In light of the recent Coronavirus pandemic, the demand for antimicrobial products such as disinfectants and hand sanitizers are skyrocketing. The aim of this article is to help you to understand the regulatory requirements needed to bring your disinfectant products into the Canadian or the US market, as well as the current regulatory exemptions and interim measures in place to help respond to COVID-19.
Most chemical products represented for use in Canada as disinfectants/sanitizers are regulated as drugs under the Food and Drugs Act. The Natural and Non-prescription Health Products Directorate (NNHPD) is the regulatory body within Health Canada that assesses applications for these products. There are two main categories of these products – Disinfectant drugs and Human-Use Antiseptic Drugs.
Disinfectant Drugs are disinfectants for use on non-critical medical devices and hard non-porous environmental surfaces and inanimate objects in domestic, industrial / institutional, hospital, food processing and/or barn premises. All disinfectant drugs are subject to pre-market assessment by NNHPD and will be assigned a Drug Identification Number (DIN) upon market authorization. All disinfectant drug applications must support the general safety, efficacy, and quality requirements, as well as the labelling requirements set out by the Food and Drugs Act and Regulations.
Health Canada has developed Monographs for Disinfectant Drugs that outlines the permitted active ingredients and concentrations, target microorganism classes, contact times, and associated use areas for these products to be licensed without the submission of additional evidence to Health Canada. The Monograph permits general claims such as “Kills viruses / fungi / bacteria / germs” and “Kills 99.99% of viruses / bacteria / fungi”. The Monograph application stream allows for an abbreviated review process and the approximate review timeline for a monograph Disinfectant application is 45 days.
When a proposed product or its labelling is outside the scope of a published Monograph, applicants are required to submit evidence to Health Canada to support the safety, efficacy and quality of the product when used in accordance with the label directions; these applications require a scientific assessment as part of their market authorization.
Fabricators, packagers/labellers, distributors, importers and testers of Disinfectant Drugs are not required to obtain an establishment licence or meet GMP compliance requirements. However, they are still expected to meet the provisions of section 8 of the Food and Drugs Act, which denotes the prohibition on selling drugs manufactured under unsanitary conditions or that are adulterated.
Human-Use Antiseptic Drugs
The Human-Use Antiseptic Drugs are antiseptic skin products for human use that are intended for personal, professional, or commercial use. All Human-Use Antiseptic Drugs are subject to pre-market assessment by NNHPD and will be assigned a Natural Product Number (NPN) or Drug Identification Number (DIN) upon market authorization. Human-Use Antiseptic Drugs containing ingredients that meet the definition of natural health product substances as per the Natural Health Product Regulations are required to apply for a Natural Product Number (NPN). All other Human-Use Antiseptic Drugs are required to file an application for a Drug Identification Number (DIN). All applications must demonstrate that the product meet safety, efficacy, quality, and labelling requirements set out by the Food and Drugs Act and Regulations and Plain Language Labelling requirements (for DINs only).
Health Canada has also developed a Monograph for Antiseptic Skin Cleansers for certain personal domestic use Human-Use Antiseptic Drugs. Personal domestic use products are those that can be self-selected by a consumer from a retail outlet for their own personal household use as part of a daily skin cleansing routine to reduce transient organisms on the skin. The Monograph specifies the allowed medicinal (active) ingredients and their concentrations, indications, and adequate directions for use. The Monograph permits general claims such as “Kills harmful bacteria / germs” and “Antiseptic skin cleanser”. Products which meet the Monograph specifications can be submitted for review under the Monograph application stream which allows for an abbreviated review process. The approximate review timelines are 45 days and 60 days for monograph DIN applications and NPN applications respectively.
Products that are outside the scope of this Monograph must submit a DIN application or an NPN application with appropriate supporting safety, efficacy and quality data for assessment. For example, products making Antiviral claims, % reduction claims, or organism specific claims must submit supporting evidence such as in-vitro test data to demonstrate efficacy. In addition, a Drug Establishment Licence (for DIN products) or a Site Licence (for NPN products) is required for any person (business or individual) in Canada to fabricate, package, label, test, import, distribute, or wholesale a drug. These activities must be conducted in compliance with GMP requirements.
Regulatory requirements for hard surface disinfectant drugs
- Drug Identification Number Application for market authorization
- Products eligible for the Monograph application stream may receive approval in 45 days
- Food and Drug Regulations compliant product label
Regulatory requirements for antiseptic skin cleansers (i.e. hand sanitizers)
- Drug Identification Number (DIN) Application or Natural Health Product (NHP) Application for market authorization
- Products eligible for the Monograph application stream may receive approval in 45 days (DIN application) or 60 days (NHP applications)
- Food and Drug Regulations compliant product label
- Manufacturers in Canada would need a Drug Establishment License (for DIN) or Site License (for NHP)
- Manufacturers outside of Canada would need a Canadian importer with a Drug Establishment License (for DINs) or Site License (for NHPs).
