Changes to the FSANZ Act come into force from 1 October 2007
Changes to the FSANZ Act came into force on 1 October 2007. The changes will improve the assessment procedures for new and amended food standards and make the regulatory process more efficient.
New application process
Until now, FSANZ has had to use a ‘one size fits all’ model for assessing applications to amend food standards, regardless of the scope of the proposed change. This has caused backlogs in applications that are frustrating for applicants.
The amendments to the FSANZ Act solve this problem by allowing three different procedures for applications, based on each application’s level of complexity.
The procedures are:
- General, a default procedure requiring nine months to complete assessments. It will be used for variations to a food regulation and involves one round of public consultation. It will be the most commonly used procedure
- Minor, requiring three months to complete an assessment, applying to minor variations to food regulatory measures including, but not limited to, correction of a typographical error or minor editorial changes. It involves one round of limited consultation with government agencies only, and if relevant, affected parties
- Major, requiring 12 months to complete an assessment. It applies to the development of a new food standard or a major variation to a food regulation that is scientifically or technically complex. It involves two rounds of public consultation
Most changes to food standards will take nine months for FSANZ to process.
New terminology
Other changes include renumbering sections of the FSANZ Act, a newApplication Handbook that provides mandatory guidelines to help applicants - FSANZ will be able to reject an application if it has not met the Handbook’s requirements - and the removal of the current terminology for Initial, Draft and Final Assessments.
These new stages of the assessment process are:
- ‘Administrative assessment’ – to decide whether an application includes certain minimum requirements (as outlined in theApplication Handbook) and the procedure by which it should be assessed.
- ‘Assessment’ – to decide whether to proceed to develop a food regulation or reject the application.
- ‘Approval’ - after the submission period, FSANZ must either approve, approve subject to amendment, or reject the draft standard or variation to an existing one. In doing so it must consider all submissions made during the submissions period and prepare for public release a report containing its decision, reasons, submissions list, analysis of submissions, Regulatory Impact Statement and draft food regulation or variation.
Publishing of applications and submissions
By Christmas 2007, members of the public will be able to access applications and submissions through the FSANZ website, except for material that is considered by FSANZ to be confidential commercial information. This is an enhancement of the current system where this information was only available on request to FSANZ via the public register and at a fee. This new access will be free of charge.
Other changes
In other changes:
- once amendments have been made to the Treaty with New Zealand, the Ministerial Council will only be able to request one review of a decision made by FSANZ;
- an applicant can request confidential treatment when seeking permission to use a high-level health claim;
- FSANZ will have the capacity to ‘stop the clock’ on an application for up to 18 months if the Ministerial Council says it is developing policy principles or guidelines pertinent to that application. For paid applications, the applicant must consent to ‘stopping the clock’.;
- if FSANZ decides an applicant has an exclusive capturable commercial benefit (ECCB), the applicant will have to pay the relevant fee or instalment within 20 business days of the date that the Administrative Assessment is made or FSANZ will reject the application;
- applicants will be able to seek permission for exclusivity for the maker / brand and product combination for a new novel food for 15 months - this option will be available within the Code, rather than as part of the FSANZ Act.
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