62002CC0443

EUR-Lex

Access to European Union law

This document is an excerpt from the EUR-Lex website

EUROPA
EUR-Lex home
EUR-Lex - 62002CC0443 - EN

Help

Search tips

Need more search options? Use the Advanced search

Document 62002CC0443

Help

Konklużjonijiet ta' l-Avukat Ġenerali - Ruiz-Jarabo Colomer - 12 ta' Frar 2004.
Nicolas Schreiber.
Talba għal deċiżjoni preliminari: Tribunale di Pordenone - l-Italja.
Artikolu 28 KE - Direttiva 98/8/KE - Tqegħid fis-suq ta' prodotti bijoċidali - Miżura nazzjonali li teżiġi awtorizzazzjoni sabiex jitqiegħdu fis-suq biċċiet ta' injam taċ-ċedru aħmar bi kwalitajiet naturali għal kontra l-kamla.
Kawża C-443/02.

ECLI identifier: ECLI:EU:C:2004:98

Language of the case

HTML

PDF

Conclusions

OPINION OF ADVOCATE GENERAL
RUIZ-JARABO COLOMER
delivered on 12 February 2004(1)

Case C-443/02

Procura della Repubblica
v
Nicolas Schreiber

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

(Article 28 EC – Directive 98/8/EC – Biocidal products – Marketing – Requirement of authorisation to sell blocks of red cedar wood with natural anti-moth properties)

1. The Tribunale di Pordenone, an Italian court of first instance with criminal jurisdiction, has referred to the Court of Justice for a preliminary ruling under Article 234 EC five questions on the interpretation of certain provisions 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, (2) in relation to Article 28 EC.

Specifically, an interpretation is sought of the terms ‘biocidal products’, ‘low-risk biocidal products’ and ‘basic substances’ applied to blocks of red cedar wood marketed, in their natural state, as an anti-moth product. The national court also wishes to know whether such objects, which are legally distributed in one Member State without the need for authorisation or registration, can be subjected to either of those requirements when it is sought to offer them for sale in another State.

I – The facts of the main proceedings

2. On 13 March 2001 officers of the Nucleo Antisofisticazioni (Anti-Forgery and Counterfeiting Unit) confiscated 20 boxes each containing 24 blocks of wood marked ‘anti-moth’ in the LIDL-Italia Srl supermarket in Cordenons, Province of Pordenone.

3. The Public Prosecutor’s Office approved that operation three days later and commenced legal proceedings against Mr Schreiber as managing director of LIDL-Italia Srl, a subsidiary of the company LIDL Stiftung Kg, whose registered office is in Germany. In the course of the proceedings, Dr R. Flego delivered an expert's report on 23 April 2001, which was relied on by the Public Prosecutor for the view that judgment should be given against him in abridged proceedings, a course followed by the Tribunale di Pordenone on 15 March 2002.

4. Three days later, Mr Schreiber lodged an objection. Criminal charges were brought against him on the ground that he had infringed Article 189 of Royal Decree 1265/1934 by offering for sale a product designated as ‘tavolette antitarme’ (anti-moth blocks) originating in Germany, which were to be regarded as constituting medico-surgical materials, without having obtained the necessary authorisation. The hearing was held on 20 November 2002, which prompted the Tribunale to seek a ruling from the Court of Justice.

II – The questions referred to the Court

5. The Italian court submitted questions in the following terms:

(1): ‘Must Article 2(1)(a) and (b) of EC Directive 98/8, in the light of the general rules which that directive introduces into the Community legal order, be construed as meaning that the terms “biocidal products” and “low-risk biocidal product” refer solely to products whose biocidal function depends on active substances added to those products by chemical or biological means by way of processes expressly designed to add such substances in order to confer on those products a biocidal function?

(2): Must Article 2(1)(c) of EC Directive 98/8, in the light of the general rules which that directive introduces into the Community legal order, be construed as meaning that the term “basic substance” refers to substances which are not added to a product to enable it to perform an intended biocidal function but that such a biocidal function must be performed in addition to the function normally performed by that product during its use (example: liquid for a dishwasher which, by virtue of the addition of a substance designed to improve its detergent function, may also perform a bactericidal function)?

