Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Archives: International

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EU Addresses the Use of Nanomaterials in Medical Devices

Posted in International, Legal/Regulatory Issues
On April 5, 2017, the European Parliament (EP) approved a regulation on medical devices, as well as a regulation on in vitro diagnostic medical devices.  The EP’s April 5, 2017, press release states that the medical devices regulation is intended to ensure that medical devices are traceable and comply with European Union (EU) safety requirements. … Continue Reading

Nanodatabase Adds 3,000th Product

Posted in International
The Nanodatabase, developed by the Technical University of Denmark Department of Environmental Engineering (DTU Environment), the Danish Ecological Council, and the Danish Consumer Council, announced on April 4, 2017, that it added product number 3,000.  According to The Nanodatabase, most products fall into the health and fitness category (1,845) while only about one-sixth of the… Continue Reading

IRSST Publishes Report for Project on Development and Validation of Methods for Sampling and Characterizing Engineered Nanomaterials in Air and on Workplace Surfaces

Posted in International, Occupational Health and Safety Issues, Research
On March 7, 2017, the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) published the final report for Project 2013-0059, “The Development and Validation of Methods for Sampling and Characterizing Engineered Nanomaterials in Air and on Workplace Surfaces.”  The report is available in French, but the abstract is available in English. … Continue Reading

SCCS Issues Final Opinion on Additional Coatings for Titanium Dioxide (Nano Form) as UV-Filter in Dermally Applied Cosmetic Products

Posted in International
On March 7, 2017, the Scientific Committee on Consumer Safety (SCCS) issued a final opinion on additional coatings for titanium dioxide (nano form) coated with cetyl phosphate, manganese dioxide, or triethoxycaprylylsilane as an ultraviolet (UV)-filter in dermally applied cosmetics.  The conclusion states that given a general lack of dermal absorption and low general toxicity of… Continue Reading

SCCS Seeks Comment on Opinion on Titanium Dioxide (Nano Form) as UV-Filter in Sprays

Posted in International, Legal/Regulatory Issues
On March 10, 2017, the Scientific Committee on Consumer Safety (SCCS) began a public consultation on its opinion on titanium dioxide (nanoform) as an ultraviolet (UV)-filter in sprays.  In July 2015, the European Commission (EC) received new data from industry to support the safe use of nano titanium dioxide when used as a UV-filter in… Continue Reading

NanoMONITOR Workshop Will Examine Supporting the Risk Assessment of Nanomaterials under REACH

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues, Research
NanoMONITOR’s first stakeholders’ day, April 4, 2017, will include a workshop on “Development of a real-time information and monitoring system to support the risk assessment of nanomaterials under REACH.”  The overall aim of the NanoMONITOR project is to develop a prototype system to generate robust, accessible, comparable, and interoperable environmental and indoor air monitoring data… Continue Reading

European NanoSafety Cluster Publishes 2017 Research Regulatory Roadmap

Posted in International, Legal/Regulatory Issues, Research
On March 9, 2017, the NanoSafety Cluster published its 2017 Research Regulatory Roadmap.  The purpose of the Roadmap is to identify both ongoing and complete activities associated with the development of regulations promoting the safety of nanomaterials.  The Roadmap identifies research areas or priorities that need to be addressed further to facilitate this process.  According… 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

ISO Publishes Standard on Vocabulary for Nano-Enabled Electrotechnical Products and Systems

Posted in International
In January 2017, the International Organization for Standardization (ISO) published International Electrotechnical Commission (IEC)/Technical Specification (TS) 80004-9:2017, “Nanotechnologies — Vocabulary — Part 9:  Nano-enabled electrotechnical products and systems.”  IEC/TS 80004-9:2017 specifies terms and definitions for electrotechnical products and systems reliant on nanomaterials for their essential functionalities.  ISO states that it is intended to facilitate communications… Continue Reading

Report Claims OECD Dossiers on Nanomaterials Are of “Little to No Value”

Posted in International, Legal/Regulatory Issues, OECD, Research
On February 23, 2017, the Center for International Environmental Law (CIEL) issued a press release announcing a new report, commissioned by CIEL, the European Environmental Citizens’ Organization for Standardization (ECOS), and the Oeko-Institute, that “shows that most of the information made available by the Sponsorship Testing Programme of the Organisation for Economic Co-operation and Development… 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

