Download Guide to complying with the Nutrition, Health and Related Claims

Guide to complying with the
Nutrition, Health and
Related Claims Standard of
the Australia New Zealand
Food Standards Code.
1
Contents page
Page No
1.
2.
3.
4.
5.
6.
7.
8.
Introduction
General conditions and restrictions for making claims
Making a nutrition content claim
Making a health claim
Making a general level health claim
Making a high level health claim
Endorsements
Glossary
3
6
9
17
19
30
34
38
Diagrams
Do I need to comply with Standard 1.2.7?
Building a nutrition content claim
Building a general level health claim (pre-approval)
Building a general level health claim (systematic review)
Building a high level health claim
Decision tree for endorsements
5
12
20
24
31
35
Templates
Compliance – nutrition content claim
Compliance – general level health claim (pre-approved)
Compliance – general level health claim (systematic review)
Compliance – high level health claim
13
21
25
32
2
1.
Introduction
This document provides advice on how to comply with the Nutrition, Health and
Related Claims Standard (Standard 1.2.7) in the Australia New Zealand Food
Standards Code (the Food Standards Code).
Standard 1.2.7 regulates nutrition content claims and health claims on food labels
and in advertisements. It also regulates endorsements on food.
This guidance document is not a legal document. The legal document is Standard
1.2.7. Food businesses using this document should also refer to Standard 1.2.7 and
the associated explanatory information. Where guidance is offered in this document
in relation to a particular clause of Standard 1.2.7, the number of the particular
clause is provided in blue text.
Standard 1.2.7 became law on 18 January 2013. A three-year transition period
means food businesses must comply with the new standard from 18 January 2016.
Standard 1.2.7 applies to foods or advertising materials for foods that are sold or
prepared for sale in Australia or New Zealand and imported into Australia and New
Zealand. If you are producing foods for overseas markets that don’t include New
Zealand you may not need to comply with Standard 1.2.7, however the destination
country may have other requirements you need to meet.
A chart has been constructed to help businesses consider whether Standard 1.2.7
applies to any claims made. This chart is provided on page 5 of this guidance
document. Explanatory text then follows concerning general conditions and
requirements for making claims.
A glossary of key terms (based on definitions in Standard 1.2.7) is provided on page
38 of this document.
You can find Standard 1.2.7 online at:
http://www.comlaw.gov.au/Details/F2013L00054
The explanatory statement, which provides detail on the purpose and intent of the
Standard and its associated clauses, can be found online at:
http://www.comlaw.gov.au/Details/F2013L00054/Explanatory%20Statement/Text
For information about establishing food health relationships by systematic review
refer to the Food Standards Australia New Zealand document ‘Guidance on
establishing food-health relationships for general level health claims (as described in
Schedule 6 of Standard 1.2.7). This can be found online at:
http://www.foodstandards.gov.au/publications/Pages/Guidance-on-establishing-foodhealth-relationships-for-general-level-health-claims.aspx
3
Guidance on calculating scores for the nutrition profiling scoring criteria is also
available on the FSANZ website at:
http://www.foodstandards.gov.au/consumerinformation/nutritionhealthandrelatedclai
ms/nutrientprofilingcal3499.cfm.
Food businesses should also contact the relevant food regulator in their state or
territory or in New Zealand if further guidance is required about complying with
Standard 1.2.7.
Full details of state and territory and New Zealand agencies responsible for enforcing
the Food Standards Code can be found on the FSANZ website at:
http://www.foodstandards.gov.au/about/foodenforcementcontacts.
4
DO I NEED TO COMPLY WITH STANDARD 1.2.7?
Are you making a nutrition content or health
claim?
No
You may not need to comply with Standard
1.2.7, however you need to comply with
appropriate labelling requirements in the Code.
Yes
Does the claim concern the
presence or absence of
certain properties identified
in Standard 1.2.7?
Has the claim been made
with the permission of an
endorsing body?
Is the claim that a food or
property of food has a
health effect?
Yes
Yes
Does the food to which the
claim is applied comply with
the Nutrition Profiling
Scoring Criterion?
You are making a nutrition
content claim: refer to
Section 3 for further advice.
Yes
No
You may not make
a health claim on
this food.
You may be classified as
an endorsement. Refer
to Section 7 for further
advice.
Yes
You are making a general
level health claim: refer to
Section 5 for further advice.
No
Does the claim refer to a
serious disease or biomarker
of a serious disease?
A nutrition content or health claim cannot:
- Be made on Kava, Infant formula products or foods with more 1.15%
Alcohol/Volume, other than carb or energy content claim.
- Compare food with a good that is therapeutic.
- Refer to the prevention, diagnosis, cure or alleviation of a disease,
condition or ailment.
- Use the descriptor ‘slimming’.
- Compare the vitamin/mineral content of one food to another.
Yes
You are making a high level
content claim: refer to
Section 6 for further advice.
Standard 1.2.7 does not apply:
- Food for further processing or labeling prior to retail sale.
- Food delivered to a vulnerable person by a DMO.
- Food provided to patient in hospital or similar institution, other
than food in a package.
- A claim concerning risks or dangers of alcohol consumption, or
5
concern moderating alcohol intake.
2.
General conditions and restrictions for making claims
There are some restrictions and conditions concerning the making of claims under
Standard 1.2.7. These are outlined below.
General restrictions
Nutrition content and health claims can’t be made for the following foods (Clause 3):
•
•
•
kava
a food that contains more than 1.15% alcohol by volume, other than a
nutrition content claim about energy or carbohydrate content
an infant formula product.
Nutrition content and health claims must not:
•
•
•
refer to the prevention, diagnosis, cure or alleviation of a disease, disorder or
condition (Clause 7);
compare a food with a good that is represented in any way to be for
therapeutic use; or likely to be taken for therapeutic use, whether because of
the way in which the food or substance is presented or for any other reason
(Clause 7);
compare the vitamin or mineral content of a food with another food (Clause 8)
unless permitted to by the Code.
A health claim (and certain nutrition content claims) must not be made on a food that
does not comply with the nutrient profiling scoring criterion (NPSC) – (Clause 17(2)).
Guideline on calculating NPSC scores can be found on the FSANZ website at:
http://www.foodstandards.gov.au/consumerinformation/nutritionhealthandrelatedclai
ms/nutrientprofilingcal3499.cfm.
Standard 1.2.7 does not apply to the following (Clause 4 and 5):
•
•
•
•
•
•
foods, other than food in a package, provided to a patient in a hospital or
other similar institution
meals provided to a vulnerable person by a delivered meals organisation
foods intended for further processing, packaging or labelling before retail sale
a claim that is expressly permitted by another standard
a claim about the risks or dangers of alcohol intake or about moderating
alcohol intake
a declaration that is required by the Act as defined in Standard 1.1.1 of the
Code.
Compliance
Food supplied in Australia is required to comply with the Australia New Zealand
Food Standards Code. This includes the composition and labelling of products which
are advertised or labelled with nutrient content and health claims. Regulators at both
6
National and State level monitor and investigate compliance with labelling and
advertising requirements of Standard 1.2.7.
Australian food law provides food regulators with a range of regulatory tools of
varying severity and efficiency that may be applied in the event of noncompliance.
