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Cite as: [2006] EUECJ C-138/5, [2006] ECR I-8339, [2006] EUECJ C-138/05

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OPINION OF ADVOCATE GENERAL

SHARPSTON

delivered on 4 May 2006 (1)

Case C-138/05

Stichting Zuid-Hollandse Milieufederatie

Minister van Landbouw, Natuur en Voedselkwaliteit

1. In the present case the College van Beroep voor het bedrijfsleven (Administrative Court for Trade and Industry) (the Netherlands) has asked the Court for an interpretation of Article 8 of Directive 91/414 concerning the placing of plant protection products on the market ("the Plant Protection Products Directive" or "the Directive"). (2)

2. That article lays down transitional measures for the implementation of the Directive.

3. The issue is essentially as follows. The Plant Protection Products Directive requires Member States to establish procedures for the authorisation of plant protection products (3) in accordance with the Directive. It also provides for the application of national authorisation systems for such products during a transitional period, pending assessment at Community level of the active substances concerned. During that transitional period, the Netherlands has amended its national legislation for the regulation of plant protection products (the Bestrijdingsmiddelenwet 1962 (Law on pesticides; "the BMW")) three times: (i) initially, before Community assessment had got under way, by providing for authorisation of such products on the basis of the same criteria as were to be used for Community assessment; (ii) subsequently, since the first approach had led to a reduction in the number of permitted products on the market, by providing for an authorisation procedure for "agriculturally essential products" on submission of a complete dossier; (iii) most recently, by adding Article 16aa to the BMW.

4. Article 16aa provides that "where the interests of agriculture so urgently require" the competent minister may grant an exemption or derogation from the prohibition on marketing and use which would otherwise apply with regard to products containing an active substance which (a) was on the market before 26 July 1993, (b) is not designated by the Plant Protection Products Directive and (c) in respect of which the review referred to in Article 8(2) of that directive is being commenced or continued.

5. By decision taken under Article 16aa the competent authority so exempted a number of active substances. The Stichting Zuid-Hollandse Milieufederatie (the South Holland Environmental Assocation Foundation: "the Foundation") contests the validity of that decision on the basis that Article 16aa is not compatible with the Plant Protection Products Directive.

Relevant Community legislation

The Plant Protection Products Directive

6. The Plant Protection Products Directive regulates both "plant protection products" and "active substances" in such products.

7. Plant protection products are defined as "active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user", intended principally to protect plants or plant products against harmful organisms. (4) The Directive accordingly concerns pesticides, fungicides and herbicides to be applied to plants.

8. The preamble contains the following recitals:

Whereas:

"[7] uniform rules on the conditions and procedures for the authorisation of plant protection products must be applied by the Member States;

[8] such rules should provide that plant protection products should not be put on the market or used unless they have been officially authorised and should be used properly having regard to the principles of good plant protection practice and of integrated pest control;

[9] the provisions governing authorisation must ensure a high standard of protection, which, in particular, must prevent the authorisation of plant protection products whose risks to health, groundwater and the environment have not been the subject of appropriate research; and human and animal health should take priority over the objective of improving plant production;

[10] it is necessary, at the time when plant protection products are authorised, to make sure that, when properly applied for the purpose intended, they are sufficiently effective and have no unacceptable effect on plants or plant products, no unacceptable influence on the environment in general and, in particular, no harmful effect on human or animal health or on groundwater;

...

[14] the Community procedure should not prevent Member States from authorising for use in their territory for a limited period plant protection products containing an active substance not yet entered on the Community list, provided that the interested party has submitted a dossier meeting Community requirements and the Member State has concluded that the active substance and the plant protection products can be expected to satisfy the Community conditions set in regard to them;

[18] however, Member States must be enabled to authorise plant protection products not complying with the abovementioned conditions when it is necessary to do so because of an unforeseeable danger threatening plant production which cannot be countered by other means; whereas such authorisation should be reviewed by the Community in close cooperation with the Member States in the framework of the Standing Committee on Plant Health ..."

9. Article 3(1) requires Member States to prescribe that a plant protection product may not be placed on the market and used in their territory unless they have authorised the product in accordance with the Directive.

10. Article 4(1) requires Member States to ensure that a plant protection product is not authorised unless, first, its active substances are listed in Annex I and any conditions laid down therein are fulfilled (Article 4(1)(a)) and, second, a number of requirements laid down in Article 4(1)(b) to (f) are met. Article 4(1)(b) to (e) essentially concern the safety and effectiveness of the product when used. Article 4(1)(f) requires maximum residue levels to have been established by the Member State and notified to, and approved by, the Commission.

11. Article 8 is headed "Transitional measures and derogations". Its paragraphs deal, sequentially, with arrangements for new products containing active substances not yet approved and listed (Article 8(1) - not relevant here), existing products containing such active substances (Articles 8(2) and 8(3)) and products required to address, in special circumstances, an unforeseeable danger that cannot be contained by other means (Article 8(4)).

