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Tag Archives: nanotubes

New Nanoscale Carbon Website — CNT Report

Readers may be interested in learning about a new subscription website devoted to nanoscale carbon — CNT Report

CNT Report is dedicated to bringing its readers the most recent news concerning important issues affecting nanoscale carbon research, development, and commercialization.  CNT Report closely covers all forms of nanoscale carbon in development on the global stage, including CNTs, graphene, fullerenes, specialty fibers, and all else in-between.  CNT Report’s primary focus is on new scientific research developments, practical applications, finance, legal and regulatory issues, and general commercialization.   CNT Report publishes news in several broad categories including: Business, Commercialization,  Finance & Deals, Insurance, Intellectual Property, International Laws & Regulations, Policy, Standards, States, Science, Applications, Current Research, and Environmental, Health and Safety.

CNT Report also accepts press releases, research results, financial news, or any other news item related to nanoscale carbon which it then makes available to all of its subscribers.  CNT Report welcomes timely contributions from its readers and makes sure that their articles receive proper attribution and credit.

 …

EPA to Issue New Carbon Nanotube Significant New Use Rule

Here is an advance copy of a new multi-walled carbon nanotube significant new use rule being published tomorrow in the federal register.  It applies only to the specific carbon nanotubes that were the subject of PMN P-08-199, and binds anyone who intends to manufacture, import, or process the specific chemical substance.  It is largely consistent with past SNURs and Consent Orders for other CNTs.  For those wondering, "processors" and "processing" is broadly defined under TSCA.  It has been used in the past to include repackaging for commercial purposes, using the material in the manufacturing of new mixtures, and/or the production of articles using the substance.…

Nanoscale Carbon Toxicity Testing Proposal Submitted to EPA

 

 

The NanoSafety Consortium for Carbon just submitted a proposed toxicity testing agreement to EPA under Section 4 of the Toxic Substances Control Act covering a range of nanoscale materials including multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene. 

 

Key elements for the curious:

  • The chemical substances to be tested may include representative (i) purified multi-walled carbon nanotubes ranging from 4 to 600 nanometers in diameter and less than 30 micrometers in length; (ii) purified double-walled carbon nanotubes ranging from 1.5 to 4 nanometers in diameter and less than 5 micrometers in length; (iii) purified single-walled carbon nanotubes ranging from .7 to 2 nanometers in diameter and less than 30 micrometers in length; and (iv) purified graphene nanoplatelets in flake/sheet form ranging from .5 nanometers to 100 nanometers thick. All test materials will be purified by the National Institute of Standards and Technology to be at least 99 percent pure. Final test materials will be approved by the EPA and will be selected to adequately represent the constituency of the final signatories to the testing agreement.

 

  • The characteristic for which testing will be conducted is subchronic inhalation toxicity in rodents, or such other toxicity testing as may be approved by EPA to achieve the intent and purpose of the testing agreement. As appropriate, consideration will be given to using in vivo instillation rather than inhalation test methods. Test data will be developed under standards based on TSCA test guidelines in 40 CFR parts 796,

“The New Steel? Enabling the Carbon Nanomaterials Revolution: Markets, Metrology, Safety, and Scale-up”

“The New Steel? Enabling the Carbon Nanomaterials Revolution: Markets, Metrology, Safety, and Scale-up” is a workshop to be held on February 28th and March 1st, 2011, at NIST’s Gaithersburg, Maryland facility. NIST has assembled an outstanding roster of speakers from industry, academia and government to address the full spectrum of issues, including a special panel on EH&S.

If you can join the workshop, please register before the registry is filled! Remember that this will be a true workshop and participants are encouraged to actively share their views and perspectives over the two days, and also to provide if possible before the workshop commences a brief (2-page) white paper on one of the three breakout session topics, listed below, to help seed the discussions. If you prepare a white paper, please send it to TheNewSteel@nist.gov

The three topic areas for the workshop breakout sessions:

• Technology Challenges and Barriers for Carbon-based Nanomaterials • EH&S – From Regulation to the Marketplace • Measurement Issues and Grand Challenges

NIST contact information is below if you have any questions or would like to receive more information regarding the workshop.

