GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — B.25.020
B.25.020 (1) The following information is required to be displayed on the outer label of a human milk fortifier: (a) a statement of the quantity, expressed in grams, of protein, fat, available carbohydrate and, where present, fibre in a quantity of human milk fortifier specified in the directions for use; (b) a statement of the energy value, expressed in Calories, in a quantity of human milk fortifier specified in the directions for use; (c) a statement of the quantity, expressed in milligrams, micrograms or International Units, of all vitamins, mineral nutrients and amino acids set out in item 6, Column II, of the table to section D.03.002 that are present in a quantity of human milk fortifier specified in the directions for use; (d) a statement of the quantity, expressed in grams, milligrams, micrograms or International Units, of any other nutritive substance that is present in a quantity of human milk fortifier specified in the directions for use; (e) directions for the storage of the human milk fortifier before and after the package has been opened; (f) the directions for use for the human milk fortifier, including directions for the preparation, use and storage of the mixture of human milk fortifier and human milk; (g) a statement indicating that the human milk fortifier is to be used only under medical supervision; (h) the expiration date of the human milk fortifier; and (i) the lot number of the human milk fortifier. (2) If the human milk fortifier does not have an outer label, (a) the information referred to in subsection (1) is required to be displayed on the inner label, except as otherwise provided in paragraph (b); and (b) the information referred to in paragraphs (1)(e) and (f) may, despite section A.01.016, be displayed on a leaflet that is affixed or attached to the container that is in direct contact with the human milk fortifier. (3) If the human milk fortifier has an outer label, the information referred to in paragraphs (1)(h) and (i) is also required to be displayed on the inner label. SOR/2021-57, s. 13
Food and Drug Regulations — B.25.021
B.25.021 It is prohibited, on the label of or in any advertisement for a human milk fortifier, to make any statement or claim relating to the content in the human milk fortifier of (a) the percentage of the daily value of (i) fat, (ii) saturated fatty acids and trans fatty acids, (iii) sodium, (iv) potassium, (v) sugars, (vi) fibre, or (vii) cholesterol; or (b) the number of Calories from (i) fat, or (ii) saturated fatty acids and trans fatty acids. SOR/2021-57, s. 13
Food and Drug Regulations — B.25.045
B.25.045 The common name of a human milk substitute or a new human milk substitute shall be infant formula . ( préparation pour nourrissons ) SOR/90-174, s. 2
Food and Drug Regulations — B.25.046
B.25.046 (1) No person shall sell or advertise for sale a new human milk substitute unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Minister in writing of the intention to sell or advertise for sale the new human milk substitute. (2) The notification referred to in subsection (1) shall be signed and shall include, in respect of the new human milk substitute, the following information: (a) the name under which it will be sold or advertised for sale; (b) the name and the address of the principal place of business of the manufacturer; (c) the names and addresses of each establishment in which it is manufactured; (d) a list of all of its ingredients, stated quantitatively; (e) the specifications for nutrient, microbiological and physical quality for the ingredients and for the new human milk substitute; (f) details of quality control procedures respecting the testing of the ingredients and of the new human milk substitute; (g) details of the manufacturing process and quality control procedures used throughout the process; (h) the results of tests carried out to determine the expiration date of the new human milk substitute; (i) the evidence relied on to establish that the new human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; (j) a description of the type of packaging to be used; (k) directions for use; (l) the written text of all labels, including package inserts, to be used in connection with the new human milk substitute; and (m) the name and title of the person who signed the notification and the date of signature. (3) Notwithstanding subsection (1), a person may sell or advertise for sale a new human milk substitute if the manufacturer has notified the Minister pursuant to subsection (1) and is informed in writing by the Minister that the notification is satisfactory. SOR/90-174, s. 2; SOR/2018-69, ss. 27, 30(F)
Food and Drug Regulations — B.25.047
B.25.047 Sections B.25.051 to B.25.059 apply in respect of new human milk substitutes. SOR/90-174, s. 2; SOR/2003-11, s. 25
Food and Drug Regulations — B.25.048
