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: EU Member State

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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

Germany Publishes Action Plan Nanotechnology 2020

Posted in EU Member State, International, Legal/Regulatory Issues, Research
The Federal Ministry of Education and Research (BMBF) recently published an English version of its Action Plan Nanotechnology 2020.  Based on the success of the Action Plan Nanotechnology over the previous ten years, the federal government will continue the Action Plan Nanotechnology for the next five years.  Action Plan Nanotechnology 2020 is geared towards the… Continue Reading

ECHA Committee Adopts First Opinion Approving Nano Biocide

Posted in EU Member State, Legal/Regulatory Issues
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… Continue Reading

ECHA Board of Appeal Annuls Four Decisions Requesting Substance Identity Information on a Nano Structured Substance

Posted in EU Member State, International, Legal/Regulatory Issues
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,… Continue Reading

Germany Publishes Review of the Joint Research Strategy of the Higher Federal Authorities

Posted in EU Member State, International, Legal/Regulatory Issues, Research
Germany Publishes Review of the Joint Research Strategy of the Higher Federal Authorities   On September 19, 2016, the Federal Institute for Occupational Safety and Health (BAuA) published a report entitled Review of the joint research strategy of the higher federal authorities — Nanomaterials and other advanced materials:  Application safety and environmental compatibility.  The report… Continue Reading

Germany Publishes Report on Nanomaterials in the Environment

Posted in EU Member State, International, Legal/Regulatory Issues
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… Continue Reading

French Ministry Publishes Report on Nanomaterial Registrations Received in 2015

Posted in EU Member State, Legal/Regulatory Issues
The Ministry for the Environment, Energy, and the Sea has posted a report, available only in French, entitled Éléments issus des déclarations des substances à l’état nanoparticulaire:  Rapport d’etude 2015.  The report analyzes nanomaterial registrations received in 2015 for reporting year 2014.  Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with… Continue Reading

Danish EPA Assesses Nano-Enabled Technologies in Cosmetics

Posted in EU Member State, Legal/Regulatory Issues, Research
On February 16, 2016, the Danish Environmental Protection Agency (Danish EPA) posted a report entitled Assessment of Nano-enabled Technologies in Cosmetics.  The report reviews the available literature on nano-enabled technologies for cosmetic products, specifically addressing soluble nano-transporters.  Accompanying the report is an appraised database summarizing the literature that formed the basis of the review.  The… Continue Reading

The Netherlands Describes Tool for Risk Assessment of Nanomaterials in Cosmetics

Posted in EU Member State, International, Legal/Regulatory Issues
On January 25, 2016, the Netherlands National Institute for Public Health and the Environment (RIVM) published a report that describes the content of a computer program that can be used for a risk assessment.  According to RIVM, the NanoCosmetics tool will need to cover all aspects of the risk assessment, including:  the physicochemical characterization of… Continue Reading

The Netherlands Publishes Report on Nanotechnologies in Medical Devices

Posted in EU Member State, International, Legal/Regulatory Issues
The Netherlands National Institute for Public Health and the Environment (RIVM) posted on December 17, 2015, a report entitled Nanotechnologies in medical devices.  RIVM conducted an investigation to provide insights into and an overview of the field of medical devices using nanotechnologies for products already on the market and for those expected within five years. … Continue Reading

Danish EPA Posts Several Publications Regarding Nanomaterials

Posted in EU Member State, International
This month the Danish Environmental Protection Agency (Danish EPA) published the following publications, in English, concerning nanomaterials: Better control of nanomaterials — summary of the 4-year Danish initiative on nanomaterials: The “Better control of nanomaterials” initiative intended to create an overview of the possible risks of using nanomaterials, focusing on consumers and the environment. The… Continue Reading

European Parliament Approves Novel Foods Proposal

Posted in EU Member State, International, Legal/Regulatory Issues
On October 28, 2015, the European Parliament (EP) approved proposed rules that would subject novel foods to a safety evaluation and authorization at the European Union (EU) level.  According to the EP’s October 28, 2015, press release, novel foods include food consisting of “engineered nanomaterials,” and would be defined as “any intentionally produced material that… Continue Reading

NNI Publishes Outcomes of the 2015 EU-U.S.: Bridging NanoEHS Research Efforts Joint Workshop

Posted in EU Member State
The National Nanotechnology Initiative (NNI) published on March 23, 2015, the outcomes of the March 12-13, 2015, joint workshop held by the U.S. and the European Union (EU), “Bridging NanoEHS Research Efforts.”  The workshop was intended to promote and deepen the collaboration on nanotechnology environmental, health, and safety (nanoEHS) research.  Workshop participants reviewed progress toward… Continue Reading

