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FOOD AND DRUGS ACTExemption Order in Respect of Foods for a Special Dietary PurposeWhereas the Minister of Health believes on reasonable grounds that the annexed Order is necessary for a health or safety purpose or is otherwise in the public interest;And whereas the Minister of Health believes on reasonable grounds that, having regard to its benefits and conditions, the annexed Order is unlikely to result in unacceptable health, safety or, if applicable, environmental risks or an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks;Therefore, the Minister of Health makes the annexed Exemption Order in Respect of Foods for a Special Dietary Purpose under section 30.05a of the Food and Drugs Actb.S.C. 2024, c. 17, s. 326R.S., c. F-27Ottawa, November 26, 2025La ministre de la Santé,Marjorie MichelMinister of Health
Interpretation
DefinitionsThe following definitions apply in this Order.List means the document entitled List of Human Milk Fortifiers, Infant Formulas and Formulated Liquid Diets for Exceptional Importation and Sale in the Case of a Shortage or Risk of Shortage that is published by the Government of Canada on its website, as amended from time to time. (Liste)Regulations means the Food and Drug Regulations. (Règlement)shortage, in respect of a human milk fortifier, human milk substitute or formulated liquid diet that is sold in Canada, means a situation in which the supply of a category of that food is insufficient to meet the demand for it. (pénurie)References to manufacturerIn sections 6 to 10, with the exception of paragraph 7(a), a reference to manufacturer is to be read as a reference to a manufacturer of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 3 applies.Words and expressionsUnless the context otherwise requires, words and expressions used in this Order have the same meaning as in Part A, B or D of the Regulations, as applicable.
Shortage or Risk of ShortageClass Exemptions — Certain Human Milk Fortifiers, New Human Milk Substitutes and Formulated Liquid Diets
Foods manufactured outside Canada — exemption criteriaEvery human milk fortifier, new human milk substitute and formulated liquid diet that is manufactured outside Canada and meets the following criteria is exempt from the application of the provisions set out in section 4:it belongs to a category of food, of which there is a shortage or risk of shortage, set out in column 1 of Part A of the List;it is authorized by a corresponding foreign regulatory authority set out in column 2 of Part A of the List for sale in a corresponding jurisdiction set out in column 3 and it is imported from that jurisdiction; andin the case of a human milk fortifier or new human milk substitute, it does not meet the criteria set out in section 13.
Foods manufactured in Canada — exemption criteriaEvery human milk fortifier, new human milk substitute and formulated liquid diet that is manufactured in Canada for consumption or use outside Canada and meets the following criteria is exempt from the application of the provisions set out in section 4:it belongs to a category of food, of which there is a shortage or risk of shortage, set out in column 1 of Part B of the List;it is authorized by a corresponding foreign regulatory authority set out in column 2 of Part B of the List for sale in a corresponding jurisdiction set out in column 3; andit is no longer intended for export.
ExemptionsA human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 2 or 3 applies is exempt from the application ofparagraphs 4(1)(a) and (d) of the Food and Drugs Act in respect of the use or presence only ofa food additive,any nutritive material that is used as an ingredient, ora vitamin, mineral nutrient or amino acid; andthe following provisions of the Regulations:the labelling and advertising provisions of Parts A, B and D,section B.16.011,paragraph B.24.003(1)(f), in respect of the requirement to comply with section B.24.102,section B.24.102,section B.25.010,subsection B.25.046(1),section B.25.051,section B.25.054,section B.25.056,section B.28.002,subsection D.01.002(2),sections D.01.009 to D.01.011,subsection D.02.009(1),subsection D.02.010(2),section D.02.011, andsection D.03.002.
Conditions
Notification of importationAn importer of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 2 applies must notify the Minister, in writing, of the importation of each shipment of the food at least five days before the day on which it is imported.Information — notificationThe notification must set out the following information in respect of the food:its brand name and product name;the category of food set out in column 1 of Part A of the List to which the food belongs, the corresponding foreign regulatory authority set out in column 2 and the corresponding jurisdiction where it is authorized for sale set out in column 3;the name and contact information of the importer;the name and contact information of the manufacturer;the intended port of entry into Canada;the estimated date of arrival of the shipment; andthe estimated total quantity of the food to be imported on the date referred to in paragraph (f).
