Conclusions
OPINION OF ADVOCATE GENERAL
MISCHO
delivered on 22 May 2003 (1)
Case C-296/01
Commission of the European Communities
v
French Republic
((Failure of a Member State to fulfil its obligations – Failure to transpose Directive 90/220/EEC – Genetically modified organisms))
I ─ Introduction
1. Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms
(2)
(
the Directive), the objective of which is to protect human health and the environment, establishes harmonised procedures and criteria in
order to control the risks liable to arise from such deliberate releases of genetically modified organisms (
GMOs). In essence, any person who wishes to carry out a deliberate release of GMOs must submit a notification to the national
competent authority and obtain authorisation from it. The Directive lays down, inter alia, the content of the notification
dossier, the procedure which must be followed by the national authorities with regard to authorisation, and the obligations
to provide information to the Commission and other Member States; it prescribes specific measures for the release into the
environment of GMOs for research and development purposes (or for any purpose other than placing on the market), and for their
release with a view to placing a product on the market.
2. According to the Commission, the French authorities have chosen to transpose the Directive by sectors of activity or products.
The French Government states that, as at 6 October 2001, 88 measures concerning GMOs had been adopted. The Commission has
concluded however that the implementation of the Directive by the French authorities is insufficient and incomplete in a number
of aspects.
3. As it considered that the responses provided by the French Government to the letter of formal notice of 16 March 1998 and
to the reasoned opinion of 5 April 2000 were unsatisfactory, the Commission, by application of 24 July 2001, brought an action
against the French Republic under Article 226 EC.
4. The Commission claims that the Court should:
- ─
declare that, by failing to transpose correctly and fully Articles 5(1), (2), (3) and (4), 6(2) and (5), 9(3), 11(1), (2),
(3) and (6), 12(3) and (4) and 19(2), (3) and (4) of the Directive, the French Republic has failed to fulfil its obligations
under the Directive and Article 249 EC;
- ─
order the French Republic to pay the costs.
5. The French Republic claims that the Court should:
- ─
dismiss the entire action as unfounded;
- ─
order the Commission to pay the costs.
II ─ Law
6. I would like, at the outset, to identify the objectives of the Directive, as stated in the preamble thereto, in particular:
- ─
the taking of preventive action with a view to attaining a high level of protection of human health and the environment, on
account of the risks likely to arise from the deliberate release of genetically modified organisms (GMOs) (first, third and
fifth recitals);
- ─
the approximation of the laws of the Member States concerning the deliberate release into the environment of GMOs, in the
light of existing disparities, which may create unequal conditions of competition or barriers to trade in products containing
such organisms (fourth recital);
- ─
the setting up of harmonised procedures and criteria for the case-by-case evaluation of the potential risks arising from the
deliberate release of GMOs into the environment (eighth recital);
- ─
the establishment of a Community authorisation procedure for the placing on the market of products containing, or consisting
of, GMOs where the intended use of the product involves the deliberate release of the organism(s) into the environment (13th recital).
7. The Directive seeks, through the procedures which it lays down, to ensure that the fullest possible information is gathered
and effectively disseminated to the competent Community and national authorities.
8. It is necessary to take these objectives into account in reviewing the implementation, by the French Republic, of the provisions
of the Directive.
A ─The field of application of the Directive
9. The Commission alleges that the French Republic has not transposed the Directive so far as concerns GMO-based reagents. According
to the Commission, the implementation of the Directive by sector is thus incomplete.
10. It is apparent, however, that this complaint was not set out in the form of order sought in the application. I therefore suggest
not examining it.
B ─Article 5(1) and (2) of the Directive
11. Article 5(1) of the Directive provides, in essence, that any person, before undertaking a deliberate release of a GMO, must
submit a notification to the competent authority. This notification is to include, according to Article 5(2), a technical
dossier supplying the information specified in Annex II and in Article 5(2), and a statement evaluating the impacts and risks
posed by the use of the GMO(s) to human health.
12. The Commission alleges that the French Republic has not fully transposed Article 5(1) and (2) of the Directive. It considers
that the various sector-based decrees lay down only in part the content of the technical dossier. According to these decrees,
the remaining information is to be specified by order. However, only three ministerial orders, dated 21 September 1994, 18
July 1995 and 18 October 2000, have been adopted.
