nano strategy fully accesible version - final

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UK Nanotechnologies StrategySmall Technologies, Great Opportunities

March 2010


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UK Nanotechnologies Strategy

Contents

Section

Foreword by Ministerial Group

Executive Summary

1. Introduction 2. Business, Industry and Innovation

3. Environmental, Health and Safety Research

4. Regulation

5. The Wider World

6. Appendix A List of Actions

7. Appendix B Organisations and Groups Involved in theManagement of Nanotechnologies

8. Appendix C NRSG Research Priorities

9. Appendix D Key Links

10. Appendix E List of Abbreviations

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Foreword by Ministerial Group

Nanotechnologies may seem like something from science- ction, but they are already ascience-reality and are being used to revolutionise products we buy, the ways in which they aremanufactured and our approaches to addressing global challenges. The UK is in an excellentposition to be at the forefront of nanotechnologies development, and we must maintainmomentum and keep pace with the biggest players on the international stage.

The UKs manufacturing base is a cornerstone of our continued and sustainable economicrecovery. Nanotechnologies have the potential to drive innovative and competitive industrybecause they can enable advancement in so many key manufacturing sectors such as automotive,aerospace, construction and biosciences.

There is a role for Government to support and facilitate these developments so that both theUK economy and its consumers can bene t fully from nanotechnologies. This means not onlyworking to create a cohesive and ourishing industry, but also acknowledging and addressingthe implications for health, safety and the environment so that we can all use products containing

nanotechnologies with con dence.Doing so requires a co-ordinated and joined-up approach across Government Departments.It is for this reason that the Ministerial Group on Nanotechnologies was formed, and we willcontinue to oversee efforts to develop the nanotechnologies industry while protecting thehealth of consumers and employees and avoiding damage to the environment. We will engagewith the public to make sure they are informed and con dent about nanotechnologies and theproducts which contain nanomaterials.

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The actions detailed in this Strategy will have effects in the short-term, and we will continue tobuild upon them until the bene ts of nanotechnologies are fully embedded in our society. Thelandscape for nanotechnologies is likely to change dramatically in the future as we understandmore about them and integrate them into our everyday lives. Governments approach will needto adapt to these changes. We will continue to work with industry, academia, non-Governmentalorganisations, non-Departmental public bodies and other interested parties to ensure that ourpolicies evolve in step with new developments. This Strategy lays the foundations to enable theUK to make the very most from these exciting and promising technologies.

Lord DraysonMinister for Science and Innovation

Dan NorrisMinister for Rural Affairs and Environment

Gillian MerronMinister of State for Public Health

Lord McKenzieParliamentary Under Secretary (Lords)Department for Work and Pensions

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Executive Summary

Government announced its intention todevelop a UK Strategy or nanotechnologies inits 2009 response to the Royal Commission onEnvironmental Pollutions report, Novel materialsin the Environment: The case of Nanotechnology.This Strategy has been in ormed by the viewso those involved with nanotechnologies rom awide range o interested parties across academia,

industry and non-Governmental organisations.

With the launch o the UK NanotechnologiesStrategy, UK Nanotechnologies Strategy: Small Technologies, Great Opportunities , Governmentis confrming its commitment to the success ul andsa e development o these technologies. We believethat nanotechnologies have the potential to: Deliver improvements or consumers in the UK; Help to sustain continued recovery and growth

in the UK manu acturing industry; Contribute to our effort to tackle global

challenges.

Our vision:The UKs economy and consumers will bene t

rom the development o nanotechnologiesthrough Governments support o innovationand promotion o the use o these emergingandenablingtechnologiesinasa e,responsibleand sustainable way refecting the needs o the public, industry and academia.

In order to achieve this goal, Government hasidentifed a number o actions, which are outlinedin this document under our categories: Business, Industry and Innovation Environmental, Health and Sa ety (EHS) Research Regulation The Wider World

Each section has its own strategic aim. These aimsare interdependent and together they help todeliver our vision.

Business, Industry and InnovationAim:Transparent, integrated, responsible and skilled nanotechnologies industry with good links to,and support from Government.

Summary of Actions: A Nanotechnologies Leadership Group will be

established to provide strategic leadership orthe nanotechnologies industry and to work toaddress the barriers to growth which a ectbusinesses in this area. The Group will bechaired by a BIS Minister.

Companies and academics will be encouragedto apply or unding through Grand Challengecalls rom the Technology Strategy Board (TSB)and Research Councils to support thedevelopment o innovative applications ornanotechnologies.

Awareness o the UK nanotechnologies capabilitywill be promoted nationally and internationallyand provision made or improvements in the

underpinning skills capacity required.

Environmental, Health and SafetyResearchAim:Better understanding of the risks associated withthe use of, and exposure to, nanomaterials, and enough people with the right skills to assess them .

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Summary of Actions: Approaches to Government EHS research

on nanotechnologies will be explored by theChief Scienti c Adviser network, with the aimof improving co-ordination. A meeting will bechaired by the Government Chief Scienti cAdviser, John Beddington.

There will be an ongoing portfolio of

Government and publically funded research intoa wide range of crucial EHS nanotechnologiesissues including the behaviour of keynanomaterials in the gut when eaten and wheninhaled into the lungs.

Contributions will be made to international workprogrammes on nanotechnologies includingthe Organisation for Economic Co-operationand Developments (OECD) Nanotechnology

Working Parties and the EUs FrameworkProgramme. The UK will work to in uence thefuture scope of these projects.

RegulationAim:Better informed policies and regulations relatingto nanomaterials and nanotechnologies.

Summary of Actions: Government will expand the scope of its work

on a scheme to succeed the pilot voluntaryreporting scheme to include products as wellas materials. A working group comprisingof cials from the Department for Business,Innovation and Skills (BIS), the Department forEnvironment, Food and Rural Affairs (Defra),the Department of Health (DH), the Food

Standards Agency (FSA) and the Health andSafety Executive (HSE) will be tasked to developa proposal.

Government will monitor the success ofimplementation of upcoming amendmentsto novel foods and cosmetics directives withrespect to nanomaterials and will in uencechanges made to the Registration, Evaluation,Authorisation and Restriction of ChemicalsRegulation (REACH) in order to ensure they arerobustly covered.

Horizon scanning and monitoring willbe performed by the Medicines andHealthcare Products Regulatory Agency(MHRA), FSA and HSE to detect necessityfor amendments to legislation inthe future.

The Wider WorldAim:

Well-informed public and stakeholders and aleading position on nanotechnologies for the UK on the world stage.

Summary of Actions: The Nanotechnologies Collaboration Group

will be established to facilitate ongoingcommunication and collaboration betweenGovernment, academia, industry and other

interested parties, including consumer groups. Information about Governments ongoing

actions on nanotechnologies will be madeaccessible to the public on a portal website.

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1. Introduction

1. There are many exciting emerging technologiesin development today which have the potentialto change the everyday lives of people acrossthe globe. Nanotechnologies are an importantset of new technologies at a very early stage intheir development. Scientists and engineers areincreasingly able to create new tools and improvethe knowledge base necessary to manipulate the

properties of nanomaterials, for example theirstrength or the speed at which they conductelectricity.

BOX 1: What are nanotechnologies?

A nanometre is one-billionth of a metre,or around 80,000 times smaller than thediameter of a human hair.

Nanoparticles exist in nature. For example,milk contains nanoscale droplets of fat andevery cell in your body relies on nanosizedprotein complexes to function.

One de nition of a nanomaterial is amaterial with at least one dimension in thenanoscale (between 1-100nm). They can beparticulate in nature, for example nanotitanium dioxide, bre-like, for example

carbon nanotubes or sheet-like, for examplegraphene. Nanomaterials can also be de nedin terms of their functionality, as opposed torelying strictly on their size alone.

Nanotechnologies can be thought of asany technology which either incorporates oremploys nanomaterials or involves processesperformed at the nanoscale.

2. Nanotechnologies are important to the futureof the UK because of their potential to improvemany types of consumer products, for example:

Medicine delivery systems which usenanomaterials to enable targeted and time-controlled release of drugs;

More compact and powerful computersystems, mobile phones and wiring systemsincorporating carbon nanotubes;

Coatings for car components which conferresistance to erosion and other damage;

Antimicrobial dressings.

3. Nanotechnologies could also help us addressuniversal challenges such as global warming andfood sustainability, for example:

Solar cells with enhanced ef ciency due to ananocoating which is far more sensitive to lowlight levels than previously used materials;

Fuel additives which allow decreased fuelconsumption in diesel engines;

Water puri cation systems with increasedef ciency and ef cacy;

Improved air puri cation membranes whichcan transform vapours escaping from cars orindustrial plants into harmless gasses.

