CELEX: 62010CC0014
Language: en
Date: 2011-03-24
Title: Opinion of Mr Advocate General Bot delivered on 24 March 2011. # Nickel Institute v Secretary of State for Work and Pensions. # Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen's Bench Division (Administrative Court) - United Kingdom. # Environment and protection of human health - Directive 67/548/EEC - Regulation (EC) No 1272/2008 - Classification of nickel carbonates, nickel hydroxides and a number of grouped nickel substances as dangerous substances - Validity of Directives 2008/58/EC and 2009/2/EC and of Regulation (EC) No 790/2009 - Adaptation of the classifications to technical and scientific progress - Validity - Methods of assessing the intrinsic properties of those substances - Manifest error of assessment - Legal basis - Obligation to state reasons. # Case C-14/10.

OPINION OF ADVOCATE GENERAL
      BOT
      delivered on 24 March 2011 (1)
      
      Case C‑14/10
      Nickel Institute
      v
      Secretary of State for Work and Pensions
      (Reference for a preliminary ruling from the High Court of Justice (England and Wales), Queen’s Bench Division (Administrative
         Court))
      
      (Environment and protection of human health – Directive 67/548/EEC – Classifications of nickel substances as dangerous substances – Whether Directives 2008/58/EC and 2009/2/EC are valid in so far as they adapt those classifications to technical and scientific
         progress – Legal basis – Methods of assessing the intrinsic properties of the substances – Obligation to state reasons – Regulation (EC) No 1272/2008 – Whether Regulation (EC) No 790/2009 is valid in so far as it incorporates those classifications)
      
      1.        This reference for a preliminary ruling concerns the validity of the classifications under European Union law of certain nickel
         substances as dangerous substances.
      
      2.        Two regulatory frameworks are relevant here. 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. (2) 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, (3) and 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. (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 European 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 High Court of Justice (England and Wales), Queen’s Bench Division (Administrative Court) is essentially
         asking the Court whether the 30th and 31st ATP Directives and the 1st ATP Regulation are valid. In particular, the referring
         court entertains doubts as to whether, in classifying the nickel carbonates in the 30th ATP Directive, (7) and in classifying nickel hydroxide, nickel dihydroxide and the group of nickel substances in the 31st ATP Directive, (8) 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 that this reference for a preliminary ruling raises certain issues that are identical to, or closely connected
         with, those raised in the Étimine case (C-15/10), 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(1) to (4) of Council
         Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission. (9)
      
      8.        Under that procedure, the Commission is to be assisted by a committee composed of the representatives of the Member States
         and chaired by the representative of the Commission. 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 them only if, on 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 a proposal relating to the measures to be taken to the Council and forward it to
         the Parliament at the same time.
      
      9.        Annex I to Directive 67/548 was most recently amended by the 30th and 31st ATP Directives.
      
      3.      Partial repeal, amendment and replacement of Directive 67/548 by Regulation No 1272/2008
      10.      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. (10)
      
      11.      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.
      
      12.      Those new classifications are set out in Annex VI, Part 3, to Regulation No 1272/2008, in particular in Table 3.1.
      
      13.      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.
      
      14.      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. (11) That annex therefore did not contain the contested classifications incorporated by the 30th and 31st ATP Directives.
      
      15.      The content of those directives was therefore added to Annex VI to Regulation No 1272/2008 when the 1st ATP Regulation was
         adopted.
      
      16.      For the purpose of incorporating the content of those directives, 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(1) to (4) of Decision 1999/468.
      
      B –    Evaluation and control of the risks of existing substances
      17.      Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (12) 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.
      
      18.      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.
      
      19.      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 missing information that is lacking and is 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.
      
      20.      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.
      
      21.      That regulatory framework was updated by Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18
         December 2006 (REACH). (13)
      
      22.      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, (14) laid down in Article 13 thereof, is to promote the development of alternative methods for the assessment of hazards associated
         with chemical substances.
      
      23.      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 the main proceedings
      A –    Risk evaluation procedure for nickel carbonates
      24.      In October 2000, the Commission, in accordance with Article 8 of Regulation No 793/93, included pure nickel carbonate in the
         fourth list of priority substances. (15)
      
      25.      The Danish Environmental Protection Agency (‘the DEPA’) was designated as rapporteur for evaluating the risks of that substance. (16) After discussion, the risk evaluation concerning pure nickel carbonate was extended to four compounds in the nickel carbonates
         group. OMG Harjavalta, one of the main producers of nickel carbonates in Europe, was given responsibility for communicating
         with the DEPA on behalf of the other producers for the purpose of evaluating the risks of the nickel carbonates in accordance
         with the relevant provisions of Regulation No 793/93.
      
