Focus: The good oil on new food regulations
29 January 2013
In brief: The new, long-awaited standard regulating nutrition and health claims has commenced, with food businesses given three years to transition to compliance with the new comprehensive regime. Partners Richard Hamer (view CV) and Andrew Wiseman (view CV), Senior Associate Ric Morgan and Lawyer Claire Agius report on the new standard.
- Key features of the Health Claims Standard
- Claims framework
- Regulation of nutrition content claims under the Health Claims Standard
- Regulation of health claims under the Health Claims Standard
- Regulation of endorsements
- Further work proposed by FSANZ
How does it affect you?
- The new standard will regulate the use of both express and implied nutrition content and health claims that are made on the labels of food products, as well as in associated advertising and promotional materials, such as websites.
- During the three-year transition period, 'a food' must comply with either the old or the new regime. Food businesses will need to decide which approach to adopt in relation to a particular food. It seems a business can switch regimes for different marketing campaigns or other (eg packaging) claim sets, so long as the food and the promotion of it together comply with either the transitional standard or the new regime.
- Food businesses should weigh up the strategic advantages of continuing a marketing campaign with an existing claim that will not be permitted under the new standard, as against obtaining first-to-market advantage with a new claim if the claim is based on a pre-approved food-health relationship or if the material required to substantiate the claim is available.
- Foods that are less nutritious than is required by the nutrition profiling scoring criterion (NPSC) will not be able to carry a health claim under the new regime. This means that a substantial number of food products currently carrying health claims will not be able to do so.
- There is no sell-off period for stock at the end of the three-year transitional period, so we recommend that food businesses start the process of reviewing their labels, marketing campaigns and promotional material now.
- The food industry can expect further development in this area, with Food Standards Australia New Zealand (FSANZ) noting that it will continue to develop the standard during the transition period.
The food industry has a comprehensive new standard regulating the use of health and nutrition claims on food products. Standard 1.2.7: Nutrition, Health and Related Claims (Health Claims Standard) became law on 18 January 2013 and will operate alongside Standard 1.1A.2: Transitional Standard for Health Claims (Transitional Standard) until 18 January 2016.
During the transition period, food businesses can choose whether a 'food' will comply with the Health Claims Standard and the Australia New Zealand Food Standards Code (Food Standards Code) as amended, or the Transitional Standard and the unamended Food Standards Code. At the conclusion of the three-year transition period, there will not be a stock-in-trade period.
The new standard complements the existing consumer law regime by minimising the risk of misleading and deceptive claims about food and, in particular, addressing the concern raised in some sectors that consumers are misled by the presence of health claims on foods of low nutritional value. The new standard seeks to balance consumer needs with the food industry's continued interest in innovative food products, by coupling pre-approved food-health relationships with the option of industry self-substantiation for novel health claims.
The key features of the new regime are:
- The food must be of sufficient nutritional value to make a health claim: As a threshold issue, in order to make a health claim the nutrient profiling score of the food, or property of food, must be met, unless the food is standardised in Part 2.9 of the Food Standards Code. Foods do not need to meet the nutrient profiling score to make a nutrition content claim.
- The claims framework: The Health Claims Standard distinguishes between nutrition content claims, general level health claims and high level health claims, all of which are permissible provided that the specified requirements are met. As was the case under the Transitional Standard, therapeutic claims are not permissible in relation to food products, although some might argue that some high level health claims are, or are very close to, therapeutic claims.
- Pre-approved food-health relationships: There are currently 212 pre-approved food-health relationships in the Health Claims Standard. If a food business wishes to make a claim based on a pre-approved food-health relationship, the requirements set out in the relevant schedule to the Health Claims Standard must be met.
- Self-substantiation of food-health relationships: In the absence of a pre-approved food-health relationship, food businesses will have the option of undertaking a self-substantiation process. The substantiation process is only an option in relation to food-health relationships underpinning general level health claims, not high level health claims.
- Application to amend the Health Claims Standard: Food businesses can apply to have the Health Claims Standard amended, should they wish to make a high level health claim based on a food-health relationship that has not been included in the Health Claims Standard. To amend the Health Claims Standard, food businesses will need to follow the 'high level health claims variation' process set out in the Food Standards Australia New Zealand Act 1991 (Cth).
