Regulatory Update: 08/2012
Issued: 02 March 2012
Background
In Regulatory Update 09/2006, we announced the launch of the Biopesticide scheme. This scheme is to facilitate the entrance of more alternative control products to the market. The scheme covers pheromone products, plant extract products and products containing a biological organism. The number of active substances and products approved for the UK market has risen since the scheme was introduced.
Review
We are currently in the process of reviewing the UK’s approach to biopesticides in order to ensure we achieve the correct balance between legal requirements, risk assessment, general Government policy and cost recovery within the authorisations process. The outcome of this is expected by the end of 2012.
Refinement to scheme
In the interim we have introduced a refinement to the procedures of the biopesticide scheme with a view to maximise the likelihood of a successful application.
When engaging with applicants, preferably at the early stage of dossier development, we are focussing on issues which may be potential problems in later evaluation of the new active substance. These issues vary depending on the active substance concerned, however in many cases the main issue is active substance identity and mode of action. Active substance identity has proved a particular issue for plant extracts.
At the pre-submission stage and particularly if we have not had prior sight of the dossier, at the admissibility (completeness) stage, CRD will be carrying out a more in-depth investigation, in particular in areas known to cause delay and problems at later stages of dossier evaluation. We will endeavour to clarify issues to ensure the information in the dossier adequately informs and supports other areas of risk assessment to which the assessment depends.
Hence, applicants can expect to be asked for as full details as is practical for their active substance(s), particularly regarding identity and issues such as natural background levels.
By ensuring these issues are adequately addressed at the earliest opportunity, CRD considers this gives applicants the best chance of a positive outcome.
Contact Information
If you have any queries please contact Lisa Moakes, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX. Telephone: 01904 455952 or email applicant-enquiries@hse.gsi.gov.uk .
