All Knowledge & Insights By Date

On December 11, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “The innovator, the regulator and the citizen — building public trust through transparent, empowered and safe innovation.”  Carlos Eduardo Lima da Cunha, the European Commission (EC), explains how the EU is supporting safe by design approaches to new technologies such as nanomaterials to deliver safer products to the market.  Lima da Cunha notes that the EU has...

The European Commission’s Joint Research Center (JRC) recently published a white paper entitled Anticipation of regulatory needs for nanotechnology-enabled health products.  The white paper notes that at this time, “no specific regulatory framework exists for nanotechnology-enabled health products but the current regulatory practice requires additional guidance in order to fully cover the particularities of such products.”  The white paper identifies the following major...

On November 22, 2019, the European Commission (EC) Directorate-General for Internal Market, Industry, Entrepreneurship, and Small- and Medium-Sized Enterprises (SME) requested two scientific opinions from the Scientific Committee on Consumer Safety (SCCS): The request for a scientific opinion on platinum (nano)-colloidal platinum (nano) and acetyl tetrapeptide-17 colloidal platinum (nano) states that the EC received 18 notifications for cosmetic products containing platinum (10 notifications)...

The European Commission (EC) announced on November 15, 2019, that it published an updated catalog of nanomaterials used in cosmetic products on the European Union (EU) market.  As reported in our June 19, 2017, blog item, the EC first published a catalog in June 2017.  The catalog compiles information that responsible persons shared with the EC through the cosmetic products notification portal (CPNP) as of December 31, 2018.  The catalog lists 27 nanomaterials used...

On November 4, 2019, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published an updated Guidance on the Safety Assessment of Nanomaterials in Cosmetics.  The Guidance updates SCCS’s 2012 Guidance (SCCS/1484/12) on the safety assessment of nanomaterials in cosmetic products.  It covers the main elements of safety assessment — general considerations (Section 2), material characterization (Section 3), exposure assessment (Section 4), hazard...

The European Chemicals Agency (ECHA) issued a press release on October 8, 2019, reminding companies that by January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The new information requirements concern companies that manufacture or import nanoforms of substances that are subject to registration under REACH.  As...

On November 12, 2019, the European Chemicals Agency (ECHA) will hold a webinar on the amended information requirements for nanoforms under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  As reported in our December 4, 2018, blog item, the European Commission (EC) announced on December 3, 2018, that it adopted amendments to several REACH Annexes to clarify the information requirements for nanomaterials.  The amended...

The European Union (EU) Observatory for Nanomaterials (EUON) has created a Nanopinion section, where it invites views from different contributors ranging from policy-makers and authorities to industry and civil society on their work and priorities related to nanomaterials on the EU market.  The first item, posted on September 16, 2019, is “EUON:  past, present and future,” written by Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA).  As reported in our...

On July 3, 2019, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on the solubility of synthetic amorphous silica (SAS). The EC asked whether SCCS considers that SAS materials are soluble (100 milligram per liter (mg/L) or higher) or degradable/non-persistent in biological systems in light of the nanomaterial definition of the Cosmetics Regulation. Having considered the data provided in this dossier and that available in published...

On June 25, 2019, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) posted two requests for scientific opinions:  hydroxyapatite (nano) and copper (nano) and colloidal copper (nano).  According to the mandate for hydroxyapatite (nano), the EC received 17 notifications for cosmetic products containing hydroxyapatite in nano form.  The EC states that according to the notifications, this ingredient is used in both leave-on and rinse-off dermal and...

The European Commission’s (EC) Joint Research Center (JRC) published a press release on June 6, 2019, regarding its contribution to the Organization for Economic Cooperation and Development’s (OECD) development of Test Guidelines for the safety assessment of nanomaterials.  According to the press release, scientists from JRC have actively participated in discussions of the OECD’s Working Party on Manufactured Nanomaterials (WPMN) since early on.  The press release...

The European Commission (EC) published on June 11, 2019, a call for data on the following ingredients used in cosmetic products:  gold (nano); colloidal gold (nano); platinum (nano); colloidal platinum (nano); copper (nano); and colloidal copper (nano).  The EC states that it has concerns about the use of nano forms of gold, colloidal gold, platinum, colloidal platinum, copper, and colloidal copper “because of the potential of nanoparticles to enter cells through dermal...

As reported in our May 30, 2019, blog item, the Organization for Economic Cooperation and Development (OECD) recently published several reports in its Series on the Safety of Manufactured Nanomaterials, including Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table.  The Tour de Table compiles information provided by delegations on the occasion of the 19th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in February...

On March 5-6, 2019, a workshop on “Fostering EU‐U.S. Cooperation in Nanosafety” was held.  According to the workshop report, the workshop intended to answer two main questions: The discussion was based on the state of implementation of the 2013 report, Nanosafety in Europe 2015‐2025:  Towards Safe and Sustainable Nanomaterials and Nanotechnology Innovations, and current nanosafety activities coordinated by U.S. federal agencies participating in the U.S. National...

On 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 of the Cosmetics Regulation.  Having considered the data provided in this dossier and that available...

