Committee applications for a product approval under the Control of Pesticides Regulations (COPR)
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This page provides information on the different types of Committee applications and the process of making an application under COPR which need to be considered by the Expert Committee on Pesticides (ECP).
The application could be for either:
New active ingredient
If an application is made to HSE for approval of a product containing an active ingredient that is not present in any product presently approved under COPR, the risks associated with its pesticidal use will not have been previously assessed.
Sufficient data should be submitted to HSE to:
- establish the identity of the active ingredient;
- evaluate the physico-chemical properties of the active ingredient and product;
- ensure use of the product has no unacceptable risks to man and the environment; and
- support the efficacy claims made for the product.
The data package submitted should include, where appropriate, copies of all the study reports and cover the following:
- Physico-chemical properties
- Mammalian toxicology and toxicokinetics
- Environmental fate and behaviour and ecotoxicology
- Potential user information and consumer exposure
- Efficacy data
- A copy of the draft label
- If appropriate, a letter authorising access to studies previously evaluated by the ACP
- Any other relevant information, for example, a list of the data reports including the title and report reference.
An application is considered to be a Committee re-submission when an active ingredient is present in a currently approved product but an extension of use of that active substance is requested which needs approval by the ECP. For example, extension of use into a different area, or where there is a substantial amount of new data to evaluate to support an application for use in the same area.
The ECP will have already evaluated previous data on the active ingredient and so a full data package is not likely to be needed. Sufficient data should be submitted to HSE to allow consideration of the risks associated with any new uses and where appropriate to support the efficacy claims for controlling target pests.
If data previously submitted to HSE by another applicant are required to support this new application, and are still within a period of data protection, then a letter of access from the owner of the data should be included in the application package. If a letter of access from the data owner cannot be obtained, then new data will be required.
How to apply
Prior to an application being made, there should be a meeting between HSE and the Applicant to discuss the submission and what is required. This can be arranged by emailing the COPR approval team, contact details can be found on our contact us page.
The Applicant should submit a FEPA1 application form, along with the appropriate data package (as indicated above).
Sifting the application
On receipt of an application HSE will issue an invoice for a sift fee. On payment of the sift fee, the package submitted will be "sifted" to ensure all necessary data are included. If data gaps are identified during the sift, a request for additional data will be made.
Once the submission is deemed to be complete, HSE will issue a further invoice for an evaluation fee. HSE will begin work on the evaluation once this invoice has been paid.
Paying the fee
Applicants should pay the request within 30 days of the invoice date. If you anticipate a delay in payment please inform us as soon as possible.
Applications will not be processed until the requested fee has been received in full.
HSE accepts payments by either cheque or bank transfer. The full payment details/methods will be outlined in your invoice.
During the evaluation, further data or clarification of submitted data may be required. If this takes a significant period of time to address, it will impact on the timescale in which the evaluation can be delivered. HSE prepare an evaluation report based on the submitted data which is sent to other Government Departments with an interest.
The ACP considers the HSE evaluation together with the assessment of the other Government Departments and then puts forward its recommendations to Government Ministers. Ultimately, the decision on granting approval rests with Ministers.
Once approval is granted applicants receive a Notice of Approval detailing the conditions associated with that approval.
The process from payment of the evaluation fee to consideration by the ACP takes around 12 months.