CELEX: 62011CJ0281
Failure of a Member State to fulfil obligations
Contained use of genetically modified micro-organisms
Directive 2009/41/EC
Incorrect and incomplete transposition

By its application, the European Commission seeks a declaration from the Court that, by failing to transpose or by transposing incorrectly Article 2(a), (b), (d) to (f), Article 3(3), Article 4(3), Articles 6 to 9(1) and (2)(a), Article 10(3) and (4), Article 18(1), second subparagraph, and Article 18(3) and (4) of, and the fourth indent of Part A, the first indent of Part B and the first indent of Part C of Annex V to, Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro‑organisms, the Republic of Poland has failed to fulfil its obligations under that directive.
Legal context
European Union law
Pursuant to Article 2 of the Act concerning the conditions of accession to the European Union of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded (
OJ 2003 L 236, p. 33
) (the ‘Act of Accession’), the Republic of Poland was bound from 1 May 2004, the date of its accession, by the provisions of the Treaties and the measures taken, prior to its accession, by the European Union’s institutions.
Pursuant to Article 54 of the Act of Accession, the new Member States are to put into effect the measures necessary for them to comply, from the date of accession, with the provisions of directives and decisions, unless another time-limit is provided for in the annexes referred to in Article 24 or in any other provisions of that act or its annexes. In so far as neither Annex XII to that act, which relates to the Republic of Poland and is referred to at Article 24 of the Act of Accession, nor other provisions of that act relating to that Member State contain specific provisions relating to Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro‑organisms (
OJ 1990 L 117, p. 1
), and Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219 (
OJ 1998 L 330, p. 13
), the Republic of Poland was required to have transposed those directives on the day of its accession to the European Union.
Directive 90/219 established common measures for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment.
That directive was amended by Directive 98/81.
Directive 90/219, as amended by Directive 98/81 (‘Directive 90/219, as amended’), was repealed and replaced by Directive 2009/41, which entered into force on 10 June 2009.
Article 2 of Directive 2009/41, which is identical to Article 2 of Directive 90/219, as amended, provides the following definitions:
‘...
(a)
“micro-organism” means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, and animal and plant cells in culture;
(b)
“genetically modified micro-organism” (GMM) means a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination; within the terms of this definition:
(i)
genetic modification occurs at least through the use of the techniques listed in Annex I, Part A;
(ii)
the techniques listed in Annex I, Part B, are not considered to result in genetic modification;
...
(d)
“accident” means any incident involving an unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment;
(e)
“user” means any natural or legal person responsible for the contained use of GMMs;
...’
Under Article 3(3) of Directive 2009/41, which corresponds to the second paragraph of Article 4 of Directive 90/219, as amended:
‘[Directive 2009/41] shall not apply to the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with 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 Council Directive 90/220/EEC (
OJ 2001 L 106, p. 1
)] or pursuant to other Community legislation, which provides for a specific environmental risk assessment similar to that laid down in the said Directive, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market.’
Article 6 of Directive 2009/41 which is identical to Article 7 of Directive 90/219, as amended, is worded as follows:
‘When premises are to be used for the first time for contained uses, the user shall be required, before commencing such use, to submit to the competent authorities a notification containing at least the information listed in Annex V, Part A.’
Article 7 of Directive 2009/41, which replaces Article 8 of Directive 90/219, as amended, provides:
‘Following the notification referred to in Article 6, subsequent class 1 contained use may proceed without further notification. Users of GMMs in class 1 contained uses shall be required to keep the record of each assessment referred to in Article 4(6), which shall be made available to the competent authority on request.’
Article 8 of Directive 2009/41, which is drafted in terms nearly identical to those of Article 9 of Directive 90/219, as amended, is worded as follows:
‘1.   For first and subsequent class 2 contained uses to be carried out in premises notified in accordance with Article 6, a notification containing the information listed in Annex V, Part B shall be submitted.
2.   If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification.
However, the applicant may himself request from the competent authority a decision on the grant of a formal authorisation. The decision must be made within a maximum of 45 days from the notification.
3.   If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the competent authority, proceed 45 days after submission of the notification referred to in paragraph 1, or earlier with the agreement of the competent authority.’
Article 9 of Directive 2009/41, the wording of which is nearly identical to Article 10 of Directive 90/219, as amended, states:
‘1.   For first and subsequent class 3 or class 4 contained uses to be carried out in premises notified in accordance with Article 6, a notification containing the information listed in Annex V, Part C shall be submitted.
2.   A class 3 or higher class of contained use may not proceed without the prior consent of the competent authority, which shall communicate its decision in writing:
(a)
at the latest 45 days after submission of the new notification, in the case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and where any associated consent requirements have been satisfied for the same or a higher class than the contained use with which it is intended to proceed;
(b)
at the latest 90 days after submission of the notification, in other cases.’
Article 10 of Directive 2009/41, which corresponds to Article 11 of Directive 90/219, as amended, provides:
‘1.   Member States shall designate the authority or authorities competent to implement the measures which they adopt in application of this Directive and to receive and acknowledge the notifications referred to in Articles 6, 8 and 9.
2.   The competent authorities shall examine the conformity of the notifications with the requirements of this Directive, the accuracy and completeness of the information given, the correctness of the assessment referred to in Article 4(2) and the class of contained uses and, where appropriate, the suitability of the containment and other protective measures, the waste management, and emergency response measures.
3.   If necessary, the competent authority may:
(a)
ask the user to provide further information or to modify the conditions of the proposed contained use or to amend the class assigned to the contained use(s). In this case the competent authority may require that the contained use, if proposed, should not begin, or, if in progress, should be suspended or terminated, until the competent authority has given its approval on the basis of the further information obtained or of the modified conditions of the contained use;
(b)
limit the time for which the contained use should be permitted or subject it to certain specific conditions.
4.   For the purpose of calculating the periods referred to in Articles 8 and 9, any period of time during which the competent authority:
(a)
is awaiting any further information which it may have requested from the notifier in accordance with point (a) of paragraph 3; or
(b)
is carrying out a public inquiry or consultation in accordance with Article 12;
shall not be taken into account.’
Article 16 of Directive 2009/41, whose wording, in essence, is identical to that of Article 17 of Directive 90/219, as amended, states:
‘Member States shall ensure that the competent authority organises inspections and other control measures to ensure that users comply with this Directive.’
Article 18(1), (3) and (4) of Directive 2009/41, which corresponds to Article 19(2), (4) and (5) of Directive 90/219, as amended, provides:
‘1.   Where its disclosure affects one or more of the items mentioned in Article 4(2) of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information [(
OJ 2003 L 41, p. 26
)], the notifier may indicate the information in the notifications submitted pursuant to this Directive that should be treated as confidential. Verifiable justification must be given in such cases.
The competent authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision.
...
3.   The Commission and the competent authorities shall not divulge to third parties any information deemed to be confidential according to the second subparagraph of paragraph 1 and notified or otherwise provided pursuant to this Directive, and shall protect intellectual property rights relating to the data received.
4.   If, for whatever reasons, the notifier withdraws the notification, the competent authority must respect the confidentiality of the information supplied.’
Polish law
Article 3 of the Act on genetically modified organisms (ustawa o organizmach genetycznie zmodyfikowanych), of 22 June 2001 (Dz. U. 2007 No 36, position 233) (the ‘Law on GMOs’), sets out the following definitions:
‘1.
“organism” means any biological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses and viroids;
2.
