MANUFACTURE AND SUPPLY OF BIOCIDAL HAND SANITISER PRODUCTS DURING THE OUTBREAK: coronavirus (COVID-19)
Some of the UK’s existing manufacturers of biocidal hand sanitiser products have reported that they are 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 outbreak.
In response HSE has taken the following steps.
* DEROGATION 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), will not be required to obtain a product authorisation if they meet the relevant WHO-specified formulation II (PDF)- Portable Document Format.
Manufacturers wishing to place products that meet the WHO specified formulation onto the UK Market must contact HSE via email@example.com 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 and once provided, issue a derogation certificate.
Products should not be placed on the market until HSE has confirmed that the derogation applies to you and issued you with the certificate.
* HAND SANITISERS CONTAINING Propan-1-ol OR Ethanol
WHO does not specify a formulation for hand sanitisers containing propanol-1-ol. Therefore, although Article 55 derogations may be possible for hand sanitisers containing propan-1-ol, these will require more information from applicants to enable HSE to determine their efficacy and the risks associated with their use. Such applications will take longer to process than those for hand sanitisers containing propan-2-ol.
There is a WHO-specified formulation for hand sanitiser containing ethanol(https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf). Under the transition arrangements in the biocidal product regulations manufacturers do not require product authorisations to place hand sanitiser products containing ethanol on to the UK Market.
* 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.
Article 95 requires suppliers of active substances for use in biocidal products to have obtained a letter of access to an active substance dossier, to have submitted their own dossier to the European Chemicals Agency, or to be a participant in the European Commission’s on-going review programme of active substances.
There are currently 44 companies recognised under Article 95 for supplying propan-2-ol as a biocidal active substance, including 4 based in the UK. In addition, there are currently 98 companies recognised under Article 95 for supplying the alcohol ethanol as a biocidal active substance, including 7 based in the UK.
The sources are listed on the European Chemical’s Agency’s (ECHA) searchable database: https://echa.europa.eu/information-on-chemicals/active-substance-suppliers
* NON-ARTICLE 95 SUPPLIER’S CHEMICALS FOR USE IN HAND SANITISER
During this exceptional time of increased demand due to the coronavirus outbreak, 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 outbreak. HSE will adopt 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 will be 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 would expect 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.
* ACTIVE SUBSTANCES NOT YET SUBJECT TO AUTHORISATION UNDER THE BIOCIDAL PRODUCTS REGULATIONS
Suppliers of hand disinfectants and sanitisers should bear in mind that where the product is not yet subject to authorisation under the BPR, eg those containing ethanol, any product placed on the market must comply with other relevant legislation on Classification, Labelling and Packaging of substances and Mixtures (CLP) and other general product safety regulations.
Any workplace producing or using or storing ethanol and isopropyl alcohol must also comply with relevant health and safety regulations.
* HAND SANITISERS THAT DON’T CONTAIN ALCOHOL
This guidance relates to alcohol-based hand sanitisers.
Other active substances are available but Public Health England has advised that hand sanitisers should have 60% or higher alcohol content to be effective against the COVID-19 virus.
Further information and advice
* speak to your supplier
* contact firstname.lastname@example.org
* sign up to the biocides e-bulletin: https://www.hse.gov.uk/news/subscribe/index.htm
* visit the HSE Biocides website: https://www.hse.gov.uk/biocides/index.htm