CELEX: 62001CJ0429
Failure of a Member State to fulfil obligations
Failure to transpose Directive 90/219/EEC
Genetically modified organisms
Contained use

By application lodged at the Registry of the Court on 5 November 2001, the Commission of the European Communities brought
an action under Article 226 EC for a declaration that, by failing to transpose correctly and in full Articles 14(a) and (b),
15(1) and (2), 16(1) and 19(2) to (4) of Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically
modified micro-organisms (OJ 1990 L 117, p. 1), as amended by Commission Directive 94/51/EC of 7 November 1994 adapting to
technical progress Directive 90/219 (OJ 1994 L 297, p. 29), (
the Directive) and by failing to transpose the provisions of that directive in respect of certain contained use by the Ministry of Defence,
the French Republic has failed to fulfil its obligations under that directive and Article 249 EC.
Legal background
Community legislation
The Directive lays down rules on the contained use of genetically modified micro-organisms (
GMMs).
Contained use is defined in Article 2(c) of the Directive as
any operation in which micro-organisms are genetically modified or in which such [GMMs] are cultured, stored, used, transported,
destroyed or disposed of and for which physical barriers, or a combination of physical barriers together with chemical and/or
biological barriers, are used to limit their contact with the general population and the environment.
Its purpose being to protect human health and the environment, the Directive, inter alia, classifies GMMs and lays down the
principles of occupational safety and hygiene and of containment applicable to them.
Article 4 of the Directive thus classifies GMMs in two groups according to the risks which they present. The first group (
Group I) covers those GMMs which satisfy the criteria of Annex II to the Directive. Other GMMs are classed under the second group
(
Group II).
Moreover, in Article 2(d) and (e) of the Directive, a distinction is drawn according to the purpose for which the GMMs are
used. Thus,
Type A operations are those operations which are used for teaching, research, development, or non-industrial or non-commercial purposes
and which are of a small scale. Other operations are called
Type B.
The Directive lays down specific notification procedures for each group of GMMs (Group I or II) and type of operation (Type
A or B). It further distinguishes between two bodies of rules: the rules on authorisation, applicable to high-risk operations
which may not be carried out until they have been authorised by the national competent authority, and the rules on declaration,
which apply to operations presenting less serious risks. The Directive specifies,
inter alia
, the required content of the notification file, the procedure which must be followed in the cases of authorisation or declaration
and the duties to provide information which are incumbent on the Commission and the other Member States.
Article 14 of the Directive provides: The competent authorities shall ensure that, where necessary, before an operation commences:
(a)
an emergency plan is drawn up for the protection of human health and the environment outside the installation in the event
of an accident and the emergency services are aware of the hazards and informed thereof in writing;
(b)
information on safety measures and on the correct behaviour to adopt in the case of an accident is supplied in an appropriate
manner, and without their having to request it, to persons liable to be affected by the accident. The information shall be
repeated and updated at appropriate intervals. It shall also be made publicly available. The Member States concerned shall at the same time make available to other Member States concerned, as a basis for all necessary
consultation within the framework of their bilateral relations, the same information as that which is disseminated to their
nationals.
The Directive was amended by Council Directive 98/81/EC of 26 October 1998 (OJ 1998 L 330, p. 13). Under the amended version
of Article 14 of the Directive: The competent authorities shall ensure that before a contained use commences:
(a)
an emergency plan is drawn up for contained uses where failure of the containment measures could lead to serious danger, whether
immediate or delayed, to humans outside the premises and/or to the environment, except where such an emergency plan has been
drawn up under other Community legislation;
(b)
information on such emergency plans, including the relevant safety measures to be applied, is supplied in an appropriate manner,
and without their having to request it, to bodies and authorities liable to be affected by the accident. The information shall
be updated at appropriate intervals. It shall also be made publicly available.
The Member States concerned shall at the same time make available to other Member States concerned, as a basis for all necessary
consultation within the framework of their bilateral relations, the same information as that which is disseminated to their
nationals.
According to Article 15 of the Directive:
1.
Member States shall take the necessary measures to ensure that, in the event of an accident, the user shall be required immediately
to inform the competent authority specified in Article 11 and provide the following information:
─
the circumstances of the accident,
─
the identity and quantities of the genetically modified micro-organisms released,
─
any information necessary to assess the effects of the accident on the health of the general population and the environment,
─
the emergency measures taken.
2.
Where information is given under paragraph 1, the Member States shall be required to:
─
ensure that any emergency, medium and long-term measures necessary are taken, and immediately alert any Member State which
could be affected by the accident;
─
collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations
to avoid similar accidents in the future and to limit the effects thereof.
