ORDER OF THE COURT (Eighth Chamber)

24 January 2013 ([\*](#Footnote*))

(Appeal – Directives 67/548/EEC and 2004/73/EC – Classification, packaging and labelling of dangerous substances – Classification of n‐propyl-bromide)

In Case C‐118/12 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 24 February 2012,

**Enviro Tech Europe Ltd,** established in Kingston upon Thames (United Kingdom), represented by C. Mereu and K. Van Maldegem, avocats,

applicant,

the other parties to the proceedings being:

**Enviro Tech International Inc.,** established in Melrose Park (United States),

applicant at first instance,

**European Commission,** represented by P. Oliver and E. Manhaeve, acting as Agents,

defendant at first instance,

THE COURT (Eighth Chamber),

composed of E. Jarašiūnas, President of the Chamber, C. Toader (Rapporteur) and C.G. Fernlund, Judges,

Advocate General: N. Jääskinen,

Registrar: A. Calot Escobar,

having decided, after hearing the Advocate General, to give a decision by reasoned order,

makes the following

**Order**

1        By its appeal, Enviro Tech Europe Ltd (‘Enviro Tech’) seeks to have set aside the judgment of the General Court of the European
Union of 16 December 2011 in Case T-291/04 *Enviro Tech Europe and Enviro Tech International* v *Commission* [2011] ECR I‐0000 (‘the judgment under appeal’), by which the General Court dismissed its action for (i) annulment in part
of Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the 29th 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 (OJ 2004 L 152, p. 1, and corrigendum OJ 2004 L 216, p. 3), in so far as that directive
classifies n‐propyl‐bromide (‘nPB’) as a substance having certain dangerous properties, and for (ii) the award of damages.

**Legal context**

2        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(I), p. 234), as amended
by Commission Directive 2001/59/EC of 6 August 2001 (OJ 2001 L 225, p. 1, ‘Directive 67/548’), lays down rules concerning
the marketing of ‘substances’, defined as ‘chemical elements and their compounds in the natural state or obtained by any production
process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process
used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition’.

3        For that purpose, Directive 67/548 proceeds, in accordance with Article 4(1) thereof, to classify the substances on the basis
of their intrinsic properties according to the categories laid down in Article 2(2). Classification of a substance as ‘dangerous’
in Annex I to that directive means that, before it can be placed on the market, its packaging must be provided with mandatory
labelling including in particular danger symbols and standard phrases indicating, first, the special risks arising from the
dangers involved in the use of the substance and, second, advice on safety precautions relating to its use.

4        Article 4(2) of Directive 67/548 provides that ‘[t]he general principles of the classification and labelling of substances
and preparations shall be applied according to the criteria in Annex VI, save where contrary requirements for dangerous preparations
are specified in separate Directives’.

5        Section 1.1 of Annex VI to Directive 67/548, which forms part of the general introduction in that annex, provides:

‘The object of classification is to identify all the physico-chemical, toxicological and ecotoxicological properties of substances
and preparations which may constitute a risk during normal handling or use. Having identified any hazardous properties the
substance or preparation must then be labelled to indicate the hazard(s) in order to protect the user, the general public
and the environment.’

6        Section 2.2.4 of Annex VI to Directive 67/548, regarding highly flammable substances and preparations, provides:

‘Substances and preparations shall be classified as highly flammable and assigned the symbol “F” and the indication of danger
“highly flammable” in accordance with the results of the tests given in Annex V. Risk phrases shall be assigned in accordance
with the following criteria:

R11 Highly flammable

–        Solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue
to burn or to be consumed after removal of the source of ignition.

–        Liquid substances and preparations having a flash point below 21°C but which are not extremely flammable.

...’

7        Section 4.2.3.1 of Annex VI to Directive 67/548 divides substances toxic for reproduction in Category 2 as follows:

‘...

Category 2

Substances which should be regarded as if they impair fertility in humans

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in impaired fertility
on the basis of:

–        clear evidence in animal studies of impaired fertility in the absence of toxic effects, or, evidence of impaired fertility
occurring at around the same dose levels as other toxic effects but which is not a secondary non-specific consequence of the
other toxic effects,

–        other relevant information.

Substances which should be regarded as if they cause developmental toxicity to humans

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in developmental
toxicity, generally on the basis of:

–        clear results in appropriate animal studies where effects have been observed in the absence of signs of marked maternal toxicity,
or at around the same dose levels as other toxic effects but which are not a secondary non-specific consequence of the other
toxic effects,

–        other relevant information.

...’