“Genetically Modified Organism” [(GMO)] means a non-human organism in which the genetic material has been altered in a manner not occurring in natural conditions by mating and/or natural recombination, inter alia by way of:
(a)
Recombinant DNA techniques using vector systems involving inter alia the formation of genetic material by the incorporation, inside any virus, plasmid or other vector system, of DNA molecules produced outside an organism, and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;
(b)
techniques involving the direct introduction of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation;
(c)
non-naturally occurring methods, consisting in the fusion of genetic material of two or more different cells, the relevant procedure leading to the creation of a new cell capable of transmitting its genetic material, which is different from the parent material, to daughter cells;
...
7.
“GMO user” means a natural or legal person, or an organisational unit without legal personality, which on its own account conducts a contained use of GMOs or an activity consisting in the deliberate release into the environment of GMOs, including the placing on the market of GMO products;
8.
“accident” means any incident involving an unintended release of GMOs in the course of their contained use which may present a direct or delayed hazard to human health or the environment;
...’
Article 14 of the Law on GMOs provides:
‘1.   The Minister shall publish in the
Journal of Laws
, subject to paragraph 2, the information relating to accidents referred to at Article 33 and to their effects and to the dangers flowing therefrom.
2.   The provisions relating to access to information on the environment shall apply mutatis mutandis in the case of access to information on GMOs.’
Article 14a of that law provides as follows:
‘The following shall be disclosed:
1.
information on the general characteristics of GMOs;
2.
information relating to the name and address or principal address of a GMO user;
3.
information on the place where the contained use of GMOs or the deliberate release into the environment of GMOs was conducted;
4.
information on the place, scope and nature of the placing on the market of GMOs;
5.
information other than that listed at points 1 to 4 above and which is important for the protection of human health, safety and the environment.’
Article 16 of that law provides:
‘The contained use of GMOs requires the authorisation of the Minister, save as otherwise provided in the present chapter.’
Article 17(1) of that law states:
‘Four categories of contained uses of GMOs shall be defined according to the level of risk they represent to human health and the environment:
(1)
category I – activities which do not present any risks;
(2)
category II – activities which present a low risk;
(3)
category III – activities which present a moderate risk;
(4)
category IV – activities which present a high risk.’
Article 21 of the Law on GMOs provides:
‘1.   All applications for an authorisation relating to the contained use of GMOs referred to in Article 16 shall set out in particular:
(1)
information concerning the GMO user, including name and registered address, or the name, first name and address, and the name and first name of the person directly responsible for the proposed contained use of GMOs;
(2)
information concerning the proposed activity, including the characteristics of the GMO or combination of GMOs:
(a)
the recipient and donor systems used and the vector system applied;
(b)
the source and intended function of the genetic material involved in the modification;
(c)
the distinctive characteristics of the GMOs;
(3)
information concerning the levels and types of risk proposed;
(4)
information concerning the safety measures to be applied to the modification of the GMOs;
(5)
information concerning the measures proposed for the management of waste containing GMOs.
2.   The application for an authorisation relating to the contained use of GMOs referred to in paragraph 1 shall include:
(1)
a record of the assessment of the risks referred to in Article 6;
(2)
the emergency plan referred to in Article 19.
3.   Any application for an authorisation relating to a new contained use of GMOs shall also contain information on the results of the previous contained use.’
Article 23 of that law provides:
‘1.   The authorisation is granted for a limited period of not more than five years, after verification that the conditions for implementing the contained use of GMOs provided for by law are fulfilled, subject to paragraph 4.
2.   Before the authorisation is granted, it is possible:
(1)
to invite, where necessary, the GMO user making the application to provide, within the prescribed period, the missing documents capable of showing that the GMO user has complied with the conditions to be met in accordance with the legislation relating to the implementation of the contained use of GMOs;
(2)
to require the GMO user to submit the necessary additional information for a complete assessment of the file, and in particular the opinion referred to in Article 15;
(3)
to verify the facts set out in the application for an authorisation in order to establish whether the GMO user making the application meets the conditions for carrying out the contained use of GMOs which is the subject of the application.
3.   The costs linked to the submission of additional information and of the opinion referred to in paragraph 2 shall be payable by the applicant.
4.   The Minister shall refuse to grant the requested authorisation for category III and IV activities where there is good reason to believe that the proposed protection measures do not provide the level of guarantee required to preclude all serious or irreparable consequences in the event of an accident or to exclude any risk of an accident in the course of the proposed contained use of GMOs.’
Under Article 24 of that law:
‘1.   The authorisation relating to the contained use of GMOs shall be issued within a period of three months of having received the application. That time-limit shall be suspended in the cases referred to in points 1 and 2 of Article 23(2).
1a.   In the cases referred to at Article 29, the time-limit for issuing the authorisation relating to the contained use of GMOs, referred to in paragraph 1, shall be extended by a period equivalent to that of the consultation period up to a maximum of 30 days.
2.   Where it has been determined that the activity has been classified in a risk category which is lower than that in which, taking account of the assembled documents, it should be classified, the GMO user may be required to amend the classification of the activity.
3.   Should the GMO user refuse to amend the classification of the activity, the Minister may refuse to grant the authorisation or shall withdraw the authorisation.
4.   Where the protection of human health or the environment so requires, it is possible to set out, in the authorisation relating to the contained use of GMOs, additional conditions for the implementation of the contained use of GMOs, which relate to the application of requirements concerning the level and type of worker safety and security measures which go beyond the requirements established on the basis of Articles 17 and 18.’
Article 29 of that law provides:
‘Public participation in a procedure whose purpose is the grant of a decision authorising the contained use of GMOs is governed by the provisions on public participation in procedures relating to the protection of the environment.’
Article 31 of the Law on GMOs provides for the possibility of amending the classification in a given category by ‘a new contained use of GMOs classified in risk category I or II, carried out in the same place and in the same conditions, [which] does not require a new authorisation for the contained use of GMOs, subject to Article 24(2), to be obtained.’
Article 32 of that law states:
‘1.   The GMO user is required to inform without delay the Minister and the body referred to at Article 19(5),
(1)
of any amendment to the conditions for the contained use of GMOs which is capable of making the risks to human health or the environment worse;
(2)
of any amendment to the data referred to in Article 21.
2.   In the cases referred to in point 1 of paragraph 1, the Minister, taking into account the aspects which relate to the safety of persons or of the environment, shall ask the GMO user to amend the conditions accordingly or to suspend or terminate the contained use of GMOs, and shall set the GMO user a deadline for carrying out those actions.’
Article 34(1) of that law provides
‘1.   The Minister shall keep a register of the contained uses of GMOs.
2.   The register referred to in paragraph 1 shall include:
(1)
applications for authorisation for the contained use of GMOs, and the documents relating thereto;
(2)
notifications of new contained uses of GMOs;
(3)
authorisations for the contained use of GMOs, accompanied by supporting evidence, and information concerning the withdrawal of authorisations or amendments thereto;
(4)
the Commission’s opinion;
(5)
information on accidents, in particular:
(a)
a list of accidents;
(b)
an analysis of the causes of the various accidents;
(c)
a description of the lessons learned during relief operations and the elimination of the effects of accidents;
(d)
a list of measures taken by the GMO user in order to prevent any further accident of the same type;
(e)
an assessment of the consequences of the accident.
2a.   The register shall be kept in electronic format.
3.   The register shall be open to the public for inspection; the provisions of Article 14(2) and of Article 14a shall apply mutatis mutandis.
4.   Consultation of the register shall be free of charge.’
The Law on access to information relating to the environment and its protection, on public participation in the defence of the environment and on environmental impact assessments (ustawa o udostępnianiu informacji o środowisku i jego ochronie, udziale społeczeństwa w ochronie środowiska oraz o ocenach oddziaływania na środowisko), of 3 October 2008 (Dz. U. n
o
199, position 1277) (the ‘Law on access to information relating to the environment’), is part of the scheme which applies to the contained use of micro‑organisms which have been genetically modified on Polish territory.
