加拿大修订食品药品条例中关于风味纯酒精的规定

All businesses impacted by these Regulations were identified as medium or large businesses. The small business lens does not apply, as there are no impacts on small businesses associated with these Regulations.

These Regulations do not include new reporting requirements and will not impose new, or reduce existing, administrative burdens on business. Therefore, it has been determined that the “One-for-One” Rule does not apply.

Canada is not the only jurisdiction to enact regulations on this category of products. Some jurisdictions (e.g. the United States) chose a more targeted approach, focusing on flavoured malt-based products while others (e.g. the United Kingdom) focused on spirits-based mixes. The specific alcohol composition of these products in each jurisdiction was impacted by the existing regulatory/tax system, which allowed these products to be sold at a lower price. In each case, it appears that restrictions were enacted due to similar health and safety risks related to overconsumption among youth. Where possible, Health Canada has attempted to align these Regulations with existing regulations and policies, with necessary distinctions to address the particular circumstances in Canada.

The regulatory environment for alcohol in the United States shares many similarities with Canada. In the United States, distilled spirits are subject to higher taxes and limited retail availability, whereas beer can be legally sold in more retail locations, including convenience stores and gas stations. footnote39 As a result, manufacturers in the United States started producing flavoured purified “beer” products: for example, they started with a fermented malt beer base, which was then filtered to remove all taste, colour, and smell attributed to beer, and flavouring was added such that the final product bore the taste of the added flavouring. footnote40

On January 3, 2006, the U.S. Trade and Tax Bureau (TTB) released a regulatory ruling defining a new class of beverages called “flavoured malt beverages” and stipulating their compositional requirements: malt beverages that contain not more than 6% alc/vol may derive no more than 49% of their alcohol content from flavours and other non-beverage ingredients; for malt beverages containing more than 6% alc/vol, not more than 1.5% of the volume of the finished product may consist of alcohol derived from added flavours containing alcohol and non-beverage ingredients containing alcohol. footnote41

Most states adopted the TTB definition; however, the states of Utah, Maine, and California sought to reclassify these beverages as distilled spirits. The reclassification succeeded in Maine and Utah, and, as a result, flavoured malt beverages became subject to higher taxes and restrictions on points of sale in these states. footnote42

Health Canada’s definition of flavoured purified alcoholic beverages is based on the TTB definition of flavoured malt beverages, with two key distinctions: (1) Health Canada’s definition is not limited to malt beverages, in recognition that these products can be produced from sources other than malt; and (2) Health Canada is only regulating the alcohol content of these products and not their flavouring, as this was determined to be a more flexible approach to reducing the health and safety risks of these products.

The United States also enacted labelling requirements on a single manufacturer of flavoured purified alcohol. After several reports of deaths of young adults in 2013 due to the consumption of the flavoured alcoholic beverage, the Federal Trade Commission (FTC) examined whether the manufacturer violated federal law by using deceptive marketing and ordered alcohol facts labels on products disclosing the number of standard drinks contained in the product. footnote43

The order stipulated that all of the manufacturer’s flavoured malt beverages containing more than two servings of alcohol must include disclosures. In particular, it required that the company seek approval from the U.S. TTB to place an “Alcohol Facts” disclosure panel on their containers. footnote44

The amount of alcohol equivalent to the definition of a standard drink in the United States is slightly higher than in Canada, at 17.7 mL of pure alcohol, footnote45 or approximately 1.1 standard Canadian drinks. By setting the limit to 1.5 standard Canadian drinks instead of 1 standard Canadian drink, products containing 1 standard U.S. drink could continue to be imported into Canada without needing to be reformatted or reformulated.

In the United Kingdom, like in Canada and the United States, distilled spirits are subject to higher taxes. However, when flavoured spirits-based alcoholic beverages were first introduced in the United Kingdom, they were classified as “wine coolers.” Wine coolers at the time were subject to lower taxes than beer and spirits. footnote46Tax increases on flavoured alcoholic beverages were first applied generally in 1997, with an increase of 40% to place them in the same category as beer. In 2002, taxes on spirits-based flavoured beverages increased by 65% to become the same rate of duty as spirits. footnote47

A voluntary Code of Practice was also developed in 1996, which resulted in a number of changes to the marketing and branding of these products. Moreover, all of Britain’s major retailers signed onto the Code of Practice and many supermarket chains underwent in-store changes to ensure that flavoured alcoholic beverages were properly displayed where there could be no doubt that their content was alcoholic, and that they could only be purchased by consumers over 18 years of age. footnote48

In April 2008, the Australian federal government imposed a 70% tax on “ready-to-drink” flavoured alcoholic beverages, effectively shifting them into the same taxation category as distilled spirits. This policy intervention aimed to reduce the harm from binge drinking among young people and address the risk posed by these products, which had packaging and marketing strategies specifically designed to attract youth. More specifically, this policy intervention, known as the “alcopops tax,” sought to reverse a trend that had emerged in July 2000 when tax reforms created a loophole allowing these types of beverages to be taxed at 40% less per litre of alcohol than distilled spirits, and had resulted in the significant growth of these products in Australia. footnote49

