Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers): SOR/2021-57

Canada Gazette, Part II, Volume 155, Number 8

Registration
SOR/2021-57 March 29, 2021

FOOD AND DRUGS ACT

P.C. 2021-215 March 26, 2021

His Excellency the Administrator of the Government of Canada in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1)footnote a and section 30.5footnote b of the Food and Drugs Actfootnote c, makes the annexed Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers).

Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers)

Amendments

1 (1) The definition nutritional supplement in subsection B.01.001(1) of the Food and Drug Regulationsfootnote 1 is replaced by the following:

nutritional supplement
means a food sold or represented as a supplement to a diet that may be inadequate in energy and essential nutrients. It does not include a human milk fortifier; (supplément nutritif)

(2) Section B.01.001 of the Regulations is amended by adding the following after subsection (2):

(3) The following definitions apply in this Division.

human milk fortifier
has the same meaning as in section B.25.001. (fortifiant pour lait humain)
human milk substitute
has the same meaning as in section B.25.001. (succédané de lait humain)

2 Subsection B.01.001.1(3) of the Regulations is replaced by the following:

(3) Subsection (2) does not apply if the food is

3 Subsection B.01.005(4) of the Regulations is replaced by the following:

(4) Despite subsection (2), the information required by subparagraph B.01.007(1.1)(b)(i) or paragraph B.24.103(g), B.25.020(1)(h), B.25.057(1)(f) or (2)(f) may be shown on that part of the label that is applied to the bottom of the package if a clear indication of the location of the required information appears elsewhere on the label.

4 Paragraph B.01.008(1)(a) of the Regulations is replaced by the following:

5 Paragraph B.01.008.3(4)(e) of the Regulations is replaced by the following:

6 (1) The portion of the definition specialty food in subsection B.01.012(1) of the Regulations before paragraph (a) is replaced by the following:

specialty food
means a food — other than a human milk fortifier — that

(2) Paragraphs (a) and (b) of the definition aliment spécial in subsection B.01.012(1) of the French version of the Regulations are replaced by the following:

7 Subsection B.01.033(1) of the Regulations is replaced by the following:

B.01.033 (1) Except in the case of a formulated liquid diet, human milk fortifier or human milk substitute, it is prohibited to sell a food represented in any manner as containing hydrolyzed or partially hydrolyzed collagen, hydrolyzed or partially hydrolyzed gelatin or hydrolyzed or partially hydrolyzed casein unless the label carries the following statement on the principal display panel in the same size type used for the common name:

“CAUTION, DO NOT USE AS SOLE SOURCE OF NUTRITION”.

8 Paragraph B.01.305(3)(a) of the Regulations is replaced by the following:

9 Subsections B.01.401(4) and (5) of the Regulations are replaced by the following:

(4) Subsection (1) does not apply to a formulated liquid diet, human milk fortifier, human milk substitute, food represented as containing a human milk substitute, meal replacement, nutritional supplement or food represented for use in a very low energy diet.

(5) The label of, or an advertisement for, a formulated liquid diet, human milk fortifier, human milk substitute, food represented as containing a human milk substitute, meal replacement, nutritional supplement or food represented for use in a very low energy diet shall not contain a nutrition facts table or the phrase “nutrition facts”, “valeur nutritive” or “valeurs nutritives”.

10 Section B.01.503 of the Regulations is amended by adding the following after subsection (2):

(2.01) Despite subsections (1) and (2), it is prohibited, on the label of or in any advertisement for a human milk fortifier, to make a statement or claim set out in column 4 of the table following section B.01.513.

11 Subsection B.24.003(2) of the Regulations is replaced by the following:

(2) Subsection (1) does not apply to a human milk fortifier or human milk substitute as defined in section B.25.001.

12 (1) The definitions expiration date, human milk substitute, infant, infant food and major change in section B.25.001 of the Regulations are replaced by the following:

expiration date
means, in respect of a human milk fortifier or human milk substitute, the date
  • (a) after which the manufacturer does not recommend that it be consumed, and
  • (b) up to which it maintains its microbiological and physical stability and the nutrient content declared on the label; (date limite d'utilisation)
human milk substitute
means any food that is labelled or advertised
  • (a) for use as a partial or total replacement for human milk and as intended for consumption by infants, or
  • (b) for use as an ingredient in a food referred to in paragraph (a); (succédané de lait humain)
infant
means an individual who is under the age of one year; (bébé)
infant food
means a food that is labelled or advertised for consumption by infants; (aliment pour bébés)
major change
means, in respect of a human milk fortifier or human milk substitute, any change of an ingredient, the amount of an ingredient or the processing or packaging of the human milk fortifier or human milk substitute where the manufacturer's experience or generally accepted theory would predict an adverse effect on the levels or availability of nutrients in, or the microbiological or chemical safety of, the human milk fortifier or human milk substitute; (changement majeur)

(2) Section B.25.001 of the Regulations is amended by adding the following in alphabetical order:

human milk fortifier
means a food that
  • (a) includes at least one added vitamin, mineral nutrient or amino acid, and
  • (b) is labelled or advertised as intended to be added to human milk to increase its nutritional value in order to meet the particular requirements of an infant in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state; (fortifiant pour lait humain)

13 The Regulations are amended by adding the following after section B.25.003:

Human Milk Fortifiers

B.25.010 Subject to section B.25.013, it is prohibited to sell or advertise for sale a human milk fortifier unless the Minister has notified the manufacturer under paragraph B.25.012(1)(a) or (3)(a) that those activities are authorized.

B.25.011 An application to sell or advertise for sale a human milk fortifier shall be submitted by the manufacturer and signed by the manufacturer or an individual authorized to sign on their behalf and shall include the following information:

B.25.012 (1) After having conducted an assessment of the information submitted under section B.25.011 and any other information related to the assessment of the application, the Minister shall notify the manufacturer in writing that the sale or advertisement for sale of the human milk fortifier that is the subject of the application

(2) If the conditions set out in paragraph (1)(a) are not satisfied, the Minister may request the manufacturer to submit in writing the additional information that is necessary to satisfy the conditions.

(3) After having conducted an assessment of any additional information that is submitted by the manufacturer, the Minister shall notify the manufacturer in writing that the sale or advertisement for sale of the human milk fortifier

(4) Despite paragraphs (1)(a) and (3)(a), the Minister shall not authorize the sale or advertisement for sale of the human milk fortifier if the Minister has reasonable grounds to believe that any of the information that the manufacturer has submitted is false, misleading or deceptive.

B.25.013 The prohibition set out in section B.25.010 does not apply in respect of a human milk fortifier that is set out in the List of Human Milk Fortifiers Sold in Canada as of March 25, 2021 that is published on a Government of Canada website if, on or before April 30, 2022,

B.25.014 (1) The Minister shall notify the manufacturer in writing that they are authorized to continue to sell or advertise for sale the human milk fortifier if

(2) If the information that is submitted is insufficient to satisfy the conditions set out in subsection (1), the Minister may request the manufacturer to submit in writing the additional information that is necessary to satisfy the conditions.

(3) After having conducted an assessment of any additional information that is submitted by the manufacturer, the Minister shall notify the manufacturer in writing that

B.25.015 (1) It is prohibited to sell or advertise for sale a human milk fortifier that has undergone a major change unless

(2) The application shall be signed by the manufacturer or an individual authorized to sign on their behalf and shall include the following information:

B.25.016 (1) After having conducted an assessment of the information submitted under subsection B.25.015(2) and any other information related to the assessment of the application, the Minister shall notify the manufacturer in writing that the sale or advertisement for sale of the human milk fortifier that is the subject of the application

(2) If the conditions set out in paragraph (1)(a) are not satisfied, the Minister may request the manufacturer to submit in writing the additional information that is necessary to satisfy the conditions.

(3) After having conducted an assessment of any additional information that is submitted by the manufacturer, the Minister shall notify the manufacturer in writing that the sale or advertisement for sale of the human milk fortifier

(4) Despite paragraphs (1)(a) and (3)(a), the Minister shall not authorize the sale or advertisement for sale of the human milk fortifier if the Minister has reasonable grounds to believe that any of the information that the manufacturer has submitted is false, misleading or deceptive.

B.25.017 A manufacturer named in the List of Human Milk Fortifiers Sold in Canada as of March 25, 2021 referred to in section B.25.013 is not entitled to submit an application referred to in paragraph B.25.015(1)(a) in respect of a human milk fortifier set out in the List unless the Minister has

B.25.018 (1) If the manufacturer of a human milk fortifier is requested in writing by the Minister to submit evidence with respect to the human milk fortifier within a time limit specified by the Minister, the manufacturer shall make no further sales of the human milk fortifier — and shall not advertise it for sale — after the expiry of the time limit unless they have submitted the requested evidence.

(2) The time limit cannot be less than 24 hours after the request is made unless the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health.

(3) If the Minister determines that the evidence submitted by the manufacturer is insufficient, the Minister shall notify the manufacturer accordingly in writing.

(4) If the manufacturer is notified that the evidence with respect to the human milk fortifier is insufficient, the manufacturer shall make no further sales of the human milk fortifier – and shall not advertise it for sale — unless they submit additional evidence and are notified in writing by the Minister that the additional evidence is sufficient.

