COPR approval: how to apply
Approval is required for biocidal products within the scope of the Control of Pesticides Regulations (COPR[68]) where:
- in Great Britain (GB), one or more of the active substances is still being reviewed under the GB Biocidal Products Regulation (GB BPR)
- in Northern Ireland (NI), one or more of the active substances is still being reviewed under the EU Biocidal Products Regulation (EU BPR)
- in GB and NI, if all the active substances have been approved and the approval date for one or more is in the future. Applications must be submitted at least 6 months before the approval date
Find out if your product is eligible for GB COPR approval by checking the status of your active substance(s)[69] in GB.
If you need help determining if your product is eligible for NI COPR approval, please contact us[70].
Visit the COPR approval types page[71] to find out more about the different application routes to COPR approval.
Once approved, the biocidal product can be made available on the GB or NI market, in-line with the conditions of the approval.
Making available on the market means any supply of a biocidal product, whether in return for payment or free of charge, at all stages of the supply chain. Some examples of this could include:
- manufacturer to distributor
- distributor to retail store
- retail store to user
The conditions of approval must be complied with at each step in the supply chain and the approval holder is normally the company at the top of the supply chain. If the product is changed in any way at a step in the supply chain this may not be covered by the approval.
Enforcement action[72] may be taken where a product is supplied that does not meet the conditions of approval.
Submit an application
For new approvals the prospective approval holder or company acting on their behalf must submit a completed application form by email to HSE.
Companies may wish to mark emails as confidential where appropriate. The form must be completed in English. Please note that your application form may be returned if it is incomplete.
Application form for new COPR approvals[73]
Once approval has been granted or if you already have an existing COPR approval, you can apply for an amendment.
Application form for COPR amendments[74]
Other relevant documentation or data can be submitted by email as above, or via the HSE Secure File Sharing Service, which may include:
- copies of the proposed product labels
- a Safety Data Sheet (SDS) for the proposed biocidal product formulation
- any pre-submission correspondence with HSE
- evidence that the active substance(s) is sourced from a GB Article 95 supplier[75] (or EU Article 95 supplier for NI approvals[76])
- any relevant letters of access or authorisation
Using the HSE Secure File Sharing Service
- Once we have received and processed your application form, you may be sent a link to upload the files associated with the relevant application. Please do not use the link to upload files related to other applications.
- Links will be sent out Monday to Friday and are valid for 5 working days. If the link expires before you are able to upload your files, please email biocidesapplications@hse.gov.uk to request a new link.
- Please ensure you comply with the terms and conditions of using the HSE Secure File Sharing Service. These will be included in the email alongside the link.
- Please check the spam settings on your email account to ensure our emails are not going to your junk folder.
Things to note
- All biocidal product names must be unique, please check the database of COPR approved biocidal products[77] to determine if your proposed product name has already been used.
- Letters of access must relate to data held by HSE, you should talk to your active substance supplier to ensure they have submitted the data to HSE.
What HSE will do
After receiving your application HSE will:
- conduct a brief initial check of the information provided to confirm the correct application type – this is called fee-banding[78]
- determine how much it will cost[79] to process the application based on the application type
- issue an invoice to the applicant which must be paid within 30 days of the date of the invoice – failure to pay the requested fees will result in your application being rejected
- evaluate the application once the fee has been paid – we aim to complete the majority of applications within 70 working days from the date of fee payment
- send the applicant separate 'NS1' forms and draft copies of the approval conditions for GB and NI approvals – these are set out in draft Schedules
- take into account the applicant's comments, where relevant
- assign a HSE number to the approval. Each biocidal product trade name listed in the approval will have a suffix to this number.
- issue separate Approvals for GB and NI. These will each include a Certificate and Schedule which outlines the conditions of Approval and Consents[80]
You may be asked to provide further information at various stages of the process. When such requests are made, the indicative timeframe given above will be suspended.
If the information you provide is not satisfactory, or you fail to provide the information within the specified deadline, your application may be rejected.
What you should do
You should:
- examine the draft Schedules and return to HSE (with comments if necessary) along with a completed and signed copy of the NS1 form(s) to indicate your agreement with the approval conditions
- wait until the Certificate(s) of Approval has been issued and ensure you comply with the conditions and restrictions in the schedule(s) and COPR Consents before making the product available on the market in GB and / or NI[81]
- note your approval expiry date. The approval will expire on the date shown and is based on the status of the active substance:
- under GB BPR for GB approved products, if the active substance is approved under GB BPR after your COPR product approval is granted, the expiry date may be reduced to bring it in-line with the active substance approval date
- under EU BPR for NI approved products, if the active substance is approved under EU BPR after your COPR product approval is granted, the expiry date may be reduced to bring it in-line with the active substance approval date
- keep up to date with the status of the active substances in your product and ensure you apply for product authorisation:
- under GB BPR by the approval date for the last active substance in the product to keep your product on the market in GB
- under EU BPR by the approval date for the last active substance in the product to keep your product on the market in NI
- information on managing the transfer of your existing GB product from COPR to GB BPR[82]
- ensure you comply with the requirements of:
- GB BPR which apply to all biocidal products supplied in GB and include (but are not limited to):
- advertising requirements[83] (Article 72)
- sourcing your active substance(s) from a GB Article 95 listed supplier[84]
- EU BPR which apply to all biocidal products supplied in NI and include (but are not limited to):
- advertising requirements (Article 72)
- sourcing your active substance(s) from an EU Article 95 listed supplier[85]
- ensure you comply with general chemical and product safety law which continues to operate such as:
Amend or withdraw an approval
Once an approval is granted you can request to amend or withdraw the approval at any time.
More information about the types of amendments that can be applied for[89]
For amendments, the approval holder or company acting on their behalf must submit, in English, a completed application form to biocidesapplications@hse.gov.uk – companies may wish to mark emails as appropriate e.g. confidential. Please note that your application form may be returned if it is incomplete.
Other relevant documentation or data can be submitted by email as above, or via the HSE Secure File Sharing Service.
The majority of information provided above for new approvals is also relevant to amendments of approvals i.e. what HSE will do, what you should do.
If you wish to withdraw your approval please contact HSE.
HSE imposed amendment, suspension or revocation
Where an issue with the safety or efficacy of a product is identified HSE may need to amend, suspend or revoke the approval. Reasons for this may include:
- the approval holder has failed to comply with the conditions of Approval and Consents;
- the approval holder fails to pay the COPR Levy;
- to comply with the requirements of the GB Classification, Labelling and Packaging of Substances and Mixtures (GB CLP) Regulation or EU Classification, Labelling and Packaging of Substances and Mixtures (EU CLP);
- failure to comply with the requirements of the GB Biocidal Products Regulations (GB BPR) or EU Biocidal Products Regulations (EU BPR).
If HSE intends to amend, suspend or revoke an approval, we will notify you and give you the opportunity to submit comments or additional information within a specific time frame. We will consider any additional information that has been submitted when finalising our decision. We will inform the approval holder of the final decision and any action they may need to take as a result.