Nanotechnology
The Regulatory Landscape for the
Food Industry
Dr. Anna Gergely, Director EHS Regulatory
agergely@steptoe.com
Leatherhead Food Research 18 November 2010
1
CONTENTS
1.
2.
3.
4.
Examples of Nanotechnologies in Food
Current Regulatory Framework
Emergence of Regulation of Nanotechnology
Risk Assessment of Products enabled by
Nanotechnologies
5. Reporting/Labelling
6. Conclusions
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SOME POSSIBILITIES FOR THE USE OF
NANOTECHNOLOGIES IN FOOD
Food Packaging
‘Active’ and ‘intelligent’ packaging
Food Processing
Taste and texture, for example, nanoparticle emulsions
to improve texture (trickling agents) and reduce fat
content
Functional Foods
Nanocapsules enclosing nutrients such as vitamins or
omega 3 fatty acids (‘nanoceuticals’) for release into
body when required
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LEGAL FRAMEWORK
 Horizontal Legislation: (applicable, but pre-nano)
 General Product Safety and Product Liability Legislation
 Workers’ Protection Legislation
 Environmental Legislation
 Chemicals Legislation (REACH and CLP)
 Vertical (Application Specific) Legislation: (nano-specific)
Food / Novel Food / Food-contact / Cosmetics / Biocides/
RoHS/ Medical Devices etc.
EXISTING FRAMEWORK – POSITIONS OF
INSTITUTIONS
 EU Commission: June 2008 Communication on
Regulatory Aspect of Nanomaterials/Staff Working
Document:
 ‘Current legislation covers in principle the potential health,
safety and environmental risks in relation to nanomaterials.
Protection ... needs to be enhanced by improving
implementation of current legislation. ‘Specially mentions:
–
–
–
–
–
Regulation 258/97 (Novel Foods)
Regulation 1935/2004 (Food Contact Materials)
Directive 89/107 (Food Additives – now repealed)
Directive 2002/46 (Food Supplements).
Directive 1925/2006 (Fortification/Addition of vitamins and minerals)
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EXISTING FRAMEWORK – POSITIONS OF
INSTITUTIONS
 European Parliament: April 2009 Resolution on
regulatory aspects of nanomaterials; among others:
 Call on Commission to review all relevant legislation within
2 years (2011)
 Introduce comprehensive definition of nanomaterials into
relevant Community legislation
 Duty of care on manufacturers placing nanomaterials on the
market
 Commission to compile before June 2011 publicly available
inventory (respecting CBI) of different types/uses of
nanomaterials in EU
 Labelling of nano ingredients
 Urgent development of adequate testing protocols to assess
hazards of and exposure to nanomaterials
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EXISTING LEGAL FRAMEWORK - FOOD
 General principle of Regulation 178/2002 (Food law):
‘Food shall not be placed on the market if it is unsafe’
(Article 14(1))
 Regulation of products or processes incorporating
nanotechnology, not of nano-technology itself
 For example:
 (Existing) Novel Foods (Regulation 258/97)
 Food supplements (Directive 2002/46)
 Fortification (Regulation 1925/2006)
 New food additives Regulation 1333/2008
 Existing ‘precautionary approach’ prior
(process/product specific)
approval
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EXISTING LEGAL FRAMEWORK - FOOD CONTACT
 Regulation 1935/2004 (Framework Regulation):
Article 3: specific provisions on safety – also applies for
nanomaterials
 Directive 2002/72 (Plastics Directive):
 the establishment of a list of approved substances (the positive
list) is sufficient to demonstrate the achievement of safety
 provided the relevant restrictions are met
 No restrictions on particle size; hence the positive listing
of a substance could be claimed to also cover its nanoform (this has been changed with PIM!)
EXISTING LEGAL FRAMEWORK - FOOD CONTACT
 However, the Framework Regulation also provides, that:
 …the applicant or any business operator using the authorized
substance shall immediately inform the Commission of any new
scientific or technical information, which might affect the safety
assessment of the authorized substance in relation to human
health.
