Nano and Other Emerging Chemical Technologies Blog

The Food and Drug Administration (FDA) is scheduled to publish a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.”  According to the pre-publication version of the notice, FDA developed the guidance to provide industry with its current thinking for the development of human drug products, including those that are biological products, that contain nanomaterials.  The...

On November 30, 2017, the European Chemicals Agency (ECHA) held a webinar to explain the support documentation available for registrants that cover nanoforms in their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier.  The main focus was on the registration and read-across of nanoforms, but the webinar also covered updates for information requirements for human health and the environment.  ECHA has posted the following...

In December 2017, the World Health Organization (WHO) published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials.  WHO developed the Guidelines, which provide recommendations on how best to protect workers from the potential risks of manufactured nanomaterials (MNM).  According to WHO, its recommendations are intended to help policy-makers and professionals in the field of occupational health and safety in making decisions about the best...

In November 2017, the International Organization for Standardization (ISO) published standard ISO/TS 20787:2017, “Nanotechnologies — Aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. Nauplii.”  ISO/TS 20787:2017 specifies a test method, aiming to maximize repeatability and reliability of testing, to determine whether manufactured nanomaterials are toxic to aquatic organisms, specifically Artemia sp. nauplius.  ISO states that ISO/TS...

On November 23, 2017, the French National Research and Safety Institute for the Prevention of Occupational Accidents and Diseases (INRS) published a report summarizing studies and research completed in 2016 and in progress in 2017.  According to the report, INRS action on manufactured nanomaterials has three objectives:  (1) making knowledge on hazards available to the working world; (2) designing tools for identifying, characterizing, and measuring occupational exposures;...

On December 5, 2017, the Swedish Chemicals Agency (KEMI) announced that it has amended the information requirements for the products register to require notifiers to provide information on nanomaterials contained in chemical products.  The announcement, available in Swedish, states that the requirement will enter into force on January 1, 2018, and the first reports will be due in February 2019.  According to KEMI, the purpose of the new notification...

In December 2017, Germany’s Federal Environment Agency (UBA) published a report entitled Clarification of methodical questions regarding the investigation of nanomaterials in the environment:  Development of a decision support tool for the investigation of nanomaterial’s environmental behaviour based on dispersion behaviour and dissolution in relation to various environmental parameters.  UBA states that for an adequate and valid interpretation of data regarding the environmental fate and...

The Dutch National Institute for Public Health and the Environment (RIVM) published a brochure entitled “The European Union Observatory for Nanomaterials:  A step forward?” on November 30, 2017.  RIVM concludes that the European Union (EU) Observatory for Nanomaterials (EUON) will have a limited contribution to reducing the uncertainty regarding the safety of nanomaterials.  Although several EU Member States, including the Netherlands, supported a mandatory EU-wide registration system for...

On November 30, 2017, the National Nanotechnology Initiative (NNI) published a supplement to the President’s 2018 budget.  The supplement also serves as NNI’s annual report and summarizes the progress made in achieving NNI’s goals, the research and development (R&D) activities and plans of the participating agencies, and the agency investments in each program component area.  The President’s 2018 Budget requests $1.2 billion for the NNI, “a...

On behalf of its project partner, the Institute of Occupational Medicine, NanoReg2 seeks information from organizations that manufacture, make, use, distribute, or dispose of nanomaterials.  NanoReg2 states that, as part of the NanoReg2 Project, it is trying to find out what organizations know and understand about worker and end-user risk from nanomaterials and the concept of Safe-by-Design.  NanoReg2 encourages participation from individuals who are involved in product development, health...