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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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

Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials Available

Posted in Federal, Legal/Regulatory Issues, United States
On January 12, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a Section 8(a) of the Toxic Substances Control Act (TSCA) rule establishing reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale.  According to a pre-publication version of the final… Continue Reading

Germany Begins Consultation on Announcement Concerning Manufactured Nanomaterials

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues
The Committee on Hazardous Substances (AGS) of the Federal Institute for Occupational Safety and Health (BAuA) began a public consultation on its update to several technical rules.  AGS seeks comment on Bekanntmachung zu Gefahrstoffen (BekGS) 527, “Hergestellte Nanomaterialien.”  Although BAuA has published an English translation of Announcement 527, “Manufactured Nanomaterials,” BAuA notes that it is… Continue Reading

Bill Presented to President Obama Would Lengthen Time between NNI Strategic Plans, Reviews, and Evaluations

Posted in Federal, Legal/Regulatory Issues, United States
The American Innovation and Competitiveness Act (S. 3084) would amend the 21st Century Nanotechnology Research and Development Act (15 U.S.C. § 7501 et seq.) to change the frequency of National Nanotechnology Initiative (NNI) reports.  The strategic plan would be released every five instead of every three years, and the triennial review would be renamed the… Continue Reading

France Releases 2016 Report on Nanomaterial Reporting Scheme

Posted in International, Legal/Regulatory Issues
In November 2016, the Ministry of the Environment, Energy, and the Sea released its 2016 report, in French, Éléments issus des déclarations des substances à l’état nanoparticulaire.  The report analyzes nanomaterial declarations received in 2016 for reporting year 2015.  Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in… Continue Reading

Draft REACH Guidance Documents for Nanomaterials Move to Next Consultation Step

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) announced in its December 14, 2016, ECHA Weekly that the following drafts for updated ECHA guidance on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation have moved to the next consultation step and been sent to the Member State Committee for review: Guidance on recommendations for nanomaterials for… Continue Reading

ECHA Announces Signed Agreement for EU Observatory for Nanomaterials

Posted in International, Legal/Regulatory Issues
On December 7, 2016, the European Chemicals Agency (ECHA) announced the signing of a delegation agreement between ECHA and the European Commission (EC) on the European Union Observatory for Nanomaterials (EU-ON).  According to ECHA, the information sources for the EU-ON will include data generated by various pieces of EU legislation regulating the safe use of… Continue Reading

Australian Draft National Standard for the Environmental Risk Management of Industrial Chemicals Addresses Nanomaterials

Posted in International, Legal/Regulatory Issues
On November 24, 2016, the Australian Department of the Environment and Energy began a public consultation on the Draft National Standard for the Environmental Risk Management of Industrial Chemicals and a supporting Draft Explanatory Document.  According to the Department, the primary purpose of the papers is to outline the design and operation of the National… Continue Reading

FDA CDER Identifies Nanotechnology as Area of Interest for Site Visit Training Program for OPQ Staff

Posted in Federal, Legal/Regulatory Issues, United States
The Food and Drug Administration (FDA) published a Federal Register notice on November 16, 2016, announcing the 2017 Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program.  According to the notice, “[a] critical part of the commitment by CDER to make safe and effective high-quality drugs… Continue Reading

Germany Publishes Action Plan Nanotechnology 2020

Posted in EU Member State, International, Legal/Regulatory Issues, Research
The Federal Ministry of Education and Research (BMBF) recently published an English version of its Action Plan Nanotechnology 2020.  Based on the success of the Action Plan Nanotechnology over the previous ten years, the federal government will continue the Action Plan Nanotechnology for the next five years.  Action Plan Nanotechnology 2020 is geared towards the… Continue Reading

OECD Publishes a Number of New Reports in Series on the Safety of Manufactured Nanomaterials, Including Nanosilver Case Study and Gold Nanoparticle Occupational Exposure Assessment in Pilot Scale Facility

Posted in Legal/Regulatory Issues, Occupational Health and Safety Issues, OECD
In November 2016, the Organization for Economic Cooperation and Development (OECD) published the following new reports in its Series on the Safety of Manufactured Nanomaterials: Toxicokinetics of Manufactured Nanomaterials: Report from the OECD Expert Meeting:  As part of its Program on the Safety of Manufactured Nanomaterials, OECD initiated a series of expert meetings to discuss… Continue Reading

