ORDER OF THE COURT (Fifth Chamber)

22 January 2010 ([\*](#Footnote*))

(Appeal – Directive 91/414/EEC – Positive list – Azinphos-methyl – Decision 1999/468/EC – Commission letter – Decision not to continue the evaluation procedure – Act which may be the subject of an action for annulment – Appeal clearly unfounded)

In Case C‐69/09 P,

APPEAL under Article 56 of the Statute of the Court of Justice, brought on 6 February 2009,

**Makhteshim-Agan Holding BV,** established in Amsterdam (Netherlands), represented by K. Van Maldegem and C. Mereu, avocats,

**Makhteshim-Agan Italia Srl,** established in Bergamo (Italy), represented by K. Van Maldegem and C. Mereu, avocats,

**Magan Italia Srl,** established in Bergamo, represented by K. Van Maldegem and C. Mereu, avocats,

appellants,

the other party to the proceedings being:

**European Commission,** represented by N.B. Rasmussen and L. Parpala, acting as Agents, with an address for service in Luxembourg,

defendant at first instance,

THE COURT (Fifth Chamber),

composed of E. Levits (Rapporteur), President of the Chamber, A. Borg Barthet and M. Berger, Judges,

Advocate General: V. Trstenjak,

Registrar: R. Grass,

after hearing the Advocate General,

makes the following

**Order**

1        By their appeal, Makhteshim-Agan Holding BV, Makhteshim-Agan Italia Srl and Magan Italia Srl request the Court to set aside
in part the order of the Court of First Instance of the European Communities (now ‘the General Court’) of 26 November 2008
in Case T‐393/06 *Makhteshim-Agan Holding and Others* v *Commission* (‘the order under appeal’), by which that Court dismissed as inadmissible their action for annulment of the ‘decision’ of
the Commission of the European Communities, allegedly contained in a letter of 12 October 2006 (‘the contested letter’), ‘not
to submit a proposal’ with a view to inclusion of the active substance azinphos‐methyl in Annex I to Council Directive 91/414/EEC
of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1), or, in the alternative,
request a declaration that the Commission failed to act by unlawfully failing to submit such a proposal.

**Legal context**

*Directive 91/414*

2        Directive 91/414 establishes the Community rules governing the granting of authorisation to place plant protection products
on the market and the withdrawal of such authorisation. Under Article 4 of that directive, Member States are required to authorise
the placing on the market only of those plant protection products of which the ‘active substances are listed in Annex I’ thereto.
Article 5 of that directive sets out the conditions required for the inclusion of those substances in that annex.

3        Article 6 of Directive 91/414 provides that ‘[i]nclusion of an active substance in Annex I shall be decided in accordance
with the procedure laid down in Article 19’ of that directive.

4        Article 8(2) of Directive 91/414 provides for transitional measures and derogations for active substances not listed in Annex
I, but which were already on the market two years after the date of notification of that directive. The placing on the market
of those active substances may be authorised by Member States for a provisional period of 12 years. Article 8(2) provides
that, during that transitional period, the active substances concerned must undergo a programme of assessment after which,
following examination of an active substance by the Committee referred to in Article 19, a decision may be taken in accordance
with the procedure laid down in that article that the substance can be included in Annex I and under which conditions, or,
in cases where the requirements of Article 5 are not satisfied or the requisite information and data have not been submitted
within the prescribed period, that such active substance will not be included in Annex I.

5        That transitional period, which was initially due to expire on 26 July 2003, was extended up to 31 December 2005 by Commission
Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Directive 91/414
and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of authorisations
for plant protection products containing these substances (OJ 2002 L 319, p. 3). The period was subsequently extended – by
Article 1 of Commission Regulation (EC) No 1335/2005 of 12 August 2005 amending Regulation (EC) No 2076/2002 and Decisions
2002/928/EC, 2004/129/EC, 2004/140/EC, 2004/247/EC and 2005/303/EC as regards the time period referred to in Article 8(2)
of Directive 91/414 and the continued use of certain substances not included in its Annex I (OJ 2005 L 211, p. 6) – up to
31 December 2006, except in cases where a decision had been taken before that date on the inclusion of a particular active
substance in Annex I to Directive 91/414.

6        Article 19 of Directive 91/414, as amended by Council Regulation (EC) No 806/2003 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 (qualified majority) (OJ 2003 L 122, p. 1), provides
as follows:

‘1.      The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up pursuant to Article
58 of Regulation (EC) No 178/2002.

2.      Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC [Council Decision of 28 June 1999 laying
down the procedures for the exercise of implementing powers conferred on the Commission, OJ 1999 L 184, p. 23] shall apply.

