Swedish agencies and nanomaterials: Activities and developments

PM 4/12 Swedish agencies and nanomaterials: Activities and developments Swedish Chemicals Agency www.kemi.se

Swedish agencies and nanomaterials: Activities and developments

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

Preface The Swedish Chemicals Agency (KemI) has been assigned by the Swedish Government to produce a national action plan for a toxic-free everyday environment: Action plan for a toxicfree everyday environment 2011 2014 protect the children better. Efforts are now going on in several areas, both in Sweden, within the EU and internationally and often in cooperation with other authorities. Reducing chemical risks in the everyday environment is one step towards attaining the Swedish Parliament s environment quality objective 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 PM series elaborated by experienced colleagues, researchers or consultants. In this way, KemI presents new and essential knowledge in publications which can be downloaded from the website www.kemikalieinspektionen.se In the action plan there is particular focus on health and environmental risks with nanomaterials. Therefore KemI invited to a joint meeting on 25 November 2011 to get an overview of the nanorelated activites of Swedish government authorities. This report contains presentations of the different authorities activities within the nano area and notes from the following discussion. The main objective of the workshop was to investigate the need and suitable forms for an interagency collaboration. The report was compiled and edited by Linda Schenk at the Division of Philosophy at the Royal Institute of Technology. Project leaders and contacts at KemI were Lena Hellmér and Maria Wallén. Responsible for the project at KemI was Agneta Falk-Filipsson, Head of Unit, Risk Reduction and Support The report contains a collection of texts provided by participating agencies and a summary of the 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 and Lena 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 Appendix B.

Contents Summary... 7 Sammanfattning... 8 1 Introduction... 9 1.1 Scope and aim of this report... 9 2 Agencies summaries of nanoactivities... 10 2.1 The Foundation for Strategic Environmental Research (Mistra)...10 2.2 The Medical Products Agency (MPA)...12 2.3 The National Food Agency (NFA)...13 2.4 The National Veterinary Institute (SVA)...18 2.5 The Swedish Agency for Non-Proliferation and Export Controls (ISP)...18 2.6 The Swedish Chemicals Agency (KemI)...19 2.7 The Swedish Civil Contingencies Agency (MSB)...22 2.8 The Swedish Defense Research Agency (FOI)...23 2.9 The Swedish Defense Materiel Administration (FMV)...26 2.10 The Swedish Environmental Protection Agency (NV)...27 2.11 The Swedish National Board of Housing, Building and Planning (Boverket)...28 2.12 The Swedish National Council on Medical Ethics (Smer)...30 2.13 The Swedish Patent and Registration Office (PRV)...32 2.14 The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (Formas)...33 2.15 The Swedish Transport Administration (Trafikverket)...34 2.16 The Swedish Work Environment Authority (SWEA)...35 2.17 Joint outlook...37 3 The Nano workshop... 38 3.1 What are the largest challenges within the nano field?...38 3.2 How to reach sustainable nanomaterial innovations, i.e. to have product development to go hand in hand with research on potential risks to health and the environment?...40 3.3 Which research is needed within the nano field from a government perspective?...41 3.4 Should there be inter-agency cooperation in the nano field?...41 4 Concluding remarks... 42 Appendix A The European Commission s recommendation for a definition of nanomaterials... 43 Appendix B Workshop invitation and program in Swedish... 47 Appendix C Presentations given at the nano-workshop... 52

Summary This report is a compilation of the activities of Swedish agencies concerning nanotechnologies and nanomaterials. The aim of this report was to gain an overview of questions that Swedish agencies are involved with, and to investigate the need for and potential of an interagency network regarding nanotechnology and nanomaterials. Invitations to an interagency nanomaterials workshop were sent out to the eleven ministries within the Government Offices of Sweden and 27 government agencies or public funding agencies that were judged to have activities or interests related to nanotechnology in Sweden. In the invitation a summary of the nano activities was also requested for the purpose of this report and 16 agencies provided a text about their activities, three of these without participating at the workshop. In total, the following 17 agencies participated during the workshop on 25 November 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 Spatial Planning The Swedish Transport Administration The Swedish Work Environment Authority The major outcome of the workshop was the agreement on the formation of an interagency network for collaboration toexchange knowledge. This network will facilitate interactions between different agencies and will broaden the perspective of these actors. Nanomaterials constitute a number of challenges for agencies, some of which are shortly summarised here: To identify where nanomaterials can be found within each agency s sphere of responsibilities / 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 assessment methodology is developed for substances in the bulk, but there might be additional challenges 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

