Introduction
COPR is largely a precedent based system. When you apply for approval, we compare the product details you have submitted with other products that are currently approved in GB and NI under COPR.
We look for features in the application which would require a new risk assessment or efficacy assessment to be carried out, such as:
- higher or lower concentration of active substance
- different application rate or method
- different area of use
We will also look for features that, despite the active substance being within existing safety and efficacy precedents, may cause other concerns, such as the potential for unnecessary chemical exposure to biocidal active substances for humans, animals and the environment.
Such features may include (but are not limited to):
- the presence of more than one active substance in the same product type
- the safe use of amateur products without PPE
- to confirm the function or purpose of active substances or co-formulants in the product
We may consider this as part of the initial assessment, or during the lifetime of the approval.
If we require additional information you may need to address this with:
- a robust scientific justification, possibly supported by relevant scientific literature
- data generated to an appropriate standard, or following the relevant guidance
The initial assessment is called fee-banding and determines the type of application your product will be processed as and how long the evaluation will take.
Below is an overview of the different application types. If you’re not sure exactly which one is relevant for your product you should still submit your application and our COPR Approvals Team will work this out in the fee-banding.
A COPR approval can contain multiple trade names. An application for a new approval must contain at least one trade name.
Application form – new approvals
Once approval has been granted or if you already have an existing COPR approval then you can apply for an amendment to add new product trade names, or combine multiple approvals into a single approval containing multiple trade names.
Non-committee application types
HSE can process non-committee application types without consideration from the Expert Committee on Pesticides (ECP).
How to apply for approval or amendment using a non-committee application type.
Departmental
If the active substance in your product is present in products currently approved under COPR within the same product type but the amount of active substance or the uses fall outside existing precedents, we will need to assess data for the product before we can approve the product.
We will flag this during fee-banding and the COPR Approvals Team will provide you with guidance if you need to submit data.
Secretariat
If the active substance in your product is present in products currently approved under COPR within the same product type and the amount of active substance or the uses fall within existing precedents, your application will proceed using the secretariat route. However we may still need further information, as detailed in the introduction, before proceeding.
Back-to-back
If your product is identical to one that is already approved, you may be able to gain approval onto the same market by the back-to-back route. Identical means the same:
- formulation
- application rate
- user group(s)
- pest(s)
- usage area
Allowed differences are:
- product name
- approval holder
- marketing company
The back-to-back route can also be used to apply for a number of identical product applications at the same time.
It is possible to include multiple trade names as part of a single approval. If you wish to have the same approval holder an amendment may be a more appropriate application type.
For advice on the difference between a back-to-back and an amendment, email [email protected]
Amendment
If you have an existing product approval, you can apply for changes to your product by the amendment route if the changes are still within the existing precedent.
The addition, change or removal of an active substance requires a new approval. We cannot process this as an amendment.
Standard amendment
If you have an existing product approval, you can apply for changes to your product using an amendment. The changes should still be within the existing precedent. This also includes the addition of trade names. Full details of the type of amendment and relevant additional information are detailed on the application form.
Transitional amendment
If you have an existing product approval, while transitioning to a BPR authorisation, you can apply for changes to your product by the amendment route if the changes are still within the existing precedent. This also includes the addition of trade names. We expect the same changes to be made, or already be made to the BPR authorisation application. Full details of the type of amendment and relevant additional information are detailed on the application form.
Once your BPR application has been validated, if you want to make an amendment, email [email protected] before applying.
Series change
If you want to make changes to the approval holder details for more than one existing product approval, you can do this by the series change route.
Changes to marketing company fall under the standard/transitional amendment route.
Committee application types
Committee application types involve some assessment of the active substance and need to be considered by the Expert Committee on Pesticides (ECP).
New COPR active ingredient
If the active substance in your product is not present in any product currently approved under COPR, we will need to assess a full data package for the active substance before we can approve the product.
For advice on making an application for a new active ingredient, email [email protected]
Committee re-submission
If the active substance in your product is present in products currently approved under COPR but your product is of a different product type, we will need to assess data covering the active substance for the new use before we can approve the product.
For advice on making an application for committee re-submission, email [email protected].