62004CC0316_EN
Opinion of the Advocate-General
Opinion of the Advocate-General
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 the Plant Protection Products Directive (2) and Article 16 of the Biocidal Products Directive. (3)
2. Those articles lay down transitional measures for the implementation of the two directives.
3. The issue is essentially as follows.
Those directives require Member States to establish procedures for the authorisation of plant protection products and biocidal products.
Both directives make provision 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 amended its national system so as to permit, in effect, applications for automatic authorisation of plant protection and biocidal products which (i) had been previously authorised and (ii) contained active substances which had been designated by its competent authority.
By decision taken under the amended law the competent authority so designated a number of active substances.
The validity of that decision has been contested, inter alia on the basis that the amended law is not compatible with the abovementioned directives.
Relevant Community legislation
The Plant Protection Products Directive
4. The Plant Protection Products Directive regulates both ‘plant protection products’ and ‘active substances’ in such products.
5. 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.
6. 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.
7. 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.
8. Annex I was empty when the directive was adopted, pending completion of various stages of the Community assessment process envisaged by the legislation.
The first entry in that annex was made with effect from 1 January 1999;
further entries have been made by a series of directives continuing into 2003.
9. Article 4(5) provides:
‘Authorisations may be reviewed at any time if there are indications that any of the requirements referred to in paragraph 1 are no longer satisfied. …’
10. Article 8 is headed ‘Transitional measures and derogations’.
11. The first subparagraph of Article 8(2) provides that, by way of derogation from Article 4 and without prejudice to paragraph 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’.
12. Article 8(3) provides as follows:
‘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.’
13. The period of 12 years referred to in Article 8(2) was extended until 31 December 2005 for certain active substances and until 31 December 2008 for others. (5)
14. 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.’
15. 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
16. Recital 20 in the preamble to the Biocidal Products Directive states that close coordination should be ensured with other Community legislation and in particular with the Plant Protection Products Directive.
17. The directive concerns the authorisation and the placing on the market for use of biocidal products within the Member States. (6)
18. ‘Biocidal 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 to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means’. (7)
‘Harmful organism’ is defined as ‘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)
An exhaustive list of 23 types of biocidal products annexed to the directive includes as main group headings disinfectants and general biocidal products, preservatives and pest control products. (9)
19. 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’.
20. 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 a number of other conditions are fulfilled.
21. When the Biocidal Products Directive was adopted, those annexes had no content;
that is still the case.
The directive laid down a procedure for the inclusion of active substances in its annexes after an evaluation process.
22. Article 8(2) provides that Member States are to require applicants for authorisation of a biocidal product to submit a dossier, the contents of which are prescribed by Article 8(4).
23. Article 16 is headed ‘Transitional measures’.
Article 16(1) provides:
‘By way of further derogation from Articles 3(1), 5(1), 8(2) and 8(4) … 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 …’
24. Article 34 provides that Member States are to bring into force the measures necessary to comply with the directive not later than 24 months after its entry into force.
Article 35 states that the directive is to enter into force on the 20 th
day following its publication, namely on 14 May 1998.
Relevant national legislation
The national law before the 2002 amendment
25. The Bestrijdingsmiddelenwet 1962 (Law on pesticides, (10) ‘the BMW’) establishes the College voor de toelating van bestrijdingsmiddelen (Pesticides Authorisation Board (‘CTB’)) and provides that decisions on the authorisation or registration of pesticides are to be taken, on application, by the CTB.
The BMW was amended in 1994 to implement the Plant Protection Products Directive. (11)
26. Section 2 of the BMW, headed ‘Authorisation and registration of pesticides’, includes Articles 2 to 5.
27. 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 or, in the case of a low-risk biocidal product, registered under this Law.’
28. Article 3(1) essentially implements Article 4(1) of the Plant Protection Products Directive.
In particular, Article 3(1)(a)(1) to (10) set out conditions which substantially mirror those laid down in Article 4(1)(b)(i) to (v) of the directive and Article 3(1)(b) to (d) reflect Article 4(1)(c) to (e) of the directive.
