CELEX: 62010CJ0014
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

This reference for a preliminary ruling concerns:
–        the validity of the classifications of four substances containing nickel carbonates incorporated into Annex I to 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 (OJ, English Special Edition 1967, p. 234), as amended by Commission Directive
2001/59/EC of 6 August 2001 (OJ 2001 L 225, p. 1) (‘Directive 67/548’), 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 (OJ 2008 L 246, p.
1; ‘the 30th ATP Directive’);
–        the validity of the classifications of nickel hydroxides and other grouped nickel substances incorporated into Annex I to
Directive 67/548 by 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 (OJ 2009 L 11, p. 6, ‘the 31st ATP Directive’); and
–        the validity of those classifications in so far as they were taken from the 30th and 31st ATP Directives and incorporated
into Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification,
labelling and packaging of substances and mixtures, amending and repealing Directives 67/548 and 1999/45/EC, and amending
Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1; ‘the CLP Regulation’), by 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 (OJ
2009 L 235, p. 1; ‘the 1st ATP Regulation’).
The reference has been made in proceedings between the Nickel Institute and the Secretary of State for Work and Pensions for
judicial review of any measures of the United Kingdom Government to implement the classifications made by the 30th and 31st
ATP Directives and the 1st ATP Regulation.

Legal context

Legislation on the classification, packaging and labelling of dangerous substances and the assessment of their risks – Directives
67/548 and 93/67/EEC and the CLP Regulation
Directive 67/548 and its 30th and 31st adaptation to technical progress by the 30th and 31st ATP Directives
In the field of chemicals, Directive 67/548 was the first harmonising directive laying down rules relating to the marketing
of certain substances and preparations. It contained, in Annex I, a list harmonising the classification and labelling of more
than 8 000 substances and groups of substances according to their hazardous properties.
Article 2(2)(l), (m) and (n) of Directive 67/548 classifies as ‘dangerous’ within the meaning of the directive inter alia
substances which are ‘carcinogenic’, ‘mutagenic’ or ‘toxic for reproduction’.
Article 4(1) of Directive 67/548 provides that substances are to be classified on the basis of their intrinsic properties.
Article 4(3) states that the list of classified substances is contained in Annex I to the directive and that the decision
to place a substance in Annex I together with the harmonised classification and labelling is to be taken in accordance with
the procedure laid down in Article 29.
Under Articles 28 and 29 of Directive 67/548, the annexes thereto may be adapted to technical progress under the regulatory
procedure provided for in Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for
the exercise of implementing powers conferred on the Commission (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’). Decision 1999/468 must be read in conjunction with point 1 of
Annex III to Council Regulation (EC) No 807/2003 of 14 April 2003 adapting to Decision 1999/468/EC the 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 (OJ 2003 L 122, p. 36).
Section 1.1 of Annex VI to Directive 67/548 states inter alia that the object of classification is to identify all the physicochemical,
toxicological and ecotoxicological properties of substances and preparations which may constitute a risk during normal handling
or use.
Section 1.4 of Annex VI to Directive 67/548 provides inter alia that the label is to take account of all potential hazards
which are likely to be faced in the normal handling and use of dangerous substances and preparations when in the form in which
they are placed on the market, but not necessarily in any different form in which they may finally be used, for example diluted.
Section 1.6.1(b) of Annex VI to Directive 67/548 provides that the data required for classification and labelling of the substances
which fall within those provisions may be obtained:
‘… from a number of different sources, for example:
–        the results of previous tests,
–        information required by international rules on the transport of dangerous substances,
–        information taken from reference works and the literature, or
–        information derived from practical experience.
The results of validated structure-activity relationships and expert judgement may also be taken into account where appropriate.’
Directive 67/548 was last amended by the 30th and 31st ATP Directives, classifying inter alia certain nickel carbonates, nickel
hydroxides, and other grouped nickel substances at issue in the main proceedings (collectively ‘the nickel substances at issue
in the main proceedings’) at a high hazard level, which entailed compliance with new labelling and packaging requirements
and other legal and commercial consequences. Those ATP Directives classified the nickel substances at issue in the main proceedings
as carcinogenic in category 1 and some of them also as mutagenic in category 3 and/or reprotoxic in category 2.
Directive 93/67/EEC laying down the principles for assessment of risks under the regime laid down by Directive 67/548
It is apparent from Article 2(a) 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 (OJ 1993 L 227, p. 9), read
in conjunction with Articles 3 to 5 thereof, that assessment of the risks posed by a substance for the purposes of its classification
under Directive 67/548 involves, as a first stage, hazard identification, which is defined as being the identification of
the adverse effects which a substance has an inherent capacity to cause.
It is also apparent from Article 2(d) of Directive 93/67/EEC that risk characterisation consists in estimating the incidence
and severity of the adverse effects likely to occur in a human population or environmental compartment due to actual or predicted
exposure to a substance, and that that characterisation may include quantification of that likelihood or, in other words,
risk estimation.
