Food Industry confusion over Inulin and other Nutritive Substances following the Nutricia Court Proceedings

Food Industry confusion over Inulin and other Nutritive Substances following the Nutricia Court Proceedings

By Joe Lederman and John Gao © Lawmedia Pty Ltd, September 2007
FoodLegal
Australian Lawyers and Consultants

The New South Wales Food Authority recently brought Food Act proceedings against food manufacturer Nutricia for breach of the Australia New Zealand Food Standards Code. An injunction was later granted to Nutricia to stop the New South Wales Food Authority from requiring a mandatory recall of all affected Nutricia products. The case highlights the confusion in the food industry about the difference between a ‘food’ and a ‘nutritive substance’. This article of 1,500 words explains the legal significance for food suppliers and marketers and looks at the approaches taken by different regulatory bodies in interpreting the definition of a ‘nutritive substance’ under the Australia New Zealand Food Standards Code.

The substances in question in the legal proceedings involving Nutricia were fructo-oligosaccharides (FOS) carbohydrates and gluco-oligosaccharides (GOS) carbohydrates, which belong to the group of carbohydrates known as ‘inulin’. The New South Wales Food Authority (‘NSWFA’) believed that such substances ought to have been considered “nutritive substances” that would require express permission under the Australia New Zealand Food Standards Code in order to be added to the food. The NSWFA initiated criminal proceedings for an alleged breach of the Food Act on account of non-compliance with the Food Standards Code.

Meanwhile, concurrently with the Food Act proceedings, Nutricia initiated its own civil proceedings in the New South Wales Supreme Court and was granted an interim injunction to stop the NSWFA order for a compulsory product recall.

In deciding to grant the interim injunction, the New South Wales Supreme Court decision discussed some of the relevant issues but no final decision was made in that judgement on the issue of whether inulin was a ‘nutritive substance’ or a ‘food’.

Meanwhile, permission for the use of inulin in infant formula and baby food products is currently being assessed by the Australian food standards-setting agency Food Standards Australia New Zealand (‘FSANZ’) under Proposal P306. The draft assessment report for this proposal is expected in December 2007 with a public consultation period to follow.

Relevant provisions of the Australia New Zealand Food Standards Code

A ‘nutritive substance’ is defined under Clause 2 of Standard 1.1.1 as:


‘a substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which, after extraction and/or refinement, or synthesis, is intentionally added to a food to achieve a nutritional purpose, and includes vitamins, minerals, amino acids, electrolytes and nucleotides’.

The definition of ‘nutritive substance’ therefore seems to be an exclusive one referring to a substance which is not normally consumed as either ‘food’ in itself or as an ingredient of food.

The Nutricia case is a case dealing with the prohibition of added nutritive substances for infant formula. In regard to infant formula, Clause 6 of Standard 2.9.1 provides that:

‘a vitamin, mineral, food additive or nutritive substance must not be added to infant formula unless:

(a) expressly permitted by this Code; or
(b) it is naturally present in an ingredient of the infant formula product.’
Yet we note there is also a general restriction on the addition of nutritive substances to other types of foods by virtue of Clause 9 of Standard 1.1.1:

‘Nutritive substances must not be added to food unless expressly permitted in this Code.’

Clause 6(b) of Standard 2.9.1, mentioned above, indicates that permission is not required for the addition of nutritive substances to infant formula where the substances occur naturally in the food. The same leniency may not apply to other types of foods. As will be discussed below, it is still unclear whether Clause 6(b) refers to the further addition of extracted substances which are already naturally present in the food or whether it refers to the addition of substances as a natural part of an ingredient (such as the addition of bananas as an ingredient which naturally contains inulin). It can depend on the particular food product and the particular circumstances such as food processes, which is where FoodLegal can provide professional assistance.

At present, there does not appear to be any express permissions for the use of inulin or FOS or GOS in any food in any part of the Australia New Zealand Food Standards Code, whether relating to infant formula or foods in general.

The Proposal P306 “Preparation of a Proposal” document acknowledged, in relation to inulin, that:

‘Recent events have also raised concerns around the status of FOS [inulin] in other foods in the general food supply, in particular there is confusion about whether pre-market approval is required for their use”.

