 
  
Notice of Modification to the List of 
Permitted Food Additives with Other 
Accepted Uses  to Extend  the Use of 
Acetic Acid to 2 '-Fucosyllactose  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NO M/ADM-0197 
Febru ary 27, 2023 
 Notice of M odification to the List of Permitted Food Additives with Other Accepted  Uses  to Extend  the Use of Acetic Acid to  2'-
Fucosyllactose | 2 
 Summary  
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by the Minister of 
Health and the Food and Drug Regulations  (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 the Canada.ca website. A petitioner can request that Health Canada a uthorize  a 
new additive , or a new source  or a new condition of use for an already permitted  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 so ld in Canada.  
Health Canada’s Food Directorate received a food additive submission seeking approval for the use of acetic 
acid as a crystallization aid and washing agent during the manufacture of 2' -fucosyllactose (2' -FL). The 
requested  maximum residual le vel of acetic acid in 2'-FL is 1.0% . The residual acetic acid is not intended to 
serve a technical function in the final 2'-FL product . 
The 2'-FL is to be used as an ingredient in  infant formula and nutritional supplements for children 1 -3 years 
old (12-47 months)1.  
Acetic acid is already permitted for use as a pH adjusting agent or preservative in unstandardized foods and 
certain standardized foods at a maximum level of use consistent with Good Manufacturing Practice (GMP)2.  
 
The results of the Food Directorate’s evaluation of available scientific data support the safety of acetic acid 
when used as described  by the petiti oner .  Therefore, Health Canada has modified the  List of Permitted Food 
Additives with Other Accepted Uses  to extend  the use of acetic acid  by adding the entry shown below to the 
list.  
 
Modification to the List of Permitted Food Additives with Other Accepted Uses  
The following entry was added to the List of Permitted Food Additives with Other 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  
A.02  Acetic 
acid 2'-Fucosyllactose , 
including 2' -
fucosyllactose for use in 
infant formula  
  Crystallization aid and 
washing  agent    
 Good Manufacturing 
Practice. Residue of 
acetic acid not to exceed 
1.0% in 2' -fucosyllactose . 
In the case of infant 
formula, r esidue of acetic 
acid not to exceed 1.0% 
 
1The petitioner referred to toddler formula. These products are formulated as nutritional supplements, under 
Division 24 of the Food and Drug Regulations , for children 1 to 3 years of age  (12-47 months) . 
2 Item A.1 of the List of Permitted pH Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents , and 
item A.1 in Par t 1 of the List of Permitted Preservatives . For the definition of “Good Manufac turing Practice” set 
out in Column 4 as a Maximum Level of Use, see the  Marketing Authorization for Food Additives That May Be Used 
as pH Adjusting Agents, Acid -Reacting  Materials or Water Correcting Agents  and the Marketing Authorization for 
Food Additives That May Be Used as Preservatives , respectively.   
Notice of M odification to the List of Permitted Food Additives with Other Accepted  Uses  to Extend  the Use of Acetic Acid to  2'-
Fucosyllactose | 3 
 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  
in 2' -fucosyllactose  and 
12 ppm  in the food as 
consumed . 
 
 
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of acetic acid to be used as a 
crystallization aid and washing agent  in the manufacture  of 2'-FL. The 2’ -FLis to be used as an ingredient  in 
infant formula and nutritional supplements for children 1 to 3 years of age (12 -47 months)3. The Directorate 
conclud ed that a microbiological safety assessment was not required, and that information related to 
allergenicity, chemistry, nutrition, and toxicology supports the safety of acetic acid for its described  use. 
Therefore, Health Canada has enabled the described  use of acetic acid by adding to the  List of Permitted Food 
Additives with Other Accepted Uses  the new item numb er and its corresponding entry shown in the above 
table.  
Other Relevant Information  
Food additives such as acetic acid are required to meet food -grade specifications set out in Part B of the 
Regulations , where such specifications exist,  or those set out in the most recent  edition of the  Food 
Chemicals Codex  or the Combined Compendium of Food Additive Specifications  where there are no 
specifications in Part B . The Food Chemicals Codex  is a compendium of food grade specifications for food 
ingredients, includin g food additives, published by the United States Pharmacopeial Convention. 
Specifications in the  Combined Compendium of Food Additive Specifications  are prepared by the Joint 
FAO/WHO Expert Committee on Food Additives (JECFA)  and published by the Food and Agriculture 
Orga nization of the United Nations.  
Implementation and Enforcement  
The above modification came into force February  27, 2023, the  day it was published in  the List of Permitted 
Food Additives with Other Accepted Uses .  
The Canadian Foo d 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 new scientific information on the safety  in use of 
any permitted food additive.  Anyone wishing to submit an inquiry or new scientific information on the use of 
 
3 A number of 2’ -FL ingredients from a variety of sources have been reviewed as novel foods  in Canada . Notice of M odification to the List of Permitted Food Additives with Other Accepted  Uses  to Extend  the Use of Acetic Acid to  2'-
Fucosyllactose | 4 
 a permitted  food  additive  may do so in writing, by regular mail or electronically.  If you wish to contact the 
Food Directorate electro nically  about acetic acid , please use the words " acetic acid  (NOM -0197)" 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 0K9  
E-mail: bcs-bipc@hc -sc.gc.ca  