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11 August 2004
FINAL ASSESSMENT REPORT
PROPOSAL P234
CRITERIA & CONDITIONS FOR MAKING
NUTRITION CONTENT & RELATED CLAIMS
1
FOOD STANDARDS AUSTRALIA NEW ZEALAND (FSANZ)
FSANZ’s role is to protect the health and safety of people in Australia and New Zealand through the
maintenance of a safe food supply. FSANZ is a partnership between ten Governments: the
Commonwealth; Australian States and Territories; and New Zealand. It is a statutory authority under
Commonwealth law and is an independent, expert body.
FSANZ is responsible for developing, varying and reviewing standards and for developing codes of
conduct with industry for food available in Australia and New Zealand covering labelling,
composition and contaminants. In Australia, FSANZ also develops food standards for food safety,
maximum residue limits, primary production and processing and a range of other functions including
the coordination of national food surveillance and recall systems, conducting research and assessing
policies about imported food.
The FSANZ Board approves new standards or variations to food standards in accordance with policy
guidelines set by the Australia and New Zealand Food Regulation Ministerial Council (Ministerial
Council) made up of Commonwealth, State and Territory and New Zealand Health Ministers as lead
Ministers, with representation from other portfolios. Approved standards are then notified to the
Ministerial Council. The Ministerial Council may then request that FSANZ review a proposed or
existing standard. If the Ministerial Council does not request that FSANZ review the draft standard,
or amends a draft standard, the standard is adopted by reference under the food laws of the
Commonwealth, States, Territories and New Zealand. The Ministerial Council can, independently of
a notification from FSANZ, request that FSANZ review a standard.
The process for amending the Australia New Zealand Food Standards Code is prescribed in the Food
Standards Australia New Zealand Act 1991 (FSANZ Act). The diagram below represents the
different stages in the process including when periods of public consultation occur. This process
varies for matters that are urgent or minor in significance or complexity.
 Comment on scope, possible
options and direction of
regulatory framework
 Provide information and
answer questions raised in
Initial Assessment report
 Identify other groups or
individuals who might be
affected and how – whether
financially or in some other way
INITIAL
ASSESSMENT
Public
Consultation
DRAFT
ASSESSMENT
 Comment on scientific risk
assessment; proposed
regulatory decision and
justification and wording of
draft standard
 Comment on costs and
benefits and assessment of
regulatory impacts
Public
Consultation
FINAL
ASSESSMENT
 Those who have provided
submissions are notified of the
Board’s decision
Public
Information
MINISTERIAL
COUNCIL
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 An IA report is prepared with an outline of issues and
possible options; affected parties are identified and
questions for stakeholders are included
 Applications accepted by FSANZ Board
 IA Report released for public comment
 Public submissions collated and analysed
 A Draft Assessment (DA) report is prepared using
information provided by the applicant, stakeholders and
other sources
 A scientific risk assessment is prepared as well as other
scientific studies completed using the best scientific
evidence available
 Risk analysis is completed and a risk management plan is
developed together with a communication plan
 Impact analysis is used to identify costs and benefits to all
affected groups
 An appropriate regulatory response is identified and if
necessary a draft food standard is prepared
 A WTO notification is prepared if necessary
 DA Report considered by FSANZ Board
 DA Report released for public comment
 Comments received on DA report are analysed and
amendments made to the report and the draft regulations
as required
 The FSANZ Board approves or rejects the Final
Assessment report
 The Ministerial Council is notified within 14 days of the
decision
 If the Ministerial Council does not ask FSANZ to review a
draft standard, it is gazetted and automatically becomes
law in Australia and New Zealand
 The Ministerial Council can ask FSANZ to review the draft
standard up to two times
 After a second review, the Ministerial Council can revoke
the draft standard. If it amends or decides not to amend the
draft standard, gazettal of the standard proceeds
FSANZ has now completed two stages of the assessment process and held two rounds of public
consultation as part of its assessment of this Proposal. The regulatory environment has
changed since the completion of the second stage of the assessment process and consequently
the FSANZ Board has approved this Final Assessment Report and its recommendation to reject
this Proposal.
FSANZ will raise a new Proposal on nutrition, health and related claims. This Proposal will take
into consideration the changes to the food regulatory environment and the policy guideline set
by the Ministerial Council. Issues raised by submitters to Proposal P234 will be taken into
consideration during the assessment process of the new Proposal. Stakeholders are encouraged
to provide submissions to the new Proposal.
Further Information
Further information on this Proposal and the assessment process should be addressed to the
FSANZ Standards Management Officer at one of the following addresses:
Food Standards Australia New Zealand
PO Box 7186
Canberra BC ACT 2610
AUSTRALIA
Tel (02) 6271 2222
www.foodstandards.gov.au
Food Standards Australia New Zealand
PO Box 10559
The Terrace WELLINGTON 6036
NEW ZEALAND
Tel (04) 473 9942
www.foodstandards.govt.nz
Assessment reports are available for viewing and downloading from the FSANZ website
www.foodstandards.gov.au or alternatively paper copies of reports can be requested from
FSANZ’s Information Officer at [email protected] including other general
enquiries and requests for information.
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CONTENTS
EXECUTIVE SUMMARY AND STATEMENT OF REASONS ....................................... 5
1.
INTRODUCTION............................................................................................................ 6
1.1
2.
REGULATORY PROBLEM.......................................................................................... 6
2.1
3.
CURRENT LABELLING REQUIREMENTS .................................................................... 6
OBJECTIVE .................................................................................................................... 7
3.1
4.
NATURE OF PROPOSAL .............................................................................................. 6
SPECIFIC OBJECTIVES ............................................................................................... 7
BACKGROUND .............................................................................................................. 8
4.1
HISTORICAL BACKGROUND ...................................................................................... 8
5.
RELEVANT ISSUES..................................................................................................... 10
6.
REGULATORY OPTIONS .......................................................................................... 11
7.
IMPACT ANALYSIS .................................................................................................... 11
7.1
7.2
8.
CONSULTATION ......................................................................................................... 13
8.1
8.2
8.3
9.
AFFECTED PARTIES ................................................................................................. 11
IMPACT ANALYSIS ................................................................................................... 11
ISSUES PAPER FOR PROPOSAL P234 ....................................................................... 13
DRAFT ASSESSMENT FOR PROPOSAL P234 ............................................................ 14
WORLD TRADE ORGANIZATION (WTO) ................................................................ 14
CONCLUSION AND RECOMMENDATION ........................................................... 14
10. IMPLEMENTATION AND REVIEW ........................................................................ 15
ATTACHMENT 1 - DRAFT VARIATIONS TO FOOD STANDARDS CODE .............. 16
ATTACHMENT 2 - AUSTRALIA NEW ZEALAND FOOD REGULATION
MINISTERIAL COUNCIL: POLICY GUIDELINE PROPOSAL ON NUTRITION,
HEALTH AND RELATED CLAIMS ................................................................................. 29
ATTACHMENT 3 - P234 EXTERNAL ADVISORY GROUP ......................................... 42
ATTACHMENT 4 - P234 LIST OF SUBMITTERS .......................................................... 43
ATTACHMENT 5 - SUMMARY OF SPECIFIC ISSUES RAISED DURING PUBLIC
CONSULTATION ................................................................................................................. 47
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Executive Summary and Statement of Reasons
In May 2001, the then Australia New Zealand Food Authority (ANZFA), now Food
Standards Australia New Zealand (FSANZ) raised a proposal, Proposal P234, to review
nutrition content and other related claims. The review was to consider the most appropriate
regulatory mechanism for managing nutrition content and other related claims and to review
the criteria that should apply to making such claims.
At the 31 July 2001 meeting of the former Australia New Zealand Food Standards Council
(ANZFSC), Ministers decided to refer health and related claims to the Food Regulation
Standing Committee (FRSC) for policy development and to include nutrition content claims
in the scope of the policy framework. In response to that decision, FSANZ changed the scope
of Proposal P234 with the objective to only review the criteria and conditions for nutrition
content and related claims. Following the release of the Draft Assessment Report in March
2002 and public consultation, Ministers decided on a broad approach for nutrition, health and
related claims in May 2002. FSANZ suspended work on Proposal P234 while awaiting the
outcome of the policy development process as it was clear that the criteria for nutrition
content and related claims needed to be considered alongside health and other related claims.
In December 2003, the Australia and New Zealand Food Regulation Ministerial Council (the
Ministerial Council) agreed to a Policy Guideline for Nutrition, Health and Related Claims
(the Policy Guideline), identifying a set of high order and specific principles which aim to
ensure that the health and safety of the public is protected, whilst still allowing for food
industry innovation and trade. These principles will be considered by FSANZ during the
development of a Standard and guideline for nutrition, health and related claims. In May
2004, the Ministerial Council further discussed aspects of the Policy Guideline, particularly
in relation to the regulation of biomarker maintenance claims. The Ministerial Council
determined biomarker maintenance claims would be treated in the same way as biomarker
enhancement claims and consequently would be considered a type of high-level claim.
The regulatory options proposed by ANZFA in the Draft Assessment Report for Proposal
P234 were made prior to the development of the Policy Guideline. In view of the need to
consider criteria for nutrition content and related claims in the context of other health and
related claims as provided in the Policy Guideline, FSANZ considers that Proposal P234
should now be rejected. Relevant issues raised by P234 will be considered as part of
Proposal P293 – Nutrition, Health and Related Claims.
The new proposal for nutrition, health and related claims allows FSANZ to undertake a twostage consultation process, maximising stakeholder input on the new options and minimising
stakeholder confusion. Relevant issues that were raised in Proposal P234 have been taken
into consideration in the Initial Assessment Report for Proposal P293.
Currently most nutrition content claims are managed in Australia by the Code of Practice on
Nutrient Claims in Food Labels and in Advertisements (CoPoNC). In New Zealand, similar
claims were regulated under the New Zealand Food Regulations 1984 (NZFR) until
December 2002 when they were repealed. In addition, there are provisions for some nutrition
content claims in Standard 1.2.8 - Nutrition Information Requirements and Standard 1.3.2 Vitamins and Minerals of the Code. Current provisions for nutrition content claims will be
retained until the new Standard for the regulation of nutrition, health and related claims has
been developed.
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1.
Introduction
1.1
Nature of Proposal
On 24 November 2000, Ministers adopted the Australia New Zealand Food Standards Code.
At that time a number of outstanding matters were identified for review during the two-year
transition period. One of these was the review of the provisions for nutrition content and
related claims and, as a result, Proposal P234 was raised.
The overarching aim of Proposal P234 at Draft Assessment was to determine the most
appropriate criteria and conditions for making specific nutrition content claims whilst
ensuring consistency between Australia and New Zealand. Important components of the
review were to consider the national nutrition policies of both countries and to develop
labelling information that is accurate, essential, unambiguous, meaningful and easy to use for
consumers, does not impose unnecessary costs on manufacturers and is consistent with
international and Codex criteria.
2.
Regulatory Problem
2.1
Current Labelling Requirements
Regulation of nutrition content claims is currently determined in a number of ways. In
Australia, the majority of nutrition content claims are managed through CoPoNC. Similar
claims were regulated in New Zealand under the NZFR until these were repealed in
December 2002. They are now therefore solely regulated under fair trading law. In addition,
there are provisions for some nutrition content claims in Standard 1.2.8 – Nutrition
Information Requirements and Standard 1.3.2 – Vitamins and Minerals of the Code.
In Australia, CoPoNC sets out the various terms and conditions for content claims about
specific nutrients and ingredients such as ‘lite’, ‘high fibre’ and ‘no added sugar’. CoPoNC
does not have legal force and does not apply to imported foods. CoPoNC is not recognised in
New Zealand.
A review of nutrition content claims is necessary because of the need to develop a joint
approach to manage these claims in Australia and New Zealand, in accordance with the
Agreement Between the Government of Australia and the Government of New Zealand
Establishing a System for the Development of Joint Standards (the Treaty). In addition a
number of limitations have been highlighted in relation to the current approach to nutrition
content claims including:





inconsistency with Codex and international practice;
non compliance;
lack of confidence in, and understanding of, claims by consumers;
potential inconsistencies between current regulatory measures (CoPoNC) and fair
trading laws; and
inconsistency in relation to imported foods.
6
These limitations are a potential source of confusion for consumers and could potentially
result in an uneven playing field for industry. It is therefore necessary to examine the criteria
and conditions for making specific nutrition content claims.
3.
Objective
In developing or varying a food standard, FSANZ is required by its legislation to meet three
primary objectives, which are set out in section 10 of the FSANZ Act. These are:

the protection of public health and safety;

the provision of adequate information relating to food to enable consumers to make
informed choices; and

the prevention of misleading or deceptive conduct.
In developing and varying standards, FSANZ must also have regard to:

the need for standards to be based on risk analysis using the best available scientific
evidence;

the promotion of consistency between domestic and international food standards;

the desirability of an efficient and internationally competitive food industry;

the promotion of fair trading in food; and

any written policy guidelines formulated by the Ministerial Council.
3.1
Specific Objectives
The specific objective of this Proposal is to review the evidence base for nutrition content and
related claims, considering in particular those contained in CoPoNC, the NZFR and the Code.
The review aims to determine the most appropriate criteria and conditions for making
specific nutrition content claims whilst ensuring consistency between Australia and New
Zealand.
The Proposal P234 review has been underpinned by the following principles established by
the then ANZFA and agreed upon by the External Advisory Group:
1.
Nutrition claims should be reviewed and the preferred criteria for specific nutrients be
developed in the context of ANZFA objectives;
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2.
Nutrition information on food labels, where used, should be developed in the context
of national nutrition policies for both countries as a means of safeguarding long-term
public health and safety, and providing for informed choice. By extension, this
information can provide consistency and linkage with the Dietary Guidelines for
Australians, New Zealand’s Food and Nutrition Guidelines, Eat Well Australia and
other authoritative nutritional recommendations such as the New Zealand Dietary
Guidelines for Children;
3.
Technical information, such as terms used to describe nutrients and the quantification
of nutrients in the nutrition information panel, should be made as meaningful as
possible and limited to essential information for informed choice;
4.
Labelling information which is provided for consumers should be accurate, easy to
use, unambiguous, and assist them in identifying key nutrient contents of individual
food products, comparing nutrient contents within product categories, and choosing
among relevant food alternatives;
5.
For manufacturers, labelling information should not impose unnecessary costs, and
where possible, be introduced with other labelling changes concurrently rather than
sequentially; and
6.
Consistency of preferred nutrient criteria with International and Codex criteria for
nutrition claims. For the purpose of developing preferred criteria Codex criteria will
act as an arbitrator.
4.
Background
4.1
Historical Background
4.1.1
Proposal P234 Initial Assessment Report
In May of 2001, the then ANZFA released an Issues Paper (Initial Assessment Report) for
Proposal P234 Review of Nutrient Content and other Related Claims. An eight week round of
public consultation followed, which was the first of the required minimum of two rounds
outlined under Division 2 of the Australia New Zealand Food Authority Act 1991 (the
ANZFA Act). The objectives for the Issues Paper were to:


determine the most appropriate and effective regulatory mechanism for managing
nutrition content and other related claims in accordance with government regulatory
policy; and
review the criteria that should apply to making such claims.
Of the six possible regulatory options canvassed, full regulation (43%) or co-regulation
(16%) were the preferred approaches to managing nutrition content and related claims. Most
of the submitters who opted for co-regulation, recommended that a Code of Practice be
developed with legislative backing.
8
To assist in the review, the then ANZFA established an External Advisory Group consisting
of representatives from government, industry, consumers and nutrition experts. ANZFA also
commissioned The Allen Consulting Group (ACG) to undertake an independent cost benefit
analysis of the regulatory options to manage these claims. Co-regulation was ranked as the
most feasible option at that time.
4.1.2
Health and related claims
In mid 2001, after an extensive review, the then ANZFA finalised its advice to the former
ANZFSC for Proposal P153 The Review of Health and Related Claims. When Ministers met
on 31 July 2001, a decision was made to refer the matter to the newly established FRSC for
development of a policy framework, which was to also take account of the review of nutrition
content and related claims being undertaken by the then ANZFA. The then ANZFA agreed
to participate as an observer in the policy framework development.
It also undertook to complete development of a protocol on substantiation and to progress the
development of a Code of Practice for health and related claims.
In August 2001 the then ANZFA, agreed, pursuant to section 21 of the former ANZFA Act,
to raise a new Proposal to develop a Code of Practice to support the draft standard on health
claims (Proposal P250). The development of the Code of Practice came under Part 3 Division
2 of the former ANZFA Act, which related to proposals for the development of food
regulatory measures, including codes of practices. Section 25A of the former ANZFA Act
provided that ANZFA approved or rejected codes of practice. Under Proposal P153, an
‘Interim Code of Practice for the Communication of the Health Benefits of Food Products’
was trialled as part of the folate/neural tube defect health claims pilot, and the option of a coregulatory system was canvassed, including the scope of a code of practice. However, no
public consultation on Proposal P250 has been undertaken.
4.1.3
Proposal P250 and Proposal P234
In light of the work of FRSC under the direction of ANZFSC and the conclusions of the
cost/benefit analysis in the ACG report noting potential for efficiency gains from considering
the co-regulatory approach to health claims in the review of nutrition content claims, the then
ANZFA decided to align Proposals P234 and P250 more closely. At the time, it was
considered that there was a number of commonalities between the two reviews, most notably
the intended development of a code of practice, likely to be overseen in both instances by a
Code of Practice Management Committee.
The then ANZFA therefore decided to focus Proposals P234 on the review of criteria and
conditions for making nutrition content and related claims, and to extend Proposal P250 to
address the Development of a Code of Practice for Health, Nutrition Content and Related
Claims.
A Draft Assessment for Proposal P234 was released in March 2002 with draft variations to
Standard 1.2.8 of the Code (Attachment 1) and a second round of consultation followed.
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The Policy Guideline for Nutrition, Health and Related Claims
On 24 May 2002, the then ANZFSC agreed to a broad policy approach for the regulation of
health and nutrient claims in food labelling and advertising. FSANZ therefore decided to
suspend work on Proposal P234 until Ministers provided FSANZ with a policy guideline.
In December 2003, the Ministerial Council notified to FSANZ a Policy Guideline for
Nutrition, Health and Related Claims, with the exception of the process for the pre-market
assessment and verification of biomarker maintenance claims in accordance with the
processes outlined in the FSANZ Act. The policy aims to ensure that the health and safety of
the public is protected, whilst still allowing for food industry innovation and trade. It does
this by incorporating a number of elements designed to ensure that claims made on food or in
advertising are true, scientifically substantiated and not misleading. FSANZ must have regard
to a set of high order and specific principles during the development of a standard and
guideline for nutrition, health and related claims. In May 2004 the Ministerial Council agreed
to regulate biomarker maintenance claims as a type of high-level claim and thus requiring
pre-market assessment and approval by FSANZ. The revised Policy Guideline is at
Attachment 2.
5.
Relevant Issues
The review of nutrition content and related claims (Proposal P234) commenced in May 2001.
Since then there have been major changes to the food regulatory environment in Australia
and New Zealand. The most significant changes that have affected the review include:

a separation of responsibilities for development of food policy and the development of
food standards, with ultimate decision-making power residing with the Ministers; and

establishment of a new statutory body – FSANZ - to develop food standards. This
organisation is based on the former ANZFA. However, the development of food policy
is now the responsibility of the Ministerial Council.
The changes to the regulatory environment meant that the objectives of Proposal P234 were
changed and at Draft Assessment, Proposal P234 considered criteria and conditions for
nutrition content claims only. The Policy Guideline notified to FSANZ by the Ministerial
Council in December 2003 incorporates other nutrition claims such as nutrition function
claims, which have not been considered within the scope of Proposal P234. Nutrition
function and enhanced function claims had been considered under Proposal P153 (Health
Claims). Proposal P153 was recommended to ANZFSC in June 2001 but was not carried over
in the transition to FSANZ so has since lapsed. Proposal P293 – Nutrition, Health and
Related Claims has therefore been raised to implement all elements covered by the Policy
Guideline, as notified by the Ministerial Council.
Therefore, to ensure that FSANZ gives full regard to the Policy Guideline as required under
the new regulatory arrangements and any submissions received, FSANZ considers that the
best approach is to reject Proposal P234 and to consider nutrition content claims under the
new Proposal P293- Nutrition, Health and Related Claims. Proposal P293 will allow FSANZ
to canvass new options that will be consistent with the Policy Guideline and it will also
minimise any confusion among stakeholders that might result from the adoption of the
proposed draft variations contained in this Proposal.
10
In addition it will maximise stakeholder input into any new options posed. Previous issues
raised in response to Proposal P234 that are relevant will be taken into consideration in the
new Proposal.
6.
Regulatory Options
In the Draft Assessment phase of Proposal P234 two possible options were identified with
respect to the criteria and conditions for making nutrition content and related claims.
1.
2.
Adopt the proposed draft variations to Standard 1.2.8 - Nutrition Information
Requirements contained in the Proposal; or
Reject the proposed draft variations to Standard 1.2.8 - Nutrition Information
Requirements contained in the Proposal.
Of the identified Options in the Draft Assessment phase, only Option 2 is consistent with the
Policy Guideline developed by the Ministerial Council.
7.
Impact Analysis
7.1
Affected Parties
Parties affected by the options outlined above include:
1.
2.
3.
4.
7.2
consumers in Australia and New Zealand;
industry, including Australian and New Zealand food manufacturers, processors and
growers, exporters to Australia and New Zealand such as multi-national manufacturers
and Australian and New Zealand importers;
public health professionals in Australia and New Zealand; and
Government agencies that regulate the food industry in Australia and New Zealand and
those with an interest in food policy and regulation relevant to this Proposal.
Impact Analysis
Option 1 – adopt the proposed draft variations to Standard 1.2.8 - Nutrition Information
Requirements contained in this Proposal.
Advantages

There will be an immediate updated suite of nutrition content and related claims and
their criteria.

