
– Whether there was a failure to state reasons
131. The referring court asks the Court whether the validity of the 30th ATP Directive is vitiated by a failure to state reasons, contrary to Article 253 EC. The applicant in the main proceedings complains that the Commission has failed to set out the reasons for its view that such an extrapolation was necessary for the purposes of the contested classifications.
132. In accordance with Article 253 EC, regulations and directives must state the reasons on which they are based. It has been consistently held that the statement of reasons must show clearly and unequivocally the reasoning of the institution which adopted the measure. It must, on the one hand, enable the persons concerned to understand the full significance of and the reasons for the measure at issue in order to enable them to safeguard their rights and, on the other hand, enable the European Union judicature to exercise its powers of review of legality. (56)
133. However, the degree of reasoning required may vary. Thus, the scope of the obligation to state reasons depends on the nature of the measure and all the documents in the case. It must also be assessed with reference to the wording of the measure, the context and the procedure under which it was adopted, and to the whole body of legal rules governing the matter in question. (57)
134. Thus, as regards regulations forming part of legislation that is complex in content, the Court has held that ‘the statement of the reasons on which regulations are based is not required to specify the often very numerous and complex matters of fact or of law dealt with in the regulations, provided that the latter fall within the general scheme of the body of measures of which they form part. Consequently, if the contested measure clearly discloses the essential objective pursued by the institution, it would be excessive to require a specific statement of reasons for each of the technical choices made by the institution’. (58)
135. Furthermore, the Court has stated that the requirement of a statement of reasons must be viewed in the context of the interest which the addressee may have in obtaining explanations. (59) Accordingly, the Court accepts that a decision addressed to a Member State might not contain a detailed statement of reasons since the Government concerned was closely involved in the process by which that decision came about. (60) Consequently, where the persons concerned are involved in the process by which the measure came about, the requirement to state reasons may be circumscribed since they receive information through their involvement. (61)
136. In the preamble to the 30th ATP Directive reference is made to the need to update Annex I to Directive 67/548 to include further existing substances and to adapt existing entries if new scientific knowledge becomes available. As regards the borate substances, the Commission points out that recent preliminary and partial information was submitted by industry. It notes, however, that, since that information had not yet been peer-reviewed, special attention was to be paid to the epidemiological studies under way concerning borates, in particular the study currently being carried out in China. Finally, the Commission points out that the measures adopted under the 30th ATP Directive are in accordance with the opinion of the ATP Committee.
137. In the specific context of establishing adaptations of Directive 67/548 to technical progress, the reasoning in the 30th ATP Directive is in my view adequate.
138. First, as I have pointed out in my Opinion in Nickel Institute, the enactment of the 30th ATP Directive forms part of a complex evolving legal process and calls for high-level scientific and technical assessments. In my view, the Commission was not therefore required to specify all the technical and scientific evidence on which it relied for the purposes of the contested classifications.
139. Secondly, as has been seen, following the classification proposals put forward in 1999 by the French Republic and the Kingdom of Denmark, all the Member States and the borate producers were closely involved in the process by which the 30th ATP Directive came about, the former via attendance at the meetings of specialist experts brought together inter alia within the TCCL and the ATP Committee, and the latter in view of their obligations to report information under Regulation No 793/93.
140. Moreover, it is apparent from the information submitted to the Court that the discussions in which it was decided to use the read-across method were recorded in minutes which were available to the parties concerned prior to the adoption of the 30th ATP Directive. Consultation of the website of the Commission Directorate-General for Health and Consumers and the many annexes attached by the intervener to its observations (62) in fact show that the record of those proceedings was published and accessible. In view of its involvement in the procedure and the accessibility of the Commission’s documents, Étimine was fully apprised, to my mind, of the discussions and the methods adopted by the Commission for the purposes of the contested classifications. Clearly, the applicant in the main proceedings is now in a position to bring its action before the national court in full knowledge of the facts. As to the European Union judicature, I take the view that it is likewise in a position to exercise its power of review.
141. In the light of those considerations, I therefore take the view that the 30th ATP Directive is not vitiated by a failure to state reasons.
