ETA recently submitted a Letter to the Editor of Food and Chemical Toxicology to address an article in its July publication, “GRAS from the ground up: Review of the Interim Pilot Program for GRAS notiﬁcation” by Hanlon et al., 2017. The ETA letter clarifies and expands upon points highlighted by Hanlon et al. regarding the common knowledge element of the safety of food enzymes used to support the generally recognized as safe (GRAS) designation. The letter outlines a peer-reviewed, generally recognized safety evaluation methodology for microbial enzymes, which provides the US FDA with a review framework for enzyme GRAS Notices. This approach may serve as a model to other food ingredient categories for a scientiﬁcally sound, rigorous, and transparent application of the GRAS concept.
Read the response here.
Journal: Food and Chemical Toxicology,
The Enzyme Technical Association (ETA) recently contributed an article titled “The Generally Recognized As Safe (GRAS) Process for Industrial Microbial Enzymes” to Industrial Biotechnology, a peer-reviewed journal that provides news on bio-based industries. The article discusses the process for how the GRAS designation is determined for industrial microbial enzymes. GRAS is a regulatory designation by the U.S. Food and Drug Administration (FDA) that exempts a food substance from FDA premarket review if it is commonly known throughout the scientific community as safe under the conditions of its intended use. The article also discusses how the GRAS designation is particularly well suited for industrial microbial enzymes, which have a long history of safe use in food processing and animal feed.
The Enzyme Technical Association took part in a panel presentation discussing the generally recognized as safe (GRAS) concept during the IFT16 meeting in Chicago, Illinois. The Panel consisted of Tony Pavel (Cargill), Lori Gregg (Novozymes), Diane Shanahan (BASF), Vince Sewalt (DuPont Industrial Biosciences), and James La Marta (DSM). The panel discussed the enzyme industry’s model approach for a scientifically sound, rigorous, and transparent application of the GRAS concept. Topics covered included: GRAS definition; Enzymes, a History of Safety in Use and Manufacture; Manufacture process & Enzyme Characterization; Production Strain Construction & Safe Strain Lineage; Toxicology & Margin of Safety; GRAS framework, Track record of enzymes. Click here to access the presentation slides.
On September 21, several media articles referred to a recent study published in Occupational & Environmental Medicine on "genetically modified (GM)-enzymes". It is important to note that the allergy risk discussed in these articles and the research publication refers to individuals working with enzymes in industrial processes and not to consumers.
Manufacturers have safely produced and used enzymes for decades following workplace procedures put in place to protect their workforce. The risk of work-related enzyme allergy is controlled when proper workplace practices, engineering controls, and protective equipment are used.
Enzymes are large proteins and, like other proteins, they are produced in living cells of humans, plants, animals and microorganisms. All living organisms require enzymes for growth and for the production and utilization of energy which is essential for life. Enzymes are regulated worldwide and approved as safe biological ingredients in the manufacture of numerous products such as detergents, textiles and food. The allergy risk from enzymes produced by genetically engineered (GE) microorganisms is no different than enzymes produced by non-GE microorganisms.
ETA members supply enzymes to industry that provide environmentally-friendly products to consumers by using less energy, water and raw materials and generating less waste. Each year, the enzyme industry continues to innovate and further improve the environmental footprint of everyday products.
For more information and media inquiries, please contact:
Ann Begley, General Counsel
Gary Yingling, Senior Counsel
The ETA was established in 1970 to represent the interests of the enzyme industry across North America. In recent years, however, a need for consistent, globally-harmonized support for the enzyme industry led the ETA to expand its membership to Central and South American companies in 2016. “As enzymes grow in popularity and use in various industries, more companies engage the ETA for support in promoting education, health, safety and regulatory considerations for enzyme products,” said John Sedivy, Chair of ETA. “It’s our goal to provide an international collaborative forum for these activities to take place. The close business relationships between many North-, Central-, and South American enzyme companies provided the catalyst for expanding the ETA’s membership.”
To see a list of ETA member companies, or to consider membership, please visit www.enzymeassociation.org.
Our organization has undergone positive growth over the past year, and with growth often comes change. Since it began, the Enzyme Technical Association (ETA) has represented enzyme producers and marketers in the ever-changing regulatory and policy environment of the industry. A recent expansion into Central and South America, however, sparked the opportunity to present the ETA in a new light with a fresh, contemporary logo leading the way.
“This was really an opportunity for the ETA to update its identity and tell a story about the impact enzymes have for a better world,” stated Gary Hayen, Chair of the Website/Public Relations/Communications Committee at the ETA. “The expansion into Central and South America allows the ETA to represent multi-national companies with a broader footprint in the Western Hemisphere, as well as businesses solely operating in Central and South America. The design of the new logo reflects the expanded scope of the organization–represented by two joining halves of a circle. The green color represents the biological origin of enzymes as well as their positive benefits to the environment through the reduction of chemicals, raw materials, water and waste in industry.”
We look forward to making the transition to our new visual identity with our members and partners in the coming weeks.
For more information, or to include the new ETA logo on corporate communication materials, please contact Ann Begley at 202-739-5613.
The use of asparaginase to reduce acrylamide in certain food processing applications is included in both the U.S. Food and Drug Administration’s Draft Guidance for Industry: Acrylamide in Foods, as well as FoodDrinkEurope’s Acrylamide Toolbox.
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.