All Knowledge & Insights By Date

On 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 a number of non-governmental...

The 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 own or in one or more mixture(s), in quantities of ten kg or more per year, to...

The Danish Environmental Protection Agency (EPA) published on March 20, 2013, a proposal for technical information requirements for nanomaterials. The Danish EPA states that its proposal may be used in legislation concerning nanomaterials, such as the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The Danish EPA reviewed information requirement recommendations from expert groups, associations, and authorities. According to the Danish...

On March 20, 2013, five German agencies published a report entitled Nanotechnology — Health and Environmental Risks of Nanomaterials, which includes a joint set of recommendations for future safety assessments of nanomaterials. Under a joint research strategy set up in 2007, over 80 research projects on nanomaterials were reviewed. The report includes recommendations to: The report was prepared by the Federal Institute for Risk Assessment, Federal Environment Agency, Federal...

The United Kingdom’s (UK) Health and Safety Executive (HSE) has posted a guidance document describing how to control occupational exposure to manufactured nanomaterials in the workplace. HSE intends the guidance to assist in compliance with the Control of Substances Hazardous to Health Regulations 2002 (COSHH) (as amended). HSE states that the guidance is specifically about the manufacture and manipulation of all manufactured nanomaterials, carbon nanotubes (CNT), and other bio-persistent...

On March 18, 2013, Safe Work Australia (SWA) released two research reports examining nanotechnology work health and safety issues, Investigating the Emissions of Nanomaterials from Composites and Other Solid Articles During Machining Process and Evaluation of Potential Safety (Physicochemical) Hazards Associated with the Use of Engineered Nanomaterials. SWA noted the perceived safety risks of nanomaterials and that Australia is taking a precautionary approach towards nanomaterials under the...

The March 16, 2013, Canada Gazette includes a significant new activity (SNAc) notice for cobalt iron manganese oxide, carboxylic acid-modified, which the notice states is not included on the Domestic Substances List (DSL). The notice defines SNAc as: (a) [A]ny use where the substance is engineered to contain particles of particle size ranging from 1 to 100 nanometres in one or more dimensions, in a quantity greater than 100 kg per calendar year other than for a use...

On March 11, 2013, the European Union’s (EU) FP7 project on Mitigation of Risk and Control of Exposure in Nanotechnology-based Inks and Pigments (nanoMICEX) announced publication of its first newsletter. According to nanoMICEX, project participants have been working to improve the conditions for workers in the inks and pigments industry, and the newsletter describes the latest news and developments. The newsletter reports on the March 2012 kick-off meeting, where participants discussed...

On February 22, 2013, Empa announced the availability of a study prepared on behalf of Switzerland’s Federal Office for the Environment (FOEN) entitled Human and Ecotoxicity of Synthetic Nanomaterials: Initial Insights for Major Accident Prevention. The study is intended to address whether new criteria for the determination of the quantity thresholds in the Ordinance on Protection against Major Accidents (OMA) may result from the accident potential or possible new hypothetical accident...

On March 4, 2013, the European Agency for Safety and Health at Work (EU-OSHA) announced the results of a joint project by the European Federation of Building and Woodworkers (EFBWW), the European Furniture Manufacturers Federation (UEA), and the European Furniture Industries Federation (EFIC) on the use of nanomaterials in the European furniture sector. The Dutch institute “IVAM Research and consultancy on Sustainability” (IVAM UvA BV) investigated the current awareness among stakeholders...

The European Chemicals Agency (ECHA) announced on February 28, 2013, that the International Uniform Chemical Information Database (IUCLID) user manual for nanomaterials has been updated. According to ECHA, the updated manual allows registrants to select the form of the test material used in all study summaries reported in their dossiers, and “nanomaterial” is one of the available options. The manual provides instructions on how to structure information on different forms of the registered...

The Organization for Economic Cooperation and Development (OECD) published on February 14, 2013, the updated Current Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table. The purpose of the Tour de Table is to allow each delegation the opportunity to describe recent or planned national initiatives and/or events related to the safety of manufactured nanomaterials. According to OECD, this will facilitate the implementation of the projects of the WPMN by...

The European Commission (EC) announced on February 5, 2013, that it completed its five-year review of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The pre-publication version of the EC’s report states that the EC “will make an impact assessment of relevant regulatory options, in particular possible amendments of REACH Annexes, to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration...