The CLP Regulation and its first adaptation to technical progress by the 1st ATP Regulation
The CLP Regulation adapts Directive 67/548, inasmuch as the latter concerns the classification, labelling and packaging of
chemical substances, to the Globally Harmonised System of Classification and Labelling of Chemicals (‘the GHS’). The GHS consists
of a set of recommendations adopted by the Economic and Social Council of the United Nations, intended to enable dangerous
chemicals to be identified and users to be informed of the hazards which they pose by means of standardised symbols and phrases
on packaging labels.
Recital 53 in the preamble to the CLP Regulation states that, in order to take full account of the work and experience accumulated
under Directive 67/548, including the classification and labelling of specific substances listed in Annex I to that directive,
all existing harmonised classifications should be converted into new harmonised classifications using the new criteria.
Articles 36 and 37 of the CLP Regulation, which are included in Chapter I (headed ‘Establishing harmonised classification
and labelling of substances’) of Title V, lay down the procedure for the harmonised classification and labelling of substances
which fulfil the criteria set out in Annex I to that regulation for hazards such as carcinogenicity, mutagenicity and reproductive
toxicity.
Article 37 entitles the competent authorities of the Member States and, in more limited circumstances, manufacturers, importers
and distributors of substances to submit detailed proposals for harmonised classification and labelling to the European Chemicals
Agency (ECHA), which replaced the European Chemicals Bureau from 1 June 2008.
Article 53 of the CLP Regulation, headed ‘Adaptations to technical and scientific progress’, authorises the European Commission
to adopt measures intended to adapt Annexes I to VII to the regulation to technical and scientific progress, including ‘taking
due account of the further development of the GHS’, and provides that those measures are to be adopted in accordance with
the regulatory procedure with scrutiny laid down in Article 5a(1) to (4) of Decision 1999/468.
By virtue of Article 55(2) and (11) of the CLP Regulation, Annex I to Directive 67/548 was deleted and replaced by Part 3
of Annex VI to the regulation from 20 January 2009. Table 3.1 in Annex VI sets out the new classification following that conversion
and Table 3.2 reproduces the old classification established under Directive 67/548 as amended by Commission Directive 2004/73/EC
of 29 April 2004 adapting to technical progress for the 29th time Directive 67/548 (OJ 2004 L 152, p. 1; corrigenda at OJ
2004 L 216, p. 3, and OJ 2004 L 236, p. 18).
When the CLP Regulation entered into force on 20 January 2009, Annex VI thereto thus did not reflect the classifications at
issue, incorporated into Annex I to Directive 67/548 by the 30th and 31st ATP Directives.
Article 60 of the CLP Regulation provides that Directive 67/548 is to be repealed with effect from 1 June 2015. However, Article
61(3) of the regulation lays down the transitional provision that from 1 December 2010 until 1 June 2015 substances are to
be classified in accordance with both Directive 67/548 and the CLP Regulation.
Point 1.1.1.3 of Annex I to the CLP Regulation provides in particular that all available information bearing on the determination
of the hazard of a substance, such as the results of suitable
in vitro
tests, relevant animal data, information from the application of the category approach (grouping, read-across) or structure-activity
relationship results, is considered together.
Annex VII to the CLP Regulation contains a table to assist translation of a classification made for a substance under Directive
67/548 into the corresponding classification under the CLP Regulation.
On the basis of Article 53 of the CLP Regulation, the 1st ATP Regulation transferred the classifications established by the
30th and 31st ATP Directives to Part 3 of Annex VI to the CLP Regulation and translated them, so that they were included without
amendment in Table 3.2 in Annex VI to the CLP Regulation whilst, in Table 3.1 in that annex, they were simply translated into
classifications made on the basis of the CLP Regulation, using the translation table in Annex VII thereto. The 1st ATP Regulation
entered into force on 25 September 2009.

Legislation on the evaluation and control of the risks of existing substances – Regulation (EEC) No 793/93 and the REACH Regulation
Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (OJ
1993 L 84, p. 1), 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’), supplemented the system laid down by Directive 67/548 for notification
of new substances.
It was repealed following the entry into force, on 1 June 2008, of Regulation (EC) No 1907/2006 of the European Parliament
and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals
(REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93
and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC,
93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, and corrigendum at OJ 2007 L 136, p. 3; ‘the REACH Regulation’).
Articles 3 and 4 of Regulation No 793/93 obliged manufacturers and importers to submit to the Commission certain relevant
data on the substances to be evaluated, depending on the quantity imported or produced, and to make all reasonable efforts
to obtain the data. However, in the absence of information, manufacturers and importers were not bound to carry out further
tests on animals in order to submit such data.
Article 8 of Regulation No 793/93, read in conjunction with Article 15, provided that, on the basis of the information submitted
by manufacturers and importers, lists of priority substances requiring immediate attention because of their potential effects
on man or the environment were to be adopted in accordance with a comitology procedure with scrutiny.
Under Article 9 of Regulation No 793/93, headed ‘Data to be supplied for substances appearing on the priority lists’, manufacturers
and importers were obliged to provide all available information and corresponding study reports for risk assessment of the
substances concerned and, if necessary, to carry out the testing necessary to obtain missing data. By way of derogation from
that rule, manufacturers and importers could submit a reasoned request to the Member State authority designated as rapporteur
in accordance with Article 10 of the regulation for exemption from some or all of the additional testing on the grounds that
a given piece of information was either unnecessary for risk assessment or was impossible to obtain.
