Vaping Products Reporting Regulations

Vaping Products Reporting Regulations Her Excellency the Governor General in Council, on the recommendation of the Minister of Mental Health and Addictions and Associate Minister of Health, makes the annexed Vaping Products Reporting Regulations under section 7.8a of the Tobacco and Vaping Products Actb. S.C. 2018, c. 9, s. 12 S.C. 1997, c. 13; S.C. 2018, c. 9, s. 2 Definitions The following definitions apply in these Regulations. Act means the Tobacco and Vaping Products Act. (Loi) assortment means a package that contains two or more of the types of vaping products referred to in subsection 2(1); or two or more brands of vaping products of the same type, but with different characteristics, such as different flavours or nicotine concentrations. (assortiment) civic address means for an address in Canada, the unit number, civic number, street name, municipality name, province name and postal code; and for an address outside Canada, the unit number, civic number, street name, municipality name, province or state name, postal or ZIP code and country name. (adresse municipale) GTIN means the Global Trade Item Number assigned by GS1 to a brand of vaping product or brand of assortment. (GTIN) manufacturer does not include an individual or entity that only packages, labels or distributes vaping products on behalf of a manufacturer. (fabricant) net sales means the value of a manufacturer’s sales of a vaping product or assortment during a specified period minus the value of any returns of that vaping product or assortment to the manufacturer during the same period. (ventes nettes) net volume means the volume of a vaping substance sold by a manufacturer during a specified period minus the volume of any returns of that vaping substance to the manufacturer during the same period. (volume net) unique product identifier, in relation to a brand of vaping product or brand of assortment, means the GTIN; or the alphanumeric code referred to in subsection 3(3). (identifiant de produit unique) vaping device has the meaning assigned by paragraphs (a) and (b) of the definition vaping product in section 2 of the Act. (dispositif de vapotage) vaping part has the meaning assigned by paragraph (c) of the definition vaping product in section 2 of the Act. (pièce de vapotage) vaping substance has the meaning assigned by paragraph (d) of the definition vaping product in section 2 of the Act. (substance de vapotage) Retail sale These Regulations apply to the following types of vaping products that are intended for retail sale: a vaping part that does not contain a vaping substance and that is a vaping part that contains, or that is intended to contain, a source of energy, a vaping part — including a tank, cartridge or pod — that is a reservoir for a vaping substance and that contains an aerosol-generating component, or a vaping part that contains a microprocessor; a vaping device that does not contain a vaping substance; a vaping part that contains a vaping substance; a vaping device that contains a vaping substance; and a vaping substance. Assortments These Regulations also apply to assortments that are intended for retail sale. Non-application These Regulations do not apply to a vaping product or assortment that is the subject of an authorization, including a licence, issued under the Food and Drugs Act authorizing its sale or to an assortment that includes a vaping product that has been issued such an authorization. Information These Regulations prescribe the information that manufacturers of vaping products must submit to the Minister, as well as the form and manner in which the information is to be submitted. Content of reports In addition to the information required for each type of report set out in these Regulations, every report must contain the following: the name of the manufacturer on whose behalf the report is submitted, as well as the telephone number, email address and civic address of the manufacturer’s principal place of business in Canada; the name, telephone number and email address of the individual who prepared the report and, if that individual works for an entity other than the manufacturer, the name of the entity, as well as the telephone number, email address and civic address of the entity’s principal place of business; the date of the report and an attestation by the individual who prepared it that the information in the report is true and complete to the best of their knowledge and belief and is provided in good faith; and in the case of a report on sales, the period covered by the report. Unique product identifier For each brand of vaping product or brand of assortment that does not have a GTIN, the manufacturer must create an alphanumeric code of no more than 10 characters that will serve as the unique product identifier for that brand. Language The information in the reports must be in English or French. Brands of vaping products The report on sales must contain the following information for each brand of vaping product, other than a brand of vaping product contained in an assortment, that a manufacturer sells during the period covered by the report: the unique product identifier; the type of vaping product; the brand name or the brand family name; in the case of a vaping product that is contained in a package, the