      26.      OMG Harjavalta informed the DEPA that no human toxicological data for nickel hydroxycarbonate existed and, on 27 May 2003,
         submitted a request, on the basis of Article 9(3) of Regulation No 793/93, to be exempted from the requirement to carry out
         certain tests and to provide data on the toxicity of nickel hydroxycarbonate as regards human health and the environment (‘the
         derogation statement’).
      
      B –    Procedure leading to the contested classifications
      27.      In accordance with the final paragraph of Article 10(3) of Regulation No 793/93, the DEPA forwarded the recommended risk evaluation
         and strategy to the Commission. On 16 April 2004 it submitted to the European Chemicals Bureau (which was replaced by the
         ECHA) and to the Technical Committee on Classification and Labelling of Dangerous Substances (‘the TCCL’) a formal proposal
         for a revised classification of the nickel carbonates under Directive 67/548.
      
      28.      At a meeting held on 20 and 21 April 2004, the working party of specialist experts on carcinogenicity, mutagenicity and reproductive
         toxicity discussed the proposed carcinogenicity and mutagenicity classifications.
      
      29.      The TCCL discussed the proposed classification at its meetings of 12 to 14 May 2004 and 21 to 24 September 2004. At the meeting
         of 21 to 24 September 2004, it was decided to recommend the proposed revised classification for the nickel carbonates and
         to include it in the draft proposal for the 30th ATP Directive which was to be sent to the Commission.
      
      30.      In November 2005, the DEPA repeated the proposal for the revised classification of the nickel carbonates under Directive 67/548
         in a draft risk evaluation report on the nickel carbonates and also in a draft risk evaluation report on nickel and the nickel
         compounds, which stated inter alia that the classification of the nickel carbonates as category 3 mutagens (phrase R 68) was
         ‘justified on the basis of the … derogation statement’.
      
      31.      On the basis of the TCCL’s recommendation of September 2004, the Committee for Adaptation to Technical Progress of Directive
         67/548 (17) decided, at its meeting of 16 February 2007, in favour of the proposal for the 30th ATP Directive, which reproduced the proposed
         revised classification of the nickel carbonates.
      
      32.      In March 2007, that draft proposal was notified to the Committee on Technical Barriers to Trade of the World Trade Organisation
         (WTO) (‘the TBT Committee’). On 7 November 2007, the Commission replied in writing to the comments submitted by non-member
         States. Following a discussion at the TBT Committee meeting held on 9 November 2007, the Commission decided to postpone the
         adoption of the 30th ATP Directive, so that further written comments could be submitted to it and a second discussion of the
         draft proposal take place within that Committee. On 12 March 2008, the Commission replied in writing to a second round of
         written comments and the draft proposal was reconsidered at the TBT Committee meeting of 19 March 2008.
      
      33.      On 21 August 2008, the Commission adopted the 30th ATP Directive and, in particular, the proposed revised classification of
         the nickel carbonates. On 15 January 2009, the Commission adopted the 31st ATP Directive, in particular the proposed classification
         of nickel hydroxide, nickel dihydroxide and the group of nickel substances. Those two directives were 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.
      
      III –  The reference for a preliminary ruling
      35.      The High Court of Justice (England and 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 30th ATP Directive] and/or [the 1st ATP Regulation], to the extent that they purport to classify or reclassify the
         nickel carbonates for the relevant endpoints, invalid in that:
      
      (a)      the classifications were arrived at without adequate assessment of the intrinsic properties of the nickel carbonates in accordance
         with the criteria and data requirements set out in Annex VI to [Directive 67/548];
      
      (b)      there was no adequate consideration of whether the intrinsic properties of the nickel carbonates may present a risk during
         normal handling and use, as required by sections 1.1 and 1.4 of Annex VI to [Directive 67/548];
      
      (c)      the conditions for the use of the procedure in Article 28 of [Directive 67/548] were not made out;
      (d)      the classifications were impermissibly based on a derogation statement prepared for the purposes of a risk assessment carried
         out by a competent authority pursuant to Regulation … No 793/93; and/or
      
      (e)      the reasons for adopting the classifications were not given as required by Article 253 EC?
      2.      Are [the 31st ATP Directive] and/or the 1st ATP Regulation invalid, to the extent that they purport to classify or reclassify
         the nickel hydroxides and the grouped nickel substances … in the specified respects, in that:
      
      (a)      the classifications were arrived at without adequate assessment of the intrinsic properties of the contested nickel substances
         in accordance with the criteria and data requirements set out in Annex VI to [Directive 67/548], but rather on the basis of
         certain read-across methods;
      
