Nanotechnology the challenges facing regulators - the FSAI ... · General principles of food law...
Transcript of Nanotechnology the challenges facing regulators - the FSAI ... · General principles of food law...
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Nanotechnology the challenges facing regulators - the FSAI
perspective
Dr Patrick O’MahonyChief Specialist Biotechnology
Food Safety Authority of Ireland
31st March 2009
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Food SafetyAUTHORITY OF IRELAND
Statutory Agency Established in 1999
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FSAI - Consumer Protection Agency
Science-Based
Independent of Food
Producing Sector
Open & Transparent
Public Trust
Food law enforcement &
Advice to Ministers
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FSAI Report on Nanotechnology
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FSAI Report on Nanotechnology
1. Inform Ourselves
2. FSAI Action
Nanotechnology
Risks/Benefits
Controls
Research
Regulation
Education
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Nanotechnology - It’s Not New…
“There is Plenty of Room at the Bottom”
Lecture - 1959
Richard Feynman
1918 - 1988
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Bell, 2006
80% surface area of a soccer pitch
Nanoparticles and Surface Area
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It’s Already Here
Computer equipment
Toughened Paint
Sun Protection
Surface treatments
Water Droplet on Wood
Sports equipment
Nanotechnology Today…
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Is it Good or Bad?
It’s a tool!
Nuclear BombNuclear Medicine
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Fully Charging Electric Car – 8 Hours
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Diagnostic Medical Devices
Nano-wires Can Be Programmed for Different Diseases
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Medical Treatments
Targeted drug and radiation therapy – less injury to healthy tissue
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Nano-Silver Kills Bacteria…
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Commercialisation of Technology-1
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Functional Foods (increased bioavailability/odour & taste masking)
Smart Packaging
Nano-sensors
Food Contact Materials
Nanotechnology in Food Production
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Challenges …….
• It’s here!
• Will impact most in society in different ways
• Minimal consumer awareness
• Communicate benefits and risks
• Protect consumers while not stifling innovation
• Effective risk assessment
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How Many
Are
Naturally Present?
Daewoo FridgeSupplements
What About The Stable Door?
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Scientists Say “We don’t have all the answers”
In the case of nanotechnology?
“We don’t even know all the questions!!
Assessing the Risks
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Risk analysis
Risk Assessment
Risk Management
Risk Communication
Estimate & characterise the risk
Select & implementnecessary controls to
assure an appropriate level of protection
Exchange of information and
opinions with interested parties
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Risk Assessment
Hazard identificationCollection, organisation and
evaluation of information
Hazard characterisationDetermines relationship
between pathogen/chemical and any adverse effects
Exposure assessmentDetermine how much is
ingested in a serving of food
Risk characterisationEvaluate the risk and related information
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Do we need specific food legislation on nanotechnology?
Current EU legislation does not contain specific provisions on nanomaterials
Current legislation permits nanoparticles of food-approved materials, based on macro- safety tests
No specific requirement for nanoparticles to be approved as novel ingredients or additives
No requirement to indicate their presence on food labels
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General principles of food law (Regulation
EC/178/2002 – Article 14.1. Food shall not be
placed on the market if it is unsafe)
Several existing pieces of legislation that can
potentially cover nanotechnology
• Novel foods and processes
• Food additives
• Food contact materials
Current EU Regulations?
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• Applies to foods or ingredients not on the EU market prior to 15 May 1997
• Pre-market authorisation of novel foods and processes
• Safety evaluation based on assessment of dossiers prepared by applicant
• Approval by comitology where necessary
• Standing Committee for the Food Chain & Animal Health can adjudicate novelty
Novel Food Regulation EC/258/97
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Proposal under discussion at EU Council to
amend regulation on food additives
“an amendment is under discussion that would
require separate limits to be considered for
approved additives produced using
nanotechnology”
Review of Food Additive Regulations
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Regulation (EC) No 1935/2004 on materials intended to come into contact with food
• must be sufficiently inert
• Smart packaging
Food Contact Materials
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Current work on risk assessment
•Positive evaluation of a silicon dioxide coating used as a gas barrier on
PET surfaces (Feb 2007)
•No opinion on Silver Hydrosol in food supplements (Nov 2008)
•Positive opinion on titanium nitride based nanoparticles as a food
contact material (Nov 2008)
•EFSA opinion on the risks from nanotechnologies for the safety of food,
feed and the environment (Feb 2009)
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Current work on risk assessment
Commission meeting of nanotechnology risk assessors
OECD – 2 Working Parties
WHO/FAO – Joint Expert meeting in June 2009
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Current work at the Food Safety Authority of Ireland
Scientific Committee Report
Information leaflet
Watching Brief
Advising Government
Participate in EU/international debate
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Why is Nanotechnology Important?
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