B.25.048 (1) No person shall sell or advertise for sale a human milk substitute that has undergone a major change unless the manufacturer of the human milk substitute, at least 90 days before the sale or advertisement, notifies the Minister in writing of the intention to sell or advertise for sale the human milk substitute. (2) The notification referred to in subsection (1) shall be signed and shall include, in respect of the human milk substitute, the following information: (a) the name under which it will be sold or advertised for sale; (b) the name and the address of the principal place of business of the manufacturer; (c) a description of the major change; (d) the evidence relied on to establish that the human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; (e) the evidence relied on to establish that the major change has had no adverse effect on the human milk substitute; (f) the written text of all labels, including package inserts, to be used in connection with the human milk substitute; and (g) the name and title of the person who signed the notification and the date of signature. (3) Notwithstanding subsection (1), a person may sell or advertise for sale a human milk substitute that has undergone a major change if the manufacturer has notified the Minister pursuant to subsection (1) and is informed in writing by the Minister that the notification is satisfactory. SOR/90-174, s. 2; SOR/2018-69, ss. 27, 30(F)
Food and Drug Regulations — B.25.051
B.25.051 (1) No person shall sell or advertise for sale a human milk substitute unless, when prepared according to directions for use, it complies with the provisions of this Division respecting human milk substitutes. (2) No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food complies with the nutritional requirements set out in this Division for human milk substitutes. SOR/83-933, s. 1
Food and Drug Regulations — B.25.052
B.25.052 (1) No person shall sell or advertise for sale a human milk substitute unless it meets the nutritional requirements of infants with normal or special dietary needs and it is of such a consistency that, when ready-to-serve, it passes freely through a nursing bottle nipple. (2) No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food meets the nutritional requirements of infants with normal or special dietary needs. SOR/78-637, s. 6; SOR/82-768, s. 76; SOR/83-933, s. 1
Food and Drug Regulations — B.25.053
B.25.053 (1) No person shall sell or advertise for sale a human milk substitute that requires, when prepared according to directions for use, the addition of a nutritive substance, other than water or a source of carbohydrate or both. (2) No person shall sell or advertise for sale a food represented as containing a human milk substitute that requires, when prepared according to directions for use, the addition of a nutritive substance other than water. SOR/78-637, s. 7; SOR/83-933, s. 1
Food and Drug Regulations — B.25.054
B.25.054 (1) Except as otherwise provided in this Division, no person shall sell or advertise for sale a human milk substitute unless it contains, when prepared according to directions for use, (a) per 100 available kilocalories (i) not less than 3.3 and not more than 6.0 grams of fat, (ii) not less than 500 milligrams of linoleic acid in the form of a glyceride, (iii) [Repealed, SOR/2024-244, s. 138] (iv) not less than 1.8 and not more than 4.0 grams of protein, (v) not less than 1.8 grams of protein of nutritional quality equivalent to casein, or such an amount and quality of protein, including those proteins to which amino acids are added, that, when the quality of the protein is expressed as a fraction of the quality of casein, (A) the fraction will not be less than 85/100, and (B) the product obtained by multiplying the fraction by the gram weight of the protein will not be less than 1.8, (vi) notwithstanding sections D.01.010, D.01.011 and D.02.009, the vitamin and mineral nutrient set out in Column I of an item of Table II to this Division in an amount not less than the amount set out in Column II of that item and not more than the amount set out in Column III of that item, and (vii) not less than 12 milligrams of choline; and (b) a ratio of (i) alpha-tocopherol to linoleic acid of not less than 0.6 International Units to one gram, (ii) calcium to phosphorus of not less than 1.2 grams to one gram and not more than 2.0 grams to one gram, and (iii) vitamin B 6 to protein of not less than 15 micrograms to one gram. (2) No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food complies with subsection (1). SOR/78-637, s. 7; SOR/83-933, s. 1 SOR/2024-244, s. 138
Food and Drug Regulations — B.25.055
