Unfettered access notification
Under the Northern Ireland Protocol, the EU Biocidal Products Regulation (EU BPR) applies in Northern Ireland (NI). Find out more about biocides in Northern Ireland.
The UK government is committed to unfettered access for NI goods moving to the rest of the UK market.
HSE will treat biocidal products as being authorised in Great Britain (GB) under the GB Biocidal Products Regulation (GB BPR) where an NI-based business holds a valid authorisation or permit for the product under EU BPR in NI and wants to supply the product in GB. Valid EU BPR authorisations or permits may include:
- national authorisations granted by the NI Competent Authority (NI CA), as well as those granted via mutual recognition and the same biocidal product procedure
- Union authorisations granted by the EU Commission, as well as those granted via the same biocidal product procedure
- simplified authorisations granted by the NI CA, as well as those granted via the same biocidal product procedure
- parallel trade permits granted by the NI CA
- critical situation permits granted by the NI CA
- provisional authorisations granted by the NI CA
- cultural heritage authorisations granted by the NI CA
- essential use authorisations granted by the NI CA
However, for highly regulated goods, such as biocidal products, stricter regulation is necessary to protect workers, consumers and the environment and so the following conditions must be met before the biocidal products can be placed on the market in GB:
- the authorisation or permit holder must be established in NI
- the active substance must be approved under GB BPR or included on the GB Simplified Active Substance List
- the active substance must be sourced from a supplier on the GB Article 95 List
- the NI business must notify HSE at least 90 days before making the product available on the GB market
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
To protect workers, consumers and the environment, HSE has powers to amend the terms and conditions under which a notified product can be supplied / used in GB or prohibit it from being supplied in GB. At each step in the supply chain the conditions of the notification must be complied with. If the product is changed in any way at a step in the supply chain this may not be covered by the notification eg adding a new trade name to the product label that is not covered by the notification. Enforcement action may be taken where a product is supplied that does not meet the conditions of the notification.
How to notify
The NI business or company acting on their behalf must submit, in English, a completed notification form to [email protected] – companies may wish to mark emails as appropriate eg confidential. Please note that your notification form may be returned if it is incomplete.
Only the notification form should be submitted by email. All other relevant documentation / data must be submitted via the HSE Secure File Sharing Service, including:
- your full original application under EU BPR – this includes the full original data package and any subsequent data submissions made during the EU BPR evaluation
- a copy of the relevant NI authorisation or permit
Using the HSE Secure File Sharing Service
- Once we have received and processed your notification form, you will be sent a link to upload the files associated with the relevant notification – 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
- The EU BPR authorisation holder must be established in NI.
- You must have an authorisation or permit valid in NI under EU BPR.
- The active substance must be approved under GB BPR or included on the GB Simplified Active Substance List.
- Your active substance supplier must be included on the GB Article 95 List.
- All biocidal product names must be unique – please check the list of GB authorised products to determine if your proposed product name has already been used.
- Where any part of your EU BPR authorisation or permit relies on a Letter of Access, you should make sure these data are submitted to HSE – your Letter of Access may be rejected if HSE does not hold the relevant data.
What HSE will do
After receiving your notification HSE will:
- consider the information provided, focussing on any safety concerns and / or concerns that the biocidal product / biocidal product family may not be sufficiently effective for the intended use – this will take approximately 90 days from receiving the full notification
- consider whether it is appropriate to take action to amend the terms and conditions of the supply / use for the GB market, or prohibit supply / use of the biocidal product / biocidal product family in GB
Where HSE identifies concerns, you may be asked to provide further information. When such requests are made, the indicative timeframe given above will be suspended:
- until the additional information is received by HSE; and
- from the date the additional information is received by HSE, for a further period of 90 days to allow HSE to consider that additional information
Please note if you fail to provide the information within the specified deadline, your notification may be considered as withdrawn and the product cannot be made available on the GB market.
Unfettered access notification outcome
When the consideration of a notification is completed, HSE will choose whether it is appropriate:
- for the biocidal product / biocidal product family to be supplied / used in GB under the proposed terms and conditions; or
- to take action to amend the terms and conditions of the supply / use for the GB market; or
- to prohibit supply / use of the biocidal product / biocidal product family in GB.
- treat your biocidal product / biocidal product family as if it is authorised under GB BPR
- assign a GB unfettered access reference to the biocidal product / biocidal product family
- send the applicant confirmation that the notification has been accepted
- send the applicant a copy of the conditions for supplying the product in GB – where these have been amended by HSE, this will be clearly indicated
- ensure you comply with the conditions for supplying the product in GB at all times or your biocidal product / biocidal product family will no longer be treated as authorised under GB BPR
- ensure you comply with other requirements of GB BPR which include (but are not limited to):
- packaging and labelling requirements (Article 69)
- advertising requirements (Article 72)
- record keeping requirements (Article 68)
- notification of unexpected or adverse effects (Article 47)
- ensure you comply with general chemical and product safety law which continues to operate such as:
- GB Classification, Labelling and Packaging of Substances and Mixtures (GB CLP) Regulation
- General Product Safety (GPS) Regulations
- ensure any changes made to the product under EU BPR in NI are notified to HSE via the unfettered access notification procedure at least 90 days before the date on which the changes will apply
- ensure the renewal of the product under EU BPR in NI is notified to HSE via the unfettered access notification procedure at least 90 days before the date of renewal
- contact HSE if you no longer wish to supply the biocidal product / biocidal product family in GB
HSE will not treat your biocidal product / biocidal product family as if it is authorised under GB BPR, and will prohibit it from being supplied in GB, where concerns are identified that cannot be addressed by amending the conditions of supply / use.
The notifier may have the opportunity to provide additional information where that is appropriate.