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 Public Service for Health, Food Chain Safety and the Environment if at least 100 grams of the substance or mixture is placed on the market during the year covered by the registration, and if the entity putting the substance on the market produced this substance or mixture, or puts it on the market for professional users only. Biocidal products, medicines, food and feed, food contact materials, and pigments are excluded from the scope of the Royal Decree. Nanomaterials subject to declaration requirements must be registered by January 1, 2016, if they are already on the market by this date. After January 1, 2016, all nanomaterials concerned must be registered before being placed on the market. Mixtures subject to declaration requirements must be registered by January 1, 2017, if they are already on the market by this date. After January 1, 2017, all mixtures concerned must be registered before being placed on the market.
EC Scientific Committee Clarifies Meaning of "Sprayable Applications/Products" for Certain Nanomaterials
On September 30, 2014, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted a clarification on the meaning of the term “sprayable applications/products” for certain nanomaterials. According to the clarification, the EC Member States asked SCCS to clarify the meaning of the term “sprayable applications/products” in the conclusions of its safety assessments for carbon black CI 77266, titanium oxide, and zinc oxide. The clarification states:
Generally speaking, the term spray is broad and includes:
a) aerosols dispenser, for which there is the definition contained in Directive 75/324: “non-reusable containers made of metal, glass or plastic and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state”;
b) spray bottles containing a pump that draws a liquid up from the bottom and forces it through a nozzle generating a stream or a mist.
According to the clarification, many cosmetic products are dispensed through a mechanical pump that, instead of aerosol/nebulization, produces a single dose of cream. The SCCS acknowledges a need to clarify whether “sprayable applications/products” would also include these pump dispensers for creams. In addition, the SCCS states that, for clarity of the next scientific opinions, it could adopt a harmonized terminology with the term “spray” meaning the production of aerosols and/or nebulization, and “pump dispensers” meaning the dispensing devices for single-dose cream.
The European Commission’s (EC) Joint Research Center (JRC) has published a report entitled Towards a review of the EC Recommendation for a definition of the term “nanomaterial” -- Part 2: Assessment of collected information concerning the experience with the definition. In the report, JRC assesses information collected between August 2013 and April 2014 from scientists, research institutes, regulatory bodies, non-governmental organizations, and industry regarding implementation of the EC recommendation on the definition of nanomaterial. The report builds on the first report of the series, entitled Towards a review of the EC Recommendation for a definition of the term “nanomaterial” -- Part 1: Compilation of information concerning the experience with the definition. The report states: “Based on the feedback received regarding the current definition, compiled in the first report of the series, and its assessment, presented in this second report, the JRC is now working on a set of indications on how the definition could be modified to improve its clarity, effectiveness and implementability. These recommendations will be included in a final report (Part 3 of the series), which is expected to be released later in 2014.”
OECD Issues Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011
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 oversight of nanomaterials in various OECD jurisdictions: regulatory updates; definitions and/or legal approaches for nanomaterials by jurisdiction; regulatory challenges; and opportunities for collaboration. Australia, Canada, Denmark, the European Union, France, Germany, Italy, Netherlands, and the U.S. submitted fourteen responses for legislation covering chemical substances and/or products, including industrial chemicals, therapeutics, foods and drugs, and biocides, as well as occupational health and safety, consumer products, packaging, and labeling. Respondents agreed on using existing regulatory frameworks to regulate nanomaterials, although some jurisdictions, such as France, have developed reporting regimes specific to nanomaterials to gather information on uses and quantities. According to the responses, developing regulatory definitions “still seems to be a fairly challenging issue for regulatory bodies; however, regulatory definitions have been developed and now are being used by some jurisdictions.” The definitions tend to consider a 1-100 nanometer (nm) size range, unique properties when outside of 1-100 nm, both internal and external structure, and have addressed ways to differentiate between materials that are engineered nanomaterials and traditional chemicals that have nanoscale components by using percentage cut-offs.
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 the actual reporting to the Inventory. The Guideline uses questions to determine whether a product must be reported, including the following:
2. Is your product covered by other regulations?
If you are a manufacturer or importer of only one or more of the following products (mixtures or articles), you are not obliged to report these (see section 3), and you do not have to do anything further:
2.1. Foodstuffs and food contact materials
2.2. Animal feed
2.3. Medicinal products
2.4. Medical devices
For manufacturers and importers that are not exempt, the Guideline includes a flow chart to help determine whether their products are nanoproducts that need to be reported to the Inventory. Manufacturers and importers of products for consumers that must be reported must report by August 30, 2015, for the period beginning June 20, 2014, and ending June 20, 2015.
EC Publishes Responses to Public Consultation on Transparency Measures for Nanomaterials on the Market
The European Commission (EC) has posted responses received to its public consultation on transparency measures for nanomaterials on the market. The EC states that it received 202 responses -- 100 respondents submitted the questionnaire for industry stakeholders, and 102 respondents submitted the questionnaire for other stakeholders. Fourteen respondents requested that their contributions would not be published. All other contributions are available on the EC’s website. The EC notes that some contributions are published in anonymous form upon request. The EC will publish a full summary and analysis of the public consultations “in due course.”
The National Institute for Occupational Safety and Health (NIOSH) announced in its September 5, 2014, eNews that an international committee unanimously selected Dr. Vladimir Murashov, special assistant for nanotechnology to the NIOSH Director, “to lead an international working group on the health, safety, and environmental aspects of nanotechnologies.” NIOSH states that the working group is part of a larger initiative by the International Organization for Standardization (ISO) to develop standardization in the nanotechnologies field. According to NIOSH, “[a]s convener, Dr. Murashov will guide the working group as they develop science-based standards to improve worker, consumer, and environmental protections by promoting good practice in the production, use, and disposal of nanomaterials and nanotechnology products.”
Australian Pesticides and Veterinary Medicines Authority Will Hold Nanotechnology Regulation Symposium
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 the benefits and potential risks; definitions, metrology, properties, and manufacturing; and human health and environmental considerations. APVMA intends to publish a draft nanotechnology report in late September 2014, which will provide a basis for discussion at the symposium. According to APVMA, it will encourage participants to comment on the report, “thereby contributing to a better regulatory framework for nanomaterials.” Registration for the symposium is now open.
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 highlights seven key points:
- Nanotechnologies provide solutions;
- Europe needs nanotechnologies to achieve the goals of the EU 2020 strategy;
- Safety is paramount;
- Openness and transparency are vital;
- The comprehensive European regulatory framework in place has the capacity to govern the production and use of nanomaterials;
- A common workable definition system for defining nanomaterials is welcome; and
- Europe cannot afford to miss out on the opportunities provided by nanotechnologies and the benefits they bring.
EC and SCENIHR Begin Public Consultation on Preliminary Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices
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 nanomaterials. Guidance is provided on physico-chemical characterization of nanomaterials, the determination of hazards associated with the use of nanomaterials, and risk assessment for the use of nanomaterials in medical devices. The safety evaluation of nanomaterials used in medical devices is discussed in the context of the general framework for biological evaluation of medical devices as described in the International Organization for Standardization (ISO) 10993-30 1:2009 standard. Therefore, the risk assessment is performed taking into consideration type of device, type of tissue contact, and the duration of contact, thus identifying the specific exposure scenario. The Guidance is intended to provide information to help with safety evaluation and risk assessment of the use of nanomaterials in medical devices that should be considered in conjunction with the ISO 10993-1:2009 standard. The Guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials in view of the possible distinct properties, interactions, and/or effects that may differ from conventional forms of the same materials. For the risk evaluation of the use of nanomaterials in medical devices, a phased approach is recommended based on potential release and characteristics of the nanomaterials. SCENIHR is seeking comments on the risk assessment related to the Guidance. Comments are due October 3, 2014.
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 input on the study and the related impact assessment. The validation workshop materials include:
- Introduction to the European Union (EU) legislative framework for nanomaterials and the study on transparency measures for nanomaterials;
- Evaluation of existing nanomaterial notification systems;
- Hazards and risks of nanomaterials and potential benefits of transparency measures;
- Nanomaterials markets (value chain characterization, growth, and innovation) and potential impacts of the transparency measures; and
- Outlook to the assessment of policy options.
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. Regulatory Cooperation Council (RCC) Nanotechnology Initiative is complete and that the final reports will be published this summer. According to the article, the reports will include recommendations on how Canada and the U.S. can align their nanomaterial regulatory work, including the application of consistent risk assessment approaches and methodologies and identifying categories of nanomaterials.
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 of nanomaterials within the European Union (EU). To date, the report states, two relevant register-like schemes -- both concerning nanomaterials and operating within the EU -- have been established: the French Notification System (FNS) and the Cosmetic Products Notification Portal (CPNP). Meanwhile, other transparency measures have been established or proposed by EU Member States.
- Study to Assess the Impact of Possible Legislation to Increase Transparency on Nanomaterials on the Market: Building Blocks Report (second draft): This report documents the findings of Task 2 (“Background information for building blocks of policy options”) and should complement the information provided in the Evaluation report (based on the findings of Task 1 (“Lessons learned from other schemes”) through the assessment of the FNS and the CPNP.
- Study to Assess the Impact of Possible Legislation to Increase Transparency on Nanomaterials on the Market: Options Assessment Report (first draft): This report documents the findings of Task 4 (“Support for the option assessment”), namely to identify the key issues that will need to be accounted for under each of the options being considered by the EC before a full impact assessment can be prepared. The report states: “It is important to emphasise that this report is intended to inform future policy development and analysis by the European Commission and is not intended to represent a definitive position of the Commission.”
The EC released a working document in May 2014 as part of its public consultation on transparency measures for nanomaterials in the market, which will end on August 5, 2014.
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 nanomaterial itself is not released but substances in soluble form that are classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) or environmentally dangerous substances are released. A number of products are excluded from the reporting obligation, including food and food contact materials; feed; drugs; medical equipment; cosmetic products; pesticides; and waste. The first reports, for the period beginning June 20, 2014, and ending June 20, 2015, are due August 30, 2015. The order is available only in Danish at this time. The registration portal is available online.
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 use of nanosilver to control bacterial growth could result in resistance of micro-organisms.” SCENIHR states:
SCENIHR concluded that the widespread (and increasing) use of silver containing products implicates that both consumers and the environment are exposed to new sources of silver. Human exposure is direct (food, hand-to-mouth contact, skin) and may be life long; while in the environment silver nanoparticles may be a particularly effective delivery system for silver to organisms in soil, water and sediment and may act as sources of ionic silver over extended periods of time. Therefore, additional effects caused by widespread and long term use of silver nanoparticles cannot be ruled out.
Regarding the hazard associated with the dissemination of the resistance mechanism following the use of silver nanoparticles, no studies are available at this moment, representing a serious gap of knowledge. Since other nanoparticles have been shown to substantially increase the horizontal gene transfer between bacteria -- which is extremely relevant for developing resistance -- the potential of silver nanoparticles to induce similar effects should be given particular attention. More data are needed to better understand bacterial response to ionic silver and silver nanoparticles exposure. Since the mechanisms resulting in silver nanoparticles resistance are not well understood, it is not possible to estimate at this time whether or not resistance of microorganisms will increase and spread in view of a more widespread use of silver nanoparticles in products.
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 nanomaterials. ANSES recommends:
- Implementing multidisciplinary projects to develop knowledge of the characteristics and hazards of nanomaterials, throughout the product life cycle;
- A strengthened regulatory framework for manufactured nanomaterials at the European level to characterize better each substance and its uses, taking into account the entire product life cycle; and
- Regulating certain nanomaterials, for which there are sufficient scientific data on toxicity, under the European Union (EU) Classification, Labeling, and Packaging (CLP) and Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations.
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 “nanoclaims” indicating the presence or absence of nanomaterials. The JRC states that a product register may give a better overview of the overall application of nanomaterials and potential exposure of humans and the environment. The EC already requires mandatory reporting for cosmetic products containing nanomaterials. Some EU Member States (France, Belgium, and Denmark) have or are introducing mandatory reporting schemes for a wider range of consumer products. The JRC states that several EU Member States, including Austria, Croatia, the Czech Republic, Denmark, France, Germany, Italy, Luxembourg, the Netherlands, Spain, and Sweden would prefer a harmonized central EU nanomaterials register. The report emphasizes that “only mandatory reporting/labelling of products containing nanomaterials can assure accurate and comprehensive information. Harmonised procedures are needed to avoid trade barriers and unfair commercial practices.” The report states that a claim of the presence (or absence) of nanomaterials in products should be verifiable, and provides an overview of experimental methods available for this purpose.
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 the working document over the course of the impact assessment. In support of the impact assessment, the EC is conducting a public consultation to obtain stakeholder views on the currently available information on nanomaterials on the market, the problem definition that forms the basis of the impact assessment, as well as the potential positive and/or negative impacts of the aforementioned policy options. According to the working document, the preliminary policy options are:
0. Baseline scenario;
1. Recommendation on how to implement a “best practice model” for Member States wishing to establish a national system (soft law approach);
2. Structured approach to collect information (“Nanomaterials Observatory”);
3. Regulation creating a European Union (EU) nanomaterial registry with one annual registration per substance for each manufacturer/importer/downstream user/distributor; and
4. Regulation creating an EU nanomaterial registry with one annual registration per use (including substances, mixtures and articles with intended release).
For options 3 and 4, a number of variants, taking into account specific substances, mixtures or articles, shall be considered. Some policy options may be combined. The EC states that it will organize a validation workshop to discuss the preliminary results of the study supporting the impact assessment on transparency measures for nanomaterials with interested stakeholders. The workshop will take place on June 30, 2014, in Brussels. The public consultation will close August 5, 2014.
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 data are available from intraperitoneal injection studies, inhalation studies are ongoing; mechanistic similarities with asbestos have been noted.” IARC’s preliminary list of agents to be reviewed at its September 30-October 7, 2014, meeting includes “carbon nanotubes.”
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 (BPR)?
Finally, if this active substance meets the definition of a nanomaterial what should be its specifications?
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 and regulators to address how the main long-term challenges from the regulatory perspective can be reflected and employed in the current and future research topics on nanomaterials. The workshop will cover the following topics:
- Challenges in regulatory risk assessment of nanomaterials;
- Measurement and characterization of nanomaterials;
- Metrology and dose metrics for hazard and exposure assessment throughout the life cycle;
- Environmental fate, persistence and bioaccumulation throughout the life cycle; and
- Read across and categories of nanomaterials.
Participation in the workshop will be by invitation only. Experts in the risk assessment of nanomaterials who wish to participate should express interest by May 15, 2014.
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 produce “concrete proposals for a comprehensive revision of the existing legal framework addressing the potential risks of nanomaterials.” The position paper states that:
- Nanomaterials are different from other substances;
- Risk from nanomaterials must be assessed;
- Nanomaterials should be thoroughly evaluated;
- Information on nanomaterials must be collected and disseminated; and
- Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) enforcement activities should tackle nanomaterials.
ECHA Report Includes Recommendations for Exposure Assessment and Risk Characterization of Nanomaterials under REACH
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 registrants when documenting the human health and environmental exposure assessment and risk characterization of their substances while registering them under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The report states that the outcomes of the discussion “can be viewed as generic recommendations for the exposure assessment and risk characterisation of NMs under REACH, while considering the present scientific knowledge on the field of nanotoxicology and practice, as well as challenges from participating registrants.” The report states that the provisions that apply to the registration of nanomaterials are the same as those for any other chemical substance, but notes that, “in line with scientific developments, there are specific considerations that registrants should report in specific endpoint sections, as this information will facilitate the evaluation of the adequacy of the tests performed and data obtained with regard to the safety assessment of NMs.” According to the report, the registration dossier should contain a comprehensive physicochemical characterization of the registered nanoform(s). Only when well-characterized nanoforms are reported in the dossier, can a read-across approach or use of existing data be considered for the purpose of hazard assessment. Registration dossiers including nanomaterials and bulk substances under the same technical dossier should include specific exposure scenarios for nanomaterials if these differ from the exposure scenarios developed for the bulk materials. The report states that, “[i]n principle, the existing risk assessment paradigm developed for traditional chemicals” should also apply to nanomaterials. According to the report, comprehensive risk assessments for nanomaterials currently present challenges both for human health and the environment. The following conclusions can be drawn:
Regarding the risk assessment for workers, due to the lack of validated modelling tools for nanomaterial exposure, field measurement data are currently preferred to support the risk assessment. If possible, the risk assessment should follow a multi-metric approach. The use of qualitative approaches is allowed to support measured or estimated exposure data. Concerning RMMs, the conventional control technologies to handle dusty materials are applicable to NMs and provide good control if implemented and maintained correctly.
With regards to the environment, the lack of specific hazard data complicates the risk assessment. Moreover, there are significant limitations in the applicability of conventional exposure assessment models. Registrants are advised to collect information on environmental release when possible (RIPoN 3). The current report proposes best practice to achieve realistic exposure data that can be used in environmental risk assessments.
In general, it is important to conclude with the reminder of the legal obligation that registration dossiers need to be updated with new nano-specific studies as scientific developments are progressing. Safe use claims under REACH should be based on explicit and transparent documentation supporting the hazard, exposure and risk assessment of NMs. Registrants are reminded that a lack of (hazard) data does not automatically mean that there is a lack of specific hazards or risks for a substance.
NanoDiode is conducting a survey concerning Europeans’ preferences for nanotechnologies. According to NanoDiode, the results will be used “to inspire policy makers, researchers and companies across Europe.” NanoDiode states that stakeholder engagement and dialogue is essential to the responsible development of nanotechnologies in Europe, and invites lay consumers to participate in the survey. NanoDiode, which is funded by the European Union, establishes a coordinated program for outreach and dialogue throughout Europe. It integrates engagement activities along the innovation value chain by combining “upstream” public engagement (by way of dialogues that integrate societal needs and expectations into the policy debate) with “midstream” engagement (by organizing open innovation workshops at the level of research and development) and “downstream” strategies for education and communication.
The European Union (EU) NanoSafety Cluster announced on March 18, 2014, the availability of an online nanosafety database survey. According to the EU Nanosafety Cluster, this is the first survey in a biannual effort to collect, organize, and share up-to-date information about nanosafety-related databases worldwide. The EU NanoSafety Cluster will continuously update the list of databases “with new valuable insight along its development.” The objective is to help owners and administrators of nanosafety-related databases increase awareness of their databases and to ensure interoperability of data. Reponses to the survey are due April 18, 2014.
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. Based on that result, the study quantified the administrative costs for notifiers and the competent authority, and described the benefits of an ENPR for public authorities, consumers, and notifiers. The report includes a preliminary remark from Öko-Institut e.V., which performed the study. The preliminary remark notes that during the study, various difficulties occurred, resulting in a lower reliability of calculations. Complications included companies “not interested or not able to substantiate the high burden that they allocate to such a register with reliable figures,” as well as “quite a number of companies [that] do not seem to have knowledge of the possible content of nanomaterials in their products.” According to the report, “an ENPR could bring additional value for public authorities, consumers and companies involved in nanotechnology.” The report concludes that an ENPR would “help to avoid a multiplication of administrative costs” to both companies manufacturing or importing products containing nanomaterials and the national competent authorities that would be responsible for a register at the Member State level. The report states: “Finally, from a legal point of view it can be discussed whether a register is the proportionate instrument in the light of the precautionary principle to govern the safe use of nanomaterials and products containing them. However, the introduction of an ENPR is the mildest legal instrument to control the production and use of nanoproducts compared to a restriction, a ban or a moratorium on one or more of these products.”
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 regulation, as stating: “The EP has repeatedly called for proper nano-labelling and it is highly surprising that the Commission even tried to weaken what has been decided by both Parliament and the Council. Consumers have the right to know and make their own choice. They do not want the Commission to do that for them. That is why today’s vote is important.” The press release states that the EC’s justification for the exemption, that consumers might assume that existing food additives being labeled as “nano” were new to the market, is “erroneous and irrelevant.”
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 1169/2011 on Food Information to Consumers, “all food ingredients present in the form of engineered nanomaterials have to be clearly indicated in the list of food ingredients to ensure consumer information.” According to the Committee, the Regulation does not distinguish between existing and new nanomaterials, but “explicit[l]y requires labelling of all ingredients present in the form of engineered nanomaterials.” The resolution also criticizes the proposed regulation’s size distribution threshold of 50 percent, stating that a threshold of ten percent “would be more appropriate, subject to a review.” The EP will vote on the resolution during the February 24-27, 2014, plenary session.
The European Commission (EC) published the proposed regulation as a delegated regulation in the December 19, 2013, Office Journal of the European Union, and then, on December 20, 2013, published a notice declaring it “null and void.” The withdrawal of the amendment was the result of a procedural error by the EC.
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 from toxicological tests with such products or ingredients contained within, including inhalation toxicity, genotoxicity/carcinogenicity/toxicokinetic studies, photocatalytic activity and phototoxic effect, or any other scientific data/publications considered relevant to assess the safety of such products. Information is due May 31, 2014.
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 1, 2017, for mixtures containing nanomaterial substances. Belgium states that it will evaluate the registration of products containing nanomaterials and that they will be recorded later. The press release has not yet been posted in English.
German Federal Environment Agency Supports Creation of EU Register of Products Containing Nanomaterials
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 would be to provide an overview of products containing nanomaterials that have applications in the consumer area and in an open environment. According to UBA, this would enable public authorities to set priorities in enforcement and monitoring, to estimate exposure for humans and the environment, and, in the case of adverse effects, to ensure traceability. For actors in the supply chain, a product register would create transparency. UBA states that the establishment of the product register should take place at the European Union (EU) level and be managed centrally. UBA acknowledges that a national product register would overlap with EU legislation and obligations and regulations in individual EU Member States, which would mean increased costs for authorities and stakeholders subject to notification. Substances and mixtures (manufactured or imported) that comprise or contain nanomaterials would be subject to notification, as well as articles that intentionally or unintentionally release nanomaterials.
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 and/or zinc oxide are used as UV filters in suncreams to protect the skin from UV radiation. Materials produced using nanotechnology (so-called biocomposites) in toothpaste are intended to support the natural tooth repair mechanism of saliva.
