Approval is required for biocidal products within the scope of the Control of Pesticides Regulations (COPR) where in:
- Great Britain (GB), one or more of the active substances is still being reviewed under the GB Biocidal Products Regulation (GB BPR)
- Northern Ireland (NI), one or more of the active substances is still being reviewed under the EU Biocidal Products Regulation (EU BPR)
- 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
To find out if your product is eligible for COPR approval, check the status of your active substance(s).
To find out more about the different application routes to COPR approval, go to the COPR approval types page.
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. 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. 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.
Where a product is supplied that does not meet the conditions of approval enforcement action may be taken.
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 [email protected]
Companies may wish to mark emails as confidential where appropriate. You must complete the form in English. Your application form may be returned if it is incomplete.
Application form for new COPR approvals
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
You can submit other relevant documentation or data by email as above, or using 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 (or EU Article 95 supplier for NI approvals)
- 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 [email protected] to request a new link.
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.
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. To determine if your proposed product name has already been used, check:
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.
If the product contains a formulated active substance, provide details on the technical concentration of the active substance and the overall concentration of the formulated active substance in the product on your application form.
Products which require personal protective equipment (PPE) due to their classification cannot normally be approved for amateur use, unless safe use without PPE can be demonstrated. This does not apply to the use of gloves for antifouling products. If you would like to discuss this further, contact us.
Products cannot be approved for amateur use if they are classified for:
- specific target organ toxicity by single or repeated exposure category 1
- category 1A or 1B carcinogen
- category 1A or 1B mutagen
- toxic for reproduction category 1A or 1B
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
- determine how much it will cost to process the application based on the application type - view COPR fees
- 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 and Committee and Departmental applications within 1 year, 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
We may ask you to provide further information at various stages of the process even where products are within existing safety and efficacy precedents. This is to ensure, in the light of new scientific information, products are efficacious and will not harm people, pets or the wider environment.
Examples of where we may request additional information are (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
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
If we make such a request, 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
- note your approval expiry date. The approval will expire on the date shown. Expiry dates may be amended (either extended or reduced) depending on the status of the last active substance. Examples include:
- if the active substance is approved under BPR, and a timely application for BPR product authorisation is submitted, the expiry date will be amended (either extended or reduced) to be 3 years after the date of active approval
- if the active substance is approved under BPR but no application for BPR product authorisation is submitted, the COPR approval will be revoked and a new expiry date (and phase out periods where appropriate) will be given
- if the active substance receives a non-approval decision under BPR the COPR approval will be revoked and a new expiry date (and phase out periods where appropriate) will be given
These changes will be made as part of a HSE imposed amendment or revocation.
- 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 product from COPR to the BPR is available for either transfer to GB BPR, or transfer to EU BPR
- ensure you comply with the requirements of:
- GB BPR which apply to all biocidal products supplied in GB and include:
- EU BPR which apply to all biocidal products supplied in NI and include:
- advertising requirements (Article 72)
- sourcing your active substance(s) from an EU Article 95 listed supplier
- ensure you comply with general chemical and product safety law which continues to operate such as in:
- be prepared to answer additional requests for information from HSE during the lifetime of your approval. This is to ensure, in the light of new scientific information, products remain efficacious and will not harm people, pets or the wider environment. 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
Amend or withdraw an approval
Once an approval is granted you can request to amend or withdraw the approval at any time.
More about the types of amendments that can be applied for
For amendments, the approval holder or company acting on their behalf must submit, in English, a completed application form to [email protected] – companies may wish to mark emails as appropriate, for example confidential. The application form may be returned if incomplete.
Other relevant documentation or data can be submitted by email as above, or using the HSE Secure File Sharing Service.
The majority of information provided above for new approvals is also relevant to amendments of approvals such as what HSE will do, what you should do.
If you wish to withdraw your approval, email [email protected]
HSE imposed amendment, suspension or revocation
Where an issue with the safety or efficacy of a product is identified, or where the approval holder has failed to fulfil their requirements, 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
- the active substance receives an approval or non-approval decision
- 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's 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.