1、Nanotechnologies Guidance for the responsibledevelopment of nanotechnologiesPD CEN/TS 16937:2016BSI Standards PublicationNational forewordThis Published Document is the UK implementation of CEN/TS 16937:2016. The UK participation in its preparation was entrusted to TechnicalCommittee NTI/1, Nanotech
2、nologies.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI
3、 Standards Limited 2016ISBN 978 0 580 91802 5ICS 07.030Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authority of theStandards Policy and Strategy Committee on 30 June 2016. Amendments/corrigenda issued since publicati
4、onDate Text affectedPUBLISHED DOCUMENTPD CEN/TS 16937:2016g3g3g3g23g8g6g11g17g12g6g4g15g3g22g19g8g6g12g9g12g6g4g23g12g18g17g3g22g19g50g6g12g9g12g6g4g23g12g18g17g3g23g8g6g11g17g12g20g24g8g3g23g8g6g11g17g12g22g6g11g8g3g22g19g8g29g12g9g12g14g4g23g12g18g17g3CEN/TS 16937 g3 g3g3 g16g131g155g3g884g882g883
5、g888g3g12g6g22g3g882g889g484g882g885g882g3g8g144g137g142g139g149g138g3g25g135g148g149g139g145g144g3g3g17g131g144g145g150g135g133g138g144g145g142g145g137g139g135g149g3g486g3g10g151g139g134g131g144g133g135g3g136g145g148g3g150g138g135g3g148g135g149g146g145g144g149g139g132g142g135g3g134g135g152g135g142g
6、145g146g143g135g144g150g3g145g136g3g144g131g144g145g150g135g133g138g144g145g142g145g137g139g135g149g3g17g131g144g145g150g135g133g138g144g145g142g145g137g139g135g149g3g486g3g10g151g139g134g135g3g146g145g151g148g3g142g135g3g134g177g152g135g142g145g146g146g135g143g135g144g150g3g148g135g149g146g145g144g
7、149g131g132g142g135g3g134g135g149g3g144g131g144g145g150g135g133g138g144g145g142g145g137g139g135g149g3g3 g17g131g144g145g150g135g133g138g144g145g142g145g137g139g135g144g3g486g3g15g135g139g150g136g131g134g135g144g3g156g151g148g3g152g135g148g131g144g150g153g145g148g150g151g144g137g149g152g145g142g142g1
8、35g144g3g8g144g150g153g139g133g141g142g151g144g137g3g152g145g144g3g17g131g144g145g150g135g133g138g144g145g142g145g137g139g135g144g3g23g138g139g149g3g23g135g133g138g144g139g133g131g142g3g22g146g135g133g139g136g139g133g131g150g139g145g144g3g523g6g8g17g512g23g22g524g3g153g131g149g3g131g146g146g148g145g
9、152g135g134g3g132g155g3g6g8g17g3g145g144g3g884g884g3g16g131g148g133g138g3g884g882g883g888g3g136g145g148g3g146g148g145g152g139g149g139g145g144g131g142g3g131g146g146g142g139g133g131g150g139g145g144g484g3g3g3g23g138g135g3g146g135g148g139g145g134g3g145g136g3g152g131g142g139g134g139g150g155g3g145g136g3g1
10、50g138g139g149g3g6g8g17g512g23g22g3g139g149g3g142g139g143g139g150g135g134g3g139g144g139g150g139g131g142g142g155g3g150g145g3g150g138g148g135g135g3g155g135g131g148g149g484g3g4g136g150g135g148g3g150g153g145g3g155g135g131g148g149g3g150g138g135g3g143g135g143g132g135g148g149g3g145g136g3g6g8g17g3g153g139g1
11、42g142g3g132g135g3g148g135g147g151g135g149g150g135g134g3g150g145g3g149g151g132g143g139g150g3g150g138g135g139g148g3g133g145g143g143g135g144g150g149g481g3g146g131g148g150g139g133g151g142g131g148g142g155g3g145g144g3g150g138g135g3g147g151g135g149g150g139g145g144g3g153g138g135g150g138g135g148g3g150g138g1
12、35g3g6g8g17g512g23g22g3g133g131g144g3g132g135g3g133g145g144g152g135g148g150g135g134g3g139g144g150g145g3g131g3g8g151g148g145g146g135g131g144g3g22g150g131g144g134g131g148g134g484g3g3g6g8g17g3g143g135g143g132g135g148g149g3g131g148g135g3g148g135g147g151g139g148g135g134g3g150g145g3g131g144g144g145g151g14
13、4g133g135g3g150g138g135g3g135g154g139g149g150g135g144g133g135g3g145g136g3g150g138g139g149g3g6g8g17g512g23g22g3g139g144g3g150g138g135g3g149g131g143g135g3g153g131g155g3g131g149g3g136g145g148g3g131g144g3g8g17g3g131g144g134g3g150g145g3g143g131g141g135g3g150g138g135g3g6g8g17g512g23g22g3g131g152g131g139g1
