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Register now to join Bergeson & Campbell, P.C. (B&C®) affiliate The Acta Group (Acta®) and EPPA for “PFAS Updates: What’s Happening in the U.S. and EU,” a complimentary webinar offering expert updates on per- and polyfluoroalkyl substances (PFAS) regulatory developments. These substances are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. While the U.S. Administration is new, PFAS regulation continues at a...

This week I had the pleasure of speaking with Melissa Owen, attorney/owner of Ambiente Legal, about the significant regulatory developments regarding chemical registration in Latin America, including Latin American Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) initiatives and the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). We discuss Brazil REACH, which requires by law the government to have an implementing regulation issued...

Bergeson & Campbell, P.C. (B&C®), its global consulting affiliate The Acta Group (Acta®), and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to share with you our 2025 Forecast. For all the reasons you might imagine, our seasoned team was especially challenged this year in speculating on what to expect in 2025 regarding global industrial, agricultural, and biocidal chemical regulatory and policy initiatives. Given the European Parliamentary...

On April 29, 2024, the German Environment Agency (UBA) posted an item entitled “ZnO nanoforms – REACH substance evaluation: environmental aspects.” The Federal Office for Chemicals, the Federal Institute for Risk Assessment (BfR), and UBA have been conducting a Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) substance evaluation on the registered nanoforms of zinc oxide since 2017. According to the item, based on the studies submitted by the registrants,...

The EU Academy, an online hub owned by the European Union (EU), is offering an online course on how EU legislation addresses nanomaterials. The target audience includes: The learning objectives include:...

POSTED IN INTERNATIONAL, LEGAL/REGULATORY ISSUES, OECD The Organization for Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022. Below are highlights on...

The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) issued a May 17, 2023, news item stating that it believes that the European Commission’s (EC) revised Recommendation on the definition of nanomaterial, published in June 2022, “is too restrictive and could lead to a regression in the protection of public health and the environment.” ANSES “is therefore urging the French authorities to take a more inclusive definition into account and work...

On May 2, 2023, the European Commission’s (EC) Joint Research Center (JRC) announced that it published a guidance document entitled Guidance on the implementation of the Commission Recommendation 2022/C 229/01 on the definition of nanomaterial. As reported in our June 10, 2022, blog item, in June 2022, the EC published a new Recommendation aimed at harmonizing the interpretation of the term “nanomaterial” in regulatory contexts. The updated definition of nanomaterials...

The European Chemicals Agency (ECHA) announced in its February 1, 2023, ECHA Weekly that it has released an updated appendix for nanomaterials that provides guidance on how to obtain data under the new information requirements for nanoforms. According to ECHA, this includes information on how to perform environmental testing and advice on preparation methods and testing strategies for physico-chemical testing of nanoforms. ECHA notes that the Partner Expert Group (PEG) members...

The European Chemicals Agency (ECHA) has published a January 2022 update to the Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification (version 2.0). The main changes to the document include additional guidance on the joint submission of data, clarifications regarding the need for one data set per nanoform or set of nanoforms, and information on the registration of sets of nanoforms versus single nanoforms. Changes to the Appendix are limited to...

On June 26, 2019, the Council of the European Union (EU) announced that it adopted conclusions on chemicals intended to “offer political guidance on the development of a sustainable EU chemicals policy strategy.”  The June 26, 2019, press release notes that the conclusions address in particular the topics of Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, endocrine disruptors, nanomaterials, and pharmaceuticals.  According to the...

The European Chemicals Agency (ECHA) is in the process of updating its guidance on the information requirements and chemical safety assessment (IR&CSA) for nanoforms under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. ECHA has developed three appendices concerning information requirements (appendices to IR&CSA Guidance Chapters R.7a, R.7b, and R.7c) to provide advice to registrants for use when preparing REACH registration dossiers that...

On March 19, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “ECETOC task force ensures society benefits from safe nanomaterials via efficient safety assessments that require minimal animal testing” by authors from BASF and the Center for Chemical Safety Assessment (ECETOC).  The column reviews ways to assess the safety of nanomaterials while minimizing animal testing.  According to the authors, the NanoApp developed by the ECETOC...

