GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — B.29.020
B.29.020 (1) Every applicable cautionary statement set out in column 4 of the List of Permitted Supplemental Ingredients in respect of the supplemental ingredients contained in a supplemented food must be shown (a) in a list on the label of the supplemented food; (b) grouped together and introduced by the title, in bold type, (i) “Caution”, “Caution:” or “Caution :” in the English version, and (ii) “ Attention ”, “ Attention :” or “ Attention :” in the French version; (c) without any intervening printed, written or graphic material appearing between the title and the first cautionary statement; (d) in regular or bold type; (e) in lower case letters, except that upper case letters must be used to show the first letter of each cautionary statement; and (f) separated by a bullet point or comma. (2) The list of cautionary statements must be shown in a manner that clearly differentiates it on the label by means of one or both of (a) graphics in the form of a solid-line border around the list or one or more solid lines appearing immediately above, below or at the sides of the list that are the same colour as that of the type used to show the information referred to in subsection B.01.008.1(1); and (b) a background colour that creates a contrast between the background colour of the list and the background colour used on the adjacent surface of the label, other than the surface used to display (i) a list of ingredients, (ii) a food allergen source, gluten source and added sulphites statement as defined in subsection B.01.010.1(1), (iii) a declaration referred to in subsection B.01.010.4(1), (iv) any statement referred to in subsection B.16.016(1), (v) a nutrition facts table, or (vi) a supplemented food facts table. (3) The list of cautionary statements must be shown on the label without any intervening printed, written or graphic material, (a) in English and French, adjacent to each linguistic version of the supplemented food facts table appearing in the same language, if there are separate English and French versions of the table; (b) in English and French, adjacent to a bilingual version of the supplemented food facts table, with one linguistic version of the list following the other linguistic version; or (c) in English or French, adjacent to the supplemented food facts table in the same language, if, in accordance with subsection B.01.012(3), the information required by these Regulations to be shown on the label may be shown in that language only and is shown on the label in that language. (4) If the English and French versions of a list of cautionary statements appear on the label, they must be displayed on a continuous surface of the label’s available display surface, but need not be on the same continuous surface of the label’s available display surface. (5) If the English and French versions of a list of cautionary statements appear on the same continuous surface of the label, the version that follows the other version must not begin on the same line as that on which the other version ends, unless the available display surface is less than 100 cm 2 . SOR/2022-169, s. 21 SOR/2024-244, s. 149
Food and Drug Regulations — B.29.021
B.29.021 (1) The principal display panel of a supplemented food must carry the supplemented food caution identifier that is set out in Schedule K.2 if a list of cautionary statements is shown on the label of the supplemented food. (2) The supplemented food caution identifier must be displayed in black and white and must be in accordance with the identifier set out in Schedule K.2. (3) Subject to subsection (4), the supplemented food caution identifier must be presented in one of the following formats: (a) the unilingual standard format, where two separate versions of the identifier are shown, one in English (ES) and one in French (FS); or (b) the bilingual standard format (BS), where the identifier is shown in both official languages. (4) If the principal display surface is less than or equal to 450 cm 2 and the width of each of the versions of the supplemented food caution identifier in the unilingual standard format or the width of the identifier in the bilingual standard format exceeds the width of the principal display panel, the identifier must be presented in the bilingual compact format (BC) in which the identifier is shown in both official languages. (5) The supplemented food caution identifier must be displayed in accordance with the applicable specifications set out in the Directory of Supplemented Food Caution Identifier Specifications. (6) Despite subsection (5), the supplemented food caution identifier may be displayed with larger dimensions than those set out in column 3 of the applicable table in the Directory of Supplemented Food Caution Identifier Specifications if the identifier is enlarged in a proportional manner vertically and horizontally. (7) If, in accordance with subsection B.01.012(3), the information required by these Regulations may be shown on the label of a supplemented food in English only or in French only and is shown in that language, the supplemented food caution identifier may be displayed on the principal display panel of the supplemented food in that language only on a continuous surface of the available display surface. (8) If the supplemented food caution identifier is presented in a bilingual format, the order in which the languages appear may be reversed from the order shown in the applicable identifier set out in Schedule K.2. (9) The characters and other elements of the supplemented food caution identifier must not touch each other. SOR/2022-169, s. 21
Food and Drug Regulations — B.29.022