14、42g131g132g142g135g3g146g148g145g143g146g150g142g155g3g131g150g3g144g131g150g139g145g144g131g142g3g142g135g152g135g142g3g139g144g3g131g144g3g131g146g146g148g145g146g148g139g131g150g135g3g136g145g148g143g484g3g12g150g3g139g149g3g146g135g148g143g139g149g149g139g132g142g135g3g150g145g3g141g135g135g146g
15、3g133g145g144g136g142g139g133g150g139g144g137g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g148g134g149g3g139g144g3g136g145g148g133g135g3g523g139g144g3g146g131g148g131g142g142g135g142g3g150g145g3g150g138g135g3g6g8g17g512g23g22g524g3g151g144g150g139g142g3g150g138g135g3g136g139g144g131g1
16、42g3g134g135g133g139g149g139g145g144g3g131g132g145g151g150g3g150g138g135g3g146g145g149g149g139g132g142g135g3g133g145g144g152g135g148g149g139g145g144g3g145g136g3g150g138g135g3g6g8g17g512g23g22g3g139g144g150g145g3g131g144g3g8g17g3g139g149g3g148g135g131g133g138g135g134g484g3g3g6g8g17g3g143g135g143g132g
17、135g148g149g3g131g148g135g3g150g138g135g3g144g131g150g139g145g144g131g142g3g149g150g131g144g134g131g148g134g149g3g132g145g134g139g135g149g3g145g136g3g4g151g149g150g148g139g131g481g3g5g135g142g137g139g151g143g481g3g5g151g142g137g131g148g139g131g481g3g6g148g145g131g150g139g131g481g3g6g155g146g148g151g
18、149g481g3g6g156g135g133g138g3g21g135g146g151g132g142g139g133g481g3g7g135g144g143g131g148g141g481g3g8g149g150g145g144g139g131g481g3g9g139g144g142g131g144g134g481g3g9g145g148g143g135g148g3g28g151g137g145g149g142g131g152g3g21g135g146g151g132g142g139g133g3g145g136g3g16g131g133g135g134g145g144g139g131g48
19、1g3g9g148g131g144g133g135g481g3g10g135g148g143g131g144g155g481g3g10g148g135g135g133g135g481g3g11g151g144g137g131g148g155g481g3g12g133g135g142g131g144g134g481g3g12g148g135g142g131g144g134g481g3g12g150g131g142g155g481g3g15g131g150g152g139g131g481g3g15g139g150g138g151g131g144g139g131g481g3g15g151g154g1
20、35g143g132g145g151g148g137g481g3g16g131g142g150g131g481g3g17g135g150g138g135g148g142g131g144g134g149g481g3g17g145g148g153g131g155g481g3g19g145g142g131g144g134g481g3g19g145g148g150g151g137g131g142g481g3g21g145g143g131g144g139g131g481g3g22g142g145g152g131g141g139g131g481g3g22g142g145g152g135g144g139g1
21、31g481g3g22g146g131g139g144g481g3g22g153g135g134g135g144g481g3g22g153g139g150g156g135g148g142g131g144g134g481g3g23g151g148g141g135g155g3g131g144g134g24g144g139g150g135g134g3g14g139g144g137g134g145g143g484g3g3g3g3g3g8g24g21g18g19g8g4g17g3g6g18g16g16g12g23g23g8g8g3g9g18g21g3g22g23g4g17g7g4g21g7g12g29g
22、4g23g12g18g17g3g6g18g16g12g23g50g3g8g24g21g18g19g50g8g17g3g7g8g3g17g18g21g16g4g15g12g22g4g23g12g18g17g3g8g24g21g18g19g34g12g22g6g11g8g22g3g14g18g16g12g23g8g8g3g9g111g21g3g17g18g21g16g24g17g10g3g3g3g3CEN-CENELECg3Management Centre: Avenue Marnix 17, B-1000 Brussels g825g3g884g882g883g888g3g6g8g17g3 g
23、4g142g142g3g148g139g137g138g150g149g3g145g136g3g135g154g146g142g145g139g150g131g150g139g145g144g3g139g144g3g131g144g155g3g136g145g148g143g3g131g144g134g3g132g155g3g131g144g155g3g143g135g131g144g149g3g148g135g149g135g148g152g135g134g3g153g145g148g142g134g153g139g134g135g3g136g145g148g3g6g8g17g3g144g1
24、31g150g139g145g144g131g142g3g16g135g143g132g135g148g149g484g3g21g135g136g484g3g17g145g484g3g6g8g17g512g23g22g3g883g888g891g885g889g483g884g882g883g888g3g8PD CEN/TS 16937:2016CEN/TS 16937:2016 (E) 2 Contents Page European foreword . 3 Introduction 4 1 Scope 5 2 Normative references 5 3 Terms and defi
25、nitions . 5 4 Methodology . 8 4.1 General 8 4.2 Board Accountability . 8 4.3 Stakeholder Involvement . 8 4.4 Worker Health and Safety 8 4.5 Benefits to and Risks for Public Health, Safety and the Environment . 9 4.6 Wider Social and Ethical implications and impacts . 11 4.7 Engagement with Business
