KemI PM 4/12 - Kemikalieinspektionen

PM4/12Swedish agencies and nanomaterials:Activities and developmentsSwedish Chemicals Agency – www.kemi.se

Swedish agencies and nanomaterials:Activities and developments

Order No. 511 046Sundbyberg, juni 2012Publisher: Swedish Chemicals Agency©Order address: CM Gruppen, P.O. Box 11063, SE-161 11 Bromma, SwedenPhone: +46 8 5059 33 35, Fax +46 8-5059 33 99, E-mail: kemi@cm.seThe report is available as a downloadable pdf on www.kemi.se

PrefaceThe Swedish Chemicals Agency (KemI) has been assigned by the Swedish Government toproduce a national action plan for a toxic-free everyday environment: Action plan for a toxicfreeeveryday environment 2011 – 2014 – protect the children better.Efforts are now going on in several areas, both in Sweden, within the EU and internationallyand often in cooperation with other authorities. Reducing chemical risks in the everydayenvironment is one step towards attaining the Swedish Parliament´s environment qualityobjective A Non-Toxic Environment, which is the objective that KemI is responsible for.Within the framework of the action plan, KemI compiles knowledge in KemI´s report and PMseries elaborated by experienced colleagues, researchers or consultants. In this way, KemIpresents new and essential knowledge in publications which can be downloaded from thewebsite www.kemikalieinspektionen.seIn the action plan there is particular focus on health and environmental risks withnanomaterials. Therefore KemI invited to a joint meeting on 25 November 2011 to get anoverview of the nanorelated activites of Swedish government authorities. This report containspresentations of the different authorities´ activities within the nano area and notes from thefollowing discussion. The main objective of the workshop was to investigate the need andsuitable forms for an interagency collaboration.The report was compiled and edited by Linda Schenk at the Division of Philosophy at theRoyal Institute of Technology. Project leaders and contacts at KemI were Lena Hellmér andMaria Wallén. Responsible for the project at KemI was Agneta Falk-Filipsson, Head of Unit,Risk Reduction and SupportThe report contains a collection of texts provided by participating agencies and a summary ofthe interagency workshop, which does not reflect necessarily the view of KemI.The authors of the agency texts in this report are as follows:The Foundation for Strategic Environmental Research: Christopher Folkesson Welch.The Medical Products Agency: Luisa Becedas, Monica Tammela.The National Food Agency: Evelyn Jansson Elfberg, Birgitta Lund, Lars Börje Croon, Lilianne Abramsson,Kettil Svensson.The National Veterinary Institute: Karin Artursson.The Swedish Agency for Non-Proliferation and Export Controls: Linda Hinas.The Swedish Chemicals Agency: Lena Hellmér, Maria Wallén.The Swedish Civil Contingencies Agency: Claes Löfström.The Swedish Defense Research Agency: Ulrika Bergström, Lars Österlund, Håkan Wingfors, Anders Bucht.The Swedish Defense Materiel Administration: Hans Norinder, Birgit Ramfjord.The Swedish Environmental Protection Agency: Britta Hedlund.The Swedish National Board of Housing, Building and Planning: Kristina Einarsson.The Swedish National Council on Medical Ethics: Lotta Eriksson, Göran Hermerén.The Swedish Patent and Registration Office: Fredrik Wahlin.The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning: Conny Rolén andLena Strålsjö.The Swedish Transport Administration: Malin Kotake, Jessica Simon, Hans Holmen, Mona Lundcrantz.The Swedish Work Environment Authority: Claes Trägårdh.The other text parts were written by Linda Schenk. A list of the workshop participants is provided in AppendixB.

ContentsSummary .................................................................................................................... 7Sammanfattning ........................................................................................................ 81 Introduction .................................................................................................... 91.1 Scope and aim of this report ...................................................................................................... 92 Agencies’ summaries of nanoactivities ..................................................... 102.1 The Foundation for Strategic Environmental Research (Mistra)..............................................102.2 The Medical Products Agency (MPA) ......................................................................................122.3 The National Food Agency (NFA)............................................................................................132.4 The National Veterinary Institute (SVA) ...................................................................................182.5 The Swedish Agency for Non-Proliferation and Export Controls (ISP) ....................................182.6 The Swedish Chemicals Agency (KemI) ..................................................................................192.7 The Swedish Civil Contingencies Agency (MSB) ....................................................................222.8 The Swedish Defense Research Agency (FOI).......................................................................232.9 The Swedish Defense Materiel Administration (FMV) .............................................................262.10 The Swedish Environmental Protection Agency (NV) .............................................................272.11 The Swedish National Board of Housing, Building and Planning (Boverket) ..........................282.12 The Swedish National Council on Medical Ethics (Smer) ........................................................302.13 The Swedish Patent and Registration Office (PRV) ................................................................322.14 The Swedish Research Council for Environment, Agricultural Sciences and SpatialPlanning (Formas)....................................................................................................................332.15 The Swedish Transport Administration (Trafikverket)..............................................................342.16 The Swedish Work Environment Authority (SWEA) ................................................................352.17 Joint outlook .............................................................................................................................373 The Nano workshop .................................................................................... 383.1 What are the largest challenges within the nano field? ...........................................................383.2 How to reach sustainable nanomaterial innovations, i.e. to have product developmentto go hand in hand with research on potential risks to health and the environment? ..............403.3 Which research is needed within the nano field from a government perspective?..................413.4 Should there be inter-agency cooperation in the nano field? ..................................................414 Concluding remarks .................................................................................... 42Appendix A The European Commission’s recommendation for a definitionof nanomaterials ......................................................................................... 43Appendix B Workshop invitation and program in Swedish ................................ 47Appendix C Presentations given at the nano-workshop...................................... 52

SummaryThis report is a compilation of the activities of Swedish agencies concerningnanotechnologies and nanomaterials. The aim of this report was to gain an overview ofquestions that Swedish agencies are involved with, and to investigate the need for andpotential of an interagency network regarding nanotechnology and nanomaterials. Invitationsto an interagency nanomaterials workshop were sent out to the eleven ministries within theGovernment Offices of Sweden and 27 government agencies or public funding agencies thatwere judged to have activities or interests related to nanotechnology in Sweden. In theinvitation a summary of the nano activities was also requested for the purpose of this reportand 16 agencies provided a text about their activities, three of these without participating atthe workshop. In total, the following 17 agencies participated during the workshop on 25November 2011:• The Foundation for Strategic Environmental Research• The Medical Products Agency• The Ministry of the Environment• The National Board of Health and Welfare• The National Food Agency• The Swedish Agency for Non-Proliferation and Export Controls• The Swedish Armed Forces• The Swedish Chemicals Agency• The Swedish Civil Contingencies Agency• The Swedish Defense Research Agency• The Swedish Defense Materiel Administration• The Swedish Environmental Protection Agency• The Swedish Governmental Agency for Innovation Systems• The Swedish National Council on Medical Ethics• The Swedish Research Council for Environment, Agricultural Sciences and SpatialPlanning• The Swedish Transport Administration• The Swedish Work Environment AuthorityThe major outcome of the workshop was the agreement on the formation of an interagencynetwork for collaboration toexchange knowledge. This network will facilitate interactionsbetween different agencies and will broaden the perspective of these actors.Nanomaterials constitute a number of challenges for agencies, some of which are shortlysummarised here:• To identify where nanomaterials can be found within each agency’s sphere ofresponsibilities / interest area.• Need for review of legislation and adjustment to nanomaterials• There is a need for knowledge of the use of nanomaterials in society.• Sufficient knowledge on the potential hazards of nanomaterials is lacking.• Proper risk assessment methods have to be derived and used. Current risk assessmentmethodology is developed for substances in the bulk, but there might be additionalchallenges when assessing risks of nanomaterials.• Measurement and detection methods are lacking in many cases.• Currently there is a lack of appropriate tests for toxicological evaluation.7

SammanfattningDenna rapport är en sammanställning av verksamheten på svenska myndigheter gällandenanoteknik och nanomaterial. Syftet med projektet som redovisas i denna rapport är att få enöverblick av frågor som svenska myndigheter arbetar med inom nanoområdet samt att utredabehovet av ett speciellt myndighetsnätverk angående nanoteknologi och nanomaterial. Eninbjudan till ett myndighetsgemensamt seminarium om nanomaterial skickades till samtligadepartement inom Regeringskansliet och 27 statliga myndigheter eller offentliga finansiärersom bedömdes ha aktiviteter eller intressen med anknytning till nanomaterial och nanoteknik iSverige. I inbjudan efterfrågades också ett textunderlag till denna rapport. Sextonmyndigheter har bidragit med en sammanfattning av sin nanomaterialsrelaterade verksamhet,tre av dessa utan att delta vid seminariet. Totalt deltog 17 myndigheter på seminariet den 25november 2011:• Arbetsmiljöverket• Livsmedelsverket• Läkemedelsverket• Inspektionen för strategiska produkter• Kemikalieinspektionen• Försvarsmakten• Försvarets forskningsinstitut• Försvarets materielverk• Miljödepartementet• Myndigheten för samhällsskydd och beredskap• Naturvårdsverket• Socialstyrelsen• Stiftelsen för miljöstrategisk forskning (Mistra)• Sveriges medicinsk-etiska råd• Forskningsrådet för miljö, areella näringar och samhällsbyggande (Formas)• Trafikverket• VinnovaDet viktigaste resultatet av workshopen var önskemålet att bilda ett myndighetsöverskridandenätverk för samarbete och informationsutbyte i nanomaterialsfrågan. Detta nätverk kommeratt underlätta möten mellan olika myndigheter och kommer att bredda perspektivet förmyndighetsaktörerna.Användning av nanomaterial medför en rad utmaningar för myndigheter av vilka en del kortsammanfattas här:• Att identifiera var nanomaterial kan finnas inom varje myndighets ansvars- ellerintresseområde.• Lagstiftning måste ses över för att anpassas till nanomaterial.• Behov av kännedom om spridningen av nanomaterial i samhället• Kunskap om de potentiella riskerna med nanomaterial är bristfällig.• Fungerande riskbedömningsmetoder måste utvecklas, nuvarande metoder ärutvecklade för bulkämnen och nanomaterial kan innebära nya utmaningar förriskbedömning.• Mät- och detektionsmetoder saknas i många fall.• För närvarande finns en brist på lämpliga toxicitetstester.8

1 IntroductionNanotechnology has a potential to bring benefits to society offering unique opportunities fornovel applications, ranging from more energy efficient and faster computers and mobilephones, to stronger and more durable materials, more efficient energy harvesting and storagedevices, applications based on antimicrobial or self-cleaning properties and nano-medicine.While wishing to further the beneficial opportunities, agencies also need to address theconcerns regarding risks to health and the environment and there is yet no established riskmanagement strategy for nanomaterials which complicates the issue for agencies and otherstakeholders.Regulatory applicability is an important issue for many agencies. National and internationalregulatory frameworks for chemicals in their different applications, e.g. industrial chemicals,pharmaceuticals, cosmetics, food and food contact materials, are considered to apply also tonanomaterials. Nevertheless, it is unclear how efficiently these current pieces of legislationand regulations will manage potential risks posed by engineered nanomaterials. One exampleis the European chemicals legislation, REACH. In this legislation the data requirements areassociated to tonnage triggers. Although nanomaterials are covered by REACH, the amountsimported or produced often are expected to be too low to trigger the requirements of safetyevaluation and testing. In addition, the current state of knowledge indicates that nanomaterialsmight be harmful to health and the environment already at these lower amounts (due to e.g.the high specific surface area of nanomaterials compared with bulk materials). Thus REACHmight not efficiently manage the risks of nanomaterials. A major obstruction to the evaluationof regulatory applicability has been lack of a generally accepted definition of the termnanomaterial. A definition of nanomaterial was, however, recommended by the EuropeanCommission in October 2011 (see Appendix A).A number of countries have in the ten past years presented national research programmes andstrategies regarding nanotechnologies, but Sweden has not yet adopted such a strategy. In2009, the Swedish governmental authority for innovation systems (Vinnova), was assignedwith the task to develop a proposal for a strategy for the nanotechnology area. The strategywas to target the issue of “how opportunities and risks possibly associated with the use ofnanotechnology may be safeguarded and monitored in the light of the rapid expansion withinthe area”, and has been published by Vinnova 1 . Among the proposals in this document wasthe formation of a nanotechnology delegation, which would work towards sustainable andsuccessful implementation of nanotechnological applications in Sweden.1.1 Scope and aim of this reportThis report has as an objective to give an overview of the nano-related activities of Swedishgovernment agencies. These agencies might for instance be regulators, supervisors fundingagencies, and/or users of nanomaterials. As such, different agencies have differentperspectives on the nano area, and in a joint overview new insights might be gained. TheSwedish Chemicals Agency (KemI) therefore invited to a joint workshop on 25 November2011 at which nanotechnologies and nanomaterials were to be discussed. One important aimof the workshop was to investigate the need and suitable forms for interagency collaboration.1 Vinnova. 2010. Nationell strategi för nanoteknik. Ökad innovationskraft för hållbar samhällsnytta.Vinnova. http://www.vinnova.se/sv/Publikationer/Produkter/Nationell-strategi-for-nanoteknik9

2.2 The Medical Products Agency (MPA)The responsibilities of MPA nanomaterial related activities are mainly connected to the EUlevel regulations of pharmaceuticals and cosmetics, which will be presented in the followingsections.Legislation on cosmeticsThe new Cosmetics Regulation 1223/2009/EC 2 , hereafter referred to as the regulation,contains a number of new rules concerning nanomaterials. Most of the rules are collected in aseparate article on nanomaterials (Article 16). In the compulsory notification of all cosmeticproducts to the EU Commission product registry, six months prior to placing the products onthe market companies must indicate whether their products contain ingredients in the form ofnanomaterials (Article 13 paragraph 1f ). This notification must be accompanied by extensivedocumentation regarding, e.g. specification of the nanomaterial, toxicological profile, safetyevaluation and foreseeable exposure conditions. In addition, the annual emissions should beestimated.If the Commission suspects safety of a nanomaterial, the Commission shall request theopinion of the Scientific Committee on Consumer Safety (SCCS). The Commission can ifnecessary, issue restrictions concerning specific cosmetic products containing nanomaterials .The Commission may also initiate a review of a nanomaterial and change the regulatoryrequirements specified in the previous paragraph with regard to new information andscientific developments.The Commission shall publish a list of all nanomaterials used in cosmetics and submit anannual progress report to the European Parliament which, among other things, providesstatistics on the use of nanomaterials and the development of assessment methods andguidelines for safety assessment of nanomaterials.The regulation defines nanomaterial as "an insoluble or biopersistent and intentionallymanufactured material with one or more external dimensions, or an internal structure, on thescale from 1 to 100 nm." (Article 2, paragraph 1 k and 3). The Commission shall, inaccordance with this regulation periodically review the rules on nanomaterials and proposechanges to the definition. The first review should be performed before 11 July 2018.Furthermore, the regulation establishes rules concerning labelling of nanomaterials. Allingredients present in the nanomaterial form shall be followed by "(nano)" in the list ofingredients (Article 19 paragraph 1g). In this way, consumers can get information aboutwhich products contain nanomaterials.In order to prepare for the implementation of the regulation, a working group on marketsurveillance in the European Commission (PEMSAC - Platform of European MarketSurveillance Authorities for Cosmetics) will control nanomaterials. In 2012, cosmeticproducts using nanomaterials will be mapped. Thereafter, the working group intends toanalyze products in order to identify content of nanomaterials during 2013 and 2014.Cut-off values have been discussed, concerning the size, distribution of particle sizes andwhether this should be determined by weight or percentage of the number of particles.2 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009on cosmetic products. Official Journal of the European Union L342/5912

