NGOs Call for "Nano Patch" for REACH, and EC Responds

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.

The EC’s Environment and Enterprise Directorate-Generals (DG) issued separate statements in response to the NGOs’ proposal. DG Environment stated: “We regard the NGO proposal . . . as a reaction to the Commission’s recent regulatory review on nanomaterials. We are looking forward to discussing our review with all the stakeholders.” DG Enterprise released a more detailed statement, noting that the EC “does not consider appropriate at present to change the basic registration rules under REACH and the rules for when a chemical safety assessment is required under REACH.” In addition, DG Enterprise stated: “[T]he highest volume substances such as carbon black and synthetic amorphous silica, as well as the most debated substances such as titanium dioxide, zinc oxide and carbon nanotubes, have already been registered under REACH. Together, they represent the vast majority of nanomaterials on the market in terms of tonnage and sales value.”

EC Begins Public Consultation On Discussion Paper Addressing The New Challenges For Risk Assessment

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

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.”

EC Adopts Communication on Second Regulatory Review on Nanomaterials

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.”

The Communication is accompanied by an EC Staff Working Paper on Types and Uses of Nanomaterials, Including Safety Aspects, which responds to the EP’s concern that the EC’s approach to nanomaterials is jeopardized by a lack of information on the use and safety of nanomaterials that are already on the market. The Staff Working Paper provides detailed information on the definition of nanomaterials, nanomaterial markets, uses, benefits, health and safety aspects, risk assessment, and information and databases on nanomaterials. According to the Staff Working Paper, in response to the EP’s call on the EC to compile a public inventory of the different types and uses of nanomaterials on the European market, the EC has compiled information on existing databases and intends to create an EC web platform on nanomaterial types and uses, including safety aspects.

EC's SCCS Scientific Opinion on Nano-Form Zinc Oxide Available for Comment

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.

SCCS Calls for Experts on the Safety Assessment of Nanomaterials in Cosmetic Products

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:

  • Characterization;
  • Chemistry;
  • Systemic toxicity;
  • Genotoxicity;
  • 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.

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 evaluation will take into account different categories of medical devices, including:

  • Non-invasive medical devices, e.g., devices coming into contact with the intact skin; and
  • Invasive devices such as woundcare materials, implantable medical devices, dental and bone fillings and cements, and injectable nanomaterials.

In the assessment, where relevant, the EC invites SCENIHR to differentiate between free, fixed, and encapsulated nanomaterials. SCENIHR invites interested parties to submit information that could assist it with the assessment. Information is due October 10, 2012. The EC states that it is currently preparing a proposal for a revision of the medical devices directives, which could 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.

SCENIHR posted on August 10, 2012, a call for experts on medical devices containing nanomaterials. To allow for a comprehensive assessment, SCENIHR encourages experts in various scientific fields related to the safety of medical devices containing nanomaterials to apply. SCENIHR states that “[e]xperience in risk assessment would be an advantage.” The deadline for submission for the call for experts is October 1, 2012.

 

The Netherlands Publishes Report Examining the EC's Recommended Definition of Nanomaterial

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.

EC Scientific Committee Releases Guidance on Safety Assessment of Nanomaterials in Cosmetics

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.

ECHA Will Create Working Group on Nanomaterials

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.

EC Scientific Committee Requests Information on Nanosilver

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.

EC Requests Scientific Opinion on Health Effects of Nanomaterials Used in Medical Devices

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.

CoRAP Notes Nano Concerns for Two Substances

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.”

Following the evaluation, further information may be requested from the registrants of the substances when additional data are considered necessary to clarify the suspected risk. From the publication of the CoRAP, the respective Member States have one year to evaluate substances specified for the year 2012 and, where justified, to prepare a draft decision requesting the registrant(s) to submit further information to clarify any possible risk. The decision will be taken by ECHA after consultation of the Member State Competent Authorities and the Member State Committee, or by the European Commission (EC) if there is no unanimity at the Member State Committee. For other evaluation decisions, registrants of the substances listed on the CoRAP will have opportunities to comment before any final decision is taken.