Notification of saleA manufacturer of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 3 applies must notify the Minister, in writing, of the sale of each lot of the food at least five days before the day on which it is sold.Information — notificationThe notification must set out the following information in respect of the food:its brand name and product name;the category of food set out in column 1 of Part B of the List to which the food belongs, the corresponding foreign regulatory authority set out in column 2 and the corresponding jurisdiction where it is authorized for sale set out in column 3;the name and contact information of the manufacturer; andthe estimated total quantity of the food to be sold.
DocumentIf any information shown on the label of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 2 or 3 applies does not comply with one or more of the labelling provisions that would otherwise be applicable under Part A, B or D of the Regulations, the importer or manufacturer, as the case may be, must prepare a document that sets out the following information:in at least one official language, the name and contact information of the manufacturer; andin both official languages,in the case of a human milk fortifier, a statement indicating that it is to be used only under medical supervision,in the case of a formulated liquid diet, a statement indicating that it is intended to be consumed orally or by tube feeding,the brand name and product name under which the food is sold or advertised for sale,a description of the special dietary purpose for which the food is represented,a list of the food’s ingredients,a food allergen source, gluten source and added sulphites statement, if applicable,if the food contains aspartame, a statement to the effect that the food contains phenylalanine or that aspartame contains phenylalanine,a statement of the energy value, expressed in a standardized unit of measurement, per the quantity of the food specified on the label,a statement of the quantity of the following nutrients, expressed in a standardized unit of measurement, per the quantity of the food specified on the label:protein, fat and carbohydrate and, if present, fibre,vitamins, mineral nutrients and amino acids, andin the case of a human milk fortifier or new human milk substitute, any other nutritive substances,directions for the preparation, use and storage of the food,the expiration date of the food or, if the expiration date is displayed on the label of the food, a statement indicating where the expiration date is located on the label and the format of that date, andthe lot number of the food or, if the lot number is displayed on the label of the food, a statement indicating where the lot number is located on the label.
Document — copy to MinisterThe importer or manufacturer, as the case may be, of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 2 or 3 applies must provide a copy of the document referred to in section 7 to the Minister prior to the first sale of the food to which the document relates.Updated documentIf the document is updated, the importer or manufacturer, as the case may be, must provide a copy of it to the Minister prior to the first sale of the food to which the updated document relates.
Notification of riskThe importer or manufacturer, as the case may be, of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 2 or 3 applies must notify the Minister immediately, in writing, of information in respect of any risk of injury to human health that they receive or become aware of in relation to the food.
Notification — foreign regulatory authorityIf a human milk fortifier, new human milk substitute or formulated liquid diet that belongs to a category of food set out in column 1 of Part A or B of the List is no longer authorized by a corresponding foreign regulatory authority set out in column 2 for sale in a corresponding jurisdiction set out in column 3, the importer or manufacturer, as the case may be, must notify the Minister, in writing, immediately after becoming aware of that fact.
Document — copy to purchaser or consumerAny person that sells a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 2 or 3 applies must make a paper copy of the document referred to in section 7 available to the purchaser or consumer at the time of sale.
Sale of human milk fortifiersA human milk fortifier to which the exemption under section 2 or 3 applies may only be sold in the following situations:it is sold by the manufacturer toa hospital, oran individual, ifthe individual has received a written order for a human milk fortifier from a physician or from a nurse practitioner or dietitian who is authorized to write the order under the laws of a province, andthe manufacturer has received a written request from a hospital that specifies the product name and quantity of the human milk fortifier that needs to be provided to the individual; orit is sold by a hospital to an individual who has received a written order for a human milk fortifier from a physician or from a nurse practitioner or dietitian who is authorized to write the order under the laws of a province.
