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Significantly, HARPC has changed allergen control through the Good Manufacturing Practices (GMP) revisions. In fact, over 25 allergen related GMP mentions can be found in HARPC. Recommendations have been replaced with required GMPs under the HARPC rule. Allergen cross-contact must be mentioned in the GMP’s. Allergen controls must also address handling, storage and use.
Allergen control labeling is required. This requires addressing a common issue within the industry when it comes to mislabeling. Undeclared allergens due to mislabeling are a large reason for recalls, according to the USDA in 2015, 39% of all recalls made were due to undeclared allergens. For example, sanitation practices now must include allergens as a potential cross-contact risk during production changes. Going right through the operations chain, from receiving ingredients, to incorporating those ingredients, to labeling the final product, each has a required GMP step. Documentation and following an operating procedure is a big part of proper allergen declaration on a product leaving your facility.
FDA will require that each facility update its HARPC plan every 3 years or whenever there is a significant change at that facility that may increase a potential hazard or introduce a new one. For example, when the facility adds a new allergen, as an ingredient, a new food safety plan is also needed. FDA can now take a number of steps for enforcement such as a forced recall and up to and including criminal charges.
Allergen control has not always been this complicated. The complexity has been introduced with the increased use of international ingredient sourcing. While some countries such as Japan traditionally have strict labeling laws, other countries such as China traditionally do not, making knowledge of ingredient composition difficult at best.
In order to have good governance, many companies must develop or use an outside supply chain compliance system as well as have access to organized current and proposed regulatory data. Effective supply chain compliance augments strategic and holistic material compliance programs. The system must address existing, expanding and emerging regulations, industry standards, responsible sourcing guidelines, supplier codes of conduct, exhaustive material surveys, as well as other risk and revenue related activities. Ultimately these systems must drive business value and optimization. To investigate what 3E Company can offer you can ask about our 3E Supply Chain Compliance Solutions.