FDA CPG Sec. 540.600 Fish, Shellfish, Crustaceans and other Aquatic Animals — Methyl Mercury

Overview

FDA Compliance Policy Guide Sec. 540.600 gives the agency’s regulatory-action guidance for methylmercury in fish, shellfish, crustaceans, and other aquatic animals, whether fresh, frozen, or processed.

Action Level

The CPG states that legal-action recommendations should be based on the exact edible portion used for analysis. The broader FDA action-level guidance also states that action levels are limits at or above which FDA may take legal action to remove products from the market; they are not permissible contamination targets when contamination is avoidable.

How this page interacts with HMT&C

This page records FDA’s enforcement-relevant methylmercury action level for fishery products. It does not set an HMT&C certification threshold. Source pages may cite it when a paper compares measured fish mercury values against the FDA 1 ppm action level, while keeping the distinction clear between total mercury (tHg) measurements and methylmercury (MeHg) enforcement language.

Sources

• FDA. CPG Sec. 540.600 Fish, Shellfish, Crustaceans and other Aquatic Animals - Fresh, Frozen or Processed - Methyl Mercury. Issued 6 November 1984; revised March 1995 and May 2005; updated 16 February 2007. Source URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-540600-fish-shellfish-crustaceans-and-other-aquatic-animals-fresh-frozen-or-processed-methyl
• FDA. Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed. August 2000; content current as of 20 September 2018. Source URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-action-levels-poisonous-or-deleterious-substances-human-food-and-animal-feed

Update history

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