Application as it was agreed. The departments do not support the request for Victorian Departments of Noted. The Applicant requested exclusivity on the basis that it exclusivity to the Applicant. This is because the Economic Development, has invested resources in research and development to request is an extension of use of an already Jobs, Transport and ensure higher levels of plant sterols can be uniformly existing permission therefore they believe there Resources; and Health and incorporated into their brand of breakfast cereal without has been limited investment in research and Human Services (Vic Govt) detrimental visual or flavour impacts. development by the Applicant to warrant such exclusivity. Such investments that would be required, ingredient costs and manufacturing technology and assets, are typical of commercial businesses and would be incorporated into new product development processes. They do not believe this demonstrates significant investment to justify exclusivity. The submission also notes the Higher Order Policy Principle on Novel Foods provides a regulatory environment that mentions ‘encourages fair trade’. To do so the submission suggests the permissions should not be applied exclusively. The submission agrees with observation Vic Govt Noted. The comment is noted. This issue is being considered FSANZ’s that it is debatable whether plant sterols should be by Proposal P1024 Revision of the Regulation of Nutritive – still considered novel. FSANZ should give Substances & Novel Foods. consideration to how foods and substances can be transitioned from being considered novel to status. The submission supported the Application. Dietitians Association of Noted. There is no requirement to conduct a separate Australia evaluation report after the completion of the 15-month It expressed an interest to view the evaluation exclusivity period is completed. The current assessment that and/or report after the 15 month exclusivity period has been performed, which is summarised in this report, prior to supporting a general permission after the deals with both the exclusivity period and the general exclusivity period expires. permission. The submissions support the continued use of the Department of Health Western Noted novel foods framework to consider future plant Australia sterol applications, and in particular the whole of
Application as it was agreed. The departments do not support the request for exclusivity to the Applicant. This is because the request is an extension of use of an already existing permission therefore they believe there has been limited investment in research and development by the Applicant to warrant such exclusivity. Such investments that would be required, ingredient costs and manufacturing technology and assets, are typical of commercial businesses and would be incorporated into new product development processes. They do not believe this demonstrates significant investment to justify exclusivity. The submission also notes the Higher Order Policy Principle on Novel Foods provides a regulatory environment that mentions ‘encourages fair trade’. To do so the submission suggests the permissions should not be applied exclusively. Victorian Departments of Economic Development, Jobs, Transport and Resources; and Health and Human Services (Vic Govt) Noted. The Applicant requested exclusivity on the basis that it has invested resources in research and development to ensure higher levels of plant sterols can be uniformly incorporated into their brand of breakfast cereal without detrimental visual or flavour impacts. The submission agrees with FSANZ’s observation that it is debatable whether plant sterols should be still considered novel. FSANZ should give consideration to how foods and substances can be transitioned from being considered novel to status. Vic Govt Noted. The comment is noted. This issue is being considered by Proposal P1024 – Revision of the Regulation of Nutritive Substances & Novel Foods. The submission supported the Application. It expressed an interest to view the evaluation and/or report after the 15 month exclusivity period prior to supporting a general permission after the exclusivity period expires. Dietitians Association of Australia Noted. There is no requirement to conduct a separate evaluation report after the completion of the 15-month exclusivity period is completed. The current assessment that has been performed, which is summarised in this report, deals with both the exclusivity period and the general permission. The submissions support the continued use of the novel foods framework to consider future plant sterol applications, and in particular the whole of Department of Health Western Australia Noted
A1134%20Plant%20sterols%20in%20breakfast%20cereals%20AppR.docx