Contents
Whereas 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 30.05 of the Food and Drugs Act.notenoteOttawa, November 26, 2025La ministre de la Santé,Marjorie MichelMinister of Health
Interpretation
1Definitions#
(1)The following definitions apply in this Order.
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)
(2)In 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.
(3)Unless 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.
Part 1 · Shortage or Risk of Shortage
Class Exemptions — Certain Human Milk Fortifiers, New Human Milk Substitutes and Formulated Liquid Diets
2Foods manufactured outside Canada — exemption criteria#
Every 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:
(b)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; and
(c)in the case of a human milk fortifier or new human milk substitute, it does not meet the criteria set out in section 13.
3Foods manufactured in Canada — exemption criteria#
Every 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:
(b)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; and
(c)it is no longer intended for export.
4Exemptions#
A 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 of
(a)paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect of the use or presence only of
(i)a food additive,
(ii)any nutritive material that is used as an ingredient, or
(iii)a vitamin, mineral nutrient or amino acid; and
(b)the following provisions of the Regulations:
(i)the labelling and advertising provisions of Parts A, B and D,
(ii)section B.16.011,
(iii)paragraph B.24.003(1)(f), in respect of the requirement to comply with section B.24.102,
(iv)section B.24.102,
(v)section B.25.010,
(vi)subsection B.25.046(1),
(vii)section B.25.051,
(viii)section B.25.054,
(ix)section B.25.056,
(x)section B.28.002,
(xi)subsection D.01.002(2),
(xii)sections D.01.009 to D.01.011,
(xiii)subsection D.02.009(1),
(xiv)subsection D.02.010(2),
(xv)section D.02.011, and
(xvi)section D.03.002.
Conditions
5Notification of importation#
(1)An 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.
(2)The notification must set out the following information in respect of the food:
(a)its brand name and product name;
(b)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;
(c)the name and contact information of the importer;
(d)the name and contact information of the manufacturer;
(e)the intended port of entry into Canada;
(f)the estimated date of arrival of the shipment; and
(g)the estimated total quantity of the food to be imported on the date referred to in paragraph (f).
6Notification of sale#
(1)A 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.
(2)The notification must set out the following information in respect of the food:
(a)its brand name and product name;
(b)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;
(c)the name and contact information of the manufacturer; and
(d)the estimated total quantity of the food to be sold.
7Document#
If 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:
(a)in at least one official language, the name and contact information of the manufacturer; and
(b)in both official languages,
(i)in the case of a human milk fortifier, a statement indicating that it is to be used only under medical supervision,
(ii)in the case of a formulated liquid diet, a statement indicating that it is intended to be consumed orally or by tube feeding,
(iii)the brand name and product name under which the food is sold or advertised for sale,
(iv)a description of the special dietary purpose for which the food is represented,
(v)a list of the food’s ingredients,
(vi)a food allergen source, gluten source and added sulphites statement, if applicable,
(vii)if the food contains aspartame, a statement to the effect that the food contains phenylalanine or that aspartame contains phenylalanine,
(viii)a statement of the energy value, expressed in a standardized unit of measurement, per the quantity of the food specified on the label,
(ix)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:
(A)protein, fat and carbohydrate and, if present, fibre,
(B)vitamins, mineral nutrients and amino acids, and
(C)in the case of a human milk fortifier or new human milk substitute, any other nutritive substances,
(x)directions for the preparation, use and storage of the food,
(xi)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, and
(xii)the 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.
8Document — copy to Minister#
(1)The 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.
(2)If 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.
9Notification of risk#
The 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.
10Notification — foreign regulatory authority#
If 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.
11Document — copy to purchaser or consumer#
Any 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.
12Sale of human milk fortifiers#
A human milk fortifier to which the exemption under section 2 or 3 applies may only be sold in the following situations:
(a)it is sold by the manufacturer to
(i)a hospital, or
(ii)an individual, if
(A)the 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, and
(B)the 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; or
(b)it 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.
Part 2 · Transition Strategy Products
Class Exemptions — Certain Human Milk Fortifiers and New Human Milk Substitutes
13Foods — exemption criteria#
Every 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:
(a)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;
(b)in the case of a human milk fortifier,
(i)the manufacturer provided to the Minister:
(A)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, and
(B)on or before July 15, 2024, the application under section B.25.011 of the Regulations that includes the information referred to in that section, and
(ii)the manufacturer has not been notified in writing by the Minister that the sale or advertisement for sale of the human milk fortifier is
(A)authorized under paragraph B.25.012(1)(a) or B.25.012(3)(a) of the Regulations, or
(B)not authorized under paragraph B.25.012(1)(b) or B.25.012(3)(b) of the Regulations; and
(c)in the case of a new human milk substitute,
(i)the manufacturer provided to the Minister:
(A)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, and
(B)on or before July 15, 2024, the notification that includes the information referred to in subsection B.25.046(2) of the Regulations, and
(ii)the manufacturer has not been informed in writing by the Minister that
(A)the notification is satisfactory, or
(B)the notification is not satisfactory and the submission is closed.
14Exemptions#
A human milk fortifier or new human milk substitute to which the exemption under section 13 applies is exempt from the application of
(a)paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect of the use or presence only of
(i)a food additive,
(ii)any nutritive material that is used as an ingredient, or
(iii)a vitamin, mineral nutrient or amino acid; and
(b)the following provisions of the Regulations:
(i)section A.01.014,
(ii)paragraphs B.01.008.2(1)(a) and (b), in respect of how the title of the list of ingredients is shown,
(iii)paragraph B.01.008.2(3)(b), in respect of how the ingredients in the list of ingredients are shown,
(iv)subparagraphs B.01.010.3(1)(a)(i) and (ii),
(v)paragraph B.01.010.4(1)(b),
(vi)subsection B.01.012(2),
(vii)subsection B.01.311(5),
(viii)section B.01.501,
(ix)subsection B.01.503(2.01),
(x)section B.16.011,
(xi)section B.16.017,
(xii)section B.25.010,
(xiii)subsection B.25.046(1),
(xiv)section B.25.051,
(xv)section B.25.054,
(xvi)section B.28.002,
(xvii)sections D.01.010 and D.01.011,
(xviii)subsection D.02.009(1), and
(xix)section D.03.002.
Conditions
15Document#
If 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.
16Notification of risk#
The 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.
17Notification — foreign regulatory authority#
If 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.
18Document — copy to purchaser or consumer#
Any 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.
19Sale of human milk fortifiers#
A human milk fortifier to which the exemption under section 13 applies may only be sold in the following situations:
(a)it is sold by the manufacturer to
(i)a hospital, or
(ii)an individual, if
(A)the 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, and
(B)the 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; or
(b)it 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
Federal laws of Canada reproduced under the Reproduction of Federal Law Order (SI/97-5); not the official version. Source: Justice Laws Website.