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 principle applies in the EU, the petitioner urges a ban on these small particles as soon as possible.” In its...
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The European Chemicals Agency (ECHA) recently submitted several draft guidance documents concerning nanomaterials to Partner Expert Groups (PEG) for consultation.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 is transparent and open to participation by relevant partners, ECHA will...
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 “particularly to players and decision-makers involved in discussions related to the adaptation of the various...
February 6, 2016
EC Publishes Inception Impact Assessment Concerning Possible REACH Annex Amendments for Registration of Nanomaterials
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 dossiers to attain the aims of the Registration, Evaluation, Authorization and...
On January 6, 2016, the European Union (EU) published its Commission Implementing Regulation (EU) 2016/9 regarding the joint submission of data and data sharing under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) in the Official Journal of the European Union. The European Commission (EC) Competent Authorities for REACH and CLP (CARACAL) has been developing this Regulation to clarify further what is meant by determining data sharing in a “fair,...
August 25, 2015
Companies Appeal ECHA’s Decision on Silicon Dioxide
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 challenge ECHA’s decision to include silicon dioxide on the Community Rolling Action Plan (CoRAP) “due to...
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 17, 2014, following a compliance check under the dossier evaluation procedure of the submitted registration. In each...
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 nanotubes; Titanium dioxide...
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 in Germany that...
November 15, 2012
NGOs Call for “Nano Patch” for REACH, and EC Responds
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 Review on Nanomaterials. The Communication describes the Registration,...
October 18, 2012
ECHA Will Hold Webinar on REACH Registration Dossiers for Nanomaterials and Creates Nanomaterials Working Group
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 and Restriction of Chemicals (REACH) registration dossier for a substance with nanoform(s). In addition, on...
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 Committee. The Communication concludes that “nanomaterials are similar to normal chemicals/substances in...
June 12, 2012
ECHA Will Create Working Group on Nanomaterials
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 registration dossiers. Currently, according to ECHA, the...
June 8, 2012
ECHA Updates Additional Guidance for Nanomaterials
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 aspects such as occupational exposure estimation and dose-response characterization for human...
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) Implementation Projects on Nanomaterials (RIP-oN) 2 final report. ECHA updated the Guidance via a fast-track...
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 the results of the REACH Implementation Project on Nanomaterials...
March 1, 2012
CoRAP Notes Nano Concerns for Two Substances
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 initial grounds for concern are “Substance...
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 deadline of May 31, 2013, is approaching quickly, ECHA “will facilitate...
February 10, 2012
CIEL Claims REACH Insufficient to Regulate Nanomaterials
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 not define nanomaterials, and contains no nano-specific provisions; Most nanomaterials evade registration...
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 vertebrate animals be carried out only as a last resort, however. ECHA states that, to...