13. The French Government refers to the Order of 23 December 1999 laying down the content of the technical dossier accompanying
applications for authorisation for the deliberate release of GMOs in the course of experiments relating to veterinary medicinal
products, to the Order of 18 October 2000 laying down the content of the technical dossier accompanying applications for authorisation
for the deliberate release of GMOs in the course of biomedical research relating to medicinal products for human use and to
the Order of 30 November 2001 laying down the content of the technical dossier accompanying applications for authorisation
for the deliberate release of GMOs in the course of biomedical research relating to elements and products of the human body
genetically modified after having been removed or collected. The French Government adds that other orders are being prepared.
14. The written pleadings of the French Government and the chronology of the measures referred to sufficiently demonstrate, in
my view, that on the date when the time-limit fixed by the reasoned opinion expired, that is, on 5 June 2000, the French Republic
had not implemented fully and in a satisfactory manner the provisions of Article 5(1) and (2) of the Directive. The failure
by the French Republic to fulfil its obligations is therefore established in this respect.
C ─Article 5(3) of the Directive
15. Article 5(3) of the Directive states that the competent authority may accept that releases of a combination of GMOs on the
same site or of the same GMO on different sites for the same purpose and within a limited period may be notified in a single
notification.
16. The Commission submits that the rule provided for in Article 5(3) of the Directive has not been transposed in Decrees No 93-1177
(plants, seeds and seedlings), No 94-359 (plant-protection products composed wholly or in part of GMOs), and No 95-487 (genetically
modified animal organisms).
17. The French Government replies that Article 5(3) of the Directive confers merely a power which the Member States are free to
use, or not to use.
18. The French Government also points out that in so far as Article 11 of Law No 92-654 provides that
any deliberate release or coordinated programme of such releases shall be subject to prior authorisation, the possibility of a single notification is not ruled out.
19. By contrast, in the Commission's view, Article 11 of Law No 92-654 is not sufficiently precise to constitute, in itself and
without implementing provisions, a precise, clear and transparent transposition of Article 5(3) of the Directive. The view
cannot reasonably be taken that, by virtue of Article 11 of Law No 92-654, the possibility of a single notification has been
provided for, and all the less so in the circumstances mentioned in Article 5(3) of the Directive, namely in the event of
release on different sites for the same purpose and within a limited period.
20. It is not possible, I believe, to accept that Article 11 of Law No 92-654 fully implements Article 5(3) of the Directive.
The field of application of the single notification provided for by French law and the field of application of the single
notification authorised by the Directive do not coincide: under the Directive, a programme of release spread over time cannot
be the subject of a single notification, and a single authorisation if it is not carried out for only one purpose and within
a limited period.
21. The implementation of this provision of the Directive is therefore not complete and the infringement is established.
D ─Article 5(4) of the Directive
22. Article 5(4) of the Directive provides that the notifier is to include in the notification information on data or results
from releases of the same GMOs or the same combination of GMOs previously or currently notified and/or carried out by him
either inside or outside the Community.
23. The parties agree that all the decrees implementing Law No 92-654 refer to the obligation on the notifier to supply
all information enabling the impact of the tests on public health or on the environment to be assessed.
24. The Commission considers, however, that the word
all used in these decrees does not set out the information required by Article 5(4) of the Directive with the requisite accuracy.
25. In its opinion, with the exception of the Order of 18 July 1995 and the Order of 18 October 2000, the French provisions do
not transpose Article 5(4) of the Directive. It adds that, in referring to orders which are being prepared, the French authorities
themselves admit the failure to transpose the Directive fully.
26. The French Government submits that the provision set out in Article 5(4) of the Directive also appears in the Order of 23 December
1999.
27. The French Government argues, further, that the word
all used in the decrees implementing Law No 92-654 is intended to cover all relevant information in this context, which includes
information on data or results from releases of the same GMOs or the same combination of GMOs previously notified, and that
the details provided in the orders on this point have only an essentially educational value.
28. It adds that the term
any deliberate release in Article 11 of Law No 92-654, reinforced by the term
any coordinated programme, also means that the information in the notification provided in support of the application for authorisation must automatically
include information on data and results from releases of the same GMOs or combinations of GMOs previously notified.
