Health Canada's Proposal to Amend the Food and Drug Regulations to permit the use of Acacia gum modified with Octenyl Succinic Anhydride as an emulsifier

Table of Contents

• Purpose
• Background
• Current Situation
• Safety Assessment
  • Chemical Assessment
  • Dietary Exposure and Toxicological Assessment
  • Nutritional Assessment
• Rationale for Action
• International Status
• Consultation
• Recommendations
• Comments
• Additional Information

Purpose

This document provides information on Health Canada's proposal to amend the Food and Drug Regulations ("Regulations") to permit the use of Acacia gum (gum arabic) modified with Octenyl Succinic Anhydride (OSA) as an emulsifier in unstandardized beverages (e.g. fruit-flavoured drinks, carbonated beverages), salad dressings, sauces, and icing and flavouring preparation.

Background

In Canada, all food additives are regulated under the Food and Drug Regulations and are subjected 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 thorough safety evaluation of the proposed use(s) of the additive. Food manufacturers are not permitted to use the additive in foods to be sold in Canada 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 of the issuance of an Interim Marketing Authorization.

Products used as emulsifiers in food applications are regulated as food additives. Permitted food additives are listed in the food additive tables in Division 16 of the Regulations. Table IV lists those food additives that may be used as emulsifying, gelling, stabilizing and thickening agents. Table IV does not currently provide for the use of acacia gum modified with OSA although it does permit the use of acacia gum, also called gum arabic, in a variety of foods including salad dressing, cream, beer, and unstandardized foods at a maximum level of use consistent with Good Manufacturing Practice (GMP).

Health Canada has received a submission requiring that the Regulations be amended to permit the addition of OSA-modified acacia gum as an emulsifier in selected fruit-flavoured drinks at levels of 600 mg/kg (ppm); selected beverages (e.g. carbonated juice) at 780 mg/kg (ppm); fruit juices at 1000 mg/kg (ppm); and in salad dressing, sauces and icing at levels of 10 000 mg/kg (ppm). Also, the submission indicated that OSA-modified acacia gum will also be marketed for use as an emulsifier in flavour systems. It has been stated that acacia gum modified with OSA can stabilize emulsions that unmodified acacia gum cannot.

Current Situation

Health Canada's Food Directorate has completed a safety assessment of acacia gum modified with OSA when used as described in this submission and determined that there are no health or safety concerns with the use of this additive as an emulsifier in the requested food products. With respect to technical efficacy, OSA modification makes acacia gum an effective emulsifier due to the addition of dual functional hydrophilic and hydrophobic groups. However, the uses of acacia gum modified with OSA in mayonnaise (considered within the scope of salad dressings) and fruit juices in particular are not considered acceptable. This conclusion is based on the results of consultations undertaken during the assessment, as described in the Consultation section of this document. Therefore, based on the outcome of its evaluation, Health Canada is proposing amendments to the Regulations to allow the use of acacia gum modified with OSA as an emulsifier in unstandardized beverages, French dressing, salad dressing, dressings, sauces, icings, and unstandardized flavouring and flavouring preparations, each at a prescribed maximum level of use.

Safety Assessment

Health Canada's Food Directorate scientists have conducted a detailed and rigorous evaluation of the submission that focused on safety and efficacy. Their evaluation considered the chemical, toxicological and nutritional aspects of the proposed use of acacia gum modified with OSA as described in the following sections.

Chemical Assessment

Acacia gum (gum arabic) is a natural gum obtained from the stems and branches of Acacia Senegal (L.) Willdenow or closely related species of Acacia trees grown widely in certain regions of Africa. Acacia gum consists mainly of high molecular weight polysaccharides and their calcium, magnesium, and potassium salts. Acacia gum modified with OSA is produced by reacting acacia gum with OSA. During this esterification reaction, the OSA is added to some of the polysaccharide hydroxyl groups. This modified acacia gum can be used to replace acacia gum at a much lower concentration in certain applications.

Chemical names for acacia gum modified with OSA include "gum arabic hydrogen octenylsuccinate" and OSA-modified gum arabic.

At the time of submission evaluation, food-grade specifications for acacia gum modified with OSA had not yet been elaborated by either the Food Chemicals Codex (FCC) or the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The petitioner provided data demonstrating that lead and arsenic levels in OSA-modified acacia gum are within the FCC (6th edition) specifications of not more than 5 mg/kg for lead, and not more than 3 mg/kg for arsenic. The petitioner also committed to providing data to JECFA in support of JECFA's planned evaluation of acacia gum modified with OSA. Subsequently, at the 71st meeting of JECFA in 2009, specifications for acacia gum modified with OSA were elaborated.

Food Directorate scientists have not identified any chemical safety concerns in relation to the proposed use of acacia gum modified with OSA in those foods, under the conditions of use proposed in the submission, based on the information provided.

Dietary Exposure and Toxicological Assessment

According to the petitioner, the estimated daily intake among the US population from the combined uses as an emulsifier in flavour systems and other proposed emulsifier uses at the mean per capita level is 510.8 mg/day, and the mean per user level is 515.3 mg/day. The Food Directorate's Bureau of Chemical Safety, considers that these estimates are acceptable for the purposes of the safety assessment as the food consumption values upon which the dietary intakes are based would be similar for the Canadian population.

