Nanotechnology and the FSANZ approach
By Joe Lederman (Managing Principal, FoodLegal) and John Thisgaard (FoodLegal Consultant)
Nanotechnology presents exciting opportunities for novel applications in many fields, including food production, food ingredients, additives or processing aids, food packaging, etc. Food Standards Australia New Zealand recently released two reports on the safety of nanotechnology in the context of food. This article considers what these reports might have said but did not address.
A. Nanotechnology and its role in food
Nanotechnology broadly refers to the working of matter at the nanoscale. This encompasses working on the scale of an atom or other nanoparticles. To put this into context, one nanometre is one billionth of a metre. A sheet of writing paper is approximately 100,000 nanometres thick, in contrast to producing something the size of a single nanometre or a few nanometres.
Nanotechnology is highly dependent on the current state of technology; the increasing ability to interact with nanostructures of traditional matter has been applied in many fields. Nanotechnology has been used in the medical field in the form of nanoparticle drug mixes used to target cancer cells, and in the textiles industry to create new forms of functional fabrics.
It is unsurprising that nanotechnology also presents some exciting opportunities for food. For example, nano-forms of traditional matter could be used as processing aids to improve certain qualities of food, or at the agriculture stage to improve the efficiency with which plants absorb nutrients. Nanomaterials can also be used in food packaging for better freshness or protection. Some nanoparticles occur naturally in foods, for example milk, and have been historically consumed without issue.
For any given mass of matter, an equivalent mass of nanoparticles of that matter can contain many (thousands or hundreds of thousands) more instances of those particular characteristics. Thus manipulation of particles at the nanoscale results in creating novel applications not possible with the same substance in its conventional form.
Nanoparticles usually have completely different properties than the conventional form of the substance. A mineral that is edible in its conventional substance form can well be highly toxic in the same quantity but in nanoparticle form. The range of possibilities for creating new properties and new forms of substances and combinations opens infinite possibilities.
Concerns arise regarding particles which have never been consumed in nano-form before. Should the safety of these substances be determined purely according to whether the traditional form of the matter is permitted? This would assume that the impact on safety does not change once the food is in its nano-form. Or should safety be determined on a case by case basis, for example requiring materials such as nanosilver to be assessed separately for approval as a food additive notwithstanding the fact that silver (in its traditional form) is already an approved additive?
B. Australia's approach to nanotechnology in food
In Australia, all food, including that involving nanoparticles, must comply with the Australia New Zealand Food Standards Code (Food Standards Code) as well as the Food Acts of different states and territories. Currently there are no provisions specifically referring to nanotechnology or nanoparticles. The Food Standards Code may apply in different ways; nanoparticles may be a processing aid or a food additive depending on how they are used, or may be a novel food if not historically consumed by humans. These foods would have to meet the relevant provisions (and associated safety requirements) of the Food Standards Code. Whether any regulatory pre-approval is required for the use of nanotechnology in food is therefore something that should very much be determined on a case-by-case basis.
The view that the application of nanotechnology can be covered by existing regulations without amendment is widespread; the European Union is one of the only bodies to have incorporated nanotechnology-specific terminology into their food regulations. Most other countries, including Australia, rely on non-binding guidelines issued by the regulatory body. In Australia, the Application Handbook contains information that should be included for a Food Standards Australia New Zealand (FSANZ) risk assessment under any applications to change the Food Standards Code. No application regarding a novel nanotechnology has yet been received by FSANZ.
C. FSANZ 2016 literature review of nanotechnology studies
FSANZ released two reports on nanotechnology on 7 June 2016. The reports were commissioned to conduct a literature review into the evidence of health risks associated with certain nanoparticles.
The first report looked at potential health risks regarding nanotechnologies in existing food additives. Its scope was limited to three particular nanoparticles: amorphous silica (SiO2); titanium dioxide (TiO2); and nanosilver (nanoAg). Its main concern was whether the nano size of these particles results in different attributes which create different health risks to the substance in its traditional form.
The second report looked at nanotechnologies in food packaging. Its main focus was on nano-clay and nanosilver. The report looked at the possibility of transfer of these particles from packaging to food, and the risks associated with any such transfer.
Upon publication of the reports, FSANZ announced a list of key findings drawn from the two reports. These findings were as follows:
1. "The consultant reviewed the evidence on nanoscale silicon dioxide, titanium dioxide and silver in food and found the weight of evidence does not support claims of significant health risks for food grade materials"
2. "Titanium dioxide and silicon dioxide are used internationally in a range of food products and have been used safely for decades. They are approved food additives in Australia and New Zealand. Silver is also an approved additive in Australia and New Zealand but is permitted in very few foods"
3. "Overall, the findings of the report are consistent with recently published information in the OECD's Working Party on Manufactured Nanomaterials Sponsorship Programme for the Testing of Manufactured Nanomaterials toxicological dossiers on silicon dioxide, titanium dioxide and silver"
4. "There is no direct evidence to suggest novel nanomaterials are currently being used in food packaging applications in Australia or New Zealand, with most patents found from the United States"
5. "From the case studies on the use of nano-clay and nano silver in packaging, the report concludes that there is no evidence from the literature of migration of nano-clay from packaging into food. The nanoscale nature of nanosilver (whether used in packaging or food) is also not likely to be dangerous to consumer's health"
6. "An independent peer review agreed with the overall analysis and conclusions of both reports stating that they were appropriately balanced in their reporting and that none of the nanotechnologies described are of health concern"
D. FoodLegal's comments on the FSANZ reports and findings
This section of our article raises questions about the FSANZ reports. These comments and questions are not intended to be a criticism of the reports themselves or the experts who prepared them.
Our following criticisms are directed towards the gaps in the regulatory approach, as that seems to be indicative from the narrowness of the conclusions drawn by the FSANZ reports to the lack of evidence in support of these conclusions.