The reduced tax on “ready-to-drink” alcoholic beverages in Australia between 2000 and 2008 statistically correlated with an increase in emergency room visits attributed to alcohol among females aged between 18 and 24. Following the “alcopops tax,” a statistically significant decrease in emergency room visits was noted in males aged 15 to 50, females aged 15 to 65 years, and particularly females aged 18 to 24. footnote50

In 2013, the New Zealand federal government proposed limits on the number of standard drinks and the alcohol content in “ready-to-drink” flavoured alcoholic beverages in an Alcohol Reform Bill. The legislation originally proposed restricting “ready-to-drink” beverages to 5% alc/vol and limiting them to containers holding no more than 1.5 standard drinks. Following consultations, the Government of New Zealand introduced voluntary measures to limit the risks of these beverages, and indicated they would enact regulations should the voluntary measures prove ineffective. footnote51

Industry developed and introduced the following voluntary code: a maximum strength of 7% alc/vol and a limit of 2 standard alcoholic drinks per single-serve container; use of clearly displayed labels indicating the number of standard alcoholic drinks on containers; prohibition of advertising targeting minors; limitations on advertising and/or sponsorship such that 75% of the audience must be 18 years or older; and a commitment to minimize harmful consumption. footnote52

On June 12, 2018, the Government of Quebec adopted Bill 170, which restricted the sale of beer blends with more than 7% alc/vol to only the SAQ. As a result, the sale of beer blends with more than 7% alc/vol is no longer permitted in corner and grocery stores.

Common container sizes for single-serve beer and malt-based beverages are 341 mL or 355 mL. At 7% alc/vol, a 341 mL or 355 mL container would contain approximately 1.4 standard drinks. Therefore, Health Canada’s Regulations will not further impact the majority of flavoured purified alcoholic beverages sold in Quebec in 341 mL or 355 mL containers.

There are currently no regulations specific to this type of product in any province or territory other than Quebec.

Canada is subject to the provisions of the WTO Agreement on Technical Barriers to Trade (TBT), which seeks to ensure that technical regulations do not create unnecessary obstacles to trade. The TBT does not impede Health Canada’s ability to make regulations to address a legitimate public health/safety concern. Article 2 of the TBT acknowledges and recognizes a government’s right to regulate in the public interest, but such technical regulations cannot unjustifiably encumber trade or be more trade-restrictive than necessary to achieve policy objectives.

These Regulations aim to be origin neutral, and implementation should not negatively impact the competitive opportunities of imported products compared to similar products of domestic origin. Further, the objective of protecting human health allows for a strong argument that this is not an “unnecessary obstacle to international trade.”

It is also unlikely that the amendments will discriminate between domestic and foreign investors or a third party, respecting national treatment and most-favoured nation treatment obligations under Canada’s international investment agreements (IIA), as outlined in the North American Free Trade Agreement (NAFTA), the Comprehensive Economic and Trade Agreement (CETA), and as proposed in the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). With respect to the minimum standard of treatment obligation under Canada’s IIAs, these Regulations are unlikely to meet the high threshold of arbitrary, capricious or egregious conduct required to establish a breach of that obligation.

In accordance with The Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

A gender-based analysis plus (GBA+) was conducted and it was observed that the availability of highly sweetened, flavoured alcoholic beverages may impact some populations, including women, youth and low-income populations, more significantly.

According to the Canadian Tobacco, Alcohol and Drugs Survey (CTADS), in 2017, 78% (or 23.3 million) of Canadians reported consuming an alcoholic beverage in the past year. The rate of alcohol use among young adults aged 20 to 24 (83%) was higher than among youth aged 15 to 19 (57%) and adults aged 25 years and older (79%). These rates were unchanged from results of the 2015 CTADS.

Moreover, data from the 2017 CTADS indicates that young adults (aged 20 to 24) had riskier patterns of alcohol consumption compared to youth (aged 15 to 19) and adults older than 25 years. Twenty-nine percent (or 552 000) of young adult drinkers exceeded the guideline for chronic risk, defined as no more than 10 standard drinks a week for women, with no more than 2 a day most days, and 15 standard drinks a week for men, with no more than 3 a day most days. In comparison, 18% (or 203 000) of youth drinkers and 20% (or 3.9 million) of adult drinkers exceeded this guideline.

Although findings from the CTADS 2017 indicate a similar prevalence of males and females reporting past-year alcohol use (79% and 77%, respectively), this is a result of an increase in past-year alcohol use among females compared to 2015. Evidence from the United States suggests that females consume a higher proportion of flavoured alcoholic beverages than men, and that these products may be more appealing to women because of the marketing, advertising, packaging and flavouring.