8        Section 4.2.3.3 of Annex VI to Directive 67/548, headed ‘Comments regarding the categorisation of substances toxic to reproduction’,
states inter alia:

‘... Placing in categories 2 or 3 is done primarily on the basis of animal data. Data from in vitro studies, or studies on
avian eggs, are regarded as “supportive evidence” and would only exceptionally lead to classification in the absence of in
vivo data.

In common with most other types of toxic effect, substances demonstrating reproductive toxicity will be expected to have a
threshold below which adverse effects would not be demonstrated. Even when clear effects have been demonstrated in animal
studies the relevance for humans may be doubtful because of the doses administered, for example, where effects have been demonstrated
only at high doses, or where marked toxicokinetic differences exist, or the route of administration is inappropriate. For
these or similar reasons it may be that classification in category 3, or even no classification, will be warranted.

...

For the classification of a substance into Category 2 for impaired fertility, there should normally be clear evidence in one
animal species, with supporting evidence on mechanism of action or site of action, or chemical relationship to other known
anti-fertility agents or other information from humans which would lead to the conclusion that effects would be likely to
be seen in humans. Where there are studies in only one species without other relevant supporting evidence then classification
in Category 3 may be appropriate.

...’

**Background to the dispute**

9        The background to the dispute, as described in paragraphs 43 to 63 of the judgment under appeal, may be summarised as follows.

10      nPB is a volatile organic solvent used inter alia for industrial cleaning and degreasing, especially of metallic parts.

11      The sole activity of Enviro Tech and Enviro Tech International Inc. (‘Enviro Tech International’) is the production and distribution
of a product called ‘EnSolv’ which is made from a patented preparation and is composed essentially of nPB. Enviro Tech is
a company incorporated in accordance with United Kingdom law and is wholly owned by Enviro Tech International, a company incorporated
in accordance with United States law. It holds an exclusive licence for the marketing in Europe of the product EnSolv, including
the vapour precision cleaning technology related to it. That licence was granted to it on the basis of a transfer agreement
dated 16 October 2001, by the holder of European Patent No EP 0 781 842 B1 of 29 September 1999, for the exploitation of an
invention entitled ‘Cleaning of parts using an environmentally safe solvent’.

12      Pursuant to Commission Directive 91/325/EEC of 1 March 1991 adapting to technical progress for the 12th time Directive 67/548
(OJ 1991 L 180, p. 1), nPB was classified in Annex I to Directive 67/548 as an ‘irritant Xn’ and accompanied inter alia by
the risk phrases R 10 ‘Flammable’ and R 20 ‘Harmful by inhalation’.

13      Subsequently, by Directive 2004/73, nPB was classified as a highly flammable substance (R11) and as a category 2 substance
which is toxic for reproduction (R60).

**The procedure before the General Court and the judgment under appeal**

14      On 22 July 2004, Enviro Tech and Enviro Tech International brought an action for annulment of Directive 2004/73, in so far
as it classified nPB as a highly flammable substance (R11) and as a category 2 substance which is toxic for reproduction (R60).
By the same action, they also sought an order that the Commission of the European Communities pay compensation for the damage
they had suffered as a result of its unlawful conduct.

15      By the judgment under appeal, the General Court dismissed their action for annulment as inadmissible and their action for
damages as unfounded. The General Court also ordered the applicants to pay the costs, including those relating to the interlocutory
proceedings which gave rise to the order of the President of the General Court of 10 February 2005 in Case T‐291/04 R *Enviro Tech Europe and Enviro Tech International* v *Commission* [2005] ECR II‐475.

16      In relation to the action for annulment, having held, at paragraph 98 of the judgment under appeal, that, despite the entry
into force during the present proceedings, that is to say on 1 December 2009, of Article 263 TFEU, the question of the admissibility
of the appeal must be decided on the sole basis of the fourth subparagraph of Article 230 EC, the General Court ruled, at
paragraph 120 of that judgment, that Enviro Tech and Enviro Tech International had not established that they were individually
concerned, within the meaning of that provision, by the contested classification in Directive 2004/73.

17      As regards the application for damages for the harm allegedly suffered by those companies, the General Court held that they
had not established the existence of unlawful action such as to give rise to non‐contractual liability on the part of the
European Union.

