Final assessment report



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Eg. This food is high in Y which may help maintain healthy cholesterol levels through Z.


. biomarker enhancement claims; and

Eg. This food is low in Y which may reduce your blood pressure through Z.

.

biomarker claims that make reference to a serious disease.



Eg. This food is rich in Y. In conjunction with Z, Y helps to maintain your healthy cholesterol levels and can reduce your risk of heart disease.
Regulatory Model
It is recommended that the following arrangements apply to the regulation and monitoring of nutrition, health and related claims:

. the Australia New Zealand Food Standards Code would set out the high order principles of the health claims system, the definitions of general and high level claims, and provide prescriptive, individual detail for high level claims. The standard may also set out qualifying and disqualifying criteria for certain types of claims (eg. nutrient content claims) and categories of foods which may be excluded from making claims (eg. alcohol and baby foods)

. a guideline document would provide the majority of the detail surrounding general level claims. This guideline will be designed to assist industry in utilising the system correctly;

. a ‘watchdog’ body would serve as the public face of the health claims system, and undertake a number of key tasks.

. Jurisdictions would be responsible for receiving complaints in the usual way. Enforcement of the Health Claims Standard, including assessing possible breaches and undertaking prosecutions, would be the responsibility of the State/Territory and New Zealand enforcement agencies. Enforcement agencies would be responsible for coordinating action across jurisdictions, and informing the ‘watchdog’ body of complaints received and actions taken, and providing feedback on any perceived problems with the regulation of health claims.
The ‘watchdog’ would:


    . assist FSANZ in the creation and maintenance of the guideline document (in consultation with stakeholders);

. provide recommendations to FRSC regarding proposed amendments to the Standard or the guideline document;

. receive complaints via a mailbox and refer any complaint to the relevant jurisdiction(s) for analysis and enforcement action;

. record complaints received (either directly by the watchdog or jurisdictions), and monitor enforcement actions undertaken by jurisdictions in response to those complaints; and

. provide periodic reports to FRSC.




    A schematic representation of the proposed Regulatory Arrangements is provided at page 8 of this guideline.

The newly established Implementation Sub-Committee (ISC) will act as the Health Claims ‘watchdog’. ISC consists of an official from the Australian, the New Zealand and each State and Territory Government. ISC will report to FRSC on enforcement and implementation issues and will also require a secretariat.

Consideration needs to be given as to whether these duties should be dealt with as a standing agenda item, or whether special, dedicated meetings should be convened to deal with Health Claims watchdog functions.

It is recommended that the “watchdog” function be funded by jurisdictions on a pro-rata to population basis, similar to the AHMAC model. This would be re-assessed in a review to be undertaken two years after implementation of the standard.
Advisory Panel

The proposed Advisory Panel is a register of independent experts set up under an administrative arrangement. The Advisory Panel would be available to jurisdictions on a cost-recovery basis.

Individual members from this panel would be available to assist enforcement agencies by providing their expert opinions on potential breaches, if requested. This could include advice on the adequacy of supporting evidence that food companies are holding to support their claims. The panel member would provide advice only, as opposed to an enforceable ruling, however they could be asked to assist in prosecution actions if required.

The Advisory Panel would also assist jurisdictions to build an enforcement capacity with regard to health claims during a fixed implementation period.









Substantiation Requirements

It is recommended that consideration be given to the following requirements for the type of evidence to be held, and who is required to hold it, for each level of claim.

It is the responsibility of the food manufacturer to refer to the Standard and associated guidelines and make an assessment as to the classification of the claim they wish to use.

For simple nutrient content claims, the manufacturer needs to hold evidence that the product contains the relevant component(s) in the amount(s) being claimed, and to meet any qualifying or disqualifying criteria specified in the standard. For other general level claims, there are two alternative requirements: where the evidence is ‘consistently agreed’ or where there is ‘weight of evidence’.

Consistently agreed’ evidence for a claim refers to the conclusion that there is a sufficient body of sound, relevant scientific evidence that shows consistency across different studies and among different researchers. This body of evidence permits the key determination of whether a change in the dietary intake of the substance will result in an outcome consistent with the claim being made. For ‘consistently agreed’ evidence the manufacturer is required to hold appropriate scientific evidence of why and where the claim is substantiated, as well as evidence that the product contains an adequate amount of the relevant component(s).

Weight of evidence’ applies when the accepted scientific evidence for the claim outweighs any opposing evidence. Manufacturers will be required to hold this evidence in the form of a dossier consisting of:

. copies of the relevant studies;

. an outline of all the evidence available and a summary evaluation of the totality of evidence;

. together with evidence that the product contains an adequate amount of the relevant component(s).

The basic substantiation requirements will be set out in the standard, to ensure that they are enforceable, with links to additional, detailed guidance. The detailed guidance on evidence requirements and maintaining appropriate dossiers will be provided in the guideline document that will be developed by FSANZ in conjunction with ISC and stakeholders. This guideline document will contain reference back to the standard, and will assist industry in complying with the requirements and due diligence. Manufacturers would have an obligation to ensure that the evidence used to make a claim has not changed, and, if further evidence comes to light, to reassess the validity of the health claim. Industry will be required to prepare their dossiers in advance of the claim being submitted to market and must produce this evidence on demand from enforcement agencies.

