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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. 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 disinfectant 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.
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.
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.
Nexreg can help!
Nexreg has completed our transition to a 100% virtual workforce. Compliance is essential, and we are prepared to assist with emergency SDS and label authoring. We can also help you meet the additional regulatory requirements associated with certain product types such as biocidal product registrations. For more information about our services, contact Nexreg today!
Written By: Cassandra Taylor, Senior Regulatory Consultant at Nexreg Compliance Inc.