Cosmetics containing ingredients in the form of nanomaterials must contain a reference to this effect in the list of ingredients in line with the EU cosmetics regulation (EC Reg. No. 1223/2009). The names of these components must be followed by the word “nano” in brackets.
What is known about the health effects of nanoparticles in cosmetic products?
Toxicological tests have already been made for several nanoparticles used in cosmetic products. Accordingly, the behaviour of nanoparticles made of titanium dioxide and zinc oxide on the skin has been well examined. It was confirmed in several experiments that these nanoparticles cannot penetrate healthy human skin cells and remain on the skin surface. They can remain on the skin for longer periods via the hair follicles, but they cannot penetrate it. Hair growth then transports them back to the skin surface.
There are currently many open questions in the assessment of the health risk of nanoparticles. The possible but not yet experimentally proven special potencies of particles in the biological system based on their nanoscalability are largely unknown, nor is much data available on the exposure of humans to nanoparticles.
Can sunscreen with nano-sized UV filters be used for babies?
Children aged under two years should not be exposed to direct sunlight because their skin has not yet developed its own protection function against solar radiation. Textile sun protection is also recommended in the shade.
If direct exposure to the sun cannot be avoided, a sunscreen product should be carefully applied to the uncovered areas of the body to prevent sunburn. Although knowledge of the possible risks of nanomaterials is still a bit sketchy in some places, the effects of nanoparticle-sized substances on human skin is comparatively well researched. As the tiny particles cannot penetrate healthy skin, their use in UV filters for sunscreen products does not pose a health risk.
The International Organization for Standardization (ISO) published on January 6, 2014, a report entitled Nanotechnologies -- Considerations for the development of chemical nomenclature for selected nano-objects (ISO/TR 14786:2014), which is intended to provide information and analyses in support of the development of chemical nomenclature for the naming of “nano-objects.” An earlier ISO report, ISO/TS 80004‑1:2010, defines “nano-objects” as “materials with one, two, or three external dimensions in the nanoscale,” with the nanoscale defined as the “size range from approximately 1 nm to 100 nm.” Nano-objects are further defined as nanoplates, nanofibers, and nanoparticles. ISO states that ISO/TR 14786:2014 “is intended to facilitate communications between developers and potential users of nomenclature including academia, industry, government and non-governmental organizations.” The report is available for purchase online.
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 the requirements for nanomaterial?
Nanomaterial is materials engineered at the scale of atoms and molecules. The proposal specifies that engineered nanomaterials, as defined in the Regulation on Food Information to Consumers, require a Novel Food authorisation before being used in foodstuffs. This confirms that nanomaterials are covered by the Novel Food Regulation.
The EC’s December 18, 2013, press release states that the European Parliament and the Council will consider the draft proposal and adopt their positions “in due course.” According to the press release, the earliest the amendment would enter into force would be 2016.
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 states: “The publication of Commission Delegated Regulation (EU) No 1363/2013 is to be considered null and void.”
EC Scientific Committee Memorandum on Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials Available for Comment
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 applicants so that preparation and evaluation of the safety dossiers can proceed without an undue burden on the part of either the applicants or the evaluators in the Committee.” The conclusion states that the relevance, adequacy, and quality of the data presented “are of utmost importance in relation to the smooth and transparent evaluation of safety of nanomaterials used in cosmetic products.” The “key message” is that the data provided “must be relevant to the types of nanomaterials under evaluation, sufficiently complete, and of appropriate standards to allow adequate risk assessment.” Comments are due February 17, 2014.
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 carcinogenicity of the agents that will be reviewed in this volume (carbon nanotubes, fluoro-edenite and silicon carbide). This includes all pertinent epidemiological studies and cancer bioassays, plus important mechanistic and other relevant data.” IARC notes that “[e]ligible studies should be published or accepted for publication in the openly available scientific literature.
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 are available online.
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 intentionally manufactured material, containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm to 100 nm.” Under the amendment, food additives covered by the definition “shall not be considered as engineered nanomaterials, if they have been included in the Union lists” as established by Commission Regulations (EU) No 1129/2011 and (EU) No 1130/2011. Fullerenes, graphene flakes, and single wall carbon nanotubes with one or more external dimensions below one nanometer “shall be considered as engineered nanomaterials.” “Intentionally manufactured” is defined as “the material is manufactured to perform/fulfil a specific function or purpose.”
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 nanosilver to control bacterial growth could result in resistance of micro-organisms. SCENHR states that it “concluded that the widespread (and increasing) use of silver containing products implicates that both consumers and the environment are exposed to new sources of silver.” Human exposure is direct, through food, hand-to-mouth contact, and skin, and may be life long. Silver nanoparticles “may be a particularly effective delivery system for silver to organisms in soil, water and sediment and may act as sources of ionic silver over extended periods of time.” SCENIHR thus cannot rule out “additional effects caused by widespread and long term use” of nanosilver. Regarding the hazard associated with the dissemination of the resistance mechanism following the use of nanosilver, SCENIHR notes that there is no documentation available, “representing a serious gap of knowledge.” According to SCENIHR, “[s]ince other nanoparticles have been shown to substantially increase the horizontal gene transfer between bacteria -- which is extremely relevant for developing resistance -- the potential of [nanosilver] to induce similar effects should be given particular attention.” SCENIHR states that more data are needed to understand better the bacterial response to ionic silver and nanosilver exposure. SCENIHR could not determine whether resistant microorganisms will increase and spread in view of a more widespread use of nanosilver because the mechanisms resulting in nanosilver resistance are not well understood. Comments on the preliminary opinion are due February 2, 2014.
The 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 of nanotechnology in the media has changed. According to BfR, the results show that the majority of respondents are still largely unfamiliar with the term nanotechnology, and that fewer reports on the subject appear in the media than five years ago. BfR notes that, despite the existing knowledge gaps, a “clear majority” see the benefits of nanotechnology as outweighing any potential risks. BfR describes a “noteworthy” finding regarding the differences between the sexes, in that “men’s attitudes towards nanotechnology are clearly more positive than those of women; men are more likely to advocate nanotechnology.” BfR states: “By implementing a targeted communications strategy, the BfR strives to make a contribution to closing the knowledge gaps. In particular, the different information needs of men and women must be taken into account: men tend to prefer fact-based information about nanotechnology, whereas women would like recommendations relevant to everyday life that they can easily convert into concrete behaviour.”
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 Ministry, as of June 30, 2013, more than 930 reporters submitted over 3,400 statements concerning substances placed on the market in France in 2012.
The Nanotechnology Industries Association (NIA) recently published a report entitled Closing the Gap: The Impact of Nanotechnologies on the Global Divide, which looks at how nanotechnology-based inventions and their potential applications could be implemented in developing countries, and whether they could benefit the most underprivileged populations. The report examines obstacles and problematic issues that could arise, and addresses the following concerns:
- Will nanotechnologies reach the populations they wish to assist?
- What impact could they have on world trade and already weak economies?
- What of the unprecedented nature and uncertainties surrounding the risks of nanotechnology?
- Will inventors from the developing world have to circumvent challenging intellectual property rules in order to make full use of the technology?
The report discusses possible ways forward for the fair development of nanotechnologies, as well as the possibilities for scientists and entrepreneurs from low- and middle-income countries to scale-up the benefits for their countries with the help of international cooperation and global dialogue.
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 scientific literature and determine which classification is appropriate: Group 1, carcinogenic to humans; Group 2A, probably carcinogenic to humans; Group 2B, possibly carcinogenic to humans; Group 3, not classifiable as to its carcinogenicity to humans; and Group 4, probably not carcinogenic to humans.
The 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 inflammation and DNA damage in the lungs and in cultured cells, while flexible, long and tangled MWCNTs do not. It appears that the rigidity of MWCNTs is a key feature in triggering a specific inflammatory reaction and in causing cellular alterations involved in cancer formation.” The Institute states that this new information on the adverse effects of MWCNTs will be useful in assessing which forms of MWCNTs require regulatory attention and special safety measures in occupational settings.
In November 2013, Switzerland’s Federal Office of Public Health (FOPH) updated its precautionary matrix for synthetic nanomaterials, which industry can use to assess nano-specific health and environmental risks of nanoproducts. FOPH states that the precautionary matrix “enables the structured assessment of the ‘nano-specific need for precautions’ when handling synthetic nanomaterials.” FOPH intends the matrix to assist industry with due diligence requirements, and their “duty to exercise self-control opposite employees, consumers and the environment.” According to FOPH, the precautionary matrix can identify “potentially risky applications,” allowing the initiation of precautionary measures to protect people’s health and the environment. FOPH notes that the precautionary matrix “is upgraded in close cooperation with industry, science and trade as well as consumer and environmental organisations.”
Japan’s National Institute of Advanced Industrial Science and Technology (AIST) announced in October 2013 a voluntary guidance document on measuring airborne carbon nanotubes (CNT) in workplaces. The Technology Research Association for Single Wall CNTs (TASC), a consortium of nine companies and AIST, prepared the guidance, which is intended to provide a means of CNT safety management. The guidance summarizes the available practical methods for measuring airborne CNTs: (1) on-line aerosol measurement; (2) off-line quantitative analysis (e.g., thermal carbon analysis); and (3) sample collection for electron microscope observation. The guidance also presents measurement cases performed by TASC. TASC developed the guidance under the project “Innovative carbon nanotubes composite materials project toward achieving a low-carbon society,” which is sponsored by the New Energy and Industrial Technology Development Organization (NEDO). The guidance notes that a specific method has not yet been definitively determined, and many challenges still remain.
The World Health Organization (WHO) recently published the report of the December 10-11, 2012, WHO expert meeting entitled Nanotechnology and human health: Scientific evidence and risk governance. The conclusion states that while “first generation nanomaterials are being used in a variety of applications and products, they do not seem to present an imminent public health issue.” The conclusion continues, however, and states: “Given the scientific uncertainty and still emerging evidence, and given the early indications of harm and possible adverse human health effects that have been hypothesised for some nanomaterials, a precautionary approach seems desirable.” The report notes the need for data concerning nanoparticle exposure and distribution in the human body, toxicological mechanisms, and possible adverse health effects. According to the report, available methodology, current protocols, and testing guidelines for chemical risk assessment could be used to assess nanomaterials, “but they need adaptation.” The report recommends that further initiatives “be undertaken to use available evidence on health implications, to the extent possible, to inform the risk governance of nanotechnology.”
On October 8, 2013, Sweden issued a report proposing a national action plan for the safe use and management of nanomaterials. The report’s recommendations, as described in the English summary, include specific actions within several categories. Of particular interest are the following categories and specific recommendations:
- Measures for the development of the European Union’s (EU) regulatory framework:
- The government and relevant agencies shall work to bring about a revision of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH):
- Nanomaterials are to be registered as a separate substance;
- The tonnage limits are reduced for nanomaterials;
- The information to be submitted when registering nanomaterials includes supplementary data on their physic-chemical properties and, when necessary, other relevant information;
- The obligation to register products containing nanomaterials is extended; and
- The rules regarding information to downstream users are to be revised so that they also include relevant details on nanomaterials.
- The government and relevant agencies shall work to bring about a revision of the European legislation on chemical substances and products:
- The regulatory frameworks ensure that the data submitted and the assessments made are relevant to the substance in the form it occurs.
- Manufacturers, importers, and distributors of products containing nanomaterials should be able to declare the preceding and subsequent links in the distribution chain.
- The proposed amendments to the regulation on novel foods, aimed at clarifying the regulations on nanomaterials, are to be adopted as soon as possible.
- The government and relevant agencies shall work to bring about a revision of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH):
- Measures to increase knowledge about nanomaterials on the market:
- The Swedish Chemicals Agency to be given the task of investigating how an obligation to submit information on the occurrence of nanomaterials when registering products in the product register might be worded.
- An inventory of products on the market that contain nanomaterials to be performed.
On September 3, 2013, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) posted an electronic copy of its Handbook for Notifiers, which provides guidance for importers and manufacturers of industrial chemicals in Australia. Appendix H includes guidance and requirements for notification of new chemicals that are industrial nanomaterials, and addresses the following topics:
- NICNAS working definition of industrial nanomaterial;
- Exemption categories;
- Permit categories;
- Certificate categories;
- Specified conditions for requesting additional data requirements;
- Guidance on providing additional data requirements;
- Guidance on testing health effects of nanomaterials; and
- Guidance on testing the environmental fate and effects of nanomaterials.
On September 11, 2013, the European Commission (EC) submitted to the World Trade Organization (WTO) a proposed regulation amending Regulation 1169/2011 concerning the provision of food information to consumers as regards the definition of engineered nanomaterials (ENM). The proposed regulation states that since the regulation refers to ENMs and not nanomaterials in general, natural and incidental nanomaterials should not be included in the definition. The proposed regulation states further that “it is appropriate to link the definition of ‘engineered nanomaterials’ to intentionally manufactured material, which should be explicitly defined.”Continue Reading...
On September 20, 2013, the Organization for Economic Cooperation and Development (OECD) announced a recommendation that its Member Countries apply existing regulatory frameworks to manage risks associated with manufactured nanomaterials. The Recommendation, approved on September 19, 2013, expands the scope of the Mutual Acceptance of Data (MAD) in the Assessment of Chemicals to include nanomaterials. Since 2006, OECD has been working to develop approaches for addressing risk assessments for manufactured materials. A review of the Recommendation will occur in three years to assess how it has been implemented in OECD Member Countries.
The National Nanotechnology Initiative (NNI) has posted a report on its March 2012 international “Symposium on Assessing the Economic Impact of Nanotechnology.” NNI held the symposium in conjunction with the Organization for Economic Cooperation and Development (OECD), and the American Association for the Advancement of Science (AAAS) hosted it. Participants included scientists, engineers, policy analysts, private investors, technology leaders, and the general public from both OECD and emerging economies. Participants reported on initiatives for assessing the impact of nanotechnology and other technological fields. There was a consensus that more pilot initiatives and trials are needed to gain experience and knowledge and to aid in the development of good practices or guidelines for impact assessment. The report states that the data obtained would facilitate efforts to develop robust international documentary standards, which are critical to the broad commercialization and adoption of nanotechnology. According to the report, participants drew attention to the need to obtain information about impact without greatly increasing the burden on respondents. The report notes that the symposium emphasized the importance of measuring the full range of nanotechnology’s impacts, addressing risks, costs, and benefits. Impact analyses need to be on a sound footing in order to be undertaken on a global scale and comparable, the report states, and internationally agreed upon definitions of nanotechnology are needed. The participants concluded that nanotechnology “is sufficiently mature to justify the collecting of data to support the performance of economic impact assessments.” The report provides the reasoning behind the conclusion and identifies potential challenges involved.
The Organization for Economic Cooperation and Development (OECD) posted on September 9, 2013, a final report entitled Co-Operation on Risk Assessment: Prioritisation of Important Issues on Risk Assessment of Manufactured Nanomaterials. This document follows on a report published by the Working Party on Manufactured Nanomaterials (WPMN) entitled Important Issues on Risk Assessment of Manufactured Nanomaterials, which identified a range of issues that the WPMN considered important in risk assessment and that should be addressed in the future. Because not all of these issues could be considered at the same time, WPMN circulated a survey to identify those issues for which further guidance should be developed as a priority. This document summarizes the survey results, the methodologies used to analyze the survey, and the identified priorities. These priorities will be the primary focus of projects pertaining to approaches for risk assessments of manufactured nanomaterials. On September 10, 2013, OECD posted a report entitled Environmentally Sustainable Use of Manufactured Nanomaterials, which presents the report of the September 14, 2011, workshop on the environmentally sustainable use of manufactured nanomaterials. The report includes a number of conclusions relevant for current and future OECD activities, especially those focused on life-cycle assessment (LCA) and nanomaterials, including: (1) basic structure and characteristics of LCA; (2) LCA application to nanomaterials at the research, scale-up, regulation, and market level; and (3) LCA application on nanomaterials data availability, reliability, comparability, and its generation.
The European Commission (EC) Scientific Committee on Consumer Safety (SCCS) announced on September 4, 2013, that it has extended the deadline for comments on the opinion for titanium dioxide (nano form), addendum to the opinion on zinc oxide (nano form), and revision of the opinion on 2,2’-methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) nano form. Comments are due September 18, 2013. The SCCS website states: “Please note that, according to the Rules of Procedure of the Scientific Committees, the opinions of the Scientific Committees on a particular subject will be considered closed and not subject to revision for a period of 3 years. Therefore, in order to most efficiently process its workload and manage its resources, the Commission does not plan to reopen a respective issue following the commenting period and the publication of the opinion.”
On August 24, 2013, Canada issued a significant new activity (SNAc) notice for multi-walled carbon nanotubes (MWNCT). The notice states that MWCNTs are not included on the Domestic Substances List and that “a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999.” The notice defines substance as “short tangled multi-walled carbon nanotubes” that have the following characteristics:
(a) At least 90 percent of the substance is composed of elemental carbon;
(b) The nanotubes measure from 0.09 to 10 micrometres in length, with a 1.1 micrometre average; and
(c) The diameter of the nanotubes measures from 5 to 25 nanometres, with a 12 nanometre average.
A significant new activity in relation to the substance is:
(a) Its manufacture or import in a quantity greater than 100 kilograms (kg) per calendar year when it is to be used:
(i) In consumer products as defined in Section 2 of the Canada Consumer Product Safety Act, excluding solid plastic products; or
(ii) In products intended for use by or for children from 0 to 6 years old; or
(b) In all other cases, its manufacture or import in a quantity greater than 10,000 kg per calendar year.
The notice states that despite the above restrictions, “the manufacture or import of the substance to be used to manufacture an export-only product is not a significant new activity when the manufacturing process of the product results in releases of the substance to the aquatic environment in a quantity not exceeding 1 kg per day per site after wastewater treatment.” In addition, the manufacture or import of the substance to be used as a research and development substance is not a significant new activity. Information that must be provided prior to the commencement of a proposed significant new activity includes analytical information to determine the length and diameter of the substance, as well as information describing the primary and secondary particle size, agglomeration or aggregation state, shape, chirality, surface area, and surface charge of the substance; a brief description of the manufacturing process that details precursors of the substance, reaction stoichiometry, nature (batch or continuous), and scale of the process; analytical information to determine the leachability potential of the substance and its precursors from any final product resulting from the significant new activity; and analytical information to determine the dispersibility of the substance in the most significant environmental media related to the significant new activity. If the substance will be manufactured or imported in a quantity greater than 10,000 kg per calendar, the notice specifies additional test data that must be submitted. Manufacturers or importers must identify “every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use, manufacture and import of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and risk management actions in relation to the substance imposed by the department or agency.” Finally, the notice requires submission of “all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to determining whether the substance is toxic or capable of becoming toxic.”
According 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 nanomaterials in the UK, and to develop an understanding of the types of nanomaterial on sale and in use. Of these, 66 confirmed that they are currently producing, using, and/or distributing nanomaterials in the UK. The types of nanomaterial identified include metal-based nanomaterials (silver, copper, gold), inorganic non-metallic nanomaterials (titanium dioxide, aluminium oxide), and carbon-based nanomaterials (carbon nanotubes, graphene). Other examples include photovoltaic inks and pegylated fatty acids. In 2013-2014, the Chemical Compliance Team intends to update and maintain its database of nanotechnology contacts and look to consider targets from other areas, such as other industry contacts (those not listed in nanotechnology membership directories (i.e. those identified in consumer product databases)), and universities.
ITC Seeks Information to Support Investigation of How EU Trade Restrictions Affect Exports of U.S. SMEs
The U.S. International Trade Commission (ITC) published a notice in the July 30, 2013, Federal Register announcing that, following receipt of a letter from the United States Trade Representative (USTR), it instituted investigation No. 332-541, “Trade Barriers that U.S. Small and Medium-Sized Enterprises Perceive as Affecting Exports to the European Union.” According to the notice, USTR’s letter indicated that the U.S., in the Transatlantic Trade and Investment Partnership (TTIP) negotiations, “will seek to strengthen U.S.-European Union (EU) cooperation to enhance the participation of SMEs in transatlantic trade, and to address trade barriers that may disproportionately impact small businesses.” ITC will base its report on available information, including information furnished by small- and medium-sized enterprises (SME) and interested parties. ITC will address, where information is available, specific trade barriers in individual EU Member States, and provide, to the extent applicable, qualitative distinctions among the identified trade-related barriers. ITC states that it will include suggestions gathered from SMEs or the relevant literature to strengthen U.S.-EU cooperation to enhance the participation of SMEs in transatlantic trade. ITC will hold a public hearing on October 8, 2013. Requests to appear at the hearing are due September 13, 2013, and the deadline for filing pre-hearing briefs and statements is September 20, 2013. Post-hearing briefs and other written statements are due October 15, 2013. ITC will transmit its report to USTR on January 31, 2014. As nano stakeholders may be disproportionately impacted by trade barriers, this is a valuable opportunity to comment.
On July 26, 2013, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) posted two documents for comment. The SCCS addendum to its opinion on zinc oxide (nano form) includes the following conclusion:
The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for use on the skin as UV filter in sunscreen formulations:
- ZnO nanoparticles of purity ≥96%, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1% in total.
- ZnO nanoparticles with a median diameter (D50: 50% of the number below this diameter) of the particle number size distribution above 30 nm, and the D1 (1% below this size) above 20nm.
- ZnO nanoparticles that are either uncoated or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane, and/or coated with other cosmetic ingredients as long as these cosmetic ingredients are accepted by the regulatory authorities and/or have been demonstrated to be safe for use as cosmetic ingredient.
- ZnO nanoparticles that have a comparable solubility to that reported in the dossier, i.e. below 50 mg/L (approximately the maximum solubility of the ZnO nanomaterials for which data are provided in the dossier).
The submitted 90 days inhalation study resulted in a NOAEL of 0.3mg/m3.
However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects.
The SCCS opinion on titanium dioxide (nano form) includes the following overall conclusion:
1. Does SCCS consider that use of titanium dioxide in its nanoform as an UV-filter in cosmetic products in a concentration up to maximum 25.0 % is safe for the consumers taken into account the scientific data provided?
