While more than 160 foods can cause allergic reactions in people with food allergies, the US law identifies the most common allergenic foods as “the Big 8”. These foods account for 90 percent of food allergic reactions and are the food sources from which many other ingredients are derived. Any ingredient that contains protein derived from milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans are consider allergens.
The maximum amount of an allergenic food that can be tolerated in a product without producing any adverse reaction is called the “threshold,” and at present, there are no regulatory allergen thresholds or action limits for any of the top eight food allergens. Thus, finding any allergenic protein-containing ingredient that is not declared on the label or misbranded is problematic, and that product is subject to recall.
There are many unexpected sources of food allergens. Not only could they be in food ingredients, but also in non-food chemicals used in our facilities. Did you know that tree nuts such as walnuts, coconut, and unrefined almond oil could be allergens hidden in hand soap, and that undeclared allergens have been found in some food grade lubricants?
Since undeclared allergens have become the leading cause for recalls, allergen control has changed significantly in the preventive controls rule of the US Food Safety Modernization Act (FSMA). According to the FDA, manufacturers should identify steps in their process, where prevention and control of allergen cross-contact can be implemented as well as identify methods to ensure that the finished product is properly labeled.
Any ingredients or non-food chemicals that could potentially have an allergen associated with it or have the potential to be cross-contaminated need to be addressed in your food safety plan as well as your suppliers’ food safety plans. You need to know your suppliers are controlling allergen hazards in their facilities so that when it comes time to use their ingredient or chemical, you’re confident that there are no cross-contact issues.
Allergic reactions to common ingredients in non-food chemicals such as tree nuts, walnuts, and almonds are considered both common and potentially severe. Coconut DEA is a water-soluble mixture of ethanol amides of coconut acid used as an emulsifier, surfactant, foam booster, and viscosity-enhancing agent used in a wide variety of industrial, household and cosmetic products. Coconut DEA allergy is rare despite its frequent use in several categories of products, Coconut is not a botanical nut; it is classified as a fruit, even though the FDA recognizes coconut as a tree nut. While allergic reactions to coconut have been documented, most people who are allergic to tree nuts can safely eat coconut.
Several suppliers of abrasive hand soaps incorporate pulverized walnut shells into their products. The University of Nebraska, Lincoln’s Food Allergy Research and Resource Program (FARRP) cannot be sure of the risk, if any, associated with use of such soaps. According to FARRP it would be impossible to analyze soaps for walnut residues by the ELISA diagnostic test, because the detergents would predictably interfere with antigen-antibody binding. Pulverized walnut shells are undoubtedly a byproduct of walnut shelling operations. FARRP experts do not believe that the shells actually contain the walnut allergens, but they have certainly been in intimate contact with the walnut kernel proteins. The waste shell material from shelling operations likely has residual nut meats (kernels) contained in it and that could be a probable source of a positive result.
Medicines, soaps, cosmetics, and personal care products sometimes contain peanut or tree nut oils. These oils are likely to have been refined removing the protein and are considered to be allergen free, however the risk and concern remains when cold pressed oils are used as they can contain protein residues.
Balsam of Peru, also known as myroxylon, is a sticky sap that smells like vanilla and cinnamon. It is often used as an ingredient in soaps, perfumes and shampoos both for its smell and for its quality as a fixative, which helps slow down evaporation. It can also add to certain medications and food, showing up in everything from calamine lotion to cough medicine and cola. Cinnamein (found in cinnamon oil) makes up between 60 and 70 percent of balsam of Peru, while the other 30 to 40 percent is made of unknown resins, any of which can provoke an allergic reaction. It is one of the most common causes of contact dermatitis, and about half of people who have a fragrance allergy have a reaction to balsam of Peru. The most common symptom is hand eczema in the case of skin contact, and when it's consumed, rashes may form around the mouth.
Reports tend to indicate that the risk of an allergic reaction to a soap is higher for the individual using the soap than it is from cross contact.
With the increasing scrutiny associated with various allergen audits, FSMA requirements, and undeclared allergen recalls, FARRP believes that it would be wise to replace such hand soaps with alternative brands that do not use allergens not only for food safety but for the wellbeing of staff. Fragrance-free hand soaps are recommended to prevent fragrance from being transferred to food that is handled.
Materials used for equipment and plant maintenance, such as lubricating oil, pose a risk of direct or indirect contact with raw materials, work-in-progress, and finished products. Food-grade lubricants that are ISO 21469 certified place an emphasis on careful ingredient traceability and control. This means a food-grade lubricant supplier (holding this certification) should be able to confirm the presence or absence of allergenic substances. This would eliminate the lubricant or cleaner as a potential source of allergen contamination.
As part of your allergen management program, ensure that you have procedures to address, not only ingredient suppliers, but also non-food chemical suppliers. A chemical approval or purchase authority should be in place. Keep your food-grade chemicals away from non-food grade chemicals through controlled and segregated storage. Ensure suppliers provide Technical Data Sheets and ensure that you identify where and how the chemicals are to be used. Prevention of cross-contact can be achieved through training and education. Keep good inventory control and maintain correct chemical and container use and disposal. Include the chemicals that contractors bring on site as part of your chemical and allergen control program.