The regulation of nano/biocide-treated articles is not keeping up with the development of new products and falls short on ensuring safety.
At a time of increased public health awareness, it is important to provide clarity on the use and regulation of nano/biocide-treated articles and their safety and impact on human health and the environment. Health Care Without Harm (HCWH) Europe, along with 12 other health, environment, and justice organisations, wrote to the European Chemicals Agency (ECHA) seeking clarifications on both the applicable legal framework, and risk management measures in place for such products.
Today on the EU market you can find products such as face masks treated with silver, zinc oxide, or copper nanoparticles, “anticovid” paper containing nanostructured zinc-silver, or nanosilver-containing surface disinfectants - the list goes on. Demand is growing for antimicrobial and antiviral nanocoatings, and the global nano-colloidal silver market is expected to rise at a significant rate between now and 2025 due to “pandemic protection accelerating investment in nanotechnology”.
In their public response (available here) ECHA confirmed that even if treated articles/products contain biocides (therefore potentially harmful substances), we have to trust that the manufacturers will only use approved active substances or substances covered by the Biocides Review Programme. ECHA also indicated that we must trust manufacturers to follow the Biocidal Products Regulation (BPR) labelling requirements. Yet the 2019 BEF-1 report (report of the first harmonised enforcement project on treated articles) reveals that these labels provided inadequate information in 36% of cases, and that basic information was often missing. We therefore have reason to suspect that a number of the nano/biocide-treated articles that are increasingly coming on the market since the COVID-19 pandemic are in fact not compliant with labelling requirements under the BPR.
Whilst there are a number of good measures in place to ensure that biocidal products are fit for purpose, following ECHA’s response, we believe that further measures are necessary to ensure that biocide treatment of an article is fit for purpose. This should be done according to recognised and harmonised test criteria appropriate to products’ purpose and use conditions. The efficacy of biocidal treatment in products cannot be “assumed” based on the known efficacy/general biocidal properties of the active substance alone - we need proof that treated products can provide a sufficient effect on one or several target organism groups.
It appears that as long as treated articles do not require authorisation - a process that ensures safety and efficacy and is supervised by the competent authorities - we have no way of verifying what manufacturers are “promising”.
We welcome the decision that a facemask claiming to “protect against viruses and bacteria” should be regarded as a biocidal product, however, we would emphasise that consumer protection should not be determined so heavily by the language used by manufacturers (which is easy to change), but rather on the function(s) that the product actually fulfils.
ECHA’s reply has also emphasised that determining if a treated product is a biocidal product (which requires an authorisation) or a treated article is not always straightforward and in fact requires a case-by-case assessment of the specific product. This also requires additional effort and capacity from authorities to address these cases, the number of which is growing considerably. Until 2011, these case-by-case decisions were actually published, and we would very much encourage ECHA (or the European Commission) to restart a similar procedure under the BPR, ensuring that decisions are transparent and understandable, help to harmonise decisions within the EU, and support authorities’ products surveillance.
We welcome the decision that a facemask claiming to “protect against viruses and bacteria” should be regarded as a biocidal product, however, we would emphasise that consumer protection should not be determined so heavily by the language used by manufacturers (which is easy to change), but rather on the function(s) that the product actually fulfils.
We also must emphasise the responsibility of decision-makers in the EU, as well as producers and retailers, to keep the use of biocides in consumer products to a minimum. The fundamental question is, how helpful is treating surfaces with biocides in the fight against microorganisms? Currently, there is no sufficient evidence that the presence of antimicrobial agents in clothing, furniture, or plastic adds any value to routine cleaning and disinfection.
During the current COVID-19 pandemic, antimicrobial impregnated products are increasingly being offered up as an added tool to reduce the burden of Coronaviruses – companies are not only offering these products to hospitals, but direct to consumers as well. Again, the purported specific advantage of biocide treatment is frequently questionable.
After a period of initial great uncertainty and one year into the pandemic, the evidence is now clear that Coronavirus is transmitted predominantly through the air and there has been too much focus on surfaces. Catching COVID-19 from contact with clothing, furniture, paper/plastic packaging cannot be excluded, but it is much less likely than from direct inhalation, according to more and more experts. At the same time, the World Health Organization (WHO) highlights the serious risks of excessive biocide use when tackling antimicrobial resistance during the COVID-19 pandemic.
Common sense suggests that a more balanced perspective is needed to curb excessive use of biocides these days. The paradox in the current pandemic is that in fighting against one virus, we can actually harm people’s health and environment through repetitive exposure to harmful chemicals, and accelerate resistant “superbugs”.
We advise that healthcare providers demand detailed evidence from suppliers on the effectiveness of antimicrobial products before making any purchasing decisions; they should also consider whether these products carry any associated risks that can outweigh any of the claimed benefits for patient and staff safety.
Whilst we appreciate the transparent and open response from ECHA, our concerns remain unchanged: the current situation requires regulatory oversight to keep pace with “innovations”, ensuring that they are safe and effective. We strongly encourage ECHA, the European Commission, and EU Member States to address the emerging topic of nano/biocide-treated articles used in COVID-19 context, and to bring forward guidance for resistance assessment of antibacterial biocidal products.
We advise that healthcare providers demand detailed evidence from suppliers on the effectiveness of antimicrobial products before making any purchasing decisions; they should also consider whether these products carry any associated risks that can outweigh any of the claimed benefits for patient and staff safety.
Read more about benefits and risks of treating articles with (nano)biocides in our article for The European Union Observatory for Nanomaterials - Nanosilver in healthcare – does the silver bullet exist?