29. Article 3(2)(a) implements Article 4(1)(a) of the Plant Protection Products Directive.
30. Article 3a(1) provides:
‘More detailed rules may be laid down regarding the criteria for authorisation and registration as referred to in Article 3(1)(a) and (2)(c) and the principles governing assessment may be laid down by or under a general administrative measure.’
31. Article 4(1) provides that decisions on the authorisation or registration of pesticides are to be taken, on application, by the CTB.
32. Article 5(1) provides that the authorisation or registration of a pesticide is to be valid for a renewable period not exceeding 10 years to be fixed in the decision on authorisation or registration.
The background to the 2002 amendment
33. Since Article 4(1) of the Plant Protection Products Directive requires as a condition of authorisation of such a product by a Member State that its active substances are listed in Annex I to the directive, and that any conditions laid down therein are fulfilled, national authorisation systems could not fully implement the directive until that annex had at least some content.
As indicated above, (12) that did not start to happen until 1999 and is not yet completed.
The referring court explains that in the 1990s the Netherlands Government decided to provide for the assessment and re-assessment of plant protection products in advance of the Community assessment of active substances.
That decision was made because of the intensive use of such products in the Netherlands and the specific circumstances which exist there, such as intensive agriculture, high population density and the presence of a large amount of surface water.
34. Insufficient progress having been made by 2000, the CTB decided to give priority to the assessment of active substances and drew up lists of substances classified by the degree of risk they pose to humans, animals and the environment.
Active substances posing a high risk in respect of those factors were placed on the A list.
Active substances which the CTB deemed to pose no significant or a low risk were placed on the B or C list respectively.
35. With reference to products the active substance(s) of which had been placed on the B or C list, the CTB adopted what were known as ‘procedural renewal decisions’, by which it appears that existing authorisations were, on application, automatically renewed on expiry.
By judgment of 2 July 2002 the referring court ruled that the CTB was not competent so to renew authorisations.
Article 25d was accordingly added to the BMW with effect from 4 December 2002 in order to provide a legal basis for the CTB’s practice.
The 2002 amendment – Article 25d
36. Article 25d 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, the CTB when designating an active substance is required to ‘have regard to’ its effects referred to in Article 3(1)(a)(3) to (10) of the BMW, which implement Article 4(1)(b)(iii) to (v) of the directive.
It appears to be common ground that the active substances designated by the CTB pursuant to Article 25d (or in any event those active substances at issue in the present case) are substances which are included in the B and C lists.
37. Article 25d is in the following terms:
‘1.	A pesticide whose active substance or active substances have been designated by the [CTB] shall, by way of derogation from the provisions laid down by or under Articles 3 and 3a and Article 4(1) and 5(1), be authorised or registered by operation of law with effect from the time referred to in paragraph 3.
2.	Where an active substance within the meaning of paragraph 1 is designated, regard shall be had to the effect of the active substance concerned referred to in Article 3(1)(a)(3) to (10).
3.	 The authorisation or registration referred to in paragraph 1 shall take effect on the date of termination of the authorisation or registration granted under Article 4 [and] shall, by way of derogation from Article 5(1), be valid until the date by which a Community measure adopted in relation to the active substance concerned, as referred to in Article 3(2)(a), must be implemented, on the understanding that it shall, in any event, continue until 26 July 2003 or 15 May 2010 where no Community measure stating whether the active substance concerned may be used as the basis for a plant protection or biocidal product has been adopted by the relevant date.
…
6.	Paragraph 1 shall:
(a) not apply to pesticides the authorisation or registration of which cannot be granted under a Community measure;
(b) not apply to pesticides the authorisation or registration of which must, under a Community measure, be withdrawn as from the date by which that measure must be implemented;
(c) apply solely to pesticides which contain an active substance which was already sold before 26 July 1993, in the case of a plant protection product, or 15 May 2000, in the case of a biocidal product, and was not designated by a Community measure referred to in Article 3(2)(a);
(d) apply solely to pesticides which have been authorised, or were authorised for the last time on 1 January 2001, or have been registered;
… .’
