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State of the art on the initiatives and activities relevant to risk assessment andrisk management of nanotechnologies in the food and agriculture sectors

Masami T. Takeuchi, Mina Kojima, Manfred Luetzow

PII: S0963-9969(14)00191-4DOI: doi: 10.1016/j.foodres.2014.03.022Reference: FRIN 5138

To appear in: Food Research International

Received date: 5 August 2013Revised date: 7 March 2014Accepted date: 16 March 2014

Please cite this article as: Takeuchi, M.T., Kojima, M. & Luetzow, M., State of theart on the initiatives and activities relevant to risk assessment and risk management ofnanotechnologies in the food and agriculture sectors, Food Research International (2014),doi: 10.1016/j.foodres.2014.03.022

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Title: State of the art on the initiatives and activities relevant to risk assessment and risk

management of nanotechnologies in the food and agriculture sectors.

Authors: Masami T. Takeuchia (Corresponding author), Mina Kojima

b and Manfred

Luetzowc

aFood and Agriculture Organization of the United Nations (FAO), Viale delle Terme di

Caracallar, 0153 Rome, Italy, Masami.Takeuchi@fao.org. +39 06 570 53076. bWorld Health

Organization (WHO), 20, Avenue Appia, 1211 Geneva 27, Switzerland. cSaqual GmbH, 5432

Neuenhof, Switzerland

Abstract

Food and Agriculture Organization of the United Nations (FAO) and World Health

Organization (WHO) conducted an international expert meeting on the potential food safety

implications of the application of nanotechnologies in the food and agriculture sectors in June

2009.

The present report reviews national, regional and international activities on the risk

assessment and risk management of nanomaterials in the food and agriculture sectors that

have been carried out between 2009 and 2012. Information and data have been collected on

national and international approaches that identify and implement strategies to address

potential hazards associated with the use of nanotechnology-related products or techniques.

Selected activities by international governmental and nongovernmental organizations were

reviewed and the significant achievements are noted. Meta-analysis of scientific reviews

addressing risk assessment of nanotechnologies in the food and agriculture sectors was

conducted and key principles for the safety assessment of nanomaterials were identified.

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It was concluded that although the concepts of potential use of nanomaterials in food

and the implied benefits for stakeholders including consumers have not changed significantly

since 2009, there are new products being developed and claimed to enter the market and

national and international interests in considering the needs for applying regulations on

engineered nanomaterials are increasing. The number of published risk assessment of

products used in foods that are nanomaterials or contain particles that fall within applicable

definitions is growing slowly.

Several data gaps with respect to interaction between nanomaterials and food matrices,

behaviours of nanomaterials in human body, methods to determine such interactions and

behaviours, and the relevance of such data for risk assessment continue to exist. The

international collaboration in the area of nanomaterials and nanotechnology in food and

agriculture must be strengthened. International efforts on risk assessment and risk

communication may benefit from the experience gained at national and regional level. Should

a sufficient number of case studies of risk assessment of commercial products become

available with time, a review of approaches applied and results obtained could support

development of risk assessment procedures acceptable at the international level.

Keywords

Nanotechnology; food safety; agriculture; engineered nanomaterials; manufactured

nanoparticles; FAO; WHO

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1. Introduction

The food industry is, like any other sector, driven by innovations, competitiveness and

profitability. Therefore the industry is seeking new technologies to offer products with

improved tastes, flavours, textures, longer shelf-life, and better safety and traceability. The

advent of nanotechnology has unleashed prospects for the development of new products and

applications for a wide range of industrial and consumer sectors (Roco and Bainbridge, 2001).

Many countries have identified the potential of nanotechnology in the food and agriculture

sectors and are investing significantly in its applications to food production, although the

current applications in the food and agricultural sectors are relatively few, because the science

is still newly emergent. Many countries recognize the need for early consideration of the food

safety implications of the technology as there is a limited data and information on possible

positive and negative effects that the applications may pose to human health. (FAO/WHO,

2010).