29. As to these submissions, the provisions implementing Article 5(3) of the Directive are certainly not as precise as the provision
of the Directive. It is clear that in the case of a directive, the structure of Community law requires that national implementing
provisions be as precise as the provisions of the directive, or at the very least that it be clearly established that their
effect at least corresponds to that of the provisions of the directive.
30. The implementation of a directive must be consistent with its aims in the light of the specific field which it is intended
to govern. In the context of the directive in question in the present case, the requirement for consistency means that an
operation to release GMOs must not be isolated from its context, previous operations and the consequences which it may have.
31. It appears that, from this viewpoint, the national provisions do not reflect sufficiently that requirement to place each operation
in its context having regard to its precise circumstances, and I conclude therefrom that, in this respect as well, the infringement
is established.
E ─Article 6(2) of the Directive
32. Article 6(2) of the Directive provides that the written response of the competent authority, whether positive (indicating
that the release may proceed) or negative (indicating that the notification does not fulfil the conditions of the Directive
and is rejected) must be sent to the notifier within 90 days of receipt of the notification.
33. The Commission accepts that the sector-based decrees transposing the Directive lay down an obligation on the competent authority
to notify its decision within a 90-day period, stating reasons if authorisation is refused. However, these decrees provide
that authorisation is deemed to be refused in the absence of a decision on expiry of the period of 90 days. In that case,
reasons are clearly not given for the refusal by the competent authority. Even supposing that the reasons for refusal are
disclosed to the notifier subsequently, the time-limit of 90 days laid down by the Directive cannot be complied with.
34. Thus, according to the Commission, Article 6(2) of the Directive has not been correctly transposed. By providing expressly
that silence is tantamount to refusal, a refusal for which the notifier does not know the reason, the French provisions risk
creating a doubt in the mind of the notifier as to the exact scope of his rights under the Directive in this regard.
35. Furthermore, the fact that a written response is
in practice always sent to notifiers within the prescribed period and their ability to assert their rights by way of litigation cannot
replace transposition of the provisions of the Directive.
36. Finally, the Commission refers to the judgment in
Commission v
Belgium ,
(3)
according to which tacit authorisation is incompatible with a directive which provides for the grant of authorisation.
37. The French Government submits that, through Article 4 of Decrees No 95-1172 and No 95-1173 and Article 5 of Decree No 96-317,
the provisions of Article 6(2) of the Directive are observed as regards the time-limit for notification of the decision and
the obligation to give reasons for a refusal.
38. The French Government points out that the insertion, in the decrees transposing the Directive, of an obligation to give reasons
for a refusal is not necessary from a legal point of view since, pursuant to Article 1 of Law No 79-587, adverse individual
administrative decisions must, as a matter of principle and unless expressly provided otherwise, be reasoned. In the words
of Article 3 of the Law, the required statement of reasons
must be in writing and set out the considerations of law and of fact on which the decision is based. According to Article 5 of the Law, an implied decision arising in cases where an express decision would have had to be reasoned
is not unlawful merely because reasons are not stated for it. Article 5 of the Law requires however that the grounds for any
implied refusal be disclosed to the person concerned, on his request, within a month following the request. The Directive
itself does not contain any requirements in that respect.
39. The French Government points out that it is clear from the provisions of Law No 2000-321 that the legal rule generally applicable
in France is that there is a deemed refusal in the absence of a response from the competent administrative authority on expiry
of a two-month period. Therefore, no doubt remains as to the position of the notifier.
40. The French Government maintains that the establishment of a system of implied authorisation would have been contrary to the
spirit of the Directive, which sought to wrap the deliberate release of GMOs in guarantees, having regard, in particular,
to existing uncertainties as to their effects on health and on the environment. This is the reason why, according to the French
Government, the decrees provide that, if the competent authority has not been able to determine the application for authorisation
within the prescribed time-limit, authorisation is deemed to have been refused. In the light of the requirements linked to
the protection of health and the environment, it not possible to maintain a state of uncertainty as to the consequences of
a failure by the competent authority to respond within the prescribed time-limit.
41. I fully share the Commission's view on this point. The Directive requires a Member State to take an express and reasoned decision
within 90 days after the application is lodged and the French Republic cannot plead generally applicable national law treating
the absence of a decision as an implied refusal to justify an obvious difference from the express provisions of the Directive.
It therefore appears, in this respect also, that the infringement is established.
