May 2021
There have been a number of news articles about nanotechnology in food. In the interests of transparency and to provide more detailed information we have published media statements and responses to significant media enquiries in full (below).
7 May 2021
On 6 May 2021 the European Food Safety Authority (EFSA) released an updated safety assessment of titanium dioxide. EFSA's expert Panel of Food Additives and Flavourings concluded that although the evidence for general toxic effects was not conclusive, titanium dioxide can no longer be considered safe as a food additive.
The European Commission and Member States are yet to announce what actions will be taken on current permissions in the European Union as a result of EFSA's opinion.
FSANZ, in consultation with our independent scientific advisory groups, is in the process of reviewing the EFSA safety assessment and existing evidence on the safety of titanium dioxide as a food additive. This review will consider what action may be required to protect the health and safety of consumers through food standards.
We will release further advice when the outcomes of our review are finalised.
17 March 2017
In its January 2017 response to Fairfax media FSANZ stated it would review a French study on titanium dioxide. FSANZ has reviewed the study and concluded that its design has a number of limitations which restrict its relevance to humans. The findings are also inconsistent with the body of evidence from previous animal studies which have shown that titanium dioxide was not associated with any tumour type in carcinogenicity studies in mice or rats following oral ingestion, even at very high exposure levels.
Titanium dioxide is a food additive that is approved internationally in a range of food products and has been used safely for decades. FSANZ commissioned a review of the safety of titanium dioxide in 2015 which found there is no evidence of health risks from consumption of the food grade material. This is consistent with a recent 2016 European Food Safety Authority opinion which also concluded that the use of titanium dioxide as a food additive is not of concern for human health.
Based on FSANZ’s review of the aforementioned French study, further risk assessment is not warranted at this time. FSANZ continues to monitor this rapidly evolving science and will amend its regulatory approach as appropriate.
27 January 2017 (Fairfax media)
| Question | FSANZ Response |
Is FSANZ aware of the aforementioned French study and how do you respond to its findings? | Yes, FSANZ is aware of the study and is currently undertaking a review of its findings (see 17 March 2017 update). |
On your website you state, "this is a rapidly evolving science and conclusions may need to be reviewed as the sophistication and application of nanotechnologies to food and food packaging advances. FSANZ continues to monitor this rapidly evolving science and will amend its regulatory approach as appropriate." Do the findings of this study account for a new conclusion in this space which will see as worthy of review? | As mentioned above, FSANZ is in the process of reviewing the results of this report. |
Following the publication of the aforementioned study on January 20, 2017, three of France's State Departments (Health / Commerce/ Food & Agriculture) announced last Friday afternoon that they immediately asked France's national health & safety agency to investigate dangers of titanium dioxide on consumer's health. With such action taking place in France, are there grounds for us to do the same here in Australia? | This new study needs to be considered alongside all the available evidence relating to the safety of titanium dioxide in food. FSANZ commissioned an expert toxicologist to review the available scientific literature on whether there is evidence of health risks associated with oral ingestion of titanium dioxide, including in nanoscale form, in food. This review, published in June 2016, concluded that the weight of evidence does not support claims of significant health risks. Titanium dioxide is used internationally in a range of food products and has been used safely for many years. |
The above study has been conducted on rats only and the report authors acknowledge the findings cannot be extrapolated to humans or more advanced stages of disease without further research. How much weight does FSANZ place on the findings of such a study? | The weight placed on such a study depends on many factors including the quality of how it has been conducted and the relevance of the study to real world human dietary exposures. FSANZ notes that in this study titanium dioxide was administered in solution rather than in the animals’ food. This means that extrapolation to assess the hazards of a substance in food is highly uncertain. This is particularly so for nano-particulates where food can significantly alter the nature of the substance. Chronic studies in which titanium dioxide was administered in the diet did not find any adverse effects to test subjects. Titanium dioxide has long been known to contain nanoparticles and these will have been present in the material used in the toxicity tests that supported approval of titanium dioxide as a food additive. |
In September last year FSANZ told Fairfax Media that if it "became aware of a potentially unsafe food or ingredient, we would conduct a risk assessment and recommend appropriate control measures." Does this study apply in this case? | FSANZ’s most recent evaluation of titanium dioxide indicates that the weight of evidence on nanoscale titanium dioxide does not support claims of health risks for food grade materials. However, as indicated, FSANZ is in the process of reviewing this study to determine if there is a safety concern (see 17 March 2017 update above). |
17 September 2015 (Fairfax media)
| Question | FSANZ Response |
| There are peer reviewed studies raising serious health concerns regarding the use of nanoparticles of titanium dioxide and silica in food. In FSANZ's view, is it safe for humans to consume nanoparticles of titanium dioxide and silica? What research and testing is this conclusion based on? | - FSANZ and other international food regulatory agencies have not identified any health effect known to be associated with the use of nanoparticles of titanium dioxide and silica, following oral ingestion in foods.
- If FSANZ became aware of a potentially unsafe food or ingredient, we would conduct a risk assessment and recommend appropriate control measures.
- FSANZ actively monitors local and international research and commercialisation of manufactured nanomaterials relevant to food. We’ve also been researching the use of manufactured nano materials for several years.
