1 risk governance of manufactured nanoparticles, joint workshop ep stoa panel – european...

1Risk Governance of Manufactured Nanoparticles, Joint Workshop EP STOA Panel – European Commission, Brussels, 21 November 2011

Interfaces betweenScience and Policy

Hermann Stamm

Institute for Health and Consumer ProtectionJoint Research Centre, Ispra

http://www.jrc.ec.europa.eu


KEY QUESTIONS - NANOMATERIALS

How to deal with uncertainty when there is insufficient knowledge on health impacts?

POLICYPOLICYHow to address safety issues from the regulatory sideGovernance systems to cope with NT novelties

SCIENCESCIENCESpecific queries to understand the interaction of NMwith the human body and the environment

PUBLICPUBLIC Consumer concerns about product benefits and safety


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


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


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


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


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

– Environment/Health/Safety (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


EU Regulation – Nanotechnology Relevance

Horizontal Legislation Product 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• ……


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


‘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)


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


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


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

DetectionImaging (SEM,TEM)

QuantificationExtractionSeparationElemental Analysis

CharacterizationSizephys.-chem properties….

DetectionImaging (SEM,TEM)

QuantificationExtractionSeparationElemental Analysis

CharacterizationSizephys.-chem properties….

Validated Routine Methods


Safety/Risk Assessment

RISK CHARACTERIZATION

EXPOSURE ASSESSMENT

HAZARD IDENTIFICATION

HAZARD CHARACTERIZATION


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


2µm

Thank you

for your attention

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