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

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. 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 has received a food additive submission seeking 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 Agentsby adding the following entry to the list.

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 toxicological, 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 adhesion 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), such a modification to the starch is an intermediate stage in the normal digestion of food starches in the human body that occurs in the stomach and results in hydrolysis of the starch molecule.^{Footnote 1} JECFA concluded that these modified starches are no different 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 starch 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 hypochlorite.

The toxicological database on starch treated with sodium hypochlorite consists of six short-term feeding tests as reported by JECFA.^{Footnote 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 dietary 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 Societies for Experimental Biology^{Footnote 3}, 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.

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 described 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. Bleached 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 starch (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 JECFA. 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 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 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.