OPINION OF ADVOCATE GENERAL

RUIZ-JARABO COLOMER

delivered on 12 February 2004

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) ‘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?’

(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.

(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.

– Original language: Spanish.

– OJ 1998 L 123, p. 1.

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

– 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.

– 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.

– 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).

– 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).

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

– 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.

– 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).

– 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.

– Emphasis added.

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

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

– 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.