nano-regulation in china, japan, korea, usa and eu€¦ · · 2012-09-13nano-regulation in china,...

Nano-regulation in

China, Japan, Korea, USA and EU

YoonMi Park

Young & Global Partners

1. Introduction Nanoelectronics on the Market

CNTs

Quantum

Dots

Nanosilver

Nanophosphate

Lithium ion battery

Fuel Cells /

Photovoltaic Cells

1. Introduction Nanoelectronics on the Market

1. Introduction Nanomaterials: Double-Edged Sword

Nanomaterials

High potential benefit for consumers,

workers & environment.

Unknown potential risk to human and

environment.

Government

/ Industry

How can we control potential risk of nanomaterials?

Definition

What Nanomaterial?

2. Nanodefinition What is “Nanomaterial” in Law?

Nanomaterials (纳米材料) is the material which has a structure in the three-dimensional

space in at least one dimension in the nanometer scale (from 1 nm to 100 nm (1 nm = 10 - 'm)

range of geometric dimensions), or constituted by the nano-structure unit and a material with

special properties.

GB/T 19619-2004: 纳米材料术语 (Terminology for nano materials) (AQSIQ) (Effective on 1

April 2005)

China


“Nanomaterial” refers to, among solid materials manufactured using elements, etc. as a raw

material, a nano-object with at least one of the three dimensions of approximately 1nm－100nm and a nano-structured material composed of nano-objects (including matter

composed of aggregated/agglomerated nano-objects).

Notice on Precautionary Measures for Prevention of Exposure etc. to Nanomaterials (ナノマテリアルに対するばく露防止等のための予防的対応について) (31 March 2009)

Japan


“Nanomaterials”(나노물질) means in a 3 dimension, a nano particle or nano structured

material has at least one dimensional particle size smaller than 100 nm

Technical Guidance on the Safety and Health of Workers involved in Manufacture or Handling

of Nanomaterial (나노물질제조·취급근로자안전보건에관한기술지침 2009)

South Korea

“Nanomaterials” (나노물질) means nano-objects and nano-structured materials (including

materials having an internal nano-sized structure or materials with condensed nanoparticles),

in a solid form, that are smaller than 100 nm in any dimensions. The Guidance lists fullerenes,

carbon nanotubes, nanowires and quantum dots as examples of nanomaterials

Guidance on Safety Management of Nano-based Products (Korean Agency for Technology

and Science Public Notice No.2011-0108 of 12 May 2011 (나노제품의안전관리에관한지침)


“Engineered nanoscale material” is any particle, substance, or material that has been

engineered((1) purposefully produced and (2) purposefully designed to be a nanoscale

material) to have one or more dimensions in the nanoscale(the scale measured in

nanometers ).

Concept Paper for the Nano- scale Materials Stewardship Program under TSCA

U.S


“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 external dimensions is in the size

range 1 nm-100 nm.

Commission Recommendation of 18 October 2011 on the definition of nanomaterial

EU

‘Nanomaterial’ means an insoluble or bio-persistant and intentionally manufactured

material with one or more external dimensions, or an internal structure, on the scale from 1

to 100 nm.

REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 30 November 2009 on cosmetic products


China “Nanomaterials (纳米材料)” is the material which has structure in the three-

dimensional space in at least one dimension in the nanometer scale, or

constituted by the nano-structure unit and a material with special properties.

GB/T 19619-2004: 纳米材料术语 (Terminology

for nano materials) (AQSIQ) (Effective on 1

April 2005)

Japan “Nanomaterial(ナノマテリアル)” refers to, among solid materials manufactured

using elements, etc. as a raw material, a nano-object with at least one of the

three dimensions of approximately 1nm－100nm and a nano-structured

material composed of nano-objects (including matter composed of

aggregated/agglomerated nano-objects).

Notification on Precautionary Measures for

Prevention of Exposure etc. to Nanomaterials (

ナノマテリアルに対するばく露防止等のための予防的対応について) (31 March 2009)

Korea “Nanomaterials(나노물질)” means in a 3 dimension, a nano particle or nano

structured material has at least one dimensional particle size smaller than 100

nm

Technical Guidance on the Safety and Health of

worker manufacturing and handling

Nanomaterial (나노물질제조·취급근로자안전보건에관한기술지침 2009)

“nanomaterials” (나노물질) means nano-objects and nano-structured materials

(including materials having an internal nano-sized structure or materials with

condensed nanoparticles), in a solid form, that are smaller than 100 nm in any

dimensions.