There will be consistency in the provision of nutrition content and related claims and
their criteria between Australia and New Zealand, and with claims permitted by Codex.

Nutrition content and related claims will be applicable through imported food laws in
Australia and New Zealand.
11
Disadvantages

Criteria and conditions for nutrition content and related claims will not have been
developed having regard to the Ministerial Council’s Policy Guideline.

Criteria and conditions for nutrition content and related claims will be prescribed in
Standard 1.2.8 - Nutrition Information Requirements when other health, nutrition and
related claims will be regulated in other standards.

It is highly likely that FSANZ will have to later review nutrition content and related
claims again in order to ensure that the criteria are consistent across the continuum of
claims and that nutrition content claims are considered with regard to the Policy
Guideline. Any changes will result in further revision of labels and marketing practices
for the food industry.

The potential lack of consistency between nutrition content and related claims and the
development of other standards having regard to the Policy Guideline could result in
lower compliance by the food industry due to increased confusion. This could increase
the likelihood of misleading information being provided to consumers.

There may be low compliance by the food industry with the knowledge that FSANZ
will in all likelihood have to later review nutrition content and related claims having
regard to the Policy Guideline.

The potential lack of consistency between nutrition content and related claims and the
development of other standards having regard to the Policy Guideline could result in a
greater burden on enforcement agencies.

There will be an increased need for government to educate industry and enforcement
agencies on the proposed changes in order to allay any confusion that may result from a
fractured approach to nutrition, health and related claims.

Certain claims and issues, such as qualifying and disqualifying criteria and disclaimers
will not be investigated further, despite there still being disagreement amongst
stakeholders.
Option 2 – reject the proposed draft variations to Standard 1.2.8 - Nutrition Information
Requirements contained in this Proposal.
Advantages

The scope of Proposal P234 will be incorporated into a new Proposal, which will
develop food standards having regard to the Policy Guideline.

It will reduce confusion amongst stakeholders that might otherwise arise from the
adoption of the proposed draft variations contained in this Proposal.

Stakeholders will be able to consider nutrition content and related claims as part of a
continuum with health and related claims.
12

There will be the opportunity for further consultation on contentious nutrition content
and related claims and their criteria if Proposal P234 is incorporated into a new
proposal.
Disadvantages

The regulatory measure arising from the finalisation of Proposal P234 will lead to
nutrition content and related claims being inconsistent with the Policy Guideline.

