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COMMERCIAL BAKING INDUSTRY GUIDE FOR THE SAFE USE OF POTASSIUM BROMATE

Issued by

AMERICAN BAKERS ASSOCIATION

AIB INTERNATIONAL

Copyright © 2008

Commercial Baking Industry Guide

ABA is the Washington, D.C.-based trade association that since 1897 has been the voice of the wholesale baking industry before the U.S. Congress, federal agencies, state legislatures and state agencies, and international regulatory authorities. ABA represents approximately 85% of the wholesale bakeries in the U.S. as well as their suppliers. For more information, contact: AMERICAN BAKERS ASSOCIATION www.americanbakers.org Tel: (202) 789-0300

AIB International (American Institute of Baking) is a corporation founded by the North American wholesale and retail baking industries in 1919 as a technology transfer center for bakers and food processors to "put science to work for the baker." AIB is headquartered in Manhattan, KS, home of Kansas State University and one of the world's major centers for wheat and related grain product research and development. AIB currently serves more than 900 members in the food industry in numerous countries around the world. In conjunction with the issuance of this Guide, AIB has introduced educational programs and consultative services to help bakers to maintain residues of potassium bromate at safe levels. For more information, contact: AIB INTERNATIONAL www.aibonline.org Tel: (785) 537-4750

This Guide represents ABA and AIB current thinking and information on this topic as of the date of publication. It does not create or confer any rights or obligations for or on any person. You can use any alternative approach in the use of potassium bromate if you are satisfied that it meets the requirements of all applicable federal and state statutes and regulations. Users are responsible for monitoring new developments to assure compliance with all regulatory requirements.

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Table of Contents

Page

Part 1: Part 2:

Background Using Potassium Bromate - Controlling Residues

5 6 6 8 8 9 10 10 11

Part 3:

Four Process Check Points for Potassium Bromate Usage 1. 2. 3. 4. Formulation of the Product Ingredient Delivery Mixer Oven

Part 4:

General Elements of Good Manufacturing Practices (GMP) Testing Protocols Role of AIB International

Part 5: Part 6: Bibliography

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American Bakers Association & AIB International

Part 1: Background

Potassium bromate (KBrO3) has been used in limited ways and amounts by the baking industry for almost a century with no known health concern. It has been used in baking since at least 1914 when a patent was issued by the United States Patent Office. Potassium bromate was approved by the United States Food and Drug Administration (FDA) for use in bromated flour at 50 parts per million (ppm) through the standards of identity for flour promulgated by the FDA in May 1941, and was explicitly approved for use in bread through the standards for bread and rolls promulgated in May 1952 at 75 ppm based on flour. Potassium bromate is prior-sanctioned for use in baked goods and flour under provisions of 21 CFR Parts 136 and 137. Although long considered to be a safe substance, limits placed on the amount of potassium bromate that may be added to flour were based on an expectation that the heat of the oven during baking converts bromate to a harmless bromide. Concern about the potential harmful effects of potassium bromate was raised by Japanese researchers in the mid-1980s. While the research was inconclusive, some countries adopted a precautionary-principle response and removed potassium bromate from the approved list of dough conditioners. More recent research in Japan casts doubt on this level of concern, at least as it refers to the amounts of potassium bromate used in the baking industry, concluding that there is a threshold below which no adverse effects can be detected. In the meantime, even though potassium bromate at the amounts used in baking may subsequently prove to be of little or no concern, the baking industry still needs to take the necessary steps to reduce any possible bromate residues in finished products to safe levels, which a risk analysis conducted by FDA has established at 20 ppb. For several years, the American Bakers Association (ABA) and AIB International (AIB) have been working with FDA and with the Japanese baking industry to improve testing and baking technology to permit continued use of bromate as a functional ingredient in baking in a manner that is safe and reliable, and results in no or minimal detectable residual bromate in the finished product. To this effect, and in consultation with the FDA, the wholesale baking industry has progressively reduced the amount of potassium bromate used. It is recognized that it is inappropriate to use potassium bromate in any product or production method which cannot be formulated without residues below the level of 20 ppb in the finished product. Highly sensitive testing methods have been developed and the fate of bromate in the baking process is now better understood. It is well within the normal production control measures in any modern bakery to ensure that bromate residues are well below 20 ppb.