1. The FSANZ reports are drawn with very limited scope. Their findings related only to the specific substances mentioned above. While the FSANZ reports convey a generally positive attitude to these particular substances, they do not serve to comment on the safety assessment process for nanotechnology in general.
2. No evidence because of insufficient information. The FSANZ reports concluded that "there is no evidence to suggest at human dietary exposures an unacceptable risk is likely" from consuming nano-silicon dioxide, and "there is insufficient, directly relevant information available to confidently support a contemporary risk assessment of nano-titanium dioxide in food". This seems contrary to other widespread scientific consensus.
3. S1O2 and Ti1O2. FoodLegal notes that the food safety of both silicon dioxide and titanium dioxide, specifically the inabilityof the human body to break down or expel them, were issues raised by well-known toxicology experts in a 2015 journal article Comparative assessment of nanomaterial definitions and safety evaluation considerations by Broverhof et al, published in Regulatory Toxicology and Pharmacology 73(1).
4. Lack of evidence means FSANZ has an excuse not to be assessing. One finding from the FSANZ reports is that there was no evidence of Australian use of nanomaterials in packaging, and FSANZ also points out that there have so far been no applications to change the Food Standards Code involving nanotechnology. This detracts from the issue of safety regulation by looking at what is not there, rather than what is. The fact that novel nanoparticles or technologies may or may not be being used does not reduce the need for a robust safety and risk assessment system. There should be no issue about saying that nanotechnology exists; the emphasis should be on how best to assess its safety.
5. FSANZ claims that nanotechnology is barely being used in food. In 2015, as a precursor to the 2016 FSANZ reports, FSANZ acknowledged that it was aware of the use of nanoparticles of titanium dioxide and silica in food. There are various government reports in the US and Britain indicating that billions of dollars have been spent over the last two decades in developing nanotechnologies for the food industry and many of its supply chain inputs. This is highly indicative that numerous nanomaterials are being used. Companies are not in the business of wasting their continuing investment without utilising the technology in which they are investing. FSANZ is not yet seeing the wood for the trees.
6. An absence of patent registration is used by FSANZ as evidence of the non-existence of nanoparticles in Australia. The use of patent non-registration as a threshold to prove Australian non-existence of a nanoparticle seems odd or legally ludicrous. It is also very odd that the legal expertise for this conclusion is being provided by a toxicology expert. As a consequence, it follows that Australia's system for detecting and assessing the safety of nanotechnology is deeply flawed. FoodLegal points out:
- Packaging containing nanoparticles can exist in Australia and be made by a foreign company, without needing to have a registered Australian patent
- Packaging containing nanoparticles could be imported into Australia, either as plain packaging or containing food, without a patent for the nanoparticles being registered in Australia by the importer or user
- There are numerous examples of non-patentability for legal and commercial reasons
- Users and consumers do not need to be registered as patent-holders
- Some know-how is not patented, for example, some developments may be strictly proprietary, such as a particular enzyme or flavour
- The existence of nanoparticles cannot be detected without properly calibrated scientific equipment. The registration of a patent cannot serve to say whether nanomaterials exist in packaging in Australia.
7. The conclusions in the FSANZ reports regarding these nano-substances are framed in terms of a "lack of evidence" that they are unsafe, rather than proof that they are safe. This raises questions regarding the burden and standard of proof.
8. The two FSANZ reports took the form of a literature review, meaning that they were confined to analysing the findings of previous studies from around the world. The reports did not involve any physical testing being commissioned by FSANZ.
E. The future of nanotechnology regulation
As with the introduction of any new substance or technology to do with food, the regulation of nanotechnology should first and foremost focus on safety. The biggest question is what the risk assessment framework should look like. As noted above, this should be able to be done entirely within Australia's current food regulatory framework.
Key finding no. 2 of the FSANZ reports mentioned earlier above appears to accept that the safety of the substance in its traditional form is important. Yet the safety of a substance in its traditional form should be irrelevant to determining the safety of a nanoparticle since it is quite clear that any matter will display novel properties when in nano-form.
A good risk-assessment model which could be used widely and within current regulation is proposed in the article by Broverhof et al mentioned above. This model uses a series of questions to first determine whether a substance is a nanomaterial, then whether it is a new chemical, whether it has an existing robust safety data set, whether it has novel properties arising from its nano-form and whether there is any additional information. Depending on the answer to each question, different decisions can then be made. Rather than treating nanotechnology as a separate scientific area, this approach focuses on the characteristics of nanotechnology within current regulatory frameworks. The relevant set of questions is presented as a flowchart below:
The FSANZ reports do not refer to a methodology such as the above model. The persistent use of double-negatives in the FSANZ reports (there is not enough evidence to say that a substance is not safe) and the very limited terms of reference of the FSANZ reports is disconcerting. FSANZ has shown a degree of unwillingness to engage with the real safety issues that will need to be seriously considered.
The approach of the FSANZ reports could imply that if it is scientifically determined that an already approved substance does not in fact acquire any novel properties or pose any new safety risks in its nano-form when compared with its traditional form, special pre-approval may not be required for the inclusion of the matter in its nano-form. However, such a system would only apply to some nanotechnology use, and would be only ancillary to a risk-assessment system such as that mentioned above.
Furthermore, a proper safety focus needs to go hand-in-hand with a robust process of information disclosure and discovery as to what is happening in the marketplace.
Moreover, there needs to be proper ongoing risk-assessments being based on characteristics of nanoparticles regardless of the safety of a matter in its traditional form.
The FSANZ reports stop short of looking at this in any great detail and therefore a significant hole remains in Australia's approach to nanotechnology.
This is general information rather than legal advice and is current as of 13 May 2019. We therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.