it related to a matter that warranted the variation of a food regulatory measure. 1.5 Procedure for assessment The application was assessed under the general procedure. 1.6 Decision The draft variation as proposed following assessment was approved without amendment. Thermolysin (EC 3.4.24.27) produced by A. caldiproteolyticus strain TP-7 will be listed in the table to subsection S18—9(3), permitting its use for the specific technological purpose stated below with the condition that the amount used must be consistent with good manufacturing practice (GMP). The specific technological purpose is to catalyse the hydrolysis of peptide bonds during the manufacture and/or processing of the following types of food: dairy, egg, meat, fish, protein, yeast and flavourings. The approved draft variation is at Attachment A. The variation takes effect on the date of gazettal. The related explanatory statement is at Attachment B, which is required to accompany an instrument that is lodged on the Federal Register of Legislation. 2 Summary of the findings 2.1 Summary of issues raised in submissions FSANZ called for submissions on a proposed draft variation to Schedule 18 on 12 April 2018. Three submissions were received. The Victorian Departments of Health and Human Services, and Economic Development, Jobs, Transport and Resources and the Ministry for Primary Industries supported the application. The New Zealand Food and Grocery Council (NZFGC) supported the application, however noted the conservative position FSANZ took in relation to labelling for allergens. The issues raised by the NZFGC and FSANZ’s responses are detailed in Table 1. Table 1: Summary of issues Issue Raised by FSANZ response NZFGC considered that New Zealand Food and The applicant estimated that FSANZ has taken a Grocery Council the use of thermolysin powder conservative approach to the at 0.24% w/w would lead to a possible presence of fish maximum of 7.2 mg fish protein in the food for final sale extract/kg food ingredient. and the consequent requirement for labelling. In The statement in the Call for particular, NZFGC highlighted fish must be Submissions; “that that: declared where present in the - data supplied by Amano final the existing food” reflects Enzymes Inc. showed that any requirement in the Code. This residue from the fish used in requirement applies
it related to a matter that warranted the variation of a food regulatory measure. 1.5 Procedure for assessment The application was assessed under the general procedure. 1.6 Decision The draft variation as proposed following assessment was approved without amendment. Thermolysin (EC 3.4.24.27) produced by A. caldiproteolyticus strain TP-7 will be listed in the table to subsection S18—9(3), permitting its use for the specific technological purpose stated below with the condition that the amount used must be consistent with good manufacturing practice (GMP). The specific technological purpose is to catalyse the hydrolysis of peptide bonds during the manufacture and/or processing of the following types of food: dairy, egg, meat, fish, protein, yeast and flavourings. The approved draft variation is at Attachment A. The variation takes effect on the date of gazettal. The related explanatory statement is at Attachment B, which is required to accompany an instrument that is lodged on the Federal Register of Legislation. 2 Summary of the findings 2.1 Summary of issues raised in submissions FSANZ called for submissions on a proposed draft variation to Schedule 18 on 12 April 2018. Three submissions were received. The Victorian Departments of Health and Human Services, and Economic Development, Jobs, Transport and Resources and the Ministry for Primary Industries supported the application. The New Zealand Food and Grocery Council (NZFGC) supported the application, however noted the conservative position FSANZ took in relation to labelling for allergens. The issues raised by the NZFGC and FSANZ’s responses are detailed in Table 1. Table 1: Summary of issues Issue Raised by FSANZ response NZFGC considered that FSANZ has taken a conservative approach to the possible presence of fish protein in the food for final sale and the consequent requirement for labelling. In particular, NZFGC highlighted that: - data supplied by Amano Enzymes Inc. showed that any residue from the fish used in New Zealand Food and Grocery Council The applicant estimated that the use of thermolysin powder at 0.24% w/w would lead to a maximum of 7.2 mg fish extract/kg food ingredient. The statement in the Call for Submissions; “that fish must be declared where present in the final food” reflects the existing requirement in the Code. This requirement applies
A1146%20Approval%20Report.docx