      (b)      there was no adequate consideration of whether the intrinsic properties of the contested nickel substances may present a risk
         during normal handling and use, as required by sections 1.1 and 1.4 of Annex VI to [Directive 67/548]; and/or
      
      (c)      the conditions for the use of the procedure in Article 28 of [Directive 67/548] were not made out?
      3.      Is the 1st ATP Regulation invalid, so far as it concerns the nickel carbonates and the contested nickel substances, in that:
      (a)      the conditions for the use of the procedure in Article 53 of Regulation … No 1272/2008 … were not made out; and/or
      (b)      the classifications for Table 3.1 of Annex VI to [Regulation No 1272/2008] were arrived at without adequate assessment of
         the properties of the nickel carbonates and the contested nickel substances in accordance with the criteria and data requirements
         set out in Annex I to [that] regulation, but rather on the application of Annex VII to [that] regulation?’
      
      36.      Observations have been submitted by the parties to the main proceedings as well as the Austrian, Danish, German and United
         Kingdom Governments and the Commission.
      
      IV –  My analysis
      A –    Whether the first and second questions are admissible
      37.      At the hearing, the Commission stated that it was withdrawing the plea of inadmissibility that it had raised in relation to
         the first and second questions. Since that issue is raised in the written pleadings, I should nevertheless like to refer to
         it.
      
      38.      The Commission argued that the first and second questions are inadmissible in so far as they concern the validity of the 30th
         and 31st ATP Directives, claiming that those directives were 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 failed to transpose those directives 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.
      
      39.      That line of argument is irrelevant in my view.
      
      40.      In particular, I do not share the Commission’s view that the European Union legislature repealed the 30th and 31st ATP Directives
         by deleting Annex I to Directive 67/548 under Regulation No 1272/2008.
      
      41.      While the sole purpose of the 30th and 31st ATP Directives was to amend Annex I to Directive 67/548, (18) that does not allow such a conclusion to be drawn. Indeed, those directives entail legal effects for the Member States and
         their repeal can be effected, to my mind, only by means of a formal repeal. (19) That is justified by the principle of legal certainty. Although the directives concerned have now become obsolete, the fact
         remains that they were not expressly repealed under Regulation No 1272/2008, as amended by the 1st ATP Regulation.
      
      42.      In addition, the 30th and 31st ATP Directives are instruments amending Directive 67/548. Consequently, their 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 67/548 … 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 and 31st ATP Directives. 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)
      
      43.      Lastly, the Commission made an error of assessment in maintaining that the 30th and 31st ATP Directives were repealed with
         effect from 20 January 2009.
      
      44.      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 and 31st ATP Directives as the text of Regulation No 1272/2008 had
         been ‘frozen’, when those directives were adopted, in the course of the codecision procedure.
      
      45.      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]
            and by [the 31st ATP Directive].’ (23) It is therefore clear that, prior to entry into force of the 1st ATP Regulation on 10 August 2009, the 30th and 31st ATP
         Directives were in force.
      
      46.      In the light of those factors, I therefore take the view that the 30th and 31st ATP Directives were in force on the date on
         which the referring court made this reference for a preliminary ruling.
      
      47.      Contrary to the Commission’s submission, I do not consider that an assessment of the validity of those directives 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 those directives.
      
      48.      In the light of those factors, I am of the view that the first and second questions are admissible in so far as they concern
         the validity of the 30th and 31st ATP Directives.
      
      B –    The first and second questions
      49.      The first and second questions should, to my mind, be addressed together since they raise identical issues.
      
      50.      First, the referring court entertains doubt as to the legality of the methods chosen by the Commission for the purpose of
         assessing the intrinsic properties of the substances at issue in the context of the 30th and 31st ATP Directives. In that
         regard, it asks the Court, first, whether the read-across method is consistent with the principles laid down in Annex VI to
         Directive 67/548 and, second, whether the Commission was required to consider the risks associated with normal handling or
         use of the substances at issue for the purposes of classification. Secondly, the referring court is uncertain whether Article
         28 of Directive 67/548 constitutes the appropriate legal basis for the adoption of the 30th and 31st ATP Directives. Thirdly,
         it asks the Court whether the validity of the 30th ATP Directive is vitiated by a failure to state reasons, contrary to Article
         253 EC.
      
      1.      Preliminary observations on the Commission’s discretion
      51.      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, (24) 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 nickel, the classification and labelling of which raise delicate and controversial issues from a scientific viewpoint.
         Directive 67/548 thus grants the Commission considerable discretion, as to the substance, concerning the extent of the measures
         to be taken in order to adapt the annexes to that directive to technical progress.
      
