Hand Sanitizer Legislation (COVID-19)

Written by Cassandra Taylor, Senior Regulatory Consultant, Nexreg Compliance

What is COVID-19?

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). First identified in 2019 in Wuhan China, this disease has since spread globally resulting in the current coronavirus pandemic. Communities around the world have been taking actions to minimize the spread of this deadly virus.

The Importance of Alcohol-Based Products

One effective way to disinfect hands when handwashing is not practical is by using alcohol-based hand sanitizer products. Hand sanitizer effectively kills a broad range of microorganisms including coronavirus. Accordingly, we have seen a recent global rise in the demand for alcohol based products. Hand sanitizers and disinfectants have biocidal properties and are regulated in many countries under biocide or pesticide regulations which often have specific registration requirements. In light of the recent demand for these products, some countries have put in place measures to reduce the burden on companies attempting to place on the market disinfectant products.

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Changes in Hand Sanitizer Legislation

USA Canada Germany Switzerland France Sweden

The United States Food & Drug Administration (FDA) recently released two guidance documents on the production of alcohol-based hand sanitizer to help boost supply and protect public health. The agency has indicated that it does not intend to take action against manufacturing firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs. Additionally, pharmacists in state-licensed pharmacies and federal facilities will not be required to obtain a patient-specific prescription in order to compound certain alcohol-based hand sanitizers. The guidance documents also discuss product labeling, certain manufacturing methods, and reporting requirements. The guidance will be effective for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on 31 January 2020.

Health Canada is currently accepting applications for expedited reviews to obtain a Drug Establishment Licence (DEL) or Site Licence (SL) to conduct activities related to hand sanitizers and disinfectants. Notification is still required to sell these products in Canada and authorization will be granted upon fulfillment of the requirements.

Health Canada recently released a “Guide on Health Canada’s interim expedited licensing approach for the production and distribution of alcohol-based hand sanitizers” which is intended to provided information about the interim expedited licensing approach implemented by Health Canada to support companies that intend to use their facilities to manufacture, package, label and/or import alcohol-based hand sanitizers.

Alcohol-based hand sanitizers containing ethanol or isopropanol are natural health products (NHPs) in Canada and are regulated under the Natural Health Products Regulations (NHPR). A Natural Product Number (NPN) must be obtained to legally distribute NHPs. Additionally, an SL is required to manufacture, package, label and/or import an NHP hand sanitizer in Canada.

Health Canada is temporarily authorizing the use of technical-grade ethanol in hand sanitizer products.

High demand for hand sanitizer has led to a shortage of raw materials such as ethanol. Normally, hand sanitizers are made with United States Pharmacopeia (USP) or food-grade ethanol. Health Canada has temporarily modified its rules to allow manufacturers to use other types of ethanol in hand sanitizer products without compromising safety, efficacy, and quality. Technical-grade ethanol may now be used on a short-term case-by-case basis, under specific conditions.

There are some additional labeling requirements for manufacturers taking advantage of this legislative change:

Clearly indicate that technical-grade ethanol is included as an ingredient;
Provide specific directions for use and warnings that these products are intended for adult use only, that they should not be used on broken or damaged skin, that they should not be used by women who are pregnant or breastfeeding, and that they should not be inhaled;
Provide information on how to report adverse reactions to Health Canada.

Health Canada is advising Canadians to always follow the label directions when using alcohol-based hand sanitizers.

Germany’s Federal Institute for Occupational Safety and Health has promulgated a General Decree approving the use of biocidal products containing isopropanol for hand disinfection in accordance with Article 55 (1) of Regulation (EU) No. 528/2012. The Decree specifies two formulations that are approved for manufacture and sale within Germany until 31 August 2020.

Switzerland’s Notification Authority for Chemicals has announced a General Decree regarding authorisation of the sale and human use of specific alcohol-based disinfectants. Approval is not required for specified alcohol-based biocidal products that are already approved for other uses, where the spectrum of action can be extended to influenza and coronavirus. The Decree is valid until 31 August 2020.

France authorized the marketing of specific alcohol-based products for human hygiene and surface disinfection in a recent Decree, which is valid until 31 May 2020.

Sweden has also introduced measures to ease the requirements for disinfectants due to COVID-19. The Swedish chemicals agency will grant exemptions from Articles 17 and 19 of the EU Biocidal Products Regulation (BPR) for products containing 1-propanol, 2-propanol, active chlorine generated by certain methods, or hydrogen peroxide as the active substance. This means that approval is not needed for sale on the Swedish market of surface or hand disinfectant mixtures containing these chemicals as the active ingredient. These exemptions apply until 16 September 2020. Additionally, Sweden has relaxed the language requirements for safety data sheets (SDSs) and labels of disinfectants used in healthcare and other professional activities. In addition to Swedish, the Swedish Chemicals Agency will accept labels and SDSs in English, Danish, or Norwegian. This provision applies until 30 April 2020.

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Sources:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-guidance-production-alcohol-based-hand-sanitizer-help-boost

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72623a-eng.php

https://www.baua.de/EN/Home/Home_node.html

https://www.baua.de/DE/Angebote/Aktuelles/Meldungen/2020/pdf/Allgemeinverfuegung-2-Propanol.pdf?__blob=publicationFile&v=1

https://www.bag.admin.ch/bag/en/home/das-bag/organisation/direktionsbereiche-abteilungen/direktionsbereich-verbraucherschutz/anmeldestelle-chemikalien.html

https://www.admin.ch/opc/de/federal-gazette/2020/1561.pdf

https://www.legifrance.gouv.fr/jo_pdf.do?id=JORFTEXT000041697126

https://www.kemi.se/nyheter-fran-kemikalieinspektionen/2020/kemikalieinspektionen-lattar-pa-reglerna-for-desinfektionsmedel-pa-grund-av-coronaviruset

https://www.ontario.ca/page/how-your-organization-can-help-fight-coronavirus