Pursuant to Article 16(1) of that law, the administrative authorities shall not allow the public to have access to information relating to the environment and its protection where that information concerns:
‘1.
individual data used during research carried out for public statistics and covered by the confidentiality of statistics which are the subject of the Law of 29 June 1995 on public statistics ...;
2.
cases relating to disciplinary or criminal court proceedings, where access to information is capable of disrupting the conduct of the proceedings;
3.
cases covered by copyright, which are the subject of the Law of 4 February 1994 on copyright, related rights and patent law ..., [and] which are the subject of the Law of 30 June 2000 on intellectual property ..., where access to information is capable of infringing those rights;
4.
personal data, which is the subject of the Law of 29 August 1997 on the protection of personal data ... concerning third persons, where access to information is liable to lead to a breach of the provisions relating to the protection of personal data;
5.
documents or data provided by third persons, where those persons willingly provided that information and requested that it not be disclosed, though they were not required to provide that information and could not be required to provide it;
6.
documents or data, access to which is liable to cause a risk to the environment or to the safety of the national ecology;
7.
commercially sensitive information, including inter alia the technical data provided by third parties and covered by business confidentiality, where access to that information is capable of affecting the competitive position of those third parties who have made a reasoned request for that information not to be disclosed;
8.
activities which are capable of having a broad impact on the environment, which are conducted in enclosed spaces, with regard to which the procedure involving public participation is not applicable, in accordance with Article 79(2);
9.
State defence and security;
10.
public safety.’
Articles 33 to 38 of the Law on access to information relating to the environment specify the rules concerning public participation in the decision making process.
Article 33 of that law states:
‘Before a decision requiring public participation is adopted or amended, the authority which is competent for the adoption of that decision shall inform the public, as soon as possible, of:
1.
the fact that an assessment of an activity’s impact on the environment is taking place;
2.
the initiation of the procedure;
3.
the subject of the decision to be taken in the case concerned;
4.
the authority which is competent for the adoption of the decision and the competent authorities which were consulted for their opinion or agreement;
5.
the possibilities of being made aware of the necessary documents relating to the case and the place where those documents may be consulted;
6.
the possibility of submitting observations and requests;
7.
the manner in which and the place where observations and applications may be submitted, whilst indicating in that regard that they must be submitted within a period of 21 days;
8.
the authority which is competent for the consideration of the observations and applications;
9.
the time and place of the public administrative hearing which is open to the public, as mentioned in Article 36, where it is a requirement to hold such a hearing;
10.
the procedure in relation to cross-border effects on the environment, where such a procedure is required.’
Pre-litigation procedure
On 23 October 2007, the Commission sent the Republic of Poland a letter of formal notice in which it drew that Member State’s attention to the need to ensure the complete and correct transposition of Directive 98/81.
The Republic of Poland replied to that letter of formal notice by a letter of 13 December 2007 in which it rejected the arguments put forward by the Commission in support of the claim that there had been a failure to transpose that directive or that its provisions had been transposed incorrectly.
As the Commission was not satisfied with that reply, it sent the Republic of Poland a supplementary reasoned opinion on 25 June 2009.
By letter of 20 August 2009, the Republic of Poland answered that reasoned opinion by restating the arguments put forward in its response to the Commission’s letter of formal notice.
In those circumstances, the Commission, on 6 June 2011, brought the present action.
The action
As a preliminary point, it should be recalled that the Commission has standing to seek a declaration that a Member State has failed to fulfil obligations which were created in the initial version of a European Union measure, subsequently amended or repealed, and which were maintained in force under the new provisions (Case
C-275/04
Commission
v
Belgium
[2006] ECR I-9883
, paragraph 35; judgment of 11 December 2008 in Case C‑174/07
Commission
v
Italy
, paragraph 31; and Case
C-492/08
Commission
v
France
[2010] ECR I-5471
, paragraph 31).
In the present case, it is common ground that the obligations which flow from the provisions of Directive 2009/41 relied on by the Commission correspond to those which were already applicable before the entry into force of that directive under Directive 90/219, as amended. Consequently, the Commission may plead, in the context of the present proceedings, the infringement alleged, although in the pre-litigation procedure it relied on the corresponding provisions of Directive 90/219, as amended, which was applicable at the time.
In addition, it should be stated that the Commission, in its answer, after having heard the arguments put forward by the Polish authorities in their defence, decided to withdraw the claim put forward in its application in relation to Articles 2(f), 4(3), 6, 8(1), 9(1), and the fourth indent of Part A, the first indent of Part B and the first indent of Part C of Annex V, which, therefore, are no longer the subject of the present application.
The first plea, alleging incorrect transposition of Article 2(a), (b), (d) and (e) of Directive 2009/41
‘Micro‑organisms’ and ‘genetically modified micro-organisms’
– Arguments of the parties
As a preliminary point, the Commission notes that, according to settled case-law, the need for a uniform application of Community law and the principle of equality require that the wording of a provision of European Union law which does not expressly refer to the law of Member States in order for its meaning and scope to be determined must normally be given an independent and uniform interpretation throughout the European Union; that interpretation must take into account the context of the provision and the objective pursued by the relevant legislation.
According to the Commission, the proper functioning of the scheme established by Directive 2009/41 can be ensured only by such an interpretation and by the faithful transposition of the definitions which appear in that directive, as too broad a definition of certain terms risks affecting the validity of the implementation of other provisions of that directive. Accordingly, the Commission submits that reproducing verbatim the definitions set out in a directive in the measures transposing that directive is the best way to avoid lack of uniformity in the application of European Union law in the Member States.
Whilst recognising that the Law on GMOs transposes several directives pertaining to the same field and that it thus has a broader scope than that of Directive 2009/41, the Commission notes that a correct implementation of each of the directives transposed by that legislation, which is carried out in a sufficiently transparent manner and which avoids all doubts or practical difficulties, requires that the scope
ratione personae
and
ratione materiae
of the provisions implementing those directives be none the less clearly defined and that the implementation allows for a clear distinction between the provisions transposing Directive 2009/41 and those which do not fall within the scope thereof, which is not the case here.
Furthermore, the Commission submits that, even where Member States can ensure a similar degree of protection to that resulting from Directive 2009/41, in relation to the bodies which do not fall within the scope thereof, Member States are not entitled to amend, in the course of transposing a directive, the definitions set out therein, as the uniform application of European Union law in all Member States and the principle of the autonomous and uniform interpretation of the terms appearing in that legislation would, otherwise, be rendered ineffective.
Specifically, the Commission alleges that the Republic of Poland used in the Law on GMOs, instead of the terms ‘micro‑organism’ and ‘genetically modified micro-organisms’ used in Directive 2009/41, the terms ‘organism’ and ‘genetically modified organism’, and that it failed to include, as part of the terms contained in the national legislation, ‘animal and plant cells in culture’.
The Commission also submits that the definition, set out in the Law on GMOs, of the term ‘genetically modified organism’ uses the wording ‘in which the genetic material has been altered in a manner not occurring in natural conditions’, whereas Directive 2009/41 uses more precise wording, namely ‘in which the genetic material has been altered in a way that does not occur naturally’.
In that context also, the Commission submits that the fact that the other definitions which appear in the Law on GMOs refer to ‘genetically modified organisms’ instead of ‘genetically modified micro-organisms’ also confers a broader scope on the provisions of that legislation which are based on those definitions. This in turn is alleged to lead to a lack of legal certainty and practical difficulties during the application of Directive 2009/41.