Nanomaterials Inventory for Cosmetics Will Be Published “in the Next Weeks”

Posted in International, Legal/Regulatory Issues
ClientEarth published a January 11, 2017, blog item entitled “Three-year wait for nanomaterial risk data promised ‘in the next weeks.’”  Under the Cosmetics Directive, the European Commission (EC) was to publish by January 11, 2014, an inventory of nanomaterials used in cosmetic products on the European Union market.  The EC has postponed publication of the… 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

IRSST Project Measures Nanoparticle Penetration into Protective Gloves

Posted in International, Occupational Health and Safety Issues, Research
The Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) published a news item on January 16, 2017, entitled “Nanoparticles — to handle with care.”  IRSST states that although research is still in development, it appears that nanoparticles can enter the respiratory tract or penetrate through the skin and make their way to the bloodstream, which may carry the… Continue Reading

OECD Publishes Report on Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials

Posted in OECD, Research
The Organization for Economic Cooperation and Development (OECD) published a report entitled Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials:  Current State of Knowledge and Research Needs to Advance Their Use.  Experts from academia, industry, public interest groups, and government researched, analyzed, and discussed how alternative models could be used to advance the risk… Continue Reading

Nano-Portal on Safe Handling of Nanomaterials Available in English

Posted in International, Occupational Health and Safety Issues
The Nano-Portal:  Safe Handling of Nanomaterials, the result of a project supported by the Deutsche Gesetzliche Unfallversicherung (DGUV) and developed by the Innovation Society, is now available in English.  The website is intended to extend knowledge about occupational safety and health in the fields of nanomaterials and nanotechnologies.  The Nano-Portal addresses: Awareness of prevention and… Continue Reading

KEMI Consulting on Draft Nano Register Regulation

Posted in EU Member State, International, Legal/Regulatory Issues
The Swedish Chemicals Agency (KEMI) is in the process of consulting with stakeholders on a draft regulation that would require companies to provide information on nanomaterials in chemical products to the Swedish products register by February 28, 2019.  According to KEMI, the proposal is the same as presented in its 2015 report.  Although the report… 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

Germany Begins Consultation on Announcement Concerning Manufactured Nanomaterials

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues
The Committee on Hazardous Substances (AGS) of the Federal Institute for Occupational Safety and Health (BAuA) began a public consultation on its update to several technical rules.  AGS seeks comment on Bekanntmachung zu Gefahrstoffen (BekGS) 527, “Hergestellte Nanomaterialien.”  Although BAuA has published an English translation of Announcement 527, “Manufactured Nanomaterials,” BAuA notes that it is… Continue Reading

France Releases 2016 Report on Nanomaterial Reporting Scheme

Posted in International, Legal/Regulatory Issues
In November 2016, the Ministry of the Environment, Energy, and the Sea released its 2016 report, in French, Éléments issus des déclarations des substances à l’état nanoparticulaire.  The report analyzes nanomaterial declarations received in 2016 for reporting year 2015.  Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in… Continue Reading

Presentations Available from 2016 Nanosafe Conference

Posted in International, Research
The fifth Nanosafe conference was held November 7-10, 2016, in Grenoble, France.  The conference included panel discussions on responsible development with non-governmental organizations; urban particles mitigation:  what is reasonably possible; and nanomedicine:  benefit-risk.  Topics addressed during the conference included: Measurement and characterization of nano objects; Exposure; Manufactured nano objects: Release from nano-enabled products; Safer by… Continue Reading

2017 Conference Will Focus on New Tools and Approaches for Nanomaterial Safety Assessment

Posted in International
On February 7-9, 2017, a conference focused on new tools and approaches for nanomaterial safety assessment will be held in Malaga, Spain.  The conference is jointly organized by five major Seventh Research Framework Program (FP7) projects:  NANOSOLUTIONS, GUIDEnano, Sustainable Nanotechnologies (SUN), NanoMILE, and eNanoMapper.  It will present the main results achieved in the course of… 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

Germany Publishes Report on Nanoview Project

Posted in International
On November 15, 2016, the Federal Institute for Risk Assessment (BfR) published a report, in English, entitled Nanoview — Influencing factors on the perception of nanotechnology and target group-specific risk communication strategies.  In 2007, BfR conducted a survey concerning the public perception of nanotechnology.  Given the newness of nanotechnology and that large sections of the… Continue Reading