By Lynn L. Bergeson On March 13, 2019, the European Commission (EC) published a fact sheet on the sustainability for biofuels specified.  EC adopted a delegated act that sets out the criteria for determining high low indirect land-use change (ILUC) risk feedstock for biofuels and the criteria for certifying ILUC-risk biofuels, bioliquids, and biomass fuels.  ILUC-risk fuels consist of fuels produced from food and feed crops that significantly expand globally into land with high carbon...

The 2019 U.S.-European Union (EU) NanoEHS Communities of Research (COR) Workshop will take place October 15-16, 2019, at the Europole de l’Arbois in Aix en Provence, France.  The workshop is organized by the U.S. National Nanotechnology Initiative (NNI) and the European Commission (EC).  The agenda for the October 2018 Bridging NanoEHS Research Efforts Joint Workshop and the following presentations are available:...

The European Commission’s (EC) Joint Research Center (JRC) opens its scientific laboratories and facilities, including its Nanobiotechnology Laboratory, to people working in academia and research organizations, industry, and small and medium enterprises (SME).  JRC opened a call on February 1, 2019, for the Nanobiotechnology Laboratory for the following priority topics: The call ends on May 3, 2019. JRC opened a call on March 4, 2019, for the following training...

The February 2019 issue of the European Chemicals Agency’s (ECHA) Newsletter includes an interview with Eva Valsami-Jones, Professor of Environmental Nanoscience at the University of Birmingham and leader of the European Union (EU) NanoSafety Cluster Coordination Team, on research on the safety of nanomaterials.  The NanoSafety Cluster coordinates the funding of research projects at the European level that address the safety aspects of nanomaterials and the related...

The 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 by following the “Recommendations for nanomaterials applicable to the Guidance on...

The 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 them in a regulatory context.  Corresponding to the broad scope of the definition, the report states...

The 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 their views on how EUON is performing and how it could be developed to meet their needs better.  EUON is funded by...

The 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: The position paper on emerging issues and the role of SCHEER describes how SCHEER draws the attention of the EC services to emerging issues in the...

By Lynn L. Bergeson On November 28, 2018, the European Commission (EC) published a document called “A Clean Planet for all: A European strategic long-term vision for a prosperous, modern, competitive and climate neutral economy.”  Due to EC’s expressed concerns about climate change, part of this new long-term vision includes new rulings that facilitate the production of bio-fertilizers, encourage the production of biogas from manure treatment, and increase biomass imports....

The 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 companies often did not know how to register these ‘substances in nanoform.’”...

On 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 states that it is designed to provide guidance to public authorities and to the cosmetic industry to...

On 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 an article, “An inventory of ready-to-use and publicly available tools for the safety assessment of nanomaterials,”...

On 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 nano uncoated form both in leave-on and rinse-off oral cosmetics products, including toothpastes and skin care products, with a...

By Lynn L. Bergeson The European Commission (EC) announced on October 16, 2018, the launch of a new web-based tool called BioWatch. Developed by BIOWAYS, a project funded by the European Union (EU), this new tool expands BIOWAYS’ efforts in raising awareness of biobased products and their social, economic, and environmental benefits. BioWatch consists of “an interactive online platform that provides projects in the bioeconomy sector with a free service to position themselves...

By Lynn L. Bergeson On October 11, 2018, the European Commission (EC) released a statement announcing its new action plan for a sustainable bioeconomy in Europe. The new action plan, originally announced by President Juncker and First Vice-President Timmermans in their letter of intent, aims to “improve and scale up the sustainable use of renewable sources to address global and local challenges such as climate change and sustainable development.” In his remarks, EC Vice-President for...

The European Commission (EC) has published a success story, “Controlling light at the nanoscale thanks to graphene.”  The EC notes graphene, “an atomically thin lattice of carbon, has many exceptional properties.”  A European Union (EU)-funded project is focusing on the unique capabilities of graphene plasmons to transport and control light emissions at spatial scales far smaller than their wavelength.  They can be exploited in numerous applications, including for infrared biosensing...

The September 2018 issue of the ECHA Newsletter includes an article entitled “Are the new REACH information requirements for nanos relevant for you?” written by Jenny Holmqvist, Coordinator for Nanomaterials for the European Chemicals Agency (ECHA).  As reported in our April 26, 2018, blog item, the European Commission (EC) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee voted on April 26, 2018, to amend several REACH Annexes to...

The European Commission’s (EC) Joint Research Center has published a Technical Report entitled Mapping Nanomedicine Terminology in the Regulatory Landscape.  According to the abstract, to support a better understanding of terms used in the regulatory domain, the Nanomedicines Working Group of the International Pharmaceutical Regulators Forum (IPRF) prioritized the need to map, compile, and discuss the currently used terminology of regulatory scientists coming from different geographic...

The July 19, 2018, issue of the European Commission’s (EC) Health-EU Newsletter includes an editorial entitled “The only concern to have about sunscreen is … did you remember to put it on?” written by Qasim Chaudhry, Chair of the Scientific Committee on Consumer Safety (SCCS) and Ulrike Bernauer, Chair of the SCCS Working Group on Nanomaterials in Cosmetic Products.  According to the editorial, nanomaterials as cosmetic ingredients serve various functions, including as...