On the basis of the available evidence, the SCCS has concluded that the use of TiO2 nanomaterials with the characteristics as indicated below, at a concentration up to 25% as a UV-filter in sunscreens, can be considered to not pose any risk of adverse effects in humans after application on healthy, intact or sunburnt skin. This, however, does not apply to applications that might lead to inhalation exposure to TiO2 nanoparticles (such as powders or sprayable products). Furthermore, this assessment applies to 13 out of the 15 TiO2 nanoparticles presented in the submission, but may also be applicable to other TiO2 nanomaterials that have a close-similarity to the parameters in Tables 1-3.
. . .
2. In order for the COM to differentiate in the regulation between materials in its nanoform and its non-nano form, can the SCCS give quantitative and qualitative guidance on how this differentiation should be given based on the particle size distribution or other parameters?
A detailed SCCS guidance on risk assessment of nanomaterials in cosmetics has recently been published (SCCS/1484/12). The guidance provides a detailed account of the important nano-related parameters that should be considered in relation to physicochemical characterisation, hazard identification, exposure assessment and risk assessment of nanomaterials.
Comments on both documents are due September 6, 2013.
The European Commission (EC) called for tenders on June 23, 2013, for a study to assess the impact of possible legislation intended to increase transparency on nanomaterials on the market. The EC states that the objective of the open call for tenders is to assist it “in the preparation of an Impact Assessment to identify and to develop the most adequate means to increase the transparency and to ensure the regulatory oversight for nanomaterials on the market (‘nano-registry’).” The EC states that the work should consider a register of nanomaterials and/or products containing nanomaterials in parallel to the existing Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) obligations. The successful contractor will gather relevant data needed for the Impact Assessment, including the costs and administrative burden of possible registration obligations to companies, the possible effects on competitiveness, the possible effects of discouraging innovation in Europe, and the potential benefits for consumers and policy makers. Tenders are due August 19, 2013.
The Nanotechnology Industries Association (NIA) is holding its 2013 NanoImage Competition. NIA invites scientists, photographers, and others to enter. NIA seeks “striking examples that illustrate nanotechnology’s diversity of nature, its range of applications and its unseen beauty.” Submissions will be judged on their originality, technical excellence, composition, overall impact, and artistic merit. The grand prize winner will receive an iPad. The competition is open to all persons aged 18 years and above, subject to conditions. Up to ten images in total may be submitted. Submissions are due October 11, 2013. NIA will announce the Grand Prize Winner and four runners-up on November 1, 2013.
On 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 decree, substances manufactured at the nanoscale, and preparations containing them, would be declared if more than 100 grams of these substances are placed on the market per year. If Belgium believes that a substance could present a risk to human health or the environment, it could ask registrants to provide information on potential dangers, exposure, and risks. The draft decree would apply to: substances manufactured at the nanoscale; preparations containing such substances; and articles incorporating these substances. Substances manufactured at the nanoscale included within the scope of the draft decree would encompass nanomaterials as defined in the EC’s October 2011 recommendation on the definition of nanomaterials, “including the assimilation of fullerenes, graphene flakes and carbon nanotubes, but with the exception of non-chemically-modified natural substances, substances produced accidentally and substances whose fraction between one nanometer and one hundred nanomet[er]s is a by-product of human activity.” Pigments and -- concerning the declaration of articles -- carbon black, synthetic amorphous silica, and precipitated calcium carbonate used as fillers would be excluded from the scope of the draft decree. Products already subject to regulations concerning nanomaterials, such as biocides, would also be excluded. The draft decree would apply from January 1, 2015, for nanomaterials and substances containing nanomaterials, and from January 1, 2016, for articles or complex objects that contain a substance in a nanoparticle state. European Union (EU) Member States have until October 7, 2013, to submit comments on the draft decree. Belgium could then pass the draft decree, revising it as necessary based on any comments received.
On 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 the reason hazardous substances are released from the product. The order would take effect January 1, 2014, and the first reports would be due no later than January 31, 2015. Comments are due August 16, 2013.
On June 21, 2013, the European Commission (EC) began a consultation on the modification of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation annexes on nanomaterials. According to the EC, the objective of the initiative is to provide further clarity on how nanomaterials are addressed. The EC states that REACH must ensure a high level of health, safety, and environmental protection, while also permitting access to innovative products and promoting innovation and competitiveness. The EC intends to provide clearer REACH requirements for nanomaterials to ensure that industry demonstrates safe use in the registration dossiers in accordance with REACH Article 1(1). The EC expects to propose a possible amendment of the REACH annexes in 2013. Any proposed amendment would be accompanied by an impact assessment. Comments are due September 13, 2013.
On June 19, 2013, the European Agency for Safety and Health at Work (EU-OSHA) posted a fact sheet entitled “Nanomaterials in Maintenance Work: Occupational Risks and Prevention.” EU-OSHA states that the fact sheet provides a short introduction to nanomaterials and their risks to workers’ safety and health. It explains how workers may encounter nanomaterials when undertaking maintenance work and also presents information on what should be done to prevent exposures.
The 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 nanomaterials are present on the Belgian market in a large variety of products and along the entire supply chain. The report states that declaring and tracing them along their lifecycle “would result in costs that are considered too high.” The study analyzed six options, including various restrictions of the scope, and compared them with respect to the objectives of a Belgian registry and the direct costs for industry. The final report recommends a registry “with an exemption list for selected pigments and fillers, selected supply chain actors, the possibility to avoid declaration based on scientific evidence, and a rollout phase for implementation as this option achieves the register objectives in the most effective manner -- in respect to the direct costs incurred by industry and also the amount of relevant data obtained per the number of declarations that could be used for e.g. exposure and risk assessments.”
On June 13, 2013, the Organization for Economic Cooperation and Development (OECD) Working Party on Nanotechnology (WPN) published the final report Nanotechnology for Green Innovation. The report summarizes information collected from various projects undertaken by the WPN regarding the use of nanotechnology for green innovation. It also draws on results and conclusions from the March 2012 symposium on “Assessing the Economic Impact of Nanotechnology,” which was organized by the OECD WPN and the U.S. National Nanotechnology Initiative. The report focuses on an introduction to “green nanotechnology,” strategies for green innovation through nanotechnology, and the impacts of green nanotechnology. The report also highlights investments in nanotechnology, priorities of selected countries, and opportunities for public-private collaboration.
On June 11, 2013, the European Parliament adopted a resolution calling for a “new agenda for European consumer policy.” The agenda calls for “adequate consumer protection and product safety in the markets for consumer goods produced using nanotechnology or genetically modified organisms.” The agenda also “[h]ighlights the need for close cooperation between European, national and local authorities and consumer associations in order to establish consultation mechanisms and implement the measures planned in the Agenda.”
On May 31, 2013, the European Commission (EC) began a public consultation on the new European Union (EU) occupational safety and health policy framework. According to the EC, the main purpose of the consultation is to obtain comments on the results of the evaluation of the European Strategy on Safety and Health at Work 2007-2012. The EC states that “[t]his should help identify current and future challenges in the occupational safety and health area, and identify solutions to address these challenges.” The EC staff working document highlights five main challenges, including “[i]dentifying the health and safety risks of new or emergent risks. Concerns about nanomaterials, endocrine disruptors and electromagnetic field hazards have been expressed and documented.” The EC states that it particularly seeks comments from Member State public authorities, social partner organizations, and stakeholders and experts with an interest in the area of occupational safety and health. Comments are due August 26, 2013.
The European Chemicals Agency (ECHA) began a public consultation on the draft multi-annual work program for 2014-2018. According to the draft work program, ECHA will develop “more refined guidance on the registration of substances in nano-form to provide further detailed advice reflecting the state-of-the-art in regulatory science in this respect and the anticipated adaptation of information requirements for nanomaterials in the [Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)] Annexes.” ECHA states that substance evaluation “will include evaluation of substances in nano-form and thereby contribute to advancing the information and understanding of hazards and risks posed by nanomaterials.” According to the draft work program, high priority topics in regulatory science include nanomaterials. The draft work program states: “With regard to nanomaterials, ECHA aims to ensure that the regulatory requirements of REACH, [Classification, Labeling, and Packaging (CLP)], and [Biocidal Products Regulation (BPR)] can be fully implemented to address the hazards and risks of substances in nanoform.” ECHA intends to extend further “its internal capacities in the area of the characterisation, hazard and safety assessment and risk management of nanomaterials; the Agency will also enable Member States’ experts to participate in capacity building and will share experience with stakeholders.” In addition, ECHA will participate in scientific and regulatory activities at the European Union (EU) and Organization of Economic Cooperation and Development (OECD) level “with the aim of developing appropriate guidance for industry, as well as being able to evaluate registration dossiers that contain information on the hazards, risks and risk management of nanomaterials, effectively.” Comments are due July 15, 2013.
In May 2013, the European Commission (EC) posted a January 2013 report entitled Examination and Assessment of Consequences for Industry, Consumers, Human Health and the Environment of Possible Options for Changing the REACH Requirements for Nanomaterials. According to the report, 12 of the 21 originally suggested options are considered already implemented with existing legislation and guidance. The other nine options were considered relevant for an adaptation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation and thus build the basis for the assessment. The report states that the total costs for implementing the nine options range from €11 million to €73 million as a cumulative effort for all concerned companies for a time period until 2022. These costs result from extensive application of grouping and read-across approaches under REACH. Without this approach, the costs would multiply up to €100 million and €600 million. The report states: “The overall conclusion of this impact assessment shows that additional costs for companies lead to a reduced uncertainty about potentially adverse effects of nanomaterials to human health and the environment. These may lead to considerable benefits, especially if combined with appropriate risk reduction measures.”
On May 14, 2013, COWI announced that it was commissioned by the Danish Environmental Protection Agency (EPA) to assess the impacts of nanomaterials on Denmark’s environment. According to COWI, it will perform detailed risk assessments for ten different nanomaterials, including nanotitantium dioxide, nanosilver, nanocopper, and carbon nanotubes. A spokesperson stated that COWI will chart the lifecycle of the materials and examine what substances are released into the environment during various stages. COWI will extrapolate its findings to provide an overall assessment of risks to the environment posed by nanomaterials. According to the spokesperson, at a later stage, the findings could be used as a basis for determining the need for new -risk-reduction measures. The spokesperson noted that COWI was not charged with making recommendations for legislative action, however. A separate project will examine the risks posed by nanomaterials in consumer products.
The 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 declaration requirement, and at the request of several industries,” for the first reporting year, it will grant a two-month extension.
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 organizations. According to the April 29, 2013, Chairman’s Report, during the meeting, many participants “considered that databases or registries will be indispensable for gathering the necessary information on (products with) nanomaterials.” While France has already created a national registry, and other Member States, such as Denmark and Belgium, have taken steps towards creating their own, participants “agreed that a[n] EU-registration on nanomaterials is preferred over a series of varying national databases,” which could “create more problems than solutions in improving a harmonised European policy on nanomaterials.” The Chairman’s Report states that an EC official noted that “the main problem on the table is to define the level of information on nanomaterials that is required.” According to the Report, the current EC “(which will be in office until the second half of 2014) is unlikely to take a decision on setting up a community-wide EU-database for (products with) nanomaterials.” Industry participants acknowledged that an EU-wide registry could increase public confidence in the safety of nanomaterials, but expressed their concern that a registry could also stigmatize nanoproducts and increase the costs for small- and medium-sized enterprises. The Majority Agreements states: “There is a need to further discuss the goals, costs/benefits and outcome of a register of (products with) nanomaterials. Such discussion should address:
- Public concern;
- Consumers choice;
- Information (for authorities, in the supply chain, for consumers); and
- Proportionality, etc.
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 register. The obligation to register on-site isolated intermediates or transported intermediates that fulfill the definition of nanomaterials would apply to any manufacturer of the nanomaterial intermediate in quantities of ten kg or more per year. Producers or importers of articles containing nanomaterials would be required to notify the European Chemicals Agency if the nanomaterial is present in those articles in quantities over ten kg per producer or importer per year.
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 EPA, the proposed information requirement scheme is based on the REACH methodology, i.e., a stepwise approach requiring more information at higher tonnage levels. The Danish EPA notes that the proposal “should not necessarily be seen as a proposal for updating REACH, as it could also be put forward as a stand-alone scheme for nanomaterials and used in relation to adapting other existing legislation, or it could be used for guiding.”Continue Reading...
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:
- Develop adequate measurement methods for risk assessment;
- Develop reference materials for exposure assessment and studies into the effects of nanomaterials on humans and the environment;
- Validate and harmonize test and evaluation strategies “in a national and international context” to allow results to be compared;
- Develop screening tests for adverse health and environmental risks at an early stage of material innovation;
- Develop ideas for labeling single nanomaterials; and
- Work on grouping nanomaterials based on their properties to reduce the number of complex single investigations.
The report was prepared by the Federal Institute for Risk Assessment, Federal Environment Agency, Federal Institute for Occupational Safety and Health, Federal Institute for Materials Research and Testing, and Physikalisch-Technische Bundesanstalt.
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 high aspect ratio nanomaterials (HARN). HSE prepared the guidance “in response to emerging evidence about the toxicity of these materials.” According to HSE, the control principles described in the guidance can be applied to all nanomaterials used in the workplace. HSE highlights any differences in the approach between control of CNTs and other bio-persistent HARNs to other types of nanomaterials.
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 National Enabling Technologies Strategy. SWA Chair Ann Sherry stated that while the risk to human health and safety from a number of nanomaterials and applications is low, some nanomaterials, such as carbon nanotubes, are potentially more hazardous. SWA’s press release states: “Minimisation of exposure to nanomaterials at work is essential until there is sufficient data to rule out hazardous properties. Research has shown if conventional engineering controls are designed and maintained effectively, exposure to nanomaterials can be significantly reduced.” According to the press release, as a result of the findings in the research reports, SWA intends to prepare guidance material on combustible dust hazards, including nanomaterials.
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 described in paragraph (b); or
(b) [T]he use as an ink additive in commercial or industrial settings 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 1,000 kg per calendar year.
The notice specifies data that must be provided to Canada 90 days before commencement of the proposed SNAc. Canada notes that, under the Canadian Environmental Protection Act, 1999, in circumstances where a SNAc notice is issued for a new substance, “it is the responsibility of every person who transfers the physical possession or control of the substance to notify all persons to whom the possession or control is transferred of the obligation to comply with the Significant New Activity Notice and of the obligation to notify the Minister of the Environment of any new activity and all other information as described in the Notice.” Users are responsible for being aware of and complying with the SNAc notice and submitting a SNAc notification prior to the commencement of a SNAc associated with the substance.
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 which engineered nanoparticles to characterize, how best to carry out hazard and exposure assessments, and ways in which risks will be assessed and managed. The newsletter describes work that has been done to date, while more in-depth articles by nanoMICEX partners provide information on how the partners are ensuring the safety of workers within the industry. The newsletter includes a timeline of upcoming activities in the next six months, including publication of the next newsletter in September 2013.
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 scenarios related to the human and ecotoxicity of synthetic nanomaterials. According to the study, data available at the present time are very limited and are inadequate to allow general conclusions to be drawn. Nonetheless, the study states, “initial insights for major accident prevention could be won, and a perspective on important pending questions given.” FOEN’s objective is to encourage research institutions and industry to take up these questions. FOEN “will continue to follow the national and international developments in this field, to put it in a position to introduce the necessary measures when necessary.”
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 and provided an overview of actual nano-products at the European furniture market. The joint project examined what types of nanomaterials are being used in furniture product manufacturing; the near future perspectives for using nanomaterials in furniture manufacturing; health and safety issues for workers within the workplace; and what a precautionary safe workplace would look like. According to the executive summary, the market for nanomaterial use in furniture products is still in an early phase of development. IVAM UvA BV notes that nanotechnology may have significant implications for the future of furniture manufacturing and on furniture quality and functionalities, as well as on environmental, occupational, and public health performances related to the manufacturing and end-products.
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 substance in a consistent and coherent manner. ECHA states that the updated manual also includes references and links to recent guidance updates for nanomaterials published on the ECHA website, as well as links to recent reports from projects, such as the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) and the Organization for Economic Cooperation and Development Working Party on Manufactured Nanomaterials.
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 allowing delegations to share their experiences and preoccupations with respect to safety, and will identify opportunities for future co-operation and co-ordination.
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 dossiers. If appropriate the Commission will come forward with a draft implementing act by December 2013.” The pre-publication version of the staff working paper specifically recommends that, if REACH needs amending “for other reasons,” then “consideration should be given to the introduction of the definition of a nanomaterial in line with Recommendation 2011/696/EU.”
On January 9, 2013, the Norwegian Climate and Pollution Agency (Klif) posted a notice concerning the annual update of information and mandatory reporting of quantities for chemicals for 2012 to the Norwegian Product Register. The Product Register is the central register for chemical products in Norway, and there are currently approximately 25,000 products registered. According to Klif’s notice, changes include adding a “NANO box” that registrants should mark if the chemical contains nanomaterials. The January 7, 2013, letter sent to registrants states:
Physical data that may be of significance when assessing the dangerous properties of chemicals must be declared under section 21 of the Norwegian Regulations relating to classification and labelling of dangerous chemicals. Details are given in guidelines on declaration. The definition of nano materials is given in the recommendation of the Commission by 18 October 2011. Registration of substances in nano form in the Product Register will provide better knowledge about where and how nano materials are used. The information will be used by the authorities in their work to protect human health and the environment.
For all your mandatory declared chemicals we ask you to provide information that is already known by the producer about substances on nano scale. This means that if your chemical contains a substance/substances in nano form, you should mark this in the appropriate box on the enclosed list. In addition you have to identify which constituent that is in nano form in the same box. During 2013 you will have to update the composition for all your mandatorily declared chemicals that contain substances in nano form.
Responses are due February 8, 2013.
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 information about nanoparticle substances produced/imported/distributed during the prior year. A report containing 2012 data will be due by May 1, 2013. The January 8, 2013, memorandum includes a link to a new website for reporting, as well as a link to a frequently asked questions and answers document (both in French).
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 notes that license holders are expected to continue monitoring and collecting new safety data as they emerge. Applicants are required to keep information for recordkeeping purposes when nano zinc oxide and/or nano titanium dioxide are used in sunscreen products, and this information is required to be made available upon request. Comments are due February 19, 2013.
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 to be ‘nano’ or you think may contain nano materials.” Users are instructed to:
- Search shop shelves and find products, where the word “Nano” appears on the packaging or on the product itself;
- Note down product name, manufacturer, address, and website;
- Take a picture of the product;
- Check the Nano Database to see if the product you have found has already been reported to the Danish Consumer Council; and
- Fill out the form on the website.
After a report is received, it will be forwarded to DTU Environment, “who will examine the reported product and in turn authorize its publication in the database.”
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:
- (a) Nominal length of 100 ± 50 nanometres;
- (b) Cross section dimension less than or equal to 10 nanometres; and
- (c) Sulphur content of greater than or equal to 0.5 percent and less than or equal to 1.0 percent by weight.
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 unless they are proposed for a significant new activity (SNAc) as indicated on the DSL. Substances not appearing on the DSL are considered to be new to Canada and are subject to 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 manufacture and/or use nanomaterials to determine how REACH affected their approach. Issues addressed included the relationships between substance risks and innovation and between REACH and innovation. The authors determined that REACH does not offer sufficient incentives to register nanomaterials and to apply nano-specific safety assessment procedures. In addition, according to the authors, the lack of specific provisions within REACH concerning nanomaterials results in uncertainties in the interpretation of legal concepts and obligations. The authors offer preliminary conclusions for a possible adaptation of the legal framework for nanomaterials.Continue Reading...
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:
- Performing an extensive literature search to summarize the knowledge in the field of nanotechnology applied to food and feed;
- Producing inventory lists for each type of application (e.g., food additives, enzymes, flavorings, food contact material, novel foods, feed additives, and pesticides), including at least one inventory list for food additives, one for food contact materials, and one for feed additives applications of nanotechnologies currently used and/or reasonably foreseen to be used;
- Reviewing the existing non-European Union (EU) legislation on the authorization of food additives/food contact materials/feed additives application in the area of nanotechnology; and
- Preparing a final report.
The length of the contract will be one year and is not renewable. Responses were due November 23, 2012. EFSA estimates that the contract will be completed in January 2014.
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 notified in the U.S. were inorganic carbon, most of those notified in Canada were mixed metal oxides. During the webinar, both Canadian and U.S. spokespersons noted the difficulty in sharing information, due to confidential business information (CBI) claims. The RCC would like to be able to share information to inform better their regulatory programs and risk assessment/management approaches. This would include:
- General Substance Information: Substance name, company, applications, volumes; and
- Technical Substance Specific Information: Physchem properties, technical studies, and use pattern information.
The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.Continue Reading...
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, Evaluation, Authorization and Restriction of Chemicals (REACH) program as “the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures” and notes that “more specific requirements for nanomaterials within the framework have proven necessary.” The NGOs maintain that further regulatory action is necessary, and recommend a “nano patch” for REACH, including an obligation for all nanomaterials to be considered distinct from their non-nanoscale counterparts and substantially lower volume thresholds for registration of nanoscale substances. The NGOs also call for an EU-wide registry for all nanomaterials and products on the market.Continue Reading...
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 risk assessment, taking into account both fundamental and practical considerations, and to provide a scientific discussion paper on the issue. According to the preliminary opinion, a number of additional factors, including the need to assess more complex products and processes, e.g., products of nanotechnologies, make a thorough examination of current and potential future methods particularly timely. The preliminary opinion states that research is needed for developing models suitable for predicting the fate of nanomaterials. Fully new approaches need to be developed, conceptually different from the traditional molecular-based models. The preliminary opinion states that SCENIHR, SCCS, and SCHER “are aware that the most of the proposals described in this discussion paper are not realistically suitable for amending, in the short term, risk assessment procedures for regulatory purposes. However, this discussion paper highlights needs and priorities for research in order to get the objective of higher precision, accuracy and transparency in risk assessment for protecting human and environmental health." Comments are due November 30, 2012.