The Republic of Poland disputes the arguments put forward by the Commission. In relation to the alleged imprecision of the definition set out in the Law on GMOs of the term ‘genetically modified organism’, which makes use of the wording ‘in which the genetic material has been altered in a manner not occurring in natural conditions’, that Member State disputes the existence of such an imprecision not just in substance, but also with regard to the admissibility of the Commission’s action, inasmuch as that claim was raised for the first time at the stage of proceedings before the Court. That claim should therefore be declared inadmissible.
In substance, the Republic of Poland asserts inter alia that the material scope of the Law on GMOs was not restricted to provisions ensuring the implementation of Directive 2009/41, but includes a series of rules laid down in other provisions of European Union law, including inter alia Directive 2001/18. Consequently, the Law on GMOs governs not only the contained use of genetically modified micro-organisms, but also a series of other questions linked to that use.
Consequently, the definitions of ‘organism’ and ‘genetically modified organism’ set out in the Law on GMOs refer to both genetically modified micro-organisms and other genetically modified organisms, all the elements of those definitions set out in Directive 2009/41 having been incorporated into the relevant provisions of national law. The only existing difference stems from the extension of the scope of the Law on GMOs in comparison to the provisions of Directive 2009/41. That difference is due to the fact that the definition adopted by the Polish legislation was extended in order to encompass macro‑organisms. Furthermore, the extended scope of that legislation relates to an issue which has not been harmonised at the level of the European Union.
In relation to the argument put forward by the Commission, that the definition of the term ‘organism’ adopted by the Polish legislation does not mention animal and plant cells in culture, the Republic of Poland notes that the definition, as it appears in the Law on GMOs encompasses, in accordance with Article 3(1) thereof, ‘any biological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses and viroids’. Accordingly, that definition encompasses cells in culture, such as animal and plant cells. Indeed, cells in culture are part of the extended category which is the subject of the definition which appears in that legislation, provided that they belong to biological entities, cellular or non-cellular, which are capable of replication or of transferring genetic material. The Republic of Poland submits that, inasmuch as those cells fall within the scope of the provisions of the Law on GMOs relating to the contained use of genetically modified organisms, the requirements of Directive 2009/41 are met.
In relation to the difference noted between the wording ‘the genetic material has been altered in a manner not occurring in natural conditions’, which appears in the Law on GMOs, and the wording ‘the genetic material has been altered in a way that does not occur naturally’, used in Directive 2009/41, the Republic of Poland disputes the existence of such a difference and notes, in that regard, that the use as a complement of the present participle of a verb is not capable of conflicting with the objectives laid down by the directive.
– Findings of the Court
In relation to the admissibility of the first plea as regards the wording ‘in which the genetic material has been altered in a manner not occurring in natural conditions’, it must at the outset be recalled that it is not permissible for a party to alter the very subject-matter of the case during the proceedings, and that the merits of the action must be examined solely in the light of the claims contained in the application initiating the proceedings (see, inter alia, Case
C-543/08
Commission
v
Portugal
[2010] ECR I-11241
, paragraph 20 and case-law cited).
Furthermore, by virtue of Article 21 of the Statute of the Court of Justice of the European Union and Article 38(1) of the Court’s Rules of Procedure, in the version in force at the date of commencement of the Commission’s action, the Commission must, in any application made under Article 258 TFEU, indicate the specific complaints on which the Court is asked to rule and, at the very least in summary form, the legal and factual particulars on which those complaints are based (see, to that effect, Case
C-52/90
Commission
v
Denmark
[1992] ECR I-2187
, paragraph 17; Case
C-508/03
Commission
v
United Kingdom
[2006] ECR I-3969
, paragraph 62; Case
C-487/08
Commission
v
Spain
[2010] ECR I-4843
, paragraph 71; and Case C-543/08
Commission
v
Portugal
, paragraph 21).
In the present case, it should be noted that the Commission, in its submissions in the application initiating the proceedings, stated clearly that the complaint directed at the Republic of Poland concerned its failure correctly to transpose the concept of ‘genetically modified micro-organism’, set out in Article 2(b) of Directive 2009/41, as a result of its use, in the Law on GMOs, of the terms ‘genetically modified organism’.
It is true that it was only in its application that the Commission raised, for the first time, the argument as to the imprecision of that part of the definition of the term ‘genetically modified organism’ which appears in the Law on GMOs, which refers to an organism ‘in which the genetic material has been altered in a manner not occurring in natural conditions’. According to the Commission, Directive 2009/41, which uses the terms ‘in which the genetic material has been altered in a way that does not occur naturally’, is more precise.
It should be noted that the Commission’s claim is always targeted at the same definition, inasmuch as the part of the definition which mentions the terms ‘in which the genetic material has been altered in a manner not occurring in natural conditions’ is part of the definition of the term ‘organism’, of which it is an inseparable component and which is thus the subject of the Commission’s overall claim. Accordingly, in contrast to the Republic of Poland’s submissions, the Commission merely stated its claim that that Member State had incorrectly transposed a concept set out in Directive 2009/41, by referring, in the context of the wording of that claim, to part of that concept, rather by way of further argument intended to illustrate the validity of its claim.
It follows that the fact that the Commission set out in detail a complaint which it had already made more generally in the context of the pre-litigation procedure did not alter the subject-matter of the alleged infringement, and has thus had no effect on the scope of the proceedings (see Case
C-185/00
Commission
v
Finland
[2003] ECR I-14189
, paragraphs 84 to 87; Case
C-171/08
Commission
v
Portugal
[2010] ECR I-6817
, paragraph 29; and Case C‑543/08
Commission
v
Portugal
, paragraph 23).
In the light of the foregoing considerations, the plea of inadmissibility raised by the Republic of Poland must be rejected.
As regards the merits, it should be noted that the Commission does not dispute that the Republic of Poland is entitled to extend the scope of the protection system established by Directive 2009/41 to other fields, namely to ‘organisms’ and to ‘genetically modified organisms’. The Commission none the less submits that it would be useful to secure the possibility of distinguishing sufficiently clearly national provisions implementing that directive from those which do not fall within the scope of that act of the European Union, in order to avoid a lack of legal certainty and all doubts or practical difficulties. Therefore, according to the Commission, it is appropriate to reproduce verbatim, in national implementing acts, the definitions set out in that directive, in order to ensure the uniform application of European Union legislation in all Member States.
In that regard, it must be recalled that it is settled law that transposing a directive into national law does not necessarily require its provisions to be reproduced verbatim in a specific, express law or regulation; a general legal context may be sufficient, provided that it does effectively ensure the full application of the directive in a sufficiently clear and precise manner (see Case
C-50/09
Commission
v
Ireland
[2011] ECR I-873
, paragraph 46 and case-law cited).
Furthermore, it must be stated that, in the present case, the Commission merely alleged the specific nature of Directive 2009/41, without stating, on the one hand, what that specific nature which requires a literal transposition of the concepts set out by that directive consists of, and, on the other, the exact reasons for which it considers that the method of transposition chosen by the Republic of Poland, which confers upon the terms used in the Law on GMOs a broader scope, creates a risk of not clearly identifying the rules ensuring the implementation of that directive, thus jeopardising the uniform application of European Union law. In particular, the Commission does not refer to any situations in which one of the extended definitions used in the Law on GMOs could be the cause of practical difficulties or confusion, in relation to the application of that legislation both to micro‑organisms and to genetically modified micro-organisms.
Furthermore, the Commission has failed to show that the mere use of the term ‘organism’ instead of ‘micro-organism’ could actually jeopardise the objectives of Directive 2009/41.
