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CBI DELETED COPY PETITION FOR THE ADDITION OF OAT BETA-GLUCAN OAT J3-GLUCAN TO THE NATIONAL LIST OF ALLOWED SUBSTANCES IN ORGANIC FOODS 7 CFR 205.606 Full Petition Confidential Business Information Respectfully submitted by: 'I'Al'U LYLE Law DepartmenU Regulatory Affairs 5450 Prairie Stone Parkway Hoffman Estates, IL 60192 USA
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Page 1: OAT BETA-GLUCAN OAT J3-GLUCAN Beta-Glucan.… · Appendix 1: Product Information for Oat Beta-glucan Products ... • Switzerland -Spenser Pro Mass Gainer with 1 gram of oat 13-glucan

CBI DELETED COPY

PETITION FOR THE ADDITION OF

OAT BETA-GLUCAN

OAT J3-GLUCAN

TO THE NATIONAL LIST OF ALLOWED SUBSTANCES IN ORGANIC FOODS

7 CFR 205.606

Full Petition Confidential Business Information

Respectfully submitted by:

'I'Al'U LYLE Law DepartmenU Regulatory Affairs 5450 Prairie Stone Parkway Hoffman Estates, IL 60192 USA

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Petition to Add to the National List 205.606:

Oat ~-Glucan >30% J3-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

Item A

1. Category

Non-organically produced agricultural products allowed in or on processed products labeled as "organic" - 7 CFR 205.606.

2. Justification for this category

The petitioned substance is a natural component of an agricultural commodity: oats. There are some bonds broken in the manufacture of the product but this occurs only through the use of an enzyme treatment. The soluble oat fiber remains in its natural state and is therefore non­synthetic. This substance is isolated through a simple process grinding, enzyme treatment, water extraction and drying; the process does not require any synthetic chemical additions or solvents. The only additives used in the manufacture of oat 13-glucan are water and amylase enzyme.

Additional processing steps can be included to further purify soluble oat fiber including the addition of alkaline and acidic substances and solvent extraction. This further processing with synthetic chemicals is not part of this petition. This petition only requests addition of soluble oat fiber concentrates that are isolated through grinding, enzyme treatment, water extraction and drying (no chemicals including those for pH adjustment and/or solvent extraction).

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Petition to Add to the National List 205.606:

Oat f3-Glucan >30% J3-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

Item B

1. The common name of the substance.

Oat beta-glucan or oat 13-glucan. Also labeled as: oat bran soluble fiber, oat fiber, oat soluble fiber, oat bran fiber.

2. The manufacturer - name, address, phone number, contact information

PromOat® Oat B-glucan

Tate & Lyle Oat Ingredients Alvasvagen 1 610 20 Kimstad Sweden Phone +46 11 253630 oat. [email protected]

Contact for Tate and Lyle I Petitioner: Lore Kolberg Director, Regulatory Affairs Tate & Lyle 5450 Prairie Stone Parkway Hoffman Estates, IL 60192 USA 847-396-7608 office; 224-355-9013 mobile

There is at least one manufacturer, Garuda International, with a product called 8 -CAN™ 70% Oat Beta Glucan, that further purifies a soluble oat fiber through solvent extraction (GRAS Assessment, July 19, 2012 http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-foods­gen/documents/document/ucm316626.pd0. This further processing, solvent extraction, is not part of this petition. This petition only requests addition of soluble oat fiber concentrates that are isolated through grinding, enzyme treatment, water extraction and drying (no solvent extraction).

There is also another known US supplier of oat 13-glucan in which the soluble oat fiber has been specifically extracted from the oats (exceeding 30% soluble fiber content). Nurture, Inc. manufactures a product called OatVantage ™ that has been on the market for over 10 years. It is made through water extraction in a process that is claimed to be entirely natural, however Nurture has at least two patents for the manufacture of oat 13-glucan (Method for Concentrating Beta­Glucan US 6,323,338 and Method for Concentrating Beta-Glucan Film US 6,624,300) in which they specifically mention pH adjustments made by adding alkali such as sodium carbonate and acid such as hydrochloric acid. For this reason, OatVantage™ has also not been included in this petition.

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Petition to Add to the National List 205.606:

Oat J3-Glucan >30% 13-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

3. The intended or current use of the substance.

Oat f3-glucan is a soluble fiber ingredient which is used to supplement food products to provide the positive effects recognized for whole oats yet at a much lower use level:

• Helps maintain healthy blood cholesterol levels • Promotes normal post-meal glycemic response; low glycemic effect • Helps promote digestive/intestinal health • Supplies fiber which may help promote satiety • Helps rebalance recipe fat and calorie content due to fat mimicking properties

PromOat® Oat Beta Glucan, the product manufactured by Tate & Lyle, has been used in a wide range of food products including biscuits and cakes, bread, cereals, bars, soups, shakes, smoothies and supplements.

Appendix 1: Product Information for Oat Beta-glucan Products

Tate and Lyle - Product Bulletins for PromOat® Oat Beta Glucan:

• Product Data Sheet: PromOat® Beta Glucan • PromOat® Beta-Glucan - 'The natural, heart-healthy, functional oat ingredient" -

provides more detail information about these effects. Numerous references provide supporting technical information.

• PromOat® Beta-glucan - "Give your food and beverages the goodness of oats" -provides general information on the use of oat beta-glucan in a variety of foods.

Due to the high level of f3-glucan in these oat concentrates, 4 .3 grams of the oat f3-glucan concentrate PromOat® can be added to a 10 oz entree yielding a final product with 1.5 grams of f3-glucan (1 .5% of the formula as PromOat®). At this level, which is half the daily amount of 3 grams identified in the FDA health claim, the f3-glucan has been shown to have positive physiological effects. In addition, this use level can comply with the NOP composition requirements for "Organic" foods. With water and salt at less than 65% of the formula, the oat f3-glucan concentrate level would be <5% in this entree which is consistent with the composition requirements for non-organic ingredients in "Organic" foods.

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Petition to Add to the National List 205.606:

Oat (3-Glucan >30% 13-glucan content. water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

4. The handling activities for which the substance will be used and its mode of action.

Oat ~-glucan is used as a source of soluble fiber to help promote healthy blood cholesterol levels and thereby reduce the risk of coronary heart disease. It may also be added to foods for other health benefits that are supported by clinical trials including: promotes low glycemic index, promotes normal blood sugar response after a meal and promotes satiety, which is a useful tool for weight management.

Oat ~-glucan is consumed and not digested. It impacts health through its presence in the intestinal tract. Several mechanisms have been suggested as to how ~-glucan lowers cholesterol including binding to the bile acids in the intestine, fermentation by colonic bacteria to produce beneficial short chain fatty acids that inhibit cholesterol synthesis, and interfering with the digestion of dietary fat. One or more of these likely results in the beneficial effects demonstrated by oat ~-glucan.

5. The source of the substance and a detailed description of its manufacturing or processing procedures.

Oat 13-glucan is extracted from whole oats

Confidential Business Information (CBI) Deleted

Appendix 2 shows the stepwise manufacture of PromOat® Oat Beta Glucan.

6. A summary of any available previous reviews of the petitioned substance by State or private certification programs or other organizations.

To the best of our knowledge, oat ~-glucan has not been reviewed by State or private certification programs in the past. A GRAS determination was prepared and submitted to the FDA in 2014 (see point 7). As indicated in the GRAS determination, there is a long history of the safe use of oats and products derived from oats. Expert scientists agree that publically available scientific literature is sufficient to support the safety of oat ~glucan that is produced consistent with current Good Manufacturing Practices.

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Petition to Add to the National List 205.606:

Oat J3-Glucan >30% J3-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

7. Information regarding EPA, FDA, and State regulatory authority registrations.

A GRAS determination was prepared and submitted to the FDA in 2014. See Appendix 3.

8. The Chemical Abstract Service (CAS) numbers of the substance and labels of products that contain the petitioned substance.

Chemical Abstracts Service (GAS) Registry Number for "13-glucan" of any origin (specifically including oats) is 9041-22-9. The GAS number for the mixed linkage (1-3),(1-4)-13-D-glucan is 55965-23-6.

PromOat® Oat Beta-Glucan was launched in Europe and Australia within the last five years. This conventional oat 13-glucan is currently used in a number of healthy products as a soluble fiber supplement. These are examples of products using this ingredient:

• Switzerland - Farmer Joghurt with 1 gram of oat 13-glucan per 225 gram serving (1.3% Prom Oat®)

• Switzerland - Spenser Pro Mass Gainer with 1 gram of oat 13-glucan per 60 gram serving (4.8% PromOat®)

• UK - Hovis Hearty Oats Bread with 1 gram of oat 13-glucan per 88 gram serving (3.2% PromOat®)

• UK - Marks & Spencer - Super Juice with 0. 75 grams of oat 13-glucan per 300 gram serving (0. 7% PromOat®)

Appendix 4, Tate & Lyle Oat Ingredients- Launches in the Market with Beta-Glucan, contains information on a range of products which contain PromOat® Oat Beta-Glucan.

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Petition to Add to the National List 205.606:

Oat f3-Glucan >30% ~-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

9. The substance's physical properties and chemical mode of action including:

(a) chemical interactions with other substances, especially substances used in organic production;

Oat 13-glucan (specifically the type specified in this petition) is extracted from oat bran with water and then separated from the oat protein which is made insoluble through a heat treatment. There are no known reports of it interacting with other substances in nature to form other compounds.

(b) toxicity and environmental persistence;

Oat 13-glucan is non-toxic. It exists in nature as a natural component of oats. There are no issues of environmental persistence. It is environmentally harmless.

(c) environmental impacts from its use or manufacture;

The manufacture of oat j3-glucan involves only substances found in nature. Separation of oat 13-glucan from oat bran has two objectives:

• isolate the soluble oat fiber for use as a nutritional supplement • separate off the oat protein for use as a protein supplement

There is no residual in this process that must be discarded.

(d) effects on human health;

The positive effect of oat 13-glucan in human health has been reported in numerous studies on various 13-glucans over the past 25 years. Initial studies involved the positive impact of barley and oat 13-glucan on lipid metabolism. More recent studies have involved the ability of barley and oat 13-glucan to reduce glycemic and insulinemic responses in foods and help enhance satiety.

In passing through the digestive tract, 13-glucan is not absorbed to any significant degree because of its large molecular size. Therefore, the benefits of 13-glucan occur through associations with other components and microorganisms in the digestive tract. See Appendix 3 for the Report of the Expert Panel on the Generally Recognized as Safe (GRAS) Status of PromOat® Oat Beta­Glucan.

The following section taken from the GRAS Determination (Appendix 3, page 21) summarizes one of the beneficial contributions of oat 13-glucan:

The Federal Register Notice acknowledges the beneficial contribution from {3-glucan (FDA, 1997): Based on its review of evidence submitted with comments to the proposal, as well as of the evidence described in the proposal, the agency has concluded that the type of soluble fiber found in whole oats, i.e., beta (/3)-glucan soluble fiber, is primarily responsible for the association between consumption of whole oats, including oat bran, rolled oats, and whole oat flour, and an observed lowering of blood cholesterol levels ... (l)ntakes of {3-glucan soluble fiber at or above 3 g per day were more effective in lowering serum lipids than lower intake

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levels. Petition to Add to the National List 205.606:

Oat 13-Glucan >30% 13-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

Over the years, there have been more positive physiological effects identified with the consumption of oat 13-glucan and 13-glucan in general. The GRAS Determination summarizes a significant amount of detailed information on clinical trials using 13-glucan (Appendix 3, pages 22 -33). These are the specific topics covered regarding human health in the GRAS Determination:

• Studies of the Cholesterol-Lowering Effect of Beta-Glucan • Studies on the Modulation of Blood Glucose and Insulin by Beta-Glucan • Studies of Immune-Modulating Effects of Beta-Glucan • Additional Protective Effects of Beta-Glucan • Tolerance Studies in Human Volunteers • Interaction with Nutrient Absorption • Allergenicity

The few negative impacts on human health attributed to oat 13-glucan are:

• mild, transient gastrointestinal effects such as flatulence and abdominal discomfort NOTE: these gastrointestinal effects commonly occur following a shift from a low- to high-fiber diet (IOM, 2005).

• mild allergic reactions in some individuals generally attributed to contamination of oats with gluten containing grains

The physiological benefits of oat 13-glucan far outweigh the few minor negative impacts identified in numerous clinical trials.

(e) effects on soil organisms, crops, or livestock.

Oat 13-glucan is used in handling, not crop production. It has no effect on soil organisms, crops or livestock.

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Petition to Add to the National List 205.606:

Oat 13-Glucan >30% ~-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

10. Safety information about the substance.

Oats are a traditional food with a long history of safe use. Removal of some of the components from oats results in concentrates that are as safe as the oats from which the components were extracted.

There is a thorough review of safety information in the GRAS Determination Section 5.0 Safety (Appendix 3, pages 16 - 33).

The MSDS (Material Safety Data Sheet) for PromOat® Oat Beta Glucan is provided in Appendix 5.

11. Comprehensive research reviews and research bibliographies, including reviews and bibliographies which present contrasting positions.

While we were able to find information on fiber contents from organic food sources, we were not able to find an article that identified organic sources for high levels of 13-glucan that are suitable for use as a soluble fiber supplement

The numerous articles cited in the GRAS petition provide a clear picture of the beneficial physiological impacts from the consumption of 13-glucan.

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Petition to Add to the National List 205.606:

Oat f3-Glucan >30% 13-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

12 "Petition Justification Statement" which provides justification for inclusion of a non-organically produced agricultural substance onto the National List 205.606

A wide range of studies and clinical trials have consistently revealed that fiber-rich diets are associated with significant reductions in cardiovascular disease risk. Fiber-rich diets, particularly those high in soluble fiber, have also been identified as providing physiological benefits such as:

• Reducing blood cholesterol • Reducing glycemic response • Promoting digestive/intestinal health • Promoting satiety I weight management

While most consumers are aware there are benefits to eating products that contain fiber, consumers generally do not eat the daily recommended amount. According to USDA and NHANES, Americans consume only about 65% of the recommended daily intake fiber (based on a Daily Value of 25 grams of fiber for a 2000 calorie diet). As shown in Appendix 6 USDA NHANES Nutrient Intakes from Food 2009- 2010, we eat an average of about 16 grams of fiber a day. Americans need to increase the amount of fiber in their diets to achieve the full health benefits associated with this dietary component.

Organic consumers justifiably believe that consuming organic foods is both beneficial to the earth as well as beneficial to their health. Product selection for organic consumers can include more nutritious products because these consumers are more likely to select whole foods (fruits, vegetables, whole grains, etc.). However, the need for convenient foods that are either ready to consume or easy to prepare means that organic consumers will continue to select some processed foods for their diets.

Processed foods can contain fewer nutrients such as fiber because they are formulated to provide optimum flavor and texture as well as product stability on the shelf. Fiber is removed from ingredients such as wheat flour and rice to make them more acceptable to the consumer.

Organic food formulators now have a wide range of organic whole foods available to them which are high in fiber: beans, broccoli, whole wheat flour, oats, barley. However, in many cases, it is difficult to build fiber content beyond the foods already used in the recipe. Specific formulas will not always be palatable and/or meet target flavor profiles with high levels of currently available fiber rich organic foods. Organic processors would have more opportunities to build fiber levels in their products if they had an ingredient available that is high in fiber, has bland flavor and can be added at a level of physiological significance without impacting the flavor or texture of the finished product. Due to its high soluble fiber content, bland flavor and minimal impact at low use levels, oat J3-glucan (>30% J3-glucan) is an ideal ingredient to supplement fiber content in a wide range of food products.

The FDA acknowledges that the soluble fiber J3-glucan helps to maintain healthy blood cholesterol levels and is effective in reducing the risk of coronary heart disease. A health claim is authorized by the FDA for products containing 0.75 grams of oat and/or barley J3-glucan fiber as defined in 21CFR101.81:

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Petition to Add to the National List 205.606:

Oat (3-Glucan >30% f3-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

(c) (iii) Nature of the food eligible to bear the claim.

(A) The food product shall include: ( 1 ) One or more of the whole oat or barley foods from paragraphs (c)(2)(ii)(A)(1 ), (2 ), (3 ), and (5) of this section, and the whole oat or barley foods shall contain at least 0.75 gram (g) of soluble fiber per reference amount customarily consumed of the food product.

Appendix 7 contains 21 CFR 101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHO).

The table shown below provides a general summary of options that were investigated to fortify one 12 oz beverage with 0.75 grams of ~-glucan (or the equivalent to give the same effective level in reducing the risk of heart disease).

Soluble Amount Source of Trade Fiber Needed to Meet Formula% Impact on

Soluble Fiber Name Content Health Claim if Used in Finished (approx (0.75g13-glucan, 12 oz

Beverage per 100 g) 1.7 g psyllium)" Beverage

Sources of P-Glucan and Psyllium Fiber Currently Available for Use in Organic Foods

Organic Oats Generic 5 15 grams 4.3% Unpalatable or Barley

Organic Oat Generic 7 11 grams 3.1% Unpalatable Bran

Organic Generic 70 2.4 grams 0.7% Gelatinous, Psyllium Husk* unpalatable

Sources of P-Glucan Proposed for Use in Organic Foods in this Petition

Oat ~-glucan PromOat® 35 2.1 grams 0.6% Minimal

* FDA allows the health claim for psyllium husk as that allowed for 0. 75 grams of oat 13-glucan however the required quantity is higher. 21CFR101.81 (c) (iii) (3) Psyllium husk .. . shall contain at least 1.7 g of soluble fiber per reference amount customarily consumed of the food product.

As the table indicates, while there are currently certified organic crops that do provide a source of fiber to consumers and processors that will reduce the risk of coronary heart disease, all are relatively lower in fiber and/or have functional properties that make them difficult to use in processing/food formulation.

This demonstrates that the current sources of organic oat soluble fiber are not suitable for use in formulating a wide range of supplemented "Organic" foods. In addition, at this time, there are no concentrated sources of soluble fiber on the National List 205.606, i.e., there are no conventional sources of soluble fiber that are allowed in "Organic" foods.

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Petition to Add to the National List 205.606:

Oat ~-Glucan >30% 13-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

In addition to reducing the risk of coronary heart disease, oat 13-glucan has a number of other health benefits that have been demonstrated in studies completed by a number of independent researchers. Appendix 8 provides an overview of the health benefits and product applications for PromOat® Oat Beta Glucan.

Clearly, the organic consumer and processor alike can benefit from the availability of a source of soluble fiber that is concentrated, versatile and palatable - a source that can easily provide a physiological impact through the addition of only 0. 75 grams of soluble fiber. Oat 13-glucan (>30% 13-glucan, water extracted, no chemicals including those for pH adjustment and/or solvent extraction) is an ideal ingredient to meet this need and, because of its high content of soluble fiber, can be used at a level that would be consistent with the organic rules (i.e., use level can remain under 5% of the formula - less water and salt).

There is currently no source of organic oat 13-glucan. While oat bran and oats are widely available as organic in the US and Canada, there is no organic oat processor that is making oat 13-glucan. In addition, there is no manufacturer of oat 13-glucan that has a processing facility making certified organic products.

This is also true in the Nordic countries where a large amount of oat 13-glucan is manufactured. There are sources of organic oats and organic oat bran in this region but quantities are limited and require further development. Due to the equivalency arrangement, organic oats I organic oat bran could now be purchased from the USA for use in this Swedish manufacturing facility and this facility could become certified to make organic oat 13-glucan, however, this is not likely to occur soon due to an undetermined demand for oat 13-glucan in an organic form.

Should the use of oat 13-glucan be successful in "Organic" foods (as a conventional ingredient authorized on the National List), sources of oat 13-glucan would likely be developed from organic oats originating in the USA and/or the Nordic region.

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Petition to Add to the National List 205.606:

Oat (3-Glucan >30% j3-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

Comments Relative to Similar Petition for Oat Bran Concentrate

In 2007, GTC Nutrition submitted a petition to request the addition of oat bran concentrate to the National List (OatVantageTM listed as example, the petitioned substance was a concentrate of oat 13-glucan). A copy of the petition (without appendices) is included as Appendix 7 along with the NOSB Committee Recommendation dated May 2008.

In the petition, the justification statement provided little information about the nutritional benefits of the oat 13 glucan and it did not elaborate on the reason there was no organic equivalent product available. This is the GTC Nutrition justification statement:

OatVantage Petition justification statement: The product falls under the category §205.606 Agricultural (nonorganic) nonsynthetic substances allowed in or on processed products labelled as "organic" or "made with organic (specified ingredients)." There are currently no organic equivalents of the product available. The product is not synthetic, it is a naturally occurring oat bran source produced from whole oats. Therefore OatVantage TM should be included on the National List, as it provides a valuable source of beta-glucan. OatVantage TM is easily incorporated into a wide range of foods, snacks, beverages and dietetic foods and leads to interesting documented health benefits at low inclusion levels.

The NOSB committee reviewed the petition and rejected oat bran concentrate for inclusion on the National list 205.606 for the following reason:

The petition did not provide information demonstrating that this material cannot be obtained organically in the appropriate form, quantity, or quality.

Seven years have passed since the original similar petition was submitted. During the time since the petition was filed and rejected, no organic oat bran concentrate I oat 13-glucan has been made available on the market. The organic industry has not had the advantage of using this · physiologically functional component known to have significant health advantages over the last seven years. It is likely that physiologically functional substances such as oat 13-glucan will not be manufactured in an organic form until it can be demonstrated that the Organic industry is interested in developing processed products that contain concentrates/isolates of known health advantage. Adding an ingredient like oat 13-glucan to the National List encourages the development of organic alternatives.

In the 2007 petition, the processing information for OatVantageTM was part of the confidential business information. A review of patents granted to Nurture, the manufacturer of OatVantage™, indicates that this product is pH adjusted with chemicals such as sodium carbonate and hydrochloric acid. Therefore, this specific product is not included in this petition.

This petitioner has provided additional information beyond that submitted in 2007 in order to elucidate the nutritional value of oat 13-glucan to the organic market and consumer. In addition, the petitioner has explained the reasons the organic industry could benefit from a concentrated form of oat ~-glucan. If use of this component is allowed for companies manufacturing "Organic" products, it would prompt the development of an organic oat 13-glucan.

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Petition to Add to the National List 205.606:

Oat ~-Glucan >30% 13-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

13. Confidential Business Information Statement

The manufacturing process for PromOat® Oat Beta Glucan (Appendix 2) is confidential business information. Two versions of the petitions have been provided, one containing Confidential Business Information (CBI) and one with CBI Deleted.

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Petition to Add to the National List 205.606: Oat f3-Glucan

>30% 13-glucan content, water extracted, no chemicals including those for pH adjustment and/or solvent extraction

Appendices

Appendix 1: Product Information for Oat Beta-Glucan Products

Appendix 2: Stepwise Process for Manufacture of PromOat® Oat Beta Glucan

Appendix 3: GRAS Determination of Oat Beta-Glucan for Use in Food Submitted by: Tate & Lyle, September 5, 2014

Appendix 4: Tate & Lyle Oat Ingredients Launches in the Market with PromOat® Oat Beta Glucan

Appendix 5: Material Safety Data Sheet (MSDS) for PromOat® Oat Beta-Glucan

Appendix 6: USDA NHANES Nutrient Intakes from Food, 2009-2010.

Appendix 7: 21 CFR 101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHO)

Appendix 8: Beta-Glucan: Health Benefits and Product Applications (Tate & Lyle)

Appendix 9: Oat Bran Concentrate Petition for Inclusion on the National List of Allowed Substances

NOSS Committee Recommendation: Oat Bran Concentrate, May 2008

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Petition to Add to the National List 205.606:

Oat f3-Glucan >30% 13-glucan content, water extracted,

no chemicals including those for pH adjustment and/or solvent extraction

References (available on request)

American Celiac Society. 2014. Recommended Diet - Milk Free /Gluten (Gliadin) Free Diet. Available at http://www.americanceliacsociety.org/diet1 . html

American Dietetic Association (ADA). 2002. Position of the American Dietetic Association (ADA): Health Implications of Dietary Fiber. J. Am. Diet. Assoc. 108:1716-1731.

Anderson JW, Hanna T J. 1999. Impact of nondigestible carbohydrates on serum lipoproteins and risk for cardiovascular disease. J. Nutr. 129:1457-1466.

Angeli JPF, Ribeiro LR, Angeli JLF, Mantovani MS. 2009. Protective effects of j3-glucan extracted from barley against benzo[a]pyrene-induced DNA damage in hepatic cell HepG2. Exp. Toxicol. Pathol. 61 :83-89.

Angeli JPF, Ribeiro LR, Bellint MF, Mantovani MS. 2006 Anti-clastogenic effect of 13-glucan extracted from barley towards chemically induced DNA damage in rodent cells Hum. Exp. Toxicol. 25:319-324.

Beer MU, Arrigoni E, Amad6 R. 1995 Effects of oat gum on blood cholesterol levels in healthy young men. Eur. J. Clin. Nutr. 49(7):517-22.

Behalf K, Scholfield D, Hallfrisch J. 2004. Diets containing barley reduce lipids significantly in moderately hypercholesterolemic men and women. Am. J. Clin. Nutr. 80:1185-93.

Behal! KM, Scholfield DJ, Hallfrisch J. 1997. Effect of beta-glucan level in oat fiber extracts on blood lipids in men and women. J. Am. Coll. Nutr. 16:46-51.

Berggren AM, Bjorck IME, Margareta E, Nyman GL. 1993. Short-chain fatty acid content and pH in caecum of rats given various sources of carbohydrates. J. Sci. Food Argie. 63:397-406.

Biorklund M, van Rees A, Mensink RP, Onning G. 2005. Changes in serum lipids and postprandial glucose and insulin concentrations after consumption of beverages with 13-glucans from oats or barley: a randomized dose­controlled trial. Eur. J. Clin. Nutr. 59:1272-1281.

Bourdon I, Yokoyama W, Davis P, Hudson C, Backus R, Richter D, Knuckles B, Schneeman BO. 1999. Postprandial lipid, glucose, insulin, and cholecystokinin responses in men fed barley pasta enriched with 13-glucan. Am J Clin Nutr 69:55-63.

Boussault P, Leaute-Labreze C, Saubusse E, Maurice-Tison S, Perromat M, Roul S, Sarrat A, Ta"ieb A, Boralevi F. 2007. Oat sensitization in children with atopic dermatitis: prevalence, risks and associated factors .. Allergy 62(11):1251-6.

Charlton KE, Tapsell LC, Batterham MJ, O'Shea J, Thorne R, Beck E, Tosh SM. 2012. Effect of 6 weeks' consumption of 13-glucan-rich oat products on cholesterol levels in mildly hypercholesterolaemic overweight adults. Br. J. Nutr. 107(7):1037-47.

Cheung NK, Modak S. 2002. Oral (1-3),(1-4)-beta-D-glucan synergizes with antiganglioside GD2 monoclonal antibody 3F8 in the therapy of neuroblastoma. Clin. Cancer Res. 8(5):1217-23.

Delaney B. 2004. Evaluation of the in vivo genetic toxicity of concentrated barley j3-glucan. Food Chem. Tox. 42(1):155-156.

Delaney B, Carlson T, Frazer S, Zheng T, Hess R, Ostergren K, Kierzek K, Haworth J, Knutson N, Junker K,

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Jonker D. 2003a. Evaluation of the toxicity of concentrated barley 13-glucan in a 28-day feeding study in Wistar rats. Food Chem. Tax. 41(4):477-487.

Delaney B, Carlson T, Zheng GH, Hess R. Knutson N, Frazer S, Ostergren K, van Zijverden M, Knippels L, Jonker D, Penninks A. 2003b. Repeated dose oral toxicological evaluation of concentrated barley 13-glucan in CD-1 mice including a recovery phase Food Chem. Tox. 41(8):1089-1102.

Daou C, Zhang H. 2012. Oat beta-glucan: Its role in health promotion and prevention of diseases. Comprehensive Reviews in Food Science and Food Safety, 11: 355-365.

Dongowski G, Huth M, Gebhardt E, Flamme W. 2002. Dietary fiber-rich barley products beneficially affect the intestinal tract of rats. J. Nutr. 132:3704-3714.

European Food Safety Authority (EFSA). 2009. Scientific Opinion on the substantiation of health claims related to beta-glucans and maintenance of normal blood cholesterol concentrations (ID 754, 755, 757, 801 , 1465, 2934) and maintenance or achievement of a normal body weight (ID 820, 823) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 7:1254.

European Food Safety Authority (EFSA). 2010. Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to oat beta-glucan and lowering blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 8(12):1885.

Food and Drug Administration (FDA) (1997). Final rule for food labeling: Health claims: Oats and coronary heart disease. Federal Register. 62: 3584-3681.

Food and Drug Administration (FDA). 2002. Food labeling: Health claims; soluble dietary fiber from certain foods and coronary heart disease. Interim final rule. Federal Register 67: 61773-61783.

Food and Drug Administration (FDA) 2005. Food labeling: Health claims; soluble dietary fiber from certain foods and coronary heart disease. Interim final rule. Federal Register 70: 76150-76162.

Food and Drug Administration (FDA). 2006. GRN 000207. Barley fiber. GRAS Notification by Cargill, Inc. http://www.fda.gov/Food/lngredientsPackaginglabeling/GRAS/Noticelnventorv/ucm153790.htm

Food and Drug Administration (FDA). 2008b. Food labeling: Health claims; soluble dietary fiber from certain foods and coronary heart disease. Interim final rule. Federal Register 73: 9938-9947.

Food and Drug Administration (FDA). 2010. Food Allergies: What You Need to Know. Food Facts. June.

Food and Drug Administration (FDA}. 201 1. GRN 000344. Barley fiber. GRAS Notification by Cargill, Inc. http://www.fda.gov/Food/lngredientsPackaqinqlabeling/GRAS/Noticelnventory/ucm258862.htm

Food and Drug Administration (FDA). 2013. GRN 000437. Oat beta-glucan. GRAS Notification by Garuda Intl. , Inc. http://www.fda.gov/Food/lngredientsPackaqinglabeling/GRAS/Noticel nventory/ucm338916. htm

Garuda International, Inc. (Garuda) 2012. GRAS Notice (GRN) No. 437, GRAS Assessment of Oat 13-Glucan - B­CAN TM Food Usage Conditions for General Recognition of Safety. Prepared for Garuda, Exeter, CA by McQuate RS and Soni MG.

Granfeldt Y, Nyberg L, BjOrck I. 2008. Muesli with 4 g oat beta-glucans lowers glucose and insulin responses after a bread meal in healthy subjects. Eur J Clin Nutr. 62(5):600-7.

Hallfrisch J, Behall KM. 1997: Evaluation of foods and physiological responses to menus in which fat content was lowered by replacement with oatrim. Cereal Foods World . 42(2):100-103.

Hallfrisch J, Scholfield DJ, Behall KM. 2003. Physiological responses of men and women to barley and oat extracts (Nu-trimX). II. Comparison of glucose and insulin responses. 80(1 ): 80-83.

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Health Canada. 2007. Celiac Disease and the Safety of Oats: Health Canada's Position on the Introduction of Oats to the Diet of Individuals Diagnosed with Celiac Disease (CD). Cat.: H164-51/2007E-PDF, ISBN: 978-0-662-46940-7.

HHS/USDA 2005. The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA). Dietary Guidelines for Americans. http://www. health. 00v/dietarvouidelines/dga2005/document/pdf/DGA2005. pdf.

Hughes SA, Shewry PR, Gibson GR, McCleary BV, Rastall RA 2008. In vitro fermentation of oat and barley derived 13-glucans by human fecal microbiota. FEMS Microbiol. Ecol. 64:482-493.

Institute of Medicine (IOM) of the National Academies. 2005. Dietary, Functional and Total Fiber. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids Washington DC. National Academies Press.

Jonker D, Hasselwander 0, Tervila-Wilo A, Tenning PP. 2010. 28-day oral toxicity study in rats with high purity barley beta-glucan (Glucagel™). Food Chem. Toxicol. 48:422-428.

Keogh GF, Cooper GJ, Mulvey TB, McArdle BH, Coles GD, Monro JA, Poppitt SD. 2003. Randomized controlled crossover study of the effect of a highly beta-glucan-enriched barley on cardiovascular disease risk factors in mildly hypercholesterolemic men. Am. J. Clin. Nutr. 78:711-8.

Keogh JB, Lau CWH, Noakes M, Bowen J, Clifton PM. 2007. Effects of meals with high soluble fiber, high amylase barley variant on glucose, insulin, satiety and thermic effect of food in healthy lean women. Eur. J. Clin. Nutr. 61:597-604.

Kim H, Stote KS, Behall, KM, Spears K, Vinyard B, Conway JM. 2009. Glucose and insulin responses to whole grain breakfasts varying in soluble fiber, 13-glucan. Eur. J. Nutr. 48:170-175.

Knudsen KE, Jensen BB, Hansen I. 1993. Digestion of polysaccharides and other major components in the small and large intestine of pigs fed on diets consisting of oat fractions rich in beta-D-glucan. Br. J. Nutr. 70(2):537-56.

Kupper C. Gastroenterology. 2005. Dietary guidelines and implementation for celiac disease. 128(4 Suppl 1):S121-7.

Liljeberg HG, Granfeldt YE, Bj6rck IM. 1996. Products based on a high fiber barley genotype, but not on common barley or oats, lower postprandial glucose and insulin responses in healthy humans. J. Nutr. 126:458-466.

