Health Canada’s Notice Enables the Use of L-alpha Glycerylphosphorylcholine in Supplemented Food

Health Canada, the regulatory authority overseeing food and drug safety in Canada, has recently taken a significant step toward food supplements. On September 20, 2023, Health Canada implemented a crucial modification, permitting the use of L-alpha-glycerylphosphorylcholine, also known as alpha GPC or choline alfoscerate, as a supplemental ingredient in foods. This decision was made based on a comprehensive safety assessment conducted by Health Canada’s Food Directorate.

Background on the Health Canada Regulatory Authority

Under the Food and Drugs Act, Health Canada is authorized to establish requirements and conditions for foods available in the Canadian market. To facilitate this, the “Supplemented Foods Regulations,” which amended the Food and Drug Regulations and the Cannabis Regulations, were introduced on July 21, 2022. These regulations define the specific regulatory requirements applicable to supplemented foods, outlined within the Food and Drug Regulations (Part B, Division 29, and other relevant provisions). Additionally, Subsection 102(2) of the Cannabis Regulations plays a role in overseeing these regulations.

The permitted categories of supplemented foods and the supplemental ingredients, along with their conditions of use, are detailed in the “List of Permitted Supplemented Food Categories” and the “List of Permitted Supplemental Ingredients,” respectively. These lists are incorporated by reference into the Food and Drug Regulations and are regularly updated on the Canada.ca website.

Safety Assessment of L-alpha Glycerylphosphorylcholine

The decision to enable the use of L-alpha-glycerylphosphorylcholine in supplemented foods was grounded in a rigorous safety assessment conducted by Health Canada’s Food Directorate. This assessment encompassed various aspects, including chemistry, nutrition, microbiology, toxicology, and allergenicity. The evaluation concluded that the available information unequivocally supports the safe use of L-alpha-glycerylphosphorylcholine as a source of supplemental choline in supplemented foods, provided that its usage levels do not exceed the previously established maximum levels for choline and that all labeling requirements are met.

Public Consultation and Feedback

In recognition of the significance of this regulatory change, Health Canada initiated a public consultation process by publishing a “Notice of proposal to enable the use of L-alpha-glycerylphosphorylcholine as a supplemental ingredient in foods” on April 17, 2023. This notice was open for public comment for a period of 75 days. However, no new scientific information was submitted to the department in response to this notice. Consequently, the conclusions drawn during the initial assessment remained unchanged.

Notification: Summary of Comments and Health Canada’s Responses

As mentioned earlier, Health Canada received no comments or objections regarding the proposal. This lack of feedback reaffirms the department’s confidence in the safety assessment of L-alpha-glycerylphosphorylcholine.

Implementation and Enforcement

As of September 20, 2023, the modification allowing the use of L-alpha-glycerylphosphorylcholine in supplemented foods came into effect. This change was published in the “List of Permitted Supplemental Ingredients.” It is crucial to note that the Canadian Food Inspection Agency is responsible for enforcing the Food and Drugs Act and its associated regulations, particularly concerning foods.

In conclusion, Health Canada’s decision to use L-alpha-glycerylphosphorylcholine in supplemented foods underscores the department’s commitment to ensuring the safety and quality of food products available to Canadians. This regulatory change aligns with Health Canada’s ongoing efforts to provide consumers access to safe and beneficial dietary supplements while maintaining stringent safety standards. As this modification takes effect, consumers and food manufacturers can expect to see L-alpha-glycerylphosphorylcholine as an approved source of supplemental choline in a range of supplemented food products across Canada.

Accessing the list of Supplemental Ingredients and their conditions

This document is a valuable resource for those interested in exploring the List of Permitted Supplemental Ingredients and understanding their use conditions. It provides detailed information about the supplemental ingredients authorized for addition to supplemented foods. It outlines the specific requirements governing their usage. These conditions encompass:

1. Food Category: This indicates the type of food to which the supplemental ingredient may be added.
2. Maximum Amount and Units per Serving: Specifies the highest quantity of the supplemental ingredient that can be included in a serving of food, along with the units of measurement applicable to the stated serving size.
3. Cautionary Statements: Identifies any mandatory cautionary statements that must be included on the product label for each supplemental ingredient and establishes the threshold level at which these statements become obligatory.
4. Additional Conditions of Use and Labeling Requirements: Outlines any other conditions or labeling requirements on using the supplemental ingredient.

It is essential to note that certain ingredients are strictly prohibited from being added to supplemented foods at any level. Furthermore, additional restrictions may apply to including specific supplemental ingredients in food products.

Guidance Document for Supplemented Foods Regulations

For those seeking comprehensive guidance on supplemented foods regulations, including detailed information on permitted supplemental ingredients and their conditions of use, Health Canada has provided a dedicated resource known as the “Guidance Document for Supplemented Foods Regulations.”

This guidance document offers a wealth of information, encompassing:

1. Supplemental Ingredient Details: Comprehensive information on all permitted supplemental ingredients, their respective conditions of use, and other essential details.
2. Regulatory Compliance: Guidance on ensuring compliance with the regulations governing supplemented foods, including labeling requirements and safety standards.
3. Amendment Process: An explanation of the procedures and requirements for proposing and adding new supplemental ingredients to the List of Permitted Supplemental Ingredients.

Accessing the list of Supplemental Ingredients and their conditions

This document is valuable for those interested in exploring the List of Permitted Supplemental Ingredients and understanding their use conditions. It provides detailed information about the supplemental ingredients authorized for addition to supplemented foods. It outlines the specific requirements governing their usage. These conditions encompass:

1. Food Category: This indicates the type of food to which the supplemental ingredient may be added.
2. Maximum Amount and Units per Serving: Specifies the highest quantity of the supplemental ingredient that can be included in a serving of food, along with the units of measurement applicable to the stated serving size.
3. Cautionary Statements: Identifies any mandatory cautionary statements that must be included on the product label for each supplemental ingredient and establishes the threshold level at which these statements become obligatory.
4. Additional Conditions of Use and Labeling Requirements: Outlines any other conditions or labeling requirements on using the supplemental ingredient.

It is essential to note that certain ingredients are strictly prohibited from being added to supplemented foods at any level. Furthermore, additional restrictions may apply to including specific supplemental ingredients in food products.

Guidance Document for Supplemented Foods Regulations

For those seeking comprehensive guidance on supplemented foods regulations, including detailed information on permitted supplemental ingredients and their conditions of use, Health Canada has provided a dedicated resource known as the “Guidance Document for Supplemented Foods Regulations.”

This guidance document offers a wealth of information, encompassing

1. Supplemental Ingredient Details: Comprehensive information on all permitted supplemental ingredients, their respective conditions of use, and other essential details
2. Regulatory Compliance: Guidance on ensuring compliance with the regulations governing supplemented foods, including labeling requirements and safety standards
3. Amendment Process: An explanation of the procedures and requirements for proposing and adding new supplemental ingredients to the List of Permitted Supplemental Ingredients

By consulting this guidance document, stakeholders, including food manufacturers, can better understand the regulatory landscape for supplemented foods in Canada. It serves as a valuable reference for newcomers and experienced industry professionals, facilitating compliance with Health Canada’s stringent standards and ensuring the safety and quality of supplemented food products in the Canadian market.

In summary, Health Canada’s commitment to transparency and safety in supplemented foods is underscored by the availability of these resources. Accessing the List of Permitted Supplemental Ingredients and the Guidance Document for Supplemented Foods Regulations empowers industry players and consumers with the knowledge and tools to navigate the regulatory landscape effectively and make informed decisions regarding supplemented food products.

Click here to learn about the Supplemented Facts Table Regulations.