Landmark Europe, 2009 ©

landmark r e p o r t

nnnnaaaannnnooootttteeeechchchchnnnnoooolololologgggyyyy in consumer products:

july

challenges and opportunities for Europe

09

Landmark Europe, 2009 ©

Table of Contents

List of boxes, tables and figures .......................................................................................................... 6

EXECUTIVE SUMMARY ........................................................................................................... 7

1. THE CHALLENGE FOR EUROPE ......................................................................................... 12

What is nanotechnology? ................................................................................................................ 12

Applications of nanosciences and nanotechnologies ..................................................................... 14

Key drivers ....................................................................................................................................... 16

Consumer acceptance and trust ....................................................................................................... 16

Science and innovation ..................................................................................................................... 17

Regulatory framework ...................................................................................................................... 18

International developments and cooperation ................................................................................... 19

Key challenges for Europe .............................................................................................................. 19

Structural weaknesses in RDI ........................................................................................................... 20

Failure to convert knowledge into commercial applications ............................................................. 20

Under-investment in RDI in Europe ................................................................................................. 22

The challenge for European business .............................................................................................25

Industry initiatives and programmes ............................................................................................. 27

The social dimension: governance, ethics and public engagement .............................................. 31

Key Issues .......................................................................................................................................... 31

Public attitudes to nanotechnology ............................................................................................... 36

Landmark stakeholder survey ........................................................................................................ 38

2. THE EU’S APPROACH TO NANOTECHNOLOGY ................................................................. 42

Towards a European strategy for nanotechnology ....................................................................... 43

From strategy to action: EU Nanotechnology Action Plan 2005-2009 .........................................45

Flanking measures: reinforcing the EU’s RDI framework ............................................................. 47

Strengthening Europe’s RDI Infrastructure ...................................................................................... 47

Promoting industry innovation ....................................................................................................... 48

Measures to boost investment .........................................................................................................50

Promoting and improving intellectual and industrial property rights ............................................... 51

EU R&D Policy and projects for nanotechnologies ....................................................................... 53

The 7th RTD Framework Programme (FP7) and nanotechnology ................................................ 54

The EU’s approach to ethical and social aspects of nanotechnology ........................................... 57

EU ELSA initiatives for nanotechnology ...................................................................................... 59

Promoting public dialogue, communication and stakeholder engagement ............................... 60

Promoting international cooperation ........................................................................................... 62

3. MANAGING RISK AND BUILDING TRUST .......................................................................... 65

Safety of nanotechnologies: key concerns .................................................................................... 66

The EU’s approach to risk assessment ........................................................................................... 68

Nanotechnology risk assessment in the EU ................................................................................... 69

Landmark Europe, 2009 ©

Appropriateness of current risk assessment methodologies for nanotechnology and

nanomaterials .................................................................................................................................. 71

Risk assessment methodology and technical guidance documents for chemical substances ............ 73

Risk assessment of products of nanotechnologies ............................................................................ 74

Nanotechnology and pharmaceuticals and medical devices ............................................................. 76

Nanotechnology and food and feed ................................................................................................. 77

Nanotechnology and cosmetics ....................................................................................................... 82

Joint Research Centre and nanotechnologies ................................................................................... 84

Stepping up monitoring .................................................................................................................. 84

EU Nanotechnology Observatory ..................................................................................................... 84

Voluntary Reporting Scheme for Engineered Nanoscale Materials ................................................... 85

The international dimension: OECD activities on risk and safety aspects of nanotechnologies .. 86

4. THE REGULATORY FRAMEWORK FOR NANOTECHNOLOGY IN EUROPE ........................... 88

Broadening of the EU’s regulatory agenda ................................................................................... 89

Wider societal concerns .................................................................................................................... 89

The Precautionary Principle .............................................................................................................. 89

Regulating nanotechnology: the EU’s incremental approach ....................................................... 90

Shortcomings of the current EU regulatory regime for nanotechnology ..................................... 93

Towards common definitions, standards and metrology .............................................................. 97

Developing European standards for nanotechnologies ..................................................................... 97

EU work on definitions relating to products of nanotechnologies ..................................................... 99

Other work on terminology and definitions: ISO and BSI ............................................................... 101

Protecting researchers and workers in the EU ............................................................................. 102

EU rules on worker health and safety ............................................................................................. 102

Criticisms of existing protection of workers from nanomaterials and nanoparticles ...................... 103

European Code of conduct for responsible nanosciences and

nanotechnologies ............................................................................................................................ 105

5. NANOTECHNOLOGY AND THE REGULATION OF CONSUMER PRODUCTS IN EUROPE ....... 108

Key Horizontal Regulation ............................................................................................................ 108

General Product Safety Directive (GPSD) ....................................................................................... 108

REACH .......................................................................................................................................... 108

