Health Canada’s Proposal to Enable the Use of the New Food Additive, Cyprosin from the Flower of  
Cynara cardunculus L. var. altilis  DC., as a Food Enzyme in Various Standardized Cheeses  
  
Bureau of Chemical Safety, Food Directorate, Health Products and  Food Branch     1 
  
Health Canada’s Proposal to Enable the Use of the 
New Food Additive, Cyprosin from the Flower of 
Cynara cardunculus L. var. altilis  DC., as a Food 
Enzyme in Various Standardized Cheeses  
Notice of Proposal – Lists of Permitted Food Additives    
December  01, 2014   
Health Canada’s Proposal to Enable the Use of the New Food Additive, Cyprosin from the Flower of  
Cynara cardunculus L. var. altilis  DC., as a Food Enzyme in Various Standardized Cheeses  
  
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 the milk 
clotting (coagulating) enzyme cyprosin, obtained from the flower of the cardoon plant ( Cynara 
cardunculus L. var. altilis  DC.), in cheese making.  The en zyme is proposed for use at a 
maximum level consistent with good manufacturing practice.  The cheeses of interest are subject 
to the compositional standards set out in the Food and Drug Regulations  for:  Cream Cheese, 
Cream Cheese with (naming the added ingredients), Cottage Cheese and (Naming the variety) 
Cheese.      
 
The results of Health Canada’s evaluation of available scientific data support the safety of 
cyprosin  from this plant source when used in cheese making.  Therefore, it is the intention of 
Health Canada to modify the List of Permitted Food Enzymes  by adding the following entry to  
the list.  
 
Proposed Modification to the List of Permitted Food Enzymes  
 
Item 
No. Additive  Permitted 
Source  Permitted in or 
upon  Maximum Level of Use and 
Other Conditions  
C.4 Cyprosin  Cynara 
cardunculus  L. 
var. altilis  DC. Cream cheese; 
Cream cheese 
with (naming the 
added 
ingredients); 
Cottage cheese; 
(Naming the 
variety) cheese  Good Manufacturing Practice  
 
Rationale  
 
Health Canada’s Food Directorate has completed a pre -market safety assessment of the use of 
cyprosin obtained from Cynara cardunculus L. var. altilis  DC. in cheese making.   The 
assessment considered microbiological, chemical, toxicological, and allergenic aspects of this  
Health Canada’s Proposal to Enable the Use of the New Food Additive, Cyprosin from the Flower of  
Cynara cardunculus L. var. altilis  DC., as a Food Enzyme in Various Standardized Cheeses  
  
Bureau of Chemical Safety, Food Directorate, Health Products and  Food Branch     3 enzyme when used as described in the table above.  No safety concerns were identified by this 
assessment.  
 
Cynara cardunc ulus, or cardoon, has been traditionally cultivated as a vegetable for human 
consumption and its flowers have a history of use in some areas of Spain and Portugal as a rennet 
substitute in making traditional sheep cheese.1   
 
The long history of use of cardoon flower extracts , and the absence of reports of toxicity from 
such use, support that cyprosin, obtained by extraction from the flowers of Cynara cardunculus 
L. var. altilis  DC., is safe for use as a food enzyme in  the manufacture of cheese.   
    
Based on the results of the safety assessment, Health Canada’s Food Directorate considers that 
the data support the safety of cyprosin obtained from Cynara cardunculus L. var. altilis  DC. 
when  used under the conditions of use set out in the table above.  The Department is therefore 
proposing to enable the use of cyprosin from this source as described in that table.  
  
Other Relevant Information  
 
The Codex General Standard for Food Additives (GS FA) contains few provisions for food 
enzymes and none for cyprosin.  However, the Codex General Standard for Cheese (CODEX 
STAN 283 -1978) provides for rennet or other suitable coagulating agents to be used in making 
cheese.  In addition, the Codex Standard  for Cream Cheese (CODEX STAN 275 -1973) and the 
Codex Standard for Cottage Cheese (CODEX STAN 273 -1968) permit the use of rennet or other 
safe and suitable coagulating enzymes as ingredients in cheeses subject to these standards.   
In Australia and New Zea land, the standard for cheese (Standard 2.5.4) permits rennet or other 
suitable coagulating agents to be used in making cheese.  Food enzymes require pre -market 
approval as processing aids in Australia and New Zealand, and cyprosin  is not identified as a 
permitted processing aid.  
In Europe, the use of food enzymes is subject to national legislation.  Cyprosin is permitted for 
use in Portugal, Spain, France and the Netherlands.  
In the United States of America, there are standards2 for individual cheeses that, in Canada, are 
subject to the standard for (Naming the variety) cheese.  A number of these standards in the 
United States permit the cheeses to be made with rennet and/or other clotting enzymes of animal, 
plant, or microbial ori gin. C ream cheese can be manufactured with these enzymes, as can cream 
cheese with other foods since the latter is made with cream cheese.  Rennet and/or other safe and 
suitable clotting enzymes are permitted for use in making dry curd cottage cheese, whic h in turn 
is used to make cottage cheese.   
                                              
1 Fernández J. et al. 2006.  Industrial applications of Cynara cardunculus  L. for energy and other uses. Industrial 
Crops and Products  24:222 -229 
2 The standards are in Title 21 of the Code of Federal Regulations, Part 133 (21 CFR 133).   
Health Canada’s Proposal to Enable the Use of the New Food Additive, Cyprosin from the Flower of  
Cynara cardunculus L. var. altilis  DC., as a Food Enzyme in Various Standardized Cheeses  
  
Bureau of Chemical Safety, Food Directorate, Health Products and  Food Branch     4 Health Canada and the Canadian Food Inspection Agency (CFIA) jointly administer Canada’s 
food compositional standards, including the standards for the cheeses  that could be manufactured 
with cyprosin.  Health Cana da consulted the CFIA and two associations that represent the dairy 
industry about the proposed use of cyprosin.  None of these organizations objected to the use of 
this enzyme in cheese making.  
The Food and Drug Regulations require that all food enzymes u sed as food additives meet the 
specifications for enzyme preparations set out in the most recent edition of the Food Chemicals 
Codex (FCC). 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.  
 
Cyprosin, as with other additives used in cheese making, would be required to be declared in the 
list of ingredients on the label of prepackaged cheeses that have been manufactured with this 
enzyme . 
 
Implementation and Enforcement  
 
The proposed changes will be effective the day on which they are published in the List of 
Permitted Food Enzymes .  This will be announced via a Notice of Modification which will be 
published on the Food and Nutrition - Public Involvement and Partnerships  section of Health 
Canada’s Website . 
  
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  
For additional information or to submit comments related to this proposal, please contact:   
 
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  
 
If communicating  by e-mail, please use the word  “cyprosin ” in the subject line of your e -mail.   
Health Canada is able to consider information received by February 13, 201 5, 75 days from the 
date of this posting.