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 Australia’s Nanotechnology Work Health and Safety Program. NICNAS extensively reviewed the published literature on the toxicity of carbon nanotubes, and concluded that multi-walled carbon nanotubes may cause damage to lungs through prolonged or repeated inhalation exposure. The report recommends classification as hazardous for repeated or prolonged inhalation exposure and for carcinogenicity. For all other endpoints, NICNAS found that carbon nanotubes either were not classified as hazardous, or cannot be classified as insufficient data are available. The information sheet summarizes the key findings from the report and discusses implications for manufacturers, importers, persons in control of a business or undertaking, and workers manufacturing or using products containing carbon nanotubes.
ECHA Will Hold Webinar on REACH Registration Dossiers for Nanomaterials and Creates Nanomaterials Working Group
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 October 17, 2012, ECHA announced publication of a new web page on nanomaterials under REACH and the Classification, Labeling, and Packaging (CLP) regulation. According to ECHA, the page “will provide advice to registrants that wish to register nanomaterials and inform about” ECHA’s latest activities concerning nanomaterials. The web page states that, in October 2012, ECHA created a nanomaterials working group “to discuss scientific and technical questions relevant to REACH and CLP processes and to provide recommendations on strategic issues.” The working group is an informal advisory group consisting of experts from Member States, the European Commission, ECHA, and accredited stakeholder organizations, “with the mandate to ‘Provide informal advice on any scientific and technical issues regarding implementation of REACH and CLP legislation in relation to nanomaterials.’” ECHA states that the working group also “aims to facilitate discussions with industry regarding its experience gained in documenting intrinsic properties of the nano-forms of substances using recent methodologies and its obligations towards fulfilling REACH requirements.”
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 Canada respecting nanomaterials. The Nanotechnology Work Plan includes specific objectives, deliverables, and milestones for tangible progress within the RCC’s two-year mandate. During the November 28, 2012, webinar, RCC will provide additional background information, as well as updates on ongoing activities under the Nanotechnology Work Plan. Stakeholders should confirm their webinar attendance no later than October 25, 2012.Continue Reading...
ICCM3 Adds Measures Concerning Nanotechnologies And Manufactured Nanomaterials To Global Plan Of Action
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 information on the presence of manufactured nanomaterials within the product supply chain and throughout the life cycle, which could include possible labelling, consistent with relevant international obligations, and/or other forms of guidance relating to consumer products containing manufactured nanomaterials.” Participants also agreed to a resolution to continue work on manufactured nanomaterials as an “emerging policy issue” under SAICM, and to develop international technical and regulatory guidance and training materials for their sound management. The Resolution invites the United Nations (UN) Committees of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) to review the applicability of the GHS criteria to manufactured nanomaterials and, if necessary, to prepare a work plan for adapting them.
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 that some may be toxic and some may not.” Since possible risks are related to specific nanomaterials and specific uses, nanomaterials should be assessed on a case-by-case basis. The Communication states: “Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required.” According to the Communication, the EC “remains convinced that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures but more specific requirements for nanomaterials within the framework have proven necessary. The Commission envisages modifications in some of the REACH Annexes and encourages ECHA to further develop guidance for registrations after 2013.” To improve the availability of information, the EC states that it “will create a web platform with references to all relevant information sources, including registries on a national or sector level, where they exist. In parallel, the Commission will launch an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight, including an in-depth analysis of the data gathering needs for such purpose. This analysis will include those nanomaterials currently falling outside existing notification, registration or authorisation schemes.”Continue Reading...
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 nanoparticles with the indicated characteristics, at a concentration up to 25 percent as a UV-filter in sunscreens, “can be considered not to pose a risk of adverse effects in humans after dermal application.” SCCS notes that this does not apply to other applications that might lead to inhalation exposure to zinc oxide nanoparticles, such as sprayable products. SCCS states that the use of larger (non-nano) forms of zinc oxide as a UV-filter with a concentration up to 25 percent, as stated in its 2009 clarification, is safe and is not of any additional safety concern compared to the nano-forms assessed in the opinion. Regarding whether SCCS has any further scientific concern about the use of zinc oxide in cosmetic products, SCCS states: “In view of the lung inflammation induced by ZnO particles after inhalation exposure, the use of ZnO in cosmetic products which may result in inhalation is of concern.” SCCS also notes: “Any cosmetic products containing ZnO particles (nano or non-nano) with coatings that can promote dermal penetration will also be of concern.” Comments are due October 22, 2012.
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 Danish market poses a risk for consumers and the environment. The Ministry plans for the first reports to be due in early 2014.
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, but may have to be adapted to the specificities of nanomaterials.” According to the brochure, knowing that the testing and assessment approaches for traditional chemicals are generally appropriate for assessing nanomaterials, OECD intends to focus on the specific aspects of manufactured nanomaterials that require the adaptation and/or development of specific testing methods used for assessing human health and environmental safety and on developing guidance documents for assessing manufactured nanomaterials adapted to their specificities. OECD states that this will include guidance on estimating exposure on how to use results on physicochemicals endpoints in exposure assessment and mitigation measures to reduce exposure to safe levels. The brochure highlights OECD’s activities concerning manufactured nanomaterials since 2006, including its Sponsorship Programme for the Testing of Manufactured Nanomaterials and development of guidance on exposure measurement and on exposure mitigation.
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 meet the expected demand for safety assessments, the Commission Health and Consumers Directorate General intends to identify relevant experts who will assist the work of the SCCS. The Working Group is looking for experts with knowledge in relation to nanomaterials, particularly those used in cosmetic products, in the following areas:
- Systemic toxicity;
- Human exposure (including inhalation);
- In vitro and alternative methods; and
- Risk assessment for human health.
The deadline for submission for the call for experts is October 15, 2012.
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.
EU-OSHA Posts Literature Review on Risk Perception and Communication on Nanomaterials in the Workplace
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:
- Summarize the general principles and theories of risk perception and communication, referring to relevant trends and current guidance on these topics;
- Identify the stakeholders involved in risk perception and communication for nanomaterials in the workplace, and appraise relevant research, studies, surveys, and risk communication initiatives that have been done to date at national and international levels; and
- Consider the gaps in knowledge and limitations of the risk communication initiatives in this area, and suggest ways these might be addressed, with a view to proposing how to communicate with workers and employers on the potential risks of nanotechnologies and highlighting the difficulties involved.
EU-OSHA states that risk communication strategies need to help employers make informed decisions about their workplaces and put adequate prevention measures in place, and to empower individual workers to take personal control of their own situations to protect themselves adequately.
SCENIHR Issues Call for Information and Experts on Health Effects of Nanomaterials Used in Medical Devices
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:
- Carbon nanotubes in bone cements;
- Nanopaste hydroyapatite powder for bone void filling;
- Polymer setting material with nanoparticles in dental cements;
- Polycrystalline nanoceramics in dental restorative materials;
- Nanosilver or other nanomaterials used as coatings on implants and catheters; and
- Nanosilver used as an antibacterial agent.
The EC states that, in addition, there are reports of iron-oxide nanoparticles injected into tumor cells to be heated-up by radiation or an external magnetic field, although this use has not yet been attributed clearly to the legislation on medicines or the to the legislation on medical devices.
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:
- PAS 134:2012 -- Terminology for carbon nanostructures, 2nd edition: Revised to help ensure the use of a consistent language across the disparate industries and technologists involved in this area;
- PAS 138:2012 -- Guide to the disposal of manufacturing process waste containing manufactured nano-objects: Provides guidance regarding the disposal of manufactured nanomaterials and objects and will support manufacturers and others in making decisions as to the most appropriate way to dispose of their process waste; and
- PAS 139:2012 -- Detection and characterization of manufactured nano-objects in complex matrices: Provides guidance concerning the detection and characterization of nano-objects and to those who want to understand their impacts on human and environmental health.
Additionally, BSI is developing a fourth PAS:
- PAS 137:2012 -- Nanomaterials and nanotechnology-based products -- Guide to regulations and standards: Provides guidance for United Kingdom (UK) organizations (including small- and medium-sized enterprises (SME)) by signposting regulation and standards relevant to the importation, manufacture, processing, distribution, and sale of nanomaterials and nanotechnology-based products, thereby assisting organizations in their business development and commercial success.
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 for discussions by policy makers and stakeholders on the use and further implementation of the recommended definition in national and international legal frameworks. RIVM concludes that, while the EC’s recommendation contains the relevant aspects, further guidance is necessary to ensure the definition is interpreted consistently. According to RIVM, the next step is to incorporate the definition into legal frameworks regarding the interpretation of the term nanomaterial. RIVM states that this will lead to the collection of “nano-specific” data, contributing to further insight into the “nano-specific” properties and the fate, kinetics, and effects of nanomaterials. This will help focus on the specific needs for risk assessment and risk management of nanomaterials.
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 Guidance describes the need for special considerations in relation to the safety of nanomaterials, in view of the possible distinct properties, interactions, and/or effects that may differ from the conventional form of the same materials. The Guidance includes the main elements of risk assessment of nanomaterials in relation to possible use as cosmetic ingredients, i.e., general safety considerations, material characterization, exposure assessment, hazard identification and dose-response characterization, and risk assessment. The Guidance notes that the Cosmetics Regulation No 1223/2009 defines nanomaterial as “an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm,” and that this definition could be revised in light of the EC’s October 2011 Recommendation on the definition of a nanomaterial. According to the Guidance, if the Cosmetics Regulation definition were aligned to the Recommendation, it would provide further information on whether a material falls under the definition of a nanomaterial.
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 of action. The draft paper reviews national and international activities on the risk analysis of nanomaterials in the food and agriculture sectors that have been carried out since the meeting. It presents national and international risk assessment and risk management approaches that identify and implement strategies to address potential hazards associated with the use of nanotechnology-related products or techniques. Information on relevant regulations and risk assessment activities was gathered from the websites of 16 national and international institutions, organizations, and governments. Information on actual and planned uses of nanomaterials resulting in human exposure through food or food packaging/contact materials since 2009 was collected from a variety of sources, including the scientific literature, websites, patent databases, market analysis reports, and material presented at conferences, workshops, and symposia. Comments are due November 30, 2012.
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 water soluble nanoparticles in any composition or physical structure, including nanoparticles that are present in solid materials.” The draft report acknowledges that, if solid materials are in good condition, “scarcely any nanoparticles will be released, but due to wear and tear and handling, such as drilling and sanding, it cannot be excluded that such particles can be released with all the associated risks.” The draft report concludes that, “[f]rom the point of view of health, it is best to also register the solid materials.” Data submitted to the registry would need to include chemical and physical properties, determinants of emission and exposure, and exposure concentrations. Regarding medical surveillance, the draft report concludes that implementation of a passive system is the best option. While a passive system would not provide answers quickly on whether health risks exist when working with nanoparticles, and if so, which type of health effects, when combined with other activities, such as targeted scientific research, it “may give a valuable contribution in the future to providing insight in the potential health risks due to exposure to nanoparticles.” Comments on the draft report, which was presented to experts of employer’s organizations and trade unions, are due August 10, 2012. According to the Health Council, it will consider comments when preparing the final report, which will be presented to the State Secretary of Social Affairs and Employment.
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 scope of the registration (i.e., whether and how many nano-forms are included) is often unclear and the level of nano-specific information provided (e.g., substance characterization, hazards, exposure, and risks) shows “significant room for improvement.” ECHA agreed with MSCA representatives on a common approach to addressing the current information requirements in nanomaterial dossiers, taking into account the scientific uncertainties and legislative framework provided by REACH. ECHA states that it will implement the EC’s recommendation on the definition of a nanomaterial as a benchmark in assessing substances, and “invites registrants to proactively characterise their substances in light of this definition.” Workshop participants discussed creating a working group on nanomaterials that would provide advice on scientific and technical principles related to nanomaterials under REACH. The working group on nanomaterials would act independently, but report to the relevant ECHA committees. According to ECHA, the mandate of this working group will be further consolidated with the MSCAs. In addition, ECHA intends to disseminate the best practices that it has collected from relevant stakeholders that registered nanomaterials and that were discussed in the first “Group Assessing Already Registered Nanomaterials” meeting prior to the workshop. ECHA intends to post the best practices on its website by this summer.
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 health and for environment. According to ECHA, the updated appendices “will further enhance the advice to registrants of substances in the nanoform a full year in advance of the next REACH registration deadline,” May 31, 2013.
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, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts. Lynn L. Bergeson was on the Steering Committee and presented at the symposium. The presentation slides and plenary videos are now available online.
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 that, where nanomaterials are used in a product, the risk to the environment and to health be assessed separately. Labels would be required to include the name of all nanomaterials contained in biocidal products, followed by the word “nano” in brackets. The regulation states that “approval of an active substance shall not cover nanomaterials except where explicitly mentioned.”
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 properties listed on safety data sheets (SDS). Landkrohn stated that a lack of data has impeded the work group’s ability to create a separate hazard class for nanomaterials.
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 Chemicals Management (ICCM3), which will be held September 17-21, 2012. The Nanotechnology Industries Association (NIA) submitted detailed comments on the proposal.
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 procedure, and states that this was justified on the basis that the final RIP-oN 2 report had already been the subject of consultation with relevant stakeholders. Its content could, therefore, be considered as reflecting a consensus. Furthermore, according to ECHA, the update “needed to be made urgently in order to allow publication of the guidance as soon as possible and well in advance of the next REACH registration deadline,” May 30, 2013. The updated Guidance provides tailored advice to prepare registrations for substances in the nanoform.
The European Chemicals Agency (ECHA) sent three new draft appendices to Chapters R.8, R.10, and R.14 of the guidance on information requirements and chemical safety assessment concerning recommendations for nanomaterials to the Competent Authorities for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) (CARACAL). The draft appendices are based on the results of the REACH Implementation Project on Nanomaterials (RIPoN). The draft appendices are available at:
- R.8 -- http://echa.europa.eu/documents/10162/13643/appendix_to_r8_clean_en.pdf;
- R.10 -- http://echa.europa.eu/documents/10162/13643/appendix_to_r10_clean_en.pdf; and
- R.14 -- http://echa.europa.eu/documents/10162/13643/appendix_to_r14_clean_en.pdf.
EU OSHA Announces French Report on Feasibility of Epidemiological Surveillance System for Workers Exposed to Engineered Nanomaterials
The European Agency for Safety and Health at Work (EU OSHA) posted an item on April 16, 2012, concerning a French report on the feasibility of an epidemiological surveillance system for workers exposed to engineered nanomaterials. EU OSHA notes that the French Health and Occupational Ministries asked the French Institute for Public Health Surveillance (InVS), supported by a multidisciplinary working group convened by the Institute for Public Health Research, to assess the feasibility of an epidemiological surveillance system of workers likely to be exposed to engineered nanomaterials. The resulting report “draws up an inventory of the numerous uncertainties inherent to this field such as the question of definition, the wide range of nanomaterials, the identification of health events that could be monitored, the registration and collaboration of companies and workers likely to be concerned by nanomaterials and the metrological issues.” According to EU OSHA, InVS suggests the implementation of a double surveillance system with a prospective cohort study and repeated cross-sectional studies. The repeated cross-sectional studies would include all kinds of nanomaterials, while the cohort study would focus on a few. In conclusion, EU OHSA states, the report gives some recommendations for epidemiological research. While the French report is dated 2011, an English summary is dated 2012.
The Organization for Economic Cooperation and Development (OECD) recently published a new document in its series on the safety of manufactured nanomaterials, Important Issues on Risk Assessment of Manufactured Nanomaterials. The document was prepared by Steering Group Six of the Working Party on Manufactured Nanomaterials (WPMN), which is leading the project on cooperation on risk assessment, and was endorsed at the ninth meeting of the WPMN in December 2011. The document provides the current practices, challenges, and strategies for assessing risk in circumstances where data are limited, and there is a necessity for more research on specific risk assessment issues. OECD cautions that it is not to be construed to imply scientific and/or policy endorsement of any specific risk assessment methods or models, however. OECD notes that “this document is a living document,” and was current at the time of WPMN’s ninth meeting in December 2011. The document is subject to amendment and refinement as research affords further understanding of how to assess and manage nanomaterials.
On April 10, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) invited interested parties to submit any relevant information that could assist it with its assessment of the safety, health, and environmental effects of nanosilver. In particular, SCENIHR states, it is interested in receiving any scientific information related to the “nano” forms of silver. The EC requested on December 9, 2011, that SCENIHR prepare a scientific opinion on the safety, health, and environmental effects and role in antimicrobial resistance of nanosilver. The EC requested SCENIHR “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 “to assess whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms.” The deadline for SCENIHR’s opinion is early 2013. All information submitted to SCENIHR is considered public unless otherwise stated by the provider. Information is due to SCENIHR by June 4, 2012.
Background Papers Available from the International Symposium on Assessing the Economic Impact of Nanotechnology
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, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts. Lynn L. Bergeson was on the Steering Committee and presented at the symposium. NNI has posted the following background papers:
- Challenges for Governments in Evaluating Return on Investment from Nanotechnology and its Broader Economic Impact;
- Finance and Investor Models in Nanotechnology;
- The Economic Contributions of Nanotechnology to Green and Sustainable Growth; and
- Models, Tools and Metrics Available to Assess the Economic Impact of Nanotechnology.
On May 9-11, 2012, the Organization for Economic Cooperation and Development (OECD) and Germany’s Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) will hold a workshop entitled “Safe Management of Nanowaste.” According to the draft agenda, the objectives of the workshop are to get a better understanding of the potential risks posed by nanowaste and waste containing nanomaterials; to exchange information about existing initiatives/approaches addressing nanowaste management; and to identify what OECD and member country governments can do to ensure safe management of such materials. After the workshop, the OECD Secretariat will prepare a report on the discussions and conclusions of the workshop, for submission to the next meeting of the Working Party on Resource Productivity and Waste in November 2012. The report will include proposals for further work and potential role of OECD in this area. Because space is limited, OECD’s Business and Industry Advisory Committee (BIAC) has been invited to nominate up to three participants. Interested persons should contact BIAC by April 11, 2012. Participation will be subject to confirmation, and interested persons should wait for formal confirmation before making travel arrangements.
On March 27, 2012, the European Commission (EC) posted a request to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for a scientific opinion on the health effects of nanomaterials used in medical devices. According to the EC’s request, in the field of medical devices, the following cases of alleged use of nanomaterials have been identified by Notified Bodies:
- Carbon nanotubes in bone cements;
- Nanopaste hydroyapatite powder for bone void filling;
- Polymer setting material with nanoparticles in dental cements;
- Polycrystalline nanoceramics in dental restorative materials;
- Nanosilver or other nanomaterials used as coatings on implants and catheters; and
- Nanosilver used as an antibacterial agent, for example in wound dressings.
Furthermore, according to the request, there are reports on iron-oxide nanoparticles injected into tumor cells to be heated-up by radiation or an external magnetic field. The EC states that, when assessing nanomaterials for medical applications, the risk assessor should be aware of the specific characteristics of nanomaterials to obtain appropriate information to be able to do the risk assessment of the application of nanomaterials in a medical technology. According to the request, the EC is currently preparing a proposal for a revision of the medical devices directives. The proposal might include provisions on the risk classification, the labeling, and the instructions for use of medical devices containing nanomaterials. The deadline for SCENIHR’s opinion is March 2013.
On March 5, 2012, Safe Work Australia announced the release of an information sheet on the safe handling and use of carbon nanotubes in the workplace and a document entitled Safe Handling and Use of Carbon Nanotubes. The information sheet provides an overview of risk management for carbon nanotubes, while Safe Handling and Use of Carbon Nanotubes describes two approaches to managing the risks: risk management with detailed hazard analysis and exposure assessment, and risk management by using control banding. Either or both of these methods may be used, depending on the circumstances. Safe Work Australia states that the guidance is applicable to other forms of carbon nanofibers, such as carbon nanorods and carbon nanowires. It is also applicable to products containing carbon nanotubes and other forms of carbon nanofibers where these nanomaterials may be released during handling. Safe Work Australia has commissioned a human health hazard assessment and classification of carbon nanotubes, and it expects to publish the findings in mid-2012.
On February 29, 2012, the European Chemicals Agency (ECHA) announced the first Community Rolling Action Plan (CoRAP), which includes 90 substances that Member States will evaluate under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) substance evaluation process. For each substance, ECHA notes the initial grounds for concern. For two substances, silicon dioxide and silver, the initial grounds for concern are “Substance characterization/Nanoparticles, toxicity of different forms of the substance.” Silicon dioxide is scheduled to be evaluated in 2012, by the Netherlands, and silver is scheduled to be evaluated in 2013, also by the Netherlands. ECHA notes that, when the substances are included in the CoRAP, “they have yet not been evaluated and thus the concern is indicative and not exhaustive or conclusive.”Continue Reading...
WHO Background Document on Guidelines on Protecting Workers from Manufactured Nanomaterials Available for Comment
The World Health Organization (WHO) released a draft background document proposing content and focus for Guidelines on “Protecting Workers from Potential Risks of Manufactured Nanomaterials.” According to WHO, the Guidelines will aim to facilitate improvements in occupational health and safety of workers potentially exposed to nanomaterials in a broad range of manufacturing and social environments. The Guidelines will incorporate elements of risk assessment and risk management and contextual issues, and provide recommendations to improve occupational safety and protect the health of workers using nanomaterials in all countries, especially in low- and middle-income countries. The WHO Guideline Development Group will use the background document to identify key questions to be addressed by the Guidelines. WHO asks commenters to note that key questions to be addressed by the Guidelines “should be answerable, their number should be manageable and answers to the key questions should be useful to the target audience of these Guidelines.” Comments are due March 31, 2012.
On February 22, 2012, the European Chemicals Agency (ECHA) issued a press release announcing that it is currently preparing an update of its Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) based on the European Commission’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIP-oN). Because the next registration deadline of May 31, 2013, is approaching quickly, ECHA “will facilitate compliance of all potential registrants well in advance.” ECHA intends to update the Guidance on IR & CSA later in 2012, in line with the outcomes of RIP-oNs 2 and 3. ECHA states that registrants may already find it useful to refer to the RIP-oN reports when preparing registration dossiers covering nanomaterials. ECHA reminds registrants, however, “to ensure that safe use of their substance should be demonstrated in the registration dossier, and hence that the data of the submitted properties as well as related risk assessment and management information should be applicable and appropriate for the nanoforms covered by the registration.” According to ECHA, the RIP-oN 1 report on the substance identification of nanomaterials also contains useful information that can be integrated into the IUCLID 5 manuals. Because the experience in addressing characterization of nanoforms is still developing, ECHA states it will not revise the current guidance on substance identity. Furthermore, ECHA notes, “for other areas it is clear that further scientific development and research are still necessary before providing definitive guidance updates.”
