Notice of Modification to the List of Permitted Colouring Agents  to Extend the Use of Potassium Aluminum Silicate -Based Titanium Dioxide, 
Potassium Aluminum Silicate -Based Iron Oxide, and Potassium Aluminum Silicate -Based Titanium Dioxide and Iron Oxide as Colouring 
Agents to Unstandardized Bakery Products, Gelatin Des serts and Standardized Bite Sized Chocolate   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  
Notice of Modification to the List of Permitted Colouring 
Agents  to Extend the Use of Potassium Aluminum 
Silicate -Based Titanium Dioxide, Potassium Aluminum 
Silicate -Based Iron Oxide, and Potassium Aluminum 
Silicate -Based Titanium Dioxide and Iron Oxide as 
Colouring Agents to Unstandardized Bakery Products, 
Gelatin Des serts and Standardized Bite Sized Chocolate  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0061] 
 
 
 Octo ber 7, 201 5  
Notice of Modification to the List of Permitted Colouring Agents  to Extend the Use of Potassium Aluminum Silicate -Based Titanium Dioxide, 
Potassium Aluminum Silicate -Based Iron Oxide, and Potassium Aluminum Silicate -Based Titanium Dioxide and Iron Oxide as Colouring 
Agents to Unstandardized Bakery Products, Gelatin Des serts and Standardized Bite Sized Chocolate   
Bureau of Chemical Safety, Food Directorate, Health 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 MAs and published on Health Canada’s website.  A petitioner 
can request that Health Canada approve a n ew 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 th e 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 
titanium dioxide , mica -based iron oxide and mica -based titanium dioxide , and iron oxide 
colouring agents  for unstandardized bakery products, gelatin desserts and standardized bite sized 
chocolates at a maximum use level of 0. 15%.  The mica component of these  food additive s is 
muscovite1, which is naturally -sourced potassium al uminum silicate.  
The potassium aluminum silicate -based titanium dioxide is to be used alone or mixed with other 
permitted colouring agents. The colouring agent itself or the mixture of which it is a part is 
applied to the surface of the food for decorative  purposes.  
Potassium aluminum silicate -based titanium dioxide, as well as potassium aluminum silicate -
based iron oxide, and potassium aluminum silicate -based titanium dioxide and iron oxide  are 
already permitted for use in Canada as colouring agents for un standardized confectionery and for 
chewing gum at a maximum level of use, singly or in combination, of 1.25%, and for 
unstandardized alcoholic beverages at a maximum level of use of 0.5%, singly or in 
combination. As these three colours are considered equi valent from a safety perspective, they 
were all considered as part of the safety evaluation of the proposed new use.  
The results of Health Canada’s evaluation of available scientific data support the safety of 
potassium aluminum silicate -based titanium dioxide, as well as potassium aluminum silicate -
based iron oxide, and potassium aluminum silicate -based titanium dioxide and iron oxide, when 
used in the foods and at the maximum level of use requested by the peti tioner. Therefore, Health 
Canada has modified the List of Permitted Colouring Agents  to extend the use of all three 
potassium aluminum silicate -based colouring agents by  adding the entries to the list as shown in 
the table below.  
 
                                              
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, ir on, sodium, fluorine and/or lithium.    
Notice of Modification to the List of Permitted Colouring Agents  to Extend the Use of Potassium Aluminum Silicate -Based Titanium Dioxide, 
Potassium Aluminum Silicate -Based Iron Oxide, and Potassium Aluminum Silicate -Based Titanium Dioxide and Iron Oxide as Colouring 
Agents to Unstandardized Bakery Products, Gelatin Des serts and Standardized Bite Sized Chocolate   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3  
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  
8. Sodium Copper 
Chlorophyllin  (1) 
Frozen novelties; Ice 
cream mix; Ice milk mix; 
Sherbet;  
Unstandardized 
confectionery;  
Unstandardized frozen 
desserts; 
Unstandardized mixes 
for frozen dairy 
products  (1) 
300 p.p.m.  
10. Potassium aluminum 
silicate -based iron 
oxide  (3) 
Gelatin desserts; 
Unstandardized bakery 
products  (3) 
0.15%. 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 0.15%.  
(4) 
Colour formulations 
applied to the surface 
of bite sized chocolate, 
bite sized milk 
chocolate, bite sized 
sweet chocolate or bite 
sized white chocolate  (4) 
0.15% of the chocolate product as 
consumed. 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 0.15% of the chocolate 
product as c onsumed.  
11. Potassium aluminum 
silicate -based 
titanium dioxide  (3) 
Gelatin desserts; 
Unstandardized bakery 
products  (3) 
0.15%. If any combination of 
potassium aluminum silicate -based 
iron oxide, potassium aluminum 
silicate -based titanium dioxide or 
potas sium aluminum silicate -based 
titanium dioxide and iron oxide is 
used, the total amount not to  
Notice of Modification to the List of Permitted Colouring Agents  to Extend the Use of Potassium Aluminum Silicate -Based Titanium Dioxide, 
Potassium Aluminum Silicate -Based Iron Oxide, and Potassium Aluminum Silicate -Based Titanium Dioxide and Iron Oxide as Colouring 
Agents to Unstandardized Bakery Products, Gelatin Des serts and Standardized Bite Sized Chocolate   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 exceed 0.15%.  
(4) 
Colour formulations 
applied to the surface 
of bite sized chocolate, 
bite sized milk 
chocolate, bite sized 
sweet chocolate or bite 
sized white  chocolate  (4) 
0.15% of the chocolate product as 
consumed. 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 0.15% of the chocolate 
product as consumed.  
12. Potassium aluminum 
silicate -based 
titanium dioxide and 
iron oxide  (3) 
Gelatin desserts; 
Unstandardized bakery 
products  (3) 
0.15%. If any combination of 
potassium aluminum silic ate-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 0.15%.  
(4) 
Colour formulations 
applied to the surface 
of bite sized chocolate, 
bite sized milk 
chocolate, bite sized 
sweet chocolate or bite 
sized white chocolate  (4) 
0.15% of the chocolate product as 
consumed. If any combination of 
potassium aluminum silicate -based 
iron oxide, potassium aluminum 
silicate -based titanium di oxide or 
potassium aluminum silicate -based 
titanium dioxide and iron oxide is 
used, the total amount not to 
exceed 0.15% of the chocolate 
product as consumed.  
 
