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The European Commission (EC) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements for nanomaterials.  According to the European Chemicals Agency’s (ECHA) press release, the amendments address the knowledge gap regarding which substances registered under REACH are placed on the market as nanomaterials and in what quantities.  ECHA states that the...

On April 4, 2018, the European Chemicals Agency (ECHA) announced that it has launched a public consultation on its draft Strategic Plan for 2019-2023.  ECHA states that by 2023, it “aims to become the main source of scientific knowledge and technical know-how on chemicals, serving a wide range of [European Union (EU)] policies and stakeholders.”  The draft Strategic Plan lists three strategic priorities that are to be achieved with a set of enabling...

The European Chemicals Agency (ECHA) announced on March 15, 2018, a new website, “Chemicals in our life.”  The website is available in 23 European Union (EU) languages and “provides useful information on the benefits and risks of using chemicals and explains how the EU legislation on chemicals protects us.”  In its press release, ECHA notes that the website allows users to explore parts of the EU Observatory for Nanomaterials (EUON).  Several articles on nanomaterials...

On March 5, 2018, the European Commission (EC) announced the availability of a Communication to the European Parliament (EP), the Council of the European Union (EU), and the European Economic and Social Committee on the operation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The Communication includes proposals intended to facilitate further the implementation of REACH.  The scope of the EC’s evaluation includes a...

As reported in our June 19, 2017, blog item, the European Commission (EC) published a catalog of nanomaterials used in cosmetic products on the European Union (EU) market.  On February 5, 2018, the European Union Observatory for Nanomaterials (EUON) published a table linking nanomaterials listed in the catalog to their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration data in the European Chemicals Agency’s (ECHA)...

During its December 14-15, 2017, meeting, the Management Board of the European Chemicals Agency (ECHA) discussed ECHA’s strategy on substances in nanoforms.  According to the strategy, following recent rulings of the Board of Appeal, the “possibility for using dossier and substance evaluation under the current legal text of [the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation] to verify safe use of nanomaterials on the EU market has become...

On November 30, 2017, the European Chemicals Agency (ECHA) held a webinar to explain the support documentation available for registrants that cover nanoforms in their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier.  The main focus was on the registration and read-across of nanoforms, but the webinar also covered updates for information requirements for human health and the environment.  ECHA has posted the following...

On November 30, 2017, the European Chemicals Agency (ECHA) will hold a webinar to explain the support documentation available for registrants that cover nanoforms in their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier.  ECHA states that the main focus will be on the registration and read-across of nanoforms, but the webinar will also cover updates for information requirements for human health and the environment.  According to the agenda,...

The European Chemicals Agency (ECHA) will have six sessions at the Society of Environmental Toxicology and Chemistry (SETAC) Europe, which will be held May 13-17, 2018, in Rome, Italy.  ECHA’s sessions will include one on recent developments in regulatory science and environmental risk assessment of nanomaterials.  To support the session, ECHA welcomes abstracts on experience gained in environmental hazard and risk assessment of nanomaterials illustrated by case studies.  Presentations...

The European Chemicals Agency (ECHA) announced on September 27, 2017, that the Committee for Risk Assessment (RAC) concluded on ten opinions for harmonized classification and labeling (CLH), including titanium dioxide.  In May 2016, France submitted a CLH proposal for titanium dioxide, stating that titanium dioxide should be considered as being potentially carcinogenic to humans when inhaled and thus be classified as category 1B-H350i.  France proposed that the classification...

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...

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.  EUON provides information on uses, health and safety issues, research, regulation, and...

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 proposal for harmonized classification and labeling (CLH).  The proposal’s...

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...

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, 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...

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...

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 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 nanomaterials (e.g., the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, biocides,...

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 to control other arthropods (product-type 18).  ECHA’s October 13, 2016, annex to a news...

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...

On August 23, 2016, the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) adopted its first decision on a data sharing dispute under the Biocidal Products Regulation (BPR). Thor GmbH (Thor) lodged the appeal in 2015 after ECHA granted permission to a company to cite studies owned by Thor for the substance reaction mass of 5-chloro-2-methyl-2H-isohtiazol-3-one and 2-methyl-2H-isothiazol-3-one (CIT/MIT).  According to ECHA, Thor had insisted on a technical equivalence assessment of...

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...

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...

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 the future guidance development on hazard assessment for nanoforms” at the European Union (EU) and Organization for Economic...

On September 2, 2015, the European Chemicals Agency (ECHA) issued an updated list of biocide suppliers as required under Article 95 of the Biocidal Product Regulation (BPR).  Although prior versions of the list were released previously, this list has current legal effect since Article 95 provides that, as of September 1, 2015, a biocidal product cannot be made available in European Union (EU) markets unless the active ingredient supplier or product supplier is listed for the...

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...

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...

Not a moment too soon, the European Chemicals Agency (ECHA) released a useful and clearly written Practical Guide on Biocidal Products Regulation, ECHA-14-B-19-EN. ECHA is the European Union (EU) agency tasked with implementing the Biocidal Products Regulation (BPR), along with other EU chemical laws and regulations. Adopted in 2012, the BPR revised the Biocidal Products Directive and imposes requirements on producers of active substances and biocidal products. Starting on September 1,...

The Organization for Economic Cooperation and Development (OECD) recently released its document "OECD Guidance for Characterising Oleochemical Substances for Assessment Purposes," which is available online. The document seeks to present a "harmonised approach" for characterizing UVCB (substances of unknown or variable composition, complex reaction products or biological materials) oleochemical substances that are derivatives from animal and vegetable oils and fats. In June...

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...

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...

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...

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...

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...

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 (RIPoN 3). The EC states that, based on the scientific and...

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 a letter to the Dutch Environment Ministry that it would publish a definition by the end of...

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 the 2009 European Parliament communication on nanomaterials. An ECHA spokesperson stated that...

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 forms of a substance in a IUCLID 5.2 dossier.” The...

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, ECHA is following “international developments,” particularly work...

On May 28, 2009, during the Helsinki Chemicals Forum organized by the European Commission (EC) and European Chemicals Agency (ECHA), governmental spokespersons said that the way the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program applies to nanoscale substances is being reconsidered. ECHA Executive Director Geert Dancet stated that specific regulation of nanomaterials could be considered when the EC reviews REACH, which it is required to do by June 1,...

On July 5, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) released an ex-post evaluation report prepared by the Evaluation Working Group of the European Chemicals Agency (ECHA) with the support of PricewaterhouseCoopers.  The ex-post evaluation assessed EUON against the following criteria:  effectiveness; coherence; EU added-value; and utility.  The recommendations by the external evaluators include: Increase the effectiveness and relevance...