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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.