B.29.022 (1) The supplemented food caution identifier must be displayed (a) in the case of a supplemented food with a principal display panel whose height is less than its width, on the right half of the principal display panel; and (b) in the case of any other supplemented food, on the upper half of the principal display panel. (2) The supplemented food caution identifier must be surrounded by a buffer that (a) has a width that is equal to or greater than that set out in column 4 of the applicable table in the Directory of Supplemented Food Caution Identifier Specifications, and (b) does not contain any text or other graphic material. (3) If a supplemented food is cylindrical in shape, the outer edge of the buffer must be a minimum distance of 10% of the width of the principal display surface from the edge of the left or right side of that surface. (4) If it is impossible to comply with both paragraph (1)(a) and subsection (3), the supplemented food caution identifier may be displayed partially in the left half of the principal display panel but only to the extent necessary to comply with that subsection. SOR/2022-169, s. 21
Food and Drug Regulations — B.29.023
B.29.023 The supplemented food caution identifier must be oriented in the same manner as most of the other information that appears on the principal display panel unless the panel is displayed in the vertical plane and most of the other information is not displayed parallel with the base of the package, in which case the identifier must be oriented in such a manner that the words appearing in it are parallel with the base. SOR/2022-169, s. 21
Food and Drug Regulations — B.29.024
B.29.024 It is prohibited to label a prepackaged product with a supplemented food caution identifier or sell a product that is so labelled, unless a list of cautionary statements is shown on the label. SOR/2022-169, s. 21
Food and Drug Regulations — B.29.025
B.29.025 (1) It is prohibited to label a prepackaged product with any representation, including a word, phrase, illustration, sign, mark, symbol or design, that is likely to be mistaken for a supplemented food caution identifier, or sell a prepackaged product that is so labelled. (2) For the purposes of subsection (1), a representation does not include a nutrition symbol. SOR/2022-169, s. 21
Food and Drug Regulations — B.29.026
B.29.026 (1) Despite anything in these Regulations, it is prohibited, on the label of or in any advertisement for a supplemented food, to make a statement or claim to the effect that a supplemental ingredient that is a nutrient contained in the supplemented food is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health, if the supplemental ingredient is one for which a cautionary statement set out in the list of cautionary statements is applicable. (2) However, the label of or advertisement for a supplemented food may carry such a statement or claim if it is accompanied by a statement or claim about the specific action or effect of the supplemental ingredient in maintaining the functions of the body necessary to the maintenance of good health. (3) If the label of or any advertisement for the supplemented food carries a statement or claim referred to in subsection (1), that statement or claim and the statement or claim referred to in subsection (2) must, (a) if made on the label of or in an advertisement, other than a radio or television advertisement, for the supplemented food, (i) be adjacent to one another without any intervening printed, written or graphic material, and (ii) be shown in letters of the same size and prominence; (b) if made in a radio advertisement or in the audio portion of a television advertisement for the supplemented food, immediately follow one another; or (c) if made in the visual portion of a television advertisement for the supplemented food, (i) appear concurrently and for the same amount of time, (ii) be adjacent to one another without any intervening printed, written or graphic material, and (iii) be shown in letters of the same size and prominence. SOR/2022-169, s. 21
Food and Drug Regulations — B.29.027
B.29.027 Despite anything in these Regulations, if a supplemented food is required to show a cautionary statement that is set out in the list of cautionary statements and recommends against consumption by any individual less than 18 years of age that is part of a group identified in the cautionary statement, it is prohibited, on the label of or in any advertisement for the supplemented food, to make a statement or claim to the effect that a nutrient contained in the supplemented food is generally recognized as an aid in maintaining the functions of the body necessary to normal growth and development. SOR/2022-169, s. 21
Food and Drug Regulations — B.29.028
B.29.028 (1) Despite anything in these Regulations, if the label of a supplemented food is required to carry the statement “high caffeine content” in accordance with column 5 of the List of Permitted Supplemental Ingredients, it is prohibited to make a representation, express or implied, on the label of or in any advertisement for the supplemented food with respect to any vitamin or mineral nutrient contained in the supplemented food. (2) Subsection (1) does not apply in respect of a declaration of a vitamin in a list of ingredients or supplemented food facts table, or in respect of a declaration of a mineral nutrient in a list of ingredients, nutrition symbol or supplemented food facts table. SOR/2022-169, s. 21
Food and Drug Regulations — B.29.029