Mcintosh, GH, Whyte J, McArthur R, Nestel, PJ. 1991. Barley and wheat foods: influence on plasma cholesterol concentrations in hypercholesterolemic men. Am. J. Clin. Nutr. 53: 1205-1209.

National Foundation for Celiac Awareness (NFCA). 2014. The Gluten-Free Diet. Available at http://www.celiaccentral.org/Gluten-Free-Food/the-gluten-free-diet/

Nilsson U, Johansson M, Nilsson A, Bjorck I, Nyman M. 2008a. Dietary supplementation with beta-glucan enriched oat bran increases faecal concentration of carboxylic acids in healthy subjects. Eur. J. Clin. Nutr. 62(8):978-84.

Nilsson AC, Ostman EM, Holst JJ, Bj6rck IM. 2008b. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J. Nutr. 138(4):732-9.

Othman RA, Moghadasian MH, Jones PJ. 2011. Cholesterol-lowering effects of oat 13-glucan. Nutr. Rev. 69(6):299-309.

Oliveira RJ, Ribeiro LR, Fernanda da Silva A, Matuo R, Mantovani, MS. 2006. Evaluation of antimutagenic activity and mechanisms of action of 13-glucan from barley, in CHO-kl and HTC cell lines using the micronucleus test. T oxicol. in Vitro 20: 1225-1233.

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Rashid M, Butzner D, Burrows V, Zarkadas M, Case S, Molloy M, Warren R, Pulido 0, Switzer C. 2007. Consumption of pure oats by individuals with celiac disease: a position statement by the Canadian Celiac Association. Can. J. Gastroenterol. 21(10):649-51 .

Rieder A, Samuelsen AB. 2012. Do cereal mixed-linked 13-glucans possess immune-modulating activities? Mol. Nutr. Food Res. 56(4):536-47.

Ripsin CM, Keenan JM, Jacobs DR Jr, Elmer PJ, Welch RR, Van Horn L, Liu K, Turnbull WH, Thye FW, Kestin M, et al .1992. Oat products and lipid lowering: A meta-analysis. JAMA. 267(24):3317-25.

Robertson JA, Majsak-Newman G, Ring SG, Selvendran RR. 1997a. Solubilisation of mixed linkage (1-3),(1 - >4)-13-D-glucans from barley, effects of cooking and digestion. J. Cereal Sci. 25:275-283.

Robertson JA, Majsak-Newman G, Ring SG. 1997b. Release of mixed linkage (1-3),(1-4)-13 -D-glucans from barley by protease activity and effects on ilea I effluent. Int. J. Biol. Macromol. 21 : 5 7-60.

Saulnier L, Gevaudan S, Thibault JF. 1994. Extraction and partial characterisation of beta-glucan from the endosperms of two barley cultivars. J Cereal Sci 19:171-178.

Shimizu C, Kihara M, Aoe S, Araki S, Ito K, Hayashi K, Watari J, Sakata Y, lkegami S. 2008. Effect of high 13-glucan barley on serum cholesterol concentrations and visceral fat area in Japanese men -- a randomized, double-blinded, placebo-controlled trial. Plant Foods Hum. Nutr. 63:21 -25.

Sundberg B, Wood P. Lia A, Andersson H, Sandberg AS, Hallmans G, Aman P. 1996. Mixed-linked beta-glucan from breads of different cereals is partly degraded in the human ileostomy model. Am. J. Clin. Nutr. 64(6):878-85.

Talati R, Baker WL, Pabilonia, MS, White CM, Coleman Cl. 2009. The effects of barley-derived soluble fiber on serum lipids. Ann. Fam. Med. 7:157-163.

Tiwari U, Cummins E. 2011. Meta-analysis of the effect of 13-glucan intake on blood cholesterol and glucose levels. Nutrition. 27(10):1008-16.

Tohamy AA, El-Ghor AA, El-Nahas SM, Noshy MM. 2003. Beta-glucan inhibits the genotoxicity of cyclophosphamide, adriamycin and cisplatin Mutat. Res. 541(1 -2):45-53.

What We Eat in America, NHANES 2009 - 2010

Woodward JR, Fincher GB, 1983. Water soluble barley 6-glucans. Brewers Digest: 28-32.

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CBI Deleted Copy

Petition to Add to the National List 7 CFR 205.606: Oat Beta-Fiber

APPENDIX

Appendix 1: Product Information for Oat Beta Glucan Products

Tate and Lyle:

• Product Data Sheet: PromOat® Beta Glucan

• PromOat® Beta Glucan - "The natural, heart-healthy, functional oat ingredient" - provides more detailed information about these effects. Numerous references provide supporting technical information.

• PromOat® Beta Glucan - "Give your food and beverages the goodness of oats" - provides general information on the use of oat beta-glucan in a variety of foods.

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TATE ~~~ LYLE (!} PromOat

Beta Glucan

PRODUCT DATA SHEET: PromOat® Beta Glucan

Description: PromOat® Beta Glucan is a natural soluble dietary fibre ingredient from oat grain, rich in {1 -3, 1-4} beta glucan

Appearance: Fine, cream coloured powder

Origin: 100% Swedish oat grain which is non-GMO Avena sativa, SW Kerstin variety

Label declaration recommendation: oat beta glucan/ oat bran soluble fibre/ oat fibre/ oat soluble fibre

Supply specification Beta glucan (on dry matter)

Dry matter

Value > 33% >93%

Typical 34-36% 94-95%

Method AOAC method 995.16

Nutritional Data (Values per 100g PromOat®. expressed on dry matter) Energy 315 kcal or 1319 kJ Fat 0.5 g of which saturates <0.1 g

Carbohydrate (oat maltodextrins) 56 g of which Sugars <0.5 g

Fibre (oat beta glucan) 35 g Protein (W6,25J 4 g Salt <70mg Sodium <25mg

Microbiological data Total plate count 30° cfu/g Enterobacteriaceae cfu/g S. aureus cfu/g Yeasts cfu/g Moulds cfu/g Salmonella E. coli cfu/g

Value <1000 <10 <20 <100 <100 negative I 25g negative

Method NMKL Nr 86. 1999

NMKL Nr 144, 2000

NMKL Nr 66, 3 edt. 1999 modified

IOF 948: 1990 modified

IOF 948: 1990 modified

NMKL nr 71, 5 edt. modified

NMKL nr 125 3 edt. 1996

PromOat® Beta Glucan generates pH 6-7 when dissolved or mixed in water (1 %)

Packaging: 15kg plastic tined paper sack. Bag labelling includes batch code, label declaration and best before date

Pallets: Euro pallets which hold 24 x 15kg bags of PromOat® = 360kg in total

Storage and handling: store in a clean, dry, well-ventilated warehouse at ambient emperature-amthumiditr,awayfrorrnx:lurousmaterial

Best before: 24 months after production date

' I [email protected]

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TATE r~~ LYLE

t!I PromOaf Beta Glucan

The natural, heart-healthy, functional oat ingredient PromOata::· Beta Glucan, a unique soluble bre ingredient from oats, gives your products access to the positive effects recognized for oats, including promotion of healthy cholesterol levels and healthy digestion, and a reduced glycaemic response.

Cholesterol management

Use Pron10at Beta Glucan m foods pos1t1onecl for their bene c1al effects on heart l1ealth H1gl1 blood cholesterol is a risk factor ;n the development of coronary heart disease Many clm1cal trials over the years have sl1own than oat beta glucan helps to lower blood ct1olesterol and tllereafter help maintain healthy blood ci1olesteror concentrations

In Europe EFSA and tl1e European Co1111111ss1on l1ave granted the followmg i1ea1tt-1 c laim for oat beta giucan. Oat beta glucan has been si1own to lower, reduce blood cholesterol Hrgh cholesterol is a risk factor 111 the developrnent of coronary heart disease

Blood Glucose management

Use PromOat Bela Glucan 111 foods intended to help maintain healthy blood glucose levels Oat beta glucan has a low glycaern1c response In add1t1on research indicates that oat beta gtucan when consumed w 1tr1 meals. may help marntarn healthy btood glucose levels after the meal

In Europe EFSA and the European Comrrnss1on have granted the following 1ealtt1 cia1m for oat beta glucan Consurnpt1on of beta gfucans from oats as part of a meal contributes to a reduction of tt1e blood glucose rise after that meal

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TATE ~~~ LYLE

Give your food and beverages the goodness of oats PrornOat Beta Glucan is a gently-produced natural component of wholegra111 Swedish oats w ith the associated t·1ealth benefits of oats

And heres more good news tl11s urnque beta glucan soluble fibre is clean on taste and neutral on colour and makes a versat1 e functional ingredient for foods and drinks

Pr m ff n h n

Clean tasie neutral colour no gra1n1ness PrornOa1 Bela G!ucan 1s produced as a creamy white neutral-tast111g j)Owder U1at in tegrates eas ly into your recipes

Soluble

Soluble and clean-tas ting PromO,:i1 is idea! 111 beverages w !1ere 11 can also contniJute rnou thfeel ;;incl smoothness

Stabilizer anct viscosity rnod1 er

PrnmOat rias strong wat.::r-l)1nd111g ,'!nd e111uls1'y ng o•Dpe1tres It t:11ckens and stabilizes creamy emu!s1o'ls crem1»9 a s111ooth tex ture and indulgent crea.ny r11outl1feel in reduced fm p<odJcts

l ;norov•':r.! sneli-rff: fc: your prcdtJcts

FmrnOat no; op1y aCJds o,x!y to rf'd,iced fat •nL,ff111s or c;~kes 1! aiso •mprcves shelf life due to •ri1prcved 111o:s< c1re niar:agen~ent

E«sy 10 LI Se easy to lnndle

Pro1110at Beta G!ucan 1nrer,rales ea~ 1ty 111 111a;~uf;:ic1u11ng co:1d•t!ons Pron10a' 1s ac;o and '1eat Si able E·nal)hng its u:;e 11" a w·ae variety o' 1ndustrtat orocesses

l!l PromOat Beta Glucan

ff llin 0 n

Health Claims 1n many countries 111cll1cl1ng the EU

With a beta glucan conten t as h1gl1 as 35°!. PromOat Beta GiLrcan makes 11 easy to achieve the d aily c!osages requ1recl for ileal!h c laims

Natu1 a l Clean Label lngrechent

PromOat Beta Glucan can be used 111 your naturally pos1t1oned and clean l;;ibel products To niake Prorn081 we use 111gh qualrty rocalty

sourced non·GM Swecllsh oats and we don t add any c hemicals during processing In the EU PromOat 1s labelled as oat beta q lucan or oat bran hbre

1--1.9!1 i::1bre or Source of F•bre .::1a1'11s

1Nil11 P'O•POat you can !~cos: y0ur products frbre con1e111 a•1r! 111ore easily ac1~1eve f'ont-of-pack c1a1nis icr i1bre l1l•'rit1011

Rec!ucec !'"at and Calo r,es

ProniOat can he1n c<eate ~'' or1e-red ,JCe\".1 'e:::1pes for 11ldll'gen; 11rct1~.Jcts Its unique rnoisu,re tnr~cJ1ng ano 1exiunz1ng proper?ies a::lY..v P1omO;:;t :o be used to replace some of the fat 1ri recipes wi thout affecung the great rnste oi tl1e proc! ucts

May be su:>a!)1e lor yluter:-freE- c·oeiuc:s

ProniOat Bete Giuc;in can 11et~1 you create gtuten-frt;e o•ocluc1s sri you can offe:· consurr:ers rnore cno:ce Poss1b1li11es ior gluten-Ire.;; pos1t1on1ng a:e deperoe;1! 0·1 the recipe and the level of use

This data is pIOv1ded 111 good faith for your 1nformat1on Customers shOuld take t11e1r own advice with regards to all legal and regulatory aspects of our food 1ngred1ents and their usage for human consumption and the poss1b1hty to make a ·natural claim 111 their market Tate & t.yle ci ccepts no respons1b1hty for the vahd1ty of the clauns set above

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CBI Deleted Copy

Petition to Add to the National List 7 CFR 205.606: Oat Beta-Fiber

APPENDIX

Appendix 2: Stepwise Process for Manufacture of PromOat® Oat Beta Glucan

Confidential Business

Information \ (CBI)

Deleted

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CBI Deleted Copy

Petition to Add to the National List 7 CFR 205.606: Oat Beta-Fiber

APPENDIX

Appendix 3: GRAS Determination of Oat Beta Glucan for Use in Food

Submitted by: Tate & Lyle, September 5, 2014

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GRAS Determination of Oat Beta-Glucan for Use in Food

SUBMITIED BY:

Tate&Lyle 5450 Prairie Stone Parkway Hoffman Estates, IL 60192

SUBMITTED TO:

U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition

Office of Food Additive Safety HFS-200

5100 Paint Branch Parkway College Park MD 20740-3835

CONTACT FOR TECHNICAL OR OTHER INFORMATION

TATE & LYLE CONFIDENTIAL

Donald F. Schmitt, MPH ToxStrategies, Inc.

739 Thornapple Drive Naperville, IL 60540

September 5, 2014

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Table of Contents

1.0. GRAS Exemption Claim ............................................................................................... 5

2.0 Description of Substance ............................................................................................ 8 A. Identity .......................................................................................................................................... 8 B. Common N-ame ............................................................................................................................ 8 C. Formal/Chemical Names ......................................................................................................... 8 D. Trade Names ............................................................................................................................... 8 E. Chemical/Structural Formulas ............................................................................................. 8 F. Manufacturing Process ............................................................................................................. 9 G. Product Specifications ........................................................................................................... 11 H. Stability Data for Oat P-Glucan ........................................................................................... 13

3.0 History of Use/Regulatory Approval of Oat fl-Glucan .................................... 13

4.0 Intended Use and Estimated Intake (EDI) ......................................................... 15

5.0 Safety ............................................................................................................................... 16 A. Introduction ............................................................................................................................... 16 B. Safety Data .................................................................................................................................. 16 1. Absorption, Distribution, Metabolism, and Excretion (ADME) ............................... 17

Animal studies .................................................... ........................................................................................ 17 Human studies ................................................................................................. ..................................... ...... 17

2. Toxicological Studies .............................................................................................................. 18 Animal Studies ........................................................................................................................................... 18 Short-term studies ................................................................................................................................... 18 Genotoxicity ........................................... ...................................................................................................... 20

3. Human Studies on Beta-Glucan ........................................................................................... 21 Studies of the Cholesterol-Lowering Effect of Beta-Glucan ............................................... 22 Studies of the Modulation of Blood Glucose and Insulin by Beta-Glucan .................. 26 Studies of Immune-Modulating Effects of Beta-Glucan ....................................................... 29 Additional Protective Effects of Beta-Glucan ............................................................................ 29 Tolerance Studies in Human Volunteers ..................................................................................... 30 Interaction with Nutrient Absorption ........................................................................................... 30 Allergenicity ..................................... .. ......................................................................................................... 31

6.0 Basis for the GRAS Determination ........................................................................ 34 A. Introduction ............................................................................................................................... 34 B. Safety Determination ............................................................................................................ 34 C. General Recognition of the Safety of Oat-Beta-Glucan ................................................ 35

7.0 References ...................................................................................................................... 38

8.0 Appendices ....................................................................................................................... 44

Appendix A. Certificates of Analysis - Characterization ......................................... 45

Appendix B. Technical Product/Data Sheets ............................................................... 54

Appendix C. Stability Test Results ................................................................................... 58

Exhibit I. Report of the Expert Panel .............................................................................. 60

TA TE & LYLE CONFIDENTIAL 2

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List of Acronyms

ADME AUC BMI bw B-G c cGMP CAS CFR CHO CI COA CT CVD dL DNA DRY EFSA EU FDA g GI GLP GMO GMP GRAS GRNs h HDL IgG lgM IOM IP IU IV JHCI kDa kg L LDL mg mL mmol Mo Ab

absorption, distribution, metabolism, and excretion area under the curve body mass index body weight beta-glucan centigrade current Good Manufacturing Practice Chemical Abstracts Service Code of Federal Regulations coronary heart disease confidence interval certificate of analysis computed topography cardiovascular disease deciliter deoxyribonucleic acid dietary reference value European Food Safety Authority European Union Food and Drug Administration gram gastrointestinal Good Laboratory Practice genetically modified organism Good Manufacturing Practice Generally Recognized as Safe Generally Recognized as Safe Notifications hour high-density lipoprotein immunoglobulin G immunoglobulin M Institute of Medicine intraperitoneal International Units intravenous United Kingdom Joint Health Claims Initiative kilodalton kilogram liter low-density lipoprotein milligram milliliter millimole monoclonal antibody

TA TE & LYLE CONFIDENTIAL 3

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PO SCFA TEF TGL/TAG ug us VLDL WMD

per oral short-chain fatty acid thermic effect of food triglyceride/triacylglycerol microgram United States very low-density lipoprotein weight mean difference

TATE & LYLE CONFIDENTIAL 4

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1.0. GRAS Exemption Claim

A. Name and Address of Notifier

Tate & Lyle, through its agent ToxStrategies, Inc., hereby notifies the Food and Drug Administration that the use of the identified oat P-glucan product described below and which meets the specifications described herein is exempt from pre-market approval requirements of the Federal Food, Drug, and Cosmetic Act because Tate & Lyle has determined that such use is generally recognized as safe (GRAS) through scientific procedures.

Donald F. Schmitt, M.P.H. Senior Managing Scientist ToxStrategies, Inc. Agent for Tate & Lyle

B. Name of GRAS Substance

Date

The name of the substance that is the subject of this GRAS determination is Prom Oat® Beta-Glucan, a P-glucan from oat bran.

C. Intended Use in Food

Oat-derived p-glucans are intended for use as a source of dietary fiber for general addition to all foods except infant formula and meat and poultry products. It will be added to the same foods at per serving levels as identified in the oat and barley p-glucan GRAS Notification submissions to the U.S. FDA (all received "no objection letters", GRNs 207, 344, and 437). The amount used will not exceed the amount reasonably required to accomplish its intended technical effect.

D. Basis for GRAS Determination

This Assessment documents the evidence of the safety and the "Generally Recognized As Safe" (GRAS) status of the proposed uses of Tate & Lyle's oat-derived P-glucan product (Prom Oat®). It consists of an evaluation of the safety and the GRAS status of the proposed uses of this ingredient, and the conclusion by a panel of experts (Expert Panel) qualified by scienti fie training and experience to evaluate the safety of substances added to food that the proposed uses of Tate& Lyle's P-glucan ingredient are safe and GRAS as determined by scientific procedures.

Tate & Lyle's GRAS determination for the intended use of oat-derived P-glucan is based on scientific procedures as described under 21 CFR § l 70.30(b ). The intended use of the oat p-glucan preparation has been determined to be safe, and Generally Recognized as

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Safe (GRAS) and the safety of intake exposure under the proposed conditions of use is based on knowledge and information that is both publicly available and widely accepted by experts qualified by scientific training and experience to evaluate the safety of substances in food. The publicly available safety data combined with the widely disseminated knowledge concerning the chemistry of P-glucan from various sources such as oats, barley, and yeast combined with the long history of approval/use of such ingredients provide a sufficient basis for an assessment of the safety of oat-derived P­glucan for the uses proposed herein.

To date, the FDA has issued "no questions" letters in response to five Generally Recognized As Safe (GRAS) Notifications (GRNs) on p-glucan preparations from various sources (FDA, 2006, 2008a, 2010, 20 I I , 2013). Jn addition to containing reviews of the published safety information, the GRNs included expert panel reports that reviewed and discussed in detail the metabolism, toxicology, and human health and safety data for P-glucan. Based on these GRAS notifications, FDA currently permits the use of P-glucan preparations from a variety of sources at the use-levels indicated in the notifications.

As noted in the GRNs cited above, there is a long history of safe use of oats and products derived from oats such as oat P-glucan concentrates. Other natural sources of P-glucan concentrates such as barley have been safely consumed for decades. In addition, P­glucan is not absorbed to any significant degree because of its large molecular size. While there is a noted lack of published safety studies of oat P-glucan concentrates, the safety section herein describes numerous animal and human safety studies of barley P­glucan which is similar to oat P-glucan, as both contain polysaccharides of unbranched, linear, mixed-linkage ( I-3)( I-4)-P-D-glucan. These studies support the safe use of oat P­glucan for the proposed uses.

The focus of this GRAS self-determination is for an identical general food use of oat­derived P-glucan (excluding infant fo rmula, medical foods, and meat and poultry) as current barley- and oat-derived p-glucan products as described in ORN 207, 344, and 437 (FDA, 2006; FDA, 201 1; FDA, 20I3). Cargill, in GRAS Notification 344, estimated the combined average intake of barley betafiber by consumers from all uses of barley betafiber (i.e., general food use and meat and poultry) would be 12.4 g/person/day (8.7 g P-glucan/person/day). The 901

h percentile intake was estimated to be 23.5 g/person/day ( 16.5 g P-glucan/person/day). Cargill stated that barley betafiber would be added to food at levels of 4.3 g/serving, resulting in approximately 3 g of P- glucan/serving. Given the lower level of p-glucan (approximately 35%) in Tate & Lyle's PromOat® product, the estimated intake of P-glucan from the proposed uses of Tate & Lyle's product will be lower by approximately 50% (i.e., 4.35 and 8.25 g p-glucan/person/day for the mean and 901

h percentile, respectively). While Tate & Lyle's PromOat® product could be added at a higher per serving level, the use of oat P-glucan in this manner is considered to be self­limiting for technological reasons such as product texture and/or flavor profile. In addition, since use in meat and poultry is not being considered as part of this GRAS Notification, the resulting estimated intake will be less than the current GRAS oat- and barley-derived P glucan products that were the subject of GRN Nos. 207, 344, and 437.

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In summary, the proposed uses of PromOat® will not result in an increase in the overall consumption of p-glucan, but simply provide an alternative source of P-glucan for use in food.

Numerous studies have been conducted and published in support of the evaluation of the safety of barley P-glucan, including in vitro and in vivo animal studies as well as clinical studies in humans. While there is a lack of published preclinical safety studies on oat P­glucan, products containing oat p-glucan concentrates have been employed in numerous clinical trials. Other than mild, transient gastrointestinal (GI) effects such as flatulence and abdominal discomfort, no significant adverse effects were noted. It should be noted that these GI effects commonly occur following a shift from a low- to high-fiber diet. Evaluation of the possible effects of oats, cereal fiber and/or P-glucan on mineral absorption and allergenicity have also been considered by the U.S. FDA and the European Food Safety Auth01i ty (EFSA) and found not to present a significant safety concern as consumed as part of the normal diet.

Determination of the safety and GRAS status of this oat-derived P-glucan preparation described above for direct addition to food under its intended conditions of use was made through deliberation of an Expert Panel consisting of Michael Carakostas, DVM, Ph.D., Carol A. Knight, Ph.D., and Stanley M. Tarka, Jr., Ph.D, who reviewed a dossier prepared by ToxStrategies as well as other information available to them. These individuals are qualified by scientific training and experience to evaluate the safety of food and food ingredients. They individually and collectively critically evaluated published data and information pertinent to the safety of oat-derived P-glucan, and unanimously concluded that the intended use of oat P-glucan in food, produced consistent with cGMP and meeting appropriate specifications, as delineated above is "generally recognized as safe" ("GRAS") based on scientific procedures.

E. Availability of Information

The data and information that serve as the basis of this GRAS determination, as well any information that has become available since the GRAS determination, will be sent to the FDA upon request, or are available for the FDA's review and copying at reasonable times from ToxStrategies, Inc., Naperville, IL.

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2.0 Description of Substance

A. Identity

Oat P-glucan (beta-glucan) is a natural soluble dietary fiber ingredient derived from oat grain and is rich in { 1-3, 1-4} P-glucan.

B. Common Name

Oat P-glucan.

C. Formal/Chemical Names

The chemical names and synonyms for oat p-glucan include the fo llowing:

• p-D-glucan • (1 -3),(1-4)- P-D-glucan • P-D-glucosylglucan

The Chemical Abstracts Service (CAS) Registry Number for P-D-glucans of any origin is 904 1-22-9 (i.e., barley, oat, mushroom and yeast). The CAS number for the mixed­linkage (1-3),(1-4)- P-D-glucan is 55965-23-6.

D. Trade Names

The trade name of Tate & Lyle's oat p-glucan is PromOat® or PromOat® Beta Glucan.

E. Chemical/Structural Formulas

Oat P-glucan consists of polysaccharides of unbranched, linear, mixed-linkage (1 -3),(1 -4)- P-D-glucans. Oat and barley derived P-glucans contain approximately 70% (1-4) linkages and 30% (1 -3) linkages (Woodward and Fincher, 1983; Saulnier et al., 1994; FDA, 201 1; FDA, 2012). Typically, blocks of three or four ( 1-4)-linked p-glucosyl units are connected by (1-3) linkages. Oat-derived P-glucan appears to consist of higher tetrasaccharide and fewer trisaccharide building blocks and may have a higher molecular weight than P-glucan from barley. Furthermore, wheat-derived P-glucan contains an even greater amount of trisaccharides compared to barley-derived P-glucan. In other words, the composition of p-glucans from oat, barley, and wheat form a continuum (FDA 2011, 2012). However, the respective differences are rather small and are unlikely to produce physiological differences (FDA, 2011; FDA, 2012).

The molecular formula for P-D-glucan is (C6H1o0s)n and the molecular structure can be

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found below.

The molecular weight or the oat B-glucan present in commercially available processed food preparations ranges from about I 00 kDa to 2000 kDa (EFSA. 20 I 0). The finished product \Veight-avcrag.e molecu lar v-.-C'ight of PromOat® is 2,000 kDa.

F. Manufacturing Process

Tate & Lyle 's PromOat® product that is the subject ofthis GRAS self-determination is manufactured in a two-step process. It is manufactured fo llowing current Good Manufacturing Practice ( cGMP ) for food (21 CFR Part 110). The first-step is a dry mill process in which the oat grain is dehulled (husk and most of endosperm separated) and milled to specifications. The final output of the dry milling process is oat bran, which is employed in the second processing step, a wet process. In the wet fractionation process, the oat bran is mixed with water and food use-approved enzymes from non-GMOs (genetically modifi ed organisms) at specified temperatures. The mixture is passed through physical separation procedures and sterilized. The process output is insoluble fiber, protein, oat oil, maltodextrin (approved in 21 CFR § 184.1444 ), and oat soluble fiber rich in P-glucan. The maltodextrin and oat soluble fiber (35% P-glucan) components comprise the PromOat® product (see Step 2 below).

A flow diagram of Tate & Lyle's manufacturing process can be found below.

Step 1. Dry Process

Input

Oat Grain

Step

Dehulling

Mill ing

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Output

Hull

Flour

Bran

9

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Step 2. Wet Process

Input Step Output

Bran Mixing Chamber

Water

Enzymes

Decanter 1 Oat Fiber Insoluh le

Sterlilizing

Decanter 2 Protein & Oil (50%protein)

Separator Maltodextrin

Soluble fiber (35% B-G)

Drying Prom Oat™ Oat soluble fiber

Packing

Reagents/processing aids used in the manufacture of oat ~-glucan are limited to water and the enzyme alpha-amylase which is commonly used in food ingredient manufacturing processes. No chemical processing aids are employed in Tate & Lyle's manufacturing process. The alpha-amylase enzyme preparation employed in the process is GRAS per

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21 CFR § 184.1012, complies with Food Chemical Codex specifications, and is used at levels not to exceed current good manufacturing practice.

G. Product Specifications

Food grade specifications for Tate & Lyle's oat P-ilucan (PromOat®) are presented in Table 1. The typical P-glucan content of Prom Oat is 33-36% on a dry matter basis. PromOat® is a fine, cream-colored powder. Analytical results from three non-consecutive lots are provided in Appendix A. A comparison of three non-consecutive lots of ~-glucan to the specifications below can be found in Table 2.

Table 1. Specifications for Oat Beta-Glucan (PromOat®)

Parameter (Assay Method) S pecifica tio n

Physical Characteristics Appearance (Visual) Fine, cream colored powder

Moisture (IDF Standard 4A 1982) Typically, 4-6% on a dry basis

P-D-glucan (AOAC 995.16) 33-36%, on a dry basis

Heavy Metals*

Lead (NMKL No 161 1998) :SO.I ppm

Arsenic (NMKL No 161 1998) :SO.I ppm

Cadmium (NMKL No 161 1998) :::; 0.1 ppm

Mercury (NMKL No 161 1998) :SO.I ppm

Microbiological Analyses

Total plate count (NMKL No 86 1999) <1000 cfu/g

Enterobacteriaceae (NMKL No 144 2000) <I 0 cfu/g

Staphylococcus aureus (NMKL No 66, 3 ed, 1999 modified) <20 cfu/g

Yeasts (IDF 948; 1990 modified) <100 cfu/g

Molds (IDF 948; 1990 mod ified) <100 cfu/g

Salmonella (NMKL No 71, 5 ed, mod ified) Negative/25g

E.coli (NM KL No 125, 3 ed, 1996) Negative

* It should be noted that heavy metals levels are not routinely reported on COAs (see Appendix A), but are documented in routinely conducted analytical reports which are a lso included in Appendix A.

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Table 2. Analytical Results for 3 Lots of Oat Beta-Glucan (Prom Oat®)

Specification Lot No. Lot No. Lot No. 1326 1344 1411

~-0-glucan 33-36%, on a dry basis 34.0 35.0 34.0

Moisture 4-6%, on a dry basis 5.3 5.7 6.0

Heavy Metals*

Lead $0.1 ppm <0.020 <0.020 <0.020

Arsenic $0.1 ppm <0.010 <0.010 <0.010

Cadmium $0.I ppm <0.050 <0.050 <0.050

Mercury $ 0.1 ppm <0.020 <0.020 <0.020

Microbiological Analyses

Total plate count <1000 cfu/g <500 <600 <100

Enterobacteriaceae <10 cfu/g <10 <1 0 <10

Staphylococcus aureus <20 cfu/g <20 <20 <20

Yeasts <100 cfu/g <60 <20 <20

Molds <100 cfu/g <80 <80 <20

Salmonella Negative/25g Neg/25g Neg/25g Neg/25g

E.coli Negative Negative Negative Negative

* Heavy metals levels are not routinely reported on COAs (see Appendix A), but are documented in routinely conducted analytical reports which are also included in Appendix A.

Typical compositional and nutritional analyses of Tate & Lyle's PromOat® product containing 33-36% ~-glucan are presented in Table 3.

Table 3. Nutritional Analyses of Prom Oat®

Nutrient Amount

Calories (kcal) 3 15

Protein (g/1 OOg) 4.0

Total fat (g/I OOg) 0.5

Saturated fat (g/ I OOg) <0.1

Carbohydrate (oat maltodextrins) (g/ I OOg) 56

Total Dietary Fiber (g/l OOg) 36-38

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Soluble Fiber (g/1 OOg) 35

Sugars (g/lOOg) <0.5

Iron (mg/kg) 3.2

Sodium (mg/I OOg) <25 mg

Cholesterol (mg/ I OOg) <1.0

Calcium (mg/kg) 90

Vitamin A Retinol (IU/1 OOg) <50

Vitamin C (mg/lOOg) <1.0

The analytical (chemical and microbiological) results for oat ~-glucan summarized in the above tables and included in the COAs and Technical Data Sheets in Appendices A and B confirm that the finished product meets the analytical specifications, demonstrates that the PromOat® manufacturing process results in a consistently reproducible product, and confirms the lack of impurities/contaminants (e.g., heavy metals, pesticides, microbiological toxins).

H. Stability Data for Oat P-Glucan

Tate & Lyle's oat ~-glucan product PromOat® meets the above analytical specifications. Stability testing of Prom Oat® has been conducted at room temperature, 0°C, and 40°C for up to 18 months. After an 18-month storage period under a variety of storage conditions, PromOat® was found to be stable in terms of protein content, dry matter, ~-glucan content, molecular weight, pH, appearance, color, smell, taste, volumetric weight (density), and microbiological parameters. Stability test results can be found in Appendix C.

3.0 History of Use/Regulatory Approval of Oat ~-Glucan

There is common knowledge of a long history of human consumption of oats. Oats have been cultivated around the world for more than 2000 years. The U.S. , Germany, Russia, Canada, France, Finland, Poland, and Australia are the largest producers of oats (FDA, 2012). Numerous food products containing oats are currently marketed in the U.S. and around the world. Oat fiber has become a desirable ingredient for addition to a variety of food products as a source of dietary fiber.

Epidemiological studies and clinical trials have consistently revealed that fiber-rich diets are associated with significant reductions in cardiovascular disease risk. While there is no established dietary reference value (DRY) for soluble fiber, the amount of soluble fiber in a typical mixed diet is one-fourth to one-third of the total dietary fiber intake (ADA, 2008; FDA, 2102).

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Dietary Guidelines for Americans (HHS/USDA, 2005) recommend that adults eat half their grains as whole grains, which include oats and wheat. Adequate intake recommendations for adults (:S 50 years of age) are 38g total dietary fiber/day for men and 25g total dietary fiber/day for women (TOM, 2005). For adults greater than 50 years of age, IOM recommends 30 g/day and 21 g/day for men and women, respectively. The guidelines also note that most Americans need to increase their intake of dietary fiber (USD/DHHS, 2005). The daily reference value for dietary fiber is 25 g for a 2000 calorie diet per 21 CFR § 101.9(d).

