The European Commission launched an internet-based survey at the end of last year to gauge views on the Directive’s implementation. Responses were due by February.
Key findings and recommendations will be presented to the Commission later this year, enabling it to prepare proposals for amendment as required under the Directive.
Areas to be examined under the review include the functioning of the Directive’s simplified procedures intended to capture frame-formulations, low-risk biocidal products and commodity substances.
The Directive has had a substantial impact on industry, with companies reportedly choosing to withdraw two thirds of active substances from the market rather than pay to have them authorised for continued sale in the EU. This picture is somewhat dependent on industry estimates, given that few member states seem to have a clear idea of which biocidal products were on the market beforehand.
Companies were due to remove all unsupported substances from the market by 1 September 2006. The survey asks whether this has happened but government officials say it is difficult to tell, given the unclear picture beforehand and a lack of enforcement resources in most countries. Key issues include:
But by the end of last year, only 31 dossiers out of 49 had been completed, and only 12 of these had been evaluated at technical meetings. Only one is listed in annex I, sulfuryl fluoride, which was evaluated by Sweden. Another, dichlofluanid, has been agreed as a candidate and evaluated by the UK.
Industry groups blame the delay on the late arrival of guidance on dossier preparation and lack of expertise and resources in some member states. Government officials say some of the dossiers were "way off" requirements but also concede capacity is limited for some authorities.
Prolonged debate at technical meetings is also blamed. One regulator accused one or two others of following a "tick-box mentality" over some data requirements "rather than applying common sense."
The Commission is understood to have put a rocket under technical deliberations since last autumn, some say with a fearful eye to a likely further resource drain when the EU’s registration scheme for chemicals (REACH) comes into force later this year. One official described the pressure for "next day" decisions as "a bit of a shock for some authorities".
Whether this will be enough is also up for debate. Some say authorities and companies have gone through a steep learning curve and will become more efficient. Others point out that the product categories scheduled for later in the review process are less well-characterised and understood.
Industry groups argue that the Directive creates space for free-riders by failing to name those companies involved in generating data for authorisation applications, and by failing to specify when producers who have not paid towards the costs of the data must remove their products from the market.
Moreover, delays to the authorisation process mean a longer free ride for non-participant companies. It also means firms cannot pass on the costs of investing in data generation to customers because other companies do not have to bear these costs, which are said to run into "millions of euros" in some cases.
One example is companies’ failure to produce a data dossier for the use of chromium as a wood preservative. Some authorities decided it should therefore not be allowed on the market after last September. Others, however, accepted industry arguments that chromium acted as a fixative rather than an active substance and decided to give firms more time.
Another instance, which cost the UK government some bad national press, was when it asked for some citronella-based products to be removed from the market because the substance had not been notified, while other countries took no action.
There is also large variability in fees charged by authorities. Fees are reported to range from €75,000 to €300,000 at initial submission of a substance dossier. This can be multiplied if a single active ingredient is applied to several products.
The Health and Safety Executive has set its fees at the lower end of this range at £10,000 for a completeness check and £84,000-89,000 for full evaluation of a substance.
However, one official noted that similar discrepancies under the pesticides authorisation Directive, upon which the biocides Directive is modelled, were eventually addressed - usually by moving fees upwards - as authorities became aware of them.
Some industry representatives have suggested that such inconsistencies could be resolved by allocating biocides oversight to the EU chemicals agency due to be set up to implement the REACH Regulation.