French Agency Publishes Opinion on Silver Nanoparticles

Posted in EU Member State, International, Legal/Regulatory Issues
The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) published on March 10, 2015, an Opinion concerning exposure to silver nanoparticles that “stresses the research that has been carried out to examine the potential health and environmental effects of silver nanoparticles but notes that this is still insufficient to allow the health… Continue Reading

France Posts Report on Nanomaterials Reported as of June 2014

Posted in EU Member State, International, Legal/Regulatory Issues
The Ministry of Ecology, Sustainable Development, and Energy published a report, available only in French, concerning the second round of mandatory reporting of nanomaterials.  Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year must submit an annual report with… Continue Reading

Belgium Publishes Decree on the Nanomaterial Register

Posted in EU Member State, International, Legal/Regulatory Issues
The Belgian Royal Decree Regarding the Placement on the Market of Substances Manufactured at the Nanoscale, a Report to the King, and the Opinion of the Council of State were published in the September 24, 2014, issue of the Official Gazette. Substances defined as nanomaterials, and mixtures containing them, must be registered by the Belgian Federal… Continue Reading

OECD Issues Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011

Posted in EU Member State, International, Legal/Regulatory Issues, OECD, United States
On September 16, 2014, the Organization for Economic Cooperation and Development (OECD) published a document entitled Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011. The Report summarizes responses to the Working Party on Manufactured Nanomaterials (WPMN) Questionnaire on Regulated Nanomaterials: 2010-2011, which was issued July 12, 2012. The Questionnaire contained four sections related to the… Continue Reading

Guideline Published for the Danish Inventory of Nanoproducts

Posted in EU Member State, International, Legal/Regulatory Issues
In August 2014, the Danish Environmental Protection Agency published the Guideline for the Danish Inventory of Nanoproducts, which is intended to explain how manufacturers and importers of products for consumers should use the new Inventory. The Guideline describes who has a duty to report; which products must be reported; and how to collect information and perform… Continue Reading

Denmark Order on Nano Products Register Enters Into Force

Posted in EU Member State, International, Legal/Regulatory Issues
On June 18, 2014, Denmark’s order concerning a nano products register entered into force. The order imposes annual reporting requirements on manufacturers and importers concerning mixtures and products containing nanomaterials. The reporting requirements apply to mixtures and articles that are intended for sale to the general public and contain nanomaterials, where the nanomaterial itself is released under… Continue Reading

ANSES Calls for a Stronger Regulatory Framework for Nanomaterials

Posted in EU Member State, International, Legal/Regulatory Issues
The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) published on May 15, 2014, a review of the available literature on health and environmental issues relating to manufactured nanomaterials.  According to ANSES, the review “will help clarify scientific understanding and demonstrate the toxic effects of some nanomaterials on living organisms and the… Continue Reading

Germany Releases Study Assessing Impacts of European Register of Products Containing Nanomaterials

Posted in EU Member State, International, Legal/Regulatory Issues
Earlier this month, the German Federal Environment Agency (UBA) issued a report entitled Assessment of Impacts of a European Register of Products Containing Nanomaterials, which was intended to analyze the impacts of a European register of products containing nanomaterials (ENPR).  The study identified the sectors and companies that would be affected by an ENPR, and… Continue Reading

Belgium Creates Register of Nanomaterials

Posted in EU Member State, International, Legal/Regulatory Issues
On February 7, 2014, Belgium announced that the Council of Ministers agreed on the royal decree concerning the marketing of substances containing nanomaterials. The royal decree creates a national register of nanomaterials, requiring manufacturers to register nanomaterial substances and mixtures containing such substances. According to Belgium the register will ensure the traceability of these nanoparticles.  The register… Continue Reading

German Federal Environment Agency Supports Creation of EU Register of Products Containing Nanomaterials

Posted in EU Member State, International, Legal/Regulatory Issues
The German Federal Environment Agency (UBA) has posted an English translation of a 2012 document entitled Concept for a European Register of Products Containing Nanomaterials. The document states that, due to the particular uncertainties concerning evaluation of the possible risks of nanomaterials for human health and the environment, UBA supports the establishment of a European register… Continue Reading

German FAQs Regarding the Safety of Cosmetics Address Nanomaterials

Posted in EU Member State, International, Legal/Regulatory Issues
On January 27, 2014, the Federal Institute for Risk Assessment (BfR) posted frequently asked questions (FAQ) regarding the risk assessment of cosmetic products. BfR states that there are repeated critical public reports and discussions about several ingredients of cosmetic products, leading consumers to ask whether cosmetics pose a health risk. Several of the FAQs address nanomaterials: Why… Continue Reading