Generally, where a business supplies a product that does not meet the requirements
of Standard 1.2.7, the regulator will look at what steps the business has taken to
comply with the Standard when deciding appropriate compliance action.
Generally, food regulators will address noncompliance through a graduated
application of enforcement measures, commencing with milder measures such as
warnings.
Consumer law
Food businesses are also advised that claims must not be false or misleading. It is a
an offence, in the course of carrying on a food business, to engage in conduct that is
misleading or deceptive in relation to the advertising, packaging or labelling of food
intended for sale or food for sale.
Fair trading laws and food laws in Australia and New Zealand require that labels do
not misinform through false, misleading or deceptive representations. In Australia,
this legislation includes the Australian Consumer Law (ACL) contained in the
Competition and Consumer Act 2010, and State and Territory Fair Trading Acts and
Food Acts. In New Zealand, this legislation includes the Food Act 1981 and Fair
Trading Act 1986.
In Australia, the Australian Competition and Consumer Commission (ACCC)
enforces the Competition and Consumer Act 2010. In New Zealand, the Commerce
Commission is responsible for enforcing the Fair Trading Act 1981.
More information is available from:
Australian Competition and Consumer Commission (ACCC)
New Zealand Commerce Commission
New Zealand Ministry of Consumer Affairs
Form of the food (Clause 6)
Nutrition content and health claims made on foods should concern the form of the
food as it is to be consumed. This does not prevent claims being made on foods that
someone needs to prepare (e.g. heating or reconstituting) or that may be used with
other foods, so long as the claim applies to one of the form of the food as provided in
the Table to Clause 6. To determine the form of the food which applies the following
should be taken into account:
•
•
the information on the label for the food, including the directions for use
any information provided in an advertisement for the food.
7
When making a nutrition content or health claim the form of the food must be stated
together with the claim unless the form of the food is as sold (Clause 10 and
subclause 19(3)(b)).
Claim wording must not alter or contradict intent of Standard 1.2.7
Standard 1.2.7 does not prescribe the wording of a claim. However any statement or
information required by Standard 1.2.7 may be modified if the modification does not
alter or contradict the intended effect of the statement or information (Clause 9).
Evidence to support compliance
It is suggested that businesses maintain documentation to substantiate that claims
made on food products comply with the necessary conditions and requirements of
Standard 1.2.7.
This evidence may include:
•
•
•
testing results
details of how the product complies with appropriate clauses in Standard 1.2.7
and content in Schedule 1, 2, 3, 4, 5 or 6 of Standard 1.2.7
that the wording in the claim does not alter or contradict a requirement of
Standard 1.2.7.
Nutrition Information Panel
Clause 4 of Standard 1.2.8 of the Food Standards Code requires that additional
labelling requirements apply to certain claims. Should nutrition content or health
claims be made on foods, a nutrition information panel (NIP) must be included on the
label on the package of the food. Clause 5 of Standard 1.2.8 specifies particulars
required in a NIP. One of these requirements is for the name and the average
quantity of any nutrient or biologically active substance that a nutrition content or
health claim has been made.
Where the food is not required to have a label, this information must be provided to
the purchaser upon request or by one of the options listed in the Standard.
The Standard does exempt food in small packages from having to meet this
requirement (Clause 26).
8
3.
Making a nutrition content claim
A nutrition content claim is a claim about the presence or absence of certain
properties of food. These properties are listed in the definition of nutrition content
claim provided in the Glossary on page 38.
Nutrition content claims may be made about certain properties of foods as listed in
Schedule 1 of Standard 1.2.7 or about properties not listed in Schedule 1.
Nutrition content claims about properties of food listed in Schedule 1 (Clause 11)
Schedule 1 of Standard 1.2.7 provides conditions for making nutrition content claims
about certain properties of food. Should food businesses choose to make nutrition
content claims using information provided in Schedule 1, any applicable conditions in
Schedule 1 for the making of nutrition content claims must be observed.
An example is below:
•
•
•
•
•
Protein: Listed in Schedule 1.
Column 1 (Property of food): Protein.
Column 2 (General claim conditions that must be met): The food contains at
least 5 g of protein per serving unless the claim is about low or reduced
protein.
Column 3 (Specific descriptor or synonym): ‘Good source’, ‘Increased’.
Column 4 (Conditions that must be met if using specific descriptor in Column
3): ‘Good source’ – the food contains at least 10 g of protein per serving.,
‘Increased’ –the food contains at least 25% more protein than in the same
quantity of reference food; and the reference food meets the general
conditions for a nutrition content claim about protein.
Outcome: Nutrition content claims made about protein on foods must be
consistent with all relevant conditions provided in Schedule 1.
e.g. A food bearing a claim to be a ‘Good source of Protein’ must contain at
least 10g of protein per serving.
Where there is inconsistency between a general claim conditions (column 2 of
Schedule 1) and a specific claim condition in Column 4 for a food property, the
specific claim condition prevails (Subclause 11(4)).
Subject to certain conditions, other descriptors not mentioned in Column 3 may be
used for a property of a food listed in Schedule 1 (Subclause 11(8)).
Nutrition content claims about properties of food not listed in Schedule 1 (Clause 12) Businesses are not limited to the properties of food provided in Schedule 1 for
making nutrition content claims. Should a business make a nutrition content claim
9
about a property of food that is not listed in Schedule 1, the following conditions
apply:
The nutrition content claim may:
•
•
•
only state that the food does or does not contain the property of food; or
contains a specified amount of the property of food in a specified amount; or
a combination of the above.
Conditions for certain nutrition content claims
Lactose or trans-fatty acids (Subclause 11(5))
For nutrition content claims made about lactose or trans fatty acids – only the
descriptors provided in Column 3 relating to lactose or trans fatty acids (or synonyms
of those descriptors) from Schedule 1 may be used.
Glycaemic index and load (Subclause 11(6))
For nutrition content claims made about glycaemic index or load the food must meet
the Nutrition Profiling Scoring Criteria (NPSC). In addition for claims made about
glycaemic load no descriptors, other than a number or a descriptor expressed in
numeric form, may be used.
Gluten (Subclause 11(7))
For nutrition content claims made about gluten – only the descriptors in Column 3 of
Schedule 1 relating to gluten may be used (or a synonym of that descriptor), or the
claim may state that a food contains gluten or is high in gluten.
Folic acid, choline or fluoride (Clause 13)
Nutrition content claims about folic acid, choline or fluoride may only be made if a
health claim about these substances is made. These nutrition content claims may
only refer to the presence or an amount of folic acid, choline or fluoride in a food and
must not use any descriptors listed in Column 3 of Schedule 1.
Must not imply slimming effects (Clause 14)
Claims about energy that meet the conditions to use the descriptor ‘diet’ must not
use a descriptor that directly or indirectly imply a ‘slimming’ effect (or a synonym for
‘slimming’). In addition claims using the descriptor ‘diet’ can only be used on foods
meeting the NPSC.
Comparative claims (Clause 15)
If a comparative claim is made, the claim must be consistent with appropriate criteria
provided in Standard 1.2.7, Clause 15.
10
A diagram illustrating how to build a nutrition content claim is provided on page 12. A
template for food businesses to help in building a nutrition content claim is on pages
13 – 16.
