All Knowledge & Insights By Date

On September 2, 2014, the U.S. Environmental Protection Agency (EPA) promulgated final significant new use rules (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 36 chemical substances that were the subject of premanufacture notices (PMN). The substances include multi-walled carbon nanotube (generic) (P-08-0392), multi-wall carbon nanotubes (generic) (P-09-257), multi-walled carbon nanofibers (generic) (PMNs P-10-115, P-10-116, P-10-117, P-10-118, P-10-119,...

The Australian Pesticides and Veterinary Medicines Authority (APVMA) will host a nanotechnology regulation symposium on October 28, 2014. APVMA states that it “has worked over many years to progressively develop a regulatory framework for nanoscale agvet chemicals and chemical products.” APVMA intends the symposium to provide industry and regulators with an opportunity for dialogue on the future regulation of nanopesticides and veterinary nanomedicines. Key topics covered will include...

Fifteen European industry associations, including the Nanotechnology Industries Association (NIA) and the European Chemical Industry Council (CEFIC), have endorsed a brochure entitled “Europe needs safe and innovative nanotechnologies and nanomaterials.” According to the brochure, the associations “support the European Commission conclusion that the current European regulatory framework adequately covers nanomaterials, is science-based and proportionate.” The brochure...

On July 24, 2014, the Organization for Economic Cooperation and Development (OECD) posted a report entitled Nanotechnology and Tyres: Greening Industry and Transport, which provides a risk management framework to enable site-specific or company-specific risk assessments or risk management strategies for using nanomaterials as additives in tires. OECD states that the report emphasizes the importance of: The policies to support research in the environmental, health, and safety...

On July 31, 2014, the National Nanotechnology Coordination Office (NNCO) will hold a public webinar to provide a forum to answer questions related to the federal government’s “Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy.” According to the July 22, 2014, Federal Register notice, discussion will focus on the research activities undertaken by the National Nanotechnology Initiative...

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 provide information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of...

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 inhalation toxicity tools to assess potential chemical or...

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 options.  The EC discussed the preliminary results with stakeholders at the validation workshop and invited their...

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 manufactured nanomaterials. The article also states that the Canada-U.S....

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 reported chemical names include the term “carbon nanotube” (CNT) or “CNT.” EPA states that, because of a lack of...

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 founding, the focus of the SNWG has been to encourage the U.S. Environmental Protection Agency (EPA) and other...

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 Report (second draft): This report is one of several outcomes of a study on regulatory oversight...

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 Nanoscale Science, Engineering, and Technology Subcommittee’s Nanotechnology Environmental and...

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 and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals,...

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 normal or reasonably foreseeable use of the mixture or article, or where the...

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 products, could result in additional risks compared to more traditional uses of silver and whether the...

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 inclusion of prevention considerations into all designs that might impact workers. According to the report,...

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 environment.” ANSES states that it is difficult to assess the specific risks associated with...

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 the substance name, for food, cosmetics, and biocides.  According to the JRC, manufacturers sometimes add voluntary...

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, multi-walled carbon nanotubes are a high priority for assessment — “cancer bioassay...

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 meet the definition of a nanomaterial, as provided in Article 3(1)(z) of the Biocidal Products Regulation...

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 substances in nanoform. According to ECHA, the workshop will also provide a platform for academia...

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 from the bulk form of the substance.” The position paper asks the European Commission (EC) to...

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 press release, the company’s Kinetic Go Green Premium Food Storage Containers and Kinetic Smartwist Series Containers contain...

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 discussing the approach and challenges faced by participant...

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 National Nanotechnology Initiative (NNI) “to ensure the United States remains a leader in...

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 objectives, and a description of the preliminary policy options that are under consideration.  The EC will update...

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 estimated the number of notifiers and notifications, categories of substances, concerned mixtures, and articles....

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 Carl Schlyter, who is credited for the EP’s “scrutiny” of the proposed...

On March 7, 2014, the Organization for Economic Cooperation and Development (OECD) posted a report entitled Ecotoxicology and Environmental Fate of Manufactured Nanomaterials: Test Guidelines, which provides a report of the discussion and recommendations from the January 2013 expert meeting on ecotoxicology and environmental fate. As part of OECD’s Program on the Safety of Manufactured Nanomaterials, it initiated a series of expert meetings intended to improve the applicability...

On February 28, 2014, the National Nanotechnology Coordination Office (NNCO) announced the release of the 2014 National Nanotechnology Initiative (NNI) Strategic Plan.  The NNI Strategic Plan represents the consensus of the participating agencies as to the high-level goals and priorities of the NNI and specific objectives for at least the next three years.  It is intended to provide an integrated, interagency approach informing the nanotechnology-specific strategic plans of NNI...

On February 12, 2014, the European Parliament (EP) Committee on the Environment, Public Health and Food Safety rejected a proposed regulation that would define “engineered nanomaterials” in food. According to the Committee, the definition could lead to existing nanomaterials not being labeled due to an exemption provided for food additives approved on a European Union (EU) list. The Committee’s resolution notes that, under Article 18(3) of Regulation (EU) No...