38. The Netherlands Government states in its observations that Article 25d is intended to implement Article 8(2) of the Plant Protection Products Directive and Article 16(1) of the Biocidal Products Directive.
That government also stated at the hearing that it is a condition of authorisation by operation of law pursuant to Article 25d that a new application is submitted with a full dossier.
The main proceedings and the questions referred
39. By decision of 12 June 2002 the CTB designated a large number of active substances as active substances within the meaning of Article 25d of the BMW.
The decision was based on Article 25d and entered into force on the same day as that provision, namely on 4 December 2002.
It appears to be common ground that plant protection products containing those active substances were already on the market two years after the date of notification of the Plant Protection Products Directive, that biocidal products containing those active substances were already on the market on 14 May 2000 and that those products were previously authorised in accordance with the BMW;
those products accordingly became authorised by operation of law.
40. By decision of 12 May 2004 the CTB declared unfounded the objections to the decision of 12 June 2002 lodged by the Stichting Zuidhollandse Milieufederatie (the South Holland Environmental Assocation Foundation;
‘the Foundation’).
41. The Foundation appealed to the College van Beroep voor het bedrijfsleven.
It argued essentially that Article 25d of the BMW was inconsistent with the Plant Protection Products Directive.
That directive provides that plant protection products may be authorised only where it is established that the criteria contained in Article 4 thereof have been satisfied.
Article 8(2) of the directive speaks of ‘authorise’ and thereby refers to the entire procedure laid down in Article 4.
42. The referring court takes the view that Article 25d of the BMW differs in terms of both procedure and assessment from the system of assessment laid down in Section 2 thereof.
As regards procedure, Article 25d introduces the device of authorisation of a pesticide by operation of law, whereas Section 2 of the BMW takes as a basis an individual decision on each authorisation.
As regards assessment, Article 25d provides for an examination of the active substance and Section 2 lays down an assessment of the pesticide.
There is a considerable difference in intensity between such assessment and examination.
In the case of a normal examination of a plant protection product pursuant to Articles 3 and 3a of the BMW, a comprehensive assessment of the substance and its breakdown products, consistent with the rules on authorisation laid down in the Plant Protection Products Directive and the Biocidal Products Directive, is carried out.
In contrast, authorisation of a pesticide by operation of law flows from the designation of an active substance which has regard to the effects of that substance in terms of human and animal health and the environment detailed in Article 25d(2) of the BMW.
43. The College van Beroep voor het bedrijfsleven has stayed the proceedings and referred six questions to the Court of Justice for a preliminary ruling. (13)
44. Written observations have been submitted by the Foundation, by 3M Nederland BV and 81 other interested parties (14) joined in the main proceedings (‘3M Nederland’), by the Danish, French and Netherlands Governments and by the Commission.
The Netherlands Government states that its observations are also on behalf of the CTB.
The first question
45. By its first question, the referring court asks whether Article 8 of the Plant Protection Products Directive or Article 16 of the Biocidal Products Directive may be applied by a national court after the period referred to in, respectively, Article 23 of the Plant Protection Products Directive and Article 34 of the Biocidal Products Directive has expired.
It is clear from the order for reference that the issue raised is whether Articles 8 and 16 have direct effect;
it appears that the referring court is of the view that it can assess whether Article 25d of the BMW is compatible with those provisions only if that question is answered in the affirmative.
46. The Foundation and 3M Nederland submit that both limbs of the first question should be answered in the affirmative.
The Danish Government submits that Article 8(2) and (3) of the Plant Protection Products Directive has direct effect after expiry of the deadline for implementation only in the sense that a national court may verify whether a national authority has complied with the procedure there laid down.
A manufacturer or trader may never however claim entitlement to an authorisation on the basis of Article 8(2) or (3).