number of units of the vaping product in the package; any additional brand element or any descriptive term that distinguishes the vaping product from other vaping products in the report; and in the case of a type of vaping product referred to in any of paragraphs 2(1)(c) to (e), the name given to the vaping substance, one of the following: an indication of the flavour set out in the schedule that corresponds to the dominant flavour of the vaping substance, the word “Other”, if the dominant flavour of the vaping substance does not correspond to any of the flavours set out in the schedule, or the word “Unflavoured”, if applicable, the concentration of nicotine, if any, expressed in milligrams per millilitre, and the volume in millilitres of the vaping substance per unit of the vaping product. Sales — vaping products The report on sales must contain the following information with respect to sales made by the manufacturer and returns made to the manufacturer during the period covered by the report, for each brand of vaping product: in the case of a vaping product that is contained in a package that is not an assortment, the number of packages sold, or the number “0” if none were sold, in each province, throughout Canada and for export, and for each of the categories referred to in subparagraph (i), the number of packages that were returned to the manufacturer, or the number “0” if none were returned; in the case of a vaping product that is not contained in a package, the number of units sold, or the number “0” if none were sold, in each province, throughout Canada and for export, and for each of the categories referred to in subparagraph (i), the number of units that were returned to the manufacturer, or the number “0” if none were returned; in the case of a vaping product that is sold in Canada, the Canadian dollar value, excluding any taxes or duties, of the net sales of the vaping product in each province and throughout Canada, and the total Canadian dollar value of any vaping duty and additional vaping duty imposed under the Excise Act, 2001 on the vaping product that was sold minus the total Canadian dollar value of any vaping duty and additional vaping duty imposed on any returns of the vaping product in each province and throughout Canada; in the case of a vaping product that is sold for export, the name of each country of destination and the Canadian dollar value of the net sales of the vaping product to that country; and in the case of a type of vaping product referred to in any of paragraphs 2(1)(c) to (e), the net volume in litres of the vaping substance sold in each province, throughout Canada and for export. Brands of assortments The report on sales must contain the following information with respect to sales of assortments made by the manufacturer during the period covered by the report: for each brand of assortment sold, the unique product identifier, the brand name or the brand family name, and any additional brand element or any descriptive term that distinguishes the assortment from other assortments in the report; and a description of the contents of the assortment, including the following information for each brand of vaping product contained in the assortment: the brand name, and the name given to the vaping substance, and the total volume in millilitres of the vaping substance. Sales — assortments The report on sales must contain the following information with respect to sales made by the manufacturer and returns made to the manufacturer during the period covered by the report, for each brand of assortment: in the case of sales made by the manufacturer, the number of assortments sold, or the number “0” if none were sold, in each province, throughout Canada and for export; in the case of returns to the manufacturer for each of the categories referred to in paragraph (a), the number of assortments that were returned, or the number “0” if none were returned; in the case of an assortment that is sold in Canada, the Canadian dollar value, excluding any taxes or duties, of the net sales of the assortment in each province and throughout Canada, and the total Canadian dollar value of any vaping duty and additional vaping duty imposed under the Excise Act, 2001 on the assortment that was sold minus the total Canadian dollar value of any vaping duty and additional vaping duty imposed on any returns of the assortment in each province and throughout Canada; and in the case of an assortment that is sold for export, the name of each country of destination and the Canadian dollar value of the net sales of the assortment to that country. Time limit — initial report The initial report on sales must be submitted within the time limit set out in subsection (6) for the first complete period after the day on which these Regulations come into force. Time limit — report on sales The report on sales must be submitted for the period beginning on January 1 and ending on June 30 of a year, on or before July 31 of that year; and for the period beginning on July 1 and ending on December 31 of a year, on or before January 31 of the following year. Brand information The report on ingredients must contain the following information for each brand of vaping product that a manufacturer sells in Canada, including a brand of vaping product contained in an