Information on Health Canada's Proposal to Amend the Food and Drug Regulations to permit the use of calcium acid pyrophosphate in baking powder and unstandardized bakery products

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As a result of this process, the proposal to permit the use of calcium acid pyrophosphate in standardized baking powder and unstandardized foods, including unstandardized bakery products was published in the Canada Gazette, Part II on June 6, 2012. The proposed use of this food additive in Canada as described is now enabled.

For more information on this initiative, please contact the Bureau of Chemical Safety's Chemical Health Hazard Assessment Division at bcs-bipc@hc-sc.gc.ca.

Table of Contents

Purpose

This document provides information on Health Canada's proposal to amend the Food and Drug Regulations ("Regulations") to permit the use of calcium acid pyrophosphate in standardized baking powder and unstandardized foods, including unstandardized bakery products.

Background

In Canada, all food additives are regulated under the Food and Drug Regulations (Regulations) and are subject to rigorous controls under the Food and Drugs Act. Before a food additive is permitted for use, a submission must be filed with Health Canada's Food Directorate so the Department can conduct a rigorous safety evaluation of the proposed use(s) of the additive. Food manufacturers are not permitted to use a food additive until it has been approved by Health Canada and steps have been taken to legally enable its use, either through an amendment of the Regulations, or the issuance of an Interim Marketing Authorization.

A request has been submitted to Health Canada to allow the food additive use of 'calcium acid pyrophosphate' (chemical formula CaH2P2O7) as an acid-reacting material and leavening agent in standardized baking powder and unstandardized foods, including unstandardized bakery products. The typical level of use in the finished food would be between approximately 0.8% and 1.5% calcium acid pyrophosphate.

Calcium acid pyrophosphate is not currently listed as a permitted food additive in Canada. However, provisions currently exist for a number of phosphate salts in Table X, Division 16 of the Regulations, including two sodium phosphate salts with a similar technological function to that of calcium acid pyrophosphate: sodium acid pyrophosphate is permitted at a use level consistent with Good Manufacturing Practice (GMP) in baking powder and unstandardized foods; and sodium aluminum phosphate is permitted at GMP in unstandardized foods. Both of these permitted additives contain sodium. Therefore, calcium acid pyrophosphate would provide an alternative additive that does not contain sodium.

Current Consultation

Health Canada's Food Directorate has completed a safety assessment of the information provided in support of the proposed use of calcium acid pyrophosphate as described in the submission and determined that there are no health or safety concerns with the use of this additive in baking powder and unstandardized foods.

With respect to efficacy, it has been identified that calcium acid pyrophosphate has specific technical properties relative to other calcium phosphates, in that it can be used in slow-acting leavening agent mixtures. As for sodium aluminum phosphate and sodium acid pyrophosphate, slow-acting leavening agents react mainly during the baking process. Other baking-grade calcium and sodium phosphates react differently. For example, they may be fast-acting in that they react mainly during dough mixing and resting, at ambient temperature, or they may be heat treated at 60°C (140°F) and consequently react in the last minutes of baking. Therefore, the choice of phosphate salt will depend on the specific leavening action required.

Based on the outcome of the safety and efficacy evaluation, Health Canada is proposing amendments to the Regulations to allow the use of calcium acid pyrophosphate as an acid-reacting material and leavening agent at levels consistent with Good Manufacturing Practice in standardized baking powder and unstandardized foods, which includes unstandardized bakery products.

Safety Assessment

Food Directorate scientists at Health Canada have conducted a detailed and rigorous evaluation of the submission that focused on safety and efficacy. Their evaluation considered the toxicological aspects of the proposed use of calcium acid pyrophosphate as a food additive, as well as relevant nutritional and chemical factors, as described in the following sections.

