Unravelling the complexity of regionspecific antiviral regulations

Microban® International

Antiviral technologies have become more prevalent and have seen heightened interest and use in manufacturing sectors, particularly in response to the global COVID-19 pandemic. Consumers in some parts of the world are benefiting from the additional peace of mind afforded by built-in antiviral technologies that can reduce viral loads on the surfaces of treated products. However, compliant antiviral claims vary according to the region where those products are marketed and sold. This can result in widespread misunderstandings, and even inaccurate or noncompliant information, being displayed on goods. This article describes how antivirals may be used in different territories, and why there are regional differences between the regulations and acceptable claims sets for these products.

The use of biocides is regulated by national and regional legislation, to ensure that biocidal products are assessed to show that they can be used safely and effectively in their intended applications. If safe use cannot be demonstrated, it is likely that restrictions or prohibitions will result, not only for the active substances, but also for any biocidal products or treated articles containing those actives. This obviously limits the selection of antimicrobial products available, since re-evaluations of existing chemistries can result in restrictions on the substances that can be incorporated into finished goods. The situation becomes even more complex when these regulations need to be applied to built-in antimicrobial additives that possess antiviral functionality. Each region has its own specific regulatory requirements – there is no one-size-fits-all approach for managing these additives internationally – making global product alignment challenging. Manufacturers must be careful to avoid making non-compliant antiviral product claims, as this can have serious repercussions, including fines and product recalls. It is vital therefore that businesses have a thorough understanding of the regulatory landscape as it relates to their products.

Negotiating the validation pathway

The way in which antimicrobial substances are evaluated varies depending on the specific regulatory jurisdiction involved. The EU favours a hazard-based approach, with restrictions centered around the substances’ hazard potential, whereas the US applies a more risk-based approach, taking into consideration exposure potential as well as the overall ingredient hazard when assessing chemicals and biocides. Whatever the geographical location, manufacturers of products bearing antiviral claims must demonstrate effective control over specific target viruses – such as influenza, norovirus or SARS-CoV-2 –since broad statements of efficacy against viruses in general can be inaccurate and misleading. Some jurisdictions specify that products bearing antiviral claims require product registration in the region of sale, supported by third-party testing by an independent laboratory to validate any such claims. Often, this is accompanied by a parallel requirement to demonstrate efficacy against bacteria and fungi. If these cannot be shown to the satisfaction of the regulatory body, goods may be prohibited from sale, with the associated risk of enforcement action being taken against producers or importers that elect to market these products without appropriate supporting data.

Antiviral or antimicrobial active substances and products fall under the jurisdiction of the Biocidal Products Regulation (BPR) in Europe, and under the jurisdiction of either the Environmental Protection Agency (EPA) or the Food and Drug Administration (FDA) in the United States, depending on the substance and the specific claims being made. To be sold or distributed legally, antiviral substances must be compliant with the regulations in the country of sale. However, the global pandemic has resulted in regulatory enforcement branches reporting numerous labelling and advertising violations relating to the sale of products with unsupported or non-compliant antiviral claims. The consequence of this is likely to be stricter enforcement measures, to reduce the incidence of unproven and inaccurate labelling on products currently available in different territories around the world.

Are

health claims permitted?

Antimicrobial products typically incorporate both antibacterial and antifungal technologies. These work to inhibit the growth and reproduction of bacteria, mould and mildew, helping to prevent product degradation, malodours and unsightly staining. Antiviral technologies, on the other hand, work to inactivate virus particles, helping to reduce viral loads on treated surfaces. In the US, manufacturers can discuss the efficacy of antimicrobials in treated articles with respect to mould and bacteria, as well as how antimicrobial additives help to preserve product life and generally improve aesthetics, but any claims relating to public health require appropriate product registrations. This includes the labelling and promotion of antiviral products and treated articles, since efficacy against viruses is considered a public health claim in the US; any treated product labelled as an antiviral must be registered either as a pesticide, a medical device or a drug. The challenge for manufacturers is that the registration processes required for this are lengthy and resource intensive. As a result, many businesses choose to avoid developing products of this type altogether.

Looking forwards

The management of antiviral and antimicrobial technologies, as well as their associated claims, presents a challenge for manufacturers and importers. The approvals processes for new chemistries can involve significant effort from cross-functional groups across a business, and the best approach is to consider each product on a case-by-case basis. This is where companies like Microban International can help, using its in-depth knowledge of antimicrobial and antiviral additives to help manufacturers navigate the global regulatory framework. Looking to the future, the aim should be to support this regulation and registration process with increased consumer and partner education, improving communication while, at the same time, encouraging regulatory reform and standardisation across the industries and territories.