Article 16(1) of the Directive provides:
1.
Member States shall be required to:
(a)
consult with other Member States liable to be affected in the event of an accident in the drawing up and implementation of
emergency plans;
(b)
inform the Commission as soon as possible of any accident within the scope of this Directive, giving details of the circumstances
of the accident, the identity and quantities of the genetically modified micro-organisms released, the emergency response
measures employed and their effectiveness, and an analysis of the accident including recommendations to limit its effects
and avoid similar accidents in the future.
Under Article 19 of the Directive:
1.
The Commission and the competent authorities shall not divulge to third parties any confidential information notified or otherwise
provided under this Directive and shall protect intellectual property rights relating to the data received.
2.
The notifier may indicate the information in the notifications submitted under this Directive, the disclosure of which might
harm his competitive position, that should be treated as confidential. Verifiable justification must be given in such cases.
3.
The competent authority shall decide, after consultation with the notifier, which information will be kept confidential and
shall inform the notifier of its decision.
4.
In no case may the following information, when submitted according to Articles 8, 9 or 10, be kept confidential:
─
description of the genetically modified micro-organisms, name and address of the notifier, purpose of the contained use, and
location of use;
─
methods and plans for monitoring of the genetically modified micro-organisms and for emergency response;
─
the evaluation of foreseeable effects, in particular any pathogenic and/or ecologically disruptive effects.
5.
If, for whatever reasons, the notifier withdraws the notification, the competent authority must respect the confidentiality
of the information supplied.
Article 22 of the Directive provides that the Member States are to bring into force the laws, regulations and administrative
provisions necessary to comply with that directive not later than 23 October 1991. The amendments resulting from Directive
94/51 concern only Annex II to Directive 90/219 and must have taken effect in national law by 30 April 1995. Directive 98/81
entered into force on 5 December 1998. The period granted to the Member States for compliance with that directive expired,
in accordance with the first subparagraph of Article 2(1), 18 months after the date of its entry into force, namely on 5 June
2000.
National legislation
Article L. 511-1 of the Code de l'environnement (Environment Code) (JORF of 21 September 2000, Annex p. 38203) states: The provisions of this Title shall apply to factories, workshops, storage facilities, construction sites and, generally, facilities
used or owned by any natural or legal person, whether governed by public or private law, which may constitute a risk to or
have an adverse effect on local amenity, public health, safety and hygiene, agriculture, the protection of nature and the
environment or the conservation of sites and monuments ....
The first paragraph of Article L. 512-1 of the Environment Code states: Facilities which constitute a serious risk to or have a seriously adverse effect on the interests referred to in Article L.
511-1 shall be subject to authorisation by the Prefect.
Under Article L. 512-8 of that code: Facilities which do not constitute a serious risk to or have a seriously adverse effect on the interests referred to in Article
L. 511-1 but which nevertheless must comply with the general requirements laid down by the Prefect in order to ensure that
the interests referred to in Article L. 511-1 are protected in the
département
shall be subject to declaration.
Article L. 512-12 of the Environment Code provides: Where the interests referred to in Article L. 511-1 are not guaranteed by implementation of the general provisions on the
prevention of adverse effects inherent in the use of a facility subject to declaration, the Prefect may, where appropriate
upon application by interested third parties and following delivery of an opinion by the competent consultative committee
for the
département
, impose any necessary specific requirements by way of decree.In order to protect the interests referred to in Article L. 511-1, the Prefect may order that the assessments be carried out
and remedies applied which are necessary as a result either of an accident or incident in the facility or of a failure to
comply with the conditions imposed under this Chapter. Those measures shall be laid down in a decree adopted, save in the
case of an emergency, after an opinion has been delivered by the competent consultative committee for the
département
.
Under Article 17 of Décret  n
o
77-1133, du 21 septembre 1977, pris pour l'application de la loi n
o
76-663 relative aux facilities classées pour la protection de l'environnement of 19 July 1976 (JORF of 8 October 1977, p.
4897, Decree No 77-1133 of 21 September 1977 adopted to apply the Law on facilities classified for the purpose of environmental
protection), as amended by Decree No 2000-258 of 20 March 2000 (JORF of 22 March 2000, p. 4417), (
Decree No 77-1133): The conditions of development and use must satisfy the requirements imposed in the authorisation order and, where appropriate,
any ancillary orders....Following consultation of the fire and emergency services responsible for the
département
, provision may be made in the order for an obligation to draw up an internal plan of action to be taken in the case of an
accident. The internal plan of action shall lay down the organisational measures, the methods of intervention and the necessary
means which the operator must implement in order to protect his staff, the public and the environment....The order shall also lay down the emergency measures to be taken by the operator under the supervision of the police authority
and the obligations of the operator with respect to informing and alerting the persons liable to be affected by an accident
as to the risks involved, the safety measures to be taken and the course of conduct to be followed.