Oat P-glucan is found in the cell walls of oa~ kernels. Beside oats, p-glucan is consumed from other cereals and edible plants such as barley, rye, and wheat. Oat-derived p-glucan concentrates (e.g., Oatrim with a P glucan content of up to 10% and OatVantage™ with 54% P-glucan) are marketed in the United States and have GRAS status (FDA, 2011; FDA, 2013). Quaker Oats self-determined the GRAS status of Oatrim in 1992 (FDA, 2011). As described in GRAS Notification No. 437 (FDA, 2012), the GRAS status of Oatrim was supported by several factors including: 1) Oatrim's similarity to oat starch and maltodextrin (food ingredients with a known safety use profile), 2) the enzymatic manufacturing process was analogous to the biological digestion of starch by humans, and 3) short-term toxicity studies and safety evaluations of Oatrim' s constituents did not reveal any areas of concern (FDA, 2011; Garuda, 2012). OatVantage™ has similarly been on the market for l O+ years and no safety concerns have been reported.

The U.S. FDA and European Food Safety Authority (EFSA) have reviewed the association of soluble fiber from oats and the reduced risk of heart disease (21 CFR § 101.81) (62 FR 3584, January 23, 1997) and/or the maintenance of normal blood cholesterol concentrations (EFSA 2010). As described in Garuda's GRN No. 437 (Garuda, 2012), in October 2002, in response to a petition jointly filed by the Quaker Oats Co. and Rhodia, Inc., FDA (2002) amended the 1997 health claim for soluble fiber from rolled oats to add an additional eligible source of whole oat p-glucan soluble fiber, the soluble fraction of a -amylase-hydrolyzed oat bran or whole oat flour with a P-glucan soluble fiber content at levels up to 10%. The agency concluded, based on the publicly available scientific evidence that---in addition to rolled oats, oat bran, and whole oat flour- the soluble fraction of a-amylase-hydrolyzed oat bran or whole oat flour with a P­glucan content up to 10% and not less than that of the starting material is an appropriate source of P-glucan soluble fiber for the health claim. Regarding safety, the petitioners detem1ined their product to be GRAS, and the basis of the safety determination for their products (containing up to 25% p-glucan) was the similarity to other existing cereal adjuncts, such as pre-cooked flours, pre-cooked bran, and starches. Following its review, FDA concluded that the petitioners satisfied the preliminary requirement of 21 CFR § 10 l .14(b )(3)(ii) to demonstrate to FD A's satisfaction that the use of Oatrim, as described previously, is safe and lawful as a food ingredient at levels necessary to justify the health claim (FDA 201 1).

The FDA has also authorized a health claim for soluble fiber from whole grain barley and barley-containing products and coronary heart disease ("CHD") (21 CFR § I 01.81)

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(FDA, 2005). In August 2008, FDA published a final regulation authorizing barley betafiber as an eligible source of soluble fiber for this health claim (FDA, 2008b ). Barley soluble fiber-containing foods must provide at least 0.75 g of P-glucan soluble fiber per serving of the food. In 2008, the agency published a final regulation on the health claim regulation entitled "Soluble fiber from certain foods and risk of coronary heart disease (CHO)" to add barley betafiber as an additional eligible source of P-glucan soluble fiber. In support of the safety of barley-derived P-glucan (2::70%), the petitioner determined that its product was GRAS for the proposed uses. FDA also received two GRAS notices, ORN 207 and 344 (FDA 2006; 2011) on this subject and issued letters stating that the agency had "no questions" about the GRAS determination under the intended conditions of use.

EFSA also authorized a health claim regarding the maintenance of normal blood cholesterol concentrations for soluble cereal fibers, particularly P-glucan from oats (EFSA, 20 I 0). In an opinion on the scientific substantiation of a health claim related to oat p-glucan and lowering of blood LDL and total cholesterol, the EFSA Panel concluded that a cause and effect relationship has been established between the consumption of oat p-glucan and lowering of blood LDL-cholesterol concentrations. For support of the health claim~ the Panel recommended that foods should provide at least 3 g of oat ~-glucan/day. In a previous health claim approval, EFSA (2009) also agreed to the following claim for P-glucan: maintenance of normal blood cholesterol concentrations and maintenance or achievement of a normal body weight.

To date, FDA has reviewed two GRAS Notifications of P-glucan from barley (FDA, 2006; FDA, 2011) and one from oats (FDA, 2013). Extensive published information and data on p-glucan were submitted. All of the GR.AS notifications received "no questions" letters from the FDA. Tate & Lyle considers the information and study data described in these cited notifications as directly applicable to this notification. Furthennore, P-glucan derived from oats or barley contains polysaccharides of unbranched, linear, mixed­linkage ( 1-3 ), ( 1-4 )-P-D-glucan, and from a physiological perspective, there is virtually no difference. Thus, from a safety perspective, the available studies of barley P-glucan and the studies described in GRNs 207, 344, and 437 are applicable to the safety assessment of oat P-glucan. No recent studies raising any new safety concerns have appeared in the published literature subsequent to these evaluations, particularly the most recent GRAS notice GRN 437.

4.0 Intended Use and Estimated Intake (EDI)

Estimated intake

The focus of this GRAS self-determination is for an identical general food use of oat­derived p-glucan (excluding infant formula, medical foods, and meat and poultry) to the current barley- and oat-derived p-glucan products as described in ORN 207, 344, and 437 respectively (FDA, 2006; FDA, 2011; FDA, 2013). Cargill, in GRAS Notification 344, estimated the combined average intake of barley betafiber by consumers from all uses of

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barley betafiber (i.e., general food use, and meat and poultry) would be 12.4 g/person/day (8.7 g p-glucan/person/day). The 901

h percentile intake was estimated to be 23.5 g/person/day (16.5 g P-glucan/person/day). Cargill stated that barley betafiber would be added to food at levels of 4.3 g/serving, resulting in approximately 3 g of P­glucan/serving. Given the lower level of P-glucan (approximately 35%) in Tate & Lyle's Prom Oat® product, the estimated intake of p-glucan from the proposed uses of Tate & Lyle's product will be lower by approximately 50% (i.e., 4.35 and 8.25 g p-glucan/person/day for the mean and 901

h percentile, respectively). In addition, since use in infant formula, medical foods, and meat and poultry is not being considered as part of this GRAS Notification, the resulting estimated intake will be less than the current GRAS oat- and barley-derived p glucan products that were the subject of GRN Nos. 207, 344, and 437. In summary, the proposed uses of Prom Oat® will not result in an increase in the overall consumption of p-glucan, but simply provide an alternative source of P­glucan for use in food. Therefore, cumulative intake analysis is not considered necessary.

Self-limiting use

While Tate & Lyle's PromOat® product could be added at a higher per serving level, the use of oat p-glucan in this manner is considered to be self-limiting for technological reasons such as product texture and/or flavor profile.

5.0 Safety

A. Introduction

Tate & Lyle currently markets oat p-glucan (Prom Oat®) outside of the U.S. Both EFSA and the U.S. FDA have reviewed the safety of oat P-glucan and other cereal p-glucan sources, such as barley, and found their use to be safe based upon the avai lable animal, in vitro, and human safety data. The published data, as well as reviews conducted by regulatory agencies, support the conclusion that p-glucan, and in particular oat-derived P­glucan, is safe for use as a human food ingredient.

B. Safety Data

Beta-glucan from a variety of sources including barley and oats has been the subject of numerous published scientific evaluations and regulatory reviews (e.g., FDA, 2006, 2008a, 20 I 0, 20 I l , 20 I 3; EFSA, 20 I 1 ) . These data and regulatory submissions form the basis of the safety summary presented below and are considered directly applicable to this GRAS notification. The available animal and human metabolism and safety/toxicity information indicate that p-glucan from all sources will be similarly metabolized/handled by the body following consumption.

A summary of the most relevant studies on P-glucan metabolism and toxicity along with cl inical and epidemiological studies is presented below.

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I. Absorption, Distribution, Metabolism, and Excretion (ADME)

Oat p-glucan is a dietary fiber and is resistant to digestion by mammalian enzymes, passing into the large intestine mostly intact once ingested (IOM, 2005). While the fermentation quality of dietary fibers range widely in the large intestine, soluble fiber, such as P-glucan, is highly fermentable by bacteria in the colon to carbon dioxide, methane, hydrogen, and short-chain fatty acids (SCFAs) (IOM, 2005). Several studies in animals and humans characterizing the degradation of p-glucan in the gastrointestinal tract are reported below.

Animal studies

Berggren et al. (1993) examined cecal SCFA content, cecal pH, fermentability, and dry matter digestibility in Wistar rats fed diets containing different nondigestible components including barley p-glucan. The authors reported that P-glucan was highly fermentable (>90%) and resulted in one of the largest pool sizes of short-chain fatty acids. p-glucan (as well as oat bran) diets were associated with low dry matter digestibility (- 93%) compared to the other diets. Knudsen et al. ( 1993) studied the effect of oat P-glucan on digestion and metabolism of polysaccharides in ileum-cannulated pigs (n=4/group) using diets containing 22-76 g/kg oat P-glucan. Digestibility of p-glucan was 17-31 % in the ileum and 100% in the feces.

Dongowski et al. (2002) demonstrated very high fermentability of p-glucan in male rats. Animals were fed a control diet for 1 week followed by 1 of 4 barley diets (groups A-D) or the control diet for 6 weeks (n= 10/group; 5 groups total). The control diet contained 0.03% ~-glucan and 0.45% resistant starch, and the 4 test diets contained various amounts of p-glucan (-4-6%) and resistant starch (-4-12% ). p-glucan was detected in stomach and small intestine contents, at much lower concentrations in the cecum and colon contents, but not in the feces, indicating complete fermentation. Rats on barley test diets also had significantly higher concentrations of SCF As in feces compared to controls.

Human studies

Robertson et al. (l 997a) evaluated the effect of barley-based flapjacks (5.6 g ~-glucan, of which 1.6 g was soluble) on the ilea! contents of ileostomy patients. Ileal contents recovered after 12 hours contained 3 .64 g p-glucan, approximately 65% of what was consumed. The ileal P-glucan was approximately 60% soluble, an increase from the test meal (- 28%), indicating that solubility increased with passage through the small intestine. The authors indicated that this was likely due to digestive activities of proteolytic enzymes on the barley product, which was further supported by tests in vitro. Additionally, the authors reported that the proportion of lower molecular weight P­glucans was likely increased in the ileal contents. Robertson et al. (1997b) conducted a similar study, with findings consistent with Robertson et al. (1997a), showing that "unextractable" ~-glucans in barley can be solubilized in the upper gut and serve as a source of dietary fiber.

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Sundberg et al. ( 1996) likewise showed that there is a depolymerization of P-glucan as it transits through the upper gastrointestinal tract. In this study, 9 ileostomy patients received 4 different diets, in random order, which differed only in the type of bread: oat bread, oat bread with p-glucanase ("enzymatic oat"), barley bread, or wheat bread corresponding to P-glucan intakes of approximately 12.5, 4, 12. 9, or 1.1 g, respectively. In the oat, enzymatic oat, and barley breads, about 50% of p-glucan was soluble. In those consuming oat or barley breads, 81 -87% of p-glucan intake was excreted in ileal samples whereas individuals eating enzymatic oat and wheat breads had excretions of 58 and 36%, respectively. The peak molecular weight of the p-glucan excreted from individuals consuming the oat bread was notably lower than the p-glucan in the original oat bread indicating that depolymerization was taking place. However, the authors also noted that degradation was known to occur in the ileostomy bags, and so care should be taken when interpreting these results.

Hughes et al. (2008) evaluated the fermentation of barley and oat p-glucans by human fecal microbiota in vitro. Three barley-derived p-glucan fractions (average molecular weights of243, 172, and 137 kDa) and two oat-derived p-glucan fractions (average molecular weights of230 and 1 SO kDa) were added to human fecal samples in pH­controlled anaerobic batch culture fermenters and SCF As and lactic acid were measured. The mean SCF A ratio for all p-glucan treatments at 24 hours was 51:32:17 acetate: propionate: butyrate, which the authors reported to be propionate-rich. In general, beta-

. glucans displayed no apparent prebiotic potential.

2. Toxicological Studies

Animal Studies

Short-term studies

Dongowski et al. (2002) evaluated the physiologic effects of diets containing barley extrudates (containing p-glucan and resistant starches) in the intestines of male rats. Animals were fed a control diet for 1 week followed by l of 4 barley diets (groups A-D) or the control diet for 6 weeks (n= 10/group; 5 groups total). The control diet contained 0.03% p-glucan and 0.45% resistant starch, and the 4 test diets contained various amounts of p-glucan (-4-6%) and resistant starch (- 4-12%). The authors repo1ted that all diets were well accepted by the rats and there were no treatment-related changes in appearance or behavior. However, colon and cecum weight were significantly greater in rats on test diets, which the authors attributed to the P-glucan content.

Delaney et al. (2003a) evaluated the toxicity of a water-extracted, P-glucan-enriched, soluble barley fiber (barley betafiber) in a 28-day feeding study in Wistar rats conducted according under Good Laboratory Practice (GLP) and according to OECD Guideline 407. Animals (n=5/group/sex) were given 1, 5, or 10% barley betafiber (0.7, 3.5, or 7% P­glucan) in a modified rodent diet as a replacement for pregelatinized potato starch (digestible carbohydrate), or a starch control diet for 28 days. Mean p-glucan intakes were determined to be 0.55, 2.9, and 5.6 g/kg-bw/day. All rats survived until scheduled

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necropsy, and no treatment-related adverse effects were noted in general condition or behavior, growth, feed and water consumption, feed conversion efficiency, red blood cell or clotting potential parameters, clinical chemistry parameters, or organ weights. There were no abnormalities seen at necropsy or histopathology. Although clinical chemistry parameters (plasma urea, total protein, albumin, chloride, and calcium) exhibited slight changes, they were within the limits of historical controls and were not considered adverse. There was a dose-related increase in weight of full and empty cecum; however, this effect is typically seen in rodents on high fermentable, poorly digestible carbohydrate diets and is not considered toxicologically relevant. Increased total white blood cell counts were observed in males, which the authors attributed to increased peripheral lymphocytes as an indicator of P-glucan's immune modulating activity. This effect was not dose-dependent and only occurred in males at the low- and mid-dose levels. The authors concluded that daily consumption of concentrated amounts of barley p-glucan under the conditions of their study was not associated with signs of toxicity in Wistar rats.

Delaney et al. (2003b) conducted a similar study in CD-1 mice, a rodent species frequently used to evaluate inflammatory responses, to further investigate the potential for the immunological changes observed in rats to determine if any of these constitute an adverse effect. The study was conducted under GLP and according to a slightly modified OECD Guideline 407. Animals (n= l2/group/sex) were given I, 5, or 10% barley betafiber (0.7, 3.5, or 7 % p-glucan) in a commercial rodent diet as a replacement for pregelatinized potato starch (digestible carbohydrate), or a starch control diet for 28 days. Mean P-glucan intakes were determined to be 1.8, 9.3, or 19.0 g/kg-bw/day and 2.4, 11.6, or 23.6 g/kg-bw/day in males and females, respectively. Following 28 days, half the animals in each group were sacrificed for evaluation of clinical chemistry, hematology, and organ pathology, and the remaining mice were placed on the control diet for a 14-day recovery period. An additional (nai've) group (n=24/sex) consumed only the control diet and was used for hematological analysis given that the effect of multiple blood draws under the conditions of this study on hematology parameters was not known. Six mice from the nai've group/sex were sacrificed on days 0, 14, 27, and 41 . Blood was collected from all animals prior to study initiation (day -2), from 6 animals/group/sex on days 14 and 27, and from the remaining recovery animals on days 27 and 41. No treatment­related adverse effects were seen in any sex or dose group at any time point. No treatment-related histopathologic changes were seen in primary immune organs or peritoneal immune organs. The authors concluded that daily consumption of concentrated amounts of barley P-glucan under the conditions of the study was not associated with treatment-related adverse effects in CD-1 mice, and further, that concentrated barley P­glucan is not likely to result in adverse immunological or inflammatory effects.

More recently, Jonker et al. (20 I 0) conducted a 28-day oral toxicity study in Wistar rats using a high (75.6%) purity barley ~-glucan (Glucagel™). The study was conducted according to OECD Guideline 407 and EC Guideline B.7. Animals (n=5/group/sex) were given 0 (control 1

), 1, 5, or 10% Glucagel™ in a modified rodent diet as a replacement for

1 The control diet did not contain Glucagel™, but contained approximately 0.8% P-glucan from the basal diet.

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pregelatinized potato starch (digestible carbohydrate), or a starch control diet for 28 days. Mean P-glucan intakes were 0.62, 3.0, or 5.8 g/kg-bw/day and 0.60, 3.1, or 5.9 g/kg­bw/day in males and females, respectively (based on 75.6% P-glucan in Glucagel™). Results were generally consistent with the 28-day study in rats conducted by Delaney et al. (2003a); the treatment was well-tolerated, and there were no adverse effects on general condition and appearance, neurobehavioral observations, growth, feed or water consumption, ophthalmoscopy, hematology, clinical chemistry, urinalysis, organ weights, or pathological findings. Cecal enlargement occurred in mid- and high-dose males, which the authors described as a non-specific, physiological response following ingestion of non-digestible carbohydrate and therefore was not toxicologically relevant. Lower plasma total cholesterol and phospholipids were noted in high-dose males. The authors stated that P-glucan has known cholesterol-lowering effects in animals and plasma lipids were within the normal range, and were therefore not considered toxicologically relevant. Also considered to be toxicologically insignificant, high-dose males had a slightly increased mean plasma urea result. All other test results for renal function were statistically and biologically unremarkable. Unlike the findings of Delaney et al. (2003a), increased circulating lymphocytes were not observed in the present study. The authors concluded that consumption of up to 10% Glucagel™ (5.8-5.9 g/kg-bw/day P-glucan) for 28 days was not associated with toxicity in Wistar rats.

Genotoxicity

Delaney et al. (2004) evaluated the genotoxicity of p-glucan (barley betafiber) in a standard in vivo bone marrow micronucleus assay in mice conducted under GLP and according to OECD Guideline 474. Male CD-1 mice (n=lO/dose) were gavaged with barley betafiber in corn oil at doses of 74, 222, 666, or 2,000 mg/kg-bw. Half of the animals were sacrificed after 24 hours, the remaining after 48 hours. No clinical signs of toxicity were observed, so only the animals in the high dose group were evaluated and compared to negative and positive controls. No statistical increases in micronucleated polychromatic or nonnochromatic erythrocytes were observed. The authors concluded that barley betafiber was not clastogenic under the conditions of the study.

Several studies have evaluated the anti-genotoxic effects of P-glucans. Tohamy et al. (2003) evaluated the protective role of barley p-glucan against chromosomal aberrations in bone marrow and spermatogonial cells induced by anti-cancer drugs in CD-1 mice. P­glucan (100 mg/kg-bw) was administered i.p. to mice 24 hours prior to anti-cancer drug ( cyclophosphamide, adriamycin, or cisplatin). Animals were sacrificed 24 hours following administration of the anti-cancer drug. Pretreatment with P-glucan significantly reduced the frequency of structural chromosomal aberrations induced by the three anti­cancer drugs in bone marrow and spermatogonial cells. The authors concluded that their results suggest that p-glucan plays a role in reducing the genotoxicity associated with chemotherapeutic drugs.

Angeli et al. (2006) investigated the clastogenic/anti-clastogenic potential of barley P­glucan in a chromosomal aberration assay using cells proficient or deficient in phase I and II enzymes (rat hepatoma HTC or Chinese ovarian CHO-kl cells, respectively). Cells were incubated with p-glucan (2.5, 5, or 10 ug/L) and DNA damaging agents

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(methylmethane sulfonates, 2-aminoanthracene, and arabinoside-3-phosphate) for 12 or 24 hours. No clastogenic effects were observed, and protective effects of P-glucan were evident even at the lowest dose tested. Simi larly, Oliveira et al. (2006) evaluated the mutagenic activity of barley P-glucan (5, 10, or 20 ug/L) in a micronucleus assay in HTC or CHO-k l cells. Only the highest dose (20 ug/L) showed mutagenic activity, which was seen in both cell lines. Antimutagenicity experiments were also conducted using methylmethane sulfonates and 2-aminoanthracene, with various types of P-glucan treatments at the same concentrations (pre-treatment, simultaneous treatment, or post­treatment). The authors reported that barley p-glucan showed desmutagenic and bioantimutagenic activities at varying doses, depending on the timing of treatment and the cell line.

Angeli et al. (2009) assessed the genotoxicity of barley P-glucan in a Comet assay in HepG2 cells. Cells were incubated with P-glucan (1, 5, 25, 100, or 200 µg/ml) for 24 hours. Cytotoxicity was observed at 200 µg/mL , and genotoxicity was observed in the l 00 µg/mL dose group. The researchers also evaluated the protective effect of 1, 5, or 25 µg/mL P-glucan (administered pre-treatment, simultaneously, or post-treatment) on benzo(a)pyrene induced genotoxicity. Simultaneous treatment showed the greatest protective effect on genotoxicity, which was significant at 5 and 25 µg/L, but not at 1 µg/L. Cytotoxicity was significantly reduced at all concentrations tested. The authors reported that P-glucan possessed antimutagenic activity (mainly desmutagenic, but also bioantimutagenic ).

3. Human Studies on Beta-Glucan

In 1997, FDA authorized the use of label health claims on the association between soluble fiber from whole oats and a reduced risk of coronary heart disease. The Federal Register Notice acknowledges the beneficial contribution from p-glucan (FDA, 1997):

Based on its review of evidence submitted with comments to the proposal, as well as of the evidence described in the proposal, the agency has concluded that the type of soluble fiber found in whole oats, i.e., beta (fJ)-glucan soluble fiber, is primarily responsible for the association between consumption of whole oats, including oat bran, rolled oats, and whole oat flour, and an observed lowering of blood cholesterol levels ... (l)ntakes of fJ-glucan soluble fiber al or above 3 g per day were more effective in lowering serum lipids than lower intake levels.

Published safety s tudies of oat p-glucan concentrates are lacking, however published clinical trials exist evaluating oat P-glucan in various types of food (e.g., beverages, breads, cereal, muffins) (Garuda GRN 437, 2012). Human studies evaluating oat-derived p-glucan and its effects are discussed herein, and a number of studies of barley- and wheat-derived p-glucan are also included.

In a recent article, Daou and Zhang (2012) reviewed advances in the beneficial health effects of oat p-glucan. Oat p-glucan has been shown to decrease total and low-density lipoprotein (LDL) cholesterol, improve high-density lipoprotein (HDL) cholesterol and

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blood lipid profiles, attenuate postprandial glycemic and insulinemic responses in blood and help maintain body weight. By activating monocytes/macrophages and increasing the amounts of killer T-cells, NK cells and immunoglobulin, oat p-glucan can stimulate the immune system, which can improve the body's resistance to infectious and parasitic diseases as well as cancer.

Studies of the Cholesterol-Lowering Effect of Beta-Glucan

Soluble or viscous fibers, such as oat bran, have been shown to decrease serum cholesterol and low-density lipoprotein (LDL) cholesterol in humans. Oat bran has been shown to decrease high-density lipoprotein (HDL) cholesterol, but the difference is not significant (Anderson and Hanna, 1999).

Othman and coworkers (201 1) evaluated recent studies to determine if recent investigations support previous conclusions by the FDA and United Kingdom Joint Health Claims Initiative (JHCI) that P-glucan soluble fiber from oats can decrease plasma cholesterol levels and the risk of heart disease. The authors found in their review that studies conducted during the past 13 years support the conclusion that oat P-glucan intake of at least 3 g/day may reduce plasma total- and LDL-cholesterol levels by 5-10% in both hypercholesterolemic and normocholesterolemic participants, with an average decrease of 5-7%. The authors concluded that scientific agreement continues to support a strong relationship between oat p-glucan and cholesterol levels, with newer information being consistent with earli er conclusions drawn by the FDA and JHCI.

In a 6-week randomized controlled trial using 87 men and women with mildly elevated cholesterol levels, Charlton and coworkers (2012) evaluated whether 1.5 g/d P-glucan consumed as ready-to-eat oat flakes was as effective in reducing blood cholesterol as 3.0 g/d P-glucan from oat porridge. Participants were assigned to 1 of 3 diet arms (25% energy protein; 45% energy carbohydrate; 30% energy fat): minimal P-glucan (control), 1.5 or 3.0 g P-glucan. Total cholesterol was significantly decreased in all groups (-7.8%, -7.2 % and -5.5% in the high, low and control groups, respectively), as was LDL (-8·4%, -8.5 % and -5.5 % in the high, low and control groups, respectively); however between­group differences were insignificant. The authors concluded that oat p-glucan intakes of 1.5 g/d were as effective as 3 g/d at lowering blood cholesterol.

In their meta-analysis of the literature and of unpublished trial s on the cholesterol lowering effects of oat products, Ripsin et al. (1992) indicated that the addition of oat products to a diet yields a modest reduction in blood cholesterol level. For the 10 studies meeting the inclusion criteria, a summary effect size for change in blood total cholesterol level of -5.9 mg/dL (95% CI, -8.4 to -3.3 mg/dL) was calculated. The summary effect size for studies using wheat control groups was -4.4 mg/dL (95% CI, -8.3 to -0.38 mg/dL) . The greatest reductions in blood cholesterol were seen in trials where participants had initially higher blood cholesterol levels (2'..229 mg/dL). The authors concluded that their analysis provides strong support for the hypothesis that approx. 3 g/day soluble fiber from oat products can lower the total cholesterol level by 5-6 mg/dL. p-glucan concentrations were not specified.

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Behall et al. (1997) conducted a crossover study to assess whether moderate amounts of oat fiber extract (concentrated P-glucan), often used as a fat replacer, would reduce plasma lipid concentrations and if it could be added to a typical diet. Twenty-three subjects (7 men, 16 women) with mildly elevated blood cholesterol consumed oat fiber extracts containing high (10%) or low (1 %) P-glucan for 5 weeks after consuming a maintenance diet for one week. Total- and LDL-cholesterol were significantly lower after the oat fiber extract diets. However, compared to the maintenance diet, triglyceride levels, VLDL, HDL and HDL2 cholesterol did not significantly change. The authors concluded that modest amounts of oat extract in the diet produced significant reductions of cholesterol. Further, a significant dose response occurred between P-glucan and total cholestero l levels.

In a controlled, single-blind, randomized, cross-over trial, Beer et al. (1995) studied the effect of oat P-glucan on serum lipid concentrations in 14 healthy, hypercholesterolemic young men. Participants were assigned to a test group diet (oat gum instant whip, 9 g/day P-glucan) o r a control group (placebo instant whip) for 14 days. After completion of the first diet, subjects switched to the alternate diet. Dietary intakes of the two groups were similar. The results indicated no significant effect of the oat gum on triglyceride, total- or LDL-cholesterol levels. HDL-cholesterol was significantly higher during consumption of the test diet. The authors concluded that in healthy young men oat gum's cholesterol­lowering ability is weak. Further, the authors concluded that the impact of oat bran products on cholesterol levels cannot be estimated by the P-glucan content, but instead by measuring the viscosity and solubi lity of the P-glucan.

Biorklund et al. (2005) performed a side-by-side comparison of the effects of beverages enriched with 5 or 10 g P-glucan from oats or barley on insulin and postprandial glucose concentrations and serum lipoproteins. The study was an 8-week single-blind, dose­controlled study using 5 parallel groups of I 00 men and women with mildly elevated blood cholesterol levels. The study was conducted identically at two locations (the Netherlands and Sweden) and 89 persons (45 women, 44 men) completed the study. During an in itial 3-week period, all participants consumed a control beverage containing rice starch. For the following 5-week period, l group consumed the control beverage and 4 groups consumed a beverage containing 5 or 10 g P-glucan from barley or oats. All participants consumed their own habitual diets. Blood samples were collected during weeks 0, 2, 3, 7 and 8 and analyzed for g lucose, insulin, serum lipids and lipoproteins. Consumption of 5 g P-glucan from oats significantly lowered postprandial concentrations of glucose (30 min), insulin (30 min) and total cholesterol (7.4%). Consumption of 10 g P-glucan from oats did not significantly impact serum lipids, nor did consumption of the barley-derived P-glucan. The authors concluded that daily consumption of 5 g of oat B­glucan in a beverage improved glucose and lipid metabolism, while P-glucan from barley in the beverage matrix did not. It was noted that a dose- response effect of 5 g compared with 10 g of p-glucan was not shown in this study. Therefore, they concluded the level of p-glucan in a food product does not necessarily inform its effect on serum cholesterol concentrations.

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In a study using men and women with mildly elevated blood cholesterol, Behall et al. (2004) investigated whether barley consumption reduced CVD risk factors on a similar scale with that of other sources of soluble fiber. In the study, 7 men ( 43±5 years), 9 postmenopausal women (50±3 years) and 9 premenopausal women (47±4 years) consumed American Heart Association Step l diets for 17 weeks. After an initial 2-week period, whole-grain foods containing barley P-glucan (0, 3, or 6 g/day) were included in the Step 1 diets for 5 weeks in a Latin square design. Subjects acted as their own controls, and fasting blood samples were collected 2 times/week. Triacylglycerol and HDL levels did not differ with the 3 amounts of dietary P-glucan. Total cholesterol was significantly lower with the diet at the 3 and 6 g/day P-glucan amount than with no P-glucan; the effect was most pronounced in the postmenopausal women and the men. The authors concluded that dietary changes including higher P-glucan intake, increased consumption of whole grains including barley, and decreased fat intake can reduce risk factors for CVD.

Shimizu and co-workers (2008) conducted a study in 44 hypercholesterolemic Japanese men evaluating whether consumption of a diet in which rice was replaced by high P­glucan barley would decrease LDL and total cholesterol, as well as the visceral fat area. In this double-blinded, randomized, placebo-controlled intervention study, participants (age 30-60 years) were randomly assigned to groups consuming either a 50:50 mixture of rice and pearl barley containing 7 g/day P-glucan or rice alone (control) for 12 weeks. Recruited participants regularly consumed pearled rice as a staple food source in more than 2 of 3 daily meals. Subjects consumed the diets, which were nearly identical in calories, for the entire 12 week period. Blood samples were taken and CT scans were performed before the study and every four weeks throughout the trial. Thirty-nine men completed the study. Barley intake was shown to significantly reduce LDL (153.4±16.4 vs 147.7±27.7 mg/dL) and total cholesterol (234.8±21.7 vs 223.8±33.9 mg/dL), as well as BMI, waist circumference and visceral fat. The authors concluded that consumption of pearl barley with a high P-glucan content reduces total- and LDL- cholesterol, as well as the visceral fat area.

In a 4-week crossover-designed experiment, 21 men with mi ldly elevated blood cholesterol (5.4-7.0 mmol/L), age 30-59 years, consumed comparable wheat and barley foods for 4 weeks (Mcintosh et al., 1991 ). The authors examined the influence of two sources of dietary fiber on blood glucose and lipid concentrations. Wheat contained the largely insoluble cellulose and hemicellulose fiber (as a source of dietary fiber), while barley contained p-glucan. Both groups showed a significant increase in total dietary fiber, from a previous intake of 21-38 g/d. When compared to wheat, barley consumption was associated with a significant decrease in LDL-cholesterol (7%) and plasma total cholesterol (6%); significant changes did not occur in glucose and triglyceride concentrations. The authors concluded that barley dietary fiber is more effective than wheat dietary fiber at lowering blood cholesterol, particularly LDL-cholesterol, in men with high cholesterol levels.

Bourdon and co-workers (1999) studied the response of glucose, insulin, lipid, and cholecystokinin to 2 test meals containing P-glucan in 11 healthy American men (28.6 ± 2.0 years). One of the two meals was low in fiber (5.0 g) and the other had a high fiber

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content (15.7 g). Two additional low-fiber (control) meals contained pasta prepared from wheat flour; the main one was a commercial preparation, and an additional one was prepared in-house. The high-fiber meals contained pasta made by replacing 40% of the wheat with 1 of 2 types of barley flour: flour enriched in P-glucan during processing or barley naturally high in p-glucan (Prowashonupana). Both types of high fiber meals contained approximately 5 g p-glucan. Each participant consumed each of the 3 test meals (two high-fiber, one commercial low-fiber), on 3 different days, 1- 3 weeks apart in a randomized, crossover design. Five participants also consumed the noncommercial low­fiber control meal. Blood samples were taken at intervals from 30 to 360 min after the meal began. While both insulin and plasma glucose concentrations increased significantly after all meals, the insulin response was decreased following the meals containing barley. Cholecystokinin remained elevated for a longer time period after the barley-containing meals compared to the low-fiber meal. Four hours after the barley-containing meals, cholesterol concentrations fell below the fasting concentrations and were significantly lower than levels following consumption of the low-fiber meal. Cholesterol concentrations were not significantly altered after consumption of the low-fiber meal. The authors concluded that consumption of the barley-containing meals appeared to stimulate reverse cholesterol transport, which may be associated with barley's cholesterol-lowering effect. Also, carbohydrate was more slowly absorbed from the 2 high-fiber meals than the low-fiber meal.

