Nutrition, Health and Related Claims
‘this information is no longer current and may be out of date’
In December 2003, the Australia New Zealand Food Regulation Ministerial Council (the Ministerial Council) agreed to a new Policy Guideline for the regulation of nutrition, health and related claims. This policy is guiding Food Standards Australia New Zealand (FSANZ) during the development of a standard that will become part of the Australia New ZealandFood Standards Code (the Code). The Code covers all foods produced and imported into Australia and New Zealand.
Currently, nutrition claims (e.g.This food is high in fibre) and some function claims (e.g. Calcium is good for healthy bones and teeth) are allowed. However, all health claims are prohibited, other than claims about the benefit of women consuming folate and reducing the risk of neural tube defects in babies.
FSANZ began work on Proposal P293 – Nutrition, Health and Related Claims in 2004 and has developed a proposed draft Standard to regulate nutrition content claims and health claims. The draft Standard will remain subject to change until the Ministerial Council gives its approval and the draft Standard is gazetted and incorporated into the Code.
The intention of the draft Standard is to:
- ensure products carrying claims provide adequate information to consumers
- prevent misleading or deceptive claims on food labels or in advertising
- enable industry to innovate giving consumers a wide range of healthy food choices.
What is a claim?
As a consequence of FSANZ’s work in developing the draft Standard, a revised definition of the term ‘claim’ has been proposed in Standard 1.1.1 – Preliminary Provisions – Application, Interpretation and General Prohibitions.
If adopted, ‘claim’ would mean any ‘statement, representation, design or information in relation to a food or property of the food which is not mandatory in the Code , and includes an implied claim’.
There are three categories of claims that the draft Standard will cover: nutrition content claims, general level health claims and high level health claims.
Nutrition content claims
A nutrition content claim is a statement regarding the presence or absence of a component in the food, and in some cases the amount of the component. For example:
- good source of dietary fibre
- reduced in saturated fat
- contains lycopene
General level health claims
A general level health claim is a claim that describes a relationship between the consumption of a food, or a component in the food, and particular benefits in relation to health (a health effect). A general level health claim does not refer to a serious disease or a biomarker of a serious disease. For example, general level health claims are those which:
- describe a component of the food and its function in the body.
For example,Calcium is good for strong bones and teeth, when consumed as part of a healthy diet containing a variety of foods high in calcium.
- refer to the potential for a food or component of the food to assist in reducing the risk of, or helping to control, a non-serious disease or condition. For example, Yoghurt high in X and Y may reduce your risk of stomach upset, when consumed as part of a healthy diet with a variety of foods.
High level health claims
High level health claims reference a serious disease, or a biomarker of a serious disease. Food-disease relationships will require pre-approval by FSANZ before they can be included in the draft Standard and these will form the basis of high level health claims. The process FSANZ will follow for assessment of food-disease relationships will be set out in the Application Handbook.
High level health claims which will be permitted include those which:
- refer to the potential for a food or component of the food to assist in controlling a serious disease or condition by either reducing risk factors or improving health.
For example, Healthy diets high in calcium may increase bone mineral density
- refer to the potential for a food or component of the food to assist in reducing the risk of a serious disease or condition.
For example, Diets low in sodium may reduce risk of elevated blood pressure.
The evidence for a number of food-disease relationships has already been reviewed, with some relationships being pre-approved. The eight diet-disease relationships that have been substantiated as reaching levels of evidence commensurate with requirements for a high level health claim are:
- sodium AND blood pressure
- fruit and vegetables AND coronary heart disease (two relationships)
- saturated fatty acids [and transfatty acids] AND LDL cholesterol and heart disease (two relationships)
- calcium, vitamin D status AND osteoporosis/enhanced bone mineral density (two relationships)
- folic acid AND neural tube defects
Two further diet-disease relationships were assessed but did not reach a sufficient level of evidence for high level health claims:
- wholegrains, bran AND coronary heart disease
- long chain omega-3 fatty acids AND cardiovascular disease
Further claims
Some claims are regulated differently to those nutrition content claims or health claims described above. They include endorsements, cause-related marketing statements and dietary information.