(3): May a piece of red cedar wood, simply by virtue of the fact that it is marketed as being “anti-moth”, be classifiable as a “biocidal product”, as a “low-risk biocidal product ”or as a “basic substance” within the meaning of EC Directive 98/8, bearing in mind that: (a) the wood in question has in no way been treated chemically or biologically; (b) the substance on which the effects attributed to the wood may depend is naturally present in the product; (c) the product is substantially marketed as found in its natural state?

(4): Must Article 2(1)(c) of EC Directive 98/8 be construed as meaning that it is only if a “basic substance” is included on the list referred to in Annex IB that that substance may be exempted from the authorisation and registration provided for the marketing in the Member States of products covered by Article 2, with inclusion on the list referred to in Annex IB thus demonstrating constitutive effectiveness in all regards?

(5): Must Article 4 of EC Directive 98/8, by reference to Articles 28 EC and 30 EC, be construed as meaning that a product such as that described in Question 3, placed lawfully on the market in a Member State without any need for authorisation or registration in that Member State, may be made subject to authorisation or registration in another Member State in which it is subsequently marketed by reason of the fact that the product in question is not included on the list referred to in Annex IB to EC Directive 98/8?’

III – The national legislation

6. Mr Schreiber was prosecuted in Italy for infringing national legislation by not seeking the requisite ministerial authorisation before marketing certain insecticides in that country.

7. The national court states in its order that, according to the indictment, those blocks fell within the definition of ‘medico-surgical materials’ under Decrees of the President of the Republic Nos 223/1988 and 392/1998, since the latter classifies insect-repellent products as such in Article 1(c).

8. In the light of Article 2 of Legislative Decree No 174/2000, (3) which faithfully reflects Article 2(1) of Directive 98/8, a moth-repellent may be classified as a ‘biocidal product’ inasmuch as it neutralises, renders harmless or otherwise exerts a controlling effect on harmful organisms, falling under the heading of ‘low risk biocidal products’ or the heading ‘basic substances’. Annex IV to that decree corresponds to Annex V of Directive 98/8 and contains a list of 23 types of biocide. Point 19 of Annex IV, like point 19 of Annex V of Directive 98/8, covers repellents and attractants.

9. Article 3(1) of the same instrument requires prior possession of a ministerial authorisation for the marketing of a product classified as biocidal, whereas Article 4 relates only to registration in the case of biocidal products classified as low risk. Article 5 provides that the basic substances included in Annex IB of Directive 98/8 are not subject to those requirements, pending Community approval of that annex.

10. Under Article 17(1), by way of exception to the requirement that active substances appear on the lists prepared by the European Union, the Ministry of Health is empowered, for a period of 10 years from 14 May 2000, to apply the rules in force relating to the marketing of biocidal products, as approved by Decree No 392 of the President of the Republic of 6 October 1998. (4) In particular, the Ministry approves, under Article 2 of that decree, the sale of biocidal products containing active substances not entered on the list of products of that kind in Article 11 if the substances were already on the market in May 2000.

Under Article 1 of the latter decree, the legislation governs procedures for authorising the manufacture and marketing of medico-surgical materials. According to Article 2, applications are to be submitted to the Ministry of Health, with a copy to the Istituto Superiore di Sanità. It is issued by the former, on a proposal from the latter, within a period of six months. In the event of refusal, the decision must be given within the same period, stating the reasons on which it is based.

IV – Community legislation

11. The Tribunale di Pordenone seeks guidance on the interpretation of Articles 28 EC and 30 EC, which provide as follows:

‘Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States.’

‘The provisions of Articles 28 and 29 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States.’

12. The national court also inquires about Article 2 of Directive 98/8, which provides:

‘1. For the purposes of this Directive the following definitions shall apply:

(a): Biocidal products

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.

An exhaustive list of 23 product types with an indicative set of descriptions within each type is given in Annex V.

(b): Low risk biocidal product

A biocidal product which contains as active substance(s) only one or more of those listed in Annex I A and which does not contain any substance(s) of concern.

Under the conditions of use, the biocidal product shall pose only a low risk to humans, animals and the environment.

(c): Basic substance

A substance which is listed in Annex I B, whose major use is non pesticidal but which has some minor use as a biocide either directly or in a product consisting of the substance and a simple diluent which itself is not a substance of concern and which is not directly marketed for this biocidal use.

...’