F ─
Article 6(5) of the Directive
42. Article 6(5) of the Directive provides:If the competent authority considers that sufficient experience has been obtained of releases of certain GMOs, it may submit
to the Commission a request for the application of simplified procedures for releases of such types of GMOs. The Commission
shall, in accordance with the procedures laid down in Article 21, establish appropriate criteria and take a decision accordingly
on each application. The criteria shall be based on safety to human health and the environment and on the evidence available
on such safety.
43. The Commission considers that Article 6(5) of the Directive has not been transposed in Decree No 94-46 of 5 January 1994 laying
down conditions for the deliberate release of GMOs intended for human consumption other than plants, seeds, seedlings and
animals, or included in the composition of cleaning products for materials and articles intended to come into contact with
foodstuffs, products or beverages for human or animal consumption. Further, the Commission points out that Decrees No 93-1177,
No 94-359 and No 95-487 which provide for a simplified dossier do not mention the submission of this dossier to the Commission.
44. According to the Commission, in order for a competent authority to be able to exercise the option in Article 6(5) of the Directive,
that provision must necessarily have been transposed into national law. Article 6(5) is not aimed at governing relations between
the Member States and the Community but at specifying the detailed rules of a procedure partly centralised at Community level,
in which national administrative bodies are directly empowered to communicate with the Commission.
45. The French Government draws attention to the fact that the Directive refers to a possibility and not to an obligation. It
submits that this possibility is subject to a condition and to an analysis, namely that the competent authority considers
that sufficient experience has been obtained of releases of certain GMOs.
46. With regard to Decree No 94-96, the French Government claims that no dossier has yet been submitted and that no experience
has therefore been obtained. Once information and the experience obtained allow a decision that a simplified procedure is
required, the French Republic will be able to submit such a request to the Commission without it being necessary to state
this in the legislation.
47. I take the view that the Commission is correct in asserting that the competent authority must be able to be aware, on reading
the national measures transposing the Directive, that the option is available to it and that it may submit a request to the
Commission for the application of simplified procedures, even if no case of this kind ever arises.
48. More generally, the French Government also claims that the provisions of the Directive which organise the relations of the
Member States between themselves and with the Commission do not require to be integrated in national law.
49. In this respect, I also agree with the Commission's view: it is essential not only that formal provisions of national law
designate the competent authorities for the purpose of the measures envisaged by the Directive, but also that these authorities
are given, in the national provisions, a clear definition of their rights and obligations in that regard.
50. Article 6(5) of the Directive establishes a right for the competent authority to submit a request for the application of a
simplified procedure directly to the Commission and thus to obtain a decision from it. As the Commission contends, this provision
does not therefore govern, strictly speaking, the relations between Member States and the Community but specifies the detailed
rules of a procedure partly centralised at Community level, in which national administrative bodies are directly empowered
to communicate with the Commission. It is important that this right be transcribed expressly in the measures transposing the
Directive. The infringement is therefore established in this regard too.
G ─Article 9(3) of the Directive
51. Article 9 of the Directive provides:
1. The Commission shall set up a system of exchange of the information contained in the notifications. The competent authorities
shall send to the Commission, within 30 days of its receipt, a summary of each notification received. The format of this summary
will be established by the Commission in accordance with the procedure laid down in Article 21.
2. The Commission shall immediately forward these summaries to the other Member States, which may, within 30 days, ask for further
information or present observations through the Commission or directly.
3. The competent authorities shall inform the other Member States and the Commission of the final decisions taken in compliance
with Article 6(2).
52. The French Government considers that Article 9(3) of the Directive need not be the subject of transposing measures, since
it organises the relations between Member State authorities and between those authorities and the Commission. The French Government
points out that, with regard to other directives (namely Council Directive 92/59/EEC of 29 June 1992 on general product safety,
(4)
Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision
of information in the field of technical standards and regulations,
(5)
and Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 amending Directive 98/34),
(6)
the Commission has been satisfied with mere administrative practices, in some circumstances set out in interministerial circulars,
as is the case in France.
53. The Commission considers that this argument is irrelevant. No conclusion can be drawn from any lack of Commission action concerning
the transposition of directives other than the directive in question in the present case. For example, the provisions of Directive
92/59, namely those in Article 8 of that directive, are not comparable to those laid down in Article 9(3) of Directive 90/220.