Talati and coworkers (2009) performed a systematic literature review (through January 2008) to assess the association between consumption of P-glucan from barley and alterations in plasma lipids in hypercholesterolemic and healthy men and women. Barley studies were included if they were randomized, controlled trials that reported efficacy data for at least one lipid endpoint. Parallel and crossover trials were eligible; however, crossover studies required at least a 4-week washout period. The authors identified 8 trials (n = 391 participants) of 4-12 weeks in length, which evaluated barley' s lipid­reducing effects and met the appropriate criteria. The P-glucan dose reported in the various studies was 3-10 g/day, with a median dose of7 g/day. The P-glucan was present in various fom1s (e.g., barley bran flour, barley-containing beverages, pearled barley, barley concentrates). Barley consumption was found to significantly decrease triglycerides (weighted mean difference (WMD], -11.83 mg/dL; 95% CI, - 20.12 to - 3.55 mg/dL), total cholesterol (WMD, - 13.38 mg/dL; 95% CI, - 18.46 to - 8.31 mg/dL), and LDL-cholesterol (WMD, - 10.02 mg/dL; 95% Cl, -14.03 to -6.00 mg/dL), but did not significantly affect HDL-cholesterol. The observed reduction in total- and LDL­cholesterol is consistent with a similar published meta-analysis of p-glucan derived from oats. Since barley and oats have similar P-glucan content (3.5%-5.9% of dry matter), this is reasonable. The authors concluded that P-glucan from barley appears to beneficially impact triglycerides, total- and LDL-cholesterol, but does not affect HDL-cholesterol. They further recommended that larger clinical trials be conducted to better evaluate the potential for a dose-response relationship with barley P-glucan. It was stated, "Health practitioners should feel comfortable recommending barley /3-glucan to their patients lo help reduce total cholesterol and LDL cholesterol concentrations as recommended by the National Cholesterol Education Program guidelines. "

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Unlike the majority of the literature, Keogh and co-workers (2003) did not find an impact on blood cholesterol following p-glucan consumption. The authors conducted a randomized crossover intervention trial to determine whether consumption of a highly P­glucan enriched barley (75% by wt) would result in a clinically significant decrease in CVD risk in men with mildly elevated blood cholesterol (mean 4.0 ± 0.6 mmol LDL cholesterol/L). In this study, 18 men (38.8± 10.1 years of age) were recruited on the basis of no history of CVD, mildly elevated LDL-cholesterol (>3.5 mmol/L), and no current treatment for hyperlipidemia. Participants were randomly assigned in this 2 x 4-wk, single-blind study to either the treatment arm [8.1-11 .9 g /day P-glucan (scaled to body weight)] or the control arm (equally active dose of 6.5- 9.2 g/day glucose). An oral­glucose-tolerance test was conducted on days 0 and 29; fasted blood samples were collected on days 0, 1, 7, 14, 21, 28, and 29. Following a 4-week washout period, the dietary regimens were crossed over. There was no significant change in total-, HDL-, or LDL- cholesterol, or in postprandial or fasting glucose when measured between treatments. The authors concluded that there was no evidence of a significant improvement in CVD risk, and the effect of P-glucan enriched barley on the lipid profile varied substantially between subjects. The authors hypothesized that the lack of observed effect may result from structural changes in p-glucan due to storage, freezing, or baking of the product during the intervention period, or from commercial processing of the barley into a highly enriched P-glucan product.

Studies of the Modulation of Blood Glucose and Insulin by Beta-Glucan

Tiwari and Cummins (2011) conducted a meta-analysis on epidemiologic studies to evaluate the relationship between oat and barley P-glucan consumption on blood glucose, cholesterol and triglyceride/triacylglycerol (TGL/TAG) levels. The authors identified 30 research articles (some with multiple dose levels) yielding 126 clinical studies. After P­glucan consumption, the overall analysis showed a significant change in blood glucose level (-2.58 mmol/L, 95% CI -3.22 to -1.84) with high heterogeneity between and across studies. There was a significant inverse relation in LDL-cholesterol (-0.66 mmol/L, 95% CI -0.96 to -0.36), total cholesterol (-0.60 mmol/L, 95% CI -0.85 to -0.34), and TGL/T AG (-0.04 mmol/L, 95% CI -0.15 to 0.07). However, an increase in HDL­cholesterol was noted (0.03 mmol/L, 95% CI -0.06 to 0.13). Dose-response modeling indicated that 3 g/day consumption of p-glucan derived from oats or barley was sufficient to decrease total cholesterol. The authors considered P-glucan's effect on blood glucose to be inconclusive, with high heterogeneity, and recommended additional clinical research studies with longer periods of intervention.

Using 32 healthy volunteers with normal body mass indices, Granfeldt and coworkers (2008) evaluated the effect of an extruded muesli product, which was based on oat bran rich in p-glucan, on post-meal glycemia and insulinemia. The study was performed in 2 series: Series l (19 subjects) test breakfast meals included 3 g P-glucan; Series 2 (13 subjects) test breakfast meals included 4 g P-glucan. Muesli was served in yogurt together with white bread. While 3 g P-glucan produced no significant impact on glycemic response (compared to a control meal without P-glucan and muesli), 4 g P-glucan significantly reduced both glucose and insulin responses. The authors concluded that 4 g

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of oat-derived P-glucan appears to be a critical level for a significant decrease in insulin and glucose responses in healthy persons.

Using a Latin square design, Hallfrisch et al. (2003) conducted a study comparing insulin, glucose and glucagon responses following consumption of high-soluble p-glucan compounds from oats and barley. Eleven men and 11 women, 35- 57 years, participated in the study. After consuming a prescribed diet for 3 days, on the third day of 5 periods, participants consumed 1 g/kg of carbohydrate as glucose or 0.66 g/kg pudding (mainly sucrose) and 0.33 g/kg as oat bran, oat or barley extract (Nu-trimX) or barley flour in a random design. Compared to the glucose solution, glucose responses to oats, barley, both extracts, and areas under the curve were significantly decreased. The barley extract had the lowest insulin response. The authors stated that both oat and barley extracts retain the beneficial effects from the parent grains. While both oats and barley can help control plasma glucose response, high-soluble fiber barley is more effective than standard oats.

Liljeberg et al. (1996) performed a study with 9 healthy subjects (6 women and 3 men, 24-46 years). The purpose of the investigation was to evaluate the insulinemic and glycemic responses to porridge and bread products consisting of a barley genotype containing a high amount of p-glucan (Prowashonupana). The Prowashonupana contained 18 g/l 00 g dry weight p-glucan, which is approximately 4-fold higher than the levels in common barley or oats. In random order at I -week intervals, at breakfast, subjects consumed products (porridge, bread or flatbread) made from oats, common barley or the barley containing high P-glucan levels. All high fiber barley products produced significantly lower postprandial insulin and glycemic responses than did the white bread reference (insulin and glycemic indices were 42-72%, and 57-72%, respectively). The most pronounced effect occurred for the flatbread made with 80% high-fiber barley flour. In contrast, common barley and oat porridges induced insulin and glucose responses similar to the reference bread, indicating that naturally occurring dietary fiber in these whole-meal flours has no effect on glucose tolerance. The authors concluded that pleasant tasting, "lente" products can be prepared from barley containing a high concentration of soluble dietary fiber. As the glycemic index of these products compares favorably with that of products made from common cereals, they could be used in diets for patients who are predisposed to metabolic disease, as well as those with hyperlipidemia and diabetes.

Nilsson et al. (2008b) evaluated the impact of 8 cereal-based bread evening meals (containing 50 g available starch), varying in content of indigestible carbohydrates and glycemic index, on glucose tolerance and related indices following a subsequent standardized breakfast. Study participants were 17 healthy volunteers (6 women and 11 men, 22-32 years of age) with normal BMI (22.5±2.1 kg/m2

); one male and one female did not complete the study. The participants consumed the test meals approximately once per week in random order. One of the meals contained bread from a barley variety with elevated 13-glucan levels (14% dry basis, mutant 13, SvalOf Weibull); the other test meals contained various types of wheat or barley. At breakfast, blood samples were collected for 15- and 3-minute intervals over 3 hours for measurement of blood glucose, serum insulin, and other clinical parameters, and satiety was subjectively rated after breakfast.

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At the subsequent breakfast, glucose tolerance was improved after consuming evening meals with barley kernel-based bread (including the p-glucan-rich genotype) or white wheat flour bread enriched with resistant starch and barley fiber, compared to non­enriched white wheat bread. At breakfast, glucose response and colonic fermentation were inversely correlated (r = -0.25). Breath hydrogen (marker of colonic fermentation) correlated inversely with gastric emptying rate (r = -0.23) and positively with satiety (r = 0.27). The authors stated that the high P-glucan bread produced a low and prolonged net increment in blood glucose and a higher feeling of satiety, likely due to lowered gastric emptying rate. The authors concluded that the constitution of indigestible carbohydrates in the evening meal may impact glycemic excursions and related metabolic risk variables at breakfast through a mechanism involving colonic fermentation. These results provide evidence of a link between gut microbial metabolism and key factors involved in insulin resistance.

In a randomized crossover study of 17 normoglycemic, obese women at increased risk fo r insulin resistance, Kim et al. (2009) investigated the linearity of reduced glucose and insulin responses after consumption of whole grains containing soluble fiber. After consuming controlled diets for 2 days, the participants (51.6±2.1 years, BMI 33.2±0.8) consumed 5 hot breakfast cereal test meals containing barley and/or wheat containing varying amounts of P-glucan (0, 2.5, 5, 7.5 and 10 g). Each test day was separated by a washout period of 7 days. Blood samples were collected before and 30, 60, 120 and 180 min after test meal consumption. Consumption of 10 g p-glucan delayed the rate of glucose response and significantly decreased peak glucose response at 30 min. P-glucan content did not impact the area under the curve for 2-hour postprandial glycemic response. However, both area under the curve and peak insulin responses were significantly affected by P-glucan concentration in an inverse linear relationship. The authors concluded that in obese women who are at risk for insulin resistance, acute consumption of 10 g P-glucan can induce beneficial effects on postprandial insulin responses. The authors hypothesized that this effect may be mediated by changes in gut hormones.

Keogh and coworkers (2007) conducted a randomized-single-blinded crossover study of 14 lean, healthy women (28.6±8.3 years, BMI 22.8±2.3 kg/m2

) to investigate the impact of barley flour vs. white wheat flour on the subsequent food intake, thermic effect of food (TEF), and metabolic indices. The barley (barley cultivar, Hordeurn Vulgare var Himalaya 292) or wheat flour was incorporated into breakfast and lunch. P-glucan concentrations varied between 3.2 and 4.0 g/serving for the barley items and were 0.5 g/serving for all wheat items. Each test day was separated by a 7-day washout period. Blood samples were collected 6 hours after breakfast, then at 30, 60, 120 and 180 min after beginning lunch. The results showed that ad libitum food intake over the next 10 hours was decreased by 23% following the wheat-containing meals compared to the barley-containing meals. TEF was 5% for both test lunches. Mean area under the curve (AUC) of insulin following consumption of the wheat-containing meals was 32% greater than the barley-containing meals (78.1 ±35.3 vs 52.8±24.7 mmol/L/h). AUC for glycemic response for wheat-containing meals was 22% higher than for the barley-containing meals (4.68±1.67 rnmol/L/h, 3.67±1.91 mmol/L/h). The authors concluded that meals

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containing increased amylose and soluble fiber did not reduce spontaneous food jntake, but rather were associated with higher energy intakes, despite lowering glucose and insulin levels.

Studies of Immune-Modulating Effects of Beta-Glucan

Rieder and Samuelsen (2012) state that P-glucans are known for having immune­modulating properties and have been shown to protect against viral, bacterial, and parasitic infections in mice. The authors cite a number of studies in mice discussing immunological effec ts of oat p-glucans; effects include increased resistance to herpes virus infection, increased cytokine secretion spleen cells and macrophages, increased resistance to Eimeria vermiformis and Stapyhlococcus aureus infection, and increase in respiratory burst activity of neutrophils. Other effects include diminished spread of lung tumor metastasis, NF-KB activation of intestinal epithelial cells and leukocytes. However, human studies of oat P-glucan exposure did not cause any changes in various immunological parameters, including leukocyte activity, reported upper respiratory tract infections, cytokine production, or C-reactive protein level (Rieder and Samuelsen, 2012).

Since in vitro P-glucan can increase tumor cytotoxicity via iC3b receptors on leukocytes, Cheung and Modak (2002) studied whether (1~3),(1~4)-D-P-glucan could synergize with anti-GD2 monoclonal antibody (MoAb) 3F8 (mouse IgG3) in treating human neuroblastoma xenografts. In the study, nude, athymic mice with neuroblastoma xenografts were treated daily with P-glucan, i.p. or p.o. administration. The treatments occurred with or without i.v. MoAb administration twice a week, fo r 22-29 days. Body weights and serial tumor volumes were measured. The results showed that an antitumor effect was seen at 2'.:40 µg of p-glucan dose, i.v. or p.o. , in all human neuroblastoma lines. P-glucan with 3F8 yielded near-complete disease stabilization/tumor regression, while P­glucan or 3F8 alone did not significantly impact tumor growth. While <3% of controls remained progression free, 18% percent of the mice with LAN- I cell line and 47% of those NMB7 cell line did not show progression. No toxicities were observed in animals treated with either P-glucan alone or 3F8 plus p-glucan (4-4,000 µg/dose). It is hypothesized that p-glucan plus complement activation may increase B-cell response to tumor cells, or innate immunity may be involved following P-glucan leukocyte activation. The authors concluded that p.o. P-glucan synergized with antitumor lgM and IgG MoAb in this in vivo study. Since P-glucan was well tolerated and inexpensive, it could be potentially valuable in chemotherapy (Cheung and Modak, 2002).

Additional Protective Effects of Beta-G/ucan

Nilsson et al. (2008) administered 40 g P-glucan-enriched oat bran per day, in 4 slices of bread to 25 healthy subjects (age 24± 1.3 years) for 12 weeks. The objective of the study was to determine how the colonic concentration of carboxylic acids in healthy subjects is influenced by dietary supplementation with oat bran. Carboxylic acids, particularly butyric acid, are believed to counteract colonic diseases, such as colon cancer and ulcerative colitis. Oat bran increased the fecal carboxylic acid levels after 8 weeks, which

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also indicated an increased concentration in the distal colon. Fecal concentrations of butyric, acetic, isobutyric, isovaleric and propionic acids were significantly higher after 8 weeks on the oat bran diet as compared with initial values, but lactic acid concentrations were lower. After 12 weeks, isobutyric, acetic and propionic acid concentrations were still higher and lactic acid levels were lower. Inter-individual variation was high, whereas intra-individual variation was low. The authors concluded that oat bran may have the potential to protect against colonic diseases.

Tolerance Studies in Human Volunteers

As discussed above, in multiple studies evaluating the potential benefits of p-glucan products, human volunteers have consumed these products under controlled conditions. Toxic effects did not occur in any of the stud ies. In 2 recent meta-analyses (Tiwari and Cummins, 2011; Othman et al., 2011 ), and 1 earlier one (Ripsin et al. , 1992), safety concerns were not reported following consumption of oat P-glucan.

In an 11-week controlled crossover study by Hallfrisch and Behall ( 1997), 17 women and 7 men (37-61 years) consumed diets in which the fat content of foods was reduced by Oatrirn addition. The Oatrim contained either a low (1 %) or high (10%) level of soluble P-glucan. While a significantly longer adaptation period and gastrointestinal symptoms (5 vs. 13 days) were more often reported for the meals containing the higher P-glucan level, the effects were not serious enough for any of the subjects to withdraw or refuse to consume any of the foods. In healthy men with elevated blood cholesterol levels, Beer et al. (1995) reported that the participants experienced mild, transient GI effects after consumption of 9 g/day oat p-glucan in oat gum instant whip. In their study investigating whether barley consumption reduced CVD risk factors on a similar scale with that of other sources of soluble fiber, Behall et al. (2004) administered American Heart Association Step I diets for 17 weeks with whole-grain foods containing barley p-glucan (0, 3, or 6 g/day). Persons on the high p-glucan diet indicated they were experiencing bloating and flatulence.

Interaction with Nutrient Absorption

Due to their soluble fiber content, oats are known for retarding absorption of nutrients and their effects on satiety, as well as a deterrent for various GI disorders. Oat P-glucan lowers the rate of glucose absorption and delays intestinal absorption of carbohydrates, all beneficial effects (Oaou and Zhang, 2012).

Cargill (20 I 0) stated that P-glucan does not complex with metal ions, therefore it is not anticipated to impair absorption of essential minerals in the small intestine. Upon review of the literature, Cargill (2010) concluded that dietary fiber, at recommended intake levels, does not adversely affect vitamin and mineral absorption of the average consumer. According to the American Dietetic Association (ADA, 2008):

Potential negative effecls of excessive dietary fiber include reduced absorption of vitamins, minerals, proteins, and energy. It is unlikely that healthy adults who consume dietary fiber in amounts within the recommended ranges will have problems

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with nutrient absorption; however, high dietmy fiber intakes may not be appropriate for children and older adults because so little research has been conducted in these populations.

Allergenicity

Children with atopic dermatitis and farmers with allergies to grain dust may experience allergic reactions to oat proteins. These proteins can act as skin and respiratory allergens (Boussault et al., 2007; Garuda 2012).

Allergy manifestation resulting from consumption of oats and oat products has been debated. It has been alleged that oats may cause adverse effects in individuals with celiac disease. As a result, use of oats in gluten-free diets was not allowed. Evidence from more recent reports indicates that oats are safe for consumption by most individuals with celiac disease (Rashid et al., 2007). Health Canada (2007) critically reviewed the scientific literature and concluded that the majority of people with celiac disease can tolerate moderate amounts of pure oats that are uncontaminated with other cereal grains such as wheat, barley and rye. It is recognized that commercially available oats are variably contaminated with gluten-containing grains that can occur on the farms, during the growing cycle or during storage, cleaning, transportation or processing.

The Canadian Celiac Association stated that in past years, oats were not allowed in a gluten-free diet and were considered to be averse to persons with celiac disease. However, based on recent data, pure oats, uncontaminated with other gluten-containing grains, if consumed in limited amounts, are safe for most of those with celiac disease. For children, up to 25 g/day (1 /4 cup) and for adults, up to 70 g/day (1/2 to 3/4 cup) is a safe consumption rate (Rashid et al., 2007). With the current labeling of gluten-free foods, these are helpful guidelines for consumers with celiac disease to use as a reference. Health Canada supports the position that oats can be part of a gluten-free diet, indicating that persons with celiac disease can tolerate some amounts of pure oats (uncontaminated with other cereal grains such as wheat, barley and rye). In fact, pure oats may be beneficial to persons with celiac disease, as its palatability may increase patients' compliance with a gluten-free diet (Health Canada, 2007).

Oat consumption by celiac disease patients is not widely recommended in the U.S. due to concerns of potential contamination of commercial oats (Kupper, 2005; American Celiac Society, 2014). According to the National Foundation for Celiac Awareness (NFCA, 2014), although oats do not contain gluten, a small percentage of persons with celiac disease react to pure, uncontaminated oats. Further, most mills that process oats also manufacture grains which contain gluten, making cross contamination likely. However, up to 50 g/day of dry, gluten-free oats is considered safe (NFCA, 2014).

The potential allergenicity of ~-glucan in itself was researched in the available literature, but no relevant infonnation was located. Natural sources of ~-glucan concentrates, such as barley, have been safely consumed for decades. ~-glucan is not listed among FDA's list of the 8 major food allergens (FDA, 2010). The lack of available information and

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absence from FDA's list leads to the conclusion that allergic reactions to P-glucan itself are not of concern.

C. Safety Data Summary

There is common knowledge of a long history of human consumption of oats. Oats have been cultivated around the world for more than 2000 years. The U.S., Germany, Russia, Canada, France, Finland, Poland, and Australia are the largest producers of oats (FDA, 2012). Numerous food products containing oats are currently marketed in the U.S. and around world. Oat fiber has become a desirable ingredient for addition to a variety of food products as a source of dietary fiber.

Oat p-glucan is found in the cell walls of oat kernels. Beside oats, P-glucan is consumed from other cereals and edible plants such as barley, rye, and wheat. Oat-derived P-glucan concentrates (e.g., Oatrim with a P glucan content of up to 10% and Oat Vantage™ with 54% p-glucan) are marketed in the United States and have GRAS status (FDA, 2011; FDA, 2012). Quaker Oats self-determined the GRAS status of Oatrim in 1992 (FDA, 2011). As described in GRAS Notification No. 437 (FDA, 2012), the GRAS status of Oatrim was supported by several factors including: I) Oatrim's similarity to oat starch and maltodextrin (food ingredients with a known safety use profile), 2) the enzymatic manufacturing process was analogous to the biological digestion of starch by humans, and 3) short-term toxicity studies and safety evaluations of Oatrim's constituents did not reveal any areas of concern (FDA, 2011; FDA, 2012). OatVantage™ (54% P-glucan content) has similarly been on the market for 1 O+ years and no safety concerns have been reported.

Numerous studies have been conducted and published in support of the evaluation of the safety of barley p-glucan, including in vil ro and in vivo animal studies as well as clinical studies in humans. While there is a lack of published preclinical safety studies on oat P­glucan, products containing oat P-glucan concentrates have been employed in numerous clinical trials. Other than mild, transient gastrointestinal (GI) effects such as flatulence and abdominal discomfort, no significant adverse effects were noted. It should be noted that these GI effects commonly occur following a shift from a low- to high-fiber diet (IOM, 2005). Updated literature searches covering the period of2010 - present have revealed no recent studies that report safety concerns.

Epidemiological studies and clinical trials have consistently revealed that fiber-rich diets are associated with significant reductions in cardiovascular disease risk and other health benefits. The intended uses of Prom Oat® have the potential to increase the dietary fiber intakes among the US population. The Institute of Medicine (2005) reviewed the possible effect of cereal fiber on mineral absorption (e.g., iron, zinc, calcium, magnesium) and determined that dietary fiber, as part of a balanced diet, has not been found to adversely affect mineral status in healthy people at recommended intake levels.

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Children with atopic dermatitis and farmers with allergies to grain dust may experience allergic reactions to oat proteins. These proteins can act as skin and respiratory allergens (Boussault et al., 2007; Garuda, 2012).

Allergy manifostation resulting from consumption of oats and oat products has been the subject of debate. It has been alleged that oats may cause adverse effects in individuals with celiac disease. As a result, use of oats in a gluten-free diets was not allowed. Evidence from more recent reports indicates that oats are safe for consumption by most individuals with celiac disease (Rashid et al. , 2007).

For instance, Health Canada (2007) critically reviewed the scientific literature and concluded that the majority of people with celiac disease can tolerate moderate amounts of pure oats that are uncontaminated with other cereal grains such as wheat, barley and rye. The Canadian Celiac Association stated that in past years, oats were not allowed in a gluten-free diet and were considered to be averse to persons with celiac disease. However, based on recent data, pure oats, uncontaminated with other gluten-containing grains, if consumed in limited amounts, are safe for most of those with celiac disease. Health Canada supported this position, indicating that persons with celiac disease can tolerate some amounts of pure oats (uncontaminated with other cereal grains such as wheat, barley and rye). In fact, pure oats may be beneficial to persons with celiac disease, as its palatability may increase patients' compliance with a gluten-free diet (Health Canada, 2007).

The potential allergenicity of p-glucan itself was researched in the available literature, but no relevant information was located. Natural sources of P-glucan concentrates, such as barley, have been safely consumed for decades. P-glucan is not listed among FDA's list of the 8 major food allergens (FDA, 2010). The lack of available information and absence from FDA's allergen list leads to the conclusion that allergic reactions to P-glucan itself are not of concern.

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6.0 Basis for the GRAS Determination

A. Introduction

The regulatory framework for determining whether a substance can be considered generally recognized as safe (GRAS) in accordance with section 20l(s) (21 U.S.C. § 321 (s)) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et. Seq.) ("the Act"), is set forth at 21 CFR 170.30, which states:

General recognition of safety may be based only on the view of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. The basis of such views may be either ( 1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. General recognition of safety requires common knowledge about the substance throughout the scientific communi ty knowledgeable about the safety of substances directly or indirectly added to food.

General recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient. General recognition of safety through scientific procedures shall ordinarily be based upon published studies, which may be corroborated by unpublished studies and other data and information.

These criteria are applied in the analysis below to dete rmine whether the use of an oat-derived p-glucan for use in food for human consumption is GRAS based upon scientific procedures. All data used in this GRAS determination are publicly available and generally known, and therefore meet the "general recognition" standard under the FD&C Act.

B. Safety Determination

The subject of this GRAS determination is the use of oat-derived P-glucan for use as a source of dietary fiber for general addition to all foods except infant formula and meat and poultry products. There is a long history of the safe use of oats and products derived from oats such as oat p-glucan concentrates. Furthermore, other natural sources of P­glucan concentrates, such as barley, have been safely consumed for decades. While there is a noted lack of published safety studies of oat p-glucan concentrates, the safety section describes numerous animal and human safety studies of barley p-glucan which is similar to oat P-glucan, as both contain polysaccharides of unbranched, linear, mixed-linkage (l-3)( 1-4 )-P-D-glucan.

The focus of this GRAS self-determination is for an identical general food use of oat-

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derived P-glucan (excluding infant formula and meat and poultry) as current barley- and oat-derived 13-glucan products as described in GRN 207, 344, and 437 (FDA, 2006; FDA, 2011; FDA, 2013 ). Cargill, in GRAS Notification 344, estimated the combined average intake of barley betafiber by consumers from all uses of barley betafiber (i.e., general food use and meat and poultry) would be 12.4 g/person/day (8.7 g p-glucan/person/day). The 90111 percentile intake was estimated to be 23.5 g/person/day (16.5g13-glucan/person/day). Cargill stated that barley betafiber would be added to food at levels of 4.3 g/serving, resulting in approximately 3 g of 13- glucan/serving. Given the lower level of P-glucan (approximately 35%) in Tate & Lyle's PromOat® product, the estimated intake of j3-glucan from the proposed uses of Tate & Lyle's product will be lower by approximately 50% (i.e., 4.35 and 8.25 g 13-glucan/person/day for the mean and 901

h

percentile, respectively). While Tate & Lyle's PromOat® product could be added at a higher per serving level, the use of oat p-glucan in this manner is considered to be self­limiting for technological reasons such as product texture and/or flavor profile. ln addition, since use in infant formula, medical foods, and meat and poultry are not being considered as part of this GRAS Notification, the resulting estimated intake will be less than the current GRAS oat- and barley-derived 13 glucan products that were the subject of GRN Nos. 207, 344, and 437. In summary, the proposed uses of PromOat® will not result in an increase in the overall consumption of ~-glucan, but simply provide an alternative source of p-glucan for use in food.

Numerous studies have been conducted and published in support of the evaluation of the safety of barley P-glucan, including in vitro and in vivo animal studies as well as clinical studies in humans. While there is a lack of published preclinical safety studies on oat 13-glucan, products containing oat P-glucan concentrates have been employed in numerous clinical trials. Other than mild, transient gastrointestinal (GI) effects such as flatulence and abdominal discomfort, no significant adverse effects were noted. It should be noted that these GI effects commonly occur following a shift from a low- to high-fiber diet. Evaluation of the possible effects of oats, cereal fiber and/or 13-glucan on mineral absorption and allergenicity have also been considered by U.S. FDA and EFSA and found not to present a significant safety concern as consumed as part of the normal diet.

C. General Recognition of the Safety of Oat-Beta-Glucan

The intended use of oat P-glucan has been determined to be safe through scientific procedures as set forth in 21 CFR§l 70.3(b), thus satisfying the so-called " technical" element of the GRAS determination.

The oat p-glucan that is the subject of this notification (Prom Oat® Beta Glucan) is produced from the starting material oat bran. The oat p-glucan product is manufactured consistent with current Good Manufacturing Practice ( cGMP) for food (21 CFR Part 110). The raw materials used in the manufacturing process are food grade and/or approved for use as processing aids in food. No chemical processing aids are employed in the manufacturing process. The oat P-glucan product containing approximately 35% P-glucan has been characterized and meets the food grade specifications found in Table 1.

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There is common knowledge of a long history of human consumption of oats. Oats have been cultivated around the world for more than 2000 years. The U.S., Germany, Russia, Canada, France, Finland, Poland, and Australia are the largest producers of oats (Garuda, 2012). Numerous food products containing oats are currently marketed in the U.S. and around world. Oat fiber has become a desirable ingredient for addition to a variety of food products as a source of dietary fiber.

Epidemiological studies and clinical trials have consistently revealed that fiber-rich diets are associated with significant reductions in cardiovascular disease risk. While there is no established dietary reference value (DRV) for soluble fiber, the amount of soluble fiber in a typical mixed diet is one-fourth to one-third of the total dietary fiber intake (ADA, 2002; FDA, 2102). The intended uses of Prom Oat® (oat-derived p-glucan) will provide an alternative to other dietary sources of P-glucan as part of the total dietary fiber intakes among the U.S. population.

Oat P-glucan is found in the cell walls of oat kernels. Besides oats, p-glucan is consumed from other cereals and edible plants such as barley, rye, and wheat. Oat-derived P-glucan concentrates (e.g., Oatrim with a~ glucan content of up to 10% and OatVantage™ with 54% p-glucan) are marketed in the United States and have GRAS status (FDA, 2011; FDA, 2012).

To date, FDA has reviewed two GRAS Notifications of p-glucan from barley (FDA, 2006; FDA, 2011) and one from oats (FDA, 2013). Extensive published information and data on P-glucan were submitted. All of the GRAS notifications received "no questions" letters from the FDA. Tate & Lyle considers the information and study data described in these cited notifications as directly applicable to this notification. Furthermore, P-glucan derived from oats or barley contains polysaccharides of unbranched, linear, mixed­linkage (1-3), (1-4)-P-D-glucan, and from a physiological perspective there is virtually no difference. Thus, from a safety perspective, the available studies of barley p-glucan and the studies described in GRNs 207, 344, and 437 are applicable to the safety assessment of oat p-glucan. No recent studies raising any new safety concerns have appeared in the published literature subsequent to these evaluations, particularly the most recent GRAS notice ORN 437.

Given that oat P-glucan meets the proposed specifications for the use of P-glucan as a food ingredient for human consumption, the safe use of oat p-glucan is justified by scientific procedures. In addition, the publicly available scientific literature is sufficient to suppo1t the safety and GRAS status of the proposed oat p-glucan product.

Numerous studies have been conducted and published in support of the evaluation of the safety of p-glucan, including in vitro and in vivo animal studies as well as clinical studies in humans and are described herein. Therefore, since this safety evaluation was based on generally available and widely accepted data and infom1ation, it also satisfies the so-called "common knowledge" element of a GRAS determination.

TA TE & LYLE CONFIDENTIAL 36

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Determination of the safety and GRAS status of oat p-glucan that is the subject of this self-determination has been made through the deliberations of an Expert Panel convened by Tate & Lyle and comprised of Michael Carakostas, DVM, Ph.D., Carol A. Knight, Ph.D., and Stanley M. Tarka, Jr., Ph.D. These individuals are qualified by scientific training and experience to evaluate the safety of substances intended to be added to foods. They have critically reviewed and evaluated the publ icly available information summarized in this document and have individually and collectively concluded that oat-derived P-glucan, produced consistent with Good Manufacturing Practice and meeting the specifications described herein, is safe under its intended conditions of use. The Panel further unanimously concludes that these uses of oat P­glucan are GRAS based on scientific procedures, and that other experts qualified to assess the safety of foods and food additives would concur with these conclusions. The Panel 's GRAS opinion is included as Exhibit 1 to this document.

It is also Tate & Lyle's opinion that other qualified scientists reviewing the same publicly available toxicological and safety information would reach the same conclusion. Tate & Lyle has concluded that oat P-glucan is GRAS under the intended conditions of use on the basis of scientific procedures; and therefore, it is excluded from the definition of a food additive and may be marketed and sold for its intended purpose in the U.S. without the promulgation of a food additive regulation under Title 21 of the CFR.

Tate & Lyle is not aware of any information that would be inconsistent with a finding that the proposed use of oat p-glucan in food for human consumption meeting appropriate specifications and used according to Good Manufacturing Practice, is GRAS. Recent reviews of the scientific literature revealed no potential adverse health concerns.

TATE & LYLE CONFIDENTIAL 37

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7.0 References

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American Dietetic Association (ADA). 2002. Position of the American Dietetic Association (ADA): Health Implications of Dietary Fiber. J. Am. Diet. Assoc. 108:1716-1731.

Anderson JW, Hanna TJ. 1999. Impact ofnondigestible carbohydrates on serum lipoproteins and risk for cardiovascular disease. J. Nutr. 129: 1457-1466.

Angeli JPF, Ribeiro LR, Angeli JLF, Mantovani MS. 2009. Protective effects of p-glucan extracted from barley against benzo[a]pyrene-induced DNA damage in hepatic cell Hep02. Exp. Toxicol. Pathol. 61 :83-89.

Angeli JPF, Ribeiro LR, Bellint MF, Mantovani MS. 2006 Anti-clastogenic effect of P­glucan extracted from barley towards chemically induced DNA damage in rodent cells Hum. Exp. Toxicol. 25:3 19-324.

Beer MU, Arrigoni E, Amado R. 1995 Effects of oat gum on blood cholesterol levels in healthy young men. Eur. J. Clin. Nutr. 49(7):517-22.

Behall K, Scholfield D, Hallfrisch J. 2004. Diets containing barley reduce lipids significantly in moderately hypercholesterolemic men and women. Am. J. Clin. Nutr. 80: 1185-93.

Behall KM, Scholfield DJ, Hallfrisch J. 1997. Effect of beta-glucan level in oat fiber extracts on blood lipids in men and women. J. Am. Coll. Nutr. 16:46-51.

