3 August 2017[20–17]

Consultation Paper – W1109 – Consultation about beta-glucan and blood cholesterol health claims

FSANZ has completed a systematic review of the evidence for a relationship between oats, barley and beta-glucan and blood cholesterol concentration. The outcome of this systematic review was that a relationship between oats (and not barley) and blood cholesterol is substantiated. The Australia New Zealand Food Standards Code (the Code) currently permits a high level health claim (HLHC) to be based on a relationship between beta-glucan (from oats or barley) and blood cholesterol rather than a relationship between oats and blood cholesterol. FSANZ is calling for submissions to understand any stakeholder issues and implications for the Code that may arise from the outcomes of the systematic review.

For information about making a submission, visit the FSANZ website at information for submitters.

All submissions will be published on our website. We will not publish material that that we accept as confidential, but will record that such information is held. In-confidence submissions may be subject to release under the provisions of the Freedom of Information Act 1991. Submissions will be published as soon as possible after the end of the public comment period. Where large numbers of documents are involved, FSANZ will make these available on CD, rather than on the website.

Under section 114 of the FSANZ Act, some information provided to FSANZ cannot be disclosed. More information about the disclosure of confidential commercial information is available on the FSANZ website at information for submitters.

Submissions should be made in writing; be marked clearly with the word ‘Submission’ and quote the correct project number and name. While FSANZ accepts submissions in hard copy to our offices, it is more convenient and quicker to receive submissions electronically through the FSANZ website via the link on documents for public comment. You can also email your submission directly to submissions@foodstandards.gov.au.

There is no need to send a hard copy of your submission if you have submitted it by email or via the FSANZ website. FSANZ endeavours to formally acknowledge receipt of submissions within 3 business days.

DEADLINE FOR SUBMISSIONS: 6pm (Canberra time) 14 September 2017

Submissions received after this date will not be considered unless an extension had been given before the closing date. Extensions will only be granted due to extraordinary circumstances during the submission period. Any agreed extension will be notified on the FSANZ website and will apply to all submitters.

Questions about making submissions or the application process can be sent to standards.management@foodstandards.gov.au.

Hard copy submissions may be sent to one of the following addresses:

Food Standards Australia New Zealand Food Standards Australia New ZealandPO Box 5423 PO Box 10559KINGSTON ACT 2604 The Terrace WELLINGTON 6143

i

AUSTRALIA NEW ZEALANDTel +61 2 6271 2222 Tel +64 4 978 5630

ii

Table of contents

EXECUTIVE SUMMARY................................................................................................................................... 2

1 INTRODUCTION..................................................................................................................................... 3

2 THE CURRENT STANDARD...................................................................................................................... 3

3 BACKGROUND....................................................................................................................................... 5

4 THE SYSTEMATIC REVIEW...................................................................................................................... 6

4.1 BETA-GLUCAN AND BLOOD CHOLESTEROL CONCENTRATION................................................................................64.2 BARLEY AND BLOOD CHOLESTEROL CONCENTRATIONS.......................................................................................64.3 OATS AND BLOOD CHOLESTEROL CONCENTRATIONS..........................................................................................7

5 CURRENT SITUATION............................................................................................................................. 7

5.1 USE OF HEALTH CLAIMS ABOUT BETA-GLUCAN.................................................................................................75.2 DIETARY GUIDELINES..................................................................................................................................8

6 OVERSEAS REGULATIONS...................................................................................................................... 8

7 ISSUES FOR CONSIDERATION................................................................................................................. 9

7.1 GENERAL LEVEL HEALTH CLAIM.....................................................................................................................97.2 HIGH LEVEL HEALTH CLAIM........................................................................................................................10

8 QUESTIONS FOR SUBMITTERS.............................................................................................................. 11

8.1 QUESTIONS FOR ALL SUBMITTERS................................................................................................................118.2 QUESTIONS FOR THE FOOD INDUSTRY..........................................................................................................11

9 NEXT STEPS......................................................................................................................................... 12

10 REFERENCES........................................................................................................................................ 12

ATTACHMENT 1 – QUESTIONS FOR SUBMITTERS..........................................................................................13

QUESTIONS FOR ALL SUBMITTERS.............................................................................................................................13QUESTIONS FOR THE FOOD INDUSTRY.......................................................................................................................13

Supporting document

The following document which informed this consultation paper is available on the FSANZ website:

SD1 Systematic Review of the Evidence for a Relationship between Oats, Barley and their derived -Glucans on Blood Cholesterol Concentration

1

Executive summaryThis consultation paper concerns two existing pre-approved food-health relationships in Schedule 4 – Nutrition, Health and Related Claims of the Australia New Zealand Food Standards Code (the Code):

beta-glucan reduces blood cholesterol, which can be used as the basis for making a high level health claim (HLHC)

beta-glucan reduces dietary and biliary cholesterol absorption, which can be used as the basis for making a general level health claim (GLHC).

