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On October 9, 2017, the European Commission (EC) began a public consultation on a draft regulation that would amend Annexes I, III, VI, VII, VIII, IX, X, XI, and XII of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanoforms of substances.  The draft regulation states that: Clarifications to requirements for the registration of substances with nanoforms and related downstream user obligations should be included in Annexes I,...

The European Commission (EC) Joint Research Center (JRC) has published the NANoREG Toolbox for the Safety Assessment of Nanomaterials.  As reported in our May 8, 2017, blog item, JRC previously published a Science for Policy report entitled NANoREG framework for the safety assessment of nanomaterials.  The report was developed within the NANoREG project, “A common European approach to the regulatory testing of nanomaterials.”  The NANoREG framework represents the project’s proposal...

On September 27, 2017, the Organization for Economic Cooperation and Development (OECD) published a corrected version of the Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour De Table, which covers developments on the safety of manufactured nanomaterials that were provided by OECD delegations from March to August 2017.  It summarizes relevant information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies...

On September 15, 2017, the European Commission (EC) began a public consultation on the revision of the 2011 EC Recommendation on the definition of nanomaterial.  The EC intended the definition to achieve consistent application of the term nanomaterial across all legislation.  The definition includes descriptors that the EC intended to review by December 2014 to ensure that the definition corresponds to the needs.  In particular, the review must examine issues where there...

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...

In July 2017, the European Commission’s (EC) Joint Research Center (JRC) published a report entitled Evaluation of the availability and applicability of computational approaches in the safety assessment of nanomaterials:  Final report of the Nanocomput project.  The main aims of the Nanocomput Project were to review and assess the current status of computational methods that are potentially useful for predicting the properties of engineered nanomaterials to provide advice on the use of...

On June 30, 2017, the European Chemicals Agency (ECHA) Board of Appeal published two decisions related to nanomaterials.  In the July 5, 2017, issue of ECHA Weekly, ECHA states that the Board of Appeal “largely upheld the appeals and annulled most of the requests for information.”  In Cases A-014-2015 and A-015-2015, registrants appealed the same 2015 ECHA decision requesting information on synthetic amorphous silica (SAS) following a substance evaluation by the Netherlands Competent...

The European Chemicals Agency (ECHA) announced on May 24, 2017, publication of five documents that it intends to help registrants preparing dossiers that cover nanoforms ahead of the 2018 registration deadline under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  ECHA published two new guidance documents: Nano-specific appendix to Chapter R.6 of the Guidance on information requirements and chemical safety assessment...

The European Chemicals Agency (ECHA) has created a web page for the Nanomaterials Expert Group (NMEP), which was created in October 2012.  NMEP aims to seek common ground among experts on scientific and technical issues regarding the implementation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, the Classification, Labeling, and Packaging (CLP) regulation, and the Biocidal Products Regulation (BPR) for nanomaterials.  ECHA...

The European Commission (EC) Joint Research Center (JRC) has published a Science for Policy report entitled NANoREG framework for the safety assessment of nanomaterials.  The report was developed within the NANoREG project, “A common European approach to the regulatory testing of nanomaterials.”  The NANoREG framework represents the project’s proposal for a common understanding in the field of environmental health and safety (EHS) assessment of nanomaterials under the...

NanoMONITOR announced on May 3, 2017, the launch of a survey intended to refine the design of the real-time information and monitoring system to support the risk assessment of nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  NanoMONITOR states that the ten-minute survey will help it: Elicit stakeholders’ requirements on the NanoMONITOR web platform; Elicit stakeholders’ requirements on the NanoMONITOR station...

NanoMONITOR, a project partly funded by the European Commission Life+ with grant agreement LIFE14 ENV/ES/000662, is intended to develop a real-time information and monitoring system to support the risk assessment of nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The overall objective of the NanoMONITOR project is to improve the use of environmental monitoring data to support the implementation of REACH and to promote the...

NanoMONITOR’s first stakeholders’ day, April 4, 2017, will include a workshop on “Development of a real-time information and monitoring system to support the risk assessment of nanomaterials under REACH.”  The overall aim of the NanoMONITOR project is to develop a prototype system to generate robust, accessible, comparable, and interoperable environmental and indoor air monitoring data to support the implementation of the Registration, Evaluation, Authorization and Restriction...

On March 2, 2017, the European Chemicals Agency (ECHA) announced that its Board of Appeal issued its decision in Case A-011-2014, which concerns a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) dossier evaluation for titanium dioxide.  In its evaluation, ECHA considered only the substance identity information required and not the information requirements for human health and environmental effects.  The Contested Decision required...

According to the European Chemicals Agency (ECHA) website, several Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) guidance documents concerning nanomaterials have moved to the next step in the consultation process.  The draft recommendations for nanomaterials applicable to the guidance on quantitative structure-activity relationships (QSAR) and grouping of chemicals was sent to the Competent Authorities for REACH and Classification, Labeling, and...

According to the European Chemicals Agency (ECHA) website, the draft Guidance on information requirements and Chemical Safety Assessment:  Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a Endpoint specific guidance and Appendix R7-2 Recommendations for nanomaterials applicable to Chapter R7c Endpoint specific guidance has been sent to the Competent Authorities for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and...

On January 13, 2017, the European Chemicals Agency (ECHA) sent the draft appendix on recommendations for nanomaterials applicable to the guidance on registration to the Forum, Member State Committee, and Risk Assessment Committee for consultation.  The draft guidance outlines the minimum elements potential registrants need to consider when registering substances that fulfil the European Commission’s (EC) Recommendation for the definition of nanomaterial.  The aim of the...

The European Chemicals Agency (ECHA) announced in its December 14, 2016, ECHA Weekly that the following drafts for updated ECHA guidance on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation have moved to the next consultation step and been sent to the Member State Committee for review: Guidance on recommendations for nanomaterials for environmental endpoints: Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a Endpoint...

On October 13, 2016, OCSiAl announced that it is the first manufacturer of single wall carbon nanotubes (SWCNT) to complete Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration.  According to OCSiAl, the registration was successfully completed thanks to the collaboration between OCSiAl’s Health and Safety Department, Envigo, and Intertek, which jointly completed the work involved in demonstrating compliance with the standards and requirements of...

In cases A-008-2015, A-009-2015, A-010-2015, and A-011-2015, the European Chemicals Agency (ECHA) Board of Appeal examined appeals against compliance check decisions made by ECHA requesting further substance identity information from four registrants of a “nano structured” substance.  As reported in our July 29, 2015, blog item, ECHA adopted the contested decisions on December 17, 2014, following a compliance check under the dossier evaluation procedure of the...