Article 2 of Decree No 77-1133 specifies the required content of the application for authorisation. Point 4 of the second
paragraph of that article states: ... Where appropriate, the applicant may submit, in a single copy and under separate cover, information the dissemination
of which, in his view, may entail the disclosure of production secrets....
Article 5 of that decree provides for a public inquiry procedure. The last paragraph of that article states: At the request of the applicant, or on his own initiative, the Prefect may remove from the file submitted for the purposes
of the inquiry and of the consultation provided for below any information which may entail, in particular, the disclosure
of production secrets or facilitate measures which might adversely affect public health, safety and hygiene.
Article 27 of Decree No 77-1133 provides: The Prefect shall acknowledge the declaration and provide the person making the declaration with a copy of the general requirements
applying to the facility.The mayor of the local authority area in which the facility is to be used (in Paris, the Chief of Police) shall receive a
copy of the declaration and the document containing the general requirements. A copy of the notification shall be posted for
at least one month in the town hall (in Paris, the police headquarters) and shall state that third parties may have access
to the document containing the general requirements there. The mayor (in Paris, the Chief of Police) shall arrange for minutes
to be drawn up to record the fulfilment of this formality.At the operator's request, certain provisions may be excluded from such publication where it might lead to the disclosure
of production secrets.
Décret n
o
93-774, du 27 mars 1993, fixant la liste des techniques de modification génétique et les critères de classement des organismes
génétiquement modifiés (Decree No 93-774 of 27 March 1993 laying down the list of genetic modification techniques and the
criteria for classifying genetically modified organisms) (JORF of 30 March 1993, p. 5714) reproduces the classification in
two groups (Groups I and II) established by the Directive. In addition, Article 3 of that decree breaks GMMs down into four
classes (Classes 1 to 4) on the basis of the classification criteria in Annex II to Directive 90/219. The French Genetic Engineering
Commission has classified the use of GMOs and GMMs in research, development and teaching laboratories according to the required
level of containment. It has thus defined four containment levels, L1 to L4, entailing an increasing level of safety restrictions.
The second paragraph of Article 2 of Décret n
o
93-773, du 27 mars 1993, pris pour l'application, s'agissant des utilisations civiles, de l'article 6 de la loi n
o
92-654, du 13 juillet 1992, relative au contrôle de l'utilisation et de la dissemination des organismes génétiquement modifiés
et modifiant la loi n
o
76-663 (Decree No 93-773 of 27 March 1993 applying Article 6 of Law No 92-654 of 13 July 1992 on supervision of the use and
dissemination of genetically modified organisms to civilian uses and amending Law No 76-663) (JORF of 30 March 1993, p. 5712)
provides, in the last sentence, that the applicant is to indicate in the application for approval the information which, in
his view, must remain confidential.
Part I of Article 7 of that decree provides: Where the application relates to first use in a laboratory of genetically modified organisms falling within Classes 3 and
4 of Group II ... the approval shall refer to that fact and state that the applicant is to make an information file available
to the public....That file shall contain, to the exclusion of any information covered by industrial or trade secrets, protected by law or disclosure
of which could prejudice the interests of the laboratory operator or any other persons making using of the genetically modified
organisms:
─
...
─
any information relevant to the classification of the genetically modified organisms which may be used in the facility and
to the confinement measures, the action to be taken in the case of an accident and the technical specifications to which approval
is made subject;
─
where appropriate, the summary of the opinion given on the application for approval by the Genetic Engineering Commission;
....
The pre-litigation procedure
The French Government notified the Commission of the measures transposing the Directive in various letters sent between March
1992 and June 1998.
On 18 March 1998, the Commission addressed to the French Republic a letter giving that Member State notice to submit its observations
on the complaint that the Directive had not been transposed correctly and in full.
Taking the view that the replies given by the French authorities were unsatisfactory, the Commission delivered to the French
Republic a reasoned opinion by letter of 19 May 2000. In that opinion, the Commission called upon that Member State to take
the measures necessary to comply with the reasoned opinion within two months of its notification.
The French Government subsequently addressed to the Commission, on 21 and 28 July 2000, two notes concerning the transposition
of the Directive.
