Source: EURLEX
Language: en
Format: md

OPINION OF ADVOCATE GENERAL

KOKOTT

of 6 May 2010 1([1](#Footnote1))

**Case C‑343/09**

**The Queen, on the application of**

**Afton Chemical Limited**

**v**

**Secretary of State for Transport**

(Reference for a preliminary ruling from the High Court of Justice of England and Wales, Queen’s Bench Division (Administrative
Court) (United Kingdom))

(Directive 98/70/EC – Quality of petrol and diesel fuels – Directive 2009/30/EC – Use of metallic additives in fuels – Limit for methylcyclopentadienyl-manganese-tricarbonyl (MMT) – Validity – Proportionality – Precautionary principle)

  
  
  
  

I –  **Introduction**

1.        Methylcyclopentadienyl-manganese-tricarbonyl (‘MMT’) is a metallic additive which is added to fuel for motor vehicles. By
the rules at issue the European Union has introduced strict limits for the use of MMT and labelling requirements for metallic
additives, in the light of fears that they are a danger to human health and damage emission control systems in vehicles.

2.        The largest producer of MMT considers those fears to be clearly unfounded. It therefore takes the view that the rules breach
various principles of European Union law, in particular, the precautionary principle, the principle of proportionality and
the principle of equality. It brought these objections before the High Court of Justice, which has now sought a ruling on
the validity of those rules from the Court of Justice.

II –  **Legal framework**

3.        Directive 2009/30/EC ([2](#Footnote2)) amends Directive 98/70/EC of the European Parliament and the Council of 13 October 1998 as regards the specification of petrol,
diesel and gas-oil. ([3](#Footnote3))

4.        The subject of the reference for preliminary ruling is Article 8a of Directive 98/70, inserted by Article 1(8) of Directive
2009/30, which limits the use of MMT and lays down a labelling requirement for metallic fuel additives:

‘1. The Commission shall conduct an assessment of the risks for health and the environment from the use of metallic additives
in fuel and, for this purpose, develop a test methodology. It shall report its conclusions to the European Parliament and
to the Council by 31 December 2012.

2. Pending the development of the test methodology referred to in paragraph 1, the presence of the metallic additive methylcyclopentadienyl
manganese tricarbonyl (MMT) in fuel shall be limited to 6 mg of manganese per litre from 1 January 2011. The limit shall be
2 mg of manganese per litre from 1 January 2014.

3. The limit for the MMT content of fuel specified in paragraph 2 shall be revised on the basis of the results of the assessment
carried out using the test methodology referred to in paragraph 1. It may be reduced to zero where justified by the risk assessment.
It cannot be increased unless justified by the risk assessment. Such a measure, designed to amend non-essential elements of
this Directive shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(4).

4. Member States shall ensure that a label concerning the metallic additive content of fuel is displayed at any point where
a fuel with metallic additives is made available to consumers.

5. The label shall contain the following text: “Contains metallic additives”.

6. The label shall be attached to the place where information indicating the type of fuel is displayed, in a clearly visible
position. The label shall be of a size and font that is clearly visible and easily legible.’

5.        Recital 35 of Directive 2009/30 states:

‘The use of specific metallic additives, and in particular the use of methylcyclopentadienyl manganese tricarbonyl (MMT),
might raise the risk of damage to human health and might cause damage to vehicle engines and emission control equipment. Many
vehicle manufacturers advise against the use of fuel containing metallic additives and the use of such fuel may invalidate
vehicle warranties. It is therefore appropriate to keep under constant review the effects of the use of the MMT in fuel in
consultation with all relevant stakeholders. Pending further review it is necessary to take steps to limit the severity of
any damage that may be caused. It is therefore appropriate to set an upper limit on the use of MMT in fuel, based upon currently
available scientific knowledge. This limit should be revised upwards only if the use of higher dosage rates can be demonstrated
not to cause adverse effects. To avoid consumers unknowingly invalidating their vehicles’ warranties, it is also necessary
to require the labelling of any fuel that contains metallic additives.’

III –  **Facts, main proceedings and reference for a preliminary ruling**

6.        According to the referring court, the applicant, Afton Chemical Limited (‘Afton’), is a company based in the United Kingdom
which forms part of the Afton Chemical Group. The Afton group manufactures and sells MMT for use worldwide. The trademark
‘mmt’ is owned by an Afton group company. Afton group companies own numerous patents and patent applications in respect of
MMT. However, it appears from a statement made by Afton in the main proceedings that, in addition to Afton, a limited number
of companies in China produce MMT. ([4](#Footnote4))

7.        The referring court states that, according to the witness statements supporting Afton’s claim, MMT is a metallic fuel additive
based on manganese, which has been used in fuel for more than 30 years. It has two principal uses, namely to raise the octane
level of unleaded fuel and to protect against valve damage (so-called valve seat recession) in older vehicles running on petrol
that contains additives acting as a proxy for lead.

8.        According to the order for reference, the use of MMT in unleaded petrol is unrestricted in the majority of countries around
the world. Prior to the enactment of the Directive, there was no Community-wide limit or restriction of any kind on the use
of MMT. Further, there was no Union-wide labelling requirement in respect of metallic additives generally or MMT specifically.

9.        Afton brought an action before the High Court, which, on application by Afton, referred the following questions concerning
Directive 2009/30 to the Court:

‘1.      With reference to that part of Article 1(8) which inserts a new Article 8a(2) into Directive 98/70 limiting the use of methylcyclopentadienyl
manganese tricarbonyl in fuel to 6 mg Mn per litre from 1 January 2011 and to 2 mg from 1 January 2014, is the imposition
of such limits:

(1)      Unlawful as being based on a manifest error of assessment?

(2)      Unlawful as being in violation of the requirements of the precautionary principle?

(3)      Unlawful as lacking in proportionality?

(4)      Unlawful as being contrary to the principle of equal treatment?

(5)      Unlawful as being contrary to the principle of legal certainty?

2.      With reference to that part of Article 1(8) which inserts a new Article 8a(4), Article 8a(5) and 8a(6) into Directive 98/70
requiring the labelling of all fuels which contain metallic additives with the phrase “contains metallic additives”, is the
imposition of such a labelling requirement:

(1)      Unlawful as being based on a manifest error of assessment?

(2)      Unlawful as lacking in proportionality?’

10.      In addition to Afton, the Federal Republic of Germany, the European Parliament, the European Council and the European Commission
took part in the written procedure. All those parties, apart from Germany, also took part in the oral procedure on 15 April
2010.

IV –  **Legal assessment**

11.      The reference for a preliminary ruling questions the validity of two rules on the use of MMT. First, criticisms are raised
of the limits for the use of MMT (see below under B), and secondly, of the labelling requirement for fuels containing MMT
(see below under C). However, to begin with, I will consider the objections to the admissibility of the reference for a preliminary
ruling (see below under A).

A –    *The admissibility of the reference for a preliminary ruling*

12.      Two grounds are put forward for the inadmissibility of the reference for a preliminary ruling. First, according to the Parliament
and the Commission, there is no real legal dispute in the main proceedings as the parties share the same legal view (see below
under 1). Secondly, the Commission submits that Afton could have brought a direct action before the Community courts under
Article 230 EC against the rules at issue and was therefore precluded from relying on the invalidity of those provisions in
other proceedings (see below under 2).

1.      The dispute in the main proceedings

13.      The Parliament and the Commission contend that there is no discernible dispute in the main proceedings as to whether the provisions
in question are valid. It is therefore an inadmissible, hypothetical reference.