3. Whether the principle of proportionality was complied with
142. The referring court asks the Court whether the contested classifications were adopted in breach of the principle of proportionality. The applicant in the main proceedings argues that, pending new epidemiological studies, the Commission should have refrained from proposing a classification of the borate substances. At the very most, it should have classified the substances at issue as toxic to reproduction category 3.
143. I do not consider that criticism well founded.
144. According to settled case-law, the principle of proportionality requires that the measures adopted by European Union institutions do not exceed the limits of what is appropriate and necessary in order to attain the objectives pursued by the legislation in question. Accordingly, where an institution must choose between several appropriate measures, it must have recourse to the least onerous, and where those measures cause disadvantages, it must ensure that those disadvantages are not disproportionate to the aims pursued. (63)
145. The review carried out by the European Union judicature in this matter depends on the discretion available to the institution. Where the institution has a broad discretion in an area which entails political, economic and social choices on its part, and in which it is called upon to undertake complex assessments, judicial review is restricted. Accordingly, the Court has held that the legality of a measure adopted in that sphere can be affected only if that measure is manifestly inappropriate having regard to the objective which the institution is seeking to pursue. (64)
146. In the present case, it is therefore necessary to examine whether classification of the borate substances as toxic to reproduction category 2 constitutes a proportionate means of attaining the objectives of Directive 67/548.
147. First, it should be noted that the second recital in the preamble to Directive 67/548 states that the measures for classifying and labelling dangerous substances must, inasmuch as they concern health, safety and the protection of man and the environment, take as their basis a high level of protection. (65)
148. Secondly, the objectives of health, environmental and consumer protection are referred to in Article 95(3) EC, for which the European Union legislature takes as a base a high level of protection, taking account in particular of any new development based on scientific facts. Those objectives are also pursued in Article 174(1) and (2) EC, under which European Union policy on the environment is to be based inter alia on the precautionary principle.
149. In this instance, it is clear, in my view, that the classification of a substance, in so far as it makes it possible to inform users of the hazards associated with its handling and use, is perfectly appropriate for the purpose of attaining the objectives pursued by the European Union legislature in this field.
150. I must now consider whether or not the classification at issue goes beyond what is necessary to attain those objectives.
151. On reading the documents in the case, I note that the issue of classification of the borate substances as toxic to reproduction category 3 was raised on a great number of occasions. Although that issue was resolved at the vote on the draft 30th adaptation to technical progress, seven Member States did in fact express reservations on this point. (66) Those Member States considered a category 3 classification more appropriate in view, inter alia, of the limited risks of human exposure (humans having a vomiting reflex on ingestion) and the results of epidemiological studies. (67) However, the majority of the Member States opted for category 2 classification, considering in particular that the tests on animals clearly highlighted a risk of toxicity to reproduction; it was not possible to challenge that conclusion in the light of the available epidemiological data. (68)
152. That is the context, characterised by complex scientific assessments and the difficulty, or even impossibility, of determining with any degree of certainty the existence or extent of the hazards faced by humans, in which the Commission, supported by its experts, chose to classify the substances at issue as toxic to reproduction category 2.
153. Clearly, such a classification has implications for industry (the impact on competitiveness or production costs), social implications (the impact on employment and working conditions) and economic implications (the impact on consumer prices and the quality of the end product). In particular, that measure confers new responsibilities on industrial operators and imposes many obligations on them, in particular with regard to risk management, which may affect their economic interests. None the less, it must be borne in mind that, in this area, the precautionary principle must be applied. Thus, since it is impossible to determine with any certainty the extent of the hazards which humans may face following the handling or use of borates but there is nevertheless a likelihood of real harm to health in the light of the scientific data available, the precautionary principle justifies, to my mind, the adoption of the measures in question, which are, in fact, much more restrictive than those advocated by the industrial sector.
154. Lastly, it should be noted that, in accordance with the final recital in the preamble to Directive 67/548 and as expressly stated in the recital 2 in the preamble to the 30th ATP Directive, the Commission reserves the right to review the contested classifications if new scientific knowledge becomes available in accordance with Article 95(3) EC.
