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SANA Allergen Guidelines for Processing Dairy Like Soy Foods

1. Introduction
2. General
3. Allergen Plan (Allergen Plan diagram (pdf))
4. Tips for Manufactures
5. Allergen summary

1. Introduction

1.1 On Tuesday, July 20th, 2004, the House and Senate passed the Food Allergen Labeling and Consumer Protection Act of 2004 (S.741; Report 108-226). (To access this legislation and the report visit http://thomas.loc.gov/.) The Food Allergen Labeling and Consumer Protection Act (FALCPA) becomes effective on January 1, 2006. At that time, all products containing a major allergen or an ingredient derived from a major allergen must bear an ingredient statement that discloses the presence of the major allergen through the use of a common English name. By way of example, whey is a milk derivative and many consumers may not know that whey is derived from milk. After January 1, 2006, any product containing whey must have the word “milk” either in the ingredient statement or in a “contains _____” statement following the ingredient statement with each major allergen declared in the blank.

FALCPA applies to labeling but does not apply to manufacturing. FALCPA instructs FDA to continue to conduct allergen inspections and to issue a report to Congress on the results of its inspections. FALCPA also instructs FDA to review the various precautionary statements used on foods to identify the possible presence of major allergens (such as a “may contain soy”) and to issue a report to Congress on the use of the various precautionary statements. FALCPA does not require FDA to establish requirements for “may contain ___” and similar statements.

1.2 The following guidelines on preventing unwanted allergens in foods are intended to aid dairies and other manufacturing facilities normally not processing soy based foods; however, all companies that handle major allergens should implement the processes that are needed to ensure the major allergens are declared when present in products and that the major allergens do not end in products where they are not supposed to be. With the recent popularity of manufacturing soymilk, soy yogurt and soy frozen desserts in facilities normally manufacturing cow’s milk based foods, the need for guidelines in this area has become apparent.

1.3 Allergens can cause severe, life-threatening responses when present in foods at levels below what is visible to the naked eye. There are many recalls each year due to the presence of undeclared allergens in foods. Some of these undeclared allergens get incorporated into food accidentally through processing errors–such as the accidental inclusion of an allergen containing ingredient in a product, through errors in labeling, through shared equipment, just to name a few.

1.4 Food allergies affect a small proportion of the population. It is estimated that true allergic reactions can be life-threatening or fatal in approximately 1-2 percent of the United States population. In children, this rate rises to 5-8 percent. Many children eventually outgrow “allergies” especially those to milk and eggs by the age of 5-7. This percentage decline is attributed to a reduction of food intolerance reactions and not true food allergies. True food allergies are an unusual immunological response to the ingestion of the offending food usually medicated by immunoglobulin E (IgE). Virtually all known food allergens are proteins and an individual must first be sensitized by exposure to the protein to develop antibodies which then react to further exposures. Allergies are characterized by the rapid release of powerful cellular chemicals called histamines by the antibodies which in turn cause the symptoms of the allergic reaction within minutes or up to an hour after ingestion.

1.5 Allergic reaction symptoms can range from mild to severe. The type of symptoms includes: respiratory (rhinitis, asthma, throat swelling), gastrointestinal (nausea, vomiting, diarrhea, abdominal cramps) and skin (hives, itching, eczema). In some cases, a more severe reaction can occur which result in a rapid loss of blood pressure, severe obstruction of the airways, a generalized shock reaction and multiple organ failure. This is known as anaphylactic shock and can be fatal if not treated within minutes.

1.6 It is estimated that approximately 90% of all food allergies are attributed to 8 foods: cow’s milk, eggs, fish, crustaceans, peanuts, soybeans, tree nuts (Brazil nuts, cashews, chestnuts, hazelnuts, hickory nuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts) and wheat. More than 160 additional foods have been documented as having caused allergies. The frequency and potential severity of reactions to these Big Eight allergens and various FDA guidelines and US allergen legislation requires the food industry to address the inherent hazards.

2. General

2.1 The Code of Practice or Strategy for allergen management includes product label reviews, Good Manufacturing Practice (GMP) compliance, allergen control practices and associate training.

2.2 The Hazard Analysis and Critical Control Point (HACCP) System identifies allergens for active management during the Ingredient Hazard Analysis and should be detailed in the Allergen Ingredient Listing for all products. A finished product label review verifying ingredients should be presented in an Allergen Product Listing which details the presence/absence/type of allergen by the Uniform Product Code (UPC). The allergens present in the facility as ingredients, rework or finished products are: egg, milk, peanut, soy, wheat and the following tree nuts-almond, walnut, hazelnut, macadamia, pecan, cashew. Updates to existing ingredients and products are addressed as notification from vendors is received. New products and ingredients are addressed via the HACCP System during the Ingredient Hazard Analysis portion of the HACCP Plan Validation of new items or changes.

2.3 All Food ingredient and food contact packaging vendors are required to supply a letter of continuing guarantee and respond to a questionnaire referencing allergen policies and practices. Periodic vendor facility audits can supplement and confirm allergen related compliance. New product development and introduction teams analyze and investigate items which included food ingredients, packaging materials, rework, processing and packaging equipment to highlight potential allergen trouble sites.

3. Allergen Plan (see Allergen Plan diagram (pdf))

The allergen plan contains suggested procedures for dairy like operations. Many facilities already have allergen plans in operation and the addition of soy will easily fit into existing programs. For operations that have not addressed soy as an allergen, these guidelines should assist in setting up a viable program.

4. Tips for manufacturers

5. Allergen Summary

5.1 Allergen Facts

The information here is not intended in any way as a substitute for qualified technical advice. These suggestions are not intended to substitute for GMP regulations but rather to provide information regarding handling food allergies and managing your food products. The oversight of a company QC officer would be required

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