Does FSANZ think probiotics are banned if they are called “probiotics”?

In its commentary in the Approval Report for Proposal P1028 – Infant Formula, Food Standards Australia New Zealand (FSANZ) seems to infer that, while microorganisms traditionally used in fermentation do not need pre-market approval for use in food, if you call these same substances “probiotics”, then they should be regulated differently.

If this interpretation is applied, then the inevitable legal result is that all such microorganisms are banned in food simply by being called “probiotics”.

While this is of course a ridiculous position, and one that FSANZ had not intended to adopt, it is unlikely to be an interpretation that is imposed by food law enforcement agencies… but it highlights how regulatory commentary can undermine well-established interpretations of the law and create uncertainty in the food industry.

Can probiotics be regulated as nutritive substances or novel foods?

Whether probiotic bacteria are being “used as a nutritive substance” or are a “novel food” is crucial because, under Section 1.1.1-10 of the Australia New Zealand Food Standards Code (the Code), nutritive substances and novel foods are not permitted for use as ingredients in food unless the Code expressly permits them. There are no express permissions anywhere in the Code for “probiotics” as either novel foods or nutritive substances. So, to classify probiotics as a novel food or nutritive substance necessarily means they would be banned in food without amendment to the Code.

A substance could be a novel food if it does not have history of consumption in food and requires its safety assessed by FSANZ (as part of the Code amendment process). A substance can be used as a nutritive substance” if it has been “concentrated, refined or synthesised, to achieve a nutritional purpose when added to food” but expressly excluding substances normally consumed as food.[1] Unhelpfully, the Food Standards Code fails to define what a “nutritional purpose” is, but it is this element that appears to raise FSANZ concerns that when a bacteria is added for fermentation might be regulated differently to a bacteria added to improve gut health.

Leaving this question of purpose aside, it is clear the prohibitions on ingredients being “used as nutritive substances” or being a “novel food” should not apply to any ingredient that has a “history of human consumption” in food[2]  or is “normally consumed as food”,[3] especially when those ingredients have not been “concentrated, refined or synthesised”. On the face of these definitions, it should be impossible for any probiotic that has a history of safe consumption in food to be regulated as either a nutritive substance or a novel food, no matter whether they have associated health benefits or are added for a nutritional purpose or not.

It is this distinction between nutritive substances and substances “normally consumed as food” that traditionally allowed many food manufacturers to add isolated protein and fibre to food without any express permission to do so under the Code, and despite these ingredients clearly being concentrated, refined and added for a nutritional purpose. Section 1.1.1-10 of the Food Standards Code states as a starting premises that any food can have any other food added to it, and this section has been relied on since the creation of the Code to add many isolated nutrients but only those which have a traditional history of use.

In fact, it was a food regulator’s failed attempt to define inulin (a prebiotic fibre) as a prohibited nutritive substance rather than a traditional food ingredient[4] that led to the Code being re-written in 2016, with the aim of making it more enforceable.[5]

The lactoferrin example

However, it is this very distinction between nutritive substances and substances “normally consumed as food” that FSANZ first chose to ignore in its approval of lactoferrin as a nutritive substance in infant formula (which KHQ raised concerns about in this article). In its response to stakeholders regarding concerns over the regulation of lactoferrin, FSANZ stated that lactoferrin could be either a food or a nutritive substance depending on context:

The [Advisory Committee on Novel Foods] decision or recommendation is not relevant in this case. That recommendation relates to use of bLf in general foods and for the purpose of refortification of small amounts of naturally occurring bLf lost during processing. In that particular context, the ACNF considered bLf to not be a novel food, but a traditional food, when related only to the refortification of bLf. Moreover, the ACNF is not FSANZ. Nor are ACNF recommendations or views binding on FSANZ or represent a FSANZ position or view.[6]

Interestingly, in justifying its position that lactoferrin meets the definition of being used as a nutritive substance despite its history of use as a traditional food ingredient, FSANZ omitted the part of the definition that excludes “a substance normally consumed as food”.[7]

What has FSANZ said about probiotics in P1028?

When Proposal P1028 was gazetted on 13 September 2024, it marked the culmination of a review into the regulation and nutritional profiles of infant formula products that commenced in 2012.