The procedure before the Court
Having withdrawn, in its reply, the complaint alleging incomplete transposition of Article 15(1) of the Directive, the Commission
now claims that the Court should:
─
declare that, by failing to transpose correctly and in full Articles 14(a) and (b), 15(2), 16(1) and 19(2) to (4) of the Directive
and by failing to transpose the provisions of that directive in respect of certain contained use by the Ministry of Defence,
the French Republic has failed to fulfil its obligations under that directive and Article 249 EC,
─
order the French Republic to pay the costs.
The French Republic contends that the Court should:
─
dismiss the application, with the exception of the complaint alleging failure to transpose the Directive in respect of certain
facilities falling under the jurisdiction of the Ministry of Defence, and
─
order the Commission to pay the costs.
The action
The complaint relating to Article 14(a) of the Directive
Arguments of the parties
According to the Commission, Article 14 of the Directive is broad in scope since it applies to any use of GMMs. However, that
article has not been transposed with respect to:
─
uses of GMMs in Groups I or II for the purposes of teaching, research or development;
─
uses for industrial or commercial purposes by facilities other than those subject to authorisation, that is to say, those
which must be declared.
The Directive requires that an emergency plan be drawn up and that the emergency services be informed
where necessary, which suggests an assessment on a case-by-case basis. The Directive cannot be transposed correctly where the obligation
to adopt those measures is simply excluded in respect of certain uses or types of facility.
The French Government submits, first of all, that it is unclear from the wording of Article 14(a) of the Directive whether
there is an obligation to draw up emergency plans as a matter of course. Article 14(a) merely provides that the competent
authorities of a Member State are to require that an emergency plan be drawn up
where necessary. That phrase suggests that emergency plans are not drawn up automatically. To accept an interpretation precluding a distinction
from being drawn according to the risk posed by the facility would simply mean that the definition of the scope of the obligation
provided by the phrase
where necessary would be removed. The wording of Article 14 of the Directive as amended by Directive 98/81 confirms that the competent authorities
are under an obligation solely to determine whether an emergency plan is necessary and, if so, to ensure that such a plan
is drawn up.
As regards uses for industrial or commercial purposes by facilities which have been classified for the purposes of environmental
protection and are subject to authorisation, the French Government relies on Article 17 of Decree No 77-1133, which provides
that the authorisation order may impose an obligation to draw up an internal plan of action (IPA) to be taken in the case
of an accident.
With respect to facilities classed as subject to declaration, the French Government submits that prefects must lay down general
requirements for all the categories of such facility in their
département
. The obligation to draw up an emergency plan is one of the measures which may be imposed in that connection. The French Government
adds that, where the general requirements applicable to a category of facility do not provide for an obligation to draw up
such a plan even though it is necessary in respect of a particular facility falling within that category, the Prefect may,
under Article L. 512-12 of the Environment Code, adopt the necessary measures in the form of specific requirements.
According to the French Government, it makes no difference that the fact that an obligation to draw up an emergency plan may
be imposed is explicitly stated with regard to facilities subject to authorisation whereas it is in the competent authority's
discretion to lay down general or specific requirements for facilities subject to declaration. Since the risks posed by the
latter facilities are less serious, the possibility of imposing an obligation to draw up an emergency plan need not be provided
for expressly.
The competent administrative authority is therefore in a position to impose on the operator of any facility subject to the
scheme of classified facilities an obligation to draw up an emergency plan. The French Government concludes that, where it
is necessary that such a plan be drawn up for a particular facility, the administrative authority will be obliged to impose
such a requirement.
The French Government adds that teaching and research facilities are subject to a similar obligation. Such facilities may
operate only by virtue of approval granted on a case-by-case basis. That approval entails an obligation to comply with various
requirements, for example those contained in the guide issued by the Genetic Engineering Commission but also those laid down
in the joint orders of the Minister for the Environment and the Minister for Research.
Although that guide is not, in itself, legally binding, approvals impose on operators of teaching or research facilities an
obligation to comply with the requirements laid down in it. Accordingly, an obligation to draw up an emergency plan is imposed
on all research and teaching facilities which must comply with containment level L3 or L4. As regards those research or teaching
facilities which must comply with containment level L1 or L2, the French Government maintains that, since those levels reflect
the lesser seriousness of the risk posed, the obligation to draw up an emergency plan cannot be automatic. Such an obligation
may be imposed, if it appears necessary, on those facilities by way of specific requirements included in the approval decision.
Findings of the Court
As the Court has consistently held (see, in particular, Case C-360/87
Commission
v
Italy
[1991] ECR I-791, paragraph 13), Member States must, in order to secure the full implementation of directives in law and
not only in fact, establish a specific legal framework in the area in question.
