Published: 30 March 2020  (Updated: 31 March 2020)

Update on Hand Sanitisers – HSE Derogations

On 29 March the Health and Safety Executive (HSE) issued a communication on manufacturing and supplying biocidal hand sanitisers during the Covid-19 (coronavirus) outbreak.

  • Biocidal hand sanitisers containing propan-2-ol (isopropanol): the HSE issued a derogation under Article 55 of the Biocidal Products Regulation (BPR) for biocidal hand sanitisers that meet the World Health Organisation (WHO) formulation II.  Manufacturers wishing to place this type of product on the UK market must contact the HSE using ‘Propan-2-ol Article 55’ as the subject of the email, in order to obtain the derogation certificate.
  • Biocidal hand sanitisers containing propan-1-ol: the HSE may issue a derogation under Article 55 of the BPR for these formulations too, however these may take longer to issue and manufacturers shall provide more information on the efficacy and safety of these formulations.
  • Biocidal hand sanitisers containing ethanol: there is a WHO formulation I for hand sanitisers containing ethanol.  Under the transition arrangements in the BPR, manufacturers do not require product authorisations to place hand sanitiser products containing ethanol on to the UK Market.
  • Article 95 of the BPR provides a list of authorised suppliers of active biocidal substances.  These suppliers are listed in the European Chemicals Agency (ECHA) database.  The HSE recommends manufacturers of hand sanitisers to continue to source active substances from authorised suppliers.  However, the HSE may temporarily take a pragmatic approach to regulatory requirements that relate to supply chain obligations during the Covid-19 outbreak, as long as the manufacturer ensures that products on the market are effective and do not pose an unacceptable risk to people or the environment.

The HSE has issued the following table as a guide:

Hand Sanitiser containing

WHO formulation available

BPR Article 55 derogation required

Propan-2-ol

Yes

Yes

Propan-1-ol

No

Yes

Ethanol

Yes

No


The HSE has highlighted the fact that biocidal hand sanitisers which are made available in the UK to help protect people during the coronavirus outbreak must be safe and effective.

For more information, please visit the HSE communication linked above.

Twitter

What Twitter is saying...