Toxicological Assessment and Dietary Exposure

Food Directorate scientists evaluated various studies in their assessment of the safety in use of calcium acid pyrophosphate. With respect to dietary exposure, the possibility for increased intake of phosphate was considered in order to determine whether the use of calcium acid pyrophosphate could lead to phosphorus intakes that exceed the acceptable daily intake (ADI) of 70 mg phosphorus/kg body weight/day. As calcium acid pyrophosphate would be used in place of other types of already permitted phosphate salts, it is not expected that the food additive use of calcium acid pyrophosphate would increase dietary levels of phosphate. Further, the ratio of phosphorus intake relative to calcium intake is considered an important parameter in determining the safe use of phosphate rather than the absolute intake of phosphate. The use of calcium acid pyrophosphate in place of sodium aluminum phosphate and/or sodium acid pyrophosphate would lead to a more-favorable ratio of calcium-phosphorus intake.

Based on this information, Health Canada scientists have no toxicological objections to the use of calcium acid pyrophosphate in standardized baking powder and unstandardized foods including unstandardized bakery products, under the conditions of use proposed.

Nutritional Assessment

Food Directorate scientists have noted that calcium acid pyrophosphate would generally replace the use of sodium acid pyrophosphate on a one-to-one basis. As noted previously, this replacement would not affect the phosphorus level within the Canadian food supply. Moreover, such a replacement would decrease the amount of sodium and increase the amount of calcium in those foods in which its use would be enabled, namely baking powder, unstandardized bakery products, and other unstandardized foods.

The petitioner has indicated that there is no intention of making any nutritional claims; rather, calcium acid pyrophosphate would be used only for its technical properties. Nonetheless, Food Directorate scientists noted that any fortification claims would be subject to the proposed discretionary fortification policy, as part of the development of the Policy on Addition of Vitamins and Minerals to Foods, 2005.

Food Directorate scientists, having evaluated the data from a nutritional perspective, have expressed no objection to the use of calcium acid pyrophosphate in those foods, and under the conditions of use proposed in the submission.

Chemical Assessment

The food additive manufacturer supplied information demonstrating that the food additive calcium acid pyrophosphate (CaH2P2O7) is compliant with the food-grade specifications of the latest edition of the Food Chemicals Codex, and with the specifications for "calcium dihydrogen diphosphate" (a synonym for calcium acid pyrophosphate) established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Food Directorate scientists identified no safety concerns, from a chemical perspective, in relation to the use of calcium acid pyrophosphate in these foods, and under the conditions of use proposed in the submission.

Rationale for Action

Calcium acid pyrophosphate would serve functionally as an acid-reacting material and leavening agent in food and would therefore be regulated as a food additive in Canada. Based on the evaluation conducted by scientists in Health Canada's Food Directorate, the information provided by the petitioner has satisfactorily met the requirements for a food additive submission outlined in Section B.16.002 of the Food and Drug Regulations. Therefore, it is proposed that the regulations be amended to permit the use of calcium acid pyrophosphate as a food additive in Canada for use in those foods, and under the conditions of use proposed in the submission.

Enabling the use of this additive would allow manufacturers greater formulation flexibility, resulting in products with improved functional properties and lowered sodium content, which in turn, may benefit the consumer.

International Status

Calcium acid pyrophosphate (listed as its synonym, calcium dihydrogen diphosphate) and a number of other phosphate salts and phosphoric acid are recognized in the European Union for use as food additives. They may be used individually or in combination (expressed as P2O5) in a broad range of foods, including fine bakery wares; flours; soda bread; and batters (European Parliament Council Directive No 95/2/EC).

Food Standards Australia New Zealand (FSANZ) have provisions for the use of Schedule 2 additives, including the pyrophosphates, which would allow for the use of calcium acid pyrophosphate, where specifications exist, at GMP in a wide variety of foods, including flour products (including noodles and pasta); breads and bakery products (including biscuits, cakes and pastries). There is also specific provision for the use of certain phosphates, including pyrophosphates (INS 450), in frozen fish at GMP under Schedule1 (Substances Added to Food, Australia New Zealand Food Standards Code).

This additive is recognized by the Japan External Trade Organization (JETRO) as a dietary supplement in foods for special dietary use; as an emulsifier in processed cheese, cheese food, and processed food derived from processed cheese; and as a raising agent in baking powder.

