Notice of Modification to the List of Permitted Colouring Agents to Enable the Use of Potassium Alumin um Silicate -Based Iron Oxide, 
Potassium Alumin um Silicate -Based Titanium Dioxide, and Potassium Alumin um Silicate -Based Titanium Dioxide and Iron Oxide, as 
Colouring Agents, in Certain Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Heal th Products and Food Branch     1 
  
Notice of Modification to the List of Permitted Colouring 
Agents to Enable the Use of Potassium Alumin um 
Silicate -Based Iron Oxide, Potassium Alumin um 
Silicate -Based Titanium Dioxide, and Potassium 
Alumin um Silicate -Based Titanium Dioxide and Iron 
Oxide, as Colouring Agents, in Certain Unstandardized 
Foods  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0051] 
 
 
 May  28, 2015   
Notice of Modification to the List of Permitted Colouring Agents to Enable the Use of Potassium Alumin um Silicate -Based Iron Oxide, 
Potassium Alumin um Silicate -Based Titanium Dioxide, and Potassium Alumin um Silicate -Based Titanium Dioxide and Iron Oxide, as 
Colouring Agents, in Certain Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Heal th Products and Food Branch     2 Summary  
 
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by the 
Minister of Health and the Food and Drug 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 MA’s and publis hed on Health Canada’s 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 food 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 received a food additive submission seeking approval for the use of  mica -based 
iron oxide, mica -based titanium dioxide, and mica -based titanium dioxide and iron oxide as 
colouring agents in unstandardized confectionery and chewing gum at a maximum level of use of 
1.25%, and in unstandardized alcoholic beverages at a maximu m level of use of 0.5%.  The mica 
component of these food additives is muscovite1 which is naturally -sourced potassium aluminum 
silicate.  
 
Since this is a food additive that was not previously permitted for use in Canada, Health Canada 
published a Notice of Proposal to Enable the Use of a Three New Colouring Agents; Potassium 
Aluminum  Silicate -Based Iron Oxide; Potassium Aluminum  Silicate -Based Titanium Dioxide; 
and Potassium Aluminum  Silicate -Based Titanium Dioxide and Iron Oxide in Certain 
Unstandardized Foods  on January 26, 2015,  requesting comments.  The comment period was 
open for 75 days, during which no new scientific information about this additive was submitted 
to the Department.   Since the conclusions of the evaluation remain as described in the Notice of 
Proposal, Health Canada has modified the List of Permitted Colouring Agents  by adding the 
entries shown below to the list.  
 
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  
10 Potassium 
aluminum  silicate  
-based iron oxide   (1) Chewing gum; 
Unstandardized 
confectionery  
 
 
 (1) 1.25%.  If any combination 
of potassium aluminum  
silicate -based iron oxide, 
potassium aluminum  silicate  
-based titanium dioxide or 
potassium aluminum  
                                              
1 Muscovite is the most common form of mica and is a hydrated silicate of potassium and aluminum, i.e., 
potassium aluminum silicate. Mica is a general term applied to a group of complex mineral aluminosilicates  which 
may also contain potassium, magnesium, iron, sodium, fluorine and/or lithium.    
Notice of Modification to the List of Permitted Colouring Agents to Enable the Use of Potassium Alumin um Silicate -Based Iron Oxide, 
Potassium Alumin um Silicate -Based Titanium Dioxide, and Potassium Alumin um Silicate -Based Titanium Dioxide and Iron Oxide, as 
Colouring Agents, in Certain Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Heal th Products and Food Branch     3  
 
 
 
 
(2) Unstandardized 
alcoholic beverages  silicate -based titanium 
dioxide and iron oxide is 
used, the total amount not to 
exceed 1.25%.  
 
(2) 0.5%.  If any combination of 
potassium aluminum  silicate  
-based iron oxide, potassium 
aluminum  silicate -based 
titanium dioxide or  
potassium aluminum  
silicate -based titanium 
dioxide and iron oxide is 
used, the total amount not to 
exceed 0.5%.  
 
11 Potassium 
aluminum  silicate  
-based titanium 
dioxide  (1) Chewing gum; 
Unstandardized 
confectionery  
 
 
 
 
 
 
 
 
(2) Unstandardized 
alcoholic beverages  (1) 1.25%.  If any combination 
of  potassium aluminum  
silicate -based iron oxide,  
potassium aluminum  silicate  
-based titanium dioxide or  
potassium aluminum  
silicate -based titanium 
dioxide and iron oxide is 
used, the total amount not to 
exceed 1.25%.  
 