NNCO Announces 2016 NNI Strategic Plan

Posted in Federal, Legal/Regulatory Issues, Research, United States
On November 1, 2016, the National Nanotechnology Coordination Office (NNCO) announced the release of the 2016 National Nanotechnology Initiative Strategic Plan.  The 21st Century Nanotechnology Research and Development Act of 2003 requires National Nanotechnology Initiative (NNI) agencies to develop an updated Strategic Plan every three years.  The 2016 Strategic Plan represents a consensus among the… Continue Reading

ECHA Committee Adopts First Opinion Approving Nano Biocide

Posted in EU Member State, Legal/Regulatory Issues
On October 13, 2016, the European Chemicals Agency (ECHA) announced that the Biocidal Products Committee adopted three opinions supporting the approval of active substances for use in biocidal products, including its first opinion on a nanomaterial.  The Committee supports the use of pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated for insecticides, acaricides, and products… Continue Reading

EPA Proposes SNUR for Functionalized Carbon Nanotubes (Generic)

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
On October 27, 2016, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) for three chemical substances that were the subject of premanufacture notices (PMN), including functionalized carbon nanotubes (generic).  According to the notice, the PMN states that the substance will be used as a thin film for electronic device applications.  Based… Continue Reading

ECHA Board of Appeal Annuls Four Decisions Requesting Substance Identity Information on a Nano Structured Substance

Posted in EU Member State, International, Legal/Regulatory Issues
In cases A-008-2015, A-009-2015, A-010-2015, and A-011-2015, the European Chemicals Agency (ECHA) Board of Appeal examined appeals against compliance check decisions made by ECHA requesting further substance identity information from four registrants of a “nano structured” substance.  As reported in our July 29, 2015, blog item, ECHA adopted the contested decisions on December 17, 2014,… Continue Reading

EPA Submits Final TSCA Rule on Nanomaterials to OMB for Review

Posted in Federal, Legal/Regulatory Issues, United States
On October 7, 2016, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a final rule that would require reporting and recordkeeping information on certain chemical substances when they are manufactured or processed as nanoscale materials.  EPA issued a proposed rule, under Section 8(a) of the Toxic Substances Control… Continue Reading

Germany Publishes Review of the Joint Research Strategy of the Higher Federal Authorities

Posted in EU Member State, International, Legal/Regulatory Issues, Research
Germany Publishes Review of the Joint Research Strategy of the Higher Federal Authorities   On September 19, 2016, the Federal Institute for Occupational Safety and Health (BAuA) published a report entitled Review of the joint research strategy of the higher federal authorities — Nanomaterials and other advanced materials:  Application safety and environmental compatibility.  The report… Continue Reading

Draft 2016 NNI Strategic Plan Available for Public Comment

Posted in Federal, Legal/Regulatory Issues, United States
On September 13, 2016, the National Nanotechnology Initiative (NNI) announced in the Federal Register the availability of the draft 2016 NNI Strategic Plan for public comment.  The NNI Strategic Plan represents a consensus among NNI agencies on the high-level goals and priorities of the NNI, and on specific objectives to be pursued over at least… Continue Reading

National Academies Publishes Prepublication Version of Triennial Review of the NNI

Posted in Federal, Legal/Regulatory Issues, United States
In early September 2016, the National Academies published a prepublication version of the Triennial Review of the National Nanotechnology Initiative.  The National Nanotechnology Coordination Office (NNCO) asked the National Research Council (NRC) to conduct a triennial review of the National Nanotechnology Initiative (NNI).  In particular, the NRC was asked to assess:  (1) mechanisms to advance… Continue Reading

EC Requests Scientific Opinion on Styrene/Acrylates Copolymer (Nano) and Sodium Styrene/Acrylates Copolymer (Nano)

Posted in International, Legal/Regulatory Issues
The European Commission (EC) requested a scientific opinion from the Scientific Committee on Consumer Safety (SCCS) on styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano forms.  Under the Cosmetics Regulation, any cosmetic product containing a nanomaterial must be notified to the EC six months prior to being placed on the market.  If the EC has… Continue Reading