It is apparent from the recitals to the REACH Regulation that the current system, managed by ECHA, is intended to ensure a
high level of protection of human health and the environment and to enhance the competitiveness of the chemicals sector and
innovation. The REACH Regulation obliges undertakings which manufacture and import chemicals to evaluate the hazards and risks
resulting from their use and to take the measures necessary to manage any risk identified.
According to Article 13 of the REACH Regulation, the information supplied for the purpose of evaluation of chemicals as regards
human toxicity in particular must be obtained whenever possible by means other than vertebrate animal tests, through the use
of alternative methods, for example,
in vitro
methods or qualitative or quantitative structure-activity relationship models or from information from structurally related
substances (grouping or read-across).
Section 1.5 of Annex XI to the REACH Regulation provides for use of the read-across approach in the evaluation of chemicals.
It is laid down in particular that substances whose physicochemical, toxicological and ecotoxicological properties are likely
to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’
of substances. Application of the group concept requires that physicochemical properties, human health effects and environmental
effects in particular may be predicted from data for reference substance(s) within the group by interpolation to other substances
in the group (read-across approach).

The procedure that led to the classifications at issue
By Regulation (EC) No 2364/2000 of 25 October 2000 concerning the fourth list of priority substances as foreseen under Regulation
No 793/93 (OJ 2000 L 273, p. 5), the Commission included pure nickel carbonate in the priority list provided for in Article
8 of Regulation No 793/93 and designated the Kingdom of Denmark as the Member State responsible for its evaluation.
The Kingdom of Denmark designated the Danish Environmental Protection Agency (‘the DEPA’) as the authority responsible for
the report on the evaluation of that substance and of four other nickel substances (nickel metal, nickel sulphate, nickel
chloride and nickel dinitrate).
In the course of the DEPA evaluation procedure, the three manufacturers and the importer of nickel carbonates which were required
to provide data on those substances (‘the companies concerned’), represented by the company OMG Harjavalta, submitted on 27
May 2003, on the basis of Article 9(3) of Regulation No 793/93, a request for derogation from the requirement to carry out
certain tests (‘the derogation statement’), since they took the view that there were no human toxicological data in respect
of nickel hydroxycarbonate. The companies concerned also stated that, in the absence of such data, the classification of that
substance, using the classifications derived for water-soluble nickel compounds, should follow the worst case scenario.
According to the companies concerned, nickel hydroxycarbonate was the only nickel carbonate having a commercial use, the three
other nickel carbonates not being used outside the laboratory.
After the DEPA disclosed the results of its evaluation, on 16 April 2004 the Commission forwarded a formal proposal for a
revised classification of the nickel carbonates under Directive 67/548 to the European Chemicals Bureau and the Technical
Committee on Classification and Labelling of Dangerous Substances (‘the TCCL’).
The proposed classifications were also discussed by a Commission working group on the classification and labelling of dangerous
substances including specialised experts in the fields of carcinogenicity and mutagenicity (‘the CL Working Group’) at a meeting
held on 20 and 21 April 2004 (document ECBI/74/04 Rev. 2). Subsequently, the DEPA’s proposal was further discussed by the
TCCL at its meetings held on 12 to 14 May 2004 (document ECBI/147/04 Rev. 3) and on 21 to 24 September 2004 (document ECBI/139/04
Rev. 2). At the latter meeting, the TCCL agreed to recommend the proposed classification relating to the nickel carbonates,
and that it be included in the draft proposal for the 30th ATP Directive which was to be sent to the Commission.
It is apparent, in particular, from the minutes of the meeting of 20 and 21 April 2004 that the experts took into consideration
the fact that certain data were missing, including as regards nickel carbonate and its bioavailability, that is to say the
fraction of that substance that can be absorbed and used by the metabolism of a living organism. However, when deciding on
the final recommendation, they decided not to await any more extensive data on the bioavailability of that substance, which
would have required, in particular, the carrying out of additional tests on animals.
So far as concerns, for example, carcinogenic potential, in an initial stage the experts essentially concluded at that meeting
that nickel sulphate and nickel chloride should be classified as substances carcinogenic to man in category 1 on the basis
of existing data. Then, applying the read-across method, and taking the view that the degree of water solubility of nickel
nitrate was sufficiently similar to that of nickel sulphate and of nickel chloride, the experts decided upon the same classification
for this substance.
The experts concluded that nickel carbonate should be given the same classification because, even though it is only sparingly
soluble in water, it is, however, soluble in biological fluids – like nickel sulphate. This conclusion was also supported
by the fact that Annex I to Directive 67/548 already contained insoluble inorganic nickel compounds that were classified as
carcinogenic to man.
In this context, use of the criterion of the degree of water solubility was founded on the theory that, once dissolved in
water, a nickel salt, such as nickel carbonate, will have the same toxic characteristics as other nickel salts with a similar
degree of water solubility since, on dissolution in water, the nickel atoms and ions, whose toxic properties are well-known,
separate from the other substances forming the nickel salt whilst retaining the same characteristics.