Nevertheless, the scope of Proposal P306 remains limited to the use of inulin in infant formula and baby food products.

The real issue in the Nutricia case lies in the distinction between a ‘food’ and a ‘nutritive substance’ and whether or not inulin really ought to be considered a ‘nutritive substance’ rather than a ‘food’. As mentioned, the issue is currently being considered in criminal proceedings brought by the New South Wales Food Authority against Nutricia under the Food Act, as well as the civil proceedings initiated by Nutricia in the Supreme Court of New South Wales. This article will not deal with the particular circumstances of those cases.

Generally, there are some substances such as vitamin extracts which are clearly regarded as ‘nutritive substances’ and some products which are clearly regarded as ‘foods’. However, there may be food extracts which are regularly consumed only for a nutritive purpose which can fall into the grey area between foods and nutritive substances. Popular examples of a substances which may lie on the borderline between nutritive substances and foods would include other substances apart from inulin, such as fish oil.

Comments and observations made in the Nutricia decision

On 8 August 2007, Justice Bell of the New South Wales Supreme Court in his decision in the Nutricia case on the question of whether or not the New South Wales Food Authority could be restrained from ordering a compulsory recall of the product containing inulin, granted an injunction to Nutricia restraining the New South Wales Food Authority from ordering the compulsory recall.

The New South Wales Supreme Court Judge held that the product ought not be required to be recalled:

‘Given that no issue of safety arises, and given my acceptance of the likely commercial loss to Nutricia in the event of the seizure of the Karicare Gold Plus range before it is able to put its substitute range into the market, I considered that the balance of convenience favoured the relief that was sought [interim injunction restraining the New South Wales Food Authority from ordering a compulsory recall].’ (Paragraph 42)

In reaching this conclusion, Justice Bell commented that there was a ‘serious issue to be tried’ in relation to whether or not inulin was in fact to be considered a ‘nutritive substance’ or a ‘food’ for the purposes of the Australia New Zealand Food Standards Code.

Nutricia argued that while there was no express permission for the addition of inulin to infant formula under the Australia New Zealand Food Standards Code, it believed that inulin could be considered a ‘food’ rather than a ‘nutritive substance’ on the following grounds:

Firstly, that inulin is commonly used as ingredients in foods such as yoghurts, biscuits, mousses, diet drinks, and other products.

Secondly, the term “nutrition” has been interpreted by nutritional scientists as meaning ‘ingestion into the blood stream of substances to supply the needs of the human body’s metabolism’. However, it was being claimed by Nutricia that FOS and GOS are not ingested directly into the blood stream and therefore, arguably, could not be strictly regarded as being added for a nutritional purpose.

Thirdly, it was argued that the wording of Clause 6 of Standard 2.9.1 of the Australia New Zealand Food Standards Code suggests that any substance which is naturally present in an infant formula product can be added to it.

History of inulin in Australia

On the basis that the regulation of the addition of nutritive substances to infant formula is the same as that of adult foods, there seems to have been inconsistency in the way in which the inulin group of carbohydrates has been considered under Australian food law.

In the Full Assessment Report of Application A277 published in November 2000, the then Australia New Zealand Food Authority (‘ANZFA’) [the predecessor to Food Standards Australia New Zealand (FSANZ)] considered the inclusion of the inulin content of foods in the declaration of dietary fibre. Changes to the Australia New Zealand Food Standards Code resulting from the report were gazetted on 30 August 2001.

On page 16 of that report, it explicitly stated:

‘Inulin, and FOS are already permitted food ingredients.’

As mentioned above, ‘nutritive substances’ are defined as:

‘a substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which, after extraction and/or refinement, or synthesis, is intentionally added to a food to achieve a nutritional purpose, and includes vitamins, minerals, amino acids, electrolytes and nucleotides.’

Clearly, FSANZ’s predecessor believed in November 2000 that inulin was already a permitted food ingredient.

This is general information rather than legal advice and is current as of 30 Oct 2021. We therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.