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Compliance Guidelines - Canadian Electronic Cigarette Labeling and Packaging Regulations SOR/2019-353
Author.
LCS
Source:
Post time:
2025-09-30
The current "Vaping Products Labeling and Packaging Regulations" regulation SOR/2019-353 in Canada, below is a detailed interpretation of the relevant requirements in the latest regulations:
Applicable product scope
Applicable to all electronic cigarettes and their packaging sold in retail in Canada.
Not applicable to electronic cigarettes subject to the Food and Drug Act.
Nicotine concentration statement for electronic cigarettes
Canada prohibits the sale of electronic cigarette products with nicotine concentrations exceeding 20 mg/mL (according to Canadian SOR/2021-123 regulations), and all electronic cigarettes containing nicotine must indicate the nicotine concentration. The concentration value should be labeled with "nicotine -" followed by the unit of measurement "mg/mL.
Health Warning for Electronic Cigarettes
Any electronic cigarette containing nicotine must display a health warning. The health warning label must display the words "Health Canada" next to or below the English version of the health warning, and the words "Sante Canada" next to or below the French version of the health warning.
Nicotine free products display nicotine free declaration
Only one of the following expressions is allowed to be displayed on electronic cigarettes:
The expression in the English version is "Nicotine free", and in the French version it is "Sans nicotine";
The expression in the English version is "No nicotine", and in the French version it is "Aucune nicotine";
The expression in the English version is' Does not contain nicotine ', while in the French version it is' Ne continuous pas de nicotine'.
Information display
The required health warnings and any permitted statements must be displayed in the same way in both official languages.
Any necessary information and expressions allowed must be non ambiguous and non removable.
Integrity: The conventional method of opening electronic cigarettes or packaging must not cut, damage, or make any letters, words, or parts of the expression difficult to recognize.
Clarity: Any necessary information must be displayed in standard sans serif font, which must not be compressed, expanded, or decorated,
It is black on a white background, and its x height is relatively large relative to the rising or falling part of the font. The information display should be clear and distinguishable, and maintained throughout the entire lifespan of the electronic cigarette under normal or routine transportation, storage, sale, and use conditions. The height of the font must be determined by measuring uppercase or lowercase letters, which have ascending or descending order, such as "b" or "p".
Each character in the required information text must have the same font and size.
The nicotine concentration statement or health warning on electronic cigarettes or packaging must:
If the area of the main display panel reaches or exceeds 45cm2, the minimum height of the characters is 3mm and the minimum size is 8 dots;
If the area of the main display panel is between 10 and 45 cm2, the minimum height of the characters is 2 millimeters and the minimum size is 6 dots;
If the area of the main display panel is less than 10cm2, the minimum height of the characters is 1.5 millimeters and the minimum size is 4.5 dots.
The first word of the health warning is capitalized and bolded; The rest of the text is not in bold, but in lowercase letters.
Clear and complete content
Any necessary information displayed on the instruction manual or label must be as close as possible to the top edge of the surface of the instruction manual or label, ensuring that any nicotine concentration statement is located directly above the health warning where applicable; Display in a way that allows for complete reading without additional operation during normal or regular sales or use of electronic cigarettes. Any necessary information displayed on the instruction manual or label must be presented in font with a minimum height of 2 mm and a minimum font size of 6.
An instruction manual displaying the health warnings required for electronic cigarettes must be inserted into the packaging containing the electronic cigarettes.
The label shall not conceal or obscure any necessary information displayed on the electronic cigarette or its packaging; Do not interfere with the normal use or safe operation of electronic cigarettes.
Ingredient List Requirements
Each electronic cigarette must provide a list of ingredients and must list the common names of all ingredients in the product (abbreviations are not allowed). Both the English and French versions of the ingredient list must be titled "Ingredients:".
If any ingredient or combination of ingredients is added to an electronic cigarette solely for the purpose of producing a specific flavor or flavor combination, these ingredients must be labeled as "flavor" in the English version of the ingredient list and as "arome" in the French version of the ingredient list. For ingredients added to electronic cigarettes to create a combination flavor, the total concentration ratio of these ingredients must be used to determine the order in which flavor indications are listed in the ingredient list.
The ingredient list must be displayed on the display surface of the direct container of the electronic cigarette, as well as on the display surface of any outer packaging or on the electronic cigarette device or electronic cigarette component with a label attached to display the ingredient list.
The ingredients listed in the ingredient list must meet the following requirements:
For components in electronic cigarettes with a concentration of 1% or more, they should be arranged in descending order of their proportion;
For components with a concentration below 1%, they can be arranged in any order and immediately after the components listed in item a. When the concentration of a component in an electronic cigarette is expressed as a percentage, the percentage represents the ratio of the weight of the component to the volume of the electronic cigarette.
Child protection requirements
The construction of child protective containers must only be opened by using tools not provided with the container to operate, pierce, or remove one of its functionally necessary components; Or meet the requirements of a child testing plan that meets any of the following standards or at least equivalent standards:
Canadian Standards Association CAN/CSA Z76.1-16 standard "Reusable Sealed Child Protective Packaging"
International Organization for Standardization ISO 8317:2015 standard "Child protective packaging - Requirements and testing procedures for resealable packaging"
Title 16 of the United States Code of Federal Regulations, Section 1700.20, "Special Packaging Test Procedures"
Child protective containers must maintain their characteristics as child protective containers throughout their entire shelf life. For refillable containers, their characteristics as child protective containers must also be maintained under normal storage, sale, and use conditions.
Instructions for opening and closing
For child protective containers that meet the requirements, the display surface must be labeled with the following warning message: "USE ENTIRE CONTENT ON OPENING. THE CONTAINER IS NOT CHILD-RESISTANT ONCE OPENED."
If the main display panel area of the direct container is less than 45cm2, there is no need to display this declaration on the display surface of the direct container. If the main display panel area of the external packaging is less than 45 cm2, the declaration must be displayed on the label adjacent to the container.
If the size of the direct container is small and not packaged, a declaration must be displayed on the display surface or attached label of the direct container when the main display panel area is greater than 15cm2 but less than 45cm2; If the main display panel area of the direct container is equal to or less than 15cm2, a statement must be displayed on the accompanying label.
Toxicity information
For electronic cigarettes with nicotine concentration reaching or exceeding 0.1 mg/mL, the following information must be marked on the surface of the direct packaging container: the hazard label shown in the figure must be completely consistent (the size must be consistent); Toxicity Warning and First Aid Measures Explanation in English
POISON: if flooded, call a Poison Control Centre or doctor immediately
Information must be displayed in both official languages; And maintain clarity and readability throughout the entire shelf life of the electronic cigarette, or in refillable instant containers, under normal conditions of transportation, storage, sale, and use; Display in black font on a white background.
If the required information is presented in text form, the text must use standard sans serif fonts and meet the following conditions: no compression, expansion, or decoration processing; Each character in the required information text must have the same font and type size.
The word 'POISON' should be written in bold capital letters;
This statement is located next to or below the danger sign.
-
Display of danger symbols
The toxicity warning and first aid statement must be displayed in the following manner: -
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