11
Building a Nutrition Content Claim
Property of food
Schedule 1:
Condition for
Nutrition
Content Claims*
Compliance with
relevant
element/conditions of
Columns 1 – 4 of
Schedule 1 required,
if Schedule 1 used to
make claims.
+
Not listed in
Schedule 1
Claim may only refer
to presence or
absence of property
and/or specific
amount.
Other requirements of
Standard 1.2.7
=
Other Claim Conditions:
- Must state the form of the food to which the claim
applies, unless relates to the food as sold.
- Folic Acid, Choline, Fluoride: presence and quantity only,
health claim required.
- Gluten: Column 3 descriptor (or synonym) permitted, or
claim stating food has or is high in gluten.
- Trans Fatty Acid or Lactose: Only Column 3 descriptor
(or synonym) permitted.
- Comparative claim: Conditions in Clause 15 to be
complied with.
- Diet not to use other descriptors that imply ‘slimming’ (or
synonym of ‘slimming’).
- Cannot compare vitamin/mineral content of one food to
another, unless specifically permitted.
- NIP: The property of food that is the subject of the claim
is to be recorded in the NIP (Clause 4 and 5 of Standard
1.2.8).
Nutrition Content
Claim
Claim wording:
-The statements or
information that are
required to be on a label
or in advertisement may
be worded as desired, as
long as the effect of the
required statement or
information, as described
in the Standard, is not
altered or contradicted.
* Schedule 1 may be amended by application to FSANZ:
http://www.foodstandards.gov.au/code/changes/pages/applicationshandbook.aspx
12
Compliance template – Nutrition content claims
Businesses are referred to Sections 2 and 3 of this document for the conditions of making
nutrition content claims.
General information
1. What is the wording of the proposed nutrition content claim?
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
2. What food will the nutrition content claim be applied to?
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
3. What is the property of food (e.g. vitamin, mineral, energy or biologically active substance) that is to
be used for making nutrition content claims?
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
4. Is the property of food listed in Column 1 of Schedule 1 of Standard 1.2.7? If no go to question 7.
_________________________________________________________________________________
5. Are there conditions in Column 2 (General Claim Conditions), Column 3 (Specific descriptor) or
Column 4 (Conditions to be met if using Column 3 descriptor) listed for the property of food identified
in Column 1 above? If yes, please list as appropriate:
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
6. Demonstrate, as appropriate, how the nutrition content claim complies with all relevant conditions
from Schedule 1 of Standard 1.2.7? (e.g. amount of substance in food, testing results)
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
7. Do words in the nutrition content claim refer to the prevention, diagnosis, cure, alleviation of a
disease, disorder or condition or compare a food with a good that is represented in any way to be for
therapeutic use or likely to be taken to be for therapeutic use, whether because of the way in which
the good is presented or for any other reason?
Yes
No
If yes – the claim is NOT permitted.
8. Do any words used in the nutrition content claim alter or contradict the effect of a statement or
information required by Standard 1.2.7?
Yes
No
13
If yes – the claim is NOT permitted.
9. Do the details of the properties of the food used to make the general level health claim appear in
the nutrition information panel (NIP) on the label of the package of the food as required by Clause 4 of
Standard 1.2.8?
Yes
No
If no – the particulars of the property of the food must be declared in the NIP, or if no label
is required, the particulars of the food or property of food must be declared to the
purchaser upon request. This requirement does not apply to food in small packages1.
Specific substances: gluten, lactose, glycaemic load or trans fatty acids
10. Is your nutrition content claim made about lactose or trans fatty acids?
_________________________________________________________________________________
11. If nutrition content claim is made about any of the above substances (i.e. lactose or trans fatty
acids) what descriptors (if any) are applied?
_________________________________________________________________________________
_________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
12. Are the descriptors derived from Column 3 of Schedule 1 corresponding to the appropriate
substance, or are they synonyms of those descriptors provided in Column 3 of Schedule 1?
Yes
No
If NO – the claim is NOT permitted
13. Is your nutrition content claim made about gluten?
________________________________________________________________________________
14. If nutrition content claim is made about gluten, are the descriptors derived from Column 3 of
Schedule 1 relating to gluten, or are synonyms of those descriptors used? Or does your claim about
gluten state that a food contains gluten or is high in gluten?
Yes
No
If NO – the claim is NOT permitted
15. If a nutrition content claim is being made about glycaemic load, does it use a descriptor other than
a number, or a descriptor expressed in numeric form?
Yes
No
If YES – the claim is NOT permitted.
16. Is a nutrition content claim being made about folic acid, choline or fluoride?
Yes
No
17. If nutrition content claim is being made about folic acid, choline or fluoride does the food the
nutrition content claim is made on also carry a health claim?
Yes
1
No
2
small package means a package with a surface area of less than 100 cm (Standard 1.2.1).
14
If no – nutrition content claim may not be made on that food.
If yes – nutrition content claim may only be made about presence of folic acid, choline or fluoride and
the amount of folic acid, choline or fluoride in a specified amount of the food. No descriptors in
Column 3 of Schedule 1 (or any other descriptor) may be used for nutrition content claims made
about folic acid, choline or fluoride.
18. If the claim is made about a property of a food not listed in Schedule 1, does the claim refer to
something other than declaration of the presence or absence of that substance, and the specific
amount of that property of food in a specified amount of the food? Does the claim use a descriptor
from Column 3 of Schedule 1 (or any other descriptor) except a descriptor that indicates that the food
does not contain the property of the food.
Yes
No
If yes – the claim is NOT permitted.
If no – please provide claim wording below
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
Specific conditions of nutrition content claims: Comparative claims
19. Does the nutrition content claim compare the nutrient content of one food with another?
_________________________________________________________________________________
20. If yes, are the descriptors, ‘light’ or ‘lite’, ‘increased’, ‘reduced’ used in the nutrition content claim?
If yes, which of these terms is used?
_________________________________________________________________________________
_________________________________________________________________________________
21. If the above words are not used, but the nutrition content claim compares the nutrition content of
one food with another, what words are used to describe the comparison between the claimed food
and the reference food?
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
22. Does the claim state the identity of the reference food and the difference between the amount of
the relevant property in the claimed food and reference food?
Yes
No
If NO – the claim is NOT permitted.
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
23. Is the word ‘diet’ used in a nutrition content claim where the energy content of one food is
compared to another food?
Yes
No
_________________________________________________________________________________
_________________________________________________________________________________
15
24. If yes, is there at least a 40% difference in the energy content of the food carrying the nutrition
content claim compared to the reference food?
Yes
No
If NO – the claim is NOT permitted to use the word ‘diet’
25. If yes, please provide appropriate detail below
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
26. For claim using the word ‘diet’ as a descriptor (i.e. claims that comply with the conditions for use
of ‘diet’ descriptor), are other descriptors used that directly or indirectly refer to ‘slimming’ or
synonym’s of slimming used?
Yes
No
If yes – the claim is NOT permitted.
16
4.
Making a health claim
A health claim is any claim that a food, nutrient or substance in a food, has or may
have a health effect. See Glossary for definitions of health claim and health effect on
page 38. There are two types of health claims, general level health claims and high
level health claims. Guidance is provided in this document for the making of both
types of health claim.