Nanomaterials are also discussed within international cooperation, International Cooperationon Cosmetic Regulation in which, amongst others, the European Commission participates. Atthe last meeting appropriate methods for characterising nanomaterials have been surveyed anddiscussed.Ongoing activities within the European Medicines Agency (EMA)The approval of pharmaceuticals is regulated by Directive 2001/83/EC, and thus a major partof the nanotechnology related work of MPA in the area of pharmaceuticals is performedwithin the framework for EMA. According to the EU regulations, the marketing companymust present sufficient information to demonstrate that the benefits of the product outweighthe risks. Currently, there are no special rules for handling nanomaterials in pharmaceuticalsin the approval process. However, any issues that relate specifically to the nanomaterialproperties should be addressed on a case by case basis.EMA has started a number of groups in order to discuss the potential harmful properties andthe innovation possibilities of nanomaterials in the pharmaceutical field. In 2010 EMA held aseminar "1st International Workshop on Nanomedicines" targeted at collecting informationfrom member states and stakeholders. MPA was not represented at this seminar, but a reporthas been published and is available at the MPA’s webpage 3 . According to this report it wasconcluded that to make use of the benefits of nanotechnology for developing newpharmaceuticals (more knowledge and global expertise are needed. During the autumn of2011, EMA was forming a multidisciplinary working group for a continued dialogue betweenexperts in the nano field. EMA will also conduct a review of the pharmaceutical legislationand provide opportunities for scientific developments that benefit patients.Outlook MPAMPA will follow EMA’s and COM’s work for medical product and cosmetic products,respectively, in the nano field.2.3 The National Food Agency (NFA)Currently, NFA participates in the EU Commission working groups on food contact materialsand food additives and in an EU Council working group for the regulation of novel foods. Theissue of nanotechnology is presently discussed in these working groups. Application asMember within the Efsa Scientific Network on risk assessment of nanotechnologies in foodand feed is ongoing.Conditions for risk assessment of nanomaterials in food and feedRisk assessments of chemical substances comprise two important factors; exposure andtoxicity. Concerning exposure to a nano substance (< 100 nm) two important propertiesshould be taken into account in addition to the conventional standard of a weight measure,namely its very small size and its large surface area compared with its volume. According toEfsa (The European Food Safety Authority), adequate characterisation of a nano substance isessential for establishing its identity and physico-chemical forms in food products and under3 www.ema.europa.eu/ema/pages/includes/documents/open_document.jsp?webContentId=WC50009838013

testing conditions, i.e. the determination of physico-chemical characteristics is important forthe subsequent experimental design and for the exposure assessment.Moreover, from the toxicity point of view the characterisation of the nanosubstance as presentin biological fluids and tissues is important particularly for the ADME (absorption,distribution, metabolism, excretion) studies. Furthermore, toxicity test models and standardtesting protocols used for non-nanoform substances may not necessarily be appropriate oroptimal for the testing of nano substance.Therefore the present standard toxicologicalmethods need to be further developed or at least fine-tuned. In conclusion, there are currentlyuncertainties related to the identification, characterisation and detection of a nanosubstance.Similarly, there are a number of uncertainties related to the applicability of current standardbiological and toxicological testing methods to nano substances. Overall this implies that atpresent it is not possible to carry out a proper risk assessment of a nanomaterial.Applications foreseen by EFSAThe following broad categories of nanotechnology applications in the food and feed sectorhave been described (Chaudhry et al., 2008; Observatory-nano, 2009):- Where nanotechnology processes and materials have been employed to develop food contactmaterials (FCM). This category includes nanomaterial-reinforced materials (also referred to asnanocomposites), active FCM designed to have some sort of interaction with the food orenvironment surrounding the food, and coatings providing surfaces with nanomaterials ornanostructures.- Where food/feed ingredients have been processed or formulated to form nanostructures.This category includes applications that involve processing food ingredients at nanoscale toform nanostructures or enhance taste, texture, and consistency of the foodstuffs.- Where nanosized, nanoencapsulated, or ENM (engineered nanomaterials) ingredients havebeen used in food/feed. This category includes nanoscale ingredients, including additives(such as colourants, flavourings, preservatives) and processing aids (including nanoencapsulatedenzymes) that can be produced for a variety of uses.- Biosensors for monitoring condition of food during storage and transportation. This categoryincludes packaging which includes indicators.- Other indirect applications of nanotechnologies in the food and feed area, such as thedevelopment of nanosized agro-chemicals (including fertilisers, pesticides etc.), or veterinarymedicines.Legislation relevant for NFA activitiesGeneral legislation - Food lawAccording to the European Parliament and Council Regulation (EU) No 178/2002 layingdown the general principles and requirements of food law:Article 14.1Food safety requirementsFood shall not be placed on the market if it is unsafe.Article 17ResponsibilitiesFood and feed business operators at all stages of production, processing and distributionwithin the businesses under their control shall ensure that foods or feeds satisfy the14

2.4 The National Veterinary Institute (SVA)The SVA does not have any ongoing activities in the areas of nanomaterials ornanotechnology. SVA might in the future commence work with nanotechnologies in the areasof vaccine development and diagnostics.2.5 The Swedish Agency for Non-Proliferation and ExportControls (ISP)ISP controls the export of military equipment and other products that may have both a civilianand a military use, so-called dual-use products. ISP handles cases concerning sanctions and isalso the national authority for the Chemical Weapons Convention. The vision is “Aresponsible control of strategic products – our contribution to a safer world”.According to the European Commission recommendations, ‘Nanomaterial’ means a natural,incidental or manufactured material containing particles, in an unbound state or as anaggregate or as an agglomerate and where, for 50 per cent or more of the particles in thenumber size distribution, one or more external dimensions is in the size range 1 nm-100 nm.But fullerenes, graphene flakes and single wall carbon nanotubes with one or more externaldimensions below 1 nm should be considered as nanomaterials.Military equipmentIn the Swedish military control list, nanomaterials or related technology is not mentioned. Butit is possible that nanomaterials are controlled due to their properties and application area.Nanotechnology can be used in many ways. Materials comprising new or improved propertiescan be very useful for military equipment and will therefore be controlled.Dual-use productsISP participates in four international export control regimes; Wassenaar Arrangement (WA),Australia Group (AG), Nuclear Suppliers’ Group (NSG) and Missile Technology ControlRegime (MTCR). Technical experts meet in these groups to discuss what kind of equipmentand technology that should be controlled. WA focuses on conventional arms and dual-usegoods and technologies. AG and NSG control transfer of dual-use goods and technologyrelated to weapons of mass destruction, chemical and biological weapons and nuclearweapons, respectively. Dual-use products related to missiles capable of delivering suchweapons are controlled by MTCR. The four international export control regimes mentionedabove contribute with lists of products and technologies to Council Regulation (EC) No428/2009. The regulation also includes chemicals related to the Chemical WeaponsConvention. ISP controls export of dual-use products included in category 1-9 in appendix Ito Council Regulation (EC) No 428/2009. Control paragraphs 1C003, 1E001, 3B001 and3E001 in the regulation are examples of how ISP is affected by nano.Paragraph 1C003.c controls magnetic materials and ’nanocrystalline’ alloy stripes withspecial properties. Here, ’nanocrystalline’ materials are materials having a crystal grain sizeof 50 nm or less, as determined by X-ray diffraction. 1E001 corresponds to the technology forthe development or production of materials specified in 1C.Paragraph 3B001 controls equipment for the manufacturing of semiconductor devices ormaterials and imprint lithography equipment capable of producing features of 180 nm or less,including nano-imprint lithography tool. Consequently paragraph 3E001 controls thetechnology for the development or production of materials specified in 3B.18

Outlook of ISPISP needs to stay up-to-date with new application areas for nanomaterials andnanotechnology. A main challenge will be to identify new and evolving companies in Swedenthat develop potential dual-use products or arms.2.6 The Swedish Chemicals Agency (KemI)Nanomaterials in the KemI action plan for a toxic-free everydayenvironment 2011–2014The Swedish Government has instructed the Swedish Chemicals Agency (KemI) to producean action plan for a toxic-free everyday environment. This assignment includes reporting onmeasures needed in the period 2011 - 2014 to reduce the risk faced by people in theireveryday lives of being exposed to hazardous chemicals and was published in March 2011(http://www.kemi.se/Start/Handlingsplan-for-en-giftfri-vardag/). Research in the areas ofhealth and environmental risks of nanomaterials (NM) is an area of concern in this actionplan.Nanomaterials in EU legislationAs concluded by the European Commission in 2008, nanomaterials are in principle coveredby the legislation for which KemI is the Swedish Competent Authority in the area where theyare used. However, nanomaterials are not explicitly mentioned in the applicable legislationconcerned with the hazards to health and the environment posed by the substances. Thelegislation is harmonised There is thus no scope for more liberal or stricter nationallegislation.Reach legislationThe information requirements in REACH are minimal for chemical substances that aremanufactured in or imported into the EU in low volumes, that is to say

including nanoforms. Relevant examples are the bulk form of zinc oxide which is classified ashazardous to the environment and the bulk form of cadmium, which is classified as hazardousto health and the environment.The general rule for chemicals is that if new information emerges that a substance fulfils thecriteria for classification and this substance has not yet been classified, this substance has tobe self-classified by the companies.Nanomaterials are not mentioned in either the Dangerous Preparations Directive(1999/45/EEC) or in Directive 2006/121/2006 of the European Parliament and of the Council.Nor are nanomaterials mentioned in the Global Harmonized System of Classification andLabelling of Chemicals (CLP, regulation (EC) No 1272/2008). . An important reason is thatknowledge is lacking on the relevance of available test methods for nanomaterials, whethernew test methods are required and if so how these should be designed.New criteria are usually not devised until relevant test methods have been developed in theOECD and other internationally recognised organisations. It is in principle already possibletoday to classify nanomaterials on the basis of available test methods and classificationcriteria, even if there is no unique identification number for this form. On the other hand,there is particular uncertainty over the validity of negative results in tests. Specificclassification of a substance at nanoscale is possible today.Previous and ongoing activities on nanomaterialKemI activities on nanomaterials comprise work on a national basis, in the OECD, in the EUand also in the Nordic co-operation.National activitiesKemI has for more than five years followed recent developments and has produced PMs andseveral reports on behalf of the Swedish Government. Activities proposed in the reports byKemI to the Ministry of the Environment to secure safe use of nanomaterials were• To formulate a definition of nanomaterial (now available as a CommissionRecommendation; see Appendix A)• To introduce a mandatory reporting system• To review the REACH and CLP regulations for applicability on nanomaterial in 2012• To promote targeted research grant programmes in the area of health andenvironmental risks• To obtain resources to take part in the EU and OECD activities on nanomaterial• To initiate co-operation between Swedish authorities dealing with nanomaterial• To contribute to the SAICM (Strategic Approach to International ChemicalsManagement) goal of increased dissemination of information to developing countries.Different Governmental assignments resulted in the following reports:• Nanotechnology – high risks with small particles? KemI Report No 3/08 (in English)This report is also available in Swedish: KemI Rapport Nr 6/07• The use of nanomaterials in Sweden 2008 – analysis and prognosis. KemI PM 1/09(Summary in English)20

• Nanomaterials – activities to identify and estimate risks. KemI PM 2/09 (Summary inEnglish)• Nanomaterials – need for regulations and other measures in the EU and in SwedenKemI Report No 1/10 (Summary in English)Further, in 2009, Vinnova (Swedish Governmental Agency for Innovation Systems) wasassigned with the task to develop a strategy for the nanotechnology area. This was inconsultation with the Swedish Research Council (VR) and after consulting the SwedishResearch Council for Environment, the Agricultural Sciences and Spatial Planning (Formas)and the Swedish Chemicals Agency (KemI).Current activities include projects on regulation of nanomaterials as well as projectsconcerning health and environmental risk aspects.Nordic Co-operationA number of meetings between the Nordic countries have taken place in the last few years.Issues discussed at the meetings have focused on legislation, testing methods and researchneeds.A Nordic contribution to the testing of nanomaterials in the OECD’s Sponsorship Programmetakes place through a project financed by the Nordic Chemicals Group in which KemI isrepresented. The project group consists of researchers from Denmark, Sweden, Finland andNorway. Silver has been chosen as test material and what is to be tested is the acute andchronic toxicity to earthworms.EUThe European Commission’s working group on nanotechnology - CASGNanoThe European Commission established in 2008 a working group on nanotechnology forcompetent authorities for the REACH regulation, the Competent Authorities Subgroup onNanomaterials (CASG Nano). The group, in which KemI is active, is expected to presentadvice and recommendations to the European Commission and the ECHA (EuropeanChemicals Agency) on how nanomaterials are to be handled in the various processes underthe REACH regulation, e.g. registration and information in the distribution chain, evaluationand authorisations.Three so called REACH Implementation Projects with the purpose to update the REACHguidance documents to be applicable to nanomaterials were set up by CASGNano. KemIparticipated in the drafting of substance identification, information requirements and chemicalsafety assessment. KemI further commented on the Commission Recommendation on thedefinition of nanomaterials (COM Rec on the definition of nanomaterials by 18 Oct 2011; seeAppendix A).OECDWorking Party for Manufactured Nanomaterials - WPNMKemI takes part in ongoing work in the OECD (the Organisation for Economic Cooperationand Development) to bring about greater knowledge of the risks to health and theenvironment caused by nanomaterials. The Working Party on Manufactured Nanomaterials(WPMN) under the OECD’s Chemicals Committee is to press for international collaborationon issues concerning health and environmental risks with regard to intentionallymanufactured nanomaterials. The WPMN has appointed a number of steering groups for thispurpose focused on information concerning research projects and research strategies, testingof representative nanomaterials (Sponsorship Programme), revision of the OECD’s guidelines21

for testing, exchange and comparison of data, risk assessment, alternative test methods andexposure. In addition, representatives from several of the steering groups, were tasked withdeveloping a guidance document for the test programme (Guidance Manual for Sponsors ofthe OECD Sponsorship Programme for the Testing of Manufactured Nano-materials).In the Sponsorship Programme thirteen different manufactured nanomaterials are underevaluation. This investigation is dependent on voluntary contribution from industry, membercountries, etc. For a Nordic input, see above under Nordic Co-operation”Via the OECD/WPMN programme KemI follows the work in the global organization forstandardization ISO ISO initiated during the autumn of 2005 work with standardisation withinthe nanotechnology area (Nanotechnology ISO/TC229) (ISO, 2009). The aim is to setstandards for (i) terminology and nomenclature, (ii) measurement methods andcharacterisation, (iii) health and environmental aspects of nanotechnology, and (iv) materialspecifications.Outlook of KemIWithin REACH and CLP, there are a number of issues where there is a need for guidance ormodified or new regulations for nanomaterials. Such issues include substance identification,the tonnage system, testing methods, chemical safety and risk reduction measures, andinformation in the supply chain.There is in this respect a need for increased information on nanomaterials as compared to bulkespecially considering testing methods for physical-chemical properties, information on thetoxicokinetics of nanomaterials and information on environmental exposure and aquatictoxicity.Further, KemI advocates the introduction of an EU-wide mandatory reporting system fornanomaterials. A common reporting system on nanomaterials in products within the EU canbe linked naturally to work on development of the REACH regulation.2.7 The Swedish Civil Contingencies Agency (MSB)MSB is an agency with responsibilities and activities within regulatory, supervisory,operational issues as well as research funding. Currently MSB has very few activities directlyrelated to nanomaterials. So far nanomaterials or nanotechnology has not been brought up inthe plan of operation at any level at the MSB. MSB is currently not involved in anyinternational collaboration regarding nano issues. An analysis of how the MSB regulationsrelate to risks and opportunities of nanotechnology is yet to be performed. As this has notbeen investigated so far the question whether nano issues might fall under the MSBregulations is still open. Currently no research projects directed or funded by MSB are goingon in the nano areaOutlook MSBMSB has not put much effort into the nano issue so far. The rapid development within thenanotechnology and the diversity of nanomaterials make it however plausible that there are anumber of areas where the nano issue is, or potentially will be connected with the activities ofMSB.A coming task is to compile an overview of which challenges will face the MSB and how therapid development in the nano area will affect future work of MSB.22