The European Commission (EC) Scientific Committee on Consumer Safety (SCCS) has opened a call for information for a scientific opinion on the safety of silica (nano). The SCCS invites interested parties to submit any relevant information, such as identification of the type of cosmetic product using silica in nano-structured form and their concentration; protocols of applications; differences in solubility, including for surface coated materials; information on adverse health effects; results...

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 will open January 1, 2016, for nanomaterial substances, and January...

On February 12, 2014, the U.S. Environmental Protection Agency (EPA) issued, through a direct final rule, significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 35 chemical substances that were the subject of premanufacture notices (PMN). The 35 substances include four identified as multi-walled carbon nanotubes (generic) that were the subject of a December 3, 2012, TSCA Section 5(e) consent order. The consent order requires the use of personal protective equipment...

On February 7, 2014, the U.S. Government Accountability Office (GAO) released a report entitled Nanomanufacturing: Emergence and Implications for U.S. Competitiveness, the Environment, and Human Health, which provides highlights from a Congressionally-requested forum on specific issues in nanotechnology manufacturing that was held July 23-24, 2013. The House Committee on Science, Space, and Technology asked the GAO and the National Academies to convene the forum and elicit the...

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 of products containing nanomaterials as a precautionary measure. The objective of the product register...

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 are nanoparticles used in cosmetic products? Nanoparticles made of titanium dioxide...

On December 18, 2013, the European Commission (EC) adopted three draft proposals on animal cloning and novel food. The draft proposal concerning novel food would revise the current regulation “with a view to improving access of new and innovative food to the EU market, while still maintaining a high level of consumer protection.” An EC question and answer (Q&A) concerning the draft proposals includes the following Q&A concerning nanomaterials: What are...

On December 7, 2013, the Journal of Nanoparticle Research published online an article entitled “Occupational safety and health criteria for responsible development of nanotechnology.” The authors, who are affiliated with the National Institute for Occupational Safety and Health (NIOSH), describe five criterion actions that they believe should be practiced by decision-makers to ensure the responsible development of nanotechnology: “(1) anticipate, identify, and track potentially...

The European Commission (EC) Scientific Committee on Consumer Safety (SCCS) “Memorandum on Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials” is available for comment. The SCCS states that the current memorandum is intended to highlight the main considerations in relation to the relevance, adequacy, and quality of the data presented in safety dossiers on nanomaterials.  The SCCS also intends the memorandum “to provide further guidance and clarity to future...

IARC has posted additional information concerning IARC Monographs Volume 111, “Some Nanomaterials and Some Fibres.”  As reported previously, the Working Group will meet September 30 to October 7, 2014. The call for experts closes January 30, 2014. Requests for observer status are due June 3, 2014. The call for data closes September 3, 2014. In the call for data, IARC states that it seeks “studies that are relevant to the...

On December 2-3, 2013, the U.S.-EU Communities of Research held a workshop intended to further develop and support their activities. The goal of the workshop was to publicize progress towards their goals and objectives, clarify and communicate future plans, share best practices, and identify areas of cross-Community collaboration. Participants included American and European scientists and policy makers from academia, research institutes, industry, and governments. The presentations...

On December 20, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a document entitled Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan, 2013-2016. NIOSH describes the document as “the roadmap being used to advance basic understanding of the toxicology and workplace exposures involved so that appropriate risk management practices can be implemented during discovery, development, and...

The December 19, 2013, Office Journal of the European Union includes an amendment to Regulation 1169/2011 concerning the provision of food information to consumers as regards the definition of engineered nanomaterials. Under the regulation, all ingredients present in the form of engineered nanomaterials must be indicated in the list of ingredients. The names of such ingredients must be followed by the word “nano” in brackets. The amendment defines engineered nanomaterials as “any...

On December 13, 2013, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) released its preliminary opinion on “Nanosilver: safety, health and environmental effects and role in antimicrobial resistance.” The opinion is intended to assess whether the use of nanosilver, in particular in medical care and in consumer products, could result in additional risks compared to more traditional uses of silver, and whether the use of...

The International Organization for Standardization (ISO) has published Technical Specification (TS) 13830:2013, “Nanotechnologies — Guidance on voluntary labelling for consumer products containing manufactured nano-objects.” The purpose of the guidance “is to provide a framework to facilitate a harmonized approach for the voluntary provision of labelling for [consumer products containing manufactured nano-objects (PCMNO)] that may or may not exhibit or impart nanoscale phenomena.”...

On 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 year must submit an annual report with substance identity, quantity, and use information. According to the...

On November 28, 2013, the International Agency for Research on Cancer (IARC) announced that the Working Group for IARC Monographs Volume 111, “Some Nanomaterials and Some Fibres,” will meet September 30 to October 7, 2014. IARC states that “[d]etails will follow shortly.” This will include information concerning the call for data, call for experts, and request for observer status. During the meeting, the Working Group will review the latest available...

On December 10, 2013, the Air & Waste Management Association (A&WMA) will hold a webinar entitled “Nanoscale EHS: Environmental Health and Safety Essentials Every Practitioner Is Obligated to Know.”  The webinar description notes that possible environmental, health, and safety (EHS) implications associated with nanoscale activities are resulting in a rapidly evolving regulatory climate.  The webinar will examine nanotechnology and its applications, possible EHS implications,...