FSANZ has been reviewing the scientific currency of pre-approved food-health relationships that can be used as the basis for HLHCs. As part of this work, we have completed a systematic review of the evidence for a relationship between oats, barley and beta-glucan derived from these foods and blood cholesterol concentration (Supporting Document 1). The outcome of this systematic review is that a relationship between wholegrain oats or oat bran (and not barley) and reduced blood total cholesterol and low density lipoprotein (LDL) cholesterol concentrations is substantiated, rather than the current pre-approved food-health relationship between beta-glucan and blood cholesterol concentration.

As the pre-approved food-health relationship for a HLHC about beta-glucan does not reflect the outcomes of the systematic review, we are seeking information from stakeholders to inform next steps. Following this consultation, any potential changes to the Code would be considered via a proposal, which would include further public consultation.

The systematic review did not include the pre-approved food-health relationship for the GLHC about beta-glucan and reduced dietary and biliary cholesterol absorption. We are therefore also seeking information about the use of this claim to assist us to determine how best to manage this relationship in light of the findings of the systematic review.

2

1 IntroductionStandard 1.2.7 – Nutrition, health and related claims of the Australia New Zealand Food Standards Code (Code), was gazetted in January 2013. At that time it included 13 pre-approved food-health relationships that could be used as the basis for high level health claims (HLHC). Some of these relationships were evaluated for inclusion in the Standard by FSANZ in 2005‒2006. FSANZ has therefore been reviewing the scientific currency of these pre-approved food-health relationships.

This consultation paper concerns:

beta-glucan reduces blood cholesterol, which can be used as the basis for a HLHC beta-glucan reduces dietary and biliary cholesterol absorption, which can be used as

the basis for a general level health claim (GLHC).

These claims can be made about certain oat and barley foods that contain at least 1 gram of beta-glucan per serving.

FSANZ has completed a systematic review of the evidence for a relationship between oats, barley and beta-glucan derived from these foods and blood cholesterol concentration. The outcome of this systematic review is that a relationship between wholegrain oats or oat bran (and not barley) and blood total cholesterol and low density lipoprotein (LDL) cholesterol concentrations is substantiated, rather than a relationship between beta-glucan and blood cholesterol concentration.

As the pre-approved food-health relationship about beta-glucan does not reflect the outcomes of the systematic review, we are currently considering how best to approach amending the Code. We are seeking information on potential impacts of changing the Code to make the existing food-health relationship about beta-glucan and blood cholesterol consistent with the outcomes of the systematic review.

The systematic review did not include the pre-approved food-health relationship for the GLHC about beta-glucan and reduced dietary and biliary cholesterol absorption. We are also seeking information about the use of this claim to assist us to determine how best to manage this relationship.

2 The current standardStandard 1.2.7 – Nutrition, health and related claims sets out the claims that can be voluntarily made on labels or in advertisements about the nutrition content of food (nutrition content claims) and about the relationship between a food or property of food and a health effect (health claims). HLHCs are health claims that refer to a serious disease or a biomarker of a serious disease. GLHCs are health claims that are not HLHCs. Standard 1.2.7 sets out the conditions under which these claims can be made. Schedules 4 (Nutrition, health and related claims), 5 (Nutrient profiling scoring criteria) and 6 (Required elements of a systematic review) of the Code set out additional information for the operation of Standard 1.2.7.

HLHCs can only be made if the claimed food or property of food and the health effect claimed for that food or property of food is mentioned in the HLHC table in Schedule 4 (S4—4) of the Code, i.e. if the food-health relationship is pre-approved.

3

GLHCs can either be based on one of the pre-approved food-health relationships in Schedule 4 (S4—5) or a food-health relationship that has been self-substantiated in accordance with detailed requirements set out in the Standard and in Schedule 6.

