Technical Alert: Consultation – FSANZ Act Review

The Department of Health and Aged Care (the Department) is conducting a Public Consultation on the final stage of the FSANZ Act Review, closing 10 April 2024. Through previously conducted public consultation and ensuing work on the Review, as outlined briefly in ‘background’ below, the FSANZ Act Review has identified 27 concepts across four themes for further investigation, which have been consolidated into 20 components in an Impact Analysis.  

The Review is in the remit of the Department of Health and is being conducted independently from FSANZ however, FSANZ input and feedback on the practicalities of the concepts will be sought. 

Stakeholders are being asked for their views on the Impact Analysis and to provide feedback to characterise the impact of the proposed concepts.  Members can provide comment to CMA by Wednesday 3 April via technical@cmaustralia.org.au, or alternatively members can respond directly to the public consultation questions through the online survey by Thursday 10 April

FSANZ Act Review timeline: 

  • Once feedback from the public consultation is received, recommendations will be provided by the Department  to the Food Ministers Meeting (FMM), expected July 2024. 
  • Following FMM consideration and input, the model is anticipated to be finalised by the Department in late 2024. 
  • Commencement of the amended Act is anticipated to occur in 2025. An ‘exposure draft’ of the Act may be provided to stakeholders prior to finalisation. 

Impact analysis  

The Impact Analysis outlines the cumulative costs and benefits of these components. Each of the 20 components are being considered individually, and it is expected that the final proposal considered by Food Ministers, anticipated to occur in July 2024, will be a combination of different components within the four themes. The overall cost benefit will depend on components considered.  

The Impact Analysis poses two options for consideration: 

  • Option 1: Retain the status quo 
  • Option 2: Modernise regulatory settings 

Option 2 is comprised of four themes: 

  • Theme 1 – Purpose and Objectives: Providing greater clarity on the purpose and objectives of FSANZ. 
  • Theme 2 – Reforming Standard settings: Supporting more efficient and effective processes to develop food regulatory measures, with risk being the key driver of process. 
  • Theme 3 – Efficient and Effective Operations: Focused on better use of FSANZ’s limited resources through more effective governance, as well as achieving financial sustainability for the organisation. 
  • Theme 4 – Improving System Agility: Aimed at making the food regulatory system better integrated, streamlined, and evidence informed. 

Points of interest for members  

CMA attended a Stakeholder Forum workshop on 21 February, hosted by the Department, to discuss the upcoming public consultation on the FSANZ Act Review. While the concepts presented are generally broad, information gleaned from this forum that was noted to be of potential interest to members is provided below. Where the information can be linked to a component in the impact analysis this is noted, as well as whether the change would be operational (O) or legislative (L).  

  • At an earlier information session attended by CMA in August 2023, FSANZ noted that the Food-Medicine interface is not within the scope of this review. However, at the recent workshop representatives from the Department encouraged consultation responses addressing out of scope issues to bring awareness of these to the FMM. 
  • CMA has considered raising certain aspects in relation to enforcement and compliance; the management of products that are not entered on the ARTG, but are also not strictly foods; and the management of herbal extracts in foods. Members are invited to present other issues for CMA consideration via technical@cmaustralia.org.au.  
  • Industry representatives emphasised the need for a future-proof framework that encourages trade and innovation to safeguard Australian industry. 
  • The Department provided that there is an aim to digitise the Food Standards Code to make it searchable, improving accessibility. 
  • Definition of ‘public health and safety’ (L) –  Theme 1 – component 2.1.1 (page 49 of the impact analysis) 
  • This component discusses that the definition of ‘protection of public and safety’ within the Act (Sections 3 and 18) could be clarified to be in line with current policy guidance that captures both acute and long-term health elements. Currently there is no definition within the Act however, the Ministerial policy statement on the interpretation of public health and safety provides the following definition: 

all those aspects of food consumption that could adversely affect the general population or a particular  community’s health either in the short-term or long-term, including preventable diet related disease, illness and disability as well as acute food safety concerns.” 

Industry representatives raised questions about FSANZ’s role as a preventative health agency, noting that a such a broad definition may have the potential to result in the overregulation of the food industry as it was recognised that food itself is unable to address public health in isolation.  

