Guide to complying with the Nutrition, Health and Related Claims Standard of the Australia New Zealand Food Standards Code.

Transcription

1 Guide to complying with the Nutrition, Health and Related Claims Standard of the Australia New Zealand Food Standards Code. 1

2 Contents page Page 1. Introduction 3 2. General conditions and restrictions for making claims 6 3. Making a nutrition content claim 9 4. Making a health claim Making a general level health claim Making a high level health claim Endorsements Glossary 38 Diagrams Do I need to comply with Standard 1.2.7? 5 Building a nutrition content claim 12 Building a general level health claim (pre-approval) 20 Building a general level health claim (systematic review) 24 Building a high level health claim 31 Decision tree for endorsements 35 Templates Compliance nutrition content claim 13 Compliance general level health claim (pre-approved) 21 Compliance general level health claim (systematic review) 25 Compliance high level health claim 32 2

3 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 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 Food businesses using this document should also refer to Standard 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 became law on 18 January A three-year transition period means food businesses must comply with the new standard from 18 January Standard 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 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 online at: The explanatory statement, which provides detail on the purpose and intent of the Standard and its associated clauses, can be found online at: 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: 3

4 Guidance on calculating scores for the nutrition profiling scoring criteria is also available on the FSANZ website at: 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 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: 4

5 DO I NEED TO COMPLY WITH STANDARD 1.2.7? Are you making a nutrition content or health claim? You may not need to comply with Standard 1.2.7, however you need to comply with appropriate labelling requirements in the Code. Does the claim concern the presence or absence of certain properties identified in Standard 1.2.7? Is the claim that a food or property of food has a health effect? Has the claim been made with the permission of an endorsing body? You are making a nutrition content claim: refer to Section 3 for further advice. Does the food to which the claim is applied comply with the Nutrition Profiling Scoring Criterion? You may not make a health claim on this food. You may be classified as an endorsement. Refer to Section 7 for further advice. You are making a general level health claim: refer to Section 5 for further advice. Does the claim refer to a serious disease or biomarker of a serious disease? You are making a high level content claim: refer to Section 6 for further advice. 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. Standard 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 concern moderating alcohol intake. 5

6 2. General conditions and restrictions for making claims There are some restrictions and conditions concerning the making of claims under Standard 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: ms/nutrientprofilingcal3499.cfm. Standard 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 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

7 National and State level monitor and investigate compliance with labelling and advertising requirements of Standard 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 In Australia, the Australian Competition and Consumer Commission (ACCC) enforces the Competition and Consumer Act In New Zealand, the Commerce Commission is responsible for enforcing the Fair Trading Act 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

8 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 Standard does not prescribe the wording of a claim. However any statement or information required by Standard 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 This evidence may include: testing results details of how the product complies with appropriate clauses in Standard and content in Schedule 1, 2, 3, 4, 5 or 6 of Standard that the wording in the claim does not alter or contradict a requirement of Standard Nutrition Information Panel Clause 4 of Standard 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 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

9 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 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 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

10 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

11 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

12 Property of food Building a Nutrition Content Claim Other requirements of Standard = Nutrition Content Claim 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. t listed in Schedule 1 Claim may only refer to presence or absence of property and/or specific amount. 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). 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: 12

13 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 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? 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? 13

14 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? 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 packages 1. 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? 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? 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? If YES the claim is NOT permitted. 16. Is a nutrition content claim being made about folic acid, choline or fluoride? 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? 1 small package means a package with a surface area of less than 100 cm 2 (Standard 1.2.1). 14

15 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. 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. 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? 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? 15

16 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? 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? If yes the claim is NOT permitted. 16

17 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 relationship 2 (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 A FHR for general level health claims can be established in one of two ways: listed in Schedule 3 of Standard Following a process of systematic review as described in Schedule 6 of Standard Guidance on establishing a FHR for a general level health claim by systematic review is available at the FSANZ website: 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 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 To help in determining if a food meets the NPSC a nutrition profiling calculator is available at the FSANZ website: 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 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

18 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

19 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 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 FSANZ has prepared a guidance document to assist businesses should they choose this option. This document can be found online at: 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): stated restriction. Column 4 (Dietary Context): 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 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

