Notice of Modification to the List of Permitted Food Additives with Other Generally Accepted Uses  to Enable the Use of  
Silicon Dioxide as a Colour Stabilizer in Colouring Agent Formulations   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  
Notice of Modification to the List of Permitted Food 
Additives with Other Generally Accepted Uses  to Enable 
the Use of Silicon Dioxide as a Colour Stabilizer in 
Colouring Agent Formulations  
 
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0041] 
 
 
 Octo ber 28, 2014   
Notice of Modification to the List of Permitted Food Additives with Other Generally Accepted Uses  to Enable the Use of  
Silicon Dioxide as a Colour Stabilizer in Colouring Agent Formulations   
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 th eir 
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 petiti oner 
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 d etermine 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 silica (silicon 
dioxide) as a colour stabilizer in a number of permitted colouring agents.   
 
Silicon dioxide is already a permitted food additive in Canada. Item S.1 in the List of Permitted 
Anticaking Agents  provides for the use of silicon dioxide as an anticaking agent in 
unstandardized dry mixes and foods sold in tablet form at levels consistent with Good 
Manufacturing Practice (GMP).  Silicon dioxide is also permitted as an anticaking agent for use 
in salt, icing sugar and certain spices and seasonings at levels ranging from 0.5% to 2.0% 
depending on the food. Item S.1.01 in the List of Permitted Food Additives with Other Generally 
Accepted Uses  provides for the use of sil icon dioxide as a suspending agent in edible vegetable 
oil-based cookware coating emulsions at a maximum level of use of 2.0% of the preparation.  
 
There are no food additive provisions for the use of silicon dioxide to stabilize colouring agents, 
either i n the Lists of Permitted Food Additives or in the standards in Division 6 of the Food  and 
Drug  Regulations  that set out specifications for colouring agents .   
 
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of silicon dioxide as a colour stabilizer in colouring agent formulations.  Therefore, 
Health Canada has modified the List of Permitted Food Additives with Other G enerally Accepted 
Uses  to extend the use of silicon dioxide by adding the entry shown below to the list.   The 
colouring agent formulations referred to in this new entry apply to a combination of any 
permitted colouring agent from the List of Permitted Colouring Agents  and the silicon dioxide 
that is used to stabilize the colour.  
 
 
 
 
 
 
 
 
  
Notice of Modification to the List of Permitted Food Additives with Other Generally Accepted Uses  to Enable the Use of  
Silicon Dioxide as a Colour Stabilizer in Colouring Agent Formulations   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Modification to the List of Permitted Food Additives with Other Generally Accepted Uses  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or 
upon  Column 3  
Purpose of Use  Column 4  
Maximum Level of Use 
and Other Conditions  
S.1.01  Silicon 
Dioxide  (2)  
Colouring agent 
formulations  
 (2)  
Colour stabilizer  
 (2)  
Good Manufacturing 
Practice  
 
Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety and efficacy assessment of 
silicon dioxide as a colour stabilizer in colouring agent formulations.  The assessment considered 
the toxicological and technical aspects of the proposa l. 
 
Based on the results of the safety assessment, Health Canada’s Food Directorate considers that 
the data support the safety of silicon dioxide when used under the conditions of use set out in the 
table above.  The Department has therefore enabled the us e of silicon dioxide as described in the 
above table.  
 
Other Relevant Information  
 
Health Canada routinely consults the Canadian Food Inspection Agency (CFIA) and the food 
industry when the Department is evaluating new food additive uses that could impact foods for 
which there are compositional standards set out in federal regulations.  Several expert groups 
within the CFIA, and industry associations that represent a number of sectors of the food 
industry that could be impacted by changes to provisions for food colouring agents, were 
consulted about the use of silicon dioxide as a colour stabilizer in colouring agent formulations.  
 
None of the groups that responded objected to the proposed use of silicon dioxide.  
Silicon dioxide used in foods sold in Canada must meet the food -grade specifications for this 
additive set out in the most rece nt edition of the Food Chemicals Codex . The FCC is a 
compendium of standards for purity and identity of food ingredients, including food additives, 
which is published by the United States Pharmacopeial Convention . 
 
Implementation and Enforcement  
 
The above modification came into force Octo ber 28, 2014 , the day it was published in the  List of 
Permitted Food Additives with Other Generally Accepted Uses . 
 
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs 
Act and its associated regulations with respect to foods.   
Notice of Modification to the List of Permitted Food Additives with Other Generally Accepted Uses  to Enable the Use of  
Silicon Dioxide as a Colour Stabilizer in Colouring Agent Formulations   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4  
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 silicon dioxide . Anyone wishing to 
submit new scientific information on the use of this food additive o r 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 " silicon dioxide in colouring agent formulations " 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