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Proposal P1006 – Reconsideration of the urgent removal of a compositional provision for certain special purpose infant formula – Assessment Report

23 October 2008

Dear Sir/Madam

Thank you for the opportunity to comment on the 15 September assessment report concerning this Proposal. The New Zealand Food Safety Authority (NZFSA) has the following comments to make at this stage.

NZFSA position

NZFSA supports option 2 – “prepare a new (separate) proposal which may result in the amendments made to clause 27 of Standard 2.9.1 being varied or replaced”.

Background comment

As this and the previous Report makes clear, this Proposal arose when FSANZ’s attention was drawn to the fact that a commencement provision (subclause 27(2) of Standard 2.9.1) had come into effect on 20 June 2007, creating what FSANZ described as a “significant risk to the public health and safety of a very vulnerable population group, i.e. infants with medical conditions”. The relevant provision concerned infant formula that is specially formulated to satisfy particular metabolic, immunological, renal, hepatic and malabsorptive conditions in infants (hereafter referred to as “certain special purpose infant formulas”).

This urgent Proposal was developed in recognition of concerns that the conditions that the commencement provision applied from 20 June 2007 “may adversely constrain” infant formula manufacturers and impact on supply of certain special purpose infant formulas. Yet the operation of the commencement provision itself followed a five year “temporary exemption” sought by industry in 2002 to enable it to depart from the (then) proposed infant formula base compositional requirements, and to enable FSANZ to progress with developing regulation for these products within the exemption period.

While the Assessment Report refers to an extract from the 2002 Report, a fuller extract is helpful, in explaining the background to the exemption, and the nature of the evidence and submissions then available to ANZFA (emphasis added):

“The proposed standard requires these formulations to comply with the base formulation for healthy infants whilst permitting modification of the specific nutrient or nutrients necessary for the specific condition or disorder. Health professionals have stated that it may be even more important for the base formula of the product to comply with the new standard, as these consumers are the more vulnerable infants.

Currently marketed products do not comply with the proposed base formulation and manufacturers have stated that given the small volume of this market they will not be modifying these formulations to comply with the standard, and are likely to withdraw supply of these formulations to sick babies. The supply of approved products for these infants needs to be guaranteed for obvious health and safety reasons.

Therefore, although it is proposed that special purpose products are expected to conform to the base standard for healthy infants except where necessary to meet the particular needs of the infant with the special condition, ANZFA is proposing to include a temporary exemption for the compositional requirements of the standard to permit the supply of these products. The exemption is recommended for a period of five years from the adoption of the standard. This period will allow ANZFA to develop a special standard for ‘foods for special medical purposes’ that could include these highly specialised infant formula products. This will ensure that the particular needs of these infants are protected.”

At the Initial Consideration phase of this Proposal, like other Government and industry submitters, NZFSA supported the draft variation to sub clause 27(2) of Standard 2.9.1 under the section 95 urgency provisions of the FSANZ Act 1991. NZFSA recognised that it was vital to maintain the supply of certain special purpose infant formulas products to infants in New Zealand and Australia.

The 30 June 2008 draft variation has for the moment, retained the status quo and ensured the continued supply of these products. FSANZ must now reassess the variation pursuant to s 101 of the Act and consider whether or not to reaffirm it (option 1) or prepare a new (separate) proposal which may result in the amendments made to clause 27 of Standard 2.9.1 being varied or replaced. To that end, submitters are asked to consider whether there are any “unforeseen unintended consequences or unresolved issues” resulting, which would require further consideration through preparation of a new separate proposal.

NZFSA comments on P1006 Assessment Report

As NZFSA signalled at the initial assessment phase, our preferred option is Option 2 - namely a new proposal. We do not accept FSANZ’s stated reasoning for preferring Option 1. Our reasons are as follows:

• The original Standard followed an extensive decade long review of infant formula. At the time the draft Standard was under consideration at the Supplementary Final Assessment (P93) in 2002, it was ANZFA’s clear intention to set compositional requirements for these products, and to require that formulas meet the base standard for healthy infants, except where necessary to meet special requirements due to a particular condition. That may well reflect the reference quoted above to health professionals’ concerns that it may be even more important for the base formula of the product to comply with the (then proposed) infant formula standard, as these consumers are the more vulnerable infants.

