Avis juridique important

61999J0258

European Court reports 2001 Page I-03643

Summary

(Parliament and Council Regulation No 1610/96, Art. 3)

(Parliament and Council Regulation No 1610/96, Art. 3(1)(a) and (d))

Parties

In Case C-258/99,

REFERENCE to the Court under Article 234 EC by the Arrondissementsrechtbank 's-Gravenhage, Netherlands, for a preliminary ruling in the proceedings pending before that court between

Bureau voor de Industriële Eigendom (BIE),

on the interpretation of Articles 1 and 3 of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (OJ 1996 L 198, p. 30),

THE COURT (Sixth Chamber),

composed of: C. Gulmann (Rapporteur), President of the Chamber, V. Skouris, J.-P. Puissochet, R. Schintgen and F. Macken, Judges,

Advocate General: F.G. Jacobs,

Registrar: D. Louterman-Hubeau, Head of Division,

after considering the written observations submitted on behalf of:

- BASF AG, by P. Kuipers and W. VerLoren van Themaat, Advocaten,

- Bureau voor de Industriële Eigendom (BIE), by C. Eskes and R.A. Grootoonk, acting as Agents,

- the German Government, by W.-D. Plessing and A. Dittrich, acting as Agents,

- the United Kingdom Government, by R. Magrill, acting as Agent, and D. Alexander, Barrister,

- the Commission of the European Communities, by K. Banks and H.M.H. Speyart, acting as Agents,

having regard to the Report for the Hearing,

after hearing the oral observations of BASF AG, represented by P. Kuipers and W. VerLoren, the Netherlands Government, represented by M.A. Fierstra, acting as Agent, the United Kingdom Government, represented by D. Alexander, and the Commission, represented by H.M.H. Speyart, at the hearing on 12 October 2000,

after hearing the Opinion of the Advocate General at the sitting on 30 November 2000,

gives the following

1 This request for a preliminary ruling concerns the interpretation of Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ 2012 L 26, p. 1), as amended by Directive 2014/52/EU of the European Parliament and of the Council of 16 April 2014 (OJ 2014 L 124, p. 1) (‘Directive 2011/92’).

2 The request has been made in proceedings between, on the one hand, Waltham Abbey Residents Association and, on the other hand, An Bord Pleanála (Planning Board, Ireland; ‘the Board’), Ireland and the Attorney General (Ireland), concerning authorisation granted by the Board for a strategic residential housing development.

Legal context

European Union law

Directive 2011/92

Recitals 7 to 9 of Directive 2011/92 state:

‘(7) Development consent for public and private projects which are likely to have significant effects on the environment should be granted only after an assessment of the likely significant environmental effects of those projects has been carried out. …

(8) Projects belonging to certain types have significant effects on the environment and those projects should, as a rule, be subject to a systematic assessment.

(9) Projects of other types may not have significant effects on the environment in every case and those projects should be assessed where the Member States consider that they are likely to have significant effects on the environment.’

Article 2(1) of that directive provides:

‘Member States shall adopt all measures necessary to ensure that, before development consent is given, projects likely to have significant effects on the environment by virtue, inter alia, of their nature, size or location are made subject to a requirement for development consent and an assessment with regard to their effects on the environment. Those projects are defined in Article 4.’

Under Article 3(1) of that directive:

‘The environmental impact assessment shall identify, describe and assess in an appropriate manner, in the light of each individual case, the direct and indirect significant effects of a project on the following factors:

…

(b) biodiversity, with particular attention to species and habitats protected under [Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ 1992 L 206, p. 7), as amended by Council Directive 2013/17/EU of 13 May 2013 (OJ 2013 L 158, p. 193) (“Directive 92/43”)] and Directive 2009/147/EC [of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ 2010 L 20, p. 7)];

…’

Article 4 of Directive 2011/92 provides:

‘1. Subject to Article 2(4), projects listed in Annex I shall be made subject to an assessment in accordance with Articles 5 to 10.

(a) a case-by-case examination;

(b) thresholds or criteria set by the Member State.

Member States may decide to apply both procedures referred to in points (a) and (b).

Where a case-by-case examination is carried out or thresholds or criteria are set for the purpose of paragraph 2, the relevant selection criteria set out in Annex III shall be taken into account. Member States may set thresholds or criteria to determine when projects need not undergo either the determination under paragraphs 4 and 5 or an environmental impact assessment, and/or thresholds or criteria to determine when projects shall in any case be made subject to an environmental impact assessment without undergoing a determination set out under paragraphs 4 and 5.

Where Member States decide to require a determination for projects listed in Annex II, the developer shall provide information on the characteristics of the project and its likely significant effects on the environment. The detailed list of information to be provided is specified in Annex IIA. The developer shall take into account, where relevant, the available results of other relevant assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The developer may also provide a description of any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

The competent authority shall make its determination, on the basis of the information provided by the developer in accordance with paragraph 4 taking into account, where relevant, the results of preliminary verifications or assessments of the effects on the environment carried out pursuant to Union legislation other than this Directive. The determination shall made available to the public and:

(a) where it is decided that an environmental impact assessment is required, state the main reasons for requiring such assessment with reference to the relevant criteria listed in Annex III; or

(b) where it is decided that an environmental impact assessment is not required, state the main reasons for not requiring such assessment with reference to the relevant criteria listed in Annex III, and, where proposed by the developer, state any features of the project and/or measures envisaged to avoid or prevent what might otherwise have been significant adverse effects on the environment.