It is clear from the wording of Article 14(a) of the Directive that, before an operation covered by it commences, the competent
authorities are to ensure that, where necessary, an emergency plan is drawn up. The Community legislature did not exclude
generally certain types of facility from the obligation to draw up such a plan. It follows that the competent authorities
must assess, on a case-by-case basis and in the light of the risks posed, whether it is necessary for an emergency plan to
be drawn up. Effective transposition of Article 14(a) requires that the national rules impose on those authorities a specific
obligation to carry out such an assessment where, with regard to certain types of facility, there is no requirement that an
emergency plan be drawn up as a matter of course.
The French legislation does not satisfy that requirement.
It is true that, with respect to facilities classed as subject to declaration, the Prefect may impose an obligation to draw
up an emergency plan by either general or specific requirements. However, there is no provision clearly imposing on him an
obligation to assess, on a case-by-case basis and in the light of the risks posed, the need to draw up an emergency plan.
The same reasoning applies in relation to teaching or research facilities which must comply with containment level L1 or L2.
The mere possibility of imposing on those facilities, by way of specific requirements, an obligation to draw up an emergency
plan cannot be regarded as an effective transposition of Article 14(a) of the Directive.
The French Government submits that approvals impose an obligation to comply with the requirements contained in the guide issued
by the Genetic Engineering Commission and that those requirements call for the drawing up of an emergency plan in respect
of teaching or research facilities which must comply with containment level L3 or L4. However, even if that is the case in
fact, the French Government has failed to show that the competent authorities are legally bound to provide for such an obligation
in the approvals in question. In addition, only research laboratories are covered and not all teaching and research facilities
which must comply with those containment levels.
Consequently, the action must be regarded as being well founded in so far as it relates to Article 14(a) of the Directive.
The complaint relating to the first subparagraph of Article 14(b) of the Directive
Arguments of the parties
The Commission points out that, as far as it as aware, the only provision transposing Article 14(b) into French law is Article
17 of Decree No 77-1133, which relates to the use of GMMs for industrial or commercial purposes. Article 17 provides that
the authorisation order may lay down the emergency measures to be taken by the operator and the operator's obligations with
regard to informing and alerting the persons liable to be affected by an accident as to the risks involved, the safety measures
to be taken and the course of conduct to be followed. However, that provision concerns only facilities subject to authorisation
and not all facilities. It also appears that Article 14(b) of the Directive has not been transposed with respect to use for
teaching, research or development purposes.
As regards informing the public, the Commission submits that, even assuming that safety measures are provided for in the general
and specific requirements to which those facilities may be subject, the fact that the public may have access to those requirements
─ which, as far as the public is aware, may or may not contain safety measures ─ is insufficient to fulfil the obligation
to make those requirements available to the public directly and automatically.
The French Government observes that, as worded, the obligation laid down in Article 14(b) of the Directive is distinct from
that which is the subject of the complaint relating to Article 14(a). The passage in the latter provision concerns the obligation
to draw up an emergency plan while the passage in Article 14(b) concerns the obligation to inform the public of
safety measures and of the
correct behaviour to adopt in the case of an accident.
It is, however, difficult to distinguish an emergency plan from safety measures and rules on the conduct to be adopted in
the case of an accident. The two obligations therefore appear to be closely linked. That interpretation is confirmed by the
amendment made to Article 14 of the Directive by Directive 98/81. The effect of that amendment was, first, to move the phrase
concerning the obligation to supply the emergency plans to the emergency services to the passage in point (b) of that article
and, second, to limit the scope of the duty to inform so that it no longer applies in respect of any person liable to be affected
but solely in respect of bodies and authorities liable to be affected. The provision in question therefore lays down an obligation
to supply the emergency plans to the emergency services, to inform the bodies and authorities liable to be affected of the
main provisions of those plans, to update them and to make them available to the public.
Given that it takes the view that an emergency plan need only be drawn up where it is necessary, the French Government did
not provide for an obligation to communicate as a matter of course the measures provided for in such a plan to the authorities
and bodies responsible for implementing it.
With respect to facilities classed as subject to authorisation, the obligation laid down in Article 14(b) of the Directive
is expressly reproduced in Article 17 of Decree No 77-1133. With respect to facilities classed as subject to declaration,
Article 27 of that decree provides that a copy of the notification of the general requirements applying to the facility is
to be posted in the town hall for at least one month and must state that third parties may have access to those requirements
there.
The French Government points out that, where they submit an application for approval, certain teaching and research facilities
are also subject to an obligation to lodge an information file with the town hall. Under Part I of Article 7 of Decree No
93-773, that file is to contain
any information relevant to the classification of the genetically modified organisms which may be used in the facility and
to the confinement measures, the action to be taken in the case of an accident and the technical specifications to which approval
is made subject. With respect to other teaching and research facilities, the administrative authority may, where an emergency plan is necessary,
also lay down the procedures to be followed in informing the public.