(5) In this section, evidence with respect to the human milk fortifier means

B.25.019 (1) Even if the Minister has notified the manufacturer of a human milk fortifier that the sale or advertisement for sale of the human milk fortifier is authorized, it may only be sold in the following situations:

(2) The following definitions apply in this section.

dietitian
means a person who is registered and entitled under the laws of a province to practise as a dietitian and who is practising as a dietitian under those laws in that province. (diététiste)
hospital
has the same meaning as in section B.24.001. (hôpital)
nurse practitioner
has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (infirmier praticien)
physician
has the same meaning as in section B.24.001. (médecin)

B.25.020 (1) The following information is required to be displayed on the outer label of a human milk fortifier:

(2) If the human milk fortifier does not have an outer label,

(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.

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

14 The Regulations are amended by adding the following after section B.25.060:

Additional Rules

15 Subsection B.25.061(2) of the Regulations is replaced by the following:

(2) Subsection (1) does not apply in respect of a human milk fortifier, human milk substitute or new human milk substitute.

16 Subsection B.25.062(1) of the Regulations is replaced by the following:

B.25.062 (1) Subject to subsection (2), it is prohibited to sell an infant food if the food contains a food additive.

17 Subsection D.01.001(1) of the Regulations is amended by adding the following in alphabetical order:

human milk fortifier
has the same meaning as in section B.25.001; (fortifiant pour lait humain)
human milk substitute
has the same meaning as in section B.25.001; (succédané de lait humain)

18 Subsection D.01.001.1(2) of the Regulations is replaced by the following:

(2) Subsection (1) does not apply if the food is

19 The portion of subsection D.01.003(1) of the Regulations before paragraph (a) is replaced by the following:

D.01.003 (1) For the purposes of these Regulations, the vitamin content of a food — other than a formulated liquid diet, human milk fortifier, human milk substitute or food represented as containing a human milk substitute — shall be determined

20 The portion of subsection D.01.004(1) of the Regulations before paragraph (a) is replaced by the following:

D.01.004 (1) It is prohibited, on the label of or in any advertisement for a food — other than a formulated liquid diet, human milk fortifier, human milk substitute or food represented as containing a human milk substitute — to make a statement or claim concerning the vitamin content of the food unless

21 The Regulations are amended by adding the following after section D.01.007:

D.01.008 Sections D.01.009, D.01.010 and D.01.011 do not apply to a human milk fortifier.

22 The portion of subsection D.02.002(1) of the Regulations before paragraph (a) is replaced by the following:

D.02.002 (1) It is prohibited, on the label of or in any advertisement for a food — other than salt for table or general household use containing added iodide, prepackaged water and ice, a formulated liquid diet, human milk fortifier, human milk substitute or food represented as containing a human milk substitute — to make a statement or claim concerning the mineral nutrient content of the food unless

23 Section D.02.009 of the Regulations is renumbered as subsection D.02.009(1) and is amended by adding the following:

(2) Subsection (1) does not apply to a human milk fortifier.

24 Item 6 of the table to section D.03.002 of the Regulations is replaced by the following:
 

Column I

Food

Column II

Vitamin, Mineral Nutrient or Amino Acid
6 Human milk fortifiers, infant formulas and formulated
liquid diets

Amino acids — alanine, arginine, aspartic acid, cystine, glutamic acid, glycine, histidine, hydroxyproline, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine;

Minerals — calcium, chloride, chromium, copper, iodide, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc;

Vitamins — alpha-tocopherol, biotin, choline, d-pantothenic acid, folic acid, niacin, riboflavin, thiamin, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin K.

Transitional Provisions

25 (1) In this section, new Regulations means the Food and Drug Regulations as they read on the day on which these Regulations come into force.

(2) A human milk fortifier, as defined in section B.25.001 of the new Regulations, that is set out in the List of Human Milk Fortifiers Sold in Canada as of March 25, 2021 that is published on a Government of Canada website does not need to be labelled in accordance with the new Regulations if it is labelled in the same way as it was labelled immediately before the day on which these Regulations come into force.

(3) Subsections (1) and (2) cease to have effect on the second anniversary of the day on which these Regulations come into force.

Coming into Force

26 These Regulations come into force on the day on which they are published in the Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Human milk fortifiers (HMFs) are infant foods which are intended to be added to human milk (i.e. breast milk) to increase its nutritional value and provide necessary nutrients for infants who are born prematurely or for other infants as medically required (e.g. small for gestational age, high protein needs). Providing HMFs to infants in such circumstances is a best practice in clinical care. Currently, there are no provisions specific to HMFs in the Food and Drug Regulations (FDR), meaning the general food framework applies. It is necessary to amend the FDR to include provisions related to HMFs to enable the addition of vitamins, mineral nutrients, amino acids and food additives to HMFs, and also to help safeguard the health and safety of vulnerable infants who need HMFs to meet their nutritional requirements. The lack of a regulatory framework for HMFs is a long-standing health and industry-stakeholder irritant that results in a less transparent process for industry, which can negatively impact market access to new or innovative products.

In recognition of the importance of HMFs to help meet the nutritional needs of preterm and other infant populations, Health Canada currently has a temporary review process that enables Canadian hospitals access to certain HMFs assessed to be safe by the Department. However, clear regulatory requirements are needed for long-term product development and innovation as well as to align with other jurisdictions such as the United States (U.S.), where the HMFs available in Canada are currently manufactured. Amendments to the FDR are needed to establish a regulatory framework for the sale of HMFs in Canada, in order to help ensure their continued safety.

Background

According to the World Health Organization (WHO), preterm birth rates are increasing around the world. Each year, about 30 000 infants are born prematurely in Canada. The preterm birth rate in Canada fluctuates between 6% – 8% of all live births.footnote 2 Health professionals in neonatal intensive care units (NICUs) and epidemiologists recognize that advanced maternal age and multiple births increase the risk of a preterm birth. Advances in medical care have improved preterm infant survival rates, with infants weighing as little as 330 g now able to survive.footnote 3 The survival of certain preterm infants is supported by the use of HMFs that provide critical nutrition to this population.

HMFs are infant foods that are intended to be added to human milk to increase its nutritional value and provide necessary nutrients for certain preterm infants or other infants as medically required. HMFs contain a combination of nutrients important to the growth of infants, such as added vitamins, mineral nutrients, or amino acids, as well as protein, fat, and carbohydrates. They are available in powder or liquid formats and are intended to be added to human milk in specific amounts according to the unique nutritional needs of each infant. HMFs are never consumed on their own, as they are not considered nutritionally adequate unless they are added to human milk.

Human milk, in particular the infant's own mother's milk, is recommended for feeding infants once they start enteral (tube or oral) feeding since it has been demonstrated to provide nutritional and immunological benefits over infant formulas.footnote 4 However, human milk alone does not provide sufficient amounts of nutrients for optimal growth and development of preterm infants or for infants with certain medical conditions such as very low birth weight for gestational age or ongoing high protein needs.footnote 4 If these infants are fed only human milk, they can be at risk of developing specific deficiency diseases, such as calcium-phosphorus deficiency (osteopenia) or zinc deficiency. These deficiencies can slow growth, which can increase the risk of impaired neurocognitive development.footnote 5

HMFs are used by hospitals to address these nutrient gaps and provide optimal nutrition to infants under their care. The use of HMFs is considered the current practice in North America for certain preterm and other infants as medically required. Studies have shown that the use of human milk with added HMF allows for most of the immunological benefits of human milk to be maintained, while also improving the nutritional status of preterm infants compared to those fed only human milk.footnote 4,footnote 6 HMFs are commonly used by hospitals in Canada until the infant reaches an equivalent gestational age of 34 to 38 weeks or a weight of 1 800 g to 2 000 g.footnote 4

History of HMFs in Canada

HMFs were first made available in Canada in the mid-1980s, through Temporary Marketing Authorizations (TMAs). A TMA is a regulatory instrument that allows the temporary sale of a food that is deemed safe, but does not meet one or more of the compositional, packaging, labelling or advertising requirements of the FDR. TMAs are used for the purpose of generating information in support of a regulatory amendment. Under the TMAs, the manufacturers could only distribute their HMF products to specific hospitals, and for use only under the supervision of specifically identified physicians. These manufacturers also agreed to provide Health Canada with the results of studies related to their respective HMFs, including safety and efficacy data from post-market surveillance. Three HMFs were granted market access through TMAs; one of those was discontinued in 2006.

By the mid-2000s, Health Canada had gathered sufficient data and began working on developing a formal regulatory framework in consultation with health stakeholders and manufacturers. As there was no longer a need to gather data through the TMA process, Health Canada did not issue more TMAs or renew the existing ones.

HMFs are important foods, since preterm, and other infants as medically required, need HMFs to meet their nutritional requirements. As a result, hospitals continued to require access to HMFs after the expiry of the TMAs and prior to the establishment of a formal regulatory framework. To address this need, Health Canada established a temporary review process to help ensure the safety of HMFs. This was reflected in an agreement with the Canadian Food Inspection Agency (CFIA) to permit HMFs previously available under TMAs, as well as new HMFs assessed and deemed safe by Health Canada, to be sold and used in Canadian hospitals. Under this current system, Health Canada continues to review submissions for HMFs new to the Canadian market and HMFs that have undergone a major change (i.e. any change to composition, manufacturing or packaging that impacts the nutrient level, microbiological or chemical safety of the HMF), to help ensure that the products do not present a risk to preterm infants or other infants requiring HMFs.