• A “temporary exemption” for five years was introduced by ANZFA to enable a special Standard to be developed to “ensure that the particular needs of these infants are protected”. Instead, as clause 27(1) states, as varied by P1006, such formulas may be “specifically formulated” to satisfy particular conditions. It is contrary to the ANZFA’s original intent to prolong the “temporary exemption” for years beyond that envisaged, which will be the effect of FSANZ’s current preferred option.

• While the Assessment Report claims that this Proposal has resulted, and will result in “clarity regarding the regulatory status of these special purpose products”, which will “avoid the need for unnecessary enforcement action” NZFSA considers that the varied standard in fact carries over a lack of regulatory clarity as to the addition of substances such as: additives, nutritive substances such as prebiotics, ingredients, vitamins and minerals, or other optional ingredients that are being added overseas or in the domestic market for infant formulas for healthy babies. The compositional standard does not go into sufficient depth for regulators to take enforcement action. As ANZFA clearly intended, the standard for these products needs to be developed with more depth, underpinned by their respective nutritional requirements.

• FSANZ must also have regard to other statutory objectives, including consistency between international and domestic standards, as well as the need for standards to be based on “risk analysis using the best available scientific evidence”. The recently adopted Codex standard on Infant Formula, founded on such evidence, now provides extensive guidance for the regulation of infant formulas for special medical purposes (Codex Standard 72-1981 refers). The P1006 Reports do not refer to this Standard in any detail, which FSANZ should have regard to. We note that the Codex Standard requires compliance with many of the base requirements for infant formula for healthy infants, except where modification is required to meet the particular condition. We note that was, to a large extent, the intent of the clause that P1006 has removed, and replaced with a requirement that products comply “in all other respects” with this Division.

• The Benefit Cost Analysis contained in the Assessment Report suggests that Option 1 protects public health and safety, and maintains regulatory clarity. NZFSA does not consider that the analysis sufficiently engages with the issues. It is our view that the “protection of public health and safety” objective is only partly satisfied – while infants suffering from the specified conditions are guaranteed a supply of these products, in contrast to the Standards that apply to infant formulas to healthy infants, the Code still does not provide a detailed standard for either pre-term formulas or certain special purpose infant formulas to protect their health and safety.

• We note that FSANZ “proposes to undertake a review of the infant formula standard in relation to the broader consideration of the regulation of special purpose infant formula”, but that the “scope and timing” of this is yet to be determined. The Assessment Report envisages waiting on the completion of Ministerial Council Guidelines on the intent of Part 2.9, before that review and completion of work on P242 takes place. NZFSA considers that this work should not be held off any longer. As we mentioned in our submission at the Initial Consideration stage, the Preliminary Final Assessment report for P242 (Foods for Special Medical Purposes) expressly states 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 were therefore excluded from its scope. That Report envisaged that such infant formula products would be considered under a separate proposal following completion of P 242. In those circumstances, NZFSA strongly supports the work on Special Purpose Infant Formulas progressing outside of the work on P242.

• NZFSA appreciates that the Food Regulation Standing Committee’s Working Group on Infant Formula Products (the FRSC Working Group) is currently developing policy guidelines for infant formula products. It is anticipated that these guidelines will also cover certain special purpose infant formulas. However, the policy guidelines are not expected to address the detailed elements of any particular infant formula. Furthermore, FSANZ is part of the Working Group and involved in the development of the policy guidelines, and therefore will have knowledge of their direction and content. Therefore, standards development, by way of a proposal, could be initiated and progressed concurrently with the work undertaken by the FRSC Working Group. The resulting Draft Variation arising from a proposal to address the composition of certain special purpose infant formulas is unlikely to be concluded in advance of the FRSC policy guidelines.

• NZFSA is of the view that a proposal should be developed as part of the standards development process, as a matter of priority. This was the intention of the 5 year temporary exemption for the compositional requirements for these certain special purpose infant formulas. If work on a proposal is not started until after the completion of the FRSC policy guidelines on infant formula products, the uncertainty governing the regulation of these certain special purpose infant formulas is extended. As set out in more detail below, we also consider that formulas for pre-term and low birth -weight infants should be included in this work as a matter of priority.

