Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Tag Archives: Legal/Regulatory Issues

EC and SCENIHR Begin Public Consultation on Preliminary Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices

Posted in International, Legal/Regulatory Issues
The European Commission (EC) and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) have begun a public consultation on the preliminary opinion concerning “Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices.” The aim of the opinion is to address the use of nanomaterials in medical devices and to… Continue Reading

EC Posts Meeting Materials from Validation Workshop on Transparency Measures for Nanomaterials

Posted in International, Legal/Regulatory Issues
The European Commission (EC) has posted materials from its June 30, 2014, validation workshop to discuss the preliminary results of the study supporting the impact assessment on transparency measures for nanomaterials. The EC is conducting a study to evaluate existing notification systems for nanomaterials and to collect data in support of the assessment of different policy… Continue Reading

Canada Endorses OECD Recommendation on Nanomaterials

Posted in International, Legal/Regulatory Issues, OECD
The Summer 2014 issue of Canada’s Chemicals Management Plan Progress Report includes an item concerning nanomaterials. According to the article entitled “Canada Working on Nanomaterials at Home and Abroad,” Canada has endorsed a recommendation from the Organization for Economic Cooperation and Development (OECD) that its Member Countries apply existing regulatory frameworks to manage risks associated with… Continue Reading

EPA Promulgates SNURs for Two CNT Substances

Posted in Federal, Legal/Regulatory Issues, United States
On July 8, 2014, the U.S. Environmental Protection Agency (EPA) promulgated significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that were the subject of premanufacture notices (PMN). The rule includes two PMN substances, P-10-5 and P-11-339, that were the subject of TSCA Section 5(e) consent orders and whose… Continue Reading

Silver Nanotechnology Working Group Welcomes New Members

Posted in Legal/Regulatory Issues
The Silver Nanotechnology Working Group (SNWG) was founded in 2009 as an industry-wide effort to advance the science and public understanding of the beneficial uses of silver nanoparticles in a wide-range of consumer and industrial products. It does this by fostering the collection of environmental, occupational and health, and consumer product data on silver nanotechnology. Since its… Continue Reading

EC Posts Draft Reports for Impact Assessment on Transparency Measures for Nanomaterials

Posted in International, Legal/Regulatory Issues
On June 30, 2014, the European Commission (EC) held a validation workshop to discuss the preliminary results of the study supporting the impact assessment on transparency measures for nanomaterials. As part of the workshop, the EC released the following reports: Study to Assess the Impact of Possible Legislation to Increase Transparency on Nanomaterials on the Market: Evaluation… Continue Reading

NNI Publishes Progress Review of 2011 EHS Research Strategy

Posted in Federal, Legal/Regulatory Issues, Research, United States
On June 25, 2014, the National Nanotechnology Initiative (NNI) posted Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy, which provides an overview of progress on the implementation and coordination of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy that was developed by the… Continue Reading

FDA Issues Final and Draft Nanotechnology Guidances

Posted in Federal, Legal/Regulatory Issues, United States
On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide “greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.” One final guidance addresses FDA’s overall approach for all products that it regulates, while the two additional final guidances… Continue Reading

NICEATM Seeks Alternative Methods for Acute Inhalation Toxicity

Posted in Federal, Legal/Regulatory Issues, Research, United States
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) published a Federal Register notice on June 19, 2014, requesting available data and information on devices and/or technologies currently used for identifying potential inhalation hazards. According to NICEATM, it will use submitted information “to determine the technical requirements for developing effective… 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

EC Committee Publishes Final Opinion on Nanosilver

Posted in International, Legal/Regulatory Issues
On June 13, 2014, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published its final opinion on “Nanosilver:  safety, health and environmental effects and role in antimicrobial resistance.” SCENIHR states that the opinion is intended “to assess whether the use of nanosilver, in particular in medical care and in consumer… Continue Reading

NIOSH Releases The State of the National Initiative on Prevention through Design

Posted in Federal, Legal/Regulatory Issues, United States
Last month, the National Institute for Occupational Safety and Health (NIOSH) released a report entitled The State of the National Initiative on Prevention through Design, which provides an overview of the progress and accomplishments of the Prevention through Design (PtD) initiative. The ultimate goal is to prevent or reduce occupational injuries, illnesses, or fatalities through the… 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