J. Alexander Liddle, Group Leader Nanofabrication Research Group Center for Nanoscale Science and Technology National Institute of Standards and Technology Bldg. 216 Rm. B153 100 Bureau Drive, Stop 6203 Gaithersburg, MD 20899-6203 tel: 301 975 6050 fax: 301 975 5314 liddle@nist.gov http://cnst.nist.gov  …

Unidym Press Release

UNIDYM ANNOUNCES ALLIANCE WITH SAMSUNG ELECTRONICS

Sunnyvale, CA – December 8, 2010 – Unidym, Inc., a majority owned subsidiary of Arrowhead Research Corporation (NASDAQ: ARWR), announced today that it has completed IP cooperation and license agreements with Samsung Electronics Co., Ltd. ("Samsung"). Under the agreements:

1. Unidym licensed to Samsung patents covering CNT materials, including fundamental patents on CNT compositions of matter, synthesis of CNTs, processing of CNTs, ink formulations, and transparent conductive films.

2. Unidym transferred certain patent rights to Samsung, primarily related to electronic devices incorporating CNTs. Samsung granted back to Unidym licenses to sell products under the transferred patent rights.

3. Unidym and Samsung will continue to work together to develop and commercialize CNT-based products.

"This is an important development in carbon-based electronics," said Mark Tilley, President and CEO of Unidym. "We have worked with Samsung Electronics for several years, and we are now looking forward to this next phase in our relationship. We expect Samsung’s investment in this alliance and ongoing IP cooperation with Unidym will open the market for printable carbon electronics."

About Samsung Electronics Co., Ltd.

Samsung Electronics Co., Ltd. is a global leader in semiconductor, telecommunication, digital media and digital convergence technologies with 2009 consolidated sales of US$116.8 billion. Employing approximately 174,000 people in 193 offices across 66 countries, the company consists of eight independently operated business units: Visual Display, Mobile Communications, Telecommunication Systems, Digital Appliances, IT Solutions, Digital Imaging, Semiconductor and LCD. Recognized as one of the fastest growing global brands, Samsung …

NIOSH Recommends Exposure Limit of 7 μg/m 3 for Carbon Nanotubes

This article originally appeared on the National Nanomanufacturing Network’s InterNano website. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

In late November, the National Institute for Occupational Safety and Health (NIOSH) published a Current Intelligence Bulletin entitled "Occupational Exposure to Carbon Nanotubes and Nanofibers." The document is not an official "agency determination or policy," and was released solely by NIOSH for peer-review and comment. NIOSH’s carbon nanotube recommended exposure limit (CNT REL) is set at 7 μg/m 3 for these preliminary purposes.

The old saying that "a picture is worth a thousand words" is once again proved by the document’s cover image which is a remarkable "field emission micrograph of a multi-walled carbon nanotube…penetrating the pleura of the lung." The finely detailed image of a CNT penetrating a lung membrane should cause any reader to stop and closely consider the document’s recommendations.

The document begins by noting that while there are no scientific reports of "adverse health effects in workers producing or using carbon nanotubes…or carbon nanofibers," NIOSH is concerned because some studies have shown that the potential for worker exposure exists. Additionally, some in vivo studies have shown adverse reactions to carbon nanotubes in rodents — including pulmonary inflammation and fibrosis. Further, some in vitro and in vivo studies have led researchers to theorize that inhalation of certain carbon nanotubes in large doses may potentially cause asbestos-type exposure effects.

NIOSH explains that the scientific basis for its CNT REL is an extrapolation from subchronic in vivo toxicity studies …

An Industry-Driven Approach to EHS Issues

My new Nanotechnology Law & Business article — "An Industry Driven Approach to EHS Issues: ‘The NanoSafety Consortium for Carbon’" — can be found here.  The abstract follows.

The NanoSafety Consortium for Carbon (NCC) is an industry-driven group formed to proactively address potential environmental, health, safety, and regulatory concerns related to the commercia-lization of its members’ nanoscale carbon products. NCC was formed to take advantage of an offer by the EPA for a consortium of companies to providing testing regarding carbon nanotube toxicity. This article provides background on NCC’s activities, purpose, and goals.…

The 2010 Nobel Prize in Physics

TheSwedish Royal Academy of Sciences, in accordance with the will of Afred Nobel, announced the winners of the 2010 Nobel Prize in Physics on Tuesday October 5, 2010. As most people have heard by now, the winners were Russian expatriates Andre Geim and Konstantin Novoselov , both Professors at the UK’s University of Manchester.  Professors Geim and Novoselov were cited for their discovery of graphene, using Scotch tape. Graphene, according to an article in the New York Times:

. . .is a form of carbon in which the atoms are arranged in a flat hexagon lattice like microscopic chicken wire, a single atom thick. It is not only the thinnest material in the world, but also one of the strongest and hardest.