12. The first subparagraph of Article 8(2) provides that, by way of derogation from Article 4 and without prejudice to Article 8(3), "a Member State may, during a period of 12 years following the notification of [the directive], authorise the placing on the market in its territory of plant protection products containing active substances not listed in Annex I that are already on the market two years after the date of notification". (5)

13. The fourth subparagraph of Article 8(2) provides:

"During the 12-year period referred to in the first subparagraph it may, following examination by the Committee referred to in Article 19 of such active substance, be decided by the procedure laid down in that Article that the substance can be included in Annex I and under which conditions, or ... that such active substance will not be included in Annex I. The Member States shall ensure that the relevant authorisations are granted, withdrawn or varied, as appropriate, within a prescribed period."

14. Article 8(3) provides:

"Where they review plant protection products containing an active substance in accordance with paragraph 2, and before such review has taken place, Member States shall apply the requirements laid down in Article 4(1)(b)(i) to (v), and (c) to (f) in accordance with national provisions concerning the data to be provided."

15. Article 8(4) provides:

"By way of further derogation from Article 4, in special circumstances a Member State may authorise for a period not exceeding 120 days the placing on the market of plant protection products not complying with Article 4 for a limited and controlled use if such a measure appears necessary because of an unforeseeable danger which cannot be contained by other means. In this case, the Member State concerned shall immediately inform the other Member States and the Commission of its action. It shall be decided without delay, in accordance with the procedure laid down in Article 19, whether and under which conditions the action taken by the Member State may be extended for a given period, repeated, or revoked."

16. The period of 12 years referred to in Article 8(2) has been extended until 31 December 2006 for active substances assessed in the framework of the first stage of the Commission's programme for examining such substances, until 30 September 2007 for those assessed in the framework of the second stage and until 31 December 2008 for those assessed in the framework of the third stage. (6)

17. Article 13(1) prescribes the dossiers which Member States are to require applicants for authorisation of a plant protection product to submit with their application. Article 13(6) provides:

"By way of derogation from paragraph 1, for active substances already on the market two years after notification of this directive, Member States may, with due regard for the provisions of the Treaty, continue to apply previous national rules concerning data requirements as long as such substances are not included in Annex I."

18. Article 23(1) requires Member States to bring into force the laws, regulations and administrative provisions necessary to comply with the directive within two years following notification thereof. It is common ground that the directive was notified on 26 July 1991.

The Biocidal Products Directive

19. The questions referred also briefly mention Directive 98/8 concerning the placing of biocidal products on the market ("the Biocidal Products Directive"). (7)

20. That directive concerns the authorisation and the placing on the market for use of biocidal products within the Member States. "Biocidal products" are defined as products intended, by chemical or biological means, to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any organism which has an unwanted presence or a detrimental effect for humans, their activities or the products they use or produce, or for animals or for the environment. (8)

21. Article 3(1) requires Member States to "prescribe that a biocidal product shall not be placed on the market and used in their territory unless it has been authorised in accordance with this Directive".

22. Article 5(1) provides that Member States are to authorise a biocidal product only if "the active substance(s) included therein are listed in Annex I or IA and any requirements laid down in these Annexes are fulfilled" and if a number of other conditions are fulfilled.

23. Article 16(1) provides:

"By way of ... derogation from Articles 3(1), 5(1) ... a Member State may, for a period of 10 years from [14 May 2000], continue to apply its current system or practice of placing biocidal products on the market. It may, in particular, according to its national rules, authorise the placing on the market in its territory of a biocidal product containing active substances not listed in Annex I or IA for that product type. Such active substances must be on the market on [14 May 2000] as active substances of a biocidal product ...".

Relevant national legislation

The BMW

24. The BMW establishes the College voor de toelating van bestrijdingsmiddelen (the Pesticides Authorisation Board; "the CTB") and provides that decisions on the authorisation or registration of pesticides are to be taken, on application, by that body. The BMW was amended in 1994 in order to implement the Plant Protection Products Directive. (9)

25. Article 2(1) provides:

"It is prohibited to sell, place in stock or store, bring into the Netherlands or use any pesticide which is not shown to be authorised ... under this Law."

26. Article 3 states that a plant protection product is not to be authorised unless prescribed conditions are satisfied. Those conditions substantially mirror those laid down in Article 4(1) of the Plant Protection Products Directive.

27. Article 16a(1)(a) provides that in special circumstances the competent Minister may grant an exemption or derogation from Article 2(1) for a period not exceeding 120 days "if such a measure appears necessary because of an unforeseeable danger which cannot be contained by other means" (reflecting the wording of Article 8(4) of the Plant Protection Products Directive).

28. Article 16aa(1) provides that "where the interests of agriculture so urgently require" the competent minister may grant an exemption or derogation from the prohibition which would otherwise apply with regard to products containing an active substance which (a) was on the market before 26 July 1993, (b) is not designated by the Plant Protection Products Directive and (c) in respect of which the review referred to in Article 8(2) of that directive was commenced or in progress after 26 July 2003.