• The availability of and access to these products might be one area that is addressed by the FRSC Working Group. Any outcome relating to availability and access can be incorporated into the proposal at that time. At present, these products can be sold direct to the consumer; however they are intended to be used only under medical supervision. There may therefore be grounds for restricting availability of these products (for example, no retail sales, only availability through hospitals or pharmacies).

• It is not clear to NZFSA why FSANZ considers that in the case of these infant formula products, development or consideration of certain Proposals “following completion of the Ministerial policy guidelines” is appropriate, but no such deference or delay appeared to be envisaged by FSANZ with respect to P306, which also concerns, in part, infant formula products. In that Proposal it is noted that FSANZ’s approach has been to recognise that the Ministerial Council has agreed to develop policy guidance, but that its timing is “not yet known”, and to proceed in the absence of policy guidance, despite its potential impact on any resulting standards relating to infant formula.

• Submissions on the Food Standards Australia New Zealand Amendment Bill 2007 and the explanatory memorandum to the Bill itself show intent with the new “stop the clock” provisions to align the FSANZ standard setting and Ministerial Council policy setting processes. To achieve its statutory objectives, consistency and transparency are important. NZFSA is concerned that this difference in approach to awaiting relevant Ministerial Council policy guidance, across two infant formula proposals has not been adequately explained. NZFSA’s concern at the contrast in approach is heightened, given the absence of real progress on regulating the formulas that are the subject of this Proposal in the past six years, despite the clear intent of ANZFA, and the relevant Standard, to ensure the protection of infants with these specified conditions within that timeframe.

Additional comment on Infant Formula Products formulated for premature or low birth weight infants

Finally, we note that the P1006 Assessment Report states that FSANZ has conducted an audit of the Code in response to concerns raised at how P1006 originated, and that “no other clauses require attention in a manner which gave rise to this urgent Proposal”. In our preparation of this submission, we have revisited the Supplementary Final Assessment Report for P93, with respect to infants with special nutritional requirements, including pre-term and low birth weight infants. Some of those infants may also require formulas that are the subject of P1006.

At the end of a ten year review, which identified ”highly variable nutrient” and medium chain triglyceride levels in such formulas, as well as issues concerning the use of those formulas, the appropriateness of using human breast milk (e.g. full term) levels as a base for pre-term infants, and departures from recommended vitamin and mineral levels proposed by experts, we note that ANZFA proposed a temporary regulation for such formulas as follows:

“ANZFA intends to undertake an assessment of the compositional requirements for pre–term formula however; insufficient resources are available to do this assessment within this Inquiry into draft Standard 2.9.1. It is recommended that a new proposal be prepared to assess the safety and efficacy of formula prepared for pre–term babies and the current specific regulation be replaced by a temporary general provision.” (Report at 7.1.4)

“Summary recommendations for Section 7.1

1. Clauses 32–35 be deleted from Standard 2.9.1 and replaced by a clause to the effect that infant formula product may be specifically formulated to satisfy the needs of pre–term or low birth weight infants but in all other respects must comply with the standard for infant formula products. This provision will provide temporary regulatory status for these foods and require manufacturers to be able to justify their variations from the general standard.

2. ANZFA prepares a proposal to review the provisions for safe formula for pre–term and low birth weight infants within 5 years of draft Standard 2.9.1 being adopted.” (Report at 7.1.5)

That has not occurred since June 2002. That raises two issues from NZFSA’s perspective. The first, plainly, is that the review ANZFA recommended on pre-term and low birth weight formulas for vulnerable infants is well overdue, and requires attention. It may well be that such a review could be linked to that we propose in respect of the products that are the subject of P 1006, given that some of the same issues appear to be common to these two subdivisions in Standard 2.9.1, as both classes of formulas are likely to be imported in small volumes from overseas.

The second point is that the audit of the Code FSANZ has recently conducted, may not have caught “recommendations” such as this, where “temporary” standards have been developed expressly on the basis that they would be followed by a detailed review, within a set time frame, but that did not include a commencement provision. FSANZ might consider the value of instituting a process to ensure that reviews foreshadowed in assessment reports occur within the recommended timeframe and that “temporary standards” do not acquire a permanency that was never intended.

Yours sincerely