Experience of ANF Economies in Standardization in the Field of Nanotechnology

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1 2012/SOM2/SCSC/CON/003 Experience of ANF Economies in in the Field of Submitted by: Industrial Technology Research Institute (ITRI) 9 th Conference on Standards and Conformance in the Field of Innovations and Related Good Practices Kazan, Russia May 2012

2 Experience of ANF economies in in the Field of Tsung-Tsan Su Iran UAE Korea Japan China India Chinese Taipei Hong Kong Thailand Vietnam Malaysia Singapore ANF Liaison officer to ISO TC229 General Director, MCL, ITRI Co-Program Director, National Program on Nano technology, Chinese Taipei Indonesia Australia 22 May. 2012, The 9th Conference on Standards and Conformance in the Field of Innovations and Related Good Practices, APEC, Russia 1 New Zealand Outline About ANF Approaches in standardization of Lead or Participate in International ISO TC 229 Innovative Labeling System (nanomark) nanomark System in Chinese Taipei Copyright ITRI 工業技術研究院 2 1

3 Copyright ITRI 工業技術研究院 About Asia Nano Forum (ANF) Founded in May Member Economies 6 Observers (8 th ANF Summit) Austria: -- Federal ministry of transport, innovation and technology -- Austrian Academy of Sciences France / OECD WPN Russia : RUSNANO Sri Lanka: Wayamba Univerity of Sir Lanka UK: IoN Headquarter : Singapore Non-government Organization Population : ~Half of World Populations Central Government Investment on : ~ One Third WW Investment Nano-related Publications : Over 50% Share Globally 3 Iran India United Arab Emirates Thailand Singapore Korea China Chinese Taipei Hong Kong Vietnam Malaysia Indonesia Australia Japan New Zealand Approaches in of Lead or Participate in International ISO TC229 Innovative Labeling System (nanomark) 4 2

4 ISO TC 229 For Four Working Groups JWG1 Terminology and Nomenclature Convenor Clive Willis Economy Canada JWG2 and WG3 Health, Safety and Environmental Aspects of Nanotechnologies Toshiyuki Fujimoto, Yukihiro Ushiku Laurie Locascio WG4 Material Specifications Limin Wang Japan USA China 5 Member Activities On Nano 6 3

5 May, 2012 ANF Members ISO TC229 Terminology Nomenclature Health, Safety Environment Australia China Hong Kong P-member P-member O-member NT-001 (2005). Coordinated development of TC229 Business Plan National (2005) Convenor of ISO/TC229/WG4 Follow China standard Very active participation in the work of TC229/WG1 and roadmapping GB/T 19619~2004 (Basic Standards) GB/T Adopt 4 ISO documents -- Active participation in the work of TC229/WG2 and roadmapping. NMIA have established a nanometrology program 45 Nano dimensional MC standards 15 nano products standards 49 RMs 17Draftings Optical traceable AFM for the nanoscale length calibration Very active participation in the work of TC229/WG3, road mapping and the development of TR "Health and safety practices in occupational settings relevant to nanotechnologies Established Nanosafety Lab in 2003 at the Institute of High Energy Physics, CAS Nanosafety Join Lab established in National Center for NanoSci. Tech. (2006, 6.22) Industrial Standard on on Clothes Working Group for Health, Safety and Environmental Aspects of Nanotechnologies (SAC TC279/WG6) was funded on March 25, 2010 Nanotoxicology 7 ANF Members ISO TC229 India P-member National on constituted by BIS(2007) Indonesia P-member Agency for National has established working team for nanotechnology Terminology Nomenclature Adopt 4 ISO documents Adopt 4 ISO documents Round-robin tests to be conducted to develop a standard for AFM characterization and evaluation of nanomaterials Electron microscopic characterization of multiwalled carbon nanotube Proposed to develop a standard on Luminescent Nanomaterials and Magnetic Nanoparticles Iran P-member 3 nantional ISIRI Establishing Iran nanostandardisation terminology committee (WG s) and core terms Nanometrology and since in Creating national nanotechnology Center (to be opened database for (In Farsi language) in 3 years) nanotechnology standards and safety. Funding research Nano-tree programs on project in WG1 nanotechnology (ISO/TC229): standardization and safety issues including final stage of master and PhD publishing. programs. 8 May, 2012 Health, Safety Environment Developed a standard on toxicity evaluation of ZnO nanomaterials A Medical Biotechnology and Sectional constituted by BIS Proposed to set up a regulatory board to examine nanotech products Regulatory Framework, focused programmes in health and agriculture ICMR, ICAR, DBT, DIT, BIS and several other Ministries, industry reps and other concerned parties Adopt 2 ISO documents -- Agency for Drug and Food Assessment begins considering nanotechnology application in drug and food fields Succofindo (an institution for product certification) also begins considering nanotechnology enabled products Adopt 2 ISO documents Establishing National Nano-product Risk Assessment Task Group. Developing 2 National Standards 7 National Standards under develop ISIRI Nano technology Health and safety in nano-occupational settings - Code of Practices ISIRI Nanotechnologies- Analysis of hemolytic properties of nanoparticles 4