Proposed EU Biocidal Products Regulation Addresses Nanomaterials

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.”

The proposed legislation incorporates the EC’s recent recommendation on the definition of a nanomaterial, stating:

“nanomaterial” means a natural or manufactured active substance or non-active substance 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;

Fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.

For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:

(a) ‘particle’ means a minute piece of matter with defined physical boundaries;

(b) ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components; [and]

(c) ‘aggregate’ means a particle comprising of strongly bound or fused particles.

The EC would have the authority to determine, at the request of a member state, whether a substance is a nanomaterial. It would also have the authority to adopt delegated acts to adapt the definition of nanomaterial “in view of technical and scientific progress and taking into account the Commission Recommendation.” Under the proposed legislation, where nanomaterials are used in a product, the risk to the environment and to health must 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. Every five years, member states would be required to submit to the EC a report on the implementation of the biocides regulation in their respective territories. The report must address several topics, including information on the use of nanomaterials in biocidal products and the potential risks.

Both the EU Council and the EP must approve the proposed legislation. The EP is scheduled to vote on the proposed legislation in January 2012.

EC Requests SCENIHR for Scientific Opinion on Nanosilver

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 Posts Report on Nanotechnology EHS Landscape

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.

ObservatoryNANO identified and grouped key organizations and projects into seven major areas:

  • Research;
  • Knowledge Transfer and Review;
  • Standardization;
  • Guidance;
  • Regulation;
  • Public Engagement; and
  • Professional Bodies.

The landscaping document provides a short overview of the organizations working within each area, together with links and references to further information.

EC Publishes Final RIPoN Reports

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.”

EC Adopts Recommendation on Definition of Nanomaterial

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.

The Recommendation states that, by December 2014, the EC will review the definition “in the light of experience and of scientific and technological developments. The review should particularly focus on whether the number size distribution threshold of 50 % should be increased or decreased.”

According to information on the EC website, it will use the definition primarily to identify materials for which special provisions might apply (e.g., for risk assessment or ingredient labeling). The EC notes:

Nanomaterials are not intrinsically hazardous per se but there may be a need to take into account specific considerations in their risk assessment. Therefore one purpose of the definition is to provide clear and unambiguous criteria to identify materials for which such considerations apply. It is only the results of the risk assessment that will determine whether the nanomaterial is hazardous and whether or not further action is justified.

The EC posted “[d]etailed and technical information” about the definition in a “Questions and Answers” document.

EC Requests Guidance on Safety Assessment of Nanomaterials in Cosmetics

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.”

The EC specifically requests guidance on:

  1. The essential elements that must form part of safety dossiers for the assessment of nanomaterials in cosmetic products, based on the data requirements for the pre-market notification listed in Article 16 of Regulation (EC) No. 1223/2009, i.e. taking into account points 3a to 3f of Article 16 (identification of the nanomaterial, specification, quantity, toxicological profile, safety data, and exposure).
  2. The possibility to develop criteria and conditions that would allow the safety assessment of nanomaterials on a category-based approach rather than on a case-by-case basis.
  3. The suitability of alternative methods already validated for the assessment of conventional chemical substances for the assessment of nanomaterials in light of the current (as of 2009) ban on animal testing in the European Union.
  4. The set of attributes unique to manufactured nanomaterials that will need to be addressed by newly developed and/or newly validated alternative methods for the testing of toxicological end points for which there will be a ban on the testing on animals after March 2013.

 

REACH Conference Participants Discuss 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.”

JRC-IHCP Argues for Definition of Engineered Nanomaterials

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.”

EU Project Tackles Engineered Nanomaterials Risk

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.

Netherlands Delegation Notes Risks Associated with Nanomaterials

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.”

ECHA Preparing Nano Inventory from REACH and CLP Submissions

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.

EFSA Publishes Guidance for Assessing Engineered Nanomaterial Applications in Food and Feed

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.”

EU Ecolabeled Products Could Include Nanomaterials

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.