4. The worldwide transition towards the greateruse of nanotechnologies is a signi cant economicopportunity for the UK. The global market innano-enabled products is expected to grow from$2.3 billion in 2007 to $81 billion by 2015 1.To fully meet this opportunity, the UK will needto build upon its existing commercial strengths innanotechnologies, which include:

The third highest number of nanotechnologiescompanies in the world;

1 Nanomaterials and Markets 2008-2015, Nanopost, quoted in Nanoscale TechnologiesStrategy 2009-12, Technology Strategy Board, September 2009

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Strengths in nano-optics and nanoscale materials; The fourth largest number of nanotechnologies

patents applied for globally; A leading role in the development of international

nanotechnologies standards through the BritishStandards Institution (BSI).

5. Novel materials often raise questions around the

ways in which they interact with humans, animalsand the environment, their safety and the level ofcaution that should be exercised when they areplaced on the market in products. While thereis currently no evidence that any nano-enabledproducts cause harm to humans, animals or theenvironment, in the case of nanotechnologies,the position is complicated by the potentialnumber of nanomaterials in circulation, which

may each have different properties, uses andexposure pathways.

6. At present, it is thought that the greatest levelof risk may be posed by nanomaterials whichare in the form of free particles, such as in apowder or liquid. When xed into a structure,for example in a solid material like a plastic orin a coating, it is far less likely that nanoparticlescould be absorbed into the body or enter into theenvironment. However, it is not yet clear whether

xed nanoparticles will remain so when the itemthey are incorporated into is disposed of. Thereis a possibility that they could leach into theenvironment, and, if so, uncertainties remain overthe level of risk they would pose. For this reasonthat there is a need for research into how bothfree and xed nanomaterials behave throughoutthe whole life of the products in which they

are used.

Past and Present

7. There have been a number of reports overthe past six years that have looked at thebene ts offered and potential risks posed bynanotechnologies, including the joint Royal Societyand Royal Academy of Engineering (RS/RAEng)report 2, the Council for Science and Technology(CST) review of Government progress 3 and theRoyal Commission on Environmental Pollution(RCEP) report4. Most recently, the House of Lordshave conducted an inquiry into Nanotechnologiesand Food 5 which reported earlier this year. Linksto these reports and Governments responses tothem can be found in Appendix D.

8. Government acknowledges the potentialbene ts of nanotechnologies and has been

working to promote their safe use in a numberof ways following the advice of RS/RAEng in2004, for example:

A cross-Government approach has been taken: The Ministerial Group on Nanotechnologies

(chaired by the Science and InnovationMinister, Lord Drayson) was established toprovide strategic oversight and leadership;

The Nanotechnology Research Co-

ordination Group (NRCG) was formed tobring together Government Departments,Agencies, Research Councils and DevolvedAdministrations to set the priorities for theUKs research programme;

The Nanotechnology Issues Dialogue Group(NIDG) was formed to bring togetherGovernment Departments, Agencies andDevolved Administrations to ensureco-ordinated policy development;

2 Nanoscience and nanotechnologies: opportunities and uncertainties (2004)3 Nanoscience and Nanotechnologies: A Review of Governments Progress on its Pol

Commitments (2007)4 Novel Materials in the Environment: The case of nanotechnology (2008)5 House of Lords Science and Technology Committee 1st Report of

2009-10 Nanotechnologies and Food (2010)


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Stakeholders have been engaged; The Nanotechnology Stakeholder Forum

(NSF) was formed to engage more widelywith stakeholders to in uence and discussdevelopment of Government policy;

A range of international and domestic activitieshave been carried out by Departments,Research Councils and Agencies to improve

the environmental, health and safety (EHS)knowledge base, create appropriate regulationand support industry.

9. In 2009, Government announced its intentionto develop a UK Nanotechnologies Strategy toconsolidate activities across all Departments andAgencies 6. In order to inform the Strategy, anevidence gathering exercise was carried out toseek the views of interested stakeholdersincluding academics, consumer groups andindustry representatives. A full summary ofresponses has been published on theDepartment for Business, Innovation and Skills(BIS) website7 and the following headline issueswere noted:

Recognition that nanotechnologies have thepotential to have positive impacts on a widerange of manufacturing and consumerindustries including those which are pivotal tothe economy, such as the automotive industryand those which underpin wider societalchallenges, such as the alternative energyindustry;

Concern over the level of Government fundingof research into the EHS risks of manufacturednanomaterials and strategic co-ordination ofresearch efforts:

Demand for consolidated sources ofinformation for; the public detailing Government activity

on nanotechnologies; industry detailing regulatory/reporting/

risk assessment requirements.

10. In addition, a project commissioned by BIS

and conducted by several Knowledge TransferNetworks (KTNs) and Materials UK invited a widerange of key industry gures to participate in amini-Innovation and Growth Team (mini-IGT) tofeed into the Government exercise. Companiessuch as Johnson Matthey, Rolls Royce, Marks &Spencer, P zer, Unilever and Oxonica participatedin the project. The resulting report 8 includedrecommendations for Government to considerwhen developing the UK NanotechnologiesStrategy.

11. Responses to the evidence gathering exercise,as well as the mini-IGT report have been keyinputs to the development of this Strategy.

A UK Nanotechnologies Strategy12. Government recognises its role in optimisingthe UKs position to bene t from the developmentof nanotechnologies. In order to achieve this,Government must act in the following areas andthese will form the basis of this Strategy:

Business, Innovation and Industry; Environmental, Health and Safety Research; Regulation; The Wider World.

6 Government Response to the Royal Commission on Environmental Pollution (2009)7 Nanotechnologies: in uence and inform the UK Strategy http://interactive.bis.gov.uk/nano/ 8 Nanotechnology: a UK Industry View can be downloaded from www.nanoktn.com


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13. Above all, it is Governments role toprotect health and the environment during thedevelopment and use of nanotechnologies. ThisStrategy represents an important step in thisongoing process.

14. This document presents Governmentsoverall strategy for the responsible development

of nanotechnologies, and re ects Strategiesproduced independently by several public bodies,for example the Technology Strategy Board 9 (TSB)and Research Councils UK (RCUK) 10 . It highlightsthe actions that Government and others willbe taking to ensure that the UK maximisesthe economic and social bene ts from thesetechnologies in a safe, responsible and sustainableway taking into account the views of industry,academia and the general public. The overarchingaim of the Strategy is detailed in Box 2.

BOX 2: Aim of the UKNanotechnologies Strategy: SmallTechnologies, Great Opportunities

The UKs economy and consumers will bene tfrom the development of nanotechnologiesthrough Governments support of innovationand promotion of the use of these emergingand enabling technologies in a safe, responsibleand sustainable way re ecting the needs ofthe public, industry and academia.

15. The outcomes of the actions in each chapterdo not stand alone. In fact, they are eachstrengthened by the outcome of actions in the

other chapters, as illustrated in Figure 1 (overleaf).

For example, EHS research provides a goodknowledge base, which is essential to informappropriate regulation, which in turn is necessaryfor the public to feel reassured that products onthe market are safe for them to buy.

16. The interdependence of the different actionareas and outcomes in the Strategy clearly

demonstrates the importance of an overarchingand consolidated approach to co-ordinatingGovernment activities in this area. The work spansseveral Government Departments and Agencies,as well as involving the input of many externalstakeholders. An outline of organisations involvedin the management of nanotechnologies, as wellas the groups which facilitate their interaction isavailable at Appendix B. This Strategy delivers aclear message about how Government will bringtogether activities in this area to ensure that thevery most can be made from these exciting andpromising technologies.

BOX 3: What are nanotechnologiesused for?

Nanotechnologies are beginning to bethought of as essential, underpinning toolsacross science and industry. They are beingused by many organisations for very differentpurposesandtheskillsandexpertisenecessaryvary greatly. For example, a biologist may beusing a nanomaterial in their work producinglife changing medicines, while a builderincorporates a self cleaning window, coatedwith a nanomaterial, into a new house.

9 Nanoscale Technologies Strategy 2009-201210 Nanoscience through Engineering to Application


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Figure 1

Well-in ormed publicand stakeholders anda leading position on

nanotechnologies or theUK on the world stage

Better in ormed policiesand regulations relating

to nanomaterials andnanotechnologies

The WiderWorld

Regulation

OUTCOMES

ACTIONS

THE STRATEGIC AIMThe UKs economy andconsumers will bene trom the development o

nanotechnologies throughGovernments support o

innovation and promotion othe use o these emerging andenabling technologies in a sa e,

responsible and sustainableway refecting the needs o thepublic, industry and academia.