2.8 The Swedish Defense Research Agency (FOI)FOI – The Swedish Defence Research Agency is a governmental agency under the SwedishMinistry of Defence. In the areas of nanotechnology and nanotoxicology FOI performsresearch within defence and security related research programs [see e.g. S. Savage, Suited toDefence, Materials World 18 (3) 31-33 (2010) and Box 1, below].Nanotechnology is a fast growing area and engineered nanoparticles are increasingly used inindustrial applications, including electronics, pharmaceutical, energy, paper and pulp, andcleantech industries. There is no doubt that use of new nanotechnologies and nanomaterialswill be of great value in a number of applications ranging from microelectronics, medicine, tolarge-scale deployment in energy systems and environmental technologies. However,nanotechnologies may also introduce new unknowns, which eventually may cause adverseeffects to humans and the environment at some stage during their life-cycle. Herenanoparticles 5 , either alone or in combination with other environmental pollutants, have beenidentified as a new potential risk. Although there will be in some cases a limited choice ofmaterials without compromising on specific properties, life-cycle analysis at an early stage ofnanotechnology development is advisable before procurement and production.We are exposed to particulate matter originating from anthropogenic sources such as fires,industrial processes, and transportation. In some industrial work places the levels may also beelevated. It is generally recognised that we will become increasingly exposed also toengineered nanoparticles during the life-cycle of nanomaterials in the forthcoming decades.Defence research is currently engaged in several nanotechnology related R&D projects, someof which have already resulted in new products 6 . There is a need to scrutinise health andenvironmental risks of these developments. Furthermore, military and civilian personneldeployed in international peace keeping missions may be exposed to particulate emissionswhich are different compared with those in domestic environments.There is limited information concerning health effects of specific nanoparticles either alone orin combination with other substances. In addition to possible health aspects of the generalpopulation, there is limited information concerning specific vulnerable groups includingpatients with cardiovascular and respiratory diseases and children.A major challenge in the field is therefore to meet the increased release of nanoparticles withacquisition and analysis of relevant data for risk assessment, including• Physico-chemical characterisation of nanoparticles under relevant exposure conditions• Environmental fate• Health related and environmental exposure assessment including bioavailability andbiodistribution• Hazard assessment and dose-response relationshipsHere, collaboration between producers and other stakeholders together with regulatoryauthorities, and researchers across several disciplines are essential.5 A common definition is that nanoparticles have diameters < 0.1 μm, while ultrafine particles havediameters in the range 0.1 – 1 μm. The latter is the size range of environmental particles coming frome.g. emissions.6 The Swedish Armed Forces Nanotechnology Program 2002-2008 is one such effort, which up to nowhas resulted in several commercial nanotechnology products.23

Nanotoxicology activities at FOICurrent nanotoxicology activities at FOI consist of the following activities: 1) Fieldmeasurement of particle exposure, 2) Development of air sampling strategies and samplingtechniques, 3) Development of exposure systems for airborne particles, 4) Physical andchemical characterisation of environmental and manufactured nanoparticles, including sizeand composition of agglomerates in cells, 5) Cellular uptake and distribution of nanoparticlesin biological tissues and cells, 6) Studies of oxidative stress, inflammatory response, andimpact on asthma in combination with exposure to respiratory allergens. Box 1 lists recentreports and publications from FOI concerning nanotoxicology.National and international collaborationsWithin the field of nanotoxicology, FOI collaborates internationally with the NorwegianInstitute of Public Health and the US Air Force Research Laboratories in Dayton, Ohio, andcollaborates nationally with Umeå University, Karolinska Institute, and Uppsala University.FOI researchers are currently involved internationally in standardisation work (CEN), andnationally in the Swedish standards Institute (SIS) nanotechnology committee. FOI is alsorepresented in the NMP steering group of SwedishNanoTech, and in the advisory board of theFormas Nanosphere program.Box 1. Recent reports and publications in the nanotoxicological areaAndersson PO, Lejon C, Ekstrand-Hammarström B, Akfur C, Bucht A, Österlund L(2011) Polymorph- and size-dependent uptake and toxicity of TiO 2 nanoparticles inliving lung epithelial cells. Small 7: 514-23Gustafsson Å, Lindstedt E, Svensson-Elfsmark L, Bucht A (2011)Lung exposure of titanium dioxide nanoparticles induces innate immune activationand long-lasting lymphocyte response in the DA rat. Journal of Immunotoxicology,8: 111-21Ekstrand-Hammarström B, Akfur CM, Andersson PO, Lejon C, Österlund L, Bucht A(2011) Human primary bronchial epithelial cells respond differently to titaniumdioxide nanoparticles than the lung epithelial cell lines A549 and BEAS-2B.Nanotoxicology Jul 25 (ahead of print)Ramstedt M, Ekstrand-Hammarström B, Shchukarev A, Bucht A, Österlund L Welch M,Huck WTS (2009)Bacterial and mammalian cell response to poly (3-sulfopropyl methacrylate) brushesloaded with silver halide salts. Biomaterial 30:1524-31Wingfors H, Hägglund L, Magnusson R (2011)Characterization of the size-distribution of aerosols and particle-bound content ofoxygenated PAHs, PAHs, and n-alkanes in urban environments in Afghanistan.AtmosphericEnvironment 45: 4360-9Rzhepishevska1 O, Ekstrand-Hammarström B, Popp M, Björn B, Sjöstedt A, Antti H,RamstedtM (2011)The Antibacterial Activity of Ga 3+ is influenced by ligand complexation as well asthe bacterial carbon source. Antimicrobial Agents Chemotherapy 55: 5568-80FOI-report: Ahlinder L, Österlund L, Wiklund Lindström S (2011)Raman mapping and hyperspectral data analysis: a study of in vitro cellular responseto titanium dioxide and goethite nanoparticles. FOI-R--3126—SEFOI-report: Ahlinder L, Österlund L (2011)Hyperspektral analys av celler och vävnad exponerade för luftburna partiklar. FOI-R--2995—SEEDA-report: Österlund L, Wikström P, Wästerby P, Savage S, Ekstrand-HammarströmB, Leffler P (2008)Study on Nanotechnology into CBRN Defence. EDA report 07-R&T-002, pp. 1-8824

Collaboration between authoritiesDuring the last decade, FOI has performed research and literature reviews, and written reportsin the area of nanotechnology that have been financed for instance via external funding suchas by the Swedish Armed Forces, Nordic Innovation Centre, Swedish Defence MaterialAdministration, European Defence Agency, Formas and FAS as well as via projectscommissioned by other Swedish governmental agencies.Some important issues in safety assessment of nanotechnology and nanomaterialsSafety assessment of nanoparticles cannot yet be generalised based merely on chemicalcomposition, size or shape. As an example, we have studied anatase and rutile the two mostcommon polymorphs of titanium dioxide (i.e. TiO 2 materials with same chemical compositionbut different crystal structure). Anatase and rutile can be manufactured with various sizes (orare naturally occurring) and our studies (Andersson 2011; Ekstrand-Hammarström 2011)show that uptake and biological response of these particles in cultured lung cells is highlydependent on exposure conditions (cell media), and that this in turn depends on thephysicochemical properties of the agglomerate. This is governed by polymorph type (anataseor rutile), and strength of interaction between the individual nanoparticles. A consequence isthat the primary particle size is not directly correlated with cellular uptake. Taken together,different TiO 2 polymorphs, even with similar primary particle size, show very differentuptake, kinetics and inflammatory response due to differences in agglomeration properties(i.e. interaction between primary particles).Developing new materials and ensuring safety is a multidisciplinary task that requiresdevelopment of suitable screening systems which eventually must be performed on a case bycase basis. Structuring of toxicological data into models (ecosystem, animal and humanmodels) would be necessary, as well as more precise data on environmental fate and particlebioavailability and biodistribution after relevant routes of exposure. For this, there is a needfor validated test systems including validated detection methods in relevant matrices such asair, water and biological samples, biomarkers for exposure assessment and tests that addresssafety for sensitive groups. In all these above mentioned areas, well-characterisednanoparticles, and physicochemical characterisation is of great importance to be able tocompare, interpret and generalise data.Promote innovation of nanomaterials in parallel with health and environmental aspectsThere are many promises associated with nanomaterials and nanotechnologies. Today muchresearch is done in the areas of microelectronics, medical diagnostics, drug delivery, greennanotechnologies for solar hydrogen and solar electricity, air and water cleaning. Althoughmany of the new material may be safe to use we need methods to address these issues in alife-cycle perspective. The costs of developing new materials and products are normally large.Considering the promising technological opportunities, it is urgently needed to find ways topromote studies of safety issues to avoid unnecessary set-backs. Collaborative programs,including expertise in nanoscience, toxicology and health-risk assessment combined withcapability to study biological uptake, biodistribution and possible toxic effects should beencouraged.Outlook of FOIFOI strategies in nanotoxicology:• Follow national and international nanotechnological development with main focus onpossible impacts of new materials and technologies on societal security and humanhealth.25

• Develop methods to elucidate bioavailability and biodistribution of nanoparticles,including development of multidimensional in vitro and in vivo spectroscopic imagingtechniques.• Describe possible health effects with focus on exposure via inhalation.2.9 The Swedish Defense Materiel Administration (FMV)The Swedish Defense Material Administration is the Swedish Authority that is responsible forsupplying the Swedish Armed Forces with materiel, systems and methods. The procurementtask includes putting together the documentation for the enquiry, advertising the procurementand/or sending out tender enquiries directly, receiving tenders, assessing possible suppliers,evaluating tenders, notifying successful tenderers, concluding contracts and subsequentfollow-up action.Research ProjectsDuring 2003-2009 FMV together with FOI received an appropriation of 100 million SEKfrom the Swedish armed forces. The idea was to start projects in the nano area at universitiesand research institutes and also to involve companies. The goal was to make demonstrationstogether with companies, which could start production of nanotechnology and/ornanomaterial applications, which would be of great advantage for the Swedish armed forces.The four successful projects were:• Multispectral Camouflage Coating with different layers for different wavelengths forVIS&NIR, IR and RADAR.• Sensor protection from laser light or spots for optical devices and goggles.• Bio Nano Lab a mobile system for analysis of biological agents, lab on chips.• THz system. Nano-components for the THz region. Scanning of people at 25 mdistance.Purchasing routinesA main challenge for FMV is to identify the products that contain nanomaterials. Beforepurchasing FMV asks a few questions about the contents of the objects.• Are any chemical substances in nanoform, that is, a material with a structure where atleast one dimension is maximum 0.1 µm, intentionally added to the product?• What substances in nanoform have been added? Specify thechemical name and CAS no or EC no.• In which form (for example fullerenes, nanoparticles, and nanotubes) is the substance• added?• Are the substances in nanoform free or embedded in a matrix?• In what parts of the product are the substances in nanoform added?• What functions do the substances in nanoform have in the product?• Information on health or environmental effects of the nanomaterials in question, ifavailable.26

Outlook of FMVDevelopments in safety assessment as well as technical applications will be followed.Further efforts will be taken towards identifying uses of nanomaterials in products within theinterest area of FMV, and the work of developing purchasing routines for identification ofnanomaterials will be continued.2.10 The Swedish Environmental Protection Agency (NV)The main focus right now is to follow developments within the nano area until moreinformation is available concerning environmental effects and risks. Representatives from NVhave participated in different national meetings within the nano area arranged by otheragencies. Currently no nanorelated projects are going on r nor is NV participating in anyinternational forum in this field.The Environmental CodeThe general rules of the Environmental Code should be applicable to the nano area. Thepurpose of the Environmental Code is to promote sustainable development which will assurea healthy and sound environment for present and future generations. To achieve this, the codeshall be applied so that:• human health and the environment are protected against damage and detriment,whether caused by pollutants or other impacts• valuable natural and cultural environments are protected and preserved• biological diversity is preserved• the use of land, water and the physical environment in general is such as to securelong term good management in ecological, social, cultural and economic terms• reuse and recycling, as well as other management of materials, raw materials andenergy are encouraged so that natural cycles are established and maintained.The area of application of the Environmental Code is directly linked to the promotion ofsustainable development. The Code is applicable to all activities or measures that are ofsignificance for this purpose to be achieved. It therefore concerns all types of measures andoperations that can be of importance to those interests the Code is intended to protect,regardless of whether they are part of a private individual's daily life or are some form ofbusiness activity.The area of application of the Code is not just important for the situations in which the Codecan be used. Primarily, it decides what types of environmental issues that can be examined ina court of law, for example, a pre-condition that may be set for the start of an environmentallyhazardous activity might be anything that promotes sustainable development.All in all, this means in many cases that the regulations that were part of previousenvironmental legislation now have a new and broader application.Outlook of NVA challenge within the area is to be able to estimate possible environmental effects ofengineered nanomaterial. We are able to measure e.g. silver released to the environment ingeneral but not the nanoparticles per se. We have naturally formed air particles of all sizesincluding nanosize particles. The presence of nanoparticles is therefore not a new issue. Thechallenge is to be able to measure what is engineered material and what is not. So far the27

analyses have been concentrated to analysis of material attached to the particles with silver asone example.An area where research is needed is environmental effects of engineered nanoonmaterial. Thishas to be a basis for decisions on possible actions.Possible routes for engineered nanomaterial to reach the environment may be via sewagetreatment plants, waste deposits, landfills and other waste treatment operations. We howeverhave to await further development of test methods. Each type of nanoproduct will most likelyhave to be treated as a unique chemical agent.2.11 The Swedish National Board of Housing, Building andPlanning (Boverket)Boverket has responsibilities regarding the built environment, use of land and natureresources, town and country planning, building construction, management of the builtenvironment, and for issues regarding housing. Boverket does not participate in any workinggroup related to nano technology or nano materials. Boverket does not have any completed,ongoing or planned project or government assignment on nanomaterials.Relevant legislation and its applicabilityBoverket has mandate to provide legislation for the protection of hygiene, health andenvironment for construction works. According to the Planning and Building Regulations(2011:338) the following shall apply for construction works:Buildings are to be designed and built in such a way that they pose no unacceptable risk tousers or neighbours´ thygiene or health, particularly not as a result of1. Release of toxic gas,2. Presence of dangerous particles or gases in the air,3. Hazardous radiation,4. Pollution or poisoning of water or land5. Inadequate treatment of waste water, smoke, or solid or liquid waste, or6. Presence of moisture in parts of the works or on surfaces within the works. 7Boverket has the mandate to clarify this further in the Building Regulations, BBR, which hasbeen done for a number of areas but not specificcally to nanomaterials.7 Original text in Swedish: Egenskapskrav avseende skydd med hänsyn till hygien, hälsa och miljö9 § För att uppfylla det krav på skydd med hänsyn till hygien, hälsa och miljö som anges i 8 kap. 4 §första stycket 3 plan- och bygglagen (2010:900) ska ett byggnadsverk vara projekterat och utfört påett sådant sätt att det inte medför en oacceptabel risk för användarnas eller grannarnas hygien ellerhälsa, särskilt inte som följd av1. utsläpp av giftig gas,2. förekomst av farliga partiklar eller gaser i luften,3. farlig strålning,4. förorening eller förgiftning av vatten eller mark,5. bristfällig hantering av avloppsvatten, rök eller fast eller flytande avfall, eller6. förekomst av fukt i delar av byggnadsverket eller på ytor inom byggnadsverket.28

