Criminal proceedings against Nicolas Schreiber

(Reference for a preliminary ruling from the Tribunale di Pordenone)

(Article 28 EC – Directive 98/8/EC – Placing of biocidal products on the market – National measure requiring authorisation for the placing on the market of blocks of red cedar wood having natural anti-moth properties)

Summary of the Judgment

(Directive 98/8 of the European Parliament and of the Council, Arts 2(1)(a) and 3(2)(ii))

(Directive 98/8 of the European Parliament and of the Council, Art. 4(1))

(Arts 28 EC and 30 EC)

Such blocks cannot be classed as a product containing only a ‘basic substance’ used for biocidal purposes such that they may be placed on the market in a Member State without prior authorisation or registration, but must be classed as a ‘biocidal product’ within the meaning of Directive 98/8 if they are sold as an anti-moth product containing an active substance that repels moths and are mentioned on the list of biocidal products drawn up under Annex V to that directive. In this respect, the fact that the repellent effect of the active substance is natural does not obviate the need for the blocks in question to be classified as ‘biocidal products’.

(see paras 28, 30, 32-33, operative part 1)

(see para. 39, operative part 2)

(see paras 49-50, operative part 3)

JUDGMENT OF THE COURT (First Chamber) 15 July 2004(1)

(Article 28 EC – Directive 98/8/EC – Placing of biocidal products on the market – National measure requiring authorisation for the placing on the market of blocks of red cedar wood having natural anti-moth properties)

In Case C-443/02,

REFERENCE to the Court under Article 234 EC by the Tribunale di Pordenone (Italy) for a preliminary ruling in the criminal proceedings before that court against

on the interpretation 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 (OJ 1998 L 123, p. 1), and Article 28 EC,

THE COURT (First Chamber),

composed of: P. Jann (Rapporteur), President of the Chamber, A. Rosas, S. von Bahr, R. Silva de Lapuerta and K. Lenaerts, Judges,

Advocate General: D. Ruiz-Jarabo Colomer, Registrar: L. Hewlett, Principal Administrator,

after considering the written observations submitted on behalf of:

– Mr Schreiber, by M. Casini and F. Capelli, avvocati,

– the Belgian Government, by A. Snoecx, acting as Agent,

– the Commission of the European Communities, by L. Ström, acting as Agent, and M. Moretto, avocat,

after hearing the Opinion of the Advocate General at the sitting on 12 February 2004,

gives the following

1 This request for a preliminary ruling concerns the interpretation 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 (OJ 1998 L 123, p. 1), and Article 28 EC.

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

Recitals 7 to 9 of Directive 98/8 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.

ECLI:EU:C:2025:140

(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 98/8 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.

(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.

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

Definitions

The terms ‘biocidal product’, ‘low-risk biocidal product’ and ‘basic substance’ are defined in Article 2 of Legislative Decree No 174 of 25 February 2000 (ordinary supplement to GURI No 149 of 28 June 2000, ‘the biocides decree’).

The biocides decree implemented Directive 98/8.

Articles 3 and 4 of the decree require authorisation for the placing on the market of biocidal products and the registration of low-risk biocidal products. Article 5 provides that products which contain only a basic substance may be placed on the market and used without authorisation or registration provided that they are included in the corresponding list drawn up at Community level.

Article 17(1) of the biocides decree provides that, during the transitional period laid down by Article 16 of Directive 98/8, the Ministero della Sanità (Minister for Health) is empowered to apply the rules in force concerning the placing on the market of biocidal products set out in Decree No 392 of the President of the Republic of 6 October 1998 on the production and placing on the market of medico-surgical instruments (GURI No 266 of 13 November 1998, ‘the medico-surgical instruments decree’).

Article 1 of the decree requires that there be prior authorisation for the placing on the market of insect repellents.

The main proceedings and the questions referred

Such blocks cannot be classed as a product containing only a ‘basic substance’ used for biocidal purposes such that they may be placed on the market in a Member State without prior authorisation or registration, but must be classed as a ‘biocidal product’ within the meaning of Directive 98/8 if they are sold as an anti-moth product containing an active substance that repels moths and are mentioned on the list of biocidal products drawn up under Annex V to that directive. In this respect, the fact that the repellent effect of the active substance is natural does not obviate the need for the blocks in question to be classified as ‘biocidal products’.