Member States shall ensure that the competent authority makes its determination as soon as possible and within a period of time not exceeding 90 days from the date on which the developer has submitted all the information required pursuant to paragraph 4. In exceptional cases, for instance relating to the nature, complexity, location or size of the project, the competent authority may extend that deadline to make its determination; in that event, the competent authority shall inform the developer in writing of the reasons justifying the extension and of the date when its determination is expected.’

Annex II.A of that directive contains the list of ‘information to be provided by the developer on the projects listed in Annex II’. That list reads as follows:

‘1. A description of the project, including in particular:

(a) a description of the physical characteristics of the whole project and, where relevant, of demolition works;

(b) a description of the location of the project, with particular regard to the environmental sensitivity of geographical areas likely to be affected.

3. A description of any likely significant effects, to the extent of the information available on such effects, of the project on the environment resulting from:

(a) the expected residues and emissions and the production of waste, where relevant;

(b) the use of natural resources, in particular soil, land, water and biodiversity.

4. The criteria of Annex III shall be taken into account, where relevant, when compiling the information in accordance with points 1 to 3.’

Annex III to that directive sets out the ‘criteria to determine whether the projects listed in Annex II should be subject to an environmental impact assessment’.

Directive 2014/52

Recitals 11 and 29 of Directive 2014/52 state:

‘(11) The measures taken to avoid, prevent, reduce and, if possible, offset significant adverse effects on the environment, in particular on species and habitats protected under [Directive 92/43] and Directive 2009/147 …, should contribute to avoiding any deterioration in the quality of the environment and any net loss of biodiversity, in accordance with the [European] Union’s commitments in the context of the [United Nations Convention on Biological Diversity, signed in Rio de Janeiro on 5 June 1992,] and the objectives and actions of the Union Biodiversity Strategy up to 2020 laid down in the [Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions] of 3 May 2011 entitled ‘Our life insurance, our natural capital: an EU biodiversity strategy to 2020’ [(COM(2011) 244 final)]

…

(29) When determining whether significant effects on the environment are likely to be caused by a project, the competent authorities should identify the most relevant criteria to be considered and should take into account information that could be available following other assessments required by Union legislation in order to apply the screening procedure effectively and transparently. In this regard, it is appropriate to specify the content of the screening determination, in particular where no environmental impact assessment is required. Moreover, taking into account unsolicited comments that might have been received from other sources, such as members of the public or public authorities, even though no formal consultation is required at the screening stage, constitutes good administrative practice.’

Directive 92/43

Article 6(3) of Directive 92/43 provides:

‘Any plan or project not directly connected with or necessary to the management of the site but likely to have a significant effect thereon, either individually or in combination with other plans or projects, shall be subject to appropriate assessment of its implications for the site in view of the site’s conservation objectives. In the light of the conclusions of the assessment of the implications for the site and subject to the provisions of paragraph 4, the competent national authorities shall agree to the plan or project only after having ascertained that it will not adversely affect the integrity of the site concerned and, if appropriate, after having obtained the opinion of the general public.’

Article 12(1) of that directive provides:

‘Member States shall take the requisite measures to establish a system of strict protection for the animal species listed in Annex IV(a) in their natural range, prohibiting:

(a) all forms of deliberate capture or killing of specimens of these species in the wild;

(b) deliberate disturbance of these species, particularly during the period of breeding, rearing, hibernation and migration;

(c) deliberate destruction or taking of eggs from the wild;

(d) deterioration or destruction of breeding sites or resting places.’

Point (a) of Annex IV to that directive mentions ‘all species’ of bats belonging to the suborder of ‘microchiroptera’.

Irish law

must be interpreted as meaning that where, in the context of a screening procedure carried out under that provision, a third party has provided the competent authority with objective evidence as regards the potential significant effects of that project on the environment, in particular on a species protected under Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora, as amended by Council Directive 2013/17/EU of 13 May 2013, that authority must ask the developer to provide it with additional information and take that information into account before deciding whether or not an environmental impact assessment is necessary for that project. However, where, despite the observations submitted to that authority by a third party, the competent authority is able to rule out, on the basis of objective evidence, the possibility that the project in question is likely to have significant effects on the environment, that authority may decide that an environmental impact assessment is not necessary, without being required to ask the developer to provide it with additional information.

Gratsias

Passer

Smulders

Delivered in open court in Luxembourg on 6 March 2025.

Registrar

President of the Chamber

ECLI:EU:C:2025:140

15

22 Under Article 1(2) of that regulation, substances are defined as chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process.

23 It follows from points 2, 3 and 8 of Article 1 of Regulation No 1610/96, taken together, that the concept of a product covers chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process, which have general or specific action against harmful organisms or on plants, parts of plants or plant products.

