The biopesticide Scheme
The biopesticide Scheme was introduced in 2006 following a pilot scheme.
Since the introduction of the initial scheme we have made some refinements in light of experience evaluating these types of applications 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 (botanicals).
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.
Review of Scheme
A review of the Biopesticide Scheme was made and the outcome reported in July 2013.
The ADAS report considered the barriers to the commercialisation of biopesticides and the scope for strengthening support for biopesticides within current regulatory and other constraints. However, they can have inherent advantages over conventional chemicals in terms of environmental impacts and crop residues. With the agreement of Defra minsters CRD, therefore introduced a package of measures to strengthen support for biopesticides.
- The package of support for companies provided by the Chemicals Regulation Division (CRD ) involving advice and lower fees for biopesticide applications was strengthened fees for the pre-submission meetings held with those seeking EU approval for a new biopesticide active substance will be discounted from the application fee if the application proceeds.
- CRD is working with the Commission and other MS to provide clearer guidance to assist companies submitting applications for authorisations. We contributed to the development of the Commission's draft guidance on botanicals. We also see scope for some revision of the current data requirements for microbial biopesticides. We will support a review of these requirements in the light of the practical experience gained in considering dossiers submitted for new biopesticides or those in 'list 4' of the pesticides review programme.
- The new EU zonal system for pesticide product authorisations offers opportunities to reduce any regulatory barriers to UK authorisations. We will work with other Member States to develop zonal and mutual recognition procedures to improve the chance that a product available elsewhere in the EU also becomes available to UK growers if there is a demand.
In addition, CRD will work with the International Biopesticides Manufacturing Association on training initiatives designed to improve companies understanding of the regulatory process and to improve the quantity and quality of the applications that they make for approvals.
The ADAS report notes the contribution that government research funding has made to pest control science, but draws attention to growers' support for the more applied direction of some recent pesticides research. The government agrees that, within the total sum available for biopesticides, greater priority should be given to such applied work.