B.29.029 (1) If a list of cautionary statements is shown on the label of a supplemented food, the representations set out in subsection (2) must meet the following requirements: (a) if the representation is displayed on the principal display panel, (i) the height of the upper case letters in the representation must not exceed two times the height of the upper case letters, excluding any accents, in the supplemented food caution identifier, other than in the words “Health Canada” and “Santé Canada”, and (ii) the height of the tallest ascender of the lower case letters in the representation must not exceed two times the height of the tallest ascender of the lower case letters in the supplemented food caution identifier, other than in the words “Health Canada” and “Santé Canada”; and (b) if the representation is displayed on any continuous surface, other than on the principal display panel, (i) the height of the upper case letters in the representation must not exceed two times the height of the upper case letters, excluding any accents, in the cautionary statements, and (ii) the height of the tallest ascender of the lower case letters in the representation must not exceed two times the height of the tallest ascender of the lower case letters in the cautionary statements. (2) For the purposes of subsection (1), the representations are the following: (a) a declaration referred to in subsection B.01.301(1) or (2); (b) any representation that expressly or implicitly indicates that the supplemented food or any substance it contains has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004; and (c) any health-related statement, logo, symbol, seal of approval or mark. (3) This section does not apply to the brand name or product name of a supplemented food. SOR/2022-169, s. 21
Food and Drug Regulations — B.29.030
B.29.030 A prepackaged product, other than a supplemented food, is adulterated if it contains a supplemented food as an ingredient. SOR/2022-169, s. 21
Food and Drug Regulations — B.29.031
B.29.031 A prepackaged product, other than a supplemented food, is adulterated if a substance listed in column 1 of the List of Permitted Supplemental Ingredients has been added to it other than in accordance with these Regulations. SOR/2022-169, s. 21
Food and Drug Regulations — B.29.032
B.29.032 A supplemented food does not have a poisonous or harmful substance in or on it for the purposes of paragraph 4(1)(a) of the Act — or is not adulterated for the purposes of paragraph 4(1)(d) of the Act — by reason only that a supplemental ingredient has been added to it. SOR/2022-169, s. 21
Food and Drug Regulations — B.30.001
B.30.001 The following definitions apply in this Division. equivalent method means a method of analysis that is equivalent to a microbiological reference method as determined in accordance with the document entitled Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis , published by the Government of Canada on its website, as amended from time to time. ( méthode équivalente ) microbiological reference method means a method of analysis set out in column 2 of the document entitled Table of Microbiological Reference Methods for Food , published by the Government of Canada on its website, as amended from time to time, in respect of a corresponding microorganism set out in column 1. ( méthode de référence microbiologique ) Table of Microbiological Criteria means the document entitled Table of Microbiological Criteria for Food , published by the Government of Canada on its website, as amended from time to time. ( Tableau des critères microbiologiques ) SOR/2024-244, s. 150
Food and Drug Regulations — Food and Drug Regulations
equivalent method means a method of analysis that is equivalent to a microbiological reference method as determined in accordance with the document entitled Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis , published by the Government of Canada on its website, as amended from time to time. ( méthode équivalente )
Food and Drug Regulations — Food and Drug Regulations
microbiological reference method means a method of analysis set out in column 2 of the document entitled Table of Microbiological Reference Methods for Food , published by the Government of Canada on its website, as amended from time to time, in respect of a corresponding microorganism set out in column 1. ( méthode de référence microbiologique )
Food and Drug Regulations — Food and Drug Regulations
Table of Microbiological Criteria means the document entitled Table of Microbiological Criteria for Food , published by the Government of Canada on its website, as amended from time to time. ( Tableau des critères microbiologiques )
Food and Drug Regulations — B.30.002
B.30.002 A food set out in column 1 of the Table of Microbiological Criteria is adulterated if a corresponding microorganism set out in column 2 is present in or on the food and at least one of the following conditions is met: (a) the number of sample units of the food with a level of the microorganism greater than that set out in column 5 is greater than the number set out in column 4; or (b) the level of the microorganism in any of the sample units of the food is greater than the level, if any, set out in column 6. SOR/2024-244, s. 150
Food and Drug Regulations — B.30.003
B.30.003 A food set out in column 1 of the Table of Microbiological Criteria is, in respect of the presence of a corresponding microorganism set out in column 2, exempt from the application of paragraph 4(1)(a) of the Act, if neither condition described in paragraphs B.30.002(a) or (b) is met in relation to the microorganism. SOR/2024-244, s. 150
Food and Drug Regulations — B.30.004
B.30.004 For the purpose of sections B.30.002 and B.30.003, (a) the number of sample units taken for a food set out in column 1 of the Table of Microbiological Criteria for the purpose of determining the level of a microorganism set out in column 2 must be the number of sample units set out in column 3 in relation to that microorganism; and (b) the level of a microorganism present in or on a food is to be determined in accordance with an applicable microbiological reference method or an equivalent method. SOR/2024-244, s. 150
Food and Drug Regulations — C.01.001
