GB Article 95: How to apply
Applications for inclusion on the GB Article 95 List can be made to HSE by:
- UK based companies who make active substances available on the market in Great Britain (GB)
- UK based companies who make biocidal products available on the GB market
- UK representatives of companies based outside the UK who make active substances or biocidal products 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
If the supplier of an active substance is not on the GB Article 95 List, then biocidal products containing that active substance cannot be made available on the GB market. If the active substance supplier does not want to go on the GB Article 95 List, the biocidal product supplier / manufacturer could gain their own entry on the list instead.
Enforcement action may be taken if it cannot be demonstrated that the active substance in a biocidal product that is made available on the GB market is compliant with GB Article 95.
A company that is based outside the UK may appoint a UK representative, which must be established in the UK, to act on their behalf for the purposes of GB Article 95. This allows non-UK companies to appear on the GB Article 95 List next to their UK representative.
How to apply
The company or their UK representative must submit, in English, a completed application form to [email protected] – 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 via the HSE Secure File Sharing Service – companies should submit one of the following:
- a complete active substance dossier in IUCLID format
- a letter of access to a complete active substance dossier
- a reference to a complete active substance dossier for which all data protection periods have expired
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 [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.
- Dossiers should be submitted in one of two formats:
- IUCLID (International Uniform Chemical Information Database)
- structured file system consisting of word, excel and PDF documents etc – it is expected that this kind of submission will only be applicable to applicants who already have a dossier in this format and do not have a current IUCLID version
- Paper dossiers (or partial paper dossiers) must not be submitted.
- Dossiers should consist of three main sections:
- data in the form of study reports
- summaries of those data – either in IUCLID or word documents
- assessments of the hazard, exposures, risks and efficacy of the active substance in a representative product, including an overall summary – using this Risk Assessment Report (RAR) template
- All documents / attachments should be included within your IUCLID dossier, where applicable
- Guidance on information requirements for active substances and biocidal products – applicants should use this document when preparing dossiers for GB Article 95 inclusion
- Biocides Submission Manual (BSM) series - describes how to build IUCLID dossiers with detailed and illustrative technical assistance
- Guidance and training on IUCLID is also available – please note that HSE is unable to provide support on IUCLID
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
- estimate how much it may cost (“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
- check for any data gaps
- make a decision as to whether you should be included on the GB Article 95 List for the relevant active substance / product type combination
- 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 inclusion on the list being withheld
You may be asked to provide further information at various stages of the process. 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.
An application can be rejected at any stage if the relevant fees or requested information / data are not submitted or are unacceptable.
Making changes to existing entries
If you want to make a change to an existing entry on the GB Article 95 List eg if your company has changed its name, you should inform HSE in writing at [email protected].
If you are taking over another company’s entry, both parties should jointly inform HSE and include all relevant letters of access.