Environmental pollution ................................................................................................................. 110

Product-specific regulations and related controls ....................................................................... 111

Cosmetics ....................................................................................................................................... 111

Detergents and household products ............................................................................................... 113

Medical applications ....................................................................................................................... 114

Food ........................................................................................................................................... 115

Novel foods .................................................................................................................................. 116

Food additives .............................................................................................................................. 118

Vitamin and mineral supplements and fortification ...................................................................... 119

Food packaging and contact materials ......................................................................................... 120

RECOMMENDATIONS ....................................................................................................................... 123

References ......................................................................................................................................... 125

Landmark Europe, 2009 ©

List of Boxes, Tables and Figures

Boxes

Box 1. Examples of potential areas of nanotechnology-enabled applications and products .................. 14

Box 2. Examples of actual and potential applications ............................................................................ 15

Box 3. Potential risks and challenges facing companies investing in or using nanotechnologies............ 26

Box 4. Examples of company & industry association codes of conduct for nanotechnology .................. 28

Box 5. European focussed nanotechnology industry associations ......................................................... 29

Box 6. FP7 programme actions .............................................................................................................. 55

Box 7. FP7 focus areas for nanosciences and nanotechnologies ............................................................. 56

Box 8. Summary of EFSA's main conclusions on engineered nanomaterials in food and feed ............... 80

Box 9. Code of conduct for responsible N&N research: general principles .......................................... 106

Tables

Table 1. EU research and innovation: key challenges, policy objectives and responses ......................... 23

Table 2. Overview of environmental and consumer organisations’ views of nanotechnology ............... 32

Table 3. Landmark nano stakeholder survey: benefits versus risks / occupation of respondent ............. 41

Table 4. Landmark nano stakeholder survey: benefits versus risks / level of knowledge of respondent . 41

Table 5. Key nanotechnology challenges for Europe ............................................................................. 45

Table 6. EU RTD Framework Programme dates and funding ................................................................ 53

Table 7. Examples of nano-related projects under EU Framework RTD Programmes ........................... 54

Table 8. Examples of ELSA nano-related projects under EU RTD Framework Programmes ................. 59

Table 9. Examples of safety-related projects under EU RTD Framework Programmes ......................... 70

Figures

Figure 1. Stakeholder awareness of nanotech ....................................................................................... 38

Figure 2. Level of stakeholder concern .................................................................................................. 39

Figure 3. Labelling of nanotech ............................................................................................................. 40

Figure 4. Benefits versus risks of nanotech ........................................................................................... 40

Landmark Europe, 2009 ©

THE SOCIAL DIMENSION:

GOVERNANCE, ETHICS AND

PUBLIC ENGAGEMENT

Issues of safety, toxicity and environmental

impact of nanotechnology, particularly as it is a

new and dynamic field, are vitally important and

are currently being investigated. They should

not, however, marginalise consideration of wider

social and ethical issues. The latter issues may in

some respects be more challenging since the EU,

US and other countries already have tried-and-

tested risk-assessment and risk-management

procedures in place that can be applied (albeit it

with appropriate adaptation or adjustment) to

many areas of nanotechnologies. The EU’s risk-

assessment framework is discussed in detail in

part 3.

While risk assessment is necessarily narrow in

focus and highly technical, the social and ethical

issues are diverse, often complex and touch upon

many aspects of cultural, political and economic

beliefs and choices. The overriding focus to date

on risk assessment and safety aspects of

nanotechnologies and the perceived failure to

address adequately wider ethical and societal

issues is of concern to some. The Economic and

Social Research Council (ESRC) in the UK has

carried out extensive reviews of social, ethical

and economic aspects of the development of

nanosciences and technologies and has warned66

that 'focusing on risk leads to overconcentration on

the risks of nano substances to the neglect of wider

social risks and uncertainties'.

The emphasis on risk is widespread and

understandable, not least because eminent

reports like that of the UK Royal Society and

Royal Academy of Engineering lay emphasis and

priority on the need for further study and

possible regulation of nanoparticles and

potential adverse health, environmental and

safety impacts of nanotechnology. At the same

time, RS/RAE suggest that it is nanotech

applications envisaged in medium (5 to 15 years)

and longer (more than 20 years) time scales that

are likely to raise significant social and ethical

concerns.

There is consequently a risk of social science

becoming a mere bolt-on, downstream

consideration of innovation and applications

rather than a more fundamental integral part of

the whole debate on the development of

nanotechnology.

THE KEY ISSUES

A number of commentators have identified a

broad range of social, economic and ethical

issues raised by nanotechnology that need to be

addressed. Few of these in reality are specific to

nanotechnology as most arise more broadly in

respect of many scientific innovations. That said,

nanotechnology’s potential scope of application

may require them to be considered from a

specific perspective of nanotechnology or the

precise technology (or its use) envisaged.

