2021 Compliance Monitoring Project: Review of ethanol-based hand sanitizers

Why we did this project

At the start of the COVID-19 pandemic, there was an urgent need for products used to limit the spread of COVID-19, including hand sanitizers.

Health Canada put in place a temporary interim measure. This measure allowed hand sanitizer products that did not fully meet regulatory requirements, but did not compromise the safety of the public, to be imported and sold in Canada. Additionally, we expedited the review of licences to increase the market supply.

Learn more about the interim measure and expedited licencing approach:

In 2021, we looked at several ethanol-based hand sanitizers sold in Canada to verify if they posed a risk to health. We chose natural health products (NHPs) that were either licensed through our expedited licensing approach or accepted under the interim measure since the start of the pandemic.

Licensed NHP hand sanitizers sold in Canada must follow the requirements of both the:

NHP hand sanitizers accepted for sale under an interim measure were required to follow the specific criteria under which they were accepted.

What we did

We obtained 40 products directly from market authorization holders (MAHs). We chose the products based on various risk criteria, such as whether they were sold to vulnerable sub-populations (for example, schools or hospitals) and/or in high volume.

We tested and reviewed the products to assess their quality, safety and efficacy. We verified the following:

Impurities: The levels of methanol, benzene, acetaldehyde, acetal acetate and ethyl acetate in the product were below the established safety limits.
Ethanol:
- The concentration was between 60% and 80% (v/v) for efficacy and within the product's specifications for quality.
- The type of ethanol was appropriate for use in topical hand sanitizers.
Package and label: Products were labelled according to their licence requirements (for example, the label listed the correct ingredients and brand name). For products with unconventional containers, such as beverage or food containers, they had:
- an appropriate closure
- specific warning statements and graphic requirements.

What we found

We tested 40 products and found that:

15 products were compliant or only had minor issues that did not pose a risk to health
25 products were not compliant and posed a risk to health

Although we found compliance issues for most products, not all issues posed a risk to health. Issues identified included product labels missing information or having incorrect information or products having ethanol concentration outside the allowed limits. The types of issues we found are described in Figure 1.

Figure 1. Text version below. — **Figure 1: Types of issues found during our project**

What enforcement actions we took

When taking enforcement actions, Health Canada:

considers the nature and extent of the non-compliance
takes action appropriate to the risk identified to protect the health and safety of the Canadian population

We worked with the companies to resolve the non-compliances. We asked companies to recall and/or stop selling products that posed a risk to health.

Learn more about hand sanitizers that have been recalled:

Recalls and safety alerts for affected hand sanitizers

We also sent regulatory notices to companies for higher-risk issues such as impurities detected at high levels. We informed companies of the intended or immediate actions we were taking on their product licence, COVID-19 site licence or regular site licence, such as suspension, cancellation or revocation.

Some companies decided to discontinue their licences after receiving these notices. The number and type of actions that Health Canada took are described in Figure 2.

Figure 2. Text version below. — **Figure 2: Enforcement actions taken by Health Canada**

You can find the status of a product or site licence in the:

What we will do with the results

Health Canada uses the results of compliance monitoring projects to:

ensure the Canadian population has access to NHPs that are safe, effective and meet quality standards
help us improve our regulatory oversight of NHPs
provide guidance to the NHP industry to help them meet regulatory requirements.

This project also helps to enhance our response to future public health emergencies by providing a better understanding of gaps and potential solutions when putting in place emergency measures.

We will continue to inform the Canadian population about our proactive monitoring activities.

