Contains Nonbinding Recommendations 
Compliance Policy Guide 
Sec. 555.400 Aflatoxins in Human Food: 
Guidance for FDA Staff
You may submit either electronic or written comments regarding this guidance at any time. 
Submit electronic comments to https://www.regulations.gov.  Submit written comments to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852.  All comments should be identified with the docket number FDA-
2018-D-0721 listed in the notice of availability published in the Federal Register.  
For questions regarding this document, contact the Center for Food Safety and Applied Nutrition 
(CFSAN), Office of Compliance at CFSANCompliancePolicy@fda.hhs.gov. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
and 
Office of Regulatory Affairs  
[June 2021]  Contains Nonbinding Recommendations 
Table of Contents 
I. Introduction
II. Background
III. Policy
IV. Regulatory Action Guidance
V. Specimen Charges Contains Nonbinding Recommendations 
Compliance Policy Guide 
Sec. 555.400 Aflatoxins in Human Food: 
Guidance for FDA Staff 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on this topic.  It does not establish any rights for any person and is not binding on FDA or the 
public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
for this guidance at the phone number listed on the title page. 
*I.  Introduction
The purpose of this document is to provide guidance for FDA staff on aflatoxins in human food.  
We revised this document to update the format and to include revisions for clarity, references to 
other aflatoxin Compliance Policy Guides (CPGs), and a reference to the Memorandum of 
Understanding between the Agricultural Marketing Service (AMS) of the United States 
Department of Agriculture (USDA) and FDA. 
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 guidance, should be viewed only as recommendations, 
unless specific regulatory or statutory requirements are cited.  The use of the word should in 
FDA guidance means that something is suggested or recommended, but not required. 
II. Background
Aflatoxins (B1, B2, G1, and G2) are toxic metabolites produced by the molds Aspergillus flavus, 
Aspergillus nomius, and Aspergillus parasiticus.  Toxicological manifestations of aflatoxins 
include teratogenicity, mutagenicity, and carcinogenicity in susceptible animal species.  
Consumption of food with high levels of aflatoxins is associated with liver cancer in humans.  
Aflatoxins may occur in food as a result of mold growth in susceptible raw agricultural 
commodities.  The growth of molds that produce aflatoxins is influenced by environmental 
factors such as temperature, humidity, and extent of rainfall during the pre-harvesting, 
harvesting, or post-harvesting periods.  Foods most susceptible to molds that produce aflatoxins 
include: peanuts, corn, some tree nuts including Brazil nuts and pistachios, and some small 
1  Contains Nonbinding Recommendations 
grains such as rice.  Because aflatoxins are known carcinogens to humans, the presence of 
aflatoxins in foods should be reduced to the lowest levels attainable using modern agricultural 
and processing techniques. 
III. Policy
Aflatoxins are poisonous or deleterious substances, which may render a food injurious to health.  
FDA may consider human food containing total aflatoxins greater than 20 micrograms per 
kilogram (mcg/kg) or parts per billion (ppb) to be adulterated within the meaning of section 
402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(a)(1)). 
IV. Regulatory Action Guidance
The following represents the criteria for submitting a recommendation for seizure or a 
recommendation that the article is subject to import refusal to CFSAN, Office of Compliance, 
Division of Enforcement (HFS-605), for aflatoxins in human food, except Brazil nuts, peanuts 
and peanut products, and pistachio nuts:   
 Both original and check analyses show total aflatoxins (i.e., aflatoxins B1, B2, G1, G2)
greater than 20 ppb, and
 Identity of any aflatoxin present (i.e., aflatoxins B1, B2, G1, G2) is confirmed.
Divisions should include a detention without physical examination (DWPE) request, if 
applicable, in the recommendation that the article is subject to import refusal.  
CFSAN will evaluate such requests and recommendations on a case-by-case basis, based on the 
information specific to each regulatory package. 
See the following CPGs for guidance on aflatoxins in Brazil nuts, peanuts and peanut products, 
and pistachio nuts:  
 CPG Sec. 570.200 Aflatoxins in Brazil Nuts
 CPG Sec. 570.375 Aflatoxins in Peanuts and Peanut Products
 CPG Sec. 570.500 Aflatoxins in Pistachio Nuts
Coordination with USDA/AMS 
See the Memorandum of Understanding (MOU-225-19-031) between USDA/AMS and FDA for 
information regarding working arrangements for sampling and analyzing raw peanuts, Brazil 
nuts, and pistachio nuts for aflatoxins. 
V. Specimen Charges
2  Contains Nonbinding Recommendations 
Domestic Seizure 
The article of food was adulterated when introduced into, and while in interstate commerce, and 
is adulterated while held for sale after shipment in interstate commerce, within the meaning of 21 
U.S.C. 342(a)(1), in that it bears and contains a poisonous or deleterious substance, namely 
aflatoxins, which may render it injurious to health. 
Import Refusal 
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C 
Act in that it appears to be adulterated within the meaning of section 402(a)(1) of the FD&C Act 
in that it bears and contains a poisonous or deleterious substance, namely aflatoxins, which may 
render it injurious to health.* 
*Material between asterisks is new or revised*
Issued: 10/1/80 
Revised: 4/1/81, 3/1/83, 3/95, 5/05, 11/29/05, 06/01/2021
3