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Commercial Baking Industry Guide

Part 2: Using Potassium Bromate

According to the United States Department of Agriculture (USDA), breads, cereals, rice and pasta provide complex carbohydrates (starches), which are an important source of energy especially in low fat diets. These foods also provide vitamins, minerals, and fiber. Based on caloric needs, the USDA Dietary Guidelines and the Food Guide Pyramid, grain intake can go as high as 10 ounce equivalents per day. However, based on the 2,000 calorie diet shown on food labels, six ounces are recommended, with at least half being whole grain. The use of potassium bromate results in a pleasing quality product that is popular with the consumer. Potassium bromate is a slow acting oxidizing agent that works during fermentation, proofing and baking. The oxidation process affects the dough structure and rheology. It improves dough handling properties contributing to loaf volume, grain and texture. Potassium bromate is used to help bread rise in the oven and to create a good texture. This oxidation is critical in poor crop years. Currently potassium bromate is used in a targeted way by bakeries for certain products. When used properly, potassium bromate does turn to harmless bromide in the finished baked product. Nevertheless, it is important to recognize that potassium bromate is an ingredient that should be handled carefully. From the time that concerns about potassium bromate were raised, the American baking industry has been working with suppliers to limit its use and to develop substitutes. In 1990, AIB did a study of potassium bromate substitutes and found limited application. Subsequently, AIB has conducted courses in potassium bromate and newer enzyme technologies to better train bakers in the use of oxidants. Substitutes are still being developed -- however, they still do not meet all the needs of the baking industry. Controlling Residues ABA in cooperation with AIB has conducted studies since 1993, and since 1995 has regularly presented scientific papers on potassium bromate at meetings in the United States and around the world. Numerous articles have appeared in bakery journals and magazines about the safe use of potassium bromate. The basic variables that control the potential residual potassium bromate in the finished baked food are the amount of potassium bromate added, the length of bake time and bake temperature. The baker can control these variables. (For more information on reducing residues to safe levels, please refer to the Bibliography, and particularly to articles 1 and 2.) A number of reliable methods for measuring potassium bromate residues in baked goods have been developed, and these methods are readily available through individual U.S. universities and commercial laboratories. They are also available to bakeries with their own analytical laboratories. First attempts in the late 1980's in England to develop a methodology to measure residual potassium bromate in finish baked foods were not completely successful. However, in the early 1990's FDA began to refine a method. Also at work, scientists at Yamazaki Baking Co. Ltd. Tokyo, Japan were developing their own testing method, as were researchers at the Dead Sea Bromine Group, Beer Sheva, Israel. 6

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American Bakers Association & AIB International

Part 2 (Continued)

One current methodology used to measure potassium bromate in finished baked foods is accurate to 3 ppb and is the product of cooperation among scientists at FDA and Yamazaki Baking Company. This methodology was published in Food Additives and Contaminants, 1997, Vol. 14, No. 8, 809-818. The title of the article is "Measurement of bromate in bread by high performance liquid chromatography (HPLC) with post-column flow reactor detection." AOAC International has given peer verified status to the method. In 2006, after several years of research, a quick test method was developed by a cooperative effort between Dr. Charles Warner of the FDA and Katsuichi Himata of Yamazaki Baking Company. This methodology is still being improved and is available through AIB International to any bakery with laboratory facilities that wants to have a simple testing method available during the product formulation stage and to monitor ongoing bakery performance.

Production Reminder -- the addition of potassium bromate by both the miller and baker may make it difficult to strictly control the total amount added. It is therefore essential that potassium bromate be added at the mill (on the baker's instruction) or by the baker, but not by both.

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Commercial Baking Industry Guide

Part 3: Four Process Check Points for Potassium Bromate Usage

The typical processing procedure for bread and rolls is as follows:

During the course of developing and producing bakery products, there are four critical Check Points at which to monitor proper potassium bromate usage. 1) Formulation of the product. It should be recognized that it may be impossible to formulate some types of baked goods without incurring potassium bromate residues because of differences in ingredients or process methodology. During the formulation stage, the finished product baked from each formulation that uses potassium bromate should be tested using the HPLC (or equivalent) method to verify that there are no or minimum residues at this stage. Detection of residues requires reformulation. Bakers should always strive to minimize the amount of potassium bromate needed to achieve the desired result in their formulas.