EPA, EC, and OECD Officials Publish Article in Nature Nanotechnology

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.”

EC Committee Approves Opinion on Scientific Basis for the Definition of Nanomaterial

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.

 

EC Begins Consultation on Recommendation on Definition of the Term Nanomaterial

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.”

Belgium Calls for REACH Register to Ensure Traceability of Nanomaterials

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:

  1. Define the obligation to inform the consumer of the presence of nanomaterials in consumer products;
  2. 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;
  3. Identify the most appropriate regulatory path at the EU level for risk evaluation and management;
  4. 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
  5. Regulate the claims made on labels of products containing nanomaterials.

 

EC Opens Public Consultation on Scientific Basis for a Definition of Nanomaterial

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.

 

EC JRC Releases Report Concerning Definition of Nanomaterial for Regulatory Purposes

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.

 

JRC states that this calls both for a clarification of the meaning of the word “material” and a clear definition of the nanoscale limits. Enforceability of the definition will require the adoption of instructions on how such limits can be applied for nanoscale materials with size distributions. Size-derived properties, nanoscale materials incorporated in a matrix, and the origin of the material are also points that should be considered.  JRC states: “It is clear that any definition will have implications within the context in which it is used and may need adaptation for specific regulations or directives. It should therefore be emphasised that adoption of a definition will also involve policy choices, and accordingly will entail political decisions.”

EU and China Sign MOU Concerning Nanotechnology Risk Assessment

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.”

EP Committee Adds Nanosilver and Long Multi-Walled Carbon Nanotubes to Proposed RoHS Recast

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.

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.

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.

EC Opens Public Consultation on the Nanotech Research Code of Conduct

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.

EC Adopts 2007-2009 Nanotechnology Implementation Report

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.”

EC Will Review Legislation to Ensure Safety of Nanomaterials

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.

Dimas examined whether the existing regulatory framework of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program is sufficient to ensure “a high level of protection of health, safety and the environment” from nanotechnology products. Dimas stated that nanomaterials are covered by REACH under the definition of a chemical substance, and the general obligations therefore apply as for any other substance. According to Dimas, the “important” question to ask is whether the one tonne threshold used by REACH is appropriate for nanomaterials. Dimas stated:

Once we have a better idea of the scope and nature of nanomaterials on the European market we can then take a step back and go through the rules.  We will need to consider whether registration of the majority of nanomaterials will take place in 2010 or only at the end of the registration timetable in 2018 and if there are some nanomaterials that will not be registered under REACH.  We will also need to look at other key provisions in REACH to see if they are adequate for nanomaterials.

EU Examining How REACH Applies to Nanomaterials

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.”

EC Begins Public Consultation to Prepare for Scientific Hearing on Nanotechnology

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.

 

European Parliament Urges the Labeling of Nanomaterials in Consumer Products

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.

 

EP Committee Report Calls for "No Data, No Market" for Nanomaterials

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.

EP Approves Updated EU Legislation on Cosmetics That Addresses Nanomaterials

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.”

EC Committee Adopts Opinion on Assessing the Risks of Nanotechnology

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.

The Opinion identifies the following issues:

  • Characterization of manufactured nanomaterials: There is currently a need for reference nanomaterials.  The absence of well-defined parameters to measure and of standardized test protocols is identified as a major obstacle for reference material production.  It should be noted that for use in biological systems certain compounds need to be added, which may have an effect on nanomaterial composition and properties resulting in changes in (toxic) behavior.
  • Human exposure: Exposure estimates for consumers from food and consumer products remains difficult. Information on the presence of manufactured nanomaterials solely relies on information provided by manufacturers.  In addition, exposure estimation is also hampered by lack of information on product use and use of multiple products containing manufactured nanomaterials.  The main issues may be summarized as problems in replicating actual exposure conditions in laboratory tests and the lack of general availability of robust and specific measurement methods.  Exposure assessment needs to consider each stage in the life-cycle.
  • Human hazard: The main issues for human hazard identification may be summarized as a need to ensure that each test system is appropriate for nanomaterials and to ensure that endpoints of potential particular concern (e.g., cardio-vascular effects) are properly addressed.
  • Environmental exposure: The main issues may be summarized as the development of suitable methods to assess the distribution of nanomaterials in the environment and the lack of portable monitoring equipment to measure levels of nanomaterials in different environmental media. In addition, for many manufactured nanomaterials the methods currently used (carbon dioxide production, integration into biomass) for determining biological degradation will not be applicable.
  • Environmental hazard: The main issues for environmental hazard assessment may be summarized as the need for validation of laboratory test systems for characterizing the effects of nanomaterials and the need for studies of the impacts of specific nanomaterials on ecosystems.
  • Risk assessment: Health and environmental hazards have been demonstrated for a variety of manufactured nanomaterials.  It should be noted that not all nanomaterials induce toxic effects, however. As there is not yet a generally applicable paradigm for nanomaterial hazard identification, a case-by-case approach for the risk assessment of nanomaterials is still recommended.

EFSA Consults on Draft Opinion on Nanotechnologies and Food and Feed Safety

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.

Key conclusions of the draft opinion include:

  • Established international approaches to risk assessment currently used for non nano chemicals can also be applied to ENM;
  • It is currently not possible to satisfactorily extrapolate scientific data on non nano chemicals and apply it to their nano-sized versions.  Consequently specific case-by-case risk assessments should be performed when assessing their safety, based on specific data from relevant safety tests applicable to the particular application;
  • Possible risks arise because ENM have particular characteristics, due in part to their small size and high surface area.  Small size increases their ability to move around in the body in ways that other substances do not, while their high surface area increases their reactivity; and
  • Additional limitations and uncertainties exist, particularly in relation to characterizing, detecting and measuring ENM in food, feed, or the body.  There is also limited information on absorption, distribution, metabolism, and excretion, as well as the toxicity of ENM.

 

EC Removes REACH Exemptions Because of Nano Concerns

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.”

EC Requests Voluntary Submission of Data on Nanoparticles in Cosmetics

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.”

 

The EC seeks data concerning:

  • The chemical composition, the chemical impurities, the form and its flexibility, the agglomeration and coalescence behavior, the stability, the surface reactivity, the biodegradability, and the solubility of the nanoparticles;
  • The storage conditions of the particles prior to the manufacturing of the cosmetic product, and the molecules with which the particles come into contact;
  • The proportion of nanoparticles in the final product (in mass concentration, number concentration, and surface area);
  • The other components of the final product;
  • Modification of the particles occurring within the cosmetic product during or after the manufacturing process; and
  • The interaction between the various factors for each of the products on which data are provided.

Comments are due December 31, 2008.

 

ETUC Passes Resolution on Nanotechnologies and Nanomaterials

On June 26, 2008, the European Trade Union Confederation (ETUC) passed a resolution on nanotechnologies and nanomaterials, which calls for the application of the precautionary principle. The resolution states that application of the precautionary principle is necessary to avoid “past mistakes [made] with putatively ‘miracle’ technologies and materials. According to ETUC, the number of workers coming into contact with nanomaterials will increase sharply as nanotechnologies are applied to difference industry sectors, including the chemical, pharmaceutical, and electronics industries. The ETUC urges the European Commission (EC) to amend the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation “so as to give better and wider coverage to all potentially manufacturable nanomaterials.” Because nanomaterials are manufactured or imported below the threshold of one tonne per year and may evade the REACH registration requirements, “ETUC demands that different thresholds and/or units (e.g., surface area per volume) are used for registration of nanomaterials under REACH.”