Corrective Modifications to the List of Permitted Colouring Agents   
 
Health Canada has also modified the List of Permitted Colouring Agents  to make two corrections  
as follows.  First, the term “Confectionery” in column 2 of item 8 of the list has been changed to 
“unstandardized confectionery” to reflect the intended provision to permit the use of sodium 
copper chlorophyllin in unstandardized confectionery only and not standardized confectionery 
such as “Chocolate”.   
 
Second, in the French version of the list ( Liste des colorants autorisés ), the name “Dioxyde de 
titane et d’oxyde de fer sur support de silicate de potassium et d'aluminium” that appears in  
Notice of Modification to the List of Permitted Colouring Agents  to Extend the Use of Potassium Aluminum Silicate -Based Titanium Dioxide, 
Potassium Aluminum Silicate -Based Iron Oxide, and Potassium Aluminum Silicate -Based Titanium Dioxide and Iron Oxide as Colouring 
Agents to Unstandardized Bakery Products, Gelatin Des serts and Standardized Bite Sized Chocolate   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     5 column 3 of sub -items 10.(1), 10.(2), 11.(1), 11.(2), 12.(1) and 12.(2) has been changed  to 
“Dioxyde de titane et oxyde de fer sur support de silicate de potassium et d'aluminium” for 
consistency with the common name of this food additive appearing in item 12 of column 1 of 
this lis t. 
 
Rationale  
 
Health Canada’s F ood Directorate completed a p remarket safety assessment of the new uses of 
potassium aluminum silicate -based colouring agents as set out in the table above .  The 
assessment considered the microbiological, toxicological, nutritional and chemical suitability of 
these uses of these colou ring agents, and found that the requested uses are acceptable from a 
food safety perspective. Therefore, the Department has enabled the requested uses of potassium 
aluminum silicate -based colouring agents by modifying the List of Permitted Colouring Agents  
as described in the above table.  
 
Other Relevant Information  
 
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 aluminium silicate -based pearlescent pigments, Type II (i.e., 
mica -based iron oxide), and potassium aluminium silicate -based pearlescent pigments Type III 
(i.e., mica -based titanium dioxide and iron oxide).  The potassium aluminum silicate -based 
colouring agents that were evaluated by Health Canada meet these food -grade specifications.   
 
Implementation and Enforcement  
 
The above modification came into force Octo ber 7, 2015 , the day it was published in List of 
Permitted Colouring Agents . 
 
The Canadian Food Inspection Agency is responsi ble 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 food additive, including potassium aluminum silicate -based colouring 
agents . Anyone wishing to submit new scientific information on the us e 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 electronically, please use the words " potassium aluminum 
silicate -based colouring agents " in the subject line  of your e -mail.  
 
Bureau of Chemical Safety , Food Directorate  
251 Sir Frederick Banting Driveway   
Notice of Modification to the List of Permitted Colouring Agents  to Extend the Use of Potassium Aluminum Silicate -Based Titanium Dioxide, 
Potassium Aluminum Silicate -Based Iron Oxide, and Potassium Aluminum Silicate -Based Titanium Dioxide and Iron Oxide as Colouring 
Agents to Unstandardized Bakery Products, Gelatin Des serts and Standardized Bite Sized Chocolate   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     6 Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0L2  
E-mail:  bcs-bipc@hc -sc.gc.ca