However, in the BBR (BFS 2011:6) Section 6:11 Materials, it is specified that materials andconstruction products used in a building should not negatively affect the indoor environmentor the building’s immediate surroundings when the requirements on function in theseregulations are met. 8Boverket also has a mandate to regulate chemicals in building products for the protection ofthe indoor environment. The mandate is found in section 29 of the Chemical Products andBiotechnical Organisms Ordinance (2008:245). 9 Before issuing such regulations, Boverketshould consult KemI or, if the regulation has consequences for transports, relevant transportauthorities.Outlook of BoverketThe construction sector constantly develops new materials, while information on compositionas well as environmental and health effects are not always satisfactory. The life span of abuilding is between 50-100 years. It is a challenge to make the manufacturers of buildingproducts provide information on composition and environmental and health impacts, and thatthe information then is used in decision making. Boverket currently lacks sufficientknowledge about environmental and health risks from nanomaterials. If evidence ofhazardous properties are found, Boverket will investigate the possibilities of regulationthrough the building legislation.8 Original text in Swedish: Material och byggprodukter som används i en byggnad ska inte i sig ellergenom sin behandling påverka inomhusmiljön eller byggnadens närmiljö negativt då funktionskraven idessa regler uppfylls.9 Original text in Swedish: 29 § Boverket får i fråga om byggprodukter meddela sådana föreskriftersom1. avses i 25 § första stycket 1, 10 och 13, och2. behövs till skydd för inomhusmiljön.Innan Boverket meddelar en sådan föreskrift, ska verket samråda med Kemikalieinspektionen. Omföreskriften har betydelse för transporter, ska verket också samråda med den eller de berördatransportmyndigheter som avses i 2 § förordningen (2006:311) om transport av farligt gods.Förordning (2010:1166).The reference in § 29 refers to the following text:25 § Kemikalieinspektionen får meddela föreskrifter om1. sådana kunskapskrav, försiktighetsmått och produktval som avses i 2 kap. 2–4 §§ miljöbalken ifråga om hantering, införsel och utförsel av kemiska produkter, biotekniska organismer och varor,/…/10. sådan produktinformation och uppgiftsskyldighet som avses i 14 kap. 19 § miljöbalken,/…/13. krav på tillstånd eller särskilda villkor för hantering, införsel och utförsel av kemiska produkter,biotekniska organismer och varor som utöver det som följer av 1–12 behövs från hälso- ellermiljöskyddssynpunkt.29

2.12 The Swedish National Council on Medical Ethics (Smer)The Swedish National Council on Medical Ethics (referred to as the Council in the following)is an advisory board to the Swedish government and parliament on ethical issues raised byscientific and technological advances in biomedicine. The Council actively followsnanomedical developments through horizon scanning, internal hearings and internationaldialogue with other national bioethical councils in the European Union.In October 2010, the Council, submitted an opinion entitled ‘Ethical aspects ofnanotechnology’ to the Government. The purpose was to draw attention to the ethical issuesraised by new nanosciences and nanotechnologies (N&N) research, and to emphasise theimportance of considering ethical aspects when designing future government initiatives forresearch and development. (Please find the opinion on www.smer.se).In the opinion the Council highlights the following areas:• EU regulations and commitments with regard to nanotechnology and ethics• Ethics in national nano strategies (Finland, Norway, Germany, the Netherlands, the UKand the United States)• Statements by national bioethics councils (France, Austria, Canada)• Ethical aspects of nanotechnologyMost recently professor Göran Hermerén represented the Council in a Polish Presidencyconference “Nanoethics” held in Warsaw, Poland, October 20-21 2011.The conference had aparticular focus on the EC Code of Conduct for responsible nanosciences and nanotechnologiesresearch outlined in the Commission Recommendation of 07/02/2008, and itsimplementation among the member states in the European Union.Ethical aspects of nanotechnologyWith regard to the ethical aspects of nanotechnology and nanomedicine, the followingproblem areas are particularly important:• Safety and risks• Research ethics and informed consent• Transparency and public debate• Equity issuesSafety and risksThe Council considers that research into the health and environmental risks is an area thatmust be prioritised, and therefore welcomes the Swedish Chemicals Agency’s proposal thatSweden should work to ensure that the EU and Swedish research funders set aside more fundsfor this purpose. Like the European Group on Ethics in Science and New Technologies(EGE), the Council also considers that substantial resources should be used to investigate theethical, legal and social implications (ELSI). The Council also wants to stress that the needfor additional research is urgent, as nanotech products are already on the market.Assessing and actively considering the risks that new technologies and research can involveby taking various measures is a prerequisite for new technologies and research to be able todevelop in a responsible way.Regardless of whether the precautionary principle is used to guide research and developmentof nanomedicine and nanotechnology, the risks associated with a specific nanomaterial/30

nanotech application must be assessed and actively dealt with if we want to act responsibleand avoid backlash. There are uncertainties and knowledge gaps concerning the effects ofnanomaterials on health and the environment, and the methods used to assess and managerisks must be improved.Research ethics and informed consentThe knowledge gaps in research of the risks associated with nanoparticles mean that it isdifficult to carry out clinical research and obtain informed consent from participating patients.It is important that decisions are taken in the best interests of the individual. The question iswhether the existing regulations in this area for research on human beings provide enoughprotection for the individual.It is fundamental that the research community itself has knowledge of, and continuouslydiscusses, the ethical implications that research findings and applications may have onindividuals and also on society as a whole. To achieve responsible development ofnanotechnology, the ethical discussion must be an integral part of the entire innovationprocess. Basic questions for the responsible and ethical researcher to reflect on are: Why andfor what purpose is the research being undertaken? Who will benefit from it? What furtherimplications and applications might the research findings lead to?Finally, it is important that nanotechnology is also critically evaluated, and that ELSI is animportant part of the background data before a new nanotech application or method isintroduced.Transparency and public debateNational bioethics councils in the EU hold continuous discussions on the various possibilitiesof involving society and citizens in the debate on bioethical issues, with the aim of creatingbroadly supported, legitimate decisions. The importance of public debate on nanotechnologyhas been emphasised by several bodies in the EU.To facilitate responsible development in nanotechnology and N&N research, the Councilconsiders that openness and transparency with regard to the ethical issues are required at allstages of development. If a broad discussion of the risk issues fails to materialise at an earlystage, there is a danger that research will be stigmatised, which was the case in thedevelopment of genetically modified organisms (GMOs) and led to consumer resistance inmany countries.The ethical issues should have a prominent role in dialogue and communication with thepublic. It is important that identification and evaluation of the risks and uncertainties anddiscussion of which research areas should be prioritised take place openly between differentactors and in dialogue with the public.Equity and social justice issuesThere are ethical implications in deciding what type of research projects are to be givenpriority. One question that is often asked is whether rich countries have a moral duty todevelop and share advanced technology that could benefit poor countries.The Council believes that the objectives of nanomedical research should be considered takinginto account the need for a more equitable distribution of health care resources and the aim ofachieving better global health.31

Other ethical issuesThere are also other ethical issues in the area of nanomedicine. How do we protect the privacyof the individual when more and more data, both medical and non-medical, is collected? Whathappens if the information obtained via refined nanomedical diagnostic tests is used by a thirdparty, e.g. insurance companies and employers? How do we ensure that patents onnanomedical technologies do not limit the availability of treatment on financial grounds? Afurther medical-ethical implication is whether nanotech diagnostic techniques should be madeavailable and offered in cases where there is no appropriate treatment available for thecondition in question. Ethical issues also arise around the opportunities offered bynanomedicine to enhance human capacities over and above what is typical or statisticallynormal. These are issues to do with our understanding of what it is to be human, society’sview of performance and disability, the right to care and our view of responsibility andautonomy.The Council considers an open discussion of these issues to be of fundamental importance tothe responsible development of nanotechnology.Outlook SmerDespite the fact that many nanotech methods, products and materials have already beenintroduced onto the market, there are major knowledge gaps with regard to the risks tohumans and the environment associated with nanoparticles. This is a result of a partial lack ofreliable test methods to investigate the health and environmental hazards of variousnanomaterials. The possibility of verifying the safety of a nanotech product and ensuring thatit is not hazardous before it is released onto the market must be a basic principle. Otherwise,we risk harming humans and the environment for many generations to come.In light of this, the Swedish National Council on Medical Ethics would like to particularlyhighlight the following points:• Research to determine the health and environmental risks associated with nanomaterials isurgently needed.• Risk analysis and ethical evaluation of research and new technologies are ongoingprocesses that must accompany and be integrated into all stages of innovation processes.Ongoing research and the pace at which knowledge changes mean that analyses must beconstantly reappraised. The knowledge gaps in the nanotech area have direct significance forethical discussions of how to proceed with research and various applications.• To ensure responsible development of nanotechnology, an ethical analysis must beintegrated into a future Swedish strategy on nanotechnology. It is crucial that the ethicalaspects are continuously taken into account at research and political level and in dialogue withthe public.• Ethical aspects must be taken into account in future considerations concerningnanotechnology and highlighted in research funding.2.13 The Swedish Patent and Registration Office (PRV)The PRV’s main activity is to search and examine patent applications, some of which aredealing with nanotechnology or nanomaterials. The PRV examines if the technology or thematerial, in the application, is patentable or not. The PRV also classifies patent applicationsaccording to the classification codes provided by the European Patent Office (EPO), and32

nanotechnology patents constitutes one class (labelled B82Y). This class is also divided intonine sub-categories:• nanobiotechnology or nano-medicine,• nanotechnology of information processing, storage and transmission,• nanotechnology for interacting, sensing or actuating,• nano-optics,• nano-magnetism,• nanotechnology for materials and surface science,• methods or apparatus for measurement or analysis of nanostructures,• manufacture or treatment of nanostructures, and• subject matter not provided for in other groupsPatents and patent applications are available in the Swedish Patent Database, which can beaccessed via the Internet (www.prv.se/spd/). In this database it is also possible to do a searchbased on classification codes.2.14 The Swedish Research Council for Environment, AgriculturalSciences and Spatial Planning (Formas)The Swedish Research Council Formas is a national research council that comes under theMinistry of the Environment. This means that Formas receives most of its financial allocationfrom this ministry. The rest of the allocation comes from the Ministry for Rural Affairs.The mission of Formas is to promote and support basic research and need-driven research inthe areas Environment, Agricultural Sciences and Spatial Planning. The research supportedshould be of highest scientific quality and of relevance to the areas of responsibility of theCouncil. Formas may also fund development projects to a limited extent.The Appropriation Directions set out the tasks which the Government entrusts to Formas.Reports on the progress of work on these tasks are continually submitted to the Governmentin the form of evaluations, state of the art, research strategies and research programmes.The work of Formas extends over three areas, support for research, strategy and analysis andresearch information. The result of the work is presented in Formas' annual report. Formas'three primary areas are:• Environment and Nature• Agricultural Sciences, Animals and Food• Spatial PlanningThe activities around nano at Formas are mostly financing of research projects within theareas of environmental technology (nanotechnology) and environmental pollution (risk withnano). Between 2004 and 2010 the research projects related to risks or applications ofnanotechnology and nanomaterials were granted the total amount of SEK 100 million.Outlook of FormasAt the moment Formas is not planning for a strategic call within the nano area. Howeverproposals concerning positive solutions for the environment involving nanotechnology andproposals concerning risk with nano have become more and more common and alsosuccessful in Formas annual open call during recent years.33

