2. Action for Article 95 suppliers
To remain on the GB Article 95 list, you must both:
- confirm to HSE by 31 December 2022 that you are established in the UK (Great Britain or Northern Ireland)
- resubmit your data or letter of access to HSE by 31 December 2022
Established in the UK
Being established in the UK usually means having a registered office, headquarters or permanent business establishment in the UK. In other words, you or your business must have a physical presence in Great Britain or Northern Ireland. This must be:
- your permanent business location or
- the permanent location of the human and technical resources needed to carry out, either in whole or in part, your business operations
You or your business must be a legal entity in the UK. Branch offices are the same legal entity as the parent company – a UK branch office is not a UK legal entity if the parent company is based overseas.
How to resubmit your data or letter of access and tell HSE you’re established in the UK
To resubmit your data or letter of access:
- complete thisEU Exit biocides resubmission form
- email the form to [email protected]
- provide additional information and data (outlined in the checklists in Section 6 of the form) using HSE’s Secure File Sharing Service
To tell HSE that you are established in the UK:
- complete this EU Exit biocides establishment form
- email the form to [email protected]
- provide additional information (outlined in the checklist in Section 3 of the form) using HSE’s Secure File Sharing Service
You can submit both forms at the same time, or you can submit them separately, however you must complete both actions by the deadline.
If you have already provided your data or letter of access to comply with earlier GB resubmission deadlines, you do not need to submit this again.
Providing additional information
When we process your form, we will send a link to HSE’s Secure File Sharing Service. The link will be valid for 7 calendar days and is specific to your application – please do not use the link to upload files for other applications.
Letter of access
If any part of your application relies on a letter of access, it’s your responsibility to ensure that the data owner submits the relevant data to HSE by the deadline.
The letter of access must be valid under GB BPR. HSE accepts EU BPR letters of access providing they are accompanied by a written statement from the issuer confirming that the access extends to GB BPR; however, the data owner may choose to issue GB BPR specific letters of access instead.
If you’re unsure or are having difficulties with letters of access or data, please resubmit your application by the deadline and describe the issues or data gaps - there is no need to contact us in advance of making your resubmission.
You should submit data dossiers in IUCLID format. If you are unable to, you must justify why you cannot.
You must supply reference lists on theGB reference list template.
Using EU versions of supporting documents
HSE accepts EU versions of supporting documents such as the:
- active substance draft Risk Assessment Report (RAR)
- Safety Data Sheets (SDSs).
Letters of confirmation
If your form states that you are changing the company that is the GB Article 95 supplier or GB Article 95 representative, you must submit a letter from each company involved, confirming that they agree to:
- transfer responsibility to the new company
- accept responsibility from the current company
- the change of representative who will act on their behalf
HSE will not charge for:
- making changes to the GB Article 95 list as a result of confirming your establishment status
- receiving or handling active substance data resubmitted solely in support of an existing GB Article 95 listing
- receiving or handling letters of access resubmitted solely in support of an existing GB Article 95 listing
Where data also support an application for active substance approval, the normal fees for evaluating data and applications apply. Fees will not be requested until HSE is ready to start work on your active substance application.