End of road for two-thirds of biocides

Detailed rules for a ten-year programme to review the safety of biocides on the EU market were set out in a European Commission Regulation at the end of November.1 The first major impact will be to force almost two-thirds of currently available biocidal active substances off the market within three years.

The new Regulation stems from the 1998 Directive on biocidal products. This requires the environmental and health hazards of all existing biocidal active substances - those on the EU market in May 2000 - to be reviewed at EU level in a ten-year programme starting in 2002. Biocidal products containing substances which clear this hurdle will then need authorisation at national level (ENDS Report 332, pp 23-27 ).

The first step in the programme was completed last January. This required the "notification" or "identification" of existing substances to the Commission, enabling it to compile authoritative lists of substances and establishing the basis for the next steps in the programme.

During this first step, some 960 substances were notified or identified. These form an exhaustive list of existing active substances set out in an annex to the new Regulation.

Under the Regulation, active substances now fall into three groups:

  • Those which were neither notified nor identified must not be used in biocidal products from 14 December, when the Regulation entered into force. Nothing has come of official suggestions last year that they might be allowed a year's grace before being withdrawn from the market. Any such chemical will now be treated as a new substance, with the producer having to submit a full dossier of test data and get a positive result from an official evaluation before being able to use it in a biocidal product.

  • Substances which were identified but not notified - usually because the manufacturers judged the cost of supporting them through the review programme to be prohibitive - can only be used in biocidal products until 1 September 2006. The same holds for any "product types" which were not covered by any notifications. There are 23 product types listed in the 1998 Directive.

  • Notified substances may remain in use - subject to any national controls - for the product types for which notifications were accepted by the Commission until their safety has been reviewed at EU level.

    Only some 360 substances fall in this category - around 37% of the total number of existing substances.

    The remainder will disappear from the EU's biocidal armoury in less than three years, mirroring a process which has already occurred in the pesticides field.

    The notifications for the 360 or so substances in this group cover around 1,680 substance/product type combinations (see table).

    The table also shows the timetable set by the Regulation for the four-phase review programme. The first decisions on substances in phase one - wood preservatives and rodenticides - are expected towards the end of 2005. The work will build to a peak in phase three, and it remains an open question whether the competent authorities will have sufficient resources to avoid a repetition of the delays which have plagued the EU's pesticides review programme over the past decade.

    The Regulation also formally appoints Member States as rapporteurs for the review programme's first two phases. The UK is rapporteur for ten wood preservatives in phase one, and 19 of the 205 phase two substances.

    An important set of provisions deals with the procedures for the review programme. These are in some key respects more generous to both the competent authorities and to industry than had been expected a year ago.

    The procedure begins with a company submitting a dossier of test data, accompanied by a summary dossier containing, among other things, a risk assessment. The rapporteur Member State must carry out a completeness check within three months.

    However, the deadline for the completeness check will be extendable to six months after submission of a dossier where its acceptability is the subject of consultations with other national authorities. In "exceptional circumstances", the rapporteur may also set a later deadline for the submission of some information where a company was unable to submit it on time.

    Once a dossier is accepted, the rapporteur must evaluate it and prepare a "competent authority report" recommending whether the substance should or should not be accepted.

    This time last year, a 12-month deadline for completion of evaluations was being contemplated - but it failed to make it into the Regulation, no doubt because national authorities did not want to have their hands tied. This may be of concern to some biocide producers, since competitors who did not notify a substance or bear the cost of preparing a dossier will have a free ride until the evaluation is completed.

    Rapporteurs may often find themselves evaluating more than just the dossier. The Regulation enables companies to require the rapporteur to take into account additional information submitted up to nine months after the acceptance of the original dossier, where the rapporteur was notified that this would be forthcoming at the time the dossier was submitted. In order to be taken into account, the extra information must be "equally or more reliable owing to the application of the same or higher quality standards", and must support a different conclusion concerning the substance. The clause is, in effect, a last opportunity for companies to stop their products being barred.

    Competent authority reports will be publicly available except for information which must be treated as confidential under the 1998 Directive. The Regulation also contains provisions intended to promote data sharing and minimisation of animal testing, and to allow companies, trade associations or even Member States to take over supporting a biocidal substance through the review process where the original applicant pulls out.

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