14.      However, as a rule, there is a presumption that the questions referred are not purely hypothetical but are relevant to the
decision in the main proceedings. ([5](#Footnote5)) Indeed, when a question on the validity of a measure adopted by the Community institutions is raised before a national court,
it is for that court to decide whether a decision on the matter is necessary to enable it to give judgment and consequently
whether it should request the Court to rule on that question. Accordingly, where the national court’s questions relate to
the validity of a provision of Community law, the Court is obliged in principle to give a ruling. ([6](#Footnote6))

15.      It is only in exceptional circumstances that it is for the Court to examine the conditions in which the case was referred
to it by the national court, in order to assess whether it has jurisdiction. ([7](#Footnote7)) According to settled case-law, a reference from a national court may be refused only where it is quite obvious that the interpretation
of Community law sought by that court bears no relation to the actual facts of the main action or its purpose, or where the
problem is hypothetical and the Court does not have before it the factual or legal material necessary to give a useful answer
to the questions submitted to it. ([8](#Footnote8)) Save for such cases, the Court of Justice is, in principle, bound to give a ruling on questions concerning the interpretation
of Community law. ([9](#Footnote9)) In this context, the concept of interpretation also includes the examination of validity. ([10](#Footnote10))

16.      In the present case, Afton’s interest in establishing the invalidity of the provisions at issue is obvious. They considerably
restrict the possible use of MMT and thus limit Afton’s possible sales. The United Kingdom, represented by the defendant Ministry
of Transport, is bound to implement the disputed provisions, as their validity must be presumed at least until it is established
otherwise. ([11](#Footnote11)) According to Afton, it is for that reason that the Ministry announced its intention to implement the rules on receiving the
application in this case. Although the Ministry of Transport raises no express objections to Afton’s claim, it is thereby
formally opposing Afton’s position. ([12](#Footnote12)) It cannot, therefore, be doubted that the dispute is genuine.

2.      The possibility of a direct action

17.      The Commission also submits that Afton could have brought an action against the disputed provisions under Article 230 EC.

18.      That argument is drawn from the so-called TWD case-law. According to that case-law, a legal measure concerning an individual
cannot be challenged where, with respect to that individual it must be regarded as an individual decision whose annulment
the individual could undoubtedly have sought under Article 230 EC. In such a case, that individual may not plead the unlawfulness
of that legal measure before the national court. ([13](#Footnote13))

19.      It cannot be ruled out that Afton could have brought a direct action in the present case. In that event, it would have been
necessary, under Article 230(4) EC, for the provisions at issue to concern Afton directly and as an individual, so that they
are equivalent to a decision directed at it. There is much in favour of the view that Afton, because of its prominent position
on the market for MMT and its intellectual property rights in that respect, is so clearly identified that specific rules on
the use of MMT concern it individually. ([14](#Footnote14)) In addition, while the provisions at issue require implementation, they allow for no room for manoeuvre, which suggests that
Afton is directly affected. ([15](#Footnote15))

20.      Nevertheless, under the TWD case-law, Afton would only be precluded from relying on the invalidity of the rules at issue in
the domestic proceedings if there is no doubt that the company could have brought an action for annulment of the disputed
provisions under Article 230 EC. ([16](#Footnote16)) However, to date there have been no comparable cases to serve as a precedent which would rule out any doubt. Doubt as to
whether Afton is individually concerned might be raised by the fact that, in addition to Afton, there are apparently Chinese
companies which produce MMT, so that Afton’s market position might be of a purely factual nature. And, as the provisions in
question are contained in a directive, there are still doubts as to whether Afton is directly affected. Accordingly, the TWD
case-law is not applicable in the present case.

21.      If the Court of Justice should none the less conclude that there is no doubt that Afton could bring an action, an exception
to the TWD case-law would be called for, at least in this case. There are, in fact, no grounds in the present case for the
imposition of this restriction of legal protection against legal acts of the Union, which is not expressly regulated.

22.      The TWD case-law is intended to prevent the circumvention of time-limits for actions. ([17](#Footnote17)) If a time-limit has not been observed, a person who could have brought an action before the Community courts within the time-limit,
should not be able to secure review of a measure through a reference for a preliminary ruling.

23.      However, in the present case, Afton brought its action as early as 29 June 2009, that is to say, well within the time-limit
laid down in the fifth paragraph of Article 230 EC. Directive 2009/30 was published in the Official Journal on 5 June 2009.
In accordance with Article 81(1) of the Rules of Procedure, the time-limit for bringing an action thus began to run on 20
June 2009. Taking into consideration the extension of 10 days on account of distance, a direct action could have been lodged
until the end of August 2009. In the present case it is, therefore, not a question of circumventing time-limits for bringing
an action. Nor is there any provision which would oblige Afton to apply directly to the Union Courts. Accordingly, there
is no need to restrict the fundamental right of Afton to plead the invalidity of the rules at issue in national proceedings.

24.      The reference for a preliminary ruling is therefore admissible.

B –    *The first question referred – Validity of the limits for MMT*

25.      The first question, which is divided into five parts, concerns the limits for MMT. I will examine the parts of the question
in the order in which they were asked. The emphasis is on the principle of proportionality, in the framework of which the
precautionary principle and, in part, the question of a manifest error of assessment are also relevant.

1.      The claim that there was a manifest error of assessment

26.      To begin with, the question is raised whether the limits are based on a manifest error of assessment. Afton submits in that
connection that the health risks connected with the use of MMT were not investigated and that the Commission came to the conclusion
that the evidence in regard to environmental risks did not warrant any limitation of the use of MMT.

27.      The claim of a manifest error of assessment relies on settled case-law on the question whether a wide margin of manoeuvre
(discretion) can be reviewed.

28.      In an area such as that at issue here, in which the legislature is required to make political, economic and scientific choices,
and in which it must undertake complex investigations, it has a wide discretion. ([18](#Footnote18)) In that connection it may rely on the expertise of administrators, scientists, interest groups and the public. In the framework
of judicial proceedings such resources are not available to the same extent. The Union court may not therefore put itself
in the place of the legislature ([19](#Footnote19)) and monitor the exercise of its political responsibility. ([20](#Footnote20))

29.      The exercise of this discretion is, however, not entirely exempt from judicial scrutiny. In cases where they have a wide discretion,
Community bodies must examine carefully and impartially all the relevant aspects of the individual case. ([21](#Footnote21)) Not only must the Community Courts, inter alia, establish whether the evidence relied on is factually accurate, reliable
and consistent but also whether that evidence contains all the information which must be taken into account in order to assess
a complex situation and whether it is capable of substantiating the conclusions drawn from it. ([22](#Footnote22))

30.      However, contrary to the view of Afton, an error of assessment cannot, on its own, call into question the validity of a legal
act. Rather, what matters is whether the error of assessment was legally relevant.

31.      The question whether scientific information warrants a limit on the use of MMT relates to the conclusions which the legislature
draws from the information available to it. Those conclusions are the subject of the examination of the principle of proportionality
and may also concern the examination of the principle of equality. I will therefore go into this aspect in more detail in
the course of examining those principles.

32.      In contrast, the alleged failure to investigate health risks relates to the conditions for the adoption of limits. They are
set on the basis of Article 95 EC, which allows the approximation of the provisions laid down by law, regulation or administrative
action which have as their object the establishment and functioning of the internal market. Under Article 95(3), the Commission,
in its proposals concerning health, safety, environmental protection and consumer protection, are to take as a base a high
level of protection, taking account in particular of any new development based on scientific facts. Within their respective
powers, the European Parliament and the Council are also to seek to achieve this objective.

33.      As, according to recital 35 of Directive 2009/30, the limits are for the purpose of protecting health in particular, the legislature
had to take account of all new developments based on scientific results as regards the possible health risks of MMT. ([23](#Footnote23)) A failure to take account of available information on health risks of the use of MMT may constitute a manifest error of assessment
in the application of Article 95 EC.

