Monday, November 16, 2015

FSIS Updates Allergen Guidance with Focus on Incoming Ingredients

FSIS issued an updated version of their Allergen Control Guidance.  Allergen issues remain on the leading causes for recalls.  According to FSIS:
What is causing undeclared allergen recalls?
  • New Ingredient
  • New Supplier
  • Misprinted Label
  • Product in Wrong Package
  • Product Reformulation
  • Ingredient Reformulation
 A focus of this update involves ingredient related allergen issues. Inspectors are discovering issues as they evaluate incoming ingredients and a company's formulation. 
"FSIS has found that many of these recalls occurred because of a change in product formulation by the establishment or a change in a supplier’s ingredient formulation that was not reflected on the labeling of the finished meat or poultry product. "
A noted change was an explanation of a Letter of Guarantee (LOG) and a Certificate of Analysis (COA). Too many rely on a LOG to protect them against a supplier related allergen issue, but a LOG cannot be counted on to prevent allergen issues.
"An establishment should review and update the LOGs regularly to ensure that the decisions made in the hazard analysis are supported and to ensure that any formulation changes made by its suppliers are detected prior to incorporating the associated ingredient into the production process. Generally, an annual LOG will not be sufficient to support decisions made in the hazard analysis."
One of the nice additions is Appendix 6 - Allergenic Ingredients in Foods.  In this appendix, there is a list of common ingredients that contain specific allergens that may be missed.  This is a nice reference.  (For example, marzipan may contain eggs).
FSIS Website
FSIS Compliance Guidelines 
Allergens and Ingredients of Public Health Concern: Identification, Prevention and Control, and Declaration through Labeling 
November 2015

[from the document - page
This document provides guidance to assist establishments in addressing the hazard posed by allergens in their products. In doing so, establishments must comply with the Food Safety and Inspection Service (FSIS) hazard analysis and critical control point (HACCP) and labeling regulations. 
This guidance document presents best practice recommendations by FSIS, based on the best scientific and practical considerations. The recommendations in this guidance do not represent requirements that must be met. The focus of this document is meat and poultry products, with an emphasis on FSIS-regulated establishments, state-regulated establishments, and operations where all or part of the premises meet the "food processing plant" definition as defined in the 2013 Food Code. This guidance represents FSIS’s current thinking, and we encourage establishments to use it. 
This guidance is an update of the document that was issued and announced in the Federal Register of April 21, 2014 (79 FR 22083). FSIS has updated this guidance based on comments it received during the public comment period, which closed on June 20, 2014. FSIS made the following changes in response to the comments: 
• Clarified and described a letter of guarantee (LOG), the difference between a LOG and a certificate of analysis (COA), and the communication and coordination between an establishment and its suppliers that FSIS recommends when establishments rely on LOGs. 
• Added Appendix 6 entitled, "Allergenic Ingredients and Foods" to the guidelines as a resource to identify potential sources of "Big Eight" allergens. 
• Clarified that the emphasis of the document is on FSIS-regulated establishments, state-regulated establishments, and operations where all or part of the premises meet the "food processing plant" definition, as defined in the 2013 Food Code. 
• Changed to the text to emphasize the purpose of a hazard analysis, add recommendations for establishments, and clarify ingredients of public health concern. 
Although comments on this guidance document will no longer be accepted through, FSIS will update this document as necessary should new information become available.

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