...’

*Regulation (EEC) No 3600/92*

7        By Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the
first stage of the programme of work referred to in Article 8(2) of Directive 91/414 (OJ 1992 L 366, p. 10), as amended by
Commission Regulation (EC) No 2266/2000 of 12 October 2000 (OJ 2000 L 259, p. 27) (‘Regulation No 3600/92’), the Commission
implemented the evaluation procedure for a number of substances, with a view to their possible inclusion in Annex I to Directive
91/414. Azinphos-methyl was among those substances.

8        Article 4(1) of Regulation No 3600/92 provides that ‘[a]ny producer wishing to secure the inclusion of an active substance
referred to in Annex I hereto ... in Annex I to ... Directive [91/414], shall so notify the Commission within six months of the
date of entry into force of this Regulation.’

9        Article 7 of Regulation No 3600/92 provides:

‘1. For each active substance for which it has been designated rapporteur, the Member State shall:

(a)      examine the dossiers referred to in Article 6(2) and (3), ... as well as any information as referred to in the third indent
of Article 5(4) and any other available information ...

...

3.      After receiving the summary dossier and the report referred to in paragraph 1, the Commission shall refer the dossier and
the report to the [Standing] Committee [on Plant Health] for examination.

...’

10      On completion of the examination carried out by the Standing Committee on Plant Health, the Commission is required to prepare
a draft of the decision on the inclusion or non-inclusion of the substance concerned in Annex I to Directive 91/414. The draft
is then submitted to that committee for approval in accordance with the procedure laid down in Article 19 of Directive 91/414.

*Decision 1999/468*

11      Article 5 of Decision 1999/468, entitled ‘Regulatory procedure’, provides:

‘1.      The Commission shall be assisted by a regulatory committee composed of the representatives of the Member States and chaired
by the representative of the Commission.

2.      The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall
deliver its opinion on the draft within a time-limit which the chairman may lay down according to the urgency of the matter.
...

3.      The Commission shall, without prejudice to Article 8, adopt the measures proposed if they are in accordance with the opinion
of the committee.

4.      If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission
shall, without delay, submit to the Council a proposal relating to the measures to be taken ...

...

6.      The Council may ... act by qualified majority on the proposal, within a period to be laid down in each basic instrument but
which shall in no case exceed three months from the date of referral to the Council.

If within that period the Council has indicated by qualified majority that it opposes the proposal, the Commission shall re-examine
it. It may submit an amended proposal to the Council, re-submit its proposal or present a legislative proposal on the basis
of the Treaty.

...’

**Facts giving rise to the dispute in the main proceedings and the contested letter**

12      Azinphos-methyl is an active substance present in plant protection products which were already on the market two years after
26 July 1991, the date of notification of Directive 91/414. Those products could for that reason benefit from the derogation
provided for in Article 8(2) of that directive and remain on the market without their active substance having been included
in Annex I to Directive 91/414. That 12‐year derogation was twice extended up to 31 December 2006.

13      On 20 July 1993, Makhteshim-Agan International Coordination Center notified the Commission of a request for inclusion of azinphos-methyl
in Annex I to Directive 91/414.

14      Following examination of the data lodged within the framework of the evaluation procedure, the Commission, on 3 March 2006,
referred to the Standing Committee on Plant Health a draft directive for the inclusion of azinphos-methyl in Annex I to Directive
91/414. Since that Committee did not issue an opinion, the Commission, pursuant to Article 19 of Directive 91/414, read in
conjunction with Article 5 of Decision 1999/468, submitted to the Council on 13 June 2006 a draft directive to the same effect
as that which had already been submitted to the Standing Committee on Plant Health.

15      In a vote held on 18 September 2006, the Council, by a qualified majority, opposed that draft.

16      By the contested letter, which was addressed to the Federal Republic of Germany, as the rapporteur Member State, and to the
other Member States in copy, the Director-General of the Commission’s ‘Health and Consumer Protection’ Directorate-General
incorporated the statement of reasons adopted by the Council in its vote on18 September 2006 and stated as follows:

‘The Commission sees no possibility of changing the Council’s mind on this substance. Thus, it would serve no useful purpose
for the Commission to resubmit the same proposal or an amended one (for example by proposing a directive including the substance
in Annex I with even further conditions). For the same reasons, it would be pointless for the Commission to submit a legislative
proposal under Article 37 EC: the Council’s position would remain the same, and it would be unrealistic to imagine that such
a text could be adopted before the deadline of 31 December 2006.