An international expert meeting on the potential food safety implications of the

application of nanotechnologies in the food and agriculture sectors was convened by the Food

and Agriculture Organization of the United Nations (FAO) and the World Health

Organization (WHO) in June 2009. In this work, we have summarized and analyzed

information that has become available since the 2009 expert meeting in order to determine

possible options for actions to be followed by relevant international organizations like FAO

and WHO.

2. Material and methods

Information on relevant risk assessment and risk management activities was gathered from

the websites of national and international institutions, organizations and governments.

Countries were selected to represent a spectrum that is representative from regional point of

view. A systematic review was conducted with the keywords such as “nanomaterial”, “food”,

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“regulation” and “safety”. It should be noted that terms used in this paper reflect the

definitions applied within the various sources of information; no attempt was made to align

the terminology with definitions agreed to by the 2009 expert meeting or other definitions

applied internationally, for example, by the Codex Alimentarius Commission

(http://www.codexalimentarius.org/).

Information on actual and planned uses of nanomaterials resulting in human exposure

through food or food packaging/contact materials since 2009 was collected from a variety of

sources, including the scientific literature, websites, patent databases, market analysis reports

and material presented at conferences, workshops and symposia.

3. Results and Discussion

3.1.Application of nanomaterials in food: current status

Current and projected nanotechnology applications in the food and agriculture were

identified by the FAO/WHO expert meeting report (FAO/WHO, 2010) such as nanostructured

ingredients, nanodelivery systems for nutrients, nanosized inorganic and organic food

additives, food packaging, nanocoating of food surfaces, nano filtration and no new concepts

have been developed since then. For the years of 2009-2011, 183 patents were identified that

contain the keywords “nano* AND food*” in the patent title at http://wokinfo.com. Among

these patents, 47 related to packaging or coating applications, 19 patents concerned nano-

additives, and 10 patents covered nanotechnology applications for the detection of compounds

in food. The use of nanotechnology and nanomaterials in food and agriculture was also the

focus of a number of review monographs that summarize the status quo or state of art

(Chaudry et al., 2010; Frewer et al,. 2011; Huang, 2012).

In general, more research on the application of nanomaterials in food is expected. In

particular, research on nanoemulsion will increase because of the transfer from parallel efforts

in the drug delivery sector (ObservatoryNano, 2010). However, there are some barriers to

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commercialization for nanoemulsions. First, suitable food-grade ingredients must be

identified for formulating food nanoemulsions. Second, many of the approaches that have

been developed within research laboratories may not be suitable for scale-up to industrial

production; suitable processing operations must be identified for economic production of

food-grade nanoemulsions on an industrial scale. Third, as nanodroplets may have an

enhanced bioavailability, in vivo evaluation of nanoemulsion droplets is required; however,

such studies are limited (McClements & Jiajia, 2011).

One specific area of interest is the use of nanomaterials in wastewater treatment to

improve the safety and quality of water used for agriculture, aquaculture and human

consumption. It might be possible to develop, for example, low-cost

nanofilter/nanomembrane materials that could be of interest to developing countries.

Technological solutions using nanotechnology in packaging to reduce food losses or facilitate

traceability could be also of interest (FAO/WHO, 2012). The future use of nanomaterials,

especially for industrial purposes, has recently raised specific concerns regarding their

disposal at the end of their life cycle. Such materials may not be degradable and may persist

in the environment where they may interact with compounds in the environment. This

potential hazard is already causing concern in developing countries to which waste containing

nanomaterials may be exported (FAO/WHO, 2012).