Specifically, Health Canada conducts a detailed review of the evidence to evaluate the safety, nutritional adequacy, ingredients and nutritional composition of the HMF. The objective of this review is to help ensure that the levels of nutrients, including vitamins, mineral nutrients and amino acids, are safe and suitable for the intended infants. The assessment also includes an analysis of the manufacturing process and the labelling of the product to verify that it carries essential information including an ingredient list, nutrition information, directions for preparation, storage and use, an expiration date, and lot numbers. If, after an assessment, the Department deems that the HMF is safe, Health Canada adds the product to a list of HMFs permitted for sale. This list is provided to hospital NICUs and the CFIA. HMFs managed under this system are used under medical supervision in a hospital/clinical setting and are not available to the general public.

Under this temporary review process, the sale of 2 of the 3 HMFs, which had previously received TMAs continued (one HMF was discontinued by the manufacturer). The Department also reviewed submissions for 7 additional HMF products in 2010, 2014 and 2019 and added them to the list of approved HMFs. Currently 10 HMFs are available in Canada from three manufacturers based in the U.S.

Challenges of the current approach

The existing approach has allowed HMFs to remain available for preterm infants or other infants as medically required. However, there are several limitations to operating in the absence of a regulatory framework:

Companies rely on federal regulations, including the FDR, to guide their decisions to bring products to Canada, or to manufacture them in Canada. Despite having a process in place to help ensure the safety of HMFs, limited information is publicly available about the current process including the evidence that is needed for HMFs to be sold in Canada. It is difficult for companies who do not already manufacture HMFs to determine the path to market for these products in Canada. This can result in new products reaching the Canadian market much later than in the U.S. due to the lack of predictability and regulatory clarity.

Stakeholders have identified the lack of a regulatory framework for HMFs as a long-standing regulatory irritant to economic growth and innovation. In order to address this concern, Health Canada included the framework for HMFs in the agri-food and aquaculture sector regulatory review roadmap of 2019.

Objective

The objective of these amendments is to establish a regulatory framework for the sale of HMFs in Canada. This framework will set out the information and evidence that must be submitted to the Minister of Health for review, in order to help ensure the safety and nutritional adequacy of HMFs and the health and safety of the infant population that relies on them.

This objective will be achieved by establishing a pre-market assessment scheme for HMFs and HMFs that have undergone a major change; setting conditions of sale, including stopping sale if evidence shows the HMF product is no longer safe or nutritionally adequate; permitting the addition of vitamins, mineral nutrients, and other key ingredients to HMFs; and setting out labelling requirements.

Description

The Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers) [the regulations] will amend the FDR to update existing provisions and add new provisions in Part B (Food) and Part D (Vitamins, Minerals and Amino Acids) to create a regulatory framework for HMFs.

Creation of new headings in Division 25, Part B

Firstly, a new heading in Division 25 titled “Human Milk Fortifiers” will be created, under which the majority of the new regulatory requirements will be set out. This heading will be situated between the provisions for “Infant Foods” (sections B.25.002 and B.25.003) and “Human Milk Substitutes and Food Containing Human Milk Substitutes” i.e. infant formula (sections B.25.045 to B.25.060), as HMFs are also a type of infant food distinct from infant formula. The provisions under this heading will capture the following elements: requirements for pre-market review, conditions related to the sale of HMFs, and labelling requirements.

Secondly, a new heading in Division 25 titled “Additional Rules” will be created after section B.25.060, as the remaining sections deal with other foods in addition to human milk substitutes, such as human milk fortifiers and infant foods.

Definitions

The regulations will also amend the FDR to add a new provision defining “human milk fortifier.” HMFs will be defined as a food that includes at least one added vitamin, mineral nutrient or amino acid that is labelled and advertised as intended to be added to human milk to increase its nutritional value, in order to meet the particular requirements of an infant in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state, which includes prematurity. The intended use of HMFs is for certain preterm infants but is also intended to provide flexibility for health professionals to use HMFs for other infants when they deem it to be necessary. This definition also excludes products added to human milk that do not contain added vitamins, mineral nutrients or amino acids, as they are generally lower risk and considered a different product from HMFs by the medical community (e.g. protein modular, which is a product that is added to some infant foods to increase protein content).

The definition for “major change” will be expanded to apply to HMFs. The current definition for “major change” only applies to infant formula. A major change is any change of ingredient, the amount of an ingredient or change in the processing or packaging.

Other existing definitions that will be amended in light of the new scheme for HMFs are as follows:

Pre-market review of HMFs

Pre-market review of HMFs prior to sale is necessary to help ensure the safety and nutritional adequacy of HMFs for their intended use. Under the regulatory amendments, it will be prohibited to advertise for sale or to sell an HMF unless the Minister has notified the manufacturer in writing that they are authorized to sell the HMF and advertise it for sale.

New HMFs on the market

The regulations will amend the FDR to add provisions setting out application requirements for the pre-market review of an HMF. This includes providing the Minister of Health with

In the assessment, the Minister of Health will determine whether all of the required information has been submitted and whether the information provided is sufficient to establish that the HMF is safe. The Minister of Health will also be able to request in writing additional information relevant to the application if it is required to assess the HMF. When conducting a pre-market review of a new HMF, the Minister of Health may also consider other relevant information, including information provided to, or obtained from, a foreign regulator. The Minister will notify the manufacturer in writing whether the sale or advertisement for sale of the HMF is authorized. Finally, the Minister shall not authorize the sale or advertisement for sale of the HMF if there are reasonable grounds to believe that the information submitted is false, misleading or deceptive.

Guidance on the pre-market submission process will be published on the Government of Canada's website.

HMFs that have undergone a major change

It will be prohibited to sell or advertise for sale a human milk fortifier that has undergone a major change, unless the manufacturer makes a pre-market application with the required information, listed below, reflecting the change. The HMF with the major change will only be permitted to be sold and advertised for sale once the application is assessed by the Minister of Health and the Minister of Health notifies the manufacturer in writing that the HMF is authorized to be sold and advertised for sale.

The regulations will amend the FDR to add provisions setting out application requirements for the pre-market review of a major change:

The Minister of Health will assess that all the required information has been submitted, and is sufficient to establish that the HMF is safe. The Minister of Health will also be able to request in writing additional information relevant to the application if it is required to assess the HMF. Similar to new HMFs, for HMFs that have undergone a major change, the Minister of Health may also consider other relevant information, including information provided to, or obtained from, a foreign regulator. The Minister will notify the manufacturer in writing whether the sale or advertisement for sale of the HMF that has undergone a major change is authorized. Finally, the Minister shall not authorize the sale or advertisement for sale of the HMF if the Minister has reasonable grounds to believe that the information submitted is false, misleading or deceptive.

Guidance on this process will be published on the Government of Canada's website.

HMFs currently on the market

To identify existing HMF products and their specific manufacturers, a list of HMFs that have been assessed as safe by Health Canada, entitled the List of Human Milk Fortifiers Sold in Canada as of March 25, 2021 (the List), will be published on the Government of Canada's website and incorporated by reference into the FDR.

Manufacturers of HMFs that have previously undergone an assessment by Health Canada and that are included on the List will not be required to resubmit a full pre-market application, provided that the HMF has not undergone a major change since the date indicated in the List in connection with that HMF. Manufacturers of these HMFs will be required to submit an attestation that the HMF has not undergone a major change since that date as well as provide new label text that complies with the new labelling requirements.

Manufacturers will be required to submit this information in sufficient time for the Minister of Health to assess the information before April 30, 2022. If the information submitted is insufficient to assess the attestation or label text, the Minister of Health may request additional information to satisfy the requirements. The Minister of Health will then notify the manufacturer in writing whether they are authorized to continue to sell or advertise for sale the HMF. The manufacturer will have two years to make any necessary label changes in order to come into compliance with these amendments to the FDR.

If after April 30, 2022, a manufacturer has not submitted the required information and the Minister of Health has not notified them in writing that they are authorized to continue to sell and advertise for sale the HMF, the manufacturer cannot continue to sell or advertise for sale the HMF in Canada. The manufacturer will need to resubmit an application to introduce a new HMF to the market. This will be outlined in a Health Canada guidance document specific to the transitioning of HMFs currently marketed in Canada.

Further, should a manufacturer wish to submit an application for a major change for an HMF that is in the List, it must first satisfy the above conditions, and then the manufacturer is entitled to submit an application for a major change. A manufacturer of an HMF identified in the List may also apply for a major change if it has previously applied as a new HMF and received a notice in writing from the Minister of Health authorizing the manufacturer to sell or advertise for sale the HMF.

Guidance on this process will be sent directly to the manufacturers that are included on the List of HMFs permitted to be sold in Canada.

Conditions related to the sale of HMFs

Home use of HMFs

In Canada, HMFs are currently only available in hospitals because of the specialized medical training required to manage the nutritional needs of certain preterm infants and other infants using HMFs. Hospitals select and administer HMFs based on the specific nutritional needs of each infant, monitor the requirements and regularly adjust the dosage based on the health status of the infant. Over- or under-fortification could lead to serious adverse effects.

While the administration of HMFs in a clinical setting is expected to remain the primary way in which infants receive HMFs, there is evidence to suggest that a short period of use post-discharge will be beneficial in some circumstances. Recent studies suggest that the use of HMFs post-discharge could improve the growth trajectory of certain infants with ongoing medical conditions, provided there is sufficient oversight by a medical professional.footnote 7 The use of HMFs at home, in certain cases, may permit infants to be discharged from the NICU earlier. This may be an associated benefit for HMF use post-discharge as there is evidence indicating that some infants with prolonged hospitalization fail to thrive (poor growth rates) which may negatively impact parent-child relationships. Most stakeholders agreed that a small subset of infants will benefit from HMFs being available for post-discharge use; estimates ranged from 5% – 30% of infants and were based on the stakeholders' own knowledge and judgment.