Guidance on Safety Management of Nano-

based Products (Korean Agency for Technology

and Science Public Notice No.2011-0108 of 12

May 2011, KS A 6203) (나노제품의안전관리에관한지침)

US “Engineered nanoscale material” is any particle, substance, or material that has

been engineered to have one or more dimensions in the nanoscale.

Concept Paper for the Nano-

scale Materials Stewardship Program under

TSCA

EU “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 external dimensions is in the size range 1 nm-100 nm.

Commission Recommendation of 18 October

2011 on the definition of nanomaterial

“Nanomaterial’ means an insoluble or biopersistant and intentionally

manufactured material with one or more external dimensions, or an internal

structure, on the scale from 1 to 100 nm.

REGULATION (EC) No 1223/2009 OF THE

EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 30 November 2009

on cosmetic products

Nano-regulation?

3. Nanoregulation China

2004 Seven Nano-standard released (2004-10-26) : Notice No.2004-10 on Newly Approved

National Standards of P.R.China (26 October 2004, Administration of Quality Inspection,

Supervision and Quarantine, State Administration of Standardization) (中华人民共和国国家标准批准发布公告2004年第10号(总第72号) (2004年10月26日, 国家质量监督检验检疫总局, 国家标准化管理委员) )

2011

National Steering Committee for Nanoscience and Nanotechnology

(NSCNN) established (2010-06-01)

Nanotechnology Standards are reviewed (2010-12-30): Nanotechnology Standards are

reviewed by the National Nanotechnology Standardization Technical Committee (NSTC),

the Technical Committee 279, nanomaterial-specific subcommittee under the

Standardization Administration of China (SAC).

Notice on Standard Draft Planning on 17 National Standards including "the Standard on

the Health and Safety Practices in Occupational Settings Relevant to Nanotechnologies

(22 August 2011, Standardization Administration of China) // 「「「「关于下达关于下达关于下达关于下达《《《《职业场所职业场所职业场所职业场所纳米技术的健康和安全纳米技术的健康和安全纳米技术的健康和安全纳米技术的健康和安全》》》》等等等等17项国家标准制修订项目计划的通知项国家标准制修订项目计划的通知项国家标准制修订项目计划的通知项国家标准制修订项目计划的通知 (国家标准化管理国家标准化管理国家标准化管理国家标准化管理委员会委员会委员会委员会, 2011年年年年8月月月月22日日日日) (2011-08-22)

2010

GB/T 13221-2004 纳米粉末粒度分布的测定X 射线小角散射法 [Nanometer powder—Determination of particle size distribution—Small angle X-ray] (AQSIQ) (Effective on 1 April 2005)

GB/T 19345-2003 非晶纳米晶软磁合金带材 (Nanometer powder — Determination of particle size distribution — Small angle X-ray) (AQSIQ) (Effective on 1 May 2004)

GB/T 19346-2003 非晶纳米晶软磁合金交流磁性能测试方法 [Measuring method of magnetic properties at alternative current for amorphousand nanocrystalline soft magnetic alloys]

(AQSIQ) (Effective on 1 May 2004)

GB/T 19587-2004 气体吸附BET法测定固态物质比表面积[Determination of the specific surface area of solids by gas adsorption using the BET method] (SAC) (Effective on 1 April 2005)

GB/T 19588-2004 纳米镍粉 [Nano-nickel powder] (AQSIQ) (Effective on 1 April 2005)

GB/T 19589-2004 纳米氧化锌 [Nano-zine oxide] (AQSIQ) (Effective on 1 April 2005)

GB/T 19590-2004 超微细碳酸钙 [Nano-calcium carbonate] (AQSIQ) (Effective on 1 April 2005)

GB/T 19591-2004 纳米二氧化钛 [Nano-titanium dioxide] (AQSIQ) (Effective on 1 April 2005)

GB/T 19619-2004 纳纳纳纳米材料米材料米材料米材料术语术语术语术语 (Terminology for nano materials) (AQSIQ) (Effective on 1 April 2005)

GB/T 20307-2006 纳米级长度的扫描电镜测量方法通则 [General rules for nanometer-scale length measurement by SEM] (AQSIQ) (Effective on 1 February 2007)

GB/T 21510-2008 纳米无机材料抗菌性能检测方法[Antimicrobial property detection methods for nano-inorganic materials] (AQSIQ) (Effective on 1 August 2008)

GB/T 21511.1-2008 纳米磷灰石/聚酰胺复合材料第1部分: 命名[Nanoapatite/Polyamide composite - Part 1: Designation] (AQSIQ) (Effective on 1 August 2008)

GB/T 21511.2-2008 纳米磷灰石/聚酰胺复合材料第2部分：技术要求 [Nano-apatite/Polyamide composite - Part 2: Technology requirements] (AQSIQ) (Effective on 1 August 2008)