47. It is settled case-law that a national court hearing a case which falls within the scope of a given directive must, if at all possible, interpret national law, whether adopted before or after the directive, in the light of the wording and the purpose of the directive in order to achieve the result pursued by the latter. (15)
Accordingly, as the Commission and the Netherlands Government submit, it seems clear that the referring court will need an interpretation of the relevant provisions of the Plant Protection Products Directive and the Biocidal Products Directive whether or not they have direct effect.
I therefore do not consider it necessary to answer the first question referred in the terms in which it is expressed, since the national court will have sufficient guidance from the answers to the remaining questions.
That is all the more so since, according to the Netherlands Government, the national provision at issue in the present case – namely Article 25d of the BMW – is intended to implement Article 8(2) of the Plant Protection Products Directive and Article 16(1) of the Biocidal Products Directive, the subject-matter of the second, third and fourth questions referred.
The second question
48. By its second question, the referring court asks whether Article 16 of the Biocidal Products Directive has the same meaning as Article 8(2) of the Plant Protection Products Directive.
It appears from the order for reference that that question was prompted by the fact that Article 25d of the BMW relates both to plant protection and biocidal products.
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 Article 16(1), which in its view permits a Member State during the transitional period to retain its ‘current system or practice’ of placing biocidal products on the market, however that system or practice operates.
49. Since the referring court’s third question asks for an interpretation of Article 16 of the Biocidal Products Directive and its fourth question asks for an interpretation of Article 8(2) of the Plant Protection Products Directive, it seems preferable to consider those questions first;
the answer to the second question will then become apparent.
The third question
50. By its third question, the referring court asks (i) whether Article 16(1) of the Biocidal Products Directive is to be interpreted as a standstill obligation, (ii) whether, if not, it imposes limits on amendments to national rules concerning the placing on the market of biocidal products and (iii) if so, what those limits are.
51. It is apparent from the order for reference that the national court is essentially asking 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;
(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 . (16)
52. In that case, the Court 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.
53. The Foundation takes the first line referred to by the national court, submitting that in permitting Member States to continue to apply their current system Article 16 means that that system must in principle be maintained and that alterations to it are authorised only if they result in a system more in conformity with the directive.
54. I am not convinced by that interpretation.
Article 16(1) states that it applies by way of derogation from Articles 3(1), 5(1), 8(2) and 8(4).
Those provisions constitute the core of the authorisation procedure laid down by the directive:
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’, 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 a number of other conditions are fulfilled, and Article 8(2) provides that Member States are to require applicants for authorisation of a biocidal product to submit a dossier, the contents of which are prescribed by Article 8(4).
55. Clearly no measures adopted by a Member State during the transitional period could comply wholly with those provisions with regard to active substances not yet listed in Annexes I and IA:
indeed Article 16(1) was presumably designed precisely to cater for that situation.
56. It must also be borne in mind that Article 16(1) is a transitional provision designed to apply for 10 years in a field where environmental and health and safety concerns are paramount.
A system or practice which was current at the start of that period may obviously need modifying in the light of scientific developments.
57. However, it does not follow that a Member State has an unfettered power to amend its legislation during the transitional period laid down by the Biocidal Products Directive.
It follows from the judgment of the Court in Inter-Environnement Wallonie
that a Member State may not amend its legislation in a manner which is liable seriously to compromise the result prescribed by the directive.
The Biocidal Products Directive prescribes (i) ‘a framework of rules relating to the placing on the market for use of biocidal products’, (17) 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 biocidal products. (18)
A Member State would not therefore in my view be entitled to amend its legislation so as to provide, for example, that biocidal products previously subject to an authorisation procedure could be placed on the market for use as such without any authorisation.
58. In the present case, the legislative amendment at issue relaxes the authorisation procedure for biocidal products containing active substances which are, first, contained in lists established at national level of active substances deemed by the relevant national authority to pose no significant risk or a low risk to humans, animals and the environment and, second, the subject of a previous authorisation.
