Manufacturing Gluten-Free Foods Jay Berger Miss Roben’s, Inc. AKA The Allergy Grocer

Who Is Miss Roben’s? Dedicated gluten-free (GF) manufacturer with 50+ proprietary mixes Dedicated gluten-free (GF) manufacturer with 50+ proprietary mixes –Caters both to Celiac & those with multiple food allergies & intolerances –Dedicated plant -no wheat, gluten, dairy, peanuts, tree nuts, eggs, soy (lecithin in one pre-made chocolate chip), shellfish, fish, or sesame in plant National mail order business for over 1,000 other select GF products National mail order business for over 1,000 other select GF products Family owned (husband & wife) Family owned (husband & wife) –Self-educated to GF & food manufacturing –Wear multiple hats (research & development, plant production & operations, etc) –Always < 15 employees; one operation site so able to change on the ‘fly’ with minimal “red tape”

Miss Roben’s Continued Provide extensive assistance via phone & internet: Provide extensive assistance via phone & internet: –Constantly redirect & re-network consumers to more appropriate resources (medical, dieticians, national/local support groups, etc) –Distribute other manufacturer’s contact information –Extensive baking assistance even if using competitor’s products Belong to over 30 different Celiac & associated newsgroups Belong to over 30 different Celiac & associated newsgroups Based on this experience it appears that consumers: Based on this experience it appears that consumers: –Rely heavily on labels for processed foods –Seek out GF on label –Devote multiple extra hours both to label reading & follow up calls to manufacturers –Typically have poor knowledge of manufacturing process & terms –Often inadvertently purchase unsafe products (esp. Spelt)* –Require assistance in calculating nutritional facts that are not clearly marked per serving analysis

Q1: Define GF*: General Industry No Wheat, Barley, Rye, Oats**, Spelt, Triticale, Kamut No Wheat, Barley, Rye, Oats**, Spelt, Triticale, Kamut NO derivatives, extracts, or processing aids from any of the above. Exception: distilled vinegars other than malt vinegar NO derivatives, extracts, or processing aids from any of the above. Exception: distilled vinegars other than malt vinegar Ingredients &/or finished product test ranges anywhere from < parts per million (ppm) Ingredients &/or finished product test ranges anywhere from < parts per million (ppm) * Ref: Don Kasarda (grain scientist), National Celiac Support groups, American Dietetic Association, various medical journals ** Potential cross-contamination

Q1: Gluten-Free Additionally Defined At Miss Roben’s Whenever possible (90%) use dedicated, single source ingredient suppliers who do all aspects of production - grow, harvest, mill, package) in-house to provide least possible risk of cross contamination. Whenever possible (90%) use dedicated, single source ingredient suppliers who do all aspects of production - grow, harvest, mill, package) in-house to provide least possible risk of cross contamination. Ingredients purchased through a distributor (<10%) must come from supplier already sealed/prepackaged. Ingredients purchased through a distributor (<10%) must come from supplier already sealed/prepackaged. Each ingredient supplier (even if distributor is used) must provide written documentation on company letterhead of: Each ingredient supplier (even if distributor is used) must provide written documentation on company letterhead of: »Product specifications & 100 gram analysis »Processing conditions statement (next page) »If possible, written certification from 3 rd party that ingredient has been tested by independent lab (lab & testing procedures widely vary) »Further certifications for Kosher, Organic, Vegan Product label, website, catalog all explain to consumer how we define GF & processing conditions. Product label, website, catalog all explain to consumer how we define GF & processing conditions.

Product/Ingredient Name: ________________________________________ UPC Code #_______________________________ Contact Person, Title, & Phone #: _____________________________________ Is the ingredient/product produced & packaged in the same facility? ___Yes __ No If it is packaged at another facility, please make a copy of this form to mark & complete it for the conditions where it is packaged. Please use Yes or No statements where appropriate & identify specifics wherever possible (e.g. soy-lecithin, dairy-cream, nuts-whole cashews, further details etc) where applicable. Allergen Present in same plant? If yes, in the same room? Present in product? Are any ingredients used in product derived from this? Used as a processing aid for this product? In plant & manufacture d on same line? In plant & manufacture d on same day? Gluten (include s wheat, oats, rye, barley) Dairy (includes lactose, whey, casein) Soy (lecithin, oil, protein)

Do you test for Wheat? ___Yes ___No If yes, what PPM is it tested to? Do you test for Gluten? ___Yes ___No If yes, what PPM is it tested to? Do you test for Peanuts? ___Yes ___No If yes, what PPM is it tested to? Do you test for Tree Nuts? ___Yes ___No If yes, what PPM is it tested to? Do you test for Eggs? ___Yes ___No If yes, what PPM is it tested to? Do you test for Dairy? ___Yes ___No If yes, what PPM is it tested to? If used, is your baking powder aluminum-free? ___Yes ___No Is your product/ingredient certified Kosher? If so which certification does it hold? Is your product/ingredient Organic? What is the shelf life of this product/ingredient? Describe your cleaning procedures & other methods for allergen avoidance in processing & packaging? _________________________________________________________________________________ ____________________________________________________________________________________ ___________________________________________________________________________________ Is there anything else we should know to better help us? _________________________________________________________________________________ ____________________________________________________________________________________ ___________________________________________________________________________________

~Q1. Challenges To Defining GF Since there is no standardized definition for GF manufacturer must: Since there is no standardized definition for GF manufacturer must: –Educate self & staff using the current confusing & vague explanation of the GF diet (& will they interpret it correctly?) –Decide: »Are oats ok? »When is it GF enough (i.e. not in ingredients, not on shared lines, at ppm, etc)?