29. Article 16aa(2) provides that an exemption or derogation may be subject to conditions or limitations and withdrawn at any time. However, it is to be noted that such exemptions or derogations are not otherwise limited in duration.

The background to Article 16aa

30. It appears from the order for reference that in 1995 the Netherlands chose not to make use of the transitional provisions set out in Article 8(2) of the Plant Protection Products Directive but decided, in anticipation of the assessment of active substances at Community level, to examine the eligibility for authorisation of plant protection products in the light of the Community criteria. The effect was that authorisations of a substantial number of products were not renewed on termination. Netherlands growers were accordingly able to use a smaller number of products than their competitors in other Member States.

31. In an attempt to reverse that development, the BMW was amended by the addition of Article 25c which provided for an authorisation procedure for "agriculturally essential plant protection products". However, that measure was apparently unsuccessful since the industry (10) was deterred by the costs associated with the requirement that a complete dossier be submitted. The Foundation also notes that applicants were required to show that their products were indeed essential and that no applicant in fact succeeded in this.

32. Accordingly, in 2002 Article 25c was replaced by Article 16aa.

The main proceedings and the reference to the Court

33. On 21 April 2004 the Minister van Landbouw, Natuur en Voedselkwaliteit (Minister for Agriculture, Nature and Food Quality; "the Minister") adopted the Decision on Exemptions for Plant Protection Products 2004. That decision, which was adopted under Article 16aa of the BMW, granted to the users referred to therein and for the benefit of the crops described therein an exemption from the prohibition laid down in Article 2(1) of the BMW, subject to compliance with certain conditions. The decision stipulated that it was to expire as from 1 January 2005.

34. On 28 April 2004 the Minister adopted a decision amending the abovementioned decision by extending the exemption contained therein to specific applications of a number of plant protection products.

35. In June 2004 the Foundation lodged an objection against the decision of 28 April 2004.

36. In October 2004 the Minister declared that objection in part inadmissible and in part unfounded.

37. The Foundation has appealed to the referring court. That court has doubts concerning a number of questions of interpretation of the Plant Protection Products Directive. Accordingly it has stayed the proceedings and referred six questions to the Court of Justice for a preliminary ruling. (11)

38. Written observations have been submitted by the Foundation, by the Danish, French, Greek and Netherlands Governments and by the Commission. No hearing was requested and none has been held.

The decision in Stichting ZHM I

39. The Court has already given some guidance on the interpretation of Article 8 of the Plant Protection Products Directive, together with Article 16 of the Biocidal Products Directive, in the context of earlier proceedings brought by the Foundation in Case C-316/04 ("Stichting ZHM I"). (12)

40. Stichting ZHM I concerned Article 25d of the BMW, also added in 2002. That provision essentially provides for re-authorisation by operation of law - and hence without the full assessment that would otherwise be required pursuant to Article 3(1) of the BMW - of previously authorised products whose active substances have been designated by the CTB. Instead of carrying out the full assessment, the CTB when designating an active substance is required to "have regard to" certain of its effects.

41. The Foundation challenged a decision by which the CTB had designated a number of active substances. Plant protection products containing those substances thereby benefited from automatic re-authorisation under Article 25d of the BMW.

42. The Court delivered its judgment in Stichting ZHM I after the reference had been made and the observations lodged in the present case. As will appear below, most of the questions referred have been directly or indirectly answered by that judgment.

43. It may however be useful at this stage to mention some aspects of Article 8(2) and (3) of the Plant Protection Products Directive which follow from the judgment in Stichting ZHM I. Both those provisions apply during the transitional period.

44. Article 8(2) permits Member States to authorise plant protection products already on the market on 26 July 1993, even where they contain active substances not yet assessed at Community level. The Court ruled that, in granting such authorisation, Member States are not required to comply with Article 4 of the Directive. (13)

45. An authorisation pursuant to Article 8(2) will not, however, necessarily remain valid until the active substance concerned has been assessed at Community level. That is because Article 8(3) permits Member States at their initiative to review plant protection products which have been authorised pursuant to Article 8(2) if there are any indications that any of the requirements for granting them are not satisfied. That review must take place while the authorisation granted under Article 8(2) is still current. In order to decide whether to carry out such a review, the Member States must apply the requirements of Article 4(1) (14) of the Directive; in that context, national provisions will determine the data to be provided. (15)

46. A more general preliminary observation as to the place of Article 8 within the Directive may also be helpful. It is clear that the legislator's intention was to deal comprehensively in Article 8 with the different sets of circumstances that might justify a limited and/or temporary derogation from the comprehensive and unified rules otherwise laid down by the Directive. It is equally clear, from the general tenor of these provisions, albeit that they authorise derogations from the normal rules, that the overall aims and objectives of the Directive are nevertheless to be respected as far as possible.