155. Taking account of those factors, I am of the view that the contested classifications do not go beyond what is necessary to achieve the objectives of Directive 67/548.
156. In the light of the foregoing, I therefore consider that the Commission did not infringe the principle of proportionality by classifying the borate substances as toxic to reproduction category 2.
157. It follows from all the foregoing that consideration of the first question has disclosed nothing to affect the validity of the 30th ATP Directive or the validity of the 1st ATP Regulation, in so far as the Commission classified the borate substances referred to under entries 005-007-00-2, 005-008-00-8, 005-011-00-4, 005-011-01-1 and 005-011-02-9 of that directive as toxic to reproduction category 2 (R 60 and R 61).
C – The second question
158. The second question was formulated in the same terms in the Nickel Institute case. I will, therefore, adopt the same considerations as those set out in my Opinion in that case.
1. Whether the legal basis for the 1st ATP Regulation is valid
159. In question 2(a), the referring court asks the Court whether the Commission could legitimately rely on Article 53 of Regulation No 1272/2008 for the purpose of adopting the 1st ATP Regulation.
160. As is apparent from recital 2 in the preamble to the 1st ATP Regulation, the Commission considered it ‘necessary to amend Annex VI to Regulation … No 1272/2008 in order to reflect the recently adopted amendments to Annex I to Directive 67/548 … introduced by [the 30th ATP Directive]’. The Commission also considered that ‘[t]hose measures constitute[d] adaptations to technical and scientific progress within the meaning of Article 53 of Regulation … No 1272/2008’.
161. The applicant in the main proceedings maintains that the only permissible legal basis for the measures contained in the 1st ATP Regulation is to be found in Article 37 of Regulation No 1272/2008, not Article 53 thereof. What the applicant is in fact seeking is a new assessment by the competent authorities of the intrinsic properties of the substances at issue.
162. I take the view that Article 37 of Regulation No 1272/2008 does not apply in this instance, in view of the purpose of that provision.
163. That provision forms part of Chapter I under Title V of that regulation, entitled ‘Establishing (69) harmonised classification and labelling of substances’. Under that provision, Member States and representatives of industry in the sector may submit to the ECHA a proposal for harmonised classification and labelling of substances in accordance with the principles established in that regulation. The proposal is first examined by the ECHA Committee for Risk Assessment and subsequently by the Commission, which must then submit a draft decision concerning the inclusion of that substance together with the relevant classification and labelling elements in Table 3.1 of Part 3 of Annex VI to Regulation No 1272/2008. (70)
164. In my view, Article 37 of that regulation establishes the procedure to be followed where a proposal is submitted to adopt, for the first time, harmonised classification or labelling of a substance on the basis solely of the criteria established in Annex I to that regulation. It is therefore not possible under that procedure for the harmonised classification and labelling of substances in respect of which a decision has already been taken on the basis of the principles laid down in Directive 67/548 to be incorporated.
165. On the other hand, that is, to my mind, entirely possible if Article 53 of Regulation No 1272/2008 is taken as the basis. As shown by its title, that provision establishes the procedure for ‘[a]daptations to technical and scientific progress’ of that regulation. Under that provision, ‘[t]he Commission may adjust and adapt … Annexes I to VII [to that regulation] to technical and scientific progress’. (71) It seems clear to me that, in adopting the 1st ATP Regulation, the Commission ‘adjusted and adapted’ Regulation No 1272/2008 to the latest amendments to Directive 67/548 introduced by the 30th and 31st ATP Directives. It will be recalled that those amendments could not be included in the first version of Regulation No 1272/2008 as the text of the regulation was ‘frozen’ during the codecision procedure. It should also be recalled that those amendments were, to my mind, justified since there was technical progress within the meaning of Article 28 of Directive 67/548.
166. In the light of those factors, I therefore consider that Article 53 of Regulation No 1272/2008 constitutes a permissible legal basis for the measures contained in the 1st ATP Directive.
