Notice of Modification to the List of 
Permitted Colouring  Agents  to Exten d 
the Use of Spirulina  Extract  to Certain 
Unstandardized Foods  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0160 
February  8, 2021 
  
Notice of Modification to the List of Permitted Colouring Agents  to Extend  the Use of  Spirulina  Extract to Certain Unstandardized 
Foods  – Reference Number: NOM/ADM -0160| 2 
 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 Pe rmitted 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 foo d 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.  
Health Canada’s Food Directorate received a food additive submission seeking approval for the use of 
Spirulina (Arthrospira  platensis ) extract  as a colouring agent in various foods such as beverage dry mixes, 
unstandardized confectionery , custards, desser t coatings, frosting, frozen novelties,  gelatin, ice cream, 
puddings,  toppings, and yogurts . The requested maximum level of use , in all the se foods,  is 0.1% . For the 
beverage dry mixes, the requested maximum level of use applies to the beverage as consumed . 
Spirulina  extract is already permitted for use as a colouring agent in a variety of foods at a level consistent 
with Good Manufacturing Practice (GMP) , including certain foods requested by the petitioner .  
The results of the Food Directorate’s evaluation  of available scientific data support the safety of extending 
the use of Spirulina  extract to the other foods of interest to the petitioner, namely custards , dessert coatings, 
non-alcoholic beverage dry mixes, puddings, toppings, and  unstand ardized chocolate confectionery, to be 
used at level consistent with GMP , as is already permitted for other uses of this colouring agent . Therefore, 
Health Canada has modified the List of Permitted Colouring Agents  to extend the use of  Spirulina  extract to 
these foods by adding “Custards”, “Dessert coatings”, “Puddings”, and “Toppings” to subitem (2) ; removing 
“unstandardized chocolate confectionery” as an exception in subitem ( 5), which has the effect of permitting 
Spirulina  extract in unstandardized chocolate confectionery because it is a type of “ Unstandardized 
confectionery ”; and adding “ Unstandardized non -alcoholic beverage dry mixes” to subitem (6).   For clarity, 
these changes are shown in bold  in the below table . 
 
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  (2) 
Custards; Dessert coatings; Gelatin 
desserts; Puddings; Unstandardized frozen 
desserts ; Toppings  (2) 
Good Manufacturing Practice  
(5) 
Unstandardized confectionery  (except 
unstandardized chocolate confectionery)  (5) 
Good Manufacturing Practice  
(6) 
Unstandardized non -alcoholic beverages;  (6) 
Good Manufacturing Practice   
Notice of Modification to the List of Permitted Colouring Agents  to Extend  the Use of  Spirulina  Extract to Certain Unstandardized 
Foods  – Reference Number: NOM/ADM -0160| 3 
 Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and 
Other Conditions  
Unstandardized non -alcoholic beverage 
concentrates ; Unstandardized non -
alcoholic beverage dry mixes  
 
Based on the safety evaluation, the entry for “unstandardized confectionery” was expanded to all include all 
types of unstandardized confectionery including those that contain chocolate. However, this entry excludes 
any chocolate product that meets one of the standards set out in Division 4  of the Food and Drug 
Regulations . 
Rationale  
Health Canada’s Food Directora te completed a premarket safety  assessment of Spirulina  extract  for use as a 
colouring agent  in the foods of interest to the petitioner that are not already permitted to be coloured with 
Spirulina  extract .  The assessment concluded that information related to  allergenicity , chemistry, 
microbiology, nutrition  and toxicology supports the safety of Spirulina  extract  for these new  uses.  Therefore, 
the Department has enabled the se new  uses of Spirulina  extract  by modifying  the List of Permitted Colouring 
Agents  with the changes 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  edition of the  Food Chemicals Codex  or the Combined Compendium of Food Additive 
Specifications .  The Food Chemicals Codex  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 specifications prepared by the Joint 
FAO/WHO Expert Committee on Food Additives (JECFA), is published by the Food and Agriculture 
Organization of the United Nations.  Currently there are tent ative specifications for Spirulina  extract1 
established by JECFA.   
Implementation and Enforcement  
The above modification came into force February 8, 2021, the day it was published in  the List of Permitted 
Colouring Agents .  
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its 
associated regulations with respect to foods.   
                                                             
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 Extend  the Use of  Spirulina  Extract to Certain Unstandardized 
Foods  – Reference Number: NOM/ADM -0160| 4 
 Contact Information  
Health Canada's Food Directorate is committed to reviewing new scientific information on the safety in use of 
any permitted food additive, including Spirulina  extract .  Anyone wish ing to submit new scientific information 
on the use of this additive or to submit inquiries may do so in writing, by regular mail or electronically.  If you 
wish to contact the Food Directorate electronically, please use the words " Spirulina  extract  (NOM -0160)" in 
the subject line of your e -mail.  
Bureau of Chemical Safety, Food Direct orate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0K9  
E-mail: hc.bcs -bipc.sc@canada.ca