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): Bacillus amyloliquefaciens (ICS Codes: 67.220, 67.060, 67.100.30, 67.120.10, 67.120.99, 67.160, 67.190, 67.230)

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: Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Bacillus amyloliquefaciens as a Source Organism for Food Enzymes that are Currently Permitted to be Sourced from Bacillus subtilis  Language(s): English and French  Number of pages: 8 and 9

6.

Description of content: Health Canada's Food Directorate completed a detailed safety assessment of a food additive submission seeking approval for the use of Bacillus amyloliquefaciens as a permitted source organism for those enzymes (namely amylase, glucanase, hemicellulase, pentosanase and protease) that can also be sourced from Bacillus subtilis.

Bacillus amyloliquefaciens is already listed as an approved source organism for amylase for use in infant cereal products.

As no safety concerns were raised through this assessment, the Department has enabled the food additive use described in the information document below by updating the List of Permitted Food Enzymes, effective 15 July 2015.

Health Canada's Food Directorate is committed to reviewing any new scientific information on the safety in use of any food additive, including the food enzyme Bacillus amyloliquefaciens. Anyone wishing to submit new scientific information on the use of this food additive or to submit any inquiries may do so in writing, by regular mail or electronically.

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:

[X]      Codex Alimentarius Commission (e.g. title or serial number of Codex standard or related text) The Inventory of Substances Used as Processing Aids (IPA), which is a reference tool maintained by the Codex Committee on Food Additives (CCFA), lists both B. subtilis and B. amyloliquefaciens as sources of various enzymes, and notes in particular that B. subtilis formerly also covered the strains that are now known under the name B. amyloliquefaciens.

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

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

[ ]        None

Does this proposed regulation conform to the relevant international standard? 

[X] 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 - "Public Involvement and Partnerships" Website, posted 15 July 2015 (available in English and French):

http://www.hc-sc.gc.ca/fn-an/consult/index-eng.php (English)

http://www.hc-sc.gc.ca/fn-an/consult/index-fra.php (French)  

10.

Proposed date of adoption (dd/mm/yy): 15 July 2015

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): 15 July 2015

[ ]      Trade facilitating measure  

12.

Final date for comments: [ ] Sixty days from the date of circulation of the notification and/or (dd/mm/yy): 27 September 2015

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 of Modification to the List of Permitted Food Enzymes to Enable the Use of Bacillus amyloliquefaciens as a Source Organism for Food Enzymes that are Currently Permitted to be Sourced from Bacillus subtilis" is available through the following weblink:

http://www.hc-sc.gc.ca/fn-an/consult/nom-adm-0053/index-eng.php (English)

http://www.hc-sc.gc.ca/fn-an/consult/nom-adm-0053/index-fra.php (French)