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Proposal P1006 Remove Commencement Provisions for Certain Special Purpose Infant Formula Initial Consideration Report

17 June 2008

Dear Sir/Madam

Thank you for the opportunity to comment on this proposal. The New Zealand Food Safety Authority (NZFSA) has the following comments to make.

Support for Option 2

NZFSA supports the Draft variation to the Code, as shown in Attachment 1 of Proposal P1006.

In light of the expiry of the five year exemption period, and the absence of a compositional standard for specialised infant formula products, NZFSA supports the draft variation to the Code to remove this commencement provision, as shown in Attachment 1 of Proposal P1006.

NZFSA recognises that it is vital to maintain supply of products to infants in New Zealand and Australia requiring an infant formula that has been specially formulated to satisfy particular metabolic, immunological, renal, hepatic and malabsorptive conditions.

In deciding whether or not to support this proposal, NZFSA has taken into account that FSANZ states in its Proposal that it has not been made aware of any evidence that the previous regulatory approach prior to 20 June 2007 (and now proposed option), has not provided adequate protection of public health and safety during the five year exemption period. It is also noted that the proposed amendment is limited in its scope, (namely to infant formula products formulated for metabolic, immunological, renal, hepatic and malabsorptive conditions), and that it requires that in all other respects, such products will be required to meet the requirements of Division 3.

NZFSA also recognises that in contrast to other infant formulas, these products will usually only be available by prescription, and used under medical supervision, which will mitigate risks. We recognise that the scope of this Proposal does not allow for the consideration of the availability of these products. However when FSANZ undertakes the full review of this decision (as discussed below), NZFSA is of the view that any special conditions associated with the availability of these products should be considered and contained within the Food Standards Code (for example, should these products be available only by prescription and/or under medical supervision).

NZFSA also endorses FSANZ's commendable aim for certainty for consumers, industry and enforcement agencies as to the regulatory status of special purpose infant formulas, and reiterates the need for such clarity across all infant formula products.

Review of Special Purpose Infant Formula

We note that if this amendment is approved, FSANZ must within 12 months of gazettal, undertake a full review of this decision and any variation to the Code. Within Proposal P1006 (section 5.3), FSANZ references the work undertaken on Proposal P242 – Foods for Special Medical Purposes. We note that the Preliminary Final Assessment Report for P242 indicates that due to the complexity of the issues involved with the regulation of specialised infant formula products, these products cannot be considered within P242, and therefore should be excluded from the scope of P242 and considered under a separate proposal following completion of Proposal P242. Due to the statutory 12 month timeframe and the complexity of the issues, NZFSA strongly supports the work on Special Purpose Infant Formula within the scope of Subdivision 2, Division 3, of Standard 2.9.1 progressing outside of the work on P242.

Yours sincerely