3.2.Relevant activities at the national/regional level since 2009

3.2.1. Australia/New Zealand

Food Standards Australia New Zealand (FSANZ) recently published an article

describing its regulatory approach to nanoscale materials in the International Food Risk

Analysis Journal (Fletcher & Bartholomaeus, 2011). The primary focus is not on the size of

the material per se, but on materials likely to exhibit physicochemical and/or biological

novelty. FSANZ differentiates between nanoscale materials that undergo dissolution in water

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or oil in the final food or in the gastrointestinal tract and nanoscale or microscale materials

that are insoluble in water and oil and non-biodegradable, particularly those that may not be

readily excreted. FSANZ has not yet received any applications to approve any novel type of

engineered nanoscale particles for food use, therefore no risk assessments have been

undertaken.

3.2.2. Brazil

Experts from the Brazilian Competitiveness Forum on Nanotechnology met in 2011 to

address the issue of regulating nanotechnology for the industrial sector (NIA, 2011). The

topics discussed during the meeting include the development of possible standards, laws and

guidelines for nanotechnology regulation in Brazil (ABDI, 2010).

3.2.3. Canada

Regulations in Canada make no explicit reference to nanomaterials at this time. Health

Canada considers any manufactured substance or product and any component material,

ingredient, device or structure to be a nanomaterial if it is at or within the nanoscale in at least

one external dimension or has internal or surface structure at the nanoscale; or it is smaller or

larger than the nanoscale in all dimensions and exhibits one or more nanoscale

properties/phenomena (Health Canada, 2011). In order to identify and assess potential risks

and benefits of nanotechnology-based health and food products, Health Canada encourages

manufactures to request a pre-submission meeting with the responsible regulatory authority to

discuss the type of information that may be required for their product’s safety assessment.

3.2.4. China

The Food Safety Law, which came into effect in 2009, does not contain any legislation

relating to nanomaterials (Food Safety Law of China, 2009). Until now, applications for using

nanominerals or food ingredients have not been accepted by regulatory authorities, but the

safety evaluation of nanotechnology in foods continues to be discussed.

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3.2.5. European Union (EU)

Based on the opinion that was published by the Scientific Committee on Emerging

and Newly Identified Health Risks “Scientific basis for the definition of the term nanomaterial”

(SCENIHR, 2010), the European Commission (EC) adopted the following recommendation

on the definition of nanomaterials: “Nanomaterial” means a natural, incidental or

manufactured material containing particles, in an unbound state or as an aggregate or as an

agglomerate and where, for 50% or more of the particles in the number size distribution, one

or more external dimensions is in the size range 1 nm – 100 nm (EC, 2011). A common

system for authorisation of food additives in Europe requires re-evaluation of the safety of

any food additive to ensure that, once permitted, food additives are kept under continuous

observation and re-evaluation. This assures that an approved additive produced by a different

production process (e.g. to generate nano-form) will undergo re-evaluation of safety.

The European Food Safety Authority (EFSA) published a scientific opinion with the

title “Guidance on the risk assessment of the application of nanoscience and nanotechnologies

in the food and feed chain” (EFSA Scientific Committee, 2011). EFSA concluded that the risk

assessment paradigm including hazard identification and hazard characterisation followed by

exposure assessment and risk characterisation is appropriate for these applications of

nanoscience and nanotechnologies in the food and feed chain (EFSA, 2009). The EFSA has

set up a scientific network on the risk assessment of nanotechnology in food and feed, in

which all member states are represented, to create an overview of national research activities

to facilitate collaboration and exchange of information

[http://www.efsa.europa.eu/en/supporting/pub/362e.htm].

3.2.6. Japan

Nanotechnology was specified as one of the priority research targets in the third

Science and Technology Basic Plan for 2006-2010 by the Japanese government (Government

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of Japan Council for Science and Technology Policy, 2006). A survey results on the use of

nanotechnology in the food sector funded by the Food Safety Commission Japan (FSCJ)

reported that there was no need for specific nanomaterial regulation at present in Japan (FSCJ,

2010). However the report concluded that there were questions on the classification of

nanotechnology-using food products as well as significant data gaps, which precluded the

drawing from firm conclusions. If any regulation needed to be introduced, safety assessment

methods would need to be established first.

