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Assessing the Impact of the Revision of Directive 98/8/EC concerning the Placing of Biocidal Products on the Market 

Client:   European Commission, Directorate General Environment

Date:     2008

Partners:  Hydrotox GmbH and Milieu Ltd

RPA’s previous study, on the impacts of Directive 98/8/EC concerning the placing of biocidal products on the market (BPD), indicated that a number of issues needed to be addressed, including:

  • the reduced availability of active substances;
  • the significant delays in the review programme;
  • problems with operation of the simplified;
  • the lack of certainty about the rules on data protection, data sharing and avoidance of animal testing;
  • concerns about effective implementation and enforcement;
  • the proportionality and cost of data requirements; and
  • the exclusion of treated materials.

Policy Options Evaluated

This study evaluated the impacts of major, feasible, policy options to address these issues:

  • Scope of the Directive: extending the Directive to include ‘limbo’ products (food processing aids and food contact materials), treated materials, reducing the number of product types;
  • Product authorisation: improving guidance and strengthening provisions for mutual recognition, introducing single Member State or central authorisation for some or all products;
  • Data sharing: improved guidance, mandatory sharing of vertebrate animal test data for product authorisation and for active substances;
  • Data requirements: further guidance, revised requirements for low-risk substances, direct authorisation for low risk products and rewording to minimise animal testing;
  • Fees: increased transparency of the current system, harmonised fee structures, mandatory range for fees and reduced fees for SMEs; and
  • Biocides use: including biocides within the pesticides thematic strategy, incorporating provisions on safe use into the Directive or a separate Directive on sustainable use of pesticides.

Impacts Considered

For each of the policy options considered, the study addressed the impacts on:

  • industry: economic impacts, including competitiveness and competition, administrative burden; particularly impacts on SMEs;
  • public authorities: economic impacts, administrative burden;
  • product availability: ability to combat harmful organisms, investment in safer products and innovation;
  • social impacts: public health and safety, employment; and
  • environmental impacts.

Overall Impacts

The options relating to the scope of the BPD could increase costs for industry.  The greatest cost increases would arise from extending the scope to ‘limbo’ products and to treated materials.  In all other policy areas, the options would reduce costs for industry and some of these savings could be very significant. 

The options on scope, product authorisation and data sharing would require additional work by public authorities, to develop guidance, but the costs are unlikely to be significant.  The options for single Member State or Community product authorisation could provide major efficiency savings from reduced duplication of effort.  The work required to develop criteria relating to the options on data requirements could be larger, but so are the potential efficiency savings.  Some of the options on fees could lead to reduced revenue for some authorities and increased revenue for others.  However, Competent Authorities would probably adjust their fees to maintain their level of income in most cases.

Apart from the options on the scope of the directive, which would be neutral, most of the options would be likely to increase product availability by reducing the costs of product authorisation.

For most policy areas, there would be no significant overall impacts on employment, as the size of the overall market is likely to remain the same, but there could be some switching of employment between companies. 

The options on the scope of the directive would be likely to have positive impacts on both health and the environment, by including biocides that are not currently regulated. 

The analysis carried out in the study focuses on the separate impacts of options within each of the policy areas.  Combining options from different policy areas could significantly increase the potential benefits. 

Further Developments

The study will be published, together with the Commission’s impact assessment, with the Commission’s proposals for revision of the BPD.  This profile will be updated as developments occur.

Links

 

The European Commission DG Environment website for biocidal products.

Study on impact of the implementation of Directive 98/8/EC concerning the placing on the market of biocidal products (read/download report from DG Environment website or from RPA website)

 

Study on impacts of possible measures to manage articles or materials treated with biocides – in particular when imported (read/download report)