34.      The obligation to take account of the latest scientific findings does not, however, warrant strict rules of evidence. Rather,
the Community legislature’s broad discretion, which implies limited judicial review of its exercise, applies not only to the
nature and scope of the measures to be taken but also, to some extent, to the finding of the basic facts. ([24](#Footnote24))

35.      Nevertheless, even though such judicial review is of limited scope, it requires that the Community institutions which have
adopted the act in question must be able to show before the Court that in adopting the act they actually exercised their discretion,
which presupposes the taking into consideration of all the relevant factors and circumstances of the situation the act was
intended to regulate. ([25](#Footnote25))

36.      This appraisal need not be apparent in detail from the grounds stated for the legal act in question. 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. ([26](#Footnote26)) Rather, any doubts as to the sufficient appraisal of scientific information may generally be dispelled by other means.

37.      The Commission often lays the foundations for the appraisal of the available scientific information by basing its proposal
on comprehensive investigations. The Parliament and the Council are able to pursue their appraisal in the subsequent legislative
procedure on this basis.

38.      However, Afton rightly points out that this is not possible in this case. Although the Commission based the proposal for Directive
2009/30 inter alia on health protection, ([27](#Footnote27)) it expressly ruled out an appraisal of the health risks of MMT – in contrast to the appraisal of the risks of emission control
systems. ([28](#Footnote28))

39.      This limitation of the examination of risk is in line with the examinations required by Directive 2003/17/EC, ([29](#Footnote29)) which formed the basis for Directive 2009/30 as regards metallic fuel additives. Under the version of Article 9(1)(f) of
Directive 98/70 resulting from amendment by Directive 2003/17, in its review of fuel specifications the Commission was to
consider in particular the effective functioning of new pollution abatement technologies and the impact of metallic additives
on their performance. There was never any mention of health risks in this connection.

40.      Accordingly, the Commission assumed that the health risks of MMT would in future be assessed in the framework of notification
under Regulation No 1907/2007 (REACH). ([30](#Footnote30)) ([31](#Footnote31))

41.      The reference to the objective of protection against health risks therefore requires the other institutions participating
in the legislative procedure to assess the available scientific information later.

42.      Accordingly, the Parliament, in particular, and the Council gave a comprehensive account, in the court proceedings, of the
state of research on the health risks of the use of MMT which they claim has been taken into account in the legislative procedure.
Such an account is generally sufficient to justify the assumption that the information given was actually assessed in the
legislative procedure. ([32](#Footnote32))

43.      However, Afton undermines that assumption. On 29 December 2008, on the basis of Regulation (EC) No 1049/2001, ([33](#Footnote33)) the company requested from the Parliament, Council and Commission the scientific documents and evidence which were taken
into account in the decision on the limits for MMT. The Parliament made three documents on Biofuels, another theme of Directive
2009/30, available and the Council provided a fairly large number of internal documents. According to statements by Afton,
which have not been disputed, none of those documents contained scientific information on the risks of the use of MMT.

44.      The Parliament and the Council point out in that connection that the scientific information in question was not in the possession
of the respective institutions but in the possession of the parliamentary rapporteur or the Member States.

45.      As regards the Parliament this argument is not very persuasive as the rapporteur is a member of that institution. The documents
relating to a legislative procedure which are in the possession of the rapporteur must thus in principle be regarded as being
in the possession of the Parliament. ([34](#Footnote34))

46.      The Council, on the other hand, argues convincingly that the representatives of the Member States would not generally disclose
the details of the scientific basis of their voting behaviour but that their decision was generally based on the expertise
of domestic administrative authorities. Nevertheless, the absence of Council documents in which the scientific basis of the
Council decision is recorded, gives rise to doubt as to whether the decision really has a scientific basis.

47.      In those circumstances it can no longer be presumed – merely on the basis of submissions in the Court proceedings – that the
Parliament and Council took account of scientific information on the health risks of MMT in the legislative procedure.

48.      However, the Commission did produce a so-called ‘Non-Paper’ on MMT ([35](#Footnote35)) in June 2008, which was used in the legislative procedure. Afton was aware of that document and cited it in support of its
position on other questions. The Non-Paper summarised in one and a half pages the state of the research on possible health
risks of the use of MMT in fuels. There is nothing to indicate that this summary is incorrect or incomplete.

49.      Thus, while the misleading information given by the Parliament and the Council in response to the request for access to documents
is regrettable, contrary to appearances, the available scientific information on the health risks of the use of MMT was taken
into account in the legislative procedure.

50.      The claim of a manifest error of assessment regarding the compilation of the information required to decide on limits is thus
not substantiated.

2.      The precautionary principle

51.      The second part of the question concerns the complaint that the conditions for the application of the precautionary principle
were not met.

52.      Where it proves impossible to determine with certainty the existence or extent of the risk envisaged because of the insufficiency,
inconclusiveness or imprecision of the results of the studies conducted, but the likelihood of real harm to human or animal
health or to the environment persists should the risk materialise, the precautionary principle justifies the adoption of restrictive
measures. ([36](#Footnote36))

53.      Various rules of secondary law define the precautionary principle further in connection with the Commission’s implementing
powers. It is in this area that the case-law ([37](#Footnote37)) has been developed which Afton chiefly cites in support of the complaint of a breach of the precautionary principle.

54.      However, Directive 2009/30 was adopted directly on the basis of Article 95 EC. A legislative measure of that sort cannot be
directly assessed according to whether it observes the precautionary principle. Rather, the precautionary principle applies
primarily in connection with the assessment of the principle of proportionality. ([38](#Footnote38)) I will examine it further in that connection.

3.      The principle of proportionality

55.      The proportionality of the limits is the subject of the third part of the question.

56.      The principle of proportionality is one of the general principles of Union law which the legislature must observe. ([39](#Footnote39)) The acts of the bodies of the Union must, therefore, not exceed the bounds of what is appropriate and necessary in order
to achieve the objectives legitimately pursued by the legislation in question; when there is a choice between several appropriate
measures recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims
pursued. ([40](#Footnote40))

57.      Nevertheless, here too, the wide margin of assessment (discretion) of the legislature comes into play. ([41](#Footnote41)) A measure adopted in the exercise of that discretion, breaches the principle of proportionality only if it is manifestly
unsuitable for achieving the objective pursued by the competent body ([42](#Footnote42)) (see below under (b)), if there are clearly less onerous measures which are equally effective ([43](#Footnote43)) (see below under (c)) or if the measures taken are clearly out of proportion to the objectives pursued ([44](#Footnote44)) (see below under (d)). First, however, it must be considered whether the limits pursue objectives which are recognised in
Union law (see below under (a)). ([45](#Footnote45))

a)      The objectives pursued by setting the limits

58.      The objectives pursued by the setting of limits for MMT are based, according to recital 35 of the preamble to Directive 2009/30,
on the fact that the use of this substance might raise the risk of damage to human health and might cause damage to vehicle
engines and emission control (or reduction) equipment. The last-mentioned objective at first sight falls under the heading
of consumer protection. As the parties agree, however, it is also at least implicitly aimed at environmental protection, as
damage to equipment for emission reduction, such as catalytic converters for the cleaning of exhaust gases, may give rise
to higher emissions and thus greater damage to the environment. ([46](#Footnote46))

59.      As Article 95(3) EC calls for a high level of protection in the area of health, safety, environmental protection and consumer
protection, the objectives pursued by the limits are not only recognised but are given great weight.

60.      If it were proven that the use of MMT was damaging to human health and damaged vehicle emission control equipment, restrictions
could be based on the principle of prevention (Article 174(2) EC). However, this is clearly not the case.

61.      According to the documents before the Court the scientific dispute in this case concerns, rather, the question whether risks
to human health or emission reduction are linked to the use of MMT in fuels. Such effects can be neither proved or ruled out.