6 ANF Members Japan ISO TC229 P-member S. Korea P-member (2005) Lead Asian Collaboration on for Photocatalysis Materials and Products NBCI coordinates and facilitate the development of nanotech industry standard Launched nanotechnology standardization development roadmap. (Oct. 2007) Nano-tech (2006) CNT standard Technology (2004) Terminology Nomenclature Working on a draft definition of terms of NanoCarbon Published national standard: TS Z0027:2010 (ISO/TS 27687:2008) Nanotechnologies - Terminology and definitions for nano-objects - Nanoparticle, nanofibre and nanoplate (March, 2010) KSL (Photocatalyst) KSAISOTS27687 (Nano-object) 9 Active in NanoCarbon Photocatalyst Effort 5-year Project on Research and Development of Nanoparticle Method (FY2006~2010) 15 photocatalyst standards 33RM (Particle mean diameter) 4CRM 3 standards on particle counter (adopt ISO document) Active in nano Ag and CNT 10 Korean standards Active in ISO/TC229 IEC/TC113 (contribute 6 items) Health, Safety Environment May, 2012 Launched open forum and Society Aug Cross ministerial initiative in addressing societal implication of nanotechnology and responsible R D as a priority area in 3rd ST basic plan. 5-year Project on Evaluating Risks associated with Manufactured Nanomaterials (FY , 17MUSD) 5 Ministry reports published (2008~2009) 3-year Project on Risk Assessment of Nanomaterial KS A Guidance in workplace laboratory Developing platform technology for green nanoproducts Developing Standards method for exposure assessment of manufactured nanomaterials such as CNTs and silver nanoparticles May, 2012 ANF Members Malaysia New Zealand -- Singapore ISO TC229 P-member P-member on (17 members) (2005) Working Groups for ISO/TC229 (1) ERMA : Environmental Risk Management Authority 10 Terminology Nomenclature National TC and WG Meeting (2007~2008) New Zealand researcher joined ISO working group on nomenclature for nanomaterials Follow ISO s Adopt 2 ISO documents The National Metrology Centre has been transferred from SPRING Singapore to ASTAR since 01 Jan Health, Safety Environment National TC and WG Meeting (2007~2008) Active in awareness seminars Cosmetics containing nanoparticle ( ERMA (1) ) Independent study on Nanomaterials risk assessment to be commissioned Independent review of regulatory framework for manufactured nanomaterials completed. To be published in 2011 Survey of Nanomaterials usage in Singapore commissioned (2010) 5

7 May, 2012 ANF Members ISO TC229 Terminology Nomenclature Health, Safety Environment Singapore P-member Working Groups for ISO/TC 229 Follow ISO s Metrology roadmap establishments: - Optical frequency comb -LRM-AFM -µ-cmm - High precision 2D optical vision system - High precision surface roughness roundness measurement systems - Spherical aspherical surface measurement systems Fabrication Characterisation of SPM Calibration Standards Development of long diamond tip AFM probes for metrological application 11 May, 2012 ANF Members ISO TC229 Terminology Nomenclature Health, Safety Environment Chinese Taipei Thailand -- Vietnam -- O-member Two nanomark s (2004) Chinese Taipei Standard Council (2009) on lead by Thailand Industrial Standards Institute (TISI) Terminology Standard for Nanomaterials (CNS ) Dictionary (2007,12) Chinese Version on Nano-objects (2012) Participation in the work of ISO/TC229/ JWG1 Developing national standard for terminology and definitions of nano-objects ( ) Consumer Products : 37 Test Protocols, 6 drafts 6 Photocatalyst Standard 3 RM (Step-height) 1 new standard on SEM Adopt ISO documents on DLS measurements Initiating Interlaboratory Comparison on Nanoparticle size Program (2009~2011) Establishing Nanoscale Metrology and Traceability for National Laboratories ( ) Developing Nano Q as a standard nanomark for selected thai nanoproducts Reviewing Regulatory Framework Active in QD, ZnO Developed high capture efficiency, local exhaust hoods for nanoparticles Chinese Taipei Position on EHS Epidemiological studies of exposed worker Established Sub-committee on Nano-Safety and Risk Management (2009) Nanomaterials Safety Program (2008~2012) Participation in work of TC229/WG3 and OECD Chemicals (2006-) Initiating National Standards for Safe Handling of (2010) 12 (2) Thailand Industrial Standards Institute 6

