Allergens and Their Significance in Supply Chain Compliance

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May 10, 2016 - Bernie Henn

The Food Safety Modernization Act (FSMA) has posed significant changes in the food industry, with specific changes to allergen controls and good manufacturing practices (GMPs). Having GMPs for allergen control is no longer just a company best practice but a requirement of companies under FSMA.

Why might you care about allergens? Well, according to the USDA in 2015, 39% of all recalls made were due to undeclared allergens. Allergen adulterations are a supply chain issue on several supplier tier levels. The issue will require additional supply chain resources for both FSMA compliance and to ultimately reduce undeclared allergen risk.

Why the concern? It is important to understand that a food allergy involves the activation of the immune system. It is different from a food intolerance, which is generally caused by an enzyme deficiency and does not involve the immune system. Complete avoidance of the allergen is desired when addressing a true food allergy. Allergenic reactions are due to an inappropriate immunological response to an otherwise harmless food.

Specific defenses involve the production of antibodies in response to a foreign substance. A specific antibody is produced to attack a specific antigen and is capable of binding to and removing the antigen. One of five antibody types is IgE which is the one associated with significant allergic reactions.

In an allergic reaction, the body mistakenly views an ingested protein of a food as an antigen and the immune system hosts an immune reaction by the production of IgE antibodies, which will bind to the antigen and a mast cell, forming a complex. A mast cell is part of the immune cellular network, and when the antigen-antibody-mast cell complex is formed, the release of mast cell content will occur. The mast cell contains histamine amongst other vasoactive amines. When released by mast cells, histamine causes a number of activities, such as acid secretion in the stomach, inflammation and leaking of fluid into tissues, restriction of airways, the lowering of blood pressure, itching, and rashes.

An immediate hypersensitivity reaction by IgE-antigen-mast cell complex formation will cause one of two types of attacks: systemic or localized. Either reaction may occur within minutes or up to a few hours after initial sensitization and subsequent ingestion of the offending foods. Systemic reactions result in vomiting, abdominal cramps, diarrhea, and respiratory distress and, in severe cases, anaphylactic shock. Localized reactions center on the skin and result in rashes, hives, eczema, and itching. A delayed hypersensitivity reaction may also occur greater than eight hours after ingestion.

Common sites for allergic reactions are those areas in which mast cells are located and concentrated, such as the following:

  • Mouth: swelling of the lips or tongue

  • Airways: breathing restrictions, asthma, rhinitis

  • Digestive tract: nausea, vomiting, diarrhea

  • Skin: hives, rash, itching

The best way for an affected consumer to avoid experiencing an immune response is to practice continued allergen avoidance. The goal is always to thwart aggressive immune system responses.  

Allergens are specifically a part of FSMA under the Preventive Controls Rule, and precisely under, HARPC (Hazard Analysis and Risk-Based Preventive Controls). The list of Allergens remains the same and not changed by HARPC.  There are 8 allergens in the USA requiring certain labeling via the Food Allergen Labeling and Consumer Protection Act of 2004, (FALCPA) which focused on the declaration of controlled allergens. The allergens on the list are often indicated to cause 90% of food allergies. The FALCPA applies to packaged foods in the USA regardless of whether the food is produced in the USA or imported. Raw agricultural commodities, except for soy lecithin, are exempt from the FALCPA. Highly refined oils are also exempt.  

This allergen list is made up of eight major foods or food groups including:

  1. Milk

  2. Eggs

  3. Fish

  4. Crustacean shellfish

  5. Tree nuts

  6. Peanuts

  7. Wheat

  8. Soybeans

In the U.S., labeling regulations do not require products to indicate the presence of sulfites in foods unless it is added specifically as a preservative; however, many companies voluntarily label sulfite-containing foods. Sulfites added as a preservative, are only required to be listed if there are more than 10 parts per million (ppm) in the finished product. Sulfites have not been allowed on raw fruits and vegetables or those labeled as “fresh” in the USA since 1986. Sulfites may trigger a reaction in asthmatics.

Allergens are listed and regulated differently in Canada and the European Union. Canada adds Sesame Seeds and Mustard to make a total of 10 allergens. The EU lists 14 allergens.

The European Union Allergens include:

  1. Milk and dairy products including lactose

  2. Eggs

  3. Fish

  4. Crustaceans

  5. Nuts including: almonds, hazelnuts, walnuts, cashews, pecan nuts, Brazil nuts, pistachio nuts, macadamia nuts, Queensland nuts

  6. Peanuts

  7. Cereals containing gluten (wheat, rye, barley, oats, spelt, kamut)

  8. Soybeans

  9. Mustard

  10. Sesame seeds

  11. Celery

  12. Sulphur dioxide and sulphites more than 10mg/kg

  13. Lupin (a legume belonging to the same plant family as peanuts)

  14. Molluscs (Mollusks) including: clams, oysters, scallops, squid, cuttlefish, octopus, snails, slugs etc.

Additional allergen regulations are in place in Australia, New Zealand and Japan.

For more information, don’t forget to visit us this week at the Food Safety Summit!

This is the first of a three part series. Please check back with for parts 2 and 3. If you have any questions on this series please go HERE.