COPR approval: How to apply
Approval is required for products within the scope of the Control of Pesticides Regulations (COPR) where:
- in Great Britain (GB), the active substance is still being reviewed under the GB Biocidal Products Regulation (GB BPR)
- in Northern Ireland (NI), the active substance is still being reviewed under the EU Biocidal Products Regulation (EU BPR)
Find out if your product is eligible for NI COPR approval by checking the status of your active substance(s) in NI.
Applications to amend existing COPR products can be made in the run-up to the relevant active substance BPR approval date:
- for existing GB COPR approved products, the GB BPR active substance approval date
- for existing NI COPR approved products, the EU BPR active substance approval date
The latest deadline to submit COPR amendment applications to HSE is 3 months before:
- the last active substance approval date under GB BPR for GB products
- the last active substance approval date under EU BPR for NI products
Amendment applications submitted after these deadlines will not be accepted.
See the COPR approval page to find out more about the different routes to COPR approval and the types of amendments to existing approvals that can be applied for.
Once approved,the biocidal product can be made available on the GB and / 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 – eg if you want to supply a product to several different companies to be marketed under several different names, you will need a separate approval for each trade name / marketing company even if the product formulation is identical.
Enforcement action may be taken where a product is supplied that does not meet the conditions of approval.
How to apply
The prospective 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 eg confidential. Please note that your application form may be returned if it is incomplete.
Only the application form should be submitted by email. All other relevant documentation / data must be submitted via the HSE Secure File Sharing Service, which may include:
- a copy of the proposed product label
- a Safety Data Sheet (SDS) for the proposed biocidal product
- 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 / authorisation
Using the HSE Secure File Sharing Service
- Once we have received and processed your application form, you will 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 – 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.
- 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 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
- determine how much it will cost 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 an HSE number to the biocidal product
- issue separate Certificates of Approval for GB and NI approvals – these will each include an Approval Notice and Schedule
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. Please note 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
- examine the draft Schedule(s) and return it 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) 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 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 substance(s) 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
- 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):
- 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
- ensure you comply with general chemical and product safety law which continues to operate such as:
- contact HSE if you intend to amend or withdraw your approval:
- amendments to GB approved products must be submitted no later than 3 months before the active substance approval date under GB BPR
- amendments to NI approved products must be submitted no later than 3 months before the active substance approval date under EU BPR