8 May, 2012 ANF Members ISO TC229 Terminology Nomenclature Health, Safety Environment UAE -- ADFCA: Awareness Seminar 2010 Hospital design and upgrade conference addressed: the Effects of nanotechnology on The future design and operation of hospitals Definition and brief introduction to nanotechnology application of nanotechnology in health industry (present and future) Benefits of nanotechnology associated risk with using nanotechnology (2) Thailand Industrial Standards Institute 13 ISO Standards ANF Economies Standards Code Title economy ISO/TS 27687:2008 ISO/TS : 2010 ISO/TS : 2010 Nanotechnologies -- Terminology and definitions for nano-objects -- Nanoparticle, nanofibre and nanoplate Nanotechnologies -- Vocabulary -- Part 1: Core terms Nanotechnologies -- Vocabulary Part 3: Carbon nano-objects Chinese Taipei, India, Indonesia, Japan, Korea, Thailand, China, India, Indonesia, Thailand Chinese Taipei, India, Indonesia, Japan ISO/TS :2011 Nanotechnologies -- Vocabulary -- Part 4: Nanostructured materials Indonesia ISO/TS :2011 Nanotechnologies -- Vocabulary -- Part 5: Nano/bio interface China, Indonesia ISO/TS :2011 ISO/TR 12802:2010 Nanotechnologies -- Vocabulary -- Part 7: Diagnostics and therapeutics for healthcare Nanotechnologies -- Model taxonomic framework for use in developing vocabularies -- Core concepts Indonesia India ISO/TS 12805:2011 ISO/TR 11360: 2010 Nanotechnologies -- Materials specifications -- Guidance on specifying nano-objects Nanotechnologies -- Methodology for the classification and categorization of nanomaterials Indonesia India, Indonesia 14 7

9 ISO/TS Code Title economy ISO 10808:2010 ISO Standards ANF Economies Standards Nanotechnologies -- Charaterization of single-wall carbon nanotubes using scanning electron microscopy and energy dispersive X-ray spectrometry analysis Nanotechnologies -- of nanoparticles in inhalation exposure chambers for inhalation toxicity testing Iran Indonesia ISO/TS 10867: 2010 Nanotechnologies -- of single-wall carbon nanotubes using near infrared photoluminescence spectroscopy) Indonesia, Malaysia ISO/TS ISO/TS 11251:2010 ISO :2007 ISO :2007 ISO :2007 Nanotechnologies -- of single-wall carbon nanotubes using ultraviolet-visible-near infrared (UV-Vis-NIR) absorption spectroscopy Nanotechnologies -- of volatile components in singlewall carbon nanotube samples using evolved gas analysis/gas chromatograph-mass spectrometry Determination of particle size distribution -- Single particle light interaction methods -- Part 2: Light scattering liquid-borne particle counter Determination of particle size distribution -- Single particle light interaction methods -- Part 3: Light extinction liquid-borne particle counter Determination of particle size distribution -- Single particle light interaction methods -- Part 4: Light scattering airborne particle counter for clean spaces Iran Malaysia Japan Japan Japan 15 ISO Standards ANF Economies Standards Code Title economy ISO 10801:2010 ISO/TR 12885:2008 Nanotechnologies -- Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method Nanotechnologies -- Health and safety practices in occupational settings relevant to nanotechnologies Iran, Indonesia China, India, Indonesia ISO/TR 13121:2011 Nanotechnologies -- Nanomaterial risk evaluation India ISO/NP ISO 29701:2010 Nanoparticles - Determination of muramic acid as a biomarker for silver nanoparticles activity Nanotechnologies -- Endotoxin test on nanomaterial samples for in vitro systems -- Limulus amebocyte lysate (LAL) test Iran Indonesia, Iran 16 8

