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Health, Nutrition and Related Claims: Enabling Provisions in New Zealand Law

3 Background

3.1 Introduction

In New Zealand, health, nutrition and content claims relating to food products are regulated under the Australia New Zealand Food Standards Code (the Code). The Code has been developed to regulate all food sold in Australia and New Zealand and is administered by Food Standards Australia New Zealand (FSANZ), a trans-Tasman regulatory body established under the provisions of the Food Treaty. As a signatory to this treaty, New Zealand is obliged “to take such legislative or other steps as are necessary to adopt or incorporate, by reference and without amendments” any food standards recommended to and adopted by the Australia New Zealand Food Regulation Ministerial Council (the Ministerial Council), the political body that oversees the work of FSANZ. This obligation is realised in New Zealand statutory law under section 11B(b) of the Food Act 1981 which gives effect to the Food Treaty.

3.2 The current situation

At present, nutrition claims are allowed under the Code. These are detailed in Standard 1.2.8 Nutrition Information, and include claims in relation to:

• polyunsaturated or monounsaturated fatty acid content of foods;

• omega fatty acid content of foods

• low joule claims in relation to food

• lactose claims in relation to food

• the gluten content of food, and

• the salt, sodium or potassium content of food.

Vitamin and mineral content claims, including claims that a food is “a good source” of a vitamin or mineral are permitted under Standard 1.3.2 Vitamins and Minerals.

Health claims, however, are prohibited in the Code by Transitional Standard 1.1A.2 with one exception: the claim that the maternal consumption of folate reduces the risk of neural tube defects in developing foetuses.

In New Zealand, health claims related to food also fall under the jurisdiction of the Medicines Act 1981, which prohibits the application of therapeutic claims to a category of product called Related Products defined under the Act to include any “food in respect of which a claim is made that the substance or article is effective for a therapeutic purpose.”

Therapeutic purpose is defined in the Medicines Act as:

• treating or preventing disease, or

• diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition, or

• Altering the shape, structure, size, or weight of the human body, or

• Otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating or reducing or postponing, or increasing or accelerating, the operation of that function, or in any other way.

The folate health claim enabled by Transitional Standard 1.1A.2 in the Code is considered a therapeutic claim under the Medicines Act. It was therefore necessary in 1998, when the Transitional Standard was introduced into the Code, to grant an exemption for the folate health claim under the Medicines Act so as to give the claim legal effect in New Zealand and thereby fulfil New Zealand’s obligations under the Food Treaty.

This exemption, the Medicines (Related Products (Exempted Foods)) Regulations 1998, had a built-in “sunset” or expiry clause and was subsequently repealed and replaced in 1999 and 2000, to facilitate the extension of the folate health claim pilot project and in 2002 and 2003 to allow time for the determination of future policy. As with the earlier exemptions, the exemption of the folate health claim under the Medicines (Related Products (Exempted Foods)) Regulations 2003 has a built-in “sunset clause.” The exemption will expire on 13 August 2007.

With the anticipated introduction of the Health Claims Standard, it is now necessary that an exemption to the Related Products provisions of the Medicines Act be made indefinite. It is therefore necessary to publicly consult on the objectives and options associated with making the exemption indefinite.

3.3 Scope of the discussion document

It must be emphasised that the scope of this discussion document is limited to the regulatory mechanism best suited to give legal effect to Standard 1.2.7 in New Zealand. Public consultation on the proposal for the Standard itself is being carried out by FSANZ in a separate process. The preliminary final assessment report on the proposed Standard (P293) was released for a six week consultation closing on 16 May 2007.

Further Information about the Standard and access to the preliminary final assessment report is available at:

http://www.foodstandards.govt.nz/standardsdevelopment/proposals/proposalp293nutritionhealthandrelatedclaims/index.cfm.

3.4 Standard 1.2.7 Health, Nutrition and Related Claims

The future policy for health claims in New Zealand and Australia was decided on 12 December 2003 when the Ministerial Council endorsed a Health, Nutrition and Related Claims Policy Guideline that included folate and a range of other health claims. FSANZ is currently developing Standard 1.2.7 Health, Nutrition and Related Claims (the Health Claims Standard) through a process of commissioned research, research reviews and public consultation.

The basic design of the proposal for the Health Claims Standard is the categorisation of health claims as either high level, for which specific permissions will be available in the Code, or general level, for which manufacturers will be responsible for substantiating claims and holding substantiation information. FSANZ is also developing qualifying criteria to ensure that food products carrying health claims do not exceed set limits for their food type of components such as saturated fats, sugars or sodium.

Several diet-disease relationships have been scientifically substantiated through reviews commissioned by FSANZ. High-level health claims based on the following diet-disease relationships will be pre-approved in the Health Claims Standard:

• the relationship between the high dietary intake of calcium, vitamin D status, and the reduced risk of the frail elderly, especially women, developing osteoporosis

• the relationship between the high dietary intake of calcium and enhanced bone mineral density, particularly in women

• the relationship between reduction in the dietary intake of sodium and reduction in blood-pressure

• a relationship between reduction in the dietary intake of saturated fatty acids and a reduction in LDL-cholesterol levels

• a relationship between reduction in the dietary intake of trans-fatty acids and saturated fatty acids and a reduction in LDL-cholesterol levels, and

• a relationship between increased intakes of folic acid in the peri-conceptional period and the reduced risk of the development of neural tube defects in foetuses.

As with high-level claims, general-level claims will need to be substantiated in an appropriate science-based framework, however, evidence of this substantiation will be held by the manufacturers or suppliers of the food product. FSANZ has developed material to assist in determining whether manufacturer or supplier evidence is sufficient to substantiate a general level claim.

3.4.1 Impacts of the Health Claims Standard on industry

For industry, it is a commercial decision as to whether a health claim is applied to a product. In making such a choice, any costs associated with the labelling and marketing of that product will be borne by industry as a marketing investment and potentially passed on to the consumer only in the instance when the consumer deigns the health benefit gained by consuming the product to outweigh the financial cost of purchasing it.

3.4.2 Impacts of the Health Claims Standard on consumers

In order to ascertain the impact of health claims applied to food products on consumers, FSANZ has carried out detailed research into consumer responses to claims. These findings and other detailed research have informed the design of the Health Claims Standard. The results of the FSANZ commissioned research returned a considerable variability in responses but there were a number of common findings across the study that underpinned participants’ responses and behaviours.

Further detail of research commissioned by FSANZ is available on the FSANZ website at: http://www.foodstandards.govt.nz/standardsdevelopment/proposals/proposalp293nutritionhealthandrelatedclaims/index.cfm

It is anticipated that the specific criteria for high level claims will ensure that consumers are given accurate information about products with verifiable health benefits. The Health Claims Standard will also be coordinated with the other labelling standards in the Code to ensure the provision of detailed and accurate information to consumers.

3.4.3 Compliance

The Health Claims Standard will provide a clear framework for compliance. It will give confidence to manufacturers and retailers in designing labels and marketing devices to meet the requirements of New Zealand law and will also provide consumers with assurance that the information provided on food labels is not misleading.