      52.      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 a 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 EC Treaty conferred that task. (25)
      
      2.      The assessment of the intrinsic properties of the nickel carbonates
      53.      In accordance with Article 4(1) of Directive 67/548, substances are to be classified on the basis of their intrinsic properties
         (extremely flammable, toxic, carcinogenic, etc.). The general principles governing the classification of those substances
         are set out in Annex VI to the directive.
      
      54.      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’.
      
      55.      In particular, section 1.6.1(b) of that annex (26) states that the data required for classification of the substances in question may, if necessary, 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.
      
      56.      According to the applicant in the main proceedings, by carrying out the contested classifications in the 30th and 31st ATP
         Directives, the Commission failed to comply with the general principles of classification set out in Annex VI to Directive
         67/548. First, the applicant claims that the competent authorities based their assessment on the read-across method rather
         than on an evaluation of the intrinsic properties of the substances at issue. Secondly, it complains that the Commission failed
         to consider the risks posed by the substances concerned during normal handling or use.
      
      a)      Use of the read-across method [Questions 1(a) and 2(a)]
      57.      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.
      
      58.      First, the Commission did not, to my mind, deviate 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.
      
      59.      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. (27) 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. (28) 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, including a study on the classification of the nickel substances. (29)
      
      60.      Clearly, therefore, use of the read-across method is broadly accepted and widely publicised in the scientific community.
      
      61.      That 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). (30) Endpoint information relating to one chemical substance is therefore used to predict the same endpoint for another chemical
         substance which is regarded as similar. (31) Thus, that method avoids the need to test every substance for every hazard endpoint.
      
      62.      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.
      
      63.      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.
      
      64.      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. (32)
      
      65.      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.
         As pointed out by the United Kingdom Government, the read-across method always involves the use of data relating to other
         substances.
      
      66.      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.
      
      67.      Secondly, the REACH Regulation promotes the use of that technique (33) to avoid recourse to further tests on animals.
      
      68.      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 (34) and/or for the risk assessment of those substances.
      
      69.      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,(35) to which Annex VI to Directive 67/548 expressly refers.
      
      70.      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 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.
      
      71.      Thirdly, account must be taken of the fact that use of the read-across method has, in the present case, been scrutinised by
         experts.
      
      72.      Whether or not use of that method is justified from a scientific point of view is, to my mind, a matter for expert scientific
         opinion; it is not for the Court to assess its merits.
      
      73.      None the less, I note that a broad range of scientific experts, meeting in working parties and committees, (36) as well as representatives from the nickel sector, were brought together over several years for the purpose of the assessments
         at issue. Those assessments were based on epidemiological studies carried out on workers exposed to nickel compounds and experimental
         carcinogenicity studies carried out on laboratory animals. They were also based on information from specialist publications. (37)
      
      74.      In the studies carried out by the various groups, it was found that the toxicity risk assessment for the nickel carbonates
         should be based on the toxicity of the nickel ion, which the nickel substances are composed of. As is apparent from the Opinion
         on the Risk Assessment Report delivered on 4 May 2006 by the Scientific Committee on Health and Environmental Risks, (38) the actual release of that ion or its bioavailability is responsible for the genotoxic and carcinogenic effects of those
         substances. The nickel compounds were therefore considered to belong to the same group. Since the bioavailability of that
         ion was assessed by reference to its solubility, the experts took the view that where the water solubility of a given nickel
         compound is sufficiently similar to that of another nickel compound for which toxicological data are available, those factors
         could justify the same classification.
      
      75.      Consequently, it seems to me that the physicochemical properties and the effects on human health of the nickel carbonates
         were predicted on the basis of data for nickel compounds from the same group, after expert studies and consultations based
         on a great many scientific works had been carried out, ultimately arriving at a consensus.
      
      76.      In assessing the carcinogenicity and toxicity of the nickel carbonates, the Commission followed the opinion of those groups
         of experts.
      
      77.      Therefore, 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.
      
      b)      Assessment of the risks during normal handling or use of the substances [Questions 1(b) and 2(b)]
      78.      As I have pointed out, the object of classification is, in accordance with sections 1.1 and 1.7 of Annex VI to Directive 67/548,
         to identify all the physicochemical, toxicological and ecotoxicological properties of substances which may constitute a risk during their normal handling or use. (39) In that regard and in accordance with section 1.4 of that annex, the label must take account of all potential hazards which
         are likely to be faced in such handling or use.
      
      79.      In this case, the applicant in the main proceedings submits that the Commission failed to take account of the risks entailed
         in the normal handling or use of the substances at issue for the purposes of the contested classification. It points, in particular,
         to the fact that three of the four nickel carbonates are never handled or used outside a laboratory.
      
