Written evidence submitted by the Safer Disinfectant Network
The Safer Disinfectant Network is pleased to submit written evidence for the OPSS’s consideration.
The Covid-19 pandemic has seen an exponential expansion of the infection prevention and control market, with the introduction of many new hand hygiene and surface cleaning and disinfection products. This has been in response to public demand and public health guidance that has rightly emphasised the importance of regularly cleaning and sanitising one’s hands and the regular cleaning and disinfection of high touch surfaces and objects to reduce the risk of transmission of Covid-19.
However, this market expansion has highlighted the existing lack of regulation for cleaning and disinfectant products in the UK, certainly compared to the regimes of other countries. A lack of requirements and enforcement on products in the UK market mean it is possible for products to make inaccurate or misleading claims as to their efficacy on packaging, labelling, and marketing materials.
Whilst procurement for the NHS requires demonstrations of product efficacy, this lack of regulation and enforcement means many other end-users – particularly consumers – are at risk of purchasing products that do not provide the level of protection they claim against a range of viruses and pathogens. At best this means consumers could be spending money on ineffective products; at worst, that they could be at higher risk from viruses and pathogens.
About the Safer Disinfectant Network
The SDN is a collaboration of infection prevention and control experts and manufacturers, with its members including leading academics and experienced professionals who have supported and provided to the NHS throughout the pandemic.
Members of the SDN are committed to promoting best practice and ensuring public safety by encouraging high standards of effectiveness within disinfectant products, based on rigorous testing and independent clinical evidence, and clarity on claims of product efficacy.
Members include Gama Healthcare, Ecolab, Diversey, PDI Healthcare, Ecohydra, Lifeclean and the Infection Prevention Society.
A lack of existing regulation on hand sanitiser and surface disinfectant products is arguably unsuccessful in influencing consumer and business behaviour, not in mitigating potential risks with products.
The reason for this is that the UK has minimal regulatory and enforcement regimes on such products compared to other countries, such as the United States, Australia, and the Republic of Ireland. Details of the regimes in these countries are set out in Appendix A of this document.
As outlined above, a consequence of the Covid-19 pandemic has an exponential increase in demand for hand sanitiser products and surface disinfectants. This has been driven by public health guidance, greater consumer awareness of the importance of hand hygiene and the regular and thorough cleaning and disinfection of high-touch surfaces and objects. This has in turn has led to an influx of new products in the UK market, and whilst many will conform to best practice, many others will not have been subject to appropriate testing in an accredited laboratory to verify the efficacy claims made on the packaging and in marketing materials.
This means it is possible for products to make claims such as ‘killing 99 percent of bacteria’ or ‘protecting against Coronavirus for 30 days,’ without these being proven through laboratory testing. It is worth noting that suppliers of hand sanitisers are not allowed to make pathogen-specific claims in their advertising unless they are regulated as medicinal rather than biocidal products. The MHRA is clamping down on biocidal products making such claims, which appears to be activity specific to the UK – however, as this rule does not apply to surface disinfectants, manufacturers producing both hand sanitisers and surface disinfectants can and have listed a raft of pathogen-specific test results on product and company website, without stating whether these apply to the sanitiser or the disinfectant products.
Inevitably, price point is a determining factor for many consumers and end-users, unless there is high degree of product knowledge or a formal procurement process in place (as is the case with NHS Supply Chain) that requires efficacy claims to be proven.
This means consumers are exposed to products that may not provide the level of protection they claim, increasing the risk of virus or pathogen transmission. In some cases, products may even have an undisclosed corrosion effect as a consequence of their formulation (e.g., they are highly alkaline), which can cause damage to equipment and surfaces, incurring greater cost for end-users.
It is questionable as to whether the OPSS and Trading Standards are equipped to identify and address issues in the case of hand hygiene and surface disinfectant products.
This is again caused by the lack of robust regulation of products in the UK, certainly when compared to the regimes of other countries. Whilst products that might have a corrosive effect could be detected and reported, the lack of requirement for products to prove their efficacy claims means they may not provide the level of protection they claim against viruses and pathogens. This can leave end-users at greater risk of virus/pathogen transmission, which would be unbeknownst to them.
The lack of a regulatory framework and by consequence enforcement in the UK market – certainly compared to those of other countries – makes it difficult to adapt to the challenges in the infection prevention and control market, i.e., how to ensure products deliver the levels of efficacy they claim.
The regimes in the US, Australia, and Ireland (set out in Appendix 1) provide helpful comparisons. The adoption of the requirement for products to substantiate their efficacy claims through appropriate testing in an appropriate laboratory would help prevent scenarios in which consumers are spending money on and using ineffective products.
For further information, please contact the Safer Disinfectant Network via firstname.lastname@example.org.
Appendix 1: Infection prevention and control product regulatory regimes in overseas markets
CASE STUDY: UNITED STATES
The EPA reviews and registers antimicrobial pesticides, which include disinfectants for use on pathogens like SARS-CoV-2. In the US, robust compliance programs are in place, with the Retail Industry Leaders Association (RILA) working closely with trusted suppliers to ensure that all products that they sell meet or exceed all applicable U.S. safety standards and legal requirements. The EPA also coordinates with the U.S. Department of Justice and other federal partners to enforce by law against those selling fraudulent or unregistered products.
In response to COVID-19, in March of 2020 the EPA introduced ‘List N’ as a way of navigating the marketing claims of various disinfectant manufacturers. The EPA expects all products on List N to kill the coronavirus SARS-CoV-2 (COVID-19) when used correctly in accordance to label direction.
CASE STUDY: AUSTRALIA
The Therapeutic Goods Administration is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health, the TGA regulates the quality, supply, and advertising of disinfectant products. Claims that a disinfectant has an effect against any virus must be expressly permitted by the TGA before being used in consumer advertising (including on the label).
In response to the COVID-19 pandemic, the TGA permitted SARS-CoV-2 and COVID-19 virus claims. However, developed a list that comprised of disinfectant products that have been entered into the Australian Register of Therapeutic Goods (ARTG) with specific claims against SARS-Cov-2 (COVID-19) or COVID-19 on the product label.
CASE STUDY: IRELAND
The Pesticide Control Division (PCD) of the Department of Agriculture, Food and the Marine (DAFM) is the competent authority for biocidal products in Ireland. Human hygiene biocidal products such as hand sanitisers and other disinfectants for general use and for food and feed area use must be registered with DAFM prior to making available on the market in Ireland. Only biocidal products listed on the DAFM biocide registers are legal to market and use in Ireland.