Notice of Modification to the List of 
Permitted Colouring  Agents  to Enable 
the Use of Spirulina  Extract  in Various 
Foods  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: [NO M/ADM-0152] 
September  4, 2020  
 Notice of Modification to the List of Permitted Colouring Agents  to Enable the Use of Spirulina  Extract in Various Foods  –  
Reference Number: [NOM/ADM -0152 ]| 3 
 Notice of Modification to the List of Permitted Colouring Agents  to Enable the Use of Spirulina  Extract in Various Foods  – 
Reference Number: [NOM/ADM -0152]| 3 
 Summary  
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by the Minister of 
Health and the Food and Drug Regulations  (Regulations) .  Approved food additives and their permitted 
conditions of use are set out in the Lists of Permitted Food Additives  that are incorporated by reference in 
the MAs and published on the Canada.ca website.  A petitioner can request that Health Canada approve a 
new additive or a new condition of use for an already approved food additive by filing a f ood additive 
submission with the Department's Food Directorate.  Health Canada uses this premarket approval process to 
determine whether the scientific data support the safety of food additives when used under specified 
conditions in foods sold in Canada.  
The food industry has for some time expressed interest in the use of  Spirulina  products to impart colour to 
foods. Health Canada’s Food Directorate received a food additive submission seeking approval for the use of 
Spirulina  extract as a colouring agent i n unstandardized confectionery at a maximum level of 2%.  
The results of the Food Directorate’s evaluation of available sci entific data support the safety  of Spirulina  
extract when used as a colouring agent in the food requested by the petitioner as well a s a variety of other 
foods. Cons equently, Health Canada proposed  to enable the use of this new colouring agent as set out in the 
table below.  
Since this is a food additive that was not previously permitted for use in Can ada, Health Canada’s  proposal to 
enable the use of Spirulina extract as a colouring agent in various foods – Reference number: NOP/ADP -0034  
was published on January 9, 2020,  which was open to the public for comment for 75 days.  No new scientific 
information was submitted to the Department as a result of this Notice of Proposal.  Since the conclusions of 
the eval uation remain as described in the publication, Health Canada has enable d the  use of Spirulina extract  
by adding the entries shown in the table below to the  List of Permitted Colouring Agents . 
 
Modification to the List of Permitted Colouring Agents  
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and Other 
Conditions  
15. Spirulina  extract  (1)   
Frostings; Icings; Icing sugar  (1)  
Good Manufacturing Practice  
(2)  
Gelatin desserts; Unstandardized 
frozen desserts  (2)  
Good Manufacturing Practice  
(3)  
Ice cream mix  (3)  
Good Manufacturing Practice  
(4)  
(Naming the fruit) Jelly with pectin  (4)  
Good Manufacturing Practice  
(5)  
Unstandardized confectionery 
(except unstandardized chocolate 
confectionery)  (5)  
Good Manufacturing Practice  
(6) 
Unstanda rdized non -alcoholic  (6)  
Good Manufacturing Practice  Notice of Modification to the List of Permitted Colouring Agents  to Enable the Use of Spirulina  Extract in Various Foods  – 
Reference Number: [NOM/ADM -0152]| 4 
 Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and Other 
Conditions  
beverages; Unstandardized non -
alcoholic beverage concentrates  
(7)  
Yogurt  (7)  
Good Manufacturing Practice  
Rationale  
Health Canada’s Food Directora te completed a premarket safety  assessment of Spirulina  extract for use as a 
colouring agent . The assessment concluded that information related to allergenicity, chemistry, microbiology, 
nutrition, and toxicology supports the safety of Spirulina  extract for its proposed use . Therefore, the 
Department has enab led the proposed use of Spirulina extrac t by adding to the  List of Permitted Colouring 
Agents  the new item number and its corresponding entries  shown in the above table.  
Other Relevant Information  
The Food and Drug Regulations  require that food additives such as Spirulina  extract  that do not have food -
grade specifications set out in Part B of the Regulations meet the food -grade specifications set out in the  
most recent version of the  Food Chemicals Codex  or the Combined Compendium of Food Additive 
Specifications . The Food Chemicals Codex  (FCC) is a compendium of standards for purity and identity for food 
ingredients, including food additives, published by the United States Pharmacopeial Convention. The 
Combined Compendium of Food Additive Specifications , which contains spec ifications prepared by the Joint 
FAO/WHO Expert Committee on Food Additives (JECFA), is published by the Food and Agriculture 
Organi zation of the United Nations.  Currently there are tentative specifications for Spirulina  extract1 
established by JECFA.  
Notification – Summary of Stakeholder Responses  and Health 
Canada’s Replies  
Health Canada received 10 response s from stakeholders related to Health Canada’s p roposal to enable the 
use of Spirulina extract as a colouring agent in various foods – Reference number: NOP/ADP -0034  published 
on January 9, 2020 , and the Department replied as summarized in the table below .  
Stakeholder  Stakeholder 
Response  Number of 
responses  Health Canada’s reply  
Industry  Requested copy of 
propo sal 1 
 Copy provided  
                                                             
1 SPIRULINA EXTRACT (TENTATIVE) – Residue Monograph prepared by the meeting of the Joint FAO/WHO Expert  
Committee on Food Addit ives (JECFA), 86th Meeting 2018 : http://www.fao.org/3/ca3742en/ca3742en.pdf  Notice of Modification to the List of Permitted Colouring Agents  to Enable the Use of Spirulina  Extract in Various Foods  –  
Reference Number: [NOM/ADM -0152 ]| 5 
 Notice of Modification to the List of Permitted Colouring Agents  to Enable the Use of Spirulina  Extract in Various Foods  – 
Reference Number: [NOM/ADM -0152]| 5 
 Stakeholder  Stakeholder 
Response  Number of 
responses  Health Canada’s reply  
Industry  Requested 
clarification on  
(a) the food -grade 
specifications of 
Spirulina extract , and  
(b) the scope of 
proposal  2 Provided clarification : 
(a) Spirulina  extract  must  meet tentative 
specifications  developed by JECFA;  
(b) the foods that are the subject of the proposal 
are shown in the table in the NOP  
Industry  Support ed proposal  3 Acknowledged position  
Industry  Requested 
clarification about 
the implementation 
date  1 Indicated steps that would be followed to authorize  
use of Spirulina  extract  
Industry  Requested extension 
of use to additional 
food categories  2 Explained that a food additive submission would be 
needed to extend the use of Spirulina extract to 
foods other than those included in the original 
proposal  
Academia  Requested 
information to 
enable phycocyanin 
as a colouring agent  1 Indicated  that phycocyanin is the principle 
colouring pigment in Spirulina  extract but that 
isolated or purified phycocyanin would have to 
undergo a thorough pre -market evaluation, 
focussin g on safety, prior to being considered for 
use as a colouring agent in foods in Canada  
Implementation and Enforcement  
The above modification came into force September  4, 2020 , the day it was published in  the List of Permitted 
Colouring Agents .  
The Canadian Food Inspection Agency is responsible for the enforcement of t he Food and Drugs Act and its 
associated regulations with respect to foods.   
Contact Information  
Health Canada's Food Directorate is committed to reviewing any new scientific information on the safety in 
use of any food additive, including Spirulina  extract . Anyone wishing to submit new scienti fic information on 
the use of this additive  or to submit any inquiries may do so in writing, by regular mail or electronically. If you 
wish to contact the Food Directorate electro nically, please use the words " Spirulina  extract (NOM -0152)" in 
the subject line of your e -mail.  
Bureau of Chem ical Safety, Food Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0K9  
E-mail: hc.bcs -bipc.sc@canada.ca