Better understanding othe risks associated with

the use o and exposure tonanomaterials and enoughpeople with the right skills

to assess them

Transparent, integrated,responsible and skilled

nanotechnologies industryand businesses with goodlinks to, and support rom

Government

EnvironmentalHealth and

Sa ety Research

Business,Industry andInnovation

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2. Business, Industry and Innovation

17. There are currently market applications ofnanotechnologies available for purchase or at theresearch and development stage across a widerange of sectors, including; coatings, particles,porous structures, composites, medicines anddiagnostics, toname a few. However, ascompaniesmove speedily to develop new and more advancedproducts involving nanotechnologies, they are

becoming increasingly aware of the challengeswhich must be addressed. These include:

The fragmentation of the industry; A need for greater collaborative research and

new skills; A need for industry to engage with the public

in order to raise awareness of the bene tsof nanotechnologies-based products, and tocounter any negative perceptions or concerns;

Regulatory burdens.

18. It is against this backdrop that BIScommissioned a mini-IGT to prepare a report 11

on nanotechnologies on behalf of UK industry.

19. This chapter looks at some of the issuesraised by industry in the mini-IGT report, and theopportunities and barriers identi ed. The actionswhich Government will take to enable industry todevelop nanotechnologies to their full potentialare set out. These will allow the innovative useof nanotechnologies and nanomaterials, withappropriate support made available to helpbusinesses exploit good ideas and create newproducts, bene ting consumers, industry and thewider economy alike.

The Global Market: Opportunities forGrowth20. There are currently around 800 nanotechnologiesproducts or product lines on the market globally;this has increased from approximately 210 in 2006 12.However, there is a wide variation in estimates forthe size of the global nanotechnologies market,and predictions of its future size. Despite thevariations in forecasts, very rapid growth in theglobal market for nanotechnologies-enabledproducts is predicted across the board. Even themore conservative forecasts predict that the totalglobal revenue for nanotechnologies will growfrom around $2bn in 2007 to $81bn in 2015 13.These gures are broken down in Figure 1overleaf.

The UK Market21. The UK is ranked third in the world, after theUS and Germany, when it comes to the numberof nanotechnologies companies operating 14. TheEuropean Commission completed a study of theeconomic development of nanoscale technologyin 2006 15. According to this the UK was:

fourth in terms of number of patents appliedfor, after the US, Japan, and Germany;

very strong in nano-optics, placed third afterthe US and Japan;

fourth on nanoscale materials after the US,Japan and Germany.

11 Nanotechnology: a UK Industry View http://www.matuk.co.uk/docs/Nano_report.pdf

12 OECD (2009) Nanotechnology: An overview based on indicators and statistics; worpaper 2009/7

13 Nanomaterials and Markets 2008-2015, Nanopost, quoted in Nanoscale TechnologiesStrategy 2009-12, Technology Strategy Board, September 2009

14 www.nanovip.com15 The economic development of nanotechnology An indicators based analysis,

European Commission, November 2006


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Figure 1: Predicted Growth in Global Revenue of Nanotechnologies 16

Sector Nanotechnologies revenue in2007 ($m)Predicted nanotechnologiesrevenue in 2015 ($m)

ICT 585 41,402

Automotive 404 7,134

Aerospace & Defence 323 3,768

Agriculture, Food/Drink 265 3,210

Consumer goods 188 6,225

Life Sciences 145 5,670

Textiles 122 2,170

Energy 90 3,615

Environment & Water 86 3,885

Construction 66 1,672

Brand & Product Security 30 2,650

Totals 2,304 81,401

Nanotechnologies Industry22. While it is relatively easy to de ne bulk formsof materials according to large scale, primarysupply industries (e.g. glass, steel etc) this is notthe case for nanomaterials; here the technologieshave been applied to the development of productsand processes across many industries, particularlyover the past ten years.

23. Developing a comprehensive picture ofthe UK nanotechnologies supply chain, frommanufacturers or importers of nanomaterials,service providers, through to end users (companieswho produce a nal product for consumers topurchase), has proven dif cult. The mini-IGTattempted to provide a picture using data from

the Nanotechnology KTN 17 . Their survey estimatedthat there are around 220 companies in the UK

for which nanotechnologies makes up asigni cant portion of their business. The mini-IGTbelieves that this gure is conservative and maybe only a fraction of the true number because theinvolvement of many organisations is suf cientlyremoved from the nanomaterial itself; for examplea manufacturer of windows might use a waterresistant coating containing a nanomaterialpurchased from a supplier without consideringthemselves to be a nanotechnologies company.

24. Figure 2 (next Page), shows the range ofapplications that UK companies are focusing onin order to develop and exploit the opportunitiespresented by nanotechnologies.

25. Coatings and inks, biotechnology, specialitychemicals, electronics, sensors, instrumentation,medicaldevicesanddrugdeliveryareclearlythekeymarket sectors where companies are most active.16 Nanoscale Technologies Strategy 2009-12, Technology Strategy Board, September 200917 The Nanotechnology Knowledge Transfer Network facilitates the transfer of knowledge

and experience between industry and research bodies

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Figure 2: Market Application Focus of UK Nanotechnologies Companies 18

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End user sectors for these applications include:information and communications (hardware),automotive, healthcare and medicines, aerospace

and defence, and food and drink.

26. The majority of companies that responded tothe mini-IGT survey were small and medium-sizedenterprises (SMEs) with some 34% of companiesbeing involved in nanotechnologies for more thanten years.

UK CapabilitiesResearch27. The UK has a world-class reputation innanotechnologies research with a nationwide

network of research institutes and universitiesinvolving approximately 1,500 research scientistsfocusingon thedevelopmentofnanotechnologies 19.

28. TSB invested approximately 30m in a portfolioof research into nanotechnologies between 2006and 2009. This included work in a diverse rangeof application areas, for example; healthcare, lowcarbon energy and advanced manufacturing.Further investment was made as a result of widercompetitions when successful proposals utilisednanotechnologies. An example of this was thecompetition on Materials for Energy, held in 2007,where 75% of the supported projects involved ananotechnologies based solution.

18 Nanotechnology: a UK Industry View http://www.matuk.co.uk/docs/Nano_report.pdf 19 UKTI http://www.ukinvest.gov.uk/Nanotechnology/en-GB-list.htm


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29. Twenty- our Micro and Nanotechnology (MNT)acilities were set up by Government between

2003-07 and orm a major part o the UKs microand nano technologies in rastructure. These wereestablished primarily by open competition andare geared to support and enhance collaborativeresearch programmes, technology trans er initiativesand capital projects. The centres are open access

acilities and are supported by combined TSB,Regional Development Agencies (RDAs), DevolvedAdministration and industrial unding.

30. With a signifcant research port olio innanoscience, Research Councils are supportingthe UKs ability to harness the interdisciplinarynature o nanotechnologies. This includes investmentto help address commercialisation challengessuch as: The scale-up o small, laboratory-based

methods to technology that is viable on acommercial scale;

Investigation o manu acture easibility usingdemonstrator models and the deployment onew technology in real-li e situations.

A recent RCUK initiative has been the programmeo Grand Challenge investments in energy,healthcare and the environment, made as parto the cross council programme, Nanosciencethrough Engineering to Application 20. These projectshave been scoped with input rom business,academia and the public and by March 2010,28m will have been invested to assist thedevelopment o solutions in the challenge areas.The second stage o the Grand Challenges willhave joint unding rom the Research Councils

and the TSB, and plans are outlined in Action 2.6.To date, Grand Challenge unds have supportedprojects to develop:

Cheaper and more e fcient approaches toenergy generation through solar technology;

Novel methods or diagnosing disease andimproved approaches to drug delivery;

Technologies to reduce the UKs carbonemissions by capturing and converting carbondioxide into valuable products such as energyand chemicals.

Action 2.1Research Councils will partner with business,KTNs and the TSB to maximise the pull-throughof promising nanotechnologies research outputsto commercialisation. To achieve this, undingwill be provided to ensure that the bestper orming grand challenge projects can deliver

urther improvement over what is currentlystate-o -the-art. Close collaboration with businessand other government departments will be criticalto ensuring that this initiative is a success and willdeliver real benefts to the UK.

Knowledge Transfer Activities31. The Nanotechnology KTN and other KTNssuch as Materials, Chemistry Innovation andSensors & Instrumentation acilitate the trans ero knowledge and experience amongst industry

and research institutions. They are able to o ercompanies dealing with nanotechnologies accessto in ormation on new processes, patents and

unding as well as helping them to keep up to datewith regulatory requirements. Services providedby KTNs include; networking events, a directoryo micro and nanotechnologies providers, onlinecommunications, project partnering services, andtechnology brokerage.

Standards32. A standard is an agreed, repeatable way odoing something, or example, making a creditcard so that it can be used all over the world or20 http://www.rcuknano.org.uk/


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quality testing to ensure that there is paritybetween different companies producing similarproducts. The establishment of standards is animportant step towards the commercialisation ofresearch and fostering of innovation; they establisha common framework and understanding, providingthe bridge between research and industry.