26、Partners. 11 4.8 Transparency and Disclosure 11 Bibliography . 12 PD CEN/TS 16937:2016CEN/TS 16937:2016 (E) 3 European foreword This document (CEN/TS 16937:2016) has been prepared by Technical Committee CEN/TC 352 “Nanotechnologies”, the secretariat of which is held by AFNOR. Attention is drawn to t
27、he possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound
28、 to announce this Technical Specification: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Port
29、ugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. PD CEN/TS 16937:2016CEN/TS 16937:2016 (E) 4 Introduction Nanotechnology-related development brings novel functionalities to materials, and new applications. They have been accompanied by a societal demand t
30、o assess their effects, given the lack of (reliable) information related to this novel area. While assessing risks, benefits, lack of (reliable) information, or ambiguity, is not specific to this field, the question of responsible development, including societal and ethical aspects, is often raised
31、in the context of nanotechnologies. As the technology matures, lack of (reliable) information should be reduced and the risks associated with the use of such technology should be minimised. Ambiguity may arise in presence of contradictory scientific results and diversity of opinions, and should as f
32、ar as possible be reduced over time. Making appropriate decisions regarding policy, strategy, human health and the environment, safety or communication in nanotechnology is therefore a task that most small, medium and large organisations involved in this field face today. It is therefore clear that
33、making the right decisions in an open, transparent and balanced manner is critical for industry to continue to develop nanotechnologies responsibly. Organisations working in the nanotechnology area should ensure to develop and implement an appropriate set of norms with the same approach for all prod
34、ucts or services of the organization. To ensure the responsible development of nanotechnologies, this Technical Specification (TS) provides a guidance to communication and interaction with relevant stakeholders. It describes the process that an organization or group of organisations may choose to fo
35、llow to ensure accountability, transparency, safety (for workers, consumers, and for the environment) and clear communication. The approach proposes to compare benefits and risks of nanotechnology activities, and seeks to encourage the implementation of preventive or corrective actions before commer
36、cialisation (such as design modification). This Technical Specification can be used by organisations working in nanotechnology supply chains, academia, policy makers and non-governmental organisations (NGOs). This Technical Specification may also be used by the organisations providing services to th
37、e industry such as consulting, finance or insurance companies. This Technical Specification provides guidance that does not supersede or substitute for any applicable legal requirements. PD CEN/TS 16937:2016CEN/TS 16937:2016 (E) 5 1 Scope This Technical Specification provides a guidance for the resp
38、onsible development of nanotechnologies taking into account: Board Accountability; Stakeholder Involvement; Worker Health and Safety; Benefits to and Risks for Public Health, Safety and the Environment; Wider Social and Ethical Implications and Impacts; Engagement with Business Partners; Transparenc