On February 19, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “eREACHNano helps you to register nanoforms under REACH” by Dorte Rasmussen, Ph.D., who has been working on the exposure and risk assessment of chemicals at DHI A/S for almost 25 years.  Rasmussen describes eREACHNano, a tool developed to explain Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requirements for nanoforms. ...

The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the 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 20th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in September 2020.  Below are highlights from the Tour de Table: Between November 2018 and August 2020, EPA...

Beginning November 2, 2020, following the next release of the International Uniform Chemical Information Database (IUCLID), companies will be required to provide a name for the nanoforms or sets of nanoforms of their substance when registering nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  According to an item in the European Chemicals Agency’s (ECHA) September 30, 2020, weekly news, companies that have already...

The European Chemicals Agency (ECHA) has posted the German Federal Institute for Occupational Safety and Health’s (BAuA) substance evaluation conclusion document for multi-walled carbon nanotubes (MWCNT), synthetic graphite in tubular shape and tangled.  The conclusion provides a summary of how the information on the substance can be used for the purposes of regulatory risk management. Concern(s) Subject to Evaluation MWCNTs were originally selected for substance evaluation to...

On June 26, 2020, the European Commission (EC) published a regulation in the Official Journal of the European Union that amends Annex II of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  Annex II describes the requirements for compiling safety data sheets (SDS).  The EC notes that specific requirements for nanoforms of substances took effect on January 1, 2020, and that information related to those requirements is to be...

The European Union (EU) Observatory for Nanomaterials (EUON) posted a Nanopinion on June 12, 2020, entitled “Pigments:  The oldest nanomaterials in human history facing modern day challenges.”  Dr. Heike Liewald, Managing Director, Eurocolour e.V., and Giuliana Beck, Advisor, German association of producers of pigments and fillers, describe how the introduction of nano-specific requirements in statutes has significantly increased the regulatory burden.  The authors state that...

On May 5, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “NanoApp helps navigate legal obligations under REACH.”  Olivier de Matos, Secretary General of the European Center for Ecotoxicology and Toxicology (ECETOC), describes the web-based app that was designed to help registrants follow the European Chemicals Agency’s (ECHA) guidance on sets of nanoforms.  According to de Matos, the app primarily covers the “Appendix for...

The European Chemicals Agency (ECHA) issued a press release on February 24, 2020, stating that it has received a low number of registration dossiers for nanomaterials.  ECHA states that it has received only 95 unique submissions for 36 substances covering nanoforms according to the updated Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requirements.  ECHA expected to receive updated registrations for approximately 300 substances, based...

On February 24, 2020, the European Chemicals Agency (ECHA) will hold a webinar on “Registering nanoforms:  practical advice.”  As of January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the updated Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  Beyond this date, companies must have a registration compliant with these requirements to manufacture or import...

As of January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the updated Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  ECHA organized a webinar on November 12, 2019, on the revised annexes and how companies can prepare to meet the new requirements.  ECHA states that the first part of the webinar explained what a nanoform is and how to build a set of similar...

The European Chemicals Agency (ECHA) announced on December 3, 2019, that it has developed a new Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification.  According to ECHA, it aligns ECHA’s guidance with the amended annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation that will apply to nanomaterials and enter into force on January 1, 2020.  The new guidance document explains the term nanoform,...

The International Chemical Secretariat (ChemSec) announced on November 14, 2019, that it added more chemicals, including carbon nanotubes, to its Substitute It Now! (SIN) List.  ChemSec describes carbon nanotubes as “one of the more well-studied nanomaterials” and notes that “they are used to make durable, lightweight materials, for electrical conductivity, as a super black pigment and for water purification, among other uses.”  Dr. Anna Lennquist, Project Manager for...

On November 12, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Nanomaterials in Europe’s workplaces:  what are the risks and how can they be managed?” and written by Elke Schneider, European Agency for Health and Safety at Work (EU-OSHA).  Schneider states that at the EU level, the requirements for managing nanomaterials and their potential risks are the same as those for managing other hazardous substances.  Under the EU’s...

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...

On September 19, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) announced the results of a study it commissioned to examine “next generation” nanomaterials and determine whether the current terminology used in the EU chemicals regulations, as well as the implementation of the current legal requirements for identifying nanomaterials, are likely to pose technical challenges.  The objectives of the study were to: According to EUON, the study findings...

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...