Admissibility

47. France has raised a preliminary issue as to the admissibility of the first two questions referred. Since these questions have, in any event, already been answered by the judgment in Stichting ZHM I, notwithstanding analogous admissibility issues there raised (unsuccessfully) by France, (16) I do not think that this point need detain the Court further.

The first question

48. By its first question, the referring court asks whether Article 8 of the Plant Protection Products Directive may be applied by a national court after the period referred to in Article 23 thereof has expired. It is clear from the order for reference that the issue raised is whether Article 8 has direct effect. The referring court is of the view that it can only assess whether Article 16aa of the BMW is compatible with that provision if that question is answered in the affirmative.

49. The first question is identical to the first limb of the first question referred in Stichting ZHM I.

50. In its judgment in that case, the Court stated that "when it applies domestic law, and in particular legislative provisions specifically adopted for the purpose of implementing the requirements of a directive, the national court is bound to interpret national law, so far as possible, in the light of the wording and the purpose of the directive concerned in order to achieve the result sought by the directive and consequently comply with the third paragraph of Article 249 EC". (17)

51. In his Opinion in that case, Advocate General Jacobs, having made the same point, had noted that the referring court would need an interpretation of the relevant provisions of the Plant Protection Products Directive and the Biocidal Products Directive whether or not they had direct effect. He therefore did not consider it necessary to answer the first question referred in the terms in which it was expressed, since the national court would have sufficient guidance from the answers to the remaining questions. (18)

52. The Court similarly did not give a direct answer to that question, presumably for the same reason.

53. In my view, the first question referred in the present case calls for the same response.

The second question

54. By its second question, the referring court asks whether Article 8(2) of the Plant Protection Products Directive has the same meaning as Article 16 of the Biocidal Products Directive. The referring court notes that Article 16(1) of the Biocidal Products Directive provides that a Member State may "continue to apply its current system or practice of placing biocidal products on the market" for the transitional period. Essentially it is asking whether Article 8(2) of the Plant Protection Products Directive is to be interpreted in the same way as that provision, which (in its view) permits a Member State during the transitional period to retain its "current system or practice" however that system or practice operates.

55. That question is identical to the second question referred in Stichting ZHM I. (19)

56. In its judgment in that case, the Court ruled that Article 16(1) of the Biocidal Products Directive has the same meaning as Article 8(2) of the Plant Protection Products Directive. (20)

The third and fourth questions

57. By its third question, the referring court asks whether Article 8(2) of the Plant Protection Products Directive is a standstill obligation in the sense that a Member State has the power to alter its existing system or practice only in so far as that results in an assessment in connection with the authorisation of plant protection products which is consistent with that directive. By its fourth question, it asks whether, if the third question is answered in the negative, Article 8(2) imposes limits on amendments to national rules concerning the placing on the market of biocidal products, and if so what limits. It is therefore convenient to deal with these questions together.

58. In Stichting ZHM I, the referring court had asked whether Article 16(1) of the Biocidal Products Directive was a standstill obligation and whether, if not, that provision contained other restrictions on the right of Member States to amend their existing authorisation systems during the transitional period.

59. By those questions, the national court was essentially asking (21) whether a Member State may alter its system or practice in place at the time the Biocidal Products Directive entered into force (i) only in so far as the assessment in connection with the authorisation of biocidal products is carried out in accordance with the directive; or (ii) only in so far as the alterations do not affect the scheme of the existing system or practice; or (iii) subject to no limitations other than those which under Article 10 EC are applicable during the period laid down for implementation in accordance with Inter-Environnement Wallonie. (22)

60. In Inter-Environnement Wallonie, the Court had ruled that during the period laid down for transposition of a directive Member States must refrain from taking any measures liable seriously to compromise the result prescribed by the directive and that it is for the national court to assess whether that is the case as regards the national provisions at issue. (23)

61. In Stichting ZHM I the Court ruled that Article 16(1) of the Biocidal Products Directive does not constitute a "standstill" obligation. However, the Member States" right to amend their systems for the authorisation of biocidal products cannot be regarded as unlimited. The principle enunciated by the Court in Inter-Environnement Wallonie in respect of the transposition period applies mutatis mutandis to a transitional period, such as that provided for in Article 16(1) of the Biocidal Products Directive, during which Member States are authorised to continue to apply their national systems, even though those systems do not comply with that directive. Consequently, it is for the national court to determine whether that is the case with regard to the national provisions the lawfulness of which it is required to examine. (24)

62. The Court also concluded in its judgment in Stichting ZHM I that the transitional regimes provided for in Article 8(2) of the Plant Protection Products Directive and Article 16(1) of the Biocidal Products Directive have the same meaning, since the purpose of both those provisions is to allow the Member States, during the transitional periods defined in those two directives, to apply existing national authorisation procedures for the placing on the market of the products covered by those directives and containing active substances which have not yet been evaluated at Community level. (25)

63. I draw the following conclusions from that analysis. First, Article 8(2) of the Plant Protection Products Directive is similarly not to be construed as a standstill obligation. Second, the second paragraph of Article 10 EC and the third paragraph of Article 249 EC require that during the transitional period prescribed in Article 8(2) the Member States must refrain from adopting any measures liable seriously to compromise the result prescribed by the Plant Protection Products Directive. Third, it is for the national court to determine whether that is the case with regard to the national provisions the lawfulness of which it is required to examine, in the light of any further criteria for assessing compatibility provided by the Court.

