HSE has worked closely with other government agencies, manufacturers and their trade associations to help ensure that they can continue to meet the increased demand for vital active substances.
Some of the UK’s existing manufacturers of biocidal hand sanitiser products had reported that they were facing significant challenges to their normal supply chains from increasing demand for the raw ingredients needed to meet unprecedented and urgent demand during the COVID-19 pandemic.
In response HSE took the following steps.
Derogations from product authorisation requirements for hand sanitisers containing Propan-2-ol
Article 55 (1) of the Biocidal Products Regulation (BPR) enables HSE, in cases of danger to public health, animal health or the environment which cannot be contained by other means, to provide short term derogations from the requirements for product authorisation.
Biocidal hand sanitiser products containing Propan-2-ol (also known as isopropanol or isopropyl alcohol/IPA), are not required to obtain a product authorisation if they match the relevant WHO-specified formulation II.
Manufacturers wishing to place products that meet the WHO specified formulation onto the UK Market must contact HSE via [email protected] using 'Propan-2-ol Article 55' as the subject title of the email. HSE will respond quickly to request details about the products being manufactured.
Products should not be placed on the market until HSE has confirmed that the derogation applies to you.
Other types of hand sanitiser
Hand sanitisers containing other active substances, or that do not match the WHO propan-2-ol formulation, can be supplied and used in the UK if they meet the relevant regulatory requirements.
Rules for supplying chemicals for use in biocidal products
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 suppliers of active substances for use in biocidal products to be included on the relevant Article 95 list. There are separate Article 95 lists that apply to Great Britain and to Northern Ireland:
Non- Article 95 supplier's chemicals for use in hand sanitisers
During this exceptional time of increased demand due to the coronavirus pandemic, it may be necessary for hand sanitiser manufacturers to find alternative suppliers of raw ingredients to supplement those obtained via regular supply chains.
HSE’s primary concern is that safe and effective biocidal hand sanitisers are available in the UK to help protect people during the coronavirus pandemic. HSE has adopted a pragmatic and proportionate approach to regulatory requirements that relate to supply chain obligations during this period. The focus of any HSE activity by inspectors is to ensure that products on the market are effective in combating the coronavirus and do not pose an unacceptable risk to people or the environment.
HSE expects product manufacturers to have taken all reasonable steps to source ingredients in such a way that they are compliant with Article 95 obligations.
However, HSE Inspectors will take a sensible and proportionate approach if they come across hand sanitisers that are not strictly in line with normal BPR supply chain requirements under Article 95, recognising the urgent wider need for safe and effective products.
In making commercial decisions, manufacturers need to be mindful of maintaining high levels of safety and efficacy of the products they make available to the public and others.
Impact of the end of the Brexit Transition Period
Any derogations for the WHO propan-2-ol formulation granted before 31 December 2020 remain valid in the UK (both Great Britain and Northern Ireland).
Further information and advice
- More information on the use, manufacture and supply of hand sanitisers and surface disinfectants during the coronavirus pandemic
- Speak to your supplier
- Contact [email protected]
- Sign up to the biocides e-bulletin
- Visit our Biocides website
This page is reviewed regularly and updated to reflect any changes in the guidance.
Page last reviewed: 28 May 2021
Next review due: 30 June 2021