For health claims based on pre-approved food-health relationships, the wording of the health claim must include a statement about the relevant population group in Column 3 (if any) and words to the effect of the relevant dietary context statement in Column 4 of the tables in Schedule 4. These conditions are described in Table 1 below for the HLHC about beta-glucan and in Table 2 below for the GLHC.

The FSANZ Application Handbook1 sets out guidelines for making an application to seek amendments to sections S4—4 or S4—5 including the addition of a new pre-approved food-health relationship for the purposes of making a HLHC or GLHC, respectively. Section B.4 of Guideline 3.2.6 in the Application Handbook states that the application must include a scientific assessment about how the studies reviewed demonstrate, with a high degree of certainty, that a causal relationship exists between the food or property of food and the health effect.

Table 1: Conditions for the HLHC about beta-glucan (S4—4 of Schedule 4)

Column 1 Column 2 Column 3 Column 4 Column 5

Food or property of food

Specific health effect

Relevant population

Context claim statements

Conditions

Beta-glucan Reduces blood cholesterol

Diet low in saturated fatty acids

Diet containing 3 g of beta-glucan per day

The food must contain:(a) one or more of the

following oat or barley foods:(i) oat bran;(ii) wholegrain oats;

or(iii) wholegrain

barley; and(b) at least 1 g per serving

of beta-glucan from the foods listed in (a).

Table 2: Conditions for the GLHC about beta-glucan (S4—5 of Schedule 4)

1 FSANZ Application Handbook is available at http://www.foodstandards.gov.au/code/applications/Pages/default.aspx

4

Column 1 Column 2 Column 3 Column 4 Column 5

Food or property of food

Specific health effect Relevant population

Dietary context Conditions

Beta-glucan Reduces dietary and biliary cholesterol absorption

Diet low in saturated fatty acidsDiet containing 3 g of beta-glucan per day

The food must contain:(a) one or more of the

following oat or barley foods:(i) oat bran; or(ii) wholegrain oats;

or(iii) wholegrain

barley; and(b) at least 1 g per

serving of beta-glucan from the foods listed in (a).

3 BackgroundStandard 1.2.7 (including associated schedules) was developed under Proposal P293 – Nutrition, Health and Related Claims. Consideration of P293 commenced in 2003. The draft Standard was approved by the FSANZ Board in 2008, however the then COAG Legislative Forum on Food Regulation (the Forum) asked FSANZ to review the Standard. Following this review, which included consultations on further amendments to the draft Standard, the Standard was gazetted in January 2013.

There are 13 pre-approved food-health relationships that can be used as the basis for HLHCs and 200 pre-approved food-health relationships that can be used as the basis for GLHCs. Some of these relationships were evaluated for inclusion in the Standard by FSANZ in 2005‒2006 and others were added as the Standard developed. The pre-approved relationships were drawn from a variety of sources. The sources of both relationships about beta-glucan currently in the Code are outlined below.

The pre-approved food-health relationship for the GLHC about beta-glucan and reduced dietary and biliary cholesterol absorption was first included in draft Standard 1.2.7 during the review of the Standard as mentioned above. At that time (2009 Consultation Paper2) FSANZ proposed that GLHCs only be permitted if they were supported by GLHC relationships listed in the Standard. Relationships were drawn from a number of sources, including from a prescribed list of authoritative sources, for example, health claims that had been reviewed and accepted by Health Canada, and from health claims approved under the Food and Drug Administration Modernization Act of 1997 (FDAMA claims) by the United States Food and Drug Administration (FDA). The relationship about beta-glucan and dietary and biliary cholesterol absorption (for a GLHC) was based on a similar claim that was approved by the US Food and Drug Administration as meeting ‘Significant Scientific Agreement’3. The rationale was explained in the Consultation Paper (Attachment 8) as follows:

FSANZ previously reviewed the evidence for a high level health claim relationship for wholegrains and heart disease. The relationship was not approved as a high level health

2 The 2009 P293 consultation paper is available from the following link: Proposal P293 - Nutrition, Health and Related Claims3 Significant scientific agreement refers to the extent of agreement among qualified experts in the field. Section 403(r)(3)(B)(i) of the Federal Food, Drug, and Cosmetic Act states that the Secretary of Health and Human Services (Secretary) (and, by delegation, FDA) shall issue a regulation authorizing a health claim only if the Secretary determines, based on the totality of publicly available scientific evidence that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence (US FDA 2017).