62.      Such uncertainty has an effect on the manner in which the principle of proportionality is applied. Under such circumstances,
protective measures may be taken under the precautionary principle, without any need to wait for the existence and extent
of such dangers to become clear. ([47](#Footnote47))

63.      However, Afton takes the view that precautionary measures may only be taken in extraordinary circumstances, where there is
serious, sound evidence that the risk of damage exists. If such evidence does not dispel scientific uncertainty, it ought
at least to permit reasonable doubt and meet the high standard of expertise and independence required of scientific experts’
reports. In particular, the measures must be necessary or, in view of the level of risk which the competent body has established
as unacceptable for society, essential.

64.      As regards measures taken by the Member States which, for example, limit trade in goods, the Court of Justice has held that
protective measures under the precautionary principle can be adopted only if they are based on a risk assessment which is
as complete as possible in the particular circumstances of an individual case, which indicate that those measures are necessary
in order to ensure that the products in question do not present a danger for human health. ([48](#Footnote48)) In particular, the risk assessment may not properly be based on a purely hypothetical approach. ([49](#Footnote49))

65.      Citing various judgments of the General Court – which have not been reviewed by the Court of Justice regarding the points
at issue – ([50](#Footnote50)) Afton submits that similar requirements applied to legal measures of the Union.

66.      While the findings of the General Court in those cases were formulated in general terms, those cases concerned decisions of
the Council or the Commission which were made on the basis of the relevant secondary law. That contained specific requirements
as to scientific grounds, ([51](#Footnote51)) which embodied the precautionary principle. The Parliament rightly observed that such requirements were necessary if only
because the cases concerned the revocation of authorisations which had previously been issued on the basis of a scientific
procedure.

67.      Those requirements cannot be transferred to legislation under the Treaty, as no further requirements regarding the application
of the precautionary principle are laid down there. In fact, the case-law set out below shows that the Union can issue bans
by way of precaution without a comprehensive risk assessment, which apply at least until the risk can be ruled out.

68.      The judgment in *Alliance for Natural Health and Others* concerned the regulation of free trade in food supplements. Directive 2002/46/EC ([52](#Footnote52)) reserved such freedom for substances about which, at the time when the directive was adopted, the competent European scientific
authorities had available adequate and appropriate scientific data capable of providing them with the basis for a favourable
opinion. This restriction of free trade was qualified by the possibility of authorising further food supplements in line with
scientific and technological developments. The Court saw this as an appropriate way of reconciling the objective of the internal
market with that relating to the protection of human health. ([53](#Footnote53))

69.      Thus, in that case, even the *absence* of a comprehensive risk assessment by the competent European authorities was sufficient to justify restrictions.

70.      The position is similar as regards site protection under Article 6(3) of Directive 92/43 (the Habitats Directive): pursuant
to Article 6(3) of the Habitats Directive, the competent national authorities are to authorise a project only if they have
made certain that it will not adversely affect the integrity of the site in question. That is the case where no reasonable
scientific doubt remains as to the absence of such effects. ([54](#Footnote54)) Thus, it is not the prohibition of measures, but their authorisation in the first place, which must be based on a comprehensive
risk assessment.

71.      The possibility of an exceptional authorisation for imperative reasons under Article 6(4) of the Habitats Directive does not
affect the position at all, since it also requires an assessment of the risks of the project for the site. ([55](#Footnote55))

72.      Finally, the registration requirement in Regulation No 1907/2007 (REACH) ([56](#Footnote56)) also embodies the precautionary principle ([57](#Footnote57)) in a ban on the marketing of substances which applies until an assessment of certain risks is submitted. ([58](#Footnote58)) The Court of Justice did not question this approach to regulation when it ruled on the obligation to register monomers. ([59](#Footnote59))

73.      The case-law set out above is an inevitable result of the broad discretion conferred on the legislature in the application
of the principle of proportionality and the precautionary principle and in the selection of the basic data, when complex legislation
is to be adopted.

74.      In principle, similar considerations apply to measures taken by the Member States. ([60](#Footnote60)) The fact that the Court of Justice frequently makes them subject to stricter requirements is a result of the subject-matter
of the legislation in each case. ([61](#Footnote61)) In trade in goods this is a reflection of the principle of mutual recognition. If Member States admit certain products, it
must be assumed that a risk assessment has been made. Consequently, there is a higher standard for the grounds to be stated
for any more far-reaching restrictions imposed by other Member States. If, on the other hand, the Union regulates the way
certain risks are dealt with in a uniform manner throughout the Union and the experience of all Member States is taken into
account in the process, it must be possible to take protective measures without first carrying out a comprehensive risk assessment
in every individual case. The anticipated damage might already have occurred while such an assessment is being carried out.

75.      The justification of limits thus does not depend primarily on the assessment of risks by the Court of Justice. Rather, it
is for the legislature to draw conclusions from the scientific debate. The Court of Justice may only call into question the
substantive evaluation made by the legislature if there are manifestly no risks or they have clearly been incorrectly estimated.
Nevertheless – at least when examining the objective of the legislation – there can be no question of that on the basis of
the scientific debate regarding risks accepted by both.

76.      In summary, it must be concluded that prevention of the risks of the use of MMT for human health and the environment should
be recognised as objectives of the limits.

b)      Appropriateness

77.      The limits are not manifestly inappropriate to serve as a precaution against the risks of the use of MMT. Limits, by their
nature, prevent greater use of MMT and thus restrict the amount of MMT which might cause damage.

78.      However, Afton submits that it cannot be established whether manganese in fuels is to be attributed to MMT. Afton concludes
from this that limits cannot be implemented in practice and are therefore inappropriate for the prevention of the risks of
the use of MMT.

79.      That conclusion is, however, not compelling. Even if there is (still) no method for demonstrating directly that manganese
in fuels must be attributed to MMT, this can be inferred indirectly. Thus, the fact that the permissible level of manganese
has been exceeded could be viewed as sufficient to give rise to a rebuttable presumption of unauthorised use of MMT. Germany
pertinently points out that Afton has not explained how manganese could otherwise find its way into fuels.

80.      There is, therefore, no substantiated doubt as to whether the limits can be implemented and are appropriate for attaining
their objective.

c)      The need for limits

81.      At the next stage of the examination of proportionality it must be investigated whether the limits can be regarded as the
most moderate means of attaining their objectives. At first sight there are no indications that other protective measures
would have been as effective as those currently provided for.

82.      Afton points out, however, that according to the Commission’s impact assessment, voluntary measures could prevent risks as
effectively as compulsory measures. ([62](#Footnote62)) Thus, according to the Commission’s original assessment, compulsory measures were not the most moderate means.

83.      In taking that view, Afton is clearly assuming that that assessment follows inevitably from the Commission’s scientific information
and is therefore binding also on the other institutions participating in the legislative procedure.

84.      That is, however, not the case.

85.      Rather, in reaching its conclusions, the Commission exercised the discretion conferred on it. That exercise of its discretion
does not prevent the other institutions participating in the legislative procedure from drawing different conclusions from
the available information. The broad discretion of the legislature is not restricted to the Commission but is conferred on
all the institutions participating in the legislative procedure and their members.

86.      The relevant procedure in each case determines which assessment is decisive. In the present case the co-decision procedure
under Article 251 EC was applied. It embodies the principle of democracy which was expressly enshrined in Article 6(1) EU
as one of the foundations of the European Union. ([63](#Footnote63)) While the democratic decision-making process it provides for requires first a Commission proposal, for the adoption of Directive
2009/30 it required a qualified majority in the Council and the absolute majority of votes cast in the Parliament. Those
majorities clearly took a different view from the Commission. Such differences of opinion cannot, as such, be criticised by
the courts, as the institutional balance in the relevant legislative procedure would otherwise be called into question.

