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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FDA Extends Comment Period for Proposed Rule for OTC Sunscreen Drug Products

Posted in Federal, Legal/Regulatory Issues, United States
On April 18, 2019, the Food and Drug Administration (FDA) published a Federal Register notice announcing that it is extending the comment period for its February 26, 2019, proposed rule that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes… Continue Reading

France Bans Titanium Dioxide Food Additive Beginning in 2020

Posted in EU Member State, International, Legal/Regulatory Issues
On April 17, 2019, the Ministry of Ecological and Solidarity Transition issued a press release announcing that France will prohibit foods containing food additive E171 (titanium dioxide) from being placed on the market beginning January 1, 2020.  The press release cites the April 15, 2019, opinion from the Agence nationale de sécurité sanitaire de l’alimentation,… Continue Reading

18th Annual NanoBusiness Conference Will Be Held in June in Washington, D.C.

Posted in Legal/Regulatory Issues, United States
The NanoBusiness Commercialization Association (NanoBCA) will hold its 18th Annual NanoBusiness Conference on June 4, 2019, in Washington, D.C.  Speakers will include: Arpana Verma, Ph.D., Chief Science Officer, NanoMech Industries, Inc.; Doyle Edwards, Director, Government Programs, Brewer Science; Lynn L. Bergeson, Managing Director, Bergeson & Campbell, P.C.; Hugues Jacquemin, Chief Executive Officer (CEO), OCSiAI LLC;… Continue Reading

Presentations Available from EFSA Stakeholder Workshop on Nanoscience and Nanotechnology

Posted in International, Legal/Regulatory Issues
The European Food Safety Authority (EFSA) held a stakeholder workshop on April 1-2, 2019, on the implementation of its guidance on the risk assessment of applications of nanosciences and nanotechnologies in the food and feed chain.  As reported in our July 5, 2018, blog item, “EFSA Publishes New Guidance on Nanotechnologies in Food and Feed,”… Continue Reading

ECHA PEG Reviewing Draft Appendix for Nanoforms Applicable to the Guidance on Registration and Substance Identification

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) has posted the draft version of a guidance document, Appendix for nanoforms applicable to the Guidance on Registration and substance identification.  The draft guidance is being reviewed by a Partner Expert Group (PEG).  The draft Appendix has been developed to provide advice to registrants preparing registration dossiers that cover nanoforms. … Continue Reading

California Committee Includes Ultrafine Titanium Dioxide on Its Draft Priority 1 List for PEL Review

Posted in Legal/Regulatory Issues, Occupational Health and Safety Issues, State, United States
The California Division of Occupational Safety and Health’s (Cal/OSHA) Health Effects Advisory Committee (HEAC) for the Development of Permissible Exposure Limits (PEL) will meet on June 4, 2019.  According to the meeting agenda, HEAC will discuss the selection of Priority 1 substances for HEAC review.  HEAC has posted a draft 2019 Priority 1 List consisting… Continue Reading

EC Committee Accepting Comment on Preliminary Opinion on Solubility of Synthetic Amorphous Silica

Posted in International, Legal/Regulatory Issues, Research
On March 15, 2019, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its preliminary opinion on the solubility of synthetic amorphous silica (SAS).  The EC asked whether the SCCS considers that SAS are soluble (100 milligram per liter (mg/L) or higher) or degradable/non-persistent in biological systems in light of the nanomaterial definition… Continue Reading

2019 NanoEHS CORs Workshop Will Be Held in October

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues, Research, United States
The 2019 U.S.-European Union (EU) NanoEHS Communities of Research (COR) Workshop will take place October 15-16, 2019, at the Europole de l’Arbois in Aix en Provence, France.  The workshop is organized by the U.S. National Nanotechnology Initiative (NNI) and the European Commission (EC).  The agenda for the October 2018 Bridging NanoEHS Research Efforts Joint Workshop… Continue Reading

FDA Proposed Rule for OTC Sunscreen Drug Products Addresses Sunscreens Containing Nanomaterials

Posted in Federal, Legal/Regulatory Issues, United States
The Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as… Continue Reading

Case Study Demonstrates Successful Application of ECHA’s Read-Across Guidance to Multi-Walled Carbon Nanotubes

Posted in International, Legal/Regulatory Issues, Research
The February 2019 issue of Computational Toxicology includes an article entitled “Grouping of multi-walled carbon nanotubes to read-across genotoxicity:  A case study to evaluate the applicability of regulatory guidance.”  The article describes a case study, performed by scientists at the European Commission’s (EC) Joint Research Center (JRC), to explore and illustrate read-across of genotoxicity data… Continue Reading

JRC Publishes Overview of Concepts and Terms Used in the EC’s Definition of Nanomaterial

Posted in International, Legal/Regulatory Issues
The European Commission’s (EC) Joint Research Center (JRC) published on February 13, 2019, a report entitled An overview of concepts and terms used in the European Commission’s definition of nanomaterial.  The report supports the implementation of the EC’s Recommendation on a definition of nanomaterial (2011/696/EU).  It addresses the definition’s key concepts and terms and discusses… Continue Reading