Berggren AM, Bjorck IME, Margareta E, Nyman GL. 1993. Short-chain fatty acid content and pH in caecum of rats given various sources of carbohydrates. J. Sci. Food Argie. 63:397-406.

Biorklund M, van Rees A, Mensink RP, Onning G. 2005. Changes in serum lipids and postprandial glucose and insulin concentrations after consumption of beverages with P­glucans from oats or barley: a randomized dose-controlled trial. Eur. J. Clin. Nutr. 59: 1272-1281.

Bourdon I, Yokoyama W, Davis P, Hudson C, Backus R, Richter D, Knuckles B, Schneeman BO. 1999. Postprandial lipid, glucose, insulin, and cholecystokinin responses in men fed barley pasta enriched with P-glucan. Am J Clin Nutr 69:55-63.

Boussault P, Leaute-Labreze C, Saubusse E, Maurice-Tison S, Perromat M, Roul S, Sarrat A, TaYeb A, Boralevi F. 2007. Oat sensitization in children with atopic dermatitis: prevalence, risks and associated factors .. Allergy 62(11):1251-6.

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Charlton KE, Tapsell LC, Batterham MJ, O'Shea J, Thome R, Beck E, Tosh SM. 2012. Effect of 6 weeks' consumption of p-glucan-rich oat products on cholesterol levels in mildly hypercholesterolaemic overweight adults. Br. J. Nutr. 107(7):1037-47.

Cheung NK, Modak S. 2002. Oral (1 - 3),(1-4)-beta-D-glucan synergizes with antiganglioside GD2 monoclonal antibody 3F8 in the therapy of neuroblastoma. Clin. Cancer Res. 8(5): 1217-23.

Delaney B. 2004. Evaluation of the in vivo genetic toxicity of concentrated barley P­glucan. Food Chem. Tox. 42(1):155-156.

Delaney B, Carlson T, Frazer S, Zheng T, Hess R, Ostergren K, Kierzek K, Haworth J, Knutson N, Junker K, Jonker D. 2003a. Evaluation of the toxicity of concentrated barley p-glucan in a 28-day feeding study in Wistar rats. Food Chem. Tox. 41 (4):477-487.

Delaney B, Carlson T, Zheng GH, Hess R, Knutson N, Frazer S, Ostergren K, van Zijverden M, Knippels L, Jonker D, Penninks A. 2003b. Repeated dose oral toxicological evaluation of concentrated barley P-glucan in CD-I mice including a recovery phase Food Chem. Tox. 41(8): I089-1 102.

Daou C, Zhang H. 2012. Oat beta-glucan: Its role in health promotion and prevention of diseases. Comprehensive Reviews in Food Science and Food Safety, 11: 355- 365.

Dongowski G, Huth M, Gebhardt E, Flamme W. 2002. Dietary fiber-rich barley products beneficially affect the intestinal tract ofrats. J. Nutr. 132:3704-3714.

European Food Safety Authority (EFSA). 2009. Scientific Opinion on the substantiation of health claims related to beta-glucans and maintenance of normal blood cholesterol concentrations (ID 754, 755, 757, 801 , 1465, 2934) and maintenance or achievement of a normal body weight (ID 820, 823) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 7: 1254.

European Food Safety Authority (EFSA). 20 I 0. Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to oat beta-glucan and lowering blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal 8( 12): 1885.

Food and Drug Administration (FDA) (1997). Final rule for food labeling: Health claims: Oats and coronary heart disease. Federal Register. 62: 3584- 3681.

Food and Drug Administration (FDA). 2002. Food labeling: Health claims; soluble dietary fiber from certain foods and coronary heart disease. Interim final rule. Federal Register67: 61773-61783.

Food and Drug Administration (FDA) 2005. Food labeling: Health claims; soluble

TATE & LYLE CONFIDENTIAL 39

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dietary fiber from certain foods and coronary heart disease. Interim final rule. Federal Register 70: 7 6150-7 6162.

Food and Drug Administration (FDA). 2006. GRN 000207. Barley fiber. GRAS Notification by Cargill, Inc. http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/Noticelnventory/ucm 153 790.htm

Food and Drug Administration (FDA). 2008b. Food labeling: Health claims; soluble dietary fiber from certain foods and coronary heart disease. Interim final rule. Federal Register 73: 9938-9947.

Food and Drug Administration (FDA). 2010. Food Allergies: What You Need to Know. Food Facts. June.

Food and Drug Administration (FDA). 201 1. GRN 000344. Barley fiber. GRAS Notification by Cargill, Inc. http://www.fda.gov/Food/1ngredientsPackagingLabeling/GRAS/Noticelnventory/ucm258 862.htm

Food and Drug Administration (FDA). 2013. GRN 000437. Oat beta-glucan. GRAS Notification by Garuda Intl., Inc. hltp://www.fda.gov/Food/lngredientsPackagingLabeling/GRAS/Noticelnventory/ucm338 916.htm

Garuda International, Inc. (Garuda) 2012. GRAS Notice (GRN) No. 437, GRAS Assessment of Oat P-Glucan - 8 -CAN™ Food Usage Conditions for General Recognition of Safety. Prepared for Garuda, Exeter, CA by McQuate RS and Soni MG.

Granfeldt Y, Nyberg L, Bjorck I. 2008. Muesli with 4 goat beta-glucans lowers glucose and insulin responses after a bread meal in healthy subjects. Eur J Clin Nutr. 62(5):600-7.

Hallfrisch J, Behal I KM. 1997: Evaluation of foods and physiological responses to menus in which fat content was lowered by replacement with oatrim. Cereal Foods World. 42(2) : 100- 103.

Hallfrisch J, Schol field DJ, Behall KM. 2003. Physiological responses of men and women to barley and oat extracts (Nu-trimX). IL Comparison of glucose and insulin responses. 80(1): 80-83.

Health Canada. 2007. Cel iac Disease and the Safety of Oats: Health Canada's Position on the Introduction of Oats to the Diet oflndividuals Diagnosed with Celiac Disease (CD). Cat. : H164-51/2007E-PDF, ISBN: 978-0-662-46940-7.

HHS/USDA. 2005. The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA). Dietary Guidelines for Americans.

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http://www.health.00v/dietarvouidelines/dga2005/document/pdf/DGA2005.pdf.

Hughes SA, Shewry PR, Gibson GR, McCleary BY, Rastall RA. 2008. In vitro fermentation of oat and barley derived P-glucans by human fecal microbiota. FEMS Microbiol. Ecol. 64:482-493.

Institute of Medicine (IOM) of the National Academies. 2005. Dietary, Functional and Total Fiber. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids Washington DC. National Academies Press.

Jonker D, Hasselwander 0, Tervila-Wilo A, Tennin~. PP. 2010. 28-day oral toxicity study in rats with high purity barley beta-glucan (Glucagel M). Food Chem. Toxicol. 48:422-428.

Keogh GF, Cooper GJ, Mulvey TB, McArdle BH, Coles GD, Monro JA, Poppitt SD. 2003. Randomized controlled crossover study of the effect of a highly beta-glucan­enriched barley on cardiovascular disease risk factors in mi ldly hypercholesterolemic men. Am. J. Clin. Nutr. 78:711-8.

Keogh JB, Lau CWH, Noakes M, Bowen J, Clifton PM. 2007. Effects of meals with high soluble fiber, high amylase barley variant on glucose, insulin, satiety and thermic effect of food in healthy lean women. Eur. J. Clin. Nutr. 61:597-604.

Kim H, Stote KS, Behall, KM, Spears K, Vinyard B, Conway JM. 2009. Glucose and insulin responses to whole grain breakfasts varying in soluble.fiber, P-glucan. Eur. J. Nutr. 48: 170-175.

Knudsen K E, Jensen BB, Hansen I. 1993. Digestion of polysaccharides and other major components in the small and large intestine of pigs fed on diets consisting of oat fractions rich in beta-D-glucan. Br. J. Nutr. 70(2):537-56.

Kupper C. Gastroenterology. 2005 . Dietary guidelines and implementation for celiac disease. 128(4 Suppl l ) :S l21-7.

Liljeberg HG, Granfeldt YE, Bjorck IM. 1996. Products based on a high fiber barley genotype, but not on common barley or oats, lower postprandial glucose and insulin responses in healthy humans. J. Nutr. 126:458-466.

Mcintosh, GH, Whyte J, McArthur R, Nestel, PJ. 1991. Barley and wheat foods: influence on plasma cholesterol concentrations in hypercholesterolemic men. Am. J. Clin. Nutr. 53: 1205-1209.

National Foundation for Celiac Awareness (NFCA). 2014. The Gluten-Free Diet. Available at http://www.celiaccentral.org/Gluten-Free-Food/the-gluten-free-diet/

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Nilsson U, Johansson M, Nilsson A, Bjorck I, Nyman M. 2008a. Dietary supplementation with beta-glucan enriched oat bran increases faecal concentration of carboxylic acids in healthy subjects. Eur. J. Clin. Nutr. 62(8):978-84.

Nilsson AC, Ostman EM, Holst JJ, Bjorck IM. 2008b. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J. Nutr. 138(4):732-9.

Othman RA, Moghadasian MH, Jones PJ . 201 1. Cholesterol-lowering effects of oat P­glucan. N utr. Rev. 69(6):299-309.

Oliveira RJ, Ribeiro LR, Fernanda da Silva A, Matuo R, Mantovani, MS. 2006. Evaluation of antimutagenic activity and mechanisms of action of p-glucan from barley, in CHO-kl and HTC cell lines using the micronucleus test. Toxicol. in Vitro 20: 1225-1233.

Rashid M, Butzner D, Burrows V, Zarkadas M, Case S, Molloy M, Warren R, Pulido 0 , Switzer C. 2007. Consumption of pure oats by individuals with celiac disease: a position statement by the Canadian Celiac Association. Can. J. Gastroenterol. 2 1 ( 10):649-5 1.

Rieder A, Samuelsen AB. 2012. Do cereal mixed-linked P-glucans possess immune­modulating activities? Mol. Nutr. Food Res. 56(4):536-47.

Ripsin CM, Keenan JM, Jacobs DR Jr, Elmer PJ, Welch RR, Van Horn L, Liu K, Turnbull WH, Thye FW, Kestin M, et al .1992. Oat products and lipid lowering: A meta­analysis. JAMA. 267(24):3317-25.

Robertson JA, Majsak-Newman G, Ring SG, Selvendran RR. l 997a. Solubi lisation of mixed linkage (1 -3),(1 - 4)-P-D-glucans from barley, effects of cooking and digestion. J. Cereal Sci. 25:275-283.

Robertson JA, Majsak-Newman G, Ring SG. 1997b. Release of mixed linkage (1 - 3),(1

-4)-P -D-glucans from barley by protease activity and effects on ilea! effluent. Int. J . Biol. Macromol. 21 :57-60.

Saulnier L, Gevaudan S, Thibault JF. 1994. Extraction and partial characterisation of beta-g1ucan from the endosperms of two barley cultivars. J Cereal Sci 19: 171-178.

Shimizu C, Kihara M, Aoe S, Araki S, Ito K, Hayashi K, Watari J, Sakata Y, Ikegami S. 2008. Effect of high P-glucan barley on serum cholesterol concentrations and visceral fat area in Japanese men -- a randomized, double-blinded, placebo-controlled trial. Plant Foods Hum. Nutr. 63:21-25.

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Sundberg B, Wood P, Lia A, Andersson H, Sandberg AS, Hallmans G, Aman P. 1996. Mixed-linked beta-glucan from breads of different cereals is partly degraded in the human ileostomy model. Am. J. Clin. Nutr. 64(6):878-85.

Talati R, Baker WL, Pabilonia, MS, White CM, Coleman CI. 2009. The effects of barley­derived soluble fiber on serum lipids. Ann. Fam. Med. 7: 157-163.

Tiwari U, Cummins E. 201 1. Meta-analysis of the effect of P-glucan intake on blood cholesterol and glucose levels. Nutrition. 27( 10): 1008-16.

Tohamy AA, El-Ghor AA, El-Nahas SM, Noshy MM. 2003. Beta-glucan inhibits the genotoxicity of cyclophosphamide, adriamycin and cisplatin Mutat. Res. 541 (1-2):45-53.

Woodward JR, Fincher GB, 1983. Water soluble barley 6-glucans. Brewers Digest: 28-32.

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8.0 Appendices

TA TE & LYLE CONFIDENTIAL 44

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Appendix A. Certificates of Analysis - Characterization

TATE ~~~ LYLE

CERTIFICATE OF ANALYSIS

Product: 100 015 PromOat Betaglucan

Batch no:

Prod. Date:

Best before:

Chemic.al analYsis Average value Beta Glucan Dry matter

Bacte1iolo~iral analvsis

Total plate count Enterobacteri.aceae Staff. Aureus Yeast Moulds Sa.lmone lla E-coli

Tate&Lyle Sweden AB 03-09-2014

-. .. .. ,,

1326

2-t-06-2013

23-06-2015

34 94,7

<500 <10 <20 <60 <80 Negf25g. Negative

. ) .. ; ~ t' ( ( f / -

' ;.. /

/>'{ I // f .. -f -- ~ -v ~,

Ingbritt Johan.~son Quality Manager

TA TE & LYLE CONFIDENTIAL

cfu/g dh/g cftl!g cfti.lg cftJ./g

45

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TATE ~~~ LYLE

CERTIFICATE OF ANALYSIS

Product: 100 015 PromOat Betaglucau

Barch uo:

Prod. Date:

Best before:

Chemical analYc;is Average value Beta Glucau Dry matter

Bacretiolo~cal analvc;is

Total plate count Enterobacteriaceae Staff. Aureus Yeast Moulds Salmonella E-<:oli

Tare&Lyle Sweden AB 03-09-20U

-, - .

30-10-201.t

29-10-2015

35 94.3

<600 <10 <20 •:.'20 <80 ~eg/2Sg. ~egative

, / ~ ,.\\o- L {tt/ 1 , . ~rli 't ' )J ·:.~ ·-.... .)

lngbri It Johansson Quality Manager

TATE & LYLE CONFIDENTIAL

% %

cfo/g cth/g cfu/g cftllg cfulg

46

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TATE ~~~ LYLE

CERTIFICATE OF ANALYSIS

Product: 100 015 PromOat Betaglucan

Barch no:

P rod. Date:

Best before:

Chemic a I analYsis Average value Beta Gh1can Dry matter

Bac-re1iolo~iral anah·sis

Total plate count Etuerobacteriaceae Staff. A.Ufeus Yeast Moulds Salmonella E~oli

Tare&Lyll' Swed.en AB 03-09-201-l

-

Ull

11-03-2014

10-03-2016

Result

34 94

<100 <10 <20 <20 <.20 ~eg/25g. ~egative

' j • , I (. _ .( f / I >' { 1 / .{ <· 1 "hrG~·"'-. J I

Ingbritt Johansson Quality Man.ager

TA TE & LYLE CONFIDENTIAL

l711it

% ~,o

d h/g cftllg cftllg cftl/g d h/g

47

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SL40IJ Ca~ CC.-.) 91 ~ :: 10% NMKL No 13CI 11101 EU'..>ELC mod

SL411 Magne~m 1Mg) 370 mol\Q :: 10"4 NMKL No 13111901 EIJSEJ..J2 mod

SL413 iron {Fe) < 2.0 n>Q'lQ ±30'4 NMKL No 13111001 EUSELt2 mod

SL410 Pocassium \K) 74.00 mol\g ± 15"4 NMKL No 13111901 EU"...EU2 mod

SL40~ Phosphorus fP) 2800 mol\Q ± 10% NMKL No 13Q 1991 EU"..ELl2 moo

Sl.415 Z...OtZn) 1.5 mo~ ::20"4 NMKL No 130 1001 EIF.,EU! mod

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TA TE & LYLE CONFIDENTIAL 48

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LW03Y T-2 Toxin <10 µg/kg ±~% In house m•thod (210/

LW0'41 aaraltnon• (ZON) <10 µg/kg ± 35~~ In house m.U.Od (210/

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TATE & LYLE CONFIDENTIAL

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49

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~~~ e u rof i ns

Tate&Lyle Sweden AB lngbritt Johansson Alvasvagen 1 6 10 20 KIMSTAD

Rappo11 utfardad av ackled1terat laboratorium

Rcpo11 issued by Accredited Laboratory 1 .. 1

!'>• • ti • • .. ••

Euro flns Food & Agro THting Sweden AB Box 887 S,Ohagsg. 3 SE-53119 loOkopuig wW\v.ourofins.se

Tit, " 46 10 490 8310

AR-13-LW-028445-01

1 1111 ~11 m!U1lllltlllllll lll1llmFlllll'lll ID EUSELl-00046392 Client code·: LW9901581

ANALYTICAL REPORT Sample code · 525-2013·07170U8

Chen\ Sample Soluble Oat Fibre Batch. 1326

Received 2013-07-17

Repo11 finished 2013·07-30 Start of analysis 2013-07-22

Analysis Result: MRL Unit Un cert. Method Lab

LWOOV Fat acc. SolClec 0.42 g/100 g : 30% EUSEV

Sl41 2 Sodium (Na) 280 m~lkg t25% NMKL No 139 1991 EUSEl/2 mod

SL408 Calcium (Ca) 83 mgikg t 10% NMKL No 139 1991 EUSEL!? mod

Sl4 11 Magnesium (Mg) 380 mglkg .t10% NMKL No 139 1991 EUSELJ2 mod

SLA13 lrori (Fe) 3.2 mglkg t 30% NMKL No 139 1991 IWSF.L/2 mod

SL409 PhosphOlUS (P) 31 00 mgJl<g t 10•4 NMKL No 139 1991 EVSELl2 mod

SL405 Aluminium (Al) <5.0 mg/Kg t 30% NMKL No 161 1998 EVSE!.12 mod

Sl.403 Lea<! (Pb) <0.020 mg/kg >;20% NMKL No 161 1998 eVSEl/2 mod

Sl404 Cadmium (Cd) <0.010 mglkg :t 20% NMKL No 161 1998 EUSEL12 mod

SI 402 Arsenic (As) <0.050 rng/kg 'J; :i5% NMKL No 161 1998 EUSEU2 mod

SL39'3 Mercury (Hg) < 0.020 mg/kg % 30% EN 16277'2012 EUSEU2

JJOOO Aftatox1n 8 1 <0.1 IJOll<9 internal methoo based EUltAWE3 on EN 14123

JJ006 A ftatoxin Fl2 <0.1 µglkg Internal method based EUHAV\£3 on EN 14123

JJ006 AllatonnG1 <0.1 µg/kg inlemal method based E'VHAWE3 on EN H 123

JJ006 A flatoxin G2 <0.1 µ911<9 intornal method based EUHAWE3 on EN 141 23

LW020 Ochfatoxin <0.10 µg/kg :t30% NMKL H3 EU SEU

LW03Z Oeoxynivalenol (Vormtoxin l 200 µglkg '25% In Muse method (210) EUSF.1.1

LW03X HT·2 Toxin <10 µg/k g ! 30'4 In house rnethod (210) EUSELI

LV./03Y f-2 roxin <10 JJflll<g : 30'.4 In house melhod (21 OJ EVSEU

LW0~1 Zearalenono (ZON) <10 IJglkg % 25% In houee method (210) EUSELI

Uocert Moasuroment uncertainty

Symbol CMCt'IRtiCf\_ • (Not patt of the accre d1UAK>n)

Portorming laboroloiy 11 nothing efao 11 a1atcd Eurotins Food & Agro (t 'dkopin~J

TATE & LYLE CONFIDENTIAL 50

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• eurofins .. ~ AR-13-LW-028445-01 ... I llJUllll!lflDBllflllmllD'rnll ll EUSEU-00046392

Ll''130 l)mot11ylanu11a$1dphololui..1ide o.ou n\~/kg SW K 1 -f~-m016,1 (OMSTJ

l.P130 01pheoylamine 0.01' 0,05 mg/kg SlV K1·14·m016,1

MJ011 S1arch ane1 sugar / g/1009 AOAC 99612

SLB89 Sutp~'" tolal tS) 1'00 mgll.g t 20°~ NMKL No 161 1990 moo

LP1~i0 N1> 1l ttu1r pe.st1dde r~s1ouea detectco iSLV Kt~f ... rn0 16.1),

Samplo conctuslon:

Pesticide residues have a measurement uncertainty al an interval of 3o-60%.

Ulrica Svensson. ASM

This test report has been created electrorncally and has been verified and authonsed.

Test wts ptrformod by

l',UHAWE3

EUNOTR2 EUSEU EUSl:Ll2

~01!1m

f:urulin& Wt.J Contan11n~r'll$ GmbH (H~•rtblJfC) Eorotlns FoOd & 119ro Testing No.w•yAS (S<ansen) lrond""1m

Euroions fOOd & 119ro Tesung Sweden AS. l.Jdkop;rig f-urofins t..nvw-onmcn1 Sweden. l tdkop.ng

" (P..OI P')1 d UM! ilCC:f8d4•~'

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TN: retl.Att nwy noc oc r~ e&tePI t1 ll.'I ~ • wc'(1~C'\fall o( W. l&t>OrltOty ~ rft.l.AlS , ...,,,. Cl'ly to lhe swr.:plc •nlllyted

TA TE & LYLE CONFIDENTIAL

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.:·-. e u rofi ns

Ta!<~XI yfe 8w1;<l('n AB lngbntt Jcnn:1sson i\Jv,'lsv.'igon 1 6 10 20 KIMSll\U

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ANALYTICAL REPORT .----------------------------------------------.... ·--$ .1.."Tl:_l-t- ¢00C· )26-2-0 13-120)0224

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TATE & LYLE CONFIDENTIAL 52

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TATE & LYLE CONFIDENTIAL

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53

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Appendix B. Technical Product/Data Sheets

TA TE & LYLE CONFIDENTIAL 54

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PromOat'" TECHNICAL DATA SHEET: PromOatn.i BETA GLUCAN

Description: PromOat ... Beta Glucan is a natural soluble dietary fibre ingredient from oat grain. rich in {1 -3, ·1-4} beta glucan

Appearance : Fine, cream coloured powder

Origin: 100% Swedish oat grain which is non-GMO Avena sativa. SW Kerstin variety

1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND COMPANY/UNDERTAKING

Product identity I name

Product use

Product make-up

Company

PromO.ltTM Beta Gluc~m

Food ingredient I food preparations

Oat kernel extract: Beta glucan soluble fibres and arnylodextrins from oat bran

Tate & Lyle Oat Ingredients Alvasvagen 1 SE 610 20 K1mstad Sweden

Te l no + 46 11 25 36 30

Email [email protected]

2. COMPOSITION / INFORMATION ON INGREDIENTS

PromOat™ Beta Glucan is a fraction of mflled whole oat grain, derived from the bran, which is gently processed using an alpha-amylase enzyme and physical separation in down-stream processing, and is particularly rich in the soluble fibre component, beta glucan. The product a lso contains dextnns (amylodextrins) and gluco-oligosaccharides from the oat grain. Insoluble fibre, proteins and oils present in the original oat bran fraction are removed from the product by centrifugation. PromOatn. Beta Glucan is supplied as a drum dried powder.

11 ' • :-.· ~ '~~ 1 • ~· '· _ - · ." oa! [email protected] 112

TATE & LYLE CONFlDENTIAL 55

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TECHNICAL DATA SHEET: PromOat1M BETA GLUCAN

3. PHYSICAL AND CHEMICAL DATA

PromOat™ Beta Glucan is a fraction of oat bran.

Dietary Fibre Soluble 11 glucan Total Dietary Fibre Carbohydrate (dextrin) Protein Mineral ash Fat

Supplied With a typical moisture content of 4-6%

Appearance: Fine, cream coloured powder

Density (g/cm3): circa 0.25

Water solubility: good to moderate

l n 1.i.:. °" .l.J l u.i.:. \..,V I 'll' lLJ.i.:.1 '111.M.L

33-36% 36-38% 54-57%

<4.5% 1-3%

0.5-1%

PromOat ·~

..JV

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TATE ~~~ LYLE Prom Oat

Beta G!ucan

PRODUCT DATA SHEET: PromOat® Beta Glucan

Description: PromOat® Beta Glucan is a natural soluble dietary fibre ingredient from oat grain. rich in {1-3, 1-4} beta glucan

Appearance: Fine, cream coloured powder

Origin: 100% Swedish oat grain which is non-GMO Avena sativa, SW Kerstin variety

Label declarat ion recommendation: oat beta glucan/ oat bran soluble fibre/ oat fibre/ oat soluble fibre

Supply specification Beta glucan (on dry matter)

Dry matter

Value > 33% > 93%

Typical 34-36% 94-95%

Method AOAC method 995.16

Nutrit ional Data (Values per 1009 PromOat11i. expressed on dry matter) Energy 31 5 kcal or 1319 kJ Fat 0.5 g

of lo\tlich aaturates <O. i g

Carbohydrate (oat maltodextrins) 56 g of wl'lch Sugars <0.5 9

Fibre (oat beta glucan) 35 g Protein (N' 025) 4 g Salt <70mg SOdlum <25mg

Microbiological data Total plate count 30° dulg Enterobactenaceae cfu/g S. aureus cfu/g Yeasts cfu/g Moulds dulg Salmonella E. coli cfu/g

Value <1000 <10 <20 <100 <100 negative I 25g negative

Method NMKL Nr 86, 1999

NMKL Nr 144, 2000

NMKL Nr 66, 3 edt. 1999 modified

IDF 94S: 1990 modified

IDF 94S: 1990 modified

NMKl nr 71, 5 edt. nioddied NMKL nr 125 3 edt. 1996

PrornOat® Beta Glucan generates pH 6-7 when dissolved or mixed in water ("1%)

Packaging: 15kg plastic lined paper sack. Bag labefling includes batch code, label declaration and best before date

Pallets : Euro pallets which hold 24 x 15kg bags of PromOat® = 360kg in total

Storage and handling: store 1n a clean, dry, well-ventilated warehouse at ambient temperature and humidity, away from odorous materials

Best before: 24 months after production date

"'~-.a ... :·· • ' ,, .. r .... ! "i · _,\ . ,

" " • 4 I. 111

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Appendix C. Stability Test Results

Analysis Start R 3 mos. R 3 mos. v 3 mos. F 6 mos. R 6mos. V 6 mos. F 9 mos. R 9 mos. V 9 mos. F

Peroxide number mekv/kg x x x x x x x x x x

Free fatty acids g/ l OOg x x x x x x x x x x

Protein content• g/lOOg 3.9 3.9 3.9 3.8 3.7 3.9 4 3.9 3.9 3.9

Dry matter g/lOOg 9S.S 9S.3 96 9S.S 9S.5 96.3 95.6 94.8 95.8 9S.S

Beta-glucan g/lOOg 34.3 34.6 35.3 34.7 34.3 3S 3S.7 33.6 34.7 33

Mol. wt. milj.Dalton 2.3 2.2 2.1 2.1 2.2 2.1 2.1 2.1 2.2 1.9

pH 10% solution 5.9 S.9 6 6 5.9 6. 1 6.1 5.9 6 6.1

Aooearance OK OK OK OK OK OK OK OK OK OK Color OK OK OK OK OK OK OK OK OK OK

Smell OK OK OK OK OK OK OK OK OK OK

Taste OK OK OK OK OK OK OK OK OK OK Vol. wt. kg/I 0.56/0.59 0.56/0.59 0.5S/0.58

Total count cfu/g 200 so 50 <SO 2SO <SO 100 <SO <SO <SO Total thermophilic count

cfu/ g so <SO <50 <50 50 150 <SO <SO <SO <SO

Enterobact. cfu/g <10 <10 <10 <10 <10 <10 <10 <10 <10 <10

Bacillus.cereus cfu/g <20 <20 <SO <20 <20 <20 <20 <20 <20 <20

Staph. aureus cfu/ g <20 <20 <SO <20 <20 <20 <20 <20 <20 <20

Yeast cfu/g <20 <20 <20 <20 <20 <20 <20 <20 <20 <20

Molds cfu/g <20 20 20 <20 <20 <20 <20 <20 <20 <20

E. coli cfu/g x x x x x x x x x x

* R - room t emperature; V - 40°C; F - freezer (0°C)

TATE & LYLE CONFIDENTIAL

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Analysis 12 mos. R 12 mos. v 12 mos. F 18 mos. R 18 mos. V 18 mos. F

Peroxide number mekv/kg x x x x x x

Free fatty acids g/lOOg x x x x x x

Protein content• g/lOOg 3.9 3.9 3.9

Dry matter g/lOOg 94.4 9S.3 9S.7 94.S 96.2 9S.S

Beta-glucan g/lOOg 3S.l 3S.2 33.8 33.3 3S.3 34.2

Mel. wt. milj.Dalton

pH 10% solution S.9 6.1 6.1

Appearance OK OK OK OK OK OK Color OK OK OK OK OK OK

Smell OK OK OK OK NA OK Taste OK OK OK OK OK OK Vol. wt. kg/I O.S6/0.S8 0.56/0.57 O.S4/0.S9 O.S4/0.S6 0.SS/O.S8 0.S4/0.56

Total count cfu/g <SO so <SO <SO <SO so Total thermophi lic count cfu/g so <SO <SO 100 <SO <SO

Enterobact. cfu/g <10 <10 <10 <10 <10 <10

Bacillus. cereus cfu/g <20 <20 <20 <20 <20 <20

Staph. aureus cfu/ g <20 <20 <20 <20 <20 <20

Yeast cfu/g <20 <20 <20 <20 <20 <20

Moldsdu/g <20 <20 <20 <20 <20 <20

E. coli cfu/g x x x x x x

• R - room temperature; V - 40°C; F - freezer (0°)

TA TE & LYLE CONFIDENTIAL 59

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Exhibit I. Report of the Expert Panel

TA TE & LYLE CONFIDENTIAL

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CBI Deleted Copy

Petition to Add to the National List 7 CFR 205.606: Oat Beta-Fiber

APPENDIX

Appendix 4 : Tate & Lyle Oat Ingredients Launches in the Market with PromOat® Oat Beta Glucan

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TATE ~~~ LYLE

• ft t IO. t t ft It It t t t t t t t to t t t 1 o t t I t I It It It t I It t I I I• O t It O '• • o * O • • • O O O O • • • • • I •• • O + 0 ' O • • • O • O • • • 0 t o • O O 0 0 • O O O O • • • t ~ IO Io o 0 o o o • • o o • t 0 ' 0 t o o I O o o It o o • I I o o o o o o I I I o o o • o o o o o o • o O o O • ~ O o o f of I ! I f f o o o o tot o to ft If f t I I o 10 t I f It I I If If It t t • • t t ff t t t f I

Tate & Lyle Oat Ingredients Launches in the Market with Beta-Glucan

I(!) PromOat Bota Glucon

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Migros - Yogurt Switzerland

.:.

With 1g of beta-glucan per portion (225g)

100g containing 1 'up t~25g) c:ontelns

Energy 41 Okj (98kcal) l i , kc-a l

Protein 6g 1<1$

Carbohydrate 14g 3~

of wtuch sugars 7g Hi~ ------Fat 1.l g .'!.7i

of wtuch saturates O • .!g o .~~ - - - - - .,.....,,..,... -

Fibre 3.Sg tli

( of which oat beta-glue an - o.~g---~-~--- I ~ ]

Sochum

Cooking salt

0.07g

.. O.l g

0.16i

0.4

TATE ~~ LYLE 2

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Blevita Hafer Honig: Spelled Cookies with Oatmeal and Honey Flavor Switzerland ··································································· · ······· · ···· · ·· · · · ····· · ·· · ··· ·· ··············· · · ·· ··········· · ················ · ······ · · · ·· · ·······················································~····

With 1 g of beta-glucan per portion (36g)

100g containing 1 Portion (36~) cohtelns

Energy 1650ltj (392kcal) M,kcal --·

Protein l3g 4.Si -- ··--

Carbohydrate 57g 21~

of which sugars 4.Sg 1.5i

Fat 10g 3.Sa

of which sarurares 1g -..o.5.t

Fibre 11g c~

I of which oat beta-gluca n 2.Bg I ~ I Sooium a. sag o. ~ 1 i

Cooking salt 1.3g o.se

TATE ~~ LYLE 3

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Sponser Pro Mass Gainer - Dietary Supplement Switzerland

AROMES/CONDITIONHEMENT

Chocolat Vanilla

Bolte de 1200 g Bolte de 1200 g, 2000 g

VAl.EUR NUTRITIVE$

VALEUR NUTRITIVE PER 100 0 POUDRE enetQie kJ (kcal) 1680139fil omteine 30 (J

glucides 61 Q dont - sucrose 17g -g.lucose 7.1 g - fructose OQ - lactose 0.40 lipid es 3.0Q - dont acides gras satutes 2.Bg - dont t:riQlvcerides moven 1.5 0

I .C L -- ·--- ... -! - l'lnnl L • • • • •· •••••• , 7;;

sodium 0.28g VITAMINES Ill.UR• E 4.0mo 33% c 21mo 3111% 81 o.3rno 27% 82 0.5mo :le% niacine S.3mo 33% B6 0.5mo 3!% acide folioue 67 uo 3111% 812 0.8 uo 32%

With 1 g of beta-glucan per portion (60g) bioline 17 un ~% 1 acide oantothltniaue 2.0mo 33%

SELS MINERAUX %.UR calclum 400mo 50% maon6slum 60mo 16%

I phosohore 280mo 1110% chrome 3111 µg 85%

ere a tine 2.!5 c 'apportjournalier reoomma.nd6

1 l'ORTION (IO Q) 10071238)

18 a 37 g

10 g Ill.Jg

Og 0.20 1.6g 1.7 g 0.9o .. -, Oh I

o. i7 (l Ill.UR•

2.111 ma 20% 16mo 20%

o.2mo 18% 0.3mo 21% 3.2 Mo 20'Mi 0.3ma 21%

1110 ua 20% 0.5 Uri 20% 10 llfl 20%

1.2mo 20% %A.JR•

240mo 30% 36 "10 10"9

168 ll1Q 2•% 20 µg 50~

1.60

T )·C .:'.4 TATE ~~·~ LYLE 4

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BetaBalance - Sachet Supplement UK With 1 g of beta-glucan per portion {6g)

~ · 4

lil PromOat Boto Glucon

TATE 1~~ LYLE 5

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Hovis Hearty Oats - Bread UK

With 1 g of beta-glucan per portion (2 slices - 889)

Energy

Fat

of which saturates

Carbohydrate

- -of which sugars

..

