Allergens and Their Significance in Supply Chain Compliance: FSMA Requires Managing Undeclared Allergens

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May 12, 2016Bernie HennBlog

FSMA is changing how companies manage undeclared allergen risk during the production of finished products. For example, raw agricultural commodities are exempt from FALCPA. That does not mean there is not still a risk that a commodity ingredient contains an undeclared and unexpected allergen such as a peanut protein. Food fraud can also be an allergen source. An example of food fraud is an undocumented substitution of a cheaper peanut protein for an almond protein.

Ignorance is not an excuse with FSMA. Specifically you will find the changes FSMA brings in the HARPC portion of the Preventive Controls Rule. Food allergens may now be considered as a hazard to your supply chain. Companies must have a system in place to mitigate risk. You may decide to both survey and test your supplier’s product to reduce that risk. Testing brings its own set of challenges.  In the end, it is important that any allergen presence be declared on your final package. If not, you will find yourself recalling all potentially affected products after it is discovered by your downstream supply chain.

Another risk that needs to be mitigated is cross-contact, also called incorrectly, cross-contamination. Separate equipment, facilities, hot water, soap and even bleach for cleaning proteins may be necessary to avoid cross-contact. If you have two products running at different times, you need to make sure that cross-contact does not occur from machine to machine and from pallet to pallet including all storage and transportation. Harm to customers, as well as brand damage, should be avoided. In the HARPC portion of the Preventive Controls Rule, you have to identify hazards that are likely to occur and develop controls to mitigate the possibility of these hazards from materializing.

Cross-contact is now a part of your food safety plan within the HARPC rule. There will be an expectation of discussion as to why, or why not, allergen cross-contact is included or not included in your food safety plan. Cross-contact has to be addressed not just internally in your operations, but with your supply chain as well. 

If you are receiving an ingredient that could potentially have an allergen associated or has the potential to be cross-contaminated, you want to make sure this is addressed in your supplier’s food safety plans. You need to know your suppliers are controlling the hazard in their facilities so that when you use that ingredient, you are completely confident of no cross-contact issues. 

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