33. The UK is playing a key role in leadingthe development of nanotechnologies standardsthrough BSI. The majority of nano-standardisationinitiatives in the International and Europeanstandardisation organisations have been proposedby the UK. To date BSI, with Governmentassistance, has developed ten standards, detailsof which can be found on the BSI website 21.

Action 2.2Government will continue to supportstandardisation work in innovative andemerging technologies, including that ofthe BSI Nanotechnologies standards workprogramme. Standards in support of occupationaland environmental health and safety havebeen identi ed as a priority, underpinned bythe relevant measurement, characterisation andterminology standards.

Barriers to Growth34. The UK has a very strong technical base innanotechnologies and has historically been verysuccessful in research. It is crucial that this successfollows through to the commercialisation ofnano-enabled technologies.

A Fragmented Industry, Lacking Leadership

35. Companies developing nanotechnologiesapplications and end users are present acrossa wide range of sectors and many of these

companies are SMEs. There is therefore a lack ofcritical mass within the industry around which astrategic direction can emerge; for example, mostSMEs are operating in isolation, and not able toform standards or make use of the knowledge orexpertise of others.

36. The variety of businesses, including niche

producers and those with sector speci capplications, means that manufacturers facechallenges in developing new processes andexploring potential markets for them. Manystruggle to establish effective supply chainsand generate the critical mass needed to getdevelopments to a commercial stage.

37. A need has been identi ed by industry for acomprehensive national strategy to address theseissues, along the lines of key competitors such asthe US and Germany. This would provide greaterco-ordination across sectors. More cohesiveleadership would support growth and ensureeffective engagement with Government.

A Lack of Collaborative Research and New Skills38. To avoid duplication and facilitate thedevelopment of best practices there is a need for

greater communication amongst industry andwith the academic community, thereby enablingthe sharing of knowledge and the identi cationof shared challenges.

39. People with suf cient skills in this high-value,high-skilled, knowledge-based market are essentialto drive innovation and sustain the developmentof nanotechnologies. Currently the two mostimportant barriers to the supply of skilled peopleare the lack of adequate training programmesand the high cost of those that do exist 22 .

21 www.bsigroup.com 22 Nanotechnology: a UK Industry View, Mini Innovation & Growth Team, 2010


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CASE STU 1: Vehicle Ef ciency

Car engines produce heat energy as a wasteproduct and they must have effective coolingsystems to prevent overheating. Traditionalcooling systems can use a lot of fuel; ifimprovements could be made to their function,then fuel could be saved. A small, high-technology company in Leeds are workingwith nanotechnologies to achieve this result.They are developing thermal transfer uidswhich use nanoparticles to enable heat to passmore ef ciently through cooling circuits. Whenthese nano uids are installed into a radiatorsystem, they have the potential to reduce fuelconsumption, thereby reducing the carbonfootprint of the vehicle and saving money for

the vehicle owner.Researchers have been aware of the potentialof nano uids for around ten years, but thetechnology couldnt be applied to real lifesituations until scientists from the Instituteof Particle Science and Engineering at Leeds

University developed novel technologies forsuspending nanoparticles in uids so thatthey dont stick together or form a residue.The company they formed in 2006 employs

ve people and is backed by British venturecapital. They enjoy partnerships with potentialcollaboration companies based in Japan,

Germany and the US as well as coolantsuppliers and are on schedule to bring theirtechnology to market by the end of 2010.

Public Perception

40. Further work is needed by industry andGovernment to improve public understanding ofthe bene ts which nanotechnologies currently hold,as well as their potential in the future. Peoplemust also have con dence that suf cient riskassessments are taking place by companies usingnanomaterials in their products. More detail onpublic engagement can be found in Chapter 5.

Regulatory Burdens

41. Companies developing nanotechnologiesrequire information in advance regarding theregulatory regime which will be necessary whentheir product goes to market. If this is deemedto be excessive, it can prevent businesses fromventuring into the nanotechnologies market,or from using them within their own operatingmarkets. Further consideration of a proportionateregulatory regime is set out in Chapter 4.


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Creating a Uni ed IndustryAction 2.3A Nanotechnologies Leadership Group(NLG) will be established, based on therecommendation of the Nanotechnologiescommunity through the mini-IGT and will bechaired by a BIS Minister. It will focus on issuesraised by the mini-IGT and comprise stakeholdersfrom across industry, research institutes, RDAsand academia. Its key tasks will be to:

Provide strategic leadership and directionto the wide range of sectors engaged in thedevelopment and application of nanoenabledtechnologies;

Highlight developments or industry needs thatprovide potential commercial opportunitiesacross sectors that can use nanotechnologies;

Encourage the development of new industrialcollaborations, supply chains and networks;

Encourage and provide direction to the nationaldevelopment of new processes, materialsand products;

Help to monitor delivery of the commitmentsin the UK Nanotechnologies Strategy.

It is envisaged that NLG will meet at least twice ayear. It is intended to be a short term activity, andits work will be reviewed after two years.

Action 2.4NLG will have strong links to theNanotechnology Special Interest Group whichis evolving from the mini-IGT and the KTNProgramme, providing input and opportunitiesfor dialogue with a wide range of industryrepresentatives with an interest in nanotechnologies.

Action 2.5TSB has completed a strategic review to identifyhow to maximise the bene ts from MNT centres.This will also feed in to the Hermann Hausersreview of Technology and Innovation Centres due to report in March. In future TSB supportfor the majority of the MNT centres will bechannelled through research and development

(R&D) competitions. TSB will continue toactively manage this investment and will bestrengthening the knowledge transfer andco-ordination activities to ensure technologyproviders are connected to potential users,working in conjunction with NLG. This willaccelerate the commercial exploitation of UKcapabilities. Two key areas are:

Nanomedicine TSB, in consultation with

stakeholders, will develop the business case forpotential future investment in nanomedicineresearch. This investment will be co-ordinatedclosely with other potential funding bodies.

Nanosafety TSB will extend the SafeNano project 23 which provides nanotechnologieshealth and safety information to allow continuityof provision in this area.

23 www.safenano.org
http://www.safenano.org/http://www.safenano.org/


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eveloping Technology and ExpertiseAction 2.6The TSB Nanoscale Technologies Strategy 2009-2012 was launched in October 2009 and targetsthe ways by which nanotechnologies can addressmajor challenges facing society such asenvironmental change, ageing and growingpopulations, and global means of communicationand information sharing. This will provide theframework for future applied researchpredominantly through activity inspired bythe needs of wider technologies andchallenge led calls, including:

Fighting Infection through etectionCompetition This competition, worth upto 11m funding from TSB and Departmentof Health (DH) opened in January 2010 and

comprises feasibility studies, fast-track projectsand larger R&D projects. It is expected thata signi cant portion of the funding will beawarded to nanotechnologies projects. TheNano4life 24 event held on 4th February2010 is an example of the type of activitythat is required to connect and catalyse thenanotechnologies community to prepare forthis competition along with wider healthcare

focused activity; Regenerative Medicine Programme Thiswill include the launch of competitions in thenext six months in regenerative medicinetherapeutics, tools and technologies. The totalinvestment will be around 21.5m, withfunding from TSB, Engineering and PhysicalSciences Research Council (EPSRC), Biotechnologyand Biological Sciences Research Council(BBSRC) and Medical Research Council (MRC).It is envisaged that a signi cant percentageof applications to this activity will have ananotechnologies based element;

The second stage of the Nanosciencefrom Engineering to Application GrandChallenges will be jointly funded by RCUKand the TSB. Their primary aim will be tocommercialise early stage research with themost promising solutions to societal challenges: Solar Energy The second stage of this

challenge is scheduled for late 2010 with

indicative funding of 5m; Healthcare This challenge is aimed at

nanoscale targeted delivery of therapeuticsand healthcare diagnostics. The secondstage is scheduled for 2011 with indicativefunding of 10m;

Carbon Capture and Utilisation Anannouncement on rst stage funding willbe made in March 2010 followed by furtherstage 2 activity in 2012.

Action 2.7In England, RDAs will support businessinnovation on nanotechnologies through aportfolio of simpli ed business support products,and will work closely with TSB to deliverregional schemes that support the UKNanotechnologies Strategy: Small Technologies,Great Opportunities. In particular, R As willhelp businesses work with universities in theirregions by offering networks and innovationvouchers that are relevant to the businessesin a region. The evolved Administrationswill provide tailored support structures forbusinesses within their borders 25 .

