Originally proposed in 1993, the biocides Directive is intended to create a common framework for the authorisation of biocides other than agricultural pesticides and certain other products already covered by EC rules. Twenty-three types of products - ranging from wood and masonry preservatives, slimicides and drinking water disinfectants to rodenticides and anti-fouling chemicals - are covered by the Directive. Member States have until May 2000 to bring it into force.
The broad goal of the legislation is to ensure that only those biocidal products containing active substances to be listed in Annex I of the Directive are placed on the market. Existing substances will or will not be placed on Annex I after their efficacy and safety to humans and the environment have been evaluated at EC level. New substances will also have to be evaluated before being placed on Annex I. Authorisation of individual products containing Annex I substances will be done at Member State level. Provision has been made for mutual recognition of one country's decisions by others.
The Directive requires the evaluation of existing active substances to be completed ten years after its adoption - by 2008. A forthcoming Regulation will set out the review programme, including priorities for evaluation and a timetable.
Streamlined authorisation procedures have been included, in part at the UK's insistence, for "low-risk" biocidal products and for products containing "basic" substances. Active substances judged suitable for use in "low-risk" products will be listed in Annex Ia, while "basic" products will be listed in Annex IB. The latter substances are essentially commodity chemicals with only minor biocidal uses. Potential candidates expressly specified in the Directive for inclusion in Annex IB are carbon dioxide, nitrogen, ethanol, 2-propanol, acetic acid and kieselguhr.
The simplified approval procedures for products containing these two groups of substances were, however, tightened up at the last minute following "conciliation" negotiations between the European Parliament and Council of Ministers.
Firstly, the Directive now requires that applications for inclusion of active substances in Annex IA or IB must be accompanied by a full technical dossier of the kind required for Annex I listing. However, this change may prove to be more cosmetic than real because the dossier specifications are prefaced by a provision that "information which is not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied."
A second change made at Parliament's insistence concerned the requirement that neither low-risk biocides nor basic substances should be "substances of concern". The late amendment stipulates that such substances are those classified as "dangerous" under existing EC chemicals classification rules and present in a biocidal product at concentrations which would lead to its classification as "dangerous" under the 1988 Directive on dangerous preparations. However, a substance may also be regarded as a "substance of concern" if there are "other grounds for concern."
Parliament, however, got little from the Council over its demands to be involved in the procedure for placing substances on Annexes I, IA or IB. The decision will be taken by national officials on the new Standing Committee on Biocidal Products chaired by the European Commission, with the Council becoming involved in disputed cases. Parliament will merely be notified by the Commission of proposed decisions to list substances in the annexes.
A notable feature of the Directive which stemmed from a Swedish proposal is the inclusion of the principle of "comparative assessment" in EC chemicals legislation for the first time. The Directive provides that an active substance may be refused entry on Annex I or deleted from it if there is another Annex I substance "for the same product type which.presents significantly less risk to human health or to the environment."
Where refusal or removal is being considered, an assessment will have to be carried out to demonstrate that the alternative "can be used with similar effect on the target organism without significant economic or practical disadvantages for the user and without an increased risk for health or for the environment." A weakness of the procedure is that it does not allow for comparison of biocides with non-chemical means of control.
The principle also comes with several qualifications. For instance, the "chemical diversity" of substances must be adequate to prevent the build-up of resistance in target organisms. Refusal or removal of an Annex I entry may only be applied "after allowing the possibility, where necessary, of acquiring experience from use in practice." And decisions to remove an Annex I entry are not to have immediate effect, but delayed for a maximum of four years.
Despite the streamlined approval provisions for low-risk products and other elements of flexibility built into the Directive, biocide producers remain deeply concerned that the costs of preparing dossiers and possibly additional testing will be prohibitively expensive for many of the 10-18,000 biocidal products currently on the EC market (ENDS Report 274, p 44 ).
Costs will depend on how the Directive is applied by Member States. This, in turn, will depend in part on guidance currently being prepared on issues such as comparative assessment by the Swedish authorities and on data requirements by the Finnish authorities.
In a parliamentary answer in May, junior Environment Minister Baroness Hayman said that the Health and Safety Executive is seeking to ensure that the Finnish guidance "takes full account of the flexibility which the Directive provides so that costs are minimised."
The HSE is also "encouraging industry to play its part," she added, "by lobbying the European Commission and other Member States. HSE has discussed with industry the possibility of their forming task forces to share data to help reduce costs."
Companies wishing to be kept up to date on progress in implementing the Directive should contact Dr Alex Tsavalos, HD D4: Pesticides Registration Division, HSE, Magdalen House, Stanley Precinct, Bootle L20 3QZ.