5

claim because much of the data in the review related to soluble fibres from specific grains rather than from all wholegrains. Because of previous work, FSANZ gave consideration to the possibility of a GLHC relationship also noting that claims for beta glucan are in the marketplace. FSANZ considers that the evidence between dietary and biliary cholesterol absorption and beta glucan from oats and barley is appropriate to approve a GLHC. A similar claim for soluble fibre (principally beta glucan) and heart disease is recognised in the US health claims regulations and this was used to adapt the conditions for use of the claim.

The pre-approved food-health relationship for the HLHC about beta-glucan and reduced blood cholesterol was first included in draft Standard 1.2.7 during the review of the Standard in a consultation paper in February 20124.At that time FSANZ proposed to review the health claims approved by the European Union (EU) and to adapt acceptable claims for inclusion as food-health relationships in Standard 1.2.7. The pre-approved food-health relationship for the HLHC about beta-glucan was based on a health claim that was one of only 19 EU claims authorised in the EU at that time. In May 2012, the EU approved a further 222 health claims in addition to its earlier list of 19. FSANZ then adopted more of these EU claims making a total of 183 food-health relationships drawn from the EU.

In the P293 2012 Review Report5, FSANZ committed to developing and implementing a process to maintain the scientific currency of pre-approved food-health relationships. As part of this work FSANZ has been reviewing the scientific currency of the pre-approved food-health relationships for HLHCs. The systematic review in SD1 was completed as part of this work.

4 The systematic reviewThree food-health relationships were considered in the systematic review. An overview of the outcomes for each relationship is provided in this section. The complete systematic review is at SD1.

4.1 Beta-glucan and blood cholesterol concentration

The following food-health relationship was assessed in the systematic review:

Dietary intake of beta-glucan from oats or barley reduces blood cholesterol concentration.

Fifty-four randomised controlled trials (RCTs), containing 57 strata (trial arms) were included in the review, however, as none of the studies tested pure beta-glucan, they did not directly test the effects of beta-glucan on blood cholesterol. As no RCT assessed the effects of intake of 100% pure beta-glucan on blood cholesterol concentration, FSANZ considered that the results described in the literature could not be unequivocally attributed to beta-glucan and could only be attributed to the tested product. It was concluded that this food-health relationship could not be assessed.

A condition in Schedule 4 of the Code for making a health claim about beta-glucan and blood cholesterol specifies that the food must contain wholegrain oats, oat bran or wholegrain

4 The 2012 P293 consultation paper is at the following link: http://www.foodstandards.gov.au/code/proposals/documents/P293%20Nutrition_Health_related%20claims%20consult%20paper1.pdf5 The P293 Review Report is at the following link: http://www.foodstandards.gov.au/code/proposals/pages/proposalp293nutritionhealthandrelatedclaims/p293reviewreport.aspx

6

barley. FSANZ therefore extended the analysis to separately assess food-health relationships between: 1) wholegrain barley and blood cholesterol concentration; and 2) wholegrain oats and oat bran and blood cholesterol concentration. These are outlined in the following two sections.

4.2 Barley and blood cholesterol concentrations

The following food-health relationship was assessed:

Dietary intake of wholegrain barley reduces blood total and LDL cholesterol concentrations.

Seven RCTs were included in the review, with 7 strata included in the meta-analysis. Other strata from the review were excluded because they used oats or poorly defined concentrated and heavily processed barley or oats fibre.

The meta-analysis demonstrated that consumption of barley significantly changed blood total and LDL cholesterol concentrations by -0.32 and -0.25 mmol/L, respectively. In contrast, there was no significant effect on HDL cholesterol concentration (-0.03 mmol/L).

The relationship between barley and blood total and LDL cholesterol concentrations was shown to be consistent, with plausible mechanisms to explain the observed effect. The magnitude of the noted reduction was significant regardless of the participant’s blood cholesterol status, that is, whether they had a normal cholesterol concentration (< 5.5 mmol/L blood total cholesterol concentration) or were hypercholesterolaemic (≥ 5.5 mmol/L). However, the quality of the evidence was down-rated for serious imprecision due to the low number of participants. Therefore, FSANZ considers that the body of evidence demonstrates that the relationship between barley and reduction of blood total and LDL cholesterol concentrations has a ‘Moderate’ degree of certainty and so the relationship is not substantiated.