13. The last question submitted in these proceedings relates to Article 4 of Directive 98/8, which requires Member States to recognise each others’ authorisations and registrations of biocidal products and low risk biocidal products. Paragraph 1 provides:

‘1. Without prejudice to Article 12, a biocidal product that has already been authorised or registered in one Member State shall be authorised or registered in another Member State within 120 days, or 60 days respectively, of an application being received by the other Member State, provided that the active substance of the biocidal product is included in Annex I or I A and conforms to the requirements thereof.

...’

V – Procedure before the Court of Justice

14. Written observations were submitted within the period laid down in Article 23 of the Statute of the Court of Justice by Mr Schreiber, the Belgian Government and the Commission.

At the hearing on 8 January 2004, oral argument was presented by Mr Schreiber’s lawyer and the Agent for the Commission.

VI – Consideration of the questions submitted

A – Preliminary points

15. Despite the fact that the questions submitted by the Tribunale di Pordenone are of significant interest, the answers to be given by the Court of Justice will inevitably be rather unsatisfactory. That is because, as the Commission rightly points out in its written observations, the harmonisation of provisions concerning the marketing of biocidal products undertaken by Directive 98/8 is far from complete.

As indicated in the second and third recitals in the preamble to Directive 98/8, biocidal products, previously known as non-agricultural pesticides, are used for the control of organisms that are harmful to health and cause damage to natural or manufactured products. They pose various risks to human health, animals and the environment in a variety of ways owing to their intrinsic properties and associated use patterns. The review of the situation in the Community carried out by the Commission in the 1990s showed differences in the regulatory situation from one Member State to another which could constitute barriers not only to trade in biocidal products but also to trade in products treated with them, thereby affecting the functioning of the internal market.

16. Therefore, in the interest of promoting the free movement of such products, Article 4 of Directive 98/8 introduces mutual recognition of authorisations, so that a biocidal product permitted or registered in one Member State must be treated in the same way in the other States, within 120 days (authorisation) or 60 days (registration), provided that the active substance is included in Annex I or Annex IA and conforms with the requirements thereof. The directive also applies to authorisation for the use and marketing of biocidal products in the Member States and to the compilation of a positive list of the active substances which they contain.

17. At the present stage of advancement, the directive raises a number of problems. First, Annexes I and IA, which are intended to include the lists of active substances and the requirements accepted at Community level for their inclusion among biocidal products or low-risk biocidal products, and Annex IB, which is intended to list basic substances, have not been completed. Inclusion of products on those lists is a matter for the Standing Committee on biocidal products, within a time-limit of 10 years.

18. Second, the transitional measures in Article 16 enable the Member States, likewise for a period of 10 years, to continue to apply their current systems or practices for the marketing of biocidal products and, in particular, to authorise the placing on the market in their territories of biocidal products containing active substances not listed in Annex I or IA for those product types provided that, on a specified date, they are on the market as active substances of a biocidal product for purposes other than process-orientated research and development. (5)

19. Under Article 16(2) of Directive 98/8, the Commission commenced a 10-year programme of work. As indicated in recital 2 in the preamble to Regulation No 1896/2000, the first phase of that review would enable the Commission to identify existing active substances of biocidal products, on the basis of information given by the producer or formulator, and to specify those which should be evaluated for possible inclusion in Annexes I, IA or IB. Article 4(1) of that regulation set a time-limit, expiring on 28 March 2002, for producers, formulators and associations wishing to apply for the inclusion in Annex I or IA of the directive of an active substance existing in one or more product types to send notice to the Commission. The same approach was adopted in relation to Annex IB. Regulation No 1687/2002, (6) however, granted an additional period expiring at the end of January 2003.

A further stage of the review was announced, to commence in 2002. Regulation (EC) No 2032/2003 7 –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/EEC and amending Regulation No 1896/2000 (OJ 2003 L 307, p. 1). laid down detailed provisions for implementing the second phase of the work programme and systematically examining all the active substances already on the market by 14 May 2000 as active substances of biocidal products. In its written observations in these proceedings, the Commission reported that, according to its forecasts, the evaluation of active substances notified for possible inclusion in the annexes should be completed between 2006 and 2010.

