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FED
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UTE
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ENT Nanotechnology - dealing with
uncertainty in consumer protection
Astrid Epp
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 2
Overview Structure I Federal Institute for Risk Assessment (BfR): Tasks II Nanotechnology in Consumer Products: Overview III Risk Assessment of Nanotechnologies IV Nanotechnology and Consumer Protection V Conclusion
Guiding Questions
What is the current situation in nanotechnology from a consumer protection perspective?
What are the problems in assessing the possible health risks of nanomaterials?
Is scientific uncertainty something new in the area of consumer protection?
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 3
established in 1 November 2002
in the area of responsibility of the German Federal Ministry of Food, Agriculture and Consumer Protection (BMELV)
located in Berlin
independent in its scientific assessments
independent in its research
I Federal Institute for Risk Assessment (BfR)
History
Kaiserliches Gesundheitsamt (1876-1919)
Reichsgesundheitsamt (1919-45)
Bundesgesundheitsamt (1952-1994)
Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV) (1994-2002)
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 4
Objectives qualified scientific risk assessment, free from
influence from political, business, and social circles
open and transparent risk communication at the early stages of the risk assessment process
I Federal Institute for Risk Assessment (BfR)
Concept Separation of
risk assessment/risk communication
from risk management
Consumer Protection focused on
health of the consumer
Consumers’ freedom of choice (deception/deceit)
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 5
Responsibilities
Biological safety
Food and feed safety
Chemical safety
Product safety
I Federal Institute for Risk Assessment
Health-related
consumer protection
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 6
Organisation Chart: Departments involved in „Nano- Activities“
Risk Assessment: expert reports, opinions according to internationally recognized scientific criteria
National & International Bodies: committees & panels, working groups
Research Activities & Cooperations : primarily to strengthen risk assessment processes
Risk Communication: informing the public in a transparent, comprehensive way
President
Vice President
Risk Communication
Department 2
Food Safety
Department 5
Chemicals Safety
Department 6
Safety of Consumer Products
Department 7
Exp. Toxicology ZEBET
Department 9
I Federal Institute for Risk Assessment (BfR): („Nano“) Tasks
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 7
I Federal Institute for Risk Assessment (BfR): („Nano“) Tasks
National Level
„Behördendialog“: Joint activity of several public Authorities & Federal Institutes evaluating nano-related issues (e.g.BMU, BMELV, BMWi, BMFT, BAuA, UBA, BfR)
NanoKommission & NanoDialog (BMU) Stakeholder dialogue on further development of nanotechnology, establishing regulatory frames & risk assessment; participators from science & research, industry, administration and NGOs
Working Group: „Senatsarbeitsgruppe“ (BMELV) Expert opinions on synthetic nanomaterials in food and feed
Senate Commission on Food Safety & DFG working group “nanotoxicology“: Risk assessment of nanoparticles in food
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 8
I Federal Institute for Risk Assessment (BfR): („Nano“) Tasks
International Level
European Food Safety Authority (EFSA) BfR is active in scientific committee/working group on nanotechnology
Europaen Chemicals Agency (ECHA) Nanomaterials in REACH process
OECD Working Party on Manufactured Nanomaterials (WPMN) (2009-2012); BfR participates in Steering Group 3: Hazard assessment Steering Group 6: Development of risk assessment approaches Steering Group 8: Exposure assessment approaches co-chairs Steering Group 7: Integrated testing strategy applying in vitro methods
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 9
I Federal Institute for Risk Assessment (BfR): („Nano“) Tasks
Risk Communication: Research and Activities
Perception of Nanotechnology in Internet-based Discussions (08/2010) The risks and opportunities of nanotechnology and nanoproducts: results of an online discourse analysis
BfR Delphi Study on Nanotechnology (09/2010) Expert Survey of the Use of Nanomaterials in Food and Consumer Products
Risk Perception of Nanotechnology - Analysis of Media Coverage (10/2010)
BfR Consumer Conference Nanotechnology (03/2009) Pilot project to identify consumer risk perception
Public Perceptions about Nanotechnoloogy (01/2009) Representative survey and basic morphological-psychological study
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 10
II Nanotechnolgy in Consumer Products
Nanotechnology as key technology for the 21th century
Many consumer product applications
Early social discourse
Inclusion of natural scientific criteria as exposition, ubiquity, persistence, reversibility
and
sociocultural criteria as fearfulness, voluntariness, concernment, risk-benefit ratio,
controllability
Communication of the degree of scientific uncertainty
Nanotechnology – A challenge for consumer protection
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II Nanotechnology in Consumer Products
Nanotechnology is used in many areas of daily life like cosmetics, foods and consumer products without this being obvious to the consumer
Characteristics of Nanoparticles In comparison to larger particles nanoparticles can exhibit
• Altered physical properties (conductivity, colour, transparency, density)
• Altered chemical properties (reactivity, catalytical properties, solubility, structure)
• Alterede biological properties (membrane penetration, diffusion capability, lung entry)
Nanoparticles can therefore exhibit a different potential of hazard in comparison to larger particles of the same material
This raises the question whether new nano products may bring with them unknown risks for humans.