On July 17, 2018, the European Union (EU) Observatory for Nanomaterials (EUON) announced the availability of a study that it commissioned, Critical review of the relevance and reliability of data sources, methods, parameters and determining factors to produce market studies on manufactured nanomaterials on the EU market.  The study presents the results of a critical review of the relevance and reliability of data sources, methods, parameters, and determining factors to...

The European Commission (EC) announced on June 15, 2018, that researchers from the European Union (EU)-funded NANOPACK project found a solution for extending food shelf-life by using smart antimicrobial surfaces applied to active food packaging.  According to the EC, the researchers are now running five pilot production runs of the new polymer composite, based on tiny nanotube formations, to test its technical, industrial, and commercial viability.  The researchers “form...

On June 25, 2018, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on styrene/acrylates copolymer (nano) and sodium styrene/acrylates copolymer (nano).  The EC received eight notifications of cosmetic ingredients containing the copolymers in nano forms.  According to the applicants, the ingredients are used in nano-coated form in leave-on cosmetic products with maximum reported concentration limits of 0.06 percent. ...

The “2nd Quantifying Exposure to Engineered Nanomaterials from Manufactured Products (QEEN II) Workshop” will be held October 9-10, 2018, in Washington, D.C.  Sponsored by the Consumer Product Safety Commission (CPSC) and co-hosted by the National Nanotechnology Initiative (NNI), the Workshop will highlight new research on the tools and methods available to characterize and quantify effective population exposures, as well as the presence and release potential of...

The European Union Observatory for Nanomaterials (EUON) has posted the workshop report from the March 9, 2018, Stakeholder Dialogue meeting.  According to the report, the annual meeting focused on providing an update on EUON and allowing stakeholders an opportunity to share their views on expectations on the future development of EUON.  During his welcome address, Jukka Malm, European Chemicals Agency (ECHA), acknowledged that some stakeholders preferred a mandatory register...

The European Commission (EC) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements for nanomaterials.  According to the European Chemicals Agency’s (ECHA) press release, the amendments address the knowledge gap regarding which substances registered under REACH are placed on the market as nanomaterials and in what quantities.  ECHA states that the...

On March 13, 2018, the European Commission (EC) Ombudsman issued its recommendation in a case concerning the EC’s refusal to grant access to its catalog of nanomaterials used in cosmetics, as well as to related notification from cosmetics manufacturers.  As reported in our August 8, 2017, blog item, ClientEarth announced on July 31, 2017, that it filed a complaint with the Ombudsman about the EC’s “unlawful handling of a long-delayed list of nano-chemicals in...

On March 5, 2018, the European Commission (EC) announced the availability of a Communication to the European Parliament (EP), the Council of the European Union (EU), and the European Economic and Social Committee on the operation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The Communication includes proposals intended to facilitate further the implementation of REACH.  The scope of the EC’s evaluation includes a...

By Lynn L. Bergeson On March 1, 2018, the European Commission announced the approval of a €4.7 billion Italian support scheme for the production and distribution of advanced biofuels, including advanced biomethane, for use in the transport sector.  Under the scheme, producers of advanced biomethane and biofuels will receive a premium to compensate for higher production costs compared to fossil fuels.  The scheme will run from 2018 until 2022 and will be financed by transport...

By Kathleen M. Roberts On January 31, 2018, the European Commission (EC) launched a new investigation into subsidized imports of biodiesel from Argentina.  The investigation was initiated based on a complaint filed by the European Biodiesel Board (EBB) on behalf of producers representing over 25 percent of the European Union (EU) biodiesel production.  The EC determined that the complaint includes sufficient evidence that the Argentinean biodiesel producers have benefitted from a...

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...

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...

By Kathleen M. Roberts On August 25, 2017, the National Farmers’ Union (NFU) announced that the European Commission confirmed the extension of the Red Tractor voluntary scheme for biofuels for an initial three months.  Red Tractor is a certification body used to prove that crops meet European Union (EU) sustainability requirements.  To receive public support or count towards mandatory national renewable energy targets, biofuels used in the EU must comply with the...

The European Commission (EC) Environment Directorate General (DG) published an August 2017 report entitled Assessing the environmental safety of manufactured nanomaterials.  The report “shows that, despite early fears, nano-sized particles are not inherently more toxic than larger particles; however, differences between them may be notable and new insights are still being provided by research.”  The report’s aim is “to present the most promising strategies and most significant...

By Kathleen M. Roberts On July 26, 2017, the European Commission announced the launch of the Bioeconomy Knowledge Centre, which was created by the Joint Research Centre (JRC) and the Directorate General for Research and Innovation (DG RTD) to better support policy makers with science-based evidence in the bioeconomy field.  Rather than generate information, the objective is to build on JRC’s expertise in knowledge management.  The online platform will collect, structure, and...

On June 8, 2017, the European Commission (EC) published eight NanoData Landscape Compilation reports.  The EC states that the reports offer a snapshot of the environment for nanotechnology in different application fields:...