A food health relationship2 (FHR) is the relationship between a food or property of
food and a health effect. All health claims require a FHR to be established. A high
level health claim must be based on a FHR provided in Schedule 2 of Standard
1.2.7. A FHR for general level health claims can be established in one of two ways:
•
•
listed in Schedule 3 of Standard 1.2.7.
Following a process of systematic review as described in Schedule 6 of
Standard 1.2.7. Guidance on establishing a FHR for a general level health
claim by systematic review is available at the FSANZ website:
http://www.foodstandards.gov.au/publications/Pages/Guidance-on-establishing-foodhealth-relationships-for-general-level-health-claims.aspx
A health claim must not be made on a food that does not comply with the nutrition
profiling scoring criteria (NPSC) described in Schedule 4 of Standard 1.2.7. This
requirement does not apply to foods standardised in Part 2.9 of the Code. The
method to calculate a food’s nutrient profiling score is described in Schedule 5 of
Standard 1.2.7. To help in determining if a food meets the NPSC a nutrition profiling
calculator is available at the FSANZ website:
http://www.foodstandards.gov.au/consumerinformation/nutritionhealthandrelatedclai
ms/nutrientprofilingcal3499.cfm.
A health claim must state the food or the property of the food and the health effect
used in the establishment of the FHR. If the health effect only applies to a specific
sector of the population rather than the whole population this must be included as
part of the health claim.
Health claims may be made as split claims. See Glossary for definition of split claim.
If a split claim is made on a label or advertisement a statement must be made on the
same label or same advertisement indicating where all the claim elements required
by Standard 1.2.7 may be found on that label or advertisement.
Dietary context statements are required for all health claims, except those made on
small packages. See Glossary for definition of small packages. A dietary context
statement must state that the health effect must be considered in the context of a
healthy diet involving the consumption of a variety of foods and must be appropriate
for the claim being made.
2
http://www.foodstandards.gov.au/publications/Pages/Guidance-on-establishing-food-health-relationships-forgeneral-level-health-claims.aspx
17
Health claims about phytosterols, phytostanols and their esters do not require a
dietary context statement to be made if the claim is presented together with the
advisory statement required by clause 2 of Standard 1.2.3.
18
5.
General Level health claim
A general level health claim is defined as a health claim that is not a high level health
claim (see Glossary of terms on page 38).
All requirements concerning the making of claims provided in Sections 2 and 4 of
this guidance document apply to the making of general level health claims.
There are two pathways for establishing food health relationships (FHR) that
underpin a general level health claim. Pre-approved FHR’s are described in
Schedule 3 of Standard 1.2.7. Any of these relationships may be used for making
general level health claims. Should a relationship from Schedule 3 be used for
making a general level health claim, all necessary conditions relating to that
relationship need to be observed.
FHR’s for the making of general level health claims may also be established by
following a process of systematic review as described in Schedule 6 of Standard
1.2.7. FSANZ has prepared a guidance document to assist businesses should they
choose this option. This document can be found online at:
http://www.foodstandards.gov.au/publications/Pages/Guidance-on-establishing-foodhealth-relationships-for-general-level-health-claims.aspx
An example of a general level health claim based on Schedule 3 FHR is below:
• Calcium is listed in Schedule 3.
• Column 1 (Food or property of food): Calcium.
• Column 2 (Specific health effect): Necessary for normal teeth and bone
structure.
• Column 3 (Relevant population): No stated restriction.
Column 4 (Dietary Context): No stated restriction.
Column 5 (Conditions): The food must meet the general claim conditions for
making a nutrient content claim about calcium.
A diagram illustrating how to build a general level health claim (preapproved food
health relationship) is provided on page 20. A template for food businesses to help in
building a general level health claim (preapproved food health relationship) is
provided on pages 21 – 23. A diagram illustrating how to build a general level health
claim (systematic review) is page 24. A template for food businesses to help in
building a general level health claim (systematic review) is provided on pages 25 –
29.
19
5a Building a General Level Health Claim (pre-approval)
Schedule 3: Food health
effect relationship*
Compliance with
relevant elements
of Columns 1 – 5
of Schedule 3.
+
Other requirements of
Standard 1.2.7
Special Claim Conditions:
- Must state the form of the food to which the
claim applies, unless relates to the food as sold.
- If health effect only applies to a specific sector of
the population and not total population this must
be included as part of the health claim.
- Claim to be accompanied by dietary context
statement, unless food in small package.
- If split claim made on label or advertisement,
statement to be made on label or advertisement
indicating where all claim elements required by
Standard 1.2.7 may be found.
- If claim is made about phytosterols, phytostanols
and their esters, dietary context statement not
required, if claim presented with advisory
statement (clause 2 of Standard 1.2.3).
- NIP: The property of food that is the subject of
the claim is to be recorded in the NIP (Clause 4
and 5 of Standard 1.2.8).
Health Claim
=
Claim wording:
-The statements or
information that are
required to be on a label
or in advertisement may
be worded as desired, as
long as the effect of the
required statement or
information, as described
in the Standard, is not
altered or contradicted.
* Schedule 3 may be amended by application to FSANZ:
http://www.foodstandards.gov.au/code/changes/pages/applicationshandbook.aspx
20
5a Com
mpliance tem
mplate – General
G
Lev
vel Health claims (prreapproved
d)
Business
ses are referrred to Sectio
ons 2, 4 and 5 of this doc
cument for co
onditions forr the making
g
of genera
al level health claims.
i
General information
1. What iss the wording of the propos
sed general le
evel health claim? Does th
he claim refer to a serious
disease or
o a biomarkerr of a serious disease?
N.B. Gene
eral level hea
alth claims can
nnot refer to a serious dise
eases or a bio
omarker of a serious
s
disease.
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
2. What fo
ood will the ge
eneral level health
h
claim be applied to?
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
3. Is the fo
orm of the foo
od to which th
he claim relate
es one of the forms of the food as proviided in the
Table to Clause
C
6 of Sttandard 1.2.7
7?
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
s the food belo
ong to in the N
Nutrition Proffiling Scoring Criteria (NPS
SC) as listed in
4. What category does
d 1.2.7?
Column 1 of Schedule 4 of Standard
Category 1
Category 2
Category 3
ecific categorry as listed in Column 2 of
5. What iss the final nutrient profiling score of the food in its spe
Schedule 4 of Standard
d 1.2.7?
________
___________
____________
___________
___________
____________
____________
___________
__
See the
e following webs
site for informatio
on on calculating the nutrient proffiling score.
http://w
www.foodstandarrds.gov.au/consu
umerinformation//nutritionhealthan
ndrelatedclaims/n
nutrientprofilingcal3499.cfm
If food
d is Categoryy 1, nutrient prrofiling score must be less than 1 to qua
alify for health
h claim.
If food
d is Categoryy 2, nutrient prrofiling score must be less than 4 to qua
alify for health
h claim.
If food
d is Categoryy 3, nutrient prrofiling score must be less than 28 to qu
ualify for heallth claim.
Foods
s defined in Part
P 2.9 of the
e Food Standa
ards Code do
o not need to comply
c
with the
t NPSC.
n meet the NPSC the he
ealth claim is
s not permittted.
