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Health claims standard timeline

(January 2013)

Download: Nutrition, Health and Related Claims timeline (pdf 40 kb) | (word 71 kb)

 

Date

Summary of Events

 

December 2003

The then Australia New Zealand Food Regulation Ministerial Council (the Ministerial Council) asked FSANZ to develop a standard to regulate nutrition, health and related claims and provided a policy guideline. In doing so, the Ministerial Council recognised the increasing complexity of the food supply, especially with the appearance of more functional foods, and the benefits of regulating all nutrition and health claims under a unified and mandatory system.

May 2004

Two advisory groups were established:

  • an external Scientific Advisory Group, responsible for developing the Substantiation Framework for Nutrition, Health and Related Claims (this group subsequently met on six occasions)
  • a Standard Development Advisory Committee, to provide scientific, technical, policy, regulatory/enforcement, cost benefit or other information as required (the Committee subsequently met on nine occasions).

Ministers provided updated policy guidance on the issue of biomarker maintenance claims.

August 2004

FSANZ released the Initial Assessment Report for public comment. This report canvassed stakeholder views on a broad range of issues, including how FSANZ could most effectively have regard to the Policy Guideline and which of three proposed regulatory options was preferred:

  • Option 1: maintain the status quo

  • Option 2: develop a new standard and guideline(s) for nutrition, health and related claims

  • Option 3: develop a new standard for nutrition, health and related claims.

FSANZ received 147 submissions in response to this report.

November 2005

The Draft Assessment Report was released for public comment. This report also included the preferred regulatory option and the draft standard, which set out the criteria and conditions for making claims and incorporated substantiation requirements. These included:

  • specific qualifying and disqualifying criteria for nutrition content claims

  • a simple approach for generic eligibility criteria for health claims that comprised cut-off points for sodium, saturated fat and total sugars per serve.

  • food-health relationships underpinning general level health claims would be exempt from pre-market assessment and approval because they do not reference a serious disease

  • food-disease relationships underpinning high level health claims would need to be pre-approved by FSANZ.

The Draft Assessment Report included information on high level health claims assessed by the Scientific Advisory Group that was set up in 2004. FSANZ received 131 submissions in response to this report.

April 2007

After analysing submissions to the Draft Assessment Report, FSANZ conducted an extraordinary round of public consultation through the release of a Preliminary Final Assessment Report. Further public comment was sought on the following issues:

  • risk management of nutrition content claims

  • the use of a nutrient profiling system to determine the eligibility of foods to carry general level health claims

  • endorsements

  • dietary information

  • application of the standard

  • other minor issues related to certain nutrition content claims.

The report also included a revised draft standard.

FSANZ received 92 submissions in response to this report.

December 2007

Following consideration of the submissions to the Preliminary Final Assessment Report and substantial targeted consultation throughout the year, FSANZ sought further comment on three specific issues through the release of a Consultation Paper. The issues were:

  • food eligibility criteria for vitamin and mineral claims

  • an additional claim about saturated fatty acids

  • the proposed Scientific Substantiation Framework.

This Consultation Paper included revised drafting for the Scientific Substantiation Framework.

FSANZ received 65 submissions in response to this Consultation Paper.

March 2008

The FSANZ Board approved draft Standard 1.2.7 and the Ministerial Council was subsequently notified of its decision.

The draft standard included a regulatory approach for general level health claims based on industry self-substantiation. High-level health claims required pre-market assessment and approval.

June 2008

The Ministerial Council requested a review of the draft standard, to be completed by September 2008. Their concerns included the regulatory approach for general level health claims, enforcement issues and concern that foods carrying nutrition content claims were not required to meet the nutrient profiling scoring criterion. They considered that the industry self-substantiation approach for general level health claims recommended in March 2008 (at Final Assessment) was resource intensive and too difficult for enforcement agencies.

September 2008

The Ministerial Council extended the three month statutory period for completing the review by ten months to April 2009.

October 2008

The Ministerial Council requested the presentation of the Review report be deferred until it could be considered concurrently with the outcomes of the independent Review of Food Labelling Law and Policy, being conducted in 2009. The reporting timeframe for the review was extended to March 2010.

March 2009

FSANZ released a Consultation Paper on the changes proposed for two of the key issues raised in the review request, namely:

  • a new version of the draft standard in which the text and the structure were revised for the purpose of improving clarity

  • the regulatory approach for general level health claims. In this Consultation Paper, FSANZ sought comments on two options:

1. industry self-substantiation as recommended in the Final Assessment Report, with minor amendments

2. FSANZ pre-approval of general level health claim food-health relationships.

FSANZ received 71 submissions on the paper.

