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EU moots options for revision of biocide rulesqrcode

Jun. 19, 2008

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Jun. 19, 2008

Options for harmonising biocide registration fees and for reducing the regulatory burden on niche products have been outlined by the European Commission. Officials from the Commission's Environment Directorate-General presented the options at a stakeholder consultation last month on plans to revise the EU biocidal products Directive (98/8). The Directive covers non-crop pesticides. The meeting sought to provide more details on issues discussed at a similar workshop in January, which highlighted industry concern over high registration costs and the potential loss of active ingredients.

Fees have been a thorny topic for the industry. The current Directive allows member states to establish fee systems to cover the costs of evaluation and registration work. However, this has led to varying and high fees, acknowledged Pierre Choraine. The range in fees is Euros10,000-354,000 ($15,500-548,700) for ai evaluations and Euros1,000-70,000 ($1,550-108,500) for product authorisations. This could result in up to Euros1 million ($1.6 million) being paid for an ai that is being supported in 13 product types through the Directive's review of existing ais, he said.

Mr Choraine outlined four options for fees. The first would be to keep the national systems but increase the transparency on member states' fee levels and structures. The second would be to impose a harmonised fee structure, whereby member states charge their full fee for the first product type and a reduced fee for subsequent product types, with an instalment system for payments. Alternatively, a centralised fee system could be operated at EU level. A final option would be to introduce specific provisions to reduce the fee burden for small and medium-sized companies.

Similarly, improvements are needed in clarifying the provisions for waiving data requirements and helping companies, stressed Karola Maxianova. One option would be to oblige member states to inform applicants of their right to request a waiver, including the grounds for such a waiver, and to assist them in their request, she said. The authorities should clarify that core and additional data can be waived, she added.

In addition, there is a need to reform the "low risk" and "basic substances" concepts and to make them more attractive to companies wanting to support their ais through the re-registration procedure, said Ms Maxianova. Annex IA, which covers the provisions for and listing of EU-approved "low-risk" ais needs a "fundamental reform", she said. Either it should be reformed in line with the exemptions operating under the EU Registration, Evaluation and Authorisation of Chemicals (REACH) Regulation, or there should be a new system of direct authorisation of "low-risk" products at EU level. Meanwhile, Annex IB, which covered "basic substances", was never used and should be repealed, Ms Maxianova said.

The implementation of Directive 98/8 to date has largely focused on the evaluation and registration of ais, which is carried out at EU level. As yet, there has been no practical experience of applying the Directive's rules to the next stage, which is the national authorisation of products containing EU-approved ais and the mutual recognition of such authorisations by other EU member states, pointed out Mr Choraine.

In drawing up revision plans for the Directive, the EU authorities need to decide whether to maintain the national product registration system and strengthen mutual recognition procedures, or whether to extend the centralised system so that it covers products as well as ais, Mr Choraine said.

Measures to strengthen mutual recognition could be to allow or obligate: member states to initiate mutual recognition; and applicants to submit their applications at the same time in the different member states where they aim to sell the product. Once a product has been approved by one member state, it would be cleared for introduction in the other member states. There would be no need for further administrative procedures other than complying with labelling rules, Mr Choraine pointed out. The system could include a safeguard clause to allow member states to object to product introductions under "pre-defined circumstances", he added.

Alternatively, the current provisions could be replaced by a system of one single product authorisation at EU level, with an assessment by an EU agency or rapporteur member state, followed by a Commission decision. This could be best applied to products that: contain a new ai; or are used in industrial applications; or are "low risk". Mr Choraine said.

An impact assessment of the revision plans is expected to be finalised in September, said Birgit Van Tongelen. Final proposals for revising Directive 98/8 are due in November, said Chantal Bruetschy. The main revision will be preceded by a "mini-revision", which will serve to extend the review programme for existing ais until the main revision comes into force, Ms Bruetschy added.

Source: Agrow

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