During the Summit on the Global Agenda 2011, the World Economic Forum’s Global Agenda Council on Emerging Technologies asked members to identify the technology trends that would have the greatest global impact. The trends, which were presented in order of greatest potential to provide solutions to global challenges, include “nanoscale design of materials” as fourth on the list. According to the Council, “increasing demand on natural resources requires unprecedented gains in efficiency. Nanostructured materials with tailored properties, designed and engineered at the molecular scale, are already showing novel and unique features that will usher in the next clean energy revolution, reduce our dependence on depleting natural resources, and increase atom-efficiency manufacturing and processing.” Nanotechnology was also mentioned in other trends: Number 6, “Utilization of carbon dioxide as a resource” (“[n]ovel catalysts, based on nanostructured materials, can potentially transform carbon dioxide to high value hydrocarbons and other carbon-containing molecules”); Number 8, “High energy density power systems” (“emerging technologies are coming together to lay the foundation for advanced electrical energy storage and use, including the development of nanostructured electrodes, solid electrolysis and rapid-power delivery from novel supercapacitors based on carbon-based nanomaterials”); and Number 9, “Personalized medicine, nutrition and disease prevention” (emerging technologies, including nanotechnology, “are laying the foundation for a revolution in healthcare and well-being that will be less resource intensive and more targeted to individual needs”).
The Center for International Environmental Law (CIEL) published a report on February 6, 2012, entitled Just Out of REACH: How REACH Is Failing to Regulate Nanomaterials and How It Can Be Fixed. According to CIEL, there are four key gaps in the registration phase of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation:
- REACH does not define nanomaterials, and contains no nano-specific provisions;
- Most nanomaterials evade registration until 2018, yet they can still enter the European Union (EU) market;
- REACH’s schedule for registration hinges on the number of tonnes of a chemical, essentially missing all nanomaterials, which are generally produced in far smaller quantities; and
- REACH test guidelines fail to consider the special properties of nanomaterials.
CIEL proposes stand-alone regulation, aligned with REACH, but specifically tailored to nanomaterials. CIEL states that such a regulation “would establish clear, legally binding provisions for nanomaterials and create a transparent and predictable legal environment for the safe production and use of nanomaterials in the EU.”
International Symposium on Assessing the Economic Impact of Nanotechnology Will Be Held in March 2012
On March 27-28, 2012, the American Association for the Advancement of Science (AAA) will host the “International Symposium on Assessing the Economic Impact of Nanotechnology.” The Working Party on Nanotechnology (WPN) of the Organization for Economic Cooperation and Development (OECD), in collaboration with the U.S. National Nanotechnology Initiative (NNI), organized the Symposium. Lynn L. Bergeson is on the Steering Committee and will speak at the Symposium. The objective of the Symposium is to explore systematically “the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts.” Participants will address the scope of economic impacts of nanotechnology; input and output factors; metrics for other technological assessments; consideration of the appropriateness of these metrics for nanotechnology materials and products; the role of research funding portfolios; intellectual property frameworks; venture capital; public-private partnerships; state and local initiatives; international cooperation; and metrics such as private sector and industry investments, patents and publications, and the development of a technologically-educated workforce as metrics for nanotechnology. Attendees are being invited from a broad spectrum of backgrounds and expertise, including technology leaders, key decision makers, economists, investors, policy analysts, scientists and engineers from industry, business, government, academia, and the general public. Registration will open February 10, 2012, and will be on a first-come, first-served basis until the capacity is met. Positions are expected to fill quickly.
Lynn L. Bergeson will participate in a February 7, 2012, Bloomberg BNA webinar entitled “The Greening of Consumer Products: Legal, Regulatory, and Strategic Considerations.” Bloomberg BNA states that the webinar is intended to help users:
- Identify the core concepts of green product development and the maturation of conventional environmental protection themes on which green product steward concepts rely;
- Describe the diversity of legal and regulatory authorities, domestic and international, that are relevant to chemical, industrial, and consumer product manufacturers from a legal compliance perspective;
- Analyze the role of private party standards and evolving concepts of product stewardship in product design and management;
- Address the trends and emerging themes embedded in the commercial value chain that must be monitored to be competitive and successful;
- Explore the challenges and value of green product marketing; and
- Develop basic strategies for legal compliance and commercial success in green product marketing.
The European Parliament (EP) passed a resolution on December 15, 2011, stating that nanomaterials must be covered by current European Union (EU) health and safety rules, based on a mid-term review of the EU’s 2007-2012 health and safety at work strategy. The resolution, which was adopted with 371 votes in favor, 47 against, and 15 abstentions, also calls for the assessment of the effects of new technologies on health. The EP calls for legislation to ensure that nanomaterials are covered by the current European Occupational Health and Safety regulation.
Japan’s Ministry of Economy, Trade and Industry (METI) established a Committee on Safety Management for Nanomaterials, which was scheduled to hold its first meeting on December 2, 2011. METI states that it established the Committee “on the basis of the results obtained from the project ‘Research and Development of Nanoparticle Characterization Methods’ commissioned by the New Energy and Industrial Technology Development Organization (NEDO) and the latest scientific knowledge.” The Committee will focus on risks caused by nanomaterials, and study appropriate management procedures for nanomaterials considering the actual usage and life cycles. According to Japan’s November 30, 2011, press release, the Committee will compile an interim report “around spring to summer in 2012.”
On November 23, 2011, the European Union (EU) Council’s committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be reviewed regularly, with approvals or renewals valid for a maximum of ten years, and less for “problematic” substances. The proposed legislation states that there is “scientific uncertainty” about the safety of nanomaterials, and “to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials, if possible based on the work of appropriate international fora, and to specify that the approval of an active substance does not include the nanomaterial form unless explicitly mentioned.” The proposed legislation calls on the European Commission (EC) to “regularly review the provisions on nanomaterials in the light of scientific progress.”Continue Reading...
The European Commission (EC) requested on December 9, 2011, that the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) prepare a scientific opinion on the safety, health, and environmental effects and role in antimicrobial resistance of nanosilver. According to the EC, while recent review papers suggest that nanosilver may not be hazardous to humans, data are insufficient to carry out a full risk assessment. The EC states that indirect adverse effects on human health may occur via an increasing resistance of micro-organisms against silver, including nanosilver and silver-based compounds, which could limit the usefulness of nanosilver in medical devices and other medical applications. Furthermore, the EC states, silver can be present in different forms, and it is not clear how these different forms of silver influence its antimicrobial properties, a possible increase of antimicrobial resistance, and the healing process. The EC notes that recent reviews and publications proposed to use a combination of nanosilver and the “usual antibiotics” for the treatment of specific infectious diseases caused by resistant bacteria. The EC requests SCENIHR “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 “to assess whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms.” The deadline for SCENIHR’s opinion is early 2013.
ObservatoryNANO posted on November 24, 2011, a report on the nanotechnology environment, health, and safety (EHS) landscape. ObservatoryNANO, which is funded by the European Commission, intends to support European policy makers by providing scientific and economic analysis of nanoscience and nanotechnology developments. ObservatoryNANO notes that activity concerned with the EHS aspects of nanotechnologies has been growing for a decade. ObservatoryNANO states that the aim of the EHS landscaping report is to provide a map and overview of key organizations and their activities within the field worldwide in relation to nano-EHS. ObservatoryNANO intends the landscaping document to support communication of efforts, outlining those key initiatives, activities, and projects within the field. According to ObservatoryNANO, because of the challenge of keeping track of the rapidly changing field, the landscaping document provides only a snapshot of efforts ongoing within 2011, and will change with time.Continue Reading...
The Nanotechnology Industries Association (NIA) will hold a workshop on November 30, 2011, entitled “Defining Nano!? Compliance Requirements & Market Impact of the EU Definition of ‘Nanomaterials.’” The workshop, which will be held in Brussels, Belgium, is intended to answer questions such as which market sectors will be affected by additional regulatory compliance, the economic impact on current and future applications of nanotechnologies, how the European Union (EU) definition will be implemented in European legislation and in EU member states, and what companies can do in the short-term to offset the cost of long-term compliance.
On November 3, 2011, the European Chemicals Agency (ECHA) began a consultation on a testing proposal for multi-wall carbon nanotubes, synthetic graphite in tubular shape. Under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, manufacturers and importers must obtain information on toxic effects of substances. REACH requires that new testing of a substance involving vertebrate animals be carried out only as a last resort, however. ECHA states that, to ensure that the best use has been made of existing information, it publishes all test proposals involving vertebrate animals for endpoints specified in Annexes IX and X under REACH. After a testing proposal has been published, third parties have 45 days to submit “scientifically valid information and studies that address the relevant substance and hazard endpoint, relating to the testing proposal.” The hazard endpoint for which vertebrate testing was proposed is long-term toxicity to fish. The deadline for submitting information is December 19, 2011. ECHA will consider any scientifically valid information and studies that address the relevant substance and hazard endpoint. ECHA publishes its responses to these contributions for the testing proposals after adoption of the related final decision.
The European Commission (EC) began in 2009 a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIPoN), which it intended to provide advice on key aspects of the implementation of REACH with regard to nanomaterials. The EC recently posted final reports concerning nanomaterials and information requirements (RIPoN 2) and chemical safety assessment (RIPoN 3). The EC states that, based on the scientific and technical state of the art with regard to nanomaterials, the reports were developed so that the advice on specific issues related to nanomaterials can be integrated into the existing REACH guidance documents. The EC notes that “inclusion of any of the advice from the reports into the [European Chemicals Agency (ECHA)] guidance is exclusively the responsibility of ECHA. The presented reports do not represent ECHA guidance.” Nevertheless, the EC states, “while awaiting the official guidance up-date, companies are invited to consult the two reports and take the recommendations into account as appropriate when preparing or updating REACH registration dossiers and evaluating hazard information for potential classification under CLP.” The EC also posted a third report on substance identity. The EC cautions, however, that since it was not possible to reach consensus amongst the experts on the recommendations in the third report, “further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA.”
The European Commission (EC) adopted on October 18, 2011, a Recommendation on the definition of a nanomaterial. The Recommendation “invites” member states, European Union agencies, and economic operators to use the following definition of nanomaterial “in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies”:
2. “Nanomaterial” means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm.
In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.
3. By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.
On October 11, 2011, Health Canada announced the availability of its Policy Statement on Health Canada’s Working Definition for Nanomaterials. Health Canada received 29 comments from stakeholders on its March 2010 Interim Policy Statement, which it revised based on stakeholders’ feedback. According to Health Canada, other revisions were prompted by developments in international norms, evolving scientific evidence, and regulatory program needs. Health Canada states that it will update its Policy Statement “as the body of scientific evidence and international norms progress.” The Policy Statement on Health Canada's Working Definition for Nanomaterial, summary of comments received, and frequently asked questions are available online.Continue Reading...
The European Commission (EC) has asked the Scientific Committee on Consumer Safety (SCCS) to prepare a guidance document on the safety assessment of nanomaterials in cosmetics. In its request for guidance, the EC notes that a number of documents provide general guidance on the health risk assessment of manufactured nanomaterials, but experience with the assessment of specific substances is limited. The guidance, which is due February 2012, should address the essential elements that would be required in a manufactured nanomaterial safety dossier (i.e., physicochemical characterization, toxicological evaluation, exposure assessment). According to the EC, the guidance will facilitate the submission of safety dossiers at present, as well as assist in the implementation of the provisions of Article 16 of the Cosmetics Regulation (EC) No. 1223/2009/, “which will impose strict conditions and timelines for the notification and the assessment of cosmetic products containing nanomaterials on the responsible persons and the SCCS respectively, starting on January 2013.”Continue Reading...
Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced on September 28, 2011, the availability of a review of the 2007-2009 literature on toxicological and health effects relating to six nanomaterials. NICNAS commissioned the review and analysis of literature concerning fullerenes, carbon nanotubes, and nanoforms of zinc oxide, titanium dioxide, cerium oxide, and silver. According to NICNAS, it chose these nanomaterials because it considers them “to already be in, or close to, commercial use in Australia.” The goal of the review was to identify any available scientific evidence of important toxicological/health effects that had not been covered by the scope of previous reviews and therefore supplement currently available scientific information on these substances.Continue Reading...
During the September 23, 2011, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) conference organized by the European Chemicals Agency (ECHA) and European Commission (EC), Astrid Schomaker, Directorate-General (DG) Environment, stated that the EC has been working on a definition of nanomaterials, and that it “should be coming after the summer.” The EC previously stated in a letter to the Dutch Environment Ministry that it would publish a definition by the end of June. Karl Falkenberg, Director-General for DG Environment, stated that the issue is “triangular -- we have to put together environmental, trade and health perspectives.” Conference delegates disagreed whether nanomaterials are appropriately addressed under REACH. According to Alexander Nies, Deputy Director-General for Germany’s Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, ECHA has found only three cases where substances qualify as nanomaterials, even though there are “more than 900 companies in Germany that produce nanomaterials.” Nies urged the EC to adapt REACH to deal with the specific features of nanomaterials. Adrian Harris, Director-General for the European Engineering Industries Association, responded that the Association supports “rationalization” rather than increasing demands under the registration process. Harris stated that “REACH in its present form is fit to address nanotechnology.”
German Advisory Council Releases Report Concerning Precautionary Strategies for Managing Nanomaterials
The German Advisory Council on the Environment (SRU) released on September 1, 2011, a report entitled Precautionary Strategies for Managing Nanomaterials, which makes recommendations for a “responsible and precautionary development” of nanotechnology. According to SRU, its objective is to allow for innovation while also identifying and reducing risks at an early stage. SRU concludes that while chemical, product, and environmental regulations are “generally applicable” to nanomaterials, the specific characteristics of nanomaterials could impede the application of the regulations. Closing the regulatory gaps “would require a uniform definition for nanomaterials, their treatment as separate substances in chemicals risk assessments and the obligation for manufacturers to submit data sets specifically adapted to nanomaterials.” SRU states that activities that it believes pose “a certain cause of concern are, in particular, the use of nanomaterials in consumer sprays, the growing sales of consumer products containing silver nanoparticles and the production and processing of carbon nanotubes, which are suspected to be carcinogenic -- especially those with a high aspect ratio.” To increase transparency regarding the presence of nanomaterials in consumer products, SRU recommends a register for products containing nanomaterials and an extension of existing labeling requirements. The SRU was founded in 1971 to advise the German government and consists of seven university professors from a range of different environment-related disciplines. SRU’s advice is independent from external instructions.
The August 25, 2011, issue of Nature includes a letter from Hermann Stamm, European Commission (EC) Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP). In response to Andrew Maynard’s article entitled “Don’t define nanomaterials,” in the July 7, 2011, issue of Nature, Stamm argues that a definition of engineered nanomaterials for regulatory purposes is “urgently needed.” Maynard proposes that a “‘one size fits all’ definition of nanomaterials will fail to capture what is important for addressing risk,” and suggests that regulators use “a list of nine or ten attributes (including size and surface area) for which certain values trigger action.” Stamm, however, maintains that size is “the most appropriate parameter on which to base a broad definition.” Maynard concludes that adaptive regulations are necessary to respond to scientific evidence, while Stamm acknowledges that a definition “would need revision in line with fresh scientific evidence.”
Earlier this month the Danish Environmental Protection Agency (DEPA) published a document entitled Survey on Basic Knowledge about Exposure and Potential Environmental and Health Risks for Selected Nanomaterials, which is intended to provide an overview of the existing knowledge about seven of the most common nanomaterials, their environmental and health properties, the use of those nanomaterials, and the possibility of exposure of humans and the environment. DEPA selected fullerenes, iron, silver, nanoclay, and titanium, cerium, and silicon dioxides for the project. Based on current uses, DEPA concluded that current applications of nano-iron and nano-clay cannot cause unexpected “nano-associated” health or environmental problems. Although DEPA identified no specific risk associated with current uses of any of the identified nanomaterials, it concluded “there are areas where there may be reason for attention and thus need for more knowledge.”
The National Nanotechnology Initiative (NNI) has posted the presentations from the March 10-11, 2011, workshop entitled “US-EU: Bridging NanoEHS Research Efforts,” which was intended to continue the robust dialogue between the U.S. and European Union (EU) on issues of shared concern pertinent to nanotechnology research initiatives. The workshop covered the following areas:
- Significant discussion about environmental, health, and safety (EHS) questions for nanotechnology-enabled products;
- Hands-on participation in joint programs of work that will better leverage resources; and
- Development of communities of practice areas, including identification of key points of contact, interest groups, themes between key U.S. and EU researchers, and key U.S. and EU funding sources for near-term and future collaborations.
The European Commission (EC) announced on July 13, 2011, that European Union (EU)-funded scientists have developed risk assessment criteria for engineered nanomaterials “that will help support experts in making innovation and policy decisions.” According to the EC, findings reveal that product design can affect the unintentional release of engineered nanomaterials. The scientists suggest that the risk assessment criteria should be used to assess and minimize potential risks, which the EC states “would benefit those working in the building sector in particular, because it is estimated that nanomaterials will be used to develop 15% to 30% of facade coatings within the next 4 years.” The study is presented in the journal Environment International.
The recast of the Directive on the Restriction of Hazardous Substances (RoHS) was published in the July 1, 2011, Official Journal of the European Union. The notice calls for the restriction of other hazardous substances and their substitution by more “environmentally friendly alternatives” as soon as scientific evidence is available, and taking into account the precautionary principle. The notice specifically states that these “other hazardous substances” include “any substances of very small size or with a very small internal or surface structure (nanomaterials) which may be hazardous due to properties relating to their size or structure.” Proposed restrictions on additional substances, including nanosilver and long multi-walled carbon nanotubes, were not supported by the European Union (EU) Council and were not included in the version of the legislation passed by both the EU Council and European Parliament (EP).
The Netherlands delegation submitted a paper entitled “Risks associated with nanomaterials” for discussion during the June 21, 2011, meeting of the Environment Council of the European Union (EU). The paper states that, under current EU legislation and the precautionary principle, “industry bears primary responsibility for the safety of its products for workers and consumers.” The current legislation is intended, however, “to assess the hazards of chemical substances used in products, such as cosmetics, but is not geared to evaluating the specific hazards related to nanoengineered particles.” According to the delegation, a key problem is the lack of a generally accepted definition of what constitutes a nanomaterial. The paper calls on the European Commission (EC) to take three steps to regulate nanomaterials: (1) reach agreement on a broadly applicable definition of nanomaterials that covers as many materials with nanospecific risks as possible; (2) ensure traceability and enable a fast and adequate response should a specific nanomaterial ever be found to be hazardous; and (3) develop an adequate risk assessment system for nanomaterials and for products with nanoscale features, and, where necessary, of risk control measures. The paper urges the EU to take action, rather than member states, to prevent industry from facing non-harmonized definitions of nanomaterials, different substance databases, additional administrative costs, and possible market restrictions for certain materials or products. The paper notes that, in the absence of such measures, however, member state initiatives “may be necessary to protect health and the environment.”
OECD Provides Snapshot on Current and Planned Activities on the Safety of Manufactured Nanomaterials
On May 26, 2011, the Organization for Economic Cooperation and Development (OECD) posted a document entitled “Current Developments/Activities on the Safety of Manufactured Nanomaterials,” which provides information on the outcomes and developments of the OECD Working Party on Manufactured Nanomaterials (WPMN) related to the safety of manufactured nanomaterials. OECD states that the document “provides a snapshot of information on current/planned activities related to the safety of manufactured nanomaterials in OECD member countries and other delegations that attended the 8th meeting of OECD’s Working Party on Manufactured Nanomaterials (Paris France, 16-18 March 2011).” The document also includes written reports on current activities from other international organizations such as the International Organization for Standardization (ISO), Food and Agriculture Organization of the United Nations (FAO), and World Health Organization (WHO).
The Silver Nanotechnology Working Group (SNWG) prepared a May 2, 2011, statement regarding the German Federal Institute for Risk Assessment's (BfR) April 12, 2011, statement concerning consumer products containing nanosilver. SNWG notes that, in December 2009, BfR published an opinion advising against the use of nanosilver in consumer products. Industry and other groups, including SNWG, asked BfR to reconsider its position, and BfR held a workshop on February 17, 2011, on nanosilver. SNWG states that, despite BfR’s assurance that follow-up dialogue would occur after the workshop, BfR instead issued its April 12, 2011, statement, which restated BfR’s initial opinion. According to SNWG, BfR has “essentially ignore[d] the facts presented to BfR during the workshop.” SNWG reviews BfR’s concerns regarding nanosilver -- the use of silver aims to replace normal hygiene measures, the potential for bacterial resistance from silver, and claims of unusual effects of nanosilver -- and addresses each. SNWG highlights the benefits to consumers from antimicrobial products, including longer shelf-life and protection from the degrading action and colonization of bacteria. SNWG notes that BfR disregarded multiple references regarding the low risk of resistance to silver and wrongly singled out nanosilver to address a concern about silver resistance in general. Finally, SNWG rebuts BfR’s assumptions concerning the use of silver and nanosilver, and concludes that the “mode of action is therefore not unusual in comparison to other silver forms employed in the marketplace or used throughout history.” SNWG describes additional issues of concern regarding BfR’s position on nanosilver, including its misunderstanding of materials and history; the selective harm to small- and medium-sized enterprises; and its preemption of the European Union regulatory process.
The European Chemicals Agency (ECHA) is compiling an inventory of nanomaterials included in the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossiers and Classification, Labeling, and Packaging (CLP) notifications for the European Commission (EC), and intends to deliver the inventory by the end of June 2011. The EC requested the inventory in response to the 2009 European Parliament communication on nanomaterials. An ECHA spokesperson stated that detailed results from the inventory would be available towards the end of 2011, and the inventory may be disseminated at a later date, but this has not yet been discussed. According to the spokesperson, ECHA has found three registration dossiers and 14 CLP notifications in which “nanomaterial” was selected as the form of the substance. The spokesperson stated that ECHA will be able to identify 50-60 REACH registration dossiers that include information on nanomaterials that will be sent to the Joint Research Centre for assessment under a separate project to address if and how information on nanomaterials is included in REACH registration dossiers.