On the other hand, health professionals have highlighted potential risks associated with improper administration or preparation of the HMFs. Generally, there is a need to tailor the preparation of HMFs to the nutrient needs of the infant. HMFs are concentrated products, and administering more HMF than an infant requires could result in negative health impacts to the infant. Therefore, it is not appropriate for the general public to have access to HMFs without medical oversight.

In light of the potential benefits of at-home use of HMFs, Health Canada is building flexibility into the FDR for the use of HMFs outside of hospitals, while maintaining the necessary level of medical oversight to help ensure their proper use by caregivers. The amendments to the FDR will permit HMFs to be sold to individuals outside of hospitals if they have a written order from a physician, nurse practitioner or dietitian. Nurse practitioners and dietitians will be permitted to write orders for HMFs where they are authorized to do so in their province or territory.

A definition of “dietitian” will be added to the relevant section, and mean a person who is registered and entitled under the laws of a province to practise as a dietitian and is practising as a dietitian in that province.

Some definitions will be added to the relevant section as having the same meaning as found either in the FDR or the New Classes of Practitioners Regulations:

Furthermore,

Post-discharge programs with similar requirements have been in place in the U.S. for approximately a decade with no known issues.

Stop sale

New evidence related to establishing the nutritional adequacy of an HMF, or the test results carried out to determine the expiration date of an HMF, may become available after the HMF has been assessed and its sale or advertisement for sale is authorized by the Minister of Health. In order to properly evaluate this new information, the Minister of Health may require evidence from the manufacturer. As such, in order to help mitigate any potential harm from the use of HMFs, the amendments to the FDR provide that if a manufacturer is requested to submit evidence within a specific time limit, the manufacturer cannot make any further sales of that HMF after that unless the evidence is submitted. The time limit cannot be earlier than 24 hours after the request for evidence is made, unless the Minister has reasonable grounds to believe that there is serious and imminent risk of injury to human health.

If the Minister of Health determines that the evidence is insufficient, the manufacturer will be notified in writing; they will be required to stop selling and advertising for sale the HMF until they provide additional evidence to the Minister of Health. If the additional evidence is sufficient, the Minister notifies the manufacturer in writing.

Food for special dietary use

HMFs meet the definition of “food for special dietary use” in section B.24.001 of the FDR, since they are specially formulated to meet the particular needs of preterm or other infants.

Addition of vitamins, mineral nutrients and amino acids

The FDR regulates the addition of vitamins, mineral nutrients and amino acids to foods to help ensure that Canadians receive sufficient but not excessive amounts of these nutrients in their diet. The FDR prohibits the addition of vitamins, mineral nutrients and amino acids to foods unless otherwise permitted in the FDR.

The regulations will amend the FDR to permit the addition of vitamins, mineral nutrients, and amino acids to HMFs, with no prescribed maximum or minimum levels. The levels of nutrients added to a new HMF or an HMF that has undergone a major change will be reviewed and assessed on a case-by-case basis to help ensure its safety and nutritional adequacy. Setting no maximum and minimum levels in regulation will allow for more flexibility in the nutritional composition of HMFs, which will permit more specialized product development. The nutrient requirements of preterm infants are highly variable, as nutrient requirements differ at different weights and ages. Including specific compositional requirements for HMFs could limit innovation and different product formulations that could benefit this vulnerable population.

Choline is an essential nutrient that has been safely added to HMFs, infant formula and formulated liquid diets in the past. Recently, choline was reclassified as a vitamin under the FDR and, as such, became subject to the restrictions applicable to the addition of vitamins to foods. The amendments to the FDR will explicitly permit choline to be added to HMFs, infant formula and formulated liquid diets.

Food additives

A food additive typically is a chemical substance that is added to food during manufacturing that either becomes a part of the food or affects its characteristics for the purpose of achieving a particular technical effect. A food that contains a food additive can only be sold in Canada if the use of the food additive in the food is set out in Health Canada's Lists of Permitted Food Additives, which are incorporated by reference into the food additive Marketing Authorizations (MAs) and published on the Government of Canada's website. The Lists are generally organized according to the technical purpose for which the additives on each List may be used (e.g. List of Permitted Preservatives; List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents).

Some HMFs currently marketed in Canada contain one or more food additives. Health Canada has assessed these uses of food additives as safe and will permit them in HMFs by adding the uses to the applicable Lists of Permitted Food Additives through a notice of modification published on the Public involvement and partnerships web page.

Also, concurrent with or shortly after the regulatory amendments for HMFs come into force, Health Canada intends to amend two of the food additive MAs, the Marketing Authorization for Food Additives That May Be Used as Food Enzymes and the Marketing Authorization for Food Additives That May Be Used as Preservatives. This is being proposed so that in the future the Department will be able to permit, through an administrative process, certain new food additive uses for HMFs or other infant foods, if requested. This would be done by adding the new use to the List of Permitted Food Additives that is incorporated by reference into the MA, after evaluating the safety and efficacy of the new food additive use in the HMF. First, a notice of intent for these amendments to the MAs will be published on the Public involvement and partnerships web page.

Manufacturers wishing to request that Health Canada permit uses of food additives in HMFs not permitted by the List modifications referred to above can do so through the food additive submission premarket review process.

Another amendment related to food additives is in subsection B.25.062(1) to replace the phrase “a food that is labelled or advertised for consumption by infants” with “infant food” to simplify and modernize the language.

Labelling requirements

The FDR include labelling requirements that apply to most prepackaged foods, such as requirements for nutrition information labelling, ingredient labelling, nutrition-related claims (e.g. nutrient content claims), date markings and lot numbers. Amendments to the FDR will adapt some of these requirements for HMFs, as well as introduce a requirement for directions for preparation, storage and use, a cautionary statement to only use HMFs under medical supervision and require that information on a label for HMFs must appear in both official languages.

Nutrition information labelling

The FDR will prohibit the use of a Nutrition Facts table (NFt) on the label of an HMF. The daily values (DVs) used in the NFt for foods intended solely for infants and/or children are based on nutrient requirements for infants six months of age or older but less than one year of age, or for children one year of age or older but less than four years of age, respectively. Since HMFs are used by infants less than six months of age, it is not appropriate to apply DVs which are based on the dietary requirements for the general population of infants and children in the respective age group in this circumstance. Accordingly, HMFs will be added to the existing provisions prohibiting certain foods from carrying an NFt.

The FDR will require HMF labels to include nutrition information that sets out the energy value in calories and the amount of key nutrients (protein, fat, carbohydrate, fibre, vitamins [including choline], mineral nutrients, amino acids and any other nutritive substance) in a quantity of the HMF that is indicated in the directions for use. The nutrients that must be declared on the label, along with their units, will be specified in the FDR. For some nutrients, the units of measurement will differ slightly from those required for other foods as they may correspond to smaller amounts of a particular nutrient (e.g. milligrams or micrograms versus grams). Also, manufacturers would be permitted to indicate the source of their protein, for example if it originates from cow's milk or human milk (e.g. HMF based on cow's milk or on human milk) on HMF labels. This is the current practice for infant formulas.

Ingredient labelling

Under the amendments to the FDR, most of the existing requirements for ingredient labelling (e.g. font size and case, spacing, colour, legibility, borders), will apply to HMFs. However, HMFs will be exempt from the requirement to group types of sugars together in the list of ingredients. Types of sugars are generally grouped together in the ingredient list so that consumers can easily identify all the sugars added to a food, helping consumers make more informed and healthier choices. However, HMFs are to be used under medical supervision and consumers do not make choices on the type of HMF used. Therefore, grouping of sugars will be less useful for medical professionals who are responsible for the selection and administration of HMFs, which are based on the infant's medical or nutritional needs.

Nutrition-related claims

The following provisions of the FDR related to claims are being amended:

A provision will be added to Division 25 stating that, similar to the related provision for human milk substitutes in section B.25.059, no statements or claims relating to the percentage of daily value for certain nutrients (fat, saturated or trans fatty acids, sodium, potassium, sugars, fibre or cholesterol) or the number of calories from fat or saturated or trans fatty acids will be permitted to appear on the label or in any advertisement for HMFs.

HMFs contained in a single container

If the HMF is in a single container (i.e. is not sold in a box containing smaller sachets or bottles and does not have an outer label) the information, directions and statements required to be shown on the outer label of a container shall be shown on the label, including the expiration date and lot number. Additionally, the directions for the preparation, storage and use may appear on a leaflet that is affixed or attached to the HMF's container. This will permit the use of “peel-back” labels if desired.

Directions, date markings and lot numbers

The amendments to the FDR will include requirements for directions on the outer label for the storage of the HMF before and after it has been opened. Directions for the preparation, use and storage of the HMF mixed with human milk as well as the directions for use of the HMF must also appear on the outer label. The above directions will not be required to be grouped on the label.

A statement identifying that the HMF is to be used only under medical supervision will also be required on the outer label.

