Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of Quillaia  
Extract (Type 2) as an Emulsifying Agent for Oil -Based Colouring Formulations and Unstandardized Oil -Based Ingredients  
when Used in Certain Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  Notice of Modification to the List of Permitted Emulsifying, 
Gelling, Stabilizing or Thickening Agents  to Enable the Use 
of Quillaia  Extract (Type 2) as an Emulsifying Agent for 
Oil-Based Colouring Formulations  and Unstandardized 
Oil-Based Ingredients when Used in Certain Foods  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0069] 
 
March  4, 2016   
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of Quillaia  
Extract (Type 2) as an Emulsifying Agent for Oil -Based Colouring Formulations and Unstandardized Oil -Based Ingredients  
when Used in Certain Foods   
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 publis hed on Health Canada’s website.  A petitio ner 
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 det ermine 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 quillaia 
extract (Type 2) as an emulsify ing agent at various maximum levels of use, calculated as 
saponin1, in oil -based colouring formulations or unstandardized oil -based ingredients when used 
in the production of the following  foods:  unstandardized carbonated beverages, iced and instant 
tea products, marinades for meat or poultry, powdered sauces and mixes, dry soup mixes, 
vegetable juices and blends, and savoury snack food (25 ppm2); powdered forms of fruit drinks, 
caffeinat ed energy drinks, sports drinks  and “electrolyte drinks” (25 ppm); unstandardized 
flavoured a lcoholic beverages, chewing gum  and fruit drinks (50 ppm) and “vitamin water 
beverages ” (130 ppm). In addition, quillaia extract (Type 2) w as requested to  be used in 
unstand ardized oil -based flavouring preparations at a maximum level of 7.67% for use in 
unstandardized foods and standardized foods where a standard includes provision for the 
addition of unstandardized flavouring preparations.   
 
Quillaia extract (type unspecifie d) is already permitted for use in Canada . The List of Permitted 
Food Additives with Other Generally Accepted Uses  includes a provision for its use as a foaming 
agent in  beverage bases, beverage mixes  and soft drinks at a level of use consistent with good 
manufacturing practice (GMP). There is also a separate provision for the use of saponins in these 
same foods for the same purpose and at the same level of use.  
 
The results of Health Canada’s evaluation of available scientific data support the safety of 
quillaia extract (Type 2) when used as requested by the petitioner.  Therefore, Health Canada has 
modified the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to extend 
the use of quillaia extract (Type 2) by adding the entries shown below to the list.   
 
 
 
 
 
 
                                              
1 Quillaia  extract (Type 2) has a high saponin content, saponin being the component that acts as an emulsifier.  
2 Parts per million   
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of Quillaia  
Extract (Type 2) as an Emulsifying Agent for Oil -Based Colouring Formulations and Unstandardized Oil -Based Ingredients  
when Used in Certain Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or u pon Column 3  
Maximum Level of Use and 
Other Conditions  
Q.1 Quillaia 
extract 
(Type 2)  (1) 
Oil-based colouring formulations or 
unstandardized oil -based ingredients 
for use in chewing gum, non -
carbonated water -based flavoured and 
sweetened beverages or unstandardized 
flavoured alcoholic beverages   (1) 
Good Manufacturing Practice. 
The total amount of quillaia 
extract (Type 2) in the finished 
food not to exceed 50 p.p.m., 
calculated as saponin.  
(2) 
Oil-based colouring formulations or 
unstandardized oil-based ingredients 
for use in dry sauce mixes, dry soup 
mixes, marinades for meat (Division 
14) and poultry, ready -to-drink tea, 
savoury snack food, unstandardized 
beverage mixes, unstandardized 
carbonated non -alcoholic beverages or 
unstandardized veget able juice  (2) 
Good Manufacturing Practice. 
The total amount of quillaia 
extract (Type 2) in the finished 
food not to exceed 25 p.p.m., 
calculated as saponin.  
(3) 
Oil-based colouring formulations or 
unstandardized oil -based ingredients 
for use in caffeinated energy drinks, 
sports drinks or beverages with vitamin 
and mineral nutrients added, except 
beverages with vitamins added in 
accordance with Part D of the Food 
and Drug Regulations  (3) 
Good Manufacturing Practice. 
The total amount of quillaia 
extract (Type 2) in the finished 
food not to exceed 130 p.p.m., 
calculated as saponin.  
(4) 
Unstandardized oil -based flavouring 
preparations  (4) 
Good Manufacturing Practice  
 
 
 
 
 
 
 
  
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of Quillaia  
Extract (Type 2) as an Emulsifying Agent for Oil -Based Colouring Formulations and Unstandardized Oil -Based Ingredients  
when Used in Certain Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 Corrective Modification to the List of Permitted Emulsifying, Gelling, Stabilizing, or 
Thickening Agents  
 
A minor corrective modification is also made to subitem T.3( 8) where the term “comminuted” is 
replaced by the term “minced”. The terms “comminuted” and “minced” are considered to have 
the same meaning by Health Canada and the Canadian Food Inspection Agency. Since the term 
“comminuted” was repealed from the Fish In spection Regulations , Health Canada proposes to 
preferentially use the expression “minced”. Correspondingly, the term “haché” replaces the term 
“déchiqueté” in the Liste des agents émulsifiants, gélifiants, stabilisants ou épaississants 
autorisés .  
 
Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety assessment of the requested 
uses of quillaia extract (Type 2).  The assessment considered microbiological, toxicological, 
nutritional, chemical and technical aspects of this additive , and found that the requested uses are 
acceptable from a food safety perspective. Therefore, the Department has enabled the requested 
uses of quillaia extract (Type 2) by modifying the List of Permitted Emulsifying, Gelling, 
Stabilizing or Thickening Agen ts as described in the above table.   
 
Implementation and Enforcement  
 
The above modification came into force March  4, 2016 , the day it was published in  the List of 
Permitted Emulsifying, Gelling, Stabilizing or Thickening 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 food additive, including quillaia extract (Type 2) . Anyone wishing to 
submit new scientifi c 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 word s “quillaia extract (Type 2) ” 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