Essential use authorisation
HSE can only grant essential use authorisations for biocidal products where the active substance in the product has received an essential use derogation for
- Great Britain (GB), under the GB Biocidal Products Regulation (GB BPR)
- Northern Ireland (NI), under the EU Biocidal Products Regulation (EU BPR)
Find out about when active substances can receive essential use derogation[68].
The authorisation holder is normally the company at the top of the supply chain and should be established within the UK.
Once authorised, the biocidal product can be made available on the GB or NI markets, as applicable. 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
At each step in the supply chain the conditions of authorisation 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 authorisation eg adding a new trade name to the product label that is not covered by the authorisation.
Enforcement action[69] may be taken where a product is supplied that does not meet the conditions of authorisation.
Essential use authorisations will only be available for a limited time, for example until products are able to be authorised via the normal routes[70]. They are subject to specific conditions such as:
- appropriate risk mitigation measures
- an active substance dossier being submitted by the specified deadline or alternatives are being sought
- any other conditions specified by the active substance essential use derogation
Current GB essential use derogations in GB and NI
The table below lists the essential use derogations that are currently valid in GB and NI.
| Active substance | CAS number | EC number | Product type | Uses | Deadline for submitting active substance dossier | Market valid in (GB, NI or both) | Link to details | Comments |
|---|---|---|---|---|---|---|---|---|
| Copper | 7440-50-8 | 231-159-6 | PT02 | For control of Legionella in water for human use, such as bathing and showering water | 31 December 2014 | GB and NI |
GB: Decision 2014 No. 85[71] NI: EU Commission Decision 2014/85/EU[72] |
The copper electrodes, from which copper ions are generated should be authorised. The equipment itself does not need to be evaluated or authorised. |
| Copper | 7440-50-8 | 231-159-6 | PT05 | For control of Legionella in drinking water | 31 December 2014 | GB and NI |
GB: Decision 2014 No. 85[73] NI: EU Commission Decision 2014/85/EU[74] |
The copper electrodes, from which copper ions are generated should be authorised. The equipment itself does not need to be evaluated or authorised. |
| Copper | 7440-50-8 | 231-159-6 | PT02 | For control of Legionella and other harmful organisms in water for swimming pools and animal pools. | 31 December 2014 | GB and NI |
GB: Decision 2014 No. 395[75] NI: EU Commission Decision 2014/395/EU[76] |
The copper electrodes, from which copper ions are generated should be authorised. The equipment itself does not need to be evaluated or authorised. |
| Copper | 7440-50-8 | 231-159-6 | PT11 |
For the prevention of biofouling in the water inlet/pumps and throughout the entire pipework and waterway system of offshore oil and gas platforms, and other marine and coastal installations. For the prevention of biofouling of the water inlet/pumps and throughout the entire pipework and waterway system of a ship. |
31 December 2014 | GB and NI |
GB: Decision 2014 No. 395[77] NI: EU Commission Decision 2014/395/EU[78] |
The copper electrodes, from which copper ions are generated should be authorised. The equipment itself does not need to be evaluated or authorised.. |
Details of products with an essential use authorisation in GB can be found on the list of UK authorised biocidal products.[79]
Where a product contains more than one active substance, all the actives will be included on the authorised products list. For example, if a product contains both copper (which has an essential use derogation) and silver (which does not require an essential use derogation) then both copper and silver will be stated as the active substances on the list.
How to apply
The prospective authorisation holder or company acting on their behalf must submit, in English, a completed application form (.docx) [80] to biocidesapplications@hse.gov.uk – companies may wish to mark emails as appropriate eg confidential. Please note that your application form may be returned if it is incomplete.
If you want to market the same product in both GB and NI, you only need to complete one application form. Make sure that there is a relevant active substance essential use derogation valid in both markets.
Only the application form should be submitted by email. All other relevant documentation / data must be submitted via the HSE Secure File Sharing Service, including:
- a copy of the proposed product label
- Safety Data Sheets (SDSs) for:
- the proposed biocidal product
- all active substances and co-formulants in the proposed biocidal product
- a draft Summary of Product Characteristics (SPC) for the biocidal product using the single biocidal product SPC template (.docx) (.docx) [81]
- any pre-submission correspondence with HSE
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 to Friday and are valid for 7 calendar days. If the link expires before you are able to upload your files, please email biocidesapplications@hse.gov.uk to request a new 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 authorisation holder should be established in the UK.
- All biocidal product names must be unique within the relevant market – please check the list of UK authorised products[82] to determine if your proposed product name has already been used on the GB or NI markets
- Letters of Access must relate to data held by HSE
What HSE will do
After receiving your application HSE will:
- conduct a brief initial check of the information to confirm that it meets the requirements for the application type
- estimate how much it may cost[83] ("initial estimated fee") to process the application based on the information provided
- 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
- accept the application once the initial estimated fee has been paid
- make a decision as to whether the biocidal product can be authorised in GB or NI – this will take approximately 30 days from accepting the application
- issue an invoice for a "top up" fee if the cost of evaluating the application has gone beyond the initial estimated fee, which must be paid within 30 days of the date of the invoice – failure to pay the requested fees will result in your authorisation being cancelled
You may be asked to provide further information at various stages of the process. When such requests are made, the indicative timeframes 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.
Product authorisation decision
When the evaluation of an application is completed, a decision will be made as to whether the biocidal product can be authorised.
Successful applications
HSE will:
- send the applicant a copy of the draft authorisation conditions HSE intends to set for the product – these are set out in a draft Certificate of Authorisation
- take into account the applicant's comments, where relevant
- assign an authorisation number to the biocidal product
- issue a signed Certificate of Authorisation
You should:
- examine the draft Certificate of Authorisation and return it to HSE (with comments if necessary) to indicate your agreement with the authorisation conditions
- wait until the signed Certificate of Authorisation has been issued and ensure you comply with the conditions and restrictions in the authorisation before making the product available on the GB or NI markets. If you have any existing stocks that do not meet the new conditions and restrictions of the authorisation please contact us.
- ensure you comply with any deadlines associated with the derogation decision for the active substance or contained in the authorisation.
- note your authorisation expiry date - the authorisation will expire on the date shown
- note the date/deadline for submission of the active substance dossier.
- ensure you comply with other requirements of GB BPR and EU BPR which include (but are not limited to):
- advertising requirements[84] (Article 72)
- notification of unexpected or adverse effects (Article 47)
- 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[88] your authorisation
Failure to comply with any of the conditions of the derogation, authorisation or applicable legislation may lead to the withdrawal of the authorisation.
Unsuccessful applications
HSE will not issue an authorisation where an application does not meet the required standards.
The applicant may have the opportunity to modify / update their application to make it acceptable where that is appropriate.
Rejecting applications
An application can be rejected at any stage if the relevant fees or requested information / data are not submitted or are unacceptable.