24 A collaboration between the Nanotechnology KTN and the Wellcome Trust

25 Wales Flexible Support for Businesshttp://fs4b.wales.gov.uk; Scotland; SMART:SCOTLAND and Regional Selective Assistance grantswww.scottishbusinessgrants.gov.uk ; NI Grant for R&Dwww.investni.com/r+d and Flexible Support for Businesswww.investni.com
http://fs4b.wales.gov.uk/http://www.scottishbusinessgrants.gov.uk/http://www.investni.com/r+dhttp://www.investni.com/http://www.investni.com/http://www.investni.com/r+dhttp://www.scottishbusinessgrants.gov.uk/http://fs4b.wales.gov.uk/


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Raising Awareness and EducationAction 2.8The Science and Innovation Network (SIN) willhelp identify the policies and best-practicesadopted by leading nations for assessing anyrisks in relation to nanotechnologies and itssafe exploitation. It will also disseminate keyUK policy messages on the safe developmentof nanotechnologies.

Action 2.9The skill requirements of thenanotechnologies sector will be addressedthrough a range of complementaryGovernment policies, as outlined inGovernments framework for highereducation Skills for Growth 26 and Higher

Ambitions27

: 35,000 additional advanced apprenticeships

available for 19-30 year olds over the next twoyears to meet technical skills needs in advancedmanufacturing sectors;

Measures to make the adult skills and highereducation systems more responsive to theneeds of employers;

Resources for skills focused on areas of the

economy which can do the most to drivegrowth and jobs, including science, technology,engineering and mathematics (STEM) at highereducation level;

Work with the relevant sector skills councilsand UK Commission for Employment and Skillsto identify longer term skills needs in advancedsectors and ways in which these needs canbe addressed;

RDAs will address skills supply for growthsectors, such as nanotechnologies, in their skillsstrategies, so that skills provision is responsiveto regional strategic economic needs as well asto shorter-term business needs.

International Co-operationAction 2.10

BIS, TSB, UK Trade & Industry (UKTI) andSIN will ensure that the UK is embeddedin strong international nanotechnologiesbusiness collaborations, includinginvestment in R& opportunities andleadership of the Organisation for EconomicCo-operation and evelopments (OEC )Working Party on Nanotechnology (WPN).

Action 2.11BIS, working in partnership with the TSB, willwork to in uence future European policyand support instruments to encourage moreeffective deployment of nanotechnologies.The European Commission has announcedplans to create a High Level Group to assessthe competitive position of ve key enablingtechnologies (nanotechnologies, micro-electronics, advanced materials, biotechnologyand photonics) and to make recommendationsby the end of 2010.

26 www.bis.gov.uk/skillsforgrowth27 www.bis.gov.uk/higherambitions
http://www.bis.gov.uk/skillsforgrowthhttp://www.bis.gov.uk/higherambitionshttp://www.bis.gov.uk/higherambitionshttp://www.bis.gov.uk/skillsforgrowth


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3. Environmental, Health and Safety Research

42. Actions in this area will help to establish a fullerunderstanding of risks associated with the useof nanomaterials and any resulting exposure tothem. Like all materials and chemicals, the speci csafety implications for any given nanomaterialare likely to differ signi cantly from material tomaterial. Also, the way in which the material isused has an effect on the likelihood of human or

environmental exposure. Research into this areais essential in order to understand how differentnanomaterials may impact on human health andthe wider environment.

43. Government recognises the strong opinionsexpressed by stakeholders on the subject ofthe EHS implications of nanotechnologiesduring the 2009 evidence gathering exercise,Nanotechnologies: in uence and inform the UK Strategy . Many contributors felt that there wasnot enough co-ordination of Governmentresearch efforts and that a greater level ofinvestment should be committed to investigationof the effects of nanomaterials on human healthand the environment.

Action 3.1The Government Chief Scienti c Adviser

will chair a meeting with Chief Scienti cAdvisers from the relevant epartments todiscuss approaches to improve epartmentalengagement and co-ordination ofnanotechnologies research.

Recent Findings44. The past few years have brought a signi cantincrease in research into the characterisation

and applications of nanomaterials and thepotential risks arising from their manufactureand use. Research commissioned by GovernmentDepartments and Agencies (see Box 4), as

well as research publicly nanced through theResearch Councils (see Box 6) have enhancedthe nanotechnologies knowledge base in someimportant areas.

45. Researching the potential risks associatedwith nanotechnologies is an international effort.By ensuring that the UK is linked into international

research networks, we are able to bene t from amuch wider knowledge base. In addition to theadvances made in the UK, important work hasbeen carried out in other countries, with examplesdetailed in Box 5. Much of the international workdetailed has been funded through the OECD orEUs Framework Programme; these are exploredin more detail in Chapter 5.

Government and Research46. In 2005, in light of the recommendationsmade in the RS/RAEng report, NRCG set 19research objectives. Since then, high qualityresearch, has developed our understandingsigni cantly. The EMERGNANO report, which wascommissioned by Defra and published in March2009, took an independent view of the globalprovision of research into the EHS implications ofnanotechnologies 28 . It noted that signi cantprogress had been made in a number of areas,including those described in Box 5. However, thereport also concluded that some key questionsremain and there is currently insuf cient evidenceto carry out robust risk assessments of manyexisting nanomaterials.

28 http://www.defra.gov.uk/environment/quality/nanotech/reports.htm#emergano
http://www.defra.gov.uk/environment/quality/nanotech/reports.htm#emerganohttp://www.defra.gov.uk/environment/quality/nanotech/reports.htm#emerganohttp://www.defra.gov.uk/environment/quality/nanotech/reports.htm#emergano


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BOX 4: Examples of environmental,health and safety research funded byUK Government into nanotechnologies:

The REFNANO project, commissioned bythe Department for Environment, Foodand Rural Affairs (Defra), has been amajor step forward in the prioritisationof needs for reference materials andmeasurement methods in supportof nanoparticle toxicology and riskassessment. The resulting reporthas formed the basis for the OECDsNanomaterials sponsorship programme,mentioned later in this chapter 29.

The potential inhalation effects of carbonnanotubes have been a focus of work

at Edinburgh University. These studiesobserved the formation of granulomain the lining of the abdomen of miceinjected with carbon nanotubes of aspeci c size range and aspect ratio.These ndings, which are being exploredfurther, have enabled Government toproduce risk management guidanceon the handling and disposal of carbon

nanotubes (CNTs)30

. An important summary has beenprepared on the principal physico-chemical factors controlling interactionsbetween nanoparticles and cells. Thislooked at the in uence of particle sizeand surface area, charge and chemistry 31 .

BOX 5: Examples of international researchinto the environmental, health and safetyimplications of nanotechnologies:

It now seems clear that ltration systemsare an effective means of personalprotection from exposure to nanomaterials,particularly in the workplace, with severalstudies nding improving ef ciency asparticle size decreases 32 .

Studies have improved the understandingof kinetics of nanoparticle uptake ininvertebrate and vertebrate models andhave related this to toxicity 33 .

Research has focussed on the effects ofnanoparticles on microbial organisms andcommunities, and there have been efforts

to bring together what has been learnedhere with human toxicology ndings 34 .

Edinburgh Napier University and theInstitute of Occupational Medicine haveled an EU Framework Programme fundedReview of Health and EnvironmentalSafety of Engineered Nanoparticles. Thiscomprehensive and critical scienti creview has looked at fullerenes, CNTs,

and metal and metal oxide nanomaterialsand brings together the ndings of manyhigh quality studies, providing a roadmap towards protocols for robust riskassessment 35 .

A large body of work has also providedimportant early data on the possiblebehaviour and effects of nanosilver in theaquatic environment. This was summarisedintheUKAdvisoryCommitteeonHazardousSubstances Report on Nanosilver (2009).

29 Aitken et al. (2007) REFNANO: Reference materials for engineered nanoparticletoxicology and metrology

30 Donaldson et al. (2008) Carbon nanotubes introduced into the abdominal cavitydisplay asbestos-like pathogenic behaviour in a pilot study

31 Hankin et al. (2008) CELL PEN: A study to identify the physico-chemical factorscontrolling the capacity of nanoparticles to penetrate cells

32-35 Emergnano: A review of completed and near completed environmental, health ansafety research on nanomaterials and nanotechnology (2009)


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BOX 6: Research Councils andnanotechnologies.

In addition to the commercialisation researchsupported by the Research Councils, asdetailed in Chapter 2, they fund EHS researchin two ways:

Responsive mode, where scientists submitapplications for funding which are subjectedto peer review and open competition.Approximately 80-100m per annum isallocated to researchers for projects involvingnanotechnologies in this way (both EHS andnon-EHS research), and current priorities forthis type of funding include internationalcollaboration and research to betterunderstand the health and safety ofnanomaterials. EPSRC has signpostednanometrology and nanotoxicology in theirresponsive mode panels, in linewith the NRSG research priorities. This hasresulted in one award so far; Swansea andLeeds universities received a total of 1.2mof funding for a project entitled, Nanoparticle

Cytometrics: a quantitative analysis of thetoxic effect of nanoparticles.