20. In the list of active substances of 8 April 2003, cedar oil (Cedar Oil, Cedernholzöl Texas 22%) appears, under No CAS 68990-83-0, on page 20, whereas cedarwood oil is on page 22, (8) under No CAS 8000-27-9. According to the notes to that list, which contains a total of 645 substances, the first cedar oil referred to above was the subject of a joint notification, verified and accepted, whereas the second one mentioned is not the subject of any additional clarification. Although recital 3 in the preamble to Regulation No 1687/2002 states that the preliminary list of existing active substances notified is to indicate, in respect of each, the annex to Directive 98/8 in which inclusion is sought, the latter information does not appear in the list published.

The fifth recital in the preamble to Regulation No 2032/2003 states that existing active substances that have been identified only (and they include, in Annex III, both cedar oil and cedarwood oil) will not be evaluated within the framework of the review programme or included in Annexes I, IA or IB to Directive 98/8. Under Article 4(2), as from 1 September 2006 the Member States must cancel existing authorisations or registrations for biocidal products containing the active substances listed in Annex III, which includes those listed and identified, for which no notification has been accepted and regarding which no interest has been expressed, making certain that those biocidal products are not marketed within their territory.

21. Consequently, prior to the entry into force of Regulation No 2032/2003, cedar oil was an active substance regarded as ‘existing’, since it was already on the market by May 2000. (9) In those circumstances, Article 16(1) of Directive 98/8 allowed the Member States to continue to apply, for 10 years, the system of marketing biocidal products which they had used until that date. Accordingly, there is nothing to prevent Italy from relying on the legislation in force at that time regarding the sale of products containing that oil as an active substance, for the purpose of combating insects.

That appears to have been the aim pursued by that Member State in adopting Legislative Decree No 174/2000, adapting domestic legislation in line with Directive 98/8 and referring, for the marketing of biocidal products during the transitional period, to Decree No 392/98 of the President of the Republic, which governs the procedure for authorising and selling medico-surgical materials, including insect repellents.

22. Lastly, attention should be drawn to the consequences arising in this area from the entry into force of Regulation No 2032/2003. Active substances not included in Annex I thereto are deemed not to have been marketed before 14 May 2000.The condition imposed by Article 16(1) of Directive 98/8 for national authorities to authorise the sale of biocidal products was that the active substances thereof should already have been on the market as such on that date. Accordingly, biocidal products with a licence can continue to be sold until 1 September 2006, but it has ceased to be permissible to apply national legislation governing their registration if they incorporate any of the active substances not included in that annex.

B – Answer to the first question and part of the third

23. The first three questions from the Tribunale di Pordenone are closely interrelated, so much so that the text of the third coincides in part with that of the first and in part with that of the second.

For that reason, it is appropriate to reformulate them, dealing first with the question whether a block of red cedar wood, on sale in its natural state, without having undergone any chemical or biological treatment whatsoever, should, because its anti-moth effects derive from the actual make-up of that wood, be classified as a biocidal product or a low-risk biocidal product within the meaning of Article 2(1)(a) and (b) of Directive 98/8, subject to the requirement of authorisation or registration, or whether, on the contrary, those terms cover only products whose biocidal capability depends on added active substances.

24. In Mr Schreiber’s view, the Italian legislature has not correctly implemented Directive 98/8: since Decree No 392/98 of the President of the Republic specifically refers to the simplified authorisation procedure, it did not take account of the fact that the Community definition of ‘biocidal products’ does not coincide entirely with the term ‘medico-surgical materials’. From the literal wording of Article 2(1)(a), he infers that biocidal products function through active substances which have been incorporated in them by chemical or biological means, for which reason those which already contain them in their natural state cannot be regarded as such.

25. For the Belgian Government, those products are biocidal provided that their action against harmful organisms is clearly shown on the label, and it takes the same view regarding low-risk biocidal products. The concept of active substance thus corresponds not only to a product obtained by an industrial process but also to one which occurs spontaneously in nature.

26. The Commission has expressed the same view.

27. Article 2(1)(a) of Directive 98/8 refers to biocidal products 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. That provision refers to Annex V, which gives an exhaustive list of 23 types of product, with indicative descriptions. The annex is divided into four main groups. The third lists pest control products, encompassing six types: 14: rodenticides; 15: avicides; 16: moluscicides; 18: insecticides, acaricides and products to control other arthropods; and 19: repellents and attractants used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds) by repelling or attracting, including those that are used for human or veterinary hygiene either directly or indirectly.

