Nanotechnology - PowerPoint PPT Presentation

Loading...

PPT – Nanotechnology PowerPoint presentation | free to download - id: 3f45b6-YWQzM



Loading


The Adobe Flash plugin is needed to view this content

Get the plugin now

View by Category
About This Presentation
Title:

Nanotechnology

Description:

Nanotechnology The Regulatory Landscape for the Food Industry Dr. Anna Gergely, Director EHS Regulatory agergely_at_steptoe.com Leatherhead Food Research 18 November 2010 – PowerPoint PPT presentation

Number of Views:721
Avg rating:3.0/5.0
Slides: 28
Provided by: Dabr5
Learn more at: http://www.steptoe.com
Category:

less

Write a Comment
User Comments (0)
Transcript and Presenter's Notes

Title: Nanotechnology


1
Nanotechnology The Regulatory Landscape for the
Food Industry Dr. Anna Gergely, Director EHS
Regulatory agergely_at_steptoe.com Leatherhead
Food Research 18 November 2010
2
CONTENTS
  • 1. Examples of Nanotechnologies in Food
  • Current Regulatory Framework
  • Emergence of Regulation of Nanotechnology
  • 4. Risk Assessment of Products enabled by
    Nanotechnologies
  • 5. Reporting/Labelling
  • 6. Conclusions

3
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

4
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.

5
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)

6
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

7
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 approval
    (process/product specific)

8
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 nano-form (this has been
    changed with PIM!)

9
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

10
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 existing
    authorization for bulk substances see PIM
  • Developing proper criteria for the safety
    evaluation of nanomaterials, allowing their
    petitioning and appropriate listing as authorized
    substances in their nano-forms

11
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.)

12
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)

13
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

14
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

15
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 1464462007)

16
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

17
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

18
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)

19
DRAFT NOVEL FOODS REGULATION
  • Recast of Regulation No. 258/97
  • Current and proposed Regulation apply only, if
    the foods 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)

20
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

21
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 didnt 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

22
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

23
REPORTING/INVENTORIES
  • Belgian Presidency proposes to establish
    nanomaterials register under REACH
  • 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

24
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

25
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

26
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

27
THANK YOU http//www.steptoe.com/nanoresourcec
enter Dr. Anna Gergely, Director EHS
Regulatory agergely_at_steptoe.com
About PowerShow.com