A voluntary recall of enzyme preparations contaminated with the antibiotic chloramphenicol was recently announced by a U.S.-based enzyme company that imported and distributed the affected product.  The chloramphenicol-contaminated enzyme products were imported from a small enzyme producer located in India.  It has been reported that contaminated enzyme products from this Indian producer have also been imported into Europe, Japan and Canada.

The safety and quality of our products is of paramount importance to the enzyme industry.  The industry is working with the U.S. Food and Drug Administration (“FDA”), the Canadian Food Inspection Agency (“CFIA”), the European Food Safety Authority (“EFSA”), and the Food Safety Commission of Japan (“FSCJ”).  The contaminated enzymes were used to manufacture a number of products, including food and dietary supplements.  Enzymes are generally used at very low levels in food processing, resulting in only trace amounts or undetectable levels of the contaminant in most final foods.  The Enzyme Technical Association (“ETA”) is not aware of any adverse health reactions associated with the low levels of chloramphenicol contamination.

Chloramphenicol is not permitted for use in the manufacture of food, and the use of chloramphenicol in the production of enzymes is not a standard industry practice.  The North American enzyme industry has an excellent safety record, and the safety of our industry’s products and the health of our customers are our highest priorities.

The ETA and its member companies will continue to work with the FDA and CFIA to actively address the current contamination and take steps to prevent such an incident from occurring again in the future.

Inquiries may be directed to the ETA General Counsel and Secretary, Anthony Pavel, at +1 (202) 739-5612.

ETA Chloramphenicol Statement (Downloadable PDF)