Risk assessment of use of nanotechnology in food industry and risk management of use of nanotechnology in food

1. Regulatory approaches of
nanotechnology in food industry
Sushant Gawali
Nanotechnology and
Risk assessment

2. 2
C O N T E N T S
• Introduction
• Nanotechnology in Food industries
• Risk assessment criteria
• Toxicity measurements and evaluation techniques
• Risk assessment frameworks

3. • To understand and manipulate materials at the atomic, molecular,
and macromolecular scales.
• To study materials, structures, and engineering systems in sizes
ranging from 1 - 100 nm.
What is Nanotechnology?
3

4. 4
• Delivery and slow release of bioactive compounds in nutraceuticals and
functional foods to improve human health,
• In water purification and as sensors to assess food safety,
• Micro-encapsulation, deodorization, disinfection,
• Antimicrobial and antifungal functions,
• In the development of new forms of food packaging,
• Improved traceability and in the monitoring of foods during transportation
and storage, etc.
Potential applications of nanotechnology in food industry

5. Reference: Safety of Nanotechnology in Food Industries, Electronic physician; Volume 6, Issue 4, October-December 2014

6. 6
• The term Risk assessment refers to the evaluation of potential conditions that
could involve the development of a risk (potential for harm, injury, or worse to
people or the environment) based on the application, use, disposal, or even
storage of a nanomaterial.
• Risk management is considered the methodology that is employed to handle
the potential situations that could arise from the presence of nanomaterials
being improperly contained.
What is Risk assessment?

7. 7

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• Exposure assessment of nanoparticles
• Toxicology of nanoparticles
• Ability to deduce nanoparticle toxicity using existing toxicological
databases
• Environmental and biological fate, transport, persistence, and
transformation of nanoparticles
• Recyclability and overall sustainability of nanomaterials
Criteria may be considered for risk assessment in Nanotechnology

10. 10
Toxicity measurement of nanoparticles used in food industry
• Size, shape and surface structure
• Chemical composition
• Solubility
• Surface charge
• Coating
• Dissolution
• Agglomeration

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Toxicity evaluation methods and techniques used
• Various models including in-silico, microbial system, cell culture, in-vitro and in-vivo
models can be used to assess the genotoxicity of the nanomaterials in food industry.
• The Ames test has been extensively accepted to assess the genotoxicity of a variety of
NMs. It is used to detect mutagenesis based on the reversion of histidine auxotrophs
to autotrophs.
• Different assays such as the gene mutation assays like hypoxanthine phosphor-ribosyl
transferase (HPRT), comet assay, phosphatidylinositol glycan class A (PIG-A), thymidine
kinase, chromosomal aberration test and micronucleus assay, adopted in mammalian
cells.

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Nanotechnology
Risk
Assessment
Framework

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The frameworks are based on the same risk assessment paradigm,
consisting of hazard identification, exposure assessment and risk
characterization, but are diverse in their aim, applicability domain, basic
assumptions and alignment to one or more regulations.
Risk assessment frameworks of NPs

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NANoREG nanospecific approach for risk assessment
 Screening level assessment framework.
 Aim: To prioritize those nanomaterial applications that may lead to high risks for human
health. To identify those aspects of exposure, kinetics and hazard assessment that are most
likely to be influenced by the nanospecific properties of the material under assessment.
NanoRiskCat
 Screening level assessment framework.
 Aim: A systematic tool that can support companies and regulators in their first-tier
assessment and communication on what they know about the hazard and exposure
potential of consumer products containing nanomaterials.
DF4nanoGrouping framework
 Specific framework focused on human health hazards, via inhalation.
 Aim: Efficient strategy to sort out nanomaterials that could undergo hazard assessment
without further testing.

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LICARA nanoSCAN
 Generally applicable risk comparison framework.
 Aim: A screening tool for SMEs that provides a qualitative evaluation of the potential benefits
and risks of a new or existing nano-enabled product. A comparison against a reference
product or “doing nothing” is made.
NANoREG D6.04
 Generally applicable risk screening framework.
 Aim: Strategy to efficiently screen for indicators of potential risks during early stages of an
innovation process. Based on six key risk potentials: solubility/dissolution rate, stability of
coating, accumulation, genotoxicity, inflammation and ecotoxicity.
MARINA Risk Assessment Strategy
 General strategy.
 Aim: To develop a flexible and efficient approach for data collection and risk assessment. The
generated information should be sufficient to assess the risks of nanomaterials.

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Regulatory developments in Food Nanotechnology
• USA became the first nation to establish governmental initiatives towards nanoscale
research by establishing the National Nanotechnology Initiative (NNI). The Food and
Drug Administration (FDA) is amongst the principal government agency to define
nanotechnology and nano-food products.
• In the United Kingdom, the Royal Society and the Royal Academy of Engineering have
studied the benefits and risk accompanying with nanotechnology in concern with
environment and human health.
• In Japan, the Ministry of Education, Culture, Sports, Science, and Technology is in charge
for research and development activities and is building co-operative research platforms
for research and development in nanotechnology and materials science.
• In China, the National Center for Nanoscience and Technology is engaged in basic and
applied researches in nanoscience.

17. CASE
STUDY
#1

18. CASE
STUDY
#2

19. 19
• Safety of Nanotechnology in Food Industries by Seyed Mohammad Amini, Marzieh
Gilaki, Mohsen Karchani.
• Risk assessment frameworks for nanomaterials: Scope, link to regulations, applicability,
and outline for future directions in view of needed increase in efficiency by Agnes G.
Oomen et.al.
• Nanotechnology Risk Assessment by Walt Trybula and Deb Newberry.
• Nanomaterials in Food and Agriculture: An overview on their safety concerns and
regulatory issues by Aditi Jain, Shivendu Ranjan, Nandita Dasgupta & Chidambaram
Ramalingam.
R E F E R E N C E S