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January 2018 - Nanoparticles and infant formula

(January 2018)

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.

The issue

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 science

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.

More information

Read more about nanotechnology in food

Expert reaction to media reports about nanoparticles in infant formula

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