Existing NI products: transfer to EU BPR
Article 89 of the EU Biocidal Products Regulation (EU BPR) allows biocidal products to transition to authorisation under EU BPR, if they are currently made available on the market under national law in NI.
Such products will contain existing active substances that are under review for the relevant product type, as part of the EU Review Programme.
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
Biocidal products that are already available on the NI market under other national law fall into two categories:
- those with approval under the Control of Pesticides Regulations (Northern Ireland) (COPR NI)[68]
- those not needing HSE approval under COPR NI - but they may need to comply with other national law in NI
Find out which category your product falls into[69].
If you have a product on the market in Great Britain (GB) under COPR (GB) or other GB national law, the requirements may be different[70].
Action needed
To keep your product on the market in NI, whichever of the above categories it falls into, you will need to:
- check the status of the active substance(s) in your product[71] on the EU List of Active Substances[72]
- apply for product authorisation[73] under EU BPR by the approval date for the last active substance in the product
Note that for most applications for product authorisation in NI, you cannot submit via the EU system, R4BP 3. You will need to use the HSE biocidal product authorisation application form (.docx) [74].
If your application must be submitted via the EU system (R4BP 3), such as for a Union authorisation, please contact us. This will ensure that your COPR approval in NI is not revoked in error.
You can continue to make applications to amend COPR approved products in NI while transitioning to an EU BPR authorisation, including the addition of trade names.
Find out how to apply for transitional amendments[75].
Once your EU BPR application has been validated, if you want to make an amendment, please contact HSE prior to making an application.
You can continue to place new products on the NI market under COPR NI or other national law providing one of the following is true:
- all the active substances in the product are still under review for the relevant product type under the EU Review Programme for existing active substances
- one or more of the active substances has already been approved for the relevant product type, and at least one of the other active substances in the product is still under review for the relevant product type under the EU Review Programme for existing active substances
Requirements vary for:
- in situ generated active substances and biocidal products, including precursors. Find out more about in situ generation and check the requirements[76].
- products that contain active substances subject to EU BPR renewal decisions.
Products made available on the market under COPR NI or other national law in NI must:
- comply with the requirements of COPR[77] NI or other legislation or schemes, where applicable in NI
- comply with specific elements of EU BPR such as EU Article 95[78] and advertising requirements[79]
What happens next
At all points of the process, when approved, while your application is being evaluated or during the phase out period if not approved, you must continue to comply with:
- the requirements of the COPR[80] NI or other national law, where applicable
- EU Classification, Labelling and Packaging of Substances and Mixtures (EU CLP) Regulation[81]
- General Product Safety (GPS) Regulations[82], where relevant
- specific elements of EU BPR such as:
- EU Article 95[83]
- advertising requirements[84]
- record keeping[85]
- providing information to the National Poisons Information Service[86]
EU BPR application submitted by the deadline
Biocidal products can stay on the market under COPR NI or other national law in NI while your EU BPR application is being evaluated, for up to 3 years after the approval date for the last active substance.
EU BPR application not submitted by the deadline
If you do not apply for product authorisation under EU BPR by the deadline, your product can only continue to be made available on the market in NI within the following phase-out periods:
- up to 180 days for making the product available (at all stages of the supply chain)
- up to 365 days for its use
Outcome of EU BPR application
Product authorisation granted
From the date of authorisation, any new stocks of the product made available on the NI market must comply with:
- the EU BPR authorisation conditions and restrictions for the product
- other elements of EU BPR such as:
- EU Article 95[87]
- advertising requirements[88]
- record keeping[89]
- providing information to the National Poisons Information Service[90]
- EU Classification, Labelling and Packaging of Substances and Mixtures (EU CLP) Regulation[91]
- General Product Safety (GPS) Regulations[92], where relevant
Existing stocks of your product can continue to be made available on the market under COPR or other national law in NI within the following phase-out periods:
- up to 180 days for making the product available (at all stages of the supply chain)
- up to 365 days for its use - any existing COPR approval in NI will expire 365 days from the date of authorisation under EU BPR
Product authorisation not granted, or application rejected
If, after evaluation, it is concluded that an EU BPR product authorisation cannot be granted, or the application is rejected at any stage, your product can only continue to be made available on the market in NI within the following phase-out periods:
- up to 180 days for making the product available (at all stages of the supply chain)
- up to 365 days for its use
Active substances not approved
If one or more of the active substances in your product is given a non-approval decision under EU BPR, your product can only continue to be made available on the market in NI within the following phase-out periods:
- up to 12 months for making the product available (at all stages of the supply chain)
- up to 18 months for its use - any existing COPR NI approval in NI will expire 18 months from the date of the non-approval decision