Relevantly to probiotics, FSANZ chose to retain Section 2.9.1-11 which expressly permits the addition of lactic-acid producing microorganisms (LAM) to infant formula. It is perhaps a reflection of the vulnerable nature of infant formula consumers that FSANZ felt this section was required at all, as LAM are traditional food ingredients and have been for millennia, and as such already had permission to be added to infant formula by virtue of Section 1.1.1-10. By way of contrast, there are no permissions to add fats or sugars to infant formula; just prescribed nutritional minimums and maximums. The same legal drafting approach could have been applied to LAM.

Now, many LAM are also “probiotics”, in that they can survive digestion to the point where they can contribute beneficially to the gut microbiome. As a result, Section 2.9.1-11 expressly allows some probiotics to be added to infant formula (so long as they are also LAM).

At the time of publication, every single strain of living probiotic that has been assessed by the ACNF (on which FSANZ sits) has been found to be a traditional food. Not a single living probiotic strain has been identified by the ACNF as a “novel food”, let alone being a “nutritive substance”.[8]

Notwithstanding this clear permission to add some probiotics to infant formula, FSANZ was clear in its commentary that the LAM was only intended to be permitted to be added for acidification (i.e. fermentation) purposes, not for any health benefits. And yet… FSANZ expressly chose not to amend the law limiting the purpose for which LAM could be added:

Based on submitter comments to the 1st CFS, FSANZ understood that the proposed option to restrict the existing permission ‘for acidification’ would significantly disrupt the availability of domestically and internationally manufactured infant formula products.[9]

So … if some probiotics can be added to infant formula, and FSANZ deliberately chose to allow them to be added without restriction as to their purpose in the food, then probiotics can be added to infant formula. Right?

Yes, according to the law FSANZ has written. No, according to FSANZ’s commentary:

This permission does not permit the addition to infant formula products of specific strains as probiotics. The latter would constitute addition of a substance used for a nutritive purpose for which an express permission would be required.[10]

Does using the word “probiotic” reclassify the ingredient?

As mentioned above, no substance that is normally and safely consumed as food can be regulated as a nutritive substance according to the Code as currently written.

Furthermore, if FSANZ truly considered probiotics to be nutritive substances, it could have listened to the requests of food law enforcement agencies who expressly asked that LAM be added to the table in Schedule 29 along with all the other permissions to add nutritive substances. Moving LAM to this table would make it clear that FSANZ and the Code actually regulated LAM as nutritive substances:

This submitter suggested drafting amendments are made to subsection 2.9.1—11 that provide clarification that LAM added to infant formula, follow-on formula or SMPPi for nutritional purposes is a nutritive substance and needs to be included in the table to Schedule 29-7 or Schedule 29- 8.[11]

However, again, FSANZ expressly chose not to do this and left the permission to add LAM in Standard 2.9.1, leaving a strong legal argument that LAM are traditional food ingredients and not nutritive substances, no matter whether they perform a nutritional purpose or an acidification one.

Final thoughts

Let us ignore that:

• the Food Standards Code excludes traditional foods from classification as nutritive substances;
• the ACNF has identified probiotics as traditional foods;
• FSANZ has chosen not to list LAM as nutritive substances; and
• FSANZ has chosen not to restrict the addition of LAM based on nutritional purposes.

Let us instead take FSANZ’s view expressed in commentary (but not in law) to its logical conclusion: if the addition of any specific strain of bacteria for food as a “probiotic” rather than for acidification re-classifies that strain from being a traditional food to being a nutritive substance, this means that every single food product on the market that claims to contain “probiotics” would be in breach of the Food Standards Code. Because, again, there is no permission anywhere in the Food Standards Code to add probiotics as a nutritive substance to any food product.

In other words, the logical conclusion of FSANZ’s commentary in P1028 is that adding probiotics for the purpose of being “probiotics” is banned in all food.

It is clear that the law, both as written and as enforced, does not work that way.

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[1] The Food Standard Code, Section 1.1.2-13.

[2] The Food Standard Code, Section 1.1.2-8.

[3] The Food Standard Code, Section 1.1.2-13.

[4] See NSW Food Authority v Nutricia Australia Pty Ltd [2008] NSWSC 1382.

[5] As done through FSANZ Proposal P1025.

[6] See Approval Report – Application A1253, Pages 11-12 [Emphasis added].

[7] See Approval Report – Application A1253, Page 5.

[8] See ACNF Record of Views.

[9] See Approval Report – Proposal P1028, Page 57.

[10] See Approval Report – Proposal P1028, Page 59.

[11] See Approval Report – Proposal P1028, Page 210.