Consequently, the classifications of the nickel carbonate substances as carcinogenic to man in category 1, mutagenic in category
3 and reprotoxic in category 2 were supported by use of the read-across method founded on the criterion of the degree of water
solubility and on existing data as to other similar nickel substances.
In response to the recommendation of the CL Working Group and the TCCL, on 16 February 2007 the Committee on Adaptation to
Technical Progress (‘the ATP Committee’) gave an opinion in favour of the proposal for the 30th ATP Directive as a whole (document
JM/30ATP/09/2006).
After a procedure within the framework of the World Trade Organisation (WTO) where the draft proposal encountered opposition
from certain non-member States which produce borates, the Commission, taking the view that that procedure had brought no fresh
information to light, adopted the 30th ATP Directive on 21 August 2008. The Member States were required to transpose that
directive into national law by 1 June 2009 at the latest.
The nickel hydroxides and one hundred or so other grouped nickel substances at issue in the main proceedings were classified
by the 31st ATP Directive.
In this regard, the conclusions which had been reached by the specialised experts in the comitology procedure that resulted
in the adoption of the 30th ATP Directive persuaded the DEPA to evaluate another whole series of nickel substances and to
put forward in 2005 supplementary proposals for the classification of such substances. The evaluation was again carried out
with the aid of the read-across method, relying on the degree of water solubility of those substances and on existing data
as to the toxic characteristics of the free nickel ion, even if other data on their bioavailability still did not exist.
Following discussions within the TCCL, the latter recommended classification of those chemical substances and on 19 November
2008 the ATP Committee decided in favour of the proposal by unanimity save for six abstentions. The 31st ATP Directive was
adopted on 15 January 2009. As in the case of the 30th ATP Directive, the Member States were required to transpose the 31st
ATP Directive into national law by 1 June 2009 at the latest.
Annex I to Directive 67/548 was repealed on the entry into force of the CLP Regulation on 20 January 2009 and was replaced
by Annex VI to the latter, which as at that date contained only the classifications in Annex I to Directive 67/548 as last
amended by Directive 2004/73.
The content of the 30th and 31st ATP Directives was added to Annex VI to the CLP Regulation by the 1st ATP Regulation. The
1st ATP Regulation was adopted on 10 August 2009 on the basis of Article 53 of the CLP Regulation following a proposal of
approval adopted unanimously by the ATP Committee on 25 March 2009, and it entered into force on 25 September 2009. That proposal
of the committee was founded, in particular, on the conclusions of a working group of 27 experts who met from 17 to 24 March
2009 within the framework of the International Agency for Research on Cancer (IARC) and who supported the classification of
the nickel substances as substances carcinogenic to man in category 1.

The main proceedings and the questions referred for a preliminary ruling
The claimant in the main proceedings, the Nickel Institute, is a non-profit organisation representing the interests of 29
companies which, together, account for 90% of the world’s annual nickel output.
The defendant in the main proceedings, the Secretary of State for Work and Pensions, is the minister in the United Kingdom
who has responsibility for the classification of chemical substances.
On 2 December 2008 and 9 April 2009, the Nickel Institute brought two actions against the Secretary of State for Work and
Pensions before the High Court of Justice of England and Wales, Queen’s Bench Division (Administrative Court), for judicial
review of ‘the intention and/or obligation’ of the United Kingdom Government to implement the classifications made by the
30th and 31st ATP Directives and the 1st ATP Regulation.
First, the Nickel Institute contests the validity of the classification by the 1st ATP Regulation of four nickel carbonate
substances initially classified in entry 028‑010-00-0 in Annex 1F to the 30th ATP Directive. Second, it contests the validity
of the classification by the 1st ATP Regulation of the nickel hydroxides, initially classified in entry 028-008-00-X in Annex
1A to the 31st ATP Directive, and of the classification by that regulation of more than 100 other grouped nickel substances,
initially classified in entries 028-013-00-7 to 028‑052‑002 of Annex 1B to the 31st ATP Directive (collectively ‘the classifications
at issue’).
It is in those circumstances that the High Court of Justice of England and Wales, Queen’s Bench Division (Administrative Court),
decided to stay the proceedings and to 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 (together, “the contested 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 [the CLP Regulation] were not made out; and/or
(b)      the classifications for Table 3.1 of Annex VI to the CLP Regulation were arrived at without adequate assessment of the intrinsic
properties of the nickel carbonates and the contested nickel substances in accordance with the criteria and data requirements
set out in Annex I to the CLP Regulation, but rather on the application of Annex VII to the CLP Regulation?’

Consideration of the questions referred

Admissibility of Questions 1 and 2
In its written observations, the Commission requested that the first two questions referred for a preliminary ruling be declared
inadmissible in so far as they relate to the validity of the 30th and 31st ATP Directives, which according to the Commission
were repealed when the CLP Regulation entered into force on 20 January 2009. However, at the hearing it withdrew this objection
of inadmissibility, taking the view that, in any event, the classifications inserted into Annex VI to the CLP Regulation,
by means of the 1st ATP Regulation, merely reproduce the classifications already made in the 30th and 31st ATP Directives
on the basis of the scientific recommendations put forward by a number of committees of experts within the framework of Directive
67/548.