The fifth question

64. The fifth question referred, which is put if the fourth question is answered in the negative, asks by what criteria the national court should assess whether measures taken are liable seriously to compromise the result prescribed by the Plant Protection Products Directive.

65. It appears from the order for reference that the national court wishes to know in particular whether Article 10 EC or provisions of the Plant Protection Products Directive preclude a Member State from reversing its initial decision to implement that directive by setting up a new exemption from authorisation, rather than by using the power conferred by the provision to maintain its existing system or practice.

66. The Foundation's starting point is that the ninth recital to the Plant Protection Products Directive sets a high standard of protection and makes it clear that the environment and human and animal health should take priority over the objective of improving plant production. The authorisation process plays a key role, implying that the authorisation itself must have a sufficient qualitative standard. Thus, authorisation must include an adequate risk assessment. That is, indeed, the only explanation for the requirement for an authorisation. (26) An inadequate assessment compromises a number of the objectives which the Directive seeks to attain, in so far as possible, as from 1993 - in particular, achieving a high standard of protection of health and the environment and preventing plant protection products being marketed before they are adequately assessed.

67. The Foundation is doubtful that applying Article 16aa of the BMW results in an adequate assessment. The "urgent interests of agriculture" appear to be paramount. In practice, Article 16aa leaves it to the competent minister whether or not to take account of ecological criteria and other interests. Nothing compels him to carry out a risk assessment. In practice, plant protection products have been exempted even where they do not comply with one or more ecological criteria. Thus, Article 16aa conflicts directly with the objectives of the Directive and compromises their realisation.

68. The Netherlands Government, unsurprisingly, takes the opposite view. Its starting point is that (by analogy with Advocate General Jacobs" analysis of the Biocidal Products Directive in Stichting ZHM I), (27) the Plant Protection Products Directive prescribes (i) a framework of rules relating to the placing on the market for use of plant protection products, at the core of which is the authorisation procedure, (ii) the mutual recognition of authorisations and (iii) the establishment at Community level of a positive list of active substances which may be used in plant protection products. Against that background it stresses the following points.

69. First, in the Netherlands plant protection products cannot be authorised unless there has been a favourable administrative decision. That is also the case for plant protection products which contain existing active substances with have not yet been the subject of assessment at Community level.

70. Second, Article 16aa of the BMW concerns solely plant protection products containing existing active substances which have not yet been the subject of assessment at Community level. Authorisations granted on the basis of that provision are in practice granted only for a few months and in any event for a maximum of one year. Such an authorisation may moreover be granted only where the product presents no danger for public health or the health of the operator who applies it and where there is no unacceptable risk for the environment. The fact that Article 16aa does not require an applicant to provide the information referred to in Article 13(1) of the Directive is not incompatible with the Directive, since Article 13(6) permits Member States to continue to apply previous national rules concerning data requirements.

71. Third, if the Commission decides not to enter an active substance on the list in Annex I or imposes conditions on such an entry, the temporary authorisation is varied or withdrawn within the time-limit which the Commission has set for that effect in its decision. In Netherlands law, the Minister may at any point withdraw an authorisation (Article 16aa(2)). Moreover by virtue of Article 16aa(1)(c) he may be bound to do so, because an authorisation may be granted pursuant to Article 16aa only for plant protection products based on active substances which have not yet been the subject of assessment by the Commission.

72. Finally, Article 10 EC does not preclude a Member State from reversing its initial choice not to use the transitional regime, a fortiori where that decision is the result of delays at Community level.

73. The Commission considers that the regime introduced by Article 16aa of the BMW constitutes a de facto authorisation and not a "review" within the meaning of Article 8(3) of the Directive. The system put in place by Article 16aa must therefore be assessed on the basis of Article 8(2). (Article 8(4) of the Directive is not relevant, because Article 16aa does not seek to authorise a plant protection product in case of unforeseeable danger.) The Directive does not lay down specific conditions applicable to the authorisation of such products during the transitional period. The Commission notes that the referring court implies that the risks for humans and the environment are kept to an acceptable level. The result prescribed by the Directive does not therefore seem to be seriously compromised.

74. The Danish Government suggests that, since the period for implementing the Directive expired some time ago, the Member States" leeway during the transitional period must be assessed solely on the basis of the provisions of the Directive, in particular Article 8 in conjunction with the relevant provisions of Article 4, within the context of the timescale for implementation contained in Article 23. Article 10 EC is not relevant.

