Current arrangements for Article 95 compliance come to an end
In response to the pandemic, HSE took steps to assist industry’s efforts to increase the availability of hand sanitisers to help reduce the spread/transmission of COVID-19.
One of these steps was adopting a pragmatic and proportionate approach to the requirement for all biocidal products supplied in the UK to contain active substances sourced from suppliers on the Article 95 list.
Information gathered from a range of stakeholders suggests that hand sanitiser manufacturers are no longer experiencing any difficulties in sourcing their active substance from an Article 95 supplier.
This means that the proportionate approach to the Article 95 requirement, put in place at the beginning of the pandemic for hand sanitiser products, will be discontinued.
Accessing the UK market
Businesses wishing to supply hand sanitiser products must ensure that their active substance is sourced from a supplier on:
- the GB Article 95 List, in Great Britain
- the EU Article 95 List, in Northern Ireland
Alternatively, businesses may apply to get on the relevant Article 95 list themselves:
- GB Article 95: How to apply - (HSE GB website)
- Application and assessment procedure EU Article 95 List - (ECHA website)
Background
Article 95 of the BPR aims to create a level playing field across industry by ensuring that all suppliers of biocidal products have paid a share of the cost of supporting the active substance dossier through an evaluation process.
The BPR requires either the supplier of the active substance used in a biocidal product, or the supplier of that biocidal product, to be included on the Article 95 list for the relevant active substance / product type combination.
This requirement applies to all biocidal products made available on the UK market, including:
- products authorised under the BPR
- products in the process of getting a BPR authorisation
- products regulated under other national legislation in the UK, such as the Control of Pesticides Regulations (COPR)
- products where the active substance / product type combination is still being reviewed e.g. ethanol
To aid the rapid supply of hand sanitiser products, HSE adopted a pragmatic and proportionate approach to these regulatory requirements, focussing on ensuring that high levels of safety and efficacy of hand sanitiser products were maintained.
As part of the approach, HSE expected product manufacturers to have taken all reasonable steps to comply with Article 95 obligations. At all times, manufacturers were expected to continue to be mindful of maintaining high levels of safety and efficacy of the products they were making available to the public and others.