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

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EPA’s Regulatory Agenda Includes TSCA Section 8(a) Nanomaterials Rule with TBD Effective Date

Posted in Federal, Legal/Regulatory Issues, United States
On July 20, 2017, the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions.  The Agenda includes a U.S. Environmental Protection Agency (EPA) item (RIN 2070-AJ54) concerning the Toxic Substances Control Act (TSCA) Section 8(a) reporting rule for nanoscale materials.  According to the Agenda item, the final rule effective date is “To Be… Continue Reading

Canada Intends to Publish Nanoscale Prioritization Results in 2018

Posted in International, Legal/Regulatory Issues
According to the July 7, 2017, issue of the Chemicals Management Plan Progress Report, Health Canada and Environment and Climate Change Canada are in the process of prioritizing nanoscale forms of substances on the Domestic Substances List.  As reported in our July 27, 2015, blog item, Canada conducted a mandatory information-gathering survey under Section 71… Continue Reading

IARC Will Convene Advisory Group in 2018/2019 to Consider Nominations

Posted in International, Legal/Regulatory Issues
To assist the International Agency for Research on Cancer (IARC) in selecting agents for review in future Monographs, IARC regularly convenes international, interdisciplinary Advisory Groups to review all public nominations and to recommend those it considers to be of high priority.  According to information on its website, IARC will convene its next Advisory Group in… Continue Reading

ECHA Announces Two Decisions on Appeals Related to Nanomaterials

Posted in International, Legal/Regulatory Issues
On June 30, 2017, the European Chemicals Agency (ECHA) Board of Appeal published two decisions related to nanomaterials.  In the July 5, 2017, issue of ECHA Weekly, ECHA states that the Board of Appeal “largely upheld the appeals and annulled most of the requests for information.”  In Cases A-014-2015 and A-015-2015, registrants appealed the same… Continue Reading

NanoDefine Will Hold Workshop on Measurement and Classification of Nanomaterials According to the EC Definition

Posted in International, Legal/Regulatory Issues
On October 24, 2017, NanoDefine will hold a one-day workshop in Frankfurt/Main, Germany.  The main purpose of the workshop is to provide a practical demonstration of newly developed measurement techniques to end-users who have to implement the European Commission’s (EC) recommendation on the definition of a nanomaterial (2011/696/EU).  NanoDefine experts have developed a wide panel… Continue Reading

Germany Publishes Meeting Report from Expert Dialogue on Application of Nanotechnologies in the Construction Sector

Posted in International, Legal/Regulatory Issues
On June 1, 2017, the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety published meeting documents from the Expert Dialogue on “Opportunities and Risks of the Application of Nanotechnologies in the Construction Sector.”  The documents include a summary of discussion, meeting agenda, and report, Regulation of construction products and possibilities to address… Continue Reading

WHO Seeks Comment on Draft Document Concerning Assessing the Risk of Immunotoxicity Associated with Exposure to Nanomaterials

Posted in International, Legal/Regulatory Issues, Research
The World Health Organization’s (WHO) International Program on Chemical Safety (IPCS) published a draft Environmental Health Criteria (EHC) Document, Principles and Methods to Assess the Risk of Immunotoxicity Associated with Exposure to Nanomaterials.  According to IPCS, the target audience is risk assessors in a regulatory setting, researchers, and industry that needs to provide the data… Continue Reading

EC Publishes Catalog of Nanomaterials Used in Cosmetic Products Placed on the EU Market

Posted in EU Member State, Legal/Regulatory Issues
On June 15, 2017, the European Commission (EC) published a catalog of nanomaterials used in cosmetic products on the European Union (EU) market.  Regulation (EC) No. 1223/2009 on cosmetic products requires the EC to publish a catalog of all nanomaterials used in cosmetics placed on the market, indicating the categories of products and the reasonably… Continue Reading

ECHA Launches EU Observatory for Nanomaterials

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues, Research
On June 14, 2017, the European Chemicals Agency (ECHA) announced the launch of the European Union (EU) Observatory for Nanomaterials (EUON).  ECHA states that EUON “offers a unique web-based information point with factual and neutral content about nanomaterials on the EU market.”  EUON is targeted at a wide audience, including consumers, workers, regulators, and scientists. … Continue Reading