2.15 The Swedish Transport Administration (Trafikverket)Nanotechnology has developed extremely rapidly in recent years and chemical products andmaterials containing nano particles are found today in a wide range of applications in thebuilding and construction sector. There are also many potential areas for use which may berelevant in the future. Interest and questions surrounding nano technology have increased inrecent years and for Trafikverket and for the contractors they hire, it has become a verytopical issue.Trafikverket's ongoing nano projectTrafikverket is responsible for the new construction, operation and maintenance of thecountry's state-owned roads and railways, and the potential applications for nano technologywithin operations are many. Today we have limited knowledge of the extent of the use ofnano materials in Trafikverket's operations. To increase our understanding, Trafikverketinitiated a project in the spring of 2011 which was aimed at surveying the use of productscontaining nanomaterials. The project also considered the need for guidance and routines forthe use of nanoproducts. The project was completed in December 2011.The inventory reveals that nanomaterials are used primarily for the sealing and impregnationof different types of surfaces. More specifically, it involves the treatment of surfaces atstopping places, reflective foils on road signs, the sealing of safety posts, the treatment ofnoise protection, safety barriers, screens on roadside cameras and grouting in tunnels. Allproducts identified to have something in common, they all contain nano-size silica particles indispersion with either water or alcohol as a solvent.Further potential uses of nanomaterials have been identified in the project. Examples of suchareas include the protection of the bottoms of boats on road ferries, their use in toilets inferries' toilet and bathroom facilities and windows and also to protect against graffiti as wellas in the coating on overhead lines.The results of the project will be detailed in a final report. The report is expected tocontribute to increased knowledge about the use of nanomaterials in the construction sectorand the possible risks to health and the environment. Other operators within the constructionsector will also be able to make use of the project's results to make in-depth analyses of theirown operations.Challenges within the nanoareaChallenges and opportunities within the nano area are numerous. Nano technology can openup entirely new possibilities in technical applications at the same time as the potential risks tohealth and the environment must be addressed. Challenges specific for Trafikverket are:Identify nanomaterials in operationsOne difficulty is to identify the products containing nanomaterials and to become aware ofany new products that will be available in the future. The possibilities of identifying productstoday are small because legislation does not require that producers specify whether theproduct contains nanomaterials, neither in the product name nor in the safety data sheet.Managing potential risksThe lack of knowledge as to how nanomaterials´ impact on health and the environment leadsto difficulties in the evaluation of products. Knowledge of a macro-molecule's toxicological34

properties to the substance cannot be extrapolated in nano-scale. It is also unclear whether it ispossible to extrapolate effects between species. Trafikverket sees a major challenge as to howwork should be realised in order to assess the risks and evaluate products used in itsoperations.Trafikverket's chemical audit function is working systematically with the examination ofchemical products used in Trafikverket's operations. The criteria for auditing are harmonisedwith BASTA (The aim of the BASTA system is to speed up the phasing out of hazardoussubstances in constructions). These criteria do not currently take up nanocharacteristics at thesame time as it is not clear as to whether legislation within the chemicals sector is applicableto nanomaterials.The application of the Environmental Code's rules of considerationNanotechnology makes it possible for the development of new properties in materials andchemical products. In some cases the use of nano products reduces costs, e.g. cleaning cyclesare extended. At the same time, knowledge of the risks to health and the environment whenusing nanomaterials is extremely inadequate. Perhaps the greatest challenge in the nano areais how Trafikverket should apply the Environmental Code's rules of consideration such as theprecautionary principle and the product choice principle at the same time as the developmentand introduction of new technologies become possible. One of the key issues thatTrafikverket is working with today is how strict the precautionary principle should be appliedand whether the use of nanomaterials should be banned or regulated until more informationand knowledge is available about the potential risks.Outlook of TrafikverketTrafikverket is working actively to keep up-to-date with and follow developments in the fieldboth internationally and nationally. At present, Trafikverket does not participate in any workgroups within the OECD or EU that are dealing with the nano issue. Trafikverket plans,however, to maintain continued and active outlook of the field of nanotechnology and tofurther develop our knowledge of the possibilities and risks with nanoproducts within theconstruction sector.2.16 The Swedish Work Environment Authority (SWEA)The Swedish Work Environment Authority (SWEA) is the administrative authority for issuesrelating to the working environment. The Swedish Work Environment Act defines the outerframework of work environment regulation. This act does cover nanoparticles, as it states thatany substance that can cause harm to health or accidents only is allowed to be used undercircumstances that provide adequate safety. More detailed regulations are found in theprovisions on Chemical Hazards in the Working Environment, AFS 2000:4, which build onthe EU Council Directive 98/24/EC and on the protection of the health and safety of workersfrom the risks related to chemical agents at work and Council Directive 2004/37/EG on theprotection of workers from the risks related to exposure to carcinogens or mutagens at work.According to these provisions the employer should:• Perform a risk assessement.• Assess hazardous properties.• Collect information on properties and proper actions from the supplier, for instancethrough the material safety data sheet.• Indicate proper handling and protective equipment.• Assess the exposures.35

There is also a specified order of action steps to be taken,:• Substitution to substances of lower risk.• Working methods, processes and technical devices should be selected so that the risksare reduced.• Protective measures taken at the source.• Work should be restricted to certain times or locations.• Use of personal protective equipment (last resort measure).Of specific relevance for nanoparticles in the work environment are the requirements onrespiratory protective equipment. If the personal protective equipment is for respiratoryprotection, it should be a particle filter of class P3 (filters at least 99.95% of airborneparticles) which also should be controlled in a fit test in which particles down to 20 nm in sizeare measured inside and outside of the mask.SWEA participation in working groupsStandardisationSWEA participates in two working groups within the Swedish Standards Institute (SIS) thatare of relevance for the nano area:SIS TK 423 Luftkvalité, mätmetoder och exponeringbedömning [Air quality, measurementmethods and exposure assessment] (under ISO/TC 146/SC 2 Air Quality).SIS TK 516 Nanoteknik/AG 3 Miljö, hälsa och säkerhet [Nanotechnologies/Environment,health and safety] (under CEN/TC 229 Nanotechnologies).EU level groupsThe Senior Labour Inspectors Committee (SLIC) WG CHEMEX, which works with theconnection between REACH and national occupational health and safety regulations.The Scientific Committee for Occupational Exposure Limits, SCOEL, which produces thescientific substantiation for the EU’s occupational exposure limits 10 .Chemicals at the workplace, a working group of the Advisory Committee on Safety andHealth at Work 11 .National/Nordic groupsThe Swedish Criteria Group, which is the Swedish expert group providing scientificdocumentation for occupational exposure limits.The Nordic Expert Group, which is a Nordic collaboration for production of criteriadocuments on chemicals for occupational exposure limits.Completed projectsSWEA participated in the development of the ISO technical report “Workplace atmospheres –Ultrafine, nanoparticle and nano-structured aerosols – Inhalation exposure characterizationand assessment” (SIS-ISO/TR 27628:2007). This standard provides guidelines on how tocharacterise occupational nanoaerosol exposures.10 See also 95/320/EC: Commission Decision of 12 July 1995 setting up a Scientific Committee forOccupational Exposure Limits to Chemical Agents11 See also Council Decision 2003/C 218/01 of 22 July 2003 setting up an Advisory Committee onSafety and Health at Work and repealing Decisions 74/325/EEC and 74/326/EEC.36

In 2010 SWEA commissioned a systematic review of known hazards and exposures to carbonnanotubes in the work environment. The report was written by researchers from LundUniversity that are active within the Nano-Safety and Metalund networks and was publishedin early 2011 12 . This report contains an overview of the available toxicological knowledge,identifies knowledge gaps and outlines recommendations for possible protective measures inthe light of the current uncertainties.Outlook of SWEAThe future work of SWEA within the nano area holds many challenges, of which someexamples are:• Acquiring a basis for risk assessment of nanomaterials in the workplace.• Gaining sufficient knowledge of where and how nanoparticles are formed, and wherethey are used and handled.• Deriving occupational exposure limits and finding a suitable measure (e.g. mass, areaor number of particles)• Investigating and improving the applicability of REACH for nanomaterials• Striving for collaboration between DG Environment and DG Employment, SocialAffairs and Inclusion.2.17 Joint outlookRecurring themes among the different agency outlooks have been the need to gain furtherknowledge and to follow the developments in international regulations and other workgroups. Gaining knowledge concerns both the information of use of nanomaterials in societyand (eco)toxicological information.The regulatory agencies will continue to follow and/or take part in international groups andEU level regulations. From a supervisory perspective the main concern is to identify use ofnanomaterials, as there is currently no readily available system for this. In addition, theNational Food Agency also considers small scale laboratory studies, aiming at toxicity testingof substances occurring in foods. More knowledge of properties of nanomaterials andpotential effects on health and environment are urgently needed in order to derive the properregulatory tools, e.g. a suitable measuring unit for occupational exposure limits.All agencies have an interest in gaining further knowledge of the potential effects on healthand the environment of nanomaterials. Among the participants one agency is a researchinstitute, FOI, the Swedish Defense Research Agency. Areas of research within nanotoxicologythat are to be pursued concern bioavailability and biodistribution, and focus is also oninhalation exposure. As a research funding agency, Mistra is currently investigating thepossibilities for investing in programmes on nanotechnologies. Within the area of Formas nospecific nanotechnologies call is planned. As is pointed out by the Swedish National Councilon Medical Ethics, Smer, nanotechnologies might also contribute to other risks than those tohuman health and the environment. Questions of integrity and fairness are examples, andSmer highlights that ethical analysis should be integrated in strategies and policies as well as12 Gustavsson, P., Hedemer, M., Rissler, J. (2011) Kolnanorör – exponering, toxikologi ochskyddsåtgärder i arbetsmiljön. [Carbon nanotubes – exposure, toxicology and protective measures inthe work environment]Swedish Work Environment Authority, report 2011:1.37

in research calls. Some agencies also advocate a reporting system on nanomaterial inproducts.There are also agencies that are or could become users of nanomaterials. Among the agenciescurrently using, or actively consider introducing products that are suspected to containnanomaterials work is targeted at finding means to identify whether nanomaterials are presentor not in the procured products.3 The Nano workshopThe workshop started with presentations from seven of the participating authorities, in orderto get an overview of the different perspectives and actions already taken.• The Swedish Chemicals Agency – Maria Wallén• The National Food Agency – Lilianne Abramsson and Kettil Svensson• The Swedish Defense Research Agency - Ulrika Bergström• The Swedish Transport Administration - Malin Kotake• The Swedish National Council on Medical Ethics – Göran Hermerén• The Swedish Work Environment Authority – Claes Trägårdh• The Swedish Governmental Agency for Innovation Systems – Ulf HolmgrenThe detailed program and list of participants are included in Appendix B and the presentationsare included as Appendix C, both appendices are in Swedish.Before the discussions the other participants were also given an opportunity to presentthemselves and their agency’s relationship to nanomaterials briefly. Four questions were usedas a starting point for the joint discussion session:• What are the largest challenges within the nano field?• How to reach sustainable nanomaterial innovations, that is to have productdevelopment to go hand in hand with research on potential risks to health and theenvironment?• Which research is needed within the nano field from a government perspective?• Should there be inter-agency cooperation in the nano field?The following sections are structured according to these four questions.3.1 What are the largest challenges within the nano field?During the rounds of presentations several issues and challenges were brought up, the mainchallenges are summarised as follows. A common conclusion was that the amount ofnanomaterials in products will likely increase. As a first challenge the agencies have toidentify where nanomaterials can be found within each agency's responsibilities and/or area ofinterest. This concerns a wide scope of issues such as legislation, supervision, use by theagency and societal use. The second question pertains to the risk assessment methods. It iscurrently unclear whether risk assessment methods will be applicable for nanomaterials. Riskassessment methodology is developed for substances in the bulk, and there might beadditional challenges when risk assessing nanomaterials. In connection with the riskassessment challenge there are additional issues of methodological constraints. First,measurement and detection methods suitable for nanomaterials are lacking in many cases.Second, there are uncertainties regarding the appropriateness of currently available tests fortoxicological evaluation. The general concern at the workshop was that the current state of38

knowledge, and the associated uncertainties, will not suffice as a basis for decisions on riskmanagement measures. Knowledge is a prerequisite for agencies to act, and in addition to theones just described the following challenges were also brought up in the discussion.Applicability of regulationsSeveral participants lifted the question of how laws and regulations are, or should be,designed to capture the potential risks of nanomaterials, and do that in an efficient manner. Itis also desirable that regulation and policies at the same time encourage the development ofbeneficial (and safe) applications. That issue leads forward to the question of what can beconsidered as reasonable and effective testing requirements and risk assessment methodology.Also, performing tests and risk assessments should, as in REACH, lie on the producers andimporters.A large challenge for several agencies is also how to apply considerations outlined in theenvironmental code, such as the precautionary principle, the substitution principle and theknowledge requirements, in parallel with enabling development and introduction of newtechnologies. For instance, how strict should the precautionary principle be interpreted?Should use of nanomaterials be restricted or even banned until further knowledge on potentialrisks has been gained?Identifying use and occurrence of nanomaterialsObviously, it is very important for many agencies to find out which products that containnanomaterials. How should authorities, and other stakeholders, identify the nanomaterialsused in products available on the market? Nanomaterial content is generally not used as aselling point, so producers will not include information about nanomaterial content that way.For most products there are no regulatory requirements to label nanomaterial content either,so identifying nanomaterials in products will not be straight forward. However, from 2013nanomaterial ingredients in cosmetics will have to be identified as such in the list ofingredients. For food, the appropriate agency according to current regulations already isauthorised to have transparency in manufacturing, at least within the EU. However, itbecomes much more difficult to gain insight to the production that takes place in countriesoutside the EU. In order to know whether nanomaterials are present in food, analyticalmethods are needed. At this point, the discussion turned to the point of who should beresponsible for such analyses: the agencies or the manufacturers and importers? A concernthat was raised was that, if the responsible agency wishes to be certain about a particularproduct’s nanomaterial content, it may fall upon that agency to take the cost of analysingproducts upon arrival in the EU.Product registryKemI has in a previous report 13 proposed an EU-wide mandatory reporting of nanomaterialsin consumer products 14 . This suggestion was also brought up in the discussion, and severalgovernment officials thought it was an interesting proposal at first sight. The question of how13 KemI. 2010. Säker användning av nanomaterial. Behov av reglering och andra åtgärder. Rapportfrån ett regeringsuppdrag. Rapport nr 1/10.14 The subject is also under discussion within the EU, the DG Environment has commissioned a reportfrom the RIVM on the development of an inventory of nanomaterials in consumenr products. Thereport can be found at: http://ec.europa.eu/environment/chemicals/nanotech/pdf/study_inventory.pdf39

such a system would look like is a point that needs to be discussed in more detail. One initialquestion concerning the design of a reporting system was brought up: Should it be designed toidentify products with nanomaterials in them or for nanomaterials that may be present inproducts? This refers to the issue of whether it is more useful for agencies to know whichnanomaterials that are used in society or in what kind of products nanomaterials can be found,or possibly a combination of these two levels of information. Examples were brought up ofother countries that already have decided to introduce a national reporting system. The agencyrepresentatives expressed an intention to learn from these national experiences, while alsobalancing this with the intention not to wait too long to take action. It was also reported thatvoluntary reporting systems have been shown to be rather ineffective, which would be anargument for Swedish agencies to aim for a mandatory system.While discussing a nanomaterials registry, one person raised the issue of lack of knowledge ina different angle, if nanomaterials show to be without any risks, an undesirable outcome is tomake a registry of nanomaterials in products, and then it turns out in a few years that there arereally no hazards associated with the use of nanomaterials. Then we have a record of safenanomaterial, but it might be an unwarranted cost to administer such a registry.First exposuresThe first ones to be exposed to nanomaterials will most probably be persons working in thedevelopment and production of nanomaterial applications. Thus, a need for early actions is tobe expected for SWEA, as it is the agency responsible for occupational health issues. On theother hand, it is REACH and the CLP regulations that govern the information of hazards toworkers and consumers, e.g. through the rules on what should be included in material safetydata sheets (MSDS). For instance occupational exposure limits are to be given in the MSDS,but as mentioned earlier, there currently is no basis for setting such limit values yet, or testmethods to obtain it.3.2 How to reach sustainable nanomaterial innovations, i.e. tohave product development to go hand in hand with researchon potential risks to health and the environment?An official national policy or strategy for nanomaterials and nanotechnology could,depending on contents, be an important contribution to the aim of sustainable research anddevelopment. However, Sweden does not yet have a national nanotechnology programme.In the joint discussion it was mentioned that nanomaterials are not harmful to the environmentand health by definition. However, some asked whether the current state of uncertainty posesa reason to put a moratorium on the development of nanomaterials applications right now asthere is a dilemma between sufficiently managing the nanomaterial related risks and embracethe opportunities of the technology.Who should fund risk research?A first issue is to get some indication on how much funding should be targeted towardsdevelopment of applications and how much towards risk research. It was agreed that thecurrent proportions are unsatisfactory, as only about 5 per cent of the research funding tonanotechnology is aimed at funding of research on risks of nanomaterials or ethical, legal and40

