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24 Apr 2009

Health claims and food products: A new chapter in the P293 saga

by Madeleine Kearney

FSANZ is proposing to move away from an industry self-substantiation model to a regulatory system based on a "prohibit unless specifically listed" principle. 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.

Consultation Paper

The Consultation Paper seeks input from stakeholders on two matters:

  • 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 user-friendliness.

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 permitted.

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 industry.

FSANZ has requested submissions by 15 May 2009.

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Clayton Utz communications are intended to provide commentary and general information. They should not be relied upon as legal advice. Formal legal advice should be sought in particular transactions or on matters of interest arising from this communication. Persons listed may not be admitted in all States and Territories.