Nanotechnology - dealing with INSTITUTE ASSESSMENT ... · uncertainty in consumer protection Astrid...

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ENT Nanotechnology - dealing with

uncertainty in consumer protection

Astrid Epp

Astrid Epp, 23.09.2010, NanoTrust-Workshop, Vienna

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?


  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)


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)


Responsibilities

  Biological safety

  Food and feed safety

  Chemical safety

  Product safety

I Federal Institute for Risk Assessment

Health-related

consumer protection


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



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



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



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


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


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.


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)


2005: 54 Products

2009: 1015 Products Silver: 259 Products (2009)

Carbon: 82 Products (2009)

Titanium: 50 Products (2009)


Health & Fitness: 605 Products Food & Beverage: 98 Products

Product Categories


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


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



European Data: Relevant Areas of Application



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



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



  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:



(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


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.



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)



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



NanoDialogue (2008): No Cause for Concern-Criteria


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 ...)



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)



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”)


Based on the 'Concern-Criteria' and 'No cause for Concern-Criteria' nanomaterials can be tentatively ranked in the following three categories:



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


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)


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


„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


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


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


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


Thanks

Mark Lohmann Stephanie Kurzenhäuser Ellen Ulbig

Gaby-Fleur Böl Dept. Risk Communication Federal Institute for Risk Assessment, Berlin

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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 [email protected] www.bfr.bund.de


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

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