Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Archives: Legal/Regulatory Issues

Subscribe to Legal/Regulatory Issues RSS Feed

SEMI Will Host Webcast on New TSCA Requirements for Nanoscale Materials

Posted in Federal, Legal/Regulatory Issues, United States
On June 1, 2017, in concert with industry partners, SEMI will host an information-sharing webcast concerning the new regulatory requirements for nanoscale materials under the Toxic Substances Control Act (TSCA).  Jim Alwood, Program Manager in the U.S. Environmental Protection Agency’s (EPA) Chemical Control Division, will provide a summary and answer questions about the new TSCA… Continue Reading

EPA Seeks Comment on Draft Guidance for Nanoscale Materials Reporting Rule

Posted in Federal, Legal/Regulatory Issues, United States
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.”  82 Fed. Reg. 22452.  The promised guidance provides answers to questions EPA has received… Continue Reading

ECHA Creates Web Page for Nanomaterials Expert Group

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) has created a web page for the Nanomaterials Expert Group (NMEP), which was created in October 2012.  NMEP aims to seek common ground among experts on scientific and technical issues regarding the implementation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, the Classification, Labeling, and Packaging (CLP)… Continue Reading

EPA Will Publish Draft Guidance for Reporting Nanoscale Materials for Comment

Posted in Federal, Legal/Regulatory Issues, United States
The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.”  EPA states in the pre-publication notice that the guidance provides answers… Continue Reading

EPA Delays Effective Date of TSCA Section 8(a) Rule Concerning Nanoscale Materials

Posted in Federal, Legal/Regulatory Issues, United States
The U.S. Environmental Protection Agency (EPA) published on May 12, 2017, a Federal Register notice delaying the effective date of the January 12, 2017, rule concerning Toxic Substances Control Act (TSCA) Section 8(a) reporting requirements from May 12, 2017, to August 14, 2017.  EPA notes that Section 553(b)(1)(B) of the Administrative Procedure Act (APA) allows… Continue Reading

EPA Will Delay Effective Date of TSCA Section 8(a) Rule Concerning Nanoscale Materials

Posted in Federal, Legal/Regulatory Issues, United States
The U.S. Environmental Protection Agency (EPA) is scheduled to publish on May 12, 2017, a Federal Register notice delaying the effective date of the January 12, 2017, rule concerning Toxic Substances Control Act (TSCA) Section 8(a) reporting requirements from May 12, 2017, to August 14, 2017.  EPA notes that Section 553(b)(1)(B) of the Administrative Procedure… Continue Reading

JRC Publishes NANoREG Framework for the Safety Assessment of Nanomaterials

Posted in International, Legal/Regulatory Issues
The European Commission (EC) Joint Research Center (JRC) has published a Science for Policy report entitled NANoREG framework for the safety assessment of nanomaterials.  The report was developed within the NANoREG project, “A common European approach to the regulatory testing of nanomaterials.”  The NANoREG framework represents the project’s proposal for a common understanding in the… Continue Reading

NanoMONITOR Begins Survey to Refine Design of Real-Time Information and Monitoring System

Posted in International, Legal/Regulatory Issues
NanoMONITOR announced on May 3, 2017, the launch of a survey intended to refine the design of the real-time information and monitoring system to support the risk assessment of nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  NanoMONITOR states that the ten-minute survey will help it: Elicit stakeholders’ requirements on the… Continue Reading

Lynn L. Bergeson Will Speak at 16th Annual NanoBusiness Commercialization Association Conference

Posted in Legal/Regulatory Issues, United States
The NanoBusiness Commercialization Association (NanoBCA) will hold its 16th annual conference on June 15, 2017, in Washington, D.C.  Speakers will include Lynn L. Bergeson, Managing Director, Bergeson & Campbell, P.C., as well as: Jim Phillips, Chairman and Chief Executive Officer (CEO), NanoMech Corporation; Doyle Edwards, Director, Government Programs, Brewer Science; Matthew Putman, Ph.D., CEO, Nanotronics… Continue Reading

NanoMONITOR Demo Version Now Available Online

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues, Research
NanoMONITOR, a project partly funded by the European Commission Life+ with grant agreement LIFE14 ENV/ES/000662, is intended to develop a real-time information and monitoring system to support the risk assessment of nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The overall objective of the NanoMONITOR project is to improve the use… Continue Reading

Swiss National Research Program Will Hold Closure Event in June

Posted in International, Legal/Regulatory Issues, Research
On June 2, 2017, the National Research Program “Opportunities and Risks of Nanomaterials” (NRP 64) will hold a closure event, parallel to the Swiss Nano Convention, which will be held June 1-2, 2017.  NRP 64 began its research work in December 2010 and has studied the development, use, behavior, and degradation of synthetic nanomaterials, as… Continue Reading

EU Addresses the Use of Nanomaterials in Medical Devices

Posted in International, Legal/Regulatory Issues
On April 5, 2017, the European Parliament (EP) approved a regulation on medical devices, as well as a regulation on in vitro diagnostic medical devices.  The EP’s April 5, 2017, press release states that the medical devices regulation is intended to ensure that medical devices are traceable and comply with European Union (EU) safety requirements. … Continue Reading