Sammanfattning Denna rapport är en sammanställning av verksamheten på svenska myndigheter gällande nanoteknik och nanomaterial. Syftet med projektet som redovisas i denna rapport är att få en överblick av frågor som svenska myndigheter arbetar med inom nanoområdet samt att utreda behovet av ett speciellt myndighetsnätverk angående nanoteknologi och nanomaterial. En inbjudan till ett myndighetsgemensamt seminarium om nanomaterial skickades till samtliga departement inom Regeringskansliet och 27 statliga myndigheter eller offentliga finansiärer som bedömdes ha aktiviteter eller intressen med anknytning till nanomaterial och nanoteknik i Sverige. I inbjudan efterfrågades också ett textunderlag till denna rapport. Sexton myndigheter har bidragit med en sammanfattning av sin nanomaterialsrelaterade verksamhet, tre av dessa utan att delta vid seminariet. Totalt deltog 17 myndigheter på seminariet den 25 november 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 Vinnova Det viktigaste resultatet av workshopen var önskemålet att bilda ett myndighetsöverskridande nätverk för samarbete och informationsutbyte i nanomaterialsfrågan. Detta nätverk kommer att underlätta möten mellan olika myndigheter och kommer att bredda perspektivet för myndighetsaktörerna. Användning av nanomaterial medför en rad utmaningar för myndigheter av vilka en del kort sammanfattas här: Att identifiera var nanomaterial kan finnas inom varje myndighets ansvars- eller intresseområde. 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 är utvecklade för bulkämnen och nanomaterial kan innebära nya utmaningar för riskbedömning. Mät- och detektionsmetoder saknas i många fall. För närvarande finns en brist på lämpliga toxicitetstester. 8

1 Introduction Nanotechnology has a potential to bring benefits to society offering unique opportunities for novel applications, ranging from more energy efficient and faster computers and mobile phones, to stronger and more durable materials, more efficient energy harvesting and storage devices, applications based on antimicrobial or self-cleaning properties and nano-medicine. While wishing to further the beneficial opportunities, agencies also need to address the concerns regarding risks to health and the environment and there is yet no established risk management strategy for nanomaterials which complicates the issue for agencies and other stakeholders. Regulatory applicability is an important issue for many agencies. National and international regulatory frameworks for chemicals in their different applications, e.g. industrial chemicals, pharmaceuticals, cosmetics, food and food contact materials, are considered to apply also to nanomaterials. Nevertheless, it is unclear how efficiently these current pieces of legislation and regulations will manage potential risks posed by engineered nanomaterials. One example is the European chemicals legislation, REACH. In this legislation the data requirements are associated to tonnage triggers. Although nanomaterials are covered by REACH, the amounts imported or produced often are expected to be too low to trigger the requirements of safety evaluation and testing. In addition, the current state of knowledge indicates that nanomaterials might 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 REACH might not efficiently manage the risks of nanomaterials. A major obstruction to the evaluation of regulatory applicability has been lack of a generally accepted definition of the term nanomaterial. A definition of nanomaterial was, however, recommended by the European Commission in October 2011 (see Appendix A). A number of countries have in the ten past years presented national research programmes and strategies regarding nanotechnologies, but Sweden has not yet adopted such a strategy. In 2009, the Swedish governmental authority for innovation systems (Vinnova), was assigned with the task to develop a proposal for a strategy for the nanotechnology area. The strategy was to target the issue of how opportunities and risks possibly associated with the use of nanotechnology may be safeguarded and monitored in the light of the rapid expansion within the area, and has been published by Vinnova 1. Among the proposals in this document was the formation of a nanotechnology delegation, which would work towards sustainable and successful implementation of nanotechnological applications in Sweden. 1.1 Scope and aim of this report This report has as an objective to give an overview of the nano-related activities of Swedish government agencies. These agencies might for instance be regulators, supervisors funding agencies, and/or users of nanomaterials. As such, different agencies have different perspectives on the nano area, and in a joint overview new insights might be gained. The Swedish Chemicals Agency (KemI) therefore invited to a joint workshop on 25 November 2011 at which nanotechnologies and nanomaterials were to be discussed. One important aim of 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-nanoteknik 9