10 Approaches in of Lead or Participate in International ISO TC229 Innovative Labeling System (nanomark) Chinese Taipei IRAN THAILAND 2004 Voluntary Focus on Consumer Products 2009 Mandatory if apply government support Voluntary Focus on fabrics, Paint ceramic products Outline About ANF Approaches in standardization of Lead or Participate in International ISO TC 229 Innovative Labeling System (nanomark) nanomark System in Chinese Taipei Copyright ITRI 工業技術研究院 18 9

11 nanomark System in Chinese Taipei -- Nanoproduct Labeling System Why Labeling What to Label How to Label Examples 19 Why Labeling With Nano, product price could be skyrocketed by more than ten times! ( 台視新聞網 ) NanoLife House has Everything, from tea to sport shoes! ( 聯合報 ) Tea (organic Ge):NTD 3,300/kg Nano Vest:>NTD 1,500 Nano Underwear:>NTD 2,300 Nano Socks:NTD 350/pair News from Media (2006) What nano is?many fakes!they are more expensive!( 聯合報 ) Cosmetics:NTD 3,000/30mL Nano Bag:NTD 1,500 (3 times the original one) Nano Women Underwear:NTD 5,800 Nano Socks:>NTD 2,000/pair Nano Pillow:NTD 2,980 Nano Pearl Powder:NTD 12,000/kg Nano Long Wavelength Health Device:>NTD 60,000 Are They Real Nano-enabled Products? 20 10

12 Why Labeling Protect Consumers :Avoid waste money Protect Good Companies:Eliminate unfair competitions between good and bad products Increase Public Trust :Facilitate healthy development of nanotechnology Facilitate Trade :Stimulate economic growth Accelerate Good Nanoproduct Development 21 What to Label Consumer Products Key Components Materials * Impossible to Certify All Commercial Nanoproducts Criteria/Test Methods are not all ready * Select Criteria Market Size Available Test Methods/Labs for Nanoscale Unique Properties Companies Interest Prudent with Risk Potential Products 22 11

13 Requirements Basic Requirements Nano Scale (in principle, < 100nm) Unique Properties Quality System Installed Safety Issues being taken care/traceable Products Contract to use nanomark 23 Example Anti-bacterial Socks How to define anti-bacteria without confusing consumers de-odour purpose, not to cure skin diseases e.g. athlete s foot How many bacteria have to be tested Representative Staphylococcus aurous:atcc 6538P Safe/easy to handle Klebsiella Pneumoniae:ATCC 4352 National standard (CNS 14945) How effective anti-bacteria socks should be (original, after wash) Achievable Test Protocol (conditions, raw materials and final products) Top 50% companies Water Wash times 0 20 Anti-bacterial Socks Companies (local abroad) A B C D E F ATCC 6538P < 0 > 99.9 > 99.9 < 0 ATCC 4352 > < 0 > < 0 ATCC 6538P > ATCC 4352 > < > 90% 12

14 Example --Anti-bacterial Socks Safety Issues -What s the criteria National Standard:CNS Skin Irritation Test Oral Acute Toxicity Test Anti-bacterial Socks Skin Irritation Oral Acute Toxicity * Primary Irritation Index -Leaching Test Company A PII*=0, no irritation No abnormal phenomena or toxic response observed One Sock in 6.8L H 2 O/50 /180rpm/12min Water sample Atomic Absorption Analysis Ag < 0.01 ppm (Chinese Taipei EPA regulation:drinking water, Ag < 0.05 ppm) 25 Status of nanomark System in Chinese Taipei Certified Products Passed 38 certification standards 38(33) Companies with 19 categories and 1109 products (5 companies dropped out) 11 Registered testing laboratories Abrasionresistance enhancement 5 % Others 38% Deodorization 5 % Nano scale 29 % Antibacterial 24% House Appliances 1% Textile 2% Paint 2% Metal 1% Plastics Rubber 12% Metal 9% House Appliances 9% Building Materials 81% Textile 18 Plastics Rubber 3% Paint 18% Building Materials 42% 26 13

15 Global Collaborations Prospect Consistent Criteria Mutual Recognitions Chinese Taipei IRAN THAILAND 2004 Voluntary nanomark 2009 Mandatory if apply government support 2011 Voluntary Focus on fabrics, Paint ceramic products Accelerate Good Nanoproduct Development 27 14