P293_DAR_Executive_Summary

P293 - Nutrition, Health and Related Claims - Draft Assessment Report

Food Standards Australia New Zealand (FSANZ) had careful regard to the Policy Guidance on Nutrition, Health and Related Claims provided by the Australia and New Zealand Food Regulatory Ministerial Council (Ministerial Council) in 2003 when developing a regulatory framework for nutrition, health and related claims. The Policy Guideline sets out the policy principles underpinning the regulation of nutrition, health and related claims. It differentiates two main types of health claims - general level and high level - in terms of the reference to a serious disease or biomarker of a serious disease in the case of the latter, and indicates the possible approaches to be taken to regulate these health claims and nutrition content claims [1] . The policy guideline aims to allow claims in order to achieve public health benefits and to encourage industry to develop new products, whilst ensuring that consumers are not misled.

Some nutrition claims in Australia and New Zealand are currently regulated by theAustralia New Zealand Food Standards Code(the Code). Additionally some members of the Australian food industry follow a voluntary code of practice on nutrient claims. The New Zealand food industry uses the formerFood Regulations 1984for guidance in the same manner as the Code of practice. Fair trading legislation in both countries serves to regulate false and misleading claims. The code has a transitional standard for health claims, which prohibits all health claims except for one relating to folate ingestion in women around the time of conception.

This situation is deemed to have limitations including difficulties in relation to compliance with a voluntary code of practice, the lack of incentive for innovation by industry and a restriction on claims that could be of value to consumers and could enhance public health. Furthermore, there are difficulties in interpretation, application and enforcement of the transitional Standard.

FSANZ has therefore considered the benefits and costs of the introduction of a new standard allowing health claims and the different regulatory options that could be applied to health, nutrition and related claims. In developing this Draft Assessment Report FSANZ has:

• consulted with a wide variety of stakeholders through open meetings, targeted consultations and analysed detailed submissions to the Initial Assessment Report from 147 submitters;
• undertaken research to assess the use of nutrition and health claims and the consumer understanding and use of these claims;
• prepared a benefit-cost analysis;
• considered international regulations for health, nutrition and related claims;
• considered relevant research;
• developed further the framework substantiating health claims, applied the framework in assessing the evidence for a number of high level claims [2] and considered approaches used elsewhere for substantiating general level claims [3] ; and
• received advice from expert and advisory groups.

On the basis of this evaluation FSANZ recommends the introduction of a new standard for health, nutrition and related claims, with the management of both general level and high level claims being predominantly by a standard (refer Attachment 1 for Draft Standard). A user guide will include interpretive advice concerning the requirements of the Standard, and guidance on substantiation of general level claims and seeking pre-market approval of high level health claims. The Substantiation Framework will be in a guideline, which will be incorporated by reference into the health claims Standard. This means claims will be legally required to be substantiated in accordance with the Framework.

Some modifications to the criteria for content claims as presently set out in the Code and in the voluntary code of practice are being proposed to improve consistency, to update recommendations and to support a risk management approach based on public health concerns and the provision of information to consumers. In addition, all labels carrying content claims will be required to indicate the percentage daily intake (%DI) represented by the claimed component in the nutrient information panel, where a %DI value applies, together with the %DI for energy to allow consumers to make informed choices. Criteria for specific nutrient content claims (those which were evaluated to be important to meet public health objectives or which may otherwise mislead consumers) will be specified in the standard. Other content claims can continue to be made providing they are not misleading. Specific disqualifying criteria will apply to some content claims.

Claim definitions and the regulatory parameters (i.e. pre-requisite conditions, specific criteria and wording conditions) work together to identify and regulate nutrition and health claims. These requirements will apply to both general level and high level claims. All health claims will require reference to both the specific health benefit and the property [4] of the food responsible for that benefit. The property will have to be present above defined levels (qualifying criteria) in order to avoid misleading consumers. Foods able to carry claims must also meet generic disqualifying criteria, as applicable, based primarily on total sugars, saturated fat and sodium.

All general level health claims are either to be based on a list of pre-approved nutrient function statements provided in the Substantiation Framework, or supported by authoritative, generally accepted information sources outlined by the Substantiation Framework for general level health claims, or evidence prepared as specified in a substantiation user guide. Holding the evidence for substantiation of these claims is the responsibility of individual suppliers and pre-approval of any general level health claims will not be required. In addition there are some specific wording conditions in relation to the claims.

FSANZ is proposing to approve a number of high level claims that will be available to use at the time the Standard comes into effect. FSANZ has therefore commissioned expert reviews of a number of diet-disease relationships. Health claims based on the following diet-disease relationships have been substantiated [5] :

• a relationship between dietary intake of calcium, vitamin D status and risk of the frail elderly, particularly women, developing osteoporosis;
• a relationship between increased dietary intake of calcium and enhanced bone mineral density, particularly in women;
• a relationship between reduction in dietary intake of sodium and reduction in blood pressure;
• a relationship between intake of folic acid in the peri-conceptional period and risk of development of neural tube defects in the foetus;
• a relationship between saturated fatty acids and LDL-cholesterol levels; and
• a relationship between unsaturated trans fatty acids and saturated fatty acids and LDL-cholesterol levels.

A review of the evidence supporting the following diet-disease relationships is underway for:

• long chain Omega-3 fatty acid intake and risk of developing heart disease;
• wholegrains and heart disease; and proposed for
• fruit and vegetable intake and heart disease or other biomarkers, at a later date.

Suppliers may use high level claims based on substantiated relationships, subject to defined specific criteria and conditions. Any new high level claims require pre-approval by FSANZ through the application process to vary the Code. Recently the Ministerial Council recommended changes to the Food Standards Australia New Zealand Act 1991(FSANZ Act), which when implemented will also mean it will be possible to keep applications for high level claims confidential, until any claim is approved.

Whilst the proposed new Standard will consolidate a number of aspects in relation to health, nutrition and related claims, at this stage the criteria around claims relating to vitamins and minerals presently specified in the Code will not be changed. The exception to this is that the criteria will be based on a per serve basis rather than a reference quantity as is currently prescribed in Standard 1.3.2. A review of the actual criteria will be done subsequent to the present proposal when new nationally applicable Nutrient Reference values have been finalised. The existing application for vitamin and mineral content claims of disqualifying criteria on the basis of 'claimable foods' will apply to both content and health claims for vitamins and minerals, pending the above review.

Claims that have been deemed to fall outside the framework have been designated 'related claims' and are subject to separate provisions. These include cause-related marketing statements that will require a disclosure statement, but no other criteria or conditions apply; and some existing endorsements [6] will be pre-approved by FSANZ and will be exempt from the Standard. Other present endorsements will be considered as general level health claims or high level claims and will need to conform to the relevant claims criteria and conditions. Future endorsements will need to meet selected elements of the claims classification framework, according to the nature of the endorsements.

FSANZ has given consideration to specific types of claims (such as dietary interaction claims, glycaemic index, gluten claims, weight management claims and 'diet' claims) and specific food types (such as whole foods and foods containing biologically active substances). Some specific recommendations apply to such cases.