HAND SANITISER REGULATORY
But, similar to the European Union, manufacturers are given a certain element of trust to ensure products that are being brought to market are safe for consumers, and due to the nature of the coronavirus pandemic, the FDA is restricted in its ability to carry out regular checks that would need to be carried out in a non-Covid world. This includes site visits to 3,500 newly-registered companies that are now producing hand sanitiser in the US. The governing body also reminded consumers that no hand sanitiser is FDA-approved, despite many claiming to have received the fictitious certification.
“So, we’re allowing certain entities who usually aren’t and
“Authorisation is only required once the biocidal active substance in their formulation has completed a review for its safety under the Biocidal Product Regulation,” the HSE tells Cosmetics Business. “Some common biocidal active substances, such as ethanol, are undergoing that formal review process, so products based on these actives do not yet require authorisation.”
In the US, regulations on hand sanitisers differ somewhat. “It is the responsibility of firms that manufacture OTC [over the counter] drug products, such as hand sanitiser, to comply with all requirements and to ensure that their products do not violate the provisions of the Federal Food, Drug and Cosmetic Act and FDA regulations,” a spokesperson from the country’s Food and Drug Administration tells Cosmetics Business.
In contrast to the European Union, all hand sanitisers are classed as drugs. Therefore, in order to produce a biocidal hand
haven’t registered as drug manufacturers to step in and make these products, as long as they imply and follow the requirements that we’ve put out in our guidance. But if they do deviate from the guidance they’re subject to enforcement actions from the agency,” the FDA adds. Predictably, the result is more than 200 sanitisers registered on the FDA’s website as unfit for public use.
COMPANIES CAUGHT OUT
“Some bottles were tested and turned out to have 3% alcohol – that’s not even effective
sanitiser during the pandemic manufacturers must either follow the FDA’s temporary policies for producing alcohol- based hand sanitisers, follow the OTC monograph or submit a New Drug Application for approval.
“The monograph lays out four ingredients that should be used in order to create hand sanitiser that’s acceptable and won’t come under enforcement judgement from the FDA,” the spokesperson adds.
“Under the temporary policies, the formula includes either alcohol; ethanol [formulated to 80%, volume/volume] in an aqueous solution; or isopropyl alcohol, formulated to 75%, v/v, in an aqueous solution. Under the applicable OTC antiseptic monograph, the permitted concentrations of alcohol are 60-95% by volume in an aqueous solution, and the permitted concentrations of isopropyl alcohol are 70- 91.3% by volume in an aqueous solution.” To begin production, companies must also register their products in the FDA Drug Registration and Listing System. Upon listing, companies receive automatic confirmation from the FDA and “do not need to wait for further communication from FDA before the firm can begin to distribute these products”.
cosmeticsbusiness.com
Among those named by the FDA was Mexican-based cosmetics company AAA Cosmética. Once again coming up was the toxic ingredient methyl alcohol, or methanol. More than 20 batches of the company’s Advance Hand Sanitiser were reported to contain the toxic ingredient, which is commonly used for industrial purposes including, but not limited to, solvents and antifreeze, and which can cause damage to consumers’ optic nerves if ingested. “With methanol it can be that people have used it as a direct ingredient or sometimes, more worryingly, it can be listed as a trace ingredient within raw materials, just because of the way that you produce ethanol,” says Becky White, Baylis & Harding’s Global Head of Product and leader in formulating the brand’s hand sanitiser products. “It can cause headaches and potentially blurred vision, because if it’s absorbed through your skin and then travels through the blood it can have an affect on the optic nerve. “Obviously it’s not quite as quick as it would be if you ingested it and depends on the person’s skin type. So, if a product with methanol was applied to a child’s skin, their skin’s a bit more porous, so it can have disastrous effects if a child were to use a hand sanitiser containing methanol.” AAA Cosmética did not respond to Cosmetics Business’ questions on how methanol was found in its supply chain. Only time will tell if the regulations will be able to catch up with the exponential increase in hand sanitiser production, but Mintel’s Associate Director of Beauty & Personal Care, Alex Fisher, believes the trend, particularly among beauty brands, is showing no signs of slowing down. “Over the last couple of months, more and more brands are thinking about how they can not just capitalise on the market, but about how hand sanitisers and soaps are going to become a bit more of a mainstay in people’s routines – so how they can maybe incorporate something like that into their wider portfolio, within beauty especially.” Few categories have emerged unscathed by the pandemic. But Fisher believes, in an unknowing way, Covid-19 has given hand soap the revival it was in need of. “This is sort of the moment that liquid soaps and that market has been waiting for: an innovation boom.” Again, the question remains: at what cost?
December 2020 51
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