3.2.7. Malaysia

Nanotechnology has been identified by the National Innovation Council as an

essential element to meet the country’s objective to turn Malaysia into a high income

developed nation by 2020. Under the National Nanotechnology Directorate, legal instruments,

appropriate parameters and monitoring mechanisms ensure compliance with all aspects of

nanotechnology development and commercialization. Malaysia is formulating a clear

roadmap to comply with any future global safety standards relevant to nanotechnology.

At present there are no specific regulations applicable to the risk assessment of

nanotechnology in Malaysia. Risk assessment is conducted to address potential health risks in

general and is not limited to nanotechnology.

3.2.8. Republic of Korea

No regulations relating to nanomaterials were found on government websites , the 3rd

International Nanomaterials Ethics Workshop in 2011, topics including changes in safety

regulation regarding nanomaterials in European countries were discussed (Korean Ministry of

Education, Science and Technology, 2011). The Korean Ministry of the Environment

developed a document on the Guideline for the life cycle assessment (LCA) for nanomaterials,

as reported in Organisation for Economic Co-operation and Development (OECD) (OECD,

2011).

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3.2.9. Russian Federation

The control of nanomaterials in various industry sectors, including food and

agricultural production receive attention by the Federal Service for Surveillance of Consumer

Rights Protection and Human Well-Being (Rospotrebnadzor) since 2007. Several federal

ministries and scientific bodies developed the “concept of toxicological researches,

methodology of risk assessment, methods of identification and quantitative determination of

nanomaterials” (No. 79, 31.10. 2007) which notes that the set of the stated factors testifies to

nanomaterials processing physical and chemical properties and biological (including toxic)

action, differing from substances in a usual physical and chemical condition. In this

connection they have to be referred in all cases to new types of materials and production,

which characteristic of potential risk for human health and environment is compulsory in all

cases.

Under the umbrella of a federal programme bythe development of infrastructure of

Nanoindustry in the Russian Federation for 2008-2010, in total 50 standard and methods

document (guidelines and recommendations) for safety assessment and risk evaluation of the

nanotechnologies and nanomaterials were developed and approved. A predictive assessment

allows to classify nanomaterials as having high, average or low level of potential hazard. The

risk evaluation of nanoparticles and nanomateirals in the food sector is based on the

traditional scheme which was developed and approved for the assessment of chemical and

other technological hazards. The risk assessment processes are carried out in accordance with

guidelines and recommendations generally harmonized with requirements of OECD, EFSA,

FAO/WHO and other international and national bodies.

As of 2012 safety assessment of a number of nanomaterials used in production of food

and agricultural designation were carried out by the Institute of Nutrition of the Russian

Academy of Medical Science. Until now such work allowed to characterise nanoparticles of

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titanium dioxides, silicon, aluminium and iron, the nanostructured clays (nanoexfoliated clay),

fullerene C60, metal silver (Tutelyan, 2013)

3.2.10. South Africa

No safety assessment or regulations specific to nanomaterials in the food and

agriculture sectors were found on the Government of the Republic of South Africa’s website

(Government of the Republic of South Africa, 2008). South Africa’s national nanotechnology

strategy runs until 2014 to support long-term nanoscience research (Department of Science

and Technology of the Republic of South Africa, 2011)

3.2.11. Switzerland

The Swiss Federal Council launched the “Action Plan for Synthetic Nanomaterials”

that illustrate the work required for the safe handling of nanomaterials which serves as a

framework until 2015. The plan addresses development of regulatory framework conditions

for the responsible handling of synthetic nanomaterials, creation of scientific and methodical

tools aimed at identifying and preventing potential harmful effects of synthetic nanomaterials

on health and the environment, and the promotion of the public dialogue on opportunities and

risks of nanotechnology. Safety provisions for use of nanomaterials in foods is covered by

existing regulations and procedures. Pesticides are subject to an approval procedure which

specifically asks for nanospecific information. So far the Federal Office of Public Health has

not received any requests for approval of food additives containing nanomaterials. Possible

future requests would be handled analogously to those for a new, as-yet unlisted additives.

