National Authorisation
Temporary changes to GB biocides application processing times - more information[68].
HSE can grant national authorisations for biocidal products and biocidal product families in Great Britain (GB) under the GB Biocidal Products Regulation (GB BPR).
The authorisation holder is normally the company at the top of the supply chain and must be established within the UK.
Once authorised, the biocidal product / biocidal product family can be made 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
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.
How to apply
The prospective authorisation holder or company acting on their behalf must submit, in English, a completed application form (.docx) [70] 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.
Only the application form should be submitted by email. All other relevant documentation / data must be submitted using the HSE Secure File Sharing Service, including:
- a dossier in IUCLID format, or letter of access to a dossier held by HSE, that satisfies the requirements of Annex II and Annex III of GB BPR - this dossier will include information about the product / product family's:
- physical, chemical, technical and, where appropriate, biological properties
- physical hazards and respective characteristics
- methods of detection and identification
- effectiveness against target organisms
- intended uses and exposure
- toxicological profile for humans and animals
- ecotoxicology
- fate and behaviour in the environment
- risk mitigation measures
- classification, labelling and packaging
- a draft Product Assessment Report (PAR) (.docx) [71] for the biocidal product / biocidal product family
- a copy of the proposed product label
- Safety Data Sheets (SDSs) for:
- the proposed biocidal product / each biocidal product in the product family
- all active substances and co-formulants in the proposed biocidal product / biocidal product family
- a draft Summary of Product Characteristics (SPC) for the biocidal product / biocidal product family using the following templates as appropriate:
- reference list of studies (.xlsx) [75]
- any pre-submission correspondence with HSE
All documents / attachments should be included within your IUCLID dossier.
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 - Friday and are valid for 5 working 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 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 authorisation holder must be established in the UK.
- All biocidal product names must be unique - please check the list of GB authorised products [76]to determine if your proposed product name has already been used.
- Letters of Access must relate to data held by HSE - you should talk to your active substance supplier to ensure they have submitted the data to HSE.
What HSE will do
Temporary changes to GB biocides application processing times - more information[77].
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 [78]("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 and check (validate) that you have submitted all of the required information in the correct format - this will take approximately 30 days from the payment of the "initial estimated fee"
- evaluate the application to assess the risks to health and the environment, intended use and efficacy of the biocidal product / biocidal product family - this will take approximately 365 days from validating the application and takes place in two stages:
- technical sift - a quick check of the information provided to identify any obvious issues
- full evaluation - a full risk assessment of the information provided to determine if the biocidal product / biocidal product family does what it is intended to do and can be used "safely" for this intended use
- make a decision as to whether the biocidal product / biocidal product family can be authorised in GB
- 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.
If the biocidal product / biocidal product family is supplied in the form of a bait station or other physical device then we may request a sample to inform the risk assessment.
Product authorisation decision
When the evaluation of an application is completed, a decision will be made as to whether the biocidal product / biocidal product family 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 Product Assessment Report (PAR) and draft Certificate of Authorisation
- take into account the applicant's comments, where relevant
- assign an authorisation number to the biocidal product / biocidal product family
- issue a signed Certificate of Authorisation
You should:
- examine the draft Product Assessment Report (PAR) and draft Certificate of Authorisation and return them 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 market in GB
- ensure you remove from the distribution chain any existing stocks that do not meet the new conditions and restrictions of the authorisation within 180 days of the authorisation being issued - if you were previously allowed to supply the product under other national law in GB eg COPR[79]
- ensure you comply with any deadlines associated with the authorisation, such as for any post authorisation data requirements or your authorisation may be cancelled[80]
- note your authorisation expiry date - the authorisation will expire on the date shown unless the authorisation holder submits a valid application for renewal at least 550 days before the expiry date[81]
- ensure you comply with other requirements of GB BPR which include (but are not limited to):
- packaging and labelling requirements[82] (Article 69)
- advertising requirements[83] (Article 72)
- record keeping requirements[84] (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:
- contact HSE if you intend to amend or cancel [87] your 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