B.25.055 (1) Subparagraph B.25.054(1)(a)(i) does not apply to a human milk substitute represented as being for a fat-modified diet. (2) Subparagraph B.25.054(1)(a)(iv), except that portion thereof that prescribes the maximum amount of protein, and subparagraph B.25.054(1)(a)(v) do not apply to a human milk substitute represented as being for a low (naming the amino acid) diet. (3) All that portion of subparagraph B.25.054(1)(a)(vi) that prescribes the minimum amounts of vitamin D, calcium and phosphorus and subparagraph B.25.054(1)(b)(ii) do not apply to a human milk substitute represented as being for a low (naming the mineral) diet or a low vitamin D diet or both. SOR/83-933, s. 1
Food and Drug Regulations — B.25.056
B.25.056 No person shall sell a human milk substitute or a food that is represented as containing a human milk substitute (a) that contains an added nutritive substance that is (i) normally contained in human milk, and (ii) not referred to in paragraph B.25.054(1)(a) unless the amount of that substance present per 100 available kilocalories of the human milk substitute or human milk substitute portion of the food, when prepared according to directions for use, is equal to the amount thereof present per 100 available kilocalories of human milk; or (b) that contains added amino acids unless (i) the amino acids are required to improve the quality of the protein in the human milk substitute or human milk substitute portion of the food and are present in an amount not exceeding the minimum required for that purpose, or (ii) the protein content of the human milk substitute or human milk substitute portion of the food is supplied by isolated amino acids or by protein hydrolysate, or both and only the L forms of the amino acids have been added. SOR/78-637, s. 8; SOR/83-933, s. 1
Food and Drug Regulations — B.25.057
uantity of the food when ready-to-serve, (iii) the quantity of all vitamins and mineral nutrients set out in Table II to this Division in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the food as offered for sale and in International Units or milligrams in a stated quantity of the food when ready-to-serve, and (iv) the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a) in milligrams or grams per 100 grams or in milligrams or grams per 100 millilitres of the food as offered for sale and in milligrams or grams in a stated quantity of the food when ready-to-serve; (e) adequate directions for the preparation, use and storage of the food after the container has been opened; and (f) the expiration date of the food. SOR/83-933, s. 1; SOR/88-559, s. 30
Food and Drug Regulations — B.25.058
B.25.058 Notwithstanding section D.02.005, no person shall make any claim with respect to the iron content of a human milk substitute except as required by paragraph B.25.057(1)(c), unless the human milk substitute contains at least one milligram of iron per 100 available kilocalories. SOR/78-637, s. 9(F); SOR/83-933, s. 1
Food and Drug Regulations — B.25.059
B.25.059 No person shall, on the label of or in any advertisement for a human milk substitute or a food represented as containing a human milk substitute, make any statement or claim relating to the content in the food of (a) the percentage of the daily value of (i) fat, (ii) saturated fatty acids and trans fatty acids, (iii) sodium, (iv) potassium, (v) sugars, (vi) fibre, or (vii) cholesterol; or (b) the number of Calories from (i) fat, or (ii) saturated fatty acids and trans fatty acids. SOR/2003-11, s. 26; SOR/2016-305, s. 60
Food and Drug Regulations — B.25.060
B.25.060 (1) Where the manufacturer of a human milk substitute or of a food that is represented as containing a human milk substitute is requested in writing by the Minister to submit on or before a specified day evidence with respect to the human milk substitute, the manufacturer shall make no further sales of that human milk substitute or food that is represented as containing human milk substitute after that day unless he has submitted the evidence requested. (2) If the Minister determines that the evidence submitted by a manufacturer under subsection (1) is not sufficient, he or she shall so notify the manufacturer in writing. (3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to the human milk substitute is not sufficient, he shall make no further sales of that human milk substitute or of that food that is represented as containing the human milk substitute unless he submits further evidence and is notified in writing by the Minister that the further evidence is sufficient. (4) In this section, evidence with respect to the human milk substitute means (a) evidence that establishes that the human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; and (b) the results of tests carried out to determine the expiration date of the human milk substitute. SOR/83-933, s. 1; SOR/88-424, s. 2; SOR/90-174, s. 3; SOR/2018-69, ss. 12, 27
Food and Drug Regulations — B.25.061
B.25.061 (1) Subject to subsection (2), no person shall include on the label of a food any representation respecting the consumption of the food by an infant who is less than six months of age. (2) Subsection (1) does not apply in respect of a human milk fortifier, human milk substitute or new human milk substitute. SOR/83-933, s. 1; SOR/90-174, s. 4 SOR/2021-57, s. 15
