Essential use authorisation
Brexit: Transition period
The UK has now left the EU. Your health and safety responsibilities have not changed in the transition period.
This page provides information for applicants on how to apply for an Essential Use Authorisation for placing a biocidal product or biocidal product family on the UK market under regulation 13 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013 and regulation 12 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013.
In accordance with article 5 of EU Regulation (EC) 1451/2007 Member States may apply to the Commission for an extension of the deadline for the removal from the market of active substances which have been made subject to a decision not approving them for use in biocidal products (referred to below as an “essential use derogation”). Member States are able to do this only where they consider that continued use of such a substance is essential for reasons of health, safety, protection of cultural heritage or is critical for the functioning of society, and where there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health.
If the European Commission grants an active substance an essential use derogation , companies wishing to place a biocidal product/ or family of such products on the UK market must apply for an Essential Use Authorisation to HSE (UK Competent Authority for biocides), which will then be evaluated and a decision made as regards authorisation.
Any active substance essential use derogation granted by the European Commission will only be available for a specified, limited time and is subject to certain conditions, including that the active substance/s in question can only be used:
- If it is reasonable to assume there are no unacceptable effects on human or animal health or on the environment;
- subject to appropriate risk reduction measures, including those specified in the UK application to the Commission for the relevant essential use derogation, being met and where biocidal products have been labelled to reflect use conditions relating to those risk reduction measures; and
- where either
- the holder of the authorisation is seeking alternatives for such uses,
- a dossier for the active substance is being prepared for submission in accordance with the procedure laid down in Regulation (EU) 528/2012 by the deadline set out in the essential use derogation for that active substance (see the table below). The deadline given in the essential use derogation is the date by which the dossiers for the approval of the active substance have to be submitted and validated as complete by the evaluating Member State.
- the holder of the authorisation is seeking alternatives for such uses,
Failure to comply with any conditions of the active substance essential use derogation or the essential use product authorisation, including failure to submit the active substance dossier by the stated deadline, may result in the withdrawal of the essential use authorisation. In such a case continuing to place the product on the market would constitute an offence and may lead to enforcement action, including the possibility of prosecution, under the relevant UK Regulations.
UK Essential Use derogations
Since 2013 the European Commission has granted the UK the following essential use derogations
|Commission Decision||Active Substance||EC Number||CAS Number||Product Type||Uses||Deadline for submitting active substance dossier|
|Commission Decision 2014/85/EU||Copper *||231-159-6||7440-50-8||Product Type 2||For control of Legionella in water for human use, such as bathing and showering water||31 December 2014 †|
|Commission Decision 2014/85/EU||Copper *||231-159-6||7440-50-8||Product Type 5||For control of Legionella in drinking water||31 December 2014 †|
|Commission Decision 2014/395/EU||Copper *||231-159-6||7440-50-8||Product Type 2||For control of Legionella and other harmful organisms in water for swimming pools and animal pools.||31 December 2014 †|
|Commission Decision 2014/395/EU||Copper *||231-159-6||7440-50-8||Product Type 11||
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 †|
* For Copper Essential Use Authorisations the copper electrodes, from which copper ions are generated should be authorised. The equipment itself does not need to be evaluated or authorised.
† The active substance dossier for Copper for PT2, 5 and 11 was submitted and validated as complete by the Competent Authority France before 31/12/2014.
Making the application
To make an application for Essential Use Authorisation in the UK you must submit the following information to HSE;
- Application form – Commission Decision 2014/85/EU or
- Application form – Commission Decision 2014/395/EU and
- Proposed product label
Sifting the application
HSE will then assess the information to determine if it meets the derogation conditions and/or whether any additional information/data are needed.. We will also estimate how much it will cost to process the application.
The Applicant will then be invoiced the estimated fee.
Paying the estimated fee
Applicants should pay the estimated fee within 30 days of the invoice date. If an applicant anticipates a delay in payment HSE should be informed as soon as possible.
HSE accepts payments by either cheque or bank transfer. The full payment details/methods will be outlined in your invoice.
Processing of application
Following payment of the estimated fee, HSE will process the application . HSE will normally make a decision on whether or not the biocidal product/biocidal product family can be placed on the UK market within 30 days of an application being paid for.
On completion of the evaluation of an application, a decision will be made as to whether or not the biocidal product/biocidal product family can be placed on the UK market.
If the application for product authorisation is successful, the authorisation conditions HSE intends to set for the product will be set out in a Certificate of Authorisation.
An Authorisation Number will be assigned to the biocidal product/biocidal product family and the Certificate of Authorisation signed on behalf of Government Ministers and sent to the applicant.
Once the authorisation is granted that product may be placed on the market in the UK, in a manner consistent with the conditions and restrictions associated with the authorisation.
Where an application does not meet the required standards we will not issue an authorisation. The applicant may have the opportunity to modify/update their application in order to make it acceptable. We have open lines of dialogue with applicants to facilitate this.
Calculating the actual costs
We will calculate the actual cost for evaluating the application based on the total time spent. If the cost is less than the initial estimated fee, an appropriate refund will be given. Where the cost exceeds the initial estimate a top-up fee will be requested. This two stage fee approach is required as HSE’s evaluation costs need to be fully cost recovered.
Once your product is authorised you should carefully note any conditions of authorisation specified in your legal documents, and should also be aware of other obligations imposed, by for example:
- the Commission Decision granting the active substance essential use derogation;
- the EU Biocides Regulations 528/2012 (“EU BPR”) which include:
Please be aware that other legislation may also apply to the biocidal product where relevant.
If an essential authorisation is given it for a biocidal product/ biocidal product family it will apply to UK only.