28. The meaning of active substances is given in paragraph (d) of the same provision, referring to any substance or micro-organism, including a virus or a fungus, having general or specific action on or against harmful organisms.

29. According to the order for reference, the cedar wood blocks were sold as anti-moth products. They contain cedar oil or cedarwood oil, an active substance which, on evaporation, has a repellent effect on those Lepidoptera. Thus, the blocks in question, marketed for that purpose, are biocidal products within the meaning of Directive 98/8, classified as product type 19 in Annex V.

30. The Tribunale di Pordenone expresses certain reservations about accepting that possibility, for three reasons. First, the fact that the product has not undergone any prior chemical or biological process. Nevertheless the wording of the provision does not impose any such requirement.

31. Second, the fact that the repellent substance emanates naturally from the wood. But that fact is not decisive, since one of the principal aims of Directive 98/8, as indicated in the first and third recitals in its preamble, is the management, within the Community, of risks to humans, animals and the environment deriving from the use of biocidal products. As is well known, not all substances occurring in nature are innocuous, and therefore that argument is not a sufficient basis for exempting their marketing from any official control.

32. Third, the fact that the blocks are blocks of wood in its natural state. Once again regard must be had to the wording of the provision, since, apart from preparation for sale to the consumer, no industrial processing of the active substances is required.

In that connection, the reference made in Article 2(2)(a) to the definitions in Article 2 of Directive 67/548/EEC 10 –Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ, English Special Edition Series I, 1967, p. 234). categorises as biocidal products chemical elements and their compounds as they occur in their natural state or as produced by industry.

33. The possibility existed of course that the blocks concerned might be classified as low-risk biocidal products, that is to say, those which contain only one or more of the active substances included in Annex IA, in so far as they do not contain any dangerous component and represent only a slight danger to humans, animals and the environment. However, in my preliminary observations I have explained that, appearing as they do in Annex III to Regulation No 2032/2003, cedar oil and cedarwood oil will not be evaluated in the framework of the review programme and will not be included in Annexes I, IA or IB to Directive 98/8, for which reason they will not be able, as from September 2006, to be marketed in the Community as biocidal products.

34. It should therefore be ruled that a block of red cedar wood sold in the form in which it is found in nature, without undergoing any chemical or biological process whatsoever, since its anti-moth effects derive from the actual make-up of that wood, constitutes a biocidal product or a low-risk biocidal product within the meaning of Article 2(1)(a) and (b) of Directive 98/8, which is subject to authorisation or registration.

C – Answer to the second question and part of the third

35. In view of the link between these questions, it is appropriate to reformulate the second and the part of the third not yet examined. Accordingly, it remains to decide whether Article 2(1)(c) of Directive 98/8 is to be interpreted as meaning that the term basic substance includes a substance contained in a product (in this case, blocks of red cedar wood) which is sold in the form in which it is found in nature, without having anything added to it to endow it with a biocidal action, since it performs that action in addition to the function normally expected of it.

36. Mr Schreiber identifies the basic substance by reference to the ancillary nature of the biocidal function which it performs, either alone or in combination, although the purpose of its inclusion in the final product is not for it to be used for the destruction of harmful organisms. It is not therefore necessary to subject it to restrictive measures such as the prior authorisation or registration applicable to biocidal products and low-risk biocidal products. In the case of red cedar wood, whose main industrial use is the manufacture of furniture, its incidental effect is inferred solely from the label. Since the wood has not been treated, contains the insect repellent as an intrinsic component and is sold in the state in which it is found in nature, it fulfils, in his opinion, the conditions laid down by the Community definition of basic substance in Article 2(1)(c) of Directive 98/8.

37. The Belgian Government considers that the concept of basic substance is such that the marketing thereof for biocidal purposes is excluded. Once cedar wood is sold as an anti-moth product, it seems clear that it does not fulfil the latter condition. The Commission reaches the same conclusion on the basis of similar reasoning.

38. Article 2(1)(c) of Directive 98/8 lists the requirements of a basic substance: first, it must be listed in Annex IB; second, its major use must be non-pesticidal but it must have some minor use as a biocide either directly or when mixed with a diluent which does not present risks; and, third, it must not be marketed for its biocidal properties.

39. As far as the first requirement is concerned, the Commission states in its written observations that the concept of basic substance has not yet been fully harmonised. In any event, following the publication of Regulation No 2032/2003, it is clear that the active substance of red cedar wood will not be included in Annex IB.