Therefore the Commission considers that the Council’s opposition means that no further steps can be taken to approve azinphos-methyl.
In the absence of any approval at Community level by the date laid down in Article 8(2) of Directive 91/414, there would no
longer be any legal basis for keeping the substance on the market. That date is 31 December 2006 ...

Member States should therefore ensure that authorisations for plant protection products containing this substance are withdrawn
by 31 December 2006. I would be grateful if you could make this known to interested parties (manufacturers, vendors and farmers
etc.) in your Member State, and also to the notifiers with whom you had contact as rapporteur Member State.’

**The action before the General Court and the order under appeal**

17      By application lodged at the Registry of the General Court on 18 December 2006, the present appellants brought an action for
the annulment of the decision allegedly contained in the contested letter and, in the alternative, for a declaration that
the Commission had failed to act.

18      By a separate document lodged at the Registry of the General Court on 26 March 2007, the Commission raised an objection of
inadmissibility under Article 114(1) of the Rules of Procedure of the General Court. The Commission maintained, first, with
regard to the action for annulment, that, as the contested letter did not produce any binding legal effects, it was not an
act open to challenge and that the appellants were not individually affected by that letter, and, secondly, with regard to
the action for failure to act, that the appellants had not, in accordance with the second paragraph of Article 232 EC, called
on the Commission to act. The appellants presented their observations on that objection of inadmissibility on 14 May 2007
and contended that it ought to be rejected.

19      First of all, the General Court examined the admissibility of the claim for annulment.

20      After recalling, in paragraphs 30 and 31 of the order under appeal, the definition of measures which may be the subject of
an action for annulment, as well as the settled case-law concerning the Commission’s negative acts, the General Court found
in paragraphs 32 and 33 of that order that the contested letter expressed the Commission’s intention not to submit to the
Council proposals which, as such, were merely preparatory measures.

21      The General Court also pointed out, first, in paragraphs 36 to 38 of the order under appeal, that the contested letter did
not constitute the final phase in the evaluation procedure for azinphos-methyl, and that, pursuant to the procedure established
under Article 5 of Decision 1999/468, the Council’s position of 18 September 2006, which became final on expiry of the period
specified in Article 8(2) of Directive 91/414, had constituted the final phase of that procedure and had thus produced legal
effects which were binding on, and capable of affecting the interests of, the appellants.

22      Secondly, the General Court indicated, in paragraphs 39 to 43 of the order under appeal, that the reminder in the contested
letter of the consequences of the Council’s position on 18 September 2006, according to which the Member States were required
to ensure, in the event that azinphos-methyl were not to be included in Annex I to Directive 91/414, that the authorisations
for products containing that substance were withdrawn within the period prescribed, was only the Commission’s opinion, devoid
of legal effect, as the Commission had no power, once the Council had taken that position, to adopt measures authorising the
marketing of products which contained that substance.

23      Accordingly, and without having examined the other plea of inadmissibility raised by the Commission to the effect that the
appellants were not individually concerned by the contested letter, the General Court declared the action for annulment to
be inadmissible.

24      In the second place, the General Court examined the admissibility of the action for failure to act.

25      After noting that the appellants had not called on the Commission to act before bringing the action, the General Court held
that that action was inadmissible. Consequently, it dismissed the application in its entirety.

**Forms of order sought by the parties**

26      The appellants claim that the Court should:

–        set aside the order under appeal in so far as the General Court thereby declared the appellants’ application for annulment
inadmissible;

–        declare their application for annulment admissible;

–        annul the decision contained in the contested letter;

–        alternatively, refer the case back to the General Court to rule on their application for annulment; and

–        order the Commission to pay all of the costs.

27      The Commission contends that the Court should dismiss the appeal and order the appellants to pay the costs.

**The appeal**

28      Under Article 119 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, by reasoned
order dismiss the appeal in whole or in part without opening the oral procedure.

29      In support of their appeal, in which they confine themselves to challenging the order under appeal in so far as the General
Court declared their action for annulment to be inadmissible, the appellants put forward a single ground of appeal alleging
that the General Court erred in law in holding that the contested letter did not constitute a decision that could be challenged
by way of an action for annulment.

*Arguments of the parties*

30      The appellants rely essentially on two principal arguments in support of their contention that the General Court erred in
law.

31      First, the appellants submit that the General Court erred in holding, in paragraphs 32 to 37 of the order under appeal, that
the contested letter did not constitute the final phase in the procedure for the evaluation of azinphos-methyl. In so doing,
they argue, the General Court failed to have regard for the fact that, pursuant to Article 5(6) of Decision 1999/468, it was
for the Commission either to take positive action following the Council’s position of 18 September 2006, by adopting one of
the measures specified by that provision, or to refrain from taking action. However, in choosing the latter solution, the
Commission adopted a decision not to include the substance at issue in Annex I to Directive 91/414 and thereby adversely affected
the appellants.