Food and Drug Regulations — B.25.062
B.25.062 [Repealed, SOR/2024-244, s. 139] TABLE I Sodium Content in Infant Foods Column I Column II Food Total Sodium in Grams per 100 Grams of Food 1 Junior Desserts 0.10 2 Junior Meat, Junior Meat Dinners, Junior Dinners, Junior Breakfasts 0.25 3 Junior Vegetables, Junior Soups 0.20 4 Strained Desserts 0.05 5 Strained Meats, Strained Meat Dinners, Strained Dinners, Strained Breakfasts 0.15 6 Strained Vegetables, Strained Soups 0.10 SOR/78-637, s. 10; SOR/83-933, s. 1 TABLE II Item No. Column I Column II Column III Vitamin or Mineral nutrient Minimum amount per 100 available kilocalories Maximum amount per 100 available kilocalories B.1 Biotin 2 µg — F.1 Folic acid 4 µg — N.1 Niacin 250 µg — P.1 d-pantothenic acid 300 µg — R.1 Riboflavin 60 µg — T.1 Thiamine 40 µg — T.2 Alpha-tocopherol 0.6 I.U. — V.1 Vitamin A 250 I.U. 500 I.U. V.2 Vitamin B 6 35 µg — V.3 Vitamin B 12 0.15 µg — V.4 Vitamin C 8 mg — V.5 Vitamin D 40 I.U. 80 I.U. V.6 Vitamin K 1 8 µg — C.1 Calcium 50 mg — C.2 Chloride 55 mg 150 mg C.3 Copper 60 µg — L.1 Iodine 5 µg — L.2 Iron 0.15 mg — M.1 Magnesium 6 mg — M.2 Manganese 5 µg — P.2 Phosphorus 25 mg — P.3 Potassium 80 mg 200 mg S.1 Sodium 20 mg 60 mg Z.1 Zinc 0.5 mg — SOR/83-933, s. 1; SOR/98-458, s. 7(F) SOR/2022-197, s. 7
Food and Drug Regulations — B.26.001
B.26.001 In this Division, irradiation means treatment with ionizing radiation. SOR/89-175, s. 3; SOR/2017-16, s. 3
Food and Drug Regulations — B.26.002
B.26.002 This Division does not apply to foods exposed to ionizing radiation from a measuring instrument used to determine weight, estimate bulk solids, measure the total solids in liquids or perform other inspection procedures. SOR/89-175, s. 3
Food and Drug Regulations — B.26.003
B.26.003 (1) Subject to subsection (2), no person shall sell a food that has been irradiated. (2) A food that is set out in column 1 of the table to this Division that has been irradiated may be sold if both of the following requirements are met: (a) the ionizing radiation is of a type and from a source set out in column 2 for the purpose of irradiation set out in column 3; and (b) the ionizing radiation that is absorbed by the food is either within the range set out in columns 4 and 5 or, if there is no minimum absorbed dose set out in column 4, is not more than the maximum absorbed dose set out in column 5. SOR/89-175, s. 3; SOR/2017-16, s. 4
Food and Drug Regulations — B.26.004
B.26.004 (1) A manufacturer who sells a food that has been irradiated shall keep on their premises, for at least two years after the date of the irradiation, a record that contains all of the following information: (a) the name of the food that was irradiated and the quantity and lot numbers of the food; (b) the purpose of the irradiation; (c) the date of the irradiation; (d) the dose of ionizing radiation that was absorbed by the food; (e) the type and source of the ionizing radiation; (f) a statement that indicates whether the food was previously irradiated and, if it was previously irradiated, the information referred to in paragraphs (a) to (e) in respect of that previous irradiation. (2) A person who imports a food for sale in Canada that has been irradiated shall keep on their premises, for at least two years after the date of importation, a record of the information required by subsection (1). SOR/89-175, s. 3; SOR/2017-16, s. 5
Food and Drug Regulations — B.26.005
 (2) 7.0 (3) Electrons from machine sources operated at or below 10 MeV (3) To reduce microbial load, including pathogens (3) 1.5 (3) 7.0 (4) X-rays from machine sources operated at or below one of the following: (a) 7.5 MeV when the target material is tantalum or gold; (a) To reduce microbial load, including pathogens; (a) 1.5 (a) 7.0 (b) 5 MeV in any other case. (b) To reduce microbial load, including pathogens. (b) 1.5 (b) 7.0 SOR/89-175, s. 3; SOR/98-458, s. 7(F); SOR/2017-16, ss. 6, 7; SOR/2018-69, s. 27
Food and Drug Regulations — (3)
(3) Electrons from machine sources operated at or below 3 MeV
Food and Drug Regulations — (1)
(1) To reduce microbial load, including pathogens
Food and Drug Regulations — (2)
(2) To reduce microbial load, including pathogens
Food and Drug Regulations — (3)
(3) Electrons from machine sources operated at or below 10 MeV
Food and Drug Regulations — (3)
(3) To reduce microbial load, including pathogens
Food and Drug Regulations — (4)
(4) X-rays from machine sources operated at or below one of the following:
Food and Drug Regulations — (a)
(a) 7.5 MeV when the target material is tantalum or gold;
Food and Drug Regulations — (a)
(a) To reduce microbial load, including pathogens;
Food and Drug Regulations — (b)
(b) To reduce microbial load, including pathogens.