HMFs will be required to include an expiration date and a lot number on the outer label. HMFs are often sold or packaged as multiple units or sachets. As a result, the amendments to the FDR will also require the labelling of the expiration date and lot number to apply to inner labels. If there is only a single container, the expiration date and lot number must be included on the label on that container. The expiration date will be permitted to be on the bottom of a package, similar to other foods for special dietary use and infant formula.

Transitional provisions

A transitional period is provided, which will permit manufacturers of HMFs already on the market in Canada to continue using current labelling for a two-year period.

Coming into force

The regulations come into force on the day on which they are published in the Canada Gazette, Part II.

Regulatory development

Consultation

Health Canada consulted with stakeholders over a number of years in the development of the policy and regulations.

Pre-consultation, part I (2011 to 2014)

Health Canada consulted with stakeholders about the intent to develop a regulatory framework for HMFs in Canada as part of targeted consultations in 2011. Several rounds of consultation with health professionals and industry stakeholders followed in 2013 and 2014 seeking input on the principles and approach for regulating HMFs. These stakeholders included manufacturers of HMFs and clinical experts, the Canadian Paediatric Society's Nutrition and Gastroenterology Committee, and Health Canada's Paediatric Expert Advisory Committee (PEAC), comprised of representatives from academia, industry and health organizations.

Stakeholder feedback

At that time, most stakeholders expressed their concurrence regarding the development of a regulatory framework and associated controls for HMFs, which included recognizing HMFs as a distinct product requiring regulation, requiring pre-market notification, allowing the addition of vitamins and mineral nutrients, and restricting advertising. The HMF industry raised concerns that advertising restrictions would prevent them from providing educational materials about HMFs. Health Canada clarified that HMFs are intended for use in NICUs under medical supervision and for this reason should not be advertised to the general public. Stakeholders also suggested that the regulatory definition of HMFs should be less specific about gestational age and birth weight. Revisions were made to the definition of HMFs in response to the suggestion from stakeholders.

Health Canada held subsequent pre-consultations in 2013 and 2014 with manufacturers, clinical experts, and PEAC on the updated regulatory approach and also specifically on access to HMFs outside of the NICU. The majority of health stakeholders supported restricting HMFs for use within NICUs, with concerns expressed about the safety of such products used in the home setting (e.g. mixing errors, contamination, incorrect feeding amounts). Manufacturers supported restricted availability, such as with a prescription. Some experts indicated that in certain situations, infants ready for discharge could benefit from continued HMF use at home. Some health professionals also noted that they had on occasion provided caregivers with a small quantity of HMF to be used at home.

Pre-consultation, part II (July 2019)

From July 5 to 18, 2019, Health Canada held meetings with stakeholders to better understand the market for HMFs and their use in a hospital setting. Ten meetings were held with four manufacturers of HMFs as well as with health professionals from six hospitals in Ontario, Quebec and Alberta.

Stakeholder feedback

Common themes raised by stakeholders were that HMF use is increasing in NICUs, in part because of the increased use of donor milk instead of infant formula. Similar to a mother's own milk, donor milk may require fortification. Stakeholders also observed an increase in premature births. While there are standard ratios of HMF to human milk in place for feeding infants, recipes are often individually tailored by a medical professional to fit an infant's nutritional needs. Shortages of HMFs are extremely rare in NICUs in Canada. There was strong support for a formal regulatory system that is timely and flexible, as stakeholders also noted potential for future innovation in this area.

Health stakeholders were divided on the use of HMFs post-discharge from a hospital, with some acknowledging that this could be beneficial in some circumstances (e.g. for infants with ongoing high protein needs and with adequate medical supervision), while others were opposed based on a perceived inability to follow up with caregivers. Industry stakeholders supported post-discharge use of HMFs, similar to the programs that have been administered in the U.S. for approximately a decade. One company expressed interest in extending their current post-discharge program to Canada.

Pre-consultation, part III (December 2019 to February 2020)

The Department conducted targeted pre-consultations in December 2019 to February 2020 with HMF manufacturers and health stakeholders to receive further feedback on the use of HMFs outside of NICUs and adverse reaction or event reporting. The consultation focused on risk mitigation (e.g. use of a written order), monitoring, and adverse reaction or event reporting. The Department also accepted general input from stakeholders, including the opportunity to update views from previous consultations, and reached out specifically to Indigenous organizations to obtain their input.

Stakeholder feedback

Health Canada received 15 responses from stakeholders, 10 from health stakeholders, and 5 from manufacturers.

Most stakeholders agreed that a small subset of infants would benefit from HMFs being available for post-discharge use. Estimates ranged from 5% to 30% of infants and were based on the stakeholders' own experiences. A few of the hospitals commented that they have instructed caregivers to add preterm or term infant formula to human milk to meet the needs of some infants post-discharge from the hospital. Infant formula is designed to be mixed with water, not human milk, and may pose a higher risk of improper preparation and administration. Stakeholders also indicated that HMFs may be easier for caregivers to manage, as they are typically in single use pre-measured packages. Stakeholders also indicated there are health and safety risks if HMFs are not used properly outside of the hospital; however, they agreed that these risks could be managed by restricting access to HMFs (requiring a written note and limiting sale locations), proper training and instructions for caregivers, and frequent follow up with the infant and caregiver.

Stakeholders' views were mixed on whether adverse reaction reporting for HMFs should be mandatory. Due to underlying pre-existing medical conditions in preterm infants using HMFs, it would be very difficult to attribute causal association for adverse reactions reported in infants consuming HMFs. Some health stakeholders are interested in seeing more information on adverse reactions, while others cautioned about administrative burden and compliance issues. One industry stakeholder suggested that only serious events that require medical intervention (beyond stopping use of the HMF) should be reported, and another indicated that they already collect data on all issues, including adverse reactions, related to their product.

Pre-consultation, part IV (March 2020)

In March 2020, Health Canada invited industry and health stakeholders to a technical meeting to introduce key policy elements of the proposed HMF framework. Two separate meetings were held, with attendance from four manufacturers of HMFs and four health professionals from hospitals in Ontario and Nova Scotia.

Stakeholder feedback

Overall, all stakeholders were supportive of the key elements and direction of the proposed regulatory framework. Stakeholders were interested in learning more details about technical aspects related to evidence required for pre-market assessment, composition, distribution, and labelling.

Some stakeholders were interested in the criteria for assessing nutritional adequacy and ensuring that it will be flexible enough to keep up with new research. Health stakeholders also raised concerns that general directions for preparation and use on the HMF label are not specific enough for the individual nutritional requirements of the infant. Health Canada explained that use of HMFs outside a hospital would require a written order from a physician, and this written order would have clear feeding instructions for the caregiver.

Industry stakeholders asked about adverse reporting requirements, and they supported Health Canada's decision to use a voluntary reporting approach. Service standards for pre-market review were also discussed and it was communicated to industry that Health Canada will align as much as possible with the U.S. service standard of 90 days. Industry stakeholders signalled that this was an important element to have considered. A question was also raised around waiving the bilingual labelling requirement for HMFs, given that this is currently an imported product for a niche market. Health Canada indicated that an exemption will not be considered, as HMFs are used across Canada including in predominantly francophone populations. Moreover, there are HMFs currently available in Canada with labelling in both official languages.

A health stakeholder asked whether Health Canada had considered broadening the distribution of HMFs through hospital pharmacies. Health Canada noted that the feasibility of making HMFs available through pharmacies was considered. However, pharmacies do not currently carry HMFs and they do not have the appropriate expertise to provide advice on the use of HMFs to caregivers. Health Canada decided to take a cautious approach by making HMFs available only through hospitals, or directly from manufacturers at the request of a hospital with a physician's written order.

Pre-consultation, part V (September to October 2020)

From September to October 2020, Health Canada conducted targeted consultations with stakeholders on a draft copy of the regulatory amendments. All manufacturers and health stakeholders who participated in a previous consultation in 2019 and 2020 were invited to participate. International consultations through the technical barriers to trade notification system also occurred.

Three online meetings were held on October 13, October 15, and October 30, with participation from four industry stakeholders and eight health stakeholders. Additional written feedback was accepted until October 30.

Stakeholder feedback

Stakeholders appreciated the engagement and did not raise any major concerns with the text of the regulations. Clarifying questions were asked related to evidence requirements, sale of HMFs outside of hospitals, labelling, and transitioning HMFs that are already available in Canada into this new system. Many of the clarifying questions will be addressed in guidance documents that will be available on the Government of Canada's website.

Industry and health stakeholders also expressed support for HMFs to be permitted to be sold outside of hospitals through pharmacies. It was noted that sale through the pharmacy model would improve access to HMFs for rural and remote communities, as well as provide an additional safeguard that would help to ensure appropriate use. Health Canada consulted the National Association of Pharmacy Regulatory Authorities and determined that pharmacists are not trained to dispense HMFs, and that pharmacies are unlikely to carry them. Therefore, at this time, the Department will not permit the sale of HMFs by pharmacies.

Some health stakeholders expressed concerns that physicians outside of hospitals may not have the necessary background or patient history to support use of HMFs at home, and suggested permitting only neonatologists or physicians working in neonatal intensive care units to write orders for HMFs. However, restricting the class of physicians who can write orders for HMFs could unduly restrict physicians' ability to provide necessary medical care. Health stakeholders also voiced support for permitting nurse practitioners and dietitians to write orders for HMFs outside of hospitals, where this practice is permitted by their local jurisdiction. Health Canada determined that if the province or territory permits nurse practitioners and dietitians to write orders for HMFs, the HMF framework should not restrict these practitioners' ability to provide necessary medical care. Furthermore, hospitals will remain the point of access, in order to enable appropriate oversight. The Department will provide additional guidance on its website.