87.      It should also be pointed out that the rule eventually adopted is also based on the information on health risks already mentioned,
which the Commission expressly did not take into account in its assessment. Consideration of that additional risk gives rise
to an expectation of a different result from the original proposal.

88.      Thus, the fact that the rule differed from the Commission’s proposal does not point to the conclusion that the limits were
not the most moderate means.

d)      The reasonableness of the limits

89.      In connection with reasonableness it must be examined whether the disadvantages of the rule at issue were reasonable in relation
to the objectives pursued. Accordingly, the two aspects must be weighed up.

90.      In this case, protection of health and the environment, on the one hand, are pitted against economic interests in the use
of MMT, on the other. Clearly, the former, in principle, outweigh the latter.

91.      However, Afton disputes that the risks of the use of MMT outweigh the disadvantages of a restriction.

92.      In support of this view, Afton relies in particular on the fact that, during the legislative procedure, the Commission did
not consider the risks to be sufficient to restrict the use of MMT. However, as I have pointed out above, the position of
the Commission cannot bind the Council and the Parliament.

93.      Moreover, there is no compelling evidence that the assessment of the risks by the Parliament and the Council was manifestly
incorrect. Although it is true that there is to date relatively little scientific evidence of the assumed risks, Afton accepts
that, according to the studies available, the risks cannot be ruled out with certainty either.

The precautionary principle

94.      It is in precisely this situation that the precautionary principle applies. According to that principle, health and the environment
are not protected on the basis of a principle of protection from damage which is bound to occur. Rather, preventive measures
may be taken against risks whose extent is disputed. In this way, the legislature can give priority to the objective of protection
of health or the environment over restriction of other interests.

95.      It is for the legislature and not for the courts to weigh these considerations against one another. In particular, it can
decide to minimise the risks or exclude them altogether through restrictive measures. Otherwise it would have to accept that
the risks might materialise and the anticipated damage actually occur. Particularly in the case of precautions against risks
to human health, the legislature can generally hardly be accused of taking manifestly disproportionate measures.

The possibility of adapting the limits

96.      Account must be taken, in the course of weighing up these interests, of the fact that restrictive precautionary measures are
essentially of a provisional nature. They must be cancelled when new findings allay fears in that regard. ([64](#Footnote64)) In that way it is ensured, in accordance with the principle of proportionality, that the restrictions are not applied for
any longer than necessary. As the Commission points out, this at the same time creates an incentive, reflecting the ‘polluter
pays’ principle, for producers and users of such products to investigate their effects. To the extent that, on the other hand,
the legislature must prove risks in order to justify restrictions, there is an opposite incentive for these persons to prevent
the scientific investigation of such risks.

97.      Accordingly, the restrictions are imposed as a prohibition subject to prior authorisation. Article 8a(1) and (3) of Directive
98/70 expressly provides that the risks are to be investigated further and the limits revised by the Commission if necessary.
This is expressly mentioned in recital 35. If Afton succeeds in producing relevant scientific information the Commission would
be obliged to rethink the rules on MMT. ([65](#Footnote65))

98.      The foundations for such proof – if it is possible – are in the pipeline. At present health risks are examined by Afton in
collaboration with the US *Environmental Protection Agency*([66](#Footnote66)) and – as the Commission submits – also in the framework of the REACH Regulation. In addition, in accordance with Article
8a(1) of Directive 98/70, the Commission is to conduct an assessment of the risks for health and the environment from the
use of metallic additives in fuel and, for this purpose, develop a test methodology. It is to report its conclusions to the
European Parliament and to the Council by 31 December 2012.

The level at which limits are set and their effects on the use of MMT

99.      However, when weighing the objectives of the measure against its disadvantages, account must be taken of the effects of limits
on the use of MMT. They are inextricably linked to the level at which the limits are set.

100. Afton puts forward three, for the most part uncontested, arguments in that connection.

101. First, there is no specific scientific basis for setting an upper limit of 6 mg of Manganese per litre from 2011 and for reducing
that to 2 mg from 2014.

102. Second, when the limits are applied, MMT can no longer be used to protect against valve damage (so-called ‘valve seat recession’).
This affects certain older vehicles for which the fuels have to have certain additives in order to prevent valve damage. According
to Afton, when the limits are applied, the proportion of MMT in fuel is not sufficient to perform this function. Accordingly,
the limits have the same effect as a ban on the use of MMT for this purpose.

103. Afton implies that the limits for MMT prevent the use of such older vehicles. However, that argument is not persuasive as
there are other fuel additives which can also be used to replace lead. ([67](#Footnote67)) Thus, it is only Afton’s economic interest in the marketing of MMT which has to be taken into account in the weighing up
of interests.

104. Thirdly, according to Afton, MMT no longer has any practical effect at the level of 2 mg of manganese which will apply from
2014, so that this limit is tantamount to a full ban. This objection concerns MMT’s main function of raising the so-called
octane level of fuel. While a limit of 6 mg allows a perceptible rise, this is not possible at a level of 2 mg.

105. Afton’s position is based on a correct point of departure: the legislative decision on the reasonableness of a rule generally
requires that its disadvantages be weighed against its objectives. Accordingly, the legislature should examine the adverse
effects of the rules being considered. If a rule had consequences which were entirely overlooked in the legislative procedure,
the exercise of its legislative discretion could be defective.

106. In the legislative procedure there is in fact no evidence regarding the points at issue. The institutions did not even raise
these objections in the written procedure before the Court of Justice. Nevertheless, Afton’s submissions do not call into
question the reasonableness of the limits.

107. The absence of a scientific basis for the limits defines the level of knowledge of the risks: as it is unclear whether the
use of MMT causes damage at all, there is no scientific knowledge as to whether certain limits can prevent damage.

108. Afton’s arguments on this point are essentially to the effect that the risks of the use of MMT are unclear and the proposed
restrictions to a large extent preclude the use of MMT. These views shaped the legislative procedure – at least in so far
as it concerned the rules on MMT – and thus were clearly taken into account, because, since the first reading in Parliament
a full ban on MMT was on the agenda, which would have called for a similar balancing of interests.

109. Thus, it cannot be found that the legislature did not, or did not properly, exercise its discretion with regard to the reasonableness
of the limits.

110. Nor, for that matter, is the balancing of interests obviously defective in the light of the effects of limits. In view of
the uncertainty, in particular as regards health risks, even a full ban would be conceivable in principle. As the Commission
argues, the proposed limits, which are staggered over time, are a more moderate measure and are, therefore not manifestly
unreasonable.

e)      Interim conclusion

111. Examination of Article 8a(2) of Directive 98/70 has thus disclosed no breach of the principle of proportionality.

4.      The principle of equal treatment

112. According to settled case-law, the principle of equal treatment or non-discrimination requires that comparable situations
must not be treated differently and that different situations must not be treated in the same way unless such treatment is
objectively justified. ([68](#Footnote68)) Nevertheless, when considering the prohibition on discrimination, as in the case of the principle of proportionality, it
must be borne in mind that the Community legislature has a margin of manoeuvre (discretion). ([69](#Footnote69))

113. Afton argues that there is no justification for setting limits for MMT without restricting the use of other metallic additives.
MMT has a similar function to other metallic additives and does not entail any additional risks. There is even at least one
other manganese-based additive, cyclopentadienyl-manganese-tricarbonyl (CMT), whose use has not been restricted.

114. The Parliament rightly contends in response that the risks of MMT have been more fully researched than those of other metallic
additives. Different scientific information warrants different precautionary measures.

115. As regards other manganese-based additives in particular, the institutions argue, and are not opposed on this point, that
they are not used within the European Union. According to the Commission, the particular effect of this is that these additives
initially – before they are marketed – require registration under the REACH Regulation, which allows a risk assessment to
be made. For that reason there is no need at the moment to set limits for those additives.

