By
Centre for Knowledge Management of Nanoscience & Technology
(A Project of ARCI, Department of Science & Technology, Govt. of India)
Secunderabad-500 017, Telangana, India, Telephone: +91-40-27007032, 27000251
Fax: +91-40-27007031, Email: h.purushotham@gmail.com
National Summit "NANO-India" - Policy and Regulation & 3 rd Innovation
Excellence Awards on 10 th June, 2014, ASSOCHAM, New Delhi

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(An autonomous R&D Centre of Department of Science & Technology ( DST) , Govt. of India)
ARCI, Hyderabad
Headquarters
1. Surface engg.
2. Nanomaterials
3. Ceramic processing.
4. Laser processing.
5. Non oxide ceramics
6. Carbon Materials
7. Sol-Gel Coating
8. Solar Energy Materials
9. Materials Charc. & Testing
10. Tech. Acquisition,Transfer,
Internatl. Coop.
ARCI, Secunderabad
1. Centre for Knowledge Management of Nanoscience & Technology
(CKMNT)
ARCI, New Delhi Cell
1. Liaison & Patent Filing
ARCI, Chennai
1. Centre for Fuel Cell Technology
2. Centre for Automotive Energy
Materials (CAEM)
ARCI is “Translating Research to Technology “

 Market Research Reports
 Techno-Commercial Reports
 Patents Search & Analysis
 Technology Assessment Reports
 Techno Economic Feasibility Reports
 Facilitating Technology Collaborations / Transfers
 Literature Search & Analysis
 Support to Nano Mission
 Publication of “Nanotech Insights”
CKMNT Reports/ Publications
Silver-Silica-
Silicon Oil
Composite
Nano-ZnO
Nano-
Copper
Nano-
Sensors
Guidelines and
Best Practices
Regulatory
Frame Work
Directory
Newsletter
Nanofibers
Multi-Client Reports
Customised Reports

 Most Engineered nanoparticles do not appear in nature, so living organisms may not have appropriate means to deal with nanoparticles
 Some of the engineered nanomaterials are dangerous because of their size and reactivity as they have high specific surface area
 As they are tiny, they can float in the air and might easily penetrate into human, animal and plant cells causing adverse environmental and health impacts
Environmental
Issues
Human Health and
Safety Issues
Economic and
Equity Issues
Regulatory activity is political activity and combines science, public expectations and opportunity…

Nanomaterial Toxic Effect Source
Carbon nanotubes
(CNTs) & fullerenes
Titanium Oxide
Zinc Oxide
Cerium Oxide
Nanosilver, copper, alluminium
Gold
May be retained within the narrow space surrounding the lungs the ‘pleural cavity’ - for long periods of time which may lead to diseases such as granulomas, fibrosis and lung cancer
Distribute into several tissues (notably spleen, liver and lungs) and there were suggestions of substantial acute systemic toxicity
Toxicity was shown to be associated with oxidative stress
Both cytotoxic and genotoxic in human dermal fibroblasts.
http://www.hse.gov
.uk/ http://www.nicnas.
gov.au/ http://www.nicnas.
gov.au/ http://www.nicnas.
gov.au/ copper and silver NPs were more neurotoxic than aluminium NPs http://www.nicnas.
gov.au/
Gold nanoparticles decreased cell proliferation rate, adhesion, and motility of Human dermal fibroblast http://www.ncbi.nl
m.nih.gov/pmc/arti cles/PMC2988217/
More Toxicological Studies are needed to evaluate toxic effects of engineered nanoparticles

 Global R & D funding in Nano S & T is increasing and reached US
$20 billion/yr
 Nanotechnology found to have potential applications in allmost all spheres of human activity including household, medical, industrial and military
 Nanotechnology based consumer products are growing year after year (54 in 2005 to 1317 in 2010)
 The market for nanotechnology products & services are expected to reach 1.5 trillions by 2015
 Diversity of materials and applications, surrounded with uncertainty and lack of adequate information about its impacts on safety, health and environment
 Lack of standardization in nomenclature, metrics, and test materials for assessment of nanomaterials

 Scientific Knowledge gaps (Enough Data for Framing
Regulations) e.g. Toxicology of nonmaterial's is poorly understood, as there are no suitable methods to test nanoparticles for safety, health and environmental impacts
 Regulatory gaps (non-mature mandatory rules may be counter-productive)
 Maintaining the Balance (encourage innovation with appropriate precaution)
 Evaluating what works (Strengths and weaknesses)
 Transparency for trust (Credibility and Legitimacy)
 Education & Engagement
 Economics