If the food does not
p
dia
agnosis, cure
e, alleviation of
o
6. Do the words in the general level health claim refer to the prevention,
c
or compare
c
a foo
od with a good that is repre
esented in an
ny way to be
a disease, disorder or condition
u
whether b
because of th
he way in
for therapeutic use or likely to be takken to be for therapeutic use,
which the good is presented or for any
a other reasson?
Yes
No
he claim is NO
OT permitted.
If yes – th
2
21
7. What is the food-health effect relationship (e.g. vitamin, mineral, polysaccharide, phytosterol or
biologically active substance) identified in Schedule 3 of Standard 1.2.7 that is being using as the
basis for making the general level health claim?
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
8. Are there criteria identified in Column 3 (relevant population) or Column 4 (Dietary context) and
Column 5 (Conditions) appropriate for the food-health relationship identified above? If yes, please list
as appropriate:
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
9. Does the high level health claim advise consumers that the claimed health effect must be
considered in the context of a healthy diet involving the consumption of a variety of foods and is it
appropriate for the claim being made as required by subclause 19(3)(a) of Standard 1.2.7?
Yes
No
If no - the claim is not permitted in its current form (unless the food is contained in a small
package3).
Health claims about phytosterols, phytostanols and their esters do not require a dietary context statement to be made in
conjunction with the health claim if the claim is presented together with the advisory statement required by Clause 2 of
Standard 1.2.3.
10. Does the general level health claim state the form of the food to which the claim applies together with
the claim as required by subclause 19(3)(b) of Standard 1.2.7 unless the form of the food is as sold?
Yes
No
If no - the claim is not permitted in its current form.
11. Is the general level health claim being made as a split claim? If so, is a statement available on the
label of food or advertisement where all required elements of the general level health claim may be
found on the label or advertisement, as required by Clause 20 of Standard 1.2.7?
Yes
No
If no – the claim is not permitted in its current form.
12. Do the details of the properties of the food used to make the general level health claim appear in
the nutrition information panel (NIP) on the label of the package of the food as required by Clause 4 of
Standard 1.2.8?
Yes
No
If no – the particulars of the property of the food must be declared in the NIP, or if no label
is required, the particulars of the food or property of food must be declared to the
purchaser upon request. This requirement does not apply to food in small packages4.
3
4
2
small package means a package with a surface area of less than 100 cm (Standard 1.2.1).
2
small package means a package with a surface area of less than 100 cm (Standard 1.2.1).
22
13. Do words used in the general level health claim alter or contradict the intended effect of a
statement or information required by Standard 1.2.7?
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
23
5b Building a General Level Health Claim (Systematic review)
Food health relationship:
Schedule 6*
Systematic review in
accordance with Schedule 6.
- Notified to FSANZ CEO.
- Compliance with all elements
of Schedule 6 required.
- Notice to certify compliance
with all Schedule 6.
- Records provided to
jurisdiction upon request.
+
Other requirements of
Standard 1.2.7
Special Claim Conditions:
- Must state the form of the food to which the claim
applies, unless relates to the food as sold.
- If health effect only applies to a specific sector of
the population and not total population this must be
included as part of the health claim.
- Claim to be accompanied by dietary context
statement, unless food in small package.
- If split claim made on label or advertisement,
statement to be made on label or advertisement
indicating where all claim elements required by
Standard 1.2.7 may be found.
- If claim is made about phytosterols, phytostanols
and their esters, dietary context statement not
required, if claim presented with advisory statement
(clause 2 of Standard 1.2.3).
- NIP: The property of food that is the subject of the
claim is to be recorded in the NIP (Clause 4 and 5 of
Standard 1.2.8).
=
Health Claim
Claim wording:
-The statements or
information that are
required to be on a label
or in advertisement may
be worded as desired, as
long as the effect of the
required statement or
information, as described
in the Standard, is not
altered or contradicted.
* See FSANZ Guidance document: http://www.foodstandards.gov.au/publications/Pages/Guidance-on-establishing-food-healthrelationships-for-general-level-health-claims.aspx
24
5b Com
mpliance template – General
G
Lev
vel Health claims (sy
ystematic review)
r
Business
ses are referrred to Sectio
ons 2, 4 and 5 of this doc
cument for co
onditions forr the making
g
of genera
al level health claims.
i
General information
1. What iss the wording of the propos
sed general le
evel health claim? Does th
he claim refer to a serious
disease or
o a biomarkerr of a serious disease?
N.B. Gene
eral level hea
alth claims can
nnot refer to a serious dise
eases or a bio
omarker of a serious
s
disease.
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
2. What fo
ood will the ge
eneral level health
h
claim be applied to?
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
3. Is the fo
orm of the foo
od to which th
he claim relate
es one of the forms of the food as proviided in the
Table to Clause
C
6 of Sttandard 1.2.7
7?
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
s the food belo
ong to in the N
Nutrition Proffiling Scoring Criteria (NPS
SC) as listed in
4. What category does
d 1.2.7?
Column 1 of Schedule 4 of Standard
Category 1
Category 2
Category 3
ecific categorry as listed in Column 2 of
5. What iss the final nutrient profiling score of the food in its spe
Schedule 4 of Standard
d 1.2.7?
________
___________
____________
___________
___________
____________
____________
___________
__
See the
e following webs
site for informatio
on on calculating the nutrient proffiling score.
http://w
www.foodstandarrds.gov.au/consu
umerinformation//nutritionhealthan
ndrelatedclaims/n
nutrientprofilingcal3499.cfm
If food
d is Categoryy 1, nutrient prrofiling score must be less than 1 to qua
alify for health
h claim.
If food
d is Categoryy 2, nutrient prrofiling score must be less than 4 to qua
alify for health
h claim.
If food
d is Categoryy 3, nutrient prrofiling score must be less than 28 to qu
ualify for heallth claim.
Foods
s defined in Part
P 2.9 of the
e Food Standa
ards Code do
o not need to comply
c
with the
t NPSC.
n meet the NPSC the he
ealth claim is
s not permittted.
If the food does not
p
dia
agnosis, cure
e, alleviation of
o
6. Do the words in the general level health claim refer to the prevention,
c
or compare
c
a foo
od with a good that is repre
esented in an
ny way to be
a disease, disorder or condition
u
whether b
because of th
he way in
for therapeutic use or likely to be takken to be for therapeutic use,
a other reasson?
which the good is presented or for any
Yes
No
he claim is NO
OT permitted.
If yes – th
2
25
7. Does th
he general levvel health claim advise con
nsumers that the claimed h
health effect must
m
be
considere
ed in the conte
ext of a health
hy diet involviing the consu
umption of a variety
v
of food
ds and is it
appropriatte for the claim being made as required
d by subclause 19(3)(a) of Standard 1.2
2.7?
Yes
No
s not permittted in its current form (un
nless the foo
od is contain
ned in a smalll
If no - the claim is
packa
age5).
Health claims about phyytosterols, phyto
ostanols and theiir esters do not re
equire a dietary ccontext statemen
nt to be made in
conjunc
ction with the health claim if the claim
c
is presente
ed together with the
t advisory statement required by
b Clause 2 of
Standa
ard 1.2.3.
he general levvel health claim state the fo
orm of the foo
od to which th
he claim appliies together w
with
8. Does th
the claim as required by
b subclause 19(3)(b) of Sttandard 1.2.7
7 unless the fo
orm of the foo
od is as sold?