social aspects of nanotechnologies. Also, within the current system of research funding, thefunding is often divided between innovation and risk research; it would be sensible to havecalls where risk and innovation are interwoven. A desirable future scenario is that when newmaterials are developed a proper risk characterisation is also performed, and that developerswork with several alternatives, so that they can choose the right material from a riskperspective. The aim would be to include a life cycle analysis already in the developmentphase. Specific calls for funding could be used as an incentive towards this aim.A database as an incentive for phasing out hazardous materialsMany participants agreed that nanotechnology poses a fantastic opportunity for innovationand growth. One participant pointed out that a database on nanomaterials, their presence andavailable knowledge could prove useful also when it comes to the innovation aspect. For itwould give developers information on certain materials found or suspected to be unsafe, sothat if the risks seem to outweigh the benefits the material can be avoided in research anddevelopment. If companies are using such information to opt out hazardous or questionablesubstances, maybe some of the concerns with the potential risks of the final products maydecrease. A database containing the available knowledge on nanomaterials might also havethe advantage that some substances may prove to be (probably) harmless, and then encourageinnovation that uses these substances. In this respect there is also the issue of deciding howmuch evidence is required in either direction.3.3 Which research is needed within the nano field from agovernment perspective?This question is closely linked to the issue of challenges; many of the challenges are expectedto be met by further research efforts. Two of the most acute challenges are the lack ofcurrently available analytical methods and lack of methods for safety testing. Thesechallenges are shared by most authorities, and are probably even greater for environmentalrisk assessment than the human health field.3.4 Should there be inter-agency cooperation in the nano field?Vinnova 1 previously proposed how a nano delegation could be designed, but no nanodelegation has so far been formed. The proposal was that the delegation should includerepresentation from relevant governmental agencies as well as other stakeholders.Starting to discuss collaboration and networking now is very timely for some authorities.However, all agencies participating in the workshop are in different stages of their work withthe nano issue. Also important to keep in mind is that all agencies are not regulatory agencies.It was agreed that some type of cooperation or network is desirable. Pressure from a group ofagencies will have a larger influence, for instance on issues such as calls for research funding,compared with the individual agencies.In the area of knowledge acquisition it is especially important with collaboration. It needs tobe knowledge transfer between government agencies because not all have the sameopportunities to participate in research. It should also not be forgotten that industry can be afruitful partner in knowledge acquisition contexts. Trafikverket, as a potential nanomaterialuser, especially emphasised that dialogue with suppliers, product developers and other nonagencyusers is important too. Starting an agency network is only a first step, the next41

question is how can and should government agencies interact with the non-agencystakeholders?The discussion of an inter-agency collaboration was concluded with the decision to formsome kind of nanonetwork, within which the authorities will have regular meetings (1-2 timesa year). It will be helpful to have a forum to discuss nanotechnology issues.KemI does not have a designated responsibility for the nano issue, and is not necessarily theagency that should coordinate this cooperation. KemI will, however, arrange the nextmeeting. KemI will also prepare a suggestion for a model of rotating meetings.4 Concluding remarksThe agencies participating in the work with this report represent regulators, supervisors,research institutions, research funders and also users of nanomaterials. The major outcome ofthe workshop in November 2011 was the agreement on the formation of an interagencynetwork and collaboration. This collaboration will facilitate knowledge transfer and broadenthe perspective of all actors. As nanomaterials only are a small part of each agency’s area ofresponsibility, a collaborative effort will hopefully have synergistic effects on the efficiencyof Swedish nanomaterials management. A recurring theme was the question of how to reach asustainable product development, because nanomaterials and nanotechnologies offer manyapplications beneficial to society.The aim of this report has not been to provide answers to questions, but to compile thequestions of different agency actors and to find common grounds and investigate the need forand potential of an interagency network regarding the nano issues.Nanomaterials do constitute a number of challenges for agencies. Nanomaterials are to beidentified, measured and characterised and the hazardous properties need to be evaluated.These are difficult issues since the scientific methods for meeting these challenges are oftenlacking. A first step is thus to derive suitable testing and analytical methods for nanomaterials.Research funding will obviously play a crucial role.42

Appendix A The European Commission’srecommendation for a definition of nanomaterials43

Appendix B Workshop invitation and programin SwedishVälkomna till en heldag om nano för berörda myndigheterKemikalieinspektionen bjuder in myndigheter vars verksamheter är berörda avnanoteknik och nanomaterial till ett möte för kunskaps- och erfarenhetsutbyte.Mötet ska ta upp olika myndigheters aktiviteter inom nanoområdet.I en efterföljande diskussion ska bland annat följande tas upp:• Vilka är de största utmaningarna inom nanoområdet för er myndighet?• Hur får vi en ansvarsfull innovationsutveckling att gå hand i hand med ev. hälso ochmiljörisker med nanomaterial?• Vilken forskning behövs på nanoområdet sett ur ett myndighetsperspektiv?• Behövs det myndighetssamverkan inom nanoområdet?Ställföreträdande generaldirektör Jan Hammar kommer att vara moderator för diskussionen.Kunskaps- och erfarenhetsutbytet ska också utmynna i en sammanfattande rapport.TidFredagen den 25 november 2011, kl 8.45-16.00.PlatsStockholmsområdet (återkommer om lokal).Anmälan och förberedelsematerialSkickas senast den 28 oktober till Linda Schenk på e-postadressen: schenk@kth.se. Anmälanbör innehålla namn, myndighet, e-postadress och telefonnummer. Anmälan är obligatorisk.MatLunch och fika.KostnadMötet inklusive mat och dryck är kostnadsfritt.FörberedelserInför mötet ber Kemikalieinspektionen inbjudna myndigheter om en kort sammanfattning påengelska av varje myndighets nano-aktiviteter. Beskrivningen bör vara på maximalt tre sidoroch skickas senast den 28 oktober 2011 till Linda Schenk, schenk@kth.se. Linda Schenksammanställer rapporten på uppdrag av Kemikalieinspektionen.Sammanfattningen kan till exempel innehålla information om följande:• myndighetens deltagande i arbetsgrupper både internt och externt, till exempel inomEU och OECD,47

• redogörelse av den egna lagstiftningens tillämpbarhet,• nano i den egna verksamhets- eller handlingsplanen,• beskrivning av avslutade, pågående och planerade projekt rörande nano samt ev.regeringsuppdrag,• en beskrivning av vilka de största utmaningarna på nanoområdet är för er myndighet.Sammanställningen kommer att ligga till grund för utformningen av mötesprogrammet.Program för dagen skickas därför ut efter den 28 oktober.Om inbjuden myndighet inte har möjlighet att vara med den 25 novemberFör att få rapporten så komplett som möjligt är det värdefullt om även de myndigheter sominte har möjlighet att delta på mötet ändå skickar en sammanställning senast den 28 oktober.Bakgrund till mötetI Kemikalieinspektionens handlingsplan för en Giftfri vardag 2011-2014 framhålls behovetav insatser för att nå en hög skyddsnivå för eventuella hälso- och miljörisker orsakade avnanomaterial.Inbjudan skickas till följandeArbetsmiljöverket, Boverket, Energimyndigheten, Formas, Forskningsrådet för arbetsliv ochsocialvetenskaper (FAS), Försvarets materielverk, Försvarsmakten, Havs- ochvattenmyndigheten, Inspektionen för strategiska produkter, Invest in Sweden Agency,Jordbruksverket, Kommerskollegium, Konsumentverket, Livsmedelsverket,Läkemedelsverket, Myndigheten för samhällsskydd och beredskap, Myndigheten förtillväxtanalys, Naturvårdsverket, Patent och registreringsverket, Rymdstyrelsen,Socialstyrelsen, Statens veterinärmedicinska anstalt, Stiftelsen för Miljöstrategisk forskning(Mistra), Stiftelsen för strategisk forskning (SSF), Trafikverket, Vetenskapsrådet, Vinnova,Arbetsmarknadsdepartementet, Finansdepartementet, Försvarsdepartementet,Justitiedepartementet, Kulturdepartementet, Landsbygdsdepartementet, Miljödepartementet,Näringsdepartementet, Socialdepartementet, Utbildningsdepartementet, Utrikesdepartementet.Väl mött!Agneta Falk-Filipssonenhetschef på enheten för riskbegränsning och stöd, avdelningen för industri och konsumentkemikalier48

Heldag om Nano för berörda myndigheterDatum: Fredagen den 25 november 2011Tid: Kl. 08.45-16.00Plats:Kemikalieinspektionen, Esplanaden 3A, SundbybergLokal: HavetProgram8.45 – 9.30 KAFFE/TE med smörgås9.30 – 9.45 Välkomna - Jan Hammar, stf generaldirektör för KemI9.45 – 10.45 Presentationer om nano-aktiviteter vid• Kemikalieinspektionen – Maria Wallén• Livsmedelsverket – Lilianne Abramsson• Totalförsvarets forskningsinstitut - Ulrika Bergström• Trafikverket - Malin Kotake10.45 – 11.15 Fruktpaus11.15 – 12.00 Fortsatta presentationer om nano-aktiviteter vid• Statens medicin-etiska råd – Göran Hermerén• Arbetsmiljöverket – Claes Trägårdh• Vinnova – Ulf Holmgren12.00 – 12.15 Översyn av nano i Sverige – Linda Schenk, KTH49

12.15 – 13.15 LUNCH serveras i anslutning till möteslokalen13.15 – 14.15 Kort om nano-aktiviteter vid• Miljödepartementet• Naturvårdsverket• Inspektionen för strategiska produkter• Myndigheten för samhällsskydd och beredskap (MSB)• Forskningsrådet Formas• Stiftelsen för miljöstrategisk forskning (Mistra)• Försvarsmakten• Försvarets materielverk• Socialstyrelsen• Läkemedelsverket14.15 – 14.45 KAFFE/TE med kaka14.45 – 15.45 Diskussioner – moderator Jan Hammar• Vilka är de största utmaningarna inom nanoområdet för er myndighet?• Hur får vi en ansvarsfull innovationsutveckling att gå hand i hand medeventuella hälso- och miljörisker med nanomaterial?• Vilken forskning behövs på nanoområdet sett ur ettmyndighetsperspektiv?• Behövs det myndighetssamverkan inom nanoområdet?15.45 – 16.00 Sammanfattning och avslutning – Jan HammarVäl mött!Agneta Falk-FilipssonEnhetschef på enheten för riskbegränsning och stödAvdelningen för industri-och konsumentkemikalier50

List of participantsClaes TrägårdhThe Swedish Work Environment AuthorityGabriela Balodis The Swedish Work Environment AuthorityUlrika Bergström The Swedish Defense Research AgencyLena StrålsjöThe Swedish Research Council for Environment, AgriculturalSciences and Spatial PlanningBirgit RamfjordThe Swedish Defense Material AdministrationAnnat KanthThe Swedish Armed ForcesLinda HinasThe Swedish Agency for Non-Proliferation and Export ControlLinda SchenkThe Royal Institute of TechnologyLuisa BecedasThe Medical Products AgencyTuija PihlströmThe National Food AgencyLilianne Abramsson The National Food AgencyKettil SvenssonThe National Food AgencyEvelyn Jansson Elfberg The National Food AgencyConny HäggThe Ministry of the EnvironmentChristopher Folkesson Welch The Foundation for Strategic Environmental ResearchClaes LöfströmThe Swedish Civil Contingencies AgencyBritta HedlundThe Swedish Environmental Protection AgencyGudrun CasselThe National Board of Health and WelfareAnders Berglund The National Board of Health and WelfareGöran Hermerén The Swedish National Council on Medical EthicsLotta ErikssonThe Swedish National Council on Medical EthicsMalin KotakeThe Swedish Transport AdministrationMona Lundcrantz The Swedish Transport AdministrationHans HolmenThe Swedish Transport AdministrationJessica SimonThe Swedish Transport AdministrationUlf HolmgrenThe Swedish Governmental Agency for Innovation SystemsFrom the Swedish Chemicals AgencyJan HammarAgneta Falk-FilipssonYvonne AnderssonSanna ArndtSusanne ClassonMats ForkmanStefan GabringLena HellmérMaria LindforsUlf RickMaria WallénChristoffer ÖsterwallMargareta Östman51

Appendix C Presentations given at the nanoworkshop• The Swedish Chemicals Agency - Maria Wallén• The National Food Agency - Lilianne Abramsson and Kettil Svensson• The Swedish Work Environment Authority - Claes Trägårdh• The Swedish Transport Administration - Malin Kotake• Swedish National Council on Medical Ethics - Göran Hermerén• The Swedish Defense Research Agency - Ulrika Bergström• Summary of the report: Mapping Swedish research and development - Linda SchenkThe presentations were given in Swedish.52

AktiviteterSäker användning av nanomaterialNanomaterial på Kemikalieinspektionen• OECD• EU• Nationellt• Vad händer nu?Maria Wallén, toxikologAvdelningen för industri- och konsumentkemikalierKemikalieinspektionenMyndighetsmöte om nanomaterial - KemI 2011-11-25www.kemi.sewww.kemi.seKemikalieinspektionenEn tillsyns- o expertmyndighet under Miljödepartementet• Ansvar i Sverige för– Reach-förordningen - industrikemikalier– Klassificerings- och märkningsförordningen CLP– Prövning av hälso- och miljökrav för godkännande avväxtskyddsmedel ätkdd dloch biociderid– Olika produktregler ex kemikalier i leksaker ochelektriska produkter• Tillsyn över tillverkare och importörer av kemiskaprodukter och varor• Nationellt produktregister – officiella statistikenOECD; Environment DirectorateWPMN Working Party on Manufactured Nanomaterialswww.kemi.sewww.kemi.seSponsorship Programme• Översyn av OECDs befintliga riktlinjer för testning av NM• Alternativa testmetoder• Exponering o exponeringsbegränsning• Riskbedömning av NM• Databas ffa forskningsaktiviteter• Testning av representativa NM”Sponsorship programme”OECD Programme on the Safety of Manufactured Nanomaterials 2009-2012: Operational Plans of the ProjectsSeries on the Safety of Manufactured Nanomaterials No. 22; 26-Apr-2010;ENV/JM/MONO(2010)11FullerenesSWCNTsMWCNTsDendrimersNanoclaysSilver nanoparticlesIron nanoparticlesGold nanoparticlesTitanium dioxideAluminium oxideCerium oxideZinc oxideSilicon dioxide---(Polystyrene)(Carbon black)www.kemi.sewww.kemi.se53