US – Products regulated by Environmental Protection Agency
In the United States, chemical germicides formulated as sanitizers, disinfectants, or sterilants used on environmental surfaces and non-critical surfaces are regulated by the United States Environmental Protection Agency (EPA), under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Under FIFRA, any substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest (including microorganisms but excluding those in or on living humans or animals) must be registered before sale or distribution. To obtain a registration, a manufacturer must submit specific data about the safety and effectiveness of each product. For example, EPA requires manufacturers of sanitizers, disinfectants, or chemical sterilants to test formulations by using accepted methods for microbiocidal activity, stability, and toxicity to animals and humans. The manufacturers submit these data to EPA along with proposed labeling. If EPA concludes the product can be used without causing “unreasonable adverse effects,” then the product and its labeling are registered, and the manufacturer can sell and distribute the product in the United States.
Pesticides produced by foreign manufacturers and imported for sale or distribution in the United States must comply with all requirements applicable to domestic producers. This includes registering the pesticide product and obtaining an EPA Pesticide-Producing Establishment number before starting production. In addition, regulations require an importer to submit to EPA a Notice of Arrival of Pesticides and Devices (EPA Form 3540-1) for review and determination as to whether the shipment should be sampled and/or permitted entry into the United States.
US – Products regulated by Food and Drug Administration
Antiseptics are antimicrobial drugs used on living tissue and thus are regulated by Food and Drug Administration (FDA) under the Food, Drug and Cosmetic Act. The FDA has established OTC (Over-the-Counter) monographs for drugs that are generally recognized as safe and effective (or GRAS/GRAE), which are published in the government’s Code of Federal Regulations (CFR). A Monograph is a regulatory standard for ingredients, covering acceptable ingredients, doses, formulations, indications, and labeling. Any OTC product that conforms to a finalized monograph may be manufactured and marketed without the need for FDA pre-approval. Any drug product that does not comply fully to an OTC monograph will require FDA approval under a new drug application (NDA) or abbreviated new drug application (ANDA) prior to marketing. In addition, all drug products must comply with the standardized labelling requirements as outlined in the CFR.
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register their facilities with the FDA. They are also required to provide the FDA with a current list of all commercially marketed drug products. Drug products are identified and listed using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States. Foreign drug establishments whose drugs are imported into the United States are also required to register with FDA, identify a U.S. Agent, and submit drug listing information for their drugs intended for commercial distribution in the United States.
Regulatory requirements for hard surface disinfectant products
- Obtain product registration with the United States Environmental Protection Agency (EPA)
- EPA approved product label
- Obtain an EPA Pesticide-Producing Establishment number
- Importers need to submit a Notice of Arrival of Pesticides and Devices to EPA for approval
Regulatory requirements for antiseptic skin cleansers (i.e. hand sanitizers)
- May be manufactured and marketed without FDA pre-approval If the product is fully compliant to a FDA OTC monograph
- Any product that does not comply fully to an OTC monograph will require FDA approval under a new drug application (NDA) or abbreviated new drug application (ANDA).
- Code of Federal Regulations compliant product label
- Establishment Registration with the FDA
- Drug Product Listing with NDCs
- A U.S. Agent is required for Foreign drug establishments whose drugs are imported into the US
COVID-19 regulatory exemptions and Health Canada interim measures
In light of the unprecedented demand and urgent need for disinfectants and hand sanitizers during the COVID-19 pandemic, as an interim measure, Health Canada will facilitate the importation of the following:
- Products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements
- Products that are not authorized for sale in Canada but are authorized or registered in the United States or an MRA country.
Importers of products that fall under these categories are required to notify Health Canada prior to importation.
In addition, manufacturers and distributors of authorized hard surface disinfectants with the following anti-virus claims are allowed to make indirect efficacy claims for SARS-CoV-2 (the virus that causes COVID-19).
- broad-spectrum virucide or
- specific claim against a specific coronavirus, such as MERS-CoV, SARS-CoV, or human coronavirus strain 229E
Health Canada is also prioritizing the review of applications for market authorization related to disinfectants or hand sanitizers. If you or your company is looking to market your disinfectant or antiseptic products in Canada, now is the time act.
Quality Smart Solutions has a team of specialists who can provide product licensing, label compliance, and import solutions for you. We have licensed over 5000 NPNs and DINs including hand sanitizers and disinfectants. We are also a licensed importer of record for disinfectant natural health products through our sister company, Quality IMPORT Solutions. Get prepared now and contact us today to discuss how we can be your solution!
Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.
Guidance document – Disinfectant drugs https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/disinfectants/disinfectant-drugs.html
Guidance document – Management of Disinfectant Drug Applications
Guidance Document – Human-Use Antiseptic Drugs
Guidance Document: The Management of Drug Submissions and Applications
Pesticide Registration Manual: Chapter 4 – Additional Considerations for Antimicrobial Products https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-4-additional-considerations
Pesticide Registration Manual: Chapter 1 – Overview of Requirements for Pesticide Registration and Registrant Obligations https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-1-overview-requirements-pesticide
Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use https://www.federalregister.gov/documents/2019/04/12/2019-06791/safety-and-effectiveness-of-consumer-antiseptic-rubs-topical-antimicrobial-drug-products-for
Development & Approval Process | Drugs https://www.fda.gov/drugs/development-approval-process-drugs#:~:text=FDA%20approval%20of%20a%20drug,risks%20for%20the%20intended%20population.
Expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72623a-eng.php