20 5a Building a General Level Health Claim (pre-approval) Schedule 3: Food health effect relationship* Other requirements of Standard = Health Claim Compliance with relevant elements of Columns 1 5 of Schedule 3. 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 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). * Schedule 3 may be amended by application to FSANZ: 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. 20

21 5a Compliance template General Level Health claims (preapproved) Businesses are referred to Sections 2, 4 and 5 of this document for conditions for the making of general level health claims. General information 1. What is the wording of the proposed general level health claim? Does the claim refer to a serious disease or a biomarkerr of a serious disease? N.B. General level health claims cannot refer to a serious diseases or a biomarker of a serious disease. 2. What food will the general 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 Standardd 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 Standardd 1.2.7? See the following website for information on calculating the nutrient profiling score. nutritionhealthandrelatedclaims/nutrientprofilingcal3499.cfm If food is Category 1, nutrient profiling score must be less than 1 to qualify for healthh claim. If food is Category 2, nutrient profiling score must be less than 4 to qualify for healthh 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 general 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? If yes the claim is NOT permitted. 21

22 7. What is the food-health effect relationship (e.g. vitamin, mineral, polysaccharide, phytosterol or biologically active substance) identified in Schedule 3 of Standard 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? If no - the claim is not permitted in its current form (unless the food is contained in a small package 3 ). 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 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 unless the form of the food is as sold? 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? 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? 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 packages 4. 3 small package means a package with a surface area of less than 100 cm 2 (Standard 1.2.1). 4 small package means a package with a surface area of less than 100 cm 2 (Standard 1.2.1). 22

23 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

24 5b Building a General Level Health Claim (Systematic review) Food health relationship: Schedule 6* Other requirements of Standard = Health Claim Systematic review in accordance with Schedule 6. - tified to FSANZ CEO. - Compliance with all elements of Schedule 6 required. - tice to certify compliance with all Schedule 6. - Records provided to jurisdiction upon request. 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 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). 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: 24

25 5b Compliance template General Level Health claims (systematic review) Businesses are referred to Sections 2, 4 and 5 of this document for conditions for the making of general level health claims. General information 1. What is the wording of the proposed general level health claim? Does the claim refer to a serious disease or a biomarkerr of a serious disease? N.B. General level health claims cannot refer to a serious diseases or a biomarker of a serious disease. 2. What food will the general 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 Standardd 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 Standardd 1.2.7? See the following website for information on calculating the nutrient profiling score. nutritionhealthandrelatedclaims/nutrientprofilingcal3499.cfm If food is Category 1, nutrient profiling score must be less than 1 to qualify for healthh claim. If food is Category 2, nutrient profiling score must be less than 4 to qualify for healthh 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 general 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? If yes the claim is NOT permitted. 25

26 7. Does the general 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? If no - the claim is not permitted in its current form (unless the food is contained in a small package 5 ). Health claims about phytosterols, phytostanols and their esters do not equire 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 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 unless the form of the food is as sold? If no - the claim is not permitted in its current form. 9. Do words used in the general level health claim alter or contradict the intended effect of a statementt or information required by Standard ? If yes the claim is NOT permitted. 10. Does the claim the general level health claim state the form of the food to which the claim applies together with as required by subclause 19(3)(b) of Standard unless the form of the food is as sold? If no - the claim is not permitted in its current form. 11. Is the general levell health claim being made as a split claim? If so, is a statement available on the label of food or advertisement wheree 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? 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? If no the particulars of the property of the food must be declaredd 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 packages 6. 5 small pack kage means a package with a surface area of lesss than 100 cm 2 ( Standard 1.2.1). 6 small pack kage means a package with a surface area of lesss than 100 cm 2 ( Standard 1.2.1). 26