In relation to the argument submitted by the Commission alleging that an incorrect definition of the terms ‘micro-organism’ and ‘genetically modified micro-organism’ has negative repercussions on other concepts set out in that directive, such as ‘accident’ or ‘user’, it must be stated that the Commission has in no way shown that that single circumstance represents a failure to fulfil obligations on the part of the Republic of Poland.
In relation to the argument alleging the lack of a reference to animal and plant cells in culture in the term ‘organism’ as it appears in the Law on GMOs, it should be stated that, as correctly noted by the Republic of Poland, that concept, which includes ‘micro-organisms’, necessarily encompasses animal and plant cells in culture. In accordance with Article 3(1) of that legislation, those cultures come under biological entities, cellular or non-cellular, capable of replication or of transferring genetic material. On that point, the requirements of Directive 2009/41 were satisfied, that provision is sufficiently clear and, accordingly, its interpretation leaves no room for doubt.
In relation to the argument alleging linguistic differences between part of the definition of the term ‘genetically modified micro-organism’ set out in Directive 2009/41, namely the words ‘in which the genetic material has been altered in a way that does not occur naturally’, and part of the definition of the term ‘organism’ used in the Law on GMOs, namely the terms ‘in which the genetic material has been altered in a manner not occurring in natural conditions’, it should be noted that the Commission is merely alleging that the directive uses more specific wording and that it is appropriate, in order to avoid any ambiguity or uncertainty, to reproduce that wording verbatim. However, the Commission has not shown how the use as a complement of the present participle of a single verb and of the term ‘naturally’ instead of the expression ‘natural conditions’ could be contrary to both the principles applicable to the implementation of directives affirmed by the case-law cited in paragraph 60 of the present judgment and the objectives pursued by Directive 2009/41.
It follows that the Commission’s argument cannot be accepted.
‘Accident’
– Arguments of the parties
The Commission accuses the Republic of Poland, first, of extending the scope of Directive 2009/41 as regards the concept of an ‘accident’ by not only cases of ‘significant’ release but any incident involving unintended release, whether significant or not.
Furthermore, by using the verb ‘could’ in the conditional, the Polish version of the directive also includes cases in which the release presents only a potential risk, whereas the definition appearing in the Law on GMOs, which uses the verb ‘may’ in conjunction with the adjective ‘direct’, refers instead to situations in which the risk is more tangible.
The Commission states, in that context, that the different definition of the term ‘accident’ which is set out in the Polish legislation may be the cause of practical difficulties during the implementation of Article 15 of the directive, which provides inter alia for consultations with other Member States on the implementation of emergency plans, the obligation to inform the Commission of the circumstances of any accident, and the obligation, for the Commission, to keep a register of accidents.
The Republic of Poland, in submitting that the definition of the term ‘accident’ cannot be the cause of any practical difficulties, disputes all the findings put forward by the Commission in that regard and defends its interpretation of Directive 2009/41, that an unintended release which could constitute a risk for health or the environment, though not significant, constitutes an ‘accident’, within the meaning of that directive. In that regard, it points out that such an interpretation constitutes a more stringent protective measure to which Member States may resort under Article 193 TFEU.
– Findings of the Court
First, it should be noted that the main objectives of Directive 2009/41 are the protection of human health and the environment. It should also be noted, as acknowledged by the Commission, that nothing precludes the Republic of Poland, in its national legislation, from providing a definition of the term ‘accident’ which is broader than that provided for under Directive 2009/41, which also covers accidents involving genetically modified organisms. In addition, the omission of the term ‘significant’ in Article 3(8) of the Law on GMOs reflects the establishment of more stringent protection in relation to accidents involving such organisms which the Republic of Poland is also entitled to establish. Accordingly, such an omission does not jeopardise the objectives pursued by Directive 2009/41 and therefore does not constitute an incorrect transposition thereof.
In the same way, it is important to note that the use, in the Law on GMOs, of the verb ‘may’ instead of the verb ‘could’ which is used in the Polish version of Directive 2009/41 cannot be regarded as running counter to the objectives pursued by that directive, provided that the provision at issue is in no way amended by the use of that verb. The same is true of the use of the term ‘direct’ in that legislation, though the directive uses the term ‘immediate’. Therefore, in those two cases also, the Republic of Poland correctly transposed the directive, ensuring the effective application thereof in accordance with the objectives of protection pursued.
Finally, in relation to the possible negative effects of the transposition of the term ‘accident’ by the Law on GMOs in relation to Article 15 of Directive 2009/41, which provides, inter alia, for consultations with other Member States on the implementation of emergency plans, the Commission submits that that legislation does not clearly state at what point such consultation must be carried out. According to the Commission, the relevant provisions of that legislation do not make it possible to determine the situations in which the Commission must be informed of the circumstances of the accident, given that the same legislation is based on a definition of the term ‘accident’ which is different from that appearing in that directive.
In that regard, the Commission is merely alleging, first, that the Law on GMOs does not make it possible to determine clearly at which point the consultations at issue must take place, without indicating however the reasons for which the definition of the term ‘accident’ used by the Polish legislature leads, according to it, to such a result.
Secondly, the Commission submits that the consequence of the use of the term ‘accident’ in that legislation is that the rules concerning the exchange of information relating to accidents, provided for under Article 15 of Directive 2009/41, apply also to information relating to releases of GMOs which are not significant, but which may nonetheless present a direct or delayed hazard to human health or the environment. However, as has already been stated in paragraph 71 of the present judgment, legislation of which the main characteristic is a high level of precaution in relation to accidents linked to the contained use of genetically modified organisms, cannot be regarded as running counter to the objectives of that directive.
It follows that the Commission’s argument cannot be accepted.
‘User’
– Arguments of the parties
The Commission alleges that, in the Law on GMOs, the Republic of Poland defined a ‘user’ as ‘a natural or legal person, or an organisational unit without legal personality, which on its own account conducts a contained use of GMOs or an activity consisting in the deliberate release into the environment of GMOs, including the placing on the market of GMO products’. That definition, which is broader than that appearing in Directive 2009/41, leads to uncertainty, in particular in relation to the obligations of users and the monitoring thereof, such that it is appropriate to reproduce verbatim the definition of the term ‘user’ set out in the directive.
According to the Commission, the differences between the two definitions at issue are important in practice, as ‘users’ must fulfil several obligations laid down by Directive 2009/41, which are not however the subject of the present proceedings. In addition, Article 16 of that directive provides, according to the Commission, that Member States are required to organise inspections to ensure that users comply with this directive. Accordingly, the variations noted between the definition appearing in the directive and that mentioned in the Law on GMOs could lead to confusion and doubt during the application of that law.
The Republic of Poland submits that the Commission does not rely on any tangible arguments and that, consequently, the wording of the plea is not sufficiently clear, precise and consistent for the defending Member State to prepare its defence and the Court of Justice to exercise its power of review. Furthermore, that Member State notes that the present proceedings do not relate to the infringement of the many provisions mentioned in that regard by the Commission.
– Findings of the Court
It is sufficient to note that the Commission is merely alleging that only a verbatim reproduction of the definition appearing in Directive 2009/41 is capable of ensuring a correct transposition of the provisions thereof, inter alia those which relate to the term ‘user’, such as, inter alia, Articles 4(2), 5(1), 6, 7, 11(1), and 14(1), without however setting out the reasons for which it considers that the approach chosen by the Republic of Poland does not secure for the persons subject to the obligations of that directive the requisite degree of legal clarity and legal certainty.
