1. 1 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 Interfaces between Science and Policy Hermann Stamm Institute for Health and Consumer Protection Joint Research Centre, Ispra http://www.jrc.ec.europa.eu

2. 2 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 KEY QUESTIONS - NANOMATERIALS How to deal with uncertainty when there is insufficient knowledge on health impacts? POLICY How to address safety issues from the regulatory side Governance systems to cope with NT novelties SCIENCE Specific queries to understand the interaction of NM with the human body and the environment PUBLIC Consumer concerns about product benefits and safety

3. 3 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011  Worker’s safety  Handling, transport, delivery  Use and handling by consumers  Waste disposal, exposure to environment Safety through the entire life cycle! Pre-requisite for Acceptance by the Public

4. 4 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 Knowledge transfer (transparency) from key players:  Researchers  Industry  Authorisation bodies  Trade organisations and retailers  Official control bodies  Policy makers  Consumer Organisation  Consumers and other stakeholders Stakeholder Involvement

5. 5 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011  For right interpretation of scientific results: for safety assessment understanding of hazards, exposure, and risks  For transferring the knowledge from science to policy makers  For right decision making (risk/benefit assessments and subsequent management)  To give to consumers the possibility to get involved Translational Science

6. 6 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011  Definition  Safety assessment (methodologies for risk assessment)  Control of final products on the market (analytical methods, sampling, etc.)  Quality assurance tools (reference methods and materials) Harmonisation and Standardization International Cooperation

7. 7 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 Position of the European Parliament Current EU-legislation is considered inadequate Address nanomaterials explicitly in legislation Review all relevant legislation Significant lack of knowledge and information on nanomaterials already on the market Provide information to the public – E nvironment/ H ealth/ S afety ( EHS ) data –Labelling of products containing nanomaterials –Inventory on types and use of nanomaterials one the EU market RESEARCH NEEDS Safety/Risk Assessment Detection, Quantification and Characterization of Nanomaterials in Complex Matrices

8. 8 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 EU Regulation – Nanotechnology Relevance Horizontal LegislationProduct Legislation 1.Chemicals Legislation (REACH) 2.Worker Protection 3.Environmental Legislation –Integrated Pollution Prevention and Control –Major-accidents, Seveso II Directive –Water –Waste General Safety of Consumer Products Cosmetic Products Food Legislation Biocides Medical Devices Medicinal Products Restriction of Hazardous Substances Directive Plant Protection Products ……

9. 9 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 Nanomaterial Definition: Why? Societal demands for regulating NM Political requirements, e.g. European Parliament – Specific safety assessment – Product labeling Principles of European Regulation - Need to define what has to be regulated Removing uncertainties for industry and regulators how to deal with NMs Assuring equal treatment of NMs in different types of legislation Enforceability of legislation  Definition for regulatory purposes needed Many attributes of possible significance (size, surface area, …) Large variety of NMs No scientific evidence for strict limits regarding phys-chem properties Experimental difficulties – lack of validated methods Size distributions/mixtures Scientific basis to reconcile with policy needs regarding enforceability Nanomaterial ≠ harmful substance  Difficulties to find a sensible definition PROS CONS

10. 10 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011  ‘Nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm.  In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %. * http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:EN:PDF COMMISSION RECOMMENDATION of 18 October 2011 on the definition of nanomaterial (2011/696/EU)

11. 11 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 Definition of Nanomaterial: Implementation Constituent particles – agglomerates - aggregates Validated size measurement methods – Sample preparation – Measurement techniques – Evaluation and interpretation of data (number size distribution) Guidance Implementation Issues Nanomaterials in complex matrices (food, cosmetics, …) Related Problem

12. 12 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 Nano-Labelling Labelling obligation for ingredients present in the form of nanomaterials, Titanium Dioxide (nano)  No hazard labelling  Consumer information  will allow consumers to make a choice  Control??? Regulation on the Provision of Food Information to Consumers Regulation (EC) No 1223/2009 on cosmetic products

13. 13 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 Nanomaterials in Products Detection levels Inorganic/organic nanomaterials Matrix structure at the nanoscale Distinction from background Matrix-Nanomaterial interaction Detection and quantification of known/unknown material Analytical artefacts Availability of standard materials Analytical Methods Detection Imaging (SEM,TEM) Quantification Extraction Separation Elemental Analysis Characterization Size phys.-chem properties …. Detection Imaging (SEM,TEM) Quantification Extraction Separation Elemental Analysis Characterization Size phys.-chem properties …. Validated Routine Methods

14. 14 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 Safety/Risk Assessment RISK CHARACTERIZATION EXPOSURE ASSESSMENT HAZARD IDENTIFICATION HAZARD CHARACTERIZATION

15. 15 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011

16. 16 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 Main Conclusions  There is only a limited amount of scientific evidence today to suggest that nanomaterials present a risk for human health  The principles of risk assessment procedures should conform to the same procedures as any other new material, paying due respect to new phenomena that may occur due to new properties related to the nanoscale  Successful innovation – to gain acceptance – must incorporate safety by design

17. 17 Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011 2µm Thank you for your attention