October 2009

Given the delays in the commencement of the independent Review of Food Labelling Law and Policy, the Ministerial Council:

  • resolved to seek an extension until December 2010 for the report of the food labelling review to be finalised

  • agreed to extend the reporting period for FSANZ to complete the Review of the draft standard to April 2011.

April – November 2010

In response to submitter comments to the March 2009 Consultation Paper, FSANZ proposed an alternate approach for regulating general level health claims involving a health claims management plan.

FSANZ conducted some targeted briefings with consumer groups, public health agencies, jurisdictions and industry. In November, FSANZ held webinars for stakeholders on the revised approach.

December 2010

The Ministerial Council agreed to further extend the timeline for FSANZ to complete its review of the draft standard until October 2011. The extension was to allow for consideration of the outcomes of the independent Review of Food Labelling Law and Policy.

July 2011

FSANZ began revising the text and structure of the draft standard for the purpose of improving clarity and ensuring its enforceability.

Due to questions about the enforcement of the health claim management plan approach, FSANZ revised the approach for regulating general level health claims. Under the new approach, all food-health relationships underpinning health claims, both general and high level, would be pre-approved with more than 210 pre-approved food-health relationships being proposed to be included in the draft standard. Under this system, food industry would have the option of having applications for the approval of new food-health relationships assessed confidentially by virtue of the ‘high level health claims variation’ process in the FSANZ Act.

October - November 2011

The Ministerial Council agreed to extend the date to complete the review of the draft standard to 30 April 2012, so that the Ministerial Council could consider it at its face-to-face meeting, scheduled for 1 June 2012.

FSANZ conducted another round of targeted briefings with consumer groups, public health agencies, jurisdictions and industry on the proposed regulatory approach to health claims.

December 2011

FSANZ submitted an Interim Report on the Review of the draft standard to the COAG Legislative and Governance Forum on Food Regulation (the Forum; formerly the Ministerial Council) for its consideration. The Forum requested that FSANZ undertake broad consultation on the draft standard before finalising the review by the agreed date of 30 April 2012. The Forum also asked FSANZ to further consider the risk management approach for fat free and %fat free nutrition content claims.

The Forum also agreed on the whole-of-government response to the recommendations made in the Review of Food Labelling Law and Policy.

February 2012

FSANZ released a Consultation Paper calling for comment on the draft standard and new options for the management of ‘fat-free’and ’% fat-free’claims. Submitters were asked to comment specifically on the following issues:

  • the proposed draft of the standard, specifically whether the further revision of text and structure undertaken since 2009 accurately reflects the regulatory intent and provides clarity, enforceability and user-friendliness

  • whether consumers are currently, or are likely to be in the future, misled by ‘fat-free’ and ‘% fat-free’ nutrition content claims, thereby warranting the application of additional regulatory measures, and whether there is evidence to support this view. Three possible approaches were outlined in the Consultation Paper.

The submission period ended 30 March. FSANZ received 83 submissions in response to the Consultation Paper.

June 2012

In response to some stakeholder concerns with the proposed pre-approval approach for general level health claims, as proposed in the March 2009 consultation paper, the Forum agreed to further consider the regulation of such claims in the draft standard following consultation with consumers, public health organisations and industry.

July 2012

The Forum confirmed its support for the nutrient profiling scoring criterion to ensure health claims only appear on healthy foods.

The Forum asked the Food Regulation Standing Committee and FSANZ to work together in consulting all stakeholders to further develop the approach for general level health claims. The Forum asked FSANZ to consider an approach where the regulatory system for general level health claims included pre-approved food-health relationships, as well as the option of self-substantiation of new food-health relationships with detailed criteria to be set out in the standard. Following this request and further analysis and consultation, FSANZ included both FSANZ pre-approved food-health relationships and the option of industry self-substantiation of food-health relationships underpinning general level health claims in draft Standard 1.2.7.

August 2012

Workshops held in Sydney and Wellington with key stakeholders, focussing on self-substantiation requirements.

October 2012

Targeted consultation with key stakeholder groups on the revised draft Standard.

The FSANZ Board approved Standard 1.2.7 and notified the Forum of the Board’s decision to approve it.

November 2012

FSANZ Review report including Standard 1.2.7 available on FSANZ website.

7 December 2012

The Forum agreed to the draft Standard, which will become law early in 2013. Food manufacturers will then have three years to meet the new Standard’s requirements.

18 January 2013 The Standard is gazetted and becomes law. Food manufacturers have three years to meet the new Standard’s requirements.

 

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