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.
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.
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.
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.
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.”
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 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 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.
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.
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.
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.”
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.
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).
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.”
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 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.
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.”
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.”
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 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...
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 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.”
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 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 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.
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 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 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 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.”
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...
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
On April 17-18, 2008, the European Commission (EC) will hold a workshop on research on the safety of nanomaterials. The main objectives of the workshop are:
- To increase interactions between researchers to enhance networking, sharing of outcomes of the research projects, and boosting synergies between research groups across Europe and abroad;
- To improve communication of the results of research to risk assessment bodies and other interested parties, providing sound science-based data for informing opinions and scientific advice to policy makers; and
- To examine the current knowledge to review, if need be, the priorities in safety of nanomaterials’ research.