In 1996, the then Australia New Zealand Food Authority (ANZFA) released a discussion and options paper entitled ‘The safety assessment of novel foods and novel food ingredients’. It was felt necessary at that time because the number, variety and increasing use of non-traditional foods raised questions about public health and safety. ANZFA received stakeholder support to develop a Standard to formally regulate novel foods for the first time.
ANZFA started Proposal P168 – Novel Foods, to formally consider the need to regulate such foods in Australia and New Zealand. The authority recommended that novel foods be considered a sub-set of non-traditional foods and proposed definitions. It stipulated that no novel foods could be sold until first listed in that Standard. To do this, FSANZ undertakes a pre-market safety assessment so any potential concerns about a food’s safety could be met before it was sold.
The new Standard A19 of the then AustralianFood Standards Code- since revoked - was gazetted in December 1999 and Standard 1.5.1 gazetted as part of the Australia New Zealand Food Standards Code (the Code) in December 2000. Clause 2 of Standard 1.5.1 – Novel Foods (the Standard) prohibits the sale of novel foods unless included in the table to that clause. The clause came into effect on 16 June 2001. Between the gazettal of the Standard and 16 June 2001, the food industry had the opportunity to submit data to ANZFA for the assessment of novel foods while these remained on the market.
To coincide with the gazettal of Standard A19, ANZFA developed documents to assist industry in interpreting the Standard. The following two documents were made available on the then ANZFA website and both have since been updated. They were:
- ‘Format for applying to amend the Code – Novel Foods’, containing a template which could be used when making an application for permission to use a novel food
- ‘Guidelines to assist in applying to amend the Australia New Zealand Food Standards Code– Novel Foods’ (the Guidelines). These provided details of how the standard works, data requirements for the assessment of novel foods and a record of views formed in response to inquiries with respect to whether a food is novel or not.
The Guidelines were substantially reviewed and updated in early 2004, by which time ANZFA had become Food Standards Australia New Zealand (FSANZ). FSANZ made a significant new inclusion – a table presenting a record of the agency’s views, formed in response to enquiries, on whether a food is considered novel or not. The table is still available on the FSANZ website and presents the outcome views of whether a particular food or food ingredient is non-traditional or not and whether it is novel or not novel, according to the definitions in Standard 1.5.1. Previously, FSANZ dealt with enquiries on a case-by-case basis, responding directly to enquirers.
Ministerial Policy Guideline on Novel Foods
The Food Regulation Standing Committee (FRSC) established a working group to develop policy options in relation to novel foods. The novel foods working group produced a policy options paper on novel foods, which it released for public consultation in February 2003. FRSC considered the final draft policy guidelines in September 2003 and agreed that these draft policy guidelines would be provided to the Ministerial Council in December 2003.
The Ministerial Council endorsed the policy guidelines for novel foods and agreed to refer them to FSANZ in December 2003. The policy guidelines consisted of higher order principles, specific principles and policy guidance. The higher order principles can be summarised as follows:
The regulation for novel foods should:
- give priority to improvement of public health and safety
- ensure consumers have sufficient information to enable informed and healthy food choices
- be consistent with national policies on nutrition and health promotion
- draw on the best elements of international regulatory systems and be responsive to future developments
- be timely, cost effective, transparent, consistent with minimum effective regulation, encourage fair trade, industry growth, innovation and international trade.
The specific principles can be summarised as follows:
The regulation of novel foods should:
- ensure that public and industry confidence in the food system is maintained
- provide an assessment process that aims to protect commercially sensitive information and recognise industry’s intellectual property to the maximum extent possible
- ensure consumers are not mislead by novel foods which appear similar to existing foods but may differ in terms of nutrition or function.
The policy guidelines requested that FSANZ raise a proposal to review Standard 1.5.1, having regard to the guidelines’ higher order and specific policy principles.
Review of the Novel Foods Standard – P291
FSANZ raised Proposal P291 – Review of Novel Foods in response to the Ministerial Policy Guideline on Novel Foods. The two main changes as a result of this review are revised definitions for ‘non-traditional food’ and ‘novel food’ and a revised approach for determining whether a food is novel or not.
With respect to the definitions, amendments to the Standard have now been gazetted. This means that deciding whether a food is novel or not is now made according to these new definitions. To guide the process FSANZ has formed the Advisory Committee on Novel Foods.
Permission for Exclusivity of use of Novel Foods – P305
FSANZ raised Proposal P305 - Permission for Exclusivity of use of Novel Foods following requests from FRSC and the Ministerial Council. They asked FSANZ to consider the capacity for including a specific provision for exclusivity of use for novel foods in the Code. They also asked FSANZ to consider that an exclusive permission, if granted, should be limited to a period of 15 months, after which it would revert to a generic approval under the Standard.
The Final Assessment Report for Proposal P305 can be viewed on the website
The amendments to Standard 1.5.1 as a result of Proposals P291 and P305 were gazetted in December 2007.