By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,InternationalThis 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesOn 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
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member StateThe 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
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesThe 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
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesThe 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
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesThe 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
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory Issues,OECD,United StatesOn 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
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesIn 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
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesOn 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
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesThe 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
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesEarlier 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
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesOn 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
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesThe 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
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesOn 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
By Lynn L. Bergeson on Posted in EU Member State,International,ResearchThe Federal Institute for Risk Assessment (BfR) announced on November 27, 2013, that it completed NanoView, a research project on the perception of nanotechnology by the German population and media. Under the project, BfR examined whether the population’s perceptions and attitudes towards nanotechnology have changed over the last five years, as well as whether the presentation… Continue Reading
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesOn November 29, 2013, the Ministry of Ecology, Sustainable Development and Energy published an initial assessment, available only in French, of the mandatory reporting of nanomaterials, which took effect January 1, 2013. 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… Continue Reading
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory Issues,Occupational Health and Safety IssuesThe Finnish Institute of Occupational Health released a report in October 2013 entitled Evaluation of the health effects of carbon nanotubes. According to the Institute, recent studies have suggested that some types of multiwalled carbon nanotubes (MWCNT) have similar effects as asbestos. The Institute states that the report “shows that rigid, long and needle-like MWCNTs induce… Continue Reading
By Lynn L. Bergeson on Posted in EU Member State,InternationalAccording to the United Kingdom (UK) Environment Agency Chemical Compliance Team’s annual report, during 2012-2013, the Chemical Compliance Team researched the production and use of nanomaterials by UK industry. On behalf of the Department for Environment, Food and Rural Affairs (Defra), the Chemical Compliance Team surveyed 268 organizations to create a list of who is producing/using… Continue Reading
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesOn July 4, 2013, the Belgian Federal Public Service for Health, Food Chain Safety, and Environment notified the European Commission (EC) of a draft decree that would create a register of substances manufactured at the nanoscale based on declarations of products containing such substances by the parties placing these products on the market. Under the draft… Continue Reading
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesOn July 4, 2013, the Danish Environmental Protection Agency began a public consultation on a draft order for a nanomaterials register. The draft order would impose annual reporting requirements on manufacturers and importers concerning mixtures and products containing nanomaterials. The reporting requirements would apply to nanomaterials released during use of the product or if the nanomaterial is… Continue Reading
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesThe Federal Public Service Health, Food Chain Safety, and Environment (FPS), which commissioned a study on the scope of a Belgian national register for nanomaterials and products containing nanomaterials, posted the final report on June 10, 2013. According to the final report, the data collected from individual companies, in addition to market research, has shown that… Continue Reading
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesThe Ministry of Ecology, Sustainable Development and Energy recently announced that it has extended the deadline for declaring substances with nanoparticle status to June 30, 2013. According to the Ministry, it received 1,991 declarations from 457 companies by the original deadline of April 30, 2013. The Ministry states that, given the “diversity of actors covered by the… Continue Reading
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesOn April 11-12, 2013, the Netherlands Ministry of Infrastructure and the Environment hosted an invitation-only conference entitled “Building Blocks for Completing EU Regulation of Nanomaterials.” The conference was intended to identify areas where current European Union (EU) legislation on nanomaterials is insufficient. Participants include representatives from Member States, the European Commission (EC), European Parliament (EP), industry, and… Continue Reading
By Lynn L. Bergeson on Posted in EU Member State,International,Legal/Regulatory IssuesThe Swedish Chemicals Agency (KemI) published an April draft proposal to amend the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to ensure the safe handling of nanomaterials. The draft proposal would adopt the October 2011 European Commission recommendation on the definition of nanomaterial. It would require manufacturers and importers of a nanomaterial, either on its… Continue Reading