Endorsements
The terms ‘endorsement’ and ‘endorsing organisation’ are defined in the draft Standard. Designs on food labels that are nutrition content claims or health claims and meet the definition of ‘endorsement’ made by an ‘endorsing organisation’ are not subject to the requirements of the draft Standard.
The supplier of the food must have records demonstrating that the endorsing organisation is independent, formed for nutritional or health purposes, and structured in a way that guarantees that the supplier cannot influence the criteria used by the endorsement programme. These records must be made available upon request to the relevant authority.
Cause-related marketing statements
A cause-related marketing statement for food is defined to mean a nutrition content claim or health claim that is presented as a statement that the sale of a food will contribute to fundraising for an organisation. These statements will be exempt from the draft Standard if accompanied by a disclaimer. The disclaimer must be to the effect that:
- the supplier makes no claims in relation to the food being beneficial for managing a health effect
- the supplier makes no claims that the food is a source of the property of the food referred to in the cause-related marketing statement.
Dietary information
Dietary information refers to the general dietary information that is derived from national nutrition guidelines or similar, highly credible sources. Its purpose is to educate the public about recommended healthy diet patterns; however, when dietary information appears on a food label or in an advertisement for a particular branded food, it may be seen as promoting the product. The draft Standard includes provisions which effectively restrict its use by requiring dietary information to:
- relate to an associated nutrition content claim or health claim
- not exceed the associated nutrition content claim or health claim
- relate directly to the food, if the dietary information refers to food rather than a component of the food. In this instance, a nutrition content claim or health claim is not required to accompany the dietary information. For example, dietary information on the label or in an advertisement for fruit that recommends the consumption of fruit.
Dietary information statements about moderating the consumption of alcohol are exempt from these provisions.
Regulation of claims
The level of a claim determines how the claim is regulated, including the evidence required for substantiation.
Substantiation
Nutrition content claims and general level health claims on food labels or in associated advertising for food sold in New Zealand and Australia will be required to be substantiated by scientific evidence. This is to ensure claims are soundly based and do not mislead consumers. Verification of the health benefit is required for all general level health claims.
Nutrition content claims
Nutrition content claims will need to be substantiated, either by analysis or by calculating the content of the claimed component in the food.
General level health claims
To substantiate general level health claims, manufacturers must use either the FSANZ list of nutrient function statements, derive claims from the food-disease relationships from high level health claims, use authoritative sources or complete a systematic review as specified in the Scientific Substantiation Framework. Suppliers must have records to substantiate such claims.
High level health claims
Food-disease relationships must be pre-approved by FSANZ and will form the basis for high level health claims. Separate provisions for substantiation of high level health claims are therefore not required.
Progress on the draft Standard
The Final Assessment Report and draft Standard were submitted to the May 2008 meeting of the Ministerial Council. The Ministerial Council subsequently considered the recommendations in the Report and, in early June, requested a First Review of Proposal P293 – Nutrition, Health and Related Claims. The First Review request includes a number of issues for FSANZ to reconsider, in particular the enforceability of the Scientific Substantiation Framework for general level health claims and the application of the nutrient profiling scoring criteria to nutrition content claims.
In September 2008, the three month statutory period for completing the First Review of Proposal P293 was extended to ten months by the Ministerial Council to April 2009. At their October 2008 meeting, the Ministerial Council requested the presentation of the First Review report be deferred until it can be considered concurrently with the outcomes of an independent ministerial review of labelling law and policy being conducted in 2009. The Ministerial Council agreed to extend the reporting timeframe for the First Review of Proposal P293 until March 2010 and agreed that FSANZ should continue its work to address the issues identified in the First Review Request.
For more information
Further information on the development of the standard for nutrition, health and related claims, Proposal P293 - Nutrition, Health & Related Claims:
· visit our website at: http://www.foodstandards.gov.au/standardsdevelopment/proposals/proposalp293nutritionhealthandrelatedclaims/index.cfm
· contact the Information Officer on 02 6271 2241
· email info@foodstandards.gov.au