  • Risk based framework approach (O) – Theme 1 –  component 2.2.1 (pages 51-52 of the impact analysis) 
  • This component provides that a risk-based framework and approach (e.g., high, moderate, low) could be introduced to guide the development of food regulatory measures so that statutory processes relevant to applications and proposals could be amended to support a level of consultation and assessment commensurate with risk involved. This would likely result in the expediency of some applications. Members may wish to review/comment on the calibration of the indicative risk framework. Worked examples of how this framework may be applied are included in Appendix D of the Impact analyses (pp. 119-121).  
  • New pathways to amend food standards could be introduced (L) – Theme 1 –  component 2.2.2 (pages 52-53 of the impact analysis) 
  • This component discusses the potential for the Act provide for FSANZ to accept risk assessments from overseas jurisdictions (similar to the therapeutic goods COB system); the potential for international standards to be automatically recognised; and the potential introduction of a minimal check pathway for very low risk products. 

Industry representatives raised questions about how the adoption of international risk assessments and standards would work in practicality and expressed concern over wholesale automatic adoption. The Department advised that jurisdictions also hold concerns about automatic adoption due to a preference to maintain control over food standards.  

  • Streamlining decision making arrangements (L) –  Theme 2 component 2.2.3 (page 54 of the impact analysis) 

This component discussed provisions for the FSANZ Board to delegate low-risk application and proposals to the FSANZ CEO for decision. This would preserve each jurisdiction’s role in having a ‘final say’ about new or amended food standards, while recognising that particular Ministers may not feel it necessary to have oversight and decision- making authority on all changes to the standards.  

Industry stakeholders noted the potential for FSANZ to engage external expertise in decision making processes where gaps in knowledge within FSANZ exist e.g., gene technology, to increase FSANZ capacity to conduct assessments.   

  • Bringing more Traditional Foods to market (O) – Theme 2 –  component 2.2.4 (page 55 of the impact analysis) 
  • This component discusses how the food system can support more Indigenous traditional foods to be brought to market, including the potential to develop and publish a list of traditional foods or ingredients that  have undergone safety assessments, similar to the therapeutic Goods Permissible Ingredients Determination.  

Industry representatives agreed that more clarity is required on the process to establish what is  and is not included on the list. For example, if ‘olive leaf’ is included, does this also encompass ‘olive leaf extract’ if not, why not, and what other assessment would be required. Stakeholders also recognised the difficulty in defining ‘traditional foods’ noting that traditional food may extend beyond traditional Indigenous use. In addition, stakeholders noted that such a list would require ongoing maintenance to ensure currency.  

  • Generate more sustainable revenue: cost recovery (L/O) –  Theme 3 – component 2.3.3 (pages 59-61 of the impact analysis) 
  • This component discusses a potential change to the Act to enable FSANZ to cost recover for a broader range of products and services that benefit industry. The Impact analysis provides that currently, long-term decreases in funding has created significant resourcing pressure, forcing FSANZ to focus only on a sub-set of its statutory functions. Proposals include that an industry-wide levy could be implemented; or compulsory fees could apply to all applications.    
  • Introduction of Statements of Intent (O)– Theme 4 – component 2.4.5 (page 65 of the impact analysis) 
  • This component provides that inconsistent interpretation and enforcement of food standards heightens cost for industry and enforcement agencies and suggests that FSANZ could reduce uncertainty through the provision of greater guidance on food standards. This could involve including a Statement of Intent alongside food standards in the Code to describe what FSANZ wants to achieve in the writing of each food standard (akin to explanatory memoranda), which could provide basis for enforcement activities.  
  • Develop, update and maintain industry guidelines to guide interpretation of food standards (O)– Theme 4 –  component 2.4.6 (page 65 of the impact analysis) 
  • This component discusses how the development of guidelines, in consultation with industry, could assist industry, especially SMEs and sole traders, in complying with food standards.  

Industry stakeholders, noted that, while guidance may be welcome, some stakeholders such as smaller businesses and Indigenous businesses may have difficulty distinguishing between the Code, interpretive guidance and statements of Intent.  

Background 

The FSANZ Act Review commenced in July 2020, and is a comprehensive examination of the effectiveness of the FSANZ Act and the associated operations and responsibilities of Food Standards Australia New Zealand (FSANZ). The FSANZ Act is Australian legislation and underpins the Australia New Zealand Joint Food Regulatory System within which New Zealand participates as a partner under the bilateral Food Treaty. 

Extensive stakeholder consultation has been undertaken to date, including public consultation on a Scoping Paper across October and November 2020, draft Regulatory Impact Statement in April to May 2021, and targeted workshops with key government, industry, public health and consumer bodies in 2021 and 2023. 

More information is available on the review on the Food Regulation website

Resources 

  • Modernising the Food Standards Australia New Zealand Act 1991: Impact Analysis [PDF] 
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