The Nanoscience through Engineering to Application cross-council programme wasestablished in 2007 and was based on the2006 EPSRC strategy for nanotechnologies.The programme is led by EPSRC but has

involvement from all other ResearchCouncils and TSB. Between 2007 and2010, 84m has been allocated to a varietyof nanotechnology projects, includingthe multi-disciplinary Grand Challenges,provision of specialised equipment andinfrastructure, funding of three doctoraltraining centres and supporting highpotential areas of UK specialism such asthe development of graphene. Full detailsof the supported projects can be found onthe Research Council websites 36 . The levelof investment made through this cross-council programme and responsive modehas been signi cant, with 18.5% of EPSRCstotal research investment being related tonanotechnologies.

Action 3.2Taking account of EMERGNANOs ndings andwider developments in this area, NRCG hasundertaken a review of its nanotechnologiesresearch priorities. The new priorities, whichcan be found at Appendix C, set the ongoingstrategic direction of publicly funded researchon nanotechnologies. To communicate moreeffectively this new focus on strategic function ofthe group, NRCG members have agreed that thegroup should now be referred to as theNanotechnology Research Strategy Group (NRSG).

47. Government is committed to the sustaineddevelopment of the evidence base and willcontinue to support the nanotechnologiesresearch programme at both the domestic andinternational level. The actions set out belowdetail research being supported by differentGovernment Departments and Research Councilsto increase our understanding of the impacts ofuse and exposure to nanomaterials.

36 http://www.rcuknano.org.uk/what-were-funding.html
http://www.rcuknano.org.uk/what-were-funding.htmlhttp://www.rcuknano.org.uk/what-were-funding.html


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omesticAction 3.3The Health Protection Agency (HPA) launchedits National Nanotoxicology Research Centre on24th November 2009 following an initial 1minvestment. This is a unique and valuable resourcein the UK. It has been equipped to characterisenanomaterials and to generate a wide rangeof nano-aerosols, including nano- bres/wires/ tubes, as well as perform toxicological testson their effects when absorbed into the bodyvia inhalation, ingestion and through the skin.Collaborative programmes of work are beingdeveloped by leading UK researchers andapplications for funding from the ResearchCouncils are being submitted. HPA are alsoin the process of developing an in-house

programme to deliver high quality, publiclyfunded toxicological research which willimprove our understanding of the risks tohuman health posed by nanomaterials.

Action 3.4The rst project to be undertaken at theNational Nanotoxicology Research Centrewill investigate the biokinetics of inhalednanomaterials. The rst phase of the studywill nish by the end of December 2010 andwill provide a detailed understanding of thebehaviour, effects and retention in the body ofinhaled insoluble nanomaterial aerosols.

Action 3.5To help address some of the researchgaps concerning nanoparticles followingconsumption in food, the Food StandardsAgency (FSA) has commissioned twoprojects which commenced in early 2010 toinvestigate the behaviour and fate ofnanoparticles in the gut. The total level of FSA

investment in this work will be approximately304k. One project will examine an in vitroabsorption model and human toxicokineticswhilst the other will use a different in vitroabsorption model and animal toxicokinetics.

Action 3.6FSA is also jointly funding a three-year

project entitled Nanoparticles in Food: Analytical Methods for Detection and Characterisation , which commenced in January2010. This project is being undertaken by aninternational consortium under the EUFramework Programme 7 (FP7). The work to becarried out in the UK will be led by the Food andEnvironment Research Agency (FERA) and willfocus on the development of screening methodsfor the detection of engineered nanoparticles infood. The project is partly funded by the EuropeanCommission, with the FSA providing 103k, or25% of the total cost of the work carried out inthe UK.

Action 3.7The DH has committed 1.25m of funding toresearch on the health impact of nanomaterialsto take forward the cross-Government priorities

identi ed by NRSG and its task force on HumanHealth Hazard and Risk Assessment. DH hascommitted 1.1m of this funding to ve studieson; carbon nanotubes, toxicology of inhalednanoparticles, nanoparticles & atherothrombosisand nanotoxicology of materials used in surgicalapplications. These studies will be completedby 2012 and will inform Government policyon the health impact of nanotechnologies.


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Action 3.8The Health and Safety Executive (HSE) willsupport a programme of research workto understand the risks presented bynanotechnologies so that it can advise onthe adequacy of existing occupationalregulatory frameworks and the regulationof the emerging risks. In particular, HSE will

focus on the industry sectors and the numbers ofworkers who may be exposed to manufacturednanomaterials in the UK, the likely routes ofexposure to nanomaterials and the levels ofexposure found in workplaces such as factories,research facilities and retail environments.

Action 3.9The Environmental Exposure and HealthInitiative is a joint initiative supported by the

H, the Medical Research Council (MRC),Natural Environment Research Council(NERC), Economic and Social ResearchCouncil (ESRC) and efra. In total, 8-10mof funding will be made available tosupport collaborative research programmesfor up to four years. This project is concernedwith measuring and determining the impact ofenvironmental pollutants on human health.Although the scope of this project is wider than

just nanomaterials, it is anticipated thatnanotechnologies research proposals will besubmitted and that, by linking environmentalexposure and human health outcomes, betterevidence-based policy development can besupported.

InternationalAction 3.10Research into the risks posed by a number ofpriority nanomaterials will be driven forwardby the OEC s nanomaterials sponsorshipprogramme, co-ordinated by the Working Partyon Manufactured Nanomaterials (WPMN).The UK has a key role in this work, led by

efra and supported by HSE. The UK leadsinvestigation into two priority nanomaterials;cerium oxide and zinc oxide. The PROSPEcTproject, jointly funded by EPSRC, Defra, TSB andUK Industry provides 3.7m to address gaps inthe current level of fundamental scienti c researchon these two nanomaterials, as well asdevelopment of innovative solutions to theproblem of their measurement. Speci cally, the

project will establish generic protocols thatcan inform risk assessments containing thecandidate nanoparticles, as recommendedby both the Royal Commission onEnvironmental Pollution (RCEP) and theCouncil for Science and Technology (CST).

Action 3.11NERC, EPSRC, efra, the Environment Agency(EA) and the United States EnvironmentalProtection Agency will collaborate to fundphase two of the Environmental NanoscienceInitiative (ENI), a major joint research effort.Applications have been sought from consortia ofUK and US researchers for projects which aim topromote interdisciplinary research and producerobust, validated models that accurately predicttransport, fate and bioavailability of nanomaterialsand their interaction with biological and ecologicalsystems. Research is expected to commence in2010, with a total of around 5m being madeavailable over a four year period.


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CASE STU y 2: Asthma Monitors

Over 5m people are affected by asthma inthe UK and the NHS is thought to spendover 800m a year providing care for asthmasufferers 37. The ability to easily detect theseverity of someones asthma on a day to daybasis would have several advantages:

Preventative treatment could be given sothat attacks could be stopped before thepatient has symptoms;

Treatment levels could be kept to a minimumand therefore side effects reduced;

Signi cant savings could be made for the NHS.

Nitric oxide is known to be found in the breathof asthma sufferers in increasing levels when their

condition worsens38

and measuring its presenceis one of the methods being investigated byscientists trying to nd ways to assist withasthma management.

In the US, nitric oxide levels are already usedto assess the severity of patients asthma, butthey must visit a hospital for the test, so regularmonitoring is not practical. By using a highly

sensitive nanomaterial to detect the nitricoxide, a London based company is developinga sensor which can be embedded on a siliconchip and placed into handheld tools. They hopeto produce affordable, portable and easy touse devices, which could be used by asthmasufferers to regularly monitor their condition.

The company was founded in 2004 and hasbeen awarded funding for this work by TSB.They employ around ten people and are aimingto bring the asthma breath sensor to the marketwithin ve years.

Action 3.12To date the UK has attracted over 10m offunding for EHS research on nanotechnolgiesfrom the Nanosciences, Nanotechnologies,Materials and New Production Technologies(NMP) theme of the FP7. BIS will continueto provide a National Contact Point service,which will work in collaboration with the KTNsand other gateway organisations to provideadvice, help and support to UK applicants

for nanotechnologies-related aspects of FP7.Government is consulting on and developingits negotiating position in order to in uencethe scope and content of future calls madethrough the FP7. This is being done in the contextof our effort to increase the proportion of theEU budget spent on research and innovation,with commensurate reductions in the EUsnon-priority areas.

