6. Registration Processes

General Foods

Canada

This section provides information on any product notification or registration and manufacturing site registration processes.

6.1 Product Notification

N/A

6.2 Product Registration

N/A

6.3 Other Notes or Requirements

None.

6.4 Manufacturing Site Registration

N/A

6.4.1 Standard/Rules for Manufacturing Site

Establishments manufacturing food (including infant formula and young child formula) are required to comply with general food safety, sanitation, hygiene, and good manufacturing practices recognized throughout the food industry. Health Canada has prepared guidance documents on GMPs [1], and facility requirements [2].

6.4.2 Other Notes or Requirements for Manufacturing Site Registration

All parties engaging in manufacturing, packaging, labeling, importing, exporting, or conveying food across provincial or territorial boundaries within Canada are required to hold a license with the Canadian Food Inspection Agency (CFIA) in compliance with the Safe Food for Canadians Act and Safe Food for Canadians Regulations. Application for new licenses and renewals occurs through the MyCFIA account portal. 

Businesses may operate under a single license (for one facility or encompassing multiple facilities), or register each facility under an individual license. The current fee schedule shows the license fee. For 2023-2024, the license fee is $268.93 Canadian dollars. Licenses are active for 2 years.

Notes:

• A license is not required for overseas manufacturers who will be bringing infant formula products to Canada via a local importer. 
• A license is required if an overseas manufacturer is not going through a local importer or a Canadian branch of their company. In this case, an overseas manufacturer can apply for a license as a non-resident importer if they do not have a fixed place of business in Canada. Non-resident importers may be accepted if manufacturing is conducted in a country that the CFIA recognizes as having food safety systems that offer the same level of protection as Canadian systems.

6.5 References

1. Good manufacturing practices for infant formula. 2021, Health Canada

https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/infant-formula-human-milk-fortifier/good-manufacturing-practices-infant-formula.html 

2. New manufacturing facility requirements for infant formulas and human milk fortifiers. 2021, Health Canada

https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/infant-formula-human-milk-fortifier/new-manufacturing-facility-requirements-infant-formulas-human-milk-fortifiers.html