116. Thus, no breach of the principle of equal treatment can be established.

5.      The principle of legal certainty

117. The general principle of legal certainty, which is a fundamental principle of Community law, requires, in particular, that
a rule should be clear and precise, so that individuals may ascertain unequivocally what their rights and obligations are
and may take steps accordingly. ([70](#Footnote70)) However, the principle of legal certainty does not require that a rule should exclude any doubt as to its interpretation.
Rather, the issue is whether the legal measure in question displays such ambiguity as to make it difficult for that Member
State to resolve with sufficient certainty any doubts as to the scope or meaning of the contested regulation. ([71](#Footnote71))

118. Afton takes the view that it is unclear whether the limits still apply after a test methodology has been developed, given
that the first sentence of Article 8a(2) of Directive 98/70 provides for the limitation of the MMT content to 6 mg of manganese
per litre from 1 January 2011, ‘pending the development of the test methodology’. Under the second sentence this limit is
reduced to 2 mg of manganese per litre from 1 January 2014.

119. It must be conceded that, as Afton points out, Article 8a(2) of Directive 98/70 could be misunderstood if its wording is considered
in isolation. However, if the provision is read in conjunction with recital 35 and Article 8a(1) and (3) it is clear that
the development of the test methodology alone cannot entail the disapplication of the limits. Rather, the first sentence of
Article 8a(3) states expressly that ‘[t]he limit for the MMT content of fuel specified in paragraph 2 shall be revised on
the basis of the results of the assessment carried out using the test methodology referred to in paragraph 1’.

120. Thus, no breach of the principle of legal certainty can be established.

C –    *The second question – Validity of the labelling requirement*

121. The second question concerns the legality of the requirement to label fuels containing MMT. More specifically, the question
is raised whether this rule is based on a manifest error of assessment or is in breach of the principle of proportionality.
As the arguments advanced in connection with an error of assessment concern the principle of proportionality, I will examine
them in this connection.

122. Under Article 8a(4) to (6), inserted in Directive 98/70 by Directive 2009/30, service stations must display a label containing
the words ‘contains metallic additives’ if they supply fuels containing such additives.

123. According to the last sentence of recital l35, the labelling requirement should avoid consumers unknowingly invalidating their
vehicles’ warranties. The use of such fuels may, according to the second sentence of that recital, invalidate vehicle warranties.
This is because of the risks for vehicle engines and emission control devices. The labelling requirement is thus intended
to serve the purpose of consumer protection, which, under Article 153 EC is an objective of the Union. That objective is to
be achieved in particular by promotion of the consumer’s right to information.

124. However, Afton questions whether labelling without reference to vehicle guarantees can achieve its objective. Consumers do
not generally read the vehicle guarantee so carefully that they are aware of the possible consequences of the use of fuels
with metallic additives.

125. These doubts are altogether understandable. The labelling requirement could have been drafted more clearly. Nevertheless,
that does not make it inappropriate for the protection of consumers.

126. Information about the content of products is a minimum requirement in order to enable consumers to avoid risk. At least those
consumers who are aware of the risks can take account of metallic additives when they buy fuel. They would not be able to
do so if the additives were not declared.

127. Afton does not consider the labelling requirement to be the most moderate means either. First, the Commission found this to
be the case in its impact assessment and, second, the limits for MMT ought to be sufficient.

128. The Commission’s assessment – as I said above – cannot bind the other institutions participating in the legislative procedure.
They may exercise their discretion regarding the effectiveness of the various legislative options in a different way from
the Commission.

129. The question whether the protection afforded by the limits is sufficient is expressly addressed in recital 35. The limits
are not intended to rule out any risk of the use of MMT but to limit possible damage for the time being. There is therefore,
in the view of the legislature, a residual risk, which is to be dealt with through the labelling requirement. Moreover, the
labelling requirement also applies to other metallic additives for which there are no limits.

130. Thus, no more moderate measure is called for.

131. Finally, Afton considers the labelling requirement to be unreasonable as it is tantamount to a ban on metallic additives.
Service stations would have to store and supply fuels containing metal additives separately. However, they would not support
such an expense.

132. It cannot be ruled out that this assessment is correct. However, it is not based directly on the labelling requirement but
on the unattractiveness of fuels with metallic additives in comparison with fuels without such additives. If the additives
were more attractive, service stations would either pay the additional expense or do without fuels without additives. Nevertheless,
it is in no case justifiable to expose the consumer without warning to the risk of forfeiting their manufacturer’s guarantee
simply in order to allow the continued sale of a product entailing risks.

V –  **Conclusion**

133. Therefore, I propose that the Court of Justice should answer the questions referred for a preliminary ruling as follows:

Examination of the questions referred has disclosed nothing which could call into question the validity of Article 1(8) of
Directive 2009/30/EC of the European Parliament and of the Council of 23 April 2009 amending Directive 98/70/EC as regards
the specification of petrol, diesel and gas-oil and introducing a mechanism to monitor and reduce greenhouse gas emissions
and amending Council Directive 1999/32/EC as regards the specification of fuel used by inland waterway vessels and repealing
Directive 93/12/EEC.

---

[1](#Footref1) – Original language: German.

---

[2](#Footref2) – Directive of the European Parliament and of the Council of 23 April 2009 amending Directive 98/70/EC as regards the specification
of petrol, diesel and gas-oil and introducing a mechanism to monitor and reduce greenhouse gas emissions and amending Council
Directive 1999/32/EC as regards the specification of fuel used by inland waterway vessels and repealing Directive 93/12/EEC
(OJ 2009 L 140, p. 88).

---

[3](#Footref3) – OJ 1998 L 350, p. 58.

---

[4](#Footref4) – Witness Statement of Stanley Charles King, point 9.

---

[5](#Footref5) – Case C‑355/97 *Beck and Bergdorf* [1999] ECR I‑4977, paragraph 22; Case C‑333/07 *Regie Networks* [2008] ECR I‑10807, paragraph 46; and Case C‑478/07 *Budejovicky Budvar* [2009] ECR I-0000, paragraph 63.

---

[6](#Footref6) – Case C‑491/01 *British American Tobacco (Investments) and Imperial Tobacco* [2002] ECR I‑11453, paragraph 34, and Case C‑308/06 *Intertanko and Others* [2008] ECR I‑4057, paragraph 31.

---

[7](#Footref7) – Joined Cases C-295/04 to C-298/04 *Manfredi and Others* [2006] ECR I-6619, paragraph 27.

---

[8](#Footref8) – See, inter alia, Case C-415/93 *Bosman* [1995] ECR I-4921, paragraph 61, and Case C-344/04 *IATA and ELFAA* [2006] ECR I‑403, paragraph 24.

---

[9](#Footref9) – See *Bosman*, paragraph 59, and *IATA and ELFAA*, paragraph 24, cited in footnote 8.

---

[10](#Footref10) – *IATA and ELFAA*, cited in footnote 8, paragraph 24.

---

[11](#Footref11) – Case 101/78 *Granaria* [1979] ECR 623, paragraph 4; Case C‑137/92 P *Commission* v *BASF and Others* [1994] I‑2555, paragraph 48; Case C‑475/01 *Commission* v *Greece* [2004] ECR I‑8923, paragraph 18; and Case C‑199/06 *Centre d’exportation du livre français* [2008] ECR I‑469, paragraph 59.

---

[12](#Footref12) – See Case C‑412/93 *Leclerc-Siplec* [1995] ECR I‑179, paragraph 14.