A further review of nutrition content and related claims may be required to ensure
consistency with food standards developed around nutrition, health and related claims,
having regard to the Policy Guideline.
8.
Consultation
8.1
Issues Paper for Proposal P234
8.1.1
Stakeholder Forums
In the eight weeks preceding the closing date for written submissions to the Issues Paper
(Initial Assessment Report), the then ANZFA invited key stakeholders to attend forums in
Auckland, Wellington, Sydney and Melbourne to consider issues related to nutrition content
and related claims. The forums were also an opportunity to encourage stakeholders to
formally submit their feedback in writing. As a result of these face-to-face consultations, 30
of the 53 written submissions received were from organisations that had attended one of the
stakeholder forums.
8.1.2
Written submissions
A total of 53 submissions were received. The following table provides a breakdown of
submissions by country and stakeholder representation.
Stakeholder Group
Industry
Government
Public Health / NonGovernment
Consumers
Total
Australia
19
5
5
New Zealand
9
3
2
International
2
1
-
6
35
1
15
3
The wide range of views and opinions expressed in submissions to the Issues paper were
taken into account in the Draft Assessment Report.
8.1.3
External Advisory Group
The early engagement of key stakeholders from both Australia and New Zealand was
essential to the thoughtful examination of matters related to this review. As such, the then
ANZFA established an External Advisory Group (EAG) consisting of representatives from
government, industry and consumers to oversee the review and to provide expert advice when
13
required. The EAG met on four occasions. Membership for the EAG and their Terms of
Reference are at Attachment 3.
8.2
Draft Assessment for Proposal P234
A Draft Assessment Paper was released in March 2002 to commence the second round of
eight weeks of public consultation for Proposal P234.
A total of 97 submissions were received. The following table provides a breakdown of
submissions by country and stakeholder representation.
Stakeholder
Group
Industry
Government
Public Health /
Non-Government
Consumers
Total
Australia
New Zealand
Trans-Tasman
International
30
7
8
17
5
4
5
-
6
1
13
58
1
27
5
7
It is not possible to present the full details of all submissions in the body of the Report. A
summary of the issues raised during the public comment period is, however, presented at
Attachment 5.
8.3
World Trade Organization (WTO)
As members of the World Trade Organization (WTO), Australia and New Zealand are
obligated to notify WTO member nations where proposed mandatory regulatory measures are
inconsistent with any existing or imminent international standards and the proposed measure
may have a significant effect on trade.
The WTO was not notified of this matter at Draft Assessment, as nutrition content claims are
voluntary and the specific criteria that was being proposed was considered to be consistent
with Codex and/or international practice and as such was unlikely to significantly affect trade
of WTO nations.
9.
Conclusion and Recommendation
Major changes to the food regulatory environment have impacted on the review of Proposal
P234. In particular, the separation of responsibilities for development of food policy and the
development of food standards has meant that the criteria for nutrition content and related
claims have not been considered in the context of other health and related claims, as provided
by the Policy Guideline.
Therefore, in order to give adequate consideration to the Policy Guideline, it is proposed that
a fresh approach needs to be taken. It is recommended that Proposal P234 be rejected.
Relevant issues raised by P234 will be considered in a new proposal, Proposal P293 –
Nutrition, Health and Related Claims which will have regard to the Ministerial Council’s
policy guidance and involve consultation on new options.
14
These options will be formulated in the context of Australian and New Zealand national
policies and legislation and will be consistent with the information needs of consumers and
with international trade agreements. Preparing a new proposal will allow FSANZ to
undertake further consultation, maximising and focussing stakeholder input on the new
options rather than relying on consultation from the Draft Assessment for Proposal P234,
which pre-dated the Policy Guideline. Proposal P293 will also minimise any confusion that
might result from a continuation of Proposal P234. Those issues that are relevant to the new
options canvassed in the new Proposal and which were raised in Proposal P234 will be
considered in the new Proposal. The Office of Regulatory Review (ORR) will also consider
the regulatory impact statement for the new Proposal.
Current provisions for nutrition content and related claims will be retained until a new
Standard for the regulation of nutrition, health and related claims has been developed.
10.
Implementation and review
As Proposal P234 is rejected, there will be no need for an implementation or review strategy.
FSANZ has prepared a new proposal, Proposal P293, Nutrition, Health and Related Claims to
take into consideration the changes to the food regulatory environment and the Policy
Guideline for Nutrition, Health and Related Claims, which was notified to FSANZ by the
Ministerial Council. Issues raised in submissions to Proposal P234 will be taken into account
during the assessment process for the new Proposal. Stakeholders are encouraged to submit
new submissions to the new Proposal.
ATTACHMENTS
1.
2.
3.
4.
5.
Draft variations to Standard 1.2.8 of the Australia New Zealand Food Standards Code
Australia and New Zealand Food Regulation Ministerial Policy Guideline on Nutrition,
Health and Related Claims
Membership of the External Advisory Group for Proposal P234 and their Terms of
Reference
List of Proposal P234 Submitters to the Draft Assessment Report
Summary of submissions raised by Proposal P234 submitters to the Draft Assessment
Report
15
ATTACHMENT 1
DRAFT VARIATIONS TO AUSTRALIA NEW ZEALAND FOOD
STANDARDS CODE
To commence: on gazettal
[1]
Standard 1.2.8 of Volume 2 of the Food Standards Code is varied by –
[1.1]
omitting the Table of Provisions, and substituting –
Table of Provisions
Division 1 – Interpretation
1
Definitions
2
Energy factors
Division 2 – Nutrition information panels
3
Nutrition information requirements and exemptions
4
Requirements for nutrition information panels where nutrition claims are made in
relation to food
5
Prescribed declarations in a nutrition information panel
6
Expression of average energy content and quantities of nutrients and biologically
active substances
7
Percentage daily intake information
8
Food in small packages
9
Food in dehydrated or concentrated form
10
Food that must be drained before consumption
11
Food to be prepared or consumed with other food
Division 3 – Conditions for making certain nutrition claims
12
General conditions for making nutrition claims
13
Comparative claims
14
‘Free’ claims
15
Light and lite claims
16
Energy claims
17
Protein claims
18
General fat claims
19
Saturated fat claims
20
Polyunsaturated or monounsaturated fatty acid claims
21
Omega fatty acid claims
22
Cholesterol claims prohibition
23
Sugar, sugars and sweetening claims
24
Fibre claims
25
Salt and sodium claims
26
Lactose claims
27
Gluten claims
16
Division 4 – Miscellaneous
28
Methods of analysis to determine total dietary fibre and specifically named fibre
content of food
[1.2]
inserting in clause 1, immediately after the definition of carbohydrate –
comparative nutrition claim means a nutrition claim that expressly or impliedly
compares a food with a similar food or class of food.
Editorial note:
Examples of comparative nutrition claims are nutrition claims using the terms ‘reduced’, ‘less
than’ or ‘increased’.
[1.3]
inserting in clause 1, immediately after the definition of gluten –
intense sweetener has the same meaning as in Standard 1.3.1.
main meal product means a pre-packaged prepared food product designed to
constitute a complete main meal.
[1.4]
omitting from clause 1, paragraph (c) of the definition of nutrition claim, and
substituting –
(c)
amino acids, carbohydrate, fat, fatty acids, fibre, protein, starch or sugars; or
[1.5]
inserting in clause 1, immediately after the Editorial note after the definition of
nutrition claim –
nutrition claim to the effect that a food is a low energy food includes use of the
terms –
(a)
(b)
(c)
(d)
[1.6]
low joule;
low calorie;
low energy; and
diet.
inserting in clause 1, immediately after the definition of polyunsaturated fatty acids –
reference food means, in respect of a food in relation to which a nutrition claim is
made, the regular counterpart food or class of foods.
Editorial note:
The reference food may be the regular counterpart food produced by the manufacturer; or the
most similar food whose composition is referenced in published food composition databases;
or the average of regular counterpart foods on the market.
For example, the reference food for high fibre white bread may be regular white bread, either
as produced by the manufacturer, as referenced in published food composition tables or the
average of regular white breads on the market.
17
[1.7]
omitting paragraph 5(1)(e), and substituting –
(e)
[1.8]
subject to clause 20, the average quantity, expressed in grams of, protein,
fat, saturated fat, carbohydrate and sugars, in a serving of the food and in a
unit quantity of the food; and
omitting subclause 5(4), and substituting –
(4)
The nutrition information panel must include declarations of the trans,
polyunsaturated and monounsaturated fatty acids in accordance with subclause (7), where a
nutrition claim is made in respect of (a)
(b)
saturated, trans, polyunsaturated or monounsaturated fatty acids; or
omega-3, omega-6 or omega-9 fatty acids.
[1.9]
deleting from the Nutrition Information Panel format in subclause 5(7), the entry for
Cholesterol
[1.10]
omitting paragraph 8(1)(c), and substituting –
(c)
saturated, trans, polyunsaturated and monounsaturated fatty acids content of
the food where a nutrition claim is made in respect of –
(i)
(ii)
[1.11]
omitting paragraph 8(1)(d), and substituting –
(d)
[1.12]
saturated, trans, polyunsaturated or monounsaturated fatty acids; or
omega-3, omega-6 or omega-9 fatty acids; and
average quantity of energy present per unit quantity of the food where a
nutrition claim is made to the effect that the food is a low energy food.
omitting Division 3, and substituting –
Division 3 – Conditions for making certain nutrition claims
Editorial note:
Clause 13 of Standard 1.1.1 prohibits advertisements for food from containing any statement,
information, design or representations that the Code prohibits from being included in a label
for the food.
Subclauses 5(4) and 5(5) of this Standard contain requirements for nutrition information
panels to include additional declarations where nutrition claims are made in respect of certain
nutrients.
12
General conditions for making nutrition claims
(1)
Where a nutrition claim is made in relation to a property of a food that is inherent to
the category of food to which the particular food belongs, the claim must refer to that
category of food, and not only to the particular food in question.
18
Editorial note:
For example –
‘[category of the food] is a low joule food’
(2)
Where a food is of a type described in clause 9 of this Standard, any nutrition claim
in relation to that food must be in relation to the food as reconstituted.
(3)
Where a food is of a type described in clause 10 of this Standard, any nutrition claim
in relation to that food must be in relation to the drained food.
13
Comparative claims
(1)
A comparative nutrition claim must not be made unless:
(a) for the food in relation to which the claim is made, the characteristic to which the
claim relates is at least 25 %:
(i)
(ii)
(b)
(c)
greater, where the claim indicates a higher value; or
lesser, where the claim indicates a lower value;
than in the same quantity of reference food; and
the foods being compared are identified; and
the proportion by which the food differs from the same quantity of
reference food is stated in conjunction with the claim.
Editorial note:
For example –
A comparative nutrition claim to the effect that a food is reduced fat may only be made if the
food contains at least 25% less fat than the same quantity of reference food. The food being
used for comparison must be identified, and the difference in fat content of the food
compared with the reference food must be stated in conjunction with the claim. These
requirements could be satisfied by the following –
Reduced fat
Contains 30% less fat than [reference food].
14
‘Free’ claims
A nutrition claim that a food does not have a nutritional property must not be made unless
expressly permitted by this Code.
15
Light and lite claims
(1)
A nutrition claim that a food is –
(a)
(b)
light; or
lite;
19
must not be made unless –
(c)
(d)
16
the nutritional property to which the claim relates is stated in conjunction
with the claim; and
the food meets the requirements for making a nutrition claim to the effect
that the food is very low, low or reduced in relation to that nutritional
property.
Energy claims
(1) A nutrition claim to the effect that a food is a low energy food, must not be made unless
the average energy content of the food is no more than –
(a)
(b)
80 kJ per 100 mL for beverages or other liquid foods; and
170 kJ per 100 g for all other foods.
(2) Where a food in dehydrated or concentrated form is labelled with directions that
indicate that the food should be reconstituted before consumption, the average energy content
of the food must be calculated for the food as so reconstituted.
(3)
Where a nutrition claim is made –
(a)
(b)
in accordance with subclause (1) or subclause (2); and
uses the term ‘calorie’;
the declarations of energy in the nutrition information panel must be made in terms of
calories as well as kilojoules.
17
Protein claims
A nutrition claim to the effect that a food is high in protein must not be made unless the food
provides –
(a)
(b)
18
no less than 5g of protein per 100 mL for beverages and other liquid foods;
and
no less than 10 g of protein per 100 g for all other foods.
General fat claims
(1)
A nutrition claim to the effect that a food is low in fat must not be made unless the
food contains –
(a)
(b)
no more than 1.5 g of fat per 100 mL for beverages and other liquid foods;
and
no more than 3 g of fat per 100 g for all other foods.
(2) A nutrition claim to the effect that a food is very low in fat must not be made unless the
food contains no more than 0.15 g of fat per 100 g of the food.
20
(3)
A nutrition claim to the effect that a food is a certain percentage fat free must not be
made unless –
(a)
(b)
the food meets the requirements for making a claim to the effect that a food
is low in fat; and
the fat content of the food expressed as a percentage is stated in conjunction
with the claim.
Editorial note:
For example –
98% fat free
contains 2% fat
19
Saturated fatty acid claims
(1)
A nutrition claim to the effect that a food is low in saturated fatty acid must not be
made unless the food contains –
(a)
(b)
20
no more than 0.75 g of saturated fatty acids and trans fatty acids in total per
100 mL for beverages and other liquid foods; and
no more than 1.5 g of saturated fatty acids and trans fatty acids in total per
100 g for all other foods.
Polyunsaturated or monounsaturated fatty acid claims
(1)
A nutrition claim must not be made in relation to the polyunsaturated fatty acid
content or monounsaturated fatty acid content of a food unless –
(a)
(b)
the total of saturated fatty acids and trans fatty acids comprises no more
than 28 per cent of the total fatty acid content of the food; and
the fatty acid in respect of which the nutrition claim is made comprises no
less than 40 per cent of the total fatty acid content of the food.
(2)
Where a nutrition claim is made in relation to the polyunsaturated fatty acid content
or monounsaturated fatty acid content of foods for which there are compositional
requirements specified in Standard 2.4.1 or Standard 2.4.2, the quantity of saturated fatty
acids, polyunsaturated fatty acids, monounsaturated fatty acids and trans fatty acids may be
set out in the nutrition information panel as a minimum or maximum quantity in a serving of
the food.
Editorial note:
Subclause 20(2) provides manufacturers of edible oils and edible oil spreads with the option
of setting out the minimum and maximum fatty acid content of the types of fatty acids
referred to in subclause 20(2) instead of their average quantity. Total fat must still be
expressed as an average quantity in accordance with paragraph 5(1)(e).
21
21
Omega fatty acid claims
(1)
Where a nutrition claim using the word ‘omega’ is made in relation to the omega
fatty acid content of a food, the word ‘omega’ must be qualified by the type of omega fatty
acid present and this qualification must appear immediately after the word ‘omega’.
Editorial note:
For example, in the format ‘Omega-3’, ‘Omega-6’ or ‘Omega-9’.
(2) Subject to subclause (3) and subclause (4), a nutrition claim must not be made in
relation to the omega-3 fatty acid content of a food, other than fish or fish products that have
no added saturated fatty acids, unless the –
(a)
(b)
total of saturated fatty acids and trans fatty acids is less than 28 per cent of
the total fatty acid content of the food; or
food contains no more than 5 g of saturated fatty acids and trans fatty acids
per 100 g of the food.
(3)
A nutrition claim must not be made in relation to the omega-3 fatty acid content of a
food, unless the food satisfies the requirements of subclause (2) and contains no less than –
(a)
(b)
200 mg alpha-linolenic acid per serving; or
30 mg total eicosapentaenoic acid and docosahexaenoic acid per serving.
(4)
A nutrition claim to the effect that a food is a ‘good source’ of omega-3 fatty acid
must not be made, unless the food satisfies the requirements of subclause (2) and contains no
less than 60 mg total eicosapentaenoic acid and docosahexaenoic acid per serving.
(5)
Where a nutrition claim is made in accordance with subclause (3) or subclause (4),
the declarations in the nutrition information panel must indicate the source of omega 3 fatty
acids, namely, alpha-linolenic acid, docosahexaenoic acid and/or eicosapentaenoic acid.
(6)
A nutrition claim must not be made in relation to the omega-6 or omega-9 fatty acid
content of a food, unless the –
(a)
(b)
total of saturated fatty acids and trans fatty acids content of the food is no
more than 28 per cent of the total fatty acid content of the food; and
fatty acid in respect of which the nutrition claim is made comprises no less
than 40 per cent of the total fatty acid content of the food.
Editorial note:
The omega-3, omega-6 or omega-9 fatty acid content of a food that is the subject of such a
claim should be set out in the nutrition information panel in the format specified in subclause
5(7) as a sub-sub-group of polyunsaturated fatty acids or monounsaturated fatty acids, as the
case may be.
22
22
Cholesterol claims prohibition
A nutrition claim must not be made in relation to the cholesterol content of a food.
23
Sugar, sugars and sweetening claims
(1)
A nutrition claim to the effect that a food contains no –
(a)
(b)
added sugar; or
added sugars;
must not be made unless:
(c)
the food contains no added:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
(ix)
(x)
(d)
hexose monosaccharides and disaccharides, including dextrose,
fructose, sucrose and lactose; or
starch hydrolysate; or
glucose syrups, maltodextrin and similar products; or
products derived at a sugar refinery, including brown sugar and
molasses; or
icing sugar; or
invert sugar; or
fruit sugar syrup;
malt or malt extracts; or
honey; or
concentrated and/or deionised fruit juice; and
a reference to the declaration of the sugars in the nutrition information
panel is made in conjunction with the claim.
Editorial note:
For example –
No added sugars
This product contains natural sugars. See nutrition information panel for details.
(2)
A nutrition claim to the effect that a food is unsweetened must not be made unless
the food contains –
(a)
no added –
(i)
(ii)
(iii)
(iv)
(v)
(vi)
hexose monosaccharides and disaccharides, including dextrose,
fructose, sucrose and lactose; or
starch hydrolysate; or
glucose syrups, maltodextrin and similar products; or
products derived at a sugar refinery, including brown sugar and
molasses; or
icing sugar; or
invert sugar; or
23
(vii)
(viii)
(ix)
(x)
(b)
fruit sugar syrup;
malt or malt extracts; or
honey; or
concentrated and/or deionised fruit juice; and
no –
(i)
(ii)
intense sweeteners; or
sorbitol, mannitol, glycerol, xylitol, isomalt, maltitol syrup or
lactitol; and
a reference to the declaration of the sugars in the nutrition information panel is made in
conjunction with the claim.
(3)
A nutrition claim to the effect that a food is very low in sugar must not be made
unless the food contains –
(a)
(b)
no more than 0.1 g of sugars per 100 ml for beverages or other liquid food;
and
no more than 0.2 g of sugars per 100 g for all other food.
(4)
A nutrition claim to the effect that a food is low in sugar must not be made unless
the food contains –
(a)
(b)
24
no more than 2.5 g of sugars per 100 ml for beverages or other liquid food;
and
no more than 5 g of sugars per 100 g for all other food.
Fibre claims
(1)
A nutrition claim must not be made in relation to the fibre content of a food unless a
food derives –
(a)
(b)
less than 30 per cent of its average energy content from fat; and
less than 10 per cent of its average energy content from saturated fatty acids
and trans fatty acids.
(2)
A nutrition claim to the effect that a food is a source of fibre must not be made
unless the food contains –
(a)
(b)
no less than 2 g of dietary fibre per 100 g for main meal products; and
no less than 1.5 g of dietary fibre per serving for all other foods.
(3)
A nutrition claim to the effect that a food is a good source of fibre must not be made
unless the food contains (a)
(b)
no less than 4 g of dietary fibre per 100g for main meal products; and
no less than 3 g of dietary fibre per serving for all other foods.
24
(4)
A nutrition claim to the effect that a food is an excellent source of fibre must not be
made unless the food contains –
(a)
(b)
no less than 8 g of dietary fibre per 100 g for main meal products; and
no less than 6 g of dietary fibre per serving for all other foods.
(5)
A nutrition claim to the effect that a food is fibre enriched must not be made unless
the food contains (a)
(b)
25
no less than 1.5 g of dietary fibre per serving, where the fibre enrichment
component of the dietary fibre has been discounted; and
no less than 3 g of dietary fibre per serving.
Salt and sodium claims
(1)
A nutrition claim to the effect that a food has no added salt or sodium must not be
made unless the food is –
(a)
(b)
unsalted; and
a reference to the declaration of the sodium in the nutrition information
panel is made in conjunction with the claim.
(2)
A nutrition claim to the effect that a food is very low in salt or sodium must not be
made unless the food contains no more than 40 mg of sodium per 100 g of the food.
(3)
A nutrition claim to the effect that a food is low in salt or sodium must not be made
unless the food contains no more than 120 mg of sodium per 100 g of the food.
(4)
Where a nutrition claim is made in respect of the salt, sodium or potassium content
of a food, or any two or all of them, then particulars, including particulars relating to both the
sodium and potassium content of the food, must be provided in relation to the food in
accordance with subclause 5(1).
26
Lactose claims
(1)
A nutrition claim to the effect that a food is low lactose must not be made unless the
food contains no more than 0.3 g of lactose per 100 g of the food.
(2)
A nutrition claim to the effect that a food is lactose free must not be made unless the
food contains no detectable lactose.
(3)
Where a nutrition claim is made in relation to the lactose content of a food,
particulars of the lactose and galactose content of the food must be provided in accordance
with subclause 5(1).
25
Editorial note:
The declaration of the lactose and galactose content of a food in the nutrition information
panel should be in the following form:
Carbohydrate
- sugars
- lactose
- galactose
27
Gluten claims
(1)
A nutrition claim in relation to the gluten content of food must not be made unless
expressly permitted by this Code.
Editorial note:
This subclause does not prohibit the declaration of the presence of gluten, for example, in an
ingredient list on the label on a food.
(2)
A nutrition claim to the effect that a food is gluten free must not be made in relation
to a food unless the food contains no (a)
(b)
detectable gluten; and
oats or malt.
(3)
A nutrition claim to the effect that a food has a low gluten content, must not be made
in relation to a food unless the food contains no –
(a)
(b)
more than 20 mg gluten per 100 g of the food; and
oats or malt.
Editorial note:
Subclauses (2) and (3) of this clause permit nutrition claims to the effect that a food is gluten
free or has a low gluten content, providing certain specified conditions are met.
(4)
A nutrition claim to the effect that a food contains gluten or is high in gluten may be
made in relation to a food.
Editorial note:
Subclause 16(1) prohibits all nutrition claims about gluten unless expressly permitted.
Subclauses 16(2), (3) and (4) provide those express permissions.
[1.13]
omitting Division 4, and substituting –
26
Division 4 – Miscellaneous
29
Methods of analysis to determine total dietary fibre and specifically named
fibre content of food
(1)
Subject to subclause (2), the methods set out in the Table to this subclause are the
prescribed methods of analysis for the determination of total dietary fibre and any specifically
named fibre content of food for the purposes of nutrition labelling in this standard.
Table to subclause 29(1)
Column 1
Column 2
Food Component
Method of analysis
Total dietary fibre
Section 985.29 of the AOAC, 17th Edition (2000), or
Section 991.43 of the AOAC, 17th Edition (2000).
Section 997.08 of the AOAC, 17th Edition (2000).
Section 999.03 of the AOAC, 17th Edition (2000).
Inulin and fructooligosaccharide
Inulin
(2)
The results obtained using the analytical methods outlined in column 2 of the Table
to subclause 29(1) must be summed together after ensuring that there is no double counting
of any specifically named fibre.
Editorial note:
For the purposes of subclause 29(2), where a manufacturer chooses to include a specifically
named fibre in the declaration of dietary fibre, the manufacturer must first work out which
food components in column 1 are present in the food and then use the appropriate methods of
analysis in column 2, or in the case of total dietary fibre, choose which method of analysis to
use. The results of the chosen methods of analysis are then added together. If any substance
has been measured by more than one analysis, then allowance must then be made by
discounting for double counting of that amount to arrive at the total figure.
For example, the dietary fibre content of a cereal bar with added inulin is calculated by
adding the result of the analysis for total dietary fibre, using one of the two possible methods
of analysis, to the result of the analysis for inulin, and subtracting from the total that part of
the inulin content that was included in the result of the analysis for total dietary fibre.
[2]
Standard 1.3.1 of Volume 2 of the Food Standards Code is varied by omitting from
clause 4, the Editorial Note immediately following, and substituting –
Editorial Note:
In general, the use of intense sweeteners is limited to:
1.
2.
3.
foods meeting the definition of ‘reduced joule’ or ‘low joule’;
‘no added sugar or sugars’ food e.g. artificially sweetened canned fruit without
added sugar or sugars; or
specific foods in which the use of the sweetener is in addition to sugar rather than as
an alternative e.g. chewing gum, brewed soft drink (these foods are listed in
Schedule 1 on a case-by-case basis).
27
Conditions relating to the use of reduced/low joule, no added sugar, sugars and unsweetened
claims can be found in Standard 1.2.8.
Polyols, isomalt and polydextrose may be considered to be food additives when used as
humectants and texturisers. Where these substances constitute a significant part of the final
food they would be regarded as a food in their own right rather than food additives. Polyols,
isomalt and polydextrose are not considered to be bulking agents if used in large amounts to
replace sugars as they may contribute significantly to the available energy of the food.
28
ATTACHMENT 2
AUSTRALIA AND NEW ZEALAND FOOD REGULATION
MINISTERIAL COUNCIL
POLICY GUIDELINE PROPOSAL ON NUTRITION,
HEALTH AND RELATED CLAIMS
POLICY PRINCIPLES
The policy principles endorsed by Australian New Zealand Food Regulation Ministerial
Council (ANZFRMC) for nutrition, health and related claims for food provide that any
intervention by government should:
1.
give priority to protecting and improving the health of the population;
2.
enable the responsible use of scientifically valid nutrient, health and related claims;
3.
support government, community and industry initiatives that promote healthy food
choices by the population;
4.
be consistent with and complement Australian and New Zealand national policies and
legislation including those relating to nutrition and health promotion, fair trading,
industry growth and international trade and innovation;
5.
be cost effective overall, not more trade restrictive than necessary and comply with
Australia’s and New Zealand’s obligations under the WTO Agreements;
6.
contain a process of substantiation which aligns levels of scientific evidence with the
level of claims along the theoretical continuum of claims, and at minimum costs to the
community;
7.
draw on the best elements of international regulatory systems for nutrient, health and
related claims and be responsive to future trends and developments;
8.
provide for collaborative action among enforcement agencies, industry and consumers
to optimise educational resources; and
9.
allow for effective monitoring and appropriate enforcement.
The following features of any regulatory system for health, nutrition and related claims are
also considered desirable. The system should:
10.
favour pre-market approval rather than post-market reaction;
11.
enable better engagement of sectors other than government in providing nutritional
advice and information;
12.
promote a partnership between consumers, governments and industry in the delivery
and responsible use of nutrition, health and related claims which protects consumers
from false and misleading information that may result in distorted diets which harm
health and increase health inequalities; and
13.
allow for all transition issues to be clearly identified and steps taken to justify and to
minimise costs of change and transition.
29
CLAIM PRE-REQUISITES
Every health claim made must comply with the following, overarching policy principles,
regardless of their claim classification level.
The overarching policy principles are:
1. Claims can be made providing. the food and/or component is safe for consumption in
recommended quantities as part of the total diet;
. all requirements contained in Food Standards in the Australia New Zealand Food
Standards Code are met;
. the claims have been scientifically substantiated;
. there is enough of the specified component to achieve the claimed benefit when
consumed as directed;
. the eligibility criteria, including qualifying and/or disqualifying criteria (and any
excluded categories of foods, such as alcohol and infant foods), are complied with;
. the claim is socially responsible and does not promote irresponsible food consumption
patterns.
2. Except where permitted by the Food Standards Code, claims that a food or component of
a food or diet can prevent, diagnose, cure or alleviate a disease, condition, ailment, defect
or injury in humans would be considered therapeutic claims and are not permitted (eg.
eating this food protects you from getting ‘Q’ disease).
3. Claims that a food or component:
. influences performance and wellbeing;
. manages, influences, inhibits, or modifies a physiological process;
. reduces the risk of a disease, condition, ailment, defect, or injury;
may only be made in the context of the appropriate total diet (that must be described)
(eg. This food is high in ‘S’ that may help reduce your risk of ‘G’ disease. People with
‘G’ disease should eat a varied diet low in ‘A’ & ‘B’ and high in ‘S’, ‘X’ & ‘Y’. Eg. This
food contains ‘X’ which may improve ‘Y’ when eaten as part of a varied diet low in ‘A’ &
‘B’ and high in ‘X’ & ‘C’).
4. Claims about a food or component can describe a health benefit for the population but
must not:
. imply or state a universal or guaranteed benefit for all individuals, except where
permitted by the Australia New Zealand Food Standards Code;
. imply or state a health benefit for the population if the claimed benefit applies only to a
particular subgroup of the population, unless the population subgroup is stated;
. lead a consumer to self-diagnose or self-manage a condition or disease that should be
medically diagnosed and/or managed;
. encourage over-consumption of single foods or ingredients;
. state or imply that a healthy diet is reliant on the inclusion of a single food;
. arouse unwarranted and/or unrealistic expectations of the benefit to the individual;
. be alarmist. That is they cannot:
30
-
contain language that could bring about fear or distress;
lead the consumer to believe that they are suffering from a serious ailment or
disease;
lead the consumer to believe that harmful consequences may result if they do not
consume the particular product.
5. A claimed benefit must be:
. achievable when the food is consumed in quantities which can reasonably be expected
to be consumed daily as part of an appropriate total diet;
. derived from the food or component in question for which the claim is made and not
from consuming the food with a combination of specific foods.
6. Claims must communicate a specific rather than a broad benefit. (Eg. improves recovery
from exercise rather than improves sport performance)Claims that refer to: . a disease,
condition, ailment, defect or injury should include a statement explaining how the
claimed benefit is achieved. (Eg. high in ‘Z’, diets high in ‘Z’ do X which may reduce
the risk of ‘G’ disease);
. the dietary management of a biomarker, condition or disease that may require the
supervision of an appropriate health care practitioner, must have an advisory statement
to the effect that a health care practitioner’s advice is required.
8. Where advisory or warning statements in relation to the claim are required, they must
appear in close proximity to the claim in the same communication mediumWhere the
information about the claim is separated into sections (split claim) the first part of the
claim must direct the reader to further information provided elsewhere in the same
communication mediumIn a compound claim any part of the claim that falls within a
higher claim category results in the totality of the claim falling into that
categoryEndorsement Programs that state or imply a nutrition, health, or related claim
must comply with these principles and the requirements of the relevant category of claim.
They will require a statement to explain why the endorsement has been granted (eg. meets
nutrient criteria required by the endorsement program)Marketing activities that promote
charities or non profit organisations (ie. cause-related marketing programs) that relate to
disease or health must have a disclaiming statement to ensure they are not interpreted as a
nutrition, health or related claimCommunication to health professionals of a nutrition,
health, or related claim about specific food products or food types (eg. milk, meat etc)
must comply with these principles and the requirements of the relevant category of claim
31
CLAIMS CLASSIFICATION CRITERIA
The claims classification framework sets out criteria for two levels of claims: general and high.
The categorisation of a claim is based on the degree of promise to the consumer of the claim.
That is, the potential benefit to the consumer in consuming that food in preference to other
foods and, commensurately, the degree of risk to the consumer (and public health) in
following the advice of the claim.
The level of a claim, as determined by the claims classification framework, will determine to
what degree the claim is regulated, including the nature of the evidence required for
substantiation. Only high level claims will be pre-approved, with approved claims being
listed in the standard.
This could be done on a claim-by-claim (i.e. not product-by-product) basis. The standard
could also include pre-approved ‘generic’ high level claims which refer to serious diseases or
conditions, with consideration given to the Australian Dietary Guidelines or the New Zealand
Food & Nutrition Guidelines. Flexibility in wording of claims should be considered,
provided the overarching principles and claim pre-requisites are satisfied.
Consideration should be given during the FSANZ standard development process for
including the criteria for making each level of claim and any parameters (eg. qualifying and
disqualifying criteria, or exclusions for certain categories of food, such as alcohol and baby
foods) should be specifically stated in the standard. These parameters will be particularly
important to the monitoring and enforcement of nutrient content claims.
General level claims
General level claims are claims where the manufacturer has to make an assessment of the
evidence supporting the claim prior to the product going to market, and to hold the evidence
(to be produced at the request of enforcement agencies).
General level claims do not reference a serious disease. That is, references to non-serious
diseases would be allowed in this category, as would claims that make no reference to a
disease at all.
General Level claims are those which:
.
describe or indicate the presence or absence of a component in that food (Nutrient
Content Claims) (eg. This food is high in calcium); or
.
refer to maintenance of good health or normal physiological processes (including normal
growth and development, or maintenance or other like functions of the human body) (eg.
helps keep you regular as part of a high fibre diet). This includes claims that describe the
component and its function in the body (eg. Calcium is good for strong bones and teeth);
or
.
refer to specific benefits for performance and wellbeing in relation to foods (eg. gives you
energy); or
32
.
.
are whole of diet claims based on the Australian Dietary Guidelines or the New Zealand
Food & Nutrition Guidelines which may refer to the relevant benefits as described in the
associated Australian Dietary Guideline or New Zealand Food & Nutrition Guideline
background papers but do not refer to a serious disease or condition (eg. A healthy,
balanced diet that includes dietary fibre from a number of sources is one that can help
reduce your risk of constipation); or
describe how a diet, food or component can modify a function or body structure beyond
its role in the normal growth, development and maintenance and other like functions of
the human body but do not state or imply a serious disease (eg. exercise and a diet high in
calcium and calcium containing foods like product ‘X’ may help give you stronger
bones); or. refer to the potential for a food or component to assist in reducing the risk
of or helping to control a non-serious disease or condition (eg. Yoghurt high in X and Y as
part of a healthy diet may reduce your risk of stomach upsets)
High level claims
High level claims are those claims which make reference to a serious disease, including.
claims that refer to the potential for a food or component to assist in controlling a
serious disease or condition (i.e. those referring to risk reduction or a reduction or
improvement in health);
Eg. this food is high in X, which as part of a diet low in saturated fat and high in soluble
fibre may reduce your risk of heart disease.
.
claims that refer to the potential for a food or component to assist in reducing the risk of,
or improving a serious disease or condition;
Eg. This food is low in Y which may reduce your risk of having a stroke through Z.
.
are whole of diet claims which refer to a serious disease or condition based on the
Australian Dietary Guidelines or the New Zealand Food and Nutrition Guidelines which
may refer to the relevant benefits as described in the associated Australian Dietary
Guideline or New Zealand Food and Nutrition Guideline Background Papers;
Eg. A healthy diet that may lower your risk of certain kinds of cancer is one that is low in
fats and includes fibre from a number of sources including a variety of fruits and
vegetables, and wholegrain and bran cereals.
.
biomarker1 maintenanceclaims;
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.
.
A biomarker is one indicator of a person’s risk of developing a serious disease (eg blood cholesterol is a
biomarker for the risk of heart disease).
33
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.
34
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.
35
Health Claims Regulatory Model
Ministerial Council
(ANZFRMC)
Final approval of Standard
FRSC
NATIONALLY
CONSISTENT FOOD
STANDARD
(Food Standards Code)
The Health Claims standard will outline:
•
•
•
high order principles;
definitions of high and general claims;
prescriptive detail for high level
claims including details of approved
high level claims.
Policy & Evaluation
Health Claims ‘Watchdog’ Role added
to ISC Terms of Reference
Role