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American Bakers Association & AIB International

Part 3 (Continued)

2)

Ingredient Delivery: Including flour, premixes and potassium bromate. The amount of potassium bromate added to the dough will have a direct affect on the possibility for residues. All potential sources need to be monitored -- bromate may be present in flour, premixes for dough conditioners, or added separately. The amount of potassium bromate added to a product can best be controlled if a carefully monitored amount is added to the dough in the mixer. The flour supplier should be required to supply a flour certificate of analysis for potassium bromate. If the flour has some amount of potassium bromate, then that amount should be considered when additional potassium bromate is added at the mixer ­ but it is highly preferable that the flour contain no potassium bromate. The same process should be followed for azodicarbonamide (ADA) as that has been shown to inhibit the reduction of potassium bromate, and this can result in elevated residues. ADA should not be used in combination with potassium bromate. If a premix is used, the premix supplier should certify the level of potassium bromate and any other substances specified by the baker for each premix. Visual examination of the ingredient labels and ingredient documentation for each shipment is necessary. The examination should be done by the receiving employee, a production supervisor, a member of the quality control staff, or any other person who has an understanding of the proper content of the label. When the label or documentation shows that an ingredient does not meet specifications, the ingredient should be segregated and removed from the bakery. The responsible employee must make a record of the checks. The records should be reviewed by an employee with higher authority before use of each shipment. Caution: For proper handling, potassium bromate should be considered to be hazardous and care should be taken to avoid inhalation. At all times, it should be handled and labeled consistent with the Material Safety Data Sheet (MSDS).

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Commercial Baking Industry Guide

Part 3 (Continued) 3) Mixer: The amount of potassium bromate added at the mixer -- other ingredients added at the mixer. The amount of potassium bromate added to the dough is a critical variable in influencing the potential for residual amounts, and strict written procedures to regulate this activity must be in place. The amount of potassium bromate added to the dough is controlled by carefully monitoring the amount added to the mixer in strict accordance with the product formulation. Each production formula must be available to the production employee who is responsible for adding potassium bromate. (If necessary, formulations must be posted and checked by adding together the potassium bromate in all listed sources -- though a single source is highly preferable.) The employee responsible for adding ingredients to the mixer before processing begins should do the checking to ensure that potassium bromate levels in the final dough do not exceed the amount determined by the baker for the specific product. Potassium bromate is added in premixes by weight alone, by weight in premixes, by volume of bromate solution, or by numbers of tablets, strictly according to the original formulation. There should be no variation from the formulation. The posted formulation must indicate how the potassium bromate is added and the appropriate amount by weight, volume or number. The employee responsible for adding ingredients to the mixer should use the process control sheets to record the amount of potassium bromate added to the mixer. This should be done separately from the recording of other ingredients for that dough. The records should be reviewed by an employee with higher authority at least twice during a shift. Note: If potassium bromate tablets are used, all tablets must be completely dissolved before the potassium bromate is added to the dough. Note: For a sponge and dough process, the potassium bromate should only be added to the dough. 4) Oven: The bake temperature. The bake time. Bake temperature and time should be sufficient to completely bake the product according to strict adherence to the product formulation. Production Reminder ­ All employees identified with record keeping responsibilities and with supervisory responsibilities should receive a copy of this Industry Guide and participate in a meeting with the production manager or designate to ensure understanding of the Four Process Check Points, process procedures, and the use of testing and sample selection for the HPLC. A record of attendance at these meetings will be maintained by the production manager. This meeting format requires that the employees are already familiar with Good Manufacturing Practices (see next section).