37 Asthma UK Where Do We Stand 200438 The Predictive Value of Exhaled Nitric Oxide Measurements in Assessing Changes in

Asthma, Jones et al. American Journal of Respiratory and Critical Care Medicine


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4. Regulation

50. Good regulations are transparent,accountable, proportionate, consistent andtargeted 42. Regulation of materials, includingnanomaterials, is essential to ensure that they areproduced, used and disposed of without adverseeffect. The bene ts of well designed regulationfor nanotechnologies include:

Industry feel enabled to develop innovativeproducts, assured by the knowledge that theydo so within a framework which allows themto manage risk effectively;

The public are assured about products andfeel that they have suf cient consumer choiceavailable to them.

51. The actions in this chapter outline howGovernment will work towards having well-informed

and appropriately applied policies and regulationsfor nanomaterials and nanotechnologies.

52. As a cross-cutting technology, nanomaterialsare not regulated under a single legislativeframework, but under a number of sector orproduct speci c sets of regulations, both at aEuropean level and nationally. This aims to ensurethat each nanomaterial is regulated in a way thatis appropriate for its particular use. The diversityof regulations applying to nanomaterials isillustrated in the RCEPs report 43 , which lists 62regulations under which nanomaterials currentlyfall, for example the End-of-Life VehiclesRegulations 2003, the Water Act 2003 and theDetergents Regulations 2005.

53. In 2006, the Centre for Business Relationships,Accountability, Sustainability and Society (BRASS)was commissioned by the former Department forTrade and Industry to compile a report 44 examiningthe existing regulatory frameworks with regardsto nanomaterials. The research concluded thatwhile many areas had strong regulatory cover,some gaps existed. Departments and Agencies

within Government are working to ensure thatregulations and policies in all sectors are appliedappropriately to nanomaterials and that the issuesidenti ed by BRASS are addressed.

54. The sections in this chapter set outproposed actions to ensure that regulations areappropriately applied in the following key areaswhere nanomaterials are most likely to come intocontact with humans, or the environment:

Food; Cosmetics; Healthcare devices and medicines; Workplace health and safety.

42 Better Regulation Executive43 Novel Materials in the Environment: The Case of Nanotechnologies (2008)

Appendix J44 An Overview of the Framework of Current Regulation affecting the Development a

Marketing of Nanomaterials (2006)

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CASE Stu y 3: Ice Cream

Foods that contain nanoscale structures havebeen a part of our traditional diet for a verylong time without us thinking of them as such.In recent years, powerful microscopy techniqueshave revealed that the familiar properties offoods such as ice cream, milk and cheeses are theresult of speci c arrangements of their naturalcomponents water, fats and proteins thatexist at the nanoscale.

By using nanoscience to understand how thesenanostructures contribute to the properties offood, food producers can develop innovativeways of making similar products from differentingredients, for example by removing most of thefat from ice cream without losing the smooth andcreamy texture that consumers expect from thattype of product. Therefore, in this instance, thenanotechnologies being used do not involve theaddition of a nanomaterial.

The availability of food alternatives such as lowfat ice cream, which have the same sensoryproperties as their equivalents with higher fatcontents, will enable some people to reduce thefat and energy content of their diets.

Food

55. Foods which incorporate nanomaterials arecaptured by the general safety requirements ofthe EU General Food Law Regulation 45 , whichrequires that food placed on the market is notunsafe. In addition, speci c legislation exists fornovel ingredients, additives and food contactmaterials.

56. FSA has conducted a review to identify

potential gaps in regulations relating to the useof nanotechnologies in the food sector (published

August 2008) 46 . No major gaps in legislation were

identi ed by this review and it was found thatmost potential uses of nanotechnologies thatcould affect food would require some form ofapproval process before being permitted for use.

Novel Foods

57. The European regulation on novel foods 47

applies to foods and food ingredients (other thanfood additives) that were not consumed in the EUprior to 15 May 1997, including foods/ingredientsproduced using nanotechnologies.

45 (Regulation (EC) 178/2002)46 http://www.food.gov.uk/multimedia/pdfs/nanoregreviewreport.pdf47 (Regulation (EC) 258/97)

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58. The European Commission has issued aproposal to update and replace the 1997 NovelFoods Regulation. The proposal that is underdiscussion aims to provide improved clarity inrelation to nanomaterials, for example, byexplicitly including engineered nanomaterialswithin the scope of the Regulation. It also includesa de nition for engineered nanomaterials. In

principle, the UK supports the inclusion of ade nition for engineered nanomaterials in theproposal, in order to clarify that those which werenot marketed in food before 1997 are within thescope of novel foods and should undergo apre-market safety evaluation. Once adopted, thisde nition will be subject to amendment andupdate in the light of new information.

Action 4.1The European Parliament will commence itssecond reading of the proposed amendmentin 2010 and if adopted, the EU Regulation isexpected to enter fully into force in 2012. FSAwill be actively involved in negotiationswith the European Commission and MemberStates on the nal legislation and will pressfor any further amendments that are neededto ensure that it continues to provide thenecessary level of consumer protection.

Additives59. Food additives are controlled in the UK underthe newly amended European Parliament andCouncil Regulation on Additives 48 , which cameinto force in January 2010; it clari es the situationrelating to food additives produced usingnanotechnologies. FSA was actively involved

in negotiations on the amendment in Brussels,which states that where there is a change to theproduction method for an existing food additive

involving nanotechnologies, it should be re-assessed by the European Food Safety Authority(EFSA). Separate UK legislation provides forthe enforcement of this regulation such as theFood Additives Regulations, which were passedseparately in England, Scotland, Wales andNorthern Ireland in 2009 49 .

Action 4.2FSA will continue to monitor the ef cacy ofthe regulation of food additives with respectto nanotechnolgies.

Food Contact Materials60. Migration of nanomaterials into food from,for example, packaging would be consideredin the scope of regulations covering materialsand articles intended to come into contact withfood 50 . Provision exists for the EuropeanCommission or Member States to request forEFSA to conduct an independent, expert humanhealth risk assessment of any substance orcompound used in the manufacture of a foodcontact material or article. Speci c materials,such as plastics, are subject to additionalmeasures and within these measures it ispossible for a nanomaterial to be treated

separately from the normal scale substancefrom which it is derived. It will therefore onlybe possible for a nanomaterial to be authorisedfor use in food contact materials following a riskassessment by EFSA.

Action 4.3The detailed regulation of nanoscale substancesin food contact plastics is currently being clari ed

by the European Commission in preparation foran updated European regulation. The UK, led by

48 Regulation (EC) 1333/2008

49 England SI 2009 No. 3238, Scotland 2009, No. 436; NI 2009, No 416; Wales 2009,No. 3378 (W.300)


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FSA, will promote a case by case approachto such further regulation during discussionsin the European Commissions expertworking group to ensure that individualsubstances in nanoform are fully evaluatedfor safety before they are approved for usein food contact materials, and any necessaryrestrictions on their safe use are in place.

Cosmetics61. Under the current EU Directive on the Safetyof Cosmetic Products, all cosmetics are requiredto undergo a safety assessment to ensure thatthe product is safe for use as intended by theconsumer, but nanomaterials are not speci callymentioned. The required safety assessment hasto take account of the physical properties of the

substances contained in the product, includingparticle size and functionality.

62. Additionally, the assessment must includethe following details and must take into accountundesirable effects reported to the manufacturer:

General toxicological pro le of each ingredientused;

Chemical structure of each ingredient;

Level of exposure of each ingredient; Speci c exposure characteristics of the areason which the cosmetic product will be applied;

Speci c exposure characteristics of the classof individuals for whom the cosmetic productis intended.

63. From 11th July 2013, the updated EURegulation on Cosmetic Products 51 will come intoforce. It details similar requirements in terms ofthe level of safety assessment required, but willalso require manufacturers to notify the European

Commission of any new cosmetic productscontaining nanomaterials six months prior tobeing placed on the market. Products placedon the market prior to that date will also haveto be reported by 11th July 2013. The EuropeanCommission will report on the data collectedannually to the Council and Parliament.

64. The report on nanomaterials whichmanufacturers will be required to make to theCommission will cover:

Identi cation of the nanomaterial; Size of nanoparticles contained in the product; Physical and chemical properties of the

nanomaterial; Estimate of the quantity of nanomaterial

intended to be placed on the market per year;

Toxicological pro le and safety data forforeseeable exposure conditions relating to thecategory of cosmetic product.

Action 4.4BIS will act as the Competent Authority forthe EU Cosmetics Regulation and will keepa watching brief on developments involvingnanomaterials which may require furtherlegislative amendments.

65. In addition, cosmetics are covered by theCommunity Rapid Information Exchange Systemfor non-food consumer products (RAPEX). This isEuropes tool for ef cient communication fromthe Commission to enforcers and consumers inthe event of a problem developing with a product,for example if new information became availablesuggesting that a material was dangerous.


