Opinion on the proposal for a Council Directive concerning the placing of biocidal products on the market (94/C 195/21)

On 18 August 1993 the Council decided to consult the Economic and Social Committee, under Article 100a of the Treaty establishing the European Economic Community, on the abovementioned proposal.

The Section for Protection of the Environment, Public Health and Consumer Affairs, which was responsible for preparing the Committee's work on the subject, adopted its Opinion on 5 April 1994. The Rapporteur was Mr Proumens, replacing Mr Kafka.

At its 315th Plenary Session (meeting of 28 April 1994), the Economic and Social Committee adopted the following Opinion unanimously.

The Committee approves the Draft Directive, which is designed to protect human and animal health and safeguard the environment, subject to the following observations.

Nevertheless, the Committee, while aware of the complexity of the questions raised, would have preferred the texts to be clearer and more precise. If they are not amended, supplemented or explained, the Committee fears they may be interpreted differently by the relevant Member State authorities and by manufacturers, users and importers.

1. Background

1.1. During preparation of Directive 91/414/EEC concerning the placing on the market of plant protection products (1), it was felt that another Directive should be drafted dealing specifically with non-agricultural pesticides. However, it was pointed out that these products should be grouped together with others under the heading of biologically active products for use in non-agricultural applications. It was then found that the nature and the applications of these products made them very different from pesticides, and so the term 'biocides' was selected.

1.2. Biocides can be used both on microscopic organisms, such as viruses, bacteria, moulds and yeasts, and on larger organisms, such as insects, small rodents (rats, mice etc.), molluscs, algae, and even some birds.

1.3. All of these organisms can harm human and animal health, damage natural or manufactured products and attack materials, such as masonry, wood and paints. They can also cause pollution in sanitary and air-conditioning systems, and can weaken, if not undermine, dykes.

This list is far from exhaustive.

It is, of course, clear that while biocides can prevent such damage, care must be taken to ensure that their improper or inexpert use does not result in damage to humans and/or animals in particular.

2. General comments

2.1. It is clear from the above that there is a wide range of biocides with a variety of applications and targets, and that many of these have little in common with the plant protection products covered by Directive 91/414/EEC. Estimates put the number of biocides at several thousand (e.g. there are around 200 different household disinfectants alone).

2.2. In view of this diversity and the existence of national provisions in some areas, the Commission felt there was a need to draw up a Directive on the basis of Article 100a with the aim of harmonizing legislation without disregarding the impact which such products can have on the environment.

2.3. In order to determine which active substances are used in biocides, the Commission, working on the principle of subsidiarity, has proposed that the national authorities of Member States draw up a list of these substances, which will then be progressively centralized at Community level and put on the as yet non-existent list in Annex I. Apart from its importance in applying the proposed Directive, this list will make documentation work easier for companies in this field.

2.4. Secondly, companies placing biocidal products on the market would have to compile technical dossiers containing the information stipulated in the annexes to this proposal, that is:

- a dossier for active substances used in biocidal products;

- a dossier for the biocidal products themselves.

2.5. Accordingly, the Commission has proposed that the authorizations for biocidal products provided for in the Directive be granted by individual Member States and that an authorization granted in one Member State be recognized by the other Member States.

3. General remarks

3.1. The Committee shares the Commission's concern to protect human and animal health and the environment.

3.2. The Committee agrees entirely with the proposed compiling of information on active substances by the national authorities, not only because this procedure follows the subsidiarity principle, but also because, owing to geographical and climatic differences in particular, active substances which may be used in one Member State may not necessarily be used in another.

3.3. The Committee endorses the principle of mutual recognition of dossiers as already exists for other products such as agricultural pesticides or medicines derived from biotechnology. The Committee is, however, concerned that the Commission's acceptance of the possibility of exceptions might jeopardize this principle.

3.4. Without going into the question of overall estimates of the costs involved in compiling dossiers, the Committee is concerned at the estimated cost per dossier, which could be as much as ECU 120 000 for each authorization. This amount would generally be much higher for dossiers on active substances.

3.5. With such a large number of products being categorized as biocides and requiring dossiers, and with each product having a dossier in each Member State which requires a copy or a translation, the amount of paperwork involved would be difficult to handle. The Commission should assess the complexity of this administrative process in collaboration with the Member States, even where the dossiers take the form of summaries.

The Committee asks the Commission to insist that Member States ensure that the relevant authorities responsible for examining summarized dossiers accept the information contained in them without carrying out further tests and thus duplicating work already done.

3.6. The Commission itself acknowledges that implementation of the authorization scheme will take several years. A ten-year transitional period will be needed to clear biocides placed on the market before the present Directive's entry-into-force.

3.7. This scenario and the administrative consequences involved will be particularly onerous for small and medium-sized enterprises and industries, which abound in the various sectors of activity affected, as listed in Annex V to the proposed Directive.

3.8. The Committee is aware that the two main measures proposed, namely the positive list of active substances and the dossier on finished products, will have differing (financial and/or material) implications. Companies manufacturing and/or marketing the active substances will not be affected in the same way as companies using these active substances to make finished products for which they must supply a dossier.

3.9. The Committee wonders about the impact of the list of active substances to be drawn up in Annex I of the present proposal in relation to the list of dangerous substances drawn up in accordance with the provisions of Council Directive 67/548 and the subsequent amendments thereto.

3.10. On this matter, the Commission intends to dispense with the obligation to register products on Directive 67/548's list of dangerous substances as the information to be included in this proposal's active substance dossiers is more detailed than that required under Directive 67/548.

3.11. This means that in cases where active 'biocidal' substances are considered 'dangerous' under the terms of Directive 67/548, information about this will have to be included in the dossier required for Annex I.

3.12. On a different matter, the Committee would like the Commission to work on rules concerning the impact which these biocidal products may have on surface and ground water.