Fibre

Protein -

Salt

Beta-glucan

r.-»11 & 1.vte 21•.:

Per slice (44g)

460 kJ 109 kcal

1.9g

0.4g

16.4g

1.2g

2.5g

5.4g ..

0.42g

O.Sg

Per portion 2 slices (889)

920kJ 21 Bkcal

3.8g

O.Bg

32.Bg

2.4g

5g

10.Bg

0.84g

1g

TATE .. ~ LYLE 6

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Migros, Farmer Croc - Cereal Switzerland

6- 4

•• ••• •e •••••• • IJIJ IJIJIJ•IJ • • • • ••• • • • •• • • •••• • • • • o o • o • • • • • o • • e o • IJ • o • • •• IJ IJ • • • o o • IJ • • o o • • • IJ IJIJ o • o o e • IJ ••• IJ• •• • • • • • • • •' • ••' '••• • • IJ IJIJIJ ••••I IJIJIJ • • •• IJ• • IJ IJIJ • IJ eelJeee IJe IJ IJ I e I •IJ IJ IJ • IJIJ ee IJ • IJ o e f •e I. IJ e"

With 1 g of beta-glucan per portion (45g)

100g comamlng 1 Portion (45g) contti lns

Energy 1710kJ (460kcal) , S3kcal . - - ~

Protein Sg 3 .S~

Carbohydrate 65g 29i

of which sugars 2<!g 11~ ---· ·- - -

Fat 10g 4.5.a

of which saturates 3.Sg , .sg -- - ---- - - --- - - ~

Fibre 12g Si

I of which oar beta-glucan 2.Sg l f J

Sodium

Cooking salt

0.18g

o.sg

o.os~

o .~

TATE ~~ LYLE 7

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Col Cuore, Galbusera - Biscuits Italy

I tt •• * tt • '• t• tt tee• • t tt et 1 ee• ' ' 111 I II I II I I I ••• I •• ••• •• I o •• • • • • •• • • 'o ••I

~o With 1 g of beta-glucan per portion (50g)

UJ

~ ColC11.o~

-LI.. Energy

25 Fat

. -of which saturates

- '.

Carbohydrate

of which sugars

IN(.;RfDlfNTI Fibre

HIV".nt.n int~nral~ ,.-

Protein - --

Sodium

le e Beta-glucan

Per100g

1872 kJ 447 kcal

16.Sg

2.Sg

61.2g

22.Sg

10g

-8.3g

0.49

2g

Per portion 8 biscuits (50g)

936 kJ kcal 223 kcal

8.3g

1.3g

30.6g

11 .3g

Sg

4.2g

0.2g

1g

TATE ~'~ LYLE s

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Marks & Spencer - Juice UK

14

With 0. 75g of beta-glucan per portion (300ml)

Per 100ml Per portion (300ml)

Energy 280 kJ 65kcal 840 kJ 195kcal - ·-

Fat 0.9g 2.7g

of which saturates O.Sg 1.Sg

·- ... - -

Carbohydrate 13.Sg 41.49

·-of which sugars 11.Sg 35.49

·- - - . -·

Fibre 0.7g 2.1g

Protein 0.49 I 1.2g

Sodium 0.01g 0.03g

- --Beta-glucan 0.25g 0.75g

TATE J~ LYLE 9

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Vetta - Pasta Australia ......................................... ......... ..... ' .. .... .. ........ .................. .. . eo o ' o e o • e •• o • • • o o o o o o o o oo o o o' • o o o o o o o o o o • o o o o o • o • o o o o o o • · •• • o o ee e e e e o e ••• o •• eo 'e • eee 0 e ' 0 o o ee ee •• '' te e e e • • t etee ee e I et et tt

With 1 g of beta-glucan per portion (1 OOg)

NUTRITION INFORMATION t SERVINGS PER PACKACE:3.75 SEIMNC SIZE: 100g

PERY%~~ ~1~~ ENERGY PROl'EIN

1 SOOkJ (359"""

Fi\T - TOTAL -SATURATED

DIETtWt' RBRE

ll~ I.Si o.~ 4.~

-SUGARS 3.fti SODIUM 25111

17, 1500kJ ~59k<W) 25\ 12.~ 2, 1.~ 1' o.~

15ft 4.~

tlt#CR~TON RELATES TO UNCOOKED ~STA •llfl DAILY INTAKES ARE BASED ON AN A~RACiE ADULT DIET OF 8700kJ. '!OUR CWLY INTAKES MAY BE HIGHER OR I.ONER DEPENDNC ON YOUR ENERGY NEEDS.

TATE I~~ LYLE 10

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Ostras - Bread Sweden •I I II II• I• I I I 1111 I I I I II Ill I I I I I II I I I I IO II I I II• I II I I I •I•"" I• I • IO•• IO • •••• ' I"• • ••••• O •• • IO O O • • • •" o O "I O f o o •I'• Io o o o Io o o o Io• o I• o o • o o o o • o • o o o o o o o I o o Io o Io o o o o o o o 1 o o Io o o Io o o • o o o 'o o o o o o 1 o Io o o o o o o o o 1Iof11ooooo1 t 1 t if o o 11 o o 1 o 1 1 o 1 o o o o o o o I 1

Claimed to provide 1 g of beta-glucan per slice

Per100g

Energy 1020 kJ 240kcal

Fat 1.5g

::,-.=.-.~:-.= ·a -· ·1* .- 4 C .L of which saturates 0.2g I

.... _ .. ,,.... __

· ~-­:;:"' ...... 1 ·v·~..-- I ~-=---- ~ .. lil -.....-,!:;.,.-::.=;... ~........, • ._;:;,..... · U. Carbohydrate 469 = ................. .......... -------............... ~ . ..... of which sugars 4g _ ......... -­,,......,.,_ .........

...... -~-:=-:ar:-r~::.-- I. - Fibre 5.5g

... ==-' ·~ ---- ------ - · Protein 1

• 9g

Sodium 0.32g

TATE ~~ LYLE 11

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CBI Deleted Copy

Petition to Add to the National List 7 CFR 205.606: Oat Beta-Fiber

APPENDIX

Appendix 5: Material Safety Data Sheet (MSOS) for PromOat® Oat Beta-Glucan

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~PromOat™ MATERIAL SAFETY DATA SHEET (MSDS): PromOat™ BETA GLUCAN

1. IDENTIFICATION OF THE SUBSTANCE AND COMPANY

Product identity I name

Product use

Product make-up

Company

Tel no

Email

PromOat™ Beta Glucan

Food, beverage and nutritional supplements ingredient

Oat kernel extract: Beta glucan soluble fibres and amylodextrins from oat bran

Tate & Lyle Oat Ingredients Alvasv~gen 1 SE 610 20 Kimstad Sweden

+ 46 11 25 36 30

[email protected]

2. COMPOSITION/ INFORMATION ON INGREDIENTS

PromOatT"' Beta Glucan is a fraction of milled whole oat grain, derived from the bran, which is gently processed using enzymes and physical separation in down-stream processing, and is particularly rich in the soluble fibre component, beta glucan. The product also contains dextrins (amylodextrins) and gluco-oligosaccharides. Insoluble fibre, proteins and oils present in the original oat bran fraction are removed from the product by centrifugation. PromOat™ Beta Glucan is supplied as a powder.

3. PHYSICAL AND CHEMICAL DAT A

PromOat™ Beta Glucan is derived from milled whole oat grains.

Dietary Fibre (Soluble B-glucan) Total Dietary Fibre Carbohydrate (oat maltodextrins) Protein Mineral ash Fat

Supplied with a typical moisture content of 4-6%

33-36% 36-38% 54-57%

<4.5% 1-3%

0.5-1 %

oat mfo@tateandlyle com 1/5

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~PromOat™ MATERIAL SAFETY DATA SHEET (MSDS): PromOat™ BETA GLUCAN

Appearance: Fine, cream coloured powder

Melting point: Not Applicable (decomposes before melting)

Boiling point: Not applicable

Vapour density: Not applicable

Vapour pressure: Not applicable

Density (g/cm3) : circa 0.25

Flash point: Not applicable

Explosion limits: Avoid flames/sparks or equipment where sparks are generated

Auto ignition temperature: Not given

Water solubility: good

4. HAZARDS IDENTIFICATION

None identified

5. FIRST-AID MEASURES

INHALATION: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.

INGESTION: PromOat™ beta glucan is designed for human consumption and is not known to cause any adverse effects. Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Loosen tight clothing such as a collar, t ie, or belt waistband.

SKIN CONTACT Wash with soap and water.

EYE CONTACT Wash with running water, holding eyelids open, or use an eye fountain. In the unlikely event of any d iscomfort, or continuing discomfort, seek medical attention.

oat infQ@t@!M2]yle com 215

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MATERIAL SAFETY DATA SHEET (MSDS): PromOat™ BETA GLUCAN

6. FIRE-FIGHTING MEASURES

The product is in the form of a powder and may be flammable at high temperatures.

SMALL FIRE: Use DRY chemical powder.

LARGE FIRE: Use water spray, fog or foam. Do not use water jet. Combustion of any dry residues releases C02

7. ACCIDENTAL RELEASE MEASURES

SPILLAGE: Sweep up. Avoid formation of dust cloud.

WASTE DISPOSAL: Dispose of in accordance with national and regional regulations. PromOat™ Beta Glucan is entirely biodegradable.

Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements.

8. HANDLING AND STORAGE

STORAGE: Store in cool dry place away from heat and oxidizing agents. No other special precautions needed.

USAGE PRECAUTIONS: Avoid spillage and direct skin and eye contact. Safety goggles should be worn when dealing with large volumes. No particular hand protection is required.

STORAGE CLASS: Unspecified storage

Qa.!J.n!Q@tateandlyle com 3/5

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t!l PromOat ™

MATERIAL SAFETY DATA SHEET (MSDS): PromOat™ BETA GLUCAN

9. EXPOSURE CONTROL I PERSONAL PROTECTION

COMMENTS: No exposure limits noted for the ingredient Those very few people who have a specific allergy to oat grain should consult a doctor before working with PromOat™.

PROTECTIVE EQUIPMENT: Good laboratory pract ice.

RESPIRATORY EQUIPMENT None needed or recommended

HAND PROTECTION Good GLP: Use waterproof protective gloves made from, eg pvc, polyethylene, neoprene

EYE PROTECTION Good GLP: Use of approved safety glasses or goggles is recommended only when eye exposure is probable

OTHER PROTECTION None needed

HYGIENE MEASURES Always wash at the end of each working shift, before eating, smoking or using toilet facilities

10. STABILITY AND REACTIVITY

The product is stable under normal conditions of temperature and pressure. Combustible as PromOat™ is a carbohydrate-rich powder. Try to avoid formation of a PromOat™ Beta Glucan dust cloud. Regard as equivalent to starch in this respect.

Avoid contact with extremely strong oxidizing agents.

II I 1\o ' I o I I ! ,

oat 1ofo@tateanc:!lyle.com 4/5

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(!) PromOat TW

MATERIAL SAFETY DATA SHEET (MSDS): PromOat™ BETA GLUCAN

No dangerous reactions are known or reasonably foreseen.

11. HEAL TH HAZARDS I TOXICOLOGY

ACUTE EFFECTS: None

CHRONIC EFFECTS: None

TOXICITY DATA: None given

No known toxicity. Not absorbed through the skin.

Inhalation of excessive dust may transiently irritate the nose, throat and respiratory tract. Eye contact with dust may cause mild and transient irritation. Ingestion of quantities sufficient to produce any adverse effects whatsoever is not plausible in an industrial or manufacturing situation.

Skin contact is not known to be hazardous.

Oat bran soluble fibre and carbohydrates have no known carcinogenicity and are not classified as a reproductive toxin by any authoritative body or regulatory agency.

! I I 1 1 J • •

oat [email protected] 5/5

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CBI Deleted Copy

Petition to Add to the National List 7 CFR 205.606: Oat Beta-Fiber

APPENDIX

Appendix 6: USDA NHANES Nutrient Intakes from Food, 2009 - 2010.

Data Source:

What We Eat in America, NHANES 2009 - 2010, page 1 (fiber data highlighted by author) http://www.ars.usda.gov/SP2UserFiles/Place/80400530/pdf/0910/Table 1 NIN GEN 09.pdf

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Table l. Nutrieot lntakt"S from Food: Mean AmounisConsurned per Individual ' . by Gender and Age. in 1hc United States, 2009-2010

Mono- l'o ly-Gender Sample Food Carbo- Total Dietary Total SaturJtcd unsaturated unsaturated and age size energy Protem hydrate sugars fiber fat fat fat fa1

<~ears) kcal <SE) g <SE) t.t ISE\ ll (SEl J.( CSF.l 1' (SE) g <SF.l g CSF.l g CSE>

Male5: 2 . 5 . .. ... ...... 452 1553 (25 6) 55 7 ( 1.24) 216 (3.4) 111 ( 1.9) 12. I (0.25) 54.4 (t.74) 19.6 (0.76) 190 (0.61) 10 .8 (0.38) 6. 11. ......... ... 588 1922 (32.6) 68.3 ( I 40) 259 (4.5} 126 (1.9) 13.6 (0.24) 70.3 tl.56) 24.7 (0.70) 24.8 (0.56) 14.S (0.4 1)

12. 19 .......... 672 2539 (72 8) 95.2 (3. t4) 335 (I LO) 161 (5.1) 16.4 (0.70) 91.9 (3.25) 31.3 (1_17) 32.7 (US) 19.4 (G.65)

20 . 29 ............ 450 262t: (794) 101.0 (3.75) 320 (9. 7) 146 (6.2) 17.2 (0.80) 930 (3.49) 30.7 ( I tO) 33 5 (1 .36) 20.3 (0 97) 30. 39 ............. 455 2736 (44 9) 106.4 (3.4 7) 327 (7 6) 143 (6.7) 19 .7 (0.86) 97.6 (2.J3) 31 5 ( 1.10) 35.9 (0.83) 212 (0.57) 40. 49 .............. 481 2730 (73.2) 107.9 (3.04) 320 (7.8 ) 141 (4.3) 20.3 (0.98) 103.1 (4.32) 342 (1.67) 37.9 (1.60) 21.5 (0.82)

50 . 59 ..... ........ 470 2482 (55 3) 99.8 (3. t3) 279 (8.9) 122 (7 0) 18.9 (0.82) 96.6 (2 92) 32 3 ( 1.29) 34 6 (0.9&) 210 (0.66) 60- 69 ........... 449 2206 (40.0) 89.3 (I 68) 254 (4.7) 108 (4 I) 18.2 (0.49) 84.5 (2.07) 27 2 (0.80) 31.0 (0.90) 18.6 (066) 70 and over ..... 484 1907 (41.1) 74.4 (I 79) 232 (5. 1) 104 (3.8) 17. 1 (0.58) 72.4 (1.73) 23.0 10.64) 27.0 (0.69) 16. l (055)

20and over ... 2789 25 12 (30.7) 989 (l.37) 296 (3.5) 131 (2.4) 18.7 (0.39) 93.3 (1.71) 30.6 (0.71) 34 .0 (0 S7) 20.2 (0.39)

Females: 2· 5 ............. 409 1520 (36.7) 55.6 (I 49) 206 (5 2) 108 (3.3} I 1.3 (0.4 1} 54.9 ( I 72) 20.6 (0.91) 18.8 (0.61) 10.5 (0 52) 6 • I 1 .............. 566 1812 (24.5} 63.2 (1.35} 252 (4.9) 120 (2.5) 14.5 (0.46) 63.9 (0.97) 22. 1 (0.45) 22.5 (0.39) 13.5 (0.331

12- 19 .............. 593 1821 (43.9) 64.0 (1.48) 242 (6.6) 1 17 (4 .4) 12.6 (0.35) 67.9 (1.72) 23 I (0.63) 23.6 (0.64) 15.2 (0.63)

20. 29 .... ......... 524 194<; (S•I 7) 70. l (190) 250 (7.0) 120 (4 6) 13.6 (0.40) 70.8 (2 70) 236 (1.08} 25.0 (0.96) 15 7 (058) 30. 39 .... .... 499 1831 (.3 1.5} 69.6 ( 1.68) 232 (34) 104 (3.2) 16.6 (0.63) 67.8 (l.95) 222 (0.61) 24.3 (0.74) 15. 1 (0 57) 40 · 49 .............. 555 1794 (59.2) 69.0 (2.04) 228 (8.3) 105 (5.0) 15. 1 (0.70} 65.3 (2. 14} 21.2 (0.70) 22 .9 (0.73) 15.J (0.65)

50· 59 ...... 429 175<; (38.4) 69.6 (I 99) 219 (5.6) 100 (3 4) 17.0 (0.57) 66.0 ( 1.84) 21.0 (0 78) 23.6 (0.69) 15 4 (0.46) 60-69 ............ 453 1717 (35 .4) 66 8 (I 55) 209 (4 6) 96 (3.3) 15.6 (0.38) 66.7 (2.21) 2 1.9 (0.85) 23.8 (0.82) 15 I (0.6 1) 70and over ...... 5 13 1535 (34 4) 60. 1 (I 51) (96 (4.1) 89 (22) 15.2 (0.39) 57.8 (1!12) 19.0 (0.48) 20.2 (0.55) 13.5 (0.38)

20 and over... 2973 ins (IS.0) 68.0 (0.68) 224 (2. 1) 103 ( 1.0) 15.5 (0.21) . 66.0 (0.59) 2 16 (0.22) 23.4 (0.18) 15 I (0.22)

Males and females: 2 and over... 9042 20fll (1 2.9) 79.S (0.70) 259 ( 1.7) 119 ( I. I) 16.2 (0.20) 76.8 (0.75) 25.S (0.30) 27.5 (0.24) 16.8 (0.13)

'

OATA SOURCE: Who/ W~ E11t in Amer;~a. Nll.ANES 2Q09 .. 20l0. indi\.·iduab 2 ytarsc a.dover (u cludiog b.-.a.s« ~fed e:hildrtn). da_y I ditt.ary i.ntakt data. ~ni:hffl'I. Pagt I of9

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Sym l>ol Legend

• Indicates an estimate that may be less Haristically reliable than estJmates that arc not flagsed. The rules for flagging estimated means are as follows:

Footnot.s

Mean: An estimated 1ncan 1s Oagged when based oo a sample size of less than 30 times the variance inOation factor (VIF), where ~1c VIF represents a broadly calculated average design effect. or when the rclauve standard error 1s greater than 30 percent The \/IF used in this table is 2.04

' Sample weights designed for dietary analysis were u~ to allow eSllmates rcprcscmativc of the U. S population for the ycaB or collection.

'Salt adjusur1ent "not appljed to What W~ cat in Ammca, NHANES 2009·2010 and all subsequc'llt surveys. Estimates of sodium intake include salt added 10 cooking and lbod pn:parat10n as assumed in the nutrient profiles for foods in FNDDS S 0. Detw ls available at. )!j.\ICW ars usda.goyLhalbbnrc/fsrg.

1 Alcohol estimates arc shown only for 20 years and over age groups. Althou{lh the data arc colleeted for all individuals. estimates arc not presented due to "'treme vanab1hty w1dtor madequate samples~e.

Abbrtviadons SE • standard error: RAE= retino l act1v1ty equivalents: DFE • dietary folatc eqrnvalents. SFA • saturated fatty acid: MFA = monounsaruratcd fatty acid: PFA = polyunsaturated fatty acid.

/'iotes Applicable to All Tables in Series: What We Eat in Amuit·a. NHANES 2009-2010 The statistics in this table arc estimated fioro Day l dic:lar)• recall interviews conducted in the What We E.a1 tn America. National Health and Nutrition Examrnauon Survey (NHAl'.1;:$) 2009-20 I 0. The 24-hour dielal)' recalls were conducted io·person. by ttamed interviewers, usmg the USDA S· step Automated Multiple-Pass Method. Food intakes were coded and nutnent values were determined using the USDA Food and N11tnent Database for Dictnry Studies ~.O www ars.usd!!.goy/ba/bhnr!i/fmi which is based on nunient values in the USDA Nauom~ Nutrient Data~ase for Standard Reference. Release 24 (Agricultural Research Service, Nutrient Data Laboratory. 2011 ).

Intakes of nuoient.s and od1er dietary componet1ts arc based on the consumpl!OD or food w1d beverages. wcludmg water. and do not 1oclude mtake ITom suppleinents or roedicanons_

The table mcludes data from individwlls 2 years and over. Breast· fed children were excluded because breast mtlk was not quan111ied in dietruy recall mterv1ews

Sugge51ed C itation

US Oeparunent of Agnculrure. Agricultural Research Service. 2012. Nutnent Intakes from Food. Mean Amowlls Consumed per lndividu.al, by Gender and Age. What We Eat m Ame"'·o. !'HANES 2009-2010. A\•ailable. w~sda,goy}balbtmrc!fm1

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CBI Deleted Copy

Petition to Add to the National List 7 CFR 205.606: Oat Beta-Fiber

APPENDIX

Appendix 7: 21 CFR 101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHO)

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CFR- Code of Federal Regulations Title 21

FDA Horne3 Medical Devices4 Databases5

CF~e"w<§~~r~h6>f Federal Regulations Title 21

(Code of rederal R~qulat1ons) [Title :1 , Volume 2) (Rev_sed ~s of Apri l 1 , 20131 c:~E : 21CFR10 L. 81)

TITLE 21--FOO~ AND DRUGS CHAPTER I--FOOD /\.ND DP.lJG ADMINISTP~Z..TION

OEPA!'l'I'i'1ENT OF HEALTH ANO HUMAN SERVICES

SlJllCHAPTER B--FOOD FOR HUMAN CON~">UM?TION

Pl\RT 101 -- FOOD LABELING"

Subpart E--Spe..::ifi.:: Requiremenc.s for Health Claims

Page 1 of 5

Help7 j More About 21CFR 8

Se-c. lC>l.81 H1;:-alth claims : Soluble fiber from cenain fOO')S and ns~ 0f <:<.Honary n.;o;J1·t di:;eas~ (CHD) .

la )Rela cionsh ip b.:>cc.;een diec.s chat ar.: lot> rn satura tc~cl fat ancl .::hole.s r erol tJn:J r hac incl ude solvl:>le fiber from cen:ain foods an.:! che risk c>f CHD . 11) Cardiovascular c.:sease means d::. s""ases of i::!:e heart ar.d circu:.atory system. Coronary h.:art d1$ease {CHD) is one of the ~os t conroon and s~r1cus f o(ms of cardiovascular disease and refers co diseases of the heart musch' and supporting blood vessel s . Hig h blood total cholester<"Jl an.:! low density lLpoprotein 1LDLl-cholest~rol levels are associa ted with increased risk of developing coronary heart dise&se . High CHD rates occur among people wJth high total cholesterol levels ":> f 240 nu 11 igrams per deciliter \mg/dL> !6 . 21 <mmol/Ll J or above an'\ l.DL- cholesi:erol levels <,f 100 1ng/df.. (4 . 13 mrnol/I,) or: above . Florderli11e hi.9h ris l' total cho.l..asterol t ev<;-1.s range f .r<im :::'.00 t<i 239 m9/dL (5 . 1.7 to 6 . l.8 mrno l /lol and 1 30 ti) 1~9 mg/ell. ( 3 . J6 •:o ' i . 1 1 mmo l /Ll of LDL-cholesterol. The scientific evidence establishes t hat d iets high i n saturace-d fat and cholesterol axe associaced with increased levels of blood total- and LDL- choleste rol and, thus , w!.th inc re-ased risf: of CHO .

1~1 Populations wit h a l ow incjdence of CHD tend to have relatively low blood total cholestli::rol and L,fif .• -<:holester:(.)1 l evt!l s . These pr.)pul ation s also tend to t1ave diet at:y patterns that are noc. only low in total fat. especially sacucated f dt and c holesterol , but a re also r elat iv.ly high in fibeI-containing fruits, vegetables , and grain products , sucn as whole oat products .

131 Scientific evidence demons Lrates t hat diets low in sac uraced fat and cholesterol may redc.ce t.he :::.isl. of CHD . Ot;rHH eviden(;e demons tra LE-s that c h.a adJi t :1on of :rnluble fiber -from cectdin Coeds to a diet thaL is low in sacuraLed !ac and choloi:!s tecoJ may also help co reduce t:t:oi:! risk of CHD .

(r.·, i s1qn1tican..::2 or the 1"!:!1.; tionship l>er:ween d iet!': t;il.;iC an:.; 1.or.; in sat.u ra ted la t. -im.1 cho.Zesuuol and that; in..::lude soluhlfi! ti1:1ei- fr.om c 2n: .. 1i1, foc•ds and t:h;? J..isk of' CHD . (11 CH O is ·'1 maJOC publ ic he,1lth concern iri Lhe Uni ted S tates . It accounLs .tor mor·e deachs r.h.ll1 any other disease or group of diseases . Early mani.gemenc. of ri.sk .factors ::'er Cllu is a major i:-ublic hcalch qoal t hat can assis t in reducing risk of Cr!D . High blood ::otal and l .:JL­chol<?st.erol aroi:! 11\tljoi: modi [ i,;b l.e risk factors i n th~ development <>( C!ID .

(2) Intaf'.·~ s o f satura:.ed f,H ·~ xce.;;rJ rccorrun•::ndcd lo::?vels in the diet s of many people in t.he Unu:cd .Sta tes. One v f th~: ma)or put:·lic hE<alth rccomrn<::ndatJ.ons re lative t o CHO risk is to ..::o;:sumc less i::han 10 perc·~nt o f calor1e:s ~rem $c1lurated fat: and an average o( 30 p<:rcer1t o r less of t:otal calories from a: l fat . Rec0mm•.::-nded daily cholestero l ini::ak'?s nre 300 mill19te1ms tffi•J) or less per day . Sc ientific evidence dr.:monst:ra t es that diets loi.1 in sacuraLod fat and cholesterol arc a ssociated w1c.h lower blood t otal- and LDL-cholestorol levels . Soluble fiber from cectain foods . when includ ed _n a l ow saturated rat and cholesterol diet , also helps to lowor blood total- and LDL-ctolcscerol !<;:vols .

(c)Requii·emen t.s. (1) All requirem;;,nts .set for th in 101. 14 shal l be met . The label and labeling of foods c0ntain i ng ps yl l i um hus~ shall be consistent: with the provisions of 101.17 ( f ) .

(2lSpec.ific r.:>quicemeni:s --(i)Nature of rhe .::laim. A health claim associat ing di;;:ts that are h>w in saturated fat and chol.:<si::er ol and tha t include soluble f iber from certain foods w1c.h

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CFR - Code of Federal Regulations Title 21 Page 2of5

reduced risl: o f hear r: dise.:is~ may be in.:idc 0n t.l .e label or l<,beliny o( a food des~ribeJ in puragraph (C} !:'., 1i1i) :>f ::hi~ :>ect1or. , prov1d1::-d tha:: :

(Al Th"1 ,~li.\im st<H.E-S t h at. diets t;.h,;t; <ir<;, low in s.H u r:<i t.HJ f;; t:. ,rnd cho l e s t..•H'Ol and that. i nc l ude solub l e fibe r 'from C<i:l:'. Lain f oods "rM y " CH' "rn.Lgr1 t. " reduc e t:t1e r i sk of hear t: dise.1s e .

181 I n speci f y ing the disease , the claim uses the f ollowing terms : " hear t disease" or '' coronary h~a rt dise~se'';

ICI In specifying the s ubs t ance , the clai m uses t he ter m "solubl e f 1b~r " quali fied b y che nam-s- o f the e l igibli:: source of s ol uble fi ber (prov i ded in pai: agraph (C) i.2) (ii ) i o f t hl.s secti·:>:"l. Add i tionally , t h•" claim ma y use the r1amc o f the food rroducc cha t contains tr1.;,

e!Lg1bl-s- source of 3o:ucle f1be~ ;

1L)) Ir, si.;.-::c1 f y .11:g the fac componerit , the : l a1m 1.1ses ch.;: cerms " sa::urac.::d =at " c.nd "ch·J l cstei.:cl ";

IE) The clai m does not a tt r i~ute any aegree of risk reducc~on for CHD t o d1e cs t hat a re l ow in satuPated fat and cho l esterol and that incluae soluble fiber from the eligible food sour<::.,,s r rom p.a:-agraph {<::) (?.) (11) ot chis seen on ; and

! f' i Tile c I.aim d oes not .i.mp.ly that cons umpti. o n of d i.<:-ts c: h a c ar:e l.ow i n sa t u r<1te d fa t -Jnd cho l e s t ero l a nd tha t i nclude s ol ub l e f1 ber f rom t he eligi b J e food sou rces f rom pa ra g raph (c) (2) ( i il ,,f t h i s section i.s tt1e o n l y re<:ogni:ed mea ns of achiev ing a r.educe d risk of CHO .

!G! The c;;~aim spE:c1fies the daily dietary 1nt«Y.e of the so~uble f1b<'!r sour .~e ::hat is necessar'l t.o reduce r:ilE: r 1sl'. of coron<Jry he1H L diseas e isnd the contribution one se r.vi.nq of cha produ~t ma l:es to the speci Ci ed daily die t ary i n ta ke 11::-ve l . Da ily di etar y intake levels of s ol uble f ibe r sou r c es l isted i n paragraph (<::: ! ( 2 ) (ii ) of t h i s seGtion that have been associated wi th red~ced r1sk co r onary heart disease are :

(] l .,

CJ oi· more per day of (bE:ta] -gluC<•n s olt•ble fiber ! rom either whc:le oaL~ o.i:: bar l ey, or -,) ,; o:nbinat ion o' '· 1·Jhol e oats i) l1d barl~y .

( .'..' ) 7 g or more per di.=t y o f soluble fi ber fr om psyllium setZ:d h u s r . .

!:;.i)Nacur.: o f th<! subs tance -Eligible sc-urces of soluble f.ibec. (JI. I Beta ( (b<,ta) i gluc.:in soluble fiber from the wholo oat a nd barley sources listed below. [bocaJ - glucan s0lublo fiber will be d·:?termined by method No . 992 . 28 fcom che "Offi c i al Mor.hods o f An a lys is of t: he /\OAC IN'rE Hl'lt~'!' IOHAL ," 1 6t h e d . ( 1995 j , wh i 0:h is i nc0rp<:·u1 t~,d by referenc e i n ai::cordance wi th 5 IJ. S . C . 5 52 (ai and 1 Cf'R pa r t ~' 1. Copies ma y be obta ine·:l f rom t he AO'AC W TEHNAT!OIU1L, 481 N<:·r th Frede rick Ave ., s uite 500 , Gaithers burg , Mu 20877 , or ma y be examined at r::he Center for Food Safei:: y and !\pp lied M.ic:: i t i•:•n ' s Libr ary , 5100 Paint Br:anch Pkwy . , College Par!': , MD 201 40 , or at t he Notl•:>na l t .rd:1 ve s anc: •{e ·~ords Adm1n1s t racio n (!-JAi~A) . For inf.<.1r:mation o n t he a vail abili cy of t h is mate l'ial a t Nl\k/1, ·::a ll 20.::-7 41-60 30 , o r go t i;, : h ttp : I lt»•~w . archi <,;es . gov/feder al_regi ste r /code o f _ federal_ regula t ions/ i br_lo.:a tions . !1 tm l

(1 l Oat bran . Oat bran i s produced by grind ing <::lean oat: groat s or r olled oats and separating the resulting 0ac flour by sui table moans into f ra<::tions such that the oat bran fra .:: t 1on is not rnor.;, t ha n 50 p e rcen t of the original starti ng ma te r i al and provides at l e ast 5 . 5 percen t (d r y weight basis !dwb J I [b c t a ] -glucan so l uble fibe r • nd a total di etary fi be r co ntent of 16 percen t (dwb) , and s uch thac at least one-thi r d of the toca l dietary fiber is S•:>luble fiber ;

(.? )!'/,)Jled oats . Roll ed oats , also known as oatmc-a :i., p rodur;<:-d frc1m !OC> perc.;.nr: 1:Jehu.ll.ed, <::l ea 11 oa t g roa ts b y r:>t.eami rHJ , cutt llHJ , r ol.l Lng , a nd flu king , a nd p .r o v i des a t; l e ast '1 1·>1:ff<: r:-nt (dwb ) of [beta J-ghic:an soluble fi ber ano a to r.al di <:-ta ry fiber· C(>llt'i' n t o f at le<1st 10 percert .