Findings of the Court
First of all, the first subparagraph of Article 14(b) of the Directive refers, in the first sentence, to the persons liable
to be affected by an accident and, in the third sentence, to the public and therefore to a larger collective which encompasses
the first group. The first sentence lays down an obligation to inform the persons concerned without their having to request
it. Under the third sentence, the information in question is also to be made available to the public, which must therefore
be granted access to it.
Directive 98/81 amended the first sentence of the first subparagraph of Article 14(b) of the Directive to the effect that
the new provision no longer refers to the persons but to the bodies and authorities liable to be affected by an accident.
It is settled case-law that the question whether there has been a failure to fulfil obligations must be examined in the light
of the position in which the Member State found itself at the end of the period laid down in the reasoned opinion (see, inter
alia, Case C-362/90
Commission
v
Italy
[1992] ECR I-2353, paragraph 10).
Directive 98/81 was to be transposed by 5 June 2000 at the latest and, therefore, before expiry of the time-limit laid down
in the reasoned opinion sent to the French Republic by the Commission. From that date at least, that Member State was no longer
under an obligation to transpose the first sentence of the first subparagraph of Article 14(b) of the Directive.
Accordingly, the action must be dismissed as inadmissible in so far as it relates to that provision of the Directive (see,
to that effect,
Commission
v
Italy
, cited above, paragraph 13).
With respect to the complaint relating to the obligation to make available to the public the information on safety measures
and the conduct to be adopted in the case of an accident, as laid down in the third sentence of the first subparagraph of
Article 14(b), that obligation was reproduced in Directive 98/81 to the extent that that directive imposes an obligation to
make emergency plans, including the relevant safety measures to be adopted, available to the public. The Commission rightly
submits that those plans are not necessarily available to the public in all cases, as is apparent from the observations of
the French Government itself. Moreover, in order to transpose the provision in question effectively, emergency plans must
be made available to the public as such. Therefore, the fact that the public has access to documents which contain various
types of information and thus make it necessary to search for the emergency plans, such as the requirements to which the facilities
may be subject, cannot be regarded as ensuring effective transposition of that provision.
Consequently, the action must be regarded as being well founded in so far as it relates to the third sentence of the first
subparagraph of Article 14(b) of the Directive.
The complaint relating to  the second subparagraph of Article 14(b), Article 15(2) and Article 16(1) of the Directive
Arguments of the parties
The Commission submits that the direct nature of the obligations imposed on the French authorities under the second subparagraph
of Article 14(b), Article 15(2) and Article 16(1) of the Directive does not discharge those authorities from having to establish
a minimum framework for application at a national level. That framework must, in particular, identify the competent authorities
authorised to provide information to the other Member States or lay down the procedure to be followed in doing so. This is
all the more necessary because those obligations are intended indirectly to protect the public interest in the other Member
States.
The Commission claims that the second subparagraph of Article 14(b), Article 15(2) and Article 16(1) of the Directive cannot
be regarded as having been transposed in the absence of such a minimum framework.
According to the French Government, the provisions can be distinguished by the fact that they have no effect in the internal
legal order of the Member States. They merely govern the procedure for consultation between the Member States or between a
Member State and the Community institutions. That is particularly apparent from the second subparagraph of Article 14(b) of
the Directive, which refers to
bilateral relations between the Member States.
In order to substantiate the present complaint, the Commission must show that the Directive cannot be guaranteed full effect
unless the rules are applicable in the French internal legal order. However, it merely asserts that it is necessary to adopt
a minimum framework for application which, in particular, identifies the competent authorities and lays down certain rules
on implementation.
The French Government takes the view that it is unnecessary to adopt any measure in French law to ensure that the provisions
in question are fully effective.
The obligations imposed by those provisions are to be fulfilled within the framework of bilateral relations with the neighbouring
Member States and with the Community institutions. Those relations are governed by a body of provisions entrusting the conduct
of relations with foreign States to the Ministry of Foreign Affairs and that of relations with the Community institutions
to an inter-ministerial body answering to the Prime Minister, namely the Secretariat-General for inter-ministerial coordination
of matters relating to European economic cooperation. Those general provisions identify the authorities responsible, where
appropriate, for providing the information in question. Since the provisions at issue govern neither relations between the
State and individuals nor relations between individuals, specific legislation in French domestic law would serve no purpose.
Moreover, identical provisions could have been laid down in a Community regulation or decision and not in a directive. Had
that been the case, no measure would have been necessary in domestic law in order to guarantee their full effect.