Yes
No
s not permittted in its current form.
If no - the claim is
9. Do worrds used in the general level health claim
m alter or con
ntradict the inttended effectt of a
statementt or informatio
on required byy Standard 1..2.7?
Yes
No
he claim is NO
OT permitted.
If yes – th
10. Does the general le
evel health cla
aim state the form of the fo
ood to which the claim app
plies together with
the claim as required by
b subclause 19(3)(b) of Sttandard 1.2.7
7 unless the fo
orm of the foo
od is as sold?
Yes
No
If no - the claim is
s not permittted in its current form.
11. Is the general levell health claim being made as a split claiim? If so, is a statement avvailable on the
ood or advertis
sement where
e all required elements of the general le
evel health cla
aim may be
label of fo
found on the
t label or advertisement, as required by Clause 20
0 of Standard 1.2.7?
Yes
No
s not permittted in its currrent form.
If no – the claim is
12. Do the
e details of the properties of
o the food ussed to make the
t general le
evel health cla
aim appear in
the nutritio
on information panel (NIP)) on the label of the packag
ge of the food
d as required by Clause 4 of
o
Standard 1.2.8?
Yes
No
ulars of the property
p
of th
he food mustt be declared
d in the NIP, or if no labe
el
If no – the particu
is req
quired, the pa
articulars of the food or property of food
f
must be
e declared to
o the
purch
haser upon request.
r
This
s requiremen
nt does not apply
a
to food
d in small pac
ckages6.
5
6
2
small pack
kage means a pa
ackage with a surrface area of lesss than 100 cm (Standard 1.2.1).
2
small pack
kage means a pa
ackage with a surrface area of lesss than 100 cm (Standard 1.2.1).
2
26
13. Do wo
ords used in the general le
evel health cla
aim alter or co
ontradict the intended effecct of a
statementt or informatio
on required byy Standard 1..2.7?
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
ealth effect re
elationship tha
at is being using as the bassis for making
g the general
14. What is the food-he
level healtth claim?
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
________
___________
____________
___________
___________
____________
____________
___________
__
g
level health claim is based on tthe details of a relationship
p between a fo
ood or
15. If the general
property of
o food and a health effect that has been
n established
d by a processs of systematic review
described
d in Schedule 6 of Standard
d 1.2.7, has the person res
sponsible for making the claim
c
notified
the CEO of
o FSANZ?
Yes
No
If NO - the
e claim does NOT comply with Standard
d 1.2.7.
uestion 6 abovve to the CEO
O of FSANZ provided:
p
16. Has a person giving notice in qu
i)
Th
he name of th
he person giv
ving the notice
e and the add
dress in Austra
alia
an
nd New Zeala
and of that pe
erson, and
ii)
Consent to the
C
e publication by
b the Authorrity of information concerning the
re
elationship tha
at is the subje
ect of the notice plus inform
mation in i) ab
bove,
an
nd;
Certification that the relation
nship that is the subject of the notice
estion 6 abovve has been e
established byy a process of
prrovided in que
syystematic review that is de
escribed in Scchedule 6.
iii)
Yes
No
Yes
No
Yes
No
If NO to any
a of the abo
ove - the claim
m does not co
omply with Standard
S
1.2.7
7.
q
6 abo
ove to the CE
EO of the Auth
hority, if requested by a
17. Does a person giving notice in question
a
provvide records to the relevan
nt authority tha
at demonstratte that –
relevant authority,
i)
Th
he systematicc review was conducted in accordance with the process of
syystematic review described
d in Schedule
e 6; and
Yes
No
ii)
Th
he notified relationship is a reasonable conclusion off the systema
atic
re
eview.
Yes
No
If NO to any
a of the abo
ove - the claim
m does not co
omply with Standard
S
1.2.7
7.
o Schedule 67
Content of
18. Has a statement be
een made tha
at describes th
he food or pro
operty of the food,
f
the hea
alth effect and
d
the proposed relationship between the
t food or prroperty of food
d and the hea
alth effect?
Yes
No
7
refer FSA
ANZ document ‘Guidance on establishing
e
food-health relattionships for ge
eneral level hea
alth claims’ for
guidance on
o compiling re
ecords to demonstrate complia
ance with Sche
edule 6 of Stan
ndard 1.2.7
2
27
If NO, the
e systematic re
eview has no
ot been cond
ducted in accordance with the process described in
Schedule 6.
egy been prov
vided that desscribes how scientific
s
evidence has bee
en captured
19. Has a search strate
relevant to
o the propose
ed relationship, between th
he food or pro
operty of food and the heallth effect,
including the inclusion and exclusion criteria?
Yes
No
e systematic re
eview has no
ot been cond
ducted in accordance with the process described in
If NO, the
Schedule 6.
20. Has a final list of sttudies, based on the inclussion and exclu
usion criteria, been provide
ed to support
the proposed relationship?
Yes
No
If NO, the
e systematic re
eview has no
ot been cond
ducted in accordance with the process described in
Schedule 6.
21. Are th
heir studies am
mong this listt that involve studies in hu
umans? Yes
No
If NO, the
e systematic re
eview has no
ot been cond
ducted in accordance with the process described in
Schedule 6 - studies in humans arre essential.
22. Has a table with ke
ey information
n from each in
ncluded studyy been provide
ed? This table
e must includ
de
informatio
on on:
(a) th
he study reference
(b) th
he study desig
gn
(c) th
he objectives
(d) th
he sample size in the studyy groups and loss to follow
w-up or nonre
esponse
(e) th
he participant characteristiccs
(f)
method used to
m
o measure the food or property of food including amount
co
onsumed
(g) co
onfounders measured
m
(h) th
he method use
ed to measurre the health effect
e
(i)
th
he study resullts, including effect
e
size an
nd statistical significance
s
(j)
an
ny adverse efffects
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
a of the abo
ove, the systematic review has not been conducted
d in accordancce with the
If NO to any
process described
d
in Schedule
S
6.
a assessmen
nt of the qualitty of each inccluded study been
b
undertaken that inclu
udes, as a
23. Has an
minimum:
d hypothesis
(a) a clearly stated
m
off bias
(b) minimisation
Yes
No
Yes
No
2
28
(c) ad
dequate control for confounding
(d) th
he study particcipants’ backg
ground diets and other rele
evant lifestyle
e
fa
actors
(e) sttudy duration and follow-up
p adequate to
o demonstrate
e the health effect
e
(f)
th
he statistical power
p
to test the
t hypothesis.
Yes
No
Yes
No
Yes
No
Yes
No
a of the abo
ove, the syste
ematic review
w has not bee
en conducted
d in accordan
nce with the
If NO, to any
process described
d
in Schedule
S
6.
24. Has an
a assessmen
nt of the results of the inclu
uded studies as
a a group be
een provided, that considers
whether:
(a) th
here is a conssistent associa
ation between
n the food or property of fo
ood
an
nd the health effect acrosss all high quality studies.
(b) th
here is a caussal association
n between the
e consumptio
on of the food or
prroperty of foo
od and the hea
alth effect tha
at is independ
dent of other ffactors
(w
with most weig
ght given to well-designed
w
experimenta
al studies in
hu
umans).