      80.      I do not consider that criticism valid or that it can invalidate the contested classifications. That criticism, to my mind,
         confuses assessment of the hazards associated with a substance with assessment of the risks of the substance.
      
      81.      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 substances.
      
      82.      This is stated expressly in 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. (40) 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 capacity to cause’.
      
      83.      Assessment of the hazards associated with a substance must therefore not be confused with assessment of its risks.
      
      84.      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. They therefore do not reflect the actual exposure situation; nor do they make it
         possible to adopt risk management measures.
      
      85.      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. That information 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. Such classification must not be limited by consideration of specific uses.
      
      86.      Consequently, it cannot be established to my mind on the basis of the argument put forward by the applicant in the main proceedings
         that the Commission manifestly exceeded the bounds of its discretion or that it made a manifest error in exercising that discretion
         by failing to take account of the fact that some nickel carbonates are never handled or used outside a laboratory.
      
      c)      Use of the derogation statement issued by the nickel manufacturers and importers [Question 1(d)]
      87.      By Question 1(d), the referring court asks the Court, in essence, whether the validity of the 30th ATP Directive and of the
         1st ATP Regulation is affected in so far as the Commission relied on the risk assessment carried out by the DEPA, in particular
         the derogation statement issued under Regulation No 793/93, for the purposes of the contested classifications.
      
      88.      It is apparent from the information submitted to the Court that the Commission, assisted by a committee composed of representatives
         of the Member States, decided, in accordance with Article 8 of Regulation No 793/93, to include the nickel carbonates in a
         list of priority substances for the purpose of assessing the risks they pose to human health and the environment.
      
      89.      In assessing the risks associated with the nickel carbonates, manufacturers and importers were required to submit all relevant
         information available to them and carry out additional testing. (41) However, as is apparent from Article 9(3) of that regulation, manufacturers and importers may be exempted from some or all
         of that testing on the grounds that a given piece of information is either unnecessary for risk assessment or is impossible
         to obtain. In the action in the main proceedings, having informed the DEPA that no human toxicological data for nickel hydroxycarbonate
         existed, OMG Harjavalta requested on 27 May 2003 that it be exempted from the requirement to carry out tests and report information
         on the toxicity of nickel hydroxycarbonate for human health and the environment. The DEPA granted that request.
      
      90.      The applicant in the main proceedings claims that the Commission made the contested classification on the basis of the derogation
         statement. In its view, the Commission therefore disregarded the classification criteria set out in Annex VI to Directive
         67/548 and thus misused its powers, rendering the 30th ATP Directive unlawful.
      
      91.      Those criticisms are clearly unfounded.
      
      92.      First, contrary to what the applicant in the main proceedings appears to be claiming, the Commission did not base its classification
         decision on the derogation statement. In particular, as has been seen, a broad range of experts were brought together, alongside
         the Commission, for the assessment of the intrinsic properties of the nickel carbonates, taking as their basis for the assessment
         a great many scientific works and prediction methods consistent with the methods and criteria laid down in Annex VI to Directive
         67/548. Therefore, as the Danish and United Kingdom Governments state in their observations, the contested classifications
         were made on a scientific basis, independently of the request by the manufacturers and importers to be exempted from further
         testing and from reporting additional information.
      
      93.      Secondly, the applicant in the main proceedings has failed to show, in my view, that the Commission in fact relied on that
         derogation statement for the purposes of the contested classifications. Indeed, the first measure on which the applicant relies
         in support of its argument is the proposal for a revised classification of the nickel carbonates under Directive 67/548 submitted
         by the DEPA. The second measure is the minutes of the meeting held between the representatives of the European Chemicals Bureau
         and the experts from the TCCL. The conclusions reached in that document in 2004 were then redrafted to a considerable degree
         in the various expert reports.
      
      94.      In the light of those considerations, I find it difficult to conclude that the Commission could have manifestly exceeded the
         bounds of the discretion which it enjoys in this area.
      
      3.      Whether the legal basis for the 30th and 31st ATP Directives is valid [Questions 1(c) and 2(c)]
      95.      By Questions 1(c) and 2(c), the referring court asks the Court whether Article 28 of Directive 67/548 constituted an appropriate
         legal basis for the adoption of the 30th and 31st ATP Directives.
      
      96.      Article 28 of Directive 67/548 is entitled ‘Adaptation to technical progress’. It provides that the amendments necessary for
         adapting the annexes to technical progress are to be adopted in accordance with the regulatory procedure with scrutiny laid
         down in Article 5a(1) to (4) of Decision 1999/468. As I have stated, Article 5a provides that the Commission is to be assisted
         by a committee composed of the representatives of the Member States responsible for delivering an opinion on the draft adaptation
         proposed by the Commission. It also provides for a vote in the Council if the measures envisaged by the Commission are not
         in accordance with the opinion of the committee.
      