Phase IProblem formulation and scoping (exploratory)Nanomaterial Information and Identification; Material SafetyPhysical-Chemical Properties and Material CharacterizationEnvironmental Fate; Environmental ToxicologyMammalian Toxicology;Phase II Planning and conduct of risk assessment (additional)Additional testingtiPhase III Risk managementGuidance Manual for the Testing of Manufactured Nanomaterials:OECD’s Sponsorship Programme; first revision02-Jun-2010; ENV/JM/MONO(2009)20/REVPreliminary Guidance Notes on Sample Preparation and Dosimetry forthe Safety Testing of Manufactured Nanomaterials31-may-2010; ENV/JM/MONO(2010)25www.kemi.seCritical issues• Physical-chemical parameters• Sample preparation and dosimetry• Toxicokinetics• Information on enviromental fate• Inhalation toxicity• Aquatic toxicitywww.kemi.seEuropean CommissionReach Competent Authorities subgroup onNanomaterials CASG Nano• Definition – COM recommendation 18 oct 2011• Registrering – ämnesidentifiering, informationskrav• Testmetoder inklusive ”alternativa testmetoder” OECD• Kemikaliesäkerhetsbedömning - riskbedömning• Klassificering/märkning• Säkerhetsdatablad• Tillstånd och begränsningarwww.kemi.sewww.kemi.seKommissionens rekommendation av den 18oktober 2011 om definitionen av nanomaterial2. Nanomaterial är ett naturligt, oavsiktligt framställt elleravsiktligt tillverkat material som innehåller partiklar i fritttillstånd eller i form av aggregat eller agglomerat och där minst50 % av partiklarna i antalsstorleksfördelningen har en ellerflera yttre dimensioner i storleksintervallet 1–100 nm.KemI nationellt3. Med avvikelse från punkt 2 bör fullerener, grafenflagor ochkolnanorör med enkel vägg med en eller flera yttredimensioner under 1 nm betraktas som nanomaterial.5. …Ett material bör anses falla inom definitionen i punkt 2 ommaterialets specifika yta är större än 60 m 2 /cm 3 …www.kemi.sewww.kemi.se54

Rapporter från KemI om nanoteknik ochnanomaterial1. Nanoteknik – stora risker med små partiklarKemI Rapport Nr 6/072. Användningen av nanomaterial i Sverige 2008 – analysoch prognosKemI PM 1/093. Nanomaterial – aktiviteter för att identifiera ochuppskatta riskerKemI PM 2/094. Säker användning av nanomaterial - behov av regleringoch andra åtgärderKemI Rapport Nr 1/10•www.kemi.seFörslag från KemI till Miljödepartementet påaktiviteter om nanomaterial• Definition• Obligatoriskt rapporteringssystem• Se över befintlig lagstiftning för anpassning till NM• Riktade forskningsinsatser• Mer hälso- och miljöriskforskning• Medverka i OECDs och EUs verksamheter omnanomaterial• Initiera nationell myndighetssamverkan om nanomaterialwww.kemi.seBehov av revidering och/eller kompletteringav lagstiftningen (bl.a Översyn av Reach-förordningen 2012)• Definition av NM• EU-gemensamt rapporteringssystem för NM• Klassificering och märkningssystemet (CLPförordningen)anpassas till NM• Registrering av NM i Reach– Ämnesidentifiering– Utökat informationskrav (inklusive tillämpbaratestmetoder samt dosimetri och provpreparering)Tack för uppmärksamheten!www.kemi.sewww.kemi.se55

|Nanopartiklar och arbetsmiljöClaes Trägårdh, ArbetsmiljöverketFinns lagar?Ja, arbetsmiljölagstiftningen täcker även nanopartiklarAML : ämne som kan föranleda ohälsa eller olycksfall får användasendast under förhållanden som ger betryggande säkerhetFöreskrifterna om Kemiska arbetsmiljörisker AFS 2000:4 som byggerpå EU-direktivet 98/24/EG om kemiska agens i arbetet (CAD) samtcarcinogendirektivet t 2004/37/EG• Ag ska göra riskbedömning• Farliga egenskaper• Info om egenskaper och åtgärder genom leverantör i tex SDB• Hanteringssätt, arbetsutrustning mm.• ExponeringTips! Denna text ändras via menyfliken Infoga -> gruppen Text -> knappen Sidhuvud/sidfot 2011-11-29 1Tips! Denna text ändras via menyfliken Infoga -> gruppen Text -> knappen Sidhuvud/sidfot 2011-11-29 | 2Finns lagar? Forts.Planering av arbetetÅtgärdstrappan• Byt ut mot ämnen som medför mindre risk• Arbetsmetoder, processer och tekn. anordningar väljs så att riskenvid hantering reduceras• Skyddsåtgärder vid källan• Arbete på särskild tid eller plats• Personlig skyddsutrustning används (sistahandsåtgärd)Personlig skyddsutrustningPartikelfilter P3, avskiljning 99,95 %Testas enligt standarden SS-EN 143a) NaCl polydispers aerosol MMD = 0,6 µmb) Paraffinolja polydispers aerosol lognormalfördelad median Stokesdiameter (antalsfördelning) l = 04 0,4 µmFit testing of respiratory protective equipment facepeacesHSE OC 282/28Partikelräknarinstrument TSI Portacount Model 8020, ner till 20 nmKvoten partiklar utanför och innanför masken bestämsTips! Denna text ändras via menyfliken Infoga -> gruppen Text -> knappen Sidhuvud/sidfot 2011-11-29 | 3Tips! Denna text ändras via menyfliken Infoga -> gruppen Text -> knappen Sidhuvud/sidfot 2011-11-29 | 4Deltagande i arbetsgrupperStandardiseringSIS TK 423 Luftkvalité, mätmetoder och exponeringbedömning;ISO/TC 146/SC 2 Air QualitySIS TK 516 nanoteknik/AG 3 Miljö, hälsa och säkerhet, (CEN/TC 229Nanotechnologies)EUSenior Labour Inspectors Committee (SLIC) WG CHEMEX,kopplingen Reach/nationell arbetsmiljölagstiftningChemicals at the workplace, arbetsgrupp till Rådgivande kommittéenför arbetsmiljöfrågorDeltagande i arbetsgrupper, fortsEU forts.SCOEL, Scientific Committee for Occupational Exposure LimitsAVKriteriegruppen för hygieniska gränsvärdenNEG, Nordiska expertgruppen för kriteriedokument om kemiskahälsoriskerTips! Denna text ändras via menyfliken Infoga -> gruppen Text -> knappen Sidhuvud/sidfot 2011-11-29 | 5Tips! Denna text ändras via menyfliken Infoga -> gruppen Text -> knappen Sidhuvud/sidfot 2011-11-29 | 656

ProjektKunskapsöversikterKolnanorör – exponering, toxikologi och skyddsåtgärder i arbetsmiljönRapport 2011:1 Per Gustavsson m.fl. Lunds universitetStandarderdWorkplace atmospheres – Ultrafine, nanoparticle and nano-structuredaerosols – Inhalation exposure characterization and assessment(SIS-ISO/TR 27628:2007)Utmaningar• Underlag för riskbedömning på arbetsplatsen• Att Reach fungerar för nano• Hygieniska gränsvärden (massa, area eller antal)• Att få kännedom om var nanopartiklar hanteras, använd och bildas• Att DG Miljö och DG Sysselsättning, socialpolitik och inkluderingsamverkarTips! Denna text ändras via menyfliken Infoga -> gruppen Text -> knappen Sidhuvud/sidfot 2011-11-29 | 7Tips! Denna text ändras via menyfliken Infoga -> gruppen Text -> knappen Sidhuvud/sidfot 2011-11-29 | 857

Nano och matLivsmedelsrelaterade produkter• Energidrycker/sportpreparat• kosttillskott• bakteriedödande medel på hushållsredskap• hushållsprodukter (kylskåp, plastburkar, skärbrädor)• plastomslag och filmSyften med nanoteknologiEvelyn Jansson Elfberg, Lilianne A Zetterberg,Kettil Svensson• Ökad biotillgänglighet• Smak• Lukt• Konsistens• Förpackningsmaterial• -hållbarhet• -bakterieskydd• -barriäregenskaper•Förhandlingar om nyaförordningar pågår/har pågått i Bryssel• Livsmedelslagen, förordning178/2002:• Livsmedelsföretagaren är ansvarig för livsmedelsom sätts på marknaden ska vara säkra• Livsmedelsföretagaren ska dra tillbaka livsmedelfrån marknaden som inte är säkraTillsatser (förordning 1333/2008)• Om det sker en väsentlig förändring avproduktionsmetod eller det ursprungsmaterial somanvänds, eller vid en förändring avpartikelstorleken, t ex med hjälp av nanoteknik,ska den tillsats som tillverkats med dessa nyametoder eller material anses som en annan tillsatsoch återutvärdering eller ändring i specifikationenkrävas.Material och produkter i kontakt medlivsmedel (förordning 1935/2004)• …inte utgöra fara för hälsa, orsaka oacceptablaförändringar av livsmedlets sammansättning ochinte försämra dess organoleptiska egenskaper• Förordning 450/2009 om aktiva och intelligentamaterial och produkter avsedda att komma ikontakt med livsmedel ska användningen avnanomaterial regleras från fall till fall• Förslaget till förordningen om plast -nanomaterial regleras från fall till fall.58

Nya livsmedel (ej använts i störreutsträckning för konsumtion i EG före 15 maj1997)• Förordning 258/97 …de livsmedel till vilka mananvänt en ny produktionsmetod då denna innebärbetydande förändringar av livsmedletssammansättning eller struktur och som påverkardess näringsvärde, metabolism eller halten av ickeönskvärda ämnen.Vidare gäller för Nya livsmedel• Ett nytt livsmedel eller ny livsmedelsingrediens fårinte vara farlig för konsumenten, vilseleda ellerförändra livsmedelsingrediensen, det ska ej ersättapå ett sådant sätt att det blir negativt förkonsumenten(detta var med tanke på GMO)• NY FÖRORDNING nalkas !Förslag på ny förordning om Nyalivsmedel• Detta diskuteras:• Hur definieras nya livsmedel: …livsmedel sominnehåller eller består av konstrueradenanomaterial ( storlek?) Är konstrueratnanomaterial alltid ett nytt livsmedel? I så fallutvärderas från fall till fall?Tänkbara vägar in till maten (enlEFSA):Förpackningsmaterial: få studier,migration?Kapslar/dragéer: ingen informationom övergången inne i kroppenFoder till djur: ingen informationPesticider, veterinärprodukter,gödning: inget på den europeiskamarknadenRiskvärderingsaspekter :Några aspekter på toxstudier av nanoämnen:Stora kunskapsluckor:• liten erfarenhet av riskvärdering av nano i livsmedel• oro för mycket reaktiva nanopartiklar?• “ case by case” riskvärdering• exponering (olika exponeringskällor)?Behov av in vivo-data. Validerad in vitro-metod saknas.• Mest orala studier utförda på metaller och metalloxider• Bristfällig karakterisering• Få studier där nanoämnet givits i fodret• Få jämförande studier mellan nano och non-nanoformen (m.a.o.inga generella slutsatser kan dras)• in vitro till in vivo -experiment - överensstämmelse ?• Betraktas som genotoxiskt? Genotoxiskt vid höga doser gmoxidativ stress• Massa - antal partiklar – ytarea59

Seminarium om nanoteknologi och mat koncentration invitro, effekt / in vivoeffekt ? koncentration ? ingenriskbedömning!Efsa: Nanoämnen kan behövakarakteriseras i 5 steg vid riskvärdering:vid tillverkningisom tillsats/mtrlämne/pesticidi livsmedlet/simulanti test systemet (in vitro, in vivo)i människans blod, urin etcExponeringsscenarier nano (Efsa, 2011)Toxicitetstestning av nanoämne i livsmedel (Efsa, 2011)Typ av nanoämne:livsmedelstillsats, ämne i förpackning, pesticid etcFinns nanoämne i livsmedlet?NejJaTillsatt nanoämneVia migrationKvantifiering avmigrationenBeroende på t ex-Ingen migration; följ FCMvägledning eller,- Transformerad till non-nano ilivsmedlet före intag; följrelevant Efsa vägledning förnon-nanoformNanoämne absorberasfrån mag-tarmkanalen?(stabilt eller ADME info)NejJaIdentifiering och kvanti-fiering av nano/ non-nanonano(ev nedbrytning) i livsmedletIdentifiering och kvantifiering avnano/non- nano (evnedbrytning) i simulant ellerlivsmedelNanoämne överförs helt tillnon-nanoform nanoform i magtarmkanalen?JaNejJAUtför exponeringsuppskattning avnanoämnet med hänsyn till evnon-nanoformNanokvar ilivsm.?NEJUtför exponeringsuppskattning avnon-nanoformUtvärdera ev lokala effekter påmagtarmkanalen och evabsorption före transformering; -testa enligt relevant Efsavägledning för non-nano elleranvänd existerande informationNanoämne :In vitro tox test (Gentoxicitet):•Genmutationer i däggdjurs-celler•In vitro mikrokärntestIn vivo test;•ADME•Subkronisk oral 90 dagars(upprepad dosering)•In vivo gentoxicitet (om positiv invitro)?60

TrafikverketsNanoaktiviteterMalin KotakeTrafikverkets uppdragTrafikverket:• ansvarar för långsiktig planering avtransportsystemet för vägtrafik, järnvägstrafik,sjöfart och luftfart• ansvarar för byggande, drift och underhåll avstatliga vägar och järnvägar• Vi är en del av transportsektorn samt bygg- ochanläggningssektorn2 2011-11-29Trafikverket och nanoteknik/nanomaterialNuläget:• Kunskapsuppbyggnad pågår om kemiska produkter ochmaterial innehållande nanopartiklar som används iTrafikverkets verksamhet.• Trafikverkets nanoprojekt genomförs under 2011• Känd användning är rengöringsmedel för rastplatser ochvägskyltar.• Ingen aktiv styrning av användning – saknar kriterier förbedömning, riktlinjer samt rutiner• Användningen av kemiska produkter och materialinnehållande nanopartiklar förväntas spridas och öka.• Saknas kunskap om nanoprodukters risker för hälsa ochmiljöTrafikverkets nanoprojekt - värden• Inventering/kartläggning av befintlig användning gerkännedom om nanomaterials spridning ochanvändningsområden inom Trafikverket.• Sammanställning av forskningsläget och kunskapslägetgällande miljö- och hälsorisker kopplat till nanomaterialger underlag till analys, slutsatser för vidare arbete.• Riskbedömning ger underlag för att bedöma behovet avkompletterande krav och kriterier för nanomaterial samtbehov av styrning genom rutiner, riktlinjer mm.3 2011-11-294 2011-11-29Kartläggning inför inventeringInventering av nanoprodukter somanvänds i Trafikverkets verksamhet• Sammanställning av forskningsläget och kunskapsläget• Användningsområden inom bygg- ochanläggningsbranschen• Risker och möjligheter med nanomaterial/nanoteknikinom anläggningsbranschen• Användningsområden där nanoprodukter användseller har använts• Användningsområden där man är intresserad aveffekter som kan uppnås med hjälp av nanotekniksamt användningsområden där nanoteknik skullekunna förekomma5 2011-11-296 2011-11-2961