2. Whether the classifications in Table 3.1 in Part 3 of Annex VI to Regulation No 1272/2008 are lawful
167. This question concerns the classification of the substances at issue in Table 3.1 in Part 3 of Annex VI to Regulation No 1272/2008. The referring court asks the Court whether the Commission was entitled to rely on Annex VII to that regulation in order to arrive at that classification. The applicant in the main proceedings maintains that the Commission should have carried out a new assessment of the intrinsic properties of the borates on the basis of the criteria laid down in Annex I to that regulation.
168. In my view, the Commission did not, in this regard, commit any manifest error of assessment or misuse its powers in such a way as to affect the validity of the 1st ATP Regulation. I have pointed out that, in line with the intention of the European Union legislature, all existing harmonised classifications were to be converted into new harmonised classifications using the new criteria laid down in Regulation No 1272/2008. To that end, Annex VII to that regulation contains a table specifically designed to facilitate the conversion of the classification of a substance established under Directive 67/548 into the corresponding classification established under Regulation No 1272/2008. The Commission was therefore perfectly entitled to rely on that annex.
169. It follows from all of the foregoing that consideration of the second question has disclosed nothing to affect the validity of the 1st ATP Regulation adapting, for the first time, Regulation No 1272/2008 to technical progress, in so far as concerns the Commission’s classification of the borates.
V – Conclusion
170. In the light of the foregoing considerations, I propose that the Court should reply as follows to the questions referred by the High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court):
Consideration of the questions referred for a preliminary ruling has disclosed nothing to affect the validity of Commission Directive 2008/58/EC of 21 August 2008 amending, for the purpose of its adaptation to technical progress, for the 30th time, Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, or the validity of Commission Regulation (EC) No 790/2009 of 10 August 2009 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, in so far as the European Commission classified the borate substances referred to under entries 005-007-00-2, 005-008-00-8, 005-011-00-4, 005-011-01-1 and 005-011-02-9 of Directive 2008/58 as toxic to reproduction category 2 (R 60 and R 61).
1 – Original language: French.
2 – Borates are salts or esters of boric acid.
3 – OJ, English Special Edition, 1967, p. 234, as amended by Council Directive 92/32/EEC of 30 April 1992 (OJ 1992 L 154, p. 1; ‘Directive 67/548’).
4 – OJ 2008 L 246, p. 1; ‘the 30th ATP Directive’. The substances concerned are referred to under entries 005-007-00-2 (boric acid), 005-008-00-8 (diboron trioxide; boric oxide), 005-011-00-4 (disodium tetraborate, anhydrous; boric acid, disodium salt; tetraboron disodium heptaoxide, hydrate; orthoboric acid, sodium salt), 005-011-01-1 (disodium tetraborate decahydrate; borax decahydrate) and 005-011-02-9 (disodium tetraborate pentahydrate; borax pentahydrate).
5 – Regulation 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 – OJ 2009 L 235, p. 1; ‘the 1st ATP Regulation’.
7 – OJ 1999 L 184, p. 23, as amended by Council Decision 2006/512/EC of 17 July 2006 (OJ 2006 L 200, p. 11; ‘Decision 1999/468’). That provision must be read in conjunction with paragraph 1 of Annex III to Council Regulation (EC) No 807/2003 of 14 April 2003 adapting to Decision 1999/468/EC provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in Council instruments adopted in accordance with the consultation procedure (unanimity) (OJ 2003 L 122, p. 36).
8 – OJ 2009 L 11, p. 6; ‘the 31st ATP Directive’.
9 – See recitals 5 to 8 in the preamble to that regulation.
10 – OJ 2004 L 152, p. 1, and Corrigendum, OJ 2004 L 216, p. 3.
11 – OJ 1993 L 84, p. 1, as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ 2003 L 284, p. 1; ‘Regulation No 793/93’).
12 – Regulation 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, and Corrigendum, OJ 2007 L 136, p. 3; ‘the REACH Regulation’).
13 – Recital 1 in the preamble to the REACH Regulation.
14 – I am citing the facts as set out in the case which gave rise to the order of the General Court of the European Union of 7 September 2010 in Case T-539/08 Étimine and Étiproducts v Commission [2010] ECR II-0000.
15 – Possible risk of harm to the unborn child (R 63).
16 – ‘Étimine’.
17 – ‘Borax’.
