Derogations for the manufacture and supply of biocidal hand sanitizer products in the UK

The United Kingdom’s (UK’s) Health and Safety Executive (HSE) has recently published details of derogations for the manufacture and supply of biocidal hand sanitizer products. Public Health England has advised that hand sanitizers should contain minimum 60% alcohol content to be effective against SARS-CoV-2.

Hand sanitizers containing Propan-2-ol

In accordance with Article 55 (1) of Biocidal Products Regulation (BPR, Regulation (EU) 528/2012), suppliers of biocidal hand sanitizer products containing isopropyl alcohol (IPA) will not be required to obtain authorization if they meet the relevant World Health Organization (WHO)-specified formulation II. Manufacturers that wish to place these products on the market must contact HSE via biocidesenquiries@hse.gov.uk using ‘Propan-2-ol Article 55’ as the subject title of the email. HSE will promptly request details about the products being manufactured and once they are provided, will issue a derogation certificate.

Note that products should not be placed on the market until HSE has confirmed that the derogation applies, and a certificate has been issued.

Hand sanitizers containing Propan-1-ol

Applications for hand sanitizers containing 1-propanol will take longer to process than IPA applications because WHO does not specify a formulation for hand sanitizers containing this ingredient. Article 55 derogations may be possible for hand sanitizers containing propan-1-ol, but more information will be required to assess their efficacy and associated risks.

Hand sanitizers containing Ethanol

There is a WHO-specified formulation I for hand sanitizer containing ethanol. Under the transition arrangements in the BPR, product authorization is not required for manufacturers to place hand sanitizer products containing ethanol on the UK market. Ethanol based hand sanitizers must still comply with Regulation on classification, labelling and packaging of substances and mixtures (CLP, Regulation (EC) No 1272/2008) and other applicable product safety regulations.

Chemical supply rules for biocidal products

According to Article 95 of the BPR, suppliers of active substances used in biocidal products are required:

• to obtain a letter of access to an active substance dossier;
• to have submitted their own dossier to the European Chemicals Agency (ECHA); or
• to be a participant in the European Commission’s ongoing review programme of active substances.

The objective is to ensure suppliers have paid their share of the cost of the active substance evaluation and dossier preparation. The HSE has admitted that during this exceptional time, increased demand may make it necessary for manufacturers to seek alternative suppliers of raw ingredients to supplement the supply chain.

HSE is focused on ensuring that products on the market are effective against SARS-CoV-2 and do not pose an unacceptable risk to humans or the environment. Manufacturers are still expected to take reasonable steps to source active ingredients that are compliant with Article 95. Recognizing the urgent need for safe and effective products, HSE has indicated that inspectors will take a “sensible and proportionate” approach if they come across hand sanitizers that are not strictly in line with BPR Article 95 supply chain requirements.

Manufacturers are encouraged to take care to maintain high standards of safety and efficacy of the products that they make available to the public and professionals.

Click Here to visit the HSE website

Source Links:

https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf

https://www.hse.gov.uk/news/hand-sanitiser-manufacture-supply-coronavirus.htm