ISC

Enforcement
Implementation Enforcement &
Complaints resolution



Assist FSANZ in the creation and
maintenance of the guideline document.
Provide recommendations to FRSC
regarding proposed amendments to the
standards or guideline document.
Receive consumer/industry complaints via
‘mailbox’.
Forward evidence received on complaints to
relevant jurisdictions for analysis and
enforcement action.
Monitor and record all complaints received
and actions undertaken by jurisdictions.
Provide periodic reports to FRSC.
Informed by FSC
GUIDELINE DOCUMENT
PROVIDE MAJORITY OF THE
DETAIL SURROUNDING
GENERAL LEVEL CLAIMS.
STATE/ TERRITORY/ NZ
ENFORCEMENT
36
Complaints
Public/consumer groups/industry
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 preapproved 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.
37
Substantiation Requirements Diagram
PROPOSED CLAIM
Claim Classification
Framework: risk to the
Manufacturer makes an assessment against the Claims Classification Criteria.
High level Claims
Nutrient content
General level Claims
Consistently agreed
Weight of evidence
Biomarker Claims
Evidence needs claim-by-claim assessment due to the high level
category of the claim
Evidence Submitted to FSANZ
Evidence may be:
- Consistently agreed
- Weight of evidence
- Emerging evidence
Evidence of why and
where claim is
substantiated and the
adequacy of the
product’s content.
Copies of actual studies
and a summary dossier.
Detailed Guidelines developed by Government/industry/consumer working
group. Risk based compliance program to be undertaken by Jurisdictions
Evidence submitted to FSANZ
for assessment.
Requires FSANZ approval
prior to claim being made.
38
Definitions of claim
levels in Food
Standards Code
Pre-approved claims:
Evidence contained in
Dietary Guidelines and
other approved
documents
The manufacturer holds the appropriate evidence to substantiate the claim
and produces this evidence if requested by enforcement officials.
Evidence that
product has
content as
claimed.
consumer of following the
advice in the claim. Assumes
claim is true, valid,
substantiated, socially
responsible and food is safe.
To be assessed and
included during
development of
standard.
FSANZ Standard
Nature, source
and totality of
evidence
(What evidence
exists to support
the claim?)
Who holds
evidence of
substantiation
and validity?
ADDITIONAL 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 reassessed in the review of the system.
39
.
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.
Dosage: a measured quantity administered at any one time or at stated intervals. A statement
about dose or dosage would be considered a therapeutic claim and is therefore not permitted
on foods. However, a manufacturer is allowed to state the amount of a component in a
serving of the food together with the amount required to beconsumed daily to achieve the
desired effect. Specified serving sizes should reflect a realistic amount of the food that a
person might normally consume. (eg. a serve contains Xg of the component. Consume Y
serves per day, which as part of the appropriate total diet provides the claimed
benefit).Eligibility criteria: before a food is permitted to carry a claim, all stipulated
eligibility criteria for that food must be met. Eligibility criteria can include qualifying and
disqualifying criteria, such as the requirement for the presence and/or absence of components
in the food or entire food categories.
Endorsement program: in the commercial sense – an advertising testimonial: an instance of
public endorsement of a product for advertising purposes.
Nutrition, health and related claims: include all claims referring to nutrient content,
nutrient function, enhanced function, reduction of disease risk or maintenance of normal
health.
Serious disease or condition: forms of diseases, conditions, ailments or defects which are
generally accepted to be beyond the ability of the average consumer to evaluate accurately
and to treat safely without regular supervision by a suitably qualified health care professional.
40
Socially responsible: meets ethical and moral standards and does not abuse the trust or
exploit the lack of knowledge of the general public or contain language which could bring
about fear or distress.
Therapeutic claim: a claim outside the context of the total diet that a specific food or food
component will prevent, diagnose, cure or alleviate a disease, ailment, defect or injury; or
influence, inhibit or modify a physiological process. Therapeutic claims on foods are not
permitted under the Nutrition, Health and Related Claims framework, except where expressly
permitted in the Food Standards Code. Therapeutic claims may only be made for goods
which are regulated by the Therapeutic Goods Administration. A statement about dosage is
an implied therapeutic claim and is therefore not permitted on foods.
Whole of diet claims: claims which communicate the appropriate total diet required to
achieve the stated benefit.
41
ATTACHMENT 3
P234 EXTERNAL ADVISORY GROUP
Terms of Reference
Within the scope of Proposal P234 – Nutrient Content and Other Related Claims, the terms of
reference for the external advisory team are to:
1.
Consider and provide feedback on submissions/comments received in relation to
stakeholder consultations.
2.
Advise on the possible regulatory options and the specific criteria for nutrient content
and other related claims.
3.
Provide advice on the costs and benefits of possible regulatory options and the specific
criteria for nutrient content and other related claims.
Membership of the EAG
Ms Brenda Cutress, New Zealand Grocery Marketers Association;
Mr Tony Downer, Australian Food and Grocery Council;
Ms Michele Flint, Department of Health and Ageing;
Mr Peter Liehne, ANZFA (Chairperson)
Ms Celia Murphy, New Zealand Consumers Institute;
Ms Winsome Parnell, Nutrition Expert;
Mr Wayne Perkins, New Zealand Ministry of Health;
Mr Timothy Reardon, Australian Chamber of Commerce and Industry;
Ms Joanne Riddiford, Australian Competition and Consumer Commission;
Ms Rebecca Smith, Australian Consumers Association;
Dr Rosemary Stanton, Nutrition Expert; and
Dr Peter Williams, University of Wollongong
42
ATTACHMENT 4
LIST OF SUBMITTERS
A Draft Assessment Report for the review of Criteria and Conditions for Making Nutrition
Content and Other Related Claims, Proposal P234, was released in March 2002 to commence
the second round of public consultation. The following is a list of submitters who provided a
written response:
Industry
Australia
1.
Arnott’s
2.
Australian Dairy Corporation (ADC) & Australian Dairy Products Federation (ADPF)
3.
Australian Food and Grocery Council (AFGC)
4.
Australian Olive Oil Association Inc. (AOOA)
5.
Australasian Soft Drink Association Ltd (ASDA)
6.
BRI Australia Limited/ Go Grains Advisory Committee
7.
Clover Corporation Ltd (Clover)
8.
Coles Myer Limited (Coles)
9.
Dairy Farmers
10. Evans Confectionary
11. Food and Beverage Importers Association (FBIA)
12. Food Liaison
13. Food Sense
14. Food Technology Association of Victoria Inc (FTA Vic)
15. Food Technology Association of Western Australian Inc (FTAWA)
16. George Weston Foods Limited (GWF)
17. Goodman Fielder Ltd
18. Mandurah Australia Pty Ltd (Mandurah)
19. Meat and Livestock Australia (MLA)
20. Murray Goulburn Co-operative Co. Limited (MGC)
21. National Food
22. The NutraSweet Company (NutraSweet)
23. Paradise Food Industries Pty Ltd
24. Pauls Limited
25. Peters & Brownes Group (PBG)
26. Sanitarium Health Food Company (Sanitarium)
27. Snow Confectionary Pty Ltd
28. Sugar Australia Pty Ltd
29. The Wrigley Company Pty Ltd (Wrigley)
New Zealand
30. Advertising Standards Authority Inc. (ASA)
31. Communication Agencies Association of New Zealand Incorporated (CAANZ)
32. Fonterra Co-operative Group (Fonterra)
33. Griffins Foods Limited, New Zealand & Food Concepts & Design Ltd (Griffins)
34. Horleys
35. Independent Fisheries Limited
36. InforMed Systems Ltd
37. Magazine Publishers Association (MPA)
43
38.
39.
40.
41.
42.
43.
44.
45.
46.
Mainland Products Ltd
Natural Products Ltd
New Zealand Beef and Lamb Marketing Bureau (NZ Beef and Lamb)
New Zealand Grocery Marketers Association (GMA)
New Zealand Juice Association (NZJA)
New Zealand Television Broadcasters’ Council (NZTBC)
New Zealand Vegetable and Potato Growers’ Federation (NZ Veg & Potato)
Tatua Co-op Dairy Company (Tatua)
Tegel Foods Ltd (Tegel)
Trans-Tasman
47. Cerebos Foods Aust/Cerebos Gregg’s Ltd NZ (Cerebos)
48. Confectionary Manufacturers of Australasia Limited (CMA)
49. Heinz Wattie’s Australasia (HWA)
50. Nestlé Australia Ltd and Nestlé New Zealand Ltd (Nestlé)
51. Unilever Australasia (Unilever)
International
52. Calorie Control Council USA (CCC USA)
53. Danisco USA Inc
54. European Assoc of Polyol Producers (EPA)
55. International Sweeteners Association (ISA)
56. Isomalt Palatinit GmbH
57. Keller and Heckman LLP on behalf of European Assoc of Chewing Gum Industry
(EACGI) & National Association of Chewing Gum Manufacturers (NACGM)*
Government
Australia
58. Australian Competition & Consumer Commission (ACCC)
59. Chamber of Commerce and Industry, WA (CCIWA)
60. Commonwealth Consumer Affair Division Advisory Council (CCAAC)
61. Complementary Healthcare Council of Australia (CHC)
62. Dept. of Human Services, SA
63. Dunn Son and Stone
64. NSW Heath Department
65. Queensland Health
New Zealand
66. Auckland District Health Board, New Zealand (ADHB)
67. Crown Public Health (CPH)
68. Manufactured Food Database, The Auckland District Health Board (MFD)
69. Ministry of Health (MoH NZ)
70. Public Health South (PHS)
Public Health/Non-Government Organisations
Australia
71. Dr Trevor Beard
72. Dr K Cashel
73. CSIRO Health Sciences and Nutrition (CSIRO)
74. Diabetes Australia
44
75.
76.
77.
78.
Dietitians Association of Australia (DAA)
National Heart Foundation of Australia (NHF Aust)
The Pritikin Health Association of Australia Inc. (Pritikin)
R Stanton
New Zealand
79. Diabetes New Zealand
80. National Heart Foundation of New Zealand (NHF NZ)
81. New Zealand Dietetic Association (NZDA)
82. New Zealand Nutrition Foundation
International
83. Dept. of Nutrition and Food Studies, New York University (Marion Nestlé)
Consumers
Australia
84. T Beard
85. N Dindakis
86. N Hay
87. S&G Helleur
88. D Horseman
89. R Kemp
90. BA Lawton
91. R McKennery
92. National Council of Women of Australia
93. J Schultz
94. V Shenton
95. G Wilson
96. Weight Watchers - Trigg Branch
New Zealand
97. Consumers’ Institute (NZCI)
45
ATTACHMENT 5
SUMMARY OF SPECIFIC ISSUES RAISED DURING PUBLIC
CONSULTATION
COMPARATIVE CLAIMS
All ten Australian submitters who provided comment on comparable claims (AFGC, Dairy
Farmers, FTA Vic, Goodman Fielder, MGC, Sanitarium, SA Dept Human Services, Diabetes
Australia, DAA, NHF Australia) supported ANZFA’s preferred criteria. Four New Zealand
submitters (Fonterra, Natural Products, MoH NZ and the NZDA) and three trans-Tasman
submitters (CMA, Cerebos and Unilever) also supported ANZFA’s recommendation. The NZ
CI preferred the NZFR relative difference of 33%, but acknowledged that 25% is consistent
with international standards.
Although the NZGMA noted that ANZFA’s preferred criteria would enable more foods to
carry comparative claims in New Zealand, Mainland Products opposed the criteria on this
basis, arguing that the current competitive advantage will be lost because it will be easier for
international competitors to comply. The NZ Nutrition Foundation also opposed the
recommendation because of concerns that consumers will be at risk of choosing a ‘reduced’
product with an 8% higher content. It therefore recommended a full education programme for
New Zealand health professionals and consumers if the criteria are changed to a 25% relative
difference.
Additional requests for variation to the preferred criteria were that:







all ‘reduced’ claims except those that relate to ‘reduced salt/sodium’ also include a
reduction of at least 25% in energy when compared with a reference food (NHF NZ).
The NHF Australia requested this too, but only for total fat and sugar claims;
criteria for reference foods be defined within legislation (NZDA);
specific comparable claims such as ‘reduced salt’ be prohibited (NZDA);
stock-in-trade provisions be given (Independent Fisheries);
definition of ‘in conjunction with’, as stated in the draft variations to the FSC be
provided (Diabetes Australia and the DAA);
specification of minimum absolute differences be given, as is the case under CoPoNC,
to prevent trivial differences being highlighted (Sanitarium);
that the terms ‘more than’ and ‘more’ be included to promote consistency and provide
clarity (Sanitarium).
FREE
The issue of whether ‘free’ claims should be prohibited or not was extremely controversial.
Eighteen submitters, who were mainly from public health agencies supported prohibition,
while twenty-two submitters, all of whom were from industry, strongly opposed the
prohibition.
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There was support for the prohibition from Griffins, Mainland, Tatua, ADHB, CPH, MoH
NZ, NHF NZ, NZDA, NZ CI, Coles, FTA Vic, MLA, SA Dept Human Services, Diabetes
Australia, DAA, Pritikin, Rosemary Stanton and HWA. ASA also supported the prohibition
but only when the claim is not ‘free’ of a nutrient. All of those who provided reasons for their
support said that it was because of the need to conform to the interpretation of fair trading
requirements, as given by the ACCC and NZCC. HWA and Coles therefore provided their
support reluctantly. In addition, Coles and SA Dept Human Services supported an exemption
for ‘free’ claims relating to gluten and lactose.
ADC &ADPF, AFGC, ASDA, Dairy Farmers, FBIA, Food Liaison, Foodsense, Goodman
Fielder, Mandurah, MGC, Pauls, CMA, Nestlé, Unilever, CCC USA, Danisco USA, ASA,
CAANZ, InforMed Systems, Natural Products, and NZGMA all opposed the prohibition for
the following reasons:
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the rationale is based on the ‘policy’ of the ACCC and NZCC rather than on protecting
public health and safety or on preventing deception and fraud;
fair trading law prohibits manufacturers from misleading and deceptive conduct but
does not prohibit ‘free’ claims (e.g. it would be misleading and untrue to say that a food
with nil salt is ‘very low salt’). It is contrary to Section 14 of the NZ Bill of Rights Act
1990, which protects the right of free speech;
tolerance levels for nutrients that are not associated with allergy or intolerance, provide
nutritionally appropriate and, from a responsible food manufacturers perspective,
practical cut-offs;
consumers are not being misled because there is no physiological difference in
consuming foods with insignificant amounts of a nutrient as opposed to equivalent
foods with no nutrient;
there is no evidence of consumers being misled;
it is inconsistent with CoPoNC, Codex, the USA and the UK which all accept the
concept of nutritionally insignificant rather than absolute absence. It therefore does not
have regard to principle 6 in the Draft Assessment Report (‘consistency of preferred
nutrient criteria with international and Codex criteria for nutrition claims. For the
purpose of developing preferred criteria Codex criteria will act as an arbitrator’);
it is inconsistent with ‘no detectable’ criteria for gluten and lactose claims;
there are ever decreasing levels of detection by ever increasing sensitivity in analysis;
there could be a negative impact on public health as consumers will no longer be able
to use this identifier and could therefore revert to consuming higher fat or other
nutrients;
there could be a serious challenge under the WTO Technical Barrier to Trade
Agreement;
it imposes an additional regulatory burden;
it could reduce the competitiveness of exports or at least add costs by requiring separate
labels for domestic and export products;
many manufacturers have built businesses in response to consumer demand for ‘free’
products (e.g. ‘sugar free’ chewing gum);
although NIPs provide detailed information, a claim such as ‘fat free’ is more useable
and meaningful information for busy consumers;
the NIP acts as a disclaimer;
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conflict arose when CoPoNC was first developed, but it was agreed that international
practice would prevail. There has not been an issue since then and there has not been a
challenge in the Australian courts despite ample opportunity;
it will stifle innovation.
AFGC, Goodman Fielder, CMA and Nestlé recommended that Codex criteria are adopted
while Unilever and Danisco USA preferred retention of existing criteria. Goodman Fielder,
Nestlé, CMA and Unilever stated that if their first preference is not adopted, then criteria
should be based on ‘not detectable’ and in Nestlé’s case, preferably to a particular standard
method. FBIA also supported ‘no detectable’ nutrient, while ASA and Natural Products
supported zero tolerance.
Finally Goodman Fielder urged a resolution of the potential conflict between fair trading
legislation and international practices for nutrition content claims at a whole-of-government
and New Zealand level in order to avoid a WTO challenge.
REPLACEMENT TERM ‘VERY LOW’
Many submitters agreed that if ‘free’ claims are to be prohibited given advice from the
ACCC and NZCC, then a replacement term like ‘very low’ with CoPoNC criteria would be
an appropriate alternative (Goodman Fielder, Coles, FBIA, MLA, ACCC, CHC, SA Dept
Human Services, Diabetes Australia, DAA, Rosemary Stanton, Griffins, Tatua, Cerebos).
Tatua questioned whether it would be appropriate to align the provisions for a ‘low’ lactose
or gluten claim with a ‘very low’ claim as is permitted for fat and other nutrients.
In contrast a large number of submitters specifically opposed a replacement term for ‘free’
(ASA, NZ Nutrition Foundation, Nestlé, Unilever, Danisco USA, Arnott’s, ADC & ADPF,
AFGC, Food Liaison, MGC, NHF Australia). The main reasons were that ‘very low’ claims
would be misleading as
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there is either no nutrient or an insignificant amount present;
it is meaningless to consumers;
it is not used internationally;
it would create NIP labelling difficulties as the specific amount would have to be
declared;
it could result in consumers avoiding products because ‘very low’ has a different
meaning to ‘free’;
it could result in the perception that products have been reformulated and an increased
amount of a nutrient is now present.
NZ Nutrition Foundation opposed the term because of the large number of allowable claims.
NHF Australia suggested that alternative terms should be consumer tested, such as ‘minimal’.
Food Liaison considered ‘99.9% free’ preferable to ‘very low’, while InforMed Systems
suggested ‘nutritionally insignificant’ or ‘negligible’.
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ENERGY
Griffins advised that clarification is needed on claims such as ‘excellent source of energy
from carbohydrates’. Their preferred criteria for such a claim were for a maximum
percentage level for fat and sugar, 30% energy from fat and <10% of its average energy
from saturated fatty acids and trans fatty acids, and a similar criterion to the ‘reduced sugar’
claim.
Several submitters commented on the units of expression for energy. InforMed Systems was
concerned about the use of ‘joule’ rather than the readily understood term ‘calorie’, but
conceded that it is now too late to reverse back. FTA Vic believed that ‘calorie’ claims
should not be a permitted claim as consumers should now be aware of the term ‘joule’, but
recommended use of ‘calorie’ or ‘cal’ in the nutrition information panel.
LOW (IN) ENERGY/JOULE/CALORIE
Most submitters who provided comment on this claim supported it (AFGC, Dairy Farmers,
FTA Vic, CHC, Goodman Fielder, SA Dept Human Services, NZ Nutrition Foundation,
Tatua, ADHB, NZDA, CMA, Nestlé and Unilever), noting that the claim has only recently
been reviewed and incorporated into Volume 2.
Food Liaison, however, suggested that although the Codex position has been proposed for
‘low energy/joule/calorie’ claims, consideration could be given to the approach adopted by
the US and Canada, which permits an increased energy level for products like jams and
confectionary that are consumed in small amounts. Natural Products was of the view that the
claim should be expressed on a percentage basis rather than different values being provided
for beverages and solid foods. SA Dept Human Services queried when calorie claims would
be removed.
REDUCED (IN) ENERGY
There was support for ‘reduced energy/joule/calorie’ claims and the proposed criteria from
the AFGC, Dairy Farmers, FTA Vic Goodman Fielder, CHC, SA Dept Human Services,
Tatua, NZDA, CMA, Nestlé and Unilever on the basis that it is consistent with other
proposed comparative claims and with Codex recommendations. The NZDA also noted that
because overweight and obesity are well recognised as epidemic in New Zealand, such claims
can be useful. Although the ADHB and the NZ Nutrition Foundation supported the claim,
they preferred the NZFR criteria for reduced claims ‘of at least one third less compared with
its normal counterpart’. Natural Products recommended that the nutrition information for the
reference food be included in the NIP. Mainland Products and FTA Vic advised that energy
declarations in the nutrition information panel should be expressed as calories as well as
kilojoules.
CALORIE FREE
In addition to the comments made by submitters who opposed the prohibition of ‘free’
claims, the AFGC, Natural Products, Nestlé and Unilever specifically opposed the prohibition
of ‘calorie free’. The AFGC recommended that the current Codex provisions be adopted
while Natural Products believed the claim should be permitted with zero tolerance. FTA Vic,
CHC, SA Dept Human Services, Tatua, ADHB and NZDA supported the proposed drafting.
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PROTEIN
National Foods, SA Dept Human Services, ADHB and the NZDA opposed protein claims
mainly on the basis that protein intakes are much higher than required. The NZDA believed
that protein claims could easily be misinterpreted in terms of biological value and associated
fat content.
HIGH (IN) PROTEIN
Seven submitters supported the claim and its proposed criteria (AFGC, CHC, GWF, Griffins,
InforMed Systems, Natural Products, Tatua). However others had concerns with the proposed
criteria. Diabetes Australia, MGC, MLA, National Foods, DAA and ADC & ADPF argued
that because the criteria do not address protein quality, foods such as milk and cheese, which
contribute significantly to protein intake, will not meet the proposed requirement, whereas
some plant derived foods that may not necessarily contain most or all essential amino acids in
sufficient quantities will. Karen Cashel and National Foods also justified the need for protein
quality as a criterion because of its importance for certain age groups such as children.
Horelys did not believe the %DRV criteria would be appropriate for active sports people who
have higher requirements and noted that powdered protein supplements contain much higher
amounts than the proposed 10% by weight for solid foods. In contrast, SA Dept Human
Services noted that the demand for such foods by some people in the fitness industry is
unjustified.
Alternative recommendations were to base criteria on:
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‘per serving’ rather than ‘per 100g’. ADC &ADPF and MGC preferred a framework
similar to that used for fibre claims, which are based on %RDI. MLA, DAA, HWA and
Diabetes Australia suggested a minimum of 10 g protein per serving, which equates to
two times the Codex value for ‘source of protein’. HWA argued that ‘per serve’ is
consistent with vitamin and mineral claims and with voluntary Percentage Daily Intake
information for macronutrients. It also stated that baked beans and other legumes
recommended for vegetarian diets have higher serving sizes than for meat, fish and
chicken, which compensates for the lower relative protein content.
a proportion of energy rather than absolute content (Dairy Farmers).
NZFR criteria (MoH NZ).
While Tatua believed that consumers would check the Nutrition Information Panel for fat if it
were of concern, it stated that if a disqualifier is applied to fibre claims, then a similar
approach should be considered for ‘high protein’ claims.
In addition to those who opposed all protein claims, FTA Vic and NZ Beef and Lamb
opposed ‘high protein’ claims on the basis that there is no dietary evidence for the claims and
no perceived benefit.
SOURCE OF PROTEIN
Several submitters requested a ‘source of protein’ claim (AFGC, GWF, MLA, Diabetes
Australia, DAA, NZGMA, NZJA, NHF NZ, HWA, Nestlé, Unilever) because products like
milk and baked beans will not meet the proposed criteria for ‘high protein’ and because it is
provided for by Codex.
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Some argued for Codex criteria (AFGC, Nestlé, Unilever) while others believed that the
criteria defined in Volume 1 of the Code were appropriate (MLA, Diabetes Australia, DAA,
HWA).
SA Dept Human Services specifically opposed a ‘source of protein’ claim because Australian
protein intake is higher than required and protein information is already provided in the NIP.
LOW IN PROTEIN
NZ submitters who commented on ‘low protein’ claims agreed that there is no need for the
claim, despite the fact that it is provided in the NZFR (Horleys, InforMed Systems, MoH
NZ). MoH NZ stated that the review of Medical Foods would need to address claims on
specialist ‘low’ and ‘very low’ protein foods where these are required for particular medical
conditions. InforMed Systems however believed that a combination of professional
guidance as well as information in the NIP is sufficient to guide such people.
OTHER PROTEIN CLAIMS
Other protein claims that submitters supported were ‘good source of protein’ as currently
provided under Codex (NZJA, and Natural Products, Unilever), ‘very high in protein’ as
provided in the Canadian proposal (CHC and Natural Products), ‘excellent source of protein’
(Natural Products), ‘provides protein’ (GWF) and ‘protein enriched/increased’ (Natural
Products). Diabetes Australia and DAA noted that there is no definition for ‘provides
protein’, despite a clear definition in Volume 1.
FAT
General support for fat claims came from NZGMA (except for the prohibition of ‘fat free’
and the criteria for ‘%fat free’), Tatua (except for the drafting for ‘very low (in) fat’) and
FTA Vic. Karen Cashel supported ANZFA’s approach of sub-components of nutrients (e.g.
types of fatty acids) triggering full reporting of related components (i.e. fat and its major
components). Karen Cashel also supported this approach for food components that are
strongly linked in the minds of consumers (e.g. fat and cholesterol).
Several submitters had general concerns with fat claims. NZ Beef and Lamb and ADHB were
of the view that there are too many fat claims permitted, which they believe causes confusion
amongst consumers. They queried whether claims such as ‘low fat’ and ‘very low fat’
actually achieve different health benefits. ADHB therefore submitted that only ‘reduced fat’
be permitted.
Mainland did not believe the proposed claims and their criteria provided sufficient flexibility
for the meat and dairy industry. Tony Beard objected to the inconsistent use of measurements
(e.g. 5.1g of fat per 100 mL) on the basis that it is difficult to calculate the percentage of fat
within the food. He recommended measurements be based on mass as the majority of fat is
labelled in this way. Pritikin similarly objected to the units of expression, particularly for
claims such as ‘98% guilt free’, preferring the criteria be based on a percentage of the energy
content. For example the fat content for ‘Carnation Light and Creamy’, which carries the
‘98% guilt free’ claim, equates to 15% of the energy value. Pritikin also objected to ‘no
added fats’ claims when vegetable oil has been added.
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Finally, NHF Australia had concerns about inappropriate methods of fat analysis being used
in order to comply with criteria. They cited the results of three different methods of analysis
for a cereal based product (1.2, 2.6 and 5.4 g per 100g for the Soxhlet method, the acid digest
fatty acids method and the acid hydrolysis method respectively), They noted that
manufacturers are more likely to use the Soxhlet analysis when making ‘% fat free’ or ‘low
fat’ claims, which is potentially misleading for consumers and not equitable for all
manufacturers. NHF Australia therefore recommended that appropriate methods of analysis
be listed for product type (e.g. for cereal based products the acid hydrolysis method should be
used but for meat products, the Soxhlet method is preferable).
LOW (IN) FAT
Several submitters who provided comment on this claim supported the criteria (AFGC, GWF,
CHC, SA Dept Human Services, NHF NZ and Nutrition Foundation). Several other
submitters, however, wanted specific criteria developed for certain products that cannot
currently make the ‘low fat’ claim but are significantly lower in fat than the proposed 25%
reduction required for ‘reduced fat’ claims (Mainland Products, MGC, MLA, Natural
Products, DAA). Mainland Products, MGC and MLA requested criteria for ‘low fat’ dairy
products as it was pointed out that the Dietary Guidelines for Australians recommend low fat
varieties of dairy products and fat levels for different food categories are nominated (e.g. ‘low
fat’ cheese is 10% fat or less). MLA also requested that consideration be given to the unique
role of non-carbohydrate containing meat products. It was pointed out that the majority of
trimmed beef and lamb cuts contain <10% fat. DAA preferred a separate ‘low fat’ definition
for main dishes and meal type products with a suggested criterion of  5 g per 100g. Lastly
Natural Products recommended criteria of 5% or less fat for crackers.
Pritikin believed that ‘low fat’ criteria could also stipulate that products must have less than
20% energy.
REDUCED (IN) FAT
Most submitters agreed with the criteria (AFGC, CHC, SA Dept Human Services, NHF NZ,
NZDA, Natural Products, NZ Beef and Lamb, ADHB, MoH NZ, NZ Nutrition Foundation).
NHF Australia, NHF NZ and NZDA also wished to see a reduction of at least 25% in energy
when compared with a reference food, while ADHB preferred a 33% reduction of total fat
and lower total energy than the reference food.
FAT FREE
Industry groups AFGC, National Foods, Pauls, Cerebos, CMA, Nestlé, Unilever, CCC USA,
NZGMA, Natural Products and consumers Helleur and Horseman specifically opposed the
prohibition of ‘fat free’, noting that:
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there are no significant health issues with small tolerances;
it is inconsistent with ‘free’ claims for gluten and lactose and with Codex and
international criteria;
while fair trading in New Zealand has set a legal precedent that ‘free’ is absolute, the
Trade Practises legislation in Australia appears to rely on the principle of ‘average
consumers’ comprehension’ and that consumers are not being misled or deceived by
tolerances of 0.15% fat.
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It was stated that prior correspondence from the ACCC to an Australian dairy company
indicates that ‘no fat’ claims on dairy foods do not appear to be causing confusion to
consumers and previous market data provided to ANZFA show consumer acceptance
and understanding of the concept;
it is not cost-minimising. For example the cost to the dairy industry in the milk and
yoghurt segments is estimated at $A167.9 million, when their annual growths are 3.9%
and 20% respectively;
import and export of certain products might be impeded without reformulation or
relabelling;
consumers can view the mandatory NIP for the actual fat content;
it removes the opportunity for consumers to easily identify ‘fat free’ foods;
claims that are consistent with requirements of the NZCC and ACCC will be
prohibited;
it is more prescriptive legislation.
AFGC, Nestlé and CMA proposed that Codex criteria apply, while Natural Products stated
that ‘fat free’ should be permitted with zero tolerance. Dairy Farmers advised ANZFA that
‘no fat’ has become more widely used and that the criteria for ‘fat free’ should therefore also
be applied to ‘no fat’ and ‘not fat’.
Only four submitters specifically supported the prohibition (Griffins, NZ Beef and Lamb,
MoH NZ, NZ Nutrition Foundation).
VERY LOW FAT
While Coles, CHC, SA Dept Human Services and MoH NZ agreed with using the current ‘fat
free’ criteria in CoPoNC for ‘very low fat’ claims, CMA, CCC USA, Danisco USA, Natural
Products and NZDA did not, on the basis that no other country provides for ‘very low fat’
claims, it would be confusing for consumers, consumers requiring such a diet should seek
professional assistance and the claim may enhance consumption of low fibre, carbohydrate
rich foods. AFGC only supported the claim if ANZFA maintains its position on ‘free’ claims.
Griffins noted that ‘extra low fat’ and ‘very low fat’ claims are already being used by some
manufacturers and are easily understood by consumers. Pritikin recommended that in
addition to the fat criterion, products should contain <10% energy and SA Dept Human
Services supported the inclusion of a statement about the actual fat content.
% FAT FREE
A large number of submitters provided comment on ‘% fat free’ claims, with opinions
ranging from recommendations to prohibit the claim to requests for permission to apply the
claim to more than just ‘low fat’ foods.
A mixture of industry and public health agencies supported the criteria (Coles, Paradise
Foods, NHF Australia, MoH NZ) as it ensures consumers are not misled. NHF Australia cited
their consumer research, which indicates that consumers understand the claim and prefer it to
any other nutrition content claim.
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A few other submitters supported aspects of the criteria. HWA and AFGC agreed with the
proposed ‘low fat’ criteria but opposed the declaration of actual fat content in conjunction
with the claim, on the basis that it is overly prescriptive because the mandatory NIP has such
information and is inconsistent with other claims where there is no requirement to state the
