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Are ‘Undeclared Allergen’ Recalls Really Necessary?

By Dennis R. Johnson
February 28, 2011
A quick review of the FSIS current recall list shows that there is a significant number of recalls relating to undeclared allergens. In some cases, the wrong packaging was used; in others, suppliers had changed ingredients, but the change was never communicated to the processor so that its production/labeling staff could update the product labels or refuse to accept the “new” ingredient. The one common thread is that each and every one of these recalls was preventable.

The basic notion is quite simple to state but seemingly difficult to implement — the product formulation must match the label. Given the continuing recalls for undeclared allergens, one would expect that FSIS will issue another policy to charge inspectors with verifying an establishment’s ingredient/label control program.

The agency did this once before with FSIS Notice 45-05. As many of you remember, that notice led to numerous disputes as to the perceived potential for cross-contamination of allergens during processing. As a result, folks lost sight of the core issue, which is still haunting us today: Establishments are applying labels that do not declare all ingredients used in the product — those directly added by the establishment and/or those included as a component of a purchased ingredient.

Some components of a written program to control the labeling of products with allergens could include:

  • Review label stock and discard “old” labels with incorrect ingredient statements — when a formula changes, destroy obsolete labels or remove them from the regular label-storage area so there is no way someone can accidentally put them into production
  • Restrict label access — limit the employees able to draw labels out of inventory. Too often line employees will run into the label room when a line runs out of labels and will grab labels that look right, but are incorrect.
  • Review purchased ingredients — are all the components of the ingredient on the finished product label?
  • Provide a structure for product labeling — develop a checklist for R&D formula development and modifications to ensure all ingredients are on the final label.
  • Be careful that suppliers are not changing ingredients without notice — verify incoming shipments to ensure the ingredient label as received matches the label on file.
  • Pay attention — when products are being run, someone should verify that the labels being used match the formulation batch sheet. Do not assume the label is correct or that an old formulation batch sheet has not been placed into use from someone’s locker.
  • Monitor/Verify — periodically audit yourself to make sure the system is indeed working as intended.

Recalls are inevitable, sometimes things simply happen. That said, many of the current recalls dealing with undeclared allergens could have been and should have been prevented.

KEYWORDS: Allergen FSIS ingredient

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Dennis R. Johnson is a principal with Olsson Frank Weeda Terman Matz PC in Washington, D.C. Mr. Johnson has 30 years experience in food-safety law and regulation, representing large and small meat and poultry companies.

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