      97.      The applicant in the main proceedings submits that the conditions under which the Commission may have recourse to the procedure
         under Article 28 of Directive 67/548 were not met in so far as, since no technical or scientific data existed, there could
         not be said to be any technical progress concerning the substances at issue.
      
      98.      Like all the governments of the Member States which have submitted observations and the Commission, I consider that Article
         28 of Directive 67/548 constitutes a permissible legal basis for the measures contained in the 30th and 31st ATP Directives.
      
      99.      First, the applicant’s premiss that there could not be said to be any technical progress as no technical or scientific data
         existed is incorrect. Indeed, I have shown above that the adaptations of Directive 67/548 were adopted when wide-ranging consultations
         took place and a large number of expert reports produced after the Commission’s inclusion, in October 2000, of the pure nickel
         carbonates in the fourth list of priority substances. I have also taken the view that the intrinsic properties of the substances
         at issue were assessed on the basis of data collected in the course of scientific and experimental studies, data which emerged,
         inter alia, from prediction methods, all those works requiring the involvement of a broad range of experts and their consensus.
      
      100. Secondly, the question whether those data were sufficient to show that technical progress exists within the meaning of Article
         28 of Directive 67/548 and to justify adapting the classification and labelling procedures of the substances at issue is,
         to my mind, a matter for the Commission’s assessment in this area.
      
      101. In the Enviro Tech (Europe) judgment, (42) the Court observed that the Commission has a broad discretion as to complex scientific and technical facts, such as those
         relating to the evaluation of the intrinsic properties of the substances at issue, for the purpose of determining the nature
         and scope of the measures to be adopted in order to adapt the annexes to Directive 67/548. (43) Accordingly, the Commission’s decision to adapt the classification and labelling of the substances at issue can be subject
         to only limited review by the court.
      
      102. In this instance, I take the view that the Commission clearly did not exceed the bounds of its discretion or vitiate its decision
         by committing a manifest error or misusing its powers in considering that, given the current state of scientific knowledge
         and in the light of the conclusions reached by the various technical committees, there was sufficient technical progress to
         justify adapting Directive 67/548.
      
      4.      The question alleging a failure to state reasons for the 30th ATP Directive [Question 1(e)]
      103. The referring court has asked 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
         facts and legal considerations justifying the adoption of the contested classifications in the 30th ATP Directive.
      
      104. 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. (44)
      
      105. 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. (45)
      
      106. 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.’ (46)
      
      107. 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, (47) that is to say, the opportunities available to addressees for obtaining information. 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. (48) Consequently, where the persons concerned are involved in the process by which a measure came about, the requirement to state
         reasons may be circumscribed, since they acquire information through their involvement. (49)
      
      108. 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 nickel 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 outcome of the discussion within
         the International Agency for Research on Cancer (IARC) on the classification of nickel substances and any new relevant scientific
         findings or interpretations given to the data used to establish the current proposals for the nickel compounds concerned by
         the 30th ATP Directive. Finally, the Commission points out that the measures adopted under that directive are in accordance
         with the opinion of the Committee on the Adaptation to Technical Progress.
      
      109. In the specific context of establishing the adaptations of Directive 67/548 to technical progress, the reasoning in the 30th
         ATP Directive is in my view adequate.
      
      110. First, as has been seen, 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.
      
      111. Secondly, as has been seen, following the inclusion of the pure nickel carbonates in the list of priority substances in October
         2000, the Member States and the nickel 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
         Committee on the Adaptation to Technical Progress, and the latter in view of their obligations to report information under
         Regulation No 793/93. In this regard, it is apparent from the documents in the case that the applicant in the main proceedings
         was able to raise objections regarding the evaluation methods contemplated by the Commission during the administrative procedure. (50)
      
      112. Moreover, it is apparent from the information submitted to the Court by the Commission and the United Kingdom Government that
         the meetings of those experts were minuted and those minutes were available to the parties concerned prior to the adoption
         of the 30th ATP Directive. (51) Consultation of the website of the Commission Directorate-General for Health and Consumers and of the many annexes attached
         by the applicant in the main proceedings to its observations (52) in fact illustrates the public nature of those documents. Furthermore, specific studies describing in detail the discussions
         which led to the adoption of such an approach were published. (53) The applicant in the main proceedings, in view of its involvement in the procedure and the accessibility of the Commission’s
         documents, was fully apprised, to my mind, of the Commission’s reasoning. Clearly, the applicant 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.
      
      113. 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.
      
