UK – Derogation to the BPR for hand sanitisers
With the on-going public health crisis that has arisen from the Covid-19 pandemic, the availability of hand sanitisers is playing an important role in fighting the spread of the disease. With the huge increase in demand that is now being witnessed for hand sanitizers, it has rarely been more important to ensure that such products can be readily brought to market to help prevent supply shortages.
As a means of improving the availability of hand sanitisers on the UK market, the Health and Safety Executive (HSE) has utilised Article 55 of the Biocidal Products Regulation (BPR) which enables them to make short term derogations to the requirements for product authorisations in situations of public health emergencies.
Under this derogation, propan-2-ol hand sanitisers do not require authorisation according to the BPR in order to be placed on the UK market. A derogation certificate can be obtained for these products from HSE, on the condition that they meet the WHO formulation requirements.
Similarly, Article 55 derogations may be possible for hand sanitisers containing propan-1-ol. However,
as there is no WHO formulation specification in this case, applicants will be required to submit more information to determine associated risks and efficacy.
Currently, hand sanitiser products containing ethanol do not require product authorisations under the BPR transitional arrangements. This is on the condition that they meet the WHO formulation requirements and comply with classification and labelling legislation.