---

[13](#Footref13) – Case C‑188/92 *TWD Textilwerke Deggendorf* [1994] ECR I‑833, paragraphs 13, 17 and 24; Case C‑239/99 *Nachi Europe* [2001] ECR I‑1197, paragraph 37; and Case C‑343/07 *Bavaria and Bavaria Italia* [2009] ECR I-0000, paragraph 39. However, see also the criticism of that case-law in the Opinion of Advocate General Ruiz-Jarabo
Colomer in Joined Cases C‑346/03 and C‑529/03 *Atzeni and Others* [2006] ECR I‑1875, point 88.

---

[14](#Footref14) – See Case C‑309/89 *Codorníu* v *Council* [1994] ECR I‑1853, paragraph 21.

---

[15](#Footref15) – See, as regards being directly concerned by provisions of a directive, Case C‑125/06 P *Commission* v *Infront WM* [2008] ECR I‑1451, paragraphs 37 and 59 et seq.

---

[16](#Footref16) – See my opinion of 26 October 2006 in Case C‑441/05 *Roquette Frères* [2007] ECR I‑1993, point 33 et seq. and cases cited therein.

---

[17](#Footref17) – See *TWD Textilwerke Deggendorf*, cited in footnote 13, paragraph 17 et seq.

---

[18](#Footref18) – See, to that effect, Case C‑331/88 *Fedesa and Others* [1990] ECR I‑4023, paragraph 14; Case C‑157/96 *National Farmers’ Union and Others* [1998] ECR I‑2211, paragraph 61; and Case C‑558/07 *S.P.C.M. and Others* [2009] ECR I-0000, paragraph 42.

---

[19](#Footref19) – See, as regards staff case-law, Case 46/72 *De Greef* v *Commission* [1973] ECR 543, paragraph 46, Case 121/76 *Moli* v *Commission* [1977] ECR 1971, paragraph 23 et seq., and Case C‑298/93 P *Klinke* v *Court of Justice* [1994] ECR I‑3009, paragraph 31, and, as regards competition cases, Joined Cases C‑204/00 P, C‑205/00 P, C‑211/00 P, C‑213/00 P,
C‑217/00 P and C‑219/00 P *Aalborg Portland and Others* v *Commission* [2004] ECR I‑123, paragraph 105, and Case C‑431/07 P *Bouygues and Bouygues Télécom* v *Commission* [2009] ECR I-0000, paragraph 76. As regards legislation, see the opinions of Advocate General Léger in Case C‑66/00 *Bigi* [2002] ECR I‑5917, point 40, and in Case C‑257/01 *Commission* v *Council* [2005] ECR I‑345, footnote 43, of Advocate General Ruiz-Jarabo Colomer in Joined Cases C‑465/02 and C‑466/02 *Germany and Denmark* v *Commission* [2005] ECR I‑9115, point 137, of Advocate General Tizzano in Case C‑12/03 P *Commission* v *Tetra Laval* [2005] ECR I‑987, point 86, of Advocate General Trstenjak in Case C‑101/08 *Audiolux and Others* [2009] ECR I-0000, point 107, and my opinion in *S.P.C.M. and Others*, cited in footnote 18, point 76.

---

[20](#Footref20) – See *Bavaria and Bavaria Italia*, cited in footnote 13, paragraph 81.

---

[21](#Footref21) – Case C‑269/90 *Technische Universität München* [1991] ECR I‑5469, paragraph 14, Case C‑405/07 P *Netherlands* v *Commission* [2008] ECR I‑8301, paragraph 56, and Case C‑425/08 *Enviro Tech (Europe)* [2009] ECR I-0000, paragraph 62.

---

[22](#Footref22) – Case C‑12/03 P *Commission* v *Tetra Laval* [2005] ECR I‑987, paragraph 39; Case C‑326/05 P *Industrias Químicas del Vallés* v *Commission* [2007] ECR I‑6557, paragraph 76; Case C‑525/04 P *Spain* v *Lenzing* [2007] ECR I‑9947, paragraph 57; and *Netherlands* v *Commission*, cited in footnote 21, paragraph 55.

---

[23](#Footref23) – See, as regards the first indent of Article 174(3) EC, Case C‑341/95 *Bettati* [1998] ECR I‑4355, paragraph 49, and *Netherlands* v *Commission*, cited in footnote 21, paragraph 61.

---

[24](#Footref24) – Case 138/79 *Roquette Frères* v *Council* [1980] ECR 3333, paragraph 25; Case C‑310/04 *Spain* v *Council* [2006] ECR I‑7285, paragraph 121; *Industrias Químicas del Vallés* v *Commission*, cited in footnote 22, paragraph 77; and *Enviro Tech (Europe)*, cited in footnote 21, paragraph 62.

---

[25](#Footref25) – *Spain* v *Council*, cited in footnote 24, paragraph 122.

---

[26](#Footref26) – Joined Cases C‑27/00 and C‑122/00 *Omega Air and Others* [2002] ECR I‑2569, paragraph 47.

---

[27](#Footref27) – See, in particular, the recitals 1 and 11 in the preamble to the Proposal for a Directive of the European Parliament and
of the Council amending Directive 98/70/EC as regards the specification of petrol, diesel and gas-oil and introducing a mechanism
to monitor and the introduction of a mechanism to monitor and reduce greenhouse gas emissions from the use of road transport
fuels and amending Council Directive 1999/32/EC, as regards the specification of fuel used by inland waterway vessels and
repealing Directive 93/12/EEC (COM(2007) 18 final) pp. 14 and 16.

---

[28](#Footref28) – See the impact assessment of Proposal SEC(2007) 55 final/2 (point 4.12.1, p. 69), available as Council document 6145/1/07
REV 1 ADD 1.

---

[29](#Footref29) – Directive 2003/17/EC of the European Parliament and of the Council of 3 March 2003 amending Directive 98/70/EC relating
to the quality of petrol and diesel fuels (OJ 2003 L 76, p. 10).

---

[30](#Footref30) – Full title: 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 et seq.).

---

[31](#Footref31) – See the impact assessment cited in footnote 28.

---

[32](#Footref32) – See *Commission* v *Spain*, cited in footnote 24, paragraph 123.

---

[33](#Footref33) – Regulation of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament,
Council and Commission documents (OJ 2001 L 145, p. 43).

---

[34](#Footref34) – Article 4 of the Statute for Members of the European Parliament (OJ 2005 L 262, p. 1), according to which documents and
electronic records which a Member has received, drafted or sent are not to be treated as Parliament documents unless they
have been tabled in accordance with the Rules of Procedure, was not applicable at the material time. There is no need to decide
in the present case whether Article 15 TFEU and Article 42 of the Charter of Fundamental Rights of the European Union allow
such documents to be excluded from the right of access in the future.

---

[35](#Footref35) – Annex 15 to the Witness Statement of Peter Sellar.

---

[36](#Footref36) – Case C‑192/01 *Commission* v *Denmark* [2003] ECR I‑9693, paragraph 52; Case C‑219/07 *Nationale Raad van Dierenkwekers en Liefhebbers und Andibel* [2008] ECR I‑4475, paragraph 38; judgment of 10 September 2009 in Case C‑100/08 *Commission* v *Belgium*, not published in the ECR, paragraph 102; and Case C‑333/08 *Commission* v *France* [2010] ECR I-0000, paragraph 93.

---

[37](#Footref37) – Joined Cases T‑74/00, T‑76/00, T‑83/00 to T‑85/00, T‑132/00, T‑137/00 and T‑141/00 *Artegodan* v *Commission* [2002] ECR II‑4945, paragraph 192; Case T‑13/99 *Pfizer Animal Health* v *Council* [2002] ECR II‑3305 , paragraphs 142 to 145, 152 and 162; and Case T‑70/99 *Alpharma* v *Council* [2002] ECR II‑3495, paragraphs 155 to 157, 171 and 175.