32      Thus, the contested letter, in which the Commission essentially requested the Member States to withdraw authorisations for
the placing on the market of products containing azinphos-methyl, necessarily affected the appellants’ interests, in so far
as the Commission’s decision not to continue the procedure for the evaluation of that substance resulted in serious economic
losses for the appellants.

33      Secondly, the appellants take the view that the contested letter was the only act open to challenge, with the result that
a declaration that their application for annulment was inadmissible amounted to an infringement of their right to effective
judicial protection.

34      In that regard, they submit, the situation in the present case does not differ from that which led the Court to hold in Case
C-521/06 P *Athinaïki Techniki* v *Commission* [2008] ECR I-5829 that a letter closing the file concerning the assessment of the compatibility of State aid with the EC
Treaty constitutes an act amenable to an action for annulment, to the extent to which such an act affects the interests of
those who have submitted a complaint against the allegedly illegal aid. In the present case, the declaration of inadmissibility
of the form of order sought by the appellants in respect of the contested letter would prevent the appellants from vindicating
their right to effective judicial protection, since an action for annulment cannot be brought against the Council’s position
by reason of its ‘intermediate’ nature.

35      The Commission points out that, even had the contested letter not been sent to the Member States, the withdrawal of azinphos-methyl
would have been required under Article 4(1) of Directive 91/414, read in conjunction with Article 8(2) of that directive.
Consequently, that letter could not have had the binding effects which the appellants seek to attribute to it. In any event,
it was not a decision not to include the substance at issue in Annex I to Directive 91/414, as such a decision did not, in
the circumstances of the present case, fall within the powers of the Commission.

36      Furthermore, and in contrast to the situation in the case which gave rise to the judgment in *Athinaïki Techniki* v *Commission*, the contested letter was also not a preparatory measure. The letter contained mere statements of fact, and the General Court
correctly recognised it as being an act which could not be the subject of an action for annulment.

*Findings of the Court*

37      It must be recalled, as stated by the General Court in paragraph 30 of the order under appeal, that any measure the legal
effects of which are binding on, and capable of affecting the interests of, an applicant by bringing about a distinct change
in his legal position is an act or decision which may be the subject of an action for annulment (Case 60/81 *IBM* v *Commission* [1981] ECR 2639, paragraph 9, and the order in Case C-163/06 P *Finland* v *Commission* [2007] ECR I‐5127, paragraph 40).

38      With regard to the admissibility of actions for annulment, it is also settled case-law that, in order to ascertain whether
a measure produces such effects, it is necessary to look to its substance and even to the intention of its author (see, to
that effect, Case C‐147/96 *Netherlands* v *Commissio*n [2000] ECR I‐4723, paragraph 27). Therefore, the form of an act or decision is in principle irrelevant in regard to the
admissibility of an action seeking the annulment of that act or decision.

39      The appellants maintain that the General Court erred in law in taking the view that their situation had been affected, not
by the contested letter, by the position taken by the Council on 18 September 2006.

40      In that regard, it must be made clear that the intention not to act in the sense of continuing the evaluation procedure for
azinphos-methyl and the reference to the consequences of the non-inclusion of that substance in Annex I to Directive 91/414,
expressed by the Commission in the contested letter, cannot be such as to render that letter capable of being the subject
of an action for annulment.

41      In the first place, the appellants’ allegation manifestly disregards the fact, pointed out by the General Court in paragraph
40 of the order under appeal and not contested by them, that the Commission, in the light of Article 5 of Decision 1999/468
and the course of the procedure followed in the present case, did not have any power to authorise the inclusion of azinphos-methyl
in Annex I to Directive 91/414. Its intention not to continue the evaluation procedure cannot therefore be interpreted as
being a decision refusing to include azinphos-methyl in that annex.

42      In the second place, and as was correctly pointed out by the General Court in paragraph 37 of the order under appeal, it was
the Council’s position of 18 September 2006 which produced binding legal effects capable of affecting the applicants’ interests.

43      First, it must be noted that, under Article 4(6) of Directive 91/414, the authorisations for products containing existing
active substances, that is to say, substances placed on the market but not included in Annex I to that directive, had to be
withdrawn on the expiry of the derogation period.