The level and the source of regulation of a claim made in relation to food depends on the nature of the claim. The Health Claims Standard distinguishes between nutrition-content claims, general level health claims and high level health claims. Therapeutic claims are prohibited under the Health Claims Standard. Information on the distinction between each of these claims, as well as a general overview of how each claim is regulated, is below.
|Type of claim||Example||Regulated by ...||Claims must be based on ...|
|Nutrition content claim||This food is high in calcium||Health Claims Standard and associated standards1||Property of food mentioned in Schedule 1 to the Health Claims Standard.|
Otherwise, the nutrition content claim can only state that the food contains or does not contain the property of food.
|General level health claim||Calcium is good for healthy bones and teeth||Health Claims Standard and associated standards||Either:
|High level health claim||Diets high in calcium may reduce the risk of osteoporosis||Health Claims Standard and associated standards||Pre-approved food-health relationships in Schedule 2 of Health Claims Standard.|
|Therapeutic claim||This product is used to treat bone disease and works directly on your bones to make them stronger and therefore less likely to break or fracture.||Therapeutic Goods Act 1989 (Cth)||Cannot be made in relation to food.|
The Health Claims Standard does not address the use of 'simple claims' such as 'pure' and 'natural'. FSANZ has favoured industry self-regulation in relation to the use of these claims, in light of the initiative by the Australian Food and Grocery Council to develop a new section for the Code of Practice for Food Labelling and Promotion to regulate such claims. FSANZ has indicated that it will move towards restriction of simple claims, should the industry fail to demonstrate appropriate constraint.
At present, FSANZ has chosen not to regulate fat-free or percentage fat-free claims.
Before the introduction of the Health Claims Standard, regulation of nutrition content claims by the Food Standards Code was piecemeal, with the primary initiative being industry self-regulation through the Code of Practice on Nutrient Claims in Food Labels and in Advertisements administered by the Australian Food and Grocery Council.
Under the Health Claims Standard, a food business may only make a nutrition content claim in one of the following ways:
- if the property of food (eg carbohydrate, salt or cholesterol) is mentioned in Schedule 1 to the Health Claims Standard, the nutrition content claim must meet the general claim conditions set out in that Schedule (if there are any);
- if a food business wishes to use a descriptor or a synonym of the descriptor listed in Schedule 1 to the Health Claims Standard (eg 'good source', 'increased' or 'low'), then both the specific and the general claim conditions set out in Schedule 1 must be met; or
- if the property of food is not listed in Schedule 1 to the Health Claims Standard, a nutrition content claim may only state that the food contains or does not contain the property of food, that the food contains a specified amount of the property of food in a specified amount of that food, or a combination of these. The nutrition content claim cannot use a descriptor in relation to the property of food, other than indicating that the food does or does not contain the food.
Unlike health claims, there is no need for a food to meet the NPSC to make a nutrition content claim.
If a food business wishes to make a comparative claim, the reference food must be identified, and the difference between the amount of the property of the food in the claimed food and the reference food must be set out on the label of the food.
To make a health claim under the Health Claims Standard, food businesses will need to consider the following matters.
- Does the food meet the NPSC?
- Is the claim that the business would like to make a general level health claim or a high level health claim?
- Is a dietary context statement or a statement of the form of food to which the health claim relates required?
- Does the business wish to make a split health claim?
All foods other than food that is standardised in Part 2.9 of the Food Standards Code must meet the NPSC in order to make a health claim. The NPSC is used to calculate a nutrient profile score based on consideration of the energy, saturated fat, total sugar and sodium content of the food, as compared with the protein, dietary fibre, fruit, vegetable, nut and legume content of the food. FSANZ provides a NPSC calculator on its website. If a property of food is used to meet the NPSC, it must be included in the nutrition information panel.
Is the claim that the business would like to make a general level health claim or a high level health claim?
- Is the claim a pre-approved claim?
- If not, can the substantiation process be followed, or must an application be made to amend the Health Claims Standard?
As a second consideration, food businesses must consider the nature of the claim that the food business wishes to make.
If it is a high level health claim, the food-health relationship must be pre-approved and included in Schedule 2 to the Health Claim Standard. The particular conditions specified in the schedule must also be met. Where the food-health relationship is not in Schedule 2, the food business must apply for a high level health claims variation, following the process set out in Subdivision G of Division 1 of Part 3 of the Food Standards Australia New Zealand Act 1991 (Cth). This process has not been changed by the introduction of the Health Claims Standard.