18 – See the first recital in the preamble to the 30th ATP Directive.
19 – See, in that regard, Objective Four, Action A, under entitled ‘Clarifying which legislation is in force’, of the Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions, ‘Updating and simplifying the Community acquis’ of 11 February 2003 (COM(2003) 71 final).
20 – Under Article 61(1) to (3) of Regulation No 1272/2008, substances are therefore to be classified in accordance with Directive 67/548 until 1 December 2010. Then, from 1 December 2010 until 1 June 2015, ‘substances shall be classified in accordance with both Directive 67/548 … and … Regulation [No 1272/2008]’.
21 – The French version of that provision expressly provides that ‘[l]’annexe I est supprimée», and the English version that ‘Annex I shall be deleted’.
22 – The Commission relied on Article 53 of Regulation No 1272/2008, which provides, inter alia, for the adaptation of Annex VI thereto to technical progress.
23 – My emphasis.
24 – ‘the ATP Committee’.
25 – Minutes from the meeting of the Committee for Adaptation to Technical Progress of Directive 67/548, the summary record of which is available in English in Annex I to the observations of the French Government.
26 – Rules of Procedure of the Committee for Adaptation to Technical Progress of Directive 67/548, available in English in Annex 2 to the observations of the French Government.
27 – That provision applies to existing substances, listed in the European Inventory of Existing Commercial Chemical Substances (EINECS), while section 1.6.1(a) of Annex VI to Directive 67/548 applies to new substances.
28 – Case C-448/06 cp-Pharma [2008] ECR I-5685, paragraph 27 and cited case-law.
29 – Case C-343/09 Afton Chemical [2010] ECR I-0000, paragraph 28 and the case-law cited.
30 – The applicant in the main proceedings mentions soap, glass, insulation, adhesives, paper, detergents, fibreglass, ceramics, cosmetics and biocide products.
31 – My emphasis.
32 – OJ 1993 L 227, p. 9, the directive having since been repealed.
33 – My emphasis.
34 – Summary of the minutes of the meeting of the TCCL and the working group bringing together specialised experts in reproductive toxicity, on classification of boric acid and the borates, set out in English in Annex 1 to the Commission’s observations.
35 – Commission Regulation of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances in accordance with Council Regulation (EEC) No 793/93 (OJ 1994 L 161, p. 3).
36 – Draft, in English, at Annex 2 to the Commission’s observations.
37 – My emphasis.
38 – Idem.
39 – Idem.
40 – The fourth to seventh subparagraphs of point 1.1.4 of that statement read as follows:
‘… Annex VI, section 4.2.3.3, lists three reasons why animal data on reproductive toxic effects may not be relevant for humans: the level of the doses administered, for example where effects have been demonstrated only at high doses, or where marked toxico-kinetic differences exist, or the route of administration is inappropriate.
In section 1.1.3 it is demonstrated that NOAEL [No Observed Adverse Effect Level] observed in the animal studies is well below the maximum dose administered in an Annex V method for investigating reproductive toxicity.
The available data on toxico-kinetics do not indicate major differences between laboratory animals and humans. It is not known whether there are significant differences in the toxico-dynamics between humans and laboratory animal models and in the absence of such knowledge it must be assumed that the effects seen in animals could occur in humans.
The available studies on animals were conducted using the oral route of administration. This route is an appropriate route of administration in accordance with Article 2(2)(n) of Directive 67/548.’
The English acronym ‘NOAEL’ is a unit of measurement for designating the dose which has no toxic effect, that is to say, the maximum dose for a substance for which no toxic (adverse) effect is observed.
41 – See, in particular, Method B.31, referred to under Section B.IV ‘Reproductive Toxicity.
42 – See sections 3.1.1 and 4.2.3 of Annex VI to Directive 67/548.
43 – The sixth subparagraph in section 4.2.3.3 of Annex VI to Directive 67/548 concerns, in these circumstances, supporting evidence on mechanism of action or site of action, or chemical relationship to other known anti-fertility agents or other information from humans.
44 – See recital 2 in the preamble to the 30th ATP Directive.