18      In reaching that conclusion, the General Court rejected all the pleas put forward by Enviro Tech and Enviro Tech International
in support of their action for damages, with the exception of the fourth plea alleging misapplication of the precautionary
principle, the sixth plea alleging misuse of powers and the fourth and fifth limbs of the fifth plea, all of which were withdrawn.
The pleas examined by the General Court alleged, first, manifest errors of assessment by the Commission and errors of law
in the application of Directive 67/548, second, infringement of the principles of protection of legitimate expectations, third,
infringement of Article 95(3) EC and of the principle of sound administration, fifth, lack of competence and infringement
of certain general fundamental principles of EU law and, seventh, infringement of the principle of good administration and
the obligation to examine, diligently and impartially, the information and requests submitted by Enviro Tech and Enviro Tech
International.

19      As regards the third limb of the first plea, alleging manifest errors of assessment by the Commission and errors of law in
the application of Directive 67/548 concerning the criterion of ‘normal handling or use’ referred to in Section 1.1 of Annex
VI to that directive, the General Court, at paragraphs 145 and 146 of the judgment under appeal, held as follows:

‘145      With regard to the third branch, it must be held that it is true that the Court of Justice did not rule expressly on compliance
by the Commission with the criterion of “normal handling or use” within the meaning of section 1.1 of Annex VI to Directive
67/548. In that regard, it must however be noted that ... Enviro Tech ... had submitted that argument to the Court of Justice
which then took it into account [Case C‐425/08 *Enviro Tech (Europe)* [2009] ECR I‐10035, paragraphs 31 and 34]. In addition, while the Court of Justice did not refer expressly to the criterion
of normal handling or use in its assessment of the inflammability and toxicity of nPB, the fact remains that, as [Enviro Tech
and Enviro Tech International] themselves stated at the hearing, that criterion is the expression of a general principle underlying
the various assessment criteria governing the inflammability and toxicity of substances (see sections 2.2.5 and 4.2.3 of Annex
VI to Directive 67/548), meaning that the Court could not avoid taking it into account implicitly. Thus, in paragraph 69 of
its judgment, concerning the toxicity of nPB for reproduction and with reference to the requirements laid down in sections
4.2.3.1 and 4.2.3.3 of Annex VI to Directive 67/548, the Court of Justice considered that the studies in question conclude
“that the toxic effects are not produced solely on administration of high doses”.

146      It follows that the Court of Justice also rejected, in essence, the third limb of the present plea in so far as the “normal
handling or use” criterion is concerned.’

**Forms of order sought by the parties before the Court of Justice**

20      Enviro Tech claims that the Court should:

–        set aside the judgment under appeal in so far as it rejected its claim for damages and declare the Commission liable for the
damage sustained;

–        in the alternative, set aside that judgment under appeal and refer the case back to the General Court; and

–        order the Commission to pay the costs.

21      The Commission contends that the Court should dismiss the appeal and order Enviro Tech to pay the costs.

**The appeal**

22      Under Article 181 of its Rules of Procedure, where an appeal is, in whole or in part, clearly inadmissible or clearly unfounded,
the Court may at any time, acting on a report from the Judge-Rapporteur and after hearing the Advocate General, dismiss the
appeal in whole or in part by reasoned order.

23      That provision should be applied in the present case.

*Arguments of the parties*

24      Enviro Tech expressly pointed out that its appeal does not concern the judgment under appeal in so far as it declared its
action for the annulment of Directive 2004/73 inadmissible and that it only contests the General Court’s findings, at paragraphs
145 and 146 of that judgment, in rejecting the third limb of the first plea in relation to ‘normal handling or use’.

25      In support of its appeal, Enviro Tech puts forward a single ground of appeal alleging that the General Court misinterpreted
*Enviro Tech (Europe)*, which resulted in the rejection of the third limb of the first plea of illegality, invoked in support of its claims for
damages, without an assessment of the merits.

26      More specifically, Enviro Tech asserts that the General Court erred in law in holding, at paragraphs 145 and 146 of the judgment
under appeal, that in *Enviro Tech (Europe)*, the Court of Justice ‘implicitly’ took into account the criterion of ‘normal handling or use’ within the meaning of section
1.1 of Annex VI to Directive 67/548, in its assessment of the flammability and toxicity of nPB.

27      According to Enviro Tech, the General Court wrongly rejected its argument that the Commission made a manifest error of assessment
and an error of law in the application of the criterion of ‘normal handling or use’ laid down in that section, in particular
as regards the classification of nPB as a product toxic to reproduction, given that neither the question referred by the national
court in the case giving rise to *Enviro Tech (Europe)* nor the answer handed down by the Court of Justice in that judgment related to that criterion within the meaning of section
1.1 of Annex VI to Directive 67/548.