Since there is no reason for the Court to raise other grounds of inadmissibility, it has the task of ruling on the questions
referred.

Questions 1 and 2
By its first two questions, which it is appropriate to examine together, the national court asks the Court, in essence, whether
the 30th and 31st ATP Directives are valid to the extent that they incorporate the classifications at issue into Annex I to
Directive 67/548 and, consequently, whether the 1st ATP Regulation is also valid in so far as it incorporates into the CLP
Regulation the same classifications as those contained in the 30th and 31st ATP Directives.
The national court seeks more specifically to ascertain, first, whether the methods selected by the Commission for making
those classifications, in particular recourse to the read-across method, the lack of examination of the risks associated with
normal handling or use of the nickel substances at issue in the main proceedings, and recourse to the derogation statement,
are consistent with the need for an appropriate assessment of the intrinsic properties of those substances in accordance with
the criteria laid down in Annex VI to Directive 67/548. Second, the national court is uncertain whether the legal basis chosen
for adoption of the two directives in question, namely Article 28 of Directive 67/548, was appropriate for achieving that
objective. Third, it asks the Court whether there was a failure to state reasons in breach of Article 253 EC, rendering the
30th ATP Directive invalid.
Introductory observations
First of all, it should be pointed out that in this complex technical and legal context, which in essence is in a state of
flux, Directive 67/548 gives the Commission, in respect of the substance of the assessment, a broad discretion as to the scope
of the measures to be taken to adapt the annexes to that directive to technical progress (Case C-425/08
Enviro Tech (Europe)
[2009] ECR I-10035, paragraph 46).
In accordance with settled case-law, where the European Union authorities have a broad discretion, in particular as to the
assessment of highly complex scientific and technical facts in order to determine the nature and scope of the measures which
they adopt, review by the European Union judicature is limited to verifying whether there has been a manifest error of assessment
or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion. In such a context,
the European Union judicature cannot substitute its assessment of scientific and technical facts for that of the institutions
on which alone the EC Treaty has placed that task (
Enviro Tech (Europe)
, paragraph 47).
Application of the read-across method in the context of assessment of the intrinsic properties of the nickel substances at
issue in the main proceedings
The national court asks the Court whether the Commission exceeded the limits of its discretion in applying the read-across
method instead of assessing the intrinsic properties of the nickel substances at issue in the main proceedings with the aid
of the criteria and data requirements set out in Annex VI to Directive 67/548.
The Nickel Institute’s main complaint is that the Commission did not analyse the intrinsic properties of the nickel substances
at issue in the main proceedings as required in Article 4 of Directive 67/548 and section 1.1 of Annex VI to that directive.
It also complains that the Commission applied the read-across method in order to classify those substances despite the lack
of data concerning them.
The read-across method is one of the valid assessment methods provided for in point 1.1.1.3 of Annex I to the CLP Regulation.
It is also described in section 1.5 of Annex XI to the REACH Regulation as a method under which the properties of certain
substances may be predicted from existing data relating to reference substances which are structurally similar to them. It
avoids the need to test every substance for every endpoint and may, consequently, be used where there are no data concerning
the substances subject to risk assessment.
Whilst that method is expressly provided for under the REACH Regulation and under the CLP Regulation, it is not mentioned
as such in Annex VI to Directive 67/548.
The list of sources from which the data required for classification of the nickel substances at issue in the main proceedings
may be extracted, which is set out in section 1.6.1(b) of Annex VI to Directive 67/548, is merely illustrative, as is apparent
from the words ‘for example’.
Section 1.6.1(b) of Annex VI provides, however, that the results of validated structure-activity relationships and expert
judgment may be taken into account when assessing chemical substances.
The assessment of substances on the basis of structure-activity relationships is thus, like the read-across method, one of
the methods of assessment based on the category approach and represents a process for predicting the activity of a substance
from a quantitative assessment of its molecular structure which is similar to that of another substance or of another group
of substances whose effects are well-known.
Annex VI to Directive 67/548 makes express reference to 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 (OJ 1986 L 358, p. 1), under which the read-across method and the method based on structure-activity
relationships are encouraged.
Also, in 2007, the Joint Research Centre of the Commission published an extensive study relating to the use of read-across
within the framework of Directive 67/548 (‘A Compendium of Case Studies that helped to shape the REACH Guidance on Chemical
Categories and Read Across’). The examples analysed by that study include the classifications of the nickel substances at
issue in the main proceedings.
Thus, whilst it is true that, as the Advocate General has noted in points 63 and 64 of his Opinion, the method based on structure-activity
relationships displays certain differences from the read-across method, the fact remains that those two methods are not to
be regarded as independent since they are both founded on the principle of extrapolation from existing data on certain substances
in order to assess and classify other substances which have a similar structure and on which there are very limited or no
data.