Findings of the Court
It is clear from the Court's case-law that a provision which concerns only relations between Member States and the Commission
need not, in principle, be transposed. Nevertheless, given that the Member States are under an obligation to ensure full compliance
with Community law, the Commission may show that compliance with the provision of a directive governing such relations requires
the adoption of specific measures transposing that provision into the national legal order (see, to that effect, Case C-72/02
Commission
v
Portugal
[2003] ECR I-6597, paragraphs 19 and 20).
Where a Member State has elected not to lay down expressly the legal framework within which the national authorities are to
maintain such relations, it is responsible for any infringement of the relevant obligations under Community law.
In the present case, the second subparagraph of Article 14(b), Article 15(2) and Article 16(1) of the Directive all concern
solely relations between a Member State and the Commission or the other Member States.
As regards the Commission's argument that a minimum framework for application of the provisions must be laid down in the internal
legal order, it should be noted that the Commission has not claimed that the French competent authorities are prevented from
applying those provisions and guaranteeing that they take full effect.
Moreover, the Commission has not established that compliance with those provisions requires the adoption of specific measures
of transposition in national law. It maintains its complaint even in the case that Article 15(2) of the Directive is complied
with in practice. The Commission has also failed to put forward arguments showing that the practice followed by the French
authorities runs counter to the obligations laid down in the second subparagraph of Article 14(b) and Article 16(1) of the
Directive.
Consequently, the action must be dismissed in so far as it relates to the second subparagraph of Article 14(b), Article 15(2)
and Article 16(1) of the Directive.
The complaint relating to Article 19(2) and (3) of the Directive
Arguments of the parties
According to the Commission, the French legislation does not state that, where the notifier wishes certain information contained
in the application for authorisation to be treated as confidential, he must provide verifiable justification.
Article 19 of the Directive, the purpose of which is clearly to impose obligations on notifiers and to confer on the public
a right of access to information on the uses of GMMs, cannot be regarded as having been transposed by general provisions which
do not lay down in detail the scheme provided for by the Community provision.
Similarly, none of the evidence available states that the competent authority is under an obligation to consult the notifier
before making its decision and that it is to inform the notifier of that decision.
According to the French Government, Article 2 of Decree No 77-1133 specifies the required content of applications for authorisation
which, with respect to facilities classed as being subject to authorisation, serve as notification for the purposes of the
Directive. It states, with regard to the production processes which the applicant wishes to carry out, that,
where appropriate, the applicant may submit, in a single copy and under separate cover, information the dissemination of which,
in his view, may entail the disclosure of production secrets. No other provision of Article 2 or Article 3 of that decree provides for such an option.
The French Government adds that Article 27 of Decree No 77-1133 governs the procedure for publication of the declaration which,
with respect to facilities classed as subject to declaration, serves as notification for the purposes of the Directive. It
refers, in particular, to the last paragraph of that article.
With respect to teaching and research facilities, the second paragraph of Article 2 of Decree No 93-773 provides, in the last
sentence, that the applicant is to indicate in the application for approval the information which, in his view, must remain
confidential.
Therefore, in the case of all three categories of facility concerned by the implementation of the Directive, the notifier
has the option of requesting that certain information provided by him together with the application for authorisation, declaration
or approval remain confidential.
The competent administrative authority is under no obligation to treat information as confidential simply because the notifier
has requested such treatment. The fact that the application does not bind that authority is apparent from the wording of the
national provisions in question, for example the use of the conditional tense in the legislation relating to classified facilities
or the addition of the clarification
in [the applicant's] view in the legislation governing teaching and research facilities. It would therefore be superfluous to state that the competent
authority is to decide which information is in fact to be regarded as confidential since that is sufficiently clear from the
fact that the notifier's right is limited to indicating the information which, in his view, must remain confidential.
For the same reason, it would serve no purpose to state that those requests for confidential treatment are to be accompanied
by justification. Since it is not sufficient to request that the information be treated as confidential in order for that
request to be granted, the notifier must necessarily attach justification in order for it to be granted. According to the
French Government, since confidential treatment is the exception, it is self-evident that a request for confidential treatment
must be justified.
Findings of the Court
It is settled case-law that for the transposition of a directive into the legal order of a Member State it is essential that
the national legislation in question effectively ensures that the directive is fully applied, that the legal position under
national law is sufficiently precise and clear and that individuals are made fully aware of their rights and obligations (see
Case C-365/93
Commission
v
Greece
[1995] ECR I-499, paragraph 9, and Case C-97/01
Commission
v
Luxembourg
[2003] ECR I-5797, paragraph 32).