According to the Commission, the former involves obligations on Member States in emergencies which derogate from the generally
applicable law and which must, a priori, be exceptional, whereas Article 9(3) of Directive 90/220 concerns an obligation on
an authority of the Member State in question, an authority which must be required to carry out a certain kind of action in
the course of a procedure which is to be applied regularly.
54. I suggest that the Court accept the Commission's argument. Article 9(3) of the Directive imposes a clear and precise obligation
on the competent authority of each Member State, namely the obligation to inform the Commission and the other Member States
─ and here this must mean the corresponding authorities designated by the other Member States ─ of the final decision taken
following the exchange of information. This final decision is of the greatest interest to the other participants in the system
as it concerns the very question whether, ultimately, the release of a particular GMO has been authorised or refused (Article 6(2)).
55. It is necessary therefore that the competent authorities of each Member State be fully informed of this important obligation
by domestic law and that they do not have to consult the Directive in parallel to check whether they have satisfied all their
obligations.
H ─
Article 11(1) of the Directive and Annexes II and III thereto
56. Article 11(1) of the Directive specifies the content of the notification which a manufacturer or an importer to the Community
must submit to the competent authority of the Member State where the product is to be placed on the market for the first time.
Annexes II and III list the information and the requirements which the notification must include.
57. The Commission considers that these provisions of the Directive have been transposed only in part by the French authorities.
It claims that the various sector-based decrees describe the content of the technical dossier only in relation to information
concerning the assessment of the impact of tests on health and on the environment, the standard-form dossier to be transmitted
to the Commission for information and the public information sheet. According to these decrees, the remaining information
is to be specified by order. However, only three ministerial orders have been adopted (the Order of 21 September 1994 on the
plant, seed and seedling sector, the Order of 18 July 1995 on other human foodstuff sectors and cleaning products for materials
and articles intended to come into contact with foodstuffs, products or beverages for human or animal consumption, and the
Order of 18 October 2000 on biomedical research). According to the Commission, these three orders do not transpose the requirements
under the second indent of the first subparagraph of Article 11(1), or even the minimum information listed in the annexes
to the Directive which, moreover, have not been the subject of any transposing measures at all.
58. The French Government takes the view that Article 15 of Law No 92-654, under which prior authorisation is required for the
placing on the market of products consisting wholly or partly of GMOs, has transposed the obligations under Article 11(1)
of the Directive and Annexes II and III thereto.
59. It adds that, as regards the categories of products subject to specific authorisation procedures prior to being placed on
the market, Article 17 of the Law states that a single authorisation is issued pursuant to these specific procedures and the
procedure established by Law No 92-654, in accordance with detailed rules laid down by secondary legislation.
60. So far as concerns medicinal products for human or veterinary use consisting of GMOs, the French Government states that the
placing on the market of these products is dependent on authorisations issued at Community level. Finally, as high-technology
medicinal products require a European marketing authorisation, the French Government considers that no transposing measures
are necessary.
61. For medicinal products for human use, generators, kits and precursors consisting of GMOs which are not subject to Community
marketing authorisation, Article 18 of Decree No 95-1172 states that the national marketing authorisation or the pre-market
approval is equivalent to authorisation under Article 15 of the Law. In that case, Article 20-I of Decree No 95-1172 states
that the application for authorisation is to be accompanied by a technical dossier including all the information necessary
for evaluating the impact of the medicinal or other product on public health and on the environment, the content of which
is to be laid down by an order of the Minister of Health.
62. The order envisaged by Article 20-I has not been adopted by the French authorities, as these medicinal and other products
are still at the stage of clinical research, but the situation will be reviewed by the French authorities in the context of
transposition of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release
into the environment of genetically modified organisms and repealing Directive 90/220.
(7)
63. Finally, for the other health products caught by Decree No 96-850 of 20 September 1996 which are not covered by sector-based
provisions, the draft order which is being prepared will lay down the content of the technical dossier.
64. The Commission acknowledges that Article 11 of the Directive does not apply ─ and therefore need not be transposed ─ in respect
of medicinal products for human or veterinary use which consist of GMOs and are subject to a Community marketing authorisation.
65. On the other hand, the Commission contends that:
- ─
the various sector-based decrees do not set out all the information which the technical dossier must include, and the implementation
of these dossiers by order is still incomplete;
- ─
the three orders invoked by the French Government do not transpose the conditions for placing the product on the market, including
specific conditions for use and handling and a proposal for labelling which should comprise at least the requirements laid
down in Annex III.