Food Directorate scientists evaluated various toxicological studies in their assessment of the safety of acacia gum modified with OSA. This included studies investigating the safety of acacia gum modified with OSA, acacia gum itself, and modified food starches. An acceptable daily intake (ADI) of 34 mg/kg body weight/day has been established for acacia gum modified with OSA based on the lowest No Observed Adverse Effect Level (NOAEL) of 3400 mg/kg body weigth/day determined in a 90-day oral rat study. Based on the evaluated toxicity studies, the estimated consumption levels, and other information presented in this report, it is considered highly improbable that consumption of food products treated with acacia gum modified with OSA as proposed will represent a toxicological concern to consumers.

Food Directorate scientists have no safety concerns from a toxicological perspective, to the proposed use of acacia gum modified with OSA in those foods, and under the conditions of use proposed in the submission.

Nutritional Assessment

Food Directorate scientists have concluded that the nutrient density of foods already permitting the use of acacia gum would not be reduced with the use of acacia gum modified with OSA. Furthermore, the requested foods to which this product will be added are not staple foods, and thus will not affect the nutritional content of the Canadian diet.

Food Directorate scientists have no concerns from a nutritional perspective, to the proposed use of acacia gum modified with OSA in those foods, and under the conditions of use proposed in the submission.

Rationale for Action

Based on the evaluation conducted by Health Canada's scientists, the information provided by the petitioner has satisfactorily met the requirements for a food additive submission outlined in Section B.16.002 of the Regulations. Therefore, it is proposed that acacia gum modified with OSA be listed as an emulsifying agent in Table IV, to section B.16.002, Division 16 (Food Additives), part B of the Food and Drug Regulations for use in unstandardized beverages, French dressing, salad dressing, dressings, sauces, icings, and unstandardized flavouring and flavouring preparations, each at a prescribed maximum level of use.

International Status

In the US, acacia gum modified with OSA was granted Flavour and Extract Manufacturers Association (FEMA) Generally Recognized as Safe (GRAS) status for use in flavouring in a variety of food categories.

In Australia, New Zealand, the Philippines, Singapore, China, and Costa Rica, acacia gum modified with OSA is permitted as an emulsifier in flavour systems.

This same submission was reviewed in 2010 by the European Food Safety Authority's (EFSA) Panel on Food Additives and Nutrient Sources added to Food. The Panel concluded that the use of "acacia gum modified with OSA" as an emulsifier in the proposed foods and use levels to be of no safety concern.

Acacia gum modified with OSA was evaluated by JECFA at its 71st meeting (2009). JECFA elaborated specifications and allocated a temporary ADI "not specified".

Consultation

Due to this proposal involving foods that are standardized under the Food and Drug Regulations, the Canadian Food Inspection Agency (CFIA) and Food Processors of Canada (FPC) were consulted. The CFIA does not object to the proposed addition of acacia gum modified with OSA to any products where acacia gum is already permitted to be added by the Food and Drug Regulations. However, the standards for mayonnaise and for fruit juices do not allow for the use of any emulsifiers. The CFIA does not recommend that acacia gum modified with OSA be allowed to be added to mayonnaise or fruit juices due to potential economic fraud implications. There is already a standard in the Food and Drug Regulations (B.07.042- Salad Dressing) for a mayonnaise substitute which permits the addition of emulsifying agents.

The FPC has indicated that it has no objection to the use of acacia gum modified with OSA in salad dressings, mayonnaise, mayonnaise dressing or mayonnaise salad dressing or French dressing, selected fruit-flavoured drinks or other beverages. They also have no objection to the proposed use of acacia gum modified with OSA in products that contain fruit juice but which are labelled with a common name not containing the word "juice". The FPC does object to its use in pure fruit juices and labelling such a product as "(naming the fruit) juice".

Recommendations

Based on the results of its safety assessment and the above consultations, Health Canada's Food Directorate is proposing that the use of acacia gum modified with OSA be permitted in all requested food categories except standardized fruit juices and mayonnaise. Therefore, it is proposed that a new item be listed in Table IV, Division 16 of the Regulations. The listing would appear as "acacia gum (gum arabic) modified with octenyl succinic anhydride (OSA)", which is considered one of the appropriate chemical names for this compound. The table would reflect "acacia gum (gum arabic) modified with octenyl succinic anhydride (OSA)" as being approved in (1) unstandardized beverages at a maximum level of use of 0.1%; (2) French dressing, salad dressing, dressings; sauces; icings at a maximum level of use of 1%; and (3) unstandardized flavourings and flavouring preparations at a maximum level of use of 0.05%.

The standard for French dressing and for salad dressing each permit the use of an "emulsifying agent"; therefore, there is no need to modify the respective regulatory standards for these foods to enable the use of acacia gum modified with OSA in these food products.

As part of the regulatory amendments, the Department may also amend the current listings for gum arabic and its synonym acacia gum, in order to correct some inconsistencies. Table IV lists both gum arabic and acacia gum separately, with the gum arabic listing referring back to acacia gum. In Table VII, gum arabic is listed, but not acacia gum. And finally, in Table VIII, acacia gum is listed but its synonym, gum arabic, is not. Any amendments in this regard will not affect the foods in which acacia gum (gum arabic) may be used nor the corresponding maximum levels of use.

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 "Acacia Gum" 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 sche-ann@hc-sc.gc.ca, using the words "Acacia Gum" in the subject box of your e-mail

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