GB Article 95: The basics
The GB Article 95 List gives details of the suppliers for active substance / product type combinations that can be used in biocidal products in GB.
If the active substance supplier is not on the GB Article 95 List, then the biocidal product 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.
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
All of these stages could be affected if the active substance or product supplier is not on the GB Article 95 List.
The list is made up of companies, or UK representatives of companies, who:
- are participants in the GB BPR active substance Review Programme
- have supported a ‘new active substance’ for assessment
- are supporting an active substance as their product was newly in scope when the BPR came into force (an ‘Article 93 active substance’)
- have made a submission that complies with Article 95(1) of GB BPR
Note: Biocidal products containing ‘new active substances’ cannot be made available on the market until they have been authorised.
All companies on the GB Article 95 List have access to a dossier for their listed active substance / product type combination (or have a Letter of Access to allow another company’s dossier to be used on their behalf).
The GB Article 95 List is available online and is regularly updated.
Get on the GB Article 95 List
If you are supporting an active substance for approval under GB BPR you will automatically be added to the GB Article 95 List.
Any other supplier of the active substance, or any supplier of products containing the active substance, can apply to be included on the GB Article 95 List.
Products that need to comply
The requirements of Article 95 of GB BPR apply to all biocidal products made available on the GB market, including:
- products authorised under GB BPR
- products in the process of getting a GB BPR authorisation
- products regulated under other national legislation in GB such as the Control of Pesticides Regulations (COPR)
- products where the active substance / product type combination is still being reviewed
- products notified to HSE under Northern Ireland Protocol unfettered access rules
All companies making biocidal products available on the GB market must be able to demonstrate a clear auditable purchase / supply trail from a GB Article 95 active substance supplier.
- account for each step of the supply chain – from supply of the active substance to the supply of the biocidal product to the user
- come from the listed GB Article 95 supplier – a distributor of the active substance cannot state that they purchase from a GB Article 95 listed supplier – the GB Article 95 listed supplier must state that they supply the distributor
- be clear and specific – the active substance or product must be clearly named
- be in English
Acceptable evidence could be:
- an invoice
- a delivery note
- a letter from a GB Article 95 listed supplier stating that they have a supply agreement with your supplier or they have supplied the active substance to your company
If your product requires GB BPR authorisation, or approval under COPR, you will need to submit this evidence as part of your application. This evidence must also be supplied to HSE or other Enforcement Authorities if requested.
If your supplier does not wish to share sensitive documentation with you, it can be provided directly to HSE.
Action for biocidal product formulators, suppliers, and distributors
Biocidal product formulators, suppliers and distributors need to ensure the supplier of the active substance in the biocidal product is included on the GB Article 95 List for the relevant product type.
For some biocidal products there may be multiple steps in the supply chain for the active substance. In these situations, it could be the company at the top of the supply chain or any step in the supply chain that is included on the GB Article 95 List.
Biocidal product formulators, suppliers and distributors should regularly check their active substance supplier is still included on the GB Article 95 List.
Problem: active substance supplier isn’t listed
If the active substance supplier isn’t listed or is removed from the GB Article 95 List, the law prohibits biocidal products using that active substance supplier being made available on the GB market.
If the product has already been made available on the GB market eg by the formulator to the distributor, the law prohibits the distributor from supplying it any further in GB.
The law does not prohibit use of stocks of products that had already been supplied before your supplier was been removed from the GB Article 95 List.
Problem: active substance supplier is listed but the list states they are a ‘former Review Programme participant’
If the company supporting the active substance / product type combination for review in the GB BPR Review Programme has withdrawn their support, they will be highlighted on the GB Article 95 List as a ‘former Review Programme participant’.
In this situation the requirements of GB Article 95 will vary depending on the specific situation. Please contact us for advice.