For instance, a study published in 2014 in the American Journal of Drug and Alcohol Abuse examined the brand-specific consumption prevalence and consumption share of flavoured alcoholic beverages among a national sample of underage drinkers in the United States. Half of the respondents reported consuming a flavoured alcoholic beverage during the past 30 days, making these beverages second only to beer among all alcoholic beverage types. Consumption prevalence was higher among females (61.5%) than males (38.8%). footnote53

Women may also experience more harm related to the consumption of these particular types of beverages, as some products contain a quantity of alcohol that corresponds to heavy drinking, defined as 4 or more drinks per day for women and 5 or more drinks per day for men. Many flavoured purified alcoholic beverages contain as many as 4 standard drinks in a single-serve container. At the upper level, this amount of alcohol is double the recommended daily limit for women in Canada’s Low-Risk Alcohol Drinking Guidelines. Moreover, the rate of alcohol-related hospitalizations and deaths is increasing faster for women than for men in Canada. Between 2001 and 2017, the rate of alcohol-related deaths increased 26% for women compared to 5% for men. footnote54

The low price combined with the high alcohol content of many flavoured purified alcoholic beverages means that these types of alcoholic beverages may be more appealing and more accessible to youth and people with lower incomes. Many of these products are marketed specifically at young people. At certain times of the year, discounts can bring prices as low as $0.74 per standard drink. This price falls well below the recommended price of $1.71 per standard drink, making these products very accessible. footnote55

Given that data suggests these beverages may disproportionately impact women, youth and low-income populations, the Government of Canada is taking a strict approach and limiting the maximum amount of alcohol in a single-serve container of these beverages to 1.5 standard drinks.

Evidence suggests that Indigenous peoples are at a greater risk of experiencing complex mental health and substance use issues due to a variety of factors, including the intergenerational impacts of colonialism and the Indian residential school experience, as well as social, economic, and cultural inequities that persist today. footnote56,footnote57

According to phase 3 of the First Nations Regional Health Survey, the only national health survey of First Nations living on-reserve and in northern communities across Canada, approximately 35% of First Nations adults (18 years and older) on-reserve reported heavy drinking and 25% of First Nations youth reported having consumed alcohol within the past year. Of these youth, more than 50% indicated that they had engaged in heavy drinking one or more times per month. footnote58 The Canadian Community Health Survey — Annual Component, 2010–2012, a national survey conducted by Statistics Canada, provides information on First Nations living off-reserve, and Métis and Inuit adults. According to the survey, approximately 30% of First Nations living off-reserve, Métis and Inuit adults reported heavy drinking compared to approximately 19% of non-Indigenous adults. footnote59

Similarly, Indigenous youth living off-reserve reported more frequent heavy drinking than non-Indigenous youth. The Aboriginal Health Foundation indicates that premature death due to alcohol is two times greater for Indigenous peoples than for the general population, and Indigenous youth are two to six times at greater risk for every alcohol-related problem than their non-Indigenous counterparts. footnote60 Given the above, alcohol is considered an urgent public health concern by many Indigenous communities across Canada, and has been ranked as the top challenge for community wellness.

All Canadians, including Indigenous peoples and their communities, will benefit from the public health and public safety approach taken in the development of these regulatory amendments pertaining to flavoured purified alcoholic beverages, particularly the restrictions on the amount of alcohol that these products can contain.

Recognizing the unique context, interests and priorities of First Nations, Inuit and Métis across Canada, tailored interventions may be required to address problematic alcohol use by Indigenous Canadians. This is why, under the CDSS, the Government of Canada will continue to work with Indigenous governments, leaders and communities to better address substance use and related issues from a culturally competent, holistic, distinctions-based approach that addresses the social determinants of health and ensures that the unique rights, interests and circumstances of the First Nations, Inuit and Métis peoples are acknowledged, affirmed and implemented in partnership. footnote61

Regulated parties were first made aware of Health Canada’s intention to regulate in March 2018, and the Department has had ongoing engagement with industry and impacted manufacturers since then. However, due to the urgent health and safety issue demonstrated by the increase in emergency room visits by youth and two deaths attributed to these products over the past 18 months, there is no transition period after these Regulations come into force.

The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act as it relates to food.

While it is the responsibility of the industry to comply with regulatory requirements, compliance will be monitored as part of ongoing domestic and import inspection programs, respecting the resources that the CFIA has for enforcement and compliance verification. Appropriate enforcement action will be risk-based.

Compliance with and enforcement of alcohol regulations is also addressed at the PT level. Provincial and territorial liquor boards regularly assess alcoholic beverages to ensure that product listings adhere to federal and provincial/territorial regulatory requirements.

Health Canada has developed guidance in consultation with the CFIA and PT liquor boards to guide assessments and the implementation of these regulatory amendments.

Bruno Rodrigue
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Tower A, Suite 14, Ground Floor
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca

S.C. 2016, c. 9, s. 8

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