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The Council of the European Union (EU) announced on June 12, 2025, that it reached a provisional agreement with the European Parliament (EP) on the “one substance, one assessment” (OSOA) legislative package, “which aims to streamline assessments of chemicals across relevant EU legislation, strengthen the knowledge base on chemicals, and ensure early detection and action on emerging chemical risks.” The package contains three proposals: a directive concerning the re-attribution of...

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...

Download transcript. 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...

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, UBA has...

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: Scientists working within the fields of nanomaterials safety who have a basic knowledge of what nanomaterials are; and National authorities and private-sector employees with a scientific background similar to nanosafety scientists and a need for information on regulation of nanomaterials in the EU. The learning objectives...

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: Canada: Canada is developing a nanomaterial...

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...