4.3 Oats and blood cholesterol concentrations

The following food-health relationship was assessed:

Dietary intake of wholegrain oats or oat bran reduces blood total and LDL cholesterol concentrations.

Thirty-two RCTs for wholegrain oats or oat bran were included in the review, with 33 strata included in the meta-analysis. Other strata from the review were excluded because they used barley or poorly defined concentrated and heavily processed oats or barley fibre. The meta-analysis showed that consumption of oats significantly changed blood total and LDL cholesterol concentrations by -0.22 and -0.21 mmol/L, respectively. However, there was no change (0 mmol/L) in HDL cholesterol concentration.

The relationship between oats and blood total and LDL cholesterol concentrations was shown to be both consistent and causal, with plausible mechanisms to explain the observed effect. Sub-group analysis showed the effect was similar in men and women. The magnitude of the effect was slightly greater in trials of participants with normal blood cholesterol (< 5.5 mmol/L blood total cholesterol) compared with trials of participants with high blood total cholesterol (≥ 5.5 mmol/L), though this difference was not statistically significant. The effect was present in high quality studies. There was no effect of source funding on the effects described.

The body of evidence demonstrates that the relationship between oats and reduction of blood total and LDL cholesterol concentrations is substantiated with a ‘High’ degree of

7

certainty.

5 Current situation5.1 Use of health claims about beta-glucan

FSANZ has observed that some cereal-based foods currently carry either GLHCs or HLHCs about beta-glucan and blood cholesterol, in particular, oat products such as rolled oats. We are also aware that there has been some financial investment in research and development activities on beta-glucan in oats and barley.

In order to assist us in our consideration of health claims about beta-glucan and blood cholesterol, we are seeking information from the food industry about the current use of health claims about beta-glucan on food (see section 8).

5.2 Dietary Guidelines

Both the Australian and New Zealand dietary guidelines focus on consuming wholegrains.

The Australian Dietary Guidelines include the recommendation to Enjoy grain (cereal) foods, mostly wholegrain and/or high cereal fibre varieties. Oats and barley are given as examples. With regards to the evidence for this recommendation, with respect to cardiovascular disease and blood cholesterol levels, the guideline document states:

There is evidence of a probable association between the consumption of grain (cereal) foods (especially wholegrains and those with fibre from oats or barley) and a reduced risk of cardiovascular disease in adults (Grade B; Evidence Report, Section 6.3). Almost all the high level trials were conducted with oats, with the evidence of beneficial lowering of levels of LDL and total cholesterol levels. The protective effect was noted with between one to three serves per day of wholegrain foods (predominantly oats) (NHMRC 2013).

The New Zealand Dietary Guidelines recommend enjoying a variety of nutritious foods everyday, including grain foods, mostly whole grain and those naturally high in fibre. A rationale provided for this is the link with lower risk of cardiovascular disease and some other diseases. Whole and rolled oats and whole barley are given as examples of wholegrain cereals (Ministry of Health 2003).

The National Heart Foundation of New Zealand recommends eating some grain foods and for heart health, to choose whole grain varieties (National Heart Foundation of New Zealand 2017). The National Heart Foundation of Australia states on its website that Eating grain foods, mostly wholegrains, can help protect against heart disease and other chronic diseases, like type 2 diabetes and some cancers (National Heart Foundation of Australia 2017).

6 Overseas regulationsInternationally, there is no consistency with respect to approved health claims about beta-glucan, oats or barley and blood cholesterol concentration. In Canada and the United States of America (USA) health claims refer to fibre from barley or oats but not specifically to beta-glucan, however in the EU beta-glucans are specifically mentioned in the claim. Further detail is provided below.

In Canada health claims about barley and oat fibre (based on a minimum quantity of beta-glucan) and blood cholesterol have been reviewed and accepted by Health Canada (Government of Canada 2017). These claims must state the serving size of the food and the

8

amount of eligible fibre it provides to help reduce cholesterol but do not actually refer to beta-glucan itself. The amount of eligible fibre is calculated as a percentage of 3 g of beta-glucan oat or barley fibre. An example claim is 125 ml (1/2 cup) of cooked pearled barley supplies 60% of the daily amount of the fibre shown to help lower cholesterol.