Furthermore, as is apparent from the explanatory memorandum for the 31st ATP Directive, the read-across method, as a method
for assessing substances that is widely recognised by the scientific community, has been used on many occasions when classifying
substances in the context of Annex I to Directive 67/548, if only since the entry into force of Commission Directive 91/632/EEC
of 28 October 1991 adapting to technical progress for the 15th time Directive 67/548 (OJ 1991 L 338, p. 23).
As regards the scientific arguments underlying the classifications at issue, it is apparent from the minutes of the meetings
of the CL Working Group, the TCCL and the ATP Committee that, even though the experts agreed on the fact that there were limited
data concerning, in particular, the toxic characteristics of the nickel substances at issue in the main proceedings, their
bioavailability was assessed principally on the basis of the degree of water solubility, taking account of the well-known
toxic characteristics of the nickel ion of which those substances are composed. The current classification of the substances
at issue in the main proceedings was therefore decided upon on the basis of the known data concerning other nickel substances,
having a structure and degree of water solubility that are similar.
Those conclusions were also supported by the minutes of the meeting on 4 May 2006 of the Commission’s Scientific Committee
on Health and Environmental Risks (SCHER).
Moreover, the REACH Regulation recognises, in Article 13, the importance of the use of alternative methods, such as the read-across
method, in order to evaluate the human toxicity of chemicals by means other than vertebrate animal tests.
Finally, it is to be noted that application of the read-across method and the assessment which was made of the physicochemical
properties of the nickel substances at issue in the main proceedings were the result of a consensus reached at the end of
a process that lasted several years by numerous experts sitting on several scientific committees in the presence of representatives
of the industry concerned.
In the alternative, the Nickel Institute contends that, even if recourse to such a method were permissible in principle, the
application of it in the present instance would be manifestly flawed because, inter alia, the criterion of water solubility
was unable, in itself, to provide the basis for the classifications at issue, the key scientific assumption that the nickel
ion is responsible for the biological effects to be assessed was not proven and, in general, the fact that certain assessments
result from ‘expert judgment’ is nevertheless not an apposite response.
However, having regard to the scope of the review which the Court is to carry out in this field in accordance with what has
been stated in paragraphs 59 and 60 of the present judgment, these arguments of the claimant in the main proceedings do not
in themselves permit the view to be taken that the Commission, in the light of the conclusions formulated after several scientific
committees completed their work, manifestly exceeded the limits of its discretion in relying, when adopting the classifications
at issue, on the judgment of experts who had recourse in particular to the read-across method in order to assess the intrinsic
properties of the nickel substances at issue in the main proceedings.
Assessment of the risks during normal handling or use of the substances
The national court seeks to ascertain whether the validity of the 30th and 31st ATP Directives and that of the 1st ATP Regulation
are affected by the fact that the Commission is said not to have taken into consideration the fact that three of the four
nickel carbonates were neither handled nor used outside the laboratory and that other nickel substances were not used in industrial
applications. Risks associated with normal handling or use of the nickel substances at issue in the main proceedings are thus
stated not to have been taken into account during the assessment.
In this regard, although neither Directive 67/548 nor the CLP Regulation or the REACH Regulation defines ‘normal handling
or use’, it must be accepted, as the Commission has maintained, that this concept includes all handling and uses occurring
in normal circumstances, which encompasses, in particular, the need to take account of realistic and foreseeable accidents.
It must be stated at the outset, as the Advocate General has observed in point 80 et seq. of his Opinion, that the criticism
advanced by the claimant in the main proceedings rests, essentially, on confusion between assessment of the hazards and that
of the risks presented by a substance.
As is apparent, in particular, from Article 4 of Directive 67/548, read in conjunction with Articles 2 to 5 of Directive 93/67,
the classification and labelling of substances established by Directive 67/548 are based on the transmission of information
on the hazards linked to the substances’ intrinsic properties. Hazard assessment constitutes the first stage of the process
of risk assessment, which is a more specific concept. This distinction between hazards and risks was moreover maintained in
the CLP Regulation and in the REACH Regulation.
Thus, an assessment of the hazards linked to the substances’ intrinsic properties must not be limited in light of specific
circumstances of use, as in the case of a risk assessment, and may be properly carried out regardless of the place where the
substance is used (in a laboratory or elsewhere), the route by which contact with the substance might arise and the possible
levels of exposure to the substance.
In light of those considerations, it must be found that, in the course of a valid classification of the substances at issue
in the main proceedings on the basis of an assessment of the hazards linked to their intrinsic properties, the Commission
was not obliged to take into account the fact that certain nickel carbonates were handled or used only in laboratory conditions.
Recourse to the derogation statement
The national court asks the Court whether the fact that the Commission relied, for the purposes of the classifications at
issue, on the derogation statement issued in the context of Regulation No 793/93 is such as to affect the validity of the
30th ATP Directive and of the 1st ATP Regulation.
The Nickel Institute submits that the Commission exceeded its powers in basing the contested classifications on the request
for derogation submitted in May 2003 by several nickel-producing companies to the DEPA under Article 9(3) of Regulation No
793/93, thereby departing from the classification criteria laid down in Annex VI to Directive 67/548.
