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.
Forinformation about making a submission, visit the FSANZ website atinformation 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 atinformation 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 .
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 .
Hard copy submissions may be sent to one of the following addresses:
Food Standards Australia New ZealandFood Standards Australia New Zealand
PO Box 5423PO Box 10559
KINGSTON ACT 2604The Terrace WELLINGTON 6143
AUSTRALIANEW ZEALAND
Tel +61 2 6271 2222 Tel +64 4 978 5630
1
Table of contents
Executive summary
1Introduction
2The current standard
3Background
4The systematic review
4.1Beta-glucan and blood cholesterol concentration
4.2Barley and blood cholesterol concentrations
4.3Oats and blood cholesterol concentrations
5Current situation
5.1Use of health claims about beta-glucan
5.2Dietary Guidelines
6Overseas regulations
7Issues for consideration
7.1General level health claim
7.2High level health claim
8Questions for submitters
8.1Questions for all submitters
8.2Questions for the food industry
9Next steps
10References
Attachment 1 – Questions for submitters
Questions for all submitters
Questions for the food industry
Supporting document
The following document which informed this consultation paper is available on the FSANZ website:
SD1Systematic Review of the Evidence for a Relationship between Oats, Barley and their derived -Glucans on Blood Cholesterol Concentration
Executive summary
This 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-glucanreduces 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 reducedblood 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.
1Introduction
Standard 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-glucanreducesblood cholesterol, which can be used as the basis for aHLHC
- 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 oatsor oatbran (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 changingthe 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.
2The current standard
Standard 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.
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 Handbook[1] 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 Guideline3.2.6 in the Application Handbook states that the applicationmust 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 5Food 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 3g 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)
Column 1 / Column 2 / Column 3 / Column 4 / Column 5Food 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 acids
Diet containing 3g 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).
3Background
Standard 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 includedconsultations 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 wasfirst included in draft Standard 1.2.7 during the review of the Standard as mentioned above. At that time (2009 Consultation Paper[2]) 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, andfrom healthclaims 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 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 2012[4].
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 Report[5], 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.
4The systematic review
Three 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.
4.1Beta-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 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 branand blood cholesterol concentration. These are outlined in the following two sections.
4.2Barley 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 cholesterolconcentration (< 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.
4.3Oats 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.