How to report a complaint

We want to hear from you. To submit a complaint about a health product or a company that handles health products:

health product complaint form

To report a side effect for a health product:

health product side effect reporting form

List of products reviewed


Product name	Company	Natural product number (NPN) or foreign identifier	Recalls
70% Alcohol Hand Sanitizer; 70% Alcohol Hand Sanitizer Unscented	Walter Surface Technologies Inc.	80101551	Not applicable
Absolute Sanitizer; Gely	Canada Direct Imports	80099745	Request to recall
All Good Unscented Hand Sanitizer	Quality Import Solutions	NDC 76150-234-41	Not applicable
Avalon Laboratories - Ethanol Hand Sanitizer 80%; Securol Hand Sanitizer	Avalon Laboratories	80101239	Request for recall
Beroia Hand Sanitizer	Beroia Inc.	80099277	Not applicable
BiOSS	Espace Béton Inc. / BiOSS Canada Inc.	80098279	Not applicable
Bleu Lavande Désinfectant pour les mains - Hand Sanitizer	Bleu Lavande	80083179	Not applicable
Boo Bamboo Hand Sanitizer Gel	Hush Brands Inc.	80100160	Not applicable
Cyber Clean; Power Gel	The Orb Factory Limited	80098826	Not applicable
Defenz	Shiny Star Canada Ltd.	80100296 appears on the label, which is the wrong NPN. 80100294 is the correct NPN.	Request to recall
Ecological Hand Sanitizer 70%	Hunter Amenities International Limited	80099539	Not applicable
Eco Sanitizer - Hand Sanitizer Gel	Eco Sanitizer	80100135	Not applicable
Embassy Ingredients - Hand Sanitizer	Embassy Ingredients	80097955	Request to recall
Gel Hand Sanitizer	Ecolab Inc.	NDC 47593-487-31	Not applicable
Gel Hydroalcoolique au Thym Rouge	Essences Zen Inc.	80103989	Not applicable
Get Clean Moisturizing Hand Sanitizer	Shaklee Canada Inc.	NDC 59899-050-01	Not applicable
Grace & Stella INC	Grace & Stella INC	80099233	Not applicable
Hand San 510D	DuBois Chemicals Canada, Inc.	80098648	Request to recall
Hand Sanitizer	Latitude 55 Distilling Co.	80099859	Request to recall
Hands Free	AG Hair Ltd. (Vancouver Hand Made Product Co. Ltd.)	80097837	Not applicable
iMed Hand Sanitizer; Yinba	MTI-Mobiltech International Inc.	80098244	Request to recall
Insignia Instant Hand Sanitizer	Groupe Nayla Import	NDC 75410-003-03	Not applicable
Insta Safe Guard; AM Innovative Consulting Inc. - Ethanol sanitizer 67%	AM Innovative Consulting Inc.	80101932	Not applicable
Instant Hand Sanitizer	KUUS INC.	80098206	Not applicable
Luxe Health Hand Sanitizer Gel (Ethyl alcohol 74%)	Luxe Decor Sales Ltd.	80098844	Request to recall
MediCare Foaming Hand Sanitizer	Dollarama L.P.	80100289	Request for recall
Nudestix Hand Sanitizing Gel; Hand Sanitizing Gel	Nudestix Inc.	80098230	Not applicable
Peak Processing Solutions - Ethanol sanitizer 80%	2682130 Ontario Limited (o/a Peak Processing Solutions)	80098093	Request to recall
PURE75	Haywick Industries	80098346	Request for recall
Puricia	Pharmaberg Inc.	80100723	Request to recall
Pur-Vie	Literies Universelles Paga Inc.	80101600	Request for recall
Quik-Care Foam Hand Sanitizer	Ecolab Inc.	47593-491-55	Not applicable
Safeguard Alcohol Hand Sanitizer	Procter & Gamble Inc.	NDC 69423-467-59	Not applicable
Safetec Instant Hand Sanitizer	Safecross First Aid Ltd.	NDC 61010-1111-7	Not applicable
Sanirell	Wafting International Inc.	80100324	Not applicable
Soft Hands AB Hand Sanitizer	Epsilon Chemicals Ltd.	80099708	Not applicable
TerraPure Hand Sanitizer	TerraPure Sanitizer Inc.	80103052	Request to recall
Touchland Power Mist Moisturizing Hand Sanitizer (Aloe Vera)	Debut Group Inc.	NDC 72033-001-00	Not applicable
Wayward Distillery WHO Formula Hand Rub	Wayward Distillery	80098231	Request to recall
Zep Hand Sanitizer Gel	Zep Manufacturing Company of Canada	80105731	Not applicable