Among its other properties, graphene is able to conduct electricity as well as copper does and to conduct heat better than any other known material, and it is practically transparent. Physicists say that it could eventually rival silicon as a basis for computer chips, serve as a sensitive pollution-monitoring material, improve flat-screen televisions, and enable the creation of new materials and novel tests of quantum weirdness.

Among the forms of graphene that are of most interest to the nanotechnology field are graphene nanoribbons. Graphene is also related to carbon nanotubes and "buckeyballs".

EPA Releases SNURS Affecting Multi-Walled and Single-Walled Carbon Nanotubes

In the Federal Register for Friday 09/17/2010, the Environmental Protection Agency (EPA), acting under the authority granted to it under section 5(a)(2) of the TSCA, issued as a final rule Significant New Use Rules (SNURS) affecting two chemical substances identified as generic multi-walled and single-walled carbon nanotubes (MWCNTs and SWCNTs respectively). These SNURs are applicable to manufacturers, importers, and processors, who will be required to notify EPA at least 90 days in advance if they intend to use these substances "for a use that is designated as a significant new use by this final rule. . . . EPA believes that this action is necessary because these chemical substances may be hazardous to human health and the environment".

This final rule is the culmination of a process that has taken over a year. EPA had issued a direct final rule in the Federal Register issue of 06/24/2009. This direct final rule affected several chemical substances, including the MWCNTs and the SWCNTs, that had been the subject of various consent decrees issued by EPA. The language of the final rule affecting the MWCNTs read as follows:

Sec.  721.10155  Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as multi- walled carbon nanotubes (PMN P-08-177) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.     (2) The significant new uses are:     (i) Protection in the workplace. Requirements as specified in Sec.  …

Webinar: The Rise of MWNTs

On July 20, 2010, David Hwang of Lux Research gave a webinar entitled: "Lux Research Nanomaterials: The Rise of MWNTs: Oversupply Hides Real Opportunities."

Mr. Hwang’s presentation identified the top global producers of multi-walled carbon nanotubes (MWCNTs), explained why commercialization over the past 25 years has been relatively "anemic," and made some predictions for where the market is heading in the next decade. He explained that while total sales of MWCNTs were under $100 million for 2008, the market is predicted to grow to approximately 2389 tons by 2020.

Two major forces slowing past commercialization included (i) a "you first" mentality by which companies wanted to see others take the first successful steps towards commercialization before they joined the trend, and (ii) regulatory risks inherent in the development of any new technology — a commercialization bottleneck related to the potential environmental, health, and safety (EHS) impacts of certain carbon nanotubes.  (Regular readers will note that this is a recurring theme in our articles).

Mr. Hwang further explained that he believes the market for MWCNTs is currently in a transition phase, and that an oversupply will exist until 2017.  He commented that total sales in 2009 equaled $75 million and would increase to $513 million by 2020.   Mr. Hwang then covered four specific markets that are leading the commercialization for MWCNTs and provided 2009 versus 2020 material usage estimates:

 

  • Sporting goods: 4 tons (2009) versus 270 tons (2020)
  • Aerospace/defense: less than 1 ton (2009) versus 67 tons (2020)
  • Wind turbines: 130

European Parliament Members Vote for Ban on Nanomaterials, Including Nanosilver and Carbon Nanotubes

The Members of the European Union’s (“EU”) Environment Committee (“MEPs”) recently voted in favor of proposed amendments to the EU’s Restriction of Hazardous Substances Directive, first passed in 2002, banning the use of nanosilver and long multi-walled carbon nanotubes in electrical and electronic products. The legislators also approved language requiring that any electrical or electronic materials containing nanomaterials should be labeled as such and that manufacturers who use nanomaterials would be required to provide the European Commission with safety data on any materials used. Commentators have noted that the MEPs’ definition of nanomaterials is unclear and the current interpretation could require labeling for every electronic product, such as every transistor in a computer chip. A vote on the proposal is expected in October.…

Nanoscale Carbon: In Vivo Tox Bibliography

The NanoSafety Consortium for Carbon has recently posted a bibliography of in vivo tox studies on its website.  The bibliography is (obviously) a work in progress.  We would greatly appreciate it if our readers would bring to our attention any pertinent articles that are not already on the bibliography.  The articles will be used to inform and guide our attempt in crafting a representative toxicity testing regime with US EPA.  Many thanks in advance for your input.…

Analysis: “Stanford University Responds to California’s DTSC Data Call-In for Carbon Nanotubes”

This article originally appeared on the National Nanomanufacturing Network’s InterNano website earlier today.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported. 