24 Article 3 of Regulation No 1610/96, which lays down the conditions for obtaining an SPC, is based on the concept of a product. There is no indication that that concept differs from that of a product as defined in Article 1 of the regulation for the purposes of that same regulation.

25 The answer to the first part of Question 1 must therefore be that the concept of a product within the meaning of Article 3 of Regulation No 1610/96 covers chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process, which have general or specific action against harmful organisms or on plants, parts of plants or plant products.

The second part of Question 1

26 By the second part of Question 1, the national court is essentially asking whether two products which differ only in the proportion of the active chemical compound to the impurity they contain, one having a greater percentage of the impurity than the other, must be regarded as the same product within the meaning of Article 3 of Regulation No 1610/96.

27 It follows from the answer to the first part of Question 1 that two products which are constituted of the same chemical compound having the same general or specific action against harmful organisms or on plants, parts of plants or plant products, and including any impurity inevitably resulting from the manufacturing process, must be regarded as identical.

28 It is therefore apparent that a product may be identified by its chemical compound and its action on the targets mentioned in the preceding paragraph, whatever the impurities it contains. A fortiori, the nature of a product cannot change solely because of an alteration in the unit quantity of impurities where both the chemical compound it contains and that compound's action on its targets remain unchanged.

29 The answer to the second part of Question 1 must therefore be that two products which differ only in the proportion of the active chemical compound to the impurity they contain, one having a greater percentage of the impurity than the other, must be regarded as the same product within the meaning of Article 3 of Regulation No 1610/96.

The third part of Question 1

30 By the third part of Question 1, the national court asks whether the fact that a marketing authorisation must be obtained for the new plant protection product which has a different proportion of active chemical compound to impurity from that of the former plant protection product is relevant for the purposes of establishing whether or not the constituent products of those plant protection products are the same.

31 As follows from the foregoing, the marketing authorisation is not among the criteria used by Regulation No 1610/96 for defining the concept of a product.

32 The answer to the third part of Question 1 must therefore be that the fact that a marketing authorisation must be obtained for the new plant protection product which has a different proportion of active chemical compound to impurity from that of the former plant protection product is not relevant for the purposes of establishing whether or not the constituent products of those plant protection products are the same.

Question 2

33 By this question the national court is essentially asking whether the conditions laid down in Article 3(1)(a) and (d) of Regulation No 1610/96 are satisfied where a product, as a plant protection product, manufactured according to a patented process and the subject of a marketing authorisation, differs from a previously authorised product, as a plant protection product, only in the proportion of the active chemical compound to the impurity it contains, the percentage of impurity being greater in the older product than in the new one, and where that process patent has been designated as the basic patent.

34 It must be recalled that, as found in paragraph 29 above, where two products differ only in the proportion of the active chemical compound to the impurity they contain, one having a higher proportion of impurity than the other, they must be regarded as the same product within the meaning of Article 3 of Regulation No 1610/96.

35 Consequently, where a product, as a plant protection product, manufactured according to a patented process and the subject of a marketing authorisation, differs from a previously authorised product, as a plant protection product, only in the proportion of the active chemical compound to the impurity it contains, the percentage of impurity being greater in the older product than in the new one, it must follow that those two plant protection products contain the same product within the meaning of Article 3 of Regulation No 1610/96.

36 The marketing authorisation for that product, as a plant protection product, manufactured according to a patented process, cannot be regarded as the first marketing authorisation granted for that product, since the product was already the subject of an earlier authorisation as a plant protection product.

37 It follows that, with respect to the product, as a plant protection product, manufactured according to a patented process, the condition in Article 3(1)(d) of Regulation No 1610/96 is not satisfied.

38 Consequently, without it being necessary to take a position on whether the condition in Article 3(1)(a) of Regulation No 1610/96 is satisfied, the answer to Question 2 must be that the conditions laid down in Article 3(1)(a) and (d) of Regulation No 1610/96 are, in any event, not all satisfied where a product, as a plant protection product, manufactured according to a patented process and the subject of a marketing authorisation, differs from a previously authorised product, as a plant protection product, only in the proportion of the active chemical compound to the impurity it contains, the percentage of impurity being greater in the older product than in the new one, and where that process patent has been designated as the basic patent.

Decision on costs

Costs

39 The costs incurred by the Netherlands, German and United Kingdom Governments and by the Commission, which have submitted observations to the Court, are not recoverable. Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court.

Operative part

On those grounds,

THE COURT (Sixth Chamber),

in answer to the questions referred to it by the Arrondissementsrechtbank 's-Gravenhage by order of 2 July 1999, hereby rules:

3. The fact that a marketing authorisation must be obtained for the new plant protection product which has a different proportion of active chemical compound to impurity from that of the former plant protection product is not relevant for the purposes of establishing whether or not the constituent products of those plant protection products are the same.

4. The conditions laid down in Article 3(1)(a) and (d) of Regulation No 1610/96 are, in any event, not all satisfied where a product, as a plant protection product, manufactured according to a patented process and the subject of a marketing authorisation, differs from a previously authorised product, as a plant protection product, only in the proportion of the active chemical compound to the impurity it contains, the percentage of impurity being greater in the older product than in the new one, and where that process patent has been designated as the basic patent.