 15, 1993 and by the Association française de normalisation, and effective December 20, 1992, and which reiterates fully the international standard ISO 8317:1989, as amended from time to time, and (iii) Code of Federal Regulations (United States), Title 16, Section 1700.15, entitled Poison prevention packaging standards , as amended from time to time. (3) For the purposes of this section, test group means (a) in relation to children, a group of at least 200 children who (i) are healthy and have no obvious physical or mental disability, (ii) are between 42 and 51 months of age, and (iii) represent evenly, within plus or minus 10 per cent, each monthly age between 42 and 51 months calculated to the nearest month; and (b) in relation to adults, a group of at least 100 adults who (i) are healthy and have no obvious physical or mental disability, (ii) are between 18 and 45 years of age, and (iii) represent evenly, within plus or minus 10 per cent, each yearly age between 18 and 45 years calculated to the nearest year. (4) For the purpose of this section, an amendment from time to time to a standard referred to in paragraph (2)(b) becomes effective 18 months after the date designated by the competent authority as the effective date for the amendment. SOR/80-543, s. 1; SOR/85-966, s. 1; SOR/86-93, s. 1; SOR/87-484, s. 1; SOR/92-654, s. 1; SOR/93-202, s. 1; SOR/95-411, s. 1; SOR/95-521, s. 1; SOR/96-399, s. 1; SOR/96-240, s. 1; SOR/97-543, s. 5; SOR/2010-105, s. 1; SOR/2013-74, s. 1; SOR/2013-122, s. 3; SOR/2016-139, s. 1; SOR/2017-76, s. 1; SOR/2017-133, s. 1; SOR/2017-259, s. 1 SOR/2020-74, s. 1 SOR/2021-45, s. 1 SOR/2021-46, s. 11(E) SOR/2022-197, s. 8 SOR/2023-247, s. 1(F)
Food and Drug Regulations — Food and Drug Regulations
acetaminophen product has the same meaning as in Division 9; ( produit d’acétaminophène )
Food and Drug Regulations — Food and Drug Regulations
adult standard dosage unit has, with reference to a drug, the same meaning as in Division 9; ( dose normale pour adultes )
Food and Drug Regulations — Food and Drug Regulations
adverse drug reaction means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function; ( réaction indésirable à une drogue )
Food and Drug Regulations — Food and Drug Regulations
antibiotic means any drug or combination of drugs such as those named in C.01.410 to C.01.592 which is prepared from certain micro-organisms, or which formerly was prepared from micro-organisms but is now made synthetically and which possesses inhibitory action on the growth of other micro-organisms; ( antibiotique )
Food and Drug Regulations — Food and Drug Regulations
authorization holder [Repealed, SOR/2017-259, s. 1]
Food and Drug Regulations — (a)
brand name means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French, (a) that is assigned to the drug by its manufacturer, (b) under which the drug is sold or advertised, and (c) that is used to distinguish the drug; ( marque nominative )
Food and Drug Regulations — Food and Drug Regulations
case report means a detailed record of all relevant data associated with the use of a drug in a subject; ( fiche d’observation )
Food and Drug Regulations — Food and Drug Regulations
children’s standard dosage unit has, with reference to a drug, the same meaning as in Division 9; ( dose normale pour enfants )
Food and Drug Regulations — Food and Drug Regulations
child resistant package means a package that meets the requirements of subsection (2); ( emballage protège-enfants )
Food and Drug Regulations — (a)
common name means, with reference to a drug, the name in English or French by which the drug is (a) commonly known, and (b) designated in scientific or technical journals, other than the publications referred to in Schedule B to the Act; ( nom usuel )
Food and Drug Regulations — Food and Drug Regulations
COVID-19 means the coronavirus disease 2019; ( COVID-19 )
Food and Drug Regulations — Food and Drug Regulations
COVID-19 drug means a drug, other than a veterinary health product, that is manufactured, sold or represented for use in relation to COVID-19; ( drogue contre la COVID-19 )
Food and Drug Regulations — Food and Drug Regulations
discontinue means, in respect of the sale of a drug by the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug, to permanently cease the sale of the drug; ( cesser )
Food and Drug Regulations — (a)
expiration date means (a) in the case of a drug in dosage form, the earlier of the following dates, expressed at minimum as a year and month: (i) the date up to and including which the drug maintains its labelled potency, purity and physical characteristics, and (ii) the date after which the manufacturer recommends that the drug not be used; and (b) in the case of an active ingredient, whichever of the following dates is applicable, expressed at minimum as a year and month: (i) the retest date, or (ii) the date after which the manufacturer recommends that the active ingredient not be used; ( date limite d’utilisation )
Food and Drug Regulations — Food and Drug Regulations
flavour means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug solely to produce or mask a particular taste. It does not include an ingredient or combination of ingredients that impart only a sweet taste to the drug; ( saveur )
Food and Drug Regulations — Food and Drug Regulations
fragrance means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug to produce or mask a particular odour; ( parfum )
Food and Drug Regulations — Food and Drug Regulations
immediate container means the receptacle that is in direct contact with a drug; ( récipient immédiat )
Food and Drug Regulations — Food and Drug Regulations
internal use means ingestion by mouth or application for systemic effect to any part of the body in which the drug comes into contact with mucous membrane; ( usage interne )
Food and Drug Regulations — Food and Drug Regulations
ISAD Interim Order means the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 made by the Minister on September 16, 2020 and published in Part I of the Canada Gazette on October 3, 2020; ( arrêté d’urgence IVPD )