This time round, it is seeking public feedback on how infant formula products would comprise of three subcategories.
They are infant formula, follow-on formula, and special medical purpose product for infants (SMPPi), after considering public feedback received from the first round of consultation.
Since SMPPi is proposed as a subcategory of infant formula products, it would no longer consist of non-breast milk substitutes supplementary products, such as human milk fortifiers.
One of the reasons is to ensure that healthy infants are not mistakenly fed with products for infants under special care, but still regulating these products as infant formula products with composition and labelling requirements specific to these products.
“The standard needs to provide flexibility for manufacturers to formulate products consistent with a stated medical purpose to ensure products intended for very sick infants are available, and at the same time be appropriately restrictive for products designed for less serious conditions but which can still potentially be misused through inappropriate labelling or messaging to consumers,” the FSANZ said in the proposal.
Under the new proposed framework, infant formula and follow-on formula are intended only for healthy infants. The products are required to show information such as the composition, warning statements on preparation and use.
The SMPPi, on the other hand, would include any infant formula specifically formulated for the dietary management of a medically diagnosed disease, disorder or condition.
It would be mandatory for SMPPi product labelling to include information on irradiated food, legibility requirements, and nutrition information about any nutritive substance added to the product to achieve its intended medical purpose.
It must not be sold to a consumer, other than from or by a medical practitioner or dietitian; a medical practice, pharmacy or responsible institution, or a majority seller of SMPPi.
The proposed sale restriction will only affect specialised formulas currently sold in the grocery retail channel, which are typically formulas for transient gastrointestinal conditions such as diarrhoea, constipation, colic and regurgitation, according to the FSANZ.
At the moment, these products are placed alongside formulas for transient gastrointestinal medical conditions on some supermarket shelves.
“This requirement will have the effect of limiting the proliferation for formulas for transient gastrointestinal conditions,” the FSANZ explained, adding that most of the products that would be regulated as SMPPi were already prescription based and/or are on the Pharmaceutical Benefits Scheme.
Submissions for the second round of public consultation will end on July 7 (Friday), 6pm Canberra time.
There would be a five-year transition period if the proposals are adopted.
The FSANZ explained that this would allow sufficient time for the industry to adopt new labelling and composition requirements and minimise costs associated with labelling changes and reformulation.
“The transition period would not unduly impact consumers as the label information or updated composition has previously not been available, however a transition period greater than five years would unreasonably delay optimum nutrition to infants and the provision of information to consumers.”