FSANZ is proposing to move away from an industry
self-substantiation model to a regulatory system based on a
"prohibit unless specifically listed"
Submissions are due 15 May 2009.
Food Standards Australia New Zealand ("FSANZ") has
recently released Proposal P293 Nutrition, Health & Related
Claims Consultation Paper for first review.
A Brief History Of P293
The Consultation Paper is yet another step in the review process
undertaken by FSANZ in relation to the regulation of health,
nutrition and related claims. The process was initiated in 2004,
culminating with the release of a Final Assessment Report
(including a draft standard) in April 2008. This Final Assessment
Report was considered by the Ministerial Council in May 2008, who
requested that FSANZ review the draft standard on a number of
grounds. The Consultation Paper has been released by FSANZ in
response to the Ministerial Council's review request.
The Consultation Paper seeks input from stakeholders on two
the approach taken regarding the regulation of general level
health claims; and
changes to the drafting of the draft standard that have been
proposed for the purpose of improving clarity and
The proposed changes to the regulation of general level health
claims are significant, and represent a shift away from a more
flexible approach to an overly prescriptive regulatory regime.
The approach taken in the Final Assessment Report was that
general level health claims would be permitted provided that
certain criteria was met, in particular, that the Scientific
Substantiation Framework was applied to the claim and that the
records of substantiation were produced at the request of a
regulator. However, FSANZ is now proposing to move away from this
industry self-substantiation model to a regulatory system based on
a "prohibit unless specifically listed " principle
whereby general level health claims may only be made where these
have been pre-approved by FSANZ.
If the proposed changes are adopted it will mean that health
nutrition claims will only be made where they appear on FSANZ's
"list" of approved claims. Further, industry will be
required to use the specific language prescribed by the regulator
which may not always be commercially palatable. For example, the
proposed permitted claim in respect of calcium and bones in P293 is
"necessary for teeth and bone structure". It would appear
that claims regarding bone strength would no longer be
The justification for this change in approach is that permitting
industry to self-substantiate claims creates enforcement problems,
as enforcement agencies will need to "investigate and form a
view about the substitution of [health claim] relationships".
With respect, this argument borders on the farcical - it is the
role of enforcement agencies to "investigate and form a
view" on a range of issues, and it is not unreasonable to
expect a food enforcement agency to have the expertise to be able
to readily assess the veracity of health claims.
In addition, the Ministerial Council has raised a number of
other grounds of review that are not addressed in the review
report. It is unclear whether FSANZ intends to seek any further
public consultation on those additional issues.
Given the history of reform in this area it is tempting to
question the value of making submissions as it is far from certain
whether P293 will ever be implemented. However, there is a risk
that if industry is complacent on this issue that the proposed
changes flagged in the Discussion Paper will be implemented with
little or no opposition or debate about the potential cost to
FSANZ has requested submissions by 15 May 2009.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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