Furthermore, the Republic of Poland correctly asserts that Directive 2009/41 does not include a definition of the terms ‘natural person’ and ‘legal person’; those terms, consequently, fall within the jurisdiction of Member States. Thus, bodies specified by Polish law, which do not have legal personality, but which may enter into civil law relationships in the same way as natural and legal persons, should be included within the term ‘user’. A verbatim reproduction of the definition of the term ‘user’ set out in Directive 2009/41 would have excluded those bodies specified by Polish law from the scope of the obligations laid down by European Union law and deprived those bodies of the possibility of exercising their rights in the same way as the natural and legal persons referred to in the definition appearing in European Union law.
The Commission considers that the variations between the definition of the term ‘user’ set out in Directive 2009/41 and that used in the Law on GMOs lead, with respect to the implementation of the inspections mentioned in Article 16 of that directive, to confusion and doubt. The Commission fails, however, to provide any evidence capable of showing what such confusion may consist of.
It follows that the charge alleging incorrect transposition of Article 2(a), (b), (d) and (e) of Directive 2009/41 cannot be accepted.
Thus, as the first plea put forward by the Commission is unfounded, it must be dismissed in its entirety.
The second plea, alleging incomplete transposition of Article 10(3) of Directive 2009/41
Arguments of the parties
The Commission alleges that the Republic of Poland failed to transpose in full Article 10(3) of Directive 2009/41. Article 24(4) of the Law on GMOs restricts the possibility of attaching additional conditions to the contained use of GMOs only to those cases in which the need to protect human health or the environment so requires, whereas the relevant provision of the directive provides no such restriction.
The Republic of Poland answers that the Commission is relying on a new claim, which was not raised during the pre-litigation procedure, and should be deemed inadmissible. In the alternative, in relation to the merits, the Republic of Poland disputes the arguments put forward by the Commission by asserting that the criticised provision of the Law on GMOs allows for the competent authority to set out additional conditions for the carrying-out of the contained use of genetically modified organisms.
Findings of the Court
– Admissibility
As regards the plea of inadmissibility raised by the Republic of Poland, it should be noted that, in accordance with settled case-law, the subject-matter of an action under Article 258 TFEU for failure to fulfil obligations is determined by the Commission’s reasoned opinion, so that the action must be based on the same grounds and pleas as that opinion (Case C-171/08
Commission
v
Portugal
, paragraph 25 and case-law cited).
However, that requirement cannot be carried so far as to mean that in every case the statement of complaints in the operative part of the reasoned opinion and the form of order sought in the application must be exactly the same, where the subject-matter of the proceedings, as defined in the reasoned opinion, has not been extended or altered (Case C-171/08
Commission
v
Portugal
, paragraph 26). In its application the Commission may inter alia clarify its initial complaints provided, however, that it does not alter the subject-matter of the proceedings (Case C‑576/10
Commission
v
Netherlands
[2013] ECR, paragraph 35).
In the present case, it should be noted that in the letter of formal notice and in the reasoned opinion, the Commission indicated that it was complaining that the Republic of Poland had not implemented in full Article 10(3) of Directive 2009/41, on the ground that the Law on GMOs did not include any provisions entitling the competent national authority to require the user to amend the conditions of the proposed contained use of genetically modified organisms.
The Republic of Poland, during the pre-litigation procedure, relied on several provisions of the Law on GMOs in order to establish that it had correctly implemented Article 10(3), among which was Article 24(4) of the Law on GMOs.
The Commission answered that that provision of the Law on GMOs restricts the possibility of attaching additional conditions to the contained use of genetically modified organisms only to those cases in which the need to protect human health or the environment so requires, whereas Article 10(3) of Directive 2009/41 imposes no such restriction.
Therefore, in accordance with the case-law cited in paragraph 54 of the present judgment, the fact that the Commission set out in detail a claim which it had already made more generally in the application did not alter the subject-matter of the alleged infringement, and thus had no effect on the scope of the proceedings.
Having regard to the foregoing considerations, the Republic of Poland’s plea of inadmissibility must be rejected and the Commission’s second claim declared admissible.
– Substance
In relation to the consideration of the substance of that claim, it is sufficient to note that the objectives of Directive 2009/41 are the protection of human health and the environment, with which the competent national authorities are required to comply in implementing that directive. The words ‘if necessary’, which appear in Article 10(3) of that directive but whose meaning is not defined therein, must therefore be interpreted as allowing the competent national authority to ask the user to provide the information provided for in Article 10(3), or to lay down certain restrictions or conditions at its own initiative and only where protection of human health and the environment so require.
Accordingly, it is sufficient to note in that regard that by expressly stating, in national law, specifically in Article 24(4) of the Law on GMOs, that the objectives of the protection of human health and the environment, which objectives are affirmed in Directive 2009/41, must be taken into consideration during the implementation of that directive by the national authorities, the Republic of Poland has not acted counter to the objectives pursued by the directive, but in accordance with the purpose of that directive.
Furthermore, it must be stated that the Commission merely submits that the restriction provided for under Article 24(4) of the Law on GMOs, deprives the competent national authority of a significant part of the rights conferred upon it by Directive 2009/41, without however stating which rights are in issue in the present case and without showing in what way those rights are restricted by the disputed provision.
It follows that the plea of incomplete transposition of Article 10(3) of Directive 2009/41, which is unfounded, must be rejected.
The third plea, alleging failure to transpose Article 3(3) of Directive 2009/41
Arguments of the parties
The Commission claims that the Republic of Poland failed to transpose Article 3(3) of Directive 2009/41 into Polish law.
The Republic of Poland concedes that the provision was not the subject of a verbatim transposition. However, that Member State asserts, first, that given that the provision constitutes a rule intended to prevent conflicts of law, it considers it unnecessary to introduce such a rule into Polish law by means of a separate provision, as the existing general rules relating to the prevention of conflicts of law are sufficient to ensure such conflicts are settled in accordance with the rules set out in Directive 2009/41. Accordingly, the legal certainty on which operators subject to the obligations resulting from Article 3(3) of that directive must be able to rely is secured in full.
In addition, the Republic of Poland asserts that, in any event, those general rules are applied by the authorities and by the Polish courts in accordance with Directive 2009/41, in order for that directive to attain its objective.
Findings of the Court
In relation to the Republic of Poland’s argument that, by way of the national legislation at issue, it correctly implemented Directive 2009/41, it is sufficient to note that it is settled case-law that the provisions of directives must be implemented with unquestionable binding force, and the specificity, precision and clarity necessary to satisfy the requirements of legal certainty (see, inter alia,
Commission
v
Ireland
, paragraph 46, and judgment of 27 October 2011 in Case C‑362/10
Commission
v
Poland
, paragraph 46 and case-law cited).
As stated by the Commission, Article 3(3) of Directive 2009/41 not only constitutes a rule on conflict of laws whose purpose is to determine the applicable rule in a given case, but also sets out the conditions which govern the storage, culture, transport, destruction, disposal or use of genetically modified micro-organisms which have been placed on the market in accordance with Directive 2001/18 or any other European Union legislation which provides for a specific environmental risk assessment similar to that laid down in Directive 2009/41.
Accordingly, where European Union legislation is concerned, it is appropriate to establish whether that legislation provides for such an assessment and, irrespective of that condition, it is necessary to show that the contained use at issue complies with the conditions, if any, of the consent for placing on the market. Where those conditions are not met, Directive 2009/41 applies.
The Republic of Poland, in response to the Commission’s submissions, has neither explained the general rules on conflict of laws provided for under Polish law nor shown whether they are actually capable of securing the legal certainty which operators subject to the obligations flowing from the national legislation at issue must be able to rely on.
