June 10, 2022

EC Revises Definition of Nanomaterials

On June 10, 2022, the European Commission (EC) announced that it is clarifying the definition of nanomaterials in a new Recommendation that supports a coherent European Union (EU) regulatory framework for nanomaterials, helping to align legislation across all sectors. The EC states that the new definition should be used in EU and national legislation, policy, and research programs. The Recommendation states: ‘Nanomaterial’ means a natural, incidental or manufactured...
June 8, 2022

EUON Publishes Nanopinion on Urinary MicroRNA-based Early Cancer Detection Using Nanowire-based Devices

On May 31, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Urinary MicroRNA-based Early Cancer Detection Using Nanowire-based Devices” by Dr. Yasui Takao on using nanowire devices to extract microRNAs (miRNA) from urine to distinguish cancer patients from healthy individuals and improve the early detection of cancer. According to Yasui, researchers designed a device equipped with 100 million zinc oxide nanowires that can extract a...
May 31, 2022

EPA Resolves Case Involving Export of Carbon Nanomaterial in Violation of TSCA Section 12(b) and Notice of Export Requirements

The U.S. Environmental Protection Agency (EPA) filed a complaint with the Environmental Appeals Board on March 15, 2022, pursuant to Section 16(a) of the Toxic Substances Control Act (TSCA). According to the complaint, as the result of an EPA inspection of the Vorbeck Materials facility on June 20, 2019, and its follow-up actions, EPA alleges that Vorbeck has violated TSCA Section 12(b) and the Notice of Export rule requirements at 40 C.F.R. Part 707, Subpart D, thereby violating TSCA...
May 26, 2022

ISO Publishes Standard on Characterization of CNT and CNF Aerosols for Inhalation Toxicity Tests

The International Organization for Standardization (ISO) recently published ISO/TR 23463:2022, “Nanotechnologies — Characterization of carbon nanotube and carbon nanofibre aerosols to be used in inhalation toxicity tests.” The standard reviews characterization of carbon nanotube (CNT) and carbon nanofiber (CNF) aerosols for inhalation exposure studies. According to the standard, the framework for material characterization for inhalation studies consists of: Characterization of as-produced...
May 20, 2022

Improvements to ECHA’s Chemicals Database Include Nanomaterial Form Characterization Information

The European Chemicals Agency (ECHA) has made recent improvements to its chemicals database. For nanomaterials on the European Union (EU) market, the details page of the database now includes information on the nanomaterial form characterization. According to ECHA, the results page also has an improved display, allowing better access to the data and improved user interaction options. Other improvements to the database include: Properties of concern on infocards now link to more information...
May 18, 2022

France Asks Providers to Give Updated R-Nano Declaration Numbers to Customers upon Request

The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) has posted “important information” for the 2022 reporting period under R-Nano, France’s national reporting scheme for substances in nanoparticle form. ANSES states that it is asking providers to give an updated declaration number to their customers upon request, “even if they have no declaration to perform.” To do so, providers “must ‘duplicate’ the substance identity information...
May 10, 2022

EPA Research Team Develops Framework to Determine What Products to Classify and Evaluate as Nanopesticides

According to a May 9, 2022, news item published by the U.S. Environmental Protection Agency (EPA), “Advancing EPA’s Understanding of the Next Generation of Pesticides,” over the past decade, EPA “has received an increasing number of pesticide product applications that potentially contain nanomaterials.” The article notes that EPA’s current pesticide review method was not designed for nanomaterials, so each product is reviewed on a case-by-case basis. An EPA research team led by EPA...
May 5, 2022

Registration Opens for NanoHarmony and NANOMET Workshop on OECD Test Guideline Development

The NanoHarmony and NANOMET projects are holding their first face-to-face joint workshop on the development of Organization for Economic Cooperation and Development (OECD) test guidelines (TG) for nanomaterials back-to-back with the OECD Working Party on Manufactured Nanomaterials (WPMN) at the OECD Conference Center in Paris on June 29-30, 2022. NanoHarmony aims to facilitate and improve the development process of TGs from the perspective of the developers, users, and...
April 27, 2022

Germany’s Federal Institute for Risk Assessment Announces Fourth Joint Symposium on Nanotechnology

On April 20, 2022, Germany’s Federal Institute for Risk Assessment (BfR) announced that the fourth joint symposium on nanotechnology will be held May 30-31, 2022. During the symposium, experts will present their findings on topics such as the use of nanotechnology in textiles and packaging, its application in agriculture, the effects of nanomaterials on the body, and future-oriented assessment approaches. BfR notes that with nanotechnology, consumer protection is expanding into...
April 24, 2022

FDA Publishes Final Guidance for Industry on Drug Products, Including Biological Products, that Contain Nanomaterials

The U.S.  Food and Drug Administration (FDA) announced on April 22, 2022, the availability of a final guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.” 87 Fed. Reg. 24169. FDA states that the guidance applies to human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The guidance discusses both general principles and specific considerations for developing drug...