Resultat – har använt• Rastplatser - hygienutrymmen, bord• Vägmärken – reflexfolier• Kantstolpar• Bullerskydd• Sidobarriärer• Barriärelement och evakueringstunnlar• Injekteringsmedel – silicasuspension i bl a tunnlar• HastighetskamerorResultat – intresse av effekter, potentiellaanvändningsområden• Båtbottenfärger, färjornas hygienutrymmen• Klotterskydd• Självrengörande effekt på signalglas• Förhindra frost/isbildning på kontaktledning• Klotterskydd på broar• Impregnering på broar mot kloridintrång• Luftrenande asfalt, cement/betong, bullerskydd• Fog, spackel för bra hållfasthet• Specialsmörjmedel, universalfett, antikärvpasta7 2011-11-298 2011-11-29Slutsatser - inventering• Svårigheter att identifiera nanoprodukter- definition-märkning• Lågkunskapsnivå om nanoprodukter• Okänt om och hur nanoprodukter används• Intresse för nanoprodukters effekter – möjligheter och potentialRiskbedömning samt behov av krav, kriterier,riktlinjer och rutiner• Pågående arbete – klart dec 2011• Workshop 8 november - medverkan Kemi• Fortsättning 2012 – enligt resultat/slutsatser från projekt9 2011-11-2910 2011-11-29Utmaningar inom nanoområdet för Trafikverket• Identifiera nanomaterial• Hantera och bedöma potentiella risker• Tillämpa miljöbalkens hänsynsregler11 2011-11-2962

Etik och värdekonflikterNano: SMER påKemikalieinspektionenGöran Hermerén• De etiska problem somNT och NV aktualiserargäller inte barakonsumenters säkerhetoch risk-nytta.• Vem gynnas, vemdrabbas, vem fattarbesluten, vem har insynoch vem kan påverka?IPR? Info använd avtredje part?Arbetsgivare,• Framställningen börjarmed det som liggerkronologiskt nära i tiden:• SMERs debattartikel i DIoch skrivelse till regeringeng• Dessa har förberetts avflera av SMERs sakunniga• Som också medverkat iinternationellapublikationer ochkonferenser nära tio år,senast i WarszawaKronologin• Vinnova ochKemikalieinspektionenägnar mycket begränsaduppmärksamhet åt etiskaproblem. Riskfrågan• Både kunskap ochvärderingar krävs förriskvärdering. Vissakunskapsfrågor kartläggsmen värdefrågorna ärstyvmoderligt behandladeHuvudpunkter 1• De etiska aspekterna har haft enframträdande plats i såväl EUkommissionens som EUparlamentets arbete.• EGE fick av president Barroso ibehandlas, men ensidigt.uppdrag att skriva en rapport ometiska aspekter på nanomedicin,publicerad 2007, och• Kommissionen antog 2008 enrekommendation tillmedlemsstaterna (Code ofresponsible conduct in N&Nresearch).63

• Länder som gettsubstantiellt utrymmeåt etiska aspekter i sinananostrategierinkluderar Finland,Norge, Tyskland,Nederländerna,Storbritannien och USA–men inte Sverige.Huvudpunkter 2• Det finns redan tusentalsprodukter baserade pånanoteknik på marknaden.Frågor att diskutera inkluderar• risken att vi skapar ettnanosopberg som framtidagenerationer måste hantera.• En rad forskningsetiska frågoraktualiseras, i hög gradrelaterade till kunskapsluckorpå området vilket gör det svårtatt erhålla ett informeratsamtycke värt namnet.Huvudpunkter 3• Hur skall den s.k.försiktighetsprincipen tolkasoch tillämpas i dettasammanhang?• På vilka grunder skallforskningsprojekt prioriteras?• De som kan leda tillprodukter som kan säljas i derika industriländerna eller• Transparens och samhälleligdebatt är viktig föracceptans av nya tekniker.Detta har betonats av fleraorgan inom EU.• Vilka risker och möjligheterfinns att förbättramänniskan i olika avseendenmed nya tekniker, ochsådana som kan bidra till att • hur påverkar de människo‐minska gapet mellan i‐länderoch u‐länder?värde och den personligaintegriteten, samt rättviseochglobaliseringsfrågor?Huvudpunkter 4• Riskanalys och etiskutvärdering av forskningoch ny teknik är pågåendeprocesser som måste följaoch integreras i alla stadierav innovationsprocessen.• Etiken sätter inte baragränser. Konstruktiv etiskanalys kan mycket välstimulera till nynanoforskning.• Den forskning som finnsom riskhantering visar attom man inte på ett tidigtstadium• uppmärksammar risker ochför ett brett och öppetsamtal om grundläggandevärdefrågpr• kan hela teknikområdenråda ut för stigmatisering,som i debatten omgenmodifierade livsmedel.Vad kan vi lära av övriga Europa?European Group on Ethics•President Barroso har givit EGE iuppgift att skriva en rapport om etiskaaspekter på nanomedicin.•Den publicerades 2007 och skrevsmed utgångspunkt från ett europeisktetiskt ramverk•Senare kom kommissionens A codeof conduct for responsible NS and NTresearch (feb 2008) och EC har…• finansierat flera projekt som utrederetiska aspekterna av NV och NTOch internationellt….• Det finns en tidskrift somsärskilt ägnas åt etiskaproblem aktualiserade avnanoforskning: Nanoethics.• En omfattande antologipublicerades av Springerhäromåret: Fritz Allhoff,Patrick Lin (eds)Nanotechnology andsociety. Current andemerging ethical issues.Springer 2008.64

Vad återstår att göra i SMER perspektiv• En dialog och bred debatt, inte bara begränsad tillnanoforskarna, ersätter envägskommunikation• Utveckling och tillämpning av bättre metoder för riskanalys,beaktande nuvarande kunskapsgap och osäkerheter• Värdefrågorna synliggörs liksom etiska aspekter påsäkerhetsfrågor: beslut om säkerhetsstandards ochgränsvärden är inte etiskt neutrala• Riskbedömningens etik och försiktighetens pris måsteytterligare studeras/penetreras• En vidare dialog när det gäller kriterier för prioritering avforskning, som föreslogs i Code of Conduct 2008• Säkerhet och risk‐vinstproblem är inte de enda etiskafrågorna. Andra etikfrågor bör identifieras och analyseras.Framtida utmaningar• Framtida utmaningarinkluderar att skapaförutsättningar för endjupgående och bred debatt• om vilka värden som skallvara utgångspunkten för deval Sverige och Europa stårinför på kort och lång siktSlutsatser• Framtagandet avnanotekniska tillämpningarinom exempelvis hälso- ochsjukvårdsområdet gårstegvis. Vid varje stegaktualiseras etiska, socialaoch rättsliga aspekter.• Om dessa aspekterbehandlas innan man gårvidare, kan man undvikanegativa reaktioner hosallmänheten och attutvecklingen stoppas avonödig etikoro.• Det är av stor vikt attnanotekniken granskaskritiskt av andra än forskareoch näringslivet• De etiska, sociala ochrättsliga aspekterna utgören viktig del av underlagetinnan en ny metodintroduceras.• Därför väsentligt attpersoner med etiskkompetens ingår i den avVinnova föreslagnananoteknikdelegationen.65

UmeåCBRN-skyddoch säkerhetUmeåuniversitetNanopartiklarUppsalaUppsalauniversitetMaterialkarakterisering, exponeringsmätning,upptagskinetik och toxicitetUlrika Bergström, toxikologCBRN-skydd och säkerhet, FOI UmeåStockholmKarolinskaInstitutetInternationella samarbeten‣ Folkhelseinstitutet, Oslo, Norge‣ US Air Force Research Laboratories, Dayton, Ohio2011-11-25Tillverkade nanopartiklar som studerats av FOI- partikelkarakterisering och toxiska effekterNanopartiklar versus ”konventionella” substanser• Titanoxider: TiO 2•Andersson P et al Small 2011, 7, 514-23•Ekstrand-Hammarström B et al Nanotoxicology, 2011, Early Online, 1–12•Gustafsson Å et al J Immunotoxicol 2011 8:111-21• Wolframoxider: WO 3• Järnoxider: Fe 2 O 3 , FeOOHNanomaterial och dess tillämpningar har oftakomplexa strukturer och sammansättningStorlekFormYtareaYtaktivitetSammansättningNanostrukturAgglomereringOlika partikelmorfologier av samma material (TiO 2 ) uppvisarolika upptagskinetik pga agglomereringsegenskaperDistribution och identifiering av partiklar i levande cellerRaman mikrospektroskopia) b) c) d)(001)(001)(001)(011)(101)(101) (011)(101)(100)(100)(111)(101)(100)(110)a)P25/R9-10010Ramanmätning av P25 anatas Ramanmätning av R9 Rutilb)05y /m-52200P251150w vib=144 cm -1110050c)y /m-5550R94w 40vib=448 cm -133002205-10 0 10-5 0 5 100-5 0 5 1010anatasrutilP25 NP i cellkärnaP25 NP i cellkärnaKemisk reaktivitet: c > a > b >> dUpptag i celler: a >> b~dSmå, ’mjuka’ NP agglomerat (som anatas i ”P25”) tar siglättare igenom cellmembran än ’hårda’ agglomerat som rutilTitandioxidfigurer ur:* Österlund L (2010) Solid State Phenomena 162 (2010) 203-219.* Österlund L (2009) “Vibrational spectroscopy of pure and doped TiO2 photocatalysts”.In: On Solar Hydrogen and Nanotechnology (Ed.) Vayssieres L (Wiley & Sons, Singapore, 2009).Andersson PO, Lejon C, Ekstrand-Hammarström B, Akfur C, Ahlinder L,Bucht A, Österlund L. Small 2011, 7 (4), 514-23.

Olika partikelmorfologier av samma material (TiO 2 ) gerolika svar på oxidativ stress i lungepitelcellerSammanfattning• Nanoteknologin kan erbjuda nya material och produkter av stort värdeför samhälle och industri• Nanopartiklar kan tas upp i celler och agglomerering korrelerar medcellupptag och inflammatorisk respons• Arbetsrelaterad exponering• Känsliga grupper: patienter med lungsjukdomar eller skadad hud, barn…• Evaluering av exponering och effekter behöver göras för varje typ avpartikel. Kemisk/fysikalisk karakterisering viktig• Data som bygger på alla delar behövs för att bygga modeller. Kan idag integeneralisera utifrån yta, form eller sammansättning• Teststrategier, BiomarkörerKorrelation: upptag ↔ oxidativ stress• SamverkanAndersson PO, Lejon C, Ekstrand-Hammarström B, Akfur C, Ahlinder L,Bucht A, Österlund L. Small 2011, 7 (4), 514-23.Projektledare inom nanoforskning på FOI i Umeå• Lars Österlund*Fysiker (nanoteknik, nanopartiklar, beröringsfria mätmetoder – Raman)• Anders Bucht §Immunolog (partiklars påverkan på allergi och astma, inhalationsforskning)• Ola NerbrinkYrkesmedicinare (aerosolvetenskap/teknik)• Håkan WingforsMiljökemist (kemisk karaktärisering av partiklar/aerosoler)* Prof vid UU§ Adj. Prof. Vid UmU

UppdragetÖversyn av nano i SverigeLinda SchenkAvdelningen för filosofi, KTHAtt kartlägga• Hälso-och miljöriskforskning om nanomaterial• Forskning och utveckling/innovation gällandenanomaterial• Sammanställning av myndighetsaktiviteterschenk@kth.seUppdragetMetoderAtt kartlägga• Hälso-och miljöriskforskning om nanomaterial• Forskning och utveckling/innovation gällandenanomaterial• Publicerad forskning• Forskningsmedel för 2010• Enkät till företag• Sammanställning av myndighetsaktiviteterBibliometrisk analys100000Sweden nanoSweden nano-risk10000World nano-riskWorld nano10001001011985 1990 1995 2000 2005 2010Nano-risk ~1%Bibliometrisk analysMest publicerade länder, mätt i antalpublikationer.NanopublicationsNano riskpublications1USA 1. 1USA 1. 2. China 2. Germany3. Japan 3. China4.Germany 4. United Kingdom5.South Korea 5. Switzerland33.Sweden 19. Sweden68

Bibliometrisk analysForskningsmedel år 2010 (utbetalade)Mest publicerade länder, mätt i antalpublikationer.Nano Nano riskpublications publications1USA 1. 1USA 1. 2. China 2. Germany19. Sweden 3. China4.Germany 4. United Kingdom5.South Korea 5. Switzerland33.SwedenSveriges topp 51. Lunds universitet2. Chalmers3. KTH4. Uppsala universitet5. Linköpings universitetMiljoner Skr160140120100806040200100%90%80%70%60%50%40%30%20%10%0%Risks to environmentand health and ELSAInfrastructureApplication, Innovationand basic research4,5 % avforskningsmedlen 2010gick till riskforskning(inkl. ultrafina partiklar)Vilka universitet fick medel 2010?Svensk riskforskningiljoner SkrMi908070605040302010036Antal projekt finansierade under 20105239353996 5 37 7 31 2 1 1 1 1 1• Miljö- Nordmiljö AB- Göteborgs uni-Chalmers• ELSA-KTH-Chalmers• Hälsa-FOI-KI- Linköpings unisjukhus- Lunds uni-Umeå uni- Uppsala uni- Stockholm uni• Detektion&Mätning-SP(fokus industri)-FOI- Lunds uni-Örebro uni- Stockholm uniOBS: Ultrafina partiklar/avgaser inkluderade!Kumulativt antalFöretagens forskning och utvecklingOtherLife science andmedicineEnergy and cleantechElectronicsChemicalsAutomotiveEngineering industry90807060504030201001990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012Storlek på företagen somsvaradeAnt Anst. Ant Företag0 11-5 126-50 1951-250 3More than 250 13N=48n=82 Hur många är företagen?Definitionsberoende!Vinnova: 117 st25 av dessa ’nekade’ i år.Vi kontaktade 176 (197),OBS! väldigt breda kriterierNanoföretagens nanomaterial• 50% lägger mindre än 25% av sin forskningsbudget på nano• 38 av 48 jobbar med nanomaterial- Metaller och metalloxider vanligast, följt av kolbaserade- Nanopartiklar och tunnfilm• 20 tillverkar sina material själva- Köps även in från Sverige, EU, utanför EU• 10 företag tillverkar slutkonsumentprodukter- Elektronik, läkemedel/hälsoprodukter, fordonsrelaterat• Vad är fördelarna?- Nya egenskaper öppnar möjligheter- Enkom storleken- Hållbara material- Lägre kostnader (TiO 2 ?)-Inga69

Vad tycker företag om reglering?Slutsatser• Det finns ett behov av (risk-)reglering, inte nödvändigtviskopplat till företagens egen verksamhet• Behov av information och stöd gällande både riskhantering ochföretagsklimat (ekonomi/möjlighet till innovation)• Rättvis och faktabaserad lagstiftning. Antyder en viss kritikmot nuvarande omständigheter• Kritik mot hur termen nanomaterial har använts i olika fora(tex media), storlekens betydelse överskattas av många!• OBS: Företag/personer som tycker mycket! Representativt?• Mängden forskning på nanoområdet ökar- Publikationer- Forskningsmedel• Väldigt lite resurser går till nanoriskforskning- Verkar inte öka lika snabbt• Företagen är väldigt olika = har olika behov- Storlek, ålder, vetenskaplig bakgrund, branscher70

www.kemi.seSwedish Chemicals Agency, P.O. Box 2, SE-172 13 SundbybergPhone: +46 8 519 41 100, Fax: +46 8 735 76 98, E-mail: kemi@kemi.se