In late December 2009, California’s Department of Toxic Substances Control (DTSC) received the first response1 to its January 22, 2009 information request regarding carbon nanotubes2. The original request targeted 26 purported California manufacturers and/or importers of carbon nanotubes3.

It asked for information regarding analytical test methods, environmental fate and transport, and other relevant environmental, health, and safety information. The request was issued by DTSC under authority granted by California’s Health and Safety Code 699, Sections 57018-57020. Stanford University was the first entity to respond to the six specific questions contained in DTSC’s request:

1.  What is the value chain for your company? For example, in what products are your carbon nanotubes used by others? In what quantities? Who are your major customers?

2.  What sampling, detection and measurement methods are you using to monitor (detect and measure) the presence of your chemical in the workplace and the environment? Provide a full description of all required sampling, detection, measurement and verification methodologies. Provide full QA/QC protocol.

3.  What is your knowledge about the current and projected presence of your chemical in the environment that results from manufacturing, distribution, use, and end-of-life disposal?

4.  What is your knowledge about the safety of your chemical in terms of occupational safety, public health and the environment?

5.  What methods are you using to protect workers in the research, development and manufacturing environment…

New Article: Examples of Recent EPA Regulation of Nanoscale Materials Under the Toxic Substances Control Act

Nanotechnology Law & Business just published our new article on the EPA’s recent treatment of nanoscale materials under the Toxic Substances Control Act.  An abstract for the article is below and you can find a copy of the article itself here.

Abstract: This article provides a summary of recent (2008-2009) regulatory efforts by the U.S. Environmental Protection Agency under the Toxic Substances Control Act concerning nanoscale materials. These efforts include entering into two consent orders with a manufacturer of carbon nanotubes; issuing four significant new use rules for two siloxane-based nanoparticles and two carbon nanotubes (and then withdrawing the latter two); intimating that new testing and data collection rules will be implemented for certain nanoscale materials; and proposing and/or requiring acute toxicity rat inhalation testing regimes in certain instances. The authors explain these developments in detail and then provide some initial strategic and legal considerations for businesses attempting to navigate this emerging regulatory thicket.

New Edition of Nanotechnology Law Report

Here is the Summer 2009 edition of Nanotechnology Law Report.  The newsletter contains the below-listed articles (and more):

  • EPA Issues Significant New Use Rules for Carbon Nanotubes
  • Are Nanoparticles Released by Cutting or Compounding Nano-Composites?
  • Annual Nano TiO2 Production Estimated at 44,000 Metric Tons
  • Are Nano Consumer Products Headed Underground?
  • Oversight of Next Generation Nanotechnology
  • Regulating Nanotechnologies
  • More Interesting Nano-Regulatory Developments
  • Nano Tug of War
  • Pumpkins & Nanoparticles
  • Green Nano
  • NanoBiotech 2009
  • Take two silver nanoparticles and call me in the morning
  • International Approaches to the Regulatory Governance of Nanotechnology
  • ETUC Resolution on Nanotechnologies and Nanomaterials
  • Private Spending on Nano Exceeds Government Spending
  • EMERGNANO Released

EPA Issues Significant New Use Rules for Multi-Walled and Single-Walled Carbon Nanotubes

In the June 24, 2009 federal register, the U.S. Environmental Protection Agency (EPA) issued two proposed Significant New Use Rules (SNUR) under Section 5(a) of the Toxic Substances Control Act (TSCA) for multi-walled and single walled carbon nanotubes.  The SNURs followed up on the EPA’s prior September 2008 consent orders entered into with Thomas Swan & Co. Ltd. (Swan) for two of its Elicarb carbon nanotube products.