(J )l'.'llole oat rl.our . Whole oat flour is p r oduceo from 100 pt:- r c ent d<>hulled, clean oat 9roacs t. y s te.;im i n 9 a nd gr i nd.i. ng , su•;h t hat tliet:e 1s no siqn j. fi r:ant. l.os s vf oat b.ra n in t r1e t i na l p roduct , and provi d e s at lease ~ p~rcent (dwb) ~ f [be r:aJ - g lucan sol u bl e fiber and a to t al dietary fiber content of at l•ast 10 perc•nt ldwbl .

!4 )Oauun . '!'ht:- soh:ble fracLion of alpha - amylase riydrol~•zed Odt br.:1n or whole oa: :1,-iur , ,,1$0 Y.no'.·rn as o.1 trlm . O.H.r.irn .l.:> produced from eithe r c;;H. bran as defim~d in p1:.ra gr,3 ph {<:) ( ~ )

(i i ) (A) ( 1 j of l:h is s ect ion (>!' 1-1ho l (~ <M t flou r r;s ct€, fi 11E:<J i n para .:JL'<q:.>h tc i (2) (i i..; (Ai ( 3 J o f this section b y solubili:aLion of the starch in Lhe star t ing ma t er.J.al with an alpha - amylase hydrolysis process , <rnd thE:n ce.mov,;).l by ~entrifuCJat.ion of the in:3,-il1Jble compon~nls consisting of a htgh µonion of p r o1.-:in , lipid , insoluble dietary (J.i:;er , ;,nd the najoru.y o[

thr,, flolV(.'r and ,;,)lvr cmr1ponc~nr.s of th<'! su, rc.J.nq md t eri.ll. o,,trjrn s h • .l l !lave <1 l:.,<;, t.a - glur;;,n so l t;b.l.<! C: ber ::01 &1.e r~L up l.<.' l 0 p0 .rcent. (d1·1b) ,,nd 11 \'> t:. l \~SI! r. han r.h .; 1 0 .1' thE:- st.;i.r·1. 1nq 111 .. u~ r: :i 11 l. (dwb) .

15 ) r!hol~ qra in b.H ley and dry milled barley . Di::hul led and hull - loss wh-:ile g i:ai r: bcH ley with a '.b~ca] -glucan soluble fiber conc~nc of at l~ast 4 p0rc ent (dwbJ and a tota l diQtary

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CFR - Code of Federal Regulations Title 21 Page 3 of 5

fiber content of al leasL 10 percenL (dwb) . Dry milldd barl~y qrain pcoducLs incl ude bJrley lnan, b.irley flakes, b,Hlf1y 9.rir.s , pearl barley, l);.n:ley flotir , barley moi:!al , and siev'?d b«Hl.ey mc!cll tha t are prod1JCed f.t: ()fll clean, sotrnd dt~hulled or h11l l - l ess barley qc<:. i n u s in9 s i":and<t.r:d dry rrJ.J.l.ing l:e(:hnlque :>, 1o1hicli fficlY include steam.i.ng or Lemperi.ng, iHld Lhclt cont,1i11 at lea st 4 pe:cent 1dwb) of [beta]-gluc<tn soluble fiber dnd <lt leas e 8 percent (dwbJ of tor:.al die t,1 ry fiber, e.~cept.. ba r:E-y brc.n and siev<?d barley meal fer whi~h the minimum I bet..<.) -qlucar. S<"luole fiber cont..e11t i s 5 . 5 percent (dwb l and minimum toLal di'?Lary fib.;-r contenL is 1$ ~ercent {dwb ) . Deh~lled barley, hull-less barley , barley bran, barley flakes , barley qri ts , paarl barley , and barley flour are 1lS defined in Lhe BcHley Glossary (1'-1i.CC Mer.hod 55-99) , published in Appzoved Me t hods of the ~nerican Associa Lion of Cereal Choi:!miscs , 10th ed . 12000 ) , pp . 1 and 2 , wh ich is inco rporated by reference l n accordd nce with S U. S . C. 552 \a) m1d 1 C PR p.lrt 5 1 . Copi.es fn<lY be obr.ainP.d from r:he Ameri •~an .t..ssociacion of Ce r eal Chern.1s L. s , Inc., 334 0 Pilot Knob Rd ., SL . Faul , Minnesota, 55121 , or may b& e x amined a t the Center for Food Safo::Ly a1~d .r..pplied Nut..ritioii Library, 5100 Paint Branch P~:wy ., cc,llege Pari:, rv:u 20740 , or: at the Mat~onal P..rchives .rnd Records Administration (M/i.ft.A1 . ::'er inforrM1.ion on i:he availabil.Lty of this material ,n MA?~r.. , call 20~-741-6030 , or go to : .'1 c tp : .' /W'.vlv . a n.~hi ves . qov/ iede.r:al_regis tee/code_ of_ feder,Jl_ i:egula t.iC'n :>I j hi:_ lo,-:;; t:l,rns . h t .. 111 l Barley meal is unsifted, qround barl~y qrain no~ subjecLed LO ~ny processing to s~parate the bran, 9wcm, a nd e ndOS[Jl.Hm . S leved l>arl'?y meal i s an endosperm G<', ll 1·1all-en r:iched f r:i' .. ~t.i<>n of q .r,>w•d b.:1.rley ;,;ep,'1riJted Crom rne,11 by sievJ.ng or C·y air cl1:1ssir'ica tion .

( 6 ) Barler i.'ecaf.ib0r . Barley betafiber J.$ che c;tha:1ol pracipitated so!ubl-:: fraction .:·f cellu-~sQ and alpha - a•y-dse hydrolyz~d whole gra!n barley . Bailey belafiber is prod~ced by hydrolysis of whole gra1n bar:.ey flour, as defi?1ec J.n p<1ra9i:ai:•t: (.;:} \::11J.il <A l {5) o:: this secu.o!'I, with a cellulase arid .,:.pha-amylasc r:nzyme preparation , to produce a clear aqueous excra~l Lhat ~on tains mainly partially hydrolyzed beta-glucan and substanLially hydroly:ed search. The solub le , partially hydroly:ed beta - glu c a n is separa t-::d from tho insolu ble materia l by c~nt,Hugat ion, and afte r removal of t.he iriso l ubl~ ma te ria l , the! par tially hydrolyzed beta-glucan solublc fiber is separated from the oche r soluble compounds by precipitation with ethanol . The product is chen dried, milled and sifted. Barley b&tafiber s!1all have a beca-glt.1can solubl·~ fibE:r con tent of at least 70 pe .rcent on .;. dry wo::ight basis .

\ B J (1 J Psy_liurn husk from the dri ed seed coat {epidermis) of the seed of Plancago IP. >

ovata , known as blond psyllium or Indian psyll1um, P . indica , orP. psyll.ium . 7o qua:1fy for th is claim, p syllium seed husk , also known as psyll1um husk , shall have a purity of no less than ~5 percenr , such that it contains 3 percent or less protein , 4 . 5 percent or l ess of light E!;.:trane•:.us mat tE:r , and 0 . 5 perc•~n t r,.I" less of heavy ezt raneo 1Js matt•:i:: , but in no case may the combi ned extran&ous matte:: .;:Y.cei:orJ 4 . 9 p<:>rcent , as d0 t ermined by LI . S . Pharma•::opeia (lTSP) methods descr:b-::<:l J.n USP ' s "The ~Jar.ional E"ormulary ," US? 23 , !ff 18 , p . 1"341, (1 995), wh1·::h is l?K:orp0rat.::d by refei:ence in a•::coi·oance \-1:i:r. 5 ll . S . C . $S2!a l an·:l l CFR pan: ':;l.

CopJ.es may be obtained from t~e U. S . Pharmaccpeial Convention, Inc ., 12€Ql Tw1nbrook Pkwy . , Rockville , MD '.!085'.! , or may be ·::zamined at the Coem:ez: for f ood Safet:y arid Appli~·:l Nutr1c1on ' s Library , 5100 Paint Branen Pkwy ., Col l ege Park , MD 207 4u , or ac cne National !1rchives and Records hdrninisc ra tion (!MR!\/ . ~·or 1nfr.0rmat.ion on the availability of this ma terial a t Nl\R!~ . call 202- 741-6030, or (JO

t o : http : //wwiv. archi ves . go~·/ fede1·a1 regisr:er/.::ode .... .:i( .. t"ederal ..... a:gula tions/ iJn loca cions. hcml

(2 ) FDA will de te:rmine che amoum: of soluble fiber t hat lS provided t•y psyllium husk by using a modifl'::atior. of the .l\ss·:·ciac.:..on .:>f Officia l 1\nalyci.::al ~hem1s:s 1 inc..::rnac ional

1l\OAC 's ) meth·:>d f·n s.:•h:ble di.era!y fiber (9~ 1 . '13i describe:d by Lee er al ., " DE:terminat1on of ~:clublc and Insolubl-:: D1-:: cary E"1bE:t in Psyllium-.-:onta1n1ng Cereal ?reduces, " ~I~Hu;nal of che r10AC lnten;ar:ional, 78 (N·:· . 3i : 'l.:'.•l-7~9, 1995, whio::h is inc:crpora ted by ref-:rence in acc0i::dar.ce ~ii t h 5 U . s .".." . 55'..! (al and l Ci:'H part 51. Copies may b•? obtained from the NJAC lN'i'EHN/\'l'll\N:',L , 48 1 Morch f'i::ed-:: r ic:k Jwe., .!'Ul tr~ 500 , Gai. thersburg , MD '.:0877 , or may be e~amined at t he Center for Food Safe:ty and Applied Nucrit icn 's Lib rary , 5100 Paint Branch Pkwy ., Col leg·=: t'ad: , MD 207-10 oi: a t t h.: National Archives and Records Actmin1stration {NAP/\ ) . For inf•:0 rmacion on che availability of this rnat-;;rial at N/l.R/\ , call :o2-74 l-603<j , or go to : http : / / w:.•i.1 . a rdii ves. gov/federal_ register/code_ of_ tedtui!l_ regula t ians/ J hr_ loca t !O!ls. llrml

(1.i.!IN.Jtur<:> of che fc.o.:>J eligib./ e ta beaL· tile c!aim. ill) The food protJur:t slrnll include :

; 1 i One or more of t.he whole (.lat or bci cley foods from p.uagr<.1phs !cJ ('.'.:) (1i) (Al (1 ; , (2 ) , {3 ) , nnJ {5 I of this secLion , and the who le oat or barley foods shall conta in ar. l e a st 0 . 75 gram (q) of soluble fiber per reJ.'erenc.~ ;,mounL customarily consumed of th(~ food product ; or

<2 1 The food contairi_nq t he oatr:.m from paraq.rnph (Cl !2) (ii) IA) ( 4 ) oC Lllis sectio:-1 o.r lhe barley bt>tafl.ber from p...iragraph tel 1:1 (iii (Al (5 ; o : this secdon shall -~ontair. at least 0 . 75 q of beta-glucan :;oluhle fiber per ~·efer:ence amounL cusLon.arily consumed of r.he tood rcoduct.; or

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CFR - Code of Federal Regulations Title 21 Page 4 of 5

(3 l Psyllium husY. that complies with p.uagra.ph ic) (2) ( i il (8) o: t:h.i.s secnor1 , and the ps:{!. lium food s hal l c0ni:ain at. lease l . 7 g of !>Cluble fiber per reference amount cus toma rily consumed of the food pr0duct ;

(Bi 'l'he amoun t of soluble fib.;,r sJ·,a ll be dec lared i n che nui:i:i t1on l ab.;;l , consistent 1~ich 1 01.9(r.\ 16 ) Ii} (AJ .

\Cl The f•:>od shall me;;;c the nui: n . .;:nt ·:vntent requi :ereent ir. 101.6~ :or a "low sa tura ted fat:" .;nd " .ow c;hol estero! " food ; -.rncj

\ D} ·rhe food sha L.l. >neet. the n1.Jt.r ient <..:\:'ntent rt!:qtLi.rernen r.. in 101 . 6 ~~ (b ) (:(.) fo r ~" ''1 ov; fat If food, unless ch& food excee d s this r ~quiz ement du e co fat con ten t derived trom whole oac sou!·r;es Li sted '11 paragraph (Cl (2) (ii) ( f'.. ) of this s e c:-1011 .

(di Optional information . (11 The clciim may s t .H. & tt11, r; the development of hean .. disease depends o n many fi.ICV:rs and ma ~; icJenL.i.fy one or more of tiH~ foll owi.ng risk fac t;ocs to.r heart. di&eds• dbout whi ch the re is qenecal Acient if ic agreemen t : A family hiscory 0( CHD; elevated blonrl coLnl acd LOL-c~ol&sterol ; ezc~ ss body weight ; high blood pcPssure ; ~iqarette smo~ing ;

diabetes ; and physica: ~nactlvity . The claim may also provide additional ii.for mation abou ~

the benefi ts of &;:erc.:_ :c;e oind managem'9nL o: body we1.gt:t Lo he lp 10\·Jer t he ri sk of hean d i sease- ;

( ~I The cla im may state that lhe rela tionship between inta~e ot die t s t hat are low in saturated fat and cholesterol a nd thaL include soluble fiber from che eliq ible food s0urces from paragraph (cl (21 ( i i) of ch ~s sectJon and redu~ed risk of hear t disease is through t~E:

int erm&dia te lin~ o f "blood cholesteto l" or '' blood total- and LDL-~n0lesterol ;"

131 The claim may include informa tion from paragraphs (a) and lbl of t h is seccion, whic h swnmari:e tt1e relationship b et:wecn diets chat arc low in s atura ted fat: and cho2.cstE: r ol and Lha t include s o:uble fi~~r ftom cerLa in foods Jnd coronary h~a rc disease and che significance of cte relacionship ;

( 4 ) The claim m.ly spc;cify the, name .;,f thE: eligible s rJlub.10 fiber;

\ $) The claim may sta ce that a di~-t low :n saturat.:d fat and ·:holes c<.'rol thac 1n:::ludes solub:e fib.;:r from whcl~ oats o r barley i s consistent w1ch "Nucric1on a nd Your H.:a!ch : [l.ietary Gu1de2.1nes for A.11~r1.:.:1ns," U. S . D':',:-·ai.:cme n;.: of T1gi:1cul cure <USDl"l and Departme nt of Heal.ch and Humar, Serv1 ce:s illHHSi , G·:>ve rnmer~t l:'nnt1ng Office (GPv) ;

1.6l 'l'r1e •:l.ai.m nwy state t h.at iridividu.~Js 1-1.itll elevar:.ed b lood to tal- and LDJ..-chole:>t.er<Jl should consult their priys icj .ans for medica l adv lee and tzeatmen7. If the c laim d e:' ines h1.gh -:,r normal b ~ood total - and LOL-choles::erol l evels , tlv"n the cl.,im shall s tate t hat individuals with hlgh blood chol esterol should consult t hejr physicians for 1nedica l advice c1nd treatme nt ;

Pl The cl a .i.m may include .in form.a t1on o n the number of peep.le i n the United S<:ates wr10 •1a ve heart dis~ase. Th~ sources of this information shall be idencifieo , a nd it shall be =~rrent 1 nforn1at1on from th"' Nac.iorHll C<onter for Health Sr.at1st1cs , the Mat10na l Ins ti t iJtes ('~ Hr,-.;.it h , en "Nutnti.on .;nd ·,'ou.r He<• lth: Di -:-t.a i:y Guidel jne!~ for ..,.,mer.i.c;aris , " USDA .:.ind DHHS , GPO .

iel Mv d el healt11 cla im. The f0llowing modeJ heal tri <;lai ms m<iy be used ir1 food lAbel1ng LO describe the r&laL i onship betwee~ diets that ar& low in satura t ed fa L and cholesterol and Lhat 1nc;Jude soluble fiber from certain foods and reduced r isk of heart disease :

(l) Sol\JblE- fiber fr,)m .foods such as jnmne. o.( solub le f i ber sour,~e from p.Ha(jt"<3ph (c ) (21 { .ii )

of thi s section and , i f desi red, t he name c f food produc LI, as parL 0f d cJ ie t low in saturated fat and chol,,;sterol , may reduce Lhe rJ.sk of h&,irt disease . A SPr-..•1nq oC [ nam1: ,;f fo0dJ supplies _ _ grams <'>f the [grams of soluble fiber specified iL paroHJr,1ph (C) :2l ( i } iGi of l: h is sectioid soluble fiber: from [name oi thE- solubl<i:- fibe r socll:ce f r om paragrapn (C J (:2)

(i i) of chi s sec~ion ] necessary per day to have this effect .

(2 i Diets low in sat urei ted fat and cliolescerol chat include: [ _ _ grams of soluble f1b·~1 spe-::ifi·~d ir: paragraph (cl (2) (i) IG) o: chis section] of soluble f iber per day from (name of S•:>lt.:bl~ fibe r source from par.lqi.:a;::ih (CJ(.::) (ii) of this section and, if c.iesi1C'd, the, name <:·f che food pr0duct] may reduc~ the ri s k of heart disease . One s erving o! [nama of food l prcvi..;l(,S -··-- gr<Jms .:> f t hi s S •J lubl~: t i.ba r.

[ 6:: fR 'l60u , Jan . :J , 1997 , as amendc,d at ·~2 fR ~53<! ;, Mai: . Jl , 1 9$17 ; ·~3 FR e:19, F~b . :a, 199B ; (;~ !:'~ 667·1-, Dec . 27 , :;:JOl ; 67 d~ ol7tl:: , Oct . :; , 2002 ; 68 H~ 153'.:.$ , ~:ar . 31, 2003 ; 70 FR 40880 , Jul y 15 , ~005 ; 70 FR 7616~ , Dec . ~3, ::oos; 7 3 m 9947, Feb . ::s, ::!000 ; 7J F'H 23 953, >1ay 1 , 200 l<]

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CBI Deleted Copy

Petition to Add to the National List 7 CFR 205.606: Oat Beta-Fiber

APPENDIX

Appendix 8: Beta-Glucan: Health Benefits and Product Applications (Tate & Lyle)

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TATE r~~ LYLE

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l!l PromOat Beta Glucan

• Research indicates that diets higher in fibre are associated with improved health and reduced nsk of certain diseases

• Oat beta-glucan is a viscous, soluble fibre that can help maintain healthy blood cholesterol and blood glucose levels as well as support gastrointestinal health and assist in weight management

• Despite the fact that many consumers say that they are making efforts to consume diets high in dietary fibre, current fibre intakes rematn below recommendat ions

• Tate & Lyle's PromOat Beta Glucan is a great example of an ingredient that manufacturers can use In the development of new and innovative products that may promote health while helping to meet the populations dietary fibre needs

I I

Decades of research indicate that diets higher in fibre are associated with reduced risks for heart disease and diabetes· - as well as improvecl gut health and digestioni ; however, average intakes remain well below the currently recommended amounts' . With fibre intakes low across global populations. there 1s potential for !ong-tenn pubhc health 11nplicat1ons1

•3.

Dietary fibres are nondigestible carbohydrates 1n the diet that. when consumed. pass through t11e small intestine into the large intestine where they may be partially or completely fermented by colonic m1crob1ota . There are several varieties of dietary fibre. and each type provides specific t1ealth benefits: thus, 1t is recommended that individuals consume fibre from rnulttple sources. Fibres can be soluble or insoluble in water as well as viscous or nonviscous. Viscous soluble fibres. 1nclud1ng oat beta-glUC' n th

only fibres that have been shown to lower cholesterol'. Research studies have demonstrated that increasing soluble fibre intake by 5-10 g/day can reduce LOL cholesterol by 5% 0 • For greater LDL cholesterol reductions, the Therapeutic Lifestyle Changes (fLC) diet recommends soluble fibre intakes up to 25 g/day-. Cons;denng that most individuals habitually consume less th<'ln

25 grams of fibre per day in total methods to increase soluble fibre intake are needed.

Tate & Lyle's PromOat Beta Glucan 1s a viscous soluble fibre made from non-genetically modified (non-GM) Swedish oats that can be added to foods and beverages to promote healthy cholesterol levels while 1ncmas1ng dietarv filxe intake. Clinical studies t1ave dumonstmted additional health benefits associated with oat beta-glucan intake. such as ma1nta1ning health blood glucose levels, supporting gastrointestinC'll health. and assisting with weigt1t management.

Figure 1

Adul t fibre intakes by country6 ' 2

E? __ c..~1

f:i "" £ C > ;:, ..::

30

20

------- -------------······· ... r ·····-···----··--· Recommended

R?.ng·'

----------------············· ........................ ..

Most dietary fibre recomrnendat1on::; for adults call for intakes ranging from 25-38 g/day depending on country-spcc1fic guidelines· . The World Health Organi1ation (WHO) suggests worldwide recommendations of 25 g/day . Figure 1 notes a wide range of fibre 1nlakes across various countries against tl1e recornmendcd range for consumption' · . In the United States tUS), for most age and gender groups. less than 5~o meet the clietClry recornrnendations for fibre· despite consistent messC1ging to tt1e public to increase dietary fibre intake. In the United Kingdom (UK). only 13% of women and 28% of men meet dieta1 y fibre recommendations'· .

Data 1nd1ca1c !Mt consumers beheve ftbru 1s important to l1ea1t1·1 and !11at they recognize til e lack of fibre 1n their diets·" yet closing the fibre intake gap has not hce1 i easy. as many diets continue to lack adequate servi1 igs of fruits, vegetables. wl iole grains, and fibre­lortified foods. Recent innovatrons arc rnakrng it easier for food manufacturers to fortify their products to help boost fibre content and close l11is intake gap. An abundance of researcl1 continues to demonstrate that fibres added to foods provide s11n1lar benefits as "intact" fibres inherent in whole foods.

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Fibre Innovation for Health

Benefits

Oat beta-glucan has been tested by a number of independent researchers to demonstrate its phys1olog1cal health beneffts. The following are some highlights of the research on the health benefits of oat beta-glucan: • Promotes heart heatth by lowenng blood cholesterol levels • Supports healthy blood glucose levels by el citing a lower glycaem1c

rcsponse71 • Well tolerated and may support a healthy gut by producing

short-chain fatty acids • • May assist with weight manag ment through calone and fat reduction in

foods and promotion of satiety

While traditional sources of fibre like whole grains. fruits. and vegetables should be encouraged. fibres added to foods are also important contributors to dietary fibre intakes. Dietary fibres that are either eX1racted or synthesized nondigestible carbohydrates and have beneficial physiologic effects in humans are now available on the market; the US lnstrtute of Medicine refers to these as functional fibres . Fibres such as these are useful in developing products that I 1ave exceptional taste and appeal to the consumer while orfenng the san1e health benefits as fibres that arc intact and naturally 0 ~ 1 nrt;i 1n fruits, vegetables, and grains. Adding even small amounts of fibre to foods traditionally low in dietary fibre. resulting in amounts as low as 2.5-5.0 g/serving, could help in<j1viduals meet their fibre requirements without exceeding calone needs .

PromOat<!' Beta Glucan 1s an example of a versatilt: functional fibre ingredient produced by Tate & Lyle and currently used in foods and beverages in Nort11 America, Europe, and Asia as a potential solution to ncrease fibre intake without sacrificing taste. texture. or enioyment. Total daily inte1kes of beta-glucan as low as 3.0-4 .0 g/day l1ave been shown to

promote t 1ealth through mainter iance of healthy blood cholesterol and blood glucose levels while helping to meet daily recommended fibre needs '

Beta-glucans from oats and barley arc polysaccharides of linear, mixed linkAge (1,3) (1,4)-beta-D­glucans. PromOal Beta Glucan is concentrated betA-glucan derived from non-GM, Swed1sl1 oats, produced by 8 cl1e~rrncal-froe.

aqueous. enzymatic process. The finCll product is a fine, cream­color ed µowder with a caloric value of 3.2 kcal/g of ingredient. PrornOat Beta Gh 1can is a source of 35°:, oat soluble beta-glucan fibre by weigl1t and contains small amounts of carbohydrate and protein; fat content is negligible (Table 1).

Oat beta-glucans from different sources can have a wide ran9c of molecl 1lar weights, C\S processing cond1t1ons affect the final product. PromOat Beta Glucan has a high molecular weight sirnila1 to native oat beta-glucan. Tile high molecular wcigl1t makes PromOat Beta Git rcan highly viscous. Many health benefits associRlccj with oat beta-glucan are

Table 1

Nutritional content of Prom0at4' Beta Glucan•

PromOa~ Beta Glucan

Energy- 315 kcal or 1319 kj

Total fat O.Sg

Saturated fat < 0.1 9

Carbohydrate 56g

Fibre 35g (beta-glucan)'

Sugars <0.Sg

Protein 4g

Sodium < 25 mg

• Values per 100 g on a dry weight basis. • Determined by calculation using

2 kcallg for the soluble fibre portion. When using 4 kcal/g for the soluble fibre portion, the calculated calorie value is 385 kcal.

• Typical range: 34-36 g; m inimum: 33 g .

Rllributed to viscosity that increases with molecular weight ' • .

PrornOat'' Beta Glucan l1as strong water-bind111g and emulsifying properties. It ti iickens and stabilizes cn"lulsions, creRling a smooth texture ancl creamy mouth feel in reduced­fat products. Tl"lfs ingredient can also lengthen the shelf life of food products duo to unproved moisture management, and it is acKJ- ancl heat-stable. whicl1 allows for easy 1ntograt1on into many food and beverage products.

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Fibre Innovation for Health

11thy

In 2012. the World Health Organization <WHO) reported that coronary heart disease (CHO) was the leading cause of mortality. resulting in 7.6 1 rnllion deaths worldwide2' . It is well estabhshed that reduang blood cholesterol reduces the nsk of CHO. and t11e US National Cholesterol Education Program (NCEPr estimates that each 1 % reduction 1n LDL cholesterol reduces the risk of heart disease by 1-2°0~ . Several clinical studies have demonstrated that increasing intake of viscous soluble fibres like beta-glucan can effectively reduce LOL and total ct1olesterol. l llree meta-analyses have summarized nearly 50 randomized controlled trials including 1,780 normo- and hypercholesterolaemic subjects completed between 1985 to 2007' · ·-. Overall, the data suggest that 3 g/day of beta-glucan can lower LDL cholesterol by 3-5% and total cholesterol by 2-4°'o'f ·. -'-. This may result in a reduction in heart disease by 3-IO<}o, with the greatest reductions occurring in those with higher starting cholesterol levels''. Add1t1onally. the physicochern1cal properties of beta-glucans can impact the efficacy in lowering cholesterol. Oat beta-glucans with high molecular weight and solubility used at high concentrations are thougl1t to be more viscous 1n the small intestine. This increased viscosity rnay reduce reabsorptton of bile acids and increase the synthesis of new bile acids from cholesterol, thus reducing circulating LOL concentrations '.

In weighing the totality of the evidence. the European Food S<'lfety Authority (EFSA) issued a positive opinion lor the ability of oat beta­glucans to lower blood cholesterol ancl reduce the risk of cardiovascular disease . Several countries allow r1ealth claims or functional claims for bota-glucan and heart health/ cholesterol reduction. The claims are bi'lsed on a daily consumption of 3 g bcta-glucan, wh1ct1 in most cases can be divided among three to four servings of foods.

Even the most recent studies contirn 1e to support tho f1nd1ngs that oat beta-glucan may promote U1e rc'Cluction of blood cl 1olesterol. For example, Queenan et al. demonstratecl t1·1at 6 g/day or oat beta-glucan significantly reduced LDL cholesterol in those with elevated cholesterol comµared to

Figure 2

Reduction in LDL cholesterol following four weeks of oat beta-glucan consumption'9

2

.., '2' 4 5i ~ ab

(j ~I)

c

3 g 3 g 4 g 4 g Control HMW MMW MMW LMW

Treatment groups with different letters are significantly different (P<0.05l HMW = High molecular weigh\ MMW - Med111111 molecular wetghl LMW=Low molecular vvcighl

a control' ' . Further, Wolever et al. demonstrated that both oat beta-glucan dose and molecular weight <'Ire critical in cholesterol lowering· '°. In this study, 3 gidc:iy 01

a high molecular w01ght and 3 g/day and 4 g1day of a medium molecular weig~1t oat bota-glucan significantly reduced LDL cholesterol compared to a wheal fibre control (Figure 2)"'-'. PrornOat Beta Glucan is a higt1 molecular weigl 1l beta-gh 1can.

r II

Tl10 impact ol oat beta-glucan 011 blood glucose and insuhn responses has also been studied extensively over the past few decades. In 2011. EFSA determined thal a cause and effect relationship has been established between the consumption of beta-glucr1ns (from both oat and barley sources) and a reducllon of postprandial glycaemic responses-· . Their conclusion was based off of six key chnical trials that consistently demonstrated ·an effect of oat ancJ b8rley beta-gtucans 111 decreasing postprandial glycaem1c responses. without disproportio11ately increasing postprandial insulinaemic responses. at doses of at least 4 g per 30 g 01

available carbohydrates· · .' Further. EFSA determined that the mec~1anisrn by which beta-glucans lower blood glucose has been well established • . Beta-glucans increase the viscosity of the meal bolus. thereby reducing the 1nteraclion between food and digestive e111yrnes in tile stomach, delaying gastnc emptying, and reducin9 rlbsorpt1on of glucose-Because viscosity plays a large role 111 reducing l)lood glucose and insulin responses. differences 1n phys1cochemical properties of bet8-glucans. such as molecular weight. may impact the magnitude of t~1e effect.

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A recent review by Tosh concluded that the EFSA recommendation of including 4 g of beta-glucan per 30 g available carbohydrate may be too restrictive--. A total of 34 studies with 119 treatments including both oat and barley beta-glucan were 1ncludecl in this review. Thot5e studies were controlled, randomi7ed. blinded, crossover. or parallel in design and included infonnallon on available carbohydrate dose, beta-glucan dose. and postprandial blood glucose response. Data were con1bined for oat and barley products as average reductions in area under the curve (AUC) for glycaemic response were not significantly different. Tosh iound U1at glycaernic response was n iore strongly related to beta-glucan dose t11an the ratio of beta-glucan to available carbohydrate 1n processed foods. Including at least 4 g beta­glucan per -30-80 g of available carbohydrate should significantly reduce postprandial glycaernic response- .

Studies publishecJ after these reviews continue to provide evidence that beta-glucan can reduce postprandial glycaem1c response and that the physicochern1cal properlles of the bcta-glucan consumed may impact the 1nagnitude of the results. For example. Kwong et al. demonstrated that at a dose of 4 g, a l1igh molecular weight. high viscosity beta-glucan was more effective at attenuating peak blood glucose nse t11an a low molecular weight, lowe1 viscosity beta-glucan . PromOat · Beta Glucan 1s a high molecular weight beta-glucan.

PromOal' Beta Glucan may help support weight rr1anagement through enabling fat ancl calorie reduction in food formulations. Intake of beta­glucan may <'llso promote satiety and/or reduced energy intake at a subsequent meal. For example. Beck et al. ' • observed that sub1ective sahety ratings significantly increased with an oat heta-glucan dose as low as 2.2 g anrl t11at appetite suppressant hormones cholecystoki11in (CCI<) and plasma peptide YY (PYY) were significantly increased 1n a dose-dependent manner when evaluating 0 g (control). 2.2 g, 3.8 g, and 5.5 g of beta-glucan for part or all of the study population. Energy intake at a subsequent meal was also reduced 1n sub1ccts who consumed the highest dose of beta-glucan compared to the control. Allhougl1 these energy intake results did not reach statistical significance, t11e absolute difference was greater than 400 kJ (-95 kcal) in a single meal, which 1s clinically relevant as it could equate to a 0.4 kg (0.9 lb) weight loss monthly 1f maintained .

.. Tl,(; TLC Step II d iet IS rocon111 l(l11(l by lilt; us NCEP .md ti ll' Amrrican Heart Assnr:1at1on 101 111tf1v1rtuals w1t11 elevnted l llooJ clioles!crol. Tl1P rl1 ·f 1~ re('fuct!U 1n b l salurntf!• I ial ;incl cl 1oloslerol r.ornpare cl to <1 lyp1cal ww,;tern die'. .

CIYonic studies provide a better 1nd1cation of the long-terin effects of oat beta-glucan on sauety and weight management. In a randomi7od. controlled, parallel-group study of an oat-derived beta-glucan ext1act. th1rty-e1ght overweight men consun1ecf the TLC/Step II diet" for eight weel<s and breacj w1t1·1 6 g of beta-glucan 01 a wl1olo wt1eal bread control '". T1·1e two breads were equivalent in eno1 gy. protein. fat. and carbohydrate. and energy intakes between the groups were similar overall. Both body weight and body mass index (BMI) were reduced by 7.5% in the oat beta-glucan group and 4.9% in the control group. resulting in a statistically significant difference between the two groups (Figure 3)· ~.

While additional studies are needed, this emerging evidence suggests that oat bcta-glucan may support weight management efforts through 1ncreasecl satiety, cl1anges 1n satiety hormones. etnd reduced calone intake.