Such products will, on application, benefit from authorisation by operation of law;
that authorisation will expire if a Community measure adopted in relation to the active substance concerned requires implementation.
59. It does not seem to me that such a measure is liable seriously to compromise the result prescribed by the Biocidal Products Directive.
However, as the Court made clear in Inter-Environnement Wallonie, and as the Commission submits in the present case, it is for the national court to make that assessment in so far as it involves the interpretation of the national measure.
The fourth question
60. The national court puts its fourth question only if the answer to the second question is in the negative.
The second question asks whether Article 16 of the Biocidal Products Directive has the same meaning as Article 8(2) of the Plant Protection Products Directive.
However, as I have indicated I consider that the answer to the fourth question will help to provide the answer to the second question, rather than the other way round;
I accordingly propose to consider the fourth question before the second.
61. The fourth question 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 (‘existing plant protection products’), regard must also be had to the provisions of (i) Article 4 and/or (ii) Article 8(3) thereof.
62. The two limbs of that question are in fact two sides of the same coin:
the argument that, when granting an authorisation pursuant to Article 8(2) for existing plant protection products, a Member State must apply certain provisions of Article 4 arises only if the view is taken that Article 8(3) applies in such a situation.
63. That interpretation is urged by the Foundation and the Danish and French Governments, on the basis that Article 8(3), which requires Member States to apply the requirements laid down in Article 4(1)(b)(i) to (v) and (c) to (f), applies when Member States ‘review plant protection products containing an active substance in accordance with Article 8(2)’.
Those parties accordingly submit that it follows from that wording that both limbs of that question must be answered in the affirmative.
64. In Monsanto, (19) the Court was asked whether Article 8(3) applied when, pursuant to Article 8(2), an application was submitted to a Member State for first authorisation to place on the market a generic existing plant protection product, with the consequence that that Member State was under an obligation to evaluate such an application in accordance with the requirements laid down in Article 4(1)(b)(i) to (v), and (c) to (f). (20)
65. Monsanto contended that, under Article 8(2) and (3), a Member State could not authorise the placing on the market in its territory of a new plant protection product unless the applicant for authorisation provided information establishing that the product satisfied the criteria laid down by Article 4(1)(b) to (f). (21)
66. The Court stated that a review as referred to in Article 8(3) ‘implies that the plant protection product has already been authorised to be placed on the market, as may be inferred, in particular, from Article 4(5) …, according to which authorisations for plant protection products the active substances of which are listed in Annex I may be reviewed at any time if there are indications that any of the requirements for granting them are no longer satisfied’.
It continued:
‘However, a generic plant protection product in respect of which an application is submitted, pursuant to the first subparagraph of Article 8(2) …, for a first authorisation to place on the market is not a plant protection product which has already been authorised to be placed on the market.
Accordingly, when such an application for authorisation to place on the market is submitted, there can be no question of reviewing the plant protection product concerned as provided for in Article 8(3) …
…
It follows that [the Plant Protection Products Directive] does not require an application for a first authorisation to place on the market a generic [existing] plant protection product …, to be assessed in accordance with the requirements laid down in Article 4(1)(b)(i) to (v), and (c) to (f), of that directive.’ (22)
67. It seems to follow unequivocally from that ruling that where a Member State authorises the placing on the market in its territory of existing plant protection products, it is not necessary to have regard to Article 4 or 8(3) of that directive.
The referring court’s fourth question would accordingly seem to call for a negative answer, as 3M Nederland, the Netherlands Government and the Commission submit.
68. The Foundation however submits that it follows from the wording of Article 8(3), which applies where a Member State reviews plant protection products containing an active substance ‘in accordance with paragraph 2’, that that provision applies whenever a Member State grants an authorisation in accordance with paragraph 2.
69. I confess that, although the Court’s ruling in Monsanto appears to be unambiguous, I was troubled by the seeming conflict between the interpretation laid down by the Court and the apparent meaning of the words invoked by the Foundation.