(see paras 28, 30, 32-33, operative part 1)

(see para. 39, operative part 2)

(see paras 49-50, operative part 3)

The Italian authorities commenced criminal proceedings against Mr Schreiber in his capacity as managing director of LIDL-ITALIA Srl, alleging that, in March 2001, without having obtained the authorisation necessary under Italian law, that company had placed on the market 20 packages of blocks of red cedar wood having natural anti-moth properties originating in Germany, which are considered to be ‘medico-surgical instruments’ within the meaning of the medico-surgical instruments decree.

Mr Schreiber submits that those blocks are a product containing only a ‘basic substance’ within the meaning of Directive 98/8 and that, according to Article 3(2)(ii) of the directive, that product should be allowed to be placed on the market without authorisation or registration. In the alternative, he submits that the national rules infringe Article 28 EC.

In those circumstances the Tribunale di Pordenone decided to stay the proceedings and refer the following questions to the Court for a preliminary ruling:

The questions referred

Preliminary observations

It should be noted that, at the time of the facts alleged in the main proceedings, the harmonisation provided for by Directive 98/8 had not been completed in that Annexes I, IA and IB to the directive, listing the active substances whose use is authorised in biocidal products, low-risk biocidal products and products containing only basic substances, were still being compiled at Community level. Indeed, the evaluation of the active substances notified for possible inclusion in those annexes will only be completed between 2006 and 2010.

It is, however, clear from Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8, and amending Regulation (EC) No 1896/2000 (OJ 2003 L 307, p. 1), that the Commission has drawn up an interim list of active substances which will not be included in those annexes, either because no notification has been accepted by the Commission or because no Member State has expressed an interest in respect of those substances. It follows from Article 4(2) of that regulation, read together with Annex III thereto, that with effect from 1 September 2006 certain biocidal products containing active substances which are natural oils, such as cedarwood oil and cedar oil, will no longer be allowed to be placed on the market in the Member States.

In the light of the wording of the questions referred by the national court there is, however, no need for the Court to consider whether the complete prohibition on the marketing of biocidal products containing those natural oils is proportionate to the objectives pursued by the Community rules.

The first four questions: the obligation on the Member States to allow the placing on the market of products containing only ‘basic substances’

By its first four questions, which it is convenient to examine together, the national court asks essentially whether Article 3(2)(ii) of Directive 98/8 precludes a Member State from requiring prior authorisation for the marketing of blocks of cedar wood such as those in issue in the main proceedings (‘the system of prior authorisation in issue in the main proceedings’).

In that context, the referring court wishes to know whether such blocks may be classified as a product containing only a ‘basic substance’ so that, pursuant to Article 3(2)(ii) of the directive, they may be placed on the market in Italy without prior authorisation or registration, or whether they should be classified as a ‘biocidal product’ or a ‘low-risk biocidal product’ within the meaning of Directive 98/8.

It should be noted in this regard that Article 3(2)(ii) of the directive requires the Member States to allow the placing on the market without prior authorisation or registration of products containing only basic substances if they have been entered in Annex IB.

According to the definition in Article 2(1)(c) of Directive 98/8, in order to be classified as a ‘basic substance’, a substance must satisfy three conditions: (i) it must be entered in Annex IB; (ii) its major use must be non-pesticidal but it must have some minor use as a biocide, and (iii) it must not be directly marketed for a biocidal use.

By contrast, according to the definition in Article 2(1)(a), ‘biocidal products’ are active substances put up in the form in which they are supplied to the user and which are intended to destroy, deter or render harmless harmful organisms by chemical or biological means. An exhaustive list of the types of biocidal products is given in Annex V to Directive 98/8.

Lastly, Article 2(1)(b) defines a ‘low-risk biocidal product’ as a biocidal product which contains as active substances only one or more of the substances listed in Annex IA and which does not contain any substance of concern.

In the main proceedings, it is not in dispute that the blocks of cedar wood in issue were sold as an anti-moth product, that they contained cedar oil, an active substance which, upon evaporation, repels insects and, lastly, that they were included in one of the types of product listed in Annex V to Directive 98/8. By contrast, at the time of the facts alleged in the main proceedings, it could not be argued that the active substance contained in those blocks, namely cedar oil, was listed in Annexes IA or IB to that directive since those annexes had not been completed.

