CPG Sec. 500.500 Guidance Levels for 3-
MCPD(3-chloro-1,2-propanediol) in Acid-
Hydrolyzed Protein and Asian-Style Sauces  
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Regulatory Affairs 
Center for Food Safety and Applied Nutrition 
[Issued: March 14, 2008] 
TABLE OF CONTENTS 
I.  INTRODUCTION 
II.  BACKGROUND 
III.  POLICY 
IV.  REGULATORY ACTION GUIDANCE 
V.  SPECIMEN CHARGES 
This Compliance Policy Guide represents the Food and Drug Administration's (FDA's) current 
thinking on this topic. It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. You can use an alternative approach if the approach satisfies 
the requirements of the applicable statutes and regulations. If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance at the telephone 
number listed on the title page of this guidance. 
I.  INTRODUCTION: 
The purpose of this Compliance Policy Guide (CPG) is to provide guidance to help FDA 
personnel determine whether to take enforcement action based upon the presence of 3-MCPD in 
acid-Hydrolyzed Protein (HP) and Asian-style sauces in interstate commerce or offered for 
import into the United States. 
FDA's guidance documents, including this CPG, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  II.  BACKGROUND: 
Acid-hydrolyzed protein (acid-HP) is prepared by the hydrolysis of proteins by heat and food-
grade acids. During the production of acid-HP, the reaction of hydrochloric acid (HCl) with 
residual fat in the protein starting material may form 3-chloro-1,2-propanediol (3-MCPD), a 
member of a group of chemicals known as chloropropanols, which have been identified as 
carcinogens. The manufacturing process for acid-HP can be modified to reduce the levels of 3-
MCPD that are formed. 
Frequently, acid-HP is added to soybeans and other ingredients to produce soy sauce that does 
not undergo a traditional fermentation process. Acid-HP also may be added to fermented sauces 
to enhance the flavor of the sauce. Additionally, acid-HP and soy sauce are used as ingredients in 
other Asian-style sauces, such as oyster sauce, black bean sauce, teriyaki sauce, stir-fry sauce, 
hoison sauce, plum sauce, yellow bean sauce, ground bean sauce, and yakitori sauce. In some 
cases, HCl may be added directly to soybeans to make soy sauce, producing acid-HP in situ, i.e., 
acid-HP is formed during production of the soy sauce. Adding HCl directly to soybeans can 
result in reactions with residual fat to generate chloropropanols, unless the processing conditions 
are well controlled. 
The toxicity of chloropropanols has been discussed and reviewed worldwide. 3-MCPD has been 
shown to cause cancer in long-term studies with animals. Since 1996, many regulatory bodies, 
including those in the European Union, Canada, and several Asian countries, have recommended 
or required that industry take steps to ensure that 3-MCPD in acid-HP or Asian-style sauces does 
not exceed levels ranging from 0.01 parts per million (ppm) to 1 ppm. 
Prior to safety findings concerning chloropropanols, FDA issued several opinion letters stating 
that acid-HP is generally recognized as safe (GRAS) for use in foods. These opinion letters did 
not identify limitations of use or specify acceptable levels of impurities and, being issued after 
1958, are not the basis for any prior sanctions. Many of the opinion letters stated that the acid-HP 
be made from materials suitable for food use (i.e., food-grade) and produced according to good 
manufacturing practice. 
As noted above, Asian-style sauces for which acid-HP is not an added ingredient also may 
contain 3-MCPD as a result of direct addition of HCl to soybeans and other starting materials. In 
21 CFR 182.1057, HCl is listed as GRAS for use as a buffer and neutralizing agent in foods. In 
the manufacture of Asian-style sauces, HCl is used as a catalyst to stimulate a reaction between 
protein and water. This use is not to neutralize (it drives the pH away from neutral), and it is not 
part of a buffering agent. As such, its use in manufacturing soy or Asian-style sauces is not 
covered by 21 CFR 182.1057. Before concluding that the use of a substance is not GRAS, 
however, consideration must be given to whether its use meets the criteria for GRAS. 