If Article 8(3) applies where Member States ‘review plant protection products containing an active substance in accordance with paragraph 2’, how could it not apply where Member States grant authorisations in accordance with paragraph 2?
I was also puzzled by the Court’s reference to Article 4(5) in support of its interpretation of Article 8(3):
how could Article 4(5), which concerns plant protection products containing active substances listed in Annex I, be relevant to a transitional provision designed precisely to apply where the active substances concerned are not yet listed in Annex I?
70. The answer, I believe, is as follows.
Article 8(3) is intended to enable Member States to apply to plant protection products containing active substances not yet listed in Annex I, but previously authorised pursuant to Article 8(2), a similar procedure to that laid down by Article 4(5) with regard to plant protection products containing active substances listed in Annex I.
That interpretation accounts for the words ‘in accordance with paragraph 2’ – although they might have been more clearly expressed as referring to the grant of a previous authorisation rather than to the ‘review’ with which Article 8(3) is concerned; (23)
it also explains the Court’s reference to Article 4(5) in support of its interpretation of Article 8(3).
71. It may be noted that neither Article 4(5) nor Article 8(3) appeared in the Commission’s proposal, (24) amended proposal (25) or second amendment to the proposal (26) for the directive.
Since the latter document was presented by the Commission on 21 March 1991, and the directive was adopted less than four months later, it is clear that both provisions were inserted at a very late stage in the legislative procedure, presumably at the same point.
That supports the view that the two are linked (and may explain, although not excuse, the less than perfect drafting of Article 8(3)).
72. The interpretation I suggest also explains the words ‘without prejudice to paragraph 3’ which occur in Article 8(2) and from which the French Government concludes that the requirements referred to in Article 8(3) apply to the grant of an authorisation pursuant to Article 8(2).
In my view, that phrase simply means that the grant of an authorisation pursuant to Article 8(2) does not in itself guarantee immunity from subsequent review pursuant to Article 8(3).
73. The Foundation and the French Government seek to distinguish Monsanto on the basis that the plant protection product at issue in that case was a generic product.
The Foundation deduces that the true basis of the judgment is that neither Article 8(2) nor Article 8(3), but solely Article 13(6) which contains a further derogation from Article 4, was applicable.
The French Government submits (although it makes the argument in the context of the fifth question) that the Court’s conclusion – that the review provided for in Article 8(3) does not apply to an existing plant protection product – is attributable to the fact that the product at issue, being generic, could not strictly speaking be regarded as new.
74. I find it impossible to reconcile those views with the terms of the judgment in Monsanto .
Admittedly, the Court stated that the application in question came within the scope of Article 13(6). (27)
In the immediately following paragraph, however, it stated:
‘Thus, during the transitional period mentioned in Article 8(2) of Directive 91/414, Member States are to continue to apply their scheme or their practice for placing on the market, in their territory, plant protection products containing an active substance not listed in Annex I to the directive that were already on the market two years after notification of that directive.’
75. It seems clear to me that, although Article 13(6) – which concerns data requirements only – was held to be applicable to an application made during the transitional period for authorisation of a generic existing plant protection product, that provision applied alongside, and not instead of, Article 8(2), which concerns the conditions to be satisfied before authorisation may be granted.
The two provisions are of course linked:
Article 8(2), as the Court stated in Monsanto, permits Member States to continue to apply their schemes or practices for placing on the market, in their territories, existing plant protection products, while Article 13(6) permits Member States to continue to apply previous national rules concerning data requirements as long as such substances are not listed in Annex I.
76. As for the French Government’s argument, there is nothing in the judgment to suggest that the Court considered that the directive provides for different treatment of an application for a first authorisation to place on the market, on the one hand, a generic existing plant protection product and, on the other hand, a non-generic existing plant protection product.
77. I accordingly remain of the view that both limbs of the referring court’s fourth question should be answered in the negative.