actual value in conjunction with the claim (the only similar requirement is for ‘no added
sugar’, ‘no added salt’ and ‘unsweetened’ claims where reference must be made to the NIP,
not the actual amount). HWA believed that if a reference is necessary then their preference
was for an asterix to be used next to the claim. In contrast, Diabetes NZ specifically
supported the declaration of actual fat content.
A large group of public health agencies, a health professional and a consumer organisation
recommended that the claim should be prohibited (CHC, SA Dept Human Services, Diabetes
Australia, DAA, Pritikin, Rosemary Stanton, ADHB, NHF NZ, NZDA, NZ Nutrition
Foundation, NZ CI) on the basis that:
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it has the potential to mislead consumers. It implies that some percentage of the food
has no fat as the emphasis is on ‘free’ rather than ‘% fat’ (i.e. a product containing 2%
is not ‘free’ of fat). Also, as it is not comparable to a reference food, it can be
misinterpreted, especially in relation to energy content;
it does not provide any additional useful information to the ‘low fat’ claim;
a ‘fat free’ product would be able to make a ‘100% fat free’ claim;
it contributes nothing to nutrition or health;
there are many ‘x% fat free’ foods in the marketplace that have flouted the CoPoNC
‘low fat’ criteria. This has led to a great deal of confusion among consumers as ‘97%
fat free’ does not sound very different to ‘94% fat free’;
it is consistent with ANZFA’s prohibition on all ‘free’ claims, ACCC and NZCC’s zero
tolerance policy and with UK legislation.
CHC requested that if the claim is not prohibited then they preferred a ‘% fat’ claim. NZ CI
supported ANZFA’s criteria in such a case, while Pritikin suggested that criteria should be
included for energy content. A consumer, Geoff Wilson, argued that when 3% fat is
calculated as a percentage of total energy the value far exceeds 3% and thus makes a mockery
of the 3% fat claims. Consumers R. Kemp, Twigg Weight Watchers WA and Ronnie
McKennery expressed similar frustrations with the claim.
In contrast to the above, a large group of industry submitters objected to the criteria proposed
by ANZFA (Nestlé, Cerebos, CMA, Unilever, GWF, Arnott’s, Dairy Farmers, ASA,
Mainland, Natural Products, NZGMA). Nestlé, Arnott’s, GWF, Dairy Farmers, ASA and
Mainland Products argued that:
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a limit to 3 g per 100 g would limit consumer choice when such claims provide factual
and useful information when comparing a product against a high fat counterpart. GWF
suggested 5 g per 100 g while Mainland Product, Tegel Foods and Natural Products
recommended 10 g per 100 g in line with the NHF NZ ‘Pick the Tick’ programme;
under fair trading law it would not be misleading to have ‘% fat free’ claims for foods
that are not low fat foods;
it is inconsistent to allow a food with no fat to make a ‘100% fat free’ claim but not a
‘fat free’ claim;
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it is inconsistent to allow ‘% fat free’ claims but not ‘% saturated fat free’, ‘% sugar
free’, ‘% salt free’ and ‘% calorie free’ claims. In such cases advertisers are forced to
make misleading statements by using the ‘very low’ claim;
it would have a significant impact on industry such as NZ Mainland Products meat
business who make claims down to ‘90% fat free’ (e.g. for salami);
one of ANZFA’s objectives is the provision of adequate information for consumers to
make informed choices. ‘Reduced fat’ claims for meat and dairy products are more
confusing than ‘% fat free’ because of significantly varying fat contents in meat
products and because consumers are required to read the NIP to interpret ‘reduced fat’.
In addition to the submissions made by AFGC and HWA above, Cerebos, CMA, Nestlé,
Unilever, Natural Products, NZGMA objected to the declaration of the actual total fat content
in conjunction with the claim on the basis that it:
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duplicates the mandatory information in the NIP;
does not provide for minimum effective regulation as required by COAG;
is inconsistent with P246 Labelling Omnibus, which proposed Std 1.2.10 be amended
to avoid unnecessary duplication of nutrition information and characterising
declarations that might confuse consumers;
limits space on labels;
does not encourage the use of the mandatory NIP;
would require label changes for all products under the CoPoNC system, even though
the nutritional criteria for the claim has not changed;
contradicts other government policy to reduce packaging and minimise waste for
environmental purposes.
Mainland Products suggested that in addition to its recommended increased leniency to a
maximum of ‘90% fat free’, additional conditions could be applied, such as the product also
meeting the criteria for ‘reduced fat’ and the actual total fat content following the ‘% fat free’
claim on the label (expressed as a percentage of the food). Mainland Products also believed
there should be some provision for process variability such as +1/-1%.
Finally, in relation to other related claims, GWF proposed that a ‘moderate fat’ claim be
developed with no more than 5 g per 100 g and disqualifying criteria for trans and saturated
fat levels of no more than 28% total fatty acids or 1.5 g per 100 g. GWF stated that this would
support the Australian Dietary Guidelines and also enable ‘95% fat free’ claims to be made.
SATURATED FAT
NZDA stated that there is strong evidence of an association between a diet high in saturated
fat and risk of cardiovascular disease and that data suggests the New Zealand population is
consuming too much saturated fat. NZDA therefore believed that the goal of nutrition
labelling and claims should be to encourage consumers to choose foods high in unsaturated
fatty acids compared to saturated fatty acids. Accordingly, they and NHF NZ recommended a
claim such as ‘proportionally low in saturated fat’. GWF suggested that consideration be
given to a ‘very low in saturated fat’ claim for consistency with fat claims.
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Nestlé noted that trans fatty acids are not a form of saturated fatty acids as stated in the Draft
Assessment Report although some act like them in the body. They also noted that the
definitions of trans fatty acids and saturated fatty acids in Standard 1.2.8 infer that they both
have the same steric configuration. Furthermore, Nestlé stated that ANZFA is defining fatty
acids and associated claims by their physiological similarities (i.e. cholesterol raising effect)
rather than by their chemical structure and it should therefore ensure that those fatty acids,
including specific saturated fatty acids that do not produce similar physiological conditions
are not included in combination with those trans and saturated fatty acids that do produce the
physiological effect.
For instance trans fatty acids in milk do not raise LDL cholesterol. ADC & ADPF argued in a
similar way, concluding that in light of the increasing evidence indicating that not all trans
fatty acids are detrimental to health, the inclusion of generic trans fats has the potential to
mislead and may create consumer confusion. They cited epidemiological studies that trans
fatty acids form hydrogenated oils and not ruminant fat is associated with heart disease as
well as literature that indicates trans fatty acids in dairy fats (conjugated linoleic acid and
vaccenic acid) have potentially beneficial physiological properties in relation to several types
of cancer, heart disease, bone formation and immune function.
Dairy Farmers, FTA Vic, NHF Australia, HWA and Unilever supported the proposed criteria
for saturated fat claims (with the exception of Unilever’s opposition to ‘saturated fat free’).
Unilever argued that they reflect the increasing evidence of the impact of both saturated and
trans fatty acid intakes and closely link with the draft Dietary Guidelines for Australians.
Nestlé, however, pointed out that the proposed conditions are not consistent with Codex and
therefore do not allow for a harmonised approach.
LOW (IN) SATURATED FAT
Most submitters who provided comment on this claim were in support of ‘low saturated fat’
claims and the proposed criteria (AFGC, GWF, SA Dept Human Services, HWA, Unilever,
Tatua, MoH NZ, Natural Products, NZ Nutrition Foundation). Unilever’s support for the
criteria was because it reflects the increasing evidence of the impact of both saturated and
trans fatty acid intakes and closely links with the draft Dietary Guidelines for Australians
(2002).
The MoH NZ stated that removal of the NZFR ‘low fat’ criteria would enable higher fat
products such as oils to make the claim. The NZ Nutrition Foundation suggested that
consideration be given to criteria for total fat because NZ intakes are still above
recommended levels and obesity is reaching epidemic proportions. In contrast to the MoH
NZ’s rationale, the NHF NZ argued that the claim’s criteria, which are based on g per 100 g
restricts products with higher fat contents such as oils and stressed that the ratio of saturated
to polyunsaturated fatty acids plays a greater role in the diet compared to a reduction in
saturated fatty acids alone. NHF NZ and Natural Products advised that the claim’s criteria
should be calculated as a percentage rather than in terms of the stated levels. NHF NZ’s
preference was for a maximum percentage of saturated fatty acids and trans fatty acids, which
they believed should be 28% of the total fatty acids of the food in order to ensure
consistency with the provisions for fatty acid claims in Volume 2 and because the ratio of
saturated to polyunsaturated fatty acids plays a greater role than a reduction in saturated fatty
acids alone. This equates to the recommended criteria.
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Fonterra queried whether the claim should be ‘low saturated fat and trans fat’ if the criteria
are for low saturated and trans fatty acids.
REDUCED (IN) SATURATED FAT
Several NZ submitters expressed preference for different criteria to those proposed for
‘reduced in saturated fat’ claims. In order to ensure consistency with fatty acid claims in
Volume 2, the NHF NZ recommended a reduction of at least 25% saturated fatty acids, a
statement of comparison with a reference food and a total of combined trans and saturated
fatty acids of 28% of the total fatty acids of the food. NZDA similarly suggested a reduction
of at least 25% saturated fatty acids and a maximum percentage of saturated and trans fatty
acids. ADHB, however, were of the view that the reduced claim should be the only saturated
fat claim to be permitted and that the total saturated and trans fatty acid content should be
66% of the same quantity of reference food. NZ Nutrition Foundation similarly expressed
concern about the change from the NZFR criteria of ‘at least one third less’ to ‘at least 25%
less’ and suggested that the total fat content be examined as a disqualifying criteria for the
reasons discussed above.
Other New Zealand submitters supported the claim and the proposed criteria (Natural
Products, Tatua, MoH NZ). In addition to those who provided general support for saturated
fat claims, AFGC, SA Dept Human Services and NHF Australia also expressed their support.
SATURATED FAT FREE
SA Dept Human Services, NHF Australia, NZ Nutrition Foundation, Tatua, and MoH NZ
supported the prohibition of ‘saturated fat free’ claims in addition to those who provided
general support for saturated fat claims. Others however contended that the claim should be
permitted. The AFGC recommended the adoption of Codex criteria as did Nestlé and
Unilever. AFGC and Nestlé also submitted their second preferred option for a ‘very low in
saturated fat’ claim with the tolerances set by Codex’s ‘free’ claims and in Nestlé’s case, a
‘saturated fat free’ claim with ‘no detectable’ criteria. Unilever requested a similar approach
while Natural Products preferred zero tolerance for ‘saturated fat free’ claims. The reader
should also refer to the comments submitted against ‘free’ claims.
MONOUNSATURATED AND POLYUNSATURATED FATTY ACIDS
AFGC, Dairy Farmers, FTA Vic, CHC, SA Dept Human Services, NHF Australia, Natural
Products, ADHB and Unilever agreed with the proposed claims and criteria. MLA provided
the only comment in opposition, contending that the total saturated and trans fatty acid
content criteria is inconsistent with omega-3 fatty acid claims and that foods should therefore
either meet the current requirement of Clause 12(1)(a) of Standard 1.2.8 of Volume 2 or
‘contain no more than 5 g of saturated and trans fatty acids per 100 g of the food’ and Clause
12 (1)(b).
AFGC queried whether the generic provisions for comparative claims would apply to
‘increased polyunsaturated fat’ and ‘increased monounsaturated fat’ claims. AFGC and
Cerebos also noted that Volume 2 and the Draft Assessment Report for P234 have no
definitions for ‘high’ or ‘good source’ claims.
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While the former noted that this might not be a problem as such claims do not appear
commonly in the marketplace, the latter suggested a similar classification to omega-3 fatty
acid claims. NZ Beef and Lamb supported a ‘source of monounsaturated fat’ claim with
levels which allow for the inclusion of at least the highest two or three sources rather than
just one in order to increase consumer’s choice and their ability to achieve dietary goals.
Tatua highlighted that the minimum requirement for a polyunsaturated claim is inconsistent
with the NZ Nutrition Taskforce’s 2000 targets of 6-10% of total energy from
polyunsaturated fat and a total fat of 30-33% of total energy.
OMEGA FATTY ACID CLAIMS
There were some strong views expressed in opposition to the criteria for omega fatty acid
claims, especially from Australian submitters. AFGC, ADC & ADPF, Clover, MGC, MLA
and the NZGMA did not agree with the current saturated fat disqualifying criteria for the
following reasons:
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the mandatory NIP requirements when an omega fatty acid claim is made provides
sufficient information for consumers to determine their own requirements;
consumers have different needs so it is not possible to determine disqualifying criteria.
For instance long chain omega-3 fatty acids are essential for brain and eye development
so the claim has relevance for pregnant and lactating women as well as for children
who require a diet with up to 40% energy from fat.
the criteria are inconsistent with other claims and food regulations in Australia and New
Zealand. The Draft Assessment Report removed disqualifying criteria for ‘low
saturated fat’ and comparative claims. The new draft regulations for infant formula
require maximum amounts of omega-3, omega- 6, erucic acid and trans fatty acids, but
have no specific disqualifying criteria for saturated fatty acids. AFGC therefore
recommended that consistency be applied to nutrition content claims through a
minimum, maximum or proportional reduction or increase.
the criteria are inconsistent with international regulations. No other country presently
regulates disqualifying criteria for omega-3 fatty acids. Canada is not considering them
in its review either.
disqualifying criteria have relevance for health claims where the overall nutrition
profile is important to the claimed benefit, but are not relevant for nutrient content
claims which are simple statements of nutrient content. It was noted that there are no
disqualifying criteria for nutrition function claims except for vitamin and minerals.
expert bodies such as FAO/WHO and ISSFAL have developed recommendations for
omega-3 fatty acid intakes for different populations. Several fatty acid and human
nutrition experts in Australia are also reported to support removal of the disqualifying
criteria.
MLA argued that there is sound scientific reason to include DPA content in the calculation of
the total content of omega-3 fatty acids, which will thus affect the minimum content for
making such claims. MLA state that:
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DPA is a precursor of DHA. Animal studies have shown it to serve as a substrate for
the production of DHA.
DPA is a naturally occurring omega-3 fatty acid in fish muscle and oil and in lipids
from lean muscle tissue of terrestrial animals.
all studies on the beneficial effects of fish oils and flesh would have contained DPA
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there are significant increases in EPA and DPA when lean red meat is the sole source of
long chain omega-3 fatty acids in human studies.
EPA and DHA do not have identical effects in vivo in humans.
a recent Finnish study indicated that men who were in the highest fifth for serum DHA
and DPA had a 44% reduced risk of acute coronary events compared with men in the
lowest fifth.
While HWA supported the proposed criteria for omega-3 fatty acid claims, they opposed the
use of omega-6 and omega-9 claims, particularly ‘good source of omega-6 fatty acids’
because of the view that the Australia diet is too rich in linoleic acid. HWA requested the
prohibition of ‘source of’ claims for omega-6 and omega-9 fatty acids unless there are
statements accompany the claims explaining the difference between omega-3, omega-6 and
omega-9 fatty acids and outlining the overall aims for dietary balance. Fonterra did not
consider omega-6 and omega-9 fatty acid claims to be necessary either, nor did they see
justification for omega-3 claims based on the Dietary Guidelines for Australians and on the
lack of evidence demonstrating beneficial effects from omega fats added to food in nonpharmaceutical amounts (except naturally from fish consumption).
CHOLESTEROL
PROHIBITION OF ALL CHOLESTEROL CLAIMS
This issue was a controversial one in that a large number of submitters commented on it and
opinions were strongly divided. Most New Zealand submitters were in support of the
prohibition (Griffins, InforMed Systems, NZ Beef and Lamb, Tatua, CPH, NHF NZ, NZDA,
NZ Nutrition Foundation, NZ CI). Some Australian submitters also agreed with the
prohibition (Dunn Son and Stone, SA Dept Human Services, MLA, NHF Australia). The
principal rationale was that the emphasis is now on the reduction of saturated fats in the diet
rather than dietary cholesterol and not all consumers are aware of this. InforMed systems
stated that even though individuals with elevated LDL cholesterol may benefit from a
lowered dietary cholesterol intake, food standards are not developed to cater for them and
they would at any rate benefit more from a lowered intake of saturated fat. Dunn Son and
Stone requested that stock in trade extensions be considered given the re-labelling that has
already taken place in accordance with the standard.
Slightly fewer submitters opposed the prohibition (CHC, Goodman Fielder, National Foods,
Natural Products, NZGMA, Cerebos, Nestlé, Unilever). Arguments against were:
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consumers are aware of cholesterol and look for that information along with
information on fat content (CHC)
there is the potential for significant negative impact for the food industry as a result of
the prohibition (Cerebos, Nestlé, Coles). Harmonisation with international practices is
important for exporters (CHC)
some doctors advise patients to reduce their dietary cholesterol, so these consumers will
be confused by the prohibition (Natural Products, NZGMA). The NHF recommend that
people with elevated plasma cholesterol restrict the intake of cholesterol-rich food
(National Foods).
science is evolving and new trends may arise which add to consumer confusion
(Natural Products)
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there are no health and safety reasons for the exclusion of cholesterol claims from the
Code (NZGMA). There is unlikely to be evidence, which shows that significant health
issues are associated with the consumption of small amounts of cholesterol (National
Foods)
nutrition education is required if there is evidence to demonstrate that knowledge about
dietary cholesterol and blood cholesterol is poor, rather than a change in food
regulation (National Foods)
the food industry receives phone calls for requests for cholesterol claims (Nestlé)
the prohibition is not cost-minimising and would impose yet another packaging change
(National Foods).
Other comments in regard of cholesterol claims were that there are many products on the
market with ‘cholesterol free’ that do not meet the criteria (Unilever). Food Liaison noted
that the declaration of cholesterol is mandatory in the US, so US products would be illegal in
Australia and New Zealand, as the listing would contravene the Code. Coles assumed that if
the prohibition is introduced, the NIP in Standard 1.2.8 Clause 5 will be revised. CCIWA and
Arnott’s stated that there is a need for effective consumer education if the prohibition takes
effect.
LOW (IN) CHOLESTEROL
There were few comments relating specifically to ‘low cholesterol’ claims. While Unilever
supported the proposed prohibition, the AFGC, Natural Products, Cerebos and HWA all
opposed it. The AFGC argued that Codex provisions should apply, while Cerebos preferred
CoPoNC criteria and Natural Products requested NZFR criteria. Although HWA supported a
move away from cholesterol claims to saturated fat, retention of ‘low cholesterol’ was
recommended with the proviso that low saturated fat criteria apply, because of consumer
acceptance and understanding of the current claims. Cerebos also argued that ‘low
cholesterol’ claims can act as an indicator for products low in saturated fat.
REDUCED (IN) CHOLESTEROL
The AFGC, HWA and Natural Products specifically opposed the prohibition of this claim.
Both the AFGC and Natural Products recommended consistency with the criteria for
comparative claims, while HWA requested that low saturated fat criteria apply, for the same
reasons as given above. In contrast Nestlé stated that the claim could be removed.
CHOLESTEROL FREE
In addition to the many submitters who supported the prohibition of all cholesterol claims,
two submitters specifically supported prohibition of ‘cholesterol free’ claims (FTA Vic and
Mainland Products). This contrasted to the many submitters who specifically opposed the
prohibition (AOOA, GWF, ADC & ADPF, AFGC, Dairy Framers, MGC, ASA, Natural
Products, Cerebos, Unilever and Nestlé) for reasons such as:

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there is consumer interest and demand for ‘cholesterol free’ claims
the Dietary Guidelines do not oppose ‘cholesterol free’ claims
people with elevated plasma cholesterol levels should restrict their intake of
cholesterol-rich foods as recommended by the Australian Heart Foundation’s National
Nutrition and Metabolism Advisory Committee
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nutrition content claims are based on absolute values for nutritional content and are
without any value judgements about the benefits. It is not about health claims
‘cholesterol free’ claims, which consumers are aware of and accepting of can act as an
indicator for products low in saturated fat
if a claim is justifiable and true then it should be permitted.
labelling should not be prohibited if it is permitted by Codex. An attempt at
harmonisation is important for importers such as those in the olive oil industry.
Several different criteria were proposed for a ‘cholesterol free’ claim, namely zero tolerance
(ASA, Natural Products), ‘no detectable cholesterol’ (AFGC), CoPoNC criteria (AFGC,
Unilever, Cerebos) and Codex criteria (Nestlé). Some submitters also advised that
disqualifying criteria should be included such as no fat (ASA), low in saturated fat (GWF)
and a limit on saturated and trans fatty acid content as given in Standards 1.2.8 Clause 12
(Cerebos).
In support of the prohibition, SA Dept of Human Services argued that such claims have been
problematic in that foods inherently free of cholesterol have made the claim.
CARBOHYDRATES
Opinions were divided as to whether there was merit in including provisions for making
carbohydrate claims. ASDA, Coles, GWF, CHC, Diabetes Australia, DAA, Griffins, Natural
Products and Cerebos were all in support, principally because of the need to maintain
consistency with the provisions for other nutrition content claims and to improve consumer
information. Several submitters also pointed out that such claims are being used by industry
without definition and therefore have the potential to mislead.
GWF did not believe disqualifying criteria would provide value for consumers, given that the
fat, sugar and dietary fibre content are listed in the NIP when such claims are made.
Coles suggested that ‘complex carbohydrate’ be defined, whilst Nestlé did not want
‘carbohydrate modified’ defined because the term was required for some foods in Volume 1.
Manufacturers have continued using the term for consistency.
Many submitters opposed carbohydrate claims (AFGC, FTA Vic, SA Dept Human Services,
Nestlé, Unilever, ADHB, CPH, MFD, NHF NZ, NZDA, MoH NZ, InforMed Systems) on the
basis that there is no scientific rationale to justify their inclusion, there is no evidence of
market failure, they are not regulated internationally as nutrition content claims and
carbohydrate claims for sports foods are already regulated. Health professionals pointed out
that such claims could confuse consumers further as there is large variation in the types of
carbohydrates and their Glycaemic Index values.
LOW (IN) CARBOHYDRATES
In addition to the general support for carbohydrate claims, Horleys specifically supported a
‘low carbohydrate’ claim because of its relevance to sports food products and because there
are already a number of such products with the claim on the market. Their recommended
criterion was <10% for solid foods.
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Horleys also believed that there is scope for a ‘very low carbohydrate’ claim from a sports
food perspective and recommended criteria of <5% for solid foods. CMA recommended the
same criteria but for ‘low carbohydrate’ claims in order for consistency with the criteria for
‘low sugar’ claims.
The NZGMA stated that ‘low carbohydrate’ claims might be useful for consumers seeking to
reduce their energy intake. In contrast, SA Dept of Human Services specifically opposed the
claim because of recommendations to consume a high carbohydrate diet and to allay the
popular myth that weight loss is achieved by a low carbohydrate diet.
HIGH (IN) CARBOHYDRATES
In addition to the general support for carbohydrate claims, Griffins specifically supported this
claim on the basis that the Glycaemic Index is based on a high carbohydrate diet. Horleys
supported the claim because of its relevance for endurance sports food products and because
there are already a large number of such products with the claim on the market. The NZGMA
also argued that the claim might be useful, given emerging evidence of a positive effect from
the consumption of carbohydrate diets.
Horleys and Diabetes Australia did not support restrictions on the sugar content as the former
stated that simple sugars are often required in sports foods for rapid absorption, while the
latter argued that many high sugar foods like fruit have a low Glycaemic Index and contain
significant amounts of dietary fibre, vitamins and minerals. Dietary fibre and energy density
were therefore considered more suitable disqualifying criteria. Horleys argued that sports
food are not formulated with the intention of providing fibre and may even be detrimental to
sports performance, so did not support disqualifying criteria for dietary fibre. Griffins and
Coles thought consideration could be given to both sugar and dietary fibre. The former
thought that the type of sugar as well as the level was important.
SA Dept Human Services specifically opposed the claim, given the absence of a dietary
guideline to change the consumption of carbohydrates. FTA Vic noted that high carbohydrate
claims could be misleading.
SUGAR
Several submitters generally supported the proposed claims and criteria for sugar (Coles,
Dairy Farmers, FTA Vic, CHC, Natural Products, NZ Nutrition Foundation, Diabetes NZ).
Sugar Australia strongly supported the proposed changes except for ‘no added sugar’. Sugar
Australia also strongly criticised ANZFA for several statements, which they believed were
scientifically unsubstantiated. The Draft Assessment Report stated that ‘caution is advised
given the evidence that diets high in sugar are associated with obesity and dental caries,
particularly in children’, whereas Sugar Australia’s argued that:
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dental caries incidence has declined dramatically over the last few decades in most
highly developed countries while sugar consumption has changed very little;
DMFT (decayed, missing or filled teeth) scores have tended to rise in 90 countries with
sugar consumption, there was no evidence of a relationship when 29 industrialised
nations were analysed separately;
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the FAO/WHO Report on Carbohydrates concluded that sugar intake has no adverse
health effects except for dental caries. Their recommendation however is that
‘prevention programs to control and eliminate dental caries should focus on fluoridation
and adequate oral hygiene and not on sucrose intake alone’;
there is no direct causal relationship between sugars and overweight in children or
adults.
In contrast NZDA contended that sugar has for a long time been linked to the development of
dental caries and an excess intake of sweetened drinks has been implicated in the growing
overweight and obesity problems in children.
Sugar Australia also took issue with the statement that ‘foods that are high in refined sugars
are energy dense but do not provide vital nutrients’, arguing that a high simple carbohydrate
diet is not a greater risk for inadequate intake of certain micronutrients than a high complex
carbohydrate or a fat rich diet in overweight subjects and added sugars between 5-16% of
energy do not appear to have any detrimental effect on micronutrient intakes. Lastly Sugar
Australia criticised the statement that ‘in the context of knowledge that foods high in sugar
are often chosen instead of more nutritious, necessary foods’, by providing references, which
suggest that over half of the sugars consumed in Australia come from food groups promoted
as nutrient dense (i.e. milk, fruit, vegetables and cereals) and foods high in sugar are not in
practice replacing more nutritious necessary foods as nutrient quality would reduce as the
proportion of sugar increases.
National Foods specifically opposed the sugar claims on the basis that legislating on the
levels of sugars in foods fosters the myth that ‘sugar is bad’. It was concluded that
communication should be in the context of total diets and not that ‘all sugar is bad’. CCIWA
considered the allowable sugar claims too complex and preferred a more simple generic
based classification of claims.
LOW (IN) SUGAR(S) and REDUCED (IN) SUGAR(S)
Three submitters specifically supported the claims (AFGC, SA Dept Human Services, NHF
NZ) while the ADHB opposed ‘low (in) sugar(s)’. NHF Australia and NZDA recommended
that ‘reduced in sugar (s)’ claims should include a reduction of at least 25% energy. While
the NZ Nutrition Foundation supported the reduced claim, they preferred criteria of at least
33% reduction rather than 25%.
NO ADDED SUGAR(S)
Diabetes Australia and the DAA both supported a prohibition of the claim, arguing that it
causes a great deal of confusion for people with diabetes and their caregivers. InforMed
Systems preferred a prohibition for similar reasons. In contrast NZJA argued that the claim
helps support public health advice to consume only moderate amounts of products containing
added sugars.
Industry opinions was divided on the proposed disclaimers alerting consumer to the
declaration of sugars in the NIP and the presence of natural sugars for ‘no added sugar(s)’
and ‘unsweetened’ claims. The AFGC, ASDA, National Foods, Sugar Australia, CMA,
Nestlé, Unilever, NZJA opposed them, while with GWF, Coles, Dairy Farmers, FTA Vic and
Griffins supported them. Reasons for opposing the disclaimers were that:
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they amounts to double labelling and will result in enormous re-labelling
consumers are well aware of NIPs as demonstrated in ANZFA’s qualitative consumer
research
there is no evidence that consumers misunderstand the claim
CoPoNC criteria are already equivalent to or are stricter than those used in other
countries.
Sugar Australia also took issue with ANZFA’s statement that ‘studies show that extrinsic
rather than intrinsic sugars are the most damaging to teeth’, providing references including a
WHO report, which suggest that the two types of sugars are indistinguishable and intrinsic
sugars are not necessarily safe for teeth.
In contrast health professionals and a consumer group supported the proposed disclaimers
(CHC, SA Dept Human Services, Diabetes Australia, DAA, NHF Australia, ADHB, CPH,
Diabetes NZ, NHF NZ, NZDA, NZ Nutrition Foundation, NZ CI). Tatua stated that the
drafting provides clarity for the consumer. Diabetes Australia and DAA proposed the specific
wording be ‘This product contains natural sugars. See nutrition panel for total sugars
content’. In addition, they supported the inclusion of sugar alcohols in the list of sweeteners
for the criteria, given that they are a source of energy and cause confusion amongst
consumers. The NHF NZ noted that the form of starch and its degree of processing are as
important as the natural sugar content in food.
ASDA, NZJA and HWA did not support concentrated fruit juice being a prohibited added
sweetener for ‘no added sugar(s)’ claims. They argued that it differs from the other prohibited
sweeteners because it is mostly used to prepare juice products. They also noted that a fruit
juice product prepared from juice rather than concentrate would be able to make the claim but
a comparative product made from concentrated juice would not, even though the products
would have equivalent sugar levels. They therefore considered this unjustifiable. The NZJA
also added that it is important for manufacturers to be able to use the claim to distinguish
100% fruit juice made from concentrate from sweetened juices and fruit drinks. Furthermore
HWA stated that the consequences of the proposed drafting might be a trend to replacing fruit
juices with sugar as it is more cost effective for manufacturers. They noted that they presently
sweeten many of their infant foods with fruit juices instead of sugar. Similarly Natural
Products sweeten their fruit preserves by adding apple juice concentrate. As they believed
that consumers normally associate sugar with white sugar, they proposed that the claim be
permitted for products where no extra white sugar is added.
Finally, HWA noted the differences between concentrated and deionised fruit juice.
Deionised fruit juices are highly refined, lack fruit flavour volatiles and contain little more
than fructose, whereas concentrated juices are not as highly refined, contain flavour volatiles
and vary in their nutritional content.
UNSWEETENED
While many submitters specifically supported the claim and the proposed criteria (Natural
Products, Griffins, ADHB, NZ CI, NZDA, Diabetes NZ), one opposed the claim (SA Dept of
Human Services) and several opposed the disclaimer for the reasons provided under the ‘no
added sugar(s)’ claim (AFGC, ASDA, CMA, National Foods, Unilever). SA Dept Human
Services did not consider the claim very meaningful in relation to advising the public about
processed foods which are reduced in sugar.
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CPH noted that there is inconsistency in that concentrated and/or deionised fruit juice is
allowed in products that are ‘unsweetened’ but not in ones bearing a ‘no added sugar(s)’
claim. CPH also said that ‘no added sugar’ and ‘unsweetened’ are technically the same
except for the allowance of artificial sweetener, so for clarification proposed that ‘ no added
sugar and ‘artificially sweetened’ only be permitted.
SUGAR FREE
Many industry submitters, both within Australia and New Zealand and internationally, and a
few consumers, specifically and sometimes very strongly opposed the prohibition on ‘sugar
free’ claims (AFGC, Evan Confectionary, Foodsense, National Foods, Mandurah,
NutraSweet, Snow Confectionery, Wrigley, Noelene Hay, Donna Horseman, CMA, Nestlé,
Unilever, InforMed Systems, NZGMA, CCC USA, Danisco USA, EPA, ISA, Keller &
Heckman, Isomalt Palatinit GmbH). The main reasons were:
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residues of sugar left after processing of ingredients are of no dietary significance;
there is no opportunity for consumers to easily identify ‘sugar free’ foods to support
public health advice to consume only moderate amounts of sugars;
inconsistency with regulatory approaches taken overseas (principle 6 of the review of
P234) and with Codex which could result in a serious challenge under the WTO TBT
agreement;
the belief that the proposed drafting is inconsistent with fair trading laws, which
prohibit misleading or deceptive conduct, rather than ‘free’ claims and concern that
ANZFA’s interpretation of fair trading law is unnecessarily technical and literal. It was
noted that ‘free’ claims are only as good as the latest detection methods and limits and
that the trace amounts of sugar are as close to zero as is possible;
products that contain no sugar can not be promoted as ‘sugar free’
inconsistency with ‘lactose free’, ‘gluten free’, ‘lead free’ and ‘tooth friendly’;
signatories of the Code of Conduct for the Provision of Information on Food Products
in Australia are currently required to comply with CoPoNC, so the costs of re-labelling
are very significant, especially for manufacturers labelling for both domestic and export
markets. This disadvantages the competitiveness of the local industry;
a prohibition would impose more prescriptive legislation, which is not cost minimising;
the confectionary industry has invested heavily in ‘sugar free’ claims based on the
CoPoNC framework and on consumer demand. In Australia the value of the ‘sugar
free’ confectionary sector in 2001 was approximately A$15.2 million. In addition, the
‘sugar free’ gum category in 2001 is estimated at A$150 million). It has become a
recognised growth sector;
polyols have been developed for the ‘sugar free’ market. The small amounts of residual
sugars that are not hydrogenated are technically unavoidable and are covered by polyol
specifications for identity and purity;
the belief that the claim is a useful, simple and easily understood nutrition message as
evidenced by the huge growth in sales. Noted that no consumer has complained to
industry that the claim is false or misleading;
the belief that consumers are aware on reading the NIP that such products have a
tolerance. The NIP can be viewed as a disclaimer;
an overwhelming amount of literature supporting the use of ‘sugar free’ gum to
increase saliva flow and to promote stronger and healthier teeth;
innovation will be stifled.
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The above submitters varied in their preferred criteria for a ‘sugar free’ claim, with the
following alternatives being expressed:
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less than 0.5 g per 100 g solids and 0.5 g per 100 ml liquids (Codex criteria);
no more than 0.2 g of sugars per 100 g of the food or 0.1 g sugars per 100 g of liquid
food (CoPoNC criteria);
less than 0.5 g per serving;
‘no detectable’ sugar based on standard method of analysis;
no sugar;
criteria being developed for foods that are of some health relevance (e.g. ‘sugar free’
chewing gum).
Nestlé also suggested a claim for ‘sugarless’, while several submitters accepted as their last
preference an alternative term to ‘sugar free’ which conveys that sugar does not contribute
significantly to the energy content of the food.
In contrast to the strong opposition above, a few submitters expressly supported the
prohibition of ‘sugar free’ claims (Coles, Sugar Australia, SA Dept Human Services) because
they considered the claim to be misleading and because it is inconsistent with other free
claims such as ‘GM free’.
VERY LOW (IN) SUGAR(S)
Many industry groups and a few public health groups opposed use of the claim ‘very low (in)
sugar(s)’ as a replacement for ‘sugar free’ claims (Foodsense, Mandurah, National Foods,
NutraSweet, Wrigley, Natural Products, NZGMA, ADHB, CPH, NZDA, CMA, CCC USA,
Danisco USA). Industry stakeholders argued that:
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the claim would be false and misleading, as it would indicate a glycaemic effect when
products would contain negligible amounts of sugar and have no glycaemic response;
consumers would not be able to identify sugar free products, resulting in high levels of
confusion and scepticism, particularly amongst consumers who have been comfortable
with ‘sugar free’ products for over a decade;
many consumers may assume that sugar has been added to products;
the claim is not consistent with Codex or the US and Canada’s regulations;
considerable costs would be required with regard to education.
The NZDA felt that the claim was unnecessary and argued that foods using this claim are
likely to be high in fat or low in fibre.
In contrast to those that opposed the claim, SA Dept Human Services, Griffins and NZ
Nutrition Foundation specifically supported it and the proposed criteria, given the rationale
for prohibition of ‘sugar free’.
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DIETARY FIBRE
AFGC, Arnott’s, Dairy Farmers, Goodman Fielder, MGC, Dunn, Son and Stone, Nestlé,
Mainland Products, Natural Products, Tatua and NZ CI generally supported the proposed
drafting with the belief that they agree with CoPoNC provisions and with the current Codex
recommendations, which are being finalised. CMA and Unilever agreed with the exception of
the proposed disqualifier (see ‘disqualifier to prevent high fat food making fibre claims’),
while HWA were supportive except for the ‘enriched’ claim because it was not consistent
with other nutrition claims.
The MoH NZ, NHF Australia and NHF NZ recommended that criteria for fibre claims be
based on a g per 100 g basis, rather that g per serve because manufacturers may manipulate
serving sizes in order to make the claim. NHF Australia recommended though that fruit and
vegetables should be assessed on a per serve basis as certain claims would not be allowed on
a per 100 g criterion. Natural Products believed the criteria should be expressed as a
percentage for the same reasons. NZ Nutrition Foundation, ADHB and NZDA all wanted to
see fewer claims for dietary fibre. NZ Nutrition Foundation and NZDA recommended
‘source of fibre’ and ‘high fibre’ claims while ADHB proposed ‘high fibre’ only. CCIWA
considered the allowable fibre claims too complex and preferred a more simple generic based
classification of claims.
FTA Vic and Dunn, Son and Stone expressed reservations about the fact that the definition
for ‘fibre’ is only based on the method of analysis. Dunn, Son and Stone queried whether
analysis could keep apace with the developing science, while FTA Vic did not believe that
there is currently enough information about fibre and its effects and InforMed Systems
believed that there is no such thing as fibre. MFD had serious concerns with the fact that the
AOAC method is the prescribed method of analysis for dietary fibre, whereas the NZ Food
Composition Database uses the modified Englyst method, thereby placing New Zealand food
manufacturers at a distinct disadvantage to their Australian counterparts.
Finally FTA Vic recommended that the term ‘excellent’ be defined.
DISQUALIFIER TO PREVENT HIGH FAT FOODS MAKING FIBRE CLAIMS
A large number of submitters provided comment on the use of disqualifying criteria for
dietary fibre claims, with the majority, who were mostly industry stakeholders, opposing it
(Arnott’s, ADC & ADPF, AFGC, GWF, Goodman Fielder, MGC, National Foods, Pauls,
CSIRO, Diabetes Australia, DAA, Fonterra, InforMed Systems, Tatua, MFD, CMA, Nestlé,
Unilever). The arguments against use of disqualifying criteria for fat, saturated fat and trans
fatty acids were that:
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it is inappropriate and potentially misleading to prohibit a claim based on arbitrary
disqualifying criteria for which ANZFA has not provided adequate scientific
substantiation (e.g. on what basis was fat and saturated fat chosen? Why were salt and
sugar not included?) Dietary fibre and fat do not share similar diet-disease
relationships;
it creates a trade barrier as no other international regulations have a requirement for fat
and saturated fat levels when making a dietary fibre claim;
it is inconsistent with other recommendations (except for omega fatty acids);
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it withholds potentially useful information when the disqualifying criteria may not be
relevant to an individual’s needs (e.g. fibre is recommended for constipation. A low fat
diet is inappropriate for elderly people who are malnourished and who have
constipation. Other vulnerable groups may include pregnant and breastfeeding women);
foods that are currently recommended in dietary guidelines for their fatty acid profile,
such as seeds and nuts would not be able to make a fibre claim, despite being an
excellent source and despite their link to protection against heart disease. Diabetes
Australia and InforMed Systems therefore only supported disqualifying criteria for
foods that are high in saturated fat;
dairy based beverages with a fat content of 1.5% (i.e. low fat) which have
oligosaccharides and fibre added would be prevented from making a claim;
information on total fat and saturated fat are given in the NIP;
all saturated fatty acids are not ‘bad’. For instance naturally occurring trans fatty acids
in dairy fats have potentially beneficial physiological effects and stearic acid in cocoa
butter does not raise blood cholesterol, nor increase risk of heart disease;
choice of foods is reduced because the criteria do not recognise mixed foods (e.g.
muesli yoghurt) and discourages innovation such as fortifying foods with certain
fibres.
Fonterra, NHF Australia and NHF NZ queried the scientific basis for determining the
maximum level of energy from fat and saturated fat, while AFGC considered that dietary
modelling should be conducted to determine what desirable food categories would be
prevented from carrying useful fibre claims. GWF proposed that the criteria should be
increased to maintain consistency with the fatty acid claims in Standard 1.2.8 (i.e. that total
saturated and trans fatty acids comprise no more than 28% of the total fatty acid content).
There were some submitters who supported the concept of disqualifying criteria (Coles, SA
Dept Human Services, Griffins, NHF NZ, NZ Nutrition Foundation), although a few
disagreed with the criteria proposed. NHF NZ considered that more information is required
before finalising the proposed disqualifying criteria; SA Dept Human Services advocated that
sugar should be included in addition to ANZFA’s proposal and NHF Australia and NHF NZ
supported a restriction on foods that are very high in energy, in addition to ANZFA’s
proposal.
SOURCE OF FIBRE
All but one submitter who provided comment on this claim supported it (SA Dept Human
Services, Natural Products, NZDA, NZ Nutrition Foundation) although two supporters
advised that criteria should be 3 g of fibre per 100 g of food, as recommended by Codex and
prescribed in UK requirements (NZDA, NHF NZ). DAA and Diabetes Australia felt that the
value for meal type products is too high and therefore recommended 1 g per 100 g or trebling
the value for individual foods on a per serving basis (i.e. 4.5 g per serving). ADHB opposed
the claim.
HIGH FIBRE OR GOOD SOURCE OF FIBRE
Five submitters supported the claim (SA Dept Human Services, Natural Products, ADHB,
NZDA, NZ Nutrition Foundation). There were, however, differences expressed on the
criterion.
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MoH NZ preferred criterion with a higher value than the proposed 3 g per serve or 4 g per
100 g for main dishes and meal type products, as did NHF NZ, ADHB, and NZDA who all
supported criteria of 6 g per 100 g as is required in the UK. In contrast DAA and Diabetes
Australia supported a lower value (2 g per 100 g) or trebling the value for individual foods on
a per serving basis (i.e. 9 g per serving). NZDA also wished to have disqualifying criteria of
less than 10 g fat per 100g as recommended by Codex.
VERY HIGH FIBRE OR EXCELLENT SOURCE OF FIBRE
SA Dept Human Services supported the claim, while AFGC and Nestlé opposed the increase
in the criteria from 6 g per 100 g for meal products (as prescribed in CoPoNC) to 8 g on the
basis that there was no justification. Nestlé stated that the net weight of meal products is
generally 300-400 g, which means that 24-32 g dietary fibre per serve (or 80-106% of the
reference value in Standard 1.2.8 for dietary fibre) would be required to make the claim.
DAA and Diabetes Australia also felt that the criterion for meal type products was too high
and suggested 4 g per 100 g or trebling the value for individual foods on a per serving basis
(i.e. 18 g per serving).
INCREASED FIBRE, FIBRE ENRICHED AND HIGHER FIBRE
While SA Dept Human Services supported the claim, ADHB did not. Natural Products
advised that the criteria should be modified to at least 25% more fibre than the reference
product, with a statement of comparison with the reference product and meals must contain
more than 4 g fibre per 100 g.
SALT AND SODIUM
Several submitters supported salt/sodium claims (Dairy Farmers, FTA Vic, CHC, SA Dept
Human Services, Tatua, HWA) on the basis that intakes are high and low salt or salt reduced
products need promoting. Nestlé and Unilever generally agreed with the claims too, although
Unilever opposed the disclaimer for ‘no added salt’ and they both opposed the prohibition of
‘salt free’ claims.
Two public health agencies in New Zealand supported fewer salt claims. ADHB proposed
that only ‘reduced salt/sodium’ be permitted, while NZ Nutrition Foundation supported low
and reduced claims only, with a criterion for reduced claims of one third less than the normal
counterpart.
NZDA recommended that consideration be given to including a total salt level as a criterion
because consumers are confused about the relationship between salt and sodium.
LOW (IN) SALT/SODIUM
There was little comment provided in relation to this claim. SA Dept Human Services, MoH
NZ and Natural Products supported the criteria while ADHB opposed the claim. Mainland
Products believed that consideration should be given to allowing ‘low salt’ claims on bacon
and ham products were significant salt reduction (e.g. 60%) have been achieved compared to
the reference food.
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REDUCED (IN) SALT/SODIUM
Again there was very little comment provided on this claim. SA Dept Human Services,
Natural Products, ADHB and MoH NZ agreed with the proposed recommendations, while
NZDA stated that the claim is unhelpful because products that are relatively high in salt can
still make the claim.
NO ADDED SALT/SODIUM
Three public health agencies specifically supported this claim and the disclaimers (SA Dept
Human Services, NHF Australia, NHF NZ) as did the NZ CI). In contrast four industry
groups opposed the disclaimers (AFGC, Cerebos, Unilever, Natural Products) as they argued
that consumers are well aware of NIPs, the disclaimers duplicate labelling and have huge cost
implications in terms of re-labelling. Cerebos noted that the criteria are inconsistent and more
imposing than the ‘no added sugar’ claim and therefore recommended the drafting state ‘a
reference to the declaration of sodium in the nutrition information panel is made in
conjunction with the claim’. ADHB opposed the claim.
NZDA, InforMed Systems, Dr Trevor Beard and Pritikin all had concerns about the sodium
content of the foods. NZDA proposed that the NIP must contain a statement on the total
sodium content of the food as well as a statement on the front label stating the natural sodium
content. Dr Beard, however, recommended that the criteria should mean that no sodium
compound has been added and the sodium content should be 120 mg per 100 g unless the
claim includes the words ‘but note the sodium content’, which should be printed in the same
font and size as the claim. Criterion of 120 mg per 100 g was also recommended by Pritikin
and is consistent with InforMed System’s suggestion that ‘no added salt’ should only be
permitted for foods naturally low in sodium. Dr Beard stated that his recommendation would:






bring the claim into line with ‘low (in) salt’, which limits sodium even when sodium is
not mentioned;
allow flexibility in that the other 43 sodium compounds permitted as food additives can
be used, yet their use is limited to moderate amounts;
permit every unprocessed food in the Australian food tables to make the claim with the
exception of eggs and kidneys. Processed eggs and kidneys tend to have a sodium
content of 120 mg per 100 g;
prevent seafood stored in refrigerated sea water from making the claim. (Pritikin also
noted that ‘tuna in spring water’ with ‘all natural ingredients’ would be prevented from
making a claim as the sodium content is 260 mg per 100 g);
prevent processed plants from the beet family from making a claim (e.g. canned
beetroot);
provide for simple labels whilst also serving the preventive approach for regulating salt
and sodium.
SALT/SODIUM FREE
Six industry submitters specifically opposed the prohibition of ‘salt/sodium free’ claims
(AFGC, ASA, NZGMA, Natural Products, Nestlé, Unilever). Arguments were that the claim
is permitted internationally, it supports the draft Australian Guidelines (2002) and the criteria
in CoPoNC are equivalent to other countries. Suggested criteria for a claim in order of
preference were:
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



Codex criteria for consistency
CoPoNC criteria
‘not detectable’
zero tolerance.
Pritikin did not believe that claims for ‘salt/sodium free’ should be permitted.
VERY LOW (IN) SALT
SA Dept Human Services specifically supported the claim while ADHB and Natural Products
opposed it. Natural Products pointed out that the claim would confuse consumers.
GLUTEN
Industry groups, Dairy Farmers, FTA Vic, HWA, Natural Products, HWA and Unilever
agreed with the existing criteria in Volume 2, although Unilever noted the inconsistency
between the allowance of ‘gluten free’ claims with ‘no detectable gluten’ and a prohibition on
other ‘free’ claims. CHC also noted the inconsistency, adding that the criteria are contrary to
the advice from the ACCC and NZ Commerce Commission. Mainland Products believed that
‘gluten free’ is the only claim that people who are intolerant to gluten can use.
In contrast, however, a number of public health agencies strongly disagreed with the criteria
for ‘gluten free’ and ‘low gluten’ claims. New Zealand submitters were especially concerned
for the following reasons:



the criteria are inconsistent with the new proposed Codex criteria (NZDA);
food choices for people with coeliac disease are even more restrictive than before
(NZDA);
the emphasis is not on evidence based scientific research (MFD, MoH NZ, NZDA).
NZDA pointed out the December 2001 issue of The Journal of the American Dietetic
Association concluded that there is little available research to make gluten claims more
restrictive. MFD and MoH NZ both referred to their submissions made in P254 (Minor
Amendments Omnibus) and MFD also noted submissions made by Lyn Gillanders
through the NZ Food Composition Steering Committee.
The following recommendations were made by predominantly public health agencies in New
Zealand and Australia:





in order to allow for use of malt from rice or other gluten free grains, criteria for ‘gluten
free’ should be ‘no detectable gluten, oats or malt or malt products derived from glutencontaining grains’ (DAA, Diabetes Australia);
align ‘gluten free’ with Codex criteria (ADHB);
‘no detectable gluten’ for ‘gluten free’ claims should be based on standard methods of
analysis (CMA, Nestlé, CHC);
replace ‘gluten free’ with ‘very low gluten’ with the criterion of limiting gluten to 3 mg
per kg in accordance with what is acceptable to the Coeliac Society (CHC);
possibly align ‘low gluten’ criteria with a ‘very low gluten’ claim for consistency with
other nutrient claims (Tatua);
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



in order to allow for use of malt from rice or other gluten free grains, criteria for ‘low
gluten’ should be ‘no more than 20 mg gluten per 100 g of the food and no oats or malt
or malt products derived from gluten-containing grains’ (DAA);
prohibit ‘low gluten’ claims because coeliac disease is an autoimmune disease that
requires complete removal of gluten from the diet. Low gluten diets are not
recommended (Diabetes Australia);
to reassess the inclusion of oats in the criteria for gluten claims because avenin in oats
is different from gluten and there is now sufficient evidence demonstrating that it has
no effect on sufferers of celiac disease (InforMed Systems);
to reassess the inclusion of oats and malt for gluten claims as ANZFA has not done
adequate analysis (MoH NZ).
LACTOSE
HWA, Unilever, Dairy Farmers, FTA Vic, Mainland Products, NZDA, Diabetes Australia
and Natural Products all supported the existing criteria for ‘low lactose’ and ‘lactose free’
claims, although Unilever and CCIWA noted that the ‘no detectable’ criteria for ‘lactose free’
is inconsistent with a prohibition on other ‘free’ claims. CHC also noted the inconsistency,
adding that the criteria are contrary to the advice from the ACCC and NZ Commerce
Commission and that ‘very low lactose’ criteria therefore need to be set. Tatua also supported
a ‘very low’ claim for consistency with other nutrient claims. Natural Products and Diabetes
Australia supported a ‘lactose reduced’ claim but NZDA did not as they stated that such
products may still contain a significant amount of lactose and those with lactose intolerance
are advised by dietitians to only consume a diet free or low in lactose.
Fonterra queried the scientific evidence to substantiate a cut off value of 0.3 g lactose per 100
g for ‘low lactose’ claims as they stated people with lactose intolerance are likely to be able
to consume more than this without problem. Fonterra also queried the justification for not
using the same criteria as a ‘low sugar’ claim (i.e. 2.5 g lactose per 100 ml beverages and 5 g
lactose per 100 g for all other foods). A reference was provided to support this.
CMA and Nestlé preferred that ‘no detectable lactose’ for ‘lactose free’ claims be based on
standards methods of analysis. Tatua stated that the limit of detection for lactose by gas
chromatography is 0.1%, so for ‘lactose free’ claims, food need to be tested at a higher
concentration than an ‘as is’ basis in order to quantify below 0.5%.
DIET
Some submitters who commented on ‘diet’ opposed it (InforMed Systems, NZ Beef and
Lamb, ADHB, NZDA, SA Dept Human Services, Diabetes Australia, DAA) arguing that it:



is scientifically meaningless as it does not relate to any specific nutrient and is therefore
potentially misleading (InforMed systems, NZ Beef and Lamb, DAA);
is not necessary because ‘low joule’ can be used and is preferred (Diabetes Australia,
InforMed Systems); and
is simply a marketing ploy to encourage people to make short-term changes rather than
long-term healthy food and lifestyle choices (NZDA).
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Several submitters did however agree with the claim and the criteria (NZ CI, Natural
Products, NHF Australia, CHC, Goodman Fielder, GWF, ASDA). In addition, three
submitters who opposed the claim supported the ‘low joule’ criteria in the event that the
claim is included (SA Dept Human Services, DAA, Diabetes Australia). SA Dept Human
Services also preferred that the criteria include that ‘the words ‘low joule’ be stated in close
proximity to the ‘diet’ claim in order to clearly associate the two terms’. Natural Products
preferred that the criteria be expressed as a percentage.
Dunn Son and Stone, FTA Vic, Nestlé and Unilever opposed the claim being limited to the
criteria for ‘low joule’. Nestlé, AFGC, Coles and Unilever noted that dairy dessert and
yoghurts, which currently fulfil CoPoNC criteria would not be able to be made under the ‘low
joule’ criteria, thus reducing choice and information for the consumer. AFGC pointed out that
the net result would be significant costs in terms of re-labelling, reformulations and
education. Nestlé confirmed this by estimating that 80% ($11 million) of its growing ‘diet’
business will be lost to competing brands. Nestlé therefore recommended the retention of ‘not
more than 60% of the energy content of the same quantity of the reference food with an
absolute reduction of at least 170 kJ per 100 g food when compared with the same quantity of
the reference foods’.
LITE/LIGHT
This claim was very controversial in that many submitters commented on it and a wide range
of strong opinions were provided. Those in support of the claim and the criteria were mainly
from industry (CMA, Nestlé, Unilever, AFGC, Dairy Farmers, FTA Vic, GWF, Goodman
Fielder, Paradise Foods, CHC, Natural Products, Mainland Products) arguing that they are
consistent with Codex and are well established in the market place.
The majority of public health agencies and consumers, however, either opposed the claim or
aspects of the criteria. ADHB, NZ Beef and Lamb, Karen Cashel and Helleur did not support
the claim, principally because they viewed it as misleading. Karen Cashel further argued that:





use of the claim instead of standardised terms like ‘reduced’ are likely to breach the
second and third primary objectives in the ANZFA Act;
there are alternative terms available (e.g. ‘reduced’);
consumers are likely to attribute beneficial nutrition attributes to ‘light/lite’ claims
when they relate to non nutritional attributes;
adding a disclaimer to the ‘light/lite’ claim (e.g. ‘lite in fat’) will not assist consumers
in interpreting ‘lite’ claims without a qualifier (i.e. those with a non nutritional
attribute) as being possibly high in fat;
an approach that minimises misleading consumers should be the driving criteria for this
claim;
NHF Australia, SA Dept Human Services, Diabetes NZ and NHF NZ supported a prohibition
on the use of the claim in relation to non-nutritional characteristics such as colour. NHF
Australia argued that research undertaken by them indicated that aesthetic ‘light/lite’ claims
are misleading and confusing and that initial responses to the claim related to fat content, not
to colour or texture. As an alternative Karen Cashel suggested prohibiting the claim when it
relates to a nutrient or energy but permitting and defining the claim when it relates to nonnutritional attributes such as colour.
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Kemp only wanted the label to relate to fat content, while SA Dept Human Services
supported the claim when it related to energy or fat as prescribed in the US and Canada. The
latter also added that the ‘low fat’ or ‘low joule/calorie/energy’ should be made in close
proximity to the ‘light/lite’ claim so that consumers make the association between the two
terms.
Several submitters objected to the criterion allowing reduced foods to make the claim
because the foods may not reflect a nutritionally significant reduction in nutrient content (SA
Dept Human Services, DAA, Rosemary Stanton). Tatua contended that it is potentially
misleading when the claim may apply to very low, low or reduced. Rosemary Stanton pointed
out that a margarine that is reduced in fat is not ‘light/lite’ in fat or kilojoules and Lawton
similarly argued that reduced cheese that are ‘light/lite’ still have 20% saturated fat. DAA
and Tatua stated that if the criteria permit the claim to be made on reduced foods, then a
comparison statement should also be required in conjunction with the claim. In contrast NHF
Australia supported the ‘reduced’ criterion but added that when the claim relates to ‘reduced’
total fat and sugar, a 25% reduction in energy content should also apply. NHF Australia cited
findings from a review of energy intake and weight loss to support their additional criteria,
which included:



dietary fat is not an independent risk factor for development and progression of
overweight and obesity;
dietary fat reduction alone without energy restriction does not achieve weight loss in
overweight and obese individuals;
energy intake rather than macronutrient composition is the most important determinant
of weight loss in overweight and obese individuals.
NZDA and NHF NZ had a similar recommendation except that they suggested a 25%
reduction in energy and/or fat content on all products with the claim (although NHF NZ
believed that ‘light/lite’ claims in relation to salt/sodium should be exempt this additional
criterion). NHF NZ also recommended that a statement of comparison with the reference
food should be required and for claims that relate to salt, there should be a 25% reduction in
salt and a statement of comparison with the reference food. NZ Consumers’ Institute
supported qualification of the claim. HWA believed that clause 1.5 of the draft variations
should include the claim ‘light/lite’.
REGULATORY FRAMEWORK
Nearly all submitters commented on the regulatory framework. Most submitters explicitly
supported option 1, which was to adopt the proposed draft variation to Std 1.2.8 Nutrition
Information Requirements contained in the Draft Assessment Report. The Australian
supporters were Arnott’s, Dairy Farmers, CCAAC, Dunn, Son and Stone, SA Dept Human
Services, NSW Health Dept, Karen Cashel, CSIRO, Diabetes Australia, NHF Australia.
Cerebos was the only Trans Tasman group to support option 1 while New Zealand support
came from ASA, CAANZ, Fonterra, Independent Fisheries, MPA, Mainland, Natural
Products, NZGMA, NZTBC, NZ Veg & Potato, Tatua, CPH, MoH NZ, NHF NZ and PHS.
In addition, the NZ Nutrition Foundation supported Option 1 but had concerns about the
proposed P250 Code of Practice given CoPoNC history and queried why FSANZ wasn’t
looking at what the majority of submitters wanted (full regulation).
75
Three industry groups explicitly opposed Option 1 (CMA, who recommended amendments to
the proposed draft variations be adopted), FTAWA and National Foods.
Some submitters did not supports Option 1 or Option 2 but provided comment on the
regulatory framework. Seven submitters supported full regulation (CCAAC, ADHB, NZ CI,
Diabetes NZ, Griffins, HWA and InforMed Systems). Another four supported ‘co-regulation’
(ADC & ADPF, PBG, CCIWA and CHC). Furthermore, the AFGC, PBG, FTAWA, MGC,
and National Foods supported a ‘Code of Practice’. Pritikin explicitly stated that it did not
support self-regulation.
Other variations on co-regulation were expressed. CCIWA, FTAWA, MGC and PBG
supported the adoption of nutrition claims that are of public health and safety concern (e.g.
gluten and lactose) in Standard 1.2.8, but recommended that all other claims be in an industry
Code of Practice. Unilever supported a Code of Practice for all claims, except for those
claims where a review demonstrated that they do not comply with Volume 2 in which case
they should be moved into full regulation. It also requested that ‘free’ claims be controlled
under food legislation or other relevant laws. In addition it supported the AFGC submission.
Lastly several submitters made reference to the development of policy guidance on health,
nutrition and related claims. The ADC & ADPF, National Foods and Queensland Health
suggested that P234 should not proceed until such time as policy guidance has been given.
OTHER SPECIFIC COMMENTS
Submitters raised a number of other specific issues as indicated below:

Bioavailability of iron and other nutrients (NZ Beef and Lamb). Submitters believed
there should be a ‘source of iron’ claim with criteria relating to bioavailability and
consideration given to claims for other nutrients for which bioavailability is variable
such as zinc.

Glycaemic Index (GI) claims (SA Dept Human Services, HWA, Griffins). With the
exception of SA Dept Human Services, submitters supported the development of GI
claims because such claims are already in the marketplace and they are used in the
nutrition management of people on weight reduction diets, on diets for diabetes and
diets related to sports. References for determining criteria were provided, including
Miller et al. The GI Factor – The Glucose Revolution, Hoddler, 2000.

Claims relating to biologically active substances (MLA, SA Dept Human Services,
DAA, Griffins). Submitters wanted consideration to be given on a framework for
assessing evidence based new claims in relation to biologically active substances. They
are included in the definition of ‘nutrition claim’ in Standard 1.2.8 and are in the
prescribed declarations in an NIP (Clause 5 of Standard 1.2.8). It has also been
mentioned in the new draft Dietary Guidelines for Australia.

Wholegrains (GWF, DAA, Rosemary Stanton, NZ Nutrition Foundation). Submitters
wanted the issue raised, especially as it has been mentioned in the new draft Dietary
Guidelines for Australia.
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
Food prepared for consumption (Cerebos). A recommendation was made for a clause
to indicate that claims should relate to food as consumed to ensure products such as
gravy and sauce mixes, instant desserts and powdered beverages are not disadvantaged
by the criteria. This is consistent with Standard 1.2.8 Clause 14(2).

Commencement/transition period/ stock in trade (AFGC, CMA, FTAWA, GWF,
PBG, National Foods, CCIWA, Nestlé, Natural Products, NZGMA). Submitters
requested a significant phase-in period (e.g. 24 months) to accommodate ‘stock in
trade’ and to allow manufacturers to amend their labels.

Review mechanism (GWF, Cerebos, NZ Beef and Lamb, Tatua). Submitters stated
provision should be made as part of the finalisation of P234 for regular reviews to
reflect the progression of nutrition science (e.g. every three years).

Imported foods (FBIA, Nestlé, Unilever). Submitters noted that a move from CoPoNC
to regulation means that imported food must meet the requirements under the Imported
Food Control Act 1992 in Australia and the Food Act 1991 in New Zealand. It will
remove the inconsistency between imported and domestic food.

Cost/benefit analysis (AFGC). AFGC stated that given the reference to it not being
possible to obtain an exact cost of the impact of P234 as outlined in the Draft
Assessment Report, ANZFA cannot therefore carry out an appropriate cost/benefit
analysis, as required by the COAG principles, or fulfil its requirements to prepare a
regulatory impact statement and must abandon the proposal given there are no
monitoring mechanisms in place for either of the existing regimes.

Prescribed nutrient declarations (Dairy Farmers). It was proposed that cholesterol in
the NIP should be retained as consumers regularly seek this information.

Foods intrinsically high or low in a nutrient (Coles). It was noted that little mention
has been made around this issue but considered it is an important requirement in
CoPoNC that ought to be retained.
Emotive claims (Pritikin). Claims such as ‘guilt free’ and ‘baked not fried’ should be
prohibited, as they are misleading.


Method of analysis (Karen Cashel). Analytical methods appropriate for measuring
food components reported on labels should be specified in the regulations.

Use of disqualifiers/declarations (Clover, DAA). DAA recommended that
disqualifying criteria not be used for nutrient claims conditions as it is not appropriate
to withhold potentially useful information based on criteria which may not be relevant
to a consumer’s particular needs and the NIP will provide sufficient information.
Declarations other than those proposed for ‘no added sugar’ and ‘no added salt’ are of
limited value given there is sufficient information in the NIP.

DRV or %NRV (AFGC, Karen Cashel). AFGC consider %DRV an appropriate
substitute for %NRV while Karen Cashel commented that the concept of ‘daily’ for
nutrients has not been used in the terminology for RDIs for a long time and should not
be re-introduced as it is confusing and misleading.. %NRV is also confusing.
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RDIs are made on the basis of gender and age and negative health outcomes can result
if too much of some nutrients are consumed. P234 raises a complex nutrition debate
that needs to be debated if dietary recommendations across the age spectrum and
gender are to be seriously considered.

Education (FTAWA, PBG, CPH). Submitters requested an education campaign be
undertaken to inform consumers about changes to nutrition content claims.

Drafting (AFGC, Food Liaison, DAA, Nestlé, Fonterra). Nestlé queried whether the
‘and’ between the different criteria for beverages or other liquid foods ‘and’ all other
foods in clauses 16-20, 23(3), 23(4) and 24(2)-24 (4) should be ‘or’ as a food cannot
comply with both requirements. AFGC suggested that clause 16(2) is not necessary as
this is already required in clause 12(2). AFGC also suggested that clause 25(1) (a)
should read ‘unsalted or contains no added sodium as the case may be; and…’ Food
Liaison suggested it would be less confusing to repeal clauses 12-18 and insert the
revised clause commencing from clause 19. DAA suggested:
o
o
o
o
inserting ‘or is free of a nutrient’ after ‘does not have a nutritional property’
(clause 14);
inserting ‘content or is low in saturated fat’ after ‘saturated fatty acid’ (clause 19);
inserting ‘or is low in polyunsaturated fat’ after ‘polyunsaturated fatty acid’
(clause 20);
it should be made clear if the abbreviations ALA, DHA and EPA may be used
(clause 21(5)).
Fonterra stated that a reference should be included in Std 1.2.8 to the effect that the criteria
and conditions for making a vitamin or mineral claim is covered under Std 1.3.2 or
alternatively vitamin and mineral claims should be moved from Std 1.3.2 to Std 1.2.8.
Fonterra also sought clarification on whether criteria apply to ‘as purchased’ or ‘as
consumed’ or both. Tatua:







suggested amending clause 18(2) to reflect liquid foods and all other foods: ‘…0.15 g
of fat per 100 ml for beverages and other liquid foods and per 100 g for all other food’;
believed the requirements in clause 18(3) are a duplication of other labelling
requirements (i.e. duplication of fat content in the NIP) but has the clarification for
consumers;
stated that sugar definitions should include ‘Sugars has the same meaning as in
Standard 2.8.1’;
suggested amending sub-clause 4 of clause 23 from ‘...in sugar must…’ to ‘…in
sugar(s) must…’;
suggested that the last statement of proposed sub-clause 2(b) become sub-clause 2(c)
for consistency in drafting;
suggested amending sub-clause 3 of clause 23 to ‘…in sugar must…’ to ‘..in sugar(s)
must…’;
suggested amending sub-clause 1(b) of the drafting to include ‘content’ immediately
after sodium.
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