45 – It should be recalled that that this provision states that the data required for classification of the substances in question may, where appropriate, be obtained from a number of different sources including not only the results of previous tests, information taken from reference works and the literature, and information derived from practical experience but also the results of validated structure-activity relationships and expert judgment.
46 – See the document of the Commission’s Joint Research Centre, ‘A Compendium of Case Studies that helped to shape the REACH Guidance on Chemical Categories and Read Across’, 2007, available at:
http://ecb.jrc.ec.europa.eu/documents/QSAR/EUR_22481_EN.pdf. See, in particular, Gallegos, A., Langezaal, I., and Worth, A., ‘Summary of Discussions on the Use of QSARs, Read-Across and Grouping in the Technical Committee for Classification and Labelling (TC C&L)’, 28 February 2007, at p. 67 of the Commission document.
47 – See ‘Report on the regulatory uses and applications in OECD member countries of (quantitative) structure-activity relationship [(Q)SAR] models in the assessment of new and existing chemicals’, available at:
http://www.oecd.org/dataoecd/55/22/38131728.pdf.
48 – See, for example, Hart, J., ‘Nickel compounds – a category approach for metals in EU legislation’, a report to the Danish Environmental Protection Agency, January 2008, available at: http://cms.mim.dk/NR/rdonlyres/07DB028E-134E-4796-BF6D-97B9AD5F9E82/0/Nikkel.pdf; Hart, J., and Veith, GD., ‘Applying Chemical Categories to Classification & Labelling: A Case Study of Volatile Aliphatic Ethers’, a report to the Danish Environmental Protection Agency, January 2007, available at: http://www.qsari.org/documents/aliphaticethers.pdf, and Comber, M., and Simpson, B., ‘Grouping of Petroleum Substances’, September 2006, at p. 113 of the Commission document cited in footnote 46.
49 – Application of the group concept requires it to be possible for physicochemical properties, the effects on human health and environmental effects or environmental fate to be predicted from data for a reference substance or substances within the group by interpolation from other substances in the group. Ideally, a category should include all potential elements of similar substances.
50 – See paragraph 2.1 of ‘Practical guide 6: How to report read-across and categories’ and paragraph 3.1.2.4 of the ‘Evaluation under REACH – Progress Report 2009’, available on the ECHA website.
51 – See paragraph 3.1.2.2 of the ‘Evaluation under REACH – Progress Report 2009’.
52 – See also Article 10(5) of Regulation No 793/93.
53 – My emphasis. See also section 1.5 of that annex.
54 – OJ 1986 L 358, p. 1.
55 – See, for example, Gallegos, A., Langezaal, I., and Worth, A., op. cit. (p. 72 and the many references cited).
56 – See Case C-380/03 Germany v Parliament and Council [2006] ECR I-11573, paragraph 107 and case-law cited.
57 – Ibid., paragraph 108 and case-law cited.
58 – Case 250/84 Eridania zuccherifici nazionali and Others [1986] ECR 117, paragraph 38. See also Case 167/88 AGPB [1989] ECR 1653, paragraph 34.
59 – Case C-303/88 Italy v Commission [1991] ECR I-1433, paragraph 52 and case-law cited.
60 – Case 819/79 Germany v Commission [1981] ECR 21.
61 – Case T-504/93 Tiercé Ladbroke v Commission [1997] ECR II-923, paragraphs 52 to 55.
62 – See ‘Background Documentation to Boron’ available at the following address:
http://tcsweb3.jrc.it/home.php?CONTENU=/DOCUMENTS/Classification-Labelling/.
63 – Afton Chemical, paragraph 45 and case-law cited.
64 – Ibidem, paragraph 46 and case-law cited.
65 – See also recitals 1 and 3 in the preamble to Regulation No 1272/2008.
66 – See minutes of the meeting of 16 February 2007, cited in footnote 25.
67 – See, in this regard, minutes of the TCCL meeting of 20 February 2006, referred to at point 110 of this Opinion.
68 – Idem.
69 – My emphasis.
70 – That measure is adopted in accordance with the regulatory procedure with scrutiny laid down in Article 5a of Decision 1999/468.
71 – Idem.