Calcium acid pyrophosphate (calcium dihydrogen diphosphate; INS 450 vii) is considered to be covered by the 2001 JECFA safety evaluation of phosphates. Under the Codex General Standard for Food Additives (GSFA), provisions for specific phosphate salts in food are defined at the food additive group level, i.e., 'phosphates'. This means that any phosphate salt recognized in the GSFA is permitted for use in those foods in which phosphates are allowed. Currently, twenty-nine phosphate salts are listed in the GSFA for use in many different foods. Calcium acid pyrophosphate is recognized under the GSFA in three functional classes: emulsifier, raising agent (leavening agent), and stabilizer.

As the Codex GSFA continues to be developed, it is expected that additional uses for phosphates will be listed as there are a number of proposed uses for phosphates in a variety of foods currently at Steps 3 and 6 of the Codex Step Procedure.

While calcium acid pyrophosphate is not listed in the U.S. FDA Code of Federal Regulations (CFR) as generally recognized as safe (GRAS), the petitioner suggested that this substance could be considered self-affirmed GRAS, since it apparently has a long history of safe use in food in the U.S. and other calcium and sodium phosphates are on the CFR GRAS list.

Previous Consultation

The list of foods/food categories in which the use of calcium acid pyrophosphate has been requested includes baking powder, which is a standardized food under the Regulations (Division 3, Section B.03.002 [S]). Therefore, before completing its evaluation, the Food Directorate consulted with the Canadian Food Inspection Agency (CFIA); the Baking Association of Canada; the Association of Canadian Biscuit Manufacturers; and the Canadian Snack Food Association. Responses were received from the CFIA and the Baking Association of Canada.

The Consumer Protection Division and the Food Safety Division of the CFIA had no objections to the proposal to provide for the use of calcium acid pyrophosphate in standardized baking powder and unstandardized foods. The Bakery Association of Canada also had no objections to the proposed amendment of the Regulations to enable the use of calcium acid pyrophosphate as described in this proposal.

Proposal

Health Canada Food Directorate has completed a safety assessment of the relevant information, including information provided in support of the proposed use of calcium acid pyrophosphate as described in the submission, and determined that there are no health or safety concerns with the use of this additive in baking powder or unstandardized foods, including unstandardized bakery products.

Calcium acid pyrophosphate would be used in unstandardized foods and baking powder, and levels in the finished food would range from approximately 0.8% to 1.5%. However, it is considered that the maximum level of use of this additive can be governed in the Regulations by Good Manufacturing Practice (GMP). The food additive listings for other phosphates with similar technological functions set a maximum use level at GMP; however, a need to specify a numerical limit on calcium acid pyrophosphate was not identified.

Therefore, it is proposed that the Regulations be amended to permit the use of calcium acid pyrophosphate at levels consistent with GMP in baking powder and unstandardized foods as outlined below.

Specifically, amendments to Table X (Food additives that may be used as pH adjusting agents, acid-reacting materials and water correcting agents) of Division 16 would be required to provide for the use of calcium acid pyrophosphate as an acid-reacting material and leavening agent in standardized baking powder and in unstandardized foods (which includes unstandardized bakery products).

Proposed listing as it would appear in Table X
Item No. Column I
Additive
Column II
Permitted in or Upon
Column IV
Maximum Level of Use
C.1A calcium acid pyrophosphate (1) Baking powder (1) Good Manufacturing Practice
(2) Unstandardized foods (2) Good Manufacturing Practice

The standard for baking powder (Section B.03.002 [S] of Division 3) would not require amendment as it already permits the use of an 'acid-reacting material'. As such, if calcium acid pyrophosphate is listed for use in baking powder in Table X of Division 16, then no amendment of B.03.002 will be required.

Comments

Comments on this proposal may be submitted in writing, either electronically or by regular mail. If you are submitting your comments electronically, please use the words "Calcium Acid Pyrophosphate" in the subject box of your e-mail. Comments must be received by 11:59 p.m. EST, January 16, 2012.

Mailing address:
Bureau of Chemical Safety
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2203B
Ottawa, Ontario K1A 0L2

E-mail address: sche-ann@hc-sc.gc.ca

Additional Information

For more information on this initiative, please contact the Chemical Health Hazard Assessment Division at bcs-bipc@hc-sc.gc.ca. Please use the words "Calcium Acid Pyrophosphate" in the subject box of your e-mail.

This document is also available electronically, at: Food Additives.

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