Food and Drug Regulations — B.27.001
B.27.001 In this Division, commercially sterile means the condition obtained in a food that has been processed by the application of heat, alone or in combination with other treatments, to render the food free from viable forms of microorganisms, including spores, capable of growing in the food at temperatures at which the food is designed normally to be held during distribution and storage; ( stérilité commerciale ) hermetically sealed container [Repealed, SOR/2024-244, s. 141] low-acid food means a food, other than an alcoholic beverage, where any component of the food has a pH greater than 4.6 and a water activity greater than 0.85; ( aliment peu acide ) refrigeration means exposure to a temperature of 4°C or less but does not mean frozen; ( réfrigéré ) shipping container means a receptacle, package or wrapper in which containers of food are placed for transportation; ( contenant d’expédition ) water activity means the ratio of the water vapour pressure of a food to the vapour pressure of pure water, at the same temperature and pressure. ( activité de l’eau ) SOR/89-309, s. 1 SOR/2024-244, s. 141
Food and Drug Regulations — Food and Drug Regulations
commercially sterile means the condition obtained in a food that has been processed by the application of heat, alone or in combination with other treatments, to render the food free from viable forms of microorganisms, including spores, capable of growing in the food at temperatures at which the food is designed normally to be held during distribution and storage; ( stérilité commerciale )
Food and Drug Regulations — Food and Drug Regulations
hermetically sealed container [Repealed, SOR/2024-244, s. 141]
Food and Drug Regulations — Food and Drug Regulations
low-acid food means a food, other than an alcoholic beverage, where any component of the food has a pH greater than 4.6 and a water activity greater than 0.85; ( aliment peu acide )
Food and Drug Regulations — Food and Drug Regulations
refrigeration means exposure to a temperature of 4°C or less but does not mean frozen; ( réfrigéré )
Food and Drug Regulations — Food and Drug Regulations
shipping container means a receptacle, package or wrapper in which containers of food are placed for transportation; ( contenant d’expédition )
Food and Drug Regulations — Food and Drug Regulations
water activity means the ratio of the water vapour pressure of a food to the vapour pressure of pure water, at the same temperature and pressure. ( activité de l’eau )
Food and Drug Regulations — B.27.002
B.27.002 (1) No person shall sell a low-acid food packaged in a hermetically sealed container unless the food is commercially sterile. (2) Subsection (1) does not apply in respect of a low-acid food packaged in a hermetically sealed container where (a) the low-acid food is kept under refrigeration and the statement “Keep Refrigerated” and “ Garder réfrigéré ” is carried on the principal display panel of the label of its container, as well as on the label of its shipping container; or (b) the low-acid food is kept frozen and the statement “Keep Frozen” and “ Garder congelé ” is carried on the principal display panel of the label of its container, as well as on the label of its shipping container. (3) Subsection (1) does not apply in respect of tomatoes or tomato products packaged in hermetically sealed containers where the tomatoes or tomato products have a pH of 4.7 or less after heat processing. SOR/89-309, s. 1; SOR/91-149, s. 7 SOR/2018-108, s. 399 SOR/2024-244, s. 142(F)
Food and Drug Regulations — B.27.003
B.27.003 No person shall sell a low-acid food packaged in a hermetically sealed container where the container (a) is swollen; (b) is not properly sealed; or (c) has any defect that may adversely affect its hermetic seal. SOR/89-309, s. 1 SOR/2024-244, s. 143(F)