Under TSCA, the prior September 2008 consent orders were only binding on Swan.  "Consequently, after signing a Section 5(e) Consent Order, EPA generally promulgates a Significant New Use Rule (SNUR) that mimics the Consent Order to bind all other manufacturers and processors to the terms and conditions contained in the Consent Order.  The SNUR requires that manufacturers, importers and processors of certain substances notify EPA at least 90 days before beginning any activity that EPA has designated as a "significant new use. These new use designations are typically those activities prohibited by the Section 5(e) Consent Order."

Under the terms of the Septmeber 2008 consent orders which are incorporated into the new proposed SNURs, significant new uses of multi-walled and singled-walled carbon nanotubes are deemed to occur when employees do not “use gloves impervious to nanoscale particles and chemical protective clothing;” and/or fail to “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”

Thus, the new proposed SNURs require these same conditions.

Manufacturers should also be aware that the EPA considers carbon nanotubes new chemical

Are Nanoparticles Released by Compounding or the Cutting of Nano-Composites?

Perhaps the most overlooked issue when examining potential nano-related environmental, health, and safety concerns is whether there is any true likelihood of exposure in reasonably foreseeable use scenarios.  While there should continue to be extensive toxicity testing for certain nanoscale materials, the most interesting research (from my perspective) relates to potential workplace and/or condumer exposure in realistic settings.  We examine two studies along these lines below.

C. Su-Jung et al., "Control of Airborne Nanoparticles Releases During Compounding of Polymer Nanocomposites," 3 Nano: Brief Reports and Reviews 4, 301 – 309 (2008).

This study was conducted by researchers at the National Science Foundation-funded Center for High-Rate Nanomanufacturing at the University of Massachusetts at Lowell.  The scientists examined potential nanoparticle release related to the twin-screw extruder compounding of polymer nanocomposites.  The test was conducted because "commercial compounding (mixing) of nanocomposites is typically achieved by feeding the nanoparticles and polymer into a twin-screw extruder, the airborne particles associated with nanoparticles reinforcing agents are of particular concern, as they can readily enter the body through inhalation."

The nanoparticles in question were nano aluminum oxide particles acquired from Nanophase Technologies in commercially available form.  The particles were spherical in shape and ranged from 27 to 53 nm in diameter.  They were also specifically "engineered to form agglomerates with a nominal size of 200 nm."

Regarding the test itself, the scientists fed 2.3kg of polymer pellets and 0.16 kg of nano-alumina particles into a twin-screw extruder for processing and then measured potential nanoparticle release through two measurement …

Carbon Nanotubes

The April issue of Environmental Health Perspectives carries a short article summarizing a seminar at the 2009 AAAS Annual Meeting titled "Driving Beyond Our Nano-Headlights?". In the summary, there is a brief reference to work done by Vanesa Sanchez, a graduate student at Brown University. The results of her experiment are rather alarming.

Ms. Sanchez work showed that

very low doses of CNTs . . . appeared to cause lesions known as granulomas similar to what occurs with asbestos fibers. Moreover, the CNTs formed a cage-like structure that . . .  might promote granuloma formation.

It is too bad that the summary didn’t give more space to a study that could have a profound effect on future nanomanufacturing facilities and possible future governmental regulation of the nano-industry.…

California Formally Requests Carbon Nanotube Information From Manufacturers

On January 22, 2009, California’s Department of Toxic Substances Control (DTSC) sent a formal request to several California manufacturers and/or importers of carbon nanotubes seeking information regarding analytical test methods, environmental fate and transport, and other relevant environmental, health, and safety information regarding carbon nanotubes.  The request was issued by DTSC under its authority granted under California’s Health and Safety Code 699, Sections 57018-57020.

DTSC asked manufacturers to answer the following questions:

What is the value chain for your company? For example, in what products are your carbon nanotubes used by others? In what quantities? Who are your major customers?

What sampling, detection and measurement methods are you using to monitor (detect and measure) the presence of your chemical in the workplace and the environment? Provide a full description of all required sampling, detection, measurement and verification methodologies. Provide full QA/QC protocol.

What is your knowledge about the current and projected presence of your chemical in the environment that results from manufacturing, distribution, use, and end-of-life disposal?

What is your knowledge about the safety of your chemical in terms of occupational safety, public health and the environment?

What methods are you using to protect workers in the research, development and manufacturing environment?

When released, does your material constitute a hazardous waste under California Health &Safety Code provisions? Are discarded off-spec materials a hazardous waste? Once discarded are the carbon nanotubes you produce a hazardous waste? What are your waste handling practices for carbon nanotubes?

