SGS is offering a range of solutions to help manufacturers produce safe, effective, and compliant hand sanitisers.
After handwashing, using hand sanitsers is one of the best ways to ensure SARS-CoV-2, the virus that spreads COVID-19, is rendered harmless. Most hand sanitisers are alcohol-based, often using ethanol or isopropanol. To be effective they must be a minimum of 60% alcohol by volume, although many commercial brands contain between 60% and 80% alcohol by volume.
A basic hand sanitiser will also often contain glycerol (prevents dry skin), hydrogen peroxide (inactivates contaminating bacterial spores) and distilled water. In addition, commercially available hand sanitisers can also contain antiseptics, such as chlorhexidine or quaternary ammonium derivatives, and non-essential ingredients such as foaming agents, colorants and/or fragrances.
COVID-19 meant hand sanitiser supplies around the world were quickly exhausted. In response, a variety of manufacturers, including distillers and automotive industry suppliers, began manufacturing the product, although regulations in some areas did not actually allow it. To address this, several authorities eased their regulations.
In the US, either the Environmental Protection Agency (EPA) or the Food and Drug Administration (FDA) regulate antimicrobial products:
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EPA – antimicrobial products used on surfaces because they are identified as pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). They require product-specific approval by way of a ‘registration’ of antimicrobial products and sources of active ingredients. Efficacy against public health pathogens must be demonstrated using specified EPA-approved studies
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FDA – antimicrobial products used on humans or animals, regulated as over the counter (OTC) drugs under the Federal Food Drug and Cosmetics Act (FFDCA). The FDA typically determines whether the active ingredients used in OTC drugs are Generally Recognized as Safe and Effective (GRASE) through its monograph program. Under this, consumer antiseptic hand rub products can use ethyl alcohol, isopropyl alcohol or benzalkonium chloride
The EPA already had a policy that allowed manufacturers to make claims against emerging viral pathogens, provided the product met set efficacy tests. So, although registrants and sellers on the EPA’s list cannot make specific claims in relation to COVID-19, they can state they are on this list. Therefore, in effect, they are demonstrating the EPA considers this product to be effective against SARS-CoV-2 and COVID-19.
The EPA and FDA have both taken steps to help reduce the shortage in hand sanitisers. For example, the EPA has eased the reporting requirements on 280 inactive disinfectant ingredients and the FDA has relaxed certain restrictions. They have also announced that they will not enforce actions against firms preparing alcohol-based hand sanitisers for consumer and public health use until such a time that the emergency is lifted. In addition, they will not take action against compounders, so long as they use ingredients of United States Pharmacopoeia (USP) grade and utilize a formulation that is consistent with WHO guidance.
Hand sanitisers are covered by Regulation (EU) 528/2012 – the Biocidal Products Regulations (BPR) – the European Union (EU). Under Article 55 for the BPR, Member States are allowed to set aside the standard BPR authorisation requirements in the event of a public health emergency. A national derogation can be announced by a competent authority (CA) for a period of up to 180 days, which may be extended. Several EU countries have adopted derogation. Stakeholders should recognise that hand sanitiser products manufactured outside of the EU are still subject to the requirements of the BPR.
During the COVID-19 pandemic regulatory authorities have relaxed certain regulations to ensure a steady supply of hand sanitisers. As the situation develops, it can be imagined these will develop further. It is therefore important for manufacturers to ensure they are compliant with up to date regulatory information.
Utilising a global network of experts and laboratories, SGS provides a comprehensive testing and registration service to help hand sanitizer manufacturers ensure their products remain compliant with current market regulations