If a manufacturer wishes to make a high level claim, this will need to be one of the pre-approved claims, unless an application to add a new high level claim to the standard is made to FSANZ.

Pre-approved claims based on dietary guidelines and other approved documents will be assessed during the initial development of the standard so that they are available when it commences.

If a manufacturer wishes to make a high level claim that has not already been approved, an application will need to be made to FSANZ. Manufacturers will need to submit supporting evidence with their applications. This may include ‘consistently agreed’ evidence, ‘weight of evidence’, or emerging evidence. FSANZ will assess the evidence in accordance with usual statutory FSANZ processes. Approval by FSANZ, notification and acceptance by the Ministerial Council, and subsequent gazettal of variations to the standard will be required before any new high level claims can be made.



Who holds evidence of substantiation and validity?





A
Who holds evidence of substantiation and validity?
dditional guidance

To ensure the system protects public health and safety, whilst assisting and encouraging industry the following recommendations are made in relation to additional work to be undertaken:



. A communication strategy to educate and inform the food industry about what is expected under the new framework, to reduce the risk of inappropriate claims. This will include a clear strategy for general level claims, as well as guidance on the forms of media captured in the framework (ie internet etc).

. Compliance and enforcement to be closely monitored, with claims referring to a biomarker being a particular priority. Jurisdictions will also need to make audits and enforcement a priority, particularly during the introductory period. The Advisory Panel would be available on a user pays basis to jurisdictions needing timely, expert advice. The watchdog body would report to Ministers on the use of biomarker claims and other enforcement issues within 6 months of commencement.

. Further work to be undertaken to provide guidance around the definitions of ‘disease’, ‘serious disease or condition’ and ‘therapeutic claims’, to include asymptomatic disease and resolve tensions between the TGA and PAG definitions. This will be done in conjunction with the development of the standard.

. Further work is also needed to consider whether nutrient content claims can be adequately controlled, monitored and enforced. Consideration should be given whether certain parameters (eg qualifying and disqualifying criteria) (or exclusions for certain categories of food eg. alcohol and infant food) should be specifically stated in the standard. This will be done in conjunction with the development of the standard.

. Work on pre-approved claims will be concurrent with the development of the standard. It is envisaged that pre-approved claims based on the National Health and Medical Research Council (NHMRC) Australian Dietary Guidelines or the New Zealand Dietary Guidelines will be considered for inclusion in the Health Claims Standard from its commencement. For the purposes of reviewing the evidence for health claims, FSANZ should look to the NHMRC’s recent independent evaluation of nutritional and dietary evidence in developing national dietary guidelines.

. The standard should not prescribe exact wording for the pre-approved high level claims. Some flexibility in the wording of claims should be permitted provided there is compliance with the Overarching Principles. In general, approval of high level claims is to be ‘claim by claim’ and not ‘product-by-product’, although some products making high level claims may have undergone separate pre-market approval to ensure safety under other standards. Again, it is envisaged that the standard will not prescribe exact wording.

. The standard should provide sufficient detail to enable enforcement action to be taken against all breaches, for all levels of claims. However, only the ‘high’ level category is to include specific pre-approved claims, whilst still allowing for flexibility in wording.

. The Nutrition, Health and Related Claims Policy Advisory Group should have continued involvement as an external advisory group to FSANZ during the standard development process.

. Any costs associated with the ‘watchdog’ function should be funded on a pro-rata basis by jurisdictions. A model similar to the AHMAC model could be used. This will be re-assessed in the review of the system.

. A review of the health, nutrition and related claims system should be undertaken within two years of implementation of the standard. The review should take particular note of the effectiveness of the ‘watchdog’ body and its ongoing role (if any), the Advisory Panel and overall compliance of industry.

Glossary of Terms

It is recommended that consideration be given to the list of definitions for inclusion in the standard and any other guidelines.



Biomarker: any parameter from which the presence, absence or risk of a disease can be inferred by the level of the parameter (rather than being a measure of the disease itself.)

Claim: a stated or implied nutrition, health or related claim that can be communicated through all mediums including statements, symbols, vignettes, print or electronic media, or other forms of communication and or advertising.

Component: a component of a food includes a nutrient (including phytonutrient),
non-nutrient or other ingredients.

Compound claim: a claim containing two or more clauses that can stand independently. The clauses are often linked by a conjunction such as ‘and’, ‘by’, ‘but’ etc.

Conditions or diseases that are medically managed: conditions and diseases in which a health care professional would be expected to prescribe and manage therapeutic treatment and monitor progress.

Dietary management of a disease: the selection of foods or food components to optimise the health of an individual with a specific disease or condition.

Disease: an unhealthy condition characterised by clinically significant signs or symptoms.
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