The fears surrounding COVID-19 created a global behavioral shift as people began to clean and sanitize their hands more regularly. Washing with soap remains the most effective way of removing SARS-CoV-2, the virus that spreads COVID-19, from your skin.2 However, when handwashing isn’t an option, using a hand sanitizer allows the user to inactivate the virus.3
What is a Hand Sanitizer?
The need for effective hand sanitizers has become a serious problem in many countries. In response, the World Health Organization (WHO) has published a guide for manufacturing hand sanitizer using chemicals that are readily available, even in developing countries.4
Most hand sanitizers are alcohol-based and to be effective they must be a minimum of 60% alcohol by volume. Most commercial hand sanitizers contain between 60% and 80% alcohol by volume. In addition to alcohol, the WHO suggests either ethanol or isopropanol, formulations should include:
- Glycerol – to prevent dry skin
- Hydrogen peroxide – to remove bacterial spores
- Distilled water
Commercially available hand sanitizers may also include additional antiseptics, such as chlorhexidine or quaternary ammonium derivatives, and non-essential ingredients such as foaming agents, colorants and/or fragrances.5
As COVID-19 began to spread, demand for hand sanitizer quickly outstripped supply. To fill the gap, companies as diverse as distillers, parfumiers, and even automotive industry suppliers, began to make hand sanitizer.6
While these companies often had the technology and ingredients to manufacture hand sanitizer, the regulations surrounding the product in some markets did not always allow it. To address this, several authorities eased their regulations.
In the US, antimicrobial products are regulated by either the Environmental Protection Agency (EPA) or the Food and drug Administration (FDA). The EPA is responsible for antimicrobial products that are used on surfaces; 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.
Even before the pandemic, the EPA had a policy that allowed claims against emerging viral pathogens, provided the product met set efficacy tests. Registrants and sellers on the EPA’s list cannot claim on the product’s label that it is effective against COVID-19, but 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.
Antimicrobials for use on humans or animals are regulated by the FDA 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. For consumer antiseptic hand rub products this currently allows the use of:
- Ethyl alcohol
- Isopropyl alcohol
- Benzalkonium chloride
In 2017, the list of eligible active ingredients for healthcare antiseptic products was updated and broken into five categories – patient antiseptic skin preparation, health care personnel hand wash, health care personnel hand rub, surgical hand scrub, and surgical hand rub. These are detailed in Table 3 of the FDA’s ‘Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use’.7
Both the EPA and the FDA have taken steps to help reduce the shortage in hand sanitizers. For example, the EPA has eased the reporting requirements on 280 inactive disinfectant ingredients.8 The FDA has also relaxed certain restrictions to expediate the release of hand sanitizers onto the market.9 They have announced that they will not enforce actions against firms preparing alcohol-based hand sanitizers for both consumer and public health use until such a time that the emergency is lifted.10 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.11
In the European Union (EU), hand sanitizers are covered by Regulation (EU) 528/2012 – the Biocidal Products Regulations (BPR). Under Article 55 for the BPR, Member States can set aside the standard BPR authorization 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.
It should be noted, hand sanitizer products that are manufactured outside of the EU are still subject to the requirements of the BPR.
COVID-19, and the need for large quantities of hand sanitizer, has challenged global supply chains. Authorities have responded by easing restrictions. As the pandemic develops, these regulations will adapt and so manufacturers should stay informed about legislative changes to ensure they remain compliant.
Backed by 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.
Learn more about our Hand Sanitizers and Disinfectants Services.
For more information, please contact:
Global Technical Manager
Cosmetics, Personal Care & Household
REFERENCES1 Coronavirus: Where has all the hand sanitiser gone?
2 Hand Washing or Hand Sanitizer - Whats More Effective Against Coronavirus
3 COVID-19: Hand sanitizers inactivate novel coronavirus, study finds
4 Guide to Local Production: WHO-recommended Handrub Formulations
5 Hand sanitizer
6 A distillery’s switch to making hand sanitizer & Coronavirus: Louis Vuitton owner to start making hand sanitiser & BASF Canada producing hand sanitizer for donation at Windsor plant
7 Safety and Effectiveness of Health Care Antiseptics
8 US EPA eases reporting for around 280 inactive disinfectant ingredients
9 Safeguards - Alcohol Based Hand Sanitizers
10 Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products
11 Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products