 What “might” affect the safety assessment is left for the
business operator to judge
 Can be claimed to cover nanomaterials with potential
health hazard
EXISTING LEGAL FRAMEWORK - FOOD CONTACT
 Safety demonstrated on a case-by-case basis:
 With sufficient toxicological information
 With demonstrating the lack of any exposure; i.e. no migration
 All the above implies that the individual authorization of
the nano-form is required by the Authority. This calls for:
 Clarifying the confusion of relying on
authorization for bulk substances – see PIM
existing
 Developing proper criteria for the safety evaluation of
nanomaterials, allowing their petitioning and appropriate
listing as authorized substances in their nano-forms
EXISTING LEGAL FRAMEWORK - FOOD CONTACT
 Active and Intelligent Packaging Regulation (EC
No. 450/2009)
 Excludes “nanoparticles” (“substances deliberately
engineered to particle size which exhibit functional
physical and chemical properties that significantly
differ from those at a larger scale”) from the
exemption to authorize substances behind a Functional
Barrier
 Different definition than in other regulatory areas
(cosmetics, novel foods, etc.)
EMERGENCE OF REGULATION
OF NANOTECHNOLOGY IN FOOD
 Need for ‘systematic’ evaluation of food containing
engineered nanomaterials, irrespective of whether
nanomaterials thought to cause changes in food properties
(Council)
 Recognition of need for adaptation of comprehensive,
internationally agreed definition to technical and scientific
progress (EP)
 Urgent need for appropriate and specific risk assessment test
methods for engineered nanomaterials (EP, Council)
 UK House of Lords Select Committee Report on
Nanotechnologies and Food (January 2010): engineered
nanomaterials used in food must be subject to a formal EFSA
risk assessment
 Labelling (see infra)
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WORKING DEFINITIONS I
 European level
Opinion of the Scientific Committee on Emerging and Newly
Identified Health Risks (SCENIHR)
Joint Research Center Reference Report
Scientific Committee on Consumer Products (SCCS)
Definitions adopted in EU law (Cosmetics, Novel Food …)
 International level
ISO
OECD Working Party on Manufactured Nanomaterials (WPMN)
 National level
US, Australia, Canada, UK, Germany
 Definitions are not based on the same elements
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WORKING DEFINITIONS II
 UK House of Lords Select Committee Report on Nanotechnologies
and Food (January 2010):
 change in functionality (how substance interacts with the body)
and not size range should be the key
 detailed list of 'properties that are characteristic of the nanoscale'
 distinguish between naturally occurring and engineered
nanoparticles
 SCENIHR opinion on the scientific basis for the definition of the
term “nanomaterial” (July 2010):
 Size-driven definition with a two-tier approach (upper size
threshold and lower, critical size threshold)
 Overarching definition with case-by-case exclusion criteria
 JRC Reference Report “Considerations on a definition of
nanomaterial for regulatory purposes” (June 2010):
 Exclude properties other than size in a basic definition
 Focus on “particulate nanomaterials”
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WORKING DEFINITIONS III
 European Commission Draft Recommendation (open for
consultation until 19 November 2010!):
• Consists of particles, with one or more external
dimensions in the size range 1nm – 100nm for more
than 1% of their number size distribution
• Has internal or surface structures in one or more
dimensions in the size range 1nm-100nm
• Has a specific surface area by volume greater than
60m²/cm³, excluding materials consisting of particles
with a size lower than 1nm
• Particle: means a minute piece of matter with defined physical
boundaries (ISO 146446:2007)
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DEFINITION FOR COSMETIC USE
 Cosmetics Regulation (EC) No 1223/2009
 Amended to specifically address nano materials
 Intention to place a product containing nanomaterials
on the market must be notified to the Commission 6
months in advance (no obligatory assessment by the
SCCS)
 Definition for nanomaterials as “insoluble or
biopersistent and intentionally manufactured material
with one or more external dimensions, or an internal
structure on the scale of 1 to 100 nm”
 while “moving” definition; it creates difficulties in
interpretation and enforcement
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DRAFT DEFINITION FOR NOVEL FOOD USE
 Council Common Position Article 3(2)(c):
 ‘intentionally produced material that has one or more dimensions
of the order of 100 nm or less or that is composed of discrete
functional parts, either internally or at the surface, many of which
have one or more dimensions of the order of 100 nm or less,
including structures, agglomerates or aggregates, which may have
a size above the order of 100 nm but retain properties that are
characteristic of the nanoscale
Properties that are characteristic of the nanoscale include:
(i) those related to the large specific surface area of the materials
considered;
and/or
(ii) specific physico-chemical properties that are different from
those of the non-nanoform of the same material’
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NEW FOOD ADDITIVES REGULATION 1333/2008
 In conjunction with the Regulations on food enzymes (No.