27 13. Do words used in the general level health claim alter or contradict the intended effect of a statementt or information required by Standard ? 14. What is the food-health effect relationship that is being using as the basis for making the general level health claim? 15. If the general level health claim is based on the details of a relationship between a food or property of food and a health effect that has been established by a processs of systematic review describedd in Schedule 6 of Standardd 1.2.7, has the person responsible for making the claim notified the CEO of FSANZ? If NO - the claim does NOT comply with Standardd Has a person giving notice in question 6 above to the CEO of FSANZ provided: i) The name of the person giving the notice and the address in Australia and New Zealand of that person, and ii) Consent to the publication by the Authority of information concerning the relationship that is the subject of the notice plus information in i) above, and; iii) Certification that the relationship that is the subject of the notice provided in question 6 above has been established by a process of systematic review that is described in Schedule 6. If NO to any of the above - the claim does not comply with Standard Does a person giving notice in question 6 above to the CEO of the Authority, if requested by a relevant authority, provide records to the relevant authority that demonstrate that i) The systematic review was conducted in accordance with the process of systematic review describedd in Schedulee 6; and ii) The notified relationship is a reasonable conclusion of the systematic review. If NO to any of the above - the claim does not comply with Standard Content of Schedule Has a statement been made that describes the food or property of the food, the health effect and the proposed relationship between the food or property of food and the health effect? 7 refer FSANZ document Guidance on establishing food-health relationships for general level health claims for guidance on compiling records to demonstrate compliance with Schedule 6 of Standard

28 If NO, the systematic review has not been conducted in accordance with the process described in Schedule Has a search strategy been provided that describes how scientific evidence has been captured relevant to the proposed relationship, between the food or property of food and the health effect, including the inclusion and exclusion criteria? If NO, the systematic review has not been conducted in accordance with the process described in Schedule Has a final list of studies, based on the inclusion and exclusion criteria, been provided to support the proposed relationship? If NO, the systematic review has not been conducted in accordance with the process described in Schedule Are their studies among this list that involve studies in humans? If NO, the systematic review has not been conducted in accordance with the process described in Schedule 6 - studies in humans are essential. 22. Has a table with key informationn from each included study been provided? This table must include information on: (a) the study reference (b) the study design (c) the objectives (d) the sample size in the study groups and loss to follow-up or nonincluding amount consumed (g) confounders measured response (e) the participant characteristics (f) method used to measure the food or property of food (h) the method used to measure the health effect (i) the study results, including effect size and statistical significance (j) any adverse effects If NO to any of the above, the systematic review has not been conductedd in accordance with the process described in Schedule Has an assessment of the quality of each included study been undertaken that includes, as a minimum: (a) a clearly stated hypothesis (b) minimisation of bias 28

29 (c) adequate control for confounding (d) the study participants background diets and other relevant lifestylee factors (e) study duration and follow-up adequate to demonstratee the health effect (f) the statistical power to test the hypothesis. If NO, to any of the above, the systematic review has not been conductedd in accordance with the process described in Schedule Has an assessment of the results of the included studies as a group been provided, that considers whether: (a) there is a consistent association between the food or property of food and the health effect acrosss all high quality studies. (b) there is a causal association between the consumption of the food or property of food and the health effect that is independent of other factors (with most weight given to well-designed experimental studies in humans). (c) the proposed relationship between the food or property of food and the health effect is biologically plausible. (d) the amount of the food or property of food to achieve the health effect can be consumed as part of a normal diet of the Australian and New Zealand populations. If NO, to any of the above, the systematic review has not been conductedd in accordance with the process described in Schedule Has a conclusion been providedd based on the results of the studies that includes: (a) whether a causal relationship has been established between the food or property of food and the health effect based on the totality and weight of evidence. (b) where there is a causal relationship between the food or property of food and the health effect: (i) the amount of the food or property of food required to achieve the health effect (ii) whether the amount of the food or property of food to achieve the health effect is likely to be consumed in the diet of the Australian and New Zealand populations or by the target population group, where relevant. If NO, to any of the above, the systematic review has not been conductedd in accordance with the process described in Schedule 6. 29

30 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 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

31 Building a High Level Health Claim Schedule 2: Food health effect relationship* Other requirements of Standard = Health Claim Compliance with relevant elements of Columns 1 5 of Schedule 2. 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 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). 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: 31

32 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. 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? If yes the claim is NOT permitted. 32