FDA Issues Guidance Document on Acid-Hydrolyzed Protein

Last week, FDA and the Center for Food Safety and Applied Nutrition (CFSAN) issued a compliance policy guide on levels of 3-monochloro-1,2-propanediol (3-MCPD) in acid-hydrolyzed protein and Asian-style sauces. FDA is opening a comment period for a period of 60 days on this issue.

During the production of acid-hydrolyzed protein, the reaction of hydrochloric acid with residual fat in protein can cause 3-MCPD to form; 3-MCPD is a chloropropanol and a known carcinogen. Manufacturers can take steps to reduce the levels of 3-MCPD formed during this process. "The toxicity of chloropropanols has been discussed and reviewed worldwide," notes the draft guidance. "3-MCPD has been shown to cause cancer in long-term studies with animals. Since 1996, many countries, including the European Union, Canada and several Asian countries, have recommended or required that industry take steps to ensure that 3-MCPD is not detectable in acid-HP or Asian-style sauces at levels ranging from 0.01 parts per million (ppm) to 1 ppm."

Acid-hydrolyzed protein is sometimes added to soy sauces that do not undergo traditional fermentation. Manufacturers also might add it to sauces to enhance flavors.

The complete compliance policy guide, and instructions on how to submit comments on the guide, can be found at http://www.cfsan.fda.gov/~dms/cpgmcpd.html.