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American Bakers Association & AIB International

Part 4: General Elements of Good Manufacturing Practices (GMP)

The production of safe baked food products requires a solid foundation of procedures. These procedures provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. FDA describes GMPs in 21 CFR Chapter 1 Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. To use potassium bromate safely, the bakery should set up a clearly defined chain of command, with responsibilities relating to its use clearly defined. The responsible person or persons should understand the rationale behind the baking procedures that are intended to ensure acceptable residues, and they should have authority to see that procedures are followed. The following modifications to the bakery's existing GMP procedures are recommended for the use of potassium bromate: Quality Control. There should be written specifications for all ingredients, products, and packaging materials, and there should be written inventory adjustment of supplies of potassium bromate. Training. Employees who handle potassium bromate, as well as their immediate supervisors should receive specific training in its proper handling. Chemical Control. Documented procedures must be in place to assure the segregation and proper use of potassium bromate. Receiving, Storage and Shipping. A bakery must define standard operating procedures for handling, storing and release of potassium bromate. Traceability and Recall. All raw materials and products should be lot-coded, recorded and held. A recall system should be in place so that rapid and complete traces and recalls can be done when a product retrieval is necessary. Inspection of Facility. Each facility where potassium bromate is used should be formally inspected at least once per year by qualified external or internal inspectors.

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Commercial Baking Industry Guide

Part 5: Testing Protocols

This Industry Guide calls for testing for potassium bromate residues at two critical stages in the process. 1. Each formulation should be tested using the high performance liquid chromatography (HPLC) or equivalent method to verify that no or minimum potassium residues are detected before the formulation is put into production. If GMP procedures as described above are rigorously implemented in the bakery, it is expected that all products will be produced with no or minimum detectable residues. 2. As a periodic check on process control, samples of each formulation of finished product should be tested by a laboratory using the HPLC or equivalent method. On the first day of production of a new product, a test using the HPLC or equivalent method should be repeated to ensure that the product matches formulation. It is also the responsibility of the bakery to institute a suitable testing program to verify that no bromate residues are detected above the 20 ppb limit. The frequency will depend on the circumstances of each formulation, but as a general guide should occur no less than every four months. Any observance of excess residues requires a full review and correction of the production process before production is resumed.

Part 6: Role of AIB International

AIB International (American Institute of Baking) is the resource center of the American baking industry. AIB is committed to protecting the safety of the food supply chain and delivering high value technical and educational programs in the U.S. and around the world. AIB is supported by and in turn serves the baking industry through technical audit services, food safety education, baking school courses (in cooperation with Kansas State University), and research and technical services. AIB is uniquely positioned to assist baking companies implement the Industry Guide for the Safe Use of Potassium Bromate. It provides assistance in the areas listed on the next page.

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American Bakers Association & AIB International

Part 6 (Continued) 1. Inspection The Industry Guide calls for annual inspection, either by qualified internal or external inspectors, of baking facilities that use potassium bromate, AIB will either conduct these inspections as part of its regular audit program or be available to consult with bakeries that use potassium bromate to set up an internal inspection procedure. 2. Training AIB will support the Industry Guide by providing training in the proper use of potassium bromate as part of its ongoing student training programs and by making appropriate training materials available to smaller bakers who do not regularly send personnel for offsite training. 3. Testing Bromate testing services are currently available to the baking industry. For example, the University of Nebraska in Lincoln offers a potassium bromate testing service using the HPLC methodology. AIB will maintain a list of laboratories providing this service. The quick test methodology developed by FDA and Yamazaki Baking Company has been assigned to the research department of AIB. It is available to companies that want to install the methodology for their own use and to participate in collaborative development of the method. Copies of the quick test and analytical testing services using this methodology are available through AIB's Research Department. 4. ABA and AIB Industry Support ABA and AIB will continue to work together to support the Industry Guide. AIB will maintain current information about potassium bromate in its library and will issue updates in its regular bulletins that reach a wide cross section of the baking industry. It is important that millers, ingredient suppliers and other ancillary trades involved with the baking industry are knowledgeable about the industry's initiative on potassium bromate. They may be able to serve as useful partners for passing on information about potassium bromate to their customers, and for encouraging these companies to contact AIB for additional information. Regulatory Reminder ­ For several years, FDA has conducted a bromate monitoring program in which it takes samples from markets across the United States and tests them for potassium bromate residues. It is expected that the agency will continue this monitoring program. In the event that FDA finds a bakery that exceeds safe levels of potassium bromate residues in its products, it will have the option of directing the bakery to seek guidance and help from AIB International.