Both health and industry stakeholders suggested minor amendments to the definition of HMFs. Industry stakeholders noted that the proposed definition impacted other products added to human milk that do not contain added vitamins, mineral nutrients or amino acids (e.g. protein modulars). Health stakeholders expressed that since HMFs are most often given to premature infants, it was important to be more explicit in the definition and to indicate that HMFs are primarily intended for preterm infants. Stakeholders also commented that HMFs are sometimes added to preterm infant formula, but it was determined that this practice is rare and is not the purpose for which HMFs are formulated or the basis on which they are evaluated by Health Canada. The Department subsequently made adjustments to the definition of HMFs to better clarify the definition and scope of HMFs.

A request was made by some U.S. manufacturers for an exemption from bilingual labelling, citing the label space and costs associated with producing bilingual labels for such a niche product. To help protect the health and safety of the vulnerable infants using HMFs in Canada, it is important that medical practitioners and caregivers be able to read key information on the labels in English and French. Accordingly, the FDR will require labels in both official languages on HMFs. In addition, a manufacturer noted that the small packages of some HMF products may not be large enough to carry all of the required directions for storage, preparation and use. The FDR amendments will permit HMFs that do not have an outer label to show certain information in a leaflet that is affixed or attached to the immediate container, or entirely on the inner label.

Industry stakeholders noted that a one-year transition period to comply with labelling requirements would be challenging for some HMFs that are manufactured one to two times a year. Health Canada agreed to extend the transition period for labelling changes to two years, as it was determined that this would not pose a health and safety risk.

Some industry and health stakeholders supported better differentiation between HMFs made from human milk and those made from cow's milk or other protein sources. Health Canada recognizes that this information may be useful for health practitioners, and that several HMFs already voluntarily indicate the protein source, usually next to the product name. Voluntary protein source declarations will continue to be permitted on the labels of HMFs, similar to current practice for infant formula labels.

One manufacturer requested that only the quantity of added vitamins, mineral nutrients and amino acids be required on the label of the HMF. However, the quantity of all nutrients in the HMF is important for health practitioners to know, and some protein sources for HMFs (e.g. cow's milk) have significant levels of vitamins and mineral nutrients. That said, vitamins, mineral nutrients and amino acids only need to be labelled if they are present in the HMF. Manufacturers will be encouraged to declare “not a significant source of (nutrient X)” as a footnote when appropriate. For example, this is used for food products that use the simplified format for the nutrition facts table (section B.01.455 of the FDR).

In regards to applications for HMFs undergoing a major change, Health Canada was asked why a requirement to provide a rationale for the major change was being proposed. A rationale for the major change is necessary for the Department to evaluate the safety of HMFs.

Modern treaty obligations and Indigenous engagement and consultation

The regulatory framework for HMFs is for all Canadians, including Indigenous peoples. In general, Indigenous peoples could be positively impacted by these amendments, as Indigenous communities have higher preterm birth rates compared to non-Indigenous communities. First Nations, Inuit, and Métis infants have preterm birth rates of 9.0%, 11.4% and 7.6%, respectively, compared to the Canadian average of 7.8%.footnote 8 Preterm births and low birth weight (less than 5.5 lb, or 2 495 g) occurred more frequently among First Nations, Inuit, and Métis infants than among non-Indigenous infants, with the exception of small-for-gestational-age births. Health Canada specifically inquired about impacts to Indigenous peoples in its targeted consultations on the use of HMFs outside of hospitals from December 2019 to February 2020. Some health stakeholders commented that post-discharge use of HMFs will be as beneficial to Indigenous communities as it will be to any communities with premature infants who are breastfed. One industry stakeholder cautioned that the risks to infants in these communities may be higher due to decreased access to follow-up visits, qualified medical professionals, and laboratory analysis.

It is anticipated that these amendments will not have an impact on the Government's modern treaty obligations.

Instrument choice

Health Canada considered regulatory and non-regulatory options.

Status quo

Health Canada would continue its current practice of reviewing submissions for HMFs and continue use of the agreement in place with the CFIA to permit HMFs to be sold and used in Canadian hospitals. To date, this approach has allowed for a safe and reliable supply of HMFs for preterm infants and other infants as medically required in hospitals. However, this approach is dependent on industry's compliance and knowledge of the current process. The lack of a regulatory framework for HMFs has been a long-standing irritant for manufacturers and results in a less transparent process. This can negatively impact access to new and/or innovative products on the Canadian market. Furthermore, the current process was intended to be a temporary measure to allow HMFs market access in Canada until a regulatory framework was established.

Use of existing authority
Temporary marketing authorizations

TMAs are a regulatory tool used to give temporary market access to a non-compliant food when there is a need to gather information in support of a regulatory amendment. This regulatory tool was initially used for HMFs to provide market access and collect information. However, after information was gathered to support a regulatory framework for HMFs, TMAs were no longer issued or extended.

Marketing authorizations

MAs allow the Minister to implement certain food safety decisions by exempting foods from some prohibitions in the Food and Drugs Act (FDA) or the FDR. The option of regulating HMFs via an MA was considered, but is not a suitable measure over the longer term as a substitute to the creation of a regulatory framework. While an MA can be used to create exemptions, it cannot be used to establish new prohibitions at the level of the FDA or the FDR.

Regulatory option (chosen option)

As sufficient data has already been gathered through the TMAs, Health Canada is in a position to establish requirements for HMFs in the FDR. A regulatory framework will include provisions designed to help reduce the risks and help ensure the safety of HMFs. The requirements set out in the amendments to the FDR are similar to the current temporary review process and will provide appropriate controls and transparency to HMF manufacturers, importers and health professionals. The amendments to the FDR for HMFs are also identified in the Government of Canada's commitment outlined in the agri-food and aquaculture sector regulatory review roadmap of June 2019, to create a more flexible and agile regulatory framework. This will allow industry to bring safe, innovative HMF products to the Canadian market in a timely manner, while continuing to help protect the health and safety of vulnerable infants.

Regulatory analysis

Benefits and costs

The cost-benefit analysis (CBA) seeks to explain the qualitative and quantitative costs and benefits of the amendments to the FDR. A conservative approach to the costs and benefits has been taken whereby Health Canada is of the view that the benefits in this analysis are understated and the costs are overstated. The data used to complete the analysis was collected through stakeholder feedback, internal data provided by Health Canada and the CFIA, and a review of published literature.

There are 10 HMFs currently on the Canadian market, all being manufactured in and imported from the U.S. Under these amendments to the FDR, these products will be permitted to remain on the market and evidence supporting their safety and nutritional adequacy will not have to be re-reviewed unless there has been a major change. However, manufacturers will be required to make any necessary label changes and submit their product label text and an attestation that the HMF has not undergone a major change since the date indicated in the List associated with that HMF. The product label text and attestation will be reviewed by Health Canada in order to ensure compliance with the amendments to the FDR.

Three different manufacturing companies produce all 10 HMFs currently on the market: one manufacturer strictly importing their products directly to the hospitals and two manufacturing companies that produce the HMF products in the U.S., with their subsidiaries in Canada importing and selling them to hospitals. In accordance with the Canadian Cost-Benefit Analysis Guide: Regulatory Proposals (PDF), Health Canada will not consider the one U.S. manufacturer who imports their products directly to the hospitals as a Canadian business and therefore it is not in scope for this analysis. Thus, this one U.S. manufacturer will not be included when calculating the costs to Canadian businesses. However, the remaining two manufacturers are included in the cost calculation for transparency purposes, and together, they produce 4 of the 10 HMFs currently on the Canadian market.

These amendments will result in a one-time cost to industry to have their labels updated and have the necessary product information submitted to Health Canada. Industry must submit both an attestation and their updated text of all written labels in sufficient time to be assessed before April 30, 2022, and will have a two-year transition period to make the necessary label changes on their products. There will also be a one-time cost to Health Canada to review the submitted information, including the product label text and attestation. This is estimated to have a one-time total cost of $138,435 present value (PV). While the amendments to the FDR have a net monetized cost, the qualitative benefits, including helping to ensure that safe and nutritionally adequate HMFs remain available for use by preterm infants or infants with medical conditions, rationalize the requirements.

Benefits

Creating a regulatory framework for HMFs will help ensure that safe and nutritionally adequate HMFs remain available for use by preterm infants or other infants as medically required. These amendments will help make existing and new HMF products more available to Canadians, caregivers and medical practitioners. As there are currently no provisions in the FDR regarding HMFs, the amendments to the FDR will address the regulatory gaps by enabling the addition of vitamins, mineral nutrients, and amino acids to HMFs, requiring a pre-market review of HMFs, specifying requirements relating to labelling of nutritional information and directions for preparation, storage and use, and ensuring HMFs are not sold without medical oversight.

Since HMFs have been on the market since the mid-1980s, the benefits are addressed qualitatively. Implementing a regulatory framework for HMFs will provide a range of benefits across a number of stakeholder groups:

Patients and caregivers

Preterm infants or other infants with certain medical conditions who require human milk with added HMFs will continue to benefit from the availability of safe and approved HMFs that contain the macronutrients, vitamins, mineral nutrients and amino acids needed to support their healthy growth. The amendments to the FDR will help ensure that HMFs can be provided for home use by a hospital with a written order from either a physician, a dietician or a nurse practitioner (when authorized by their jurisdictions), helping to ensure the safety of infants. HMFs can also be provided for home use directly from a manufacturer with a written order from a health practitioner, as outlined above, and a written request from the hospital. The requirement to include the labelling of nutritional information and directions for preparation, storage and use will also be useful for caregivers in post-discharge situations.