EU, NT Action Plan
US, EPA Holds its first public meeting for nanosacale materials stewardship program
Recommendation on a code of conduct, EU regulatory aspects of nanomaterials
Many countries are taking initiatives for
NS & T regulations like Australia,
Switzerland, China,
Japan, India (Nano-
Mission), etc.
2 nd regulatory review of REACH (2012)
(Registration,
Evaluation,
Authorisation and
Restriction of
Chemicals)
2005
2007 2009 2011 2013
NS & T First implementation report of EU
2005-2007
2008 2010
2012
EU planned second implementation report 2009-2015
EU Safety at workplace
Directives
US would consider any nanomaterial under
Federal Insecticide,
Fungicide and
Rodenticide Act
(FIFRA)
USA Published a proposed significant new rules (SNUR) for 14 nanomaterials that were the subject of pre-manufacture notice )PMN

European Commission (EC) is reviewing all relevant legislations with a view to propose regulatory changes wherever necessary and to develop more nano specific instruments for the implementation of regulation.
2009 Acts: Cosmetic Regulation ( EC No 1223/2009, which came into force in Jul 2013)
Regulatory Activities: Included Specific provisions for nanomaterials (definition, requirement for notification, labeling and reporting of nanomaterials).
2011 Acts: Food information to consumers regulation (EU Regulation 1169/2011), approved by the EC (July 2011) which will apply from December 2014
Regulatory Activities: This regulation includes the requirement for labeling of ingredients in the form of nanomaterials (material plus word “nano” in brackets).
2012 Acts: Regulation (EC) No 1223/2009 (Article 13)
Regulatory Activities: Established the Cosmetics, Product Notification Portal (CPNP)
2013 Acts: EU Biocides Regulation
Regulatory Activities: Labeling (material plus word “nano” in brackets) and a separate evaluation of the risks deriving from nanomaterials used in various kinds of products
(antifouling agents, biocides in building materials, and antimicrobial surfaces).

European legislation covers nanomaterials in the new chemical legislation termed Registration, Evaluation and Authorization and restriction of Chemicals
(REACH), food laws, the safety at workplace directives, and finally waste management directives.
 REACH set guidelines to establish Occupational Exposure
Limits (OELs) for workers.
 Emphasises about the labeling of nanoforms of substances having altered properties compared to their macroform.
 The introduction of Material Safety Data Sheets (MSDS) is mentioned
 Emphasis is placed on strict containment procedures for CNTs

A number of different US Agencies are involved in nanotechnology regulation, including the Food and
Drug Administration (FDA), EPA, Occupational Safety and Health Administration (OSHA), the Consumer
Product Safety Commission (CPSC) and NIOSH. Like
EU, the United States is following the similar approach.
Yearly
Commission & Agency:
National Institute for
Occupational Safety and Health (NIOSH)
Regulatory Activities:
Regularly updates its series of authoritative guidance on Occupational
Health and Safety (OHS) issues of nanomaterials
2011
Commission & Agency:
Environmental Protection
Agency (EPA)
Acts: Federal Insecticide,
Fungicide and Rodenticide
Act (FIFRA)
Regulatory Activities: EPA proposed a new approach that would consider any nanomaterial as a new active ingredient for the pesticide regulation (thus differentiating them from their macro-form).
2013
Commission & Agency:
Environmental Protection Agency
(EPA)
Acts: Toxic Substances Control
Act (TSCA - the US regulatory provision for chemical substances
Regulatory Activities: Published a proposed Significant New Use
Rules (SNUR) for 14 nanomaterials that were the subject of pre-manufacture notices
(PMN). If issued in final the
SNURs would require persons who intend to manufacture, import, or process new nanoscale materials based on the chemical substances designated for a Significant new use to notify EPA at least 90 days before commencing that activity and required to notify the risks

Canada has developed a proposal for a regulatory framework for nanomaterials under the Canadian Environmental Protection
Act (CEPA), 1999. Under the provisions of this legislation
 Engineered nano-materials have to get a risk assessment under
CEPA’s New Substances Notification Regulations (NSNR) before they can be manufactured or used in Canada.
 Nanomaterials should be banned in foods and some packaging
 There should be mandatory labeling for these novel compounds in cosmetics, personal-care products and cleaning agents.
 Develop initiatives to gather information from industry on the uses, properties, and effects of nanomaterials
 Introduced a mandatory safety reporting scheme for companies producing nanomaterials

ASIA-China
 State Food and Drug Administration ('SFDA') issued a new regulation in 2006 to replace the previous regulation. Under the new regulations, 'medical devices made with nanometer biological materials (for example medical instruments made with nanometer metal silver Material ) will be classified as Class III medical devices, and be subject to the administration of the relevant regulations of Class III medical devices
 National centre for nanoscience & technology (NCNST) is the governing body for developing standards
Japan
Ministry of Economy, Trade and Industry (METI) created the Committee on Safety
Management for Nanomaterials to increase knowledge on risk management of nanotechnologies.
Republic of South Korea
Established the inter-ministerial “National Nano-safety Strategic Plan (2012-2016)”
Taiwan
Nanomark Certification system by the Industrial Technology Research Institute (ITRI) since
2004 .Voluntary reporting and certification scheme for nanotechnology products was introduced
Thailand
Industrial standards certification system (NanoQ) managed by National
Nanotechnology Center (Nanotec)