On May 10, 2011, the European Food Safety Authority (EFSA) published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed. According to EFSA, the guidance “is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain.” The guidance covers risk assessments for food and feed applications, including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides. EFSA’s Scientific Committee prepared the guidance in response to a request from the European Commission (EC). EFSA states that the guidance complements existing guidance documents for substances and products submitted for risk assessment in view of their possible authorization in food and feed. The guidance stipulates the additional data needed for the physical and chemical characterization of ENMs in comparison with conventional applications, and outlines different toxicity testing approaches to be followed by applicants. The guidance presents six scenarios outlining different toxicity testing approaches. For each scenario, the guidance indicates the type of testing required. EFSA states: “Risk assessment of engineered nanomaterials is under fast development and consequently, in keeping with EFSA’s commitment to review its guidance for risk assessment on an ongoing basis, this work will be revised as appropriate.”
On April 21, 2011, the United Kingdom’s (UK) Food Standards Agency (FSA) published a report of consumers’ views on the use of nanotechnology in food and food packaging. FSA convened a focus group in late 2010 and early 2011, and asked participants about their views on nanotechnology. According to FSA, the main findings are that:
- Participants’ reactions to nanotechnology and food reflected a variety of concerns. These included whether this was a necessary development, whose interests it would serve, and whether the benefits outweighed the perceived risks;
- Acceptance around the use of nanotechnology was conditional. For instance, participants were more positive about the use of nanotechnology to reduce the salt or fat content of foods without adversely affecting the taste or texture. Participants were negative towards the use of nanotechnology for what they perceived to be “trivial” purposes, however, such as using nanotechnology to develop new flavors and textures;
- Participants were relatively more open to the use of nanotechnology in food packaging and readily identified the potential benefits of extended shelf life and waste reduction. Participants questioned, however, whether consumers would receive the benefits of nanotechnology or whether these developments would be of most benefit to the food industry;
- The current way of regulating nanotechnologies in foods, the European Novel Foods Regulation, provided participants with a degree of confidence that the framework in place ensured the safety of nanotechnology in foods. Questions were raised, however, about the ability to predict long-term health effects of nanotechnology in food and whether wider social and environmental implications would be taken into account; and
- To provide further confidence in the use of nanotechnology in foods, participants wanted transparency about the developments, including providing them with more information. A register of foods that use nanotechnology, established by a body independent from industry and government, was received positively. The introduction of an “n” label for nanotech foods was also proposed, although participants recognized that consumers might not use or understand this information without complementary education and awareness raising.
On April 12, 2011, the German Federal Institute for Risk Assessment (BfR) issued a statement entitled “Safety of Nano Silver in Consumer Products: Many Questions Remain Open,” which reports BfR’s conclusions from a February 2011 workshop discussing existing risks and possible options for comprehensive consumer protection from nanosilver. According to BfR, “the situation continues to be characterised by the fact that not enough secured scientific findings about the specific effects of nano-sized silver particles are available.” BfR states: “Articles of daily use and consumer products may not constitute any health risk based on statutory provisions during proper use or foreseeable misuse. Since no final safety assessment for man and the environment is available so far for nanoscale forms of silver due to the missing data, BfR continues to advise against a broad use of nano silver in consumer products.”
The Strategic Approach to International Chemicals Management (SAICM) Secretariat seeks input from stakeholders by May 1, 2011, for a forthcoming report on nanotechnologies and manufactured nanomaterials, which will focus on issues relevant to developing countries and countries with economies in transition. The report will include ten sections, covering beneficial uses of nanomaterials for health and the environment; economic and social impact; and work of international organizations. A section on risk assessment and management will focus on seven subtopics, including material characterization and risk management across the life cycle. The SAICM Secretariat intends to prepare a report based on the input it receives for consideration at the Open-Ended Working Group meeting, scheduled for August 29-September 2, 2011, in Belgrade, Serbia.
The European Parliament (EP) and European Union (EU) Council failed to reach agreement on an update to the novel foods regulation, which would have updated the 1997 regulation to address several issues, including nanoscale ingredients in food. According to a March 29, 2011, press release, the EP and Council disagreed on labeling food from cloned animals and their descendents, as well as nanotechnology. The draft legislation passed by the EP in July 2010 would have banned nanoscale ingredients from food until the risks posed are better understood, and would have required that any nanoscale ingredients eventually authorized be clearly labeled as such. The EP issued a March 29, 2011, statement, which notes that the failure to reach an agreement on the legislation means “[t]here will continue to be no special measures regarding nanomaterials in food, for example.”
According to a March 10, 2011, press release, the risks connected with nanomaterials are one of the areas on which the Swedish Chemicals Agency (KemI) will focus in its national action plan, which will apply from 2011-2014. The press release states that the objective is for Sweden “to become one of the leading member states in the [European Union (EU)] in proposing new bans and restrictions.” Sweden expects the action plan to “lead to intensified cooperation and dialogue with other government agencies, industry, researchers, environmental and consumer organisations.” In December 2010, the Swedish government commissioned KemI to produce a “national action plan for a toxin-free everyday environment.” KemI intends to focus on children “as they are more vulnerable to the influence of chemicals.” KemI will examine EU legislation and work to strengthen it to limit the presence of hazardous chemicals in products. KemI states that companies that manufacture and import products “should to a larger extent substitute hazardous chemicals, and they will be supported in these efforts.” KemI intends to expand enforcement activities in the form of inspection of articles.
In February 2011, the Dutch Environmental Safety and Risk Management Directorate sent a letter to the Directorate General (DG) Enterprise and DG Environment expressing concern regarding delays in the work of the Competent Authorities Sub-Group on Nanomaterials (CASG Nano) and the European Commission’s (EC) progress regarding clarifying the definition and status of nanomaterials. The Dutch Directorate states that an essential first step is to define what nanomaterials are and asks that the EC propose a common definition to member states as soon as possible, and in time for it to be discussed at the Competent Authorities for REACH and Classification and Labeling (CARACAL) meeting scheduled for mid-2011. According to the Directorate, the definition should be sufficiently broad to ensure all substances that present a nano-related risk are covered. The Directorate also asks that the three Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) implementation projects on nanomaterials be completed before the CARACAL meeting and that the EC provide greater clarity on the criteria necessary to assess whether nanomaterials pose specific risks. The Dutch competent authority is considering which substances to propose for substance evaluation under REACH and intends to include a nanomaterial. While the evaluation would not begin until 2012, the Dutch competent authority states that it would still be valuable to provide information on which elements of REACH remain problematic in terms of assessing hazards and risks associated with nanomaterials.
On February 17, 2011, the U.S. Environmental Protection Agency (EPA) announced that it awarded $5.5 million to three consortia to support innovative research on nanotechnology. EPA states that, in collaboration with the United Kingdom's (UK) Natural Environment Research Council, it is leading this scientific research effort to understand better the potential risks to people’s health and the environment. The grants EPA awarded are intended to help researchers determine whether certain nanomaterials can leach out of products such as paints, plastics, and fabrics when they are used or disposed of and whether they could become toxic to people and the environment. According to EPA, the U.S. Consumer Product Safety Commission (CPSC) has also contributed $500,000 through a new research partnership between the two agencies. Grant awards were made to three consortia consisting of researchers from the U.S. and the UK Each U.S. team of researchers received $2 million from EPA and CPSC, for a total of $6 million. Each UK team will also receive $2 million from the UK agencies, resulting in a grand total of $12 million to conduct the research.
On February 11, 2011, the European Union (EU) Regulatory Committee voted to adopt revised environmental criteria for hand dishwashing detergents and all-purpose cleaners and cleaners for sanitary facilities. The Committee supported a European Commission (EC) proposal not to exclude nanomaterials from products awarded the voluntary EU ecolabel, despite concerns from members states, including Austria, Germany, France, Denmark, Slovakia, and Poland, as well as Norway. The EC proposed that the definition of nanomaterials should be established before a ban is introduced. According to the adopted text, “nanoforms” should comply with the existing criteria on hazardous substances.
On February 14, 2011, the Joint Research Centre (JRC) announced the creation of the first European repository of nanomaterials. According to JRC, the repository contains most types of nanomaterials that are currently assumed to be used in significant volumes in consumer products. The materials will be used as a reference point by laboratories that carry out safety assessments on nanomaterials, to make sure that their results are comparable to those of other laboratories. JRC states that this responds to a need expressed by experts in international standardization organizations. The new repository includes, among other materials, carbon nanotubes, silver nanoparticles, titanium dioxide, cerium oxide, zinc oxide, bentonite, gold, and silicon dioxide.
On February 14, 2011, the Organization for Economic Cooperation and Development (OECD) published a booklet entitled Nanosafety at the OECD: The First Five Years 2006-2010, which covers highlights of activities, priority areas, and major outcomes, as well as outreach in dealing with safety issues arising from manufactured nanomaterials. Regarding next steps, OECD states that its research and development program regarding manufactured nanomaterials is “processing rapidly,” so the program remains flexible to address emerging issues in a “timely and resource efficient way.” OECD states: “There is still much to learn to fully understand how to work safely with some nanomaterials. However, if countries continue to work together in the OECD, as they have started to do, this should ensure that the human health and environmental safety aspects are addressed appropriately and efficiently at the same time, as the economic opportunities of the technology advance.”
On January 31, 2011, State Secretary for Infrastructure and the Environment, Joop Atsma, announced that joint investments in the development of nanotechnology made by the public and private sectors in the Netherlands must devote at least 15 percent of the investment to risk analyses. According to a spokesperson, the new requirement includes an €80 million ($110.4 million) investment approved by the previous government and matched by the private sector. The independent Committee for Societal Dialogue on Nanotechnology recently released a report that found citizens have a positive attitude about the opportunities offered by nanotechnology, but are concerned about the risks.
The South Korean Ministry of Environment released on January 18, 2011, the National Chemicals Control Basic Plan, which it intends to help it implement the United Nations’ sustainable chemical control rules under the 2006 Strategic Approach to International Chemicals Management (SAICM). According to the Ministry, the Plan will reduce the amount of human carcinogens released into the environment annually by 32 percent by 2020, and will expand the national toxicity information database by 2020 to cover 34,000 chemical substances, or 80 percent of some 43,000 known to be in circulation, up from the current level of 15 percent. Under the Plan, nanosubstances are among priority chemicals that will be subject to in-depth hazard assessment, exposure analysis, and safety studies.
The European Commission (EC) announced that it will hold the fourth annual Nanotechnology Safety for Success Dialogue Workshop on March 29-30, 2011, in Brussels, Belgium. According to the EC, many market modelers identify nanotechnologies as drivers of economic growth, and as a consequence, many governments have adopted ambitious plans intended to ensure the commercial success of nanotechnologies. At the same time, the number of potential and real applications is increasing rapidly. The international community has organized itself to address the potential safety aspects of nanomaterials, in particular under the auspices of the Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials, and with the support of national and European scientific advisory bodies like the EC Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). A number of regulatory developments have taken place while the science was also advancing. The EC is convening the Workshop to:
- Take stock of the fast advancing science needed for appropriate and effective policies; and
- Analyze how these advances allow progress with respect to intelligence gathering, risk assessment, risk management, and safe design.
Registration to participate on location or via web streaming is open until March 1, 2011.
On January 25, 2011, the European Agency for Safety and Health at Work (EU-OSHA) announced that French Agency for Environmental and Occupational Health Safety (ANSES) experts have developed a control banding tool specific to nanomaterials that can potentially be used in any work environment in which nanomaterials are manufactured or used. With control banding, new products are classified into “bands,” which are defined after comparison with the hazard level of known and/or similar products, while taking into account the assessment of exposure at the work station. The process combines a qualitative risk assessment with a risk control band and proposes minimum collective preventive measures to be implemented that are consistent with the estimated level of risk. EU-OSHA notes that, “[i]n particular, the proposed tool is especially adapted to [small- and medium-sized enterprises (SME)] which do not necessarily have at their disposal the metrological characterisation equipment or detailed toxicological studies required for a proper risk assessment process.”Continue Reading...
EFSA Begins Public Consultation on Draft Guidance on Risk Assessment for Nanoscience and Nanotechnologies
On January 14, 2011, the European Food Safety Authority (EFSA) began a public consultation on a draft document entitled “Guidance on Risk Assessment Concerning Potential Risks Arising from Applications of Nanoscience and Nanotechnologies to Food and Feed.” According to EFSA, the draft guidance offers practical guidance for the risk assessment of applications involving the use of nanoscience and nanotechnology in the area of food and feed (including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides). The draft guidance states that the general risk assessment paradigm is applicable for these applications, and consequently appropriate data and information for the various steps should be made available to the risk assessor to carry out a risk assessment. Adequate characterization of engineered nanomaterials (ENM) is essential for establishing its identity and physico-chemical forms in food/feed products. In cases in which transformation of the ENM into a non-nanoform in the food/feed matrix or in gastrointestinal fluids is judged to be complete, then EFSA guidance for non-nanoforms for the specific intended use should apply. The ENM covered by the draft guidance fall into two categories: (1) when a nanoform of an already approved non-nanoform with the same intended use in food/feed is produced; and (2) when a new ENM without a corresponding approved non-nanoform is produced. In the situation where there is an approved non-nanoform of a substance with the same intended use in food/feed, the aim of the draft guidance is to indicate the supplementary and specific data required on the potential additional hazards and risks that may arise from the nanoform. In the situation where the ENM persists in the food/feed matrix and in gastrointestinal fluids and has no approved non-nanoform application, toxicity tests on the ENM should follow the relevant EFSA guidance for its intended use, with some modifications in the testing due to the nanoproperties. Comments are due February 25, 2011.
On December 17, 2010, ETC Group published a report entitled The Big Downturn? Nanogeopolitics, which updates its 2005 nanogeopolitics survey. According to ETC Group, since 2005, policymakers have begun to acknowledge that fast-tracking nanotechnology has come at a price and that some sort of regulation is necessary to address at least some of the risks posed. ETC Group states, though, that “governments and industry, hand in hand, have come too far and invested too much to give up on nanotech’s promise of becoming the strategic platform for global control of manufacturing, food, agriculture and health -- a pillar of the 21st century’s ‘green economy.’” ETC Group provides an update on the geopolitical landscape, producing a current snapshot of global investment, markets, governance, and control, including intellectual property. ETC Group is hopeful that the risks of nanotechnology will be addressed in fora such as the International Labour Organization (ILO) XIX World Congress on Safety and Health at Work in Istanbul in September 2011 and the United Nations (UN) Rio+20 Summit in 2012.
Nature Nanotechnology has posted a pre-publication version of an article entitled “Science Policy Considerations for Responsible Nanotechnology Decisions,” which is authored by regulatory officials of the U.S. Environmental Protection Agency (EPA), European Commission (EC), and the Organization for Economic Cooperation and Development (OECD). The authors offer their perspectives on possible approaches to maximizing the environmental benefits of nanotechnology and products that contain nanomaterials while minimizing the negative impacts. For the path forward, the regulators recommend that researchers and risk managers work together to develop approaches to limit exposure and identify and address those properties of specific nanomaterial types that appear to be the source of potential hazards or exposures. According to the regulators, industry “should contribute significantly to this work because it best understands the characteristics and performance of the materials it produces, as well as what types of controls (such as personal protective equipment for workers) will function best in particular occupational situations.” In recognition of the possibility to avoid risk before nanomaterials enter the environment, the regulators “support the application of a life cycle perspective and encourage the development of safer-by-design methods and approaches such as green chemistry for sustainable production of chemicals in ways that reduce environmental impact.”
Australia’s National Industrial Notification and Assessment Scheme (NICNAS) recently issued guidance on the new chemical requirements for the notification and assessment of industrial nanomaterials that are considered to be new chemicals. The new administrative arrangements will be effective from January 1, 2011, and will apply to any new chemical that falls under the following working definition of “industrial nanomaterial”:
. . . industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 [nanometer (nm)] and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale).
The Switzerland State Secretariat for Economic Affairs (SECO) has posted a December 21, 2010, guidance document for preparing safety data sheets (SDS) for synthetic nanomaterials. Safety Data Sheet (SDS): Guidelines for Synthetic Nanomaterials is intended to demonstrate the information necessary to ensure the safe handling of nano-objects and products that contain nano-objects; offer assistance on how the relevant information can be identified and in which form and which place they are to be listed in the SDSs; and contribute to making employees of companies that produce or process synthetic nano-objects aware of the particular properties of these materials. The Guidelines, which are limited to “specifically manufactured (i.e. synthetic) nano-objects which are nano-sized in two or three dimensions (i.e. nano-fibres or nano-particles),” include two fictitious examples of SDSs for synthetic nanomaterials. The Guidelines supplement the Federal Office of Public Health (FOPH) document entitled The Safety Data Sheet in Switzerland.Continue Reading...
On December 8, 2010, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) approved its opinion on the scientific basis for the definition of the term “nanomaterial.” The opinion concludes that:
- Whereas physical and chemical properties of materials may change with size, there is no scientific justification for a single upper and lower size limit associated with these changes that can be applied to define adequately all nanomaterials;
- There is scientific evidence that no single methodology (or group of tests) can be applied to all nanomaterials; and
- Size is universally applicable to define all nanomaterials and is the most suitable measurand. Moreover, an understanding of the size distribution of a nanomaterial is essential and the number size distribution is the most relevant consideration.
To define an enforceable definition of “nanomaterial” for regulatory use, the opinion proposes to set an upper limit for nanomaterial size and to add to the proposed limit additional guidance specific for the intended regulation. According to the opinion, it is critical that the guidance includes an extended description of relevant criteria to characterize the nanoscale. Merely defining single upper and lower cut-off limits is not sufficient in view of the size distributions occurring in manufactured nanomaterials. Alternatively, a tiered approach may be required depending on the amount of information known for any specifically manufactured nanomaterial and its proposed use.
On December 3, 2010, the Organization for Economic Cooperation and Development (OECD) posted two documents in its series on the safety of manufactured nanomaterials:
- Compilation and Comparison of Guidelines Related to Exposure to Nanomaterials in Laboratories -- OECD developed this document as part of its work on occupational exposure mitigation. The document compares existing published guidelines regarding the use of nanomaterials at the laboratory scale, including the manufacture and the use of products in industrial, institutional, and commercial settings. OECD states: “Since there are not globally standardized protection measures determined for nanomaterials, it is expected that this document is to be of interest for research laboratories and industrial enterprises that produce or process nanomaterials at the laboratory scale.”
- List of Manufactured Nanomaterials and List of Endpoints for Phase One of the Sponsorship Programme for the Testing of Manufactured Nanomaterials: Revision -- OECD first published this document in 2008. It provides the list of representative manufactured nanomaterials and the list of endpoints for human health and environmental safety addressed by the Sponsorship Programme for the Testing of Manufactured Nanomaterials. OECD states that, based on the current state of knowledge, the Working Party on Manufactured Nanomaterials updated the list of manufactured nanomaterials by removing carbon black and polystyrene, and adding gold-nanoparticles.
On November 24, 2010, the European Parliament (EP) overwhelmingly approved the proposed recast of the Restriction of Hazardous Substances (RoHS) Directive, which restricts the use of certain hazardous substances in electronic and electrical equipment (EEE). The EP passed by a vote of 640 to 3, with 12 abstentions, legislation that would extend the Directive to most EEE, unless specifically excluded. The legislation calls for a review of the Directive after three years, at which time new substances may be added. Exemptions for banned substances would be allowed only if they are in the interest of consumer health and safety and no alternatives are available. Proposed restrictions on additional substances, including nanosilver and long multi-walled carbon nanotubes, were not supported by the European Union (EU) Council and are not included in the version of the legislation passed by both the EU Council and EP. The EP press release notes that “nanomaterials are cited as due for further scientific scrutiny” when RoHS is reviewed in three years.
On October 25, 2010, the European Consumer Voice in Standardisation (ANEC) and European Consumers’ Organisation (BEUC) announced their 2010 inventory of consumer products containing nanomaterials. According to BEUC, ANEC and BEUC began monitoring the availability of products containing nanomaterials in 2009, and that year’s inventory listed only 151 products. The 2010 inventory includes 475 products in categories such as child products, food and drink, cosmetics, products for cars, and electronic devices. ANEC and BEUC support the Belgian Presidency’s proposal to ensure the traceability of nanomaterials.
On October 21, 2010, the European Commission (EC) began a consultation on its proposal for a definition of the term “nanomaterial” that the it intends to use as “an overarching, broadly applicable reference term” for any European Union (EU) communication or legislation addressing nanomaterials. The EC states that the definition of the term “nanomaterial” should be based on available scientific knowledge and should be used for regulatory purposes. The definition should determine when a material should be considered as a nanomaterial for legislative and policy purposes in the EU. The EC proposes to define as a nanomaterial any material meeting at least one of the following criteria:
- Consists of particles, with one or more external dimensions in the size range 1 nanometer (nm)-100 nm for more than one percent of their number size distribution;
- Has internal or surface structures in one or more dimensions in the size range 1 nm-100 nm; or
- Has a specific surface area by volume greater than 60 m2/cm3, excluding materials consisting of particles with a size lower than 1 nm.
The EC states that it intends to carry out a public consultation by 2012 and, if appropriate, review the adequacy of the definition “taking into account experience gained, scientific knowledge and the technological development.”
In an October 5, 2010, Chemical Gazette notice, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced that it is introducing new administrative processes for the notification and assessment of industrial nanomaterials that are considered to be new chemicals. The new administrative arrangements will be effective from January 1, 2011, and will apply to any new chemical that falls under the following working definition of “industrial nanomaterial”:
. . . industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 [nanometer (nm)] and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale).Continue Reading...
OECD Releases Report on Current Developments and Activities on the Safety of Manufactured Nanomaterials
In a September 22, 2010, report entitled Current Developments/Activities on the Safety of Manufactured Nanomaterials, the Organization for Economic Cooperation and Development (OECD) provides information on current and planned activities related to the safety of manufactured nanomaterials in OECD member and non-member countries that attended the seventh meeting of OECD’s Working Party on Manufactured Nanomaterials (WPMN) on July 7-9, 2010, in Paris, France. The document also includes reports on relevant current activities in other international organizations such as the International Organization for Standardization (ISO) and the World Health Organization (WHO).