The resolution sets out a series of demands in different areas related to nanotechnology development:

  • Marketing:
  • REACH’s “no data, no market” principle must apply: nanometer forms of chemicals should not be allowed on the market unless sufficient data are supplied to show no harmful effect for human health and the environment;
  • All nanomaterials, including those produced or imported in quantities below one tonne per year, must come within the REACH registration requirements; and
  • A chemical safety report must be produced for all REACH-registered substances for which a nanometer scale use has been identified.
  • Worker protection:
  • Amend Chemical Agents Directive 98/24/EC to require employers to implement risk reduction measures for substances not proven to be harmless;
  • Involve workers and their representatives in the assessment and reduction of nanomaterial-related risks;
  • Improve worker information about nanomaterials that may be present in products to which they are exposed: safety data sheets must state whether nanomaterials are present; and
  • Provide training and health surveillance for workers exposed to nanomaterials.
  • Research and Development:
  • Earmark at least 15 percent of public research budgets for health and environmental aspects; and
  • Make health and safety at work aspects a compulsory part of all research projects.

European Commission Begins Public Dialogue on Nanotechnologies

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.

EC Will Hold Workshop on Research on the Safety of Nanomaterials

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.

SCCP Releases Opinion on Safety of Nanomaterials in Cosmetic Products

The European Commission’s (EC) Scientific Committee on Consumer Products (SCCP) released on March 3, 2008, a document entitled Opinion on Safety of Nanomaterials in Cosmetic Products (Opinion). In its Opinion, the SCCP divides nanoparticles into two groups: 1) soluble and/or biodegradable nanoparticles; and 2) insoluble particles. The SCCP states that, for the soluble and/or biodegradable group, “conventional risk assessment methodologies based on mass metrics may be adequate, whereas for the insoluble particles other metrics, such as the number of particles, and their surface area as well as their distribution are also required.” According to the SCCP, when assessing possible risks associated with nanoparticles, it is crucial to consider their uptake, and that it is primarily for the insoluble particles that health concerns related to possible uptake may arise. The SCCP concludes that, at present, there is inadequate information on: hazard identification; exposure assessment; uptake; the role of physico-chemical parameters of nanoparticles determining absorption and transport across membranes in the gut and lungs; the role of physico-chemical parameters of nanoparticles in systemic circulation determining biokinetics and accumulation in secondary target organs; possible health effects; and translocation of nanoparticles via the placenta to the fetus. The Opinion states that review of the safety of the insoluble nanomaterials presently used in sunscreens is required.

EC Announces Increases in Industrial Research in Nanoelectronics

On February 22, 2008, the European Commission (EC) announced the European Nanoelectronics Initiative Advisory Council (ENIAC) Joint Technology Initiative (JTI), which is endorsed by the Council of Ministers and by the European Parliament. Over the next ten years, € 3 billion will be invested in nanoelectronics.  The ENIAC JIT is a public-private partnership that targets nanoelectronics.  Under the ENIAC JIT, the EC and European Union (EU) member states who wish to participate will pool their public funding with universities and industry, including many innovative small- and medium-sized enterprises (SME), by setting up public-private partnerships. According to the EC, while research funding in nanoelectronics so far tends to be fragmented in small projects funded by individual member states and agencies, the ENIAC JIT will allow member states and the EC “to co-operate and co-finance pan-European research initiatives focus[]ed on a strategic agenda set by Industry itself.” The following member states participate in ENIAC: Austria, Belgium, Czech Republic, Estonia, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Spain, Sweden, and the United Kingdom.  The Governing Boards of the ENIAC JIT held its first meeting on February 22, 2008.

EC Asks for Scientific Opinion on Risk Assessment of Products of Nanotechnologies

The European Commission (EC) asked its Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for a scientific opinion on the risk assessment of products of nanotechnologies. The request asks SCENIHR to identify and assess new information and update its opinions on the potential risks of products of nanotechnologies, “in particular, with respect to characterisation, eco-toxicology and toxicology as well as exposure assessments.” The EC’s request for an opinion states that the update “should be done in a step-wise manner taking into account the upcoming risk assessment demands related to specific nanomaterials and the evolving scientific information from various sources, including results from scientific research projects and activities of the European Technology Platforms related to the safety of nanomaterials. The deadline for the opinion is November 2008.