75. Neither the French Government nor the Greek Government makes separate submissions on the fifth question.

76. I agree with the Foundation that the recitals to the Directive (28) indicate that the whole system of authorisations that it puts in place is based on a high level of protection of health, groundwater and the environment. It is to be assumed that the Community legislator did not intend the leeway afforded to Member States under the various transitional provisions contained in Article 8 to undermine that objective.

77. Recital 14 describes the intended scope of Member States" power to authorise "for use in their territory for a limited period" - which I take to be a reference to the transitional period covered by Article 8 - "plant protection products containing an active substance not yet entered on the Community list". In the recital, that power is described as being subject to two requirements. The interested party must "submit a dossier meeting Community requirements"; and the Member State must have "concluded that the active substance and the plant protection products can be expected to satisfy the Community conditions set in regard to them". (29)

78. From that recital, it therefore appears that the Member States were not intended to have carte blanche under the transitional regime. Rather, although Member States may continue to apply national procedures, (i) those national procedures must be such as to permit adequate examination of the product and its active substance; and (ii) the Member State is (in effect) to carry out an assessment that is a proxy for the intended assessment at Community level, and should only authorise the active substance and the product if it is reasonably satisfied that these would be considered acceptable by Community standards.

79. Against that background, I turn to the substantive provisions reflecting recital 14. The Court has already held that Article 8(2) is to be interpreted as meaning that if a Member State authorises the placing of a product on the market in its territory under that provision, it is not required to comply with the specific provisions of Article 4 or Article 8(3) of the Plant Protection Products Directive. (30) The review procedure laid down in Article 8(3) is distinct from the authorisation procedure provided for by Article 8(2). (31) That review procedure may be applied (it seems, at any time) to products already authorised under Article 8(2); (32) and, when it is so applied, Member States must indeed observe the requirements of Article 4(1)(b)(i) to (v), and (c) to (f) of the Directive. (33)

80. It seems to me that it would be very odd to read Article 8(2) as permitting a Member State to use a procedure for authorisation under that provision that obviated the need for any detailed dossier describing the product and its active substance. It is difficult to see how, in the absence of such a dossier, the type of examination envisaged by recital 14 can actually take place. Unless and until the Member State carried out a review under Article 8(3), there would (potentially) be very little hard information underpinning the assessment and the authorisation.

81. Likewise, it would be strange if Article 8(2) permitted a procedure for authorisation that contains no binding requirement for the competent authority to take into account the effect of the product on health, groundwater and the environment. Again, in the absence of such a requirement, and unless or until a review under Article 8(3) was carried out, it is difficult to see how compliance with the objectives of the Directive could be guaranteed.

82. I accept that in practice the relevant Minister may indeed have careful and proper regard to environmental considerations before authorising a product in exercise of his powers under Article 16aa BMW. (34) The fact remains that the system put in place by Article 16aa BMW is not one that, structurally, requires him to do so.

83. Accordingly, I conclude that the national court, in assessing whether the measures taken are liable seriously to compromise the result prescribed by the Plant Protection Products Directive, should have regard inter alia to the structure of the system put in place by national law. Measures establishing a system that does not require a dossier to be submitted, and that contain no binding requirement for the competent authority to take into account the effect of the product on health, groundwater and the environment, are to be regarded as measures that are likely seriously to compromise the result prescribed by the Directive.

84. The national court also wishes, in particular, to have guidance on the separate but related issue of whether Article 10 EC or provisions of the Plant Protection Products Directive preclude a Member State from reversing its initial decision to implement that directive by setting up a new exemption from authorisation. That issue may be dealt with briefly.

85. A directive is binding upon a Member State, in accordance with the third paragraph of Article 249 EC, from the date of its entry into force. (35) Once a Member State has exercised its powers to select measures that provide for implementation during a transitional period, it may not subsequently replace those measures with new measures that provide for a lesser degree of implementation of the directive.

86. This follows from the duty of loyal cooperation laid down by Article 10 EC. A transitional period represents recognition by the Community legislator that the aims and objectives of the directive cannot realistically be achieved at once. During such a transitional period, Member States are certainly free to adapt their national laws progressively, so that by the end of the transitional period the substantive requirements of the directive are duly complied with in full. What they may not do, it seems to me, is then subsequently to change their legislation again in a "retrograde" way, i.e. to introduce new provisions that are further from, rather than closer to, what the directive ultimately requires. (36)

87. It seems to me that there is no good reason why a different principle should be applied in the case of the Plant Protection Products Directive.

88. As the order for reference makes clear, the regime applicable in the Netherlands to existing products has been modified three times. (37) The present variant (Article 16aa of the BMW) became law well after the expiry of the two year transposition period. (38) It seems to me that if Member States are obliged during the transposition period to "refrain from taking any measures liable seriously to compromise the result prescribed" (39) - an obligation that flows from Article 10 EC and from the third paragraph of Article 249 EC - that obligation must be, if anything, more compelling once the transposition period has ended.

