Safety aspects of microbial enzyme technology, exemplified by the safety assessment of an immobilized lipase preparation, lipozyme™

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Abstract
The historical use of enzymes for food processing is briefly reviewed. The manufacturing process of microbial food enzymes is described including the fundamental purity criteria recommended by Joint FAO/WHO Expert Committee on Food Additives (JECFA) and Food Chemicals Codex. Principles for safety evaluation focus on the possible presence of toxic contaminants in the commercial enzyme preparation. Possible sources of any undesirable contaminants include the raw materials used, the properties of the production strain, contamination with foreign micro‐organisms, use of additives and processing aids in recovery of the enzyme. Systems for design of toxicology programmes are reviewed. A case study is given summarizing the safety evaluation of an immobilized lipase used for the interesterification of fats and oils. Based upon a no‐effect level derived from in vitro and animal feeding studies it is concluded that the enzyme is safe for the intended use. The safety of the enzyme part of the immobilized preparation is documented by a thorough toxicology programme. The safety of the carrier, a phenol formaldehyde based ion‐exchange resin, is documented by leakage analysis of extractable materials under forced conditions, as well as by a feeding study employing a fat treated with the immobilized enzyme.

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