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Questions raised about RFO 2013-14/09 Systematic reviews on the relationships between dietary fatty acid intake and blood cholesterol No. 1 Question Saturated Fatty Acids [grouped] are likely to have different effects on blood cholesterol if in coconut oil versus meat, because the individual fatty acids are different, so that one cannot in truth say all saturated fatty acids have a particular effect; it will depend on which food they are in. It also seems likely that saturated fatty acids in coconut versus meat affect LDLc and HDLc differently. FSANZ response There are several reasons why the request for offer (RFO) refers to the effect of saturated fatty acids as a group. The existing food health relationship (saturated fats and blood cholesterol) being reviewed and updated (if necessary) refers to them as a group or class of related compounds. The relationship can be used on a range of different foods that will themselves contain a number of different saturated fatty acids and, potentially, a range of fat sources. On a practical level, a review that examined saturated fats as a group as well as individually, would be very extensive and likely to be beyond our resources and the time available for completion. However the issue of varying effects of different fatty acids is relevant in terms of FSANZ’s consideration of any conditions that might need to be established around the use of the food health relationship and also provide a guide to new relationships that could be investigated at some future time. Any new or modified food health relationships included in Standard 1.2.7 need to be supported by high quality evidence that demonstrates a consistent association between the food or property of food and the health effect across all these studies, and it is possible that the evidence in regard to specific fatty acids, or mixtures of fatty acids present in specific foods, would not at this time meet the evidence requirements set out in Schedule 6 of Standard 1.2.7, and in the Application Handbook. Under the current conditions established for use of this food health relationship, it can only be used on foods containing a level of saturated plus trans fatty acids of no more than 1.5 g per 100 g for solid food than (0.75 g per 100 mL for liquid foods). It is unlikely that the claim would 2 Some fatty acids reduce the risk of coronary heart disease (CHD) by several mechanisms other than lowering blood cholesterol. Long chain n-3 PUFAs in amounts usually eaten can’t have a sizeable cholesterol lowering effect. So they can reduce CHD more than they lower cholesterol. 3 The non saponifiable lipids in dietary fats can also affect blood cholesterol, eg the phytosterols lower and squalene raises. There are claims that n—6 PUFAs have adverse side effects, Increasing oxidation or stimulating inflammation. 4 5 It appears that the new review is NOT to deal with dietary fatty acids and CHD. I’m afraid this would seem to be too simplistic an Aim. 6 Can groups of reviewers submit a joint offer? be used on foods containing a substantial proportion of coconut (for example) or of meat. We are aware of this issue. However the work required in this instance has blood cholesterol levels as the health outcome, because the work will be used to support decisions about the adoption of food health relationships used in Europe, where blood cholesterol levels are the health outcome. Nevertheless, we would expect that the successful Supplier would highlight issues such as this in their analysis of the relationship with blood cholesterol. See response to Question 2 Although the body of the Statement of Requirement does not refer specifically to identification of adverse effects, the requirements of Schedule 6 of Standard 1.2.7 (and the Application Handbook) require any reported adverse effects to be identified in the table summarising available studies. We do not require the Supplier to review these adverse effects in detail, but would expect that the Supplier would note where a pattern of adverse effects is seen. This will help FSANZ’s consideration of any conditions that might need to be established around the use of the food health relationship. You are correct – the health effects being investigated stop at blood cholesterol (as defined in the Statement of Requirement) and do not extend to CHD. This is because the relationships we are reviewing all stop at blood cholesterol. We are considering how to deal with the extension to CHD risk as part of a separate process. Yes, we are happy for more than one expert to work together to prepare these reviews. However for contractual reasons, we need to form a contract with a single legal entity. This is covered in page 2 of the Request for Offer document: The Authority will only consider Offers submitted by single legal entities which are in existence or unincorporated joint ventures which have been established at the Closing Time. The Authority may reject an Offer if it is submitted on the 7 I’m having trouble completing the PDF version of the Request for Offer. Is a Word version available? 8 How do I deal with the requirement in schedule 2 of the RFO to describe my security clearance? basis that two or more organisations will be jointly and severally liable. Our apologies for this difficulty. We have included a Microsoft Word version of the document on this page. You can also make cross-reference to a separate Word document, provided the required information is provided in the order set out in the RFO. If you don’t have an Australian government security clearance, and we anticipate that few potential Suppliers would have this, please just note ‘not applicable’. The selected Supplier will not be expected to have a security clearance.