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 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

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

Companies Appeal ECHA’s Requests for Information Concerning Nanoforms

Posted in International, Legal/Regulatory Issues
On July 16, 2015, the European Chemicals Agency (ECHA) announced the following appeals in which the keywords include nanoforms: J.M. Huber Finland Oy, Case A-011-2015; RHODIA OPERATIONS SAS, Case A-010-2015; IQESIL SA, Case A-009-2015; and Evonik Degussa GmbH, Case A-008-2015. The cases all concern silicic acid, aluminum sodium salt. The contested decisions were adopted December… 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

elni Review Article Examines Law and Innovation in Context of Nanomaterials

Posted in International, Legal/Regulatory Issues, United States
Environmental Law Network International’s (ELNI) recent issue of elni Review includes an article entitled “Law and innovation in the context of nanomaterials: Barriers to sustainable development? Results of an empirical study,” which examines to what degree the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation promotes innovations for sustainability through nanomaterials. The authors surveyed 37 companies based… Continue Reading

NGOs Call for “Nano Patch” for REACH, and EC Responds

Posted in International, Legal/Regulatory Issues
The Center for International Environmental Law (CIEL), ClientEarth, and Friends of the Earth Germany (BUND) released on November 13, 2012, a proposal for European Union (EU) legislation to address the risks of nanomaterials. CIEL states that the non-governmental organizations’ (NGO) proposal was prompted by the European Commission’s (EC) October 3, 2012, Communication on the Second Regulatory… 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

ECHA Announces Plans to Update Guidance for Registration of Nanoform Substances

Posted in International, Legal/Regulatory Issues
On February 22, 2012, the European Chemicals Agency (ECHA) issued a press release announcing that it is currently preparing an update of its Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) based on the European Commission’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIP-oN). Because the next registration… Continue Reading

CIEL Claims REACH Insufficient to Regulate Nanomaterials

Posted in International, Legal/Regulatory Issues
The Center for International Environmental Law (CIEL) published a report on February 6, 2012, entitled Just Out of REACH: How REACH Is Failing to Regulate Nanomaterials and How It Can Be Fixed. According to CIEL, there are four key gaps in the registration phase of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation: REACH does… Continue Reading

ECHA Begins Consultation on Testing Proposal for Multi-Wall Carbon Nanotubes

Posted in International, Legal/Regulatory Issues, Research
On November 3, 2011, the European Chemicals Agency (ECHA) began a consultation on a testing proposal for multi-wall carbon nanotubes, synthetic graphite in tubular shape. Under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, manufacturers and importers must obtain information on toxic effects of substances.  REACH requires that new testing of a substance involving… Continue Reading

EC Publishes Final RIPoN Reports

Posted in International, Legal/Regulatory Issues
The European Commission (EC) began in 2009 a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIPoN), which it intended to provide advice on key aspects of the implementation of REACH with regard to nanomaterials. The EC recently posted final reports concerning nanomaterials and information requirements (RIPoN 2) and chemical safety assessment… Continue Reading

REACH Conference Participants Discuss Nanomaterials

Posted in EU Member State, International, Legal/Regulatory Issues
During the September 23, 2011, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) conference organized by the European Chemicals Agency (ECHA) and European Commission (EC), Astrid Schomaker, Directorate-General (DG) Environment, stated that the EC has been working on a definition of nanomaterials, and that it “should be coming after the summer.” The EC previously stated in… Continue Reading

ECHA Preparing Nano Inventory from REACH and CLP Submissions

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) is compiling an inventory of nanomaterials included in the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossiers and Classification, Labeling, and Packaging (CLP) notifications for the European Commission (EC), and intends to deliver the inventory by the end of June 2011. The EC requested the inventory in response to… Continue Reading

Dutch Urge EU to Act on Nanomaterials

Posted in International, Legal/Regulatory Issues
In February 2011, the Dutch Environmental Safety and Risk Management Directorate sent a letter to the Directorate General (DG) Enterprise and DG Environment expressing concern regarding delays in the work of the Competent Authorities Sub-Group on Nanomaterials (CASG Nano) and the European Commission’s (EC) progress regarding clarifying the definition and status of nanomaterials. The Dutch Directorate… Continue Reading

Belgium Calls for REACH Register to Ensure Traceability of Nanomaterials

Posted in EU Member State, International, Legal/Regulatory Issues
During a September 14, 2010, conference on nanomaterials management, Paul Magnette, the Belgian Minister for Energy, Environment, Sustainable Development, and Consumer Protection, proposed to create a specific register for nanomaterials under the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) program and to implement mandatory labeling for nanomaterials used in consumer products. According to Magnette,… Continue Reading

ECHA Publishes Technical Manual for Including Nanoforms in an IUCLID Dossier

Posted in International, Legal/Regulatory Issues, OECD
On June 11, 2010, the European Chemicals Agency (ECHA) announced the availability of a technical manual for including nanoforms in an International Uniform Chemical Information Database (IUCLID) dossier. The Nanomaterials in IUCLID 5.2 Industry User Manual “gives practical instruction to [Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)] registrants on how to include information on different… Continue Reading

ECHA Revising REACH Guidance Documents to Include Nanomaterials

Posted in International, Legal/Regulatory Issues, OECD
During the Helsinki Chemicals Forum 2010, Jukka Malm, European Chemicals Agency (ECHA) Assessment Director stated that ECHA is revising its Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) guidance documents to include technical instructions to help companies include nanomaterials in their registration dossiers and other compliance obligations for substances they make or import. According to Malm,… Continue Reading

EC Will Review Legislation to Ensure Safety of Nanomaterials

Posted in International, Legal/Regulatory Issues
In an October 9, 2009, speech at the stakeholder conference concerning nanomaterials on the market, Stavros Dimas, European Commissioner for the Environment, stated that the European Commission (EC) “will review all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental, or safety impacts over their… Continue Reading