Consultation Document on Health Canada’s Proposal to Enable the Use of a New Food Additive, Calcium                        
Hypochlorite, as a Starch -Modifying Agent  
 
  
Bureau of Chemical Safety, Food Directorate,  Health Products and Food Branch     1 
  
Consultation Document on Health Canada’s Proposal 
to Enable the Use of a New Food Additive, Calcium             
Hypochlorite, as a Starch -Modifying Agent  
 
Notice of Proposal – Lists of Permitted Food Additives    
March  28, 2014   
Consultation Document on Health Canada’s Proposal to Enable the Use of a New Food Additive, Calcium                        
Hypochlorite, as a Starch -Modifying Agent  
 
  
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 Add itives  that are 
incorporated by reference in the MAs.  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 Direct orate.  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 has received a food additive submission se eking approval for the use of calcium 
hypochlorite, as a starch -modifying agent, at a maximum level of use of good manufacturing 
practice.  
 
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of calcium hypochlorite for this purpose.  Therefore, it is the intention of Health Canada 
to modify the List of Permitted Starch -Modifying Agents  by adding the following entry to the list.  
 
Proposed Modification to the List of Permitted Starch -Modifying Agents  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted 
in or  Upon  Column 3  
Maximum Level of Use and Other 
Conditions  
C.1 Calcium 
Hypochlorite  Starch  Good Manufacturing Practice  
  
Rationale  
 
Health Canada’s Food Directorate has completed a pre -market safety and efficacy assessment of 
calcium hypochlorite when used  as described in the table above.  The assessment considered 
toxicolog ical, chemical, microbiological  and nutritional aspects of the proposal.   
 
Calcium hypochlorite is intended to replace the use of sodium hypochlorite, a permitted starch -
modifying agent, in instances where calcium hypochlorite would result in a modified starch with 
improved function for the intended application (i.e., improved ad hesion of batters).  
 
Both calcium hypochlorite and sodium hypochlorite modify starch through oxidation of the 
starch molecule.  According to the Joint Food and Agriculture Organization/World Health 
Organization Expert Committee on Food Additives (JECFA), s uch a modification to the starch is 
an intermediate stage in the normal digestion of food starches in the human body that occurs in  
Consultation Document on Health Canada’s Proposal to Enable the Use of a New Food Additive, Calcium                        
Hypochlorite, as a Starch -Modifying Agent  
 
  
Bureau of Chemical Safety, Food Directorate,  Health Products and Food Branch     3 the stomach and results in hydrolysis of the starch molecule.1  JECFA concluded that these 
modified starches are no differen t than other starch in the diet in that their digestive fate is 
identical.  
 
No toxicological studies on starch treated with calcium hypochlorite were submitted to Health 
Canada and none were found in the scientific literature.  However, there are toxicological studies 
on sodium hypochlorite.   Since calcium hypochlorite  modifies s tarch using the same mechanism 
as sodium hypochlorite and because both additives are chemically similar, Health Canada 
applied the toxicological database and other safety aspects of starch treated with sodium 
hypochlorite to the evaluation of calcium hypoc hlorite.  
 
The toxicological database on starch treated with sodium hypochlorite consists of six short -term 
feeding tests as reported by JECFA.2  Physiological reactions (diarrhoea and caecal  enlargement) 
were observed as a result of the intake of excessive amounts  (25%)  of the test material  in the  diet 
during the studies but no  overt  toxic effects were observed. Starch modified with sodium 
hypochlorite was digested similar to  unmodified dieta ry starch.  Since no toxicity was identified 
with the consumption of excessive amounts of starch treated with sodium hypochlorite, an 
acceptable daily intake (ADI) of “not specified” was established by JECFA for starch treated 
with sodium hypochlorite. ADI 's of "not specified" are only assigned to those food additives that 
are of very low toxicity and for which dietary exposure from its food additive uses (at levels 
consistent with good manufacturing practice), and acceptable background levels, would not 
present a hazard to human health.  
 