Transition Strategy ProductsClass Exemptions — Certain Human Milk Fortifiers and New Human Milk Substitutes
Foods — exemption criteriaEvery human milk fortifier and new human milk substitute for which the following criteria are met is exempt from the application of the provisions set out in section 14:it is authorized by a foreign regulatory authority in the United States, the United Kingdom, the European Union or Australia for sale within that authority’s jurisdiction and it is imported from that jurisdiction;in the case of a human milk fortifier,the manufacturer provided to the Minister:on or before January 17, 2024, a letter indicating the manufacturer’s intention to submit an application under section B.25.011 of the Regulations to sell or advertise for sale the human milk fortifier, andon or before July 15, 2024, the application under section B.25.011 of the Regulations that includes the information referred to in that section, andthe manufacturer has not been notified in writing by the Minister that the sale or advertisement for sale of the human milk fortifier isauthorized under paragraph B.25.012(1)(a) or B.25.012(3)(a) of the Regulations, ornot authorized under paragraph B.25.012(1)(b) or B.25.012(3)(b) of the Regulations; andin the case of a new human milk substitute,the manufacturer provided to the Minister:on or before January 17, 2024, a letter indicating the manufacturer’s intention to submit a notification in writing under subsection B.25.046(1) of the Regulations that they intend to sell or advertise for sale the new human milk substitute, andon or before July 15, 2024, the notification that includes the information referred to in subsection B.25.046(2) of the Regulations, andthe manufacturer has not been informed in writing by the Minister thatthe notification is satisfactory, orthe notification is not satisfactory and the submission is closed.
ExemptionsA human milk fortifier or new human milk substitute to which the exemption under section 13 applies is exempt from the application ofparagraphs 4(1)(a) and (d) of the Food and Drugs Act in respect of the use or presence only ofa food additive,any nutritive material that is used as an ingredient, ora vitamin, mineral nutrient or amino acid; andthe following provisions of the Regulations:section A.01.014,paragraphs B.01.008.2(1)(a) and (b), in respect of how the title of the list of ingredients is shown,paragraph B.01.008.2(3)(b), in respect of how the ingredients in the list of ingredients are shown,subparagraphs B.01.010.3(1)(a)(i) and (ii),paragraph B.01.010.4(1)(b),subsection B.01.012(2),subsection B.01.311(5),section B.01.501,subsection B.01.503(2.01),section B.16.011,section B.16.017,section B.25.010,subsection B.25.046(1),section B.25.051,section B.25.054,section B.28.002,sections D.01.010 and D.01.011,subsection D.02.009(1), andsection D.03.002.
Conditions
DocumentIf any information shown on the label of a human milk fortifier or new human milk substitute to which the exemption under section 13 applies is information that would otherwise be required under the Regulations to be shown in both official languages but that information is shown in only one official language, the importer must prepare a document that sets out that same information in the other official language.
Notification of riskThe importer of a human milk fortifier or new human milk substitute to which the exemption under section 13 applies must notify the Minister immediately, in writing, of information in respect of any risk of injury to human health that they receive or become aware of in relation to the food.
Notification — foreign regulatory authorityIf a human milk fortifier or new human milk substitute to which the exemption under section 13 applies is no longer authorized by a foreign regulatory authority in a jurisdiction referred to in paragraph (a) of that section for sale within that jurisdiction, the importer must notify the Minister, in writing, immediately after becoming aware of that fact.
Document — copy to purchaser or consumerAny person that sells a human milk fortifier or new human milk substitute to which the exemption under section 13 applies must make a paper copy of the document referred to in section 15 available to the purchaser or consumer at the time of sale.
Sale of human milk fortifiersA human milk fortifier to which the exemption under section 13 applies may only be sold in the following situations:it is sold by the manufacturer toa hospital, oran individual, ifthe individual has received a written order for a human milk fortifier from a physician or from a nurse practitioner or dietitian who is authorized to write the order under the laws of a province, andthe manufacturer has received a written request from a hospital that specifies the product name and quantity of the human milk fortifier that needs to be provided to the individual; orit is sold by a hospital to an individual who has received a written order for a human milk fortifier from a physician or from a nurse practitioner or dietitian who is authorized to write the order under the laws of a province.
Coming into Force
PublicationThis Order comes into force on the day on which it is published in the Canada Gazette, Part II.