1334/2008) and on food flavourings (No. 1334/2008) a
common authorization system is introduced and a common
basis of controls is established
 Food additives produced through nanotechnology requires
separate new entry in positive list from non-nano version
already on list (Article 12)
 Producers or users of a food additive are obliged to inform
the Commission of any new scientific or technical
information that may affect the safety-assessment of the food
additive (Article 26)
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DRAFT NOVEL FOODS REGULATION
 Recast of Regulation No. 258/97
 Current and proposed Regulation apply only, if the food’s
nutritional value, its metabolism profile or its level of
undesirable substances is significantly changed in relation
to its macroscale counterpart
 EP Plenary Sitting 2nd Reading, July 2010:
 ‘Novel food should include foods modified by new
production processes, such as nanotechnology and
nanoscience, which might have an impact on food’
(Recital 6, Art. 3(2)(a)(iii) Proposal)
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EMERGENCE OF REGULATION - FOOD CONTACT
Draft Plastics Implementation Measure (PIM):
 Whereas (23): “substances deliberately engineered in
particle sizes that significantly differ from those at larger
scale, e.g. nanoparticles”. Further: “…authorizations
which are based on the risk assessment of the
conventional particle size of a substance do not cover
engineered nanoparticles.”
 Article 9 of draft PIM provides:
 “Unless explicitly mentioned in the specifications […of the
positive list] the use of substances in nano-form shall not be
authorized”
 “nano-form” is not defined
EMERGENCE OF REGULATION - FOOD CONTACT
 To date: EFSA has published a positive opinion on
TiN nanoparticles in PET bottles. Basis of no concern:
lack of any detectable migration into food.
 BUT: Commission didn’t act on this opinion to include
TiN in the positive list of permitted food contact
additives
 nTiN is listed in the EU Provisional List and can be used on
the basis of this listing subject to national law
 Annex 13 of the German BGVo has listed nTiN (in effect
since September 2009)
 Other Member States: nTiN can be used on the basis of
Mutual Recognition
RISK ASSESSMENT OF PRODUCTS ENABLED BY
NANOTECHNOLOGY
 February 2009 EFSA opinion on the Potential
Risk
Arising
from
nanoscience
and
nanotechnologies on Food and Feed Safety:
 ‘The risk assessment of ENMs must be performed on a
case-by-case basis’
 ‘The available data on oral exposure to specific ENMs
and any consequent toxicity are extremely limited’
 Under these circumstances, any individual risk
assessment is likely to be subject to a high degree of
uncertainty. This situation will remain so until more
data or and experience with testing of ENMs becomes
available
 House of Lords Report:
 Urgent need for behaviour of nanomaterials in gut
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REPORTING/INVENTORIES
 Belgian Presidency proposes to
nanomaterials register under REACH
establish
 mandatory to label nanomaterials in consumer products
 2009
Milieu
Report
commissioned
by
Commission proposes Commission mandatory
nanomaterials register
 information from producers/importers required
to understand what is on market and assess exposure
 UK Food Standards Agency propose (follow
House of Lords recommendation):
 mandatory confidential database of nanomaterials
researched in food industry
• crucial information for risk assessment of nanomaterials
• legislation required
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REPORTING/INVENTORIES (cont.)
Publicly available (online) list of foods and
food packaging containing nanomaterials (those
given positive Opinion by EFSA and other
foods which appear to have nanoscale elements
• Difficult
to
gauge
precisely
extent
of
nanotechnology use in food sector – definition?
• Food industry should avoid secrecy: GMO
comparison
- ‘exactly the type of behaviour that may bring about the
public reaction [industry] is trying to avert’
- secrecy breeds mistrust
• Balance industry confidentiality concerns with need
to gain consumer confidence
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LABELLING
Labelling:
Novel Foods Regulation Proposal:
• Labelling stipulated in authorisation decision – case
by case (Council)
• Labelling to state produced with nanotechnology
(EP)
• ‘(nano)’ to appear next to nanomaterial ingredient on
label (EP)
 will consumer understand significance?
• perceived as mandatory warning or marketing claim
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CONCLUSIONS
 Regulatory framework need to balance economic
potential with both ensuring safety and gaining
public trust (avoid GMO backlash)
 Existing food legislative framework being
extended to cover nanotechnologies specifics
 For nano-specific risk assessment, verify or
develop:
 adequate risk assessment tools
 ability to know what nanotechnology is being used in
food
 Development of agreed definition and adopted
amendments of revised Novel Food Regulation a
crucial next step
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THANK YOU
http://www.steptoe.com/nanoresourcecenter
Dr. Anna Gergely, Director EHS Regulatory
agergely@steptoe.com