Guidance on the regulations respecting flavoured purified alcohol

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1.0 Purpose and scope

Health Canada has amended the Food and Drug Regulations (FDR) to restrict the amount of alcohol in flavoured purified alcohol products. You can access the text of the regulations and accompanying documentation.

This document provides further guidance to support industry compliance with the regulations.

2.0 Oversight of alcohol

2.1 Federal government

At the federal level, Health Canada regulates alcohol under the regulations for food, through the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDR). The Canadian Food Inspection Agency (CFIA) is responsible for the enforcement of the FDR as it relates to food.

Alcoholic beverages are also subject to the federal Excise Act and Excise Act, 2001. The Department of Finance is responsible for the development and evaluation of the Excise Act. The Canadian Revenue Agency (CRA), with the support of the Canadian Border Services Agency (CBSA), is responsible for its enforcement.

2.2 Provinces and Territories

Provinces and territories (PTs) have exclusive control over the distribution and sale of alcohol within their jurisdiction. They also have responsibility for enacting laws and regulations regarding the legal drinking age and advertising. Each province and territory has a liquor board or commission to oversee these activities.

PTs are responsible for the enforcement of their own jurisdictions' alcohol regulations. Liquor boards and commissions also work closely with the CFIA to ensure compliance with federal alcohol regulations.

2.3 Manufacturers and Distributors

There is no pre-market approval required for alcoholic beverages. Their sale is subject to Sections 3 to 7 of the FDA and must be in compliance with any applicable divisions under part B of the FDR. Manufacturers and distributors of alcohol products are responsible for the safety of their products and for ensuring that their products are compliant with applicable legislation and regulations.

Manufacturers are responsible for ensuring that products that meet the definition of "flavoured purified alcohol" meet the alcohol content restrictions set out in the FDR.

There are national and regional trade associations that can help manufacturers and distributors understand compliance obligations related to federal and PT alcohol regulations.

3.0 Regulations respecting flavoured purified alcohol

Health Canada has amended Division 2 (Alcoholic Beverages) of the FDR to set restrictions on the alcohol content of beverages meeting the definition of "flavoured purified alcohol".

3.1 Definition of Flavoured Purified Alcohol

Subsection B.02.004(3) of the FDR defines flavoured purified alcohol as any alcoholic beverage:

In the manufacturing of alcoholic beverages, the process of fermentation imparts taste and aroma to the alcohol based on the starting material used. This process results in the distinct flavours associated with products, such as beer, wine, cider, etc.

The production of flavoured purified alcohol uses a purification process that strips the alcohol of the taste and aroma imparted through fermentation and the beverage takes on the taste of the added substances instead.

Some of the purification processes that may be used include but are not limited to:

The definition explicitly excludes distillation. Distillation may also be considered a form of purification; however, the end result of distillation is spirits or spirits-based products, which are not in the scope of these regulations.

A product that is made from a mixture of spirits and flavoured purified alcohol is subject to these regulations.

3.2 Conditions of sale

Beverages that meet the definition of flavoured purified alcohol are limited to 25.6 mL of alcohol (representing 1.5 standard drinks) when they are sold in containers with a volume capacity of 1000 mL or less. Therefore, containers with a volume greater than 1000 mL (e.g. a 2000 mL box) are outside the scope of these regulations. This includes both non-resealable and resealable containers. The alcohol restrictions apply to flavoured purified alcohol products that are imported, or produced and sold intra-provincially and/or inter-provincially.

The alcohol content limit also does not affect beverages sold in glass containers with a volume capacity of 750 mL or more.

Restricting the alcohol content based on the number of standard drinks provides flexibility for manufacturers to meet the requirements of these regulations. Manufacturers have the option to change the alcohol concentration, the size of the container, or both, to achieve compliance with these regulations. Moreover, the 1.5 standard drink limit is the upper limit, not a target. Flavoured purified alcoholic beverages can be sold below the 1.5 standard drink limit.

To help identify the maximum percentage of alcohol by volume for any container size, the following formula can be used:
25.6 mL ÷ (volume of container in mL) = % alcohol by volume

For example:
25.6 mL ÷ 341 mL = 7.5% alcohol by volume
(This means that a 341 mL container may have up to 7.5% alcohol by volume.)

The following table lists the maximum percentages for some common alcohol beverage container sizes. These are examples of upper limits only; products with alcohol content that is lower than the concentrations listed below are also compliant with the regulations.

Maximum alcohol percentages for common alcohol beverage container sizes
Container volume Percentage of alcohol
341 mL up to 7.5% alc/vol
355 mL up to 7.2% alc/vol
473 mL up to 5.4% alc/vol
568 mL up to 4.5% alc/vol
710 mL up to 3.6% alc/vol
750 mL
(glass exempted)
up to 3.4% alc/vol
1 000 mL
(glass exempted)
up to 2.6% alc/vol

3.3 Impact on Standardized Alcoholic Beverages

Part B, Division 2 of the FDR sets compositional standards for some alcoholic beverages, such as gin, vodka, beer, wine, and cider. These products must meet the established standards in order to be labelled, packaged, sold or advertised as those products. Compositional standards are primarily for interprovincial trade purposes and provide consumers with predictability what is contained in foods and how they are produced.

The regulations respecting flavoured purified alcohol are not considered a compositional standard. It is a health and safety regulation. Any alcohol product that meets the definition of flavoured purified alcohol is subject to the conditions of sale.

At the time of publication, there was no overlap between the composition of standardized alcoholic beverages and flavoured purified alcohol. For example, beer, wine, and cider have strict compositional requirements under the FDR that do not include the process of purification for flavoured purified alcohol. Likewise, standardized spirits products (Whisky, Rum, Gin, Brandy, Liqueurs, Vodka, Tequila, Mezcal) are not be subject to these regulatory requirements as they are all produced through distillation. The definition of flavoured purified alcohol excludes the process of distillation.

However, should a new compositional standard be established or an existing standard be amended such that it meets the definition of flavoured purified alcohol, the conditions of sale would apply to the product in question.

3.4 Labelling requirements

Flavoured purified alcohol products must adhere to labelling requirements that are generally applicable to alcohol. Information on these labelling requirements is available on the Flavoured Purified Alcohol section of CFIA's Food Labelling for Industry website.

3.5 Acceptable Variation Between Alcohol on Label and Measured Value

During compliance and enforcement activities, alcohol "tolerance" represents the acceptable difference between the alcohol content declared on the label and the measured value. The alcohol content of a beverage can fluctuate after it is packaged. There may be small variances due to different testing methods and devices used. Tolerance is allowed for other types of alcoholic beverages (e.g., wine, beer, spirits).

A ± 0.5% alcohol tolerance applies to determine compliance. This is the same tolerance established by the National Quality Assurance Committee of the Canadian Association of Liquor Jurisdictions for "miscellaneous products", including coolers and ready-to-drink beverages.

A measured alcohol content that differs more than ± 0.5% from the label could be considered false, misleading or deceptive under subsection 5(1) of the Food and Drugs Act:

No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

4.0 Additional Information

Consultation on proposed restrictions to flavoured purified alcohol

Regulations Amending the Food and Drug Regulations (Flavoured Purified Alcohol): SOR/2019-147

Questions or comments on this guidance document should be directed to:

Bureau of Policy, Intergovernmental and International Affairs
Food Directorate
Health Products and Food Branch
Health Canada

Appendix A - Tips on How to Help Identify Flavoured Purified Beverages

The following quick tips can be used to recognize products that are not compliant with the new regulation on flavoured purified beverages. This guide is not exhaustive and may be updated from time to time.

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