Biocides regulation: Northern Ireland
Supplying biocidal products to the Northern Ireland market
If you wish to make biocidal products or treated articles available on the Northern Ireland market you must comply with the EU Biocidal Products Regulation (EU BPR).
You can view the regulation and find out what you need to do to comply on the European Chemicals Agency (ECHA) website.
If your business is in Great Britain (GB) you may also need to comply with GB legislation such as GB Prior Informed Consent (GB PIC) or specific customs and export rules.
Biocidal product authorisation
To hold an EU BPR product authorisation in Northern Ireland your business must be established in the EU (including Northern Ireland).
If you hold an existing product authorisation that was valid in the UK on the 31 December 2020, you need to ensure that you're established in the EU for that authorisation to remain valid in NI.
You need to tell HSE that either:
- you’re established in the EU – as soon as possible
- you no longer want to hold an authorisation in NI
Pending product applications
If you have a product application pending with HSE, you need to confirm that you want to continue with your application to access the NI market. Pending applications are those that were submitted to and accepted by the UK or ECHA under EU BPR before 1 January 2021 and no decision on the application for the UK market was taken by 31 December 2020.
Confirm - complete formNew applications for product authorisation
If you want to make a new application for product authorisation in Northern Ireland, you will need to apply to the organisations shown in the table below.
| Application type | Apply to | Comments |
|---|---|---|
| National authorisation | HSE - National authorisation | National authorisations granted for the NI market cannot be mutually recognised within the EU |
| Mutual recognition | HSE - National authorisation | Options and practicalities still under development – let HSE know as soon as possible before the active substance date of approval to keep your product on the market |
| Simplified authorisation | HSE - Simplified authorisation | Simplified authorisations granted by HSE for the NI market cannot be notified within the EU |
| Simplified notification | HSE - Simplified authorisation | Applicable only to simplified authorisations already granted in the EU |
| Union authorisation | ECHA - Union authorisation | |
| Same biocidal product authorisation for NI market only | HSE - Same biocidal product authorisation | Not applicable for simplified notifications made to HSE for the NI market National or simplified authorisations granted by HSE for the NI market via the same biocidal product route cannot be mutually recognised or notified within the EU |
| Same biocidal product authorisation for EU market | ECHA - Same biocidal product authorisation | Applicable to Union authorisations and simplified authorisations granted in the EU |
| Change or cancel an authorisation | For national authorisations (including same biocidal products and mutual recognitions) and simplified authorisations granted by HSE for the NI market - HSE - Change or cancel authorisation For union authorisations and simplified authorisations granted in the EU - ECHA - union authorisation |
|
| Renewal of an authorisation | For national authorisations (including same biocidal products and mutual recognitions) - HSE - renewal For union authorisations - ECHA - union authorisation |
National authorisations cannot be renewed via mutual recognition |
| Research and development permit | HSE - research | |
| Provisional product authorisation | HSE | For advice on this application type contact HSE biocides |
| Essential use authorisation | HSE - essential use authorisation | |
| Critical situation permit | HSE - critical situation permits | |
| Cultural heritage authorisation | HSE | For advice on this application type contact HSE biocides |
EU Article 95 list
To be included as a supplier on the EU Article 95 List your business must either:
- be established in the EU (including Northern Ireland)
- appoint an EU-representative to appear on the list on your behalf
You will need to apply to ECHA application and assessment to be included on the list or to make a change to an existing entry.
All biocidal products supplied in Northern Ireland must comply with EU Article 95.
Active substance approval
To gain approval for an active substance in Northern Ireland, businesses should apply to ECHA approval of active substances.
Exports from Northern Ireland to Great Britain
HSE will treat biocidal products as being authorised in Great Britain (GB) under the GB Biocidal Products Regulation (GB BPR) where a Northern Ireland-based business holds a valid authorisation or permit for the product under EU BPR in Northern Ireland and wants to supply the product in GB.
You must notify HSE before placing the product on the GB market.
Read our guidance on unfettered access
Exports from Northern Ireland to the EU
You must continue to comply with EU regulations such as EU BPR.
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Further help
For:
- enquiries relating to applications for biocidal products under EU BPR in Northern Ireland, email HSE at: [email protected]
- enquiries about how to apply to ECHA: contact ECHA
- any other enquiries about biocides, email: [email protected]