Concerns of particular commentators and

interest groups vary but general categories can

be discerned, such as: transparency and public

engagement in decision making; effective and

adequate consumer and environmental

protection regulation; economic issues, including

commercialisation; data protection, including IPR

and individual privacy; public and consumer

communication (including labelling and related

issues of an individual’s right to know and to be

able to make independent and informed

choices); and issues surrounding global

governance and equity (such as some NGO

concerns over potential concentration of control

over nanotechnologies and their potential

benefits and rewards resting in the hands of a

limited number of global corporations, or the

potential impacts on the least developed

countries and indigenous communities).

These issues are reflected in the positions and

demands of many NGO and civil-society groups.

The publicly stated views and key concerns of

“A broad range of social,

economic and ethical issues

raised by nanotechnology

need to be addressed”

31

Landmark Europe, 2009 ©

• likely to buy food products that had been

altered using nanotechnology, though

respondents were slightly more positive about

products with nanotechnology-enhanced

packaging.

LANDMARK STAKEHOLDER

SURVEY

Public perceptions are influenced by the views of

opinion formers and stakeholders that take and

communicate a public position on the matter.

Stakeholder opinion exerts a particularly strong

influence on the way that issues are reported in

the media, which in turn both influences and

reflects public opinion as a whole.

In order to better understand current attitudes of

stakeholders in Europe today, Landmark carried

out an opinion survey of EU-level stakeholders

and opinion formers. The survey yielded a

snapshot of the debate in Europe, which is useful

to inform stakeholders’ handling of

nanotechnology with regard to public policy, as

well as to inform emerging trends in the nascent

public debate.

The online survey was conducted among EU-

level stakeholders who were active in the field of

nanotechnology over a three-month period (June

-August 2008). We obtained a total of 191

responses from:

• Industry and trade union representatives

• Scientific experts and advisers

• European Commission officials and national

civil servants active in the EU

• MEPs, MEP assitants and national and

regional policians and representatives active

in EU instititutions

• Consumer-group and NGO representatives

• Journalists

The most interesting findings of the survey were:

• Stakeholder awareness of nanotechnology

is relatively high: Sixty-two percent of

respondents reported having heard 'a lot' or

'some' about nanotechnology. Only 3 % of

respondents claimed to have heard 'nothing

at all' about nanotech. (Figure 1)

• Actual knowledge of nanotechnology is

modest: Seventy percent of respondents

claimed to know little or less than little about

nanotech.

• Stakeholders display a high level of concern

about nanotechnology: Sixty percent of

respondents claimed to have concerns about

nanotechnology. Those who have a higher

level of knowledge seem to have a higher

38

Landmark Europe, 2009 ©

Table 5. Key nanotechnology challenges for Europe

Likewise, the Council underlined the need for 'a

sustainable and responsible development of

nanotechnology, addressing its health,

environmental, societal, industrial and economic

aspects at the earliest possible stage in order to

respond to the justified expectations and concerns

of European citizens'. The importance of engaging

in dialogue at international level was also noted

and Ministers welcomed the Commission's

intentions in this respect with a view to

establishing a framework of shared principles for

the safe, sustainable, responsible and socially

acceptable development and use of

nanotechnologies.

The key challenges Europe faces in respect of

nanosciences and nanotechnologies, including

those relating to commercialisation, are

summarised in Table 5.

FROM STRATEGY TO ACTION: EU

NANOTECHNOLOGY ACTION PLAN

2005-2009

Following the Council's endorsement of its

strategy and the autumn 2004 public

consultation, the Commission tabled in June

2005 a follow-up action plan for the period 2005-

2009. The Action Plan9 sought to turn aspirations

into reality. It defined, in the Commission's

words, 'a series of articulated and interconnected

actions for the immediate implementation of a

safe, integrated and responsible strategy for

[nanosciences and nanotechnologies]' based on

the priority areas identified in the 2004 strategy

Communication, namely: RDI; infrastructure and

European poles of excellence; interdisciplinary

human resources; industrial innovation (i.e.

commercialisation); integrating the social

dimension; public health, safety, environment

and consumer protection; international

Research, development &

innovation

Safety and risk management Regulatory framework

• Provide a coherent, coordinated EU

approach and regulatory framework that

supports and encourages scientific

endeavour and innovation.

• End fragmentation and dispersion of

R&D resources and facilities (poles of

excellence, clusters).

• Improve coordination of Member State

nanotech policies and programmes.

• Stimulate public/private partnerships

and collaboration.

• Help overcome Europe's long-standing

failure to convert scientific endeavour

into wealth- and job-generating

products & processes.

• Remove regulatory obstacles and cut

bureaucracy that delays access/time to

market.

• Provide adequate, affordable

harmonised protection of inventions

that provide adequate IPR protection

while not creating unacceptable 'nano

monopolies' or 'patent land-grabs'.