During a September 14, 2010, conference on nanomaterials management, Paul Magnette, the Belgian Minister for Energy, Environment, Sustainable Development, and Consumer Protection, proposed to create a specific register for nanomaterials under the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) program and to implement mandatory labeling for nanomaterials used in consumer products. According to Magnette, the next European Environment and Health Action Plan is expected to address the challenge of nanomaterials among its priority areas. In 2011, the European Commission (EC) must also respond to the April 2009 European Parliament (EP) resolution on the regulatory aspects of nanomaterials. The resolution calls for various “ambitious” measures to ensure safety with regard to nanomaterials and nanotechnology. Magnette put forward five proposals from the Belgian Presidency of the European Union (EU) that are intended to respond to consumer needs while ensuring their safety:
- Define the obligation to inform the consumer of the presence of nanomaterials in consumer products;
- Ensure the traceability of the chain so as to be able to return to the source, if necessary. Regarding this aspect, it would be obligatory to maintain a register of nanomaterials;
- Identify the most appropriate regulatory path at the EU level for risk evaluation and management;
- Encourage member states, during this transitory period, to take up the responsibility and draw up integrated national strategies and concrete measures in favor of risk management, information, and monitoring; and
- Regulate the claims made on labels of products containing nanomaterials.
On July 12, 2010, the European Commission (EC) opened a public consultation on the pre-consultation opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) entitled “Scientific Basis for the Definition of the Term ‘Nanomaterial.’” The EC states that its services need a working definition for the term “nanomaterial” to ensure the consistency of forthcoming regulatory developments, to guide the effective implementation of existing regulations, and to contribute to international work and dialogue on nanotechnology definitions. In its opinion, SCENIHR notes that the commonly used definition of the nanoscale is having a size between approximately 1 and 100 nanometers (nm). SCENIHR states, however, that there is no scientific evidence in favor of a single upper limit, and that there is no scientific evidence to qualify the appropriateness of the 100 nm value. According to SCENIHR, there is a need for a more elaborate description to identify unequivocally a nanomaterial or a product containing a nanomaterial for various European Union (EU) regulatory bodies. In its opinion, SCENIHR provides advice on the essential scientific elements of a working definition for the term “nanomaterial” for regulatory purposes, and discusses existing definitions formulated by various bodies. SCENIHR proposes to define an enforceable definition of “nanomaterial” for regulatory use by setting an upper limit for nanomaterial size, and adding to the proposed limit additional guidance (requirements) specific for the intended regulation. SCENIHR states:
Crucial in the guidance that needs to be provided is the extended description of the nanoscale. Merely defining single upper and lower cut-off limits is not sufficient in view of the size distributions occurring in manufactured nanomaterials. Although many nanomaterials are produced for specific properties at the nanoscale, at the moment it is not possible to identify a specific size or a specific generic property that is suddenly introduced or changed with size. Alternatively, a tiered approach may be required depending on the amount of information known for any specifically engineered nanomaterial and its proposed use.
Comments are due September 15, 2010.
On July 7, 2010, the European Parliament (EP) voted that nanoscale ingredients should be banned from food in the European Union (EU) until the health and environmental risks they might pose are better understood, and that any nanoscale ingredients that are eventually authorized should be clearly labeled as such. The EP voted on several amendments to draft legislation concerning the authorization of novel foods, including a provision that would prohibit food from cloned animals or their offspring. The EP has been unable to reach agreement with the European Council on the legislation, largely because of the provision concerning cloned animals. The Council also disagrees that foods containing nanoscale ingredients should be systematically labeled, however. According to an EP spokesperson, the legislation likely will go to conciliation, during which the EP and European Council will attempt to negotiate a compromise after two readings have failed to produce an agreement. The legislation likely will be discussed again in the fall.
On July 2, 2010, the European Commission’s (EC) Joint Research Centre (JRC) announced the availability of a reference report entitled Considerations on a Definition of Nanomaterial for Regulatory Purposes. JRC prepared the report in response to a request from the European Parliament (EP). JRC states that the aim of the report is to review and discuss issues and challenges related to a definition of “nanomaterial,” and to provide practical guidance for a definition for regulatory purposes. JRC suggests that a definition for regulatory purposes should:
- Only concern particulate nanomaterials;
- Be broadly applicable in European Union (EU) legislation, and in line with other approaches worldwide; and
- Use size as the only defining property.
On June 8, 2010, the Organization for Economic Cooperation and Development (OECD) announced the publication of two materials for use in the OECD Sponsorship Programme. The first is a revision of the Guidance Manual for the Testing of Manufactured Nanomaterials. According to OECD, the revised Guidance “is intended to support the testing undertaken in the context of OECD’S Sponsorship Programme and to ensure that the information collected from this testing programme be reliable, accurate, and consistent.” OECD states that the second document, entitled Preliminary Guidance Notes on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials, was published to assist the sponsors of the OECD Sponsorship Program, as well as to help others involved in the safety testing of manufactured nanomaterials.
On June 11, 2010, the European Chemicals Agency (ECHA) announced the availability of a technical manual for including nanoforms in an International Uniform Chemical Information Database (IUCLID) dossier. The Nanomaterials in IUCLID 5.2 Industry User Manual “gives practical instruction to [Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)] registrants on how to include information on different forms of a substance in a IUCLID 5.2 dossier.” The Manual introduces a book-keeping principle, where each form gets a specific label that enables it to be tracked throughout the dossier. Instructions are given on how to create labels for form-specific reference substances, composition blocks, endpoint study records, and analytical data. In particular, the Manual “gives instructions that will enable registrants to consistently create and label Endpoint study records such that it is clear which composition or form was used as the test substance for that study.”Continue Reading...
On June 6, 2010, the European Commission (EC) Joint Research Center Institute for Health and Consumer Protection (JRC-IHCP) and the Chinese Academy of Inspection and Quarantine signed a Memorandum of Understanding (MOU) at the European Union (EU)-China Food Safety Scientific Seminar held at the Shanghai World Expo. According to JRC-IHCP, “[b]oth institutions provide technical support for policy makers and aim to reinforce their co-operation in scientific research for consumer products safety.” The MOU is intended to support risk management, and, through new approaches in nanotechnology, to improve consumer protection. JRC-IHCP cites the globalization of markets as one reason for this joint effort, saying “food safety or consumer protection are no longer domestic issues, but need to be addressed in an international collaboration.”
On June 10, 2010, the Federal Institute for Risk Assessment (BfR) issued a press release entitled “Nanosilver has no place in food, textiles or cosmetics,” which states “BfR currently advises against using nanoscale silver ions in consumer products.” According to BfR, manufacturers of consumer products “have made use of the antimicrobial properties of silver ions for some time now,” and “silver particles in the nanorange have likewise been used.” BfR states: “It is not possible at the present time to determine in a definitive manner whether nanosilver constitutes a health risk for consumers,” and “we recommend that manufacturers refrain from using nanosilver in consumer products.” The press release states:
BfR feels there is a need for research to elucidate the fundamental issues in conjunction with the use of nanoscale silver as an antimicrobial material. On what scale do consumers come into contact with nanoscale particles? How big is the danger of resistance development?
BfR recommends refraining from using any nanoscale silver in consumer products until a definitive safety assessment becomes available. In any case nanoscale additives in food require approval. Nanosilver has not been approved for use in food. BfR welcomes this in the context of the yet to be answered questions about risk assessment.
BfR has published an Opinion on this subject.
On June 2, 2010, the European Parliament (EP) Committee on the Environment, Public Health, and Food Safety approved the proposed recast of the Directive on the Restrictions of Hazardous Substances (RoHS) in Electrical and Electronic Equipment, with 55 votes in favor, one against, and two abstentions. The Committee adopted amendments adding nanosilver and long multi-walled carbon nanotubes (MWCNT) to Annex IV, despite the fact that nanomaterials were not included in earlier proposals. In effect, there would be no threshold, with equipment prohibited from the market if it contained either nanosilver or long MWCNTs at “detectable levels.” The Committee also adopted amendments that require equipment containing nanomaterials to be labeled, and for manufacturers to be required to provide safety data on the nanomaterials to the European Commission (EC). The Committee voted in favor of an “open scope,” meaning that the RoHS Directive would apply to all electrical equipment, unless specifically excluded. The EP plenary vote on the amended proposal is scheduled for July 2010.
During the Helsinki Chemicals Forum 2010, Jukka Malm, European Chemicals Agency (ECHA) Assessment Director stated that ECHA is revising its Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) guidance documents to include technical instructions to help companies include nanomaterials in their registration dossiers and other compliance obligations for substances they make or import. According to Malm, ECHA is following “international developments,” particularly work by the Organization for Economic Cooperation and Development (OECD) concerning nanomaterial safety and testing. Malm stated: “As results become available, we are trying to introduce them into our guidance documents for steering industry on how to implement REACH in practice in their registration dossiers and other obligations.”
On April 27, 2010, ILO published a booklet entitled “Emerging Risks and New Patterns of Prevention in a Changing World of Work,” which summarizes new occupational safety and health issues, including those related to technical innovations such as nanotechnology. The booklet states:
There is a big knowledge gap between advances in the application of nanotechnology and its impact on health. Due to the extensive and highly diversified use of nanomaterials in industry, the number of workers exposed is also difficult to estimate. While little is known about the health and environmental impact of these new materials, it is likely that workers will be among the first to experience high rates of exposure.
According to ILO, the need to share information about emerging risks is “vital, at both the national and international levels.” ILO notes that “[t]he study of nanomaterials, for example, illustrates the importance of knowledge sharing in the development and application of new technologies, whereby the identification and assessment of associated hazards and risks need to be considered and communicated at a stage before widespread application in industry.”
The Organization for Economic Cooperation and Development (OECD) posted on May 5, 2010, two reports concerning nanomaterials:
- Report of the Workshop on Risk Assessment of Manufactured Nanomaterials in a Regulatory Context: This is the Report of the September 2009 Workshop on Risk Assessment of Manufactured Nanomaterials in Regulatory Context, which was co-hosted by the Business and Industry Advisory Committee (BIAC) and the Society for Risk Analysis (SRA). According to OECD, the Workshop provided an opportunity to discuss critical issues specific for risk assessment of nanomaterials in a regulatory context, and to identify approaches for risk assessment based on the current state of knowledge.
- Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials: According to OECD, this Report presents the information obtained from the Questionnaire on Regulatory Regimes on Manufactured Nanomaterials. OECD analyzed 24 legislations from nine jurisdictions. The Report summarizes objectives and activities covered by each legislation, as well as information on registration/notification, assessment, and management of substances that are either premarket or already in commerce. It also provides a number of legislative features identified in the legislations for consideration when amending or drafting legislation for regulatory oversight of nanomaterials and their products.
EP Committee Votes to Require Risk Assessments and Labeling for Food Products Containing Nanomaterials
On May 4, 2010, the European Parliament (EP) Committee on the Environment, Public Health, and Food Safety voted on draft legislation regarding “novel foods,” which are defined as those that have not been consumed to a significant degree in the European Union (EU) before May 1997. Under the legislation, foods produced by nanotechnology processes would be required to undergo risk assessment before being approved for use, and approved products would be subject to labeling requirements. According to the Committee, foods produced by nanotechnology processes must remain excluded from the European Community (EC) list until they have undergone specific and adequate risk assessments, and the possible health effects of materials at nanoscale are better understood. The draft legislation would define nanomaterials as having one or more dimensions less than 100 nanometers (nm). All ingredients present in nano-form would need to be clearly indicated in the list of ingredients. The EP plenary vote on the draft legislation is scheduled for July 2010.
MATTER and the Economic and Social Research Council Centre for Business, Relationships, Sustainability, and Society at Cardiff University will hold a joint conference entitled “Corporate Responsibility and Emerging Technologies: How Nanotechnologies Are Shaping the CSR Agenda” on June 4, 2010, in London. The free conference is intended to focus on the social and ethical dilemmas involved in the use of emerging technologies. The conference is open to all companies and stakeholders who may have an interest in the development of new technologies. The conference will explore key areas that companies should consider when using new technologies from the legal, insurance, and corporate social responsibility (CSR) perspectives, as well as to reflect on what companies are doing already to mitigate the risks and grasp the opportunities. To register for this event, please RSVP direct to email@example.com.
The January 25-29, 2010, African regional meeting on the implementation of the Strategic Approach to International Chemicals Management (SAICM) included a workshop on nanotechnology. During the meeting, 53 governments adopted a resolution that calls for a ban on the shipment of waste containing nanomaterials to countries that cannot adequately manage them; legal provisions to ensure the safe use and disposal of nanomaterials; and bio-monitoring for people exposed to nanomaterials. Importantly, it is not clear what exactly waste “containing nanomaterials” includes. The resolution also calls on governments to adopt a “no data, no market” principle, which requires comprehensive hazard assessment information to be submitted before a nanotechnology can be commercialized. The resolution is not binding and recognizes the right of countries to allow the import and use of nanomaterials, but urges that a precautionary approach be taken.
On March 18, 2010, the United Kingdom (UK) Department for Business, Innovation and Skills (BIS) announced publication of UK Nanotechnologies Strategy: Small Technologies, Great Opportunities, which sets out how the government intends to take action to ensure that everyone safely benefits from the societal and economic opportunities that these technologies offer, while addressing the challenges that they might present. The Strategy includes the following key actions:
- Government chief scientific advisers to review coordination of nanotechnologies research across government, including research on safety issues;
- A new website to keep the public informed about government work on nanotechnologies;
- A new Nanotechnologies Collaboration Group to facilitate ongoing communication and collaboration between government, academia, industry, and other interested parties;
- A new Ministerially led Nanotechnologies Leadership Group to address barriers to commercial growth in this area; and
- Government to explore a new industry reporting scheme with a broader scope covering nanomaterials, as well as products containing them.
EP Environment Committee Approves Draft Legislation That Would Require Labeling For Nanomaterials In Food
On March 16, 2010, the EP Environment Committee approved draft legislation intended to modernize, simplify, and clarify food labeling within the EU. The legislation would make minor changes to existing rules on required labeling information, such as name, list of ingredients, “best before” or “use by” date, specific conditions of use, and add a requirement to list key nutritional information. The Committee added that showing the country of origin should also be mandatory in some cases. According to EP, the Committee “demand[s] that products containing nano-materials, be clearly labelled as such, using the epithet ‘nano’ in the ingredient list.” To provide industry time to meet the new requirements, the regulation would enter into force 20 days after its publication in the EU Official Journal, but the rules on nutrition labeling would take effect three years thereafter. For food business operators with fewer than 100 employees and an annual turnover and/or annual balance sheet total under €5 million, the rules would take effect five years thereafter. EP plans its first reading of the proposed legislation in plenary session at the end of May 2010. The Council will then have to adopt its position, before the proposal is again debated in the EP Environment Committee.
On March 10, 2010, Member of Parliament Peter Julian (NDP) tabled legislation (Bill C-494) in the House of Commons that would amend the Canadian Environmental Protection Act, 1999 (CEPA) to implement procedures for the investigation and assessment of nanomaterials. The bill includes provisions concerning adding nanomaterials to the Domestic Substances List (DSL), notification of significant new activity, risk assessment procedures, and would establish a public inventory of nanotechnology and nanomaterials in Canada. According to the New Democratic Party of Canada (NDP), the proposed amendments “will help implement a national strategy to guide the development of nanotechnology.”
EC Requests Accelerated SCENIHR Scientific Opinion on the Scientific Basis for the Definition of the Term "Nanomaterial"
On March 1, 2010, the European Commission (EC) issued a request, via the accelerated procedure, for a scientific opinion on the scientific basis for the definition of the term “nanomaterial” from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). According to the EC, its services “urgently need to elaborate a working definition of the term ‘nanomaterials’ to ensure the consistency of forthcoming regulatory developments to guide, as appropriate, the effective implementation of existing regulation, and to contribute to international work and dialogue on nanotechnology definitions.” The EC states that it needs “clarification on the size ranges and other relevant characteristics and corresponding metrics reported in the scientific literature, the types of physical and chemical properties particular to nanomaterials, the relevant thresholds, as well as the most appropriate metrics to express such thresholds.” The deadline is May 2010.
Health Canada Adopts Interim Policy Statement on Health Canada's Working Definition for Nanomaterials
On March 1, 2010, Health Canada began a public consultation on its adoption of the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials (Interim Policy). Although Health Canada is accepting comments, it states that the Interim Policy “is effective immediately.” In preparing the Interim Policy, Health Canada states that it sought the informal feedback of some international stakeholders, industry trade groups, standards associations, and other Canadian federal departments. Comments are due August 31, 2010, and Health Canada intends to use the comments to update the Interim Policy as necessary.
On January 8, 2010, the United Kingdom (UK) House of Lords Science and Technology Committee announced the availability of its report entitled Nanotechnologies and Food, which criticizes the food industry for failing to be transparent about its research into the uses of nanotechnologies and nanomaterials. In its report, the Committee urges the Government and Research Councils to fund research into potential health and safety risks arising from the use of nanomaterials in the food sector. The Committee recommends that the Food Standards Agency maintain a publicly available register of food and food packaging containing nanomaterials, and suggests that the register be made available online. The Committee calls for nanomaterials to be defined clearly in food legislation to ensure that all uses of nanomaterials in food are subject to appropriate risk assessment procedures. According to the Committee, regulatory definitions should use a change in functionality, i.e. how a substance interacts with the body, as the criterion that distinguishes a nanomaterial from its larger form, to ensure that any nano-sized materials with novel properties are included. The Committee also recommends that the UK work with other European Union (EU) nations to clarify what is meant by the phrase “properties that are characteristic to the nanoscale” in the draft definition proposed for the revised Novel Foods Regulation, by the inclusion in legislation of a more detailed list of what these properties comprise. The Committee also raises concerns about the potential for the illegal importation of food products containing nanomaterials not approved for use in food in the EU.
On November 11, 2009, the European Commission (EC) began a public consultation to receive input from all people and organizations involved or interested in nanosciences and nanotechnologies research in Europe, including researchers, policy makers, industry, media, and civil society organizations. The EC adopted on February 7, 2008, a Recommendation for a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research, followed on September 26, 2008, by Council Conclusions on Responsible Nanosciences and Nanotechnologies. Both documents suggested that the EC Recommendation and Code of Conduct should be revised after two years. The EC intends to make these revisions in February 2010, and states that the results of the consultation will contribute to that. The Code of Conduct is intended to frame future research development within a set of general principles on which member states are invited to take concrete action to ensure that nanotechnologies are developed in a safe manner. The online consultation ends on January 3, 2010.
On November 9, 2009, Australia announced the availability of a public discussion paper proposing to strengthen regulation of industrial nanomaterials used in Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) developed the proposal in conjunction with its Nanotechnology Advisory Group, which includes representatives from industry, the community, and research sectors. Major regulatory reforms would include: refinement of pre-market assessment categories for nanoforms of new chemicals, particularly where human health or environmental exposure can reasonably be anticipated; and a mandatory notification and assessment program for nanoforms of existing chemicals. The discussion paper contains a questionnaire and survey intended to encourage written submissions. Comments are due December 23, 2009.
On October 29, 2009, the European Commission (EC) adopted a Communication entitled Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009. Second Implementation Report 2007-2009. The Communication outlines the key developments during 2007-2009 in each policy area of the Nanotechnology Action Plan 2005-2009, identifies current challenges, and draws conclusions relevant to the future European nanotechnology policy. According to the Communication, the EC has made significant progress on all points in the Action Plan. The Communication notes that, “[a]s a general remark, the past two years have seen a substantial development of nanotechnology, supported by a further growth in research funding and the active development of policy. . . . In view of this, efforts to address societal and safety concerns must be continued to ensure the safe and sustainable development of nanotechnology.” The Communication states that the EC “is considering proposing a new Nanotechnology Action Plan that would be one of the driving forces of the European Research Area and address important societal and environmental issues.”
In an October 9, 2009, speech at the stakeholder conference concerning nanomaterials on the market, Stavros Dimas, European Commissioner for the Environment, stated that the European Commission (EC) “will review all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental, or safety impacts over their life cycle.” The EC’s review is in response to an April 24, 2009, resolution adopted by the European Parliament that questions whether current legislation covers the relevant risks relating to nanomaterials and asks the EC to consider whether revisions are necessary to address nanomaterials. Dimas stated that the EC “has not made up its mind on how precisely to get the information needed.” The EC intends to look at measures taken by member states and non-European Union (EU) countries, including voluntary reporting programs.Continue Reading...
On September 23, 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Technologies (PEN) hosted a meeting on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies.” The program is part of a collaborative research project involving experts from the London School of Economics (LSE), Chatham House, the Environmental Law Institute (ELI), and PEN. The project is funded by a grant from the European Commission to support pilot projects on “Transatlantic methods for handling global challenges.” The purpose of yesterday’s meeting was to discuss recommendations from the research effort that are part of a report released on September 10, 2009. The meeting was also intended to generate and examine new ideas to enable greater transatlantic convergence on nanotechnology oversight today and in the future.Continue Reading...
Lynn L. Bergeson Chairs Panel at Conference on "Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies"
The London School of Economics (LSE), Chatham House, the Environmental Law Institute (ELI), and the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars held a conference on September 10-11, 2009, on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies,” in London. LSE, Chatham House, ELI, and PEN are participating in an international collaborative project, Regulating Nanotechnologies in the EU and U.S., which is funded by a grant from the European Commission. Their research findings on issues of transatlantic regulatory cooperation were published in a report during the conference. The conference was intended to bring together regulatory experts from the United States (U.S.) and European Union (EU) to discuss recommendations from this research effort and to generate and examine new ideas that would enable greater transatlantic cooperation and convergence on nanotechnology oversight today and in the future. The materials released at the conference include a briefing paper entitled Regulating Nanomaterials: A Transatlantic Agenda, and the report entitled Securing the Promise of Nanotechnologies: Towards Transatlantic Regulatory Cooperation.Continue Reading...