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 12
Source: Woodrow Wilson Database: Focus: USA, Asia ; based on public data
http://www.nanotechproject.org/inventories/consumer/analysis_draft
Increase of consumer products with “nano claim” (2005 – 2009)
Most commonly used nanomaterials in consumer products (2006 & 2009)
II Nanotechnology in Consumer Products
2005: 54 Products
2009: 1015 Products Silver: 259 Products (2009)
Carbon: 82 Products (2009)
Titanium: 50 Products (2009)
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Health & Fitness: 605 Products Food & Beverage: 98 Products
Product Categories
II Nanotechnology in Consumer Products
Source: Woodrow Wilson Database: Focus: USA, Asia ; based on public data
http://www.nanotechproject.org/inventories/consumer/analysis_draft
Health and Fitness Subcategory
Personal Care: 193 Products Clothing: 155 Products Cosmetics: 137 Products
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 14
Product inventories of consumer products with “nano” claim focused on the European Market:
Country Access Criteria Originator Source
Austria None public Semi-public
Nanotrust http://epub.oeaw.ac.at/ita/nanotrust-dossiers/dossier009.pdf
Netherland None public Semi-public
RIVM Report Dekkers et al 2007
Switzerland Semi-public Public Bundesamt für Gesundheit BAG
http://www.bag.admin.ch/themen/chemikalien/00228/00510/05626/index.html?lang=de#top
Great Britain In progress In progress
UK Food Standard Agency (FSA)
nanotechnology database 22 March 2010 http://interactive.bis.gov.uk/nano
France Non public Unknown AFSSA Nanotechnologies et nanoparticules dans l’alimentation humaine et animale
Europe Public Semi-public
BEUC, The European Consumers’ Organisation; ANEC, The European Consumer Voice in Standardisation
http://www.anec.org/attachments/ANEC-PT-2009-Nano-015.xls
European Industry
Public None public
Nanoshop Industry
www.nanoshop.com
II Nanotechnology in Consumer Products
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European Data: Relevant Areas of Application
II Nanotechnology in Consumer Products
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III Risk Assessment of Nanotechnologies
„Philosophy“ of Risk Assessment
Identify potentially hazardous situations Estimate the uncertainty associated with
the analysis Provide alternative options to reduce a
possible risk Estimate the adequateness of those options
Even when scientific knowledge is incomplete, consumer protection measures are frequently admissible and sometimes have to be taken very quickly
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 17
III Risk Assessment of Nanotechnologies
Possible risk source (risk factor, agent) description of e.g. a product, a substance or a microorganism
Hazard potential (of the risk source) contains information on the identification of possible damage to health or other
unacceptable effects Effects are related to the dose (hazard characterisation)
Exposure (Exposure estimates) Information on exposed population groups including different exposure situations (e.g. sick persons, pregnant women)
Risk characterisation Characterisation of the risk in summary form Comparison between potenital damage and the calculated/estimated exposure
Source: http://www.bfr.bund.de/cm/255/bfr_guidance_document_for_health_assessments.pdf Guidance Document for Health Assessments
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III Risk Assessment of Nanotechnologies
Restrictions on distribution/sale or commercial use;
Limit values / standards for tolerable exposure, e.g. maximum levels in foods when placed on the market;
Labelling, warnings, recommendations and restrictions on use;
Measures to avoid or reduce contamination with and multiplication of microbial agents, the reduction of such agents in the food chain by producers/manufacturers, retailers and consumers;
Action against misleading advertising claims, and increased information and education of consumers
The following consumer protection measures may be considered:
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III Risk Assessment of Nanotechnologies
(External & Internal) Exposure In which products? Suitable measuring methods? Uptake in body?
Toxic Effects Are present toxicity tests suitable? How to describe dose-effect relationships
Risk Need-to-know information for risk estimation? Is present legislation sufficient? Consistent with existing threshold limit values?
