CPG Sec 540.525 DRAFT: Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24) December 2021

COMPLIANCE POLICY GUIDE (CPG)

• Docket Number: FDA-2021-D-0367
• Issued by: Office of Regulatory Affairs; Center for Food Safety and Applied Nutrition

The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on adulteration associated with decomposition and/or histamine identified during surveillance sampling and testing of fish and fishery products susceptible to histamine formation.

The current CPG Sec. 540.525 is being revised to update FDA regulatory action guidance for sensory analysis and histamine levels in scombrotoxin-forming fish and fishery products.

The  contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.  This document is intended only to provide clarity to the public regarding existing requirements under the law.  FDA guidance documents, including this CPG, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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