Strong Demand for Anti-Microbial Coatings in Europe

Not surprisingly, in Europe, there has been strong demand for anti-microbial coatings and other products with the coronavirus raising public awareness of the need for hygiene and cleanliness.

After the COVID-19 outbreak hit Europe, sales of disinfectants and sanitizers soared with demand for chemicals like ethanol and propanol soon outstripping supply.

Detergents and alcohol were the substances with the ability to dismantle the lipid matrix enveloping the SARS-CoV-2 virus causing the COVID pandemic.

But any substance able to prevent the spread of the virus within coated surfaces over a long period had to be developed and tested in a lab. Commercialization could take so long that the product would be launched when the threat of COVID-19 had been eliminated or at least considerably reduced.

Some coatings and biocides producers are seeking to create anti-microbial coatings with a broad spectrum of active substances able to attack not only SARS-CoV-2 but other viruses dangerous enough to cause similar future pandemics.

This would be an even bigger R&D challenge because the viruses which could cause future global outbreaks with hundreds of thousands of fatalities have yet to be identified.

The barriers to the creation of effective anti-microbial coatings to prevent the spread of a highly infectious virus-like SARS-CoV-2 from surfaces to humans has been demonstrated in Europe during the
current pandemic.

The European Union’s biocides legislation – the Biocidal Products Regulation (BPR) – is considered to be too rigid and inflexible to provide a regulatory platform for the development and commercialization of protective active substances in anti-microbial coatings at times of pandemics like that of COVID-19. 

“The development of an anti-microbial coating which effectively hampers the spread of the COVID-19 virus by preventing surface-to-human transmission would be a tremendous commercial opportunity,” said Didier Leroy, technical director at CEPE, Brussels. 

“Under the BPR it can now take nine years from the start of the development of an active substance to its authorization. I am not aware of any anti-COVID substance currently going through the BPR approval procedure. The time and money needed for authorization are just not worth it.”

The EU’s regulation of biocides stretches back to 1998 when it approved a biocides directive with regulatory objectives which member states used as a framework for their own biocides legislation.

But the EU soon decided that the directive was not rigorous enough, replacing the legislation with the BPR seven years later. As a regulation rather than a directive, the BPR was incorporated directly into each member state’s laws without alteration, although it did allow countries to introduce their own separate rules where necessary.

Under the BPR, tougher criteria are applied for the authorization of new products, while the approvals of existing products on the market have had to be reviewed. As a result of the strictness of BPR anti-microbial coatings and/or their active substances had to be reformulated or withdrawn from the market altogether. There was also a steep decline in innovations.

On May 1, the EU introduced a concentration limit of 15 parts per million for methylisothiazolinone, a widely used biocidal active ingredient for food and other preservation systems. It triggered a bout of further product withdrawals, particularly since, even with the new lower concentration limit, a mixture with MIT had to carry a warning saying: “Can cause allergic skin reactions.”

During the COVID-19 pandemic, ECHA has been allowing derogations of the BPR rules but only for products whose suppliers have made approval submissions and are waiting for final authorization. They have also to be included in a list of registered suppliers under article 95 of the legislation.

During the 180-day derogation period, anti-microbial actives, including anti-viral ones, which have still not been fully approved, can be marketed in the EU. But member states effectively can veto the decision because the derogation has to be endorsed by each country in which the product is marketed.

“The decision (to grant a derogation) and to check potential (product) requirements is entirely within the competence of the member states and can only be granted for a specific national territory,” an ECHA spokesperson said. “Member state competent authorities are expected to consider the efficacy of the product before granting (derogation).”

National authorities can also extend derogations beyond the 180-day limit. This gives companies an incentive to target their products on specific countries.

“Our anti-microbial product Liquid Guard is under review by ECHA and we assume it will be finished by the end of 2023-24,” said Fabienne Hennessen of the anti-microbial coatings business of Nano-Care Deutschland AG, Saarwellingen, Germany, which has meanwhile opted to focus on individual countries. “So far we have got approval for marketing the product in about eight European countries, including Belgium, Bulgaria, France, Germany, Czech Republic and Slovenia.”

Nano-Care’s Liquid Guard comprises a silica sand nano-coating which forms a glass-type surface over base materials such as plastics, metals and stone. This is covered by an ammonium chloride anti-microbial that kills viruses, bacteria and fungi for up to 12 months.

For companies offering anti-microbial coatings with longer-term protection of at least a few years, ECHA’s derogation facility offers limited opportunities because it is time-limited.

“Few customers will want to commit themselves to an anti-microbial effective over a long period, which has not been fully approved,” said a coatings company executive.

Coatings companies are particularly reluctant to make ambitious claims about the anti-viral capabilities of their anti-microbial products, especially during this pandemic. 

AkzoNobel recently launched an enhanced anti-microbial range of architectural powder coatings developed in partnership with the UK-based anti-microbial technology specialist BioCote. The company highlighted color quality, durability and hygiene. In a press release, it emphasized that the BioCote technology did not protect against disease-causing bacteria, viruses and other harmful microbes. “This technology is not a substitute for good hygiene and/or cleaning practices,” AkzoNobel said.

In a recent blog, BioCote pinpointed difficulties in developing anti-microbials to combat viruses like SARS-CoV-2 which are generally given a high biohazard rating making the strain “unavailable for public commercial testing.”

Even if a sample of the virus could be used for laboratory research this would have to be conducted in an air-flow controlled clean room with staff using high-grade personal protection equipment.

It looks likely that the discovery and initial development work on an active substance for an anti-microbial coating with pandemic protection potential will have to be done by academia. Scientists at Ben Gurion University in Israel are developing coatings with embedded nanoparticles of safe metals such as copper to fight diseases like COVID-19. With the backing of their own technology companies, universities have the resources, particularly in terms of time, to go through the EU’s lengthy approval procedure.