Table 1: Product specifications for commercial enzyme preparation compared to JECFA and Code specifications for enzymes Specifications Analysis Product JECFA Australia New Zealand Food Standards Code (metals) (section S3—4) Lead (mg/kg) <0.10 ≤ 5 ≤2 Arsenic (mg/kg) <0.10 - ≤1 Mercury (mg/kg) <0.010 - ≤1 Cadmium (mg/kg) <0.010 - ≤1 Antimicrobial activity Not detected Not detected - Coliforms (cfu/g) <10 - ≤30 Salmonella (in 25 g) Absent Absent - E. coli (in 25 g) Absent Absent - Based on the above product specifications, the final enzyme preparation meets international and Code specifications for enzyme preparations used in the production of food. 2.2.4 Stability The aqualysin 1 enzyme has optimal activity from pH 7, with the peak at pH 9.5. Its optimum activity is achieved at approximately 70°C, within the range of 30–80°C. The enzyme has high thermostability but is inactivated at 90°C. The enzyme activity was stable in the pH range of 7–10 and the temperature of 70°C. Analyses provided in the Application confirmed that commercial powdered enzyme preparations to be stable for up to 12 months. 2.3 Food technology conclusion The stated purpose of this enzyme preparation, namely, for use as a processing aid in the manufacture of bakery products is clearly articulated in the Application. The evidence presented to support the proposed uses provides adequate assurance that the enzyme, in the form and prescribed amounts, is technologically justified and has been demonstrated to be effective in achieving its stated purpose. The stated purpose is to reduce the mechanical dough development by lowering the dough viscosity and increasing the extensibility of the dough. The enzyme performs its technological purpose during processing and manufacture of food after which it is inactivated so does not perform any technological function in the final food. It is therefore appropriately categorised as a processing aid and not a food additive. The enzyme preparation meets international purity specifications. 3 Hazard assessment 3.1 Background 3.1.1 Chemistry Aqualysin 1 is an alkaline serine protease from the extreme thermophile T. aquaticus. Relevant physicochemical and enzymatic properties of aqualysin 1, and product specifications, are in the food technology assessment (Section 2).
Table 1: Product specifications for commercial enzyme preparation compared to JECFA and Code specifications for enzymes Analysis Specifications Product JECFA Australia New Zealand Food Standards Code (metals) (section S3—4) Lead (mg/kg) <0.10 ≤ 5 ≤2 Arsenic (mg/kg) <0.10 - ≤1 Mercury (mg/kg) <0.010 - ≤1 Cadmium (mg/kg) <0.010 - ≤1 Antimicrobial activity Not detected Not detected - Coliforms (cfu/g) <10 ≤30 - Salmonella (in 25 g) Absent Absent - E. coli (in 25 g) Absent Absent - Based on the above product specifications, the final enzyme preparation meets international and Code specifications for enzyme preparations used in the production of food. 2.2.4 Stability The aqualysin 1 enzyme has optimal activity from pH 7, with the peak at pH 9.5. Its optimum activity is achieved at approximately 70°C, within the range of 30–80°C. The enzyme has high thermostability but is inactivated at 90°C. The enzyme activity was stable in the pH range of 7–10 and the temperature of 70°C. Analyses provided in the Application confirmed that commercial powdered enzyme preparations to be stable for up to 12 months. 2.3 Food technology conclusion The stated purpose of this enzyme preparation, namely, for use as a processing aid in the manufacture of bakery products is clearly articulated in the Application. The evidence presented to support the proposed uses provides adequate assurance that the enzyme, in the form and prescribed amounts, is technologically justified and has been demonstrated to be effective in achieving its stated purpose. The stated purpose is to reduce the mechanical dough development by lowering the dough viscosity and increasing the extensibility of the dough. The enzyme performs its technological purpose during processing and manufacture of food after which it is inactivated so does not perform any technological function in the final food. It is therefore appropriately categorised as a processing aid and not a food additive. The enzyme preparation meets international purity specifications. 3 Hazard assessment 3.1 Background 3.1.1 Chemistry Aqualysin 1 is an alkaline serine protease from the extreme thermophile T. aquaticus. Relevant physicochemical and enzymatic properties of aqualysin 1, and product specifications, are in the food technology assessment (Section 2).
A1131%20Aqualysin%201%20as%20a%20PA%20SD1.docx