Special Features - Covid-19: Regulatory issues for hand sanitiser
Anita Lloyd and Nicola Smith, directors in the Environmental, Safety & Health Group of Squire Patton Boggs, look at the key issues for companies starting to manufacture or import hand sanitiser
Many companies are looking at modifying their production lines and/or utilising spare capacity to manufacture hand sanitiser, which is in short supply due to the Covid-19 pandemic. Others may be looking into importing this product into the UK for the first time.
For companies already manufacturing or importing similar products, this may not pose any particular challenges. However, many companies, for example distilleries, breweries and food manufacturers, may not be familiar with the rules and regulations that apply when placing this sort of product on the market. Although some ‘red tape’ has been removed to facilitate production, some regulatory requirements still need to be followed.
Removal of ‘red tape’
Hand sanitisers are usually classified as a biocidal product and so are regulated under the EU Biocidal Products Regulation (528/2012, BPR). This still applies in the UK during the Brexit transition period and will be transposed into UK law at the end of that period. The BPR requires companies that wish to place biocidal products on the EU market to obtain an authorisation from the European Chemical Agency, before they place that product on the market.
The good news in the UK is that the Health & Safety Executive (HSE), the competent authority under the BPR, has already announced a relaxation of the rules for biocidal hand sanitiser products that use propanol as their active ingredient. These products will not need a biocidal product authorisation, provided that they use the relevant World Health Organisation (WHO) ‘specified formulation II’.
The HSE makes it clear, however, that this is not a complete de-regulation. “While this action will enable manufacturers to place hand sanitiser products on the UK market quickly, we still expect them to meet their responsibilities to adhere to the correct standards, which protect the people and the environment from potentially harmful chemical effects,” it says.
Anyone wanting to make use of this derogation must email the HSE to obtain a certificate before placing the product on the market. The HSE has confirmed that the derogation would also apply to products manufactured for internal use. There is also a WHO-specified formulation for hand sanitiser containing ethanol.
Ethanol is not currently an approved active substance under the BPR but is in the review programme and included on the so-called ‘Article 95 list’. Under the BPR’s transitional arrangements, biocidal product authorisations are not currently required to place hand sanitiser products on the UK market. Article 95 also requires that, for both authorised and review programme active substances, suppliers must be included on the Article 95 list, indicating that they have submitted a dossier, have a letter of access or are participating in the review programme.
The HSE has recognised that this is an exceptional situation and that it may be necessary for hand sanitiser manufacturers to find alternative suppliers of raw materials, given that there are a limited number of Article 95 suppliers of propan-2-ol and ethanol. The agency has therefore said that it will adopt a “pragmatic and proportionate approach to regulatory requirements that relate to supply chain obligations during this period”. It will be more concerned about the products being effective and safe than where the active substance was sourced.
The BPR derogation will not apply to sanitisers made to alternative formulations and it should be remembered that any alternative formulation or primary purpose could also mean that hand gels and sanitisers are potentially considered as a cosmetic or a medicinal product, both of which are subject to detailed regulation under other EU legislation. However, it is more likely that a basic alcohol-based hand sanitiser, whose sole purpose is to kill viruses and bacteria on hands, would be regulated as a biocide.
HMRC has also made temporary changes to the use and supply of denatured alcohol and duty-free spirits, to further help businesses who produce hand sanitiser and gel. Other government departments have issued further guidance on specifications for hand disinfectants. This reinforces the need for any specific claims made about the product to be supported by independent laboratory tests to a relevant EN standard.
Where a product does not yet need authorisation under the BPR, it remains the manufacturer’s responsibility to ensure that the products they make available are suitably and sufficiently efficacious, and that any claims they make can be substantiated. British Standard BS EN 14885 outlines standard efficacy testing for hygienic hand-wash products.
The WHO-recommended ethanol formulation has already been tested to EN 1500, which forms part of the BS EN 14885 standard. The HSE derogation for the WHO propan-2-ol formulation is a derogation from the normal requirements for product authorisation under the BPR. The HSE accepts that products successfully notified under this derogation are efficacious in line with WHO testing and it has not requested further testing as part of the derogation notification process.
Organisations like the NHS may also have specific requirements for hand sanitiser products which are intended to be used in the health care system. The HSE cannot offer advice on, or interpretation of, standards set by bodies such as the NHS or the Department for Health & Social Care (DHSC).
Despite the relaxations outlined above, companies will still need to be aware of, and comply with the following, where applicable:
* The EU Regulation on Classification, Labelling & Packaging of Substances & Mixtures (1272/2008), particularly in relation to labelling and warnings for any sanitiser products manufactured in, or imported into, the EU
* Claims that can be made about the efficacy of the product – as these need to be backed up by robust and independent data, and can affect how the product is classified (for example, specific claims about preventing the Covid-19 virus may lead the product to be classed as a medicinal product)
* The EU REACH Regulation (1907/2006), which is of more limited applicability to biocides, particularly regarding registration, but for example safety data sheets will still be required when hand sanitisers are supplied to business users (and on request to consumers)
Squire Patton Boggs