40. As regards the second requirement, it is difficult to contend that cedar wood is used fundamentally for the manufacture of furniture, an assertion which is becoming increasingly remote from the reality of present day cabinet making; (11) moreover, after the trunk is cut into blocks, the wood can no longer be used for that purpose, quite apart from that fact, even if it is assumed that someone who buys a cedar wardrobe is aware of the anti-moth properties of the raw material, its effects do not endure indefinitely, since the active substance evaporates as time goes by. It is therefore incorrect to think that the blocks at issue fulfil only a minor use as biocidal products because they are used, primarily, for another purpose.

41. The blocks in question likewise do not fulfil the third requirement. According to the account of the facts in the order for reference, they were sold precisely because of their anti-moth effect, a use included in relation to product type 19 in Annex V to Directive 98/8.

42. Consequently, subject to the proviso that the materials making up Annex IB have not yet been specified, the term basic substance within the meaning of Article 2(1)(c) does not cover the substance contained in a red cedar wood block, whose main purpose, according to its presentation for marketing purposes, is to act as a biocidal product, it being marketed as such, even though the active substance is an inherent part of the wood and it is sold without any change in the state in which it is found in nature.

D – The fourth question

43. This question seeks to clarify whether, under Article 2(1)(c) of Directive 98/8, only products listed in Annex IB can be regarded as basic substances, the marketing of which in the Member States is exempt from authorisation or registration.

44. Mr Schreiber considers that that provision gives a full and independent description of the concept, regardless of inclusion in any of the annexes. It is an exhaustive definition, providing everything necessary for registration in the relevant annex, and registration has no legal effect.

45. The Belgian Government and the Commission, on the contrary, advocate an answer in the affirmative.

46. Directive 98/8 imposes different regimes for marketing and for use of the products which it governs: Article 3(1) subjects biocidal products to authorisation; Article 3(2)(i) requires low-risk biocidal products merely to be registered; finally, under point (ii) the Member States are to allow the placing on the market and use of basic substances for biocidal purposes once they have been entered in Annex IB.

47. Also, as I pointed out in my analysis of the second question, Article 2(1)(c) defines basic substances by reference to the fact that they are listed in Annex IB. However, until that annex is completed, it is impossible to ascertain for which materials marketing in the Member States is exempt from authorisation and registration.

48. The Commission has recognised that it is impossible to list substances in the annexes until the end of the evaluation phase, which will occur between 2006 and 2010. Therefore, until such time as the annex is completed, the Member States will apply their legislation on the sale and use of those substances; only when a substance cannot be included in any annex will the Commission, in compliance with Article 16(4), submit proposals for limiting its marketing and use.

49. It must therefore be stated that the only substances which are basic substances within the meaning of Article 2(1)(c) of Directive 98/8, whose marketing in the Member States is exempt from the obligation of obtaining authorisation and registration, are those appearing in Annex IB.

E – The fifth question

50. Finally, the Tribunale di Pordenone seeks clarification as to the interpretation of Article 4 of Directive 98/8, in relation to Articles 28 EC and 30 EC, in order to determine whether a product such as red cedar blocks, lawfully marketed in a Member State without the need for authorisation or registration, can be subjected to those requirements in another State of the European Union for sale and use because they do not appear in Annex IB.

51. For Mr Schreiber, in view of the fact that the product at issue is sold in one Member State without such formalities, the national authorities have not classified it either as a biocidal product or as a low-risk biocidal product, but rather as a basic substance. Since it is a product from Germany, the principle of mutual recognition requires it to be able to move freely within the territory, without restrictions being imposed by the Member States. In this case, a national decision which makes the marketing of a product subject to prior authorisation is a measure having an effect equivalent to a quantitative restriction and one which is also disproportionate in relation to the objective pursued.

52. Both the Belgian Government and the Commission favour giving an affirmative answer; the latter, although acknowledging that it is restrictive in character, considers that the national measure is justified, even where the product has been legally marketed in another Member State.

53. From the wording of the question, it might be inferred that the red cedar wood blocks are a basic substance, appearing in Annex IB. However, it has become apparent, in the analysis of the first question, that the active substance of that wood is a biocidal product or a low-risk biocidal product, namely categories which will, in due course, make up Annexes I and IA respectively.