 Debate is on whether nanotechnology regulation requires a new legislation?
 Can the present regulatory regime address the challenges of this new technology or applications from this technology?
 What are the components of the current regulatory regime that will be able to address these new challenges?
 To what extent modifications need to be made?
 DST constituted a working group for the regulation of NT
 CSIR initiated a major project “ Nano-SHE ” in 12th Five Year plan to evaluate and create a database on various toxicological aspects of nanostructured materials
 Guidelines and best practices for safe handling of nanomaterials was compiled by CKMNT as directed by NanoMission for circulation among the nanotechnology stakeholders
 CKMNT prepared a report on “Regulatory Framework for Nanotechnology-A Global
Perspective” for the working group on nanotechnology regulation of Nano mission
 BIS is adapting new standards for nanomaterials

In India regulatory matrix has been developed and categorized under the following broad heads www.teriin.org/div/ST_BriefingPap.pdf

Source: CKMNT Report on Regulatory FrameWork for Nanotechnology: A global perspective, 2013

There is a need for standardization in various fields of nanotechnology to provide a basis for procurement, and support appropriate legislation/regulation.
Things Get weird without STANDARDS
China took the early lead in being first to establish its United Working Group for Nanomaterials
standardization in
December 2003
The recently agreed sizebased definition (i.e. 1-100nm) for nanoparticles (ISO 27687), which is scheduled to be adopted by many governments
,

CHALLENGES COMMITEES
No internationally agreed terminology/definitions
No internationally agreed protocols for toxicity testing
No standardized protocols for evaluating environmental impact
No standardized measurement techniques and instruments
No standardized calibration procedures and certified reference materials.
ANSI-Nanotechnology Standards Panel in the U.S.
ASTM Committee E56 British Standards
Committee for Nanotechnologies (NTI/1)
European Committee for Standardization
(CEN/TC 352)
IEC group nanotechnology standardization for electrical and electronic products and systems (TC 113)
The Technical Committee on
Standardization TC 441 “Nanotechnologies and Nanomaterials” RUSSIA

GB/T19619-2004
Terminology for nanomaterials
Sizing
GB/T19591-
2004 Nanotitanium dioxide
GB/T19627-2005 Particle size analysis -Photon correlation spectroscopy(ISO 13321:1996)
China –National standards published
Dec 2004, implemented Apr
2005
GB/T19588-2004 Nano-nickel power
GB/T19587-2004 Determination of the specific surface area of solids by gas absorption using the BET method(ISO 9277:1999)
GB/T19590-2004
Nano-calcium carbonate
GB/T13221-2004
Nanometer powder -
Determination of particle size distribution -Small angle X-ray scattering method (ISO/TS13762)
GB/T19589-
2004 Nano-zinc oxide
NWIP: generation of data on silver nanoparticles for inhalation toxicity testing
ISO/TC 229 Technical Committe
Participating countries:
Observing countries:
35
13
Terminology and definitions for nanoparticles –to be published as a TS
Current TC 229 work items
NWIP: the Use of Transmission
Electron Microscopy in the
Characterization of Single-walled
Carbon Nanotubes

Global Nanotechnology Regulatory Framework-An over view
India
Planning for regulatory framework
REACH and Nanomaterials
 manufacturers and importers have to submit a registration dossier (for substances manufactured or imported at or above
1 tonne per year) and a chemical safety report (for substances manufactured or imported at or above 10 tonnes per year).
 The European Chemicals Agency can require any information on the substance if deemed necessary
North
America
Europe China
Japan
U.S. National Nanotechnology
Initiaive (NNI)
 1.EHS regulatory/research issues delegated to
Nanotechnology
Environmental and Health
Implications Working Group
(NEHI)
 2.U.S. National Labs play growing role in NT research, infrastructure and commercialization
CHINA
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2003-2006, 10% of the [Chinese government's] investment in nanotechnology [was] allocated [to environmental, health, and safety research].
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In 2004, the National Bureau of the State Food and Drug
Administration ('SFDA') issued a regulation classifying 'nanometer silver antibiotic device for women’s use.
Japan
 No direct regulation of nanomaterials has as yet been implemented in Japan
 The Ministry of Economy, Trade, and Industry (METI) and the
Ministry of the Environment (MOE) have established specific nanomaterial safety working groups and conducted a preliminary survey on the safety of nanomaterials in occupational settings

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 Regulation is important since nanotechnology involves certain risks
 EU, US, and Asian countries are already reviewing their existing regulation
 Various programs and certification system have been started
 Various challenges are associated before making regulation it should not affect innovation
 Standards are important
 ISO TC 229 and various committees have been established to develop standard for nanotechnologies
 In India no regulations for nanotechnology till date.
However certain initiatives have started