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Guillaume Flament NIA

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Working safely with Nanomaterials in R&D laboratories: an update.

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Guillaume Flament NIA

  1. 1. Nanotechnology Industries Association Regulation & duties: present and future § a Global Outlook Guillaume Flament NIA Public & Regulatory Affairs Officer www. nanotechia. org
  2. 2. Today, we are going to cover: Working Safely with Nanomaterials 9 September Burlington House. London (E) 2015 NanotechnologyIndustries Association
  3. 3. Nanotechnology Industries Association — NIA . ..the sector—independent, responsible voice for the industrial nanotechnologies supply chains. .. . ..the only global industry-focused trade association for the nanotechnology sector. .. . ..proactively supports the on—going innovation and commercialisation of the next generation of technologies and promotes their safe and reliable advancement. .. . ..cooperates with regulators and stakeholders on national, European and international levels so as to secure a publically and regulatory supportive environment for the continuing advancement and establishment of nanotechnologies. .. Working Safely with Nanomaterials 9 September 2015» Burlington House: London © 2015 Nanotechnologyindustries Association
  4. 4. Nanotechnology Industries Association - NIA NIA Membership spanning the production chain - Trade & Manufacture of . intermediate Reta“ of / nanoenabled Products / ' nanoenabled Products Instrumentation & Services: Characterisation , Analysis, Detection [source: .355 Materi_a§]_____i [source: |n isiq] “ [sourcer BASF] Associated Support Services (Insurance, Legal Representation, etc. ) Working Safely with Nanomaterials 9 September Burlington House: London @2015 Nanotechnologyindustries Association
  5. 5. Regulating Nanotechnology Global overview Workin a ely with Nanomaterials 9 September 0 , Burlington House, London
  6. 6. Commercialisation patterns and regulations 0 s § - I IEIZI I I I Plastics I I i l l I I 1910 1920 1930 1940 1950 1960 1970 1900 1990 2000 2010 . .$ aao: ecnIIIII: ZIII§II 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 J s I ' ' I ' I | EI: II ' § Intemet I I I I I I 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 . ~$ . .an. ... ... ..IIIIIIIIa: ‘EI’>* 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 [Modified from Lux Research Inc. , Murday et al Nanomedicine NBM, 2009,Vol.5(3),251-273] Working Safely with Nanomaterials 9 September 2015» Burlington House: London © 2015 Nanotechnologyindustries Association
  7. 7. Commercialisation patterns and regulations 0 1» § - I I2}: — » I I Plastics I I I I I I I I 1910 1920 1930 1940 1950 1960 1970 1900 1990 2000 2010 3 5 aao: ecnIIIIIm: IIII§II 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 A s I I I I I I Intemet I I I I I I IEI: I I § 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 . ~$ I. aImIIIIIIIIIIEI: I:I§ 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 [Modified from Lux Research Inc. , Murday et al Nanomedicine NBM, 2009,Vol.5(3),251-273] Working Safely with Nanomaterials 9 September 2015» Burlington House: London © 2015 NanotechnologyIndustries Association
  8. 8. Regulating Nanotechnology - Main difficulty: — Setting a scope; defining a nanomaterial - Approaches: — General regulation is supported by guidance to support the regulation of nanomaterials - Nanomaterials are like any other chemical substance — Sector specific regulation (e. g. food regulation) makes direct reference to nano-specific rules — Nanomaterials require specific rules - Nanomaterial registries Working Safely with Nanomaterials 9 September 2015» Burlington House: London ©2015NanotechnologyIndustriesAssociation
  9. 9. Regulating Nanotechnology (3) 1'- _= _ : = Q I Countries with an approach to nanotechnology-regulation Working Safely with Nanomaterials 9 September 2015» Burlington House: London @2015 NanotechnologyIndustries Association
  10. 10. Regulating Nanotechnology (4) Focus on EU and US Approaches Working Safely with Nanomaterials 9 September 2015» Burlington House: London @2015 NanotechnologyIndustries Association
  11. 11. The Regulatory Landscape in the USA - No definition of nanomaterial - Regulatory Agencies: Environmental Regulation - Environmental Protection Agency (EPA) - Toxic Substances Occupational Health and Safety - Occupational Safety and Health Administration (OSHA) guidance Goods Regulation - Food and Drug Administration (FDA) . Federal Food’ Drug’ and Control Act (TSCA) Centers for Disease Cosmetic Act (FFDCA) - Federal Insecticide, . . Fungicide and Control and Prevention Rodenticide Act (FIFRA) (CDC) MOSH guldme - Until now: no nano-specific regulation - Preferred mode of action: uidance documents Working Safely with Nanomaterials 9 September 2015» Burlington House: London ©2015NanotechnologyIndustriesAssociation