- If changes to our processes were required as the result of any new evidence we would make those changes.
- FSANZ has engaged a leading toxicologist to undertake a review of nanotechnology and its applications with a subsequent report expected to be published in late 2015/early 2016.
- FSANZ has reviewed available information about the ways nanoscale materials are absorbed, transported and excreted from the body to underpin any future work that may require a risk assessment.
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| Is FSANZ aware that these nanoparticles are being used in common food products sold in Australia? Or are these research results a surprise? Why or why not? | - The additives mentioned may contain particles on a nanoscale, just like some other foods including milk.
- These additives have been used for decades in the global food supply.
- There are permissions for the use of titanium dioxide and silica dioxide in processed foods in accordance with Good Manufacturing Practice in the Food Standards Code.
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| For some time now FSANZ has insisted that foods containing nanomaterials aren't being sold in Australia on the basis that no companies have applied for approval, and has said there is little evidence to suggest nanotechnologies are being used in the food industry on a wide scale. But clearly, as this research shows, there are nanoparticles of titanium dioxide and silica being used in food. Is it time to do testing and begin regulating the use of nano-sized ingredients? Why or why not? | - FSANZ is aware that previous studies have shown that titanium dioxide and silicon dioxide used in foods include some particles that are in the nanoscale range.
- However, FSANZ and other international food regulatory agencies have not identified any health effect known to be associated with the use of nanoparticles of titanium dioxide and silica, following oral ingestion in foods.
- If FSANZ become aware of a health risk associated with the presence of nanoscale particles of titanium dioxide or silicon dioxide in foods, it could conduct a survey and introduce requirements in the Food Standards Code.
- We have also commissioned reports on the safety of these additives which are expected to be released later this year or early next year.
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| What sort of safety testing and pre-market approval processes has been applied to nanoparticles of titanium dioxide and silica? Can the public trust that these are safe? | - All food additives have to be thoroughly assessed for safety. Titanium dioxide and silica dioxide are used internationally in a range of food products and have been used safely for decades.
- Food manufacturers and suppliers are legally obliged to ensure that ANY food entering the market place is safe and suitable for human consumption. Foods that don’t meet legal requirements are subject to enforcement action by enforcement agencies.
- FSANZ amended its Application Handbook in December 2008 so that appropriate information is required to ensure that any novel characteristics introduced by nanotechnologies in food or food ingredients are taken into account as part of the risk assessment process.
- If particle size is important to achieving a technological or nutritional function, or may relate to a difference in toxicity, information must be provided on particle size and other specific characteristics of the nanomaterial.
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| Considering these nanoparticles have been detected in popular foods (and not specifically mentioned on ingredient labels), is it fair to say that FSANZ's regulatory system is inadequate to deal with new food technologies? Why or why not? Is it fair for the public to assume that the regulator is ineffective in protecting them from potentially harmful nanomaterials? Why or why not? | - All food manufacturers and suppliers are required under law to ensure food sold in Australia is safe and suitable. This requirement is in food legislation in the states and territories. Food must also meet the requirements in the Australia New Zealand Food Standards Code. Food law in Australia is enforced by state and territories.
- FSANZ amended its Application Handbook in December 2008 so that appropriate information is required to ensure that any novel characteristics introduced by nanotechnologies in food or food ingredients are taken into account as part of the risk assessment process.
- FSANZ notes that there are various categories of nanomaterials and recognise that those that are intentionally added, with novel properties, may need to be evaluated on a case by case basis.
- Foods, such as milk, naturally contain nano-scale constituents. Also, a number of food substances with a history of safe use are also likely to contain materials that have size dimensions in the nanoscale, but which are not specifically manufactured using nanotechnologies. The general requirements of state and territory food legislation also apply to these materials, meaning that all food must comply with the Code and be safe and suitable for human consumption.
- If FSANZ was to become aware of any public health issues with specific nanomaterials, then FSANZ would work with the state and territory enforcement agencies to develop appropriate risk management measures.
- Nanotechnology is an evolving science and FSANZ takes into account all available evidence in reviewing the safety of nanomaterials. FSANZ maintains routine scrutiny of nanotechnology food safety information.
- FSANZ considers that the current risk assessment framework is generally sufficient to assess the safety of new or novel nanoscale materials. This is consistent with other international bodies including the European Food Safety Authority, the United States Food and Drug Administration, and the World Health Oganization and Food and Agriculture Organization of the United Nations.
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| Has FSANZ commissioned any testing of foods or surveyed manufacturers and importers of food to determine if their foods contain nanomaterials? Why or why not? | - FSANZ has commissioned a report from an expert toxicologist on the safety of nano-forms of the two additives following consumption. At this point in time, FSANZ does not propose to undertake testing of food for nanomaterials. FSANZ has no evidence to date that would warrant the significant investigative and analytical resources needed to undertake testing of Australian foods to determine the general presence of nanomaterials.
- FSANZ has surveyed industry to gauge uptake and use of emerging technologies including nanotechnology only with regard to its use in food packaging. At this stage no respondents said that they were actively pursuing the use of nanotechnology in food packaging.
- FSANZ will continue to maintain a watching brief on testing developments of nanomaterials in food and how this may be incorporated into the food regulatory framework, if required, in the future.
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