European Commission Adopts Code of Conduct for Responsible Nanosciences and Nanotechnologies Research

On February 8, 2008, the European Commission (EC) announced the adoption of a code of conduct for responsible nanosciences and nanotechnologies (N&N) research. The EC recommends that member states adopt codes of conduct to govern N&N research.  The EC code of conduct is based on seven general principles that address issues such as sustainability, precaution, inclusiveness, and accountability. The code of conduct also provides guidelines that implement these principles under good governance of research; due respect of precaution; and dissemination and monitoring of the code of conduct. The EC invites member states to take concrete action involving universities, research institutes, and companies for the safe development and use of nanotechnologies.

The seven principles are:

  1. Meaning:  N&N research activities should be comprehensible to the public.  They should respect fundamental rights and be conducted in the interest of the well-being of individuals and society in their design, implementation, dissemination, and use.
  2. Sustainability:  N&N research activities should be safe, ethical, and contribute to sustainable development.  They should not harm or threaten people, animals, plants, or the environment, at present or in the future.
  3. Precaution:  N&N research activities should be conducted in accordance with the precautionary principle, anticipating potential environmental, health, and safety impacts of N&N outcomes and taking due precautions, proportional to the level of protection, while encouraging progress for the benefit of society and the environment.
  4. Inclusiveness:  Governance of N&N research activities should be guided by the principles of openness to all stakeholders, transparency, and respect for the legitimate right of access to information.  It should allow the participation in decision-making processes of all stakeholders involved in or concerned by N&N research activities.
  5. Excellence:  N&N research activities should meet the best scientific standards, including integrity of research and good laboratory practices.
  6. Innovation:  Governance of N&N research activities should encourage maximum creativity, flexibility, and planning ability for innovation and growth.
  7. Accountability:  Researchers and research organizations should remain accountable for the social, environmental, and human health impacts of their work.

EFSA Calls for Data on Applications of Nanotechnology and Nanomaterials Used in Food and Feed

On January 23, 2008, the European Food Safety Authority (EFSA) issued a notice entitled “Call for Scientific Data on Applications of Nanotechnology and Nanomaterials used in Food and Feed.” According to the notice, EFSA is seeking data that could be useful as it prepares an initial scientific opinion for the European Commission (EC) regarding the risks arising from nanoscience and nanotechnologies on food and feed safety and the environment. The EC asked EFSA to identify the nature of the possible hazards associated with actual and foreseen applications in the food and feed area, and to provide general guidance on data needed for the risk assessment of such technologies and applications. EFSA intends to release a draft of its opinion in July 2008. Data submissions to EFSA are due March 28, 2008.

EFSA requests data on the following issues:

  • Data on the safety of nanomaterials used in food and feed;
  • Food and feed applications and products containing or consisting of nanomaterials or produced by nanotechnology;
  • Methods, procedures, and performance criteria used to analyze nanomaterials in food and feed;
  • Use patterns and exposure to humans and environment;
  • Risk assessments performed on nanomaterials used in food and feed;
  • Toxicological data on nanomaterials used in food and feed;
  • Environmental studies performed on nanotechnologies and nanomaterials used in food and feed; and
  • Other data of relevance for risk assessment of nanotechnology and nanomaterials in food and feed.

EC Provides Overview of Past and Ongoing R&D

In a January 28, 2008, report entitled EU Nanotechnology R&D in the Field of Health and Environmental Impact of Nanoparticles, the European Commission (EC) provides an overview of past and ongoing research projects funded by the Framework Programmes (FP), EU member states, candidate countries, and countries associated to FP6 or FP7 in the area of possible impacts in health, environment, and safety of nanoparticles. The report has information on 106 projects, 14 of which are from the FPs, which provide around 32 million € in grants. The other 92 projects are from the EU members states, which spent around 47 million € in grants. The EC states that the “information may well be incomplete” and asks all interested parties to send additional information on research projects funded through national funding schemes. The EC intends to update the information regularly.

