6. Registration Processes
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6. Registration Processes
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Infant, Follow-up, Young Child Formula
Canada
This section provides information on any product notification or registration and manufacturing site registration processes.
6.1 Product Notification
Category 1
Category
Food for infants
Product
Human milk substitutes (infant formula) [1,2]
Human milk substitutes (infant formula) and human milk fortifiers require pre-market notification. The Food Directorate of Health Canada assesses product safety and nutritional adequacy to promote acceptable growth and development in infants. The required information for review by Health Canada includes information on composition (ingredients), manufacturing, and packaging, along with evidence that supports nutritional adequacy for infants and compliance with Canadian labeling requirements [1]. There are no fees submitted with pre-market notification. Details of the product notification process for Canada are restricted to infant formula for the purposes of this guidebook.
B.25.046 and B.25.048 of the Food and Drugs Regulations outline the statutory pre-market notification requirements for new infant formula and infant formula that have undergone a major change (as defined in B.25.001), respectively [2]. Health Canada has developed guidance documents to assist the food industry in compiling comprehensive pre-market notification submissions [3].
Mandatory information to include in the pre-market notification package:
- Product name and brand under which it will be sold or advertised for sale. The product name may include protein source (e.g. cow-milk-based, soy-based), format (e.g. liquid ready-to-feed, liquid concentrate, powder), or intended infant population (e.g. term, follow-up, preterm, infants allergic to cow’s milk).
- Name and address of the principal place of business of the manufacturer.
- Names and addresses of each manufacturing establishment (including third-party contractors).
- Description of the major change to the formulation or manufacturing process (if applicable)
- A list of all ingredients used in the product and quantities used.
- Specification sheets including nutrient, microbiological, and physical quality for each raw ingredient and the finished product as sold.
- Details of the manufacturing process and quality control procedures (such as process flow diagrams, HACCP plans, GMP [4,5]).
- Results of studies to determine the stability and expiration date of the product.
- Evidence to support nutritional adequacy to promote acceptable growth and development in infants when consumed in accordance with the directions for use. Guidance documents outlining clinical trial protocol and nutritional adequacy criteria are available from Health Canada [6,7].
- Descriptions of types of packaging used. Packaging materials must be food grade and comply with regulations in Division 23 of the Food and Drug Regulations. Letters of no objection issued by the Bureau of Chemical Safety of Health Canada should be submitted.
- Directions for preparation, use, and storage (including warning statements).
- Written text of all the label copy, including packaging inserts. Label artwork should comply with general food labeling requirements as well as labeling requirements specific to infant formula as prescribed in B.25.057 of the Food and Drugs Regulations. It is also recommended that labeling align with the International Code of Marketing of Breast-milk Substitutes.
- Name and title of the petitioner who signed the notification.
- Final version of pre-submission consultation meeting minutes (if applicable).
- Verification checklists completed (checklists available in the appendices of Health Canada’s guidance document for pre-market notifications).
- Cover letter with the date and complete contact information of the petitioner, and indicate whether the submission contains nutritional data, microbiological analyses, and food additives.
Pre-market notifications are submitted using the Food Directorate’s online application form and transport form [9]. Submissions sent through email, post, or courier will not be accepted. Questions regarding procedures may be directed to the Submission Management and Information Unit (SMIU) of Health Canada at smiu-ugdi@hc-sc.gc.ca. Health Canada aims to review the submission and provide a response within 90 days. This aligns with the statutory requirement of a 90-day notice period to Health Canada prior to initiating the sale or advertisement of the product and is contingent upon approval of the product by Health Canada.
Category 2
Category
Food for Special Dietary Use
Product
Nutritional supplements (including Young Child Formula) do not require pre-market notification or product registration.
6.2 Product Registration
Category
N/A
Product
N/A
6.3 Other Notes or Requirements
Product Notification (Infant Formula)
Members of the food industry may request a confidential pre-submission consultation with Health Canada to discuss information that should be included in the pre-market notification submission. A pre-submission consultation may be useful when new infant food ingredients are proposed, or there is sufficient change to the product formulation to warrant clinical studies to support the safety and nutritional adequacy of a new or reformulated product.
A formal request for a pre-submission consultation may be sent to the Submission Management and Information Unit (SMIU) of Health Canada at smiu-ugdi@hc-sc.gc.ca with at least 8 weeks advance notice. The request must detail the purpose of the consultation with reference to the product formulation, or novel processing, and specific questions or issues of concern. The request must also include 3 proposed dates for a consultation meeting. Based on the request, Health Canada will determine whether a pre-submission consultation is needed or if issues can be addressed through email correspondence.
If Health Canada determines that a meeting is needed, the requester will be notified of the meeting arrangements and issued a case number. At least 4 weeks prior to the meeting, the requester must submit by email a pre-submission consultation package containing a cover letter including the purpose of the consultation, meeting agenda, list of participants and affiliations, contact information for the primary contact, and any equipment or conferencing needs for the meeting. The request should use a slide presentation to present background information and details about the issues in question. Other technical information that may be presented in the package include a description of the new ingredient or process, history of development or use, compliance with regulations, and summaries of safety and nutritional data. Health Canada will distribute the package to appropriate subject matter experts in preparation for the meeting [8].
After the consultation meeting, Health Canada will provide a list of consultation participants and the requester is responsible for providing the initial draft of the meeting minutes. The final version of the meeting minutes should be included with the pre-market notification documents [8].
Product Registration
N/A
6.4 Manufacturing Site Registration
Category
N/A
Product
It is not required to formally register manufacturing sites of infant formula. However, regulations require pre-market notification to Health Canada when there are changes to the facilities manufacturing the infant formula or changes to the processing within existing or new facilities.
6.4.1 Standard/Rules for Manufacturing Site
Category
Please refer to Section 6.4.1 of the "General Foods" guidebook for Canada.
Product
Same as "Category" above.
6.4.2 Other Notes or Requirements for Manufacturing Site Registration
Category
Please refer to Section 6.4.2 of the "General Foods" guidebook for Canada.
Product
Same as "Category" above.
6.5 References
1. Bringing infant foods to the Canadian market, Infant formula and human milk fortifiers. 2023, Health Canada
https://www.canada.ca/en/health-canada/services/infant-care/infant-formula.html
2. B.25.046, Division 25, Food and Drug Regulations
https://laws.justice.gc.ca/eng/regulations/c.r.c.,_c._870/page-52.html#h-574344
3. Guide for the preparation of infant formula and human milk fortifier premarket submissions. 2021, Health Canada
4. Good manufacturing practices for infant formula. 2021, Health Canada
5. New manufacturing facility requirements for infant formulas and human milk fortifiers. 2021, Health Canada
6. Scientific evidence requirements for nutritional adequacy of term infant formulas. 2021, Health Canada
7. Growth and tolerance clinical trial protocol – healthy term newborn infants. 2021, Health Canada
8. Pre-submission consultation guidance: Mandatory pre-market submissions for the Food Directorate, Health Canada
9. How to complete the online application and transport form for pre-market submissions to the Food Directorate. 2023, Health Canada
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