The French Ministry of Ecology and Sustainable Development posted a January 8, 2013, memorandum (in French) concerning the annual 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. The report will be due by May 1 for...

On November 21, 2012, Health Canada began a public consultation on a Draft: Guidance Document — Sunscreen Monograph, which is intended to replace the existing 2006 Sunburn Protectants Monograph. The draft Monograph identifies the permitted ingredients, including nano zinc oxide and nano titanium dioxide; doses; directions and indications for use for these products, which will be required to appear on the product labels; and the recommended supporting test methods. The draft Monograph...

The December 20, 2013, issue of the Official Journal of the European Union includes a corrigendum to the amendment to Regulation 1169/2011 concerning the provision of food information to consumers as regards the definition of engineered nanomaterials. The European Commission (EC) published a notice in the December 19, 2013, Official Journal of the European Union amending the food labeling regulation concerning the definition of engineered nanomaterials. The December 20, 2013, notice...

The Danish Consumer Council and the Danish Ecological Council, in cooperation with the Technical University of Denmark (DTU) Environment, have developed a database intended to help consumers identify more than 1,200 products that may contain nanomaterials. The database is an inventory of products that contain nanomaterials or are marketed with the word “nano.” The website asks users to help “improve and expand” the database “by telling us about products that claim...

In a November 21, 2012, Canada Gazette notice, Canada amended the Domestic Substances List (DSL). The amendments include the addition of cellulose, hydrogen sulphate, sodium salt, obtained from sulphuric acid hydrolysis of the bleached pulp, with the substance having the following characteristics: Canada added the substance with substance identity number 91343, rather than a Chemical Abstracts Service (CAS) Registry Number. Substances on the DSL do not require notification...

Environmental Law Network International’s (ELNI) recent issue of elni Review includes an article entitled “Law and innovation in the context of nanomaterials: Barriers to sustainable development? Results of an empirical study,” which examines to what degree the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation promotes innovations for sustainability through nanomaterials. The authors surveyed 37 companies based in Germany that...

The European Food Safety Authority (EFSA) published in the October 10, 2012, Official Journal of the European Union a call for tender to prepare a background document on the current knowledge in the field of nanotechnology and prepare an inventory of food additives/food contact materials/feed additives applications of nanotechnologies currently used and/or reasonably foreseen to be used. According to the tender specifications, the tasks will include: The length of the...

On November 28, 2012, the Canada-U.S. Regulatory Cooperation Council (RCC) held a webinar to discuss its RCC Nanotechnology Work Plan. Canada and the U.S. created the RCC to align better their regulatory approaches in a number of areas, including nanotechnology. According to information presented during the webinar, while the U.S. has received 137 notifications concerning nanomaterial substances, Canada has received only 16. While most of the nanomaterial substances...

The Center for International Environmental Law (CIEL), ClientEarth, and Friends of the Earth Germany (BUND) released on November 13, 2012, a proposal for European Union (EU) legislation to address the risks of nanomaterials. CIEL states that the non-governmental organizations’ (NGO) proposal was prompted by the European Commission’s (EC) October 3, 2012, Communication on the Second Regulatory Review on Nanomaterials. The Communication describes the Registration,...

On October 19, 2012, the European Comission (EC) began a public consultation on a preliminary opinion entitled Addressing the New Challenges for Risk Assessment. The Inter-Committee Coordination Group of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Scientific Committee on Consumer Safety (SCCS), and Scientific Committee on Health and Environmental Risks (SCHER) established a joint working group to review risk assessment procedures and new challenges for...

On October 22, 2012, Safe Work Australia announced the availability of a report entitled Human Health Hazard Assessment and Classification of Carbon Nanotubes, as well as an information sheet on the report. The report recommends that multi-walled carbon nanotubes should be classified as hazardous unless toxicological or other data for specific types imply otherwise. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) prepared the report in support of Safe Work...

On October 30, 2012, the European Chemicals Agency (ECHA) will hold a webinar entitled “How to ensure the safe use of nanomaterials under REACH Part I: Characterisation of nanoforms of substances in registration dossiers.” According to ECHA, the webinar will provide information to registrants on the type of information to be included in a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier for a substance with nanoform(s). In addition, on...