EFSA Begins Review of Nanotechnology

The European Food Safety Authority (EFSA) met the week of November 19, 2007, to begin reviewing the regulation and risk assessment of nanotechnology. The European Commission (EC) issued a mandate for a complete evaluation by March 31, 2008, but EFSA responded that, because of the range of differing properties and safety profiles, it will not be able to complete its review by this deadline. EFSA instead proposed to issue an initial scientific opinion by Summer 2008. EFSA intends to create a working group of 10 to 15 scientific experts. The Scientific Committee held its first discussion on the EFSA working strategy on November 19-20, 2007.

First Annual Nanotechnology Safety for Success Dialogue Held in October

On October 25-26, 2007, the European Commission (EC) held the First Annual Nanotechnology Safety for Success Dialogue. Presentations included:

Canada Publishes Proposed Regulatory Framework for Nanomaterials Under CEPA

Environment Canada (EC) and Health Canada (HC) have released a document entitled Proposed Regulatory Framework for Nanomaterials Under the Canadian Environmental Protection Act, 1999 (Proposed Framework). EC/HC will hold a public workshop for stakeholders regarding the Proposed Framework on September 27, 2007, in Toronto. At the workshop, EC/HC will gather comments from participating stakeholders through discussion groups and plenary sessions. EC/HC will invite all stakeholders to provide additional written comments the weeks following the meeting. Click here to request a copy of Bergeson & Campbell, P.C.’s memorandum on the Proposed Framework.

Reader-Friendly Version of 2006 EC Report Available

The European Commission (EC) Directorate General for Health and Consumer Protection retained GreenFacts to summarize the EC’s 2006 report entitled Modified Opinion (After Public Consultation) on the Appropriateness of Existing Methodologies to Assess the Potential Risks Associated with Engineered and Adventitious Products of Nanotechnologies. According to GreenFacts, the EC’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) wrote its Opinion for a scientific audience. GreenFacts prepared its summary for a broader audience.

The summary includes the following conclusion:

Conclusion -- Are existing methodologies to assess the potential human health and environmental risks associated with products of nanotechnology appropriate?

To the question: “Are existing methodologies appropriate to assess potential and plausible risks associated with different kinds of nanotechnologies and processes associated with nanosized materials as well as the engineered and adventitious products of nanotechnologies?,” the SCENIHR is of the opinion that:

  • Although the existing methods are appropriate to assess many of the hazards associated with the products and processes involving nanoparticles, they may not be sufficient to address all the hazards.
  • More specifically, the mode of delivery of the nanoparticle to the test system should adequately reflect the exposure scenarios. Additional tests may be needed.
  • Expressing the dose of exposure in terms of mass alone is not sufficient; it also needs to be expressed in terms of total surface area, number of particles, or a combination of the two.
  • Also, the existing methods used for environmental exposure assessment are not necessarily appropriate.
  • Therefore, the current risk assessment procedures require modification for nanoparticles.

To the question: “If existing methodologies are not appropriate to assess the hypothetical and potential risks associated with certain kinds of nanotechnologies and their engineered and adventitious products, how should existing methodologies be adapted and/or completed?,” the SCENIHR is of the opinion that:

Existing methodologies need to be modified or new ones developed so that they are able:

  • To determine the physical and chemical properties of nanoparticles routinely.
  • To measure the representative exposure to free nanoparticles in air, soil, water.
  • To better assess the potential hazard of nanoparticles, including whether or not they can exacerbate pre-existing medical conditions.
  • To better detect the movement of nanoparticles inside living systems.

More specifically, these methodologies need to provide information on how nanoparticles distribute in human tissues and in the environment.