89. Furthermore, Article 13(6) of the Directive (derogating from the "normal" rule under Article 13(1) that applicants for authorisation of a plant protection product should submit a dossier with their application) states that, "for active substances already on the market two years after notification of this directive, Member States may ... continue to apply previous national rules concerning data requirements as long as such substances are not listed in Annex I". Leaving open the question of whether a Member State might apply new national rules that more closely mirrored the Directive's requirements, I read that provision as precluding subsequent modification of the relevant national rules in a retrograde sense. A fortiori that would be the case where such modification consisted of removing the requirement for a dossier to be submitted and omitting to impose any binding requirement for the competent authority to take into account the effect of the product and its active substance on health, groundwater and the environment.

90. Accordingly, I conclude that it is not permissible for a Member State to reverse its initial decision to implement the Plant Protection Products Directive by setting up a new exemption from authorisation, after the expiry of the transposition period but during the transitional period, that reflects the aims and objectives of the directive less adequately than its predecessors. Such a measure is liable seriously to compromise the result prescribed by the Directive.

The sixth question

91. By its sixth question the referring court asks whether Article 8(2) of the Plant Protection Products Directive means that where a Member State authorises the placing on the market in its territory of plant protection products containing active substances not listed in Annex I to the Directive that were already on the market two years after the date of notification thereof, regard must also be had to the provisions of Article 4 and/or Article 8(3) thereof.

92. That question is identical to the fourth question referred in Stichting ZHM I. As I have already indicated, the Court there ruled that Article 8(2) of the Plant Protection Products Directive means that if a Member State authorises the placing on the market on its territory of plant protection products containing active substances not referred to in Annex I to that directive that were already on the market two years after the date of notification of the Directive, it is not required to comply with the provisions of Article 4 or Article 8(3) of that directive.

The seventh question

93. The referring court's seventh question asks essentially whether a decision on exemption or derogation based on Article 16aa of the BMW constitutes a "review" within the meaning of Article 8(3) of the Plant Protection Products Directive, at least where a new application of a plant protection product already on the market is concerned, given that such an exemption is granted on the basis of an examination in which, by way of departure from the existing system, it is merely considered whether there are unacceptable risks to the operator/worker, human health and the environment.

94. That question is similar, but not identical, to the fifth question referred in Stichting ZHM I, which also asked about the scope of a "review" within the meaning of Article 8(3) of the Plant Protection Products Directive. The Court there ruled that a "review" within the meaning of Article 8(3) presupposes that the plant protection product at issue has already been the subject of an authorisation, and that that authorisation is still valid at the time when the review is carried out. The purpose of that review is not a re-evaluation of an active substance in isolation. Rather, it is a re-evaluation of the final plant protection product. It is at the initiative of the national authorities and not at the initiative of the individuals concerned that the relevant product is reviewed. It is therefore for the national court to assess whether a national evaluation process (in that case, the evaluation provided for in Article 25d of the BMW) corresponds to all the characteristics of a "review" within the meaning of Article 8(3). (40)

95. In the present case, therefore, it is similarly for the national court to assess whether the examination provided for in Article 16aa of the BMW corresponds to all the characteristics of a "review" within the meaning of Article 8(3), as determined by the Court in Stichting ZHM I.

96. That said, I note that the information given in the order for reference, supplemented by the observations of the Netherlands Government, suggests that the examination provided for in Article 16aa of the BMW is not a "review" within the meaning of Article 8(3). That is because it would appear that (i) an exemption or derogation is granted under Article 16aa on application by the interested party rather than on the initiative of the competent authority and (ii) the procedure was designed precisely for plant protection products which are not already the subject of a valid authorisation when that application is made.

The eighth question

97. By its eighth question the national court asks essentially whether the rules in Article 8(3) of the Plant Protection Products Directive apply only to the provision of data before a review or also to the way in which a review must be organised and carried out.

98. That question is identical to the sixth question referred in Stichting ZHM I, in which the Court ruled that Article 8(3) of the Plant Protection Products Directive contains only provisions relating to the provision of data prior to a review.

Conclusion

99. I am accordingly of the view that the questions referred by the College van Beroep voor het bedrijfsleven (the Netherlands) should be answered as follows:

Question 1:

When it applies domestic law, and in particular legislative provisions specifically adopted for the purpose of implementing the requirements of a directive, the national court is bound to interpret national law, so far as possible, in the light of the wording and the purpose of the directive concerned in order to achieve the result sought by the directive and consequently comply with the third paragraph of Article 249 EC.

Question 2:

Article 8(2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ("the Plant Protection Products Directive") has the same meaning as Article 16(1) of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market.

