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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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