Over the past decade there has been an upward trend in food allergen recalls due to cross-contamination or cross contact and mislabeling. Approximately one third of recalls between September 2009 and September 2012 were due to undeclared allergens. Not only has this become a concerning trend, but it also poses food safety risks to consumers and puts brand integrity in jeopardy. To combat the upward rise in allergen recalls, the Food Safety Modernization Act (FSMA) has included requirements for food allergen preventative controls; also included by the GFSI benchmarked schemes. These include but are not limited through supply chain management, good manufacturing practices (GMP’s), and proper labeling.
With complex supply chain systems and improved sourcing of ingredients; the supply chain management system can present a risk to ingredient integrity. In early 2015, many companies issued recalls due to cumin tainted with peanut shell powder. To control these risks, proper supply-chain preventative controls which include supplier approval programs, a full understanding of what allergens are used by the supplier, periodic verification of the ingredient or packaging by periodic testing and/or inspection of the supplier facilities, and clear inbound receiving procedures are essential to be developed. Also, proper changes in ingredient formulation should be evaluated and well documented. This program should also include a corrective action plan in the event ingredients do not comply with the standards as established by the facility and supplier.
In addition to supply-chain management systems, major contributors to allergen cross contamination or cross contact are potentially an ineffective GMPs. As part of the allergen preventative control, ingredients containing allergens must be controlled from the time of receipt to the shipment of the final product. As part of the inbound receiving procedure, ingredients containing allergens should be labeled clearly that it contains an allergen by means of a placard and/or label. Ingredients with “like” allergens should be stored in the same area, and never above non-allergens. A recommendation is to keep an approved ingredient list for ingredients received, and verify that all allergens are declared on the inbound ingredient packaging.
Other GMP’s include validating proper run sequences and standard sanitation operating procedures (SSOP’s). The run sequence or changeover matrices should start with non-allergen containing products, and end with an allergen containing product. Non-conforming product should also be clearly segregated, labeled, and reworked into the process only when like allergens are ran. When establishing SSOP’s, there should also be an assessment of the equipment, and the level of cleaning needed based on risk of contamination. The validation of SSOP’s is to be tested with approved methods that will detect for the allergen of interest. Other methods, such as ATP should be used to determine the efficacy of cleaning. The verification frequency of these SSOP’s is to be clearly defined, and well documented.
Last but not least, the biggest factor for allergen recalls is due to mislabeling. In the U.S., Food allergen Labeling and consumer Protection Act (FALCPA) mandates labeling for milk, egg, peanut, tree nuts, fish, crustacean shellfish, wheat and soy. However, In addition to big 8 allergen, sulphites, mustard seed and sesame seeds are considered allergens in other countries. The allergen labelling shall meet the requirements of the country the product is shipped to and consumed. It is estimated that up to 15 million of the American population have food allergies, and 1 in 13 children are potentially at risk for deadly reactions. It is the responsibility of food manufacturers to understand the risk and implement proper controls so that consumers are protected and well informed.