Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  and the List of  
Permitted Food Additives with Other Generally Accepted Uses  to Enable the Use of Lactylated Mono-  and Di -glycerides   
as an Emulsifying Agent and Sodium Stearoyl -2-Lactylate as a Whipping Agent, respectively, in Whipped Yogurt . 
  
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  
and the List of Permitted Food Additives with Other 
Generally Accepted Uses  to Enable the Use of Lactylated 
Mono - and Di -glycerides  as an Emulsifying Agent and 
Sodium Stearoyl -2-Lactylate as a Whipping Agent, 
respectively, in Whipped Y ogurt  
Notice of Modification –  Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0085 ] 
 
 
 January 4 , 201 7  
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  and the List of  
Permitted Food Additives with Other Generally Accepted Uses  to Enable the Use of Lactylated Mono-  and Di -glycerides   
as an Emulsifying Agent and Sodium Stearoyl -2-Lactylate as a Whipping Agent, respectively, in Whipped Yogurt . 
  
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 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 lactylated mono-  and di -glycerides  and sodium stearoyl -2-lactylate in the manufacture of whipped yogurt. 
These additives are mixed into the yogurt, prior to aeration, to help create the mousse te xture of 
the whipped yogurt. The requested maximum level of use for each additive, on the basis of the finished whipped yogurt, is 0.5% and 0.05%, respectively .  
 Both additives already have permitted uses in Canada. Lactylated mono - and di -glycerides  are 
permitted as an emulsifying agent in unstandardized foods, a food category that includes whipped yogurt. However, the current maximum level of use is lower than the concentration that 
the petitioner indicates is required in whipped yogurt.  S odium stearoyl -2-lactylate is permitted 
as a whipping agent in certain standardized egg products and in oil toppings or topping mixes, but there are no provisions that would allow its use in whipped yogurt.  
 The results of Health Canada’s evaluation of available scienti fic data support the safety of the 
requested use of lactylated mono - and di -glycerides  and sodium stearoyl -2-lactylate in whipped 
yogurt.  Therefore, Health Canada has modified the 
List of Permitted Emulsifying, Gelling, 
Stabilizing or Thickening Agents  and the List of Permitted Food Additives with Other Generally 
Accepted Uses  by adding the entries shown below to the lists.  
 
Modifications to the  List of Permitted Food Additives  
 
The following entry has been added to the List of Permitted Emulsifying, Gelling, Stabilizing or 
Thickening Agents : 
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or upon  Column 3  
Maximum Level of Use and Other 
Conditions  
L.1 Lactylated 
Mono-  and 
Di-glycerides  (3)  
Whipped yogurt  (3)  
0.5%   
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  and the List of  
Permitted Food Additives with Other Generally Accepted Uses  to Enable the Use of Lactylated Mono-  and Di -glycerides   
as an Emulsifying Agent and Sodium Stearoyl -2-Lactylate as a Whipping Agent, respectively, in Whipped Yogurt . 
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3  
The following entry has been added 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.9A  Sodium 
Stearoyl -2-
Lactylate  (5)  
Whipped yogurt  (5) 
Whipping agent  (5)  
0.05%  
 
Justification  
 Health Canada’s Food Directorate assessed the safety of lactylated  mono-  and di -glycerides and 
sodium stearoyl -2-lactylate for their requested use in whipped yogurt .  The assessment focused 
on the toxicological and nutritional aspects of this use of these additives. No food safety 
concerns were identified. Therefore, Health Canada has enabled their requested use by modifying the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  
and the 
List of Permitted Food Additives with Other Generally Accepted Uses  as described above.  
 
Other Relevant Information  
 
The Food and Drug Regulations require that food additives such as lactylated  mono-  and di -
glycerides and sodium stearoyl -2-lactylate, which do not have specifications set out in the 
Regulations, meet the food- grade specifications set out in the most recent edition of the Food 
Chemicals Codex (FCC).  The FCC is a compendium of standards for purity and identity for 
food ingredients, including food additives, which is published by the United States Pharmacopeial Convention. 
 
Implementation and Enforcement  
 
The above modifications came into force  January 4, 2017, the day they were published in the List 
of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  and 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.    
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 lactylated mono - and di -glycerides and sodium  
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  and the List of  
Permitted Food Additives with Other Generally Accepted Uses  to Enable the Use of Lactylated Mono-  and Di -glycerides   
as an Emulsifying Agent and Sodium Stearoyl -2-Lactylate as a Whipping Agent, respectively, in Whipped Yogurt . 
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 stearoyl -2-lactylate. Anyone wishing to submit  new scientific information on the use of these 
additives 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 “ lactylated mono-  and 
di-glycerid es” and/or  "sodium stearoyl -2-lactylate ” 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