Glucuronic acid is generated during the production of sodium or calcium hypochlorite modified 
starch. Glucuronic acid is a normal constituent of the body.  It is a precursor to ascorbic acid 
(vitamin C) and an integral part  of the body’s normal metabolic process for the detoxification of 
chemicals.  At the level generated in the production of the modified starch, it would not pose a 
health concern. Similarly, based on an evaluation by the Federation of American Soc ieties for  
Experimental Biology3, the United States Food and Drug Administration’s Select Committee on 
Generally Recognized As  Safe (GRAS) Substances concluded that no information was available 
that demonstrated that starch treated with sodium hypochlorite presented a hazard when 
consumed.  The Committee granted GRAS status to sodium hypochlorite oxidized starch.  Since 
then, no significant scientific information has become available that would refute that 
conclusion.  
 
No microbiological or nutritional safety concerns have been identified for the proposed use of 
calcium hypochlorite.  
 
                                              
1 WHO Food Additives Series 17  
2 WHO Food Additives Series 5 and 17  
3 Select Committee on GRAS Substances.  1979. Evaluation of the health aspects of starch and modified starch as 
food ingredients. Life Sciences Research Office, Federation of American Societies for Experimental Biology, 
Bethesda, MD.   
Consultation Document on Health Canada’s Proposal to Enable the Use of a New Food Additive, Calcium                        
Hypochlorite, as a Starch -Modifying Agent  
 
  
Bureau of Chemical Safety, Food Directorate,  Health Products and Food Branch     4 Based on the results of the safety assessment,  Health Canada's Food Directorate considers that 
the data support the safety of calcium hypochlorite when used under the conditions of use set out 
in the table above.  The Department is therefore proposing to enable the use of calcium 
hypochlorite as descr ibed in the table.  
Other Relevant Information  
 
Australia and New Zealand, the European Union and the United States do  not regulate starch -
modifying agents as food additives.  Rather, they regulate the modified starches as food 
additives.  Similarly, the Codex Alimentarius Commission’s (Codex) General Standard for Food 
Additives (GSFA) contains provisions for the use, as food additives, of modified starches as 
opposed to the starch -modifying agents.  
 
Australia and New Zealand permit the use of bleached starch as a  miscellaneous additive in 
accordance with good manufacturing practice in  a variety of processed foods .  Bleach ed starch 
must meet either the JECFA or the Food Chemicals Codex  (FCC) specifications.  In this regard, 
the FCC specification has  provision in the  monograph for “Food Starch, Modified” for the use  of 
calcium hypochlorite in the  manufacture of bleached star ch (i.e., mildly  oxidized starch).  
 
In the European Union,  oxidized starch is defined as starch treated with sodium hypochlorite.  
 
In the United States, food starch may be bleached with calcium hypochlorite, but the finished 
modified starch is only allowed  for use as a component of batter for commercially processed 
foods.  The level of chlorine, in the form of calcium hypochlorite,  is not to exceed 0.036% of dry 
starch.   
 
Codex requires that food additives in the GSFA meet specifications established by JEC FA.  As 
per the JECFA specification for modified starches, sodium hypochlorite may be used in the 
manufacture of modified starch, but the possible use of calcium hypochlorite is not reflected in 
the specifications.  
 
Implementation and Enforcement  
 
The proposed changes will be effective the day on which they are published in List of Permitted 
Starch -Modifying Agents .  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 co ntact:    
Consultation Document on Health Canada’s Proposal to Enable the Use of a New Food Additive, Calcium                        
Hypochlorite, as a Starch -Modifying Agent  
 
  
Bureau of Chemical Safety, Food Directorate,  Health Products and Food Branch     5  
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 words “ calcium hypochlorite ” in the subject line of 
your e -mail.   Health Canada is able to consider information received by June  10, 2014 , 75 days 
from the date of this posting.