Current arrangements for hand sanitiser permits 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 establishing special arrangements to issue critical situation permits that enable short-term derogations from the normal Biocidal Products Regulation (BPR) requirements for product authorisation.
As these short-term permits begin to approach their expiry dates, HSE has gathered information from a range of stakeholders about the current availability of hand sanitisers on the UK market. The outcome suggests that, whilst there is an ongoing need for hand sanitiser products, current demand can be met by products supplied under the normal arrangements in BPR.
This means that the special arrangements for supplying hand sanitiser products, put in place at the beginning of the pandemic, will be discontinued. The assessment of any ongoing applications made under the current arrangements will be completed.
Any hand sanitiser products that have already been granted a permit can continue to be supplied and used until that permit expires.
Accessing the UK market
Businesses wishing to supply hand sanitiser products should comply with the normal requirements for getting a biocidal product on the UK market.
Businesses remain able to apply for individual critical situation permits under BPR. However, as previously, they will need to demonstrate that the relevant criteria required by Article 55 (1) of BPR are met.
Background
In cases of danger to public health, animal health or the environment which cannot be contained by other means, Article 55 (1) of BPR enables HSE to issue critical situation permits for products that do not comply with the normal BPR requirements. Such permits may be issued for an initial period not exceeding 180 days and extended for a period not exceeding 550 days.
To aid the rapid supply of hand sanitiser products, HSE established a broad framework which removed the need for individual applicants to demonstrate that the Article 55 (1) criteria were satisfied.
This arrangement gave businesses two simple options for obtaining a permit to supply hand sanitiser products in the UK:
- a notification process, for products exactly matching the WHO Formulation 2 based on propan-2-ol
- an application process requiring a reduced data set to demonstrate safety and efficacy, for other hand sanitiser formulations
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