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: ECHA

ECHA Launches EU Observatory for Nanomaterials

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues, Research
On June 14, 2017, the European Chemicals Agency (ECHA) announced the launch of the European Union (EU) Observatory for Nanomaterials (EUON).  ECHA states that EUON “offers a unique web-based information point with factual and neutral content about nanomaterials on the EU market.”  EUON is targeted at a wide audience, including consumers, workers, regulators, and scientists. … Continue Reading

ECHA Committee Concludes Titanium Dioxide Should Be Classified as Suspected of Causing Cancer When Inhaled

Posted in International, Legal/Regulatory Issues
On June 9, 2017, the European Chemicals Agency (ECHA) announced that the Committee for Risk Assessment (RAC) “concluded that the available scientific evidence meets the criteria in the [Classification, Labeling and Packaging (CLP)] Regulation to classify titanium dioxide as a substance suspected of causing cancer through the inhalation route.”  In May 2016, France submitted a… 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

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

ECHA Announces Signed Agreement for EU Observatory for Nanomaterials

Posted in International, Legal/Regulatory Issues
On December 7, 2016, the European Chemicals Agency (ECHA) announced the signing of a delegation agreement between ECHA and the European Commission (EC) on the European Union Observatory for Nanomaterials (EU-ON).  According to ECHA, the information sources for the EU-ON will include data generated by various pieces of EU legislation regulating the safe use of… Continue Reading

ECHA Committee Adopts First Opinion Approving Nano Biocide

Posted in EU Member State, Legal/Regulatory Issues
On October 13, 2016, the European Chemicals Agency (ECHA) announced that the Biocidal Products Committee adopted three opinions supporting the approval of active substances for use in biocidal products, including its first opinion on a nanomaterial.  The Committee supports the use of pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated for insecticides, acaricides, and products… 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

ECHA Announces New Approach on Hazard Assessment for Nanoforms

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) announced on March 23, 2016, a new publication co-authored with the Dutch National Institute for Public Health and the Environment (RIVM) and Joint Research Center (JRC) that illustrates how to use data for different nanoforms within the same substance registration.  According to ECHA, this approach “will form a cornerstone in… Continue Reading

Companies Appeal ECHA’s Decision on Silicon Dioxide

Posted in International, Legal/Regulatory Issues
On August 19, 2015, the European Chemicals Agency (ECHA) announced appeals of its March 11, 2015, decision on substance evaluation for silicon dioxide.  Case A-015-2015 was filed by Evonik Degussa GmbH and 34 others, while Case A-014-2015 was filed by Grace GmbH & Co. KG and Advanced Refining Technologies GmbH.  The appellants in Case A-015-2015… Continue Reading

ECHA Asks Registrants to Consider New OECD Data on Nanomaterials

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) issued a June 9, 2015, press release reminding registrants to consider the Organization for Economic Cooperation and Development’s (OECD) dissemination of hazard information on the following nanomaterials, and to update their dossiers accordingly: Cerium oxide; Dendrimers; Fullerenes (C60); Gold nanoparticles; Multi-walled carbon nanotubes; Nanoclays; Silicon dioxide; Silver nanoparticles; Single-walled carbon… Continue Reading

ECHA Will Hold Webinar on REACH Registration Dossiers for Nanomaterials and Creates Nanomaterials Working Group

Posted in International, Legal/Regulatory Issues
On October 30, 2012, the European Chemicals Agency (ECHA) will hold a webinar entitled “How to ensure the safe use of nanomaterials under REACH Part I: Characterisation of nanoforms of substances in registration dossiers.” According to ECHA, the webinar will provide information to registrants on the type of information to be included in a Registration, Evaluation, Authorization… Continue Reading

EC Adopts Communication on Second Regulatory Review on Nanomaterials

Posted in International, Legal/Regulatory Issues
On October 3, 2012, the European Commission (EC) announced its adoption of a Communication on the Second Regulatory Review on Nanomaterials, which assesses the adequacy and implementation of European Union (EU) legislation for nanomaterials, indicates follow-up actions, and responds to issues raised by the European Parliament (EP), EU Council, and the European Economic and Social… Continue Reading

ECHA Will Create Working Group on Nanomaterials

Posted in International, Legal/Regulatory Issues, State
The European Chemicals Agency (ECHA) recently held a two-day workshop concerning its first experiences with nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, with an emphasis on the evaluation process. ECHA, Member State Competent Authorities (MSCA), accredited stakeholders, and the European Commission (EC) discussed how nanomaterials in general have been characterized in… Continue Reading

ECHA Updates Additional Guidance for Nanomaterials

Posted in International, Legal/Regulatory Issues
On May 25, 2012, the European Chemicals Agency (ECHA) published three new appendices, updating Chapters R.8, R.10, and R.14 of the Guidance on Information Requirements and Chemical Safety Assessment.  ECHA updated the guidance based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 3, which concerned… Continue Reading

ECHA Announces Updated Guidance for Registering Nanomaterials

Posted in International, Legal/Regulatory Issues
On April 30, 2012, the European Chemicals Agency (ECHA) announced the availability of three appendices, updating Chapters R.7a, R.7b, and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA). ECHA prepared a draft revision of the Guidance, based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)… Continue Reading

ECHA Forwards Draft Guidance Concerning Nanomaterials to CARACAL

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) sent three new draft appendices to Chapters R.8, R.10, and R.14 of the guidance on information requirements and chemical safety assessment concerning recommendations for nanomaterials to the Competent Authorities for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) (CARACAL). The draft appendices are based on… Continue Reading

CoRAP Notes Nano Concerns for Two Substances

Posted in International, Legal/Regulatory Issues
On February 29, 2012, the European Chemicals Agency (ECHA) announced the first Community Rolling Action Plan (CoRAP), which includes 90 substances that Member States will evaluate under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) substance evaluation process. For each substance, ECHA notes the initial grounds for concern. For two substances, silicon dioxide and silver, the… Continue Reading