Lynn L. Bergeson Will Speak at Conference on "Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies"
Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson will be speaking at the September 10-11, 2009, international conference on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies,” in London. The London School of Economics, Chatham House, the Environmental Law Institute, and the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars have spent the past year examining issues of transatlantic regulatory cooperation. During the conference, their research findings will be published in a major report, which is scheduled to be released on September 10, 2009. The conference is intended to bring together regulatory experts from the United States (US) and European Union (EU) to discuss recommendations from this research effort and to generate and examine new ideas that would enable greater transatlantic cooperation and convergence on nanotechnology oversight today and in the future.Continue Reading...
The Responsible Nano Forum Marks Anniversary of Royal Society and Royal Academy of Engineering Report
The Royal Society and Royal Academy of Engineering released on July 29, 2004, their report entitled Nanoscience and Nanotechnologies: Opportunities and Uncertainties. To mark the five-year anniversary of the report, The Responsible Nano Forum invited representatives from science, risk, investment, non-governmental organizations (NGO), unions, business, and consumer groups to reflect on the legacy of the report and what still remains to be done. The report, A Beacon or Just a Landmark? Reflections on the 2004 Royal Society/Royal Academy of Engineering Report, includes contributions from a range of individuals and organizations in the United Kingdom and internationally. We are pleased to announce that Lynn L. Bergeson is a contributor.
Earlier this month, in advance of the Organization for Economic Cooperation and Development’s (OECD) July 15-17, 2009, Conference on Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-Led Growth, the Action Group on Erosion, Technology, and Concentration (ETC Group) issued a draft report entitled Nanogeopolitics 2009: The Second Survey. ETC Group recommends that policies concerning nanotechnologies be developed within the United Nations (UN) system, “where all nations can have a say about the technology and where the so-called nano-nations will come clean with everybody else about what they are doing to the economy and the environment.” The report is a follow up to the ETC Group’s 2005 survey of “the nanogeopolitical landscape.” In the report, ETC Group reviews: (1) the extent to which the “markets and players” have shifted position since 2005, especially in terms of research and funding; (2) the effectiveness of various governance and regulation; and (3) recommended action to regulate better and develop responsibly nanotechnology.
On June 25, 2009, the Norwegian Board of Technology announced that the Norwegian Pollution Control Authority (SFT) has established “a scheme for Norwegian businesses to report their use of nanomaterials in chemical products.” According to a spokesperson for the Board, until now the Norwegian market has “lacked oversight of nanomaterials.” Under the scheme, information about nanomaterials in chemical products will be incorporated as a separate topic in declarations to the Norwegian Product Register, which is administered by the SFT. The initiative will supplement Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) due to its “focus on how substances are marketed and used in real life.”Continue Reading...
The European Agency for Safety and Health at Work (EU-OSHA) announced June 19, 2009, the publication of the Literature Review -- Workplace Exposure to Nanoparticles, which reviews the most recent publications on nanoparticles and focuses on the possible adverse health effects of workplace exposure. The report focuses on the possible adverse health effects of workplace exposure to engineered nanomaterials and possible subsequent activities taken to manage the risk. The report does not include nanomaterials originating from natural sources, as well as non-intended nanoscale by-products, such as diesel engine exhaust, and welding fumes. To provide a broad overview, EU-OSHA collected information from different sources, such as scientific literature, policy documents, legislation, and work programs. EU-OSHA gave priority to documents from the European Union (EU), although national and international activities are also described. The report considers studies published up to November 2008. The report identifies the following topics as priorities for future actions and activities:
- Identification of nanomaterials and description of exposure;
- Measurement of exposures to nanomaterials and efficacy of protective measures;
- Risk assessment of nanomaterials in line with the current statutory framework;
- In vivo studies for assessment of the health effects of nanomaterials;
- Validation of the in vitro methods and methods of physico-chemical properties as methods to determine health effects; and
- Training of workers and practical handling guidelines for activities involving nanomaterials in the workplace.
On June 2, 2009, the United Kingdom (UK) released its response to the Royal Commission on Environmental Pollution (RCEP) Report entitled Novel Materials in the Environment: The Case of Nanotechnology. The RCEP looked at the properties of nanomaterials and the potential pathways by which they could enter and present potential hazards to the environment and people. The UK states that it shares RCEP’s “understanding that there is no evidence of actual harm resulting from the use of nanotechnologies, but accepts that this is a possibility and that there is a need to develop our understanding further.” The UK intends to develop a “UK Strategy for nanotechnologies,” which “will build on previous and existing activities and review the UK’s priorities and strategic direction.” The UK intends to begin in Summer 2009 an “evidence gathering exercise” with stakeholders to inform development of the Strategy.
On May 28, 2009, during the Helsinki Chemicals Forum organized by the European Commission (EC) and European Chemicals Agency (ECHA), governmental spokespersons said that the way the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program applies to nanoscale substances is being reconsidered. ECHA Executive Director Geert Dancet stated that specific regulation of nanomaterials could be considered when the EC reviews REACH, which it is required to do by June 1, 2012. According to Dancet, the review could cover both the scope and implementation of REACH. Dancet stated that “nanomaterials will be covered in a more systematic way” following the review. European Union (EU) Environment Commissioner Stavros Dimas stated that “further work needs to be done to consider if further legislation is needed” to regulate nanomaterials. After the Forum, Dimas stated that separate legislation could be necessary to ensure to protect the environment and human health. According to Dimas, ECHA could manage nanomaterials, or EU legislation concerning fine particles could be used to regulate nanomaterials. The fine particle legislation concerns particles in air rather than in products, however, and a spokesperson for Dimas stated that the EC is “looking at all sorts of possibilities” and that specific approaches are “unexplored as yet.”
During the June 29-July 1, 2009, meeting of the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Substances (GHS), the Committee will discuss a paper entitled “Ongoing Work on the Safety of Nanomaterials.” The paper provides a summary of current activities by the European Union (EU), including the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, International Organization for Standardization (ISO), and the Organization for Economic Cooperation and Development (OECD). The paper includes the following questions:
- Can it be considered, for the same chemical (same [Chemical Abstracts Service (CAS) Number] and purity) that nanomaterials with new properties have the same hazards as conventional form?
- Is it possible to distinguish for a same chemical, the properties of its different nanoforms?
- How can this be done? Should new endpoints be determined?
- To which extent information about nanomaterials need be provided?
- What kind of information is needed?
- What kind of communication tool is needed for this purpose?
- What kind of collaboration can be suggested in order to contribute to clarification of nanomaterials hazard classification and indeed to heath safety and environmental issues of nanomaterials?
The European Commission (EC) will hold a scientific hearing on nanotechnology on September 10, 2009. The hearing will focus on the scientific aspects of the issues covered in the nanotechnology opinions issued by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the Scientific Committee on Consumer Products (SCCP) (which is now replaced by the Scientific Committee on Consumer Safety (SCCS)). To prepare for the hearing, the EC is launching a public consultation relating to the three main objectives to be addressed:
- Identification of any possible topics which have not been covered in the opinions from the relevant European Union (EU) risk assessment committees and bodies;
- Identification of what are -- according to current scientific knowledge -- the main potential risks that could emerge from the use of nanomaterials in the future; and
- Identification of the issues to be discussed at the hearing, including provision of background information and comments on those issues.
The outcome of the consultation will be presented at the scientific hearing. Comments are due June 19, 2009.
In an April 24, 2009, press release, the European Parliament (EP) calls for the provision of information to consumers on the use of nanomaterials in consumer products. According to the EP, all ingredients present in the form of nanomaterials in substances, mixtures, or articles should be clearly indicated in the product labeling. The press release also specifically calls for the European Commission (EC) to evaluate the need to review the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) concerning:
- Simplified registration for nanomaterials manufactured or imported below one tonne;
- Consideration of all nanomaterials as new substances;
- A chemical safety report with exposure assessment for all registered nanomaterials; and
- Notification requirements for all nanomaterials placed on the market on their own, in preparations, or in articles.
The EP also calls for the EC to evaluate the need to review worker protection legislation concerning:
- The use of nanomaterials only in closed systems or in other ways that exclude exposure of workers as long as it is not possible to detect reliably and control exposure;
- A clear assignment of liability to producers and employers arising from the use of nanomaterials; and
- Whether all exposure routes (inhalation, dermal, and other) are addressed.
On April 14, 2009, the Australian Council of Trade Unions (ACTU) issued a press release entitled “Nanotech Poses Possible Health and Safety Risk to Workers and Needs Regulation.” According to ACTU, “[t]he rapidly growing nanotechnology market in Australia requires urgent regulation to protect the health and safety of workers and consumers.” ACTU notes that, currently, there is no mandatory register in Australia of who is importing, manufacturing, supplying, or selling nanomaterials, and no requirement to label products.Continue Reading...
On March 31, 2009, the U.S. Environmental Protection Agency (EPA) announced the funding opportunity for its joint U.S. -- United Kingdom (UK) Research Program: Environmental Behavior, Bioavailability, and Effects of Manufactured Nanomaterials. EPA states that the outputs of the Program will be used to further scientific understanding of the fate, behavior, bioavailability, and effects of nanomaterials and risk management policy development. Two consortia, made up of UK and U.S. research institutions, will be selected for funding. EPA is seeking joint applications from U.S. and UK partners that:
- Propose integrated model(s) of fate, behavior, bioavailability and effects for several important and representative nanomaterial classes over key environmental pathways using intrinsic material properties and life cycle analysis as a starting point for model development;
- Validate and refine these model(s) through interdisciplinary research, addressing key assumptions and areas of uncertainty; and
- Develop effective methods and tools to detect, assess, and monitor the presence of nanomaterials in biological and environmental samples.
On March 18, 2009, the European Union’s European Agency for Safety and Health at Work (EU-OSHA) announced the results of a report entitled Expert Forecast on Emerging Chemical Risks Related to Occupational Safety And Health. According to the Agency, “[c]ontact with a wide range of chemicals and other hazardous substances at work is endangering the health of workers across Europe, and nanotechnology is one of the risks causing most concern to experts from 21 European countries.” The report identifies the main groups of substances that could pose new and increasing risks to workers, contributing to diseases ranging from allergies, asthma, and infertility to cancer.Continue Reading...
On March 31, 2009, the European Parliament (EP) Committee on Environment, Public Health, and Food Safety amended and adopted a report on the regulatory aspects of nanomaterials. The January 2009 draft report was prepared by Swedish Green EP Member Carl Schlyter and urges tighter controls on nanotechnology. The report calls on the European Commission (EC) to review all relevant legislation to implement the principle “no data, no market” for all applications of nanomaterials in products with potential health, environmental, or safety impacts over their life cycle. The report reiterates the Committee’s call for labeling of consumer products containing nanomaterials, and recommends development of testing protocols and metrology standards to assess the hazard of, and exposure to, nanomaterials over their entire life cycle, using a multi-disciplinary approach. The report was adopted by a vote of 21-14.
On March 24, 2009, the European Parliament (EP) approved an update of European Union (EU) legislation on cosmetics. The new regulation is intended to remove legal uncertainties and inconsistencies, while increasing the safety of cosmetics. The regulation would replace 27 different regulations. The new regulation addresses nanomaterials used as cosmetics ingredients. As requested by the EP, the new regulation introduces a safety assessment procedure for all products containing nanomaterials, which could lead to a ban on a substance if there is a risk to human health. The EP also succeeded in requiring that any nanomaterials present in cosmetics be mentioned in the list of ingredients on the packaging. The new regulation also includes a definition of nanomaterials, which must be adapted by the European Commission (EC) in line with scientific and technological advances. Under the new regulation, nanomaterial would be defined as “an insoluble or bioresistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”
On March 6, 2009, the United Kingdom (UK) Health and Safety Executive (HSE) published an information sheet on the risk management of carbon nanotubes (CNT). According to HSE, the information sheet “is specifically about the manufacture and manipulation of carbon nanotubes and has been prepared in response to emerging evidence about the toxicology of these materials. However, the risk management principles detailed here are equally applicable to other nanodimensioned bio-persistent fibres with a similar aspect ratio.” HSE cites as “new evidence” a recent study by the University of Edinburgh, which “found that long, straight [multi-walled CNTs] with a high aspect ratio produced a marked inflammatory reaction and the formation of granulomas when injected into the abdominal cavity of mice.”Continue Reading...
On March 5, 2009, the European Food Safety Authority (EFSA) published a document entitled The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety, which provides its scientific opinion on the potential risks arising from nanoscience and nanotechnologies on food and feed safety. EFSA’s Scientific Committee (SC) concluded that established international approaches to risk assessment can also be applied to engineered nanomaterials (ENM). The SC also concluded that a case-by-case approach would be necessary and that, in practice, current data limitations and a lack of validated test methodologies could make risk assessment of specific nano products very difficult and subject to a high degree of uncertainty. The opinion focuses on the use of nanotechnologies, particularly ENMs, in the food and feed chain. It elaborates on approaches and methodologies available for risk assessment of these very small particles but does not address any specific applications of particular ENMs.Continue Reading...
On February 18, 2009, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published its opinion on the most recent developments in the risk assessment of nanomaterials. In its opinion, SCENIHR indicates that methodologies to assess exposure to manufactured nanomaterials to humans and the environment and the identification of potential hazards require further development. For lack of a general approach, SCENIHR maintains its earlier recommendation to perform risk assessment case-by-case for each nanomaterial.Continue Reading...
On December 15, 2008, the House of Lords Science and Technology Select Committee appointed a Subcommittee to investigate the use of nanotechnologies in the food sector. The Committee intends to focus on the following areas: food products, additives, and supplements; food contact packaging; food manufacturing processes; animal feed; pesticides and fertilizers; and products that may come into contact with food, such as food containers and cooking utensils. The Committee requests evidence on questions under the following topics:
- State of the science and its current use in the food sector;
- Health and safety;
- Regulatory framework; and
- Public engagement and consumer information.
Submissions are due March 13, 2009. The Committee will hold public meetings beginning in Spring 2009, and intends to publish its report in Fall 2009.
On April 2, 2009, NanoCap and the European Parliament (EP) will hold a conference entitled “Working and Living with Nanotechnologies: Trade Union and NGO positions.” The conference objectives are to present positions and perspectives on nanotechnologies at the workplace and in the environment adopted by European trade unions and environmental non-governmental organizations (NGO), including:
- Setting priorities for the responsible development of nanotechnologies, especially regarding environmental and workplace safety;
- Exchanging views with nanotechnologies stakeholders and policymakers;
- Establishing pathways for implementing the precautionary approach; and
- Presenting a nanoethics portfolio.
EPA Announces Joint Research Partnership with UK Agencies Regarding the Behavior and Effects of Nanomaterials in the Environment
On December 29, 2008, the U.S. Environmental Protection Agency (EPA) announced that it is in the process of finalizing a major joint research effort with a number of United Kingdom (UK) agencies that is intended to develop and validate predictive tools and similar conceptual models that predict exposure, bioavailability, and effects of manufactured nanomaterials in the environment. The UK agencies include the Natural Environment Research Council, Engineering and Physical Sciences Research Council, Department for Environment, Food, and Rural Affairs, and Environment Agency. According to EPA, the research partnership will include a joint call issued by all organizations involved and will incorporate a common review and evaluation process. EPA states: “The intent is to form consortia of both UK and US investigators using combined but independent national funding arrangements.” EPA expects the solicitations to be issued in February 2009.
On November 12, 2008, the United Kingdom (UK) Royal Commission on Environmental Pollution (RCEP) published a report entitled Novel Materials in the Environment: The Case of Nanotechnology, which examines issues related to innovation in the materials sector and the challenges and benefits arising from the introduction of nanomaterials. According to RCEP, there is an “urgent need for more testing, extending existing governance arrangements and creating new arrangements concerning nanomaterials.” The report was prompted by concerns about potential releases to the environment from industrial applications of metals and minerals that have not previously been widely used. The RCEP states that, as the majority of the evidence it received was almost entirely focused on manufactured nanomaterials, it decided to focus on this sector as an exemplar. The report includes recommendations on how to address “ignorance and uncertainty in this area, which could also be applied to other areas of fast-paced technological development.”Continue Reading...
On October 17, 2008, the European Food Safety Authority (EFSA) began a public consultation on its draft scientific opinion in relation to nanoscience and nanotechnologies and food and feed safety. EFSA’s draft opinion focuses on engineered nano materials (ENM) that could be deliberately introduced into the food chain and elaborates on approaches to risk assessment. EFSA states that it “is not an assessment of any specific application of ENM.” According to EFSA, the European Commission (EC) requested the opinion “as a first step because consideration needs to be given as to whether existing risk assessment approaches can be appropriately applied to this new technology.” EFSA states that its final opinion “will then help the EC to explore appropriate measures, assess existing legislation and determine the scope of possible further requests for scientific opinions from EFSA in this field.” Comments are due December 1, 2008.Continue Reading...
On October 8, 2008, the European Commission (EC) published a regulation amending the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Annex IV to remove carbon and graphite. Although the substances were originally listed in Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties, a European Union (EU) expert committee delisted the substances in June 2008. According to the regulation, there is insufficient information for carbon and graphite to be listed in Annex IV, “in particular due to the fact that the concerned EINECS and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in this Annex.”
In an October 2, 2008, Update entitled “NIOSH Nanotechnology Research News Notes: New Papers on PPE, Toxicity; New Partnerships, Award,” the National Institute for Occupational Safety and Health (NIOSH) describes two new peer-reviewed papers, two new international partnerships, and a professional award.Continue Reading...
On September 18, 2008, the U.S. Environmental Protection Agency (EPA) announced that EPA Region 5 will host the 2008 International Environmental Nanotechnology Conference: Applications and Implications, October 7-9, 2008, in Chicago, Illinois. According to EPA, researchers from Asia, Australia, and Europe will join U.S. scientists and government officials to discuss nanotechnology applications for environmental cleanup, pollution control, and the implications of releasing engineered nanoparticles into the environment. Partner agencies represented at the conference include the Agency for Toxic Substances and Disease Registry (ATSDR), National Institute of Environmental Health Sciences (NIEHS), National Science Foundation (NSF), U.S. Army, U.S. Navy, U.S. Department of Energy (DOE), and University of Illinois at Chicago’s Great Lakes Centers for Occupational and Environmental Safety and Health.
On September 10, 2008, the European Commission (EC) requested companies to submit data “with regard to all substances used at nano-scale and the final [cosmetic] products in which they are used.” Citing the December 18, 2007, opinion of the Scientific Committee on Consumer Products concerning the safety of nanomaterials in cosmetic products and the June 22, 2007, opinion of the Scientific Committee on Emerging and Newly-Identified Health Risks regarding the appropriateness of the risk assessment methodology in assessing the risks of nanomaterials, the EC states that “there is an urgent need for closing the information gap and even the methodological gap with regard to nanomaterials in cosmetics. Without these gaps being closed, it will, in the medium term, be hardly defendable for industry and authorities to assert that cosmetic products containing nanomaterials are safe.”Continue Reading...
The August 2008 issue of The Lancet Oncology includes an article entitled “Special Report: Policy -- Future Priorities for IARC Monographs.” According to the article, carbon-based nanomaterials and ultrafine particles are included on the list of substances recommended by the International Agency for Research on Cancer (IARC) Advisory Group as high priority for assessment. The article states that carbon-based nanomaterials are “present in many consumer products; carbon nanotubes induce irreversible lung fibrosis and mesothelioma in animals.” Ultrafine particles, according to the article, were recommended because “cancer concerns arise from core particles and chemicals that adhere to their surfaces.” The Advisory Group met in June 2008 to consider nominations for review in future IARC monographs.
In its latest Background Paper, entitled Mounting Evidence That Carbon Nanotubes May Be the New Asbestos, Friends of the Earth Australia (FOEA) is calling “for an immediate moratorium on the commercial use of carbon nanotubes and the sale of products that incorporate nanotubes until research can demonstrate whether or not there is any safe level of exposure to them.” FOEA also is calling for new nanotechnology-specific regulation to protect human health and the environment, as well as for mandatory labeling of all nanoscale materials used in the workplace and in consumer products.Continue Reading...
On June 17, 2008, the European Commission (EC) issued a press release entitled “Commission starts public dialogue on nanotechnologies -- tapping economic and environmental potential through safe products.” According to the EC, while current European Union (EU) legislation “covers in principle” the environment, health, and safety issues concerning nanomaterials, “there is further need for research and international cooperation.” EC will begin a consultation with stakeholders and member states that it intends “to increase knowledge and awareness about the potential of nanotechnologies and to continue to ensure an adequate protection of nature, environment and health.” Under “Next Steps,” the EC states:
Knowledge about the characterisation of nanomaterials, hazard and exposure needs to be improved. The Commission is therefore backing targeted actions in a number of areas and at different levels, particularly in the field of research and development under the Research Framework Programmes FP6 and FP7 and the Commission’s Joint Research Centre.) Such activities are coordinated and discussed with stakeholders and in the framework of the [Organization for Economic Cooperation and Development (OECD)] and the International Standardisation Organisation (ISO) and through international cooperation.The Commission will also engage in an open dialogue with citizens and stakeholders at large to accompany the correct application of existing legislation to the new products arriving on the market.
On March 11, 2008, the German Chemical Industry Association (VCI) released a report entitled Responsible Production and Use of Nanomaterials, which is a series of documents intended to provide guidance on all aspects of a good product stewardship on nanomaterials. The documents include joint papers prepared by VCI and the German Federal Institute for Occupational Safety and Health (BAuA) and the German Society for Chemical Engineering and Biotechnology (DECHEMA). The report includes the following documents:
- Implementing Responsible Care® for a Responsible Production and Use of Nanomaterials
- Requirements of the REACH Regulation on Substances Which Are Manufactured or Imported also as Nanomaterials
- Guidance for a Tiered Gathering of Hazard Information for the Risk Assessment of Nanomaterials
- Guidance for Handling and Use of Nanomaterials at the Workplace
- Guidance for the Passing on of Information along the Supply Chain in the Handling of Nanomaterials via Safety Data Sheets
- Strategy Paper of the German Chemical Industry on the Standardization of Nanomaterials
Documents on Safety Research:
- Roadmap for Safety Research on Nanomaterials
- Environmental Aspects of Nanoparticles