Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Tag Archives: REACH

EC Proposes to Amend REACH Annexes to Address Nanomaterials

Posted in International, Legal/Regulatory Issues
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… Continue Reading

JRC Publishes NANoREG Toolbox for the Safety Assessment of Nanomaterials

Posted in International, Legal/Regulatory Issues
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… Continue Reading

OECD Tour de Table Highlights International Developments on the Safety of Manufactured Nanomaterials

Posted in International, Legal/Regulatory Issues
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… Continue Reading

EC Begins Consultation on Revising Recommendation on Definition of Nanomaterial

Posted in International, Legal/Regulatory Issues
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… Continue Reading

EC Environment DG Publishes Report on Assessing the Environmental Safety of Manufactured Nanomaterials

Posted in International, Legal/Regulatory Issues, Research
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… Continue Reading

EC Publishes Final Report of Nanocomput Project

Posted in International, Legal/Regulatory Issues, Research
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… Continue Reading

ECHA Announces Two Decisions on Appeals Related to Nanomaterials

Posted in International, Legal/Regulatory Issues
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… Continue Reading

ECHA Publishes REACH Guidance for Nanomaterials

Posted in International, Legal/Regulatory Issues
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… Continue Reading

ECHA Creates Web Page for Nanomaterials Expert Group

Posted in International, Legal/Regulatory Issues
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)… Continue Reading

JRC Publishes NANoREG Framework for the Safety Assessment of Nanomaterials

Posted in International, Legal/Regulatory Issues
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… Continue Reading

NanoMONITOR Begins Survey to Refine Design of Real-Time Information and Monitoring System

Posted in International, Legal/Regulatory Issues
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… Continue Reading

NanoMONITOR Demo Version Now Available Online

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues, Research
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… Continue Reading

NanoMONITOR Workshop Will Examine Supporting the Risk Assessment of Nanomaterials under REACH

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues, Research
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… Continue Reading

ECHA Board of Appeal Annuls Contested Decision Concerning Titanium Dioxide

Posted in International, Legal/Regulatory Issues
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… Continue Reading

Another Draft REACH Guidance Document on Nanomaterials Moves to CARACAL for Review

Posted in International, Legal/Regulatory Issues
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… Continue Reading

Draft REACH Guidance Documents on Nanomaterials Move to CARACAL for Review

Posted in International, Legal/Regulatory Issues
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… Continue Reading

Committees Reviewing Draft Appendix on Recommendations for Nanomaterials Applicable to the Guidance on Registration

Posted in International, Legal/Regulatory Issues
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… Continue Reading

Draft REACH Guidance Documents for Nanomaterials Move to Next Consultation Step

Posted in International, Legal/Regulatory Issues
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… Continue Reading

Company Announces First REACH Registration of Single Wall Carbon Nanotubes

Posted in International
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… Continue Reading

ECHA Board of Appeal Annuls Four Decisions Requesting Substance Identity Information on a Nano Structured Substance

Posted in EU Member State, International, Legal/Regulatory Issues
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,… Continue Reading

EC Denies 2014 Petition Seeking EU-Wide Ban on Nanoparticles

Posted in International, Legal/Regulatory Issues
On June 29, 2016, the European Commission (EC) provided a notice to the European Parliament regarding its response to a 2014 petition calling for a European Union (EU)-wide ban on microplastics and nanoparticles.  The petition summary states:  “Nanoparticles are so small that they penetrate cells effortlessly and can damage them, causing cancer.  Because the precautionary… Continue Reading

ECHA Consults PEGs on Nanomaterial Guidance Documents

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) recently submitted several draft guidance documents concerning nanomaterials to Partner Expert Groups (PEG) for consultation.  Following consultation with PEGs, ECHA will consult its committees and/or Forum, where relevant.  The final consultation will be with the European Commission (EC) and the relevant Competent Authorities.  To ensure that the guidance updating process… Continue Reading

Germany Publishes Report on Nanomaterials in the Environment

Posted in EU Member State, International, Legal/Regulatory Issues
On June 1, 2016, the German Environment Agency (UBA) published a report entitled Nanomaterials in the environment:  Current state of knowledge and regulations on chemical safety.  The aim of the report is to outline the necessary further development of chemicals regulations for nanomaterials with regard to the environment from UBA’s perspective.  The report is addressed… Continue Reading

EC Publishes Inception Impact Assessment Concerning Possible REACH Annex Amendments for Registration of Nanomaterials

Posted in International, Legal/Regulatory Issues
On February 2, 2016, the European Commission (EC) published an inception impact assessment concerning “Possible amendments of Annexes to REACH for registration of nanomaterials.”  According to the inception impact assessment, the EC identified a need for more specific requirements for nanomaterials to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration… Continue Reading