In those circumstances, it would not be of much use for the Court of Justice to interpret Article 4 of Directive 98/8 in relation to the mutual recognition of authorisations, since that provision will apply to biocidal products which are allowed or registered in a Member State, only if ‘the active substance of the biocidal product is included in Annex I or IA’. 12 –Emphasis added.

54. I agree with the Commission that, whilst those two annexes lack content, Article 4 does not require Italy to disapply its domestic legislation governing the sale of insect repellent products on the ground that, in another Member State, Germany in this instance, their marketing is not subject to any authorisation or registration.

But, even if Article 4 is relied on in this case, a biocidal product authorised or registered in one Member State should be recognised or authorised in the others before it is placed on the market.

55. If therefore, it is inappropriate to have recourse to Article 4, the question remains to be clarified of the conformity with Community law of domestic legislation which requires prior authorisation for the marketing of red cedar wood blocks, with biocidal properties, when they are already legally sold in another Member State.

56. According to the case-law of the Court of Justice, any legal provision of a Member State prohibiting biocidal products which have not been previously authorised from being marketed, acquired, offered, put on display or sale, kept, prepared, transported, sold, disposed of for valuable consideration or free of charge, imported or used, constitutes a measure having an effect equivalent to a quantitative restriction within the meaning of Article 28 of the Treaty. (13)

57. The various grounds of public interest which allow exceptions to the general rule prohibiting quantitative restrictions and measures having equivalent effect listed in Article 30 include the protection of public health. The Court of Justice, in that connection, has taken the view that in the absence of Community harmonisation the Member States retain residual powers to decide the level of protection of the life and health of humans, by requiring prior authorisation for the marketing of products which represent a danger.

58. So far as biocidal products are concerned, the third recital in the preamble to Directive 98/8 recognises that they may pose risks to humans, animals and the environment in a variety of ways owing to their intrinsic properties and associated use patterns. The Court of Justice itself recently expressed the view that biocidal products and substances liable to be harmful to natural or manufactured products inevitably contain dangerous components. (14)

59. By virtue of the principle of proportionality, where any of the grounds of public interest which may justify a restriction on trade within the Community is invoked, the Member States must go no further than is necessary to attain the desired objectives of protection. (15)

The Court of Justice has held that, whilst a Member State is free to require a disinfectant product which has already received approval in another Member State to undergo a fresh procedure of examination and approval it is nevertheless required to assist in bringing about a relaxation of the controls existing in intra-Community trade. It follows it is not entitled unnecessarily to require technical or chemical analyses or laboratory tests where those analyses and tests have already been carried out in another Member State and their results are available to it. 16 –Case 272/80 Frans-Nederlandse Maatschappij voor biologische Producten [1981] ECR 3277, paragraph 14.

60. It appears that the cedar wood blocks are sold without prior authorisation or registration in Germany. As indicated in my examination of the first question, once they are regarded as biocidal products or low-risk biocidal products, there is nothing to preclude another Member State from making their marketing in its territory subject to fulfilment of either of those requirements.

In particular, Article 4(2) of Regulation No 2032/2003 requires the Member States to make certain that, as from 1 September 2006, biocidal products containing, as an active substance, cedar oil or cedarwood oil are not sold in its territory. But, until that time, they are empowered by Article 16 of Directive 98/8, in conjunction with Article 4(3) of the abovementioned regulation, to permit the marketing of products containing them which are already authorised, but not to register new ones.

61. Consequently, domestic legislation like that of Italy, which makes authorisation a prior requirement for the marketing of red cedar wood blocks, with biocidal properties, constitutes a measure having an effect equivalent to a quantitative restriction within the meaning of Article 28 EC, which is justified under Article 30 EC, even where they are legally sold in another Member State.

VII – Conclusion

62. In view of all the foregoing considerations, I suggest that the Court of Justice give the following answer to the questions submitted by the Tribunal di Pordenone:

(1): A red cedar wood block sold as found in nature, without having undergone any chemical or biological treatment whatsoever, since its anti-moth effects derive from the actual make-up of that wood, constitutes a biocidal product or low-risk biocidal product within the meaning of Article 2(1)(a) and (b) of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 on the placing of biocidal products on the market.