(2) 0.5%.  I f any combination of 
potassium aluminum  
silicate -based iron oxide, 
potassium aluminum  
silicate -based titanium 
dioxide or potassium 
aluminum  silicate -based 
titanium dioxide and iron 
oxide is used, the total 
amount not to exceed 0.5%.  
 
12  Potassium 
aluminum  silicate  
-based titanium 
dioxide and iron 
oxide  (1) Chewing gum; 
Unstandardized 
confectionery  
 
 (1) 1.25%.  If any combination 
of potassium aluminum  
silicate -based iron oxide, 
potassium aluminum  
silicate -based titanium  
Notice of Modification to the List of Permitted Colouring Agents to Enable the Use of Potassium Alumin um Silicate -Based Iron Oxide, 
Potassium Alumin um Silicate -Based Titanium Dioxide, and Potassium Alumin um Silicate -Based Titanium Dioxide and Iron Oxide, as 
Colouring Agents, in Certain Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Heal th Products and Food Branch     4  
 
 
 
 
 
(2) Unstandardized 
alcoholic beverages  dioxide or  potassium 
aluminum  silicate -based 
titanium dioxide and iron 
oxide is used, the total 
amount not to exceed 1.25%.  
 
(2) 0.5%.  If any combination of 
potassium aluminum  
silicate -based iron oxide, 
potassium aluminum  
silicate -based titani um 
dioxide or potassium 
aluminum  silicate -based 
titanium dioxide and iron 
oxide is used, the total 
amount not to exceed 0.5%.  
 
Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety and efficacy assessment of 
mica -based colouring agents.  The assessment considered toxicological, chemical, 
microbiological, and nutritional aspects when used as requested in the food additive submission.  
Based on the results of the safety assessment, Health Canada's Food Directorate considers that 
the data support the safety of mica -based colouring agents when used under the conditions of use 
set out in the table above.  The Department has therefore enabled the use of mica -based 
colouring agents as described in the above table.  
Other Relevant Informatio n 
 
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has published food -grade 
specifications for potassium aluminum silicate -based pearlescent pigments, Type I (i.e., mica -
based titanium dioxide), potassium aluminum  silicate -based pearlescent pi gments, Type II (i.e., 
mica -based iron oxide), and potassium aluminum  silicate -based pearlescent pigments Type III 
(i.e., mica -based titanium dioxide and iron oxide).  The muscovite mica -based colouring agents 
that were evaluated by Health Canada meet thes e food -grade specifications.  
  
In the European Union,  potassium aluminum  silicate is permitted for use as a carrier for the 
colours titanium dioxide and iron oxide.  Both colours are permitted for use in a wide variety of 
foods.  
  
Notice of Modification to the List of Permitted Colouring Agents to Enable the Use of Potassium Alumin um Silicate -Based Iron Oxide, 
Potassium Alumin um Silicate -Based Titanium Dioxide, and Potassium Alumin um Silicate -Based Titanium Dioxide and Iron Oxide, as 
Colouring Agents, in Certain Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Heal th Products and Food Branch     5 In the United States, the  mica -based colouring agents are referred to as “mica -based pearlescent 
pigments”2 and they may be used as a colour additive at a maximum level of 1.25% in cereals, 
confections, gelatin desserts, hard and soft candies (including lozenges), nutritional supp lement 
tablets and gelatin capsules, and chewing gum.   
 
Mica -based colouring agents are not listed in the Codex General Standard for Food Additives  
(GSFA) and they are not currently permitted for use as colours in Australia or New Zealand.  
 
Notification – Summary of Comments  
 
No comments were received on the Notice of Proposal to Enable the Use of a Three New 
Colouring Agents; Potassium Aluminum Silicate -Based Iron Oxide; Potassium Aluminum 
Silicate -Based Titanium Dioxide; and Potassium Aluminum Silicate -Based Titanium Dioxide and 
Iron Oxide in Certain Unstandardized Foods . 
 
Implementation and Enforcement  
 
The above modification came into force May  28, 2015 , 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.  
 
Contact Information  
 
Health Canada's Food Directorate is committed to reviewing any new scientific information on 
the safety in use of any permitted food additive  including the three mica -based colour ing agents 
described in this notice . Anyone wishing to submit new scientific 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 elec tronically, please use the word s “mica -based colouring 
agents " in the subject line of your e -mail.  
 
Bureau of Chemical Safety , Food Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0L2  
E-mail:  bcs-bipc@hc -sc.gc.ca  
                                              
2 Defined in the U.S.A. Code of  Federal Regulations  as an additive formed by depositing titanium salts onto 
muscovite mica followed by heating to produce titanium dioxide on mica .