In the USA a health claim associating diets that are low in saturated fat and cholesterol and that include soluble fibre from certain foods (oats, barley or psyllium seed husks) with reduced risk of coronary heart disease is approved (US Government Publishing Office 2017). The claim must use the term ‘soluble fibre’ and qualify this with the name of the eligible source of fibre. The claim must also specify the daily dietary intake of the soluble fibre source that is necessary to reduce the risk of coronary heart disease and the contribution one serving of the product makes to the specified daily dietary intake level. An example claim is Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease. This cereal has 2 grams per serving. For beta-glucan, the daily dietary intake levels of soluble fibre sources that have been associated with reduced risk coronary heart disease are specified as 3 g or more per day of beta-glucan soluble fibre from either whole oats or barley, or a combination of whole oats and barley.

The details for three EU-authorised claims about beta-glucan (from oats or barley) and blood cholesterol levels (European Commission 2017) are presented in Table 3.

Table 3: EU-authorised health claims about beta-glucan and blood cholesterol levels

Nutrient, substance, food or food category

Claim Conditions of use of the claim

Barley beta-glucans Barley beta-glucans has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.

Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 3 g of barley beta-glucan. The claim can be used for foods which provide at least 1 g of barley beta-glucan per quantified portion.

Beta-glucans Beta-glucans contribute to the maintenance of normal blood cholesterol levels

The claim may be used only for food which contains at least 1 g of beta-glucans from oats, oat bran, barley, barley bran, or from mixtures of these sources per quantified portion. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 3 g of beta-glucans from oats, oat bran, barley, barley bran, or from mixtures of these beta-glucans.

Oat beta-glucan Oat beta-glucan has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease

Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 3 g of oat beta-glucan. The claim can be used for foods which provide at least 1g of oat beta glucan per quantified portion.

9

7 Issues for consideration7.1 General level health claim

As noted in section 1, the systematic review (SD1) did not address the food-health relationship about beta-glucan and reduced dietary or biliary cholesterol absorption that can be used as the basis for a GLHC. FSANZ therefore does not know whether or not a relationship between oats (rather than beta-glucan) and reduced dietary and biliary cholesterol absorption would be substantiated. We are consequently seeking information about the use of the existing GLHC to assist us to determine how best to manage this relationship in light of the findings of the systematic review (see section 8 below). If FSANZ were to proceed with recommending any changes to this relationship, this would be carried out via a proposal under the requirements of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), including public consultation (see section 9).

7.2 High level health claim

The current pre-approved food-health relationship for a HLHC about beta-glucan is not consistent with the outcomes of the systematic review (SD1), as outlined in section 4. That is, a relationship between wholegrain oats or oat bran and reduced blood total cholesterol and low density lipoprotein (LDL) cholesterol concentrations is substantiated but not between:

beta-glucan and reduced blood cholesterol concentration; or barley and reduced blood total and LDL cholesterol concentrations.

This is because these relationships were not able to be established to the required ‘High’ degree of certainty.

In order to maintain the scientific currency of the relationship in the Code, FSANZ is considering how best to approach amending the existing food-health relationship to reflect the outcomes of the latest systematic review. Amendments to Schedule 4 may include, for example, changing:

the property of food from beta-glucan to wholegrain oats and oat bran the specific health effect from reduces blood cholesterol to reduces blood total and LDL

cholesterol concentrations the context claim statements to remove reference to diets containing 3 g of beta-glucan

per day the conditions to remove reference to barley and to refer to appropriate oat foods and

foods containing oats.

To assist with this consideration, we are seeking information on the extent to which HLHCs about beta-glucan and reduced blood cholesterol levels are currently made about food (on labels and in advertising) (see section 8 below).

FSANZ is also inviting comments from stakeholders about the impacts if we were to amend the Code to make the existing food-health relationship about beta-glucan and blood cholesterol consistent with the outcomes of the systematic review.

10

8 Questions for submitters FSANZ is seeking the following information from submitters. A list of these questions is also provided in the Attachment to this paper.

8.1 Questions for all submitters

FSANZ needs to determine how best to manage the existing pre-approved food-health relationship for the GLHC about beta glucan.

1. What do you consider to be the best approach for managing this food-health relationship in the Code, given the outcomes of the systematic review for the food-health relationship for a HLHC about beta-glucan (see Section 7.1)? Please give reasons for your response.

