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

Verification notes

• Created 2026-05-18 by Codex during P0151 seafood manual-fetch ingest after Shim et al. 2004 cited FDA’s 1000 ppb action level for commercial fish.
• The CPG page gives the regulatory-action criterion as methylmercury expressed as mercury in excess of 1 ppm in the edible portion only. The broader FDA action-level list independently restates the same fish/shellfish/crustaceans/other aquatic animals entry as “1 ppm methyl mercury in edible portion” with reference to CPG 540.600.

Update history

The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and the full version history lives in git. When DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.