Conclusion on the second question
78. Having proposed answers to the third and fourth questions referred, I can now revisit the second question, by which the national court asks whether Article 16 of the Biocidal Products Directive has the same meaning as Article 8(2) of the Plant Protection Products Directive.
79. Article 16 permits a Member State to ‘continue to apply its current system or practice of placing biocidal products on the market’ and provides that it ‘may, in particular, according to its national rules, authorise the placing on the market in its territory of a biocidal product’ which meets certain criteria.
A system or practice based on authorisation is therefore one of the systems or practices, but not necessarily the only one, which the directive envisages that a Member State may retain for the transitional period.
80. However, as I have indicated in the context of the third question referred, (28) a Member State does not have an unfettered power to amend its legislation during the transitional period laid down by the Biocidal Products Directive.
It follows from the judgment of the Court in Inter-Environnement Wallonie (29) that during that period it would not be lawful for a Member State to amend its legislation in a manner which is liable seriously to compromise the result prescribed by the directive.
81. Article 8(2) permits a Member State to ‘authorise the placing on the market in its territory of plant protection products’ which meet analogous criteria.
A system or practice based on authorisation is therefore the only system or practice which the directive envisages that a Member State may apply during the transitional period.
82. Although the Court in Monsanto (30) stated that during the transitional period mentioned in Article 8(2) ‘Member States are to continue to apply their scheme or their practice for placing on the market, in their territory, plant protection products’, I do not consider that the Court was seeking to rewrite that provision – nor of course could it do so.
I consider rather that the Court was working on the assumption that a Member State’s existing system or practice for placing plant protection products on the market was based on authorisation.
That seems to follow from the preceding paragraphs in the judgment, and was also the case of the national system at issue in that case.
83. Article 8(2) of the Plant Protection Products Directive therefore limits Member States to a system or practice of authorisation for placing such products on the market, whereas Article 16(1) of the Biocidal Products Directive contains no such limitation.
It seems unlikely, however, that that difference will have much practical effect, since at the time of adoption of the Plant Protection Products Directive there were ‘rules in most Member States governing the authorisation of plant health products’. (31)
The fifth question
84. By its fifth question the national court asks essentially whether a ‘review’ within the meaning of Article 8(3) of the Plant Protection Products Directive includes an examination such as that provided for by Article 25d of the BMW, on the basis of which an active substance is designated with the result that plant protection products containing the active substance are authorised or registered by operation of law.
85. I have explained above, in the context of my discussion of the fourth question referred, why I consider that a ‘review’ within the meaning of Article 8(3) means a review of authorisations issued by Member States during the transitional period intended to be the equivalent, during that period, of the review in accordance with Article 4(5) of the directive of authorisations issued after the end of that period.
Article 4(5) provides for Member States to review such authorisations ‘if there are indications that any of the requirements referred to in [Article 4(1)] are no longer satisfied’.
Article 8(3) enables Member States to review authorisations issued in accordance with Article 8(2):
before such a review, Article 8(3) requires Member States to ‘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’ in order to decide whether to proceed to a review of plant protection products. (32)
86. It is for the national court in the present case to determine whether the examination provided for by Article 25d of the BMW amounts to such a review, as the Foundation and the French Government in substance submit.
I would say only that the information about that provision and its operation provided by the referring court and the Netherlands Government suggests that the national legislative framework at issue provides rather for a procedure whereby application is made for marketing authorisations for existing plant protection products, and accordingly appears to implement Article 8(2) of that directive rather than Article 8(3).
The sixth question
87. By its sixth question the national court asks essentially whether the rules in Article 8(3) 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.
88. In my view, there is nothing in Article 8(3) to suggest that it governs the way in which a review is organised and carried out.
I cannot in fact see how any rules regulating the organisation and operation of a review can be gleaned from the provision, which simply requires Member States to ‘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’.
The requirements in Article 4(1)(b) to (e) essentially concern the safety and effectiveness of the product concerned 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.