ECHA Proposes to Restrict Intentionally Added Microplastics

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) announced on January 30, 2019, that it has submitted a restriction proposal for microplastic particles that are intentionally added to mixtures used by consumers or professionals.  According to ECHA, if adopted, the restriction could reduce the amount of microplastics released to the environment in the European Union (EU) “by about… Continue Reading

EFSA Will Hold Stakeholder Workshop on Nanoscience and Nanotechnology

Posted in International, Legal/Regulatory Issues
The European Food Safety Authority (EFSA) will hold a stakeholder workshop on nanoscience and nanotechnology on April 1-2, 2019, in Parma, Italy.  As reported in our July 5, 2018, blog item, “EFSA Publishes New Guidance on Nanotechnologies in Food and Feed,” in July 2018, EFSA published new guidance on how to assess the safety of… Continue Reading

Stakeholders Have Opportunity to Provide Feedback on EUON

Posted in International, Legal/Regulatory Issues
The European Union (EU) Observatory for Nanomaterials (EUON) provides information on nanomaterials to a wide audience on subjects including safety, innovation, and research.  It also covers the existing EU legislation on nanomaterials and the presence and uses of specific substances on the EU market.  EUON is currently conducting a survey to allow stakeholders to express… Continue Reading

ACGIH® TLV®-CS Committee Seeks Information on Carbon Nanotubes

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
The American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee has included carbon nanotubes on its 2019 list of chemical substances and other issues under study.  Being placed on the under study list indicates that the TLV®-CS Committee has selected carbon nanotubes for development of a threshold limit value… Continue Reading

NIOSH Publishes Nanotechnology Research Plan for 2018-2025

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
On January 24, 2019, the National Institute for Occupational Safety and Health (NIOSH) published a document entitled Continuing to Protect the Nanotechnology Workforce:  NIOSH Nanotechnology Research Plan for 2018-2025.  NIOSH is using the Nanotechnology Research Plan for fiscal years (FY) 2018-2025 as a roadmap to advance:  (1) understanding of nanotechnology-related toxicology and workplace exposures; and… Continue Reading

New York Delays Enforcement of Household Cleansing Product Information Disclosure Program

Posted in Legal/Regulatory Issues, State, United States
On January 9, 2019, the New York State Department of Environmental Conservation (NYSDEC) announced a three-month delay in its enforcement of the Household Cleansing Product Information Disclosure Program (Disclosure Program), from July 1, 2019, to October 1, 2019.  NYSDEC published its announcement in the January 9, 2019, Environmental Notice Bulletin.  As reported in our June… Continue Reading

ECHA Publishes Substance Evaluation Conclusion for Silver

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) announced on December 19, 2018, that it published several new substance evaluation conclusion documents, including one for silver.  Silver was added to the Community Rolling Action Plan (CoRAP) list in 2014 and evaluated by the Netherlands.  According to the substance evaluation conclusion and evaluation report, silver was originally selected for… Continue Reading

EC Committee Includes Micro- and Nano-Plastic in the Environment and Nanoparticles Released from Building Materials and Construction Waste on List of Emerging Issues

Posted in International, Legal/Regulatory Issues
The European Commission’s (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published on January 14, 2019, a statement and a position paper on emerging health and environmental issues.  SCHEER identified and prioritized 14 emerging issues to bring to the attention of the EC services, including: Micro- and nano-plastic in the environment (priority is… Continue Reading

B&C Publishes Forecast for U.S. Federal and International Chemical Regulatory Policy 2019

Posted in Federal, International, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 8, 2019, our “Forecast for U.S. Federal and International Chemical Regulatory Policy 2019.”  In this richly detailed document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and provide… Continue Reading

Transcript Available for NIOSH Webinar on Revised Draft CIB for Silver Nanomaterials

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States
The National Institute for Occupational Safety and Health (NIOSH) has posted the transcript for the October 30, 2018, webinar on its revised draft document entitled Current Intelligence Bulletin:  Health Effects of Occupational Exposure to Silver Nanomaterials.  As reported in our September 19, 2018, blog item, the revised draft Current Intelligence Bulletin (CIB) provides an updated… Continue Reading

EPA Withdraws SNUR for Single-Walled Carbon Nanotubes

Posted in Federal, Legal/Regulatory Issues, United States
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on December 7, 2018, withdrawing significant new use rules (SNUR) promulgated under the Toxic Substances Control Act (TSCA) for 28 chemical substances, including single-walled carbon nanotubes, that were the subject of premanufacture notices (PMN).  As reported in our October 10, 2018, blog item, EPA… Continue Reading

EC Amends REACH to Require Information on Nanomaterials

Posted in International, Legal/Regulatory Issues
The European Commission (EC) announced on December 3, 2018, that it adopted amendments to several Annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to clarify the information requirements for nanomaterials.  The EC notes that REACH “has always applied to nanomaterials, but did not contain specific provisions for them, which is why… Continue Reading

EPA Will Withdraw SNUR for Carbon Nanomaterial (Generic)

Posted in Federal, Legal/Regulatory Issues, United States
The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on December 4, 2018, withdrawing significant new use rules (SNUR) promulgated under the Toxic Substances Control Act (TSCA) for 26 chemical substances, including carbon nanomaterial (generic), that were the subject of premanufacture notices (PMN).  As reported in our October 2, 2018,… Continue Reading