GB/Z 21738-2008 一维纳米材料的基本结构高分辨透射电子显微镜检测方法 [Fundamental

structures of one dimensional nanomaterials - High resolution electron microscopy characterization] (AQSIQ) (Effective on 1 November 2008)

GB/T 22458-2008 仪器化纳米压入试验方法通则 [General rules of instrumented nanoindentation test] (AQSIQ) (Effective on 1 May 2009)

GB/T 22462-2008 钢表面纳米、亚微米尺度薄膜素深度分布的定量测定辉光放电原子发射光谱法 [Nano Sub-micron scale film on steel - Quantitative depth profile analysis - Glow

discharge atomic emission spectrometry] (AQSIQ) (Effective on 1 June 2009)

GB/T 22925-2009 纳米技术处理服装 [Nanotechnology-treated clothes] (China Association of Textile Industry) (Effective on 1 December 2009)

GB/T 23413-2009 纳米材料晶粒尺寸及微观应变的测定 X射线衍射线宽化法 [Determination of crystallite size and micro-strain of nano-materials—X-ray diffraction line broadening

method] (AQSIQ) (Effective on 1 December 2009)

HG/T 3791-2005 氯乙烯-纳米碳酸钙原位聚合悬浮法聚氯乙烯树脂 [Suspension poly (vinyl chloride) resins via vinyl chloride and nanocalcium carbonate in situ polymerization]

(NDRC) (Effective on 1 January 2006)

HG/T 3819-2006 纳米合成水滑石[Nano-synthetic hydrotalcite] (NDRC) (Effective on 1 March 2007)

HG/T 3820-2006 纳米合成水滑石分析方法[Methods of test for Nanosynthetic hydrotalcite] (NDRC) (Effective on 1 March 2007)

HG/T 3821-2006 纳米氢氧化镁 [Nano-powder of magnesium hydroxide] (NDRC) (Effective on 1 March 2007)

Nanotechnology Standards in China

3. Nanoregulation Japan

2010 JISC/CNSJ - Japan Industrial Standards Committee - Council on Nanotechnology

Standards in Japan (2010-06-01) : They are drafting an International Standardization

Roadmap for Nanotechnology along with the Nanotechnology Business Creation

Initiative (NBCI).

2011

5 year project on toxicity test protocols and risk assessment methodologies for

manufactured nanomaterials (2010-06-01): At the institutional level, the Ministry of

Economy, Trade and Industry (METI) is conducting a 5 year project on toxicity test

protocols and risk assessment methodologies for manufactured nanomaterials,

coordinated by the National Institute of Advanced Industrial Science and Technology

(AIST), and the National Institute of Occupational Safety and Health Japan (JNIOSH) has

started a three-year project on exposure to manufactured nanomaterials at the

workplace.Discussion Committee on Chemical Substances (first meeting in fiscal year 2011)

(化学物質審議会化学物質審議会化学物質審議会化学物質審議会（平成平成平成平成２３年度第年度第年度第年度第１回回回回) )(2011-08-03)

Committee on Safety Management for Nanomaterials established // 「「「「ナノナノナノナノ物質物質物質物質のののの管理管理管理管理にににに関関関関するするするする検討会検討会検討会検討会」のののの設置設置設置設置についてについてについてについて (2011-11-30)

2009 Notification on Precautionary Measures for Prevention of Exposure etc. to

Nanomaterials (ナノマテリアルに対するばく露防止等のための予防的対応についナノマテリアルに対するばく露防止等のための予防的対応についナノマテリアルに対するばく露防止等のための予防的対応についナノマテリアルに対するばく露防止等のための予防的対応についてててて ) (31 March 2009)

3. Nanoregulation South Korea

2008 Guidance on the Safe Handling of Nanomaterials to be provided (26 December 2008,

Korean Agency for Technology and Standards) (나노물질작업안전지침개발 (2008년12월 26일, 기술표준원)) (2008-12-26)

2011

Standardization Initiative on Material Safety Data Sheet for Nanomaterials (10 September

2009, Ministry of Knowledge Economy) (나노물질의안전보건자료작성표준화(2009년 9월 10일, 지식경제부)) (2009-09-10)

Development of Technological Platform for the Safety of Nano-products from 2009 to

2014 (나노제품안정성확보를위한플랫폼기술개발시작) (2009-11-18)

National Chemicals Control Basic Plan (국가화학물질관리기본계획) (2011-01-18):

Under the Plan, nanosubstances are among priority chemicals that will be subject to in-

depth hazard assessment, exposure analysis, and safety studies.