(c) th
he proposed relationship
r
be
etween the fo
ood or propertty of food and
d the
he
ealth effect is biologically plausible.
p
(d) th
he amount of the food or prroperty of foo
od to achieve the health efffect
ca
an be consum
med as part off a normal die
et of the Austrralian and Ne
ew
Ze
ealand popula
ations.
Yes
No
Yes
No
Yes
No
Yes
No
a of the abo
ove, the syste
ematic review
w has not bee
en conducted
d in accordan
nce with the
If NO, to any
process described
d
in Schedule
S
6.
25. Has a conclusion been
b
provided
d based on the results of th
he studies tha
at includes:
(a) w
whether a caussal relationship has been e
established be
etween the fo
ood or
prroperty of foo
od and the hea
alth effect bassed on the tottality and weight of
evvidence.
(b) w
where there is a causal rela
ationship betw
ween the food or property o
of
fo
ood and the health effect:
(i))
the am
mount of the fo
ood or properrty of food req
quired to achie
eve
the hea
alth effect
(iii)
whethe
er the amountt of the food o
or property off food to achie
eve
the hea
alth effect is likely to be co
onsumed in th
he diet of the
Australian and New Zealand po
opulations or by the target
ation group, where
w
relevantt.
popula
Yes
No
Yes
No
Yes
No
a of the abo
ove, the syste
ematic review
w has not bee
en conducted
d in accordan
nce with the
If NO, to any
process described
d
in Schedule
S
6.
2
29
6
Making a High Level Health Claim
A high level health claim means a claim that refers to a serious disease or a
biomarker of a serious disease.
All requirements concerning the making of claims provided in Sections 2 and 4 of
this guidance document apply to the making of high level health claims.
Only food health relationships (FHR) described in Schedule 2 of Standard 1.2.7 may
be used for the making of high level health claims.
An example of a high level health claim is below:
• Calcium is listed in Schedule 2.
• Column 1 (Food or property of food): Calcium.
• Column 2 (Specific health effect): Reduced risk of osteoporosis.
• Column 3 (Relevant population): Persons 65 years and over
• Column 4 (Dietary Context): Diet high in calcium, and adequate Vitamin D
status.
• Column 5 (Conditions): The food contains no less than 290mg of calcium per
serving.
A high level health claim made about calcium and reduced risk of osteoporosis must
comply with all above stated conditions.
A diagram illustrating how to build a high level health claim is provided on page 31.
A template for food businesses to complete in building a high level health claim is
provided on pages 32-34.
30
Building a High Level Health Claim
Schedule 2: Food health
effect relationship*
Compliance with
relevant elements
of Columns 1 – 5
of Schedule 2.
+
Other requirements of
Standard 1.2.7
Special Claim Conditions:
- Must state the form of the food to which the claim applies,
unless relates to the food as sold.
- If health effect only applies to a specific sector of the
population and not total population this must be included as
part of the health claim.
- Claim to be accompanied by dietary context statement,
unless food in small package.
- If split claim made on label or advertisement, statement to
be made on label or advertisement indicating where all
claim elements required by Standard 1.2.7 may be found.
- If claim is made about phytosterols, phytostanols and their
esters, dietary context statement not required, if claim
presented with advisory statement (clause 2 of Standard
1.2.3).
- NIP: The property of food that is the subject of the claim is
to be recorded in the NIP (Clause 4 and 5 of Standard 1.2.8).
=
Health Claim
Claim wording:
-The statements or
information that are
required to be on a label
or in advertisement may
be worded as desired, as
long as the effect of the
required statement or
information, as described
in the Standard, is not
altered or contradicted.
* If food-health effect relationship is not in Schedule 2, a high level health claim may not be made. Schedule 2 may be amended by
application to FSANZ: http://www.foodstandards.gov.au/code/changes/pages/applicationshandbook.aspx
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Compliance template – High Level Health claims
Businesses are referred to Sections 2 and 4 of this document for conditions for the making of
health claims.
General information
1. What is the wording of the proposed high level health claim? What is the serious disease or
biomarker of a serious disease referred in the claim?
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
Examples of serious diseases are coronary heart disease, osteoporosis, osteoporotic fracture and neural tube defects.
Examples of biomarkers of serious disease are blood cholesterol and blood pressure.
2. What food will the high level health claim be applied to?
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
3. Is the form of the food to which the claim relates one of the forms of the food as provided in the
Table to Clause 6 of Standard 1.2.7?
_________________________________________________________________________________
_________________________________________________________________________________
4. What category does the food belong to in the Nutrition Profiling Scoring Criteria (NPSC) as listed in
Column 1 of Schedule 4 of Standard 1.2.7?
Category 1
Category 2
Category 3
5. What is the final nutrient profiling score of the food in its specific category as listed in Column 2 of
Schedule 4 of Standard 1.2.7?
_________________________________________________________________________________
See the following website for information on calculating the nutrient profiling score.
http://www.foodstandards.gov.au/consumerinformation/nutritionhealthandrelatedclaims/nutrientprofilingcal3499.cfm
If food is Category 1, nutrient profiling score must be less than 1 to qualify for health claim.
If food is Category 2, nutrient profiling score must be less than 4 to qualify for health claim.
If food is Category 3, nutrient profiling score must be less than 28 to qualify for health claim.
Foods defined in Part 2.9 of the Food Standards Code do not need to comply with the NPSC.
If the food does not meet the NPSC the health claim is not permitted.
6. Do the words in the high level health claim refer to the prevention, diagnosis, cure, alleviation of a
disease, disorder or condition or compare a food with a good that is represented in any way to be for
therapeutic use or likely to be taken to be for therapeutic use, whether because of the way in which
the good is presented or for any other reason?
Yes
No
If yes – the claim is NOT permitted.
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7. What is the food health relationship listed in Column 2 of Schedule 2 of Standard 1.2.7 that is to be
used for making the high level health claim?
_________________________________________________________________________________
_________________________________________________________________________________
If a food health relationship is not in Schedule 2 the claim is not permitted.
8. Are there conditions in Column 3 (relevant population) or Column 4 (Dietary context) and Column 5
(Conditions) listed for the food health relationship identified above? If yes, please list as appropriate:
_________________________________________________________________________________
9. Do words used in the high level health claim alter or contradict the intended effect of a statement or
information required by Standard 1.2.7?
Yes
No
If yes – the claim is NOT permitted.
10. Demonstrate how the high level health claim complies with all relevant criteria identified in
Schedule 2 of Standard 1.2.7?
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
11. Does the high level health claim advise consumers that the claimed health effect must be
considered in the context of a healthy diet involving the consumption of a variety of foods and is it
appropriate for the claim being made as required by subclause 19(3)(a) of Standard 1.2.7?
Yes
No
If no - the claim is not permitted in its current form (unless the food is contained in a small
package8).
Health claims about phytosterols, phytostanols and their esters do not require a dietary context statement to be made in
conjunction with the health claim if the claim is presented together with the advisory statement required by Clause 2 of
Standard 1.2.3.
12. Does the high level health claim state the form of the food to which the claim applies together with the
claim as required by subclause 19(3)(b) of Standard 1.2.7 unless the form of the food is as sold?
Yes
No
If no - the claim is not permitted in its current form.