In any event, mere administrative practices, which by their nature are alterable at will by the authorities and are not given the appropriate publicity, cannot be regarded as constituting the proper fulfilment of obligations to transpose a directive (see, in particular, Case
C-507/04
Commission
v
Austria
[2007] ECR I-5939
, paragraph 162 and case-law cited). In the same way, an interpretation, by national courts, of the provisions of domestic law in accordance with those of a directive cannot in itself achieve the clarity and precision needed to meet the requirement of legal certainty (see
Commission
v
Ireland
, paragraph 47 and case-law cited).
Consequently, the Commission’s plea alleging failure to correctly implement Article 3(3) of Directive 2009/41 in Polish law is well founded.
The fourth plea, alleging failure to transpose Articles 7, 8(2) and (3), and 9(2)(a) of Directive 2009/41
Arguments of the parties
The Commission submits that the Republic of Poland has not implemented Articles 7, 8(2) and (3), and 9(2)(a) of Directive 2009/41, which lay down inter alia the rules relating to notification of subsequent class 1 and 2 contained uses following a notification carried out in accordance with Article 6 of that directive, and the period of 45 days within which the competent authority’s decision must be made in the case of a class 3 or higher class in relation to premises which have been the subject of a previous notification.
The Republic of Poland disputes the merits of that claim; it asserts that the objective referred to in Directive 2009/41 was attained by means of the Polish notification system. It notes inter alia that Member States enjoy a measure of discretion in the context of the implementation of those provisions, as Article 7 of that directive provides that ‘subsequent class 1 contained use may proceed without further notification’. The verb ‘may’ is also used at Article 8(2) of that directive. According to the Republic of Poland, a Member State is not required to ensure that a subsequent contained use of genetically modified organisms may proceed without further notification. In addition, that Member State submits that, even supposing that the provision of Polish law requiring users of genetically modified organisms to notify the competent authority of a proposed reuse of class 1 and 2 genetically modified organisms does not comply with the provisions of Directive 2009/41, that provision should be considered as constituting a more stringent measure adopted pursuant to Article 193 TFEU. Finally, though Articles 8(3) and 9(2)(a) of that directive were not the subject of a verbatim transposition into Polish law, the attainment of the objectives referred to by that directive is ensured in full.
Findings of the Court
As a preliminary point, the claim should be divided in two parts, alleging failure to implement, respectively, Articles 7 and 8(2) of Directive 2009/41 and Articles 8(3) and 9(2)(a) thereof.
In relation to the first part of that claim, it must be stated that the Republic of Poland’s arguments are based on a misinterpretation of the provisions at issue. It is clearly and unequivocally apparent from Articles 7 and 8(2) of Directive 2009/41 that those articles refer to users upon whom is conferred the possibility of carrying out the activities mentioned in those provisions without it being necessary to otherwise notify the competent authority. That interpretation flows not only from a literal interpretation of those provisions, but is corroborated by a teleological interpretation thereof.
In that regard, it is sufficient to note that the purpose of that regulation is to allow users who have already sent notification of a use in accordance with Article 6 of Directive 2009/41 to proceed immediately with a subsequent contained use without waiting for further authorisation from the competent authority. Accordingly, both the second sentence of Article 7 of that directive, which provides that users of genetically modified micro-organisms in class 1 contained uses shall be required to keep a record of each assessment referred to in Article 4(6) of the directive, which shall be made available to the competent authority on request, and Article 8(2) of that directive, which provides that, if the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification, are directed at users.
In any event, it does not appear that the Member State concerned has transposed those articles of Directive 2009/41. That finding is corroborated by the Commission’s statement to that effect and by the Republic of Poland’s failure to challenge in that regard, and by the latter’s failure to indicate the existence of provisions implementing those same articles.
Even Article 31 of the Law on GMOs, which is not challenged by the Commission in the present proceedings, does not constitute a transposition of Article 8(2) of Directive 2009/41. As a result of the reference to risk categories I or II, whereas Article 8(2) of the directive refers to a class 2 or higher class use, the scope of Article 31 is different.
Furthermore, in relation to the second paragraph of Article 8(2) of the directive, according to which the applicant may itself request from the competent authority a decision on the grant of a formal authorisation, which must be made within a maximum of 45 days from the notification, it must be noted that the Republic of Poland did not dispute the Commission’s claim in that regard. Article 24 of the Law on GMOs, the only relevant provision in that regard, is not directed at the tangible situation contemplated by that provision of the directive and does not provide for any similar period.
Finally, in relation to the Republic of Poland’s argument regarding the application of Article 193 TFEU, it is sufficient to note that, as has been stated at paragraphs 111 and 112 of the present judgment, it does not appear that Articles 7 and 8(2) of Directive 2009/41 have, even in part, been transposed into national law, so that a comparison of the provisions of that directive to those constituting more stringent protection measures may not be carried out. Accordingly, the application of Article 193 TFEU cannot be relied on in the present case.
In relation to the second part of the fourth plea, the Republic of Poland concedes that Articles 8(3) and 9(2)(a) of Directive 2009/41 have not been transposed verbatim into national law and merely states that the objective pursued by that directive is attained by the Law on GMOs.
It is apparent from the file, and is furthermore not disputed by the Republic of Poland, that no written procedure, such as that provided for under Article 9(2)(a) of Directive 2009/41, appears in the Law on GMOs or in any other implementing act. It should also be noted that neither does the detailed procedure described in Article 8(3) of that directive have any equivalent in Polish law.
It follows from the foregoing considerations that the fourth plea must be upheld.
The fifth plea, alleging incorrect transposition of Article 10(4) of Directive 2009/41
Arguments of the parties
The Commission submits that Article 24(1a) of the Law on GMOs established a maximum period of 30 days for the extension of the time-limit for granting the authorisation relating to the contained use of genetically modified organisms in the event of public participation in a procedure whose purpose is the grant of such an authorisation, though that period is not prescribed by Article 10(4) of Directive 2009/41. Furthermore, the Commission notes that it was never notified of the Law on access to information relating to the environment, to which the Republic of Poland refers in that regard, as a transposition measure of that directive.
The Republic of Poland disputes the Commission’s statement that the Commission was never notified of the legislation as part of the notification of measures implementing Directive 2009/41. Furthermore, in relation to the substance, it asserts inter alia that as the directive does not lay down a period for the consultation, Member States may define that period. In the absence of a limitation of the duration of the public consultation, the grant by the competent authority of the authorisation of the contained use of genetically modified organisms could, in breach of the principle of legal certainty, be obstructed.
Findings of the Court
Even though the Republic of Poland has not put forward a plea that this claim is inadmissible, it should nevertheless be noted at the outset that the Court may of its own motion examine whether the conditions laid down in Article 258 TFEU for bringing an action for failure to fulfil obligations are satisfied (see, inter alia, Case C‑524/10
Commission
v
Portugal
[2012] ECR, paragraph 64, and Case C‑34/11
Commission
v
Portugal
[2012] ECR, paragraph 42).
From that point of view, it is appropriate to determine whether the reasoned opinion and the application set out that plea coherently and precisely in order that the Court may appreciate exactly the extent of the alleged infringement of European Union law, a condition which is necessary in order to enable the Court to determine whether there has been a breach of obligations as alleged (see, to that effect, judgment of 24 March 2011 in Case C‑365/10
Commission
v
Slovenia
, paragraph 19, and in Case C-34/11
Commission
v
Portugal
, paragraph 43).