The same would apply to requests for packaging materials containing nanomaterials which

come into contact with foodstuffs.

3.2.12. United States of America

In addressing issues raised by nanomaterials, United States (US) agencies adhere to

the principles for regulation and oversight of emerging technologies, as summarized by

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Holdren, Sunstain & Siddiqui (2011). The United States Food and Drug Administration

(FDA) is in the process to finalize a guidance document on considering whether an FDA

regulated product contains nanomaterials or otherwise involves the use of nanotechnology.

The draft guidance on substances to be used in dietary supplements proposes to include issues

related to nanotechnology, if such use of nanotechnology results in new or altered properties

of the ingredient (FDA, 2011). Another guidance document is also being developed, which

addresses the impact that manufacturing changes, including a change in particle size, would

have on the regulatory status of authorized materials, which will address nanomaterials (FDA,

2012). The FDA does not maintain a list of nanomaterials that it has assessed (A. McCarthy,

FDA, personal communication, 2011).

The nanomaterial research strategy from 2009 defines the US Environmental Protection

Agency (EPA)’s nanotechnology research programme to conduct focused research on

nanomaterial safety (EPA, 2009). The EPA has identified five nanomaterial types for

investigation that are widely used in products or have been recognized for their potential uses

(EPA, 2011). The materials being studied include carbon tubes and fullerenes, cerium oxide,

titanium dioxide and silver.

3.3.Relevant activities by international governmental and nongovernmental

organizations since 2009

In the last few years, the Institute of Food Technologists (IFT) has supported research and

published several articles on nanotechnology relating to an ongoing project on safety

assessment. IFT offers an on-demand online courses including “Introduction to Nanoscience”.

There have been many scientific literature published on the IFT journals and IFT conferences

have featured many sessions on the topic of nanotechnology.

The NanoRelease project from the International Life Sciences Institute (ILSI) Research

Foundation’s Center for Risk Science Innovation and Application aims to promote the safe

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development of nanomaterials by supporting the development of methods to understand the

release of nanomaterials used in products. As part of the NanoRelease project, data, methods,

guidance, standards and links are collected(ILSI, 2011). NanoCharacter is another project

aimed at developing a framework and road map for implementing widespread adoption of

principles of reporting characteristics of nanomaterials in studies of commercial nanoproducts.

The project builds on other international efforts to establish the list of what to measure and

will lay out how to get from concept to reality of consistent reporting. ILSI Europe initiated

the Novel Foods and Nanotechnology Task Force (ILSI Europe, 2011), which started its work

focusing on new technologies for the safety/nutritional assessment of novel foods and food

ingredients. ILSI Europe has developed a peer-reviewed article on the safety assessment of

engineered nanomaterials in food (Cockburn et al., 2012).

International Organization for Standardization (ISO) established the Technical

Committee 229 Nanotechnologies with the scope of standardization in the field of

nanotechnologies. Specific tasks include developing standards for: terminology and

nomenclature; metrology and instrumentation, including specification for reference materials;

test methodologies; modelling and simulations; and science-based health, safety, and

environmental practices (http://isotc.iso.org/livelink/livelink/open/tc229).

Organisation for Economic Co-operation and Development (OECD) has two relevant

working parties: (1) the Working Party on Nanotechnology and (2) the Working Party on

Manufactured Nanomaterials. Both working parties do not have food as a main subject;

nevertheless, OECD’s work on the testing and assessment of nanomaterials can be used for

food-related nanomaterial applications (M. Gonzalez, OECD, personal communication, 2011).