assortment, if the vaping product is of a type referred to in any of paragraphs 2(1)(c) to (e): any additional brand element or any descriptive term that distinguishes the vaping product from other vaping products in the report; the word “Unflavoured”, if applicable; and the concentration of nicotine, if any, expressed in milligrams per millilitre. Ingredient information The report on ingredients must contain the following information for each ingredient that is used in the manufacture of the vaping substance: its common name; its chemical name, if applicable; its registry number assigned by the Chemical Abstracts Service of the American Chemical Society, if applicable; the name and civic address of its supplier; its concentration in the vaping substance, expressed in milligrams per millilitre or millilitres per millilitre, as the case may be; and if the ingredient is nicotine, an indication of whether the nicotine is natural or synthetic or a mixture of both. More than one substance in ingredient If more than one substance was used in the manufacture of any ingredient the report on ingredients must contain the information referred to in subsection (2) for each of those substances and for any substance used in the manufacture of those substances; the information referred to in paragraph (a) may be submitted by the ingredient supplier on behalf of the manufacturer. Exception — export The report on ingredients is not required for a brand of vaping product if the vaping product, or an assortment that contains it, is manufactured solely for export. Identical vaping substance In the case of a vaping substance that is identical to that contained in another brand of vaping product for which a report on ingredients is submitted, the manufacturer may submit a report on ingredients that does not include the information referred to in subsections (2) and (3) if it includes the information referred to in subsection (1) for both brands of the vaping product. Definition of identical For the purposes of subsection (5), identical, in relation to a vaping substance, means the vaping substance contains the same ingredients in the same concentrations as a vaping substance contained in another brand of vaping product, including a brand of vaping product contained in an assortment. Time limit — report on ingredients The report on ingredients must be submitted on or before the day on which the manufacturer first sells a brand of vaping product, including a brand of vaping product contained in an assortment, that was not included in a previous report on ingredients. Reporting by manufacturer The manufacturer must submit the report on sales and the report on ingredients using the following forms established by the Minister and attaching the forms to an email: for the report on sales, the form entitled Sales Report for Vaping Products, as amended from time to time; and for the report on ingredients, the form entitled Ingredients Report for Vaping Products, as amended from time to time. Information submitted by supplier An ingredient supplier who submits information on the manufacturer’s behalf under paragraph 5(3)(b) may do so using the form established by the Minister entitled Supplemental Ingredients Report for Vaping Products (Suppliers) – Ingredients with More than One Substance, as amended from time to time, and attaching the form to an email. Notification of change If there are changes to the information referred to in subsection 5(2) after the report on ingredients is submitted, the manufacturer must submit a notification of change that meets the following requirements: it includes, for each brand of vaping product to which the change pertains, the unique product identifier, and it includes the name of the manufacturer, as well as the telephone number, email address and civic address of the manufacturer’s principal place of business in Canada; it includes the name, telephone number and email address of the individual who prepared the notification and, if that individual works for an entity other than the manufacturer, the name of the entity, as well as the telephone number, email address and civic address of the entity’s principal place of business; it includes the date of the notification and an attestation by the individual who prepared it that the information in the notification is true and complete to the best of their knowledge and belief and is provided in good faith; the information in the notification is in English or French; it is submitted using the form established by the Minister entitled Notification of Change — Vaping Product Ingredients, as amended from time to time, and attaching the form to an email; and it is submitted on or before the day on which the manufacturer first sells a vaping product that was manufactured in accordance with the change. Report — December 31, 2023 A manufacturer must submit, on or before December 31, 2023, a report on ingredients that contains the information referred to in subsections 5(1) to (3) with respect to each brand of vaping product, including a brand of vaping product contained in an assortment, that the manufacturer sells during the period beginning on the day on which these Regulations come into force and ending on December 31, 2023. Registration These Regulations come into force on the day on which they are registered.