---

[38](#Footref38) – *National Farmers’ Union and Others*, cited in footnote 18, paragraph 63 et seq.; Case C‑504/04 *Agrarproduktion Staebelow* [2006] ECR I‑679, paragraph 39; and *Commission* v *France*, cited in footnote 36, paragraph 91.

---

[39](#Footref39) – Case 25/70 *Köster, Berodt & Co*. [1970] ECR 1161, paragraph 21 et seq.; Case 137/85 *Maizena and Others* [1987] ECR 4587, paragraph 15; *Fedesa and Others*, cited in footnote 18, paragraph 13; *National Farmers’ Union and Others*, cited in footnote 18, paragraph 60; *IATA and ELFAA*, cited in footnote 8, paragraph 79; *Spain* v *Council*, cited in footnote 24, paragraph 97; and Joined Cases C‑37/06 and C‑58/06 *Viamex Agrar Handel* [2008] ECR I-69, paragraph 33.

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[40](#Footref40) – See, to that effect, *Köster, Berodt & Co.*, cited in footnote 39, paragraphs 28 and 32; Case 265/87 *Schräder HS Kraftfutter* [1989] ECR 2237, paragraph 21; *Fedesa**and Others*, cited in footnote 18, paragraph 13; *National Farmers’ Union and Others*, cited in footnote 18, paragraph 60; Case C‑189/01 *Jippes and Others* [2001] ECR I‑5689, paragraph 81; *Viamex Agrar Handel*, cited in footnote 39, paragraph 35; and Joined Cases C‑379/08 and C‑380/08 *ERG and Others* [2010] ECR I-0000, paragraph 86.

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[41](#Footref41) – See above, point 28 et seq.

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[42](#Footref42) – See references in footnote 18.

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[43](#Footref43) – See the assessment in *S.P.C.M. and Others*, cited in footnote 18, paragraph 59 et seq.

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[44](#Footref44) – See, as regards this formulation in general, my opinion in *S.P.C.M. and Others*, cited in footnote 19, points 73 et seq. and cases cited therein.

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[45](#Footref45) – See the assessment in *S.P.C.M. and Others*, cited in footnote 18, paragraph 44 et seq.

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[46](#Footref46) – See the justification given for the 30th amendment proposed by Parliament, imposing a full ban on MMT (Parliament document
A6-0496/2007, p. 23).

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[47](#Footref47) – See the references in footnote 38.

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[48](#Footref48) – See, for example, Case C‑236/01 *Monsanto Agricoltura Italia and Others* [2003] ECR I‑8105, paragraph 107; *Commission* v *Denmark*, cited in footnote 36, paragraph 51; and *Commission* v *France*, cited in footnote 36, paragraph 92 et seq.

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[49](#Footref49) – See *Monsanto Agricoltura Italia and Others*, cited in footnote 48, paragraph 106; Case C‑95/01 *Greenham and Abel* [2004] ECR I‑1333, paragraph 43; Case C‑41/02 *Commission* v *Netherlands* [2004] ECR I‑11375, paragraph 52; and *Commission* v *France*, cited in footnote 36, paragraph 91. See also the judgment of the EFTA Court of 5 April 2001 in Case E-3/00 *EFTA-Supervisory Authority* v *Norway*, EFTA Court Reports 2000-2001, p. 73, paragraphs 36 to 38.

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[50](#Footref50) – See references in footnote 37.

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[51](#Footref51) – See Article 11 of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ 1970 L 270,
p. 1), as amended by Commission Directive 98/19/EC of 18 March 1998 amending Council Directive 70/524/EEC concerning additives
in feedingstuffs (OJ 1998 L 96, p. 39), which was the basis for the regulation contested in *Pfizer Animal Health* v *Council* and *Alpharma* v *Council* (both cited in footnote 37). *Artegodan* v *Commission* (also cited in footnote 37) concerned a decision under Article 15a of Second Council Directive 75/319/EEC of 20 May 1975
on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal
products (OJ 1975 L 147, p. 13), as amended by Council Directive 93/39/EEC of 14 June 1993 (OJ 1993 L 214, p. 22).

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[52](#Footref52) – Directive of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member
States relating to food supplements (OJ 2002 L 183, p. 51).

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[53](#Footref53) – Joined Cases C‑154/04 and C‑155/04 *Alliance for Natural Health and Others* [2005] ECR I‑6451, paragraph 68.

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[54](#Footref54) – Case C‑127/02 *Waddenvereniging and Vogelbeschermingsvereniging* [2004] ECR I‑7405, paragraph 59.

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[55](#Footref55) – Case C‑304/05 *Commission* v *Italy* [2007] ECR I‑7495, paragraph 83.

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[56](#Footref56) – Cited in footnote 30.

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[57](#Footref57) – See *S.P.C.M. and Others*, cited in footnote 18, paragraph 54.

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[58](#Footref58) – See Article 5 of the REACH Regulation.

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[59](#Footref59) – *S.P.C.M. and Others*, cited in footnote 18.

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[60](#Footref60) – Case C‑120/97 *Upjohn* [1999] ECR I‑223, paragraph 33 et seq., and Joined Cases C‑211/03, C‑299/03 and C‑316/03 to C‑318/03 *HLH Warenvertrieb and Orthica* [2005] ECR I‑5141, paragraph 79. See also, regarding the polluter pays principle, Case C‑254/08 *Futura Immobiliare and Others* [2009] ECR I-0000, paragraph 55, and Case C‑378/08 *ERG and Others* [2010] ECR I-0000, paragraphs 55 and 65.

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[61](#Footref61) – Kokott, J., ‘Die Durchsetzung der Normenhierarchie im Gemeinschaftsrecht’, in: Müller, G. et al.: *Festschrift für Günter Hirsch zum 65. Geburtstag*, C. H. Beck, 2008, p. 117, 124 et seq.

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[62](#Footref62) – Cited in footnote 28, point 4.12.4, p. 73.

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[63](#Footref63) – Case C‑518/07 *Commission* v *Germany* [2010] ECR I-0000, paragraph 41.

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[64](#Footref64) – *Alliance for Natural Health and Others*, cited in footnote 53, paragraph 68, and *Agrarproduktion Staebelow*, cited in footnote 38, paragraph 40, stress the need to adapt limits in the light of new findings.

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[65](#Footref65) – See *Alliance for Natural Health and Others*, cited in footnote 53, paragraph 68 et seq.

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[66](#Footref66) – Document number EPA-HQ-OAR-2004-0074, the documents submitted to date can be found at http://www.regulations.gov/search/Regs/home.html#searchResults?Ne=11+8+8053+8098+8074+8066+8084+1&Ntt=EPA-HQ-OAR-2004-0074&Ntk=All&Ntx=mode+matchall&N=0.

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[67](#Footref67) – See description of the patent WO/2001/016257, http://www.wipo.int/pctdb/en/wo.jsp?amp%3BDISPLAY=DESC&%3BWO=2001%2F16257&IA=GB2000002626&DISPLAY=DESC.

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[68](#Footref68) – *IATA and ELFAA*, cited in footnote 8, paragraph 95, and *S.P.C.M. and Others*, cited in footnote 18, paragraph 74.

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[69](#Footref69) – Case C‑292/97 *Karlsson and Others* [2000] ECR I‑2737, paragraphs 35 and 49, Case C‑227/04 P *Lindorfer* v *Council* [2007] ECR I‑6767, paragraph 78, and Case C‑127/07 *Arcelor Atlantique and Lorraine and Others* [2008] ECR I‑9895, paragraph 57.

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[70](#Footref70) – *IATA and ELFAA*, cited in footnote 8, paragraph 68, and *Intertanko and Others*, cited in footnote 6, paragraph 69.

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[71](#Footref71) – Case C‑110/03 *Belgium* v *Commission* [2005] ECR I‑2801, paragraph 31.

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