44      Second, it is clear that the Council’s position constituted the final phase of the procedure for the evaluation of azinphos-methyl
following the expiry, on 31 December 2006, of the period provided for under Article 8(2) of Directive 91/414, read in conjunction
with Article 1 of Regulation No 2076/2002. In that regard, the Commission confined itself, in the contested letter, to pointing
out the consequences, in conjunction with the expiry of that period, of the Council’s refusal to include that substance in
Annex I to Directive 91/414.

45      Consequently, since the obligation to withdraw the products containing an active substance not included in Annex I to Directive
91/414 arose independently of the contested letter, that letter cannot be considered to have affected the interests of the
appellants.

46      Furthermore, even if, as the appellants claim, the contested letter constituted a refusal to include azinphos-methyl in Annex
I to Directive 91/414, it could not, in any event, have been the subject of an action for annulment. It has been held that
the Commission’s refusal to take steps for the withdrawal or amendment of an act can constitute in itself an act the lawfulness
of which is open to challenge under the fourth paragraph of Article 230 EC only if the act that the Commission has refused
to withdraw or amend could itself have been open to challenge under that provision (see order of 13 March 2007 in Case C‐150/06 P
*Arizona Chemical and Others* v *Commission*, paragraph 23). In the present case, however, it is common ground that the measures provided for in Article 5 of Decision
1999/468, the adoption of which the appellants essentially requested and which they were refused, could not have been the
subject of an action for annulment, since those measures were necessarily of a preparatory nature and, therefore, incapable
of forming the subject of such an action.

47      Consequently, the General Court did not err in law in holding that the contested letter could not be the subject of an action
for annulment.

48      In so doing, the General Court could not have infringed the applicants’ right to effective judicial protection.

49      First, as has already been held, the right to effective judicial protection cannot in itself have the effect of setting aside
the conditions laid down in the fourth paragraph of Article 230 EC (see, to that effect, *Arizona Chemical BV and Others* v *Commission*, paragraph 41). It follows from the foregoing that the appellants have failed to establish that the contested letter could
have been the subject of an action for annulment.

50      Next, it must be noted that, by providing for application of the procedure introduced in Article 5 of Decision 1999/468, Article
19 of Directive 91/414 ensures that an application for inclusion of an active substance in Annex I to that directive can be
rejected only by a binding legal act, which may be subject to judicial review (see, to that effect, Joined Cases C-154/04
and C-155/04 *Alliance for Natural Health and Others* [2005] ECR I-6451, paragraph 83).

51      To that end, the appellants were free to challenge the decision which, in view of the foregoing considerations, affected their
interests by requesting the Community judicature to adopt interim measures designed to prevent the damage which they alleged
from occurring.

52      Finally, it is to no avail that the appellants seek to base their claims on the judgment in *Athinaïki Techniki* v *Commission*.

53      First, the Commission’s letter closing the file, which was the subject of the action for annulment at the origin of that judgment,
could not, in the context of the administrative procedure which had been initiated, be followed by any other measure amenable
to annulment proceedings (see, to that effect, *Athinaïki Techniki* v *Commission*, paragraph 54).

54      In the present case, however, as has been noted in paragraph 44 of this order, the contested letter did not constitute the
final act, or even the only act, of the procedure for the evaluation of azinphos-methyl, since the decision which affected
the appellants’ interests resulted from the Council’s position of 18 September 2006.

55      Second, the Commission’s decision not to continue with the evaluation procedure provided for in Article 88(2) EC, in the case
which gave rise to the judgment in *Athinaïki Techniki* v *Commission*, had the effect of depriving the addressees of that decision of the possibility of enforcing the procedural rights which
they derived from that latter provision (see, to that effect, *Athinaïki Techniki* v *Commission*, paragraph 36).

56      However, in the procedure at issue in the present case, the appellants have not demonstrated that the fact that it was impossible
to bring an action for annulment against the contested letter had the effect of depriving them of the procedural guarantees
to which they were entitled.

57      It follows from all of the foregoing that the General Court did not err in law when it declared that the appellants’ application
for annulment was inadmissible. Consequently, the appellants’ appeal must be dismissed as being clearly unfounded.

**Costs**

58      Under Article 69(2) of the Rules of Procedure, which is applicable to the procedure on appeal pursuant to Article 118 thereof,
the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.
As the Commission has applied for costs to be awarded against the appellants, and as the latter have been unsuccessful, the
appellants must be ordered to pay the costs.

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

1.      **The appeal is dismissed.**

2.      **Makhteshim-Agan Holding BV, Makhteshim-Agan Italia Srl and Magan Italia Srl shall pay the costs.**

[Signatures]

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