Sweden to Require Information on Nanomaterials in Product Register Notifications

Posted in EU Member State, International, Legal/Regulatory Issues
On June 7, 2017, Sweden notified the European Commission (EC) that it intends to amend the information requirements concerning the Swedish Chemicals Agency’s (KEMI) product register to require notifiers to provide information on nanomaterials contained in the product.  Under the draft regulation, the requirement will apply to nanomaterials that have been intentionally added to the… Continue Reading

ECHA Committee Concludes Titanium Dioxide Should Be Classified as Suspected of Causing Cancer When Inhaled

Posted in International, Legal/Regulatory Issues
On June 9, 2017, the European Chemicals Agency (ECHA) announced that the Committee for Risk Assessment (RAC) “concluded that the available scientific evidence meets the criteria in the [Classification, Labeling and Packaging (CLP)] Regulation to classify titanium dioxide as a substance suspected of causing cancer through the inhalation route.”  In May 2016, France submitted a… Continue Reading

Australian Consultation Paper Addresses Regulatory Treatment of Unlisted Chemicals Introduced at the Nanoscale

Posted in International, Legal/Regulatory Issues
The Industrial Chemicals Bill 2017 describes the legislative framework for a reformed, risk-based regulatory scheme for Australia to continue to regulate the introduction of industrial chemicals.  The Australian government has presented the bill to Parliament.  On June 1, 2017, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published Consultation Paper 5, which seeks feedback… Continue Reading

ISO Publishes Standard Providing Plain Language Explanation of Selected Terms from ISO/IEC 80004 Series

Posted in International, Legal/Regulatory Issues
The International Organization for Standardization (ISO) published standard ISO/TR 18401:2017, “Nanotechnologies — Plain language explanation of selected terms from the ISO/IEC 80004 series.”  The standard is intended to assist stakeholders who are making decisions about the direction, management, and application of nanotechnologies to understand better selected key terms and definitions in the ISO/IEC 80004 vocabulary… Continue Reading

KAN Reviews Nanotechnology Standardization Documents from OSH Perspective

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues
Germany’s Commission for Occupational Health and Safety (KAN) released in May 2017 a report entitled Standardization in nanotechnology — Status review and requirements analysis from the occupational safety and health perspective.  According to the report, which is in German but includes an English summary, the authors conducted a structured status review of the standardization situation… Continue Reading

Appellate Court Vacates Conditional Nanosilver Registration

Posted in Federal, Legal/Regulatory Issues, United States
On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration of a nanosilver pesticide product and vacated the conditional registration.  NRDC v. EPA, No. 15-72308.  The Natural Resources Defense Council (NRDC) as well as the Center for… Continue Reading

France Publishes English Summary of Study on Development of Nanomaterials by 2030

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues
On April 26, 2017, France’s National Research and Safety Institute (INRS) published a press release announcing the availability of an English summary of a foresight study conducted in 2014 on the development of nanomaterials by 2030 and the consequences on safety and health in small businesses in France.  Four scenarios were envisioned: (1)       Strong… Continue Reading

ECHA Publishes REACH Guidance for Nanomaterials

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) announced on May 24, 2017, publication of five documents that it intends to help registrants preparing dossiers that cover nanoforms ahead of the 2018 registration deadline under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  ECHA published two new guidance documents: Nano-specific appendix to Chapter R.6 of the… Continue Reading

IARC Publishes Monograph on Carbon Nanotubes, Fluoro-Edenite, and Silicon Carbide

Posted in International, Legal/Regulatory Issues
The International Agency for Research on Cancer (IARC) announced on May 19, 2017, publication of Volume 111 of the IARC Monographs, Some Nanomaterials and Some Fibres.  The Monograph contains evaluations of the carcinogenic hazard to humans of fluoro-edenite fibrous amphibole, silicon carbide fibers and whiskers, and carbon nanotubes.  As reported in our November 3, 2014,… Continue Reading

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