39、y and Disclosure. NOTE 1 This Technical Specification contributes to social responsibility as defined in ISO 26000:2010. NOTE 2 Nanotechnology activities include industrial production, R ISO/TS 12901-1:2012 and ISO/TS 12901-2:2014. For consumers and professional users, direct and indirect exposures
40、should be both considered. When the nanotechnology activity involves design, production, use, release, or disposal of nanomaterials, the substances used for functionalization, and, when applicable, the main known incidental nanomaterials should be taken into account in the risk assessment. NOTE 3 Sp
41、ecific risk assessment techniques could be required to assess specific (eco)toxicity risks and impacts. There are already different proposed frameworks of simplified risk assessment associated with a nanotechnology activity (OECD 2014). There are several potential methods to assess benefits to stake
42、holders of introducing a product with a function or a service. When the nanotechnology activity brings a new function, for which no previous reference is available, the user of the Technical Specification should describe at least qualitatively the added value in comparison with the closest existing
43、alternative. The energy consumption involved in the nanotechnology activity should be taken into account in the benefit assessment. Overviews and guidance can be found in OECD, 2002, ECHA, 2008, or US-EPA, 2010. The third and final step is to compare risks and benefits taking into account the lack o
44、f (reliable) information and decide whether and/or under which conditions to develop the nanotechnology activity. The output of the final step can also be to take actions to improve the reliability of information, and/or to reduce the level of risk, and/or to increase the benefits. Another possible
45、outcome is to change the design (or intended applications) of the nanotechnology activity. The benefits of the products should not be overstated or exaggerated to the best knowledge of the user. The use of a nanotechnology should not be taken systematically as a sign of enhanced product performance
46、or functionality. Nor should it indicate systematically any increased risk to users. Several approaches are possible to facilitate this decision, but the user should always make an explicit and justified choice of a particular method: where appropriate, decision rules, decision trees, scoring and we
47、ighting (multicriteria analysis or MCA), or a Cost/Benefit Analysis (CBA) may be considered. Whatever the method used, the user of the Technical Specification should take into account the distribution of benefits and risks within the value chain and among stakeholders. Approaches chosen should invol
48、ve stakeholders in a deliberative process of mutual learning and key choices, and potential changes over the years should be transparent and justified. An estimate of the reliability of the assessment shall be considered as a key feature when assessing benefits and risks. The user of the Technical S
49、pecification should especially consider the lack of (reliable) information in the following areas: g520 physical characteristics such as shape, number, size distribution at the initial stage and its evolution during the service life and the end of life of products; g520 chemical characteristics; g520 biological activity; g520 toxicology and ecotoxicology; g520 exposure scenarios; PD CEN/TS 16937:2016CEN/TS 16937:2016 (E) 11 g520 use patterns: how downstream users or recyclers will actually reuse, recycle or dispose the product; g520 markets development scenarios: con