13. Do the details of the properties of the food used to make the general level health claim appear in
the nutrition information panel (NIP) on the label of the package of the food as required by Clause 4 of
Standard 1.2.8?
Yes
No
If no – the particulars of the property of the food must be declared in the NIP, or if no label
is required, the particulars of the food or property of food must be declared to the
purchaser upon request. This requirement does not apply to food in small packages9.
8
9
2
small package means a package with a surface area of less than 100 cm (Standard 1.2.1).
2
small package means a package with a surface area of less than 100 cm (Standard 1.2.1).
33
14. Is the high level health claim being made as a split claim? If so, is a statement available on the
label of food or advertisement where all required elements of the high level health claim may be found
on the label or advertisement, as required by Clause 20 of Standard 1.2.7?
Yes
No
If no – the claim is not permitted in its current form.
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7.
Endorsing bodies and endorsements
Endorsements are nutrition content claims or health claims that are made with the
permission of an endorsing body. Foods carrying endorsements are not subject to
the nutrient profiling score required for other claims. Endorsements can only be
made if the following requirements are met (Clauses 22 and 23 of Standard 1.2.7).
Clause 22 (1) states that endorsing bodies must:
• not be related to the Supplier;
• be independent of the supplier;
• and also free from influence by the Supplier.
The Supplier using the endorsement must (during sale and for 2 years after the
product was supplied or advertised) keep and make available to regulators, if
requested, records showing that:
• it has the permission of the endorsing body to use the endorsement;
(e.g. a certificate of accreditation).
• the endorsing body has a nutrition or health related function or
purpose; and (e.g. articles of association outlining the function of the
endorsing body )
• the endorsing body is a not-for-profit entity which is not related to the
supplier using the endorsement. (e.g. company documents may
demonstrate this)
Endorsements must comply with Clause 7 (claims must not to be therapeutic in
nature) and not refer to a serious disease except when referring to the endorsing
body if the serious disease is part of the name of the endorsing body.
If these requirements are not met endorsements are treated as, and comply with the
requirements relating to nutrient content or health claims.
35
Decision tree for endorsements
Is the ‘endorsement’ a nutrition
content claim or health claim?
Yes
No
Can it only be made with the permission of the
endorsing body (endorsing body is a not-for-profit
entity which has a nutrition or health related
function or purpose) that has permitted the supplier
to use an endorsement?
The claim not regulated by
Standard 1.2.7.
If nutrition content claim: refer Section
4 of this document
Yes
Is the endorsing body related to, or
dependent on, or influenced by a supplier?
Yes
The claim is not an
endorsement, Standard
1.2.7 applies.
If health claim: refer Sections
5, 6 and 7 of this document
No
Does the supplier:
- have a financial interest in the endorsing
body; or
- has the supplier established, by itself or with
others the endorsing body; or
- exercises direct or indirect control over
endorsing body.
Yes
The claim is not an
endorsement, Standard 1.2.7
applies
If nutrition content claim: refer Section
4 of this document
If health claim: refer Sections
5, 6 and 7 of this document
No
36
Does claim comply with clause 7 of
Standard 1.2.7 (therapeutic claims)?
No
The claim cannot be
made
Yes
Does the ‘endorsement’ refer to a serious
disease, where the serious disease is named
in a place other than in the name of the
endorsing body?
(e.g. Cancer Council)
Yes
The claim cannot be
made
No
The following required record keeping requirement applies:
- evidence of permission from endorsing body to supplier
that endorsement may be used (e.g. formal letter of
permission);
- endorsing body has health- related or nutrition purpose or
function;
- endorsing body operates on a not-for-profit basis;
- endorsing body not related to supplier using endorsement.
Supplier using endorsement must:
- keep required records for information period;
- Provide to regulator upon request;
- Imported foods, importer is taken to be supplier using
endorsement.
Evidence to be
made available
to regulator
upon request
Evidence to be
made available
to regulator
upon request
37
8. Glossary (Definitions from the Australia New Zealand
Food Standards Code)
Biomarker means a measurable biological parameter that is predictive of the risk of
a serious disease when present at an abnormal level in the human body.
Claim means an express or implied statement, representation, design or information
in relation to a food or property of food which is not mandatory in the Australia New
Zealand Food Standards Code.
Comparative claim means a nutrition content claim that directly or indirectly
compares the nutrition content of one food or brand of food with another, and
includes claims using the descriptors – a) light or lite, b) increased, or c) reduced, or
words of similar import.
An endorsing body is a not-for-profit entity which has a nutrition – or health-related
purpose or function that permits a supplier to make an endorsement.
Food group means any of the following groups –
(a) bread (both leavened and unleavened), grains, rice, pasta and noodles;
(b) fruit, vegetables, herbs, spices and fungi;
(c) milk and milk products as standardised in Part 2.5 and analogues derived
from legumes and cereals mentioned in Column 1 of the Table to clause 3
in Standard 1.3.2;
(d) meat, fish, eggs, nuts, seeds and dried legumes;
(e) fats including butter, edible oils and edible oil spreads.
Fruit means the edible portion of a plant or constituents of the edible portion that are
present in the typical proportion of the whole fruit (with or without the peel or water),
but does not include nuts, spices, herbs, fungi, legumes and seeds.
General level health claim means a health claim that is not a high level health
claim.
High level health claim means a health claim that refers to a serious disease or a
biomarker of a serious disease.
Health claim means a claim which states, suggests or implies that a food or a
property of a food has, or may have, a health effect.
Health effect means an effect on the human body, including an effect on one or
more of the following:
(a)
(b)
(c)
(d)
a biochemical process or outcome;
a physiological process or outcome;
a functional process or outcome;
growth and development;
38
(e)
(f)
(g)
physical performance;
mental performance;
a disease, defect or condition.
Information period, in relation to food, means the period –
(a)
(b)
during which the food is available for sale or advertised for sale; and
the period of 2 years after the food was last sold, or advertised or
available for sale, whichever is the latest.
Label means any tag, brand, mark or statement in writing or any representation or
design or descriptive matter on or attached to or used in connection with or
accompanying any food or package
Property of food means a component, ingredient, constituent or other feature of
food.
Reference food means a food that is –
(a)
(b)
of the same type as the food for which a claim is made and that has
not been further processed, formulated, reformulated or modified to
increase or decrease the energy value or the amount of the nutrient
for which the claim is made; or
a dietary substitute for the food in the same food group as the food
for which a claim is made.
Required records means a document or documents that demonstrate that –
(a)
(b)
(c)
(d)
a supplier using an endorsement has obtained the permission of the
endorsing body to use the endorsement; and
the endorsing body has a nutrition- or health-related function or
purpose; and
the endorsing body is a not-for-profit entity; and
the endorsing body is not related to the supplier using the
endorsement.
Serious disease means a disease, disorder or condition which is generally
diagnosed, treated or managed in consultation with or with supervision by a health
care professional.
Small package means a package with a surface area of less than 100 cm2.
Vegetable means the edible portion of a plant or constituents of the edible portion
that are present in the typical proportion of the whole vegetable (with or without the
peel or water), but excludes nuts, spices, herbs, fungi, dried legumes (including dried
legumes that have been cooked or rehydrated) and seeds.
39