2009

Guidance on Safety Management of Nano-based Products (나노제품의안전관리에관한지침 (2011-05-12): The Guidance was adopted to: assure benefits and safety for

nanotechnology users and consumers of nanotechnology-based products; enhance social

acceptance of nanotechnology-based products; and promote sustainable development of

nanotechnology industries.

The First Master Plan on Management of Nanomaterials Safety 2012-2016 (제1차나노안전관리종합계획 2012-2016) (2011-10-25)

Proposed Act on the Registration and Evaluation of Chemicals (K-REACH) moving forward

despite delays and oppositions (화학물질등록및평가등에관한법률제정안입법예고 (2011-02-25)


The First Master Plan on Management of Nanomaterials Safety (2012-2016)

(제1차나노안전관리종합계획, 2012-2016) (effective on 25 October 2011)

Several action plans in the following four strategies:

1.establishing database for assessment and analysis of nanomaterials

2.establishing a system for assessment of nanomaterials safety

3.preparing a basis for systemization of nanomaterials safety management

4.cultivating professional manpower and forming partnership with stakeholders.

3. Nanoregulation USA

2007 Report on Nanotechnology and Life Cycle Assessment released (2007-03-20)

2010

ASTM Committee E56 on Nanotechnology (2008-03-15)

2008 Final framework document for the nanotechnology stewardship program released by

EPA (2008-01-28)

2009 Research strategy to study nanomaterials announced (2009-09-29)

ASTM – E56 American Society for Testing Materials International Committee on

Nanotechnology (2010-06-01)

Developments in Nanotechnologies Regulation and Standards 2010 (2010-06-01)

Under Toxic Substances Control Act, Nanomaterials classified as new substances are

subjected, as any other new chemical, to a pre-manufacture review process (pre-

manufacturing notification – PMN), to identify and assess risks of the substance

considered. (2010-06-01)

2012

NNI Releases 2011 EHS Research Strategy(2011-10-20)

Significant New Use Rule for Multi-walled Carbon Nanotubes issued (2011-05-06)2011

SNURs for 17 Chemicals including CNTs proposed (2011-12-28)

Draft Guidance Documents on Nanomaterials released by FDA (2012-04-20)

Federal Advisory Council on Occupational Safety and Health considers Dispersible

Engineered Nanomaterials (2012-05-03)

3. Nanoregulation EU

2005 Risk assessment methodology for nanomaterials reviewed by the Scientific

Committee(2005-04-28)

2011

Regulation of nanoscale silver products as pesticides demanded (2008-11-19)

National Action Plan to focus on nanomaterials (2011-03-10)

2008

2006 Opinion on nanosciences and nanotechnologies: An action plan for Europe 2005-2009

published

2009 Report on Nanomaterials under REACH published (2009-11-17)

2010 Final SCENIHR opinion for a definition of "nanomaterial" adopted (2010-12-08)

Report on nanomaterials in consumer products released (2011-05-02)

European Commission publishes final Reports on REACH Implementation Projects on

Nanomaterials(RIP-oN) (2011-10-18)

Guidance document on the safety assessment of nanomaterials in cosmetics (2011-10-07)

"Nanomaterial" defined (2011-10-20)

2012

Consultation on safety, health and environmental effects of nanosilver launched by

SCENIHR (2012-04-01)

Registration of nanomaterials guided by ECHA (2012-04-30)

3. Nanoregulation EU Member States

2007 Switzerland/ Report on risk assessment and management of synthetic nanomaterials

issued (2007-09-01)

2011

Germany/ Action Plan Nanotechnology 2015 released (2011-01-12)

2008 Netherlands/ Government requests advice on workplace exposure to nanoparticles

(2008-09-05)

2010 Belgium/ Belgian Presidency discussed measures on nanomaterials in consumer products

(2010-09-14)

Germany/ Legal feasibility study on the introduction of a nanoproduct register published

(2010-09-29)France/ Draft French decree on an annual declaration on nanomaterials released (2011-

01-05)

Netherlands/ EU action on nanomaterials requested by the Netherlands

France/ Notice to importers and exporters of hazardous chemicals regarding the update of

annex I of Regulation EC/689/2008 published (2012-12-29)

France/ Declaration of Nanomaterials required (2012-02-17)

Netherlands/ Working with engineered nanoparticles: Exposure registry and a system of

health monitoring (2012-05-22)

2012

Germany/ Recommendation on Risk assessment of nano materials at workplaces

released (2012-05-29)

Belgium/ Nanomaterials might be registered in 2013 (2012-06-01)


France/ Declaration of Nanomaterials required (2012-02-17)

Under Article 185 of France’s Environmental Commitment Bill,

“persons who manufacture, import or distribute nanoscale substances, either in pure from or

contained in loose mixtures, or materials that will discharge such substances under normal or

reasonably foreseable conditions of uses, shall periodically declare to administrative

authority…the identity, quantities and uses of those substances, as well as the identiy of the

professional users to whom they were sold or given free of charge.”