      114. It follows from all the foregoing considerations that consideration of the first and second questions has disclosed nothing
         to affect the validity of the 30th or 31st ATP Directives or, consequently, the validity of the 1st ATP Regulation, in so
         far as concerns the Commission’s classification of the nickel carbonates, nickel hydroxide and nickel dihydroxide and the
         group of nickel substances.
      
      C –    The third question
      115. By its third question, the referring court asks the Court to assess the validity of the 1st ATP Regulation, which, it will
         be recalled, adapted Regulation No 1272/2008 for the first time to technical progress.
      
      116. As is apparent from recital 53 in the preamble to Regulation No 1272/2008, all existing harmonised classifications were converted
         into new harmonised classifications using the new criteria laid down by that regulation. Moreover, as the application of that
         regulation is deferred and the classifications harmonised in accordance with the criteria laid down in Directive 67/548 are
         relevant for the classification of substances during the ensuing transition period, all existing harmonised classifications
         are also set out in an annex to Regulation No 1272/2008.
      
      117. Thus, Part 3 of Annex VI to that regulation contains two lists of hazardous substances subject to harmonised classification
         and labelling. Table 3.1 of that annex lists the hazardous substances subject to harmonised classification and labelling based
         on the criteria set out in that regulation. Table 3.2 of that annex lists the hazardous substances subject to harmonised classification
         and labelling based on the criteria set out in Annex VI to Directive 67/548. (54)
      
      118. The referring court is uncertain inter alia whether the legal basis of the 1st ATP Regulation is valid and whether the classifications
         in Table 3.1 in Part 3 of Annex VI to Regulation No 1272/2008 are lawful.
      
      1.      Whether the legal basis of the 1st ATP Regulation is valid [Question 3(a)]
      119. In the first part of its question 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.
      
      120. 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 and 31st ATP Directives]’. 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’.
      
      121. 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 not in Article 53 but in Article 37 of Regulation No 1272/2008. What the applicant is in fact
         seeking is a new assessment by the competent authorities of the intrinsic properties of the substances at issue.
      
      122. Contrary to what is claimed by the applicant in the main proceedings, 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.
      
      123. That provision forms part of Chapter I under Title V of that regulation, entitled ‘Establishing (55) 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. (56)
      
      124. 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.
      
      125. 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’. (57) 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.
      
      126. 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 [Question 3(b)]
      127. 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 nickel carbonates and the nickel substances on the basis of the criteria
         laid down in Annex I to that regulation.
      
      128. 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 indeed 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.
      
      129. It follows from all of the foregoing that consideration of the third 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 nickel carbonates, nickel hydroxide and nickel dihydroxide and the group of nickel
         substances.
      
      V –  Conclusion
      130. In the light of the foregoing considerations, I propose that the Court should answer the questions referred by the High Court
         of Justice (England and Wales), Queen’s Bench Division (Administrative Court) for a preliminary ruling as follows:
      
      Consideration of the questions referred for a preliminary ruling has disclosed nothing to affect the validity of: (i) 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; (ii) Commission Directive 2009/2/EC of 15 January 2009 amending, for the
         purpose of its adaptation to technical progress, for the 31st 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 (iii) 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.
      
      1 –	Original language: French.
      
      2 –	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’).
      
      3 –	OJ 2008 L 246, p. 1, ‘the 30th ATP Directive’.
      
      4 –	OJ 2009 L 11, p. 6, ‘the 31st ATP Directive’.
      
      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 –	Under entry 028-010-00-0 in Annex 1F to the 30th ATP Directive, the Commission classified nickel carbonates as ‘carcinogenic,
         category 1’ (R 49), ‘mutagenic, category 3’ (R 68), ‘toxic for reproduction, category 2’ (R 61), ‘toxic’ (R 48/23), ‘harmful’
         (R 20), ‘skin irritant’ (R 38) and ‘sensitising’ (R 42).
      
      8 –	The contested classifications are set out in entries 028-013-00-7 to 028-052-002 in Annex 1B to the 31st ATP Directive
         and in Annexes II and V to the 1st ATP Regulation respectively.
      
      9 –	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).
      
      10 –	See recitals 5 to 8 in the preamble to that regulation.
      
      11 –	OJ 2004 L 152, p. 1, and Corrigendum, OJ 2004 L 216, p. 3.
      
      12 –	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’).
      
      13 –	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’).
      
      14 –	Recital 1 in the preamble to the REACH Regulation.
      
      15 –	The Commission adopted Commission Regulation (EC) No 2364/2000 of 25 October 2000 concerning the fourth list of priority
         substances as foreseen under Council Regulation (EEC) No 793/93 (OJ 2000 L 273, p. 5).
      
