Nanoscale materials are not new. Food is naturally composed of nanoscale sugars, amino acids, peptides and proteins, many of which form organised, functional nanostructures. For example, proteins are in the nanoscale size range and milk contains an emulsion of nanoscale fat droplets. Humans, including infants, have consumed these particles in foods throughout history without evidence of adverse health effects related to the materials nanoscale size.
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In recent years there have been several media reports about the presence of nanoparticles in infant formula. Most of these reports have focused on hydroxyapatite, a compound of calcium and phosphate. Some of these reports have been misleading and have the potential to cause unnecessary concerns amongst caregivers.
The presence of any particle (nanoscale or not) in any product does not mean there is a safety concern. Nanoparticles (including hydroxyapatite) occur naturally in many foods. Hydroxyapatite occurs naturally in a range of foods, especially dairy products.
When consumed, calcium phosphate will be broken down by acid in the gut to produce the essential minerals; calcium and phosphorus.
Infant formula is based on milk, which naturally contains calcium phosphates in different forms. Also, three calcium phosphate compounds are permitted mineral forms of both calcium and phosphate in infant formula, which is likely to have a small amount of natural nanoscale hydroxyapatite in it.
The Food Standards Code
Under the Food Standards Code food additives and nutrient compounds, which are added to a food for either a technological purpose such as flavouring or colouring or a nutritive purpose, undergo a pre-market safety assessment.
The code also has strict requirements for infant formula. One of these is a requirement for the essential minerals calcium and phosphorus to be in the product.
Ingredients, including those that contain nanoscale particles naturally, such as milk, are not food additives.
Calls for FSANZ to recall food
Many of the articles and letters relating to the discovery of nanoparticles of calcium phosphate in infant formula have called on FSANZ to recall food. That is not possible.
FSANZ has no power to recall food. Recall powers in Australia are created by the food laws of the Australian states and territories and recalls are initiated by state and territory officials. FSANZ's role in food recalls is as a coordinator i.e. we coordinate the work of food businesses and state and territory officials (Paragraphs 13(j) and (k) of the Food Standards Australia New Zealand Act).
The Friends of the Earth Do Gooder campaign
In January 2018 a campaign was launched on the Do Gooder website that made a number of inaccurate claims. Our response to these claims is below:
Now, documents released under Freedom of Information laws show that our food regulator Food Standards Australia New Zealand (FSANZ)
Australia does not have a single food regulator and FSANZ does not have regulatory powers. In Australia, state and territory government agencies and bodies and the Department of Agriculture and Water Resources (for imported food) have regulatory powers.
(FSANZ) unilaterally legalised the use of this ingredient in baby formula after previously declaring it wasn't permitted
FSANZ has not changed the legal requirements for infant formula. It has not changed any part of the Code that applies to infant formula.
FSANZ also misled its Minister and the public by stating that members of its Scientific Nanotechnology Advisory Group (SNAG) supported its claims that the ingredient was safe
When they actually raised safety concerns. One member of our five person advisory group indicated that that they felt that the summarising of the views of the group had been premature - nobody has been misled.
In failing to recall baby formula products containing nano-hydroxyapatite FSANZ is breaching its own regulations and potentially risking the health of our babies.
FSANZ is not breaching its own regulations - FSANZ is not a regulator and has no powers to recall products - as stated above these powers are exercised by other agencies.
European Scientific Committee on consumer Safety (SCCS) opinion on hydroxyapatite
The concerns expressed by Friends of the Earth (FoE) about 'needle shape' appear to be based on the conclusions of an EC Scientific Committee on consumer Safety (SCCS) opinion on hydroxyapatite. FSANZ considers this report to be of limited relevance to the FoE-commissioned study.
The SCCS opinion on the suitability of a hydroxyapatite material for use in cosmetic products concluded that insufficient information had been provided by applicants to enable a conclusion on safety when used in toothpaste, whiteners, and mouth washes. The SCCS noted that the hydroxyapatite materials under consideration could not clearly be related to the data submitted.
The subsequent SCCS recommendation is difficult to apply to hydroxyapatite in food because:
- the studies were specifically focused on dental applications, and don't consider the solubility of the material in the gut
- the data used is not directly applicable to ingestion and therefore the report is considered of limited relevance to the detection of the trace amounts of hydroxyapatite reported in the FoE-commissioned study.
Engineered nano hydroxyapatite
FSANZ is aware that engineered nano hydroxyapatite with needle morphology is commercially available. Suppliers of this material indicate that it is used for bone tissue engineering applications that involve calcium phosphate ceramics. The price is about $1400 AUD for 100 g. In comparison, food grade tri-calcium phosphate, a natural product, is about $6.50 AUD for 100 g.
A recent report commissioned by Friends of the Earth claimed that nanoscale particles were detected in some infant formula products available for sale in Australia and New Zealand.
FSANZ has reviewed the available information and concluded it does not contain any new evidence to suggest these products pose a risk to infant health and safety. FSANZ consulted with members of our Scientific Nanotechnology Advisory Group in reaching our conclusions. See also the expert reaction from the Australian science Media Centre here.
Carers of infants should not be alarmed by this report or concerned about the safety of these products.
FSANZ notes that:
- Hydroxyapatite is soluble in acidic environments such as the stomach, so small amounts in food are likely to dissolve to release calcium and phosphate. These are essential minerals that are required to be in infant formula products.
- Calcite has low solubility in the gastrointestinal tract regardless of whether it is in nanoscale form or in larger particles. The small fraction that is absorbed is likely to be in the form of calcium.
- Silicon dioxide has been used safely as a food additive in other foods in Australia, and internationally, for many years.
- Nanoscale materials are not new. Food is naturally composed of nanoscale sugars, amino acids, peptides and proteins, many of which form organised, functional nanostructures. For example, proteins are in the nanoscale size range and milk contains an emulsion of nanoscale fat droplets. Humans, including infants, have consumed these particles in foods throughout evolution without evidence of adverse health effects related to the materials' nanoscale size.
- Nano-size particles may not be the result of intentional addition (e.g. as an additive), some are naturally occurring and others may be produced during processing.
- The presence of something, whether on the nanoscale or not, in a food that does not have a permission in the Code does not mean a food is unsafe.
Safety/regulatory requirements for infant formula in Australia
All infant formula products sold in Australia and New Zealand must meet stringent requirements set out in the infant formula standard in the Food Standards Code. This is one of the most comprehensive standards in the Code and is enforced by national, state and territory authorities and the Ministry for Primary Industries in New Zealand.
If FSANZ were to become aware of any public health issues with specific nanomaterials, we would work with the state and territory enforcement agencies to develop appropriate risk management measures.