Indeed, as is apparent in particular from Article 38(1) of the Rules of Procedure, in the version in force at the date of commencement of the present action, and from the case-law relating to that provision, the application initiating proceedings must state the subject-matter of the dispute and a summary of the pleas in law and that statement must be sufficiently clear and precise as to enable the defendant to prepare its defence and the Court to rule on the application. It is therefore necessary for the essential points of law and fact on which a case is based to be indicated coherently and intelligibly in the application itself and for the form of order sought to be set out unambiguously so that the Court does not rule
ultra petita
or indeed fail to rule on a claim (see, inter alia, judgment of 26 January 2012 in Case C‑185/11
Commission
v
Slovenia
, paragraph 29; judgment of 19 April 2012 in Case C‑141/10
Commission
v
Netherlands
, paragraph 15; and Case C-34/11
Commission
v
Portugal
, paragraph 44).
In the present case, the Commission’s observations relate only to the public inquiry or consultation mentioned in Article 10(4)(b) of Directive 2009/41, without the Commission stating whether its claim alleging incorrect transposition of Article 10(4) also refers to the periods for awaiting further information mentioned in Article 10(4)(a) of that directive.
In those circumstances, it must be stated that the present plea, in as much as it alleges an incorrect transposition of Article 10(4)(a) of Directive 2009/41 which does not satisfy the requirements of coherence, clarity and precision and misconstrues the obligations flowing from the case-law cited in paragraphs 122 and 123 of the present judgment, fails to put the Court in a position to rule on the present infringement proceedings (see, to that effect, Case C-34/11
Commission
v
Portugal
, paragraph 48), and must therefore be declared inadmissible.
As regards the merits of the plea alleging incorrect transposition of Article 10(4)(b) of Directive 2009/41, it should be noted that the Commission merely alleges that the period established by Article 24(1a) of the Law on GMOs is not prescribed by that directive, without however submitting any arguments in support of its claim that that provision of national law constitutes an incorrect transposition of Article 10(4) of that directive.
In that regard, it should be noted that Article 10(4)(b) of Directive 2009/41 provides that, for the calculation of the periods referred to in Articles 8 and 9 of that directive, the periods during which the competent authority carries out a public inquiry or consultation are not to be taken into account. On the other hand, it must be noted that no provision of that directive sets out the duration of that inquiry or consultation. Member States are therefore, in principle, free to determine, in compliance with the law of the European Union, the duration thereof, if they consider it necessary to do so.
The Republic of Poland made use of that possibility and adopted a rule limiting the duration of such a consultation to 30 days, such that the period for granting the authorisation may be extended by a maximum of 30 days. That Member State submits that that period was established as a result of considerations whose aim is to ensure that the proper course of the administrative procedure is followed. Furthermore, according to the Republic of Poland, if the maximum duration of such a consultation is not limited, the grant by the competent authority of an authorisation could be obstructed where no such period is set out. It adds that such a period is also necessary for reasons of legal certainty.
It should be noted that the objectives set out in the national legislation at issue are not incompatible with those pursued by Directive 2009/41. Indeed, they ensure efficient processing of applications for authorisations whilst upholding the interests and rights of the notifier and the needs of the national authority.
In those circumstances, it is appropriate to dismiss the fifth plea raised, which is in part inadmissible and in part unfounded.
The sixth plea, alleging failure to transpose Article 18(1), second subparagraph, and Article 18(3) and (4) of Directive 2009/41
Arguments of the parties
In the context of this plea, the Commission alleges inter alia that the Republic of Poland failed to provide, as part of the confidential treatment of certain information disclosed by the notifier, for a consultation of the notifier, in accordance with Article 18(1) of Directive 2009/41, or for the deletion of that data from the register of contained uses of genetically modified organisms, in the event of the withdrawal of an application for an authorisation.
The Republic of Poland answers that the relevant provisions of European Union law were correctly transposed by the Law on GMOs. Article 14a of that legislation, in listing the information to which the public has access, allows for the determination of the information which must never be disclosed, so that national legislation distinguishes between data which may not remain confidential and that which may not be made public. All the information received in the context of the notification and which must not be disclosed appears in that register. In the event of the withdrawal of an application for an authorisation, those data are deleted from that register.
Findings of the Court
It should be noted that the Republic of Poland submits that the protection of the information submitted by the notifier in accordance with Article 18(1) of Directive 2009/41 is restricted only to the data for which the notifier may require confidential treatment. According to that Member State that protection is excluded in relation to the information listed in Article 18(2) of that directive, so that the organisation of a consultation with the notifier is unnecessary, in as much as the need to ensure access to that information flows from the legislation. That Member State adds that it is also unnecessary to organise consultations in order to determine the information requiring confidential treatment by the competent authority, where separate provisions already provide for the information at issue not to be disclosed as a result, inter alia, of the need to ensure the protection of personal data or the overriding interest of the State.
It should be noted that those arguments are based on a misinterpretation of the relevant provisions of European Union law.
It is sufficient to state that Article 18(2) of Directive 2009/41 lists the information which in no case may be kept confidential. It follows that other information may receive confidential treatment at the request of the notifier, who shall enjoy, in that regard, a right of prior consultation under Article 18(1), second subparagraph, of the directive.
Accordingly, the interpretation that non-disclosure of information which falls under the scope of Article 18(1) of Directive 2009/41 could be automatic cannot be accepted.
In the same way, the argument relied on by the Republic of Poland, alleging that it is also unnecessary to organise consultations to determine what information requires confidential treatment by the competent authority, where separate provisions already provide for the information at issue not to be disclosed as a result, inter alia, of the need to ensure the protection of personal data or the overriding interest of the State, is unfounded. In order to ensure legal certainty and to secure the rights of the notifier, a consultation with the notifier in the context of the procedure laid down by Article 18 of Directive 2009/41 is vital; resorting to rules set out in different national legal texts whose context and interaction may be difficult to understand for the notifier is no substitute for that consultation.
Furthermore, no relevance can be attributed to the Republic of Poland’s reference to Article 16(1)(7) of the Law on access to information relating to the environment in as much as that provision relates only to certain commercially sensitive information and does not expressly provide for the notifier’s prior consultation.
Finally, the Republic of Poland contends, in its observations, that, if the notifier withdraws its application for an authorisation for the contained use of genetically modified organisms, the data submitted will be withdrawn from the register mentioned at paragraph 131 of the present judgment. However, that Member State does not advance any provision of national law capable of supporting this contention, and merely submits that the minister of the environment, who is responsible, as a government body, for keeping that register, does not fulfil its function if it does not proceed with that withdrawal, as the data set out in that register could mislead interested parties.
In that regard, it is sufficient to note that, in accordance with the case-law cited in paragraph 105 of the present judgment, mere administrative practices, which by their nature are alterable at will by the authorities and are not given appropriate publicity, cannot be regarded as constituting proper fulfilment of obligations to transpose a directive.
The sixth plea is therefore well founded.
It follows from all the above considerations that, in failing to transpose Articles 3(3), 7, 8(2) and (3), 9(2)(a), 18(1), second subparagraph, and 18(3) and (4) of Directive 2009/41, the Republic of Poland has failed to fulfil its obligations under that directive.
Costs
Under Article 138(1) 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. Pursuant to Article 138(3) of those rules, the parties are to bear their own costs where each party succeeds on some and fails on other heads.
In the present case, account should be taken of the fact that the Commission’s claims alleging incorrect transposition of Articles 2(a), (b), (d) and (e), and 10(3) and (4), of Directive 2009/41 have not been upheld.
Consequently, the Commission and the Republic of Poland must be ordered to bear their own costs.

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

1.
Declares that, in failing to transpose Articles 3(3), 7, 8(2) and (3), 9(2)(a), 18(1), second subparagraph, and 18(3) and (4), of Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms, the Republic of Poland has failed to fulfil its obligations under that directive;

2.
Dismisses the action as to the remainder;

3.
Orders the European Commission and the Republic of Poland to bear their own costs.

[Signatures]
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)   Language of the case: Polish