Regulators are seeing an increase in illegal disinfectant products entering the market, as soaring demand during the Covid-19 pandemic has led to legal exemptions for hand and surface sanitisers.
In Europe, individual countries are keeping an eye on products coming in under exemptions from the EU biocidal products Regulation (BPR), which do away with standard authorisation requirements for some products during a public health emergency.
Last month, the Swedish chemicals agency (Kemi) received more complaints than usual about illegal disinfectants. Some products contained biocidal substances that do not have BPR approval, Kemi said.
Sweden is one of the few European countries that have exempted disinfectants from the condition of being sourced from a supplier on the Article 95 list (see box). And, like others, it is allowing products containing certain active substances market access, without prior approval.
Although Kemi said it is not concerned that these derogations will be misused, the agency worries that companies "with minor knowledge are starting to produce or import products, which they might not have done enough to guarantee are safe and efficient," a spokesperson said.
"There might also be fraudulent products and companies that are taking advantage of the situation," he added.
The Danish EPA has noticed a "general rise in reports from the public of suspected non-compliant hand disinfectants." There are more products entering the market that are not based on alcohol, and their effectiveness against the virus "has not yet been documented" in the same way, the authority said.
Estonia’s national authority for biocides, the Health Board, said it is "of course concerned" about the misuse of the loosened rules.
Here, inspectors have seen an increase in non-compliant hand sanitisers. Problems include false registration numbers, false efficacy claims and illegal advertising. The Health Board reasons that there are many newcomers on the market "who are still not completely aware of all the requirements."
Estonia has issued legal exemptions for disinfectants containing ethanol and propan-2-ol. They will only be in place until 1 May and "do not mean that we are surrendering the quality of the products. The products still need to comply with BPR," the authority’s department of chemical safety said.
The Health Board is still carrying out inspections although most of these are looking at documentation only, because shops are closed and sales have moved online.
Meanwhile, Kemi said it does not exclude physical site inspections where it suspects a product is unsafe.
Whether the majority of products on the market are sufficiently effective against the coronavirus remains to be seen, the agency added: "The inspections have just started, so we do not know the outcome yet."
The disinfectants industry still welcomes the exemptions in place. European soaps and detergents trade body, Aise said it is "absolutely against any free-riders or false claims" and "deplores the fact" that some companies outside of the association’s network are not abiding by the legislation. But the organisation added that rogue companies have always marketed products with false claims.
A similar narrative comes from the US. The Household & Commercial Products Association (HCPA) said counterfeit disinfectants have been an issue for the industry for years and the problem is not necessarily exacerbated by the regulators giving disinfectants easier market access.
Rather, the pandemic has "highlighted that there is a problem with people making claims that are unsubstantiated and illegal," said Owen Caine, HCPA’s executive vice president of government relations and public policy.
The trade body has been lobbying for tougher rules on e-commerce, which Mr Caine said is the main culprit behind counterfeit disinfectants.
The US EPA has noted learning "through tips, complaints, and research" about imposter disinfectants on the US market: products that falsely claim to be effective against the coronavirus.
The agency has expedited product claim reviews and eased reporting requirements for some disinfectants, as part of efforts to increase the availability of products to fight Covid-19.
It is now teaming up with retailers to crack down on products making false claims. Following a discussion with US retailers and third-party marketplace platforms, including Amazon and eBay, EPA administrator Andrew Wheeler said they will, together, "work diligently to ensure that consumers have access to EPA-approved and verified surface disinfectant products; products that we know to be effective against the novel coronavirus."
The agency records effective products on its List N: Disinfectants for Use Against Covid-19.
Background to the BPR
Article 55 derogations
Article 55 of the BPR allows member states to put aside the standard BPR authorisation requirements in public health emergency situations. A national competent authority notifies the derogation they have applied in their territory to the European Commission. These derogations are temporary and last for a maximum of 180 days, but may be extended, on request, for a further 550 days by the Commission.
As it stands, several EU member states and the UK have made use of this mechanism to make more disinfectants available to fight Covid-19. Some derogations permit the production and marketing of disinfectants following generic WHO formulations while others specifically identify certain products.
Article 95 list
The Article 95 list is a register of companies that have been approved as suppliers of specific biocidal active substances, for use in specific product-types. Article 95 of the EU BPR says that a biocidal product "shall not be made available on the market" if the product or active supplier isn't included in the Article 95 list.
Some member states, such as Sweden and Denmark, have temporarily excluded the suppliers of certain disinfectant ingredients from this requirement.
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