In those circumstances, those blocks cannot be classified as a product containing only a ‘basic substance’ or as a ‘low-risk biocidal product’ within the meaning of Directive 98/8. They should, by contrast, be regarded as a ‘biocidal product’ within the meaning of the directive.

It should be added in that context that it matters little whether the repellent effect of an active substance is natural or whether it is the result of chemical or biological manipulation. The mere fact that a substance is natural cannot preclude the existence of a risk for humans, animals or the environment. Furthermore, the effect of the reference in Article 2(2)(a) of the directive to the definitions in Article 2 of Directive 67/548 is that ‘substances’ are defined as chemical elements and their compounds in the natural state or obtained by any production process.

Moreover, it is now certain that blocks of cedar wood such as those in issue are neither a product containing only a ‘basic substance’ nor a ‘low-risk biocidal product’ within the meaning of Directive 98/8, as Annex III to Regulation No 2032/2003 makes it clear that cedar oil will not be listed in Annexes IA or IB to the directive. Notwithstanding its classification as an ‘existing active substance’ within the meaning of Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8 (OJ 2000 L 228, p. 6), the Commission has not accepted any notification and no Member State has indicated an interest in respect of cedar oil.

Consequently, the answer to the first four questions must be that Article 3(2)(ii) of Directive 98/8 does not preclude a Member State from requiring prior authorisation for the marketing of blocks of cedar wood such as those in issue in the main proceedings.

Such blocks cannot be classified as a product containing only a ‘basic substance’ such that they may be placed on the market in Italy without prior authorisation or registration, but must be classified as a ‘biocidal product’ within the meaning of Directive 98/8.

The first part of the fifth question: the obligation on Member States to recognise authorisation and registration granted by another Member State

By the first part of its fifth question, the referring court asks essentially whether Article 4(1) of Directive 98/8 precludes a Member State from requiring prior authorisation for the marketing of blocks of cedar wood such as those in issue in the main proceedings, which have been lawfully placed on the market in another Member State in which there is no requirement of authorisation or registration.

It should be noted in that regard that that paragraph imposes an obligation on the Member States to recognise authorisation and registration granted by another Member State provided that the active substance is included in Annexes I or IA.

In the main proceedings, it is clear that the blocks of cedar wood in question have not been authorised to be placed on the market or registered in another Member State.

Moreover, at the time of the facts alleged in the main proceedings, it was not possible to foresee whether cedar oil would be included in Annexes I or IA to that directive.

Annex III to Regulation No 2032/2003 makes it clear in any event that cedar oil will not be included in Annexes I or IA to the directive.

Consequently, the answer to the first part of the fifth question must be that Article 4(1) of Directive 98/8 does not preclude a Member State from requiring prior authorisation for the marketing of blocks of cedar wood such as those in issue in the main proceedings, which have been lawfully placed on the market in another Member State in which there is no requirement of authorisation or registration.

The second part of the fifth question: the right of free movement of goods

By the second part of the fifth question, the national court asks essentially whether Article 28 EC precludes a Member State from requiring prior authorisation for the marketing of blocks of cedar wood such as those in issue in the main proceedings, which have been lawfully placed on the market in another Member State in which there is no requirement of authorisation or registration.

According to settled case-law, all trading rules enacted by Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade are measures having an effect equivalent to quantitative restrictions within the meaning of Article 28 EC and are therefore in principle prohibited (Case 8/74 Dassonville [1974] ECR 837, paragraph 5, and Case C-322/01 Deutscher Apothekerverband [2003] ECR I-0000, paragraph 66).

However, in the absence of Community harmonising measures, the free movement of a good may be restricted by national rules justified either on one of the grounds laid down by Article 30 EC or by mandatory requirements (Case 120/78 Rewe-Zentral (‘Cassis de Dijon’) [1979] ECR 649, paragraph 8).

In adopting national measures to protect public health within the meaning of Article 30 EC, it is for the Member States to decide what degree of protection they intend to assure thereto (see, to that effect, Case 272/80 <i>Frans-Nederlandse Maatschappij voor Belgische Producten</i> [1981] ECR 3277, paragraph 12, Case C-293/94 <i>Brandsma</i> [1996] ECR I-3159, paragraph 11, and Case C-400/96 <i>Harpegnies</i> [1998] ECR I-5121, paragraph 33). However, those national rules must be proportionate to the objectives pursued (Case 174/82 <i>Sandoz</i> [1983] ECR 2445, paragraph 18, and <i>Harpegnies</i>, paragraph 34).

