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
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Case Study Demonstrates Successful Application of ECHA’s Read-Across Guidance to Multi-Walled Carbon Nanotubes
Posted in International, Legal/Regulatory Issues, ResearchThe 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 IssuesThe 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 IssuesThe 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 IssuesThe 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 IssuesThe 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 StatesThe 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 StatesOn 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 StatesOn 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 IssuesThe 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 IssuesThe 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 StatesBergeson & 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 StatesThe 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 StatesThe 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 IssuesThe 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 StatesThe 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
SweNanoSafe Reports on ECHA Workshop on REACH Requirements for Nanomaterials
Posted in International, Legal/Regulatory IssuesThe Swedish National Platform for Nanosafety (SweNanoSafe) has posted a report on the European Chemicals Agency’s (ECHA) November 8-9, 2018, workshop on the upcoming Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) information requirements for nanomaterials. As reported in our April 26, 2018, blog item, the European Commission (EC) REACH Committee voted on April 26,… Continue Reading
EU NanoSafety Cluster Releases EU-U.S. Roadmap Nanoinformatics 2030
Posted in International, Legal/Regulatory IssuesThe European Union (EU) released the EU US Roadmap Nanoinformatics 2030 on November 15, 2018. The Roadmap, developed by scientists from the EU, U.S., and a few other countries, is a compilation of state-of-the-art commentaries from multiple interconnecting scientific fields, combined with issues involving nanomaterial risk assessment and governance. The Roadmap states that in bringing… Continue Reading
SCCS Revised Guidance for Testing of Cosmetic Ingredients and Their Safety Evaluation Addresses Nanomaterials
Posted in International, Legal/Regulatory IssuesOn November 7, 2018, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published the tenth revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. The guidance contains relevant information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The document… Continue Reading
JRC Scientists Publish Article on Inventory of Publicly Available Tools for the Safety Assessment of Nanomaterials
Posted in International, Legal/Regulatory Issues, ResearchOn November 5, 2018, the European Commission’s (EC) Joint Research Center (JRC) announced the availability of the NANoREG Toolbox, an inventory of publicly available tools for the safety assessment of nanomaterials. As reported in our October 5, 2017, blog item, JRC first published the inventory as a Microsoft Excel®-based dataset. JRC scientists have now published… Continue Reading
B&C Launches All Things Chemical™ Podcast with Debut Episode “Animal Testing and New TSCA”
Posted in Federal, Legal/Regulatory Issues, United StatesOn November 1, 2018, Bergeson & Campbell, P.C. (B&C®) launched a podcast called All Things Chemical™ that will engage listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the… Continue Reading
EC Committee Publishes Final Opinion on Colloidal Silver (Nano)
Posted in International, Legal/Regulatory IssuesOn October 26, 2018, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on colloidal silver (nano). According to the final opinion, the EC received 63 notifications of cosmetic products containing colloidal silver in nano form. The final opinion states that, according to the applicants, the ingredient is used in… Continue Reading
Slides Available from NIOSH Webinar on Revised Draft CIB for Silver Nanomaterials
Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United StatesOn October 30, 2018, the National Institute for Occupational Safety and Health (NIOSH) held a webinar on its revised draft document entitled Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. The meeting agenda and slide presentation are available in the docket, as well as a list of meeting attendees. As reported in… Continue Reading
JRC Posts Report on Workshop on Regulatory Preparedness for Innovation in Nanotechnology
Posted in International, Legal/Regulatory IssuesThe European Commission (EC) Joint Research Center (JRC) posted a report on the October 5-6, 2017, “NanoReg2 Regulatory Preparedness for Innovation in Nanotechnology Workshop.” Regulatory preparedness was defined at the workshop as the regulators’ timely awareness of innovations and the regulators’ actions to check whether present legislation covers all safety aspects of each innovation, including… Continue Reading