Invitations were sent out to the eleven ministries within the Government Offices of Sweden and 27 government authorities or public funding agencies that were judged to have activities or interests related to nanotechnology in Sweden. All invited agencies were also asked to provide a summary of their nanomaterial- related activities in connection to the workshop, regardless of whether they were to participate or not. Sixteen agencies provided such summaries, and these are presented in section 2. Three agencies provided texts without participating in the workshop. At the workshop 17 agencies participated, the outline of the agenda and a summary of the discussions are presented in section 3. 2 Agencies summaries of nanoactivities The 16 agencies that have provided a summary are presented in alphabetical order in the following sections. The scope of each summary varies according to the agency s tasks and relation to nanomaterials. In the invitation the following topics were suggested as a starting point for the agency summaries: Agency participation in working groups both internally and externally, for example in the EU and the OECD. Statement of the applicability of the relevant regulations. Nanomaterials in the agency s business or action plan. A description of completed, ongoing and planned projects regarding nanomaterials. A description of the main challenges in the nanofield for the agency. The National Veterinary Institute (2.4), the Swedish National Board of Housing, Building and Planning (2.11), and the Swedish Patent and Registration Office (2.13) did not participate during the workshop described in section 3. 2.1 The Foundation for Strategic Environmental Research (Mistra) Mistra is an independent foundation which funds research aimed at providing solutions for environmental issues and sustainable development. Mistra identified the potential environmental impact of nanomaterials to be of special interest several years ago. Currently Mistra does not have any programmes with nanotechnology or nanomaterials in focus, but a number of previous projects have included nanotechnological applications or the effects of nanotechnology on society and environment (table 1). Some of these which were funded within the ProEnviro programme were cofunded with the Swedish Foundation for Strategic Research. 10

Table 1 Finished Mistra projects concerning nanotechnology. Title Institute Funding MSEK Period Main applicant Nanostructured photocatalysts Chalmers 8 2005 2008 Michael Zäch Macrospheres for hydrogen storage Wolfram Nano Composites Ecological and social sustainable development of nanotechnology Uppsala University Uppsala University Göteborg University 4,5 2006 2010 Lars Stenmark 2,9 2009 2010 Mattias Karls 6,9 2005 2008 Hans Fogelberg Some current research programmes use nanotechnology and related technologies as a tool (table 2). For example, researchers within E4-Mistra are developing methods to increase the cost and resource effectiveness of transport systems whilst at the same time reducing the emission of partially combusted fuels and nitrous oxides using nano-particulate catalysts. MistraPharma are developing systems to monitor and reduce the occurrence of pharmaceuticals in waste water. Among the purification processes being investigated are nano-particle based methods. Table 2 Mistra programmes using nanomaterials as a tool. Title Institute Funding MSEK Period E4-Mistra Chalmers 43 2006 2014 MistraPharma KTH 96 2008 2015 MASE MASE Laboratorier 58 2004 AB 2010 Marine Paint Göteborg University 84 2003 2010 Main applicant Jonas Edvardsson Christina Rudén Christopher Folkeson Welch Thomas Backhaus Outlook Mistra Mistra are currently investigating the possibilities for investing in a programme under the general title Solving Environmental Problems with Nanotechnology. A very rough division of nanotechnology has led to identification of the following areas. New nanomaterials Application of nanomaterials for solving environmental problems Environmental fate of nanomaterials Environmental and health impact of nanomaterials A possible call for programme proposals covering three of these areas may be published during 2012. 11