However, first, contrary to the submissions of the claimant in the main proceedings, the Commission did not base its classification
decision on the derogation statement. As found in paragraph 75 of the present judgment, the classifications at issue were
made within the framework of the comitology procedure on the basis of the recommendations of a broad range of experts who
validated use of the read-across method and who deliberately decided not to wait for animal tests to be carried out, taking
the view that the indications concerning the bioavailability of the nickel substances at issue in the main proceedings, derived
from their degree of water solubility, and the existing data on nickel substances having a similar structure were sufficient
to make those classifications. Thus, the contested classifications were made on a scientific basis, regardless of the request
made by the industry concerned for exemption from additional testing.
Second, it admittedly follows from section 4.1.3.1.2.6, on mutagenicity, and section 4.1.2.7.2.1, on carcinogenicity, of the
risk assessment report submitted by the DEPA in March 2008 that, at a meeting held in April 2004, the experts agreed, taking
into consideration the request for exemption submitted by the sector, that nickel carbonate should be classified as a mutagen
in category 3 and a carcinogen in category 1.
Nevertheless, that derogation statement is no longer mentioned, in particular, in the summary record of the meeting of technical
experts within the framework of the ATP Committee of 29 September 2008 (document SB/31ATP/08/2008) or in the explanatory memorandum
for the 31st ATP Directive, which refer to the DEPA’s proposal to use the category approach and in particular the read-across
method to assess the nickel carbonates, upon which limited data were available.
Consequently, the argument of the claimant in the main proceedings that the Commission manifestly exceeded the limits of its
discretion in basing the classifications at issue solely on the request for derogation must be rejected.
Choice of legal basis for the 30th and 31st ATP Directives
The national court asks the Court whether the choice of Article 28 of Directive 67/548 as the legal basis for adoption of
the 30th and 31st ATP Directives was appropriate.
The Nickel Institute submits that the conditions for use of the procedure provided for in Article 28 of Directive 67/548 were
not satisfied as regards the contested classifications because there was insufficient technical or scientific progress to
justify an adaptation.
However, as is apparent from the minutes of the meetings of experts, forming part of a long consultation process conducted
over the period from 2000 to 2008, numerous experts’ reports and studies were completed in order to arrive at the final adaptations
of Directive 67/548, on adoption of the 30th and 31st ATP Directives.
Having regard to the scope of the review which the Court is to carry out in this field in accordance with what has been stated
in paragraphs 59 and 60 of the present judgment, it is not apparent that the Commission, in the light of the conclusions formulated
upon completion of those experts’ reports and studies, manifestly exceeded the limits of its discretion in taking the view
that, given the state of scientific knowledge as it stood, there was sufficient technical progress to justify adapting Directive
67/548.
It must accordingly be found that Article 28 of Directive 67/548 could validly constitute the legal basis for adoption of
the 30th and 31st ATP Directives.
Failure to state reasons for the 30th ATP Directive
The national court asks the Court whether the 30th ATP Directive is vitiated by a failure to state reasons, in breach of Article
253 EC.
The Nickel Institute considers that the Commission failed to comply with its obligations under Article 253 EC to state reasons
since the facts and legal considerations justifying the adoption of the classifications at issue do not appear in the adopted
measure itself, the minutes of the meetings of experts published subsequently not being sufficient in this regard.
Whilst it is true that the Court has held, first, that the statement of reasons for a European Union measure must appear in
that measure and, second, that it must be adopted by the author of the measure (see Case C-378/00
Commission
v
Parliament and Council
[2003] ECR I-937, paragraph 66 and the case-law cited), the fact remains that the degree of reasoning required varies.
Thus, the Court has previously held that the requirements to be satisfied by the statement of reasons depend on the circumstances
of each case, in particular the content of the measure, the nature of the reasons given and the interest which the addressees
of the measure, or other parties to whom it is of direct and individual concern, may have in obtaining explanations (Case
C-333/07
Régie Networks
[2008] ECR I-10807, paragraph 63 and the case-law cited).
It is also clear from settled case-law that the scope of the obligation to state reasons depends on the nature of the measure
in question and that, in the case of measures of general application, the statement of reasons may be confined to indicating
the general situation which led to the adoption of the measure and the general objectives which it is intended to achieve.
In that context, the Court has repeatedly ruled that 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 the various technical choices made
(see, to this effect, Case C-221/09
AJD Tuna
[2011] ECR I-0000, paragraph 59 and the case-law cited).
Furthermore, as the Advocate General has observed in point 107 of his Opinion, where the persons concerned are involved in
the process by which a measure comes about, the requirement to state reasons may be circumscribed, since they acquire information
through their involvement.
It is apparent that the contested measure complies with those rules.
The 30th ATP Directive is a measure of general application, whose preamble states that the measures provided for in the directive
are in accordance with the opinion of the ATP Committee and announces that the pertinent list of substances needs to be updated
to include further notified new substances and further existing substances, as well as to adapt certain entries to technical
progress. In this connection, it is envisaged, in particular, that special attention should be paid to the outcome of the
International Agency for Research on Cancer (IARC) discussion of the classification of nickel substances.
