1.

Notifying Member: CANADA

If applicable, name of local government involved:

2.

Agency responsible: Health Canada

3.

Products covered (provide tariff item number(s) as specified in national schedules deposited with the WTO; ICS numbers should be provided in addition, where applicable): Lipase from Aspergillus niger PLR; Leucyl aminopeptidase from Aspergillus oryzae AT1088 (ICS code: 67.220.20)

4.

Regions or countries likely to be affected, to the extent relevant or practicable:

[X]     All trading partners

[ ]      Specific regions or countries:

5.

Title of the notified document: Modification to the List of Permitted Food Enzymes to authorize the use of lipase from a new source and Modification to the List of Permitted Food Enzymes to authorize the use of leucyl aminopeptidase from a new source. Language(s): English and French. Number of pages:

6.

Description of content: Health Canada's Food and Nutrition Directorate completed the premarket safety assessments of two food additive submissions seeking authorization for 1) the use of leucyl aminopeptidase from Aspergillus oryzae AT1088 in the manufacture of bakery products; bread; Colby cheese;dairy-based flavouring preparations; flour; hydrolyzed animal, milk and vegetable proteins; hydrolyzed yeasts; spray-dried cheese powder; meat tenderizing preparations; various plant-based foods; pre-cooked (instant) breakfast cereals, whole wheat flour and yeast extracts, and 2) the use of lipase from Aspergillus niger PLR in bakery products, bread, flour, pasta and whole wheat flour.

The results of the premarket assessments support the safety of leucyl aminopeptidase from A. oryzae AT1088and of lipase from A. niger PLR for their requested uses. Consequently, Health Canada has authorized their uses as described in the information documents referenced above by modifying the List of Permitted Food Enzymes (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/5-enzymes.html), effective 30 October 2024.

The notice "Modification to the List of Permitted Food Enzymes to authorize the use of leucyl aminopeptidase from a new source" also reports on a corrective modification to the List of Permitted Food Enzymes. It explains that plant-based products that resemble fish or seafood products had been unintentionally excluded from the foods listing for carboxypeptidase D from Aspergillus oryzae AT1727 when the list was modified on 23 May 2023 and that entries for these food categories have been set out in the list for this food enzyme to correct this as of 30 October 2024.

The purpose of these information documents is to publicly announce the Department's decision in this regard and to provide the appropriate contact information for those wishing to submit an inquiry or new scientific information relevant to the safety of these food additives.

7.

Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, [ ] protect humans from animal/plant pest or disease, [ ] protect territory from other damage from pests.

8.

Is there a relevant international standard? If so, identify the standard:

[ ]        Codex Alimentarius Commission (e.g. title or serial number of Codex standard or related text):

[ ]        World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic Animal Health Code, chapter number):

[ ]        International Plant Protection Convention (e.g. ISPM number):

[X]       None

Does this proposed regulation conform to the relevant international standard?

[ ] Yes   [ ] No

If no, describe, whenever possible, how and why it deviates from the international standard:

9.

Other relevant documents and language(s) in which these are available: Health Canada's food and nutrition "Notices of proposal and notices of modification":

https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/acts-regulations/notices-proposal-notices-modification.html (English)

https://www.canada.ca/fr/sante-canada/services/aliments-nutrition/legislation-lignes-directrices/lois-reglements/avis-proposition-avis-modification.html (French)

10.

Proposed date of adoption (dd/mm/yy): The proposed food additive modifications will be legally enabled once published in Health Canada's Lists of Permitted Food Additives (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted.html).

Proposed date of publication (dd/mm/yy):

11.

Proposed date of entry into force: [ ] Six months from date of publication, and/or (dd/mm/yy): The food additive modifications noted in these documents come into force the day they are made to the Lists of Permitted Food Additives (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted.html).

[ ]      Trade facilitating measure

12.

Final date for comments: [ ] Sixty days from the date of circulation of the notification and/or (dd/mm/yy): 13 January 2024

Agency or authority designated to handle comments: [ ] National Notification Authority, [X] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:

13.

Text(s) available from: [ ] National Notification Authority, [X] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:

The notice "Modification to the List of Permitted Food Enzymes to authorize the use of lipase from a new source" is available through the following weblinks:

Modification to the List of permitted food enzymes to authorize the use of lipase from a new source (English)

Modification à la Liste des enzymes alimentaires autorisées afin d'autoriser l'utilisation de la lipase issue d'une nouvelle source (French)

The notice "Modification to the List of Permitted Food Enzymes to authorize the use of leucyl aminopeptidase from a new source" is available through the following weblinks:

Modification to the List of permitted food enzymes to authorize the use of leucyl aminopeptidase from a new source (English)

Modification à la Liste des enzymes alimentaires autorisées afin d'autoriser l'utilisation de la leucyl aminopeptidase issue d'une nouvelle source (French)

Or requested at:

Canada's Notification Authority and Enquiry Point

Technical Barriers and Regulations Division

Global Affairs Canada

111 Sussex Drive

Ottawa, Ontario, K1A 0G2

Canada

Tel: +(343) 203 4273

Fax: +(613) 943 0346

E-mail: enquirypoint@international.gc.ca