Industry

Industry will benefit from having clear regulatory requirements that will help ensure the safety of their products. In addition, a regulatory framework will help industry better manage their product submissions, which in turn could result in regulatory efficiencies in the pre-market review process. Although the HMF industry has been cooperative in supplying data regarding their products, new entrants to the sector may be unfamiliar with the informal pre-market review process. The amendments will set clear requirements concerning HMFs, allow for product innovation with respect to formulation, introduce regulatory predictability and international harmonization and help ensure their availability for sale in Canada. The regulatory approach for HMFs will replicate existing review processes and are not expected to add any significant regulatory burden to the HMF industry.

Health Canada and the CFIA

These amendments to the FDR address regulatory gaps in relation to HMFs and create clear rules, which will be applied consistently to manufacturers. These amendments will contribute to greater transparency of Health Canada's processes as there will be clearly delineated requirements in the FDR for HMFs, which is currently lacking. The CFIA will conduct enforcement and compliance activities in relation to the regulatory framework.

Healthcare professionals

A regulatory framework will more easily help facilitate new and innovative HMFs to obtain market access in Canada due to the clear pathway to market. This will result in healthcare professionals having more timely access to new and innovative HMFs due to the anticipated impact of regulatory clarity on the timing of product launches in Canada. Healthcare professionals will also benefit by having the flexibility to allow HMFs for at home use when a longer stay in hospital would not otherwise be required.

Costs of the regulatory amendments
Cost to Government

This regulatory amendment is estimated to result in a one-time cost to Health Canada of approximately $2,333 (PV) to review the product label text and an attestation for all 10 HMFs currently on the market, assuming these costs are incurred in year one, beginning in 2021, and are discounted using a 7% discount rate.

Health Canada has already been reviewing safety, nutritional adequacy, quality data and labels for HMFs since they have been available in Canada starting in the mid-1980s, with the CFIA conducting the enforcement activities based on the existing risk-based approach for all foods. They were originally made available under now expired TMAs, allowing the manufacturer to market a food product that is deemed safe over a specific amount of time while scientific data is being generated by the manufacturer. After this data was collected, Health Canada determined that TMAs were no longer appropriate for HMFs and did not renew them. However, HMFs remained on the Canadian market because of their medical necessity and history of safe use under a temporary review process that includes a detailed safety and nutritional adequacy assessment. This temporary process applied to HMFs previously permitted by TMAs, as well as newer HMFs that the Department determined to be safe.

When reviewing a new HMF or an HMF with a major change under the temporary review process, Health Canada evaluates the nutritional adequacy, safety, ingredients and nutritional composition of the product, the manufacturing process, and the labelling of the product to ensure that it carries essential information. Reviewing a new submission for an HMF involves multiple bureaus within Health Canada reviewing the pre-market package. It could take up to 888 hours to review one full pre-market data package. If the HMF product is deemed safe for sale in Canada, Health Canada adds the product to a list that is sent to CFIA and circulated to NICUs.

Under the amendments to the FDR, manufacturers of any new HMF or HMF with a major change will still be required to submit the same amount of information that would have been required under the temporary review process. However, they will also be required to submit the written text of all labels, including information on the nutrition information that will appear on the outer label, as well as the expiration date and lot numbers on both the inner and outer labels. Therefore, the amendments to the FDR will codify existing practices into law with no incremental change or increase in costs for a pre-market notification setup. Although there will be no change in the evaluation process impacting new HMFs or HMFs with a major change, HMF manufacturers with products currently on the market will be required to provide the written text of all labels and an attestation to Health Canada for review in order to remain on the market.

Based on internal review data, it is estimated that 5.25 hours of review will be required per HMF; 0.25 hours of review for the attestation completed by a level BI-03/04 employee and 5 hours of review for the label text, which includes reviewing both the nutritional information as well as the label claims/statements, involving both a level BI-03/04 and a level BI-05 employee within Health Canada.

Applying the appropriate rate of pay for public service employees at the BI-03, BI-04 and BI-05 levels, the cost to conduct one individual review could range from $229 to $270 per HMF; the average cost to review one HMF label is approximately $250. Since there are currently 10 HMFs on the Canadian market, and Health Canada assumes that all 10 will choose to continue selling their product on the market, it is estimated that it will take a total of 52.5 hours of review time at a cost of $2,496 to review all 10 labels. However, there are only five different formulations because one formulation currently exists under six different labels. Once the first product submitted is assessed and reviewed, the five subsequent product labels are not anticipated to require the full 5.25 hours allotted for review, indicating that these costs are overestimated. However, these costs are assumed to be incurred within year one, beginning in 2021, resulting in a total cost of $2,333 (PV) applying a 7% discount rate.

All manufacturers of HMFs currently on the market, including the one manufacturer exporting their products directly to Canadian hospitals, will be required to submit specific information to Health Canada that includes the label text and an attestation under the amendments to the FDR in order to remain on the market.

Cost to industry

The total cost to industry of implementing the HMF framework will include a one-time compliance cost for manufacturers to conduct the necessary label changes and a one-time cost to submit their product label text and an attestation to the Minister for review. The total one-time cost to industry in order to meet the requirements of the amendments to the FDR is estimated to be $136,103 (PV) assuming labelling costs are incurred in year two and the submission of an attestation and product label text are incurred in year one, applying a 7% discount rate.

Under the temporary review process, HMF manufacturers are submitting pre-market notifications to Health Canada in order for their products to be added to a list of permitted HMFs. These HMFs are already available on the market to be sold strictly to hospitals as part of the temporary review process. This list is provided to hospital NICUs and the CFIA. In order to be added to this list, all new HMFs or any HMF that has undergone a major change are reviewed and assessed as part of the temporary pre-market review process. Manufacturers are required to provide a scientific rationale for the formulation of a new HMF, or the rationale for any major change to an existing HMF, information regarding ingredients and their associated levels, labelling and manufacturing information, as well as evidence to support the product's safety and nutritional adequacy as part of the temporary pre-market submission. This temporary agreement with the CFIA was conditional on the demonstrated safety of HMFs and was to be a temporary measure until the process could be formalized in regulation.

Under this temporary review process, Health Canada permitted the continued sale of two HMFs, which had previously received TMAs. The Department also reviewed seven additional HMF products in 2010, 2014 and 2019, which were added to the List of permitted HMFs. Currently, 10 HMFs are available in Canada from three manufacturers based in the U.S. HMFs currently on the Canadian market have already undergone a pre-market review.

The amendments to the FDR will provide the appropriate regulatory framework for the sale of HMFs and codify the temporary review process, so it is not expected to result in any administrative change from current practices. Implementation of the amendments to the FDR will be consistent with the way these products are handled now, but through a more formal process.

When the regulations come into force, any HMF new to the market will only be permitted to be sold and advertised for sale once the manufacturer of the HMF sends a submission with the required information to the Minister of Health and the Minister notifies the manufacturer in writing that the sale or advertisement for sale of the HMF is authorized. This authorization will indicate that the submission meets regulatory requirements and the information provided is sufficient to establish that the HMF is safe. The Minister may also consider other information relevant to the application, including information provided to or obtained from a foreign regulator responsible for assessing HMFs. Guidance on this process will be published on the Government of Canada's website.

Implementing the regulatory amendments will, however, impact those HMFs currently on the market by requiring manufacturers to update their product labels to ensure they reflect the new labelling requirements and submit both their product label text and an attestation to the Minister of Health that the HMF has not undergone a major change since the date indicated in the List associated with that HMF. Manufacturers of HMFs currently on the market will have to submit the necessary documentation to the Minister of Health in sufficient time to be assessed before April 30, 2022, and will have approximately an additional year (i.e. a two-year transition period) to make any labelling changes. The two-year transition period is provided so that manufacturers will be allowed to continue selling their products during the transition period to exhaust old stock and eliminate any additional transition costs.

The labelling requirements are similar to what manufacturers are required to follow now, except for a new requirement for nutrition information to be listed on the outer label as per quantity of the HMF that is indicated in the directions for use, and for the lot number and expiration date to be present on both the outer and the inner labels, as mentioned previously. The directions for the preparation, use and storage of the HMF mixed with human milk as well as the directions for use of the HMF may be shown in a leaflet that is affixed or attached to the immediate container, if there is only a single container for the HMF. In this case, manufacturers may include these directions on a leaflet instead of on the outer label, which will provide additional flexibilities for smaller product packaging or more complex packaging, if needed. HMFs will also be required to have labelling in both official languages like most other foods. In addition, labels for HMFs will be prohibited from carrying certain nutrition claims. Manufacturers of HMFs currently on the market will be granted a two-year transition period to complete any necessary labelling changes.

