Alcohol-based hand sanitizers in beverage and food containers: Packaging and labelling requirements to reduce unintentional ingestion risk

Published: October 2, 2020

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Background

The COVID-19 pandemic has created a high demand for alcohol-based hand sanitizers, especially when hand washing is not an option, such as in public spaces. This demand is expected to continue for the next year as the economy reopens.

The high demand has led to significant shortages in both products and standard packaging. Packaging shortages have resulted in the use of unconventional types of containers such as beverage or food containers (referred to here as beverage containers). These containers include water and soda bottles, wine and liquor bottles, and children's food pouches.

The use of beverage containers for alcohol-based hand sanitizers may lead consumers to believe that these products are consumable products, thereby increasing the risk of unintentional ingestion. Ingesting hand sanitizer could cause serious harm or even be fatal, particularly in children, because of the high alcohol content. Data from the Canadian Poison Control Centres show that the number of reported incidents related to hand sanitizer has increased in 2020 compared to 2019, up to 4.5 fold higher on a month-to-month basis.

Alcohol-based hand sanitizers must comply with:

Labelling must include these statements:

In addition to these requirements, products cannot be marketed in a manner that misleads the consumer about its composition or safety. Otherwise, they may be viewed as contravening section 9 of the Food and Drugs Act and enforcement action may be taken.

The intent of this policy is to ensure hand sanitizer products packaged in beverage containers:

These measures are especially important for hand sanitizers that are produced by companies that:

Scope

This policy outlines the additional packaging and labelling requirements for alcohol-based hand sanitizers packaged in beverage containers. The document will be of interest to:

Beverage containers subject to this policy and requiring additional packaging and labelling include:

Beverage or food containers that are unable to accommodate the required closures and, as such, should not be used for hand sanitizers include:

To develop this policy document, Health Canada reviewed existing labelling requirements for other health products. We also consulted with:

Additional packaging and labelling requirements

This section outlines the requirements for the use of both an alternative closure and an additional warning statement and symbol to alcohol-based hand sanitizers packaged in a beverage container.

Packaging

Closures such as a pump or dispensing cap are conspicuous and are not generally used on beverage containers. Such closures will help to differentiate hand sanitizer packages from beverages or other ingestible products. By having to open or use the container in this way, the consumer will understand the product is not to be consumed.

These types of closures will be required for alcohol-based hand sanitizers packaged in beverage, drinking or food containers.

Section 95 of the Natural Health Product Regulations requires safety seals or security packaging for all natural health products, including alcohol-based hand sanitizers. These measures will continue to be required. They assure consumers that the product has not been opened or tampered with before purchase. However, they are not sufficient to reduce unintentional ingestion and do not meet the requirements outlined in this policy.

Acceptable closures include:

Unacceptable caps or closures include:

Front-of-pack labelling

A warning statement on the front label is considered an effective way to inform consumers that the product is not a beverage. Symbols or pictures used along with a warning statement also help to communicate potential health risks.

Additional labelling requirements include a front-of-pack warning featuring a red octagon with the text "Do not drink / Ne pas boire" and "Health Canada / Santé Canada." Attributing the warning to Health Canada will lend credibility, as the public recognizes Health Canada's role to protect the health and safety of Canadians.

This warning must include:

The graphic symbol, warning statement and Health Canada attribution must appear together within a black border, of at least 1 point, with a white background to ensure visibility. The warning should appear on the top 50% of the main display panel label.

Example of the warning:

Label contains a red octagon with words 'Do not drink / Ne pas boire' followed by 'Health Canada / Santé Canada'

Implementation

These measures must be put in place no later than 8 weeks after this policy comes into effect, allowing existing stock to be used up. Hand sanitizers packaged in beverage containers and distributed after November 27, 2020, must have an appropriate closure along with the warning statement and graphic. Distribution in Canada of alcohol-based hand sanitizers packaged in beverage containers without these measures must stop after this date.

Over-stickers with the graphic symbol and warning statement will be permitted for 6 months from implementation and up to April 2, 2021, or by the next labelling run, whichever comes sooner. By this date, the warning statements must be incorporated into the packaging and permanent label design. The over-sticker cannot cover other labelling text or information.

The addition of the warning over-sticker should be placed on products before distribution and as soon as possible within the 8-week implementation period.

Product sponsors are expected to make every effort to shift to using traditional hand sanitizer containers.

We strongly recommend against marketing hand sanitizers to children given the additional heightened risk to this vulnerable subpopulation. For more information, please see Health Canada's public advisory on hand sanitizers and children's safety and the consumer advertising guidelines for marketed health products .

Compliance and enforcement approach

Enforcement efforts will focus on compliance monitoring and promotion. Health Canada will consider escalated enforcement if we identify a risk to health and safety.

When Health Canada identifies or is notified of potential non-compliance with the Food and Drugs Act and/or its Regulations, the information is assessed. A case may be opened to verify if non-compliance has occurred. We assess and prioritize each case and take the appropriate compliance action in proportion to the risk posed to the public. The main goal of our compliance and enforcement approach is to manage the risks to Canadians by using the most appropriate level of intervention.

For more information on Health Canada's national compliance and enforcement approach for health products regulated under the Act and its regulations, please refer to the compliance and enforcement policy (POL-0001).

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