The Canada-U.S. Regulatory Cooperation Council (RCC) will hold a webinar on November 28, 2012, on its RCC Nanotechnology Work Plan. Canada and the U.S. created the RCC to align better their regulatory approaches in a number of areas, including nanotechnology. According to the U.S. Environmental Protection Agency (EPA), the purpose of the RCC’s nanotechnology initiative is to increase, where possible, regulatory transparency and coordination between the U.S. and...

During the Third International Conference on Chemicals Management (ICCM3), which was held September 17-21, 2012, participants agreed to add the measures concerning nanotechnologies and manufactured nanomaterials to the Strategic Approach to International Chemicals Management (SAICM) Global Plan of Action. The measures include “exploring the development of registers/inventories and/or market assessment activities of manufactured nanomaterials,” and “promoting the availability of...

On October 3, 2012, the European Commission (EC) announced its adoption of a Communication on the Second Regulatory Review on Nanomaterials, which assesses the adequacy and implementation of European Union (EU) legislation for nanomaterials, indicates follow-up actions, and responds to issues raised by the European Parliament (EP), EU Council, and the European Economic and Social Committee. The Communication concludes that “nanomaterials are similar to normal chemicals/substances in...

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) has posted an opinion on zinc oxide, nano-form. SCCS approved the opinion for adoption and it is now open for comment by applicants, national authorities, and other interested parties. SCCS considered whether zinc oxide in its nano-form is safe for use as a UV-filter with a concentration up to 25 percent in cosmetic products. SCCS concluded, on the basis of available evidence, that the use of zinc oxide...

Under a draft amendment to the Danish Chemicals Act, the Minister of the Environment would have the authority to write a detailed order establishing the rules for a national database of mixtures and articles containing or releasing nanomaterials. The order would also require producers and importers to report products containing or releasing nanomaterials. The information in the database is intended to form the basis of an evaluation of whether the content of nanomaterials in products on the...

On September 11, 2012, the Organization for Economic Cooperation and Development (OECD) posted a brochure entitled “Six Years of OECD Work on the Safety of Manufactured Nanomaterials: Achievements and Future Opportunities.” The brochure notes that “[a]fter six years of work, the OECD and its member countries have come to the conclusion that the approaches for the testing and assessment of traditional chemicals are in general appropriate for assessing the safety of nanomaterials,...

The International Zinc Association (IZA) prepared a response to a recent article entitled “Soybean susceptibility to manufactured nanomaterials with evidence for food quality and soil fertility interruption” and posted on the Proceedings of the National Academy of Sciences (PNAS) website. IZA states that while the article and related reports highlight that nano-zinc oxide improves crop productivity and zinc concentration in plants, they suggest that the concentration...

On August 31, 2012, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) issued a call for experts on the safety assessment of nanomaterials in cosmetic products. Under Article 16 of the Cosmetic Regulation EC No 1223/2009, any cosmetic product containing nanomaterials must be notified to the EC six months prior to being placed on the market. In case of concern, the EC will request SCCS to provide an opinion. According to the EC website, to...

The International Organization for Standardization (ISO) Technical Committee (TC) 229 on nanotechnologies is preparing guidance on the format and content of voluntary labeling for manufactured nano-objects (MNO) and products, preparations, and mixtures containing MNOs. According to ISO, the guidance, ISO/TS 13830:2011, would also address the use of the term “nano” in product labeling. The European Committee for Standardization (CEN) was initially developing the guidance and,...

The French Ministry of Ecology and Sustainable Development published an order in the August 10, 2012, Journal Officiel de la République Française concerning the content and submission requirements for the annual declarations of information relating to nanoparticle substances, as substances or as part of a mixture. The order comes into force on January 1, 2013, and provides details on how companies should meet the mandatory declaration obligations....

On June 20, 2012, European Agency for Safety and Health at Work (EU-OSHA) posted a new literature review entitled Risk perception and risk communication with regard to nanomaterials in the workplace, which found “serious gaps in our awareness of the potential risks involved in handling nanomaterials at work, and serious shortcomings in the way that those risks are communicated to workplaces.” The review intends to: EU-OSHA states that risk communication strategies need to help...

On August 8, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a request it received from the EC for a scientific opinion on the safety of medical devices containing nanomaterials. According to the request, Notified Bodies have identified the following cases of alleged use of nanomaterials: The EC states that, in addition, there are reports of iron-oxide nanoparticles injected into tumor cells to be heated-up by...