Using an adjusted estimate provided by the U.S. Food and Drug Administration (U.S. FDA), it is estimated that it will cost $26,116 (2020 Can$) on average to conduct a prepackaged label change in order to make the necessary label changes. For the purposes of the CBA, it is assumed that all four HMFs made by manufacturers that have standing as Canadian businesses will require a label change, resulting in a one-time compliance cost of $104,464. However, these costs are assumed to be incurred within year two of the two-year transition period, resulting in a total cost to industry of $91,243 (PV) applying a 7% discount rate. This is considered to be a conservative estimate as all four HMF labels already list most of the nutrients to be required by the amendments, and to Health Canada's best knowledge, state the lot number and expiration date on the inner label. Providing industry with the option to display the information on the directions noted above on a leaflet that is affixed or attached to the immediate container, if the human milk fortifier does not have an outer label, would potentially be an additional cost for those who choose this option; however, manufacturers are only required to update their product labels and including the leaflet is considered an option. It is unclear how many HMFs currently meet all these labelling requirements; therefore, it is assumed that all existing labels will need to be updated and the costs incurred with doing so are considered an upper-bound cost estimate. It is estimated that the lifecycle for HMF labels are typically 9 to 18 months, making it possible for these label changes to be incorporated into their average product lifecycle.

Manufacturers of HMFs currently permitted on the Canadian market will also be required to submit their label text and an attestation to the Minister of Health for review. Since manufacturers will not be required to submit their full labels but only the label text, industry will have some flexibility for when they decide to make the label changes, regardless of when they submit the necessary information, as long as the information is provided in sufficient time to evaluate it by April 30, 2022. Some stakeholders indicated through targeted consultations that it will take a total of 144 hours for each manufacturer to submit all of the necessary information (i.e. product label text and an attestation) and that it would cost approximately $12,000 per HMF product to submit both items. Since there are four different HMFs that are being captured under two manufacturers, the total one-time cost to submit the information for all four HMFs currently on the market is estimated to be $48,000. However, these costs are assumed to be incurred within year one, beginning in 2021, resulting in a total cost to industry of $44,860 (PV) applying a 7% discount rate.

Small business lens

Analysis under the small business lens concluded that the regulatory amendments will not impact Canadian small businesses. A small business is defined as any business, including its affiliates, that has fewer than 100 employees or between $30,000 and $5,000,000 in annual gross revenues. While several of the companies impacted have fewer than 100 employees in their Canadian affiliates, they are a part of larger U.S.-based multinational corporations that do not meet the criteria of a small business.

One-for-one rule

These amendments to the FDR may potentially increase administrative burden on industry because manufacturers of HMF products currently on the market will be required to submit specific product information in order to demonstrate that they are in compliance with the new regulations. These administrative costs will be borne once the regulations come into force, after which there will not be any ongoing administrative costs.

Table 1: One-for-one rule using the regulatory costing calculator
Constant 2012 dollars, present value base year 2012; discounted using a 7% discount rate
Cost One-for-one rule result
Annualized administrative costs (constant $2012) $3,718.00
Annualized administrative costs per business ($2012) $1,858.76

These costs are estimated based on responses provided by some industry stakeholders and validated through targeted consultations. Industry indicated to Health Canada that it will take approximately 144 hours to submit both the product label text and an attestation, costing manufacturers $12,000 per HMF product. It is assumed that between the two HMF manufacturers, a total of four submissions will be presented to Health Canada within the first year only.

Regulatory cooperation and alignment

Trade considerations

Canada is a part of the World Trade Organization Agreement on Technical Barriers to Trade, which is aimed at ensuring that technical regulations, standards, testing and certification procedures do not create unnecessary obstacles to trade. Health Canada anticipates that the implementation of the amendments to the FDR should not negatively impact the competitive opportunities of imported products, as the amendments are trade-facilitating measures (by providing a legal path to market for HMFs in Canada). Rather, the amendments provide flexibility to manufacturers by considering international data during the pre-market review. Further, the amendments would be justifiable since they help protect the health and safety of Canadians.

International approaches

There are only three HMF manufacturers that currently sell their HMFs in Canada, and they are all based in the U.S. and produce HMFs there. These manufacturers are familiar with the current regulatory environment in Canada and are supportive of the regulatory framework, as it is closely aligned with the U.S.'s approach and Canada's temporary review process. One international HMF manufacturer has also expressed interest in entering the Canadian market, but has not yet proceeded with a submission. This manufacturer has been heavily involved during consultations and is supportive of having a formal regulatory framework for HMFs in place in Canada.

There is no consistent global standard for the regulation of HMFs. Where standards exist, for example in the U.S. and Europe, HMFs tend to be regulated as a subset of another category of food (e.g. infant formula, food for special medical purposes), rather than have their own regulatory framework.

In the United States, the U.S. Food and Drug Administration (FDA) considers HMFs to be in the category of “exempt infant formula,” which exempts HMFs from the minimum and maximum levels of nutrients for infant formula when there is an appropriate scientific rationale. HMFs in the U.S. are subject to a pre-market safety review and labelling requirements, and although they are generally used in hospitals, post-discharge programs with medical oversight for HMFs have been in place in the U.S. for approximately a decade. Health Canada's regulatory amendments to the FDR align closely with that of the U.S.

The European Food Safety Authority (EFSA) classifies HMFs as “foods for special medical purposes.” It sets maximum levels for vitamins and minerals for these foods, including compositional requirements specific for foods for special medical purposes developed to satisfy the nutritional requirements of infants. HMFs can vary from these prescribed levels if rendered necessary for the intended use of the product.

Although there are not currently any specific regulations for HMFs in Australia and New Zealand, Food Standards Australia New Zealand (FSANZ) is assessing its infant formula standard and consultations support incorporating clear regulations for HMFs. At present, the use of HMFs is not based on national guidelines, but on those established by individual hospitals.

In developing its regulatory framework for HMFs, Health Canada carefully considered the U.S. and European models, and aligned its requirements where appropriate. Moreover, Health Canada will also accept foreign information where appropriate, such as evidence or information submitted to a foreign regulator as part of its HMF pre-market submission evidence package, whether the HMF is a new product to the Canadian market or an existing HMF that has undergone a major change.

Key similarities and differences: Nutrient levels

Rather than prescribing nutrient levels in regulations, Canada is implementing an outcome-based approach. All HMFs will be evaluated on a case-by-case basis to help ensure that the nutrient levels are safe and nutritionally adequate for their intended use. Health Canada takes into consideration nutrient levels permitted in HMFs by other global regulators, as well as nutrient intake recommendations for these infant populations provided by international scientific bodies. An outcome-based approach also allows Health Canada to more quickly respond to any changes in international recommended standards. This will also provide industry with flexibility to formulate HMF products to be in line with updated research findings and clinical guidance.

Key similarities and differences: Labelling

Canadian labelling requirements will be very similar to U.S. labelling requirements, with the key differences being official languages requirements and different units of measurement (i.e. metric system). Canada also takes a more precautionary approach to health claims on food products and does not permit certain “qualified” health claims, which are permitted in the U.S. [Qualified health claims are claims that have not been approved by the U.S. FDA, but are permitted on U.S. products with a qualifying statement; e.g. “Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 g per day), as part of a low saturated fat, low-cholesterol diet, may reduce the risk of diabetes mellitus type 2.”] This approach helps to protect the health and safety of Canadians against potentially misleading claims that have not been reviewed by Health Canada.

Key similarities and differences: Post-discharge

Canada will permit the use of HMFs outside of hospitals under medical supervision, including a post-discharge model similar to the one currently in place in the U.S., where a physician could order HMFs for shipping directly to the consumer.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

Consideration of gender and cultural factors were taken into account during the development of these amendments to the FDR. Women giving birth in Canada and their families are a diverse group, resulting in varying needs, expectations and hopes when it comes to medical decisions related to their children. Factors such as their religion, culture and spirituality can also impact the type of communication, support and care required by individual families and mothers. For some families, cultural and language barriers may lead to feelings of isolation and uncertainty while their child is in the NICU.footnote 9 For example, one Canadian study found that immigrant mothers of preterm infants, when compared to Canadian-born mothers, are more likely to have depressive symptoms, poorer family functioning, less social support and less integration into mainstream culture.footnote 10 These factors underline the need for culturally sensitive care both within the NICU and potentially post-discharge from hospital.

That said, the regulatory approach as it relates to in-hospital use is not anticipated to disproportionately impact particular subpopulations. As for the use of HMFs post-discharge from hospital, there were many aspects that are being taken into consideration throughout the policy development, such as availability of medical care to rural and remote communities, and the quality of education that would be offered to the families and caregivers. Recognizing that certain remote communities may not have easy access to hospitals to obtain HMFs, Health Canada will permit HMFs to be shipped directly to caregivers at the request of a hospital, provided that the individual has received a written order from a physician, nurse practitioner or dietitian (if authorized by their jurisdictions). This approach will improve the availability of HMF products to these remote communities as needed, while ensuring proper medical oversight.

Implementation, compliance and enforcement, and service standards

Implementation

The regulations will come into force on the day on which they are published in the Canada Gazette, Part II. Manufacturers of HMFs already on the market in Canada will have a two-year transition period to become compliant with the new labelling provisions, and must submit an attestation and written text of all labels in sufficient time to be assessed before April 30, 2022.

Information on the implementation of these regulatory amendments will be available through the Government of Canada website.

Compliance and enforcement

The CFIA is responsible for the enforcement of the FDA as it relates to food and of the Safe Food for Canadians Act.

While it is the responsibility of the industry to comply with regulatory requirements, compliance will be monitored as part of ongoing domestic and import inspection programs, respecting the resources that the CFIA has for enforcement and compliance verification. Appropriate enforcement action will be risk-based.

Service standards

Service standards will be provided in a Health Canada guidance document.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca