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96 FOODTECHNOLOGY SEPTEMBER 2001 VOL. 55, NO. 9 JAMES GIESE Internet Editor Detection of Food Allergens dient)” may be used. The agency has said that it is open to suggestions on how best to address the issue of allergen labeling. FDA is scheduled to hold a public meeting on labeling food allergens on August 13, 2001, in Washington, D.C. Unfortunately, deadlines for this issue prevent reporting on what happened at the meeting. The meeting will discuss the labeling of foods containing allergens and the inadvertent addition of allergens to foods due to processing practices. The purpose of the meeting was to stimulate discussion and to obtain information to assist FDA in determining what addi- tional actions may be necessary to pro- vide consumers with adequate informa- tion on product labels. The meeting will focus on three areas: (1) source or plain English labeling; (2) supplemental label- ing (e.g., “may contain” labeling); and (3) labeling of ingredients exempted from declaration (i.e., common or usual names of flavorings, spices, and colors; incidental additives). Information on these initiatives is available at the FDA Web site on allergens at www. cfsan.fda.gov/dms/wh-alrgy.html.FDA believes that the Food Allergy Issues Al- liance guidelines are an appropriate start- ing point for discussions at the public meeting. Manufacturers may want to test final product for the presence of allergens in products not intended to contain aller- gens. Manufacturer will need to deter- mine what method of analysis is used and the sensitivity of that method. They will also need to determine if the testing is routine or periodic. Although FDA has not yet designated any method of allergen testing for regu- latory purposes, there are several com- mercial enzyme-linked immuno-sorbent dustry and trade group representatives and a consumer group) has formulated guidelines for the labeling of foods that contain known allergens. The guidelines recommend the use of terms commonly understood by consumers (i.e., “plain English”) for major food allergens within, or in immediate proximity to, the ingredient declaration, to provide clear communication with the food-allergic consumer. The major food allergens referred to by the guidelines can cause serious aller- gic reactions in some individuals and ac- count for more than 90% of all food al- lergies. These major food allergens are peanuts, soybeans, milk, eggs, fish, shell- fish, tree nuts (almonds, Brazil nuts, cashews, chestnuts, filberts/hazelnuts, macadamia nuts, pecans, pine nuts, pis- tachios, and walnuts), and wheat. The guidelines state that it is impor- tant to disclose all allergenic ingredients regardless of the source. They also give procedures for the use of “Supplemental Allergen Statements.” These statements are commonly known as “may contain” labels. These labels are used when there is a chance that foods that do not con- tain a known allergen as an ingredient may inadvertently come into contact with an allergen during processing. A prominent example would be a process- ing line that makes a product containing peanuts and then switches over to make another product. The current FDA stance on allergen labeling is that manufacturers should first adhere to good manufacturing prac- tice (GMP). GMPs are essential for effec- tive reduction of adverse reactions. How- ever, FDA has stated that precautionary labeling with statements such as “may contain (insert name of allergenic ingre- LABORATORY The National Institutes of Health esti- mates that six to seven million people in the U.S. suffer from food allergies. Some of these may develop serious or life- threatening allergic reactions if exposed to the causative proteins. The only way for these people to manage their allergic reactions is to avoid foods containing the proteins. This means that food proces- sors must be careful in informing food allergic consumers about the presence of food allergens in their products. Section 403 of the Federal Food, Drug, and Cosmetic Act requires food labels to bear a complete listing of all the ingredients in a food. However, because of two narrow exemptions from the in- gredient labeling requirements, several allergic-type incidents have occurred. The first exemption provides that spices, flavorings, and colorings may be declared collectively without naming each one. Second, the regulations exempt from in- gredient declaration incidental additives, such as processing aids, that are present in a food at insignificant levels and that do not have a technical or functional ef- fect in the finished food. Because of these two exemptions, the Food and Drug Ad- ministration believes some individuals may have mistakenly consumed a prod- uct to which they are allergic. FDA is currently considering whether it is necessary to clarify its regulations to ensure that manufacturers fully under- stand the circumstances in which aller- genic food ingredients must be declared and to ensure that sensitive individuals are protected by appropriate labeling. Although food manufacturers label the ingredients in their products in ac- cordance with these existing regulatory requirements, the Food Allergy Issues Al- liance (a private group composed of in- Products Technologies &

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Page 1: Detection of Food Allergens

96 FOODTECHNOLOGY SEPTEMBER 2001 • VOL. 55, NO. 9

JAMES GIESEInternet Editor

Detection of Food Allergensdient)” may be used. The agency has saidthat it is open to suggestions on how bestto address the issue of allergen labeling.

FDA is scheduled to hold a publicmeeting on labeling food allergens onAugust 13, 2001, in Washington, D.C.Unfortunately, deadlines for this issueprevent reporting on what happened atthe meeting. The meeting will discuss thelabeling of foods containing allergensand the inadvertent addition of allergensto foods due to processing practices. Thepurpose of the meeting was to stimulatediscussion and to obtain information toassist FDA in determining what addi-tional actions may be necessary to pro-vide consumers with adequate informa-tion on product labels. The meeting willfocus on three areas: (1) source or plainEnglish labeling; (2) supplemental label-ing (e.g., “may contain” labeling); and (3)labeling of ingredients exempted fromdeclaration (i.e., common or usualnames of flavorings, spices, and colors;incidental additives). Information onthese initiatives is available at the FDAWeb site on allergens at www.cfsan.fda.gov/dms/wh-alrgy.html.FDAbelieves that the Food Allergy Issues Al-liance guidelines are an appropriate start-ing point for discussions at the publicmeeting.

Manufacturers may want to test finalproduct for the presence of allergens inproducts not intended to contain aller-gens. Manufacturer will need to deter-mine what method of analysis is usedand the sensitivity of that method. Theywill also need to determine if the testingis routine or periodic.

Although FDA has not yet designatedany method of allergen testing for regu-latory purposes, there are several com-mercial enzyme-linked immuno-sorbent

dustry and trade group representativesand a consumer group) has formulatedguidelines for the labeling of foods thatcontain known allergens. The guidelinesrecommend the use of terms commonlyunderstood by consumers (i.e., “plainEnglish”) for major food allergenswithin, or in immediate proximity to, theingredient declaration, to provide clearcommunication with the food-allergicconsumer.

The major food allergens referred toby the guidelines can cause serious aller-gic reactions in some individuals and ac-count for more than 90% of all food al-lergies. These major food allergens arepeanuts, soybeans, milk, eggs, fish, shell-fish, tree nuts (almonds, Brazil nuts,cashews, chestnuts, filberts/hazelnuts,macadamia nuts, pecans, pine nuts, pis-tachios, and walnuts), and wheat.

The guidelines state that it is impor-tant to disclose all allergenic ingredientsregardless of the source. They also giveprocedures for the use of “SupplementalAllergen Statements.” These statementsare commonly known as “may contain”labels. These labels are used when thereis a chance that foods that do not con-tain a known allergen as an ingredientmay inadvertently come into contactwith an allergen during processing. Aprominent example would be a process-ing line that makes a product containingpeanuts and then switches over to makeanother product.

The current FDA stance on allergenlabeling is that manufacturers shouldfirst adhere to good manufacturing prac-tice (GMP). GMPs are essential for effec-tive reduction of adverse reactions. How-ever, FDA has stated that precautionarylabeling with statements such as “maycontain (insert name of allergenic ingre-

L A B O R A T O R Y

The National Institutes of Health esti-mates that six to seven million people inthe U.S. suffer from food allergies. Someof these may develop serious or life-threatening allergic reactions if exposedto the causative proteins. The only wayfor these people to manage their allergicreactions is to avoid foods containing theproteins. This means that food proces-sors must be careful in informing foodallergic consumers about the presence offood allergens in their products.

Section 403 of the Federal Food,Drug, and Cosmetic Act requires foodlabels to bear a complete listing of all theingredients in a food. However, becauseof two narrow exemptions from the in-gredient labeling requirements, severalallergic-type incidents have occurred.The first exemption provides that spices,flavorings, and colorings may be declaredcollectively without naming each one.Second, the regulations exempt from in-gredient declaration incidental additives,such as processing aids, that are presentin a food at insignificant levels and thatdo not have a technical or functional ef-fect in the finished food. Because of thesetwo exemptions, the Food and Drug Ad-ministration believes some individualsmay have mistakenly consumed a prod-uct to which they are allergic.

FDA is currently considering whetherit is necessary to clarify its regulations toensure that manufacturers fully under-stand the circumstances in which aller-genic food ingredients must be declaredand to ensure that sensitive individualsare protected by appropriate labeling.

Although food manufacturers labelthe ingredients in their products in ac-cordance with these existing regulatoryrequirements, the Food Allergy Issues Al-liance (a private group composed of in-

Products Technologies&

Page 2: Detection of Food Allergens

FOODTECHNOLOGY 97VOL. 55, NO. 9 • SEPTEMBER 2001

assay (ELISA) kits for food allergenscommercially available. Currently, FDAis evaluating some of these kits and is alsocooperating with kit manufacturers toconduct international collaborative stud-ies to evaluate the performance of someof the ELISA-based methods.

Neogen Corp., 620 Lasher Place, Lan-sing, MI 48912 (phone 800-234-5333),offers several ELISA tests for the detec-tion of allergens in food products. Theseare the Veratox tests for egg allergen, milkallergen, and peanut allergen. The testsare said to require only a minimalamount of training to use, and providefully quantitative results. Neogen alsooffers the Alert screening tests for egg,milk, and peanut allergens. These testsprovide qualitative results in about 30min. Neogen’s Alert test for sulfites is saidto offer a simple, reliable, and inexpen-sive method for routine monitoring forsulfite residues in seafood throughoutproduction and distribution.

The Food Allergy Research & Re-source Program, 143 Industry Complex,

Lincoln, NE 68583 (phone 402-472-4484; www.farrp.unl.edu) was estab-lished in 1995 at the U. of Nebraska-Lincoln’s Food Processing Center to as-sist the food industry with issues associ-ated with food allergens. The group isdeveloping assays to detect allergenicfood residues that might contaminateother foods. Currently, the research isfocused on ELISAs. These ELISAs detectresidues of allergenic foods rather thanfood allergens and are useful for detect-ing allergenic food residues arising fromsuch food industry practices as usingshared processing equipment or usingrework. The group has several ELISAs invarious stages of development and workswith industry partners to commercializethem into test kits. Assays currently avail-able include peanut, egg, casein, almond,and whey in selected foods. The group isalso testing assays for soy, clam, hazel-nut, walnut/pecan, and cashew.

Elisa Technologies, Inc., 4581-L NW6th St., Gainesville, FL 32609 (phone352-337-3929), offers an assay based on

highly specific antibodies to an allergenprotein purified from peanuts(Conarachin-A) developed in collabora-tion between the U.K. Institute of FoodResearch and Cortecs Diagnostics, Ltd.The assay, marketed as the Elisa-Tek™Peanut Protein Test Kit, uses the principleof enhanced enzyme-immunoassay(EIA) and is a sensitive and specific testdesigned to detect very low (ppm) levelsof peanut content in raw and cookedfoodstuffs. The assay is a non-competi-tive, sandwich-type EIA. Color develop-ment in the assay is proportional to theoriginal amount of Con-A in the extract,and a qualitative determination of pea-nut protein content may be made eitherby visual inspection or using a spectro-photometer or plate reader. The com-pany claims that food samples contain-ing the equivalent of 0.5–2 ppm of pea-nut material, when prepared accordingto directions, gave positive responses tothe test.

Besides the peanut assay, the com-

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98 FOODTECHNOLOGY SEPTEMBER 2001 • VOL. 55, NO. 9

pany offers kits for the determinationof specific food proteins and ingredientsincluding wheat, soy, milk, and egg pro-teins. Gluten, soy, casein, and whey pro-tein kits may be used to qualitatively de-tect the respective proteins, or, using amicroplate reader and the includedstandards and controls, the assays willprovide quantitative results. The glutenkit has AOAC Official First Action sta-tus and is used to identify gluten-freefoods. A rapid gluten test that may beused to detect gluten down to 50 ppmin 5 minutes.

The Food Allergy Network, 10400Eaton Pl., #107, Fairfax, VA 22030(phone 703-691-3179; www.foodallergy.org) is a non-profit organi-zation established to increase publicawareness about food allergies and ana-phylaxis. The Web site includes infor-mation on product recalls and researchsummaries.

Indicator Tags for the food process-ing industry change color only when abatch of food is fully processed. The Re-tort Canning Process Indicator Tags, forsteam pressure cooking low-acid foods,are designed to change from purple togreen after exposure to saturated steamin batch processing retort systems. Thecolor change is an effective visual indi-cation of status, and minimizes the dan-ger of unprocessed foods entering theconsumer chain. A tag will not completeits color change if an error has occurredin the cooking process. This providesadded assurance in addition to existingcontrols. Leaving the exposed tag on willprovide permanent evidence of the foodprocess and demonstrates good practiceand traceability. Produced in sevengrades, relating to time of exposure andtemperature, the retort tags are nowavailable in sequential numbers to elimi-nate the need for numbering and to pro-vide for greater control in the produc-tion area. Temperature ranges availableare from 140 to 302oF, and the indicatorscan be supplied singly or mounted on acard. Free samples are available. For moreinformation, contact Temperature Indi-cators Ltd., Yewbarrow Studio, Grange-Over-Sands, Cumbria, England, LA116ED (phone 011-444-15395-35488;www.temperature-indicators. co.uk)—or circle 305.

Vacuum Desiccator may be used tocool, dry, and store moisture-sensitivematerial. Applications include storage ofthin-layer chromatography plates, halidesalt cells, and chemical standards. Theone-piece cabinet body is constructed ofFiberglas-reinforced polyester and can be

P R O D U C T S & L I T E R A T U R E

inverted to allow for left-hand openingand closing. Nine shelf supports aremolded into the walls of the cabinet tohold two removable aluminum shelves.The cabinet is vacuum tested to 25 in ofmercury. A three-way vacuum releaseneedle valve accommodates 1/4-in IDvacuum tubing and allows for slowvacuum release and refilling with dry ni-trogen gas. For more information, con-tact Labconco Corp., 8811 Prospect Ave.,Kansas City, MO 64132-2696 (phone816-333-8811)—or circle 306.

Plant Integrity Checks, calledLifeTime Testing Services, are designedto provide processing line testing with aminimum of disruption to the produc-tion process. Contamination is a con-stant concern during liquid processing,yet the causes can be extremely difficultto track down. The smallest pinhole orhairline crack can be the beginning ofmajor problems unless they are identi-fied and rectified early. However, testingfor defects can be a long, disruptive pro-cess requiring plant closure and disman-tling. This new testing service can checkthe integrity of heat exchangers, tanks,and vessels in a matter of hours. The test-ing of heat exchangers is a two-stage op-eration, first to identify if a defect exists,and then to isolate any faults so that theheat exchanger can be repaired. The firststage is the electrolytic differential analy-sis test. This entails filling one side of theheat exchanger with sodium sulfate,which acts as an electrolyte, and the otherside with water. The pressure of the elec-trolyte is increased to create a differen-tial, while probes monitor the conduc-tivity of the water. A consistent rise in

Page 4: Detection of Food Allergens

FOODTECHNOLOGY 99VOL. 55, NO. 9 • SEPTEMBER 2001

conductivity of the water indicates thatthere is a fault somewhere in the system.The next stage is detailed flaw detection,which uses a probe placed at intervals onthe edge of each plate. Areas with abnor-mal sound signature indicate a fault. Theheat exchanger can then be repaired. Formore information, contact APV Systems,Platinvej 8, DK-6000 Kolding, Denmark(phone +45-7632-4115)—or circle 307.

Mobile Bench may be used as an aux-iliary work space and can support loadsup to 540 lb. The corrosion-resistantwork surface of melamine laminate mea-sures 38 in by 28 in. The height adjustsin four increments, using steel pins withnuts inserted into vertical frame mem-bers. The durable welded frame is coatedwith corrosion and abrasion-resistantbaked-on epoxy powder. Toe-locks pre-vent movement when a stationary benchis required. For more information, con-tact Labconco Corp., 8811 Prospect Ave.,Kansas City, MO 64132-2696 (phone816-333-8811)—or circle 308.

Dynamic Contact Analyzers, Radian315 and 322, provide information oncontact angle, surface tension, surfaceenergy, wicking, and absorption for sol-ids and powders. Both models are basedon digital recording microbalances thatprovide greater sensitivity and reproduc-ibility. Total travel range is 70 mm with40 mm programmable range. Maximumsample diameter is 70 mm. Other fea-tures shared by both models are tempera-ture range from –10 to 100oC. For moreinformation, contact Thermo Haake, 53W. Century Rd., Paramus, NJ 07652(phone 201-265-7865)—or circle 309.

Traceability Coding System, calledECO® or Encoded Character for OpticalTechnology, combines identification (la-beling and marking), certified traceabil-ity, and secure documents to provideconsumers and processors with a guar-antee on the origin and quality of thegoods they buy. The system consists of atwo-dimensional linear code that incor-porates 10–30 times as much informa-tion as a conventional bar code in the

same space and at comparable resolu-tion. It presents characters in the formof lines that can follow the page setup ornot as the user decides. Scratch and abra-sion-proof, the system enables all the in-formation generated by an IT system tobe encoded such as text, images, sound,or control characters. It can be used withall encryption and sealing techniques.This allows access to certain items of in-formation to be controlled and thusguarantees their integrity and authentic-ity. The encoding method is thereforesuited to the need for traceability. Thesystem makes a descriptive identificationpossible of the object itself or of its pack-age, providing the user the exact infor-mation on its characteristics, origin, ordestination. This helps prevent counter-feiting. The link between an object andits attached documents can be guaran-teed, to prevent substitutions and multiplelinks. For more information, contact EcoSys International, 10 rue Louis VICAT,75015, Paris, France (011-33-156-56-63-56)—or circle 310. ●

Circle 145 or IFT e•XPRESSDocument 5379