General recognition of safety requires common knowledge about the substance throughout the 
scientific community knowledgeable about the safety of substances directly or indirectly added  to food. The common knowledge element of the GRAS standard includes two facets: (1) data 
and information relied on to establish the technical evidence of safety must be generally 
available, and (2) a basis to conclude that there is consensus among qualified experts about the 
safety of the substance for its intended use. Neither facet is, by itself, sufficient to satisfy the 
common knowledge element of the GRAS standard. Actions by national and international food 
safety organizations and conclusions concerning the carcinogenic risk posed by 3-MCPD 
demonstrate that there is not a consensus on safety for the use of acid-HP when it contains 3-
MCPD levels that exceed 1 ppm or for the use of HCl in the manufacture of soy or Asian-style 
sauces that results in the formation of 3-MCPD at levels greater than 1 ppm. 
III.  POLICY: 
Acid-HP that contains 3-MCPD at levels greater than 1 ppm is not GRAS and, therefore, it is an 
unsafe food additive. Additionally, a level of 1 ppm or more of 3-MCPD in food containing acid-
HP indicates that the level of 3-MCPD in the acid-HP ingredient exceeds 1 ppm, because water 
or other food components will lower the concentration. 
FDA will consider the following concentrations of 3-MCPD to help determine whether to take 
enforcement action with regard to acid-HP and Asian-style sauces containing 3-MCPD: 
Concentrations of 3-MCPD in Acid-HP & Asian-Style Sauces  
Concentration of 3-
Specimen 
MCPD 
Acid-HP  1 ppm (dry basis) 
Asian-style sauces to which acid-HP was added (i.e., acid-HP is included 
1 ppm (liquid basis) 
in the ingredient statement) 
Asian-style sauces for which acid-HP is not listed in the ingredient 
1 ppm (liquid basis) 
statement (i.e., HCl is added to produce acid-HP in situ). 
FDA will determine whether to take enforcement action against acid-HP and Asian-style sauces 
containing 3-MCPD on a case-by-case basis, considering the totality of the circumstances. In any 
given case, FDA may decide to initiate an enforcement action against acid-HP or Asian-style 
sauces with concentrations of 3-MCPD below 1 ppm or decide not to initiate an enforcement 
action against acid-HP or Asian-style sauces with concentrations of 3-MCPD at or above 1 ppm. 
IV.  REGULATORY ACTION GUIDANCE: 
The following represent factors to consider in determining whether to recommend seizure or 
import detention to CFSAN/Office of Compliance/Division of Enforcement (HFS-605):  1.  The acid-HP or Asian-style sauce contains 3-MCPD at or above the applicable 
concentration, and 
2.  A validated analytical method is used to determine the presence of 3-MCPD. 
V.  SPECIMEN CHARGES: 
Domestic Seizure 
For acid-HP and Asian-style sauces to which acid-HP was added (i.e., acid-HP is included in 
the ingredient statement or documented through formulation information): 
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)(2)(C)(i)) in that it bears and contains a food additive, namely acid-HP, that is 
unsafe within the meaning of 21 U.S.C. 348. 
For Asian-style sauces for which acid-HP is not listed in the ingredient statement (i.e., HCl is 
added to produce acid-HP in situ): 
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)(2)(C)(i), in that it bears and contains a food additive, namely hydrochloric acid, 
that is unsafe within the meaning of 21 U.S.C. 348. 
Import Detention 
For acid-HP and Asian-style sauces to which acid-HP was added (i.e., acid-HP is included in 
the ingredient statement or documented through formulation information): 
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FFD&C 
Act in that it appears to be adulterated within the meaning of section 402(a)(2)(C)(i) of the 
FFD&C Act in that it bears and contains a food additive, namely acid-HP, that is unsafe within 
the meaning of section 409 of the FFD&C Act. 
For Asian-style sauces for which acid-HP is not listed in the ingredient statement (i.e., HCl is 
added to produce acid-HP in situ): 
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FFD&C 
Act in that it appears to be adulterated within the meaning of section 402(a)(2)(C)(i) of the 
FFD&C Act in that it bears and contains a food additive, namely hydrochloric acid, that is unsafe 
within the meaning of section 409 of the FFD&C Act. 
Issued: March 14, 2008