OECD’s main activities are on: hosting database on research into the safety of manufactured

nanomaterials; safety testing of representative set of manufactured nanomaterials; defining the

role of alternative test methods in nanotoxicology; developing manufactured nanomaterials

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and test guidelines; developing voluntary schemes and regulatory programmes; conducting

projects to evaluate environmental risk assessment approaches; and conducting projects to

investigate the potential benefits of applications based on the use of manufactured

nanomaterials for environmentally sustainable use of nanotechnology.

Overall there have been a number of meetings, symposia and workshops on the topic of

nanomaterials organized by several international or regional bodies at global, regional and

national levels. In many unique ways, these events discussed the current status of the

technology and future possible needs, however there has not been a conclusive remarks on

how the risk assessment and risk management of nanomaterials in food and agriculture sectors

should be conducted. This confirms that this is the area that requires further active dialogues

among various stakeholders in many parts of the world.

3.4.Scientific reviews addressing risk assessment of nanotechnologies in the food and

agriculture sectors

Recent scientific reviews on risk assessment of nanotechnologies in the food and agriculture

sectors confirm that information on this topic is limited (Tran & Chaudhry, 2010; Card et al.,

2011; Horie & Fujita, 2011; Magnuson, Jonaitis & Card, 2011; Morris, 2011; Rico et al.,

2011; Krug & Wick, 2011). A review on the interaction of nanoparticles with edible plants

found that understanding of plant toxicity is at the early stages. Few studies have been

performed on the accumulation of engineered nanomaterials in crop plants such as rape,

radish, lettuce, corn and cucumber (Rico et al., 2011). Rico et al. (2011) noted that among the

studied nanomaterials, the carbon-based nanomaterials fullerenes C70 and fullerols C60(OH)20

and most of the metal-based nanomaterials (titanium dioxide, cerium oxide, magnetite, zinc

oxide, gold, silver, copper and iron) accumulated in the plants. These compounds stored in the

plants can be transferred to consumers. Depending on the studied nanomaterial and plant,

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negative effects of the nanoparticles on the food crops were observed, such as reduced

germination, reduced root growth and delayed flowering.

Card et al. (2011) evaluated published literature on the safety of oral exposure to food-

related nanomaterials and found that there are currently insufficient reliable data to allow a

clear safety assessment. Card et al. (2011) also considered that non-food-related engineered

nanomaterials require evaluation of oral toxicity in light of possible contamination of the food

supply. Morris (2011) concluded that the lack of information on the possible toxicity of

nanomaterials makes it difficult to assess the safe or Acceptable Daily Intake. According to

Magnuson, Jonaitis & Card (2011), the literature on the safety of oral exposure to

nanomaterials inadequately characterizes nanomaterials with insufficient physicochemical

parameters, concluding that “Unless nanomaterials are adequately characterized, the results of

the toxicology studies cannot be utilized to predict toxicity of other nanomaterials as changes

in any of the characteristics may result in changes in biological activity”.

The safety assessment of nanomaterials will depend on their adequately characterized

chemical properties; critical parameters include biopersistence and digestibility. Based on the

development of nano forms of trace minerals, the group led by D. Pereira (2012) at Medical

Research Council, UK Human Nutrition Research identified three different scenarios.

Digestible, non-biopersistent nanomaterials such as nano forms of a salt will be digested

(dissolve) prior to any cellular exposure; for cells and tissues, there will be no difference if

compared with conventional forms. A second type of digestible, non-biopersistent

nanomaterial, such as micellar nano formulations or ferritin, will only partially degrade in the

gut; they may therefore be absorbed as nano structures but will be rapidly broken down in

cells (Powel et al 2013). A third type, non-digestible, biopersistent nanomaterials, may remain

intact and will raise different issues, an important one being their adsorbed surface materials,

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which may be removed in the stomach and replaced in the gut by luminal molecules before

cellular uptake (FAO/WHO, 2012).