4. Specific comments

4.1. Article 2

4.1.1. The Committee wonders to what extent the very general definition of biocidal products may cause difficulties, if not disputes, when applied in one or other of the Member States.

4.1.2. Admittedly, the list of product types given in Annex V of the proposal provides some clarification, but it still leaves room for broad interpretations which could hardly be justified.

4.1.3. Accordingly, the Committee suggests that the definition be amended by adding 'exclusively or mainly' after '... intended', unless Annex V is made clearer and more explicit.

4.2. Article 3

4.2.1. The Committee feels that the term 'reasonable period' in Article 3(2) may give rise to delays which could prejudice businesses and users. It therefore proposes that the text read 'no later than 12 months after the date on which the full dossier is submitted'.

However, in the case of finished products, a shorter period of, say, six months could be laid down.

4.3. Article 5

4.3.1. While the Committee appreciates the need to review authorizations in the light of new information necessitating such a review, it nevertheless feels that a review should be undertaken only when there are specific reasons for doing so. Such a review should remain the exception.

4.4. Article 6(4)

4.4.1. The Committee feels that allowing the bodies responsible for granting authorizations to determine the manner of use or amounts used could easily lead to excesses.

It is important that any such procedure should be laid down in consultation with the industries concerned and on the basis of information contained in both the active substance dossier and the finished product dossier.

4.5. Article 7

4.5.1. This Article appears to be saying that the person responsible for placing a product on the market in the EU will only have to refer to existing information on active substances, as set out in Annex I, in the dossier which he is required to submit to the competent authorities of the Member State where he is applying for authorization. This information would be supplied by another company which would have given permission for the data to be used.

4.5.2. It should be pointed out here that, in most cases, the company marketing the finished product is not the same as the company or companies which manufacture the active substance used in it.

4.5.3. Therefore, given that the finished product dossier must contain details taken from the active substance dossier, the company will only be able to get hold of this information if it is granted a 'letter of access' by the firm which submitted details of the active substance in question.

4.5.4. Obviously, the Committee is well aware that compiling this active substance dossier is very costly (as pointed out in point 3.4) and that, therefore, it is only fair that the company manufacturing the active substance should be allowed to charge the user a proportional amount for access to its dossier.

4.5.5. Such a charge is even more justified in the case of finished products imported from third countries requiring the obligatory active substance dossier, where no payment is made for the active substance that has been produced or marketed in the EU.

4.5.6. Furthermore, for the active substance dossier, the Commission allows several companies to conduct a certain number of tests jointly to avoid repetition, particularly those tests carried out in vivo on living organisms.

4.5.7. It should be clear that, just because the 'letter of access' is justified economically, it must not be allowed to lead to a sales monopoly being sanctioned by this administrative procedure.

4.5.8. It goes without saying that if several companies manufacture the same active substance, mutatis mutandis, this monopoly would be different, with competition playing a role (although not excluding the possibility of a tacit agreement), but a single producer could impose such high charges that manufacturers of finished biocidal products might be excluded from the market.

4.5.9. The Committee therefore invites the Commission to carefully examine the consequences of this process in collaboration with the companies concerned, who, in general, have expressed their satisfaction with the way the Community authorities have collaborated with them so far on this matter.

4.6. Article 9

4.6.1. The Committee has noted that details will have to be given in Annex I of the intended uses of the active substances.

4.6.2. However, dossiers will be required to include an indication of the concentrations used in biocides for different applications. If such information is to be given, it will have to be treated in part as confidential.

4.6.3. The Committee has also asked the Commission to explain what would happen in cases where a given active substance is put to new uses. In such cases it would not be necessary to submit a new dossier. The necessary information could be added to the existing one.

4.7. Article 9(5)

4.7.1. The Committee is reluctant to accept this point, even though it is in line with the Fifth Environment Programme, and feels that it should be amended if it is retained.

4.7.2. Firstly, the text should read '... may be reviewed and even refused after examination'.

4.7.3. Then a paragraph should be added saying: 'In the case of a refusal upon review, the company shall be given a maximum of five years to withdraw the active substance. However, this grace period may not extend the ten-year period stipulated in Article 9(4)'.

4.8. Article 11

4.8.1. Comments and suggestions on this Article have already been made in points 4.5.1 to 4.5.9.

4.9. Article 12

4.9.1. See also points 4.5.1 to 4.5.9.

4.9.2. As regards Article 12(2) on the use of vertebrate animals (b, 2nd paragraph), it is clear that some form of financial compensation should be envisaged. Can the Commission look into arrangements for this ?

4.9.3. The Committee welcomes the procedure and provisions proposed by the Commission to avoid unnecessary repetition of tests on animals.

4.10. Article 17

4.10.1. In paragraph 3, confidentiality should apply to points (c) and (j).

4.11. Article 20

4.11.1. The Commission should clarify what it means by advertising. The Committee feels that the term should encompass not only media advertising (newspapers, magazines, TV, radio, leaflets, brochures, etc.) but also package labelling and notices at the point of sale.

4.12. Article 24

4.12.1. In Article 24(3) the words 'may be' should be replaced by 'shall be'.

5. Annex V

A number of questions arise in connection with the remarks made in Point 4.1 above and with Annex V, which could provide clearer definition:

5.1. For example, are disinfectants antiseptics and, if so, could they be classed as medical products ?

At any rate, 'grey areas' should be eradicated in the wording of Annex V, as these may lead to confusion, if not disputes.

5.1.1. On this point, it is essential that the rules on labelling as set out in Article 18 should be clearly defined to avoid these 'grey areas'.

Done at Brussels, 28 April 1994.

The Chairman

of the Economic and Social Committee

Susanne TIEMANN

(1) OJ No C 56, 7. 3. 1990.