Figure 3

Reduction in body weight after 6 g/day oat beta-glucan for eight weeks20

1:. r:' ;;; 5 J3 O•

~I'

"' < '-~ i '

0

·7

,4

(j

-8 *

10~----------AHA Step II diet AHA Step II diet

(control) +6 gfday oat beta-glucan

•significant difference compared to control (P<0.002)

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Fibre Innovation for Health

r , , GI 1 _ tit ri

Resists digestion and is fermented in the gut Oat beta-glucan contains a mixture of B (1-3) and 13 \1 -4) glucosidic linkages t11at reduce the digestibility of this ingred1ent:-""0 . Undigested beta­glucan serves as a valuable substrate for fermentation by colonic bacteria. leading to the production of the shOli chain fatty acids (SCFA) propionate. butyrate. and acetate. In vitro studies demonstrate that significantly greate1 production of butyrate occurs with fermentation of bota-glucan compared to inulin1·', FOS, psyllium. and corn arabinoxylan:'·'. Increasing butyrate is desirable as it is the rnain energy source for colonocytes and has demonstrated anti-inflammatory and ant1carcinogenic properties• - . Propionate productiori was also enhanced 1n these studies ~ , which may be beneficial due to links between this SCFA c n b 1tiety as well as inhibition of cholesterol synthesis-· -· . Fermentation of

II

oat beta-glucan has also been demonstrated in rats. Over a six week penod. faecal pH was reduced and SCFA concentrations were increased 111 rats fed oat beta-glucan. Add1t1onally. ammonia levels. 13-glucurorndase activ11y, and azoreductase activity were reduced, suggesting tha1 consumption of oat beta-glucan 1 nay reduce tho concentration of toxic compounds in Ille colon" . Cornpnred to 1ncmy other fibres, the fermentation of oat bela-glucan 1s delayed, which may further promote colonic health by enh1mc1ng productton of beneficial SCFA 1n t11e distal colon where toxic compounds from protein digestion arc created and tt1e majority of colon cancer lesions are seen'~"' ' , tiowever. additional researct1 is necdec.l.

Good digestive tolerance The n 1aion•y c tudics investigating the various health benefits of oat beta-glucan have been completed without reports of gastrointestinal disturbances. Oat beta-glucan is a well tolerated soluble fibre.

· Labelhnq ,mcJ cla1nis rnnv vc:1rv tiv cu1111trv. Custu111ers me a(jv1setl 10 c;u11~ull 111e1r uwn 1e<)t1la'. •J!'\' experts to (lel cr11 11!1P ftPPI Ol) fld: P, lctl/ P,lhng il1ict r;l<1tt11S l0r lllt ·lf produc;1:-;.

ll { ...

II I '-

PrornOat Beta Glucan can be used 1n a wide vanety of foods and bevera9es includin~ cereals. baked ~Joo<.Js. soups, sauces. salad dressin~JS, dips. s1 noot11ies, fruit juices, ancl sports dnnks. lls conlnbution to t11e product's overall fibre would be included 111 the fibre listing on the nutrition inf on nation pa1101 for food. Depending upon tile roc1pc. usage level, and local regulations, products conta1n1ng PromOat Beta Glucan rnay tJe labelled as gluten-free-.

Current fibre intakes are very low among US adults, at about one-half of t11e US daily fibre recommendation of 25-38 g/day for women and men · . In other nations . average fibre intakes also fall well below recornrnendcd intakes. Diets high in fibre have been associated with lower risk of heart disease and improved blood glucose control while also supporting digestive Malth and laxallon and a1d1ng in wo1gl it m<1migemenr' ·· ~· .

Consl 1mption of foods and beverages made w1t11 PromOat Beta Gl11can car i help close the fibre intake gcip dnd may help to reduce calone and fat 1nlake. PromOat Beta Gluc<"n 1s well tolerated. and research suggests lll<.11 11 supports healthy cholesterol <lnd blood nlucose levels, may promote 9astro1ntestinal health, ancl rnay help consumers maintain a hc81thy body weight.

Page 120: OAT BETA-GLUCAN OAT J3-GLUCAN Beta-Glucan.… · Appendix 1: Product Information for Oat Beta-glucan Products ... • Switzerland -Spenser Pro Mass Gainer with 1 gram of oat 13-glucan

Innovating to Meet Nutrition, Health, and Wellness Needs Every Day

Despite the fact t11at many consumers say tt1at tt1ey are making efforts to consume diets high in dietary fibre and t11at they review labels for dietary fibre content when purchasing products. current fibre intakes remain low 1-. This has long-term unplications for public health related to nsk of coronary heart disease. stroke. hypertension, certain gastrointestinal disorders. obesity. and the continuum of metabolic dysfunctions including prediabetes and type 2 diabetes . According to a 2014 food and healt11 survey of US consumers by the International Food lnfonnation Council. 53% of inciividuals stated that they are trying to consume more dietary fibre' " Nutrition professionals can help to move consumers toward the goal of increasing fibre intake with education on benefits and sources of dietary fibre as consumers desire to make dietary changes.

Wl'1tle individuals should increase tl1cir consumption of dietary fibre Iron l sources such as beans and peas. other vegetables. fruits, and wllole grains·, t110 incorporation of nrlrled fibre like PromOat" Beta Gluca11 into foods as pM of a well-balanced diet can help individuals n-reet their recommended fibre intakes without exceeding their cRlorie needs. As a gently processed. 111911 molecular weight. neutral tasting beta-glucan. Tate & Lyle's PromOat Beta Glucan is uniquely positioned to be an ingredient that food manufacturers can use in the development of new and 1nnovattve products to meet t11e populatton's fibre needs and provide healt11 benefits, 1nclud1ng maintenance of healthy blood cholesterol and blood glucose. supporting gastrointestinal l1ealtli, and potentially supportir 19 wci9ht management.

II

Tcite & Lyle. a global leader 111

wellness 1nnovat1on. is cornrntlle{.'1 to delivering innovative ingredients t11at can be incorporated into great­tasting foods to help consumers meet l11eir nutrition, t1ealtt1, and wellness needs every d<"ly. That is because Tate & Lyle invests heavily 1n innovation and research and in developing ingredients that can t)e incorporated into a wide variety of great-tasting food and beverage solutions. T earns of food and nutrition scientists are continuously 11111ovat1ng, researching, and testi1 ig 1ngred1ents that will meet current ancl future health and nutrition needs.

At the same time. Tate & Lyle has a robust n iarket research program designed to provide the necessnry insights on consumer prefere1 ices Jround the world. The research program allows Tate & Lyle to customize its offerings and provide tatlor-rnado solutions 1n local ancl regional markets.

tt for yo • 1ng1 ~ Oh 1t f<

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In response lo glot)al public healtl 1 efforts calling for people to reduce calories and sodium and increase fibre intakes, T<"lle & Lyle offers a number of novel ingredient solutions that meet these needs.

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TATE ~~~ LYLE References:

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t•1 Sla-:n ..:L n~s1t•nn ol tt~A·''\::f1c..1·1 Detet1c i\~soc1:lt;Ct' Hn-'.lllr't •1 ··tJl1c::it1~ts 31 t11d.:uv f t)t:• . ,,i /: • .ti: Did ~:;soc. :'.008 10011(), 1 "'16-31 : i K~:zrr:Jr(',.:>.~ MM ~~inr1 ivu. r1 ~J·)d GC. il'lr. llf-.;'"',ltn 11eqei1•_5 :)i Cfa;i.'i!'1' N::o 01;,,)'0l 'C i.llt: l.~.vB! ;,.:1'.;!>.'!(..l:J QI '\'t"M? d~tes '1''t'lkh.JS c.11d1~vJ;!"t)..A.1· o.~.t:;ve .111<! r:;lon r .. itK.e!. ~ ... ~f'CiOOh~,rn .~n12.ti:~81 ; o:;fH;t~

Thrs 1eaf1et is PfOV1ded fof general cncL1latio1 to the nUtntJOC'\ soence and health p,otessi--Ofml community and Pf Ofessio1'lal part1c.pains 11'1 the food inclust1y, 1f1clud1ng f)l"O$pe<::t.1via c11Sl()Qners for T a10 & Lyle F-'000 '" W001()1ts. tt is not de!llgned fo1 consume< use. Tate & Lyl~ accepts no legal f1abihty io1 !he accuracy 0< completeness ol its c0<1tents and custcme1s shwld not 1ely on uie contents. O istom&s snoulcl t>Ote that whie ths leaflet contoins oui gcxxHaith assessment of the 1Tu111ws discus.""1. bosed on nformation avaiableas at the p0blcation date. legal. regvlatoiy and labelling policies anrt mq\li111menls<J<esutlject to change and ~JJ'isdicllonalvariation. Cust"'"""' sh:iuld take t.~r 0•1.m advice with regaJd t-0 the leg.al and regulatory .:ispects of our food 1ngred:ei-its and ther ~1cat100 to detem1111e SU1tnbl1ty for the;1 oorticUar wposes.. product d a11ns. label~ng stramg1cs or spoo:fic.ati<Yls.

Tate & Lyle · 5450 Pr~111e Stone Patkwa.y. Hoffn1an Estates IL 00192 · i.800.526.57~'$

C. 20 14 Tate & I yle • \-.'l.VWJ ate:tndllyle.com • ww\'>•.foodnu1rit1onlu'lowledge.mfo

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CBI Deleted Copy

Petition to Add to the National List 7 CFR 205.606: Oat Beta-Fiber

APPENDIX

Appendix 9A:

Oat Bran Concentrate Petition for Inclusion on the National List of Allowed Substances

http://www.ams.usda.gov/AMSv1 .O/getfile?dDocName=STELPRDC5067939&acct=nopgeninfo

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CTC NUTRITION

BUILDING NUTRITION SOLUTIONS FOR LIFE,

Petition for Inclusion on the National List of Allowed Substances

OatVantageTM Oat Bran Concentrate

CBI Deleted Copy

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IUllDING NUTRITION SOLUTIONS fOR LlfE.

October I 0. 2007

Program Manager. liSDNAMS!T'M/NOP Room 4008-So., Ag Stop 0268 1400 Independence Ave .. SW. Wa~hington. OC 20250 Phone: 202-720-3532 Fa;\: 202-205-7808

Dear Program Manager:

Plc:a..-.c find enclo!-Cd dupl icate copie~ of GTC Nut nil on·:. petit ion to ha\'e Oat Vantage 1 M.

oat bran concentrate included o n the National List of Allowed Sul>:.tances in Organic Production. If you have any 4ue~1ion~ ur need additional information plea-;c contact me directly.

Luke R. Kazmierski Quality Assurance and Regulatory Affair~ Speciali\t GTC' Nu1ri1ion Phone: 303-216-2489 E-mai I: lkazmier~ki <!!~gtcn utrition .com

bOO Corporate Corde• Suite Ii • Ciolden. C<) XO.JOI • l!(Ml-522·4682 • www.g10.:nutr111on.o.:om A l>usinrH ""'' oj C11m Produr/\ l11trnu11in11al. Inc

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. !

1 Appendix 1

Petition Information

Appendix 2 Manufacturing Flow Diagram cce1 Deleted)

Appendix 3 Material Safety

Data Sheets

Appendix 4 International

Regulatory Status

Appendix 5 GRAS Statement

Appendix 6 Safety /Studies

Information

. __ J

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Item A: Category: §205.606 Agricultural (nonorganic) nonsynthetic substances allowed in or on processed products labelled as "organic" or "made with organic (specified ingredients)."

Item B: I. Common name of substance: OatVantage™ (Oat Bran Concentrate). oat bran derived from oats, An-na satirn

2. Manufacturer's information : GTC Nutrition 5840 Expressway Missoula, MT 59808

3. Intended or current use: Ingredient in food products

4. Handling activity: Oat Vantage is normally added to other dry ingredients or liquids.

5. Source and manufacturing proc:edures: The raw material is a naturally occurring oat bran derived from whole oats. The oat bran is milled to a concentrated f<mn using a patented aqueous process. Please sec attached flow chart (see Appendix 2).

6. Summary of previous regulatory reviews: Oat bran has been approved by several regulatory bodies regarding health c laims (see Appendix 4).

7. Information regarding regulatory registrations: Oat bran is a well known food ingredient and General ly Recognized as Safe per 21 CFR J 70.30(d) (sec Appendix 5)

8. CAS number: None

9. Chemical properties and mode of action A) The substance, oat bran. is derived from whole oats and docs not

chemically react with other substances (see MSDS. Appendix 3). B) There is no toxicity vr environmental pcrsistence as this is a naturally

occurring oat bran source produced from whole oats. C) This type of product has no signi ficant effect on the human environment

due to it being a naturally occurring oat bran source. D) Effects on human health are attached (sec Appendix 6). Generally the

product is used for the improvement of human heart health. E) Oat bran has no effect on soil organisms, crops or livestock.

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10. Safety information: MSDS attached (see Appendix 3) GRAS Statement (see Appendix 5)

11. Research reviews provided: The research reviews provided pertain to health benefits (see Appendix 6).

12. Petition justification statemcnl: The product falls under the category §205.606 Agricultural (nonorganic) nonsynthetic substances allowed in or on processed products labelled as "'organic·· or "made wilh organic (specified ingredients).'" There are currently no organic equivalents of the product available. The product is not synthetic, it is a naturally occurring oat bran source produced from whole oats. Therefore OatYantage should be included on the National List, as it provides a valuable source or beta-glucan. OatYantagc is easily incorporJtcd into a wide range of foods, snacks, beverages and dietetic foods and leads to interesting documented health benefits at low inclusion levels.

13. Commercial confidential information statement: The process flow chart for the manufacturing of OatYantage is considered confidential business infonnation (CBI). This diagram is located in Appendix 2.

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NOSB COMMITTEE RECOMMENDATION Form NOPLIST1. Committee Transmittal to NOSB

For NOSB Meeting: Mall 2008 I Substance: Oat Bran Concentrate

Committee: Crops 0 Livestock D Handling X Petition is for : Inclusion of Oat Bran CQn£!n1!'.!!! Qn the Hational Li§! § 205.606

A. Evaluation Criteria (Applicability noted for each category; Doc umentation attached) Criter ia Satisfied? (see B below)

1. impact on Humans and Environment Yes X No n N/A L -2. Essentia l & Availability Criteria Yes X No 0 NIA n 3. Compatibility & Consistency Yes 0 No 0 N/A x 4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes D No X N/A LJ

B. Substance Fails Criteria Category: 4 Comments: T he (letit ion did not (lrovide i n formation dem onstrat ing that

th is mater ial cannot be o btained organicall:t in t he am2rogriate form , guant i ty, o r g ual i ty.

C. Proposed Annotation (if any ):

Basis for annotation: To meet criteria above: --- Other regulatory criteria: ___ Citation:

0. Recommended Committee Action & Vote (State Actual Motion): For Inclusion of Oat Bran Concentrate o n the Nat ional List§ 205.606

Motion by: Steve DeMuri Seconded: Joe Smillir:. Yes: _ o_ No· _6_ Absent: _o _ Abstain: JL

Crops Agricultural x Allowed '

Livestock Non-Synthetic Prohibited2

1) Substance Handling x Synthetic Rejected3 x voted to be added

as '"allowed" on Commercially Un-

National List to § 205. _ __ with No restriction

Available as Orqanic1 Deferred' Annotation (if any)

2) Substance to be added as ·prohibited" on National List to § 205. _ __ with Annotation (if any)

Describe why a prohibited substance:

3) Substance was rejected by vote for amending National List to § 205. 606 Describe why material was rejected: Material was rejected because the petition did not demonstrate why organic oat bran. which is widely available. cannot be processed into the needed form.

4) Substance was recommended to be deferred because

If follow-up needed, who will

follow up

E. Approved by Committee Chair to transmit to NOSB:

Julie Weisman A ern 2, 2QOB Committee Ch air Date

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NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST c h ? s ate!!orv t. Adverse impacts on humans or t e environment. ubstance - Oat Bran Concentrate

Question Yes No N/A1 Documentation (TAP; petition; reimlatorv ai?:encv; other)

I . Are there adverse effects on x Per the attached MSDS appendix 3. environment from manufacture, use, or disposal? f&205 .600 b.21 2. Is there environmental x Same as above contamination during manufacture, use, misuse, or disposal? [§6518 m.31 3. Is the substance harmfu l to the x Same as above environment? f&65 I 7c(I )(A)(i);65 I 7(c)(2)(A)il 4. Does the substance contain List x None listed in the petition, ingredienc specification, or MSDS. l , 2, or 3 inerts? f&65 I 7 c (I )(B)(ii); 205.60 I (m)2l 5. Is there potential for detrimental x This is an agricultural product, and petitioner c laims it is inert. chemical interaction with other materials used? f&65 18 m.ll 6. Are there adverse biological and x Substance is an agricultural product, is GRAS, and is intended chemical interactions in agro- as an ingredient of food products. ecosvstem? f §65 18 m.5] 7. Are there detrimental x Same as above physiological effects on soil organisms, crops, or livestock? f66518 m.51 8. ls there a toxic or other adverse x None per the MSDS. action of the material or its breakdown products? [~6518 m.21 9. Is there undesirable persistence x Same as above or concentration of the material or breakdown products in environment?f&65 J 8 m.21 I 0. ls there any hannful effect on x Substance is an agricultural product, is GRAS, and is intended human health? as an ingredient of food products. [§6517 c (I )(A)(i) ; 6517 c(2)(A)i; S65 I 8 m.41 I I. Is there an adverse effect on x Substance is an agricultural product, is GRAS, and is intended human health as defined by as an ingredient of food products. appl icable Federal regulations? [205.600 b.31 12. Is the substance GRAS when x Statement attached to the petition (Appendix 5), indicates it is used according to FDA 's good GRAS under21CFR 170.30(d). manufacturing practices? (§205.600 b.51 13. Does the substance contain x None listed in the MSDS attached to the petition. residues of heavy metals or other contaminants in excess of FDA tolerances? f§205.600 b.51

-'If the substance under review 1s tor crops or livestock production, all of the qm:suons trom 2(b.600 (b) are NIA- not apphcable.

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c atel!:ory 2 I h S b s t e u stance E . I ti 0 . p d ssentia or Jn?a mc ro ? s b uchon . u sta nce - Oat Bran c oncentrate

Question Yes No N/A1 Documentation <TAP: netition; r~ulatory ae:encv; other)

I. Is the substance formulated or x The manufacturing process flow diagram is CBI deleted from manufactured by a chemical the petition, but petitioner states the oat bran is milled to a process? f6502 (21 )l concentrated form using a patented ··aoueous" process. 2. Is the substance formu lated or x See above manufactured by a process that chemically changes a substance extracted from naturally occurring plant, animal, or mineral, sources? f6502 (21)1 3. Is the substance created by x This is an ag1i cultural product naturally occurring biological processes? f6502 (2 1 )l 4. Is there a natural source o f the x This is an agricultural product substance? f§205.600 b. l l 5. Is there an organic substitute? x Material is being petitioned for inclusion on §205.606; see f§205.600 b. 11 category 4 below. 6. Is the substance essential for This is an agricultural prod uct handling of organically produced x agricultural products? [§205.600 b.61 7. Is there a wholly natural x This is an agricultural product substitute product? [&65 17 c (I )(A)(ii)l 8. Is the substance used in x This is an agricultural product being petitioned for inclusion handling, not synthetic, but not on §205.606. organically produced? f§65 17 c (J )(B)(ii i)l 9. Is there any alternative x substances? £§65 18 m.61 I 0. Is there ano ther practice that x would make the substance unnecessary? f §65 18 m.61

1!f the suhstancc under re"1ew is tor crops or livestock producllon. all of the questions lrom 205 600 (b) are N/ i\- 1101 applicable

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Category 3. Is the substance compatible with organic production practices? Substance - Oat Bran Concentrate

Question Yes No N/A 1 Documentation ff AP; oetition· re!!ulatorv a2encv; other)

I. Is the substance compatible x with organic handling? [§205.600 b.2] 2. Is the substance consistent with x organic farming and handling? [§65 17 c (I XA)(iii); 6517 c (2)(A)(ii)l 3. Is the substance compatible x with a system of sustainable agriculture? f§65 l 8 m. 71 4 . Is the nutritional quality of the x food maintained with the substance? r§205.600 b.31 5. Is the primary use as a x Substance is a food ingredient intended for human heart health preservative? f6205.600 b.41 improvement. 6 . Is the primary use to recreate or x improve flavors, co lors, textures, or nutritive values lost in processing (except when required by law, e.g., vitamin 0 in milk)? r1os.600 b.41 7. Is the substance used in x production. and docs it contain an active synthetic ingredient in the following categories: a. copper and sulfur compounds;

- - ... -·-··· - ... ..... - - - - - - -· -· - · - . - - - . - - - - ..... - - - - - - - - ·- - - · - - - - - - .. - - - - - - · - ·· - - - - - - - - . b. toxins derived from bacteria; x --··------------ --- - - . - - - . --- ---- ---- . . . --- -- --- --- . . - - - -c. pheromones, soaps, x horticultural oils, fish emulsions, treated seed, vitamins and minerals? d. livestock parasiticides and x medicines?

------- - -----·----- - .. .. . - -- ------ - . . . -- -- - ---- . . . . - . e. production aids including x netting, tree wraps and seals, insect traps, sticky barriers, row covers. and equipment cleaners?

. 1Ifthc suhstancc under review 1s lor crops or h'estock production. all ol 1he ques11ons from 20:> 600 (h) arc NIA- nol applicable

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CBI Deleted Copy

Petition to Add to the National List 7 CFR 205.606: Oat Beta-Fiber

APPENDIX

Appendix 98:

NOSB Committee Recommendation: Oat Bran Concentrate, May 2008

http://www.ams.usda.gov/AMSv1 .O/getfile?dDocName=STELPRDC5068157&acct=nopgeninfo

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NOSB COMMITTEE RECOMMENDATION Form NOPLIST1. Committee Transmittal to NOSB

For NOSB Meeting: Mal£ 2008 I Substance: Oat Bran Concentrate

Committee: Crops D Livestock D Handling X Petition is for: ln!;;IU§IQn of Oat Bran CQns;entrate on the National List § 205.606

A . Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? {see B below)

1. Impact on Humans and Environment Yes X No D NIA D 2. Essential & Availability Criteria Yes X No 0 NIA D 3. Compatibility & Consistency Yes D No D NIA x 4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes D No X NIA D

B. Substance Fails Criteria Category: 4 Comments: The getition did not grovide infonnation demonstrating that

this material cannot be ob tained organically in the aggrogriate fonn, guanti!Y, or guality.

C. Proposed Annotation (If any):

Basis for annotation: To meet criteria above: Other regulatory criteria: Citation:

D. Recommended Committee Action & Vote (State Actual Motion): For lnclusl2n of Oat Bran Cons;entrate on the National List § 205.§06

Motion by: Steve DeMuri Seconded: Joe §.mi/Ii§. Yes: _o_ No:_£__ Absent: Q__ Abstain: _Q_

Crops Agricultural x Allowed'

Livestock Non-Synthetic Prohibited2

1) Substance Handling x Synthetic Rejected3 x voted to be added as "allowed" on

Commercially Un-National List to §

205. with No restriction Deferred4 Annotation (if any) Available as Organic'

2) Substance to be added as "prohibited" on National List to§ 205. with Annotation (if any)

Describe why a prohibited substance:

3) Substance was rejected by vote for amending National List to § 205. 606 Describe why material was rejected: Material was rejected because the petition did not demonstrate why organic oat bran, which is widely available, cannot be processed into the needed form.

4) Substance was recommended to be deferred because

If follow-up needed. who will

follow up

E. Approved by Committee Chair to transmit to NOSB:

Jyli!l! W!i!l§man A12rll 2, 20Q~ Committee Chair Date

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NOSB EVALUATION C RITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST C I Ad h b ? S b atee.ory verse impacts on umans or t c environment . u stance - Oat Bran Concentrate

Question Yes No N/A 1 Documentation (TAP; petition; rerulatory agency; other)

I. Are there adverse effects on x Per the attached MSDS appendix 3. environment from manufacture, use, or disposal? f§205.600 b.21 2. Is there environmental x Same as above contamination during manufacture, use, misuse, or disposal? [§6518 m.31 3. Is the substance harmful to the x Same as above environment? f§65 I 7c(I )(A)(i);65 I 7(c)(2)(A)il 4. Does the substance contain List x None listed in the petition, ingredient specification, or MSDS. I, 2, or 3 inerts? r&65 I 7 c (I )(B)(ii); 205.60 I (m )21 5. Is there potential for detrimental x This is an agricultural product, and petitioner claims it is inert. chemical interaction with other materials used? f§65 I 8 m.1 1 6. Are there adverse biological and x Substance is an agricultural product, is GRAS, and is intended chemical interactions in agro- as an ingredient of food products. ecosystem? f §6518 m.51 7. Arc there detrimental x Same as above physiological effects on soil organisms, crops, or livestock? r&65 I 8 m.51 8. Is there a toxic or other adverse x None per the MSDS. action of the material or its breakdown products? f§65 18 m.21 9. Is there undesirable persistence x Same as above or concentration of the material or breakdown products in environment?f§65 I 8 m.21 10. Is there any hannful effect on x Substance is an agricultural product, is GRAS, and is intended human health? as an ingredient of food products. [§6517 c (I )(A)(i) ; 6517 c(2)(A)i; &6518 m.41 11 . Is there an adverse effect on x Substance is an agricultural product, is GRAS, and is intended human health as defi ned by as an ingredient of food products. applicable Federal regulations? f205.600 b.31 12. Is the substance GRAS when x Statement attached to the petition (Appendix 5), indicates it is used according to FDA 's good GRAS under2 1 CFR 170.30(d). manufacturing practices? f §205.600 b.51 13. Does the substance contain x None listed in the MSDS attached to the petition. residues of heavy metals or other contaminants in excess of FDA tolerances? [§205.600 b.51

I lf1he substance under review 1s for crops or hves1ock producuon. all of the quesuons from 205.600 (b} are NIA-not applicable .

._ ' ..

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c atego ry 2 I th S b t s e u s ance E . I ti 0 ssent1a or . p d rgan1c ro ? s b uct1on . u stance - Oat Bran Concentrate

Question Yes No N/A1 Documentation (TAP: petition: ree:ulatorv ae:encv· other)

I. Is the substance fom1Ulated or x The manufacturing process flow diagram is CBI deleted from manufactured by a chemical the petition, but petitioner states the oat bran is milled to a process? r6502 (21 )1 concentrated form using a patented ·•aqueous" process. 2. Is the substance formulated or x See above manufactured by a process that chemically changes a substance extracted from naturally occurring plant, animal, or mineral, sources? r6so2<21)1 3. Is the substance created by x This is an agricultural product naturally occurring biological processes? f6502 (21 )1 4. Is there a natural source of the x This is an agricultural product substance? f§205.600b.I 1 5. Is there an organic substitute? x Material is being petitioned for inclusion on §205.606; see f§205.600 b.1 1 category 4 below. 6. Is the substance essential for This is an agricultural product handling of organically produced x agricultural products? [§205.600 b.61 7. Is there a wholly natural x This is an agricultural product substitute product? r§65 I 7 c ( 1 )(A)(ii)l 8. Is the substance used in x This is an agricultural product being petitioned for inclusion handling, not synthetic, but not on §205.606. organically produced? f§65 I 7 c ( l)(B)(iii)l 9. Is there any alternative x substances? f§65 I 8 m.61 I 0. Is there another practice that x would make the substance unnecessary? f§65 l 8 m.61 . 11f the substance under review 1s for crops or livestock producuon, all o f the questions from 205.600 (b) are NIA- not applicable .

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Category 3. Is the substa nce compatible with organic production practices? Substance - Oat Bran Concentrate

Question Yes No N/A1 Documentation (TAP: oetition: rel!ulatorv al!encv; other)

I. Is the substance compatible x with organic handling? (§205.600 b.21 2. Is the substance consistent with x organic farming and handling? (§6517 c (I )(A)(iii); 65 17 c (2)(A)(i i)l 3. Is the substance compatible x with a system of sustainable agriculture? r§65 l 8 m.71 4. ls the nutritional quality of the x food maintained with the substance? f§205.600 b.31 5. Is the primary use as a x Substance is a food ingredient intended for human heart health preservative? r&205.600 b.41 imorovement. 6. Is the primary use to recreate or x improve flavors, colors, textures, or nutritive values lost in processing (except when required by Jaw, e.g., vitam in Din milk)? f205.600 b.41 7. Is the substance us.ed in x production, and does it contain an active synthetic ingredient in the following categories: a. copper and sulfur compounds;

-··-· ·-·. -··-.. -··-··-··-. ·-··-·· - ·· -··-··-·· -·· - ·· -··-·· ··- ··-··-·· ··-··-··-·· ··-··-··-··-·· .. -··-.. _ .. -··-.. -··-··-··-··-·· -·. -··-·· -. '-··-··-·· -··-··-.. -'' -.. -.. -··-··-··-... -·· -·· -··-··-.. -'. b. toxins derived from bacteria; x

.-.·..-••- ••-u-••- ••-••- ••-··-··- ··-··-··-··-··-··- ··- ··-·• --·-· ··-··-··-··-·· ••-••-··-··- ··-··-··-··-··-··- •··-•-n- -•- ·••- ·•-·• - ••- ... - •• - ··-··-··-··-··-··- ··--•- ·· -··-· ·-··-··-·· c. pheromones, soaps, x horticultural oils, fish emulsions, treated seed, vitamins ·and minerals?

-··-· · - · ·-·--·---··-··-·--··-·· -··- --~-··---··---·· ·· - · - - ·- ·- · - . ·· -··-·· - ·- ·· ··- ·- --··-·· - · - - ·-·-·-··-··- ·-··----- ··-·- ··-·- -·-·· -··-- -··- ·-··-··- ··-··--·- ··-·· d. livestock parasiticides and x medicines?

-.. -·· -·· -··-··-··-··-··- ·· -··-··-··-·. -··-··-··-··-··- .. ··-··-.. -·. ..-... -.. -.. ··-··-··-··-·· ··-··-··-··- ··- ··- ··-··-.. -.. -.. -.. -.. -.. -· ·-·· ..... _ ··- .. _ ··-.. -'. - .. -.. - ·. -·. -' . - ·· -··-.. - .. - ··-··-·· e. production aids including x netting, tree wraps and seals, insect traps, sticky barriers, row covers, and equ ipment cleaners?

I - > If the substance under review 1s for crops or livestock production. <111 of the questions from 205.600 (b) arc NIA not applicable.

• < • • ·~ • · '

Page 137: OAT BETA-GLUCAN OAT J3-GLUCAN Beta-Glucan.… · Appendix 1: Product Information for Oat Beta-glucan Products ... • Switzerland -Spenser Pro Mass Gainer with 1 gram of oat 13-glucan

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially unavailable? [§6610, 6518, 6519. 205.2. 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)) - Oat Bran Concentrate

Question

1. Is the comQarative descriQtion Qrovided as to why the non-organic form of the material /substance is necessary for use in organ ic hand ling? 2. Does the current and historical industry information, research, or evidence provided explain how or why the material /substance cannot be obtained organically in the appropriate form to fulfill an essential function in a system of organic handling? 3. Does the current and historical industry information, research, or evidence provided explain how or why the material /substance cannot be obtained organically in the appropriate fil!.!!l!l'. to fulfill an essential function in a system of organic handling? 4. Does the current and historical industry information, research, or evidence provided explain how or why the material /substance cannot be obtained organically in the appropriate quantity to fulfill an essential function in a system of organic handling? 5. Does the industry infonnation provided on material I substance non-availability as organic, include (but not limited to) the fo llowing: a. Regions of production (including factors such as climate and number of

-~·~giO!!~)i_ .. _ .. _, ______ -··-.. - ._ .. _,, __ - - - -.. b. Number of suppliers and amount

. ..P.!9E.1:!~~d_; .. ____ .. ___ ,,_ .. _ .. ___ ,,_··-·-.. -··-··-··-·· c. Current and historical supplies related to weather events such as hurricanes, floods, and droughts that may temporarily halt production or

--~~.s!rQY_ .C!_OP.~.~r.§.\.1.PP.l~e.~;, _ ,,_ ·-·-.. -··-"-" d. Trade-related issues such as evidence of hoarding, war, trade barriers, or civil unrest that may

-~~~...P.Q!'.?!ilx_ re~~i~t supQlie~i.~!.._ .. _, __ e. Are there other issues which may present a challenge to a consistent supply?

Yes No N/A

x

x

x

x

x

··- ··- ··-· .__ ·-·- ·- ··- ··-··- . x

·-··-··-· --··-·-·- ·--·-··-··-·· x

··-··-«- • .. -··-·· ·-··-··-··-·· x

-··----· - ·- - ··- ---·---x

Comments on Information Provided (su1licient, plausible, reasonable, thoroue.h, complete, unknown)

Petition did not provide sufficient comQarative information explaining why the non-organic fonn of the material is necessary for use in organic handling

No information was provided in the petition demonstrating the unavailability of raw organic oat bran for further processing, nor of the absence of processors to manufacture the oat bran concentrate. An internet search by the evaluator, and phone calls to several suppliers by the evaluator, indicated that organic oat bran is commercially available.

No information provided.

No information provided.

No information provided.

··-·· -··-·· -··-··-··-·~-··-··-··-· · - ··- ··-··-··-··-··- · ·-·· -··-··-··-··-.. --.-··-·-.-··-··-··-··-·· No information provided .

--·---·---·- ··-··-··-··-··-·-·-·-··-··-··-··-··-·-·-··-··-··-··-·-··-··-··-··-·· No infonnation provided.

.. -·· - ··- ·· - ............... - ··-··- ··-··- .. -··- ........ ,_ .. _,._,,_ . -· - .. .. .. ·- .. .. .... .... _. - ··-No information provided.

--------··-- ·-- -·-------··- ---No information provided.

tJ 1 •l I) ,, ~ .. · l h

• 1; \. 11\ , .'i ;1 :;


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