Enzymes: A Primer on Use and Benefits Today and Tomorrow (pdf format, 217Kb)
Working Safely with Enzymes* (English)
Working Safely with Enzymes* (Spanish, pdf format, 103kb)
Industry Guidelines for the Use of Enzymes in Dietary Supplements*
ETA Position Paper on the GRAS Status of Beta Amylase from Ungerminated Barley
ETA Position Paper on the Use of Enzymes in Fruit Juice Processing
Biotechnology, Enzymes and Allergies
Safe Handling of Enzymes, Textile Chemist and Colorist & American Dyestuff Reporter, Vol. 32, No. 1, January 2000
See also
1. Pariza, M.W. and Cook, M. (2010) "Determining the safety of enzymes used in animal feed," Regulatory Toxicology and Pharmacology. 56: 332-342.
Abstract: The purpose of this paper is to provide guidance for evaluating the safety of enzyme preparations used in animal feed. Feed enzymes are typically added to animal feed to increase nutrient bioavailability by acting on feed components prior to or after consumption, i.e., within the gastrointestinal tract. In contrast, food processing enzymes are generally used during processing and then inactivated or removed prior to consumption. The enzymes used in both applications are almost always impure mixtures of active enzyme and other metabolites from the production strain, hence similar safety evaluation procedures for both are warranted. We propose that the primary consideration should be the safety of the production strain and that the decision tree mechanism developed previously for food processing enzymes (Pariza and Johnson, 2001) is appropriate for determining the safety of feed enzymes. Thoroughly characterized non-pathogenic, non-toxigenic microbial strains with a history of safe use in enzyme manufacture are also logical candidates for generating safe strain lineages, from which additional strains may be derived via genetic modification by traditional and non-traditional strategies. For new feed enzyme products derived from a safe strain lineage, it is important to ensure a sufficiently high safety margin for the intended use, and that the product complies with appropriate specifications for chemical and microbial contamination.
2. Pariza, M.W., and Johnson, E.A. (2001) "Evaluating the Safety of Microbial Enzyme Preparations Used in Food Processing: Update for a New Century", Regulatory Toxicology and Pharmacology. 33: 173-186.
Abstract: Microbial enzymes used in food processing are typically sold as enzyme preparations that contain not only a desired enzyme activity but also other metabolites of the production strain, as well as added materials such as preservatives and stabilizers. The added materials must be food grade and meet applicable regulatory standards. The purpose of this report is to present guidelines that can be used to evaluate the safety of the metabolites of the production strain that are also present in the enzyme preparation, including of course, but not limited to, the desired enzyme activity itself. This discussion builds on previously published decision tree mechanisms and includes consideration of new genetic modification technologies, for example, modifying the primary structure of enzymes to enhance specific properties that are commercially useful. The safety of the production strain remains the primary consideration in evaluating enzyme safety, in particular the toxigenic potential of the production strain. Thoroughly characterized nonpathogenic, non-toxigenic microbial strains, particularly those with a history of safe use in food enzyme manufacture, are logical candidates for generating a safe strain lineage, through which improved strains may be derived via genetic modification by using either traditional/classical or rDNA strain improvement strategies. The elements needed to establish a safe strain lineage include thoroughly characterizing the host organism, determining the safety of all new DNA that has been introduced into the host organism, and ensuring that the procedure(s) that have been used to modify the host organism are appropriate for food use. Enzyme function may be changed by intentionally altering the amino acid sequence (e.g., protein engineering). It may be asked if such modifications might also affect the safety of an otherwise safe enzyme. We consider this question in light of what is known about the natural variation in enzyme structure and function and conclude that it is unlikely that changes which improve upon desired enzyme function will result in the creation of a toxic protein. It is prudent to assess such very small theoretical risks by conducting limited toxicological tests on engineered enzymes. The centerpiece of this report is a decision tree mechanism that updates previous enzyme safety evaluation mechanisms to accommodate advances in enzymology. We have concluded that separate mutagenicity testing is not needed if this decision tree is used to evaluate enzyme safety. Under the criteria of the decision tree, no new food enzyme can enter the market without critical evaluation of its safety.
3. De Boer, Anne Sietske and Diderichsen Borge (1991) "On the Safety of Bacillus subtilis and Bacillus amyloliquefaciens - a review", Applied Microbiology and Biotechnology, 36: 1-4.
4. Barbesgaard, Peder, Hans Peter Heldt-Hansen and Borge Diderichsen (1992) "On the Safety of Aspergillus oryzae - a review", Applied Microbiology and Biotechnology, 36: 569-572.
5. De Boer, Anne Sietske, Fergus Priest and Borge Diderichsen (1994) "On the Safety of Bacillus licheniformis - a review", Applied Microbiology and Biotechnology, 40: 595-598.
6. Nevalainen, Helena, Pirkko Sucminen and Kaarina Taimisto (1994) "On the Safety of Trichoderma reesei - a review", Journal of Biotechnology, 37: 193-200.
7. Schuster, E., N. Dunn-Coleman, J.C. Frisvad and P.W. M. van Dijck (2002) "On the Safety of Aspergillus niger - a review", Applied Microbiology and Biotechnology, 59: 426-435.
8. Conference organized by Associacas Nacional de Biossequranca (2001) "Industrial Enzymes for Food Production: Past, Present and Future Perspectives", Brasilia, May 6.
9. Olempska-Beer, Z.S., Merker, R.I., Ditto, M.D. and DiNovi, M.J. (2006), "Food-processing enzymes from Recombinant Microorganisms - a review") Regulatory Toxicology and Pharmacology, 45: 144-158.
10. International Food Biotechnology Council (1990), "Safety evaluation of foods and food ingredients derived from microorganisms" In: Biotechnologies and Food: "Assuring the Safety of Foods Produced by Genetic Modification", Regulatory Toxicology and Pharmacology 12:S114-S128.
11. Jonas, D.A., et. al., (1996) "The safety assessment of novel foods". Guidelines prepared by ILSI Europe Novel Food Task Force. Food Chem. Toxicol. 34:931-940.
*Bound copies of these documents are available from ETA ($1.00 each).
Last Modified: August 15, 2006