There is no clear and unequivocal statement in Article 2 of Decree No 77-1133 concerning facilities classed as subject to
authorisation, Article 27 of that decree concerning facilities classed as subject to declaration or the last sentence of the
second paragraph of Article 2 of Decree No 93-773 concerning teaching and research facilities that the applicant must provide
verifiable justification, as is required by the second sentence of Article 19(2) of the Directive.
The argument that a request for confidential treatment must be justified because such treatment is the exception cannot be
accepted. While the transposition of a directive by specific laws or administrative measures may be superfluous given the
existence of general principles of constitutional or administrative law, recourse to a principle such as that relied on in
the present case by the French Government does not ensure, in a sufficiently clear and precise manner, that the second sentence
of Article 19(2) of the Directive is applied in full. The notifier must be able to identify from the wording of the national
legislation the conditions to which confidential treatment is made subject, including that of verifiable justification.
The French Government has failed to put forward any arguments refuting the complaint relating to the obligation under Article
19(3) of the Directive to consult the notifier.
With respect to the obligation, provided for in the same provision, to inform the notifier of the decision adopted by the
competent authority as to which information is to remain confidential, the French Government has failed to rely on any provision
of French administrative law expressly imposing on the administrative authorities an obligation to notify such a decision.
Consequently, the action must be regarded as well founded in so far as it relates to Article 19(2) and (3) of the Directive.
The complaint relating to Article 19(4) of the Directive
Arguments of the parties
According to the Commission, there is no provision in the French legislation enabling it to take the view that Article 19(4)
of the Directive has been transposed correctly.
With respect to facilities classed as subject to authorisation, the French Government submits that all of the information
listed in Article 19(4) of the Directive must be included in the application for authorisation, with the result that it is
made public in the course of the public inquiry and, therefore, can in no case remain confidential.
Teaching and research facilities manipulating GMMs in Classes 3 and 4 of Group II are required, under Part I of Article 7
of Decree No 93-773, to make available to the public a file of information containing
any information relevant to the classification of the genetically modified organisms which may be used in the facility and
the opinion given on the application for authorisation by the Genetic Engineering Commission, which guarantees transposition of the obligation to ensure that the evaluation of foreseeable effects of the proposed research
cannot remain confidential.
The French Government concedes that some marginal adjustments to the French legislation may be necessary to ensure that Article
19(4) of the Directive is fully effective as regards facilities classed as subject to declaration or teaching and research
facilities having to comply with the containment level required for Class 1 of Group I or Class 2 of Group II.
Findings of the Court
It is sufficient to state that the French Government has acknowledged that, as regards facilities classed as subject to declaration
and certain teaching and research facilities, the French legislation must be adjusted to ensure that Article 19(4) of the
Directive is fully effective. The transposition of that provision must therefore be regarded as incomplete.
Consequently, the action must be regarded as being well founded in so far as it relates to Article 19(4) of the Directive.
The complaint of failure to transpose the Directive in respect of certain contained use by the Ministry of Defence
In its defence, the French Government admits that certain facilities used by the Ministry of Defence are not covered by any
measure transposing the Directive.
Accordingly, the action must be regarded as well founded in so far as it relates to transposition of the Directive in respect
of certain contained use by the Ministry of Defence.
In light of all the above findings, it must be declared that, by failing to transpose correctly and in full Article 14(a)
and (b), first subparagraph, third sentence, and Article 19(2) to (4) of the Directive and by failing to transpose the provisions
of that directive in respect of certain contained use by the Ministry of Defence, the French Republic has failed to fulfil
its obligations under that directive.
Costs
Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been
applied for in the successful party's pleadings. However, under Article 69(3) of those Rules, the Court may order that the
costs be shared or that the parties bear their own costs where each party succeeds on some and fails on other heads. In this
case, since the parties have each been partially unsuccessful, each must be ordered to bear its own costs.
On those grounds,
THE COURT (Sixth Chamber)
hereby:
1.
Declares that, by failing to transpose correctly and in full Article 14(a) and (b), first subparagraph, third sentence, and
Article 19(2) to (4) of Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms,
as amended by Commission Directive 94/51/EC of 7 November 1994
adapting to technical progress Directive 90/219, and by failing to transpose the provisions of that directive in respect of
certain contained use by the Ministry of Defence, the French Republic has failed to fulfil its obligations under that directive;
2.
Dismisses the remainder of the action;
3.
Orders each party to bear its own costs.
Skouris
Gulmann
Puissochet
Macken
Colneric
Delivered in open court in Luxembourg on 27 November 2003.
R. Grass
V. Skouris
Registrar
President
–
Language of the case: French.