January 12, 2018

EFSA Begins Public Consultation on Guidance for the Risk Assessment of Nanoscience and Nanotechnology Applications

On January 12, 2018, the European Food Safety Authority (EFSA) opened a public consultation on its draft guidance for the risk assessment of nanoscience and nanotechnology applications in the food and feed chain.  The guidance covers the relevant areas within EFSA’s remit, such as novel foods, food contact materials, food and feed additives, and pesticides.  EFSA notes that the guidance takes account of scientific developments that have taken place since publication of the previous...
January 10, 2018

IOSH Publishes Research Report and Industry Guidance on Nanotechnology in Construction and Demolition

On January 8, 2018, the Institution of Occupational Safety and Health (IOSH) announced the availability of a research report on nanotechnology in construction and demolition, as well as guidance for industry.  The aim of the research was to provide clarity regarding the current use of nanomaterials in the built environment and the potential benefits and risks arising for those working in the construction and demolition sectors.  Research included review of academic...
January 9, 2018

Germany Publishes Report on Scientific Stakeholder Meeting on Nanomaterials in the Environment

The German Environment Agency (UBA) has published a report summarizing the contents and outcomes of the October 2017 scientific stakeholder meeting on nanomaterials in the environment.  The meeting focused on the relevant regulatory results of recent German and European research projects on nanomaterials in the environment.  The stakeholder meeting provided a forum for participants to present the state of the knowledge on environmental nanosafety in a regulatory context, as well as to...
January 8, 2018

EEB Finds Estonian EU Council Presidency Failed to Fill Regulatory Gaps on Nanomaterials

The European Environmental Bureau (EEB) announced on December 22, 2017, the availability of its assessment of the environmental performance of the Estonian Presidency of the European Union (EU).  The assessment is based on the results of “Ten Green Tests” laid out at the beginning of Estonia’s Presidency.  The eighth test is protecting the public from hazardous chemicals, including mercury.  The test includes encouraging the European Commission (EC) “to develop a...
January 5, 2018

B&C Publishes Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018

Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 4, 2018, their “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018.”  In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and Acta offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected...
December 29, 2017

NIOSH Plans to Support Implementation of WHO Guidelines to Protect Workers from Nanomaterials

On December 15, 2017, the National Institute for Occupational Safety and Health (NIOSH) posted a blog item entitled “WHO Guidelines to Protect Workers from Nanomaterials.”  As reported in our December 13, 2017, blog item, the World Health Organization (WHO) recently published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials.  NIOSH Director John Howard, MD, describes the WHO Guidelines as “an important step in protecting workers worldwide from the...
December 28, 2017

UNEP Report on Emerging Issues of Environmental Concern Includes Nanomaterials

In early December 2017, the United Nations Environment Program (UNEP) published Frontiers 2017:  Emerging Issues of Environmental Concern.  The report covers six key emerging issues:  the environmental dimension of antimicrobial resistance; nanomaterials; marine protected areas and sustainable development; sand and dust storms; off-grid solar solutions; and environmental displacement.  The section on nanomaterials addresses nanodimensions — new discoveries about familiar materials;...
December 18, 2017

FDA Publishes Draft Guidance on Drug Products, Including Biological Products, That Contain Nanomaterials

On December 18, 2017, the Food and Drug Administration (FDA) published a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, That Contain Nanomaterials:  Guidance for Industry.”  According to 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, in which a nanomaterial is present...
December 15, 2017

FDA Will Publish Draft Guidance on Drug Products, Including Biological Products, that Contain Nanomaterials

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...
December 14, 2017

Presentations Available from ECHA Webinar on REACH Guidance for Nanomaterials

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...
December 13, 2017

WHO Publishes Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials

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...
December 12, 2017

ISO Publishes Standard on Aquatic Toxicity Assessment of Manufactured Nanomaterials in Saltwater Lakes

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...
December 8, 2017

INRS 2016/2017 Brochure Includes Studies in Progress Concerning Manufactured Nanomaterials

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;...
December 7, 2017

Sweden Announces Product Registration Requirement for Nanomaterials

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...
December 6, 2017

UBA Report Summarizes Work to Develop New OECD Test Guideline on Dispersion Stability of Nanomaterials

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...
December 5, 2017

RIVM Takes Critical Look at EUON

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...
December 4, 2017

NNI Publishes Supplement to President’s 2018 Budget Request

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...
November 29, 2017

NanoReg2 Begins Survey Concerning Knowledge of Risks from Nanomaterials and Concept of Safe-by-Design

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...
November 22, 2017

Germany Publishes Report on Relationship of Nanomaterial’s Physical-Chemical Properties and Aquatic Toxicity for the Purpose of Grouping

Germany’s Federal Environment Agency (UBA) published a November 2017 report entitled Considerations about the relationship of nanomaterial’s physical-chemical properties and aquatic toxicity for the purpose of grouping.  The report notes that, based on the variety of existing nanomaterials with numerous modifications, “the effort of investigating environmental fate and effects will be tremendous.”  As a result, it will be necessary to group nanomaterials that feature...
November 21, 2017

EC Publishes Report on Ecosystem to Accelerate Uptake of Innovation in Materials Technology

In October 2017, the European Commission (EC) Directorate-General for Research and Innovation published a report entitled An ecosystem to accelerate the uptake of innovation in materials technology:  Report by the High Level Group of EU Member States and Associated Countries on Nanosciences, Nanotechnologies and Advanced Materials.  The High Level Group of European Union (EU) Member States and Associated Countries on Nanosciences, Nanotechnologies and Advanced Materials examined the barriers...