By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory Issues,ResearchThe European Union Observatory for Nanomaterials (EUON) has posted the workshop report from the March 9, 2018, Stakeholder Dialogue meeting. According to the report, the annual meeting focused on providing an update on EUON and allowing stakeholders an opportunity to share their views on expectations on the future development of EUON. During his welcome address,… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn 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.” … Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in InternationalThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesAs 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesDuring 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory Issues,Occupational Health and Safety Issues,ResearchOn 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesAccording 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesAccording 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,Legal/Regulatory IssuesOn 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesIn 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