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Commercial Baking Industry Guide

Bibliography

Individual copies of the following papers are available from the respective journals or from the library at AIB International for a small fee to cover handling and copyright charges.

1) Cogswell, T. The use of potassium bromate. American Society of Bakery Engineers Technical Bulletin # 240: 1016, 1997. 2) Giesecke, A.G. and Taillie, S.A. Identifying factors affecting bromate residue levels in baked products: preliminary studies. Cereal Foods World. 45 (3):111-120, March 2000. 3) Himata, K., Noda, M., Ando, S., and Yamada, Y. Peer-Verified Method: Determination of bromate in bread by high performance liquid chromatography with post-column flow reactor detector. J. AOAC Int. 83:347, 2000. 4) Yamaguchi, T., Wei, M., Hagihara, N., Omori, M., Wanibuchi, H., and Fukushima, S. Lack of mutagenic and toxic effects of low dose potassium bromate on kidneys in the Big Blue rat. Journal of Mutation Research. 652:1-11, 29 March 2008. 5) Himata, K., Nakamura, M., Murakami, T., Hosoya, S., and Yamada, Y. Procedures for the safe use of potassium bromate in bread making in the Japanese baking industry. AACCI annual meeting poster, San Francisco, US, 2006. 6) Nakamura, M., Murakami, T., Himata, K., Hosoya, S., and Yamada, Y. Effects of reducing agents and baking conditions on potassium bromate in bread. Cereal Foods World. 51:69, 2006. 7) Himata, K., Warner, C., Currie, D., Graves, O., and Diachenko, G. The use of electrodialysis to prepare aqueous bread extracts for bromate determination by chemiluminescence. J. AOAC Int. 88(3):794, 2005. 8) Giesecke, A.G. The use of electrodialysis to prepare aqueous bread extracts for bromate determination by chemiluminescence. 12th ICC Cereal & Bread Congress, Harrogate, UK, May 2004. 9) Diachenko, G.W. and Warner, C.R. Potassium bromate in bakery products: food technology, toxicological concerns, and analytical methodology. Page 218 in: Bioactive Compounds in Foods. ACS Symp. Ser. 816. T.-C. Lee and C.-T. Ho, eds. American Chemical Society, Washington, DC, 2002. 10) Steinriede, K. Using potassium bromate: Reduce residue and keep quality. Baking Management, 42, May 1997.

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American Bakers Association & AIB International

11) Editorial. Research on bromate use outlined at A.S.B.E. Milling & Baking News, March 19, 1997. 12) Himata, K., Noda, M., Ando, S., and Yamada, Y. Measurement of bromate in bread by high performance liquid chromatography with post-column flow reactor detection. Food Additives and Contaminants. 14(8): 809-818, 1997. 13) Himata, K., Noda, M., Ando, S., and Yamada, Y. Measurement of inorganic residues in finished baked goods. 10th International Cereal and Bread Congress, Porto Carras (Chalkidiki), Greece, June 9-12, 1996. 14) Warner, C.R., Daniels, D.H., Joe, F.L. Jr., and Diachenko, G.W. Measurement of bromate in bottled water by high-performance liquid chromatography with post-column flow reactor detector. Food Additives and Contaminants, 13(6):633, 1996. 15) Himata, K., Kuwahara, T., Ando, S., and Yamada, Y. Determination of bromate in bread by capillary gas chromatography with mass-spectrometer detector. Food Additives and Contaminants. 11:559, 1994. 16) Grunfeld, Y. Assessment of the safety of potassium bromate usage in bread baking. (Private publication) June 1993.

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American Bakers Association

1300 I Street, NW Suite 700 West Washington, DC 20005 (202) 789-0300 · (202) 898-1164 www.americanbakers.org

AIB International

P.O. Box 3999 / 1213 Bakers Way Manhattan, KS 66505-3999 (785) 537-4750 · (785) 537-1493 www.aibonline.org

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