The British Standards Institution (BSI) announced on July 9, 2012, the availability of three new standards and the development of a fourth standard intended to help mitigate the risks involved in manufacture and disposal of nanotechnology products. The three new Publicly Available Specifications (PAS) are: Additionally, BSI is developing a fourth PAS:...

The Netherlands National Institute for Public Health and the Environment (RIVM) published on June 29, 2012, a report entitled Interpretation and implications of the European Commission Recommendation on the definition of nanomaterial. The Dutch ministries requested RIVM to interpret the meaning and implications of the European Commission’s (EC) recommendation from a scientific perspective and to consider the implications for use in legislation. RIVM intends the report to provide the basis...

On July 4, 2012, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted its Guidance on the safety assessment of nanomaterials in cosmetics. The EC requested the SCCS develop guidance on the elements that would be required in a manufactured nanomaterial safety dossier. The SCCS states that the Guidance is intended to provide information to help compliance with the requirements for the safety assessment of nanomaterials intended for use in cosmetic products.  The...

The United Nations (UN) Food and Agriculture Organization (FAO) and World Health Organization (WHO) have released a draft paper entitled State of the art on the initiatives and activities relevant to risk assessment and risk management of nanotechnologies in the food and agriculture sectors for comment. FAO and WHO commissioned the paper with the objective of summarizing and analyzing the information that has become available since their 2009 expert meeting and determining possible courses...

The Health Council of the Netherlands announced on May 22, 2012, the availability of a draft report proposing the implementation of an exposure registry and a system of health monitoring when working with engineered nanoparticles. The draft report states that, due to the concerns and lack of knowledge, the Health Council “considers it prudent” to create an exposure registry. The Health Council recommends that the exposure registry be created for “insoluble and poorly in...

The European Chemicals Agency (ECHA) recently held a two-day workshop concerning its first experiences with nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, with an emphasis on the evaluation process. ECHA, Member State Competent Authorities (MSCA), accredited stakeholders, and the European Commission (EC) discussed how nanomaterials in general have been characterized in registration dossiers. Currently, according to ECHA, the...

On May 25, 2012, the European Chemicals Agency (ECHA) published three new appendices, updating Chapters R.8, R.10, and R.14 of the Guidance on Information Requirements and Chemical Safety Assessment.  ECHA updated the guidance based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 3, which concerned aspects such as occupational exposure estimation and dose-response characterization for human...

The International Organization for Standardization (ISO) has published a Technical Report (TR) providing guidance on the physicochemical characterization of manufactured nano-objects prior to toxicological assessment.  ISO states that TR 13014:2012, Nanotechnologies — Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment, “is intended to assist health scientists and experts to understand, plan, identify, and address relevant...

On March 27-28, 2012, the Organization for Economic Cooperation and Development (OECD), in collaboration with the National Nanotechnology Initiative (NNI), and hosted by the American Association for the Advancement of Science (AAAS) held an International Symposium on Assessing the Economic Impact of Nanotechnology. The objective of the symposium was to explore systematically the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies,...

On May 10, 2012, the Council of the European Union (EU) announced the adoption of a regulation concerning the placing on the market and use of biocidal products, which include insecticides, disinfectants, and repellents, but not medicines or agricultural pesticides. The regulation will take effect September 1, 2013, with a transitional period for certain provisions. The regulation incorporates the European Commission’s (EC) recommendation on the definition of a nanomaterial, and requires...

The U.S. delegation to the July 4-6, 2012, meeting of the United Nations (UN) Subcommittee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) is considering presenting an information paper on how to classify nanomaterials under the GHS. According to Kathy Landkrohn, Occupational Safety and Health Administration (OSHA) Directorate of Standards and Guidance, the paper would be presented under a work group examining the types of physical and chemical...

The Strategic Approach to International Chemicals Management (SAICM) Secretariat is expected to publish this month comments on Switzerland’s proposal that activities relating to nanotechnology be added to the SAICM Global Plan of Action.  The proposal would include a new work area on nanotechnologies and manufactured nanomaterials, with corresponding activities, actors, and targets. The Secretariat will compile the comments to inform discussion at the third International Conference on...

On April 30, 2012, the European Chemicals Agency (ECHA) announced the availability of three appendices, updating Chapters R.7a, R.7b, and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA). ECHA prepared a draft revision of the Guidance, based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 2 final report. ECHA updated the Guidance via a fast-track...