AIHA Publishes Nanomaterial Stewardship Guidance

Posted in Legal/Regulatory Issues, Occupational Health and Safety Issues
On March 29, 2017, the American Industrial Hygiene Association (AIHA) announced the availability of nanomaterial stewardship guidance sponsored by the AIHA Nanotechnology Working Group.  The guidance addresses stewardship considerations for nanomaterials and nanoproducts based on the evolving state of the science for human health hazard, exposure, and risk assessment.  The guidance promotes a life cycle… Continue Reading

SCCS Seeks Comment on Opinion on Titanium Dioxide (Nano Form) as UV-Filter in Sprays

Posted in International, Legal/Regulatory Issues
On March 10, 2017, the Scientific Committee on Consumer Safety (SCCS) began a public consultation on its opinion on titanium dioxide (nanoform) as an ultraviolet (UV)-filter in sprays.  In July 2015, the European Commission (EC) received new data from industry to support the safe use of nano titanium dioxide when used as a UV-filter in… Continue Reading

NanoMONITOR Workshop Will Examine Supporting the Risk Assessment of Nanomaterials under REACH

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues, Research
NanoMONITOR’s first stakeholders’ day, April 4, 2017, will include a workshop on “Development of a real-time information and monitoring system to support the risk assessment of nanomaterials under REACH.”  The overall aim of the NanoMONITOR project is to develop a prototype system to generate robust, accessible, comparable, and interoperable environmental and indoor air monitoring data… Continue Reading

European NanoSafety Cluster Publishes 2017 Research Regulatory Roadmap

Posted in International, Legal/Regulatory Issues, Research
On March 9, 2017, the NanoSafety Cluster published its 2017 Research Regulatory Roadmap.  The purpose of the Roadmap is to identify both ongoing and complete activities associated with the development of regulations promoting the safety of nanomaterials.  The Roadmap identifies research areas or priorities that need to be addressed further to facilitate this process.  According… Continue Reading

ECHA Board of Appeal Annuls Contested Decision Concerning Titanium Dioxide

Posted in International, Legal/Regulatory Issues
On March 2, 2017, the European Chemicals Agency (ECHA) announced that its Board of Appeal issued its decision in Case A-011-2014, which concerns a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) dossier evaluation for titanium dioxide.  In its evaluation, ECHA considered only the substance identity information required and not the information requirements for human… Continue Reading

Report Claims OECD Dossiers on Nanomaterials Are of “Little to No Value”

Posted in International, Legal/Regulatory Issues, OECD, Research
On February 23, 2017, the Center for International Environmental Law (CIEL) issued a press release announcing a new report, commissioned by CIEL, the European Environmental Citizens’ Organization for Standardization (ECOS), and the Oeko-Institute, that “shows that most of the information made available by the Sponsorship Testing Programme of the Organisation for Economic Co-operation and Development… Continue Reading

Another Draft REACH Guidance Document on Nanomaterials Moves to CARACAL for Review

Posted in International, Legal/Regulatory Issues
According to the European Chemicals Agency (ECHA) website, the draft Guidance on information requirements and Chemical Safety Assessment:  Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a Endpoint specific guidance and Appendix R7-2 Recommendations for nanomaterials applicable to Chapter R7c Endpoint specific guidance has been sent to the Competent Authorities for Registration, Evaluation, Authorization and… Continue Reading

Nanomaterials Inventory for Cosmetics Will Be Published “in the Next Weeks”

Posted in International, Legal/Regulatory Issues
ClientEarth published a January 11, 2017, blog item entitled “Three-year wait for nanomaterial risk data promised ‘in the next weeks.’”  Under the Cosmetics Directive, the European Commission (EC) was to publish by January 11, 2014, an inventory of nanomaterials used in cosmetic products on the European Union market.  The EC has postponed publication of the… Continue Reading

Draft REACH Guidance Documents on Nanomaterials Move to CARACAL for Review

Posted in International, Legal/Regulatory Issues
According to the European Chemicals Agency (ECHA) website, several Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) guidance documents concerning nanomaterials have moved to the next step in the consultation process.  The draft recommendations for nanomaterials applicable to the guidance on quantitative structure-activity relationships (QSAR) and grouping of chemicals was sent to the Competent Authorities… Continue Reading

New Article Discusses TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials

Posted in Federal, Legal/Regulatory Issues, United States
We are pleased to announced that Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton published an article, “Practitioner Insights:  A Review and Analysis of TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials,” in the January 26, 2017, issue of Bloomberg BNA’s Daily Environment Report.  The article reviews and analyzes the… Continue Reading

KEMI Consulting on Draft Nano Register Regulation

Posted in EU Member State, International, Legal/Regulatory Issues
The Swedish Chemicals Agency (KEMI) is in the process of consulting with stakeholders on a draft regulation that would require companies to provide information on nanomaterials in chemical products to the Swedish products register by February 28, 2019.  According to KEMI, the proposal is the same as presented in its 2015 report.  Although the report… Continue Reading

Committees Reviewing Draft Appendix on Recommendations for Nanomaterials Applicable to the Guidance on Registration

Posted in International, Legal/Regulatory Issues
On January 13, 2017, the European Chemicals Agency (ECHA) sent the draft appendix on recommendations for nanomaterials applicable to the guidance on registration to the Forum, Member State Committee, and Risk Assessment Committee for consultation.  The draft guidance outlines the minimum elements potential registrants need to consider when registering substances that fulfil the European Commission’s… Continue Reading