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 (NI) 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[68].
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)[69] or specific customs and export rules[70].
Biocidal product authorisation
To hold an EU BPR product authorisation in Northern Ireland your business must be established in the EU (including Northern Ireland).
New applications for product authorisation
If you want to make a new application for product authorisation in NI, you will need to apply to the organisations shown in the table below.
| Application type | Apply to | Comments |
|---|---|---|
| National authorisation | HSE - National authorisation[71] | National authorisations granted for the NI market cannot be mutually recognised within the EU |
| Mutual recognition | HSE - National authorisation[72] | 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[73] | Simplified authorisations granted by HSE for the NI market cannot be notified within the EU |
| Simplified notification | HSE - Simplified authorisation[74] | Applicable only to simplified authorisations already granted in the EU |
| Union authorisation | ECHA - Union authorisation[75] | |
| Same biocidal product authorisation for NI market only | HSE - Same biocidal product authorisation[76] | 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[77] | 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[78] For union authorisations and simplified authorisations granted in the EU - ECHA - union authorisation[79] |
|
| Renewal of an authorisation | For national authorisations (including same biocidal products and mutual recognitions) - HSE - renewal[80] For union authorisations - ECHA - union authorisation[81] |
National authorisations cannot be renewed via mutual recognition |
| Research and development permit | HSE - research[82] | |
| Provisional product authorisation | HSE | For advice on this application type contact HSE[83] |
| Essential use authorisation | HSE - essential use authorisation[84] | |
| Critical situation permit | HSE - critical situation permits[85] | |
| Cultural heritage authorisation | HSE | For advice on this application type contact HSE[86] |
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[87] 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[88].
Northern Ireland and Ireland
Northern Ireland (NI) and Ireland must both comply with the EU BPR, and so share many similarities. There are still some distinctions between the 2 processes.
You should submit applications for national product authorisations in NI as detailed in the table above.
The key points when comparing with Ireland are that:
- in NI applications for national authorisations for biocidal products are submitted to HSE
- for Ireland, applications for national authorisations[89] are submitted through the R4BP 3 system. Any enquiries relating to Ireland should be directed to them via the R4BP 3 system
Labelling requirements for biocidal products must comply with the conditions of authorisation. Therefore, if a biocidal product has been authorised separately in NI and Ireland, the conditions of authorisation may differ between the 2. This means labelling requirements might be different for an otherwise identical product.
Union authorisations for a biocidal product are applied for via ECHA using the R4BP 3 system. Once granted they will be valid in both NI and Ireland using the same conditions of authorisation and labelling requirements.
There is currently no biocidal product notification register in NI or GB. The Irish Biocidal Product Register - Notified Products[90] is only valid in Ireland and does not include NI.
Northern Ireland Retail Movement Scheme
The Windsor Framework establishes a new way to move pre-packed retail goods from Great Britain (England, Scotland and Wales) into Northern Ireland. It is called the Northern Ireland Retail Movement Scheme.
GB public health and consumer protection standards apply for all products moving to Northern Ireland through the scheme. This includes requirements for food contact materials.
Goods that meet the definition of a ‘food contact material’ as defined in Regulation (EC) No. 1935/2004 are in scope of the Northern Ireland Retail Movement Scheme. Biocidal products, or articles that have been treated with biocidal products, may come into scope of the scheme if they meet the definition of a food contact material.
This change does not apply to retail goods produced within NI. In this case, the EU rules continue to apply.
Please read the following for further guidance: Northern Ireland Retail Movement Scheme: how the scheme will work - GOV.UK ([91]www.gov.uk)[92].
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[93].
Exports from Northern Ireland to the EU
You must continue to comply with EU regulations such as EU BPR.
Updates
To get the latest news and updates on biocides, subscribe to our email updates[94].
Further help
For further help with:
- enquiries relating to applications for biocidal products in NI email HSE
- enquiries about how to apply to ECHA[95]
- any other enquiries about biocides email HSE