HSE issue derogation for manufacturers of hand sanitizers
Published: 30 Mar 2020

The Health and Safety Executive (HSE) have issued a derogation which will aim to help the manufacturers of chemicals to adjust their production to make hand sanitizers, which are currently of significant demand.

Some of the UK's existing manufacturers of biocidal hand sanitizer products have reported that they are facing challenges to their normal supply chains due to increased demand for raw ingredients. This demand has been as result of the Covid-19 pandemic.

Normally, Regulation (EU) 528/2012 on the making available on the market and use of biocidal products requires all biocidal products to obtain an authorisation before such products can be placed on the market. That Regulation also enables the HSE to provide short term derogations from the requirements for product authorisation, in cases of danger to public health, animal health or the environment which cannot be contained by other means. 

Biocidal hand sanitizer products containing propan-2-ol (also known as isopropanol or isopropyl alcohol/IPA), will not be required to obtain a product authorisation - only if they meet the relevant WHO-specified formulation II.

Manufacturers wishing to place products that meet the WHO specified formulation on the UK market must contact the HSE by e-mail to biocidesenquiries@hse.gov.uk, using Propan-2-ol Article 55, as the subject of the e-mail.

The HSE will then respond as soon as possible to request details about the products being manufactured and once details are provided, issue a derogation certificate. Products should not be placed on the UK market until the HSE had provided a derogation certificate.

The WHO currently does not specify a formulation for hand sanitizers containing propanol-1-ol. Therefore, although derogations from the Biocidal Products Regulation may be possible for hand sanitizers containing that substance, these will require more information from applicants to enable HSE to determine the efficacy and the risks associated with their use. Such applications will inevitably take longer to process and approve by the HSE.

There is a WHO-specified formulation I for hand sanitizer containing ethanol. Under the transition arrangements in the Biocidal Products Regulation, manufacturers do not require product authorisations to place hand sanitiser products containing ethanol on to the UK Market.

The derogation guidance provided by the HSE also provides information on the:

  • rules for supplying chemicals for use in biocidal products;
  • non-Article 95 supplier’s chemicals for use in hand sanitisers;
  • active substances not yet subject to authorisation under the Biocidal Products Regulation.

For more information on this subject, see: