ECJ EUROPEAN Cleaning Journal

There is increasing attention surrounding antiviral technologies. In some jurisdictions, they can be incorporated into products and onto surfaces to reduce viral loads, helping to give consumers peace of mind.

However, permissible antiviral claims depend hugely on where the products are marketed and sold, which can lead to widespread misunderstanding and, in some cases, inaccurate information being displayed on goods. Tara Conley, director of global regulatory affairs at Microban International, tells us more.

There is increasing attention in manufacturing circles surrounding antiviral technologies, particularly as we continue to see impacts from the multi-wave global pandemic. In some jurisdictions, antiviral technologies can be incorporated into products and onto surfaces to reduce viral loads, helping to give consumers peace of mind.

However, permissible antiviral claims depend hugely on where the products are marketed and sold, which can lead to widespread misunderstanding and, in some cases, inaccurate information being displayed on goods.

Tara Conley, director of global regulatory affairs at Microban International is an expert in this field. She paves a clearer path through the regulatory maze in this exclusive piece for ECJ, discussing the use of antivirals in different territories and describing why the regulations and acceptable declarations for these products differ from region to region.

Complex regulatory landscape

Biocides are subject to global regulatory requirements which must be met in order to establish their safe and effective use in the market. Failure to demonstrate safe use can result in restrictions or prohibitions that can subsequently limit the selection of antimicrobial products available, what they can be used for and the potential integration of these chemistries into finished goods.

Applying these regulations to built-in antiviral substances can be even more complicated and, unfortunately, there is no one-size-fits-all approach for managing these additives internationally; each territory can have its own specific regulatory requirements, making global product alignment challenging. Enforcement of the rules surrounding non-compliant antiviral product claims can result in serious repercussions for manufacturers, including fines or product recalls. Therefore businesses have a significant vested interest in ensuring they have a thorough understanding of the regulatory landscape as it pertains to their products.

Navigating product validation

Different regulatory jurisdictions take independent approaches to substance evaluation. In the EU, for example, a hazard-based approach is used, where substances can be subject to restrictions based solely on their potential as a hazard. The US, by contrast, implements a more risk-based approach, taking into consideration exposure, as well as overall ingredient hazard, in their assessment of chemicals and biocides.

However, regardless of geographical location, manufacturers of antiviral products must still demonstrate effective control over specific target organisms – such as influenza, norovirus or SARS-CoV-2 – since broad statements of efficacy against viruses in general can be inaccurate and misleading. In some territories, antiviral treatments and claims may only be applied to a treated item once it has been registered as an antiviral product with the applicable regulatory agencies, and the results of testing have been validated by a third-party independent laboratory.

In many cases, there is a parallel requirement to also demonstrate efficacy against bacteria and fungi in order to support product registrations. Without sufficient proof of functionality, goods may be prevented from being sold on the market, and producers or importers could be at risk of enforcement action.

In Europe, antiviral or antimicrobial active substances and products fall under the jurisdiction of the Biocidal Products Regulation (BPR). In the US, such products may be under the jurisdiction of the Environmental Protection Agency (EPA) or the Food and Drug Administration (FDA), depending on the substance and the specific claims being made.

Only antiviral substances that are compliant with the governing bodies in their countries of sale may be sold or distributed legally, yet regulatory enforcement branches have flagged numerous labelling and advertising violations over the last two years of the global pandemic, where products with unsupported or non-compliant antiviral claims were offered for sale. As a result, stricter monitoring and prosecution measures can be expected going forward, in order to reduce the prevalence of unproven and inaccurate labelling on products currently available in different territories around the world.

Wading through health claims

Antimicrobial products typically capture both antibacterial and antifungal technologies, which work to inhibit the growth and reproduction of bacteria, mould and mildew – helping to prevent product degradation, malodours and unsightly staining – whereas antiviral technologies can reduce viral loads on treated surfaces by inactivating viral particles.

In the US, manufacturers can speak about the efficacy of antimicrobials in treated articles, with respect to mould and bacteria, and how antimicrobial additives help to preserve product life and generally improve aesthetics, but products may not bear health claims without appropriate product registrations. The labelling and promotion of antiviral articles is considered a public health claim and, as such, any treated product labelled as an antiviral must be registered either as a pesticide, or as a medical device or drug.

Unfortunately, in most cases, the registration processes involved with this are multi-year and resource-intensive projects, meaning that many businesses simply steer well clear of these projects altogether.

A roadmap for the future

The management of antiviral and antimicrobial chemicals can be a challenging landscape for manufacturers and importers to navigate. Products are best considered on a case-by-case basis, and the approvals processes for new chemistries can involve significant effort from cross-functional groups across a business.

Fortunately, the regulatory team at Microban International possesses a vast wealth of detailed knowledge on antimicrobial and antiviral additives, and is able to use that insight to provide high quality support to its numerous partners across the globe. Microban is now expanding its focus to include more consumer and partner education, with the aim of improving communication and advocating for regulatory reform and standardisation across the industry.

www.microban.com