Notice of Modification to the List of 
Permitted Carrier or Extraction Solvents  
to Extend  the Use of Certain Solvents  
to Non-flavouring Extracts  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0188 
July 21, 2022 
 Notice of Modification to the List of Permitted Carrier or Extraction Solvents  to Extend the Use of Certain Solvents  to Non-flavourin g 
Extracts – Reference Number: NOM/ADM -0188| 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 Per mitted Food Additives  (the lists) that are incorporated by 
reference in the MAs and published on the Canada.ca website. Health Canada uses a premarket approval 
process to determine the safety of food additives when used under specified conditions in foods sold in 
Canada.  Health Canada may also make modifications to the lists to align them with amendments of Part B of 
the Regulations.  
Health Canada published the Regulations Amending the Food and Drug Regulations and the Cannabis 
Regulations (Supplemented Foo ds) in the Canada Gazette , Part II creating a regulatory framework for the sale 
of supplemented foods in Canada.  To ensure supplemented foods are in compliance with all regulatory  
requirements  (including the lists ), Health Canada’s Food Directorate modif ied the List of Permitted Carrier or 
Extraction Solvents  to extend the use of certain solvents used in the manufacture of  non-flavouring extracts 
(e.g., caffeine -containing extracts  and herbal extracts ) – which had already been evaluated on a case -by-case 
basis for supplemented foods that contained these extracts and for which Temporary Marketing 
Authorization (TMA ) letter s were issued . Specifically, t he Food Directorate extend ed 1) the use of carbon 
dioxide, dichloromethane and ethyl acetate to the manufacture of caffeine extracts1 at a maximum residue  
level of 0.1 ppm in the food as consumed,  2) the use of ethanol as an extraction solvent to caffeine extracts 
and other non -flavouring extracts at levels consistent with Good Manufacturing Practice (GMP)2 and, 3)  the 
use of glycerol as a carrier solvent to non -flavouring extract preparations  at level s consistent with GMP . 
Carbon dioxide, dichloromethane and ethyl acetate are already permitted for the decaffeination of green 
coffee and tea leaves. Ethanol and glycerol are also already permitted  for use in foods such as 
unstandardized flavouring extracts and natural extractives , as an extraction solvent or a carrier , respectively . 
No food safety concerns were identified  with the extended uses of the se solvents . 
Therefore, Health Canada modified the  List of Permitted Carrier or Extraction Solvents  by adding new entries 
or changing existing  entries to the list shown below (bold font not used in the list).  
 
Modification to the List of Permitted Carrier or Extraction Solvents  
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Residue  Column 4  
Maximum Level of Use 
and Other Conditions  
3.1 Carbon dioxide  (1)  
Caffeine extracts ; 
Green coffee beans  (1) 
Good Manufacturing 
Practice  
                                                             
1 Highly purified caffeine extracts are usually obtained from the extraction solvent that remains after the process 
of decaffeinating either tea leaves or green coffee beans. After decaffeination, the resulting solvent (containing the 
caffeine and crude mat erials) is further processed and concentrated to produce a highly purified caffeine extract 
which may then be used in other food applications (e.g., as a source of caffeine in caffeinated energy drinks).  
2 “Good Manufacturing Practice” means that the amoun t of the solvent  that is added to the food in manufacturing 
and processing does not exceed the amount required to accomplish the purpose for which it has been added, as 
defined in subsection 2(2) of the Marketing Authorization for Food Additives That May Be Used as Carrier or 
Extraction Solvents . Notice of Modification to the List of Permitted Carrier or Extraction Solvents  to Extend the Use of Certain Solvents  to Non-flavourin g 
Extracts – Reference Number: NOM/ADM -0188| 3 
 Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Residue  Column 4  
Maximum Level of Use 
and Other Conditions  
and tea leaves for 
decaffeination 
purposes  
5. Ethyl acetate  (5) 
Caffeine extracts  (5) 
0.1 p.p.m. in the 
food, containing the 
caffeine extract, as 
consumed   
6. Ethanol  (7) 
Caffeine extracts; 
Non -flavouring 
extracts   (7) 
Good Manufacturing 
Practice  
8. Glycerol  (5) 
Non -flavouring 
extract preparations   (5) 
Good Manufacturing 
Practice  
15. Methylene 
Chloride 
(Dichloromethane )  (4) 
Caffeine extracts  (5) 
0.1 p.p.m. in the 
food, containing the 
caffeine extract, as 
consumed   
Rationale  
In the past, supplemented foods were permitted for sale by the Department under the  Temporary Marketing 
Authorization  framework. Supplemented food products containing non -flavouring extracts manufactured 
with certain solvents were exempted by the Food Direct orate, using a risk -based approach and on a case -by-
case basis, from the application of section B.01.043  of the Regulations.3  
No food safety concerns were identified with extending the use of (a) carbon dioxide, dichloromethane and 
ethyl acetate to caffeine extracts , (b) ethanol to caffeine extracts and non -flavouring extracts,  and (c)  glycerol 
to non -flavouring extracts preparations . The dietary exposure to these five solvents is not expected to 
increase when used as described above . Carbon dioxide, dichloromethane and ethyl acetate  are already 
permitted as extraction solvents for the manufacture of decaffeinated coffee or tea products resulting in 
maximum residues of 10 ppm in these finished products. Glycerol (as a carrier) and ethanol (as an extraction 
solvent) are already permitted in the manufacture  of various types of extracts or preparations at a maximum 
level of use consistent with GMP.  
                                                             
3 Section B.01.043 of the Regulations prohibits the use of a ny additives in foods except food additives set out in a 
table of section B.16.100, at the limit and other conditions of use prescribed in that table. Since 2012, the tables of 
section B.16.100 of the Regulations are no longer updated and t he 15 Lists of Permitted Food Additives are meant 
to replace them.  
 Notice of Modification to the List of Permitted Carrier or Extraction Solvents  to Extend the Use of Certain Solvents  to Non-flavourin g 
Extracts – Reference Number: NOM/ADM -0188| 4 
 Therefore, the Department has enabled the requested uses of these solvents by modifying or adding to the 
List of Permitted Carrier or Extraction Solvents  the new  or existing  entries shown in the above table.  
Other Relevant Information  
Food additives such as carbon dioxide, dichloromethane, eth anol, ethyl acetate and glycerol 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 .  The Food Chemicals Codex  is a compendium of standards for purity and identity for 
food ingredients, including food additives, published by the United States Pharmacopeial Convention. 
Specifications in the Combined Compendium of Food Additive Specifications  is prepared by the Joint 
FAO/WHO Expert Committee on Food Additives (JECFA)  and published by the Food and Agriculture 
Organization of the United Nations.  
Implementation and Enforcement  
The above modification came into force July 21, 2022, the day it was published in  the List of Permitted Carrier 
or Extraction Solvents .  
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 new scientific informati on on the safety in use of 
any permitted  food additive, including  carbon dioxide, dichloromethane, ethanol, ethyl acetate and glycerol .  
Anyone wishing to submit an inquiry or new scientific information on the use of these additives  may do so in 
writing, b y regular mail or electronically.  If you wish to contact the Food Directorate electro nically, please 
use the words " solvents for non -flavouring extracts  (NOM -0188)" 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