66. I share the Commission's view: the measures implementing Article 11(1) of the Directive and Annexes II and III are incomplete;
the only general provision put forward by the French Republic, namely Article 15 of Law No 92-654, merely lays down the requirement
to obtain prior authorisation, issued
after an examination of the risks for public health or the environment posed by the placing on the market and therefore far from mentions all the information required by the relevant provisions of the Directive. I conclude that,
in this regard also, the infringement is established.
I ─
Article 11(2) and (3) of the Directive
67. Article 11(2) of the Directive specifies information which the notifier must include in the prior notification, concerning
the data or results from releases of the same GMOs or the same combination of GMOs previously or currently notified and/or
carried out by the notifier either inside or outside the Community. Article 11(3) provides that the notification may also
refer to data or results from notifications previously submitted by other notifiers, provided that the latter have given their
agreement in writing.
68. The Commission points out that the content of these provisions is not reproduced in any legislation, with the exception of
the Order of 18 July 1995 on other human foodstuff sectors and cleaning products for materials and articles intended to come
into contact with foodstuffs, products or beverages for human or animal consumption, and the Order of 18 October 2000 on biomedical
research.
69. The French Government notes that, as regards veterinary medicinal products, no transposing measure is necessary because authorisation
is issued at Community level, a point which the Commission accepts.
70. As to the remainder, in the French Government's submission the implementation of these provisions falls within the scope of
the orders envisaged by Articles 20-I of Decree No 95-1172 (human medicinal products) and 21-II of Decree No 96-850 (other
products).
71. However, the Commission observes that all the decrees implementing Law No 92-654 refer to the obligation on the notifier to
provide, in connection with his application, the
information enabling the impact of the tests on public health and the environment to be assessed. The provisions referred to by the French authorities do not thereby set out with the necessary precision the matters which
the notifier must include in his notification dossier.
72. The Commission considers that it is pointless for the French Government to invoke Article 8 of the Directive (on notifications
after a release), since Article 11(2) and (3) lays down a clear and unconditional obligation which must be carried out at
the time of the notification.
73. I agree with the Commission that the French provisions do not implement Article 11(2) and (3) of the Directive with the necessary
completeness and precision and I therefore conclude that the infringement is also established in this regard.
J ─Article 11(6) of the Directive
74. Article 11(6) of the Directive states that if new information has become available with regard to the risks of the product
to human health or the environment, either before or after the written consent, the notifier shall immediately:
- ─
revise (
revoir in the French version of the provision) the information and conditions specified in Article 11(1),
- ─
inform the competent authority, and
- ─
take the measures necessary to protect human health and the environment.
75. The French Government considers that the wording of Article 19 of Law No 92-654 transposes Article 11(6) of the Directive
since it provides that all persons
must inform the authority of any new information and take
all necessary measures to protect public health or the environment.
76. The French Government contends that the obligation laid down in the first indent of Article 11(6) of the Directive is necessarily
observed when the person concerned informs the competent authority and takes the necessary measures to protect health and
the environment.
77. This submission appears, at first sight, to be based on common sense. On the other hand, however, the fact remains that the
Commission may rely on the legislative wording when pointing out that the three obligations under Article 11(6) of the Directive
are complementary and separate from each other and must be transposed separately. As, furthermore, the Commission maintains
that the first of the three obligations on the notifier (namely the obligation to revise immediately the information and conditions)
has not been set out in any of the sector-based decrees, I must conclude that the infringement is also established in this
respect.
K ─Article 12(3) and (4) of the Directive
78. Article 12(3) of the Directive provides that, where the competent authority forwards the notification dossier to the Commission
with a favourable opinion, the dossier is to include a summary of the notification together with a statement of the conditions
under which the competent authority proposes to consent to the placing on the market of the product.
79. Article 12(4) of the Directive imposes the obligation on the competent authority to inform the Commission and the other Member
States of additional information disclosed by the notifier as regards the risks of the product, if the competent authority
receives additional information pursuant to Article 11(6) of the Directive.
