OAT BETA-GLUCAN OAT J3-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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Item A

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

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. info@

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 -CANTM 70% Oat Beta Glucan, that further purifies a soluble oat fiber through solvent extraction (GRAS Assessment, July 19, 2012 . 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 OatVantageTM 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, OatVantageTM 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 f3glucan concentrate level would be 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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