28      In that regard, Enviro Tech claims that, in *Enviro Tech (Europe)*, where the question of toxicity for reproduction was examined in paragraphs 66 to 71, the Court of Justice specifically referred
to section 4.2.3 of Annex VI to Directive 67/548 as containing the criteria for classification of a substance as toxic for
reproduction. In that judgment, the Court of Justice did not therefore refer to section 1.1 of Annex VI to Directive 67/548.

29      The Commission submits that Enviro Tech’s assertion that its argument regarding the criterion of ‘normal handling or use’
was not raised before the Court of Justice in the case which gave rise to *Enviro Tech (Europe)* is ineffective.

30      According to the Commission, first, the second sub-question of the first question referred for a preliminary ruling in that
case clearly alluded to the criterion of ‘normal handling or use’ and, second, at paragraph 31 of that judgment, the Court
of Justice showed that it was fully aware of this allusion.

31      The Commission also submits that, given that the criterion of ‘normal handling or use’ is one of the principles underlying
the various assessment criteria for effecting the relevant classifications under Directive 67/548, the Court of Justice was
obliged, by necessary implication, in the context of its assessment of the flammability and toxicity of nPB, to have taken
it into account when upholding the validity of the contested classifications.

32      The Commission contends that the appeal should be dismissed as unfounded and that, in reality, by its appeal, Enviro Tech
is seeking to contest the Court’s ruling in *Enviro Tech (Europe)*.

*Findings of the Court*

33      Enviro Tech seeks, in essence, to show that the General Court made an error of law in finding that, in *Enviro Tech (Europe)*, the Court of Justice implicitly ruled on the Commission’s compliance with the criterion of ‘normal handling or use’ within
the meaning of section 1.1 of Annex VI to Directive 67/548 in the context of its assessment of the flammability and toxicity
of nPB.

34      In that regard, it must be noted that, contrary to the appellant’s claim, the General Court correctly held that it is apparent
in particular from paragraph 31 of *Enviro Tech (Europe)* that that company, as party to the main proceedings giving rise to that judgment, had raised before the Court of Justice
the argument concerning an alleged manifest error of assessment on the part of the Commission in the application of the criterion
of ‘normal handling or use’.

35      It is true that, in *Enviro Tech (Europe)*, the Court of Justice did not rule expressly on compliance by the Commission with the criterion of ‘normal handling or use’
within the meaning of section 1.1 of Annex VI to Directive 67/548. Nevertheless, it is apparent from the Court’s reasoning
in that judgment that the Court took it into account. At paragraph 69 of that judgment, the Court pointed out that, according
to the studies in question, ‘the toxic effects are not produced solely on administration of high doses’. The General Court,
at paragraph 145 of the judgment under appeal, referred to that passage in order to illustrate its assessment that the criterion
of normal handling or use is ‘the expression of a general principle underlying the various assessment criteria governing the
inflammability and toxicity of substances’.

36      However, as is apparent from the actual wording of section 1.1, located in Annex VI of Directive 67/548 under the section
headed ‘General Introduction’, that criterion is the expression of a general principle which must be taken into consideration
along with each of the specific assessment criteria laid down in that annex in order to classify a substance under one of
the categories contained in that directive.

37      In those circumstances, the General Court correctly held, at paragraph 145 of the judgment under appeal, that the criterion
of ‘normal handling or use’ underlies the assessment criteria governing the flammability and toxicity of the substances provided
for in the respective sections of Annex VI to Directive 67/548 and that, consequently, the Court of Justice necessarily took
it into consideration, implicitly but indubitably, in *Enviro Tech (Europe)* during its assessment of the flammability and reproductive toxicity of nPB.

38      Therefore, the General Court also correctly rejected the third limb of the first plea concerning the criterion of ‘normal
handling or use’ within the meaning of section 1.1 of Annex VI to Directive 67/548, advanced by Enviro Tech in support of
its action, without having examined the merits of the arguments raised in support of that plea.

39      It follows from the foregoing that the appeal must be dismissed as clearly unfounded.

**Costs**

40      Under Article 138(1) of the Rules of Procedure, which applies to appeal proceedings pursuant to Article 184(1) thereof, the
unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since
the Commission has applied for costs and Enviro Tech has been unsuccessful, Enviro Tech must be ordered to pay the costs.

On those grounds, the Court (Eighth Chamber) hereby orders:

1.      **The appeal is dismissed.**

2.      **Enviro Tech Europe Ltd is ordered to pay the costs.**

[Signatures]

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[\*](#Footref*) Language of the case: English.