2.2 The Medical Products Agency (MPA) The responsibilities of MPA nanomaterial related activities are mainly connected to the EU level regulations of pharmaceuticals and cosmetics, which will be presented in the following sections. Legislation on cosmetics The 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 a separate article on nanomaterials (Article 16). In the compulsory notification of all cosmetic products to the EU Commission product registry, six months prior to placing the products on the market companies must indicate whether their products contain ingredients in the form of nanomaterials (Article 13 paragraph 1f ). This notification must be accompanied by extensive documentation regarding, e.g. specification of the nanomaterial, toxicological profile, safety evaluation and foreseeable exposure conditions. In addition, the annual emissions should be estimated. If the Commission suspects safety of a nanomaterial, the Commission shall request the opinion of the Scientific Committee on Consumer Safety (SCCS). The Commission can if necessary, issue restrictions concerning specific cosmetic products containing nanomaterials. The Commission may also initiate a review of a nanomaterial and change the regulatory requirements specified in the previous paragraph with regard to new information and scientific developments. The Commission shall publish a list of all nanomaterials used in cosmetics and submit an annual progress report to the European Parliament which, among other things, provides statistics on the use of nanomaterials and the development of assessment methods and guidelines for safety assessment of nanomaterials. The regulation defines nanomaterial as "an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm." (Article 2, paragraph 1 k and 3). The Commission shall, in accordance with this regulation periodically review the rules on nanomaterials and propose changes to the definition. The first review should be performed before 11 July 2018. Furthermore, the regulation establishes rules concerning labelling of nanomaterials. All ingredients present in the nanomaterial form shall be followed by "(nano)" in the list of ingredients (Article 19 paragraph 1g). In this way, consumers can get information about which products contain nanomaterials. In order to prepare for the implementation of the regulation, a working group on market surveillance in the European Commission (PEMSAC - Platform of European Market Surveillance Authorities for Cosmetics) will control nanomaterials. In 2012, cosmetic products using nanomaterials will be mapped. Thereafter, the working group intends to analyze 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 and whether 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 2009 on cosmetic products. Official Journal of the European Union L342/59 12

Nanomaterials are also discussed within international cooperation, International Cooperation on Cosmetic Regulation in which, amongst others, the European Commission participates. At the last meeting appropriate methods for characterising nanomaterials have been surveyed and discussed. Ongoing activities within the European Medicines Agency (EMA) The approval of pharmaceuticals is regulated by Directive 2001/83/EC, and thus a major part of the nanotechnology related work of MPA in the area of pharmaceuticals is performed within the framework for EMA. According to the EU regulations, the marketing company must present sufficient information to demonstrate that the benefits of the product outweigh the risks. Currently, there are no special rules for handling nanomaterials in pharmaceuticals in the approval process. However, any issues that relate specifically to the nanomaterial properties should be addressed on a case by case basis. EMA has started a number of groups in order to discuss the potential harmful properties and the innovation possibilities of nanomaterials in the pharmaceutical field. In 2010 EMA held a seminar "1st International Workshop on Nanomedicines" targeted at collecting information from member states and stakeholders. MPA was not represented at this seminar, but a report has been published and is available at the MPA s webpage 3. According to this report it was concluded that to make use of the benefits of nanotechnology for developing new pharmaceuticals (more knowledge and global expertise are needed. During the autumn of 2011, EMA was forming a multidisciplinary working group for a continued dialogue between experts in the nano field. EMA will also conduct a review of the pharmaceutical legislation and provide opportunities for scientific developments that benefit patients. Outlook MPA MPA 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 materials and food additives and in an EU Council working group for the regulation of novel foods. The issue of nanotechnology is presently discussed in these working groups. Application as Member within the Efsa Scientific Network on risk assessment of nanotechnologies in food and feed is ongoing. Conditions for risk assessment of nanomaterials in food and feed Risk assessments of chemical substances comprise two important factors; exposure and toxicity. Concerning exposure to a nano substance (< 100 nm) two important properties should 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 to Efsa (The European Food Safety Authority), adequate characterisation of a nano substance is essential for establishing its identity and physico-chemical forms in food products and under 3 www.ema.europa.eu/ema/pages/includes/documents/open_document.jsp?webcontentid=wc5000983 80 13