Also, it is undisputed that the 30th ATP Directive falls within a complex technical and legal context which in essence is
in a state of flux, making it difficult to state detailed and individual reasons for the classifications made, and the statement
of reasons contained in the directive is therefore sufficient in view of the nature of that measure.
Finally, it is not disputed that the representatives of the industry concerned were involved in the process for drawing up
the directive. Furthermore, the scientific reasoning and the data which substantiated the classifications at issue appeared
in a number of documents and of sets of minutes of meetings of experts which were disclosed to the public before the 30th
ATP Directive was adopted.
Accordingly, it is to be concluded, in this context, that the 30th ATP Directive is not vitiated by a failure to state reasons
contrary to Article 253 EC.
Having regard to all the foregoing considerations, it must be held that examination of the first and second questions has
disclosed no factor of such a kind as to affect the validity of the 30th and 31st ATP Directives and, consequently, that of
the 1st ATP Regulation, in so far as they classified the nickel substances at issue in the main proceedings as carcinogenic
to man in category 1, mutagenic in category 3 and reprotoxic in category 2.

Question 3
By its third question, the national court raises with the Court the validity of the first ATP Regulation, which incorporates
into Tables 3.1 and 3.2 in Part 3 of Annex VI to the CLP Regulation the amendments which were made to Annex I to Directive
67/548 by the 30th and 31st ATP Directives.
The national court asks, more specifically, first, whether the choice of legal basis for the 1st ATP Regulation is sound and,
second, whether the classifications set out in Table 3.1 in Part 3 of Annex VI to the CLP Regulation are lawful.
Choice of legal basis for the 1st ATP Regulation
The national court seeks to ascertain whether the validity of the 1st ATP Regulation is affected by the fact that, in adopting
it, the Commission had recourse to Article 53, rather than Article 37, of the CLP Regulation as its legal basis.
The claimant in the main proceedings complains that the Commission used the procedure for adaptation to technical progress
that is provided for in Article 53 of the CLP Regulation, inasmuch as it chose an almost automatic method for adaptation of
that regulation to technical progress without passing through the procedure, provided for in Article 37 of that regulation,
for complex and detailed assessment of the intrinsic properties of the substances at issue in the main proceedings.
As regards this first criticism, Article 37 forms part of Chapter 1 of Title V of the CLP Regulation, a chapter which is headed
‘Establishing harmonised classification and labelling of substances’.
The use of the word ‘establishing’ in this context indicates that the procedure provided for in Article 37 of the CLP Regulation
should be used only when adopting new classifications. On the other hand, under the procedure provided for in Article 53 of
the CLP Regulation, ‘the Commission may adjust and adapt … Annexes I to VII [to that regulation] to technical and scientific
progress’.
In the present instance, the 1st ATP Regulation merely incorporates into the CLP Regulation the classifications at issue,
which had already been adopted on the basis of criteria and principles laid down within the framework of Directive 67/548.
It follows that Article 53 of the CLP Regulation could legitimately constitute the legal basis for adopting the 1st ATP Regulation.
Legality of the classifications set out in Table 3.1 in Part 3 of Annex VI to the CLP Regulation
The national court asks the Court whether, in adopting the classifications at issue in Table 3.1 in Part 3 of Annex VI to
the CLP Regulation, the Commission erred by using the translation table in Annex VII to that regulation rather than considering
the criteria in Annex I thereto.
According to the claimant in the main proceedings, the Commission should have taken up again the process of assessing the
intrinsic properties of the nickel substances at issue in the main proceedings by applying the criteria set out in Annex I
to the CLP Regulation.
As has been stated in paragraph 113 of the present judgment, a repetition of that assessment process was not necessary in
view of the fact that the 1st ATP Regulation merely incorporates into the CLP Regulation the same classifications as those
which had undergone the complex assessment procedure applicable within the framework of Directive 67/548.
As regards the translation table in Annex VII to the CLP Regulation, it is to be recalled that, as provided in Article 61(3)
of that regulation, all substances must be classified in both the old and the new system until 1 June 2015. It follows that
all the classifications established under Directive 67/548 must be translated, with the aid of the translation table set out
in Annex VII, into the corresponding classifications under the CLP Regulation.
Accordingly, the Commission was right in deciding to incorporate the classifications at issue into Table 3.1 in Part 3 of
Annex VI to the CLP Regulation with the aid of the translation table contained in Annex VII to that regulation.
In light of all the foregoing considerations, it must be held that examination of the third question has disclosed no factor
of such a kind as to affect the validity of the 1st ATP Regulation, in so far as that regulation classified the nickel substances
at issue in the main proceedings as carcinogenic to man in category 1, mutagenic in category 3 and reprotoxic in category
2.

Costs
Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court,
the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs
of those parties, are not recoverable.
On those grounds, the Court (Fourth Chamber) hereby rules:
Examination of the questions referred for a preliminary ruling has disclosed no factor of such a kind as to affect the validity,
first, 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 and of 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 and, second, 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 those directives and that
regulation classified as carcinogenic to man in category 1, mutagenic in category 3 and reprotoxic in category 2 substances
such as certain nickel carbonates, the nickel hydroxides and other grouped nickel substances at issue in the main proceedings.
[Signatures]
*
Language of the case: English.