Questions 3 and 4:

Article 8(2) of the Plant Protection Products Directive is not to be construed as a standstill obligation. However, the second paragraph of Article 10 EC and the third paragraph of Article 249 EC require that during the transitional period prescribed in Article 8(2) the Member States must refrain from adopting any measures liable seriously to compromise the result prescribed by the Plant Protection Products Directive. It is for the national court to determine whether that is the case with regard to the national provisions the lawfulness of which it is required to examine, in the light of any further criteria for assessing compatibility provided by the Court.

Question 5:

If a Member State reverses its initial decision to implement the Plant Protection Products Directive by setting up a new exemption from authorisation, after the expiry of the transposition period but during the transitional period, that reflects the aims and objectives of the directive less adequately than its predecessors, such a measure is liable seriously to compromise the result prescribed by that directive.

Question 6:

Article 8(2) of the Plant Protection Products Directive means that if a Member State authorises the placing on the market on its territory of plant protection products containing active substances not referred to in Annex I to that directive that were already on the market two years after the date of notification of the Directive, it is not required to comply with the provisions of Article 4 or Article 8(3) of that directive.

Question 7:

It is for the national court to assess whether the examination provided for in Article 16aa of the Bestrijdingsmiddelenwet 1962 (Law on pesticides) corresponds to all the characteristics of a "review" within the meaning of Article 8(3) of the Plant Protection Products Directive, as determined by the Court in Case C-316/04 Stichting Zuid-Hollandse Milieufederatie I.

Question 8:

Article 8(3) of the Plant Protection Products Directive contains only provisions relating to the provision of data prior to a review.

1 - Original language: English.

2 - Council Directive 91/414/EEC of 15 July 1991 (OJ 1991 L 230, p. 1).

3 - See point 7 below.

4 - Article 2(1).

5 - Presumably, the reference to "two years" in this article corresponds to the fact that Member States had two years from the date of notification to transpose the Directive.

6 - Commission Regulation (EC) No 1335/2005 of 12 August 2005 (OJ 2005 L 211, p. 6).

7 - Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 (OJ 1998 L 123, p. 1).

8 - Article 2(1)(a) and (f).

9 - By Law of 15 December 1994 (Staatsblad 1995, 4).

10- I.e., the holders of authorisations - professional growers, some of whom were small enterprises.

11 - The questions are summarised below under the individual headings.

12 - Judgment of 10 November 2005.

13 - Stichting ZHM I, paragraph 57.

14 - Other, of course, than the requirement in Article 4(1) that the active substances concerned be listed in Annex I.

15 - Stichting ZHM I, paragraphs 48 to 57.

16 - See Stichting ZHM I, paragraphs 26 to 34.

17 - Paragraph 78.

18 - Point 47.

19 - Although the second question in the present case refers to Article 16 in general rather than to Article 16(1) (the subject of the second question in Stichting ZHM I), it is clear from the order for reference that it is Article 16(1) which is likewise at issue in the present case.

20- It is helpful to read that answer in the context of Case C-306/98 Monsanto [2001] ECR-3279, paragraphs 43 to 44, to which Stichting ZHM I cross-refers, which give a more detailed explanation of the rationale behind the answer.

21 - See point 51 of the Opinion of Advocate General Jacobs.

22 - Case C-129/96 [1997] ECR I-7411.

23- See the detailed discussion at paragraphs 35 to 50, much of which is pertinent to the issues raised in the present case.

24 - Paragraphs 40 to 43, citing Inter-Environnement Wallonie, paragraph 45.

25 - Paragraphs 60 to 62, referring to Monsanto, cited in footnote 20, paragraphs 43 and 44.

26 - Article 3(1); see also the reference to assessment in Article 13(6).

27 - Point 57 of the Opinion.

28 - In particular recitals 9 and 10.

29 - Emphasis added.

30 - Stichting ZHM I, paragraph 57, following on from the more detailed statement in paragraph 51.

31 - Stichting ZHM I, paragraph 50.

32 - Stichting ZHM I, paragraph 54.

33 - Stichting ZHM I, paragraphs 48 to 50.

34 - The exact details of the review arrangements are for the national court to consider. I note, however, that one of the two advisory bodies (NOTOX) consulted by the relevant minister may have significant links to the industry.

35 - See Inter-Environnement Wallonie, paragraphs 40 to 41, and points 59 to 61 of the Opinion of Advocate General Kokott in Case C-313/02 Wippel [2004] ECR I-9483.

36 - See, in respect of an ordinary period for transposition, Case C-14/02 ATRAL [2003] ECR I-4431, paragraphs 58 and 59; as to the gradual achievement of the result intended by a directive, see point 77 of the Opinion of Advocate General Geelhoed, delivered on 14 July 2005, in Case C-320/03 Commission v Austria; see also by analogy Case C-144/04 Mangold, judgment of 22 November 2005, paragraphs 71 to 72.

37 - See point 3 above.

38 - Article 23 of the Directive.

39 - Inter-Environnement Wallonie, paragraph 45.

40 - Paragraphs 67 to 69.