EU biocides Directive review gets under way

Confusion over data protection, lack of enforcement and inconsistencies in companies’ data submissions - and how member states handle these - loom large in government and industry responses to an EU review of the 1998 biocidal products Directive. NGOs are calling for use controls similar to those in place for pesticides.

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:

  • Delays: The review of existing active substances is well behind schedule. Under the first of four phases, dossiers for all notified existing substances in the wood preservatives and rodenticides categories should have been evaluated and those authorised listed on annex I of the Directive by September 2005.

    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.

  • Data protection: There seems broad agreement that not only was the language in the original Directive itself confusing on data protection rights for firms, but that this was subsequently muddied by further legal interpretations after its adoption.

    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.

  • Consistency: Member states have not agreed methodologies for risk assessments. This has led to disagreements on definitions of product types and continuing debate on issues such as the point at which a treated article could be deemed to be a biocide.

    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.

  • Enforcement: Member states are supposed to have designated powers for enforcing decisions on biocides. In the UK, as in some other states, this is given to HM Revenue and Customs and trading standards officers. But in common with other member states, limited resources and the difficulty of identifying violate products are proving a problem.
  • Simplification: While the Directive makes provision for fast-tracking approvals for some products, officials say the criteria are not defined well enough and, as a result, such options have rarely been used, with the loss of some potentially lower risk products from the market. They want the Commission to clarify these to make them more workable.
  • Use controls: NGOs say experience with the pesticides Directive has shown that whatever precautions are taken before products are approved, by their very nature they will pose some risks in use. They want governments to adopt national action plans similar to those introduced for the pesticides Directive last year to monitor and reduce these risks.
  • Sensitive areas: Some countries want a clearer right to continue to apply tougher national measures beyond the transitional period when substances are being assessed, albeit with stringent justification requirements based on environmental or health needs. An oft-cited example is the unusual sensitivity of the Baltic Sea environment to anti-fouling agents.