4. Conclusions

The concepts of potential use of nanomaterials in food and the implied benefits for

stakeholders including consumers have not changed significantly since 2009. New products

are being developed and claimed to enter the market, but the available data from published

sources and databases do not allow verifying whether product ideas are just concepts,

unsubstantiated claims, or are already resulting in exposure of consumers to food being

produced with nanotechnology/nanomaterials at any significant rate.

The statement by the FAO/WHO expert meeting (FAO/WHO, 2010) that current risk

assessment approaches were suitable to assess nanomaterials and nanotechnologies used in

food is supported by those agencies/institutions that have investigated this issue in more detail.

National and regional food safety agencies increased their focus during the past few years on

investigating the implications of nanomaterials added to or used with food. Policies and

guidance documents have been published that allow a better understanding of how risk

assessment of nanomaterials will be performed in the future. OECD reviewed their testing

guidelines for hazard identification and characterization of food chemicals and found them to

be generally applicable for the testing of nanomaterials. Other research-oriented projects

initiated by OECD will provide valuable insights into aspects of risk assessment specific to

engineered nanomaterials. The approach to be published by ILSI for nanomaterials to be used

in food is interesting, as it tries to systematically review the information already available for

conventional material and discusses what properties would allow extrapolation from

conventional to novel nanomaterials. Further development and implementation of this concept

may lead to reduced animal testing. The main areas of chemical risk assessment at the

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international level address food additives, pesticide residues, veterinary drug residues, some

processing aids, such as enzymes, and occasionally micro-nutrients. Nanomaterials would be

within the scope of such activities; for example, a nanoscale food additive could be addressed

by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and residues from a

nanoscale pesticide could be addressed by the Joint FAO/WHO Meeting on Pesticide

Residues (JMPR). There are, however, some areas of food chemicals, such as materials in

contact with foods (e.g. food packaging), that occasionally are addressed by FAO/WHO

expert bodies, but for which no comprehensive and systematic programme is in place; for a

“nano-plastic material” to be used in food packaging, there is no risk analysis framework at

the international level currently in place. Several data gaps with respect to interaction between

nanomaterials and food matrices, behaviours of nanomaterials in human body, methods to

determine such interactions and behaviours, and the relevance of such data for risk assessment

continue to exist. Coordinated international collaboration and information exchange between

scientists from academia, industry and authorities, to address such gaps may be necessary and

useful.

A key finding of the FAO/WHO expert meeting was that public confidence in engineered

nanomaterials can be supported through institutional efforts to provide an overview of

applications of nanotechnology in food and packaging that are transparent and allow public

involvement (FAO/WHO, 2010). It was found that the mandatory labelling would lead to

greater transparency for the consumer and enable consumer freedom of choice. However,

mandatory labelling could also lead to the avoidance of the use of nanotechnologies in

consumer products, including those that are beneficial (Gruère, 2011). So far, apart from the

EU, no country has set a regulatory framework for the mandatory labelling of nanomaterials

in food (EU, 2011). The mandatory labelling of materials that meet a definition that reflects

only dimension (i.e. is not risk based) provides a new element in the discussion that might be

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of interest to the Codex Alimentarius Commission, as it could result in technical barriers to

trade of foods to which nanomaterials have been added. In a report on the EC’s public online

consultation among key stakeholders about nanomaterials, the majority of the 716

respondents regarded applications in agriculture and food with more scepticism than

applications in other areas (EC, 2010).

Acknowledgements

This work was conducted jointly by FAO and WHO, however the opinions or assertions

contained herein are our private views and are not to be construed as official or as reflecting

the view of FAO or WHO. M. Luetzow designed and conducted the research and analyzed

and organized the information/data collected. M. Takeuchi facilitated the development

process of the research and analysis, and prepared the article. M. Kojima contributed in

reviewing the information and the article. We acknowledge the responses and comments

provided by various international experts. Technical contributions from several FAO and

WHO colleagues are also gratefully appreciated.

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