EC JRC Report Discusses Labeling and Reporting Schemes for Nanomaterials

Posted in International, Legal/Regulatory Issues
On May 19, 2014, the European Commission (EC) Joint Research Center (JRC) announced the availability of a report discussing labeling and reporting schemes for nanomaterials in consumer products in the European Union (EU). The JRC notes that current EU legislation requires nanomaterials to be reported in the list of ingredients, with “nano” added in brackets after… Continue Reading

EC Begins Public Consultation on Transparency Measures for Nanomaterials on the Market

Posted in International, Legal/Regulatory Issues
As part of the Communication on the Second Regulatory Review on Nanomaterials, the European Commission (EC) announced the launch of an impact assessment intended to identify and develop the most adequate means to increase transparency and ensure regulatory oversight on nanomaterials.  The EC has provided a working document, which contains a draft problem definition, policy… Continue Reading

IARC Advisory Group Recommends Multi-Walled Carbon Nanotubes as High Priority

Posted in International, Legal/Regulatory Issues
An International Agency for Research on Cancer (IARC) Advisory Group met on April 7-9, 2014, to recommend priorities for IARC Monographs during 2015-2019. The Advisory Group assessed the responses to a call for nominations and recommended a range of agents and exposures as high or medium priorities for assessment. According to the recommendations published in Lancet Oncology,… Continue Reading

ECHA Biocidal Products Committee Issues Opinion on HeiQ AGS-20

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) Biocidal Products Committee (BPC) adopted an opinion on April 10, 2014, concerning HeiQ AGS-20 (AGS-20). The European Commission (EC) requested an opinion on the following questions: With regard to the biocidal product AGS-20, should silver or silver adsorbed on silicon dioxide be considered as the active substance? Would this active substance… Continue Reading

ECHA Planning Workshop on Regulatory Challenges in the Risk Assessment of Nanomaterials

Posted in International, Legal/Regulatory Issues
The European Chemicals Agency (ECHA) will hold a topical scientific workshop on October 23-24, 2014, on regulatory challenges in the risk assessment of nanomaterials.  The workshop will bring together experts in the field of risk assessment of nanomaterials to discuss and update scientific principles and guidelines for assessing human health and environmental risks of chemicals… Continue Reading

European NGOs Publish Position Paper on the Regulation of Nanomaterials

Posted in International, Legal/Regulatory Issues
Earlier this month, the Center for International Environmental Law (CIEL) and its European partners published a position paper on the regulation of nanomaterials at a meeting of the European Union (EU) competent authorities. According to the position paper, current EU legislation “does not guarantee that all nanomaterials on the market are safe by being assessed separately… Continue Reading

EPA Stops Sale of Unregistered Food Containers Containing Nanosilver

Posted in Federal, Legal/Regulatory Issues, United States
On March 31, 2014, the U.S. Environmental Protection Agency (EPA) announced that it issued an order to Pathway Investment Corp. of Englewood, New Jersey to stop the sale of plastic food storage containers that have not been tested or registered with EPA, in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to EPA’s… Continue Reading

ECHA Report Includes Recommendations for Exposure Assessment and Risk Characterization of Nanomaterials under REACH

Posted in International, Legal/Regulatory Issues
On March 26, 2014, SAFENANO announced that the European Chemicals Agency (ECHA) published a report entitled Human health and environmental exposure assessment and risk characterisation of nanomaterials: Best practice for REACH registrants. The report summarizes the outcomes of the third (and last) meeting of the Group Assessing Already Registered Nanomaterials (GAARN). The September 30, 2013, meeting focused on… Continue Reading

America Competes Reauthorization Act Would Reauthorize NNI

Posted in Federal, Legal/Regulatory Issues, Research, United States
On March 6, 2014, Representative Eddie Bernice Johnson (D-TX), Ranking Member of the Committee on Science, Space, and Technology, introduced the America Competes Reauthorization Act of 2014 (H.R. 4159). The bill would establish, revise, and extend specified science, technology, engineering, and mathematics programs, as well as education, research, and training programs.  The bill would reauthorize 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

European Parliament Objects to European Commission’s Definition of Engineered Nanomaterials in Food

Posted in International, Legal/Regulatory Issues
The European Parliament (EP) passed a resolution on March 12, 2014, that objects to the European Commission’s (EC) proposed regulation that would define “engineered nanomaterials” in food. According to the EP’s press release, the EC’s proposed regulation “would grant a blanket exemption from food-labelling requirements for nano-additives already on the market.” The press release quotes EP Member… Continue Reading