By Lynn L. Bergeson and Carla N. Hutton on Posted in Federal,Legal/Regulatory Issues,United StatesOn 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesOn 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in Legal/Regulatory Issues,United StatesThe 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe 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
By Carla N. Hutton and Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesThe 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 The draft guidance is being reviewed by a Partner Expert Group (PEG).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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory Issues,ResearchOn 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in Federal,Legal/Regulatory Issues,United StatesThe 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
By Lynn L. Bergeson and Carla N. Hutton on 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