Q2. Current GF Production Both food production & plant WIDELY varies Both food production & plant WIDELY varies Spans the entire spectrum from suspicious to excellent: Spans the entire spectrum from suspicious to excellent: –Wheat starch where the gluten proteins processed out (Europe)  no gluten in actual ingredients but poor manufacturing protocols to avoid cross contamination  Good Manufacturing Practices (GMP) & Good Hazard Analysis & Critical Control Point (HACCP) protocols using “clean” sourced ingredients  dedicated plant & ingredients with independent outside lab testing down to <3ppm –Production varies from shared bakeries or personal home (often by Celiac/consumer who decides to start own business  companies with dedicated plants

~Q2. Specific Challenges To GF Production Dry ingredients often lighter & starchier texture Dry ingredients often lighter & starchier texture –Form, fill, & sealing dry mixes more difficult »Essential component (xanthan, guar) very minute portion of ingredients (thorough blend) »Flours tend to ‘poof’ & harder to contain »Bag seal clogs if no mechanism to keep flour down in bag »Xanthan/guar (gluten ‘replacer’) very gummy when wet (equipment, floors, walls, clogs A/C unit) Actual mix preparation (plant AND consumer) Actual mix preparation (plant AND consumer) –Flours are much more sensitive to environmental conditions »Especially breads-much more prone to failure »Exact liquid content needed can vary from lot to lot »Raw bread dough batter is stickier & looser (changes production process) »Label benefits from more exhaustive directions for success (need to factor in costs for replacements for customer satisfaction)

Q2. Methods Most Commonly Used to Remove Gluten from Foods Absence of gluten in the ingredients (most common practice) Absence of gluten in the ingredients (most common practice) Process out the gluten proteins or denature them Process out the gluten proteins or denature them –Vinegars made from GF grains –Wheat starch (acceptable in Europe)

Q3. Is it Technologically Feasible to Produce GF Products Given Potential For Grain Cross-Contamination? Yes if: –Select ingredients from dedicated grain suppliers & dedicated GF mills –Use good HACCP, GMP, & allergen protocols in plant –Provide in-house staff education to GF –If utilize shared lines or non-dedicated ingredients, perform universally accepted enzyme-linked immunosorbent assay (ELISA) test to confirm any potential contamination on regular basis

Q3. Is GF Manufacturing Economically Feasible? YES YES –Biggest investment is time required to source ingredients & appropriate equipment (thorough blend & clean xanthan/guar) –Ingredient suppliers & distributors are accessible even to small businesses with poor purchasing power. Ingredient & operational costs are factored into price –Manufacturers can also outsource & utilize co-packers with dedicated GF rooms & equipment or dedicated GF manufacturing plants (that would decrease their operational & ingredient costs) –Customer buying power & interest is already there: »1:133 with Celiac PLUS wheat allergic consumers  huge demand »Mintel Survey 2005  excellent industry potential –As GF industry grows, ingredient & production costs will decline & availability will increase  more affordable to small industry –Oats would be great asset to GF manufacturer- enhances product taste, texture, & structure  expand the available product line

Q4 & 5. Measures & Costs To Prevent Cross-Contamination at Miss Roben’s Dedicated plant (No gluten, plus none of the top 8 allergens or sesame) Dedicated plant (No gluten, plus none of the top 8 allergens or sesame) Dedicated equipment Dedicated equipment –Purchased new to avoid potential cross contamination –Exhaustive research to find ones that blend, disperse, seal, & clean (no crevices or spots to cake) with minimal time & material waste –Can handle volume runs & wash downs needed to maintain efficient & economical production Dedicated, single ingredient suppliers with written certificate of analysis (we do quarterly routine checks & also follow up if customer registers concern) Dedicated, single ingredient suppliers with written certificate of analysis (we do quarterly routine checks & also follow up if customer registers concern) Ongoing written employee allergen training tools to GF & potential methods of cross-contamination Ongoing written employee allergen training tools to GF & potential methods of cross-contamination GMP & HACCP system with a thorough sanitation program GMP & HACCP system with a thorough sanitation program Internal policy & procedures for manufacturer recalls & customer complaints Internal policy & procedures for manufacturer recalls & customer complaints

Winter 2005: Miss Roben’s Analytical Methods To Detect Gluten Yearly Celiac branding (undetermined cost) Yearly Celiac branding (undetermined cost) In-house qualitative ELISA test each batch In-house qualitative ELISA test each batch –Neogen’s Gliadin Alert® Test for wheat, barley, & rye: »Qualitative sandwich ELISA (S-ELISA) test »Shows whether sample contains more or less than 10ppm gliadin than the control provided Quarterly quantitative ELISA test via independent lab for confidential analysis (U of Nebraska’s Food Allergy Research & Resource Program) Quarterly quantitative ELISA test via independent lab for confidential analysis (U of Nebraska’s Food Allergy Research & Resource Program) –$80 ($55 members) per test –Uses two S-ELISA tests for gliadins from wheat & corresponding prolamines from rye & barley. –Neogen’s Veratox Test for Gliadin-provides accurate sample results in ppm with controls provided for 0, 2, 5, 10, & 25ppm –R-Biopharm’s RIDASCREEN® Gliadin (R7001)-tests down to 1.5 ppm gliadin (3ppm gluten) –Of note: fermented or hydrolyzed samples require special ELISA testing

Personal Suggestions Obtain dedicated ingredient suppliers who can provide written certificate of analysis & analytical testing (ppm based on FDA) Obtain dedicated ingredient suppliers who can provide written certificate of analysis & analytical testing (ppm based on FDA) Provide ongoing in-house education to staff Provide ongoing in-house education to staff –Using universally agreed upon GF definition –Easy-to-follow written educational tools Test for gluten Test for gluten »Quarterly quantitative analysis by independent lab »If shared lines, in-house every batch