Most significant knowledge gaps
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 20
Tools for a Preliminary Assessment of Risks to Human Health
Nano Risk Framework (US, Environmental Defense – DuPont 2008) A systematic and disciplined process for identifying, managing, and reducing potential environmental safety and health risks of engineered nanomaterials across all stages of a product’s lifecycle.
Precautionary Matrix for Synthetic Nanomaterials (Switzerland, Federal Office of Public Health & Federal Office for the Environment 2008, revised in 2010) The precautionary matrix is based on a limited number of evaluation parameters, including size of the particles, their reactivity and stability, their release potential, the amount of particles. These parameters are used to estimate the precautionary need for employees, consumers and the environment at each defined step in the life cycle.
European Commission/Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR 2007) The appropriateness of the risk assessment methodology in accordance with the Technical Guidance Documents or new and existing substances for assessing the risk of nanomaterials.
III Risk Assessment of Nanotechnologies
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 21
Dealing with Uncertainty: Ways and Means for a preliminary risk assessment
NanoDialogue (2006 – 2008) Launched by the Federal Environment Ministry on behalf of the German Government aims at promoting the sustainable development and use of nanotechnologies Participants are representatives from the scientific community, specialist federal
authorities, trade and industry and environmental and consumer associations.
Initial Tasks/Questions
Contribution of nanomaterials to a sustainable economic and social development in Germany (e.g.for environmental, health and consumer protection)? (WG 1 -> Opportunities for Environment and Health)
Need for interdisciplinary risk and safety research to clarify the possible impacts of the use of nanoparticles on the environment and health? (WG 2 -> Risk and Safety Resarch)
What can be done for the protection of humans and the environment? (WG 3 -> Guidelines on the responsible use of Nanomaterials)
III Risk Assessment of Nanotechnologies
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 22
NanoDialogue – NanoKommission : Working Group 2 „Risk and Safety Research“: Criteria for Concern – No Cause for Concern
Concern Criteria: indicating problematic nanomaterials and their applications
expected high level of exposure potential problematic effects problems with providing evidence for and the tracing of released nanomaterials
No cause for concern-Criteria: indicating applications likely to result in lesser hazards
nanomaterials are either firmly bound in matrices or rapidly lose their potentially problematic nano-properties (e.g. good solubility, rapid
degradability)
Source: http://www.bmu.de/files/pdfs/allgemein/application/pdf/nanokomm_abschlussbericht_2008_en.pdf
III Risk Assessment of Nanotechnologies
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 23
NanoDialogue (2008): No Cause for Concern-Criteria
Source: http://www.bmu.de/files/pdfs/allgemein/application/pdf/nanokomm_abschlussbericht_2008_en.pdf
Loss of nano-properties as a result of:
Good solubility (in water, body fluids ...), if this causes the loss of nano-properties Rapid degradability (biological, photocatalytic ...) in non-toxic degradation products Fixed, permanent bonding in matrices (stability of matrix, type of bond, end-of-life
behaviour) Presence of firmly bound aggregates (determined by conditions of production) Agglomeration behaviour: formation of stable, large agglomerates, (e.g. size, stability Nanostructured modifications on surfaces, and nanostructures that do not release
particles and are not reactive (e.g. nanopores, lotus effect ...)