• Promote international cooperation, in

particular to accelerate progress on

filling data/knowledge gaps, to agree

common definitions, metrology &

testing methodologies, and

international standards.

• Support & stimulate urgent research on

areas/aspects to help fill current

knowledge 'gaps' (e.g. toxicology, eco-

toxicology, exposure metrics etc of

NPs/MNMs.)

• Promote & facilitate exchange of

research results and data within EU,

extra-EU & between public & private

organisations.

• Support development of common

(ideally global) testing and measuring

methodologies, definitions and related

standards.

• Ensure on-going review; if necessary,

adapt EU risk assessment &

management procedures to take

account of emerging data and

knowledge concerning NPs/MNMs (e.g.

new information concerning behaviour

of materials at nano scale compared

with at macro scale).

• Encourage & support risk assessment

based on lifecycle of NPs/MNMs (both

'free' and 'fixed') to include

manufactured, use & disposal.

• Support & stimulate efforts to build

public confidence & trust in nanotech,

including effective & appropriate

scientific & risk communication, and

transparency of risk assessment

procedures and decisions.

• Ensure a predictable and proportionate

regulatory framework that reflects wider

societal goals and ethical considerations.

• Improve implementation and enforcement

of regulation, taking account of the

specificities of nanotechnologies.

• Stimulate investment in innovative

companies and start-ups.

• Avoid potential regulatory confusion by

ensuring consistent definitions are used in

EU regulations.

• Address public and other stakeholder

uncertainties over the extent to which

NPs/MNMs are adequately regulated by

existing EU rules.

• Distinguish between actual and potential

regulatory gaps; modify current

legislation, if necessary, in light of new

scientific data (e.g. thresholds used in

some legislation, specific NPs or MNMs).

• Promote and facilitate open and

transparent public engagement and

dialogue on nanotechnologies.

45

Landmark Europe, 2009 ©

It is widely recognised that if companies and

entrepreneurs are to invest in research,

development and innovation in the

nanotechnology area in Europe they require an

EU regulatory environment and legal framework

that facilitates and encourages innovative

activities. Such a framework must be predictable,

protect intellectual property adequately and

provide an open and accessible market for

innovative products. Regulations must also be

evidence-based and proportionate. At the same

time, an effective regulatory regime must

reinforce consumer confidence in innovative

goods and services by ensuring that effective and

appropriate consumer protection is in place.

Although there is no nanotechnology-specific

regulation in the EU, nanotechnology is not

unregulated. For example, among others,

general duty of care and product liability rules

will apply. Nonetheless, the current uncertainty

over the extent to which nanoparticles and nano-

enabled products are controlled effectively by

existing laws and the absence of a clear,

recognisable regulatory regime (be it stand-alone

or as part of the broader legislative canon) is

unhelpful, particularly for industry; in particular,

it feeds public concern and provides a vacuum

into which doubt and confusion can spread.

The negotiation of a future EU regulatory regime

for nanomaterials and nano-enabled products

will be influenced, like all EU legislative decision

making, by a broad range of factors and

interests. Some of the key elements that are

likely to play a significant role in respect of

nanotechnologies are highlighted below. This is

followed by a top-line overview of the extent to

which the major pieces of existing EU horizontal

and vertical process- and product-related

legislation cover consumer products, highlighting

some of the so-called 'regulatory gaps' that have

been identified by the Commission and others to

date. Many of the gaps identified arise from a

lack of adequate data on the potential effects of

nanomaterials on human health and the

environment. Consequently, effective regulation

will depend ultimately on improving risk

assessment and availability of data; in effect,

better regulation and better research will need to

progress in parallel.

Such regulatory gaps will inevitably be the focus

of political and regulatory attention (and from

industry's perspective will present commercial

threats and/or opportunities) over the next 12 to

18 months, when some potentially crucial

decisions defining the future course of

nanotechnologies in Europe will be taken.

The European Parliament recently secured an

amendment to the draft EU Regulation on food

additives to insert a provision requiring that if the

production process of an additive is changed, for

example via a change in particle size through

nanotechnology, a fresh authorisation process

including a safety evaluation must be carried out.

MEPs are also seeking numerous

nanotechnology-related amendments to the

EU's draft Cosmetics Directive. This is clear

evidence that any updating of the current

regulatory regime for consumer products will

include discussion and close scrutiny of

nanotechnology. Given that several key

legislative proposals affecting consumer

products are currently or shortly to be under

negotiation (among others, the revisions of the

Novel Foods Regulation and the Medical

Products Directive), the implications for

manufacturers of consumer products are clear.

The EU's decision-making does not take place in

a vacuum and developments in other countries

4. The Regulatory Framework for

Nanotechnology in Europe

“Better regulation and better

research will need to progress

in parallel”

88