The following three questions are in the context of amending the Code to align the pre-approved food-health relationship for a HLHC about beta-glucan and blood cholesterol with the outcomes of the systematic review, i.e. the food-health relationship between wholegrain oats or oat bran and the reduction of blood total and LDL cholesterol concentrations is substantiated.

2. What do you consider to be the impacts of amending the Code for consumer understanding of beta-glucan, oats and barley and blood cholesterol?

3. Do you consider that such amendments to the Code would be consistent with dietary guidelines and other relevant public health messages? Why/why not?

4. What do you consider to be the impacts on the food industry of such an amendment?

Please provide documented evidence to support your views where possible.

8.2 Questions for the food industry

5. What foods do you sell that currently carry health claims (GLHC or HLHC) about beta-glucan? Please provide the following information for these foods:

• the name of the food• the wording of the health claim• the total number of foods and SKUs currently carrying health claims about beta-glucan.

11

9 Next stepsFSANZ appreciates this current consultation process may raise some uncertainty for stakeholders in relation to the pre-approved food-health relationships. With this in mind, FSANZ will evaluate the information provided by submitters and endeavour to make a decision on the intended approach as quickly as possible.

Should FSANZ consider changing the Code with respect to either the HLHC or GLHC, a proposal will be prepared in accordance with the requirements in the FSANZ Act to assess any proposed changes, including public consultation. This proposal would be carried out under the High Level Health Claims Variation procedure as outlined in the FSANZ Act. In addition to public consultation, this procedure requires that FSANZ give notice to a HLHC Committee. Recommendations from the HLHC committee on the draft amendments must then be considered by FSANZ.

10 ReferencesEuropean Commission (2017) EU Register on Nutrition and Health Claims http://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/?event=search Accessed 11 July 2017

Government of Canada (2017) https://www.canada.ca/en/health-canada/services/food-nutrition/food-labelling/health-claims.html Accessed 11 July 2017

Ministry of Health (2003) Food and Nutrition Guidelines for Healthy Adults: A background paper. Wellington.

National Health & Medical Research Council (NHMRC) (2013) Eat for health. Australian dietary guidelines. Available at https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/n55_australian_dietary_guidelines_130530.pdf . Accessed 28 June 2017

National Heart Foundation of Australia (2017) https://www.heartfoundation.org.au/healthy-eating/food-and-nutrition/grain-foods Accessed 11 July 2017

National Heart Foundation of New Zealand (2017) https://www.heartfoundation.org.nz/wellbeing/healthy-eating/eating-for-a-healthy-heart/ Accessed 11 July 2017

US Government Publishing Office (2017) Code of Federal Regulations, Title 21, Chapter I, Subchapter B, Part 101, Subpart E, §101.81 https://www.ecfr.gov/cgi-bin/text-idx?SID=1b5cd25c8dbf534d4b5f28da9f61a8f8&mc=true&node=se21.2.101_181&rgn=div8

US Food and Drug Administration (2017) https://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm2006876.htm (accessed 13 July 2017)

12

Attachment 1 – Questions for submittersQuestions for all submitters

FSANZ needs to determine how best to manage the existing pre-approved food-health relationship for the GLHC about beta glucan.

1. What do you consider to be the best approach for managing this food-health relationship in the Code, given the outcomes of the systematic review for the food-health relationship for a HLHC about beta-glucan? (see Section 7.1) Please give reasons for your response.

The following three questions are in the context of amending the Code to align the pre-approved food-health relationship for a HLHC about beta-glucan and blood cholesterol with the outcomes of the systematic review, i.e. the food-health relationship between wholegrain oats or oat bran and the reduction of blood total and LDL cholesterol concentrations is substantiated.

2. What do you consider to be the impacts of amending the Code for consumer understanding about beta-glucan, oats and barley and blood cholesterol?

3. Do you consider that such amendments to the Code would be consistent with dietary guidelines and other relevant public health messages? Why/why not?

4. What do you consider to be the impacts on the food industry of such an amendment?

Please provide documented evidence to support your views where possible.

Questions for the food industry

5. What foods do you sell that currently carry health claims (GLHC or HLHC) about beta-glucan? Please provide the following information for these foods:

the name of the food the wording of the health claim the total number of foods and SKUs currently carrying health claims about

beta-glucan.

13