III Risk Assessment of Nanotechnologies
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 24
NanoDialogue (2008): Concern-Criteria
Indications of expected high level of exposure: Production volume and/or quantity used for the field of application (probability of
exposure) High level of mobility in nanoform (e.g. in organisms, in the environment) Targeted release (e.g. agricultural applications, consumer-oriented applications,) Persistence of nano-properties Bioaccumulation
Indications of potentially problematic effects: High level of reactivity (catalytic / chemical / biological) Problematic morphology (e.g. stable, long tubes or fibres) Indications of problematic interactions Indications of problematic transformations (ageing, changes to surface properties,
porosity) or metabolites (e.g. changes to or loss of coating)
III Risk Assessment of Nanotechnologies
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 25
NanoDialogue (2008): Ranking of Nanomaterials
Group 1: Probably hazardous – concern level high A strategy is required for measures aimed at minimising exposure or avoiding certain applications
Group 2: Possibly hazardous – concern level medium A strategy is required for measures aimed at reducing exposure
Group 3: Probably not hazardous – concern level low No procedures are required over and above “good work safety practice” (or “hygiene practice”)
Source: http://www.bmu.de/files/pdfs/allgemein/application/pdf/nanokomm_abschlussbericht_2008_en.pdf
Based on the 'Concern-Criteria' and 'No cause for Concern-Criteria' nanomaterials can be tentatively ranked in the following three categories:
III Risk Assessment of Nanotechnologies
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 26
IV Nanotechnology and Consumer Protection
Relevant Applications for BfR
Nanotechnologies in the food area in the feed area in the area of food contact materials in the area of cosmetics
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 27
III Nanotechnology and Consumer Protection: Food
Food on the German Market? "Foods that contain typical novel and intentionally produced nanoparticles are not available to end consumers in the EU market at this time.“ German Federation for Food Law and Food Science (BLL)
Possible applications modification of taste, texture, sensation, consistency and fat content enhanced nutrient absorption
Novel Foods Regulation (in progress)* Notification: „Novel food should therefore include [...] foods modified by new production processes, such as nanotechnology and nanoscience, which might have an impact on food. [...]’“
Labelling: „All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word 'nano' in brackets.“ *Draft Recommendation of European Parliament’s Committee
on the Environment, Public Health and Food Safety (ENVI)
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Products (examples): Sun creams and lotions
Legal Regulation: Regulation (EC) No 1223/2009 on cosmetic products (KVO)
Preamble (30, 35): „At present, there is inadequate information on the risks associated with nanomaterials“
Labelling: All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.
III Nanotechnology and Consumer Protection: Cosmetics
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 29
„The Commission should regularly review the provisions on nanomaterials in the light of scientific progress“
Market Surveillance:
By 11 January 2014, the Commission shall make available a catalogue of all nanomaterials used in cosmetic products placed on the market indicating the categories of cosmetic products and the reasonably foreseeable exposure conditions
The Commission shall submit to the European Parliament and the Council an annual status report, which will give information on developments in the use of nanomaterials in cosmetic products within the Community
III Nanotechnology and Consumer Protection: Cosmetics
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 30
Nanosilver
Advantageous antimicrobial properties of silver ions (in foods, cosmetics, everyday products)
Lotions may contain silver salts as preservatives
Refrigerators or athletic socks and other textiles are equipped with silver compounds in order to inhibit the growth of germs or avoid the development of odours
III Nanotechnology and Consumer Protection: Nanosilver
Recently nanoscale silver compounds have also increasingly been used for these purposes
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Nanoscale silver as antimicrobial agent
To what extent are consumers exposed to nanoscale silver particles?
What are the effects of nano-silver in humans? How great is the potential to develop resistance towards silver and the spread of
resistance towards silver or antibiotics?
BfR Opinion Nr. 024/2010, 28 December 2009
„BfR recommends manufacturers to avoid the use of nanoscale silver or nanoscale silver compounds in foods and everyday products until such time that the data are comprehensive enough to allow a conclusive risk assessment which would ensure that products are safe for consumer health.“
III Nanotechnology and Consumer Protection: Nanosilver
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 32
V Conclusion
Is scientific uncertainty something new in the area of consumer protection? no, scientific uncertainty is part of everyday-work of risk assessment existing means and ways (e.g. guidance for risk assessment, criteria for preliminary
assessment; case-by-case assessment/tiered approach)
What is the current situation in nanotechnology from a consumer protection perspective? Consumer exposition is unclear due to unclear information about nano-products Definition of nanomaterials contested and subject to discussion Existing legal regulations in the process of adapting/covering Nanomaterials
What are the problems in assessing the possible health risks of nanomaterials? knowledge gaps (e.g. exposition, dose-effect relationships) development of suitable mesauring methods and toxicity tests
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 33
Thanks
Mark Lohmann Stephanie Kurzenhäuser Ellen Ulbig
Gaby-Fleur Böl Dept. Risk Communication Federal Institute for Risk Assessment, Berlin
FED
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L IN
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FO
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ENT Thank you for your attention
Astrid Epp
Federal Institute for Risk Assessment Thielallee 88-92 D-14195 Berlin Tel. +49 30 - 184 12 - 0 Fax +49 30 - 184 12 - 47 41 bfr@bfr.bund.de www.bfr.bund.de
Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna Page 35
Cooperation on Consumer Health Protection in Germany
Federal Research Centres
Federal Institute for Risk Assessment
Federal Office of Consumer Protection
and Food Safety
Federal Ministry of Food, Agriculture and Consumer Protection
Federal / Länder Ministries competent for consumer protection
Federal Goverment/Länder Com- mittees in the fields of consumer
protection and food safety Advisory service
Data
Cooperation
Recommended