80. The Commission states that Article 12(3) of the Directive has not been fully transposed because only two orders mention a
summary of the dossier requesting marketing authorisation. Nor does any of the legislation intended to transpose the Directive
mention the obligation on the competent authority to draw up a statement of the conditions under which it proposes to consent
to the placing on the market of the product, with a view to transmitting it to the Commission. The Commission adds that Article
12(4) has been transposed only in Decree No 94-359, Decree No 95-1172 and Decree No 96-850. Furthermore, Article 12(4) has
not been transposed for the sectors which are not covered by transposing measures.
81. The Commission takes the view that Article 12(3) and (4) of the Directive sets out the details of a procedure under which
national administrative bodies are required to communicate certain information to the Commission and to the other Member States.
It is thus necessary for national law to set out for those authorities the legal framework within which they operate.
82. The French Government repeats that provisions which prescribe the communication of information to other Member States and
to the Commission do not require to be covered by transposing measures.
83. In that regard, I can only confirm that I have already explained the necessity, for each Member State, to specify in the transposing
measures the obligations imposed on the competent authorities.
84. As regards transmission of the statement of the conditions to which marketing authorisation is to be subject, the French Government
invokes Article 20-VI of Decree No 95-1172 and Article 22 of Decree No 96-850, which provide that the competent authority
is to forward the dossier to the Commission accompanied where relevant by specific conditions. Moreover, Article 12(4) of
the Directive is transposed by Article 21 of Decree No 95-1172 and Article 25 of Decree No 96-850.
85. The Commission replies that in Article 20-VI of Decree No 95-1172 the specific conditions are listed exhaustively, which is
not envisaged by Article 12(3) of the Directive. As for Decree No 96-850, the Commission points out that it has a limited
field of application.
86. It is clear from the foregoing that, in this respect also, the Commission's complaints are valid and that the infringement
is established.
L ─Article 13(2) and (4) of the Directive
87. In the grounds of its application, the Commission pleads failure to implement Article 13(2) and (4) of the Directive. However,
as the Commission does not mention these provisions in the form of order sought in its application, I consider that the Court
need not examine this point.
M ─Article 19(2) and (3) of the Directive
88. Article 19(2) of the Directive provides that the notifier may indicate the information in the notification submitted under
the Directive, the disclosure of which might harm his competitive position and should be treated as confidential. Verifiable
justification must be given in such cases. Article 19(3) provides that the competent authority is to decide, after consultation
with the notifier, which information will be kept confidential and is to inform the notifier of its decision.
89. The Commission observes that, as set out in Article 21(1) of Law No 92-654, an applicant for authorisation to release GMOs
or to place a product on the market may indicate to the authorities the information provided in support of his application
the disclosure of which might prejudice his interests or which concerns confidential matters protected by legislation. However,
according to the Commission, the Law does not require the notifier to give verifiable justification. With the exception of
Decree No 94-359, no sector-based decree imposes an obligation on the notifier to give verifiable justification.
90. As for Article 19(3) of the Directive, according to the Commission neither Law No 92-654 nor the sector-based decrees transposing
the Directive (with the exception of Decree No 94-359 relating to plant-protection products) lay down obligations to consult
the notifier and to inform him once a decision has been taken.
91. The French Government claims that the substance of Article 19(2) and (3) of the Directive is transposed by virtue of Article
21 of Law No 92-654 and the sector-based secondary legislation.
92. In the view of the French Government, the Commission appears not to know that, under French administrative law, it is generally
for the person pleading confidentiality to prove it.
93. In relation to Article 19(3) of the Directive, the French Government considers that administrative law is sufficient to transpose
the Directive precisely, because it provides that:
- ─
decisions, including refusals, must be reasoned (Article 1 of Law No 79-587);
- ─
individual administrative decisions are to be taken following an
inter partes procedure during which the person concerned has the opportunity to put forward his comments (Article 24 of Law No 2000-321).
94. So far as concerns the transposition of Article 19(2) of the Directive, I suggest that the Court uphold the Commission's view.
In the light of the interests which the Directive aims to protect, the request for confidentiality must be based on a verifiable
justification the detailed rules for which must be set out in specific transposing measures.
95. On the other hand, as regards the transposition of Article 19(3) of the Directive, it is uncertain whether the general principles
of French administrative law provide the necessary procedural guarantees. I suggest that the Court give the French Republic
the benefit of the doubt on this point.
