Documents reveal FSANZ misled minister regarding the safety and legality of nanoparticles in baby formula


By Jeremy Tager

In July 2017, independent testing1 commissioned by Friends of the Earth found nanoparticles in popular Australian infant formula products that are both illegal in Australia and potentially dangerous.

Now, documents released under Freedom of Information laws show that our food regulator Food Standards Australia New Zealand (FSANZ) unilaterally 'legalised'2 the use of nano-hydroxyapatite (n-Ha) in baby formula after previously declaring3 it wasn't permitted. FSANZ also misled its minister ‒ Dr David Gillespie ‒ and the public by stating4 that members of its Scientific Nanotechnology Advisory Group (SNAG) supported its claims that the ingredient was safe ‒ when they actually raised safety concerns.5

Legalising the presence of nano-hydroxyapatite

The documents reveal that FSANZ back-flipped6 on its position that the use of nano-hydroxyapatite in baby formula was illegal and reinterpreted its legislation to serve industry. It did so by accepting without evidence industry claims that the particles weren't intentionally added and then deciding that they therefore weren't subject to the Food Code's prohibition7 on the use of nutritive substances in infant formula unless they are expressly permitted.

FSANZ neither sought nor had evidence that the nano-hydroxyapatite wasn't intentionally added but accepted the claim immediately; ignoring the conclusion of Arizona State University scientists that it was both synthetically produced and likely intentionally added. FSANZ also ignored SNAG's conclusion that they didn't know if the nano-hydroxyapatite was intentionally added based on the available information.

FSANZ staffer Trevor Webb asked how do "we intend to manage the change in opinion re approval".8 This is a critical admission that FSANZ has completely reversed its position on the legality of n-Ha in baby formula. FSANZ failed to inform its Minister of its new interpretation of the Food Code.

In its de facto legalisation of the use of nano-hydroxyapatite in baby formula, FSANZ has failed to adhere to the Food Regulation Ministerial Council's policy for ensuring the safety of baby formula. This states that:

"Pre-market assessment … should be required for any substance proposed to be used in infant formula and follow-on formula that:

  1. i) does not have a history of safe use at the proposed level in these products in Australia and New Zealand; or
  2. ii) has a history of safe use in these products in Australia and New Zealand, but which, having regard to source, has a different form/structure, or is produced using a substantially different technique or technology."9

Asserting safety

In advice10 to the Minister and in a public statement11 on its website, FSANZ also claimed its Scientific Nanotechnology Advisory Group (SNAG) supported its conclusion that the nanoparticles of hydroxyapatite found in baby formula were safe. A SNAG member contacted12 FSANZ unhappy with this misrepresentation ‒ pointing out that at the only meeting SNAG had had to that point, the safety of nano-hydroxyapatite hadn't even been discussed.

SNAG met subsequently13 and could not reach consensus on the safety of n-Ha, or support FSANZ's claims that n-Ha fully dissolves in infant stomachs. FSANZ never notified Minister Gillespie of SNAG's actual views.

The documents reveal FSANZ coordinated its response with the baby formula industry. FSANZ goes so far as to write: "Are they engineered? Use industry response they are not adding Ha so irrelevant".14

When the Chinese Government inquired about the legality of nano-hydroxyapatite in baby formula, because China is a major importer of Australian baby formula, FSANZ misled them as well. The agency ignored the question and provided general declarations of how seriously it took food safety.15

Extraordinarily, the Minister now responsible for FSANZ ‒ Bridget McKenzie ‒ has refused to investigate the conduct of FSANZ, relying exclusively on FSANZ positions, most of which are either inaccurate or misleading. For example, in a letter to Friends of the Earth the Minister states that "Further investigation by FSANZ on this matter showed that nano-hydroxyapatite is synonym for a range of calcium phosphate compounds, some of which are permitted forms for infant formula."16

What FSANZ obviously hasn't told the Minister is that calcium phosphate compounds can only be added to baby formula if the ingredient is expressly permitted in the food code. FSANZ's own staff have admitted that nano-hydroxyapatite is not a permitted form of calcium phosphate.17

It is inexcusable that FSANZ is prepared to put babies at risk because it doesn't want to force the formula industry to abide by the law. When an agency starts moving the legal and scientific goal posts without evidence and solely for the benefit of industry, the problem is serious.

It is clear that there is a systemic problem with FSANZ. It consistently refuses to regulate, ignores legitimate health concerns and won't act for the public good except in the most extreme cases. The agency needs to be fully investigated and overhauled.

References:

  1. FoE (2017) Illegal and potentially toxic nanoparticles found in baby formula, 2/7/17, http://emergingtech.foe.org.au/illegal-and-potentially-toxic-nanoparticles-found-in-baby-formula/
  2. Document 20, June FOI, http://emergingtech.foe.org.au/wp-content/uploads/2018/01/Doc-20_Redacted.pdf; Document 21, June FOI, http://emergingtech.foe.org.au/wp-content/uploads/2018/01/Doc-21-Meeting-Notes-19-May-2017_Redacted.pdf; Document 17, July FOI, http://emergingtech.foe.org.au/wp-content/uploads/2018/01/17-SNAG-mtg-31-May.pdf; Document 80, July FOI, http://emergingtech.foe.org.au/wp-content/uploads/2018/01/80-RE_-nano-particles-in-infant-formula.pdf
  3. Screen grab of FSANZ's website, Oct 2016, http://emergingtech.foe.org.au/wp-content/uploads/2017/06/FSANZ-website-statement-on-nano-hydroxyapatite-Oct-16-1.pdf
  4. Screen grab of FSANZ's website, 10/7/17, https://web.archive.org/web/20170710183910/http://www.foodstandards.gov.au/consumer/foodtech/nanotech/Pages/Nanoparticles-and-infant-formula.aspx
  5. Document 65, July FOI
  6. Screenshot of FSANZ's webpage 10/7/17, http://emergingtech.foe.org.au/wp-content/uploads/2018/01/Nanoparticles-and-infant-formula-FSANZ-website-10_7_17.pdf; Document 20, June FOI
  7. Document 21, June FOI; Document 17, July FOI; Document 40A, July FOI; Document 49, July FOI; http://emergingtech.foe.org.au/wp-content/uploads/2018/01/49-FW_-Proposed-SNAG-Teleconference-DLMFor-Official-Use-Only.pdf; Document 20, June FOI, http://emergingtech.foe.org.au/wp-content/uploads/2018/01/Doc-20_Redacted.pdf; Document 21, June FOI
  8. Document 20, June FOI
  9. www.foodstandards.gov.au/code/fofr/fofrpolicy/Documents/Infant%20Formula%20May%202011.pdf
  10. Document 40A, July FOI
  11. Screenshot of FSANZ's webpage 10/7/17, http://emergingtech.foe.org.au/wp-content/uploads/2018/01/Nanoparticles-and-infant-formula-FSANZ-website-10_7_17.pdf
  12. Document 46, July FOI, http://emergingtech.foe.org.au/wp-content/uploads/2018/01/46-Re_-Proposed-SNAG-Teleconference-SECUNCLASSIFIED.pdf
  13. Document 20, June FOI
  14. Document 21, June FOI
  15. Document 61, July FOI, http://emergingtech.foe.org.au/wp-content/uploads/2018/01/61-RE_-Follow-up-questions-Nanoparticles-in-IF-DLMFor-Official-Use-Only.pdf
  16. Senator the Hon Bridget McKenzie (2018) Letter to Friends of the Earth (available on request)
  17. Documents 5, 6, July FOI

Published in Chain Reaction #132, April 2018. National magazine of Friends of the Earth Australia.


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