Approval and Endorsements

Here are some of the approval’s and endorsements that Safertiser’s main active ingredient has received from local and international health authorities.

New Zealand Environmental Protection Authority (NZEPA)

• https://epa.govt.nz/database-search/chemical-classification-and-information-database-ccid/view/13823
• Approval Number: HSR005673
• CAS Number: 68424-85-1

Canadian Government Approved compound for use against SARS-CoV-2 (COVID-19)

• https://www.canada.ca/en/health-canada/services/drugs-health-products/disinfectants/covid-19/hand-sanitizer.html
• https://www.canada.ca/en/health-canada/services/drugs-health-products/disinfectants/covid-19/list.html

World Health Organisation Recommended Compound for use against SARS-CoV-2 (COVID-19)

• https://www.who.int/docs/default-source/coronaviruse/laboratory-biosafety-novel-coronavirus-version-1-1.pdf?sfvrsn=912a9847_2 [Section 3.c. Appropriate Disinfectants]
• On 12 February 2020, the World Health Organisation (WHO) recommended labs use the same active ingredient* in Safertiser to disinfect and sanitize as there was sufficient evidence to suggest it has proven efficacy against enveloped viruses, such as COVID-19. (*Quaternary Ammonium Compounds/Benzalkonium chloride.)
• WHO Laboratory biosafety guidance related to the novel coronavirus (2019-nCoV) dated 12/02/2020: “Appropriate disinfectants with proven activity against enveloped viruses should be used (e.g. quaternary ammonium compounds).”

Over 203 unique United States Environmental Protection Agency (USEPA) Registrations and Approvals for using Quaternary Ammonium against SARS-CoV-2

• https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2
• The FDA has delegated the EPA to review and approve Emerging Viral Pathogen Claims for SARS-CoV-2.

Over 1442 unique FDA approved registrations.

• https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory [NDC Database File]

US EPA Substance Registry Services

• https://iaspub.epa.gov/sor_internet/registry/substreg/searchandretrieve/advancedsearch/externalSearch.do?p_type=CASNO&p_value=68424-85-1
• Internal tracking number: 429654

Australian Government: The active in Safertiser is not subject to any specific national environmental regulations.

• https://www.nicnas.gov.au/chemical-information/imap-assessments/imap-assessments/tier-ii-environment-assessments/benzalkyl-quaternary-ammonium-surfactants

The chemicals in this group are not listed under Schedule 1 (the Toxic Substances List) of the Canadian Environmental Protection Act 1999 (CEPA 1999) (Government of Canada, 2013b).

• Government of Canada (2013b). List of Toxic Substances in Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). Accessed 19 April 2016 at http://www.ec.gc.ca/.

According to the UN the chemicals in this group are not currently identified as Persistent Organic Pollutants (UNEP, 2001), ozone depleting substances (UNEP, 1987), or hazardous substances for the purpose of international trade (UNEP & FAO, 1998).

• UNEP (1987). The Montreal Protocol on Substances that Deplete the Ozone Layer. United Nations Environment Programme, Ozone Secretariat, Nairobi, Kenya. Accessed 12 March 2016 at http://ozone.unep.org/.
• UNEP (2001). The Stockholm Convention on Persistent Organic Pollutants. United Nations Environment Programme, Secretariat of the Stockholm Convention, Châtelaine, Switzerland. Accessed 12 November 2013 at http://www.pops.int/.
• UNEP & FAO (1998). The Rotterdam Convention on the Prior Informed Consent procedure for Certain Hazardous Chemicals and Pesticides in International Trade. United Nations Environment Programme and Food and Agriculture Organization of the United Nations, Châtelaine, Switzerland. Accessed 12 November 2013 at http://www.pic.int/.

In the European Union, the active ingredient in Safertiser (benzyl-C12-16-alkyl dimethyl ammonium chlorides) is currently registered for use under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation (ECHA, 2015c).

• ECHA (2015c). Pre-registered substances. European Chemicals Agency, Helsinki, Finland. Accessed 1 April 2015 at http://echa.europa.eu/.

FDA issues final rule on Safety and Effectiveness of Consumer Hand Sanitisers, leaving Benzalkonium Chloride to be sold for the time being WITHOUT the need for Drug Approval.

• “At this time, three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to make a determination regarding whether these active ingredients are generally recognized as safe and effective for use in OTC consumer antiseptic rub products.”
• https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-consumer-hand-sanitizers