In the present case, it is necessary to examine in turn four points: (i) whether there is a restriction within the meaning of Article 28 EC; (ii) whether there are Community harmonising measures on the matter; (iii) whether the system of prior authorisation at issue in the main proceedings may be justified on the basis of Article 30 EC, and (iv) whether that system is proportionate.

First, it should be noted that a scheme prohibiting the placing on the market of biocidal products without prior authorisation constitutes a restriction on the free movement of goods within the meaning of Article 28 EC (see, to that effect, <i>Brandsma</i>, paragraph 6, and <i>Harpegnies</i>, paragraph 30).

Second, at the time of the facts alleged, the placing on the market of blocks of cedar wood such as those at issue in the main proceedings had not been fully harmonised at Community level in that Annexes I, IA and IB to Directive 98/8 had not been completed and no other system had been established for that product. However, at that time, Directive 98/8 had already harmonised the definition of ‘biocidal product’.

Third, a system of prior authorisation such as that in issue in the main proceedings pursues an objective for the protection of public health within the meaning of Article 30 EC. Since blocks of cedar wood such as those in issue in the main proceedings must be considered to be ‘biocidal products’ within the meaning of Directive 98/8 and, according to the third recital in the preamble to that directive, biocidal products can pose risks to humans, animals and the environment in a variety of ways due to their intrinsic properties and associated use patterns, a system requiring prior authorisation for their marketing satisfies the objective of protecting public health.

Fourth, the system of prior authorisation at issue in the main proceedings is proportionate to the legitimate objective pursued. Whilst it is true that blocks of cedar wood such as those at issue in the main proceedings may be placed on the market in Germany without prior authorisation or registration, the fact that one Member State imposes less strict rules than another Member State does not mean that the latter’s rules are disproportionate (see, to that effect, Case C-384/93 <i>Alpine Investments</i> [1995] ECR I-1141, paragraph 51).

In those circumstances, a system requiring prior authorisation for the placing on the market of blocks of red cedar wood having natural anti-moth properties must be classed as a measure having equivalent effect contrary to Article 28 EC. However, since such a system corresponds to the level of protection of public health that the Member State concerned intends to assure, in that it concerns the placing on the market of all biocidal products and is not disproportionate to that objective, it may be regarded as justified under Article 30 EC.

Consequently, the answer to the second part of the fifth question must be that the fact that a Member State requires prior authorisation for the marketing of blocks of cedar wood such as those in issue in the main proceedings, which have been lawfully placed on the market in another Member State in which there is no requirement of authorisation or registration, constitutes a measure having equivalent effect contrary to Article 28 EC, which may nevertheless be regarded as justified on grounds of the protection of public health under Article 30 EC.

Costs

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

On those grounds,

THE COURT (First Chamber),

in answer to the questions referred to it by the Tribunale di Pordenone by order of 20 November 2002, hereby rules:

Article 3(2)(ii) 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 does not preclude a Member State from requiring prior authorisation for the marketing of blocks of red cedar wood having natural anti-moth properties.

Such blocks cannot be classed as a product containing only a ‘basic substance’ such that they may be placed on the market in Italy without prior authorisation or registration, but must be classed as a ‘biocidal product’ within the meaning of Directive 98/8.

Article 4(1) of Directive 98/8 does not preclude a Member State from requiring prior authorisation for the marketing of blocks of red cedar wood having natural anti-moth properties, which have been lawfully placed on the market in another Member State in which there is no requirement of authorisation or registration.

The fact that a Member State requires prior authorisation for the marketing of blocks of red cedar wood having natural anti-moth properties, which have been lawfully placed on the market in another Member State in which there is no requirement of authorisation or registration, constitutes a measure having equivalent effect contrary to Article 28 EC, which may nevertheless be regarded as justified on grounds of the protection of public health under Article 30 EC.

Delivered in open court in Luxembourg on 15 July 2004.

Registrar

President of the First Chamber

Language of the case: Italian.