  12. 12. The European Regulatory Landscape (1 ) - European Parliament ‘Own Initiative Paper’on regulatory aspects of nanomaterials A6-0255/2009: — ‘no data, no market’, EU register. .. - European Commission Recommendation on the Definition of ‘Nanomaterial’ 2011/696/EU 2. ‘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 % or more of the particles in the number size distribution, one or more extemal dimensions is in the size range 1 nm-100 nm. Working Safely with Nanomaterials 9 September 2015» Burlington House: London © 2015 NanotechnologyIndustries Association
  13. 13. The European Regulatory Landscape (2) “nanomaterials are similar to normal chemicals/ substances in that some may be toxic and some may not” Risk Assessment of Products of Nanotechnologies, SCENIHR 2009 - EC Regulatory Reviews on Nanomaterials — 2008 & 2012 “REACH is the best framework for nanomaterials management” ‘Work in progress: Modification of REACH annexes to nanomaterials — Promised studies on nanomaterials at the workplace Working Safely with Nanomaterials 9 September 2015» Burlington House: London @2015 Nanotechnotogyindustries Association
  14. 14. The European Regulatory Landscape (3) General Horizontal Chemical Re. .u. Latio. n.s Vertical Specific Regulations General Product Safety Directive Product Liability Occupational Health and Safety REACH Classification Labelling and Packaging (CLP) Food Food Contact materials Cosmetics Biocidal products Medical devices Plant protection Pharmaceuticals Working Safely with Nanomaterials 9 September 2015, Burlington House, London © 2015 Nanotechnology industries Association
  15. 15. The European Regulatory Landscape (4) General General Product Safety Directive Product Liability Occupational Health and Safety REACH Horizontal Chemical . .Re u lations Classification Labelling and Packaging (CLP) Vertical Food Specific Regulations Cosmetics . products a devices tion Pharmaceuticals Working Safely with Nanomaterials 9 September 2015» Burlington House: London @2015 Nanotecnnoiogyindustries Association
  16. 16. Existing Nanomaterial Registries : -I5 NOR 2013 Iniirl CAN 2015 I I FRA2012 I: DK 2014 - BEL 2014 Countries with mandatory reporting schemes for nanomaterials Working Safely with Nanomaterials 9 September 2015» Burlington House: London @2015 Nanotecnnoiogyindustries Association
  17. 17. Comparing existing Mandatory Reporting Schemes I The French ‘r-nano‘ - Notification per substance - 100g - Substances only - Only manufactured nanomaterials I . - Manufacturers, importers, distributors - Exemption for defence only - Entry into force: 2013 - Online tool - Fines The Danish ‘nanoproduktregister’ - Notification per use - No threshold - Products and substances - Natural, incidental and manufactured nanomaterials - Manufacturers, importers - Numerous exemptions - Entry into force: 2014 - Online tool - Fines . leueialpublh mivhe The Belgian Royal decree - Notifications per use - 100g - Substances, then mixtures, then products - Pre-market notification - Manufacturers, Importers, distributors - Numerous exemptions - Entry into force: 2016 (substances), 2017 (mixtures) - Online tool - Fines and imprisonment Working Safely with Nanomaterials 9 September 2015, Burlington House, London The Canadian Notice . i - Information collection on 206 pie-selected nanomaterials - 100kg - Substance, mixture and products - Manufacturers, importers - Exemptions - One—off registration in 2016 - Online tool ~ Fines and imprisonment © 2015 Nanotechnology industries Association
  18. 18. Working Safely with Nanomaterials 9 September 2015. Burlington House. London © 2015 Nanotechnologylndustries Association
  19. 19. Nanomaterials under the Toxic Substances Control Act (TSCA) - 2010 — US EPA proposes two rules for: — Nanoscale Materials; Reporting under TSCA Section 8(a) — Nanoscale Materials; Significant New Use Rule - 2014 - Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements : — ‘EPA is developing a proposal to require reporting and recordkeeping under TSCA section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The proposed reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment. ’ Working Safely with Nanomaterials 9 September 2015» Burlington House: London © 2015 Nanotecnnologyindustries Association
