Changes to Procedures for New Product Applications under the Control of Pesticides Regulations (COPR)

In addition to the normal COPR work, staff in the Biocides and Pesticides Unit (BPU) are also working on Biocidal Product Directive (BPD) evaluations so it has been necessary to make some changes to our current procedures to meet the tight demands of the European timetable in relation to the BPD. These are outlined below:

Letters of intent to supply an active ingredient

Following a review of our policy concerning the requirement to provide Letters of Intent to supply (LOIs), from 1 March 2007, BPU will no longer request LOIs to supply for backlog/grandfathered-in* active ingredients.  However, we will continue to request LOIs for active ingredients whose sources are ‘controlled’** or ‘recognised’** by BPU.  Also, Letters of Access (LOAs) for active ingredients that are still under data protection will still be required. BPU will let you know whether a LOI is required during the fee-banding or evaluation process.

Draft-label guidance

When considering new product applications, BPU currently provides specific comments on each draft product-label. From 1 March 2007, BPU will be sending out a generic draft product-label, which lists all the points that the applicant should consider when creating the product-label.

Deadlines to respond for information required by BPU

We will continue to set deadlines for applicants to respond to BPU.  If no response is received by the proposed deadline, BPU will close the product-file. If the applicant wishes to pursue the application at a later date they will need to re-apply for product approval and a new fee will be charged. There will be no exceptions to this rule.

*  backlog/grandfathered-in active ingredients are those that have not been reviewed under COPR.
**  ‘controlled’ or ‘recognised’ active ingredients are those that have been reviewed under COPR.

UK CA
February 2007