Applicants requesting approval of a novel food or nutritive substance may also apply for a period of ‘exclusive’ use to apply to a brand or class of food for up to 15 months.
Exclusive permissions for novel foods were introduced in 2007 under Proposal P305 – Permission for Exclusivity of Use of Novel Foods. This followed requests from the food regulation ministers for FSANZ to consider:
- the capacity for including a specific provision for exclusivity of use for novel foods in Standard 1.5.1, and
- a limit on the period of exclusive permission as a novel food for a particular brand of up to 15 months, after which any exclusive permissions revert to a generic permission at the expiration of the approved period of exclusivity.
The above is reflected in the current Food Regulation Policy guideline on novel foods, which includes the following specific policy principle: To provide an assessment process that aims to protect commercially sensitive information and recognise industry’s intellectual property to the maximum extent possible.
With advances in innovation, FSANZ has observed an increasing number of nutritive substances seeking pre-market assessment. In recognition of the novel technologies and extensive data requirements for these types of applications, FSANZ extended consideration of exclusive permissions to nutritive substance applications. The first exclusive permission for a nutritive substance was considered by the Food Ministers Meeting in November 2020 as part of the assessment and approval of Application A1155 - 2’-FL and LNnT in infant formula and other products, with several other applications considered since this time. The same considerations and 15 month limit on exclusivity apply.
The FSANZ Act permits FSANZ to make a standard that may relate to a particular brand of food (paragraph 16(2)(b)). This enables FSANZ to set exclusive permissions for a brand of food (e.g. only a particular brand or brands of a novel food or nutritive substance may be sold during the exclusive permission period). In deciding whether to set an exclusive permission, FSANZ must have regard to specific assessment criteria prescribed by the FSANZ Act (section 18 and 29).
The decision of whether to set an exclusive use permission is taken as part of a more general consideration of whether a novel food or nutritive substance, if approved, should have conditions of use imposed on it. This is described in the Note to section 1.5.1—3. The Australia New Zealand Food Standards Code (the Code) does not mandate specifying the brand of food and the classes of food in which that brand/food may be sold when an exclusive permission is granted. It allows FSANZ, when appropriate, to impose a condition that the sale of the novel food or nutritive substance be restricted to a particular food class or brand of food, either as a stand-alone condition or as part of a set of conditions, for a period of up to 15 months post-gazettal. At the end of that 15 month period, the permission becomes generic and non-brand specific i.e. the food may be sold under any brand.
An exclusive use permission is usually only considered by FSANZ if an applicant expressly applies for it. Such an application would usually be a paid application on the basis that its approval would confer an exclusive capturable commercial benefit on the applicant.
At present, any manufacturer can submit an application using data generated by others if that data is publicly available. Additionally, neither the FSANZ Act nor the Code prevent approval of second or subsequent applications within the 15 month exclusive permission period for the use of the same novel food by other food companies (i.e. under a different brand). Any subsequent applications must follow the same application process, including meeting the requirements of the FSANZ Application Handbook and payment of a charge, if applicable. A subsequent application for a different brand, if approved, would be likely to attract a limited period of exclusivity because the initial and existing exclusive permission would automatically revert to a generic and non-brand specific permission at the end of its exclusive use period.
Only a limited number of exclusive use permissions have been sought to date.
In deciding whether the Code should include measures relating to exclusive use, FSANZ is required by section 29 of the FSANZ Act to have regard to the following matters, among others:
- whether costs that would arise from such a measure outweigh the direct and indirect benefits to the community, Government or industry that would arise from that measure;
- whether other measures would be more cost-effective than such a measure;
- other relevant matters such as:
- the need for any such measure to be based on risk analysis using the best available scientific evidence (which includes economic evidence);
- the desirability of an efficient and internationally competitive food industry.