      16 –	Under Article 10(1) of Regulation No 793/93, for each substance on the priority lists, a Member State is given responsibility
         for its evaluation in accordance with the procedure laid down in Article 15 of that regulation, whilst ensuring fair burden
         sharing between Member States. The Member State is to designate a rapporteur for that substance from among the competent authorities
         referred to in Article 13 of the regulation. The rapporteur is to be responsible for evaluating the information submitted
         by the manufacturer(s) or importer(s) in conformity with the requirements of Articles 3, 4, 7 and 9 of Regulation No 793/93
         and any other available information, and for identifying, after consultation of the producers or importers concerned, whether,
         for the purpose of the risk evaluation, it is necessary to require the manufacturers or importers of priority substances to
         submit further information and/or to carry out further testing.
      
      17 –	See Article 29 of Directive 67/548, read in conjunction with Article 5(1) of Decision 1999/468 and with paragraph 1 of
         Annex III to Regulation No 807/2003. 
      
      18 –	See the first recital in the preamble to the 30th ATP Directive and the second recital in the preamble to the 31st ATP
         Directive.
      
      19 –	See, in this context, Objective Four, Action A, 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 –	Case C‑448/06 cp-Pharma [2008] ECR I-5685, paragraph 27 and cited case-law, and Case C‑343/09 Afton Chemical [2010] ECR I-0000, paragraph 28.
      
      25 –	Afton Chemical, paragraph 28 and case-law cited.
      
      26 –	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.
      
      27 –	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.
      
      28 –	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.
      
      29 –	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, G.D., ‘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 27.
      
      30 –	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.
      
      31 –	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.
      
      32 –	See paragraph 3.1.2.2 of the ‘Evaluation under REACH – Progress Report 2009’.
      
      33 –	See also Article 10(5) of Regulation No 793/93.
      
      34 –	My emphasis. See also section 1.5 of that annex.
      
      35 –	OJ 1986 L 358, p. 1.
      
      36 –	See points 27 to 32 of this Opinion.
      
      37 –	See the document of the World Health Organisation, International Agency for Research on Cancer, ‘Chromium, Nickel and Welding,
         Summary of Data Reported and Evaluation’, IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, vol. 49, 5 November 1997, included in Annex I to the Commission’s observations.
      
      38 –	Available in English on the website of the European Commission, Directorate-General for Health and Consumers (see, in particular,
         p. 4 et seq.).
      
      39 –	My emphasis.
      
      40 –	OJ 1993 L 227, p. 9, that directive having been repealed.
      
      41 –	See, inter alia, Article 9 of that regulation.
      
      42 –	Case C‑425/08 [2009] ECR I-10035.
      
      43 –	Paragraphs 46 and 47 of that judgment and the case-law cited.
      
      44 –	See Case C-380/03 Germany v Parliament and Council [2006] ECR I-11573, paragraph 107 and case-law cited.
      
      45 –	Ibid., paragraph 108 and case-law cited.
      
      46 –	Case 250/84 Eridania zuccherifici nazionali and Others [1986] ECR 117, paragraph 38. See also Case 167/88 AGPB [1989] ECR 1653, paragraph 34.
      
      47 –	Case C‑303/88 Italy v Commission [1991] ECR I-1433, paragraph 52 and case-law cited.
      
      48 –	Case 819/79 Germany v Commission [1981] ECR 21.
      
      49 –	Case T‑504/93 Tiercé Ladbroke v Commission [1997] ECR II-923, paragraphs 52 to 55.
      
      50 –	See PowerPoint presentation given by the applicant in the main proceedings in Brussels on 29 September 2008, contained
         in Annex 3 to the Commission’s observations.
      
      51 –	See, for example, final risk assessment report on nickel carbonates, published by the DEPA, available on the website of
         the Danish Environment Ministry (the Kingdom of Denmark was designated as rapporteur under Regulation No 793/93) at the following
         address: http://www.mst.dk/NR/rdonlyres/2929A8CB-8A5B-43C9-BB67-506D847E960E/0/Ni_carbonate_EU_RAR_HH_March_2008_finaldraft.pdf.
      
      52 –	See ‘Background documentation to nickel-entries in ATP 30’ and ‘Background documentation to nickel-entries in ATP 31’,
         available on the Commission website at the following address: http://tcsweb3.jrc.it/home.php?CONTENU=/DOCUMENTS/Classification-Labelling/.
      
      53 –	See Commission document cited in footnote 27, and Hart, J., op. cit.
      
      54 –	See recital 1 in the preamble to the 1st ATP Regulation.
      
      55 –	My emphasis.
      
      56 –	That measure is adopted in accordance with the regulatory procedure with scrutiny laid down in Article 5a(1) to (4) of
         Decision 1999/468.
      
      57 –	Ibid.