(2): Subject to the proviso that the materials making up Annex IB of Directive 98/8 have not yet been specified, the term basic substance within the meaning of Article 2(1)(c) of that directive does not cover the substance contained in a red cedar wood block, whose main purpose, according to its presentation for marketing purposes, is to act as a biocidal product, it being marketed as such, even though the active substance is an inherent part of the wood and it is sold without any change in the state in which it is found in nature.

(3): Only substances listed in Annex IB are basic substances within the meaning of Article 2(1)(c) of Directive 98/8, the marketing of which in the Member States is exempted from the requirement of obtaining authorisation or registration.

(4): Domestic legislation like that of Italy, which makes authorisation a prior condition for the marketing of red cedar wood blocks, with biocidal properties, constitutes a measure having an effect equivalent to a quantitative restriction within the meaning of Article 28 EC, which is justified under Article 30 EC, even where they are sold legally in another Member State.

1 –: Original language: Spanish.

2 –: OJ 1998 L 123, p. 1.

3 –: GURI No 149 of 28 June 2000, ordinary supplement No 101.

4 –: GURI No 266 of 13 November 1998. That decree governs simplification of procedures for authorisation, with a view to the production and marketing of medico-surgical materials.

5 –: Both for determination of the starting date of the period of 10 years and the setting of the date by which active substances had already to have been on the market, the Community legislature refers to Article 34(1) of Directive 98/8. That provision, however, contains no date whatsoever: it merely imposes on the Member States the obligation to adjust their national legislation within a period of 24 months after the entry into force of the directive, which, under Article 35, occurred on the 20th day following that of its publication. This peculiar legislative approach does not make it clear whether the Member States have until May 2008 or 2010 to carry on applying their own system for the marketing of biocidal products or whether the substances had to have been marketed before May 1998, when it entered into force, or May 2000 when the Member States were obliged to implement the directive. Commission Regulation (EC) 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC (OJ 1998 L 228, p. 6) clarifies this point by defining as existing active substances all active substances in biocidal products already on the market on 14 May 2000.

6 –: Commission Regulation (EC) No 1687/2002 of 25 September 2002 on an additional period for notification of certain active substances already on the market for biocidal use as established in Article 4(1) of Regulation (EC) No 1896/2000 (OJ 2002 L 258, p. 16).

7 –: 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/EEC and amending Regulation No 1896/2000 (OJ 2003 L 307, p. 1).

8 –: These data can be consulted at webpage http://ecb.jrc.it/biocides.

9 –: Article 4(3) provides that, from the date of entry into force of the regulation, any active substance not listed in Annex I is to be deemed not to have been placed on the market for biocidal purposes before 14 May 2000.

10 –: Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ, English Special Edition Series I, 1967, p. 234).

11 –: According to the Bible, the First Book of the Kings, chapters 5, 6 and 7, Solomon instructed Hiram, the King of Tyre and Sidon, to order that cedars of Lebanon be cut down to construct the Temple of Jerusalem, promised by his father to Jehovah. Solomon raised a levy in Israel of 30 000 men and also 70 000 porters. The precious wood was used for the beams joining the surrounding raised gallery with the inner courtyard, the coffered ceiling, the covering of the walls and the decoration of the Holy of Holies. ‘And the cedar of the house within was carved with knops and open flowers: all was cedar; there was no stone seen’. It was also used for the altar and the nave, in combination with other woods: wild olive, cypress and fir. Solomon’s palace itself, built later, had such a profusion of wood that it was known ‘as the house of the forest of Lebanon’, since it contained four rows of cedar pillars, and that wood was also used for the porch ‘for the throne where He might judge, the Porch of Judgment’, from floor to ceiling.

12 –: Emphasis added.

13 –: Case C-400/96 Harpegnies [1998] ECR I-5121, paragraph 30; and Case C-293/94 Brandsma [1996] ECR I-3159, paragraph 6.

14 –: .Harpegnies and Brandsma, cited above, paragraphs 33 and 11 respectively.

15 –: C-388/95 Belgium v Spain [2000] ECR I-3123, paragraph 59; Case C-469/00 Ravil [2003] ECR I-5053, paragraph 51; and Case C-108/01 Consorzio del Prosciuto di Parma [2003] ECR I-5121, paragraph 66.

16 –: Case 272/80 Frans-Nederlandse Maatschappij voor biologische Producten [1981] ECR 3277, paragraph 14.

Top

Choose the experimental features you want to try