As stated by the Court in Monsanto, those requirements are the criteria on the basis of which Member States must decide whether to proceed to a review of plant protection products. (33)
They thus have nothing to do with the organisation and operation of such a review.
Conclusion
89. I am accordingly of the view that the questions referred by the College van Beroep voor het bedrijfsleven should be answered as follows:
(1) During the period laid down in 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, Member States may not amend their national rules concerning the placing on the market of biocidal products in such a way that the amended rules are liable seriously to compromise the result prescribed by the directive;
it is for the national court to assess whether that is the case as regards the national provisions at issue.
(2) Where a Member State pursuant to Article 8(2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market authorises the placing on the market in its territory of plant protection products containing active substances not listed in Annex I to that directive that were already on the market two years after the date of notification of that directive, it is not necessary for it to have regard to the provisions of Article 4 or Article 8(3) thereof.
(3) It is for the national court to determine whether the examination provided for in Article 25d of the Bestrijdingsmiddelenwet 1962 as amended is a ‘review’ within the meaning of Article 8(3) of Directive 91/414.
(4) Article 8(3) of Directive 91/414 does not regulate the way in which a ‘review’ within the meaning of that provision must be organised and carried out.
(1) .
(2)  –	Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1).
(3)  –	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 (OJ 1998 L 123, p. 1).
(4)  –	Article 2(1).
(5)  –	Commission Regulation (EC) No 2076/2002 of 20 November 2002 (OJ 2002 L 319, p. 3).
(6)  –	Article 1(1)(a).
(7)  –	Article 2(1)(a).
(8)  –	Article 2(1)(f).
(9)  –	See Article 2(1)(a) and Annex V.
(10)  –	The law uses the term ‘bestrijdingsmiddelen’, generally translated as ‘pesticides’, to include both plant protection products (‘gewasbeschermingsmiddelen’) and biocidal products (‘biociden’).
(11)  –	By Law of 15 December 1994 ( Staatsblad
1995, 4).
(12)  –	See point 8.
(13)  –	On 25 March 2005 the same court referred for a preliminary ruling eight further questions, of which some replicate part of the first, the second, the fourth and the the sixth questions referred in the present case, in separate proceedings brought by the Foundation against the Minister for Agriculture, Nature and Food Quality concerning a decision taken under a different provision of the BMW (Case C-138/05).
(14)  –	Undertakings in the Netherlands plant protection and biocidal products sector.
(15)  –	Case C-106/89 Marleasing [1990] ECR I-4135, paragraphs 7 and 8;
confirmed in numerous subsequent cases, most recently Case C-196/02 Nikoloudi, judgment of 10 March 2005, paragraph 73.
(16)  –	Case C-129/96 [1997] ECR I-7411, paragraphs 45 and 46.
(17)  –	See recital 4 in the preamble.
(18)  –	Article 1(1).
(19)  –	Case C-306/98 [2001] ECR I-3279, paragraph 43.
(20)  –	Paragraph 29.
(21)  –	Paragraph 21.
(22)  – Paragraphs 34 to 36 and 41.
(23)  –	That construction appears to be supported by the Dutch (‘Wanneer Lid-Staten een nieuw onderzoek instellen naar gewasbeschermingsmiddelen die een overeenkomstig lid 2 te onderzoeken werkzame stof bevatten …’) and German (‘Bei der Überprüfung von Pflanzenschutzmitteln, die einen Wirkstoff gemäß Absatz 2 enhalten …’).
(24)  –	COM(76) 427 final;
OJ 1976 C 212, p. 3.
(25)  –	COM(89) 34 final;
OJ 1989 C 89, p. 22.
(26)  –	COM(91) 87 final;
OJ 1991 C 93, p. 7.
(27)  –	Paragraph 42.
(28)  –	See point 57.
(29)  –	Cited in note 16.
(30)  –	Cited in note 19, paragraph 43.
(31)  –	Recital 5 in the preamble.
(32)  –	See Monsanto, paragraph 39.
(33)  –	Paragraph 39.