testing conditions, i.e. the determination of physico-chemical characteristics is important for the subsequent experimental design and for the exposure assessment. Moreover, from the toxicity point of view the characterisation of the nanosubstance as present in biological fluids and tissues is important particularly for the ADME (absorption, distribution, metabolism, excretion) studies. Furthermore, toxicity test models and standard testing protocols used for non-nanoform substances may not necessarily be appropriate or optimal for the testing of nano substance.therefore the present standard toxicological methods need to be further developed or at least fine-tuned. In conclusion, there are currently uncertainties related to the identification, characterisation and detection of a nanosubstance. Similarly, there are a number of uncertainties related to the applicability of current standard biological and toxicological testing methods to nano substances. Overall this implies that at present it is not possible to carry out a proper risk assessment of a nanomaterial. Applications foreseen by EFSA The following broad categories of nanotechnology applications in the food and feed sector have been described (Chaudhry et al., 2008; Observatory-nano, 2009): - Where nanotechnology processes and materials have been employed to develop food contact materials (FCM). This category includes nanomaterial-reinforced materials (also referred to as nanocomposites), active FCM designed to have some sort of interaction with the food or environment surrounding the food, and coatings providing surfaces with nanomaterials or nanostructures. - Where food/feed ingredients have been processed or formulated to form nanostructures. This category includes applications that involve processing food ingredients at nanoscale to form nanostructures or enhance taste, texture, and consistency of the foodstuffs. - Where nanosized, nanoencapsulated, or ENM (engineered nanomaterials) ingredients have been used in food/feed. This category includes nanoscale ingredients, including additives (such as colourants, flavourings, preservatives) and processing aids (including nanoencapsulated enzymes) that can be produced for a variety of uses. - Biosensors for monitoring condition of food during storage and transportation. This category includes packaging which includes indicators. - Other indirect applications of nanotechnologies in the food and feed area, such as the development of nanosized agro-chemicals (including fertilisers, pesticides etc.), or veterinary medicines. Legislation relevant for NFA activities General legislation - Food law According to the European Parliament and Council Regulation (EU) No 178/2002 laying down the general principles and requirements of food law: Article 14.1 Food safety requirements Food shall not be placed on the market if it is unsafe. Article 17 Responsibilities Food and feed business operators at all stages of production, processing and distribution within the businesses under their control shall ensure that foods or feeds satisfy the 14

requirements of food law which are relevant to their activities and shall verify that such requirements are met. Article 19 Responsibilities for food: Food business operators. If a food business operator considers or has reason to believe that food which it has imported produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market and inform the competent authorities thereof. Food additives According to European Parliament and Council Regulation (EU) No 1333/2008 on food additives: Article 6.1 General conditions for inclusions and use of food additives in Community lists. A food additive may be included in the Community lists in Annexes II and III only if it meets the following conditions and, where relevant, other legitimate factors, including environmental factors. It does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer at the level of use proposed: Article 12 Changes in the production process or starting materials of a food additive already included in a Community list. When a food additive is already included in a Community list and there is a significant change in its production methods or in the starting materials used, or there is a change in the particle size, for example through nanotechnology, the food additive prepared by those new methods or materials shall be considered as a different additive and a new entry in the Community lists or a change in the specifications shall be required before it can be placed on the market. Novel Food European Parliament and Council Regulation (EU) No 258/1997 concerning novel foods and novel food ingredients: Article 1.2 (f) Food and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances. Information: Regulation of Novel food is on hold at present in the Commission as EP voted against due to the cloning item. Member states are waiting for a new proposal from the Commission with or without the question of cloning. In March 2010 the following was agreed upon by the member states. 15

Position (EU) No 6/2010 of the Council at first reading With the view to the adoption of a Regulation of the European Parliament and of the Councilon novel foods, amending Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97 AND Commission Regulation (EC) No 1852/2001. Adopted by the Council on 15 March 2010. Definition of engineered nanomaterial in proposed new regulation of Novel food: Article 3 Definitions 3.2 (a) novel food means food that was not used for human consumption to a significant degree within the Union before 15 May 1997, including: 3.2 (a) (iv) food containing or consisting of engineered nanomaterials; (which means Engineered nanomaterials are always novel food independent of significant changes.) 3.2(c) engineered nanomaterial means any internationally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale. Properties that are characteristic of the nanoscale include: i) Those related to the large specific surface area in the materials considered; and/or ii) Specific physico-chemical properties that are different from those of the non-nanoform of the same material; Food contact material According to article 3 of the European Parliament and Council Regulation (EU) No 2035/2004: 1. Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could: (a) endanger human health or (b) bring about an unacceptable change in the composition of the food; or (c) bring about a deterioration in the organoleptic characteristics thereof. 2. The labelling, advertising and presentation of a material or article shall not mislead the consumers. These provisions apply to all food contact materials including nanomaterial. According to article 5 of the food plastics Regulation (EU) No 10/2011 only substances evaluated by EFSA and authorised by the European Commission are allowed in the manufacture of plastic layers in plastic materials and articles. And as stated in preamble (27) of the regulation nanoparticles should be assessed on a case-by-case basis as regards their risk until more information is known about such new technology. To date the only application with nanoparticles approved is titanium nitride, as a production aid for use of up to 20 mg/kg in PET plastics. No migration to the packed food was identified. Food information to consumer Regulation of the European Parliament and of the Council (EU) No 1169/2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, 16

Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004,Annex to regulation on the provision of food information to consumers: 25) In order to inform consumers of the presence of engineered nanomaterials in food, it is appropriate to provide for a definition of engineered nanomaterials. Taking into account the possibility of food containing or consisting of engineered nanomaterials being a novel food, the appropriate legislative framework for that definition should be considered in the context of the upcoming review of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients. 4 Article 2.2 (t) "engineered nanomaterial" means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale. Properties that are characteristic of the nanoscale include: (i) those related to the large specific surface area of the materials considered; and/or (ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material. Article 18 3. All ingredients present in the form of engineered nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word "nano" in brackets. 4. Technical rules for applying paragraphs 1 and 2 of this Article are laid down in Annex VII. 5. For the purposes of achieving the objectives of this Regulation, the Commission shall, by means of delegated acts in accordance with Article 51, adjust and adapt the definition of engineered nanomaterials referred to in point (t) of Article 2(2) to technical and scientific progress or to definitions agreed at international level. Outlook of NFA The issue of nanotechnology is presently discussed within NFA and a number of people of the staff are partially engaged in this area. Regulatory projects encompass participation in the present overview initiated by KemI. Regarding research projects, some preliminary ideas about small scale laboratory projects including in vivo (and in vitro) experiments on substances occurring in food are presently discussed. Control will be a challenge. Although there are some specific restrictions/rules which apply to nanomaterials within the food legislation, as pointed out above, the flow over the Internet of nanoproducts (e.g. food supplements) and imported nanoproducts to small retailers/dealers creates an important problem. Taking into account the huge problem of characterisation and measuring nanoparticles/substances in e.g. food supplements, this completely makes it impossible to control the nanoproducts on the EU market despite the fact that there is some specific food legislation already. 4 OJ L 43, 14.2.1997, p. 1. 17

2.4 The National Veterinary Institute (SVA) The SVA does not have any ongoing activities in the areas of nanomaterials or nanotechnology. SVA might in the future commence work with nanotechnologies in the areas of vaccine development and diagnostics. 2.5 The Swedish Agency for Non-Proliferation and Export Controls (ISP) ISP controls the export of military equipment and other products that may have both a civilian and a military use, so-called dual-use products. ISP handles cases concerning sanctions and is also the national authority for the Chemical Weapons Convention. The vision is A responsible 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 an aggregate or as an agglomerate and where, for 50 per cent or more of the particles in the number 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 external dimensions below 1 nm should be considered as nanomaterials. Military equipment In the Swedish military control list, nanomaterials or related technology is not mentioned. But it 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 properties can be very useful for military equipment and will therefore be controlled. Dual-use products ISP participates in four international export control regimes; Wassenaar Arrangement (WA), Australia Group (AG), Nuclear Suppliers Group (NSG) and Missile Technology Control Regime (MTCR). Technical experts meet in these groups to discuss what kind of equipment and technology that should be controlled. WA focuses on conventional arms and dual-use goods and technologies. AG and NSG control transfer of dual-use goods and technology related to weapons of mass destruction, chemical and biological weapons and nuclear weapons, respectively. Dual-use products related to missiles capable of delivering such weapons are controlled by MTCR. The four international export control regimes mentioned above contribute with lists of products and technologies to Council Regulation (EC) No 428/2009. The regulation also includes chemicals related to the Chemical Weapons Convention. ISP controls export of dual-use products included in category 1-9 in appendix I to Council Regulation (EC) No 428/2009. Control paragraphs 1C003, 1E001, 3B001 and 3E001 in the regulation are examples of how ISP is affected by nano. Paragraph 1C003.c controls magnetic materials and nanocrystalline alloy stripes with special properties. Here, nanocrystalline materials are materials having a crystal grain size of 50 nm or less, as determined by X-ray diffraction. 1E001 corresponds to the technology for the development or production of materials specified in 1C. Paragraph 3B001 controls equipment for the manufacturing of semiconductor devices or materials and imprint lithography equipment capable of producing features of 180 nm or less, including nano-imprint lithography tool. Consequently paragraph 3E001 controls the technology for the development or production of materials specified in 3B. 18