The European Chemicals Agency (ECHA) announced on July 3, 2019, that several new features and improvements are now publicly available in its chemicals database, including new information in substance Infocards.  ECHA has updated the substance Infocards with a new nanomaterial form section that shows whether the substance is placed on the European Economic Area (EEA) market in nanoform and provides links to the European Union (EU) Observatory for Nanomaterials (EUON).  As...

The European Union (EU) Observatory for Nanomaterials (EUON) announced on July 3, 2019, that it has added a new search tool for nanomaterials to its website.  According to EUON, it will enable regulators to form a better view of available data and give consumers access to chemicals safety information.  The search tool combines data submitted by companies in their registration dossiers under the Registration, Evaluation, Authorization and Restriction of Chemicals...

On May 16, 2019, the Swedish National Platform for Nanosafety (SweNanoSafe) announced the availability of eREACHNano, “a new web tool focused on helping small and medium-sized companies that may lack sufficient in-house expertise on the regulation covering nanomaterials.”  The web tool explains the data requirements for nanoforms according to the guideline documents of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, including:...

The 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.  It states that the advice provided covers nanospecific advice for issues related with registration and...

The 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 substance evaluation to clarify concerns about nanoparticles/ecotoxicity of different forms of the...

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.’”...

The Swedish National Platform for Nanosafety (SweNanoSafe) has posted a report on the European Chemicals Agency’s (ECHA) November 8-9, 2018, workshop on the upcoming Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) information requirements for nanomaterials.  As reported in our April 26, 2018, blog item, the European Commission (EC) REACH Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements...

The Nanotechnology Industries Association (NIA) announced on October 5, 2018, that the NanoReg2 project, of which NIA is a partner, has published a comprehensive review of European Union (EU) legislation addressing chemical substances and the potential for grouping and read across in nanomaterials.  The article, “Insights into possibilities for grouping and read-across for nanomaterials in EU chemicals legislation,” considers both the overarching regulation of chemical substances under the...

The Nanotechnology Industries Association (NIA) published an open newsletter on September 19, 2018, that includes an invitation to NIA’s October 11, 2018, open webinar on regulatory priorities.  The open webinar will cover the latest news on the nanomaterials definition, amendments to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Annexes, the Organization for Economic Cooperation and Development (OECD) Malta project, and the latest news on nanowaste...

On September 21, 2018, the Organization for Economic Cooperation and Development (OECD) announced four new case studies on integrated approaches for testing and assessment (IATA), including a Case Study on Grouping and Read-Across for Nanomaterials — Genotoxicity of Nano-TiO2.  The European Union (EU) Joint Research Center (JRC) developed the case study for the genotoxicity of nano-titanium dioxide (TiO2) for illustrating the practical use of IATA.  The case study applies the...

NanoMONITOR announced on June 25, 2018, that the NanoMONITOR Monitoring Station is available upon request to use in facilities to obtain robust data on the concentration of engineered nanomaterials.  NanoMONITOR’s brochure states that access is provided on a transnational basis with no charge to the user.  According to NanoMONITOR, by developing a real-time information and monitoring system, NanoMONITOR supports the risk assessment of nanomaterials under the...

On May 23, 2018, the European Union Observatory for Nanomaterials (EUON) published an article entitled “Nordic information campaign on REACH-relevant regulation for nanomaterials.”  According to EUON, Norway, Sweden, Finland, and Denmark are coordinating an information campaign through the N-Nano project group of the Nordic Chemical Working Group of the Nordic Council of Ministers.  The goal of the campaign is to develop a web-based tool to provide information on European Union...

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 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...

As reported in our June 19, 2017, blog item, the European Commission (EC) published a catalog of nanomaterials used in cosmetic products on the European Union (EU) market.  On February 5, 2018, the European Union Observatory for Nanomaterials (EUON) published a table linking nanomaterials listed in the catalog to their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration data in the European Chemicals Agency’s (ECHA)...

During its December 14-15, 2017, meeting, the Management Board of the European Chemicals Agency (ECHA) discussed ECHA’s strategy on substances in nanoforms.  According to the strategy, following recent rulings of the Board of Appeal, the “possibility for using dossier and substance evaluation under the current legal text of [the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation] to verify safe use of nanomaterials on the EU market has become...

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...

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...