N ─Article 19(4) of the Directive
96. Article 19(4) provides as follows: In no case may the following information when submitted according to Articles 5 or 11 be kept confidential:
- ─
description of the GMO or GMOs, name and address of the notifier, purpose of the release and location of release;
- ─
methods and plans for monitoring of the GMO or GMOs and for emergency response;
- ─
the evaluation of foreseeable effects, in particular any pathogenic and/or ecologically disruptive effects.
97. According to the Commission, all the sector-based decrees implementing Law No 92-654 include a standard provision requiring
an applicant for authorisation to release GMOs to attach a public information sheet to the application dossier. The list of
data to be included on the sheet does not mention information as regards the location of release or the name and address of
the notifier. Since the French authorities have intended to implement the requirements flowing from Article 19(4) of the Directive
by means of a
public information sheet, it is imperative for the sheet to include all the matters mentioned in that provision as not allowed to be kept confidential.
The Commission points out, furthermore, that the Order of 21 September 1994, which specifies the content of the public information
sheet in the Annex thereto, does not mention information regarding emergency response plans, contrary to Decree No 93-1177
which the order is nevertheless supposed to implement.
98. The French Government contends that Article 19(4) of the Directive is transposed by Article L.513.3-II of the Environment
Code (previously Article 21 of Law No 92-654) which is directly applicable, as, moreover, is Article 19(4) of the Directive.
French legislation distinguishes between cases where non-confidential information is submitted in connection with applications
for the deliberate release of GMOs for the purpose of research and cases concerning applications for marketing authorisation.
Annex II to the Directive provides that certain information which must be included in notifications under Article 5 of the
Directive for releases for the purpose of research is not required in notifications under Article 11 of the Directive for
placing a product on the market. The Commission is therefore wrong to look for provisions transposing Article 19(4) of the
Directive in the sector-based decrees.
99. The French Government also points out that the absence from the public information sheet envisaged by the standard provision
under Law No 92-654 of certain information which is not categorised as confidential by the Directive, namely the location
of the release and the name and address of the notifier, does not in any way affect its non-confidential nature. The French
Government contends that this information is, on request, to be communicated to the public as of right, pursuant to Articles
1 and 6 of Law No 78-753 of 17 July 1978 laying down various measures to improve relations between administrative authorities
and the public.
(8)
100. The French Government adds, finally, as regards biomedical research, that it had considered that it was inappropriate to give
excessive publicity to the name and address of the research location, in order to protect those operations.
101. I do not share the Commission's view according to which, since the French authorities have intended to implement the requirements
flowing from Article 19(4) of the Directive by means of a
public information sheet, it is imperative for the sheet to include all the matters mentioned in that provision as not allowed to be kept confidential.
102. Article 19(4) relates to the information
submitted according to Articles 5 or 11. These provisions concern the notifications to be made to the competent authority.
103. It does not in any way follow from the Directive that a Member State which chooses to publish a
public information sheet must include in that sheet all the non-confidential information which the notifier is bound to communicate to the competent
authority.
104. The lack of confidentiality of certain information under the Directive must be distinguished from an obligation to publicise
this information. Therefore, in my view, the French Republic is entitled to consider that the obligation to respond to a request
for information under administrative law suffices in order to comply with the provisions in question of the Directive. This
would not be the case only if, in practice, the French authorities refused to reply to requests for information, which the
Commission has not claimed.
105. I conclude that, in this respect, the infringement is not established.
III ─ Conclusion
106. I therefore suggest that the Court:
- ─
declare that, by failing to transpose correctly and fully Articles 5(1), (2), (3) and (4), 6(2) and (5), 9(3), 11(1), (2),
(3) and (6), 12(3) and (4) and 19(2) and (3) of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into
the environment of genetically modified organisms, the French Republic has failed to fulfil its obligations under the Directive
and Article 249 EC;
- ─
dismiss the remainder of the action;
- ─
order the French Republic to pay the costs.
- 1 –
- Original language: French.
- 2 –
- OJ 1990 L 117, p. 15.
- 3 –
- Case C-230/00 [2001] ECR I-4591.
- 4 –
- OJ 1992 L 228, p. 24.
- 5 –
- OJ 1998 L 204, p. 37.
- 6 –
- OJ 1998 L 217, p. 18.
- 7 –
- OJ 2001 L 106, p. 1.
- 8 –
- . Journal Officiel de la République Française of 18 July 1978, p. 2851.