Recipients have one year to supply the requested information.…

Interim Report: Lukewarm Response to EPA’s Nanoscale Material Stewardship Program

Earlier today, the EPA published an interim status report regarding its Nanoscale Materials Stewardship Program.  A final report is expected in early 2010.

Nanoscale Materials Stewardship Program, Interim Report, January 2009, U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics.

At the outset, EPA notes that "[t]he findings and conclusions [of the] report should not be construed or interpreted to represent any Agency regulatory or statutory guidance or statement of official Agency policy."   Several companies submitting NMSP data should be relieved by this disclaimer, as EPA identified 18 nanoscale materials in NMSP submissions which may be considered new chemical substances under TSCA and subject to premanufacturing notice requirements.  Whether EPA takes any enforcement steps in this regard remains to be seen.

Getting to the highlights of the report, EPA concludes that the NMSP has (thus far) produce mixed results:

  • "In the aggregate, the NMSP has sufficiently advanced EPA’s knowledge and understanding to enable the Agency to take further steps towards evaluating and, where appropriate, mitigating potential risks to health and the environment."
  • "It appears that nearly two-thirds of the chemical substances from which commercially available nanoscale materials are based were not reported under the Basic Program."
  • "It appears that approximately 90% of the different nanoscale materials that are likely to be commercially available were not reported under the Basic Program."
  • "The low rate of engagement in the In-Depth Program suggests that most companies are not inclined to voluntarily test their nanoscale materials."

EPA’s overall conclusion is that:

"[T]he NMSP can be considered …

PDF of “A Nano-Mesothelioma False Alarm”

Nanotechnology Law and Business was kind enough to let us post a PDF of "A Nano-Mesothelioma False Alarm" here after several readers requested a copy. 

Please be sure to visit the journal to see the rest of this issue’s articles:

  • Grading of Fullerene Nanotubes for Composite Applications
  • Next Generation Carbon Fiber
  • Patenting Graphene: Opportunities and Challenges
  • Oxonica v. Neuftec: Nanoparticle Fuel Additive Litigation in the United Kingdom
  • Mediating the Uncertainty and Abstraction of Nanotechnology Promotion and Control: “Late” Lessons from Other “Early Warnings” in History
  • The Implications of Recent Nanomaterials Toxicity Studies for the Nanotech Community
  • A Nano-Mesothelioma False Alarm
  • Convergence of Cleantech and Nanotech and the Benefits to the Nanotech Sector
  • French and European Community Law on the Nanometric Forms of Chemical Substances: Questions About How the Law Handles Uncertain Risks
  • The Validity of European Nanotechnology Patents in Germany
  • Book Review of Nanotechnology & Society: Current and Emerging Ethical Issues
  • Top Ten Ways Nanotech Will Impact Cleantech
  • Updates

 

 …

Carbon Nanotubes and TSCA Registrations

Today, US EPA issued a Federal Register notice stating the Toxic Substances Control Act (TSCA) registration requirements are "potentially applicable to carbon nanotubes."  EPA confirmed its position the CNTs are "chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA inventory."  The bottom line is stated succinctly by EPA: "Many CNTs may therefore be new chemicals under TSCA Section 5."…

Registration of Carbon Nanoscale Materials Required Under REACH

The EC’s 2006 Registration, Evaluation, Authorisation and Registration of Chemicals ("REACH") regulations place "the responsibility for the management of the risks of [chemical] substances with. . .[the companies that] manufacture, import, place on the market or use [the] substances in the context of their professional activities."  Guidance on Registration, Guidance for the Implementation of REACH, European Chemicals Agency, Version 1.3, May 2008, at p. 12.  

To this end, REACH requires companies manufacturing or importing chemical substances in quantities greater than one ton per year to register those substances before they "can be manufactured, imported or placed on the market."  As part of these requirements, "manufacturers and importers need to collect or generate data on the substances and assess how risks to human health and environment can be controlled by applying suitable risk management measures."  This can often be an expensive and time consuming process.

Providing some relief in certain circumstances, Article 2(7)(a) of Regulation (EC) No 1907/2006 provides that certain substances are exempt from registration under REACH because "sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties." These substances are listed in REACH Annex IV.

On October 8, 2008, the EC removed carbon and graphite from Annex IV "due to the fact that the concerned Einecs and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in" Annex IV.   We first posted

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