Manufacturers, importers and distributers would have to report on an

annual basis regarding the nanomaterials made available on the French

market if they exceed the threshold of 10 grams per year.

3. Nanoregulation Revolution? Evolution!

Existing Chemical Law

China Regulation on the Safety Management of Hazardous Chemicals (危险化学品安全管理条例)

(latest amended 2 March 2011)

Japan Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc

(化学物質の審査及び製造等の規制に関する法律)

South Korea Toxic Chemicals Control Act (유해화학물질관리법)

Proposed Act on the Registration and Evaluation of Chemicals (Ministry of Environment Public

Announcement No.2011-74 of 25 February 2011) // 화학물질등록및평가등에관한법률제정안입법예고

USA TSCA (Toxic Substance Control Act)

SNURs (Significant New Use Rules)

EU REACH (Regulation concerning Registration, Evaluation, Authorisation of Chemicals)

CLP (Regulation concerning Classification, Labeling and Packaging of Substances and Mixtures)

3. Nanoregulation Revolution? Evolution!

Existing Chemical Law Potential Application to NM

USA TSCA (Toxic Substance Control

Act)

-PMN(premanufacture notices ) for nanomaterials

-Classification of nanomaterials as “new” or existing is changing,

however it is recommended documentary requirements for a “new”

substance .

-ALL CNT is required to be registered individually as new substances.

Significant New Use

Rules(SNURs)

-use of a substance as a “significant new use”: certain infromation to be

submitted before manufacture of the substance.

- CNT

EU REACH (Regulation concerning

Registration, Evaluation,

Authorisation of Chemicals)

-REACH implementation projects on nanomaterials (RIP-oNs) provides

scientific and technical advice on brining nanomaterials under REACH

compliance.

- RIP-oN 1: on substance identification

- RIP-oN 2: on information requirements

- RIP-oN 3: on chemical safety assessment.

Regulation on cosmetic products Cosmetic products containing nanomaterials to notify six months before

placing them on the market

FRANCE / Decree 2012-232 on

the annual declaration of

nanoparticle substances (17

February 2012)

-Manufacturers, importers and distributors would gave to report on an

annual basis regarding the nanomaterials made available on the French

market if they exceed the threshold of 10 grams per year.

4.Conclusion Asia keep their eyes on the EU and USA Nano-Regulations

EU

•EU/ Nanomaterials in REACH will strongly influence regulatory actions at

national level.

•EU/ “Nanomaterials” defined.

•France/ Declaration of Nanomaterials

•Netherlands, Belgium …/ Registration of Nanomaterials

•The Environmental Protection Agency (EPA) has a dedicated activity on the

regulation of nanomaterials under the Toxic Substances Control Act

•Pursuant to “Significant new use rules (SNUR)” , if there is any significant

new use of existing chemicals, the company have to issue a notification on a

regular basis for specific use and type of nanomaterials (mainly carbon

nanotubes, fullerenes, titanium and silica based compounds).

•Not specific regulation yet, but monitoring movement of EU and USA and

make legislation developed in EU and USA as a benchmark for their

development.

•Especially they keep their eyes on the debate on REACH and nanomaterials.

Until 2012

USA

4.Conclusion Asia keep their eyes to the EU and USA Nano-Regulations

From 2013Korea:

•Proposed Act on the Registration and Evaluation of Chemicals (Ministry of

Environment Public Announcement No.2011-74 of 25 February 2011)

(화학물질등록및평가등에관한법률제정안입법예고 ) : but there is no

provisions regarding nanomaterials.

•The First Master Plan on Management of Nanomaterials Safety 2012-2016 //

제1차나노안전관리종합계획 2012-2016 (2011-10-25)Japan:

•Act on the Evaluation of Chemical Substances and Regulation of Their

Manufacture, etc (化学物質の審査及び製造等の規制に関する法律): but there is no provisions regarding nanomaterials.

•5 year project on toxicity test protocols and risk assessment methodologies

for manufactured nanomaterials(2010-06-01)China:

•Regulation on the Safety Management of Hazardous Chemicals

(危险化学品安全管理条例) (latest amended 2 March 2011)

USA EU

USA:

•TSCA, SNURs

EU:

•REACH (REACH Implementation Project on

Nanomaterials)