  20. 20. Nanomaterials under the Toxic Substances Control Act (TSCA) - 2010 — US EPA proposes two ru/ leskfor: — Nanoscale Ma’%erms riSCA Section 8(a) — Nanoscale Matimgx cant New’Use Rule - 2014 - Chemica ‘Sfiistances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements : — ‘EPA is developing a proposal to require reporting and recordkeeping under TSCA section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The proposed reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment. ’ Working Safely with Nanomaterials 9 September 2015» Burlington House: London © 2015 Nanotecnnologyindustries Association
  21. 21. Proposed rulemaking on TSCA Section 8(0) - Scope: — No definition of a nanomaterial — ‘chemical substances that are solids at 25 °C and atmospheric pressure and that are manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100 nanometers (nm) and exhibit unique and novel characteristics or properties because of their size’ - 135 days pre-manufacturing notification to EPA for manufacturing or processing chemical substances as nanoscale materials 2 — "certain information, including specific chemical identity; — production volume; — methods of manufacture; processing, use, exposure, and release information; and, — available health and safety data. ’ Working Safely with Nanomaterials 9 September 2015» Burlington House: London © 2015 Nanotecnnologyindustries Association
  22. 22. ‘Transparency Measures for Nanomaterials’ - EU Member States pushed for it — in 2012,10 European Member States plus Croatia pushed for a European Reporting Scheme with a letter to the European Commission - German UBA(2014): — ‘a single ENPR on the European level would cause far less market distortion than individually different registers at the national level’ - Study to Assess the Impact of Possible Legislation to Increase Transbarencv on Nanomaterials on the Market (2014) W bipro W RPA R. lak&PolicyAnnlyd: s Working Safely with Nanomaterials 9 September 2015» Burlington House: London © 2015 Nanotecnnologyindustries Association
  23. 23. EC commissioned Impact Assessment Policy options: bipro §£i}_ - Two baseline scenarios: — 0A: no register — OB: current situation (i. e. current (French Reporting Scheme and Cosmetics Products Notification) and future (Danish & Belgian)) - Recommendation on ‘best practice model for Member State registries’ (i. e.‘soft law’), but no register at EU-level - Structured approach to collating data from existing schemes and reports (i. e.‘Nanomaterial Observatory’) - Mandatory EU registry with one notification per year per substance - Mandatory EU registry with one notification per year per use Working Safely with Nanomaterials 9 September 2015» Burlington House: London © 2015 Nanotecnnologyindustries Association
  24. 24. CCllIl‘: _ll: ;;icll: ;T" No official conclusions yet CASG-Nano Meeting (December 2014) Working Conclusions on ‘Transparency measures for nanomaterials on the market’ (COMS DG ENTR) REACH is the appropriate framework — “REACH is the best framework for nanomaterials management” Formal conclusion expected shortly i K 5‘4'l'“_Fr= aa. rri «i. [cmmr? ::: :"cm"5 'Wcz/ '%I;1rr; / ESE SE: EUROPEAN = a_ cowussiou Enuseh no zuiz co. xr2or: > 5*: 5.. .: COMML'N'lC. 'flO. ' man 111: comnssxos ‘[0 THE EUROPEAN mxtlanmm, IBI comcn. up nu: xovnw zconomc urn SOCL-l. CDM. l. l'lTEE Sxonll Kegllntnry nm. . in s. ... .m-am (Tm mm :12; nlzunu) {s‘D(2L| I:) zss sun HY! -rtmug , .YuI= l5r~wtiiwlmrurnrutartnlb : r fla| g]'(= |ul‘u= ir IAOILK, ,=1I. |llIn1g[mni '-'i[Ill. L1‘q, ._kllIl| IIlI each}! mu-xxatinn-Ilumll-riluwxuIlavn-1-mdlzlnuui
  25. 25. Concluding Remarks - Regulation of Nanotechnology disorderly increases - General evolution towards nanomaterial registries but what they aim to achieve is unclear - Regulators should rather adapt their existing frameworks (i. e. REACH, TSCA) with better guidance than create new schemes — added value? - No nano-specific actions in OHS regulation - Regulatory uncertainty is risk for industry Working Safely with Nanomaterials 9 September 2015. BU| 'unQt0n HOU5e. London © 2015 Nanotechnology| ndus1rIesAssocia ion
  26. 26. Nanotechnology Industries Association Thank you! Guillaume Flament Public & Regulatory Affairs Officer Lisbon Nanotechnology Industries Association Nanotechnology Industries Association t: +32 2 850 61 97 APa"ad° 17 . . EC Rebelva — Carcavelos e: gulllaume. flament@nanotechlaorg 2776901 Rebelva w: www. nanotechia. org portugar Brussels (main office) London Nanotechnology Industries Association (aisbl) Nanotechnology Industries Association (ltd) 143 Avenue de Tervueren Lion House 1150 Woluwe-Saint-Pierre, Brussels Red Lion Street Belgium London, WC1R 4GB United Kingdom ’ @nanotechia WWW. n h I a .0 © 2015 Nanotechnology industries Association

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