By now many in the food industry are aware of the action being taken by the NSW Food Authority against Nutricia over its infant formula products, but you might not be aware of the concurrent civil action being taken by Nutricia or FSANZ's proposal P306 (Addition of inulin, FOS or GOS to food) or Orafti's application A613 - Amend definition of Nutritive Substance - or of their implications for the food industry generally.
What is the dispute over?
Nutricia added fructo-oligosaccharides ("FOS") and galacto-oligosaccharides ("GOS") to some of its infant formula products, both for mouth-feel and for the dietary fibre they contain. As you can imagine, infant formula is closely regulated; among other things the Australia New Zealand Food Standards Code prohibits the addition of "nutritive substances" in infant formula products unless the Code expressly allows them or it is naturally present in an ingredient of the infant formula product.
The Code doesn't expressly allow inulin, FOS or GOS. Nutricia went to court to seek a declaration that neither FOS nor GOS were "nutritive substances", and that GOS occurs naturally anyway.
The NSW Food Authority then launched criminal proceedings and told Nutricia it would seize its products, but gave an undertaking it would hold off to allow Nutricia to voluntarily withdraw its products and replace them with products without FOS or GOS. It then however decided to go ahead with the seizure.
The NSW Supreme Court last month decided that it would be held to its undertaking, allowing Nutricia to complete its switch of products. So far, it's round one to Nutricia.
Why does this matter?
Nutricia now finds itself embroiled in two sets of proceedings - the civil one it launched itself, and the criminal one launched by the NSW Food Authority. The same issue has arisen across the Tasman.
There are a few lessons to learn from all this.
First, the regulator does bite and it does have teeth. The days when prosecutions for breach of the food legislation were rare are over. These are the second set of proceeding brought in the NSW Supreme Court (and not the Local Court) of which we are aware.
Secondly, inulin is widely used in food products. Both the civil and criminal proceedings will have to deal with a key issue - are inulin, FOS and GOS "nutritive substances"? If a court decides they're not, the status quo will be preserved. Conversely, if they are "nutritive substances" then a whole number of food products on the Australian market will be illegal and in breach of Clause 9 of Standard 1.1.1 and their use in food products will cease
Thirdly, the criminal proceedings will in part also deal with alleged health claims made on the packaging of the infant formula products. The NSW Food Authority alleges that the following claim is in breach of clause 3(a) of Standard 1.1A.2 "[NAME OF PRODUCT]. From 6 months, [NAME OF PRODUCT]. is a premium formula designed to meet the increasing nutritional requirements of growing infants. Its unique formulation of special ingredients, include Nutricia prebiotics. These nutritionally support your baby's digestive and natural immune systems".
Decisions on health claims are fairly rare, and we expect any decision to be an important guide to what is and isn't allowable.
h5>P306 Addition of Inulin/FOS & GOS to foods
FSANZ has developed a proposal to consider the status of inulin FOS and GOS in foods for the purposes of providing regulatory certainty, P306 will include only one round of public consultation. It proposes to omit a round of public consultation following the preparation of the Proposal on the basis that to do so will not have a significant adverse effect on the interests of anyone.
On 22 August 2007, FSANZ has sent a letter dated to interested parties confirming that it has commenced work on a Proposal P306 to in respect of the legal status of FOS and GOS. It calls for information including the amount of inulin or FOS added to foods and the purpose of the addition to the food.
Proceed with caution!
In circumstances where the key issue in the Supreme Court proceedings is whether are inulin, FOS and GOS are nutritive substances, any company providing information to FSANZ will need to take care how it drafts its response. Under the Food Standards Code, "nutritive substance" is 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."
The meaning of "nutritional purpose" is not defined in the Food Standards Code and it is not clear to us whether the addition of fibre or prebiotics would qualify in circumstances where neither relates to energy (nutrition). Our understanding is that inulin is also added to a wide number of foods in Australia for a number of technological purposes
Depending upon the outcome of P306 it has the potential, therefore, to have a significant adverse effect on the interests of a number of Australian food companies.
A613 - Amend definition of Nutritive Substance
Orafti, the leading worldwide manufacturer of inulin and FOS, has also filed an application with FSANZ seeking to amend the definition of nutritive substances to allow the continued use of inulin and FOS in general foods. Orafti is of the view that inulin and oligofructose (FOS) do not fall within the current definition of nutritive substance within the Code.
In this respect, its views are consistent with, and it also relies upon, the previous views expressed by the Australian food regulatory agencies in letter in 1993 from the Australian National Food Authority confirming the food status of inulin, oligofructose and in 1994 from the New Zealand Ministry of Health, the Australian Food Standards Code of 1995 showing inulin included in the Standard G5 for table spreads and ANZFA's Full Assessment Report of 2001 to Application A277 concluding inulin is a dietary fibre
To remove any doubt, however, Orafti seeks two changes - to vary the definition of "nutritive substance" in Clause 2 Interpretation of Standard 1.1.1 to clarify that it applies to micro nutrient substances only and does not apply to macro nutrient ingredients such as inulin and oligofructose; and to include a definition for new category of "nutritive ingredient" in Clause 2 Interpretation of Standard 1.1.1 that applies to both micro nutrients substances (ie. nutritive substances) and to macro nutrient ingredients.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.