Proposed European regulation concerning the placing on the market and use of biocidal products

A consultation on this proposed European Regulation will run from 27 July 2009 to 7 October 2009.

The European Commission has published a proposed European Regulation concerning the placing on the market and use of biocidal products. The new European Regulation would replace the current regulatory regime for biocides, which is laid out in the Biocidal Products Directive 98/8/EC and transposed into UK law by the Biocidal Products Regulations 2001. Once in force (scheduled for January 2013), the European Regulation would be directly acting on all Member States, including the UK.

The proposed European Regulation is a reaction to the general consensus across Europe that the current regulatory regime for biocidal products is not working. When adopted in 1998, the Biocidal Products Directive 98/8/EC envisaged a 10-year programme to review all active substances in biocidal products and so-called “existing” active substances. However, progress has been very slow and to date (end June 2009) only some 30 existing active substances have been reviewed, and no biocidal products have yet been authorised in Member States. Some stakeholders have also been critical of what they consider to be disproportionate and inconsistent costs associated with the current regime.

The proposed European Regulation retains the concept of assessing active substances at EU level for inclusion in a positive list and then authorising biocidal products for the market but it aims to improve and update certain elements of the system. Amongst the key changes proposed are;

• Extending the scope of the regulatory regime to cover treated materials containing biocides
• Adopting a centralised Community product authorisation scheme for some products
• Requiring mandatory data-sharing of vertebrate animal test data
• Reducing the burden of data requirements
• Harmonising the fee structure across Member States (but not the fees themselves).

You can view the text of the proposed Regulation and supporting documents on the European Commission website at; http://ec.europa.eu/environment/biocides/revision.htm

HSE will be negotiating on this Regulation in Europe on behalf of the UK and is publishing this consultation document to encourage all those in the biocides industry to share their views on the proposals. 

It is hoped that the Regulation will enable significant improvements in the system and we would like to hear where changes are supported. However, we also want to hear where you believe proposals will not work and why. The consultation document will be available on HSE's website on 27 July and responses are invited until 7 October.