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Health Equipment and Medicines66. The Medicines and Medical DevicesDirectives52 set a high standard for the safety,quality, performance and ef cacy of healthcareproducts and there is an onus on manufacturers,including those that utilise nanotechnologies,to ensure that these stringent requirements arefollowed. The existing pieces of legislation underwhich nanotechnologies in healthcare productsare currently regulated are continually assessed,taking into consideration new materials orproducts being developed.

Medicines67. The Commission on Human Medicinesreviewed the toxicology of healthcarenanoparticles in September 2006 53 . The

European Medicines Agency (EMA) publisheda re ection paper in June 2006 54 discussing thecurrent thinking and initiatives taken by EMAin view of recent developments in relation tonanotechnologies-based medicinal products.Neither of these reviews identi ed an immediateneed for regulation speci c to nanotechnologies.It is likely that speci c guidance will be createdin the future, once there is enough data toallow for the creation of systematic guidance.Since 2006, EMA has established a dedicatednanotechnologies group within the InnovationTask Force that deal with emerging technologies.The UK, represented by MHRA keeps abreastof the work of this group. This group meetswith applicants, explores possible scienti c andregulatory solutions, is active in providing scienti cand regulatory input on various EuropeanCommission initiatives and has established linkswith regulatory authorities in other regions.

Medical evices68. A European Medical Devices Expert WorkingGroup on new and emerging technologies isassessing the adequacy of the medical devicesregulatory framework based on informationpresented by a speci c nanotechnologies taskforce. The existing regulations for medical devicesrequire manufacturers to carry out an analysis

of the risks associated with a medical device, toeliminate or reduce these where feasible, and toassess the balance of risks and bene ts.

Action 4.5MHRA believes that current EU regulations forMedicines and Medical Devices are suf cientlystringent and broad in scope to cover risksassociated with nanotechnologies. MHRA willkeep nanotechnologies developments underreview and will work with the EuropeanCommission, EMA and the European Medical

evices Expert Working Group to assess therelevant existing regulations with regard tonanotechnologies.

Occupational Health and Safety69. Nanomaterials in the workplace are regulatedunder the Control of Substances Hazardous toHealth (COSHH). The principles of risk assessmentembedded in COSHH apply to nanomaterials,and even though data gaps exist, the regulatoryresponse is to take a precautionary approach. HSEhave published guidance on safe working withnanomaterials and speci c guidance on the riskmanagement of carbon nanotubes.

52 Directive 2001/83/EC and Directive 93/42/EEC as amended53 Re ection Paper on Nanotechnology-based Medicinal Products for Human Use

(EMEA/CHMP/79769/2006)54 The Toxicology of Nanoparticles used in Healthcare Products (2006)

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Action 4.64.6 While there are no current plans for anyspeci c guidance on risk management for materialsother than carbon nanotubes, this position willbe kept under review by HSE, for example,by monitoring new toxicological literatureas it is published . Should research resultsdemonstrate that a given material poses a particular

risk, HSE will issue guidance as appropriate,working in conjunction with regulators from otherEU and OECD countries, industry, trade bodies,unions etc.

70. The Dangerous Substances and ExplosiveAtmospheres Regulation (DSEAR) may also berelevant to some nanomaterials. Substancescapable of forming explosive atmospheres fallunder DSEAR and the requirements of thisRegulation to assess and manage the risk ofexplosion. There are still uncertainties regardingthe properties of some nanomaterials in thisrespect and until better data is available, HSErecommends that a precautionary approach isadopted. HSE will work towards addressing theuncertainties around ammability/explosivity inthe context of nanomaterials.

TheRegistration,Evaluation,Authorisationand Restriction of Chemicals (REACH)Regulation71. The EU Registration, Evaluation, Authorisationand restriction of CHemicals (REACH) Regulationdeals with controls on chemicals and their safeuse. It aims to improve the protection of humanhealth and the environment through the betterand earlier identi cation of the intrinsic properties

of chemical substances. As nanomaterials areconsidered substances by the EuropeanCommission, they are included in principle withinthe scope of REACH. However, it is recognised

that some aspects of REACH were not designedwith nanomaterials in mind and may give rise toimplementation issues. For example, the annualweight thresholds governing the registration ofqualifying substances may exclude nanomaterialsmanufactured and imported in small quantities.

72. An EU Member State Competent Authority

sub-group on nanomaterials (CASG-Nano)55

hasbeen established; its objective is to exchange viewson existing and arising implementation issuesand other matters in relation to nanomaterialsunder REACH. HSE represents the UK on thisgroup. Whilst Defra takes a lead on REACH policy,HSE is the UK REACH Competent Authority,with responsibilities including enforcement andevaluation of selected priority substances.

73. To progress the work of CASG-Nano, threeREACH Implementation Projects on Nanomaterials(RIPoNs) have been established to look at:

Substance identi cation of nanomaterials; Information requirements for nanomaterials

under REACH; Addressing nanomaterials in chemical safety

assessments.

The contract for carrying out the work of thelast two of these projects has been awarded toa consortium led by the UK-based organisationSAFENANO.

74. The rst deadline for registration of qualifyingsubstances under REACH is 30th November 2010.It is expected that this rst tranche of registrationswill provide information on some nanomaterials,

for example, where they have bulk forms producedor imported in volumes greater than 1000 tonnes

55 This is a subgroup of the Member State Competent Authorities advisory group (CARAwhich advises the Commission and the European Chemicals Agency on REACH anRegulation on classi cation, labeling and packaging of substances and mixtures

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per year, or where they are classi ed as meetingcertain hazard criteria. Further REACH registrationdeadlines will follow in June 2013 and June 2018and may affect the overall regulatory landscapefor nanotechnologies.

Action 4.7It has been proposed that some changes to the

REACH legislation may be necessary in order toregulate nanomaterials as effectively as possible.Work is ongoing to develop practical guidanceon substance identi cation and provide advice onhow to deal with information requirements andchemicals safety assessments for nanomaterials.HSE and efra will lead the UKs input onthe management of nanomaterials throughREACH via the CASG-Nano sub-group.

Reporting Scheme75. Whilst it is expected that some information willbecome available through the requirements of theEuropean REACH Regulation, Government wishesto improve its understanding of nanomaterials,and products which contain nanomaterials, incirculation in the UK.

76. Defra ran a two-year trial voluntary reportingscheme (VRS) between September 2006 andSeptember 2008. It invited information onengineered nanomaterials with two or moredimensions up to 200nm that are free at anypoint in the products life-cycle. The VRS wasopen to anyone involved in the manufacture oruse of nanomaterials, or anyone involved innanoscience research or managing wastesconsisting of engineered nanoscale materials.

Detailed information was requested about thereporting organisation and the nanomaterial(s)being used (including properties, exposure,toxicity and ecotoxicity).

77. Thirteen responses were received. Theinformation was used to inform Governmentresearch priorities, and contributed to ourmanagement of potential risks by improving ourknowledge of who was using nanomaterials inthe UK and under what conditions. However, webelieve that the response rate represents only arelatively small proportion of those dealing with

nanomaterials in the UK.

78. Government has re ected upon the VRSand has been looking into the next steps fora nanotechnologies reporting scheme. Theevidence gathering exercise highlighted thatcertain stakeholders felt that Government shouldhold information about products which containnanomaterials in addition to the nanomaterialsthemselves. This nding was discussed at NSF inJanuary 2010; members of the Group generallyfelt that a scheme including information aboutproducts which use nanomaterials would bewelcomed. This widens the scope of the originalscheme and will require further consideration toensure that such a scheme can take into accountthe needs of Government, stakeholders, industryand the public.

Action 4.8Through further discussions with groupssuch as NLG, KTNs, the NanotechnologiesCollaboration Group (see Chapter 5) andWhich?, Government will agree and de nethe wider range of information that wouldbe useful to stakeholders and work todevelop a scheme to collect information onboth nanomaterials and products containing

nanomaterials that are available in the UK.

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Action 4.9Action 4.8 will be taken forward by a cross-Government working group that will includeBIS, efra, H, FSA and HSE. As well asengagement with interested parties, thisbroader approach may well involve jointlyfunded research to establish, for example,some baseline information.

79. In expanding the remit, it is important thatthe right approach is adopted, to ensure thatany wider voluntary scheme is effective inaddressing a number of needs. For example, awider ranging scheme would enable better co-ordination across those parts of Government withinterests in nanotechnologies (see Box 7). Takinga co-ordinated, co-operative approach acrossGovernment will prevent duplication of effortand should provide more consistent informationfor industry and consumers.

80. Several products lists have previously beendeveloped e.g. the Woodrow Wilson list 56 andwe are aware that other countries are consideringintroducing reporting schemes, includingmandatory schemes e.g. France and the USA.These will be taken into account in taking forward

the revised scheme. Government will also considerhow any scheme would compare to requirementson industry in other countries to ensure UKbusinesses would not lose competitiveness. Inparticular, consideratio

nano strategy fully accesible version - final

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