A general level health claim can be made if it is based on a pre-approved food-health relationship standardised in Schedule 3 of the Health Claims Standard. Alternatively, if the food-health relationship is not pre-approved, the food business has the option of substantiating the relationship by ensuring that the relationship between a food, or property of food, and a health effect have been established by a process of systematic review. The process to be followed is set out in Schedule 6 of the Health Claims Standard. The key purpose of substantiation is to determine whether the evidence for the relationship between a food, or property of food, and a health effect is robust. The level of evidence required by FSANZ is that it be 'robust and unlikely to be overturned by another study'.2
The substantiation process will be useful in circumstances where existing products meet the NPSC but do not make a pre-approved claim. An existing systematic review may be used, if it is updated to satisfy all the elements required by the substantiation process.
FSANZ has provided the following guidance in relation to the substantiation process,3 and intends to amend the Application Handbook to provide further guidance.
- Description of the food-health relationship: A food business must state the food, or property of food, the health effect and the proposed relationship between the food, or property of food, and the health effect.
- Search strategy: A food business must describe the strategy used to capture the scientific evidence relevant to this food-health relationship.
- Identification of relevant studies: Relevant studies should be selected using inclusion and exclusion criteria (which should be specified) and ensuring that studies in humans are included.
- Compilation of key information from each study: A food business must tabulate details including study design, objectives, participant characteristics and sample size.
- Assessment of the quality of each study: This assessment must be made after consideration of issues such as minimisation of bias, adequate control for confounding, study duration and number of participants.
- Assessment of the results collectively: This involves an assessment of whether there is a consistent association between the food, or property of food, and the health benefit, and an assessment of whether the relationship is biologically plausible.
- Conclusion: The food business is required to conclude whether, based on the results of the studies, there is a causal relationship between the food, or property of food, and the health benefit. The food business must also indicate what amount of food, or property of food, is required to achieve the health effect.
Is a dietary context statement or a statement of the form of food to which the health claim relates required?
In addition to the requirements set out in Schedule 2 or 3 of the Health Claims Standard, a health claim must include a dietary context statement stating that the health benefit must be considered in the context of a healthy diet. Small packages, which are defined as packages that are 100 sq cm or less, are excluded from this requirement.
A health claim must also contain a statement of the form of food to which the health claim relates, unless it is the form in which the food is sold.
A business can choose to structure a health claim as a split health claim, provided that the statement setting out the food property and the specific health effect claimed indicates where on the advertisement, or label, the other information requirements are located. By way of example, an acceptable split claim could be structured as follows:
Front of pack: Calcium is good for strong bones (see back for details).
Back of pack: Calcium is good for strong bones, when consumed as part of a healthy diet high in calcium.
The Health Claims Standard also introduces regulation on the use of endorsements, supplementing consumer law prohibitions on misleading and deceptive conduct with the specific requirements that an endorsement can only be made if:
- the endorsing body is a not-for-profit entity with a nutrition- or health-related purpose or function that permits a supplier to make an endorsement;
- the endorsing body is independent of, and free from, influence by the supplier of the food; and
- the supplier retains stipulated records (including documents that demonstrate that the supplier has permission to make the endorsement) for the 'information period', ensuring that the documents are available on request.
FSANZ has indicated that it will use the transition period as an opportunity to continue to develop the Health Claims Standard ahead of the time when the Transitional Standard is repealed. Key tasks set by FSANZ include:
- to establish a High Level Health Claims Committee to give advice on applications to make a high level claims variation;
- to implement a process by which the currency of pre-approved food-health relationships can be maintained;
- considering the use of authoritative sources that can be used for the self-substantiation required for general level health claims;
- considering existing, and monitoring new, health claims approved in the European Union, Canada and the United States for inclusion in the Health Claims Standard; and
- the possibility of exempting certain foods from the need to meet the NPSC in order to make a health claim.
The gazettal of the Health Claims Standard comes at a time when the food industry increasingly looks to health claims as a point of differentiation in the marketplace, and when FSANZ has noted that it will have an increased role in governmental preventative health strategies. It remains to be seen whether the Health Claims Standard will prove to be an adequate tool to address tension between the industry's desire to innovate, the increased demand for nutritious and healthy products, and the consumer need for adequate information.
- Eg see Standard 1.2.8: Nutrition Information Requirements, which sets out the requirements for nutrition information panels when nutrition content and health claims are made.
- Supporting Document 8, P293 Nutrition, Health & Related Claims, FSANZ.
- This summary is drawn from FSANZ, Supporting Document 8 to P293 Nutrition, Health & Related Claims (8 November 2012).
- Richard HamerPartner,
Ph: +61 3 9613 8705
- Andrew WisemanPartner,
Ph: +61 2 9230 4701
- Philip KerrSenior Patent/Trade Mark Counsel,
Ph: +61 2 9230 4937
- Tim GolderPartner,
Ph: +61 3 9613 8925
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