To the question: “In general terms, what are the major gaps in knowledge necessary to underpin risk assessment in the areas of concern?,” the SCENIHR is of the opinion that:

The major gaps in knowledge that need to be filled to allow for satisfactory risk assessments for humans and ecosystems to be performed include:

  • The mechanisms and the rate at which nanoparticles are released from products and processes.
  • The actual levels of exposure to nanoparticles, both for humans and the environment.
  • The extent to which it is possible to calculate the toxicology of nanoparticles from the knowledge on the same chemicals in larger physical forms.
  • The movement of nanoparticles inside the body, the effects that nanoparticles cause at cellular level, and how target organs respond to different doses of nanoparticles.
  • The exposure and related health effects of workers involved in the production and processing of nanoparticles.
  • The behaviour of nanoparticles in the environment, how they are distributed, if they persist in it, and whether they accumulate in different species, including micro-organisms.
  • The effects of nanoparticles on various environmental species.

EC Committee Recommends Revisions to Technical Guidance Documents to Address Risk Assessment of Nanomaterials

On August 8, 2007, the European Commission (EC) released the scientific opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the appropriateness of the risk assessment methodology in accordance with the European Union’s (EU) technical guidance documents for new and existing substances for assessing the risks of nanomaterials. SCENIHR concluded that modifications to the existing technical guidance documents are necessary because special characterization of nanomaterial properties, which potentially differ considerably from conventional chemicals, is needed. Furthermore, the toxicological behavior and effects on health and the environment need to be assessed properly.  The opinion states that, due to the lack of common rules for the toxicology of nanomaterials, the risk assessment of nanomaterials should be done on a case-by-case basis. SCENIHR identified issues requiring improvements in the technical guidance and methodologies, and proposed a staged strategy for the risk assessment of nanomaterials. Special consideration is required for the assessment of the potential translocation of nanoparticles in humans and other species, and potential adverse effects, for example, within the cardiovascular system or following passage across the blood-brain barrier.

EuroNanoForum 2007 Proceedings Available Online

The proceedings of the June 19-21, 2007, EuroNanoForum 2007 are available. According to the European Commission (EC), they “provide an overview of the state-of-the-art in nanotechnology for industrial applications, presented by selected international top speakers to open up new perspectives in Europe for coming years.”

European Commission Initiates Consultation on Responsible Research in Nanosciences and Nanotechnologies

On July 19, 2007, the European Commission (EC) issued a press release entitled “Commission launches consultation on responsible research in Nanosciences and Nanotechnologies.” The press release states: “The European Commission has today announced a public consultation on responsible nanosciences and nanotechnologies research.  The consultation will provide input for a Recommendation to the Member States on a possible Code of Conduct for this emerging area of science, which the Commission will put forward later this year.  Contributions are expected from a broad cross-section of European society, including the scientific community, industry, civil society, policy-makers, media and the general public.”

Environment Canada Publishes Advisory Note Regarding Nanomaterials

Environment Canada (EC) recently posted a New Substances Program Advisory Note entitled “Requirements for nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers).” The Advisory Note was signed in June 2007 and states that the Canadian Environmental Protection Act, 1999 (CEPA) and the New Substances Notification Regulations (Chemicals and Polymers) (Regulations) “apply to new nanomaterials just as any other substance, whether a chemical or a polymer.

The Note includes the following questions and answers:

What are the requirements under the Regulations for nanomaterials which are manufactured or imported?

Nanomaterials which are manufactured in or imported into Canada are subject to the same regulatory requirements as chemicals and polymers, and notifiers must submit a New Substances Notification package prior to the manufacture in or import into Canada of the new substance.

Although not required, Environment Canada and Health Canada recommend notifiers request a Pre-notification Consultation (PNC) during the planning or preparation of a notification. For example, a notifier can request a PNC to assist with determining whether the substance is notifiable, as well as to clarify notification procedures or information requirements, and to determine the acceptability of waiver requests and/or test protocols.

What nanomaterials are subject to the Regulations?

Nanomaterials which are manufactured in or imported into Canada that are not listed on the Domestic Substances List (DSL) are considered new. The nanoscale form of a substance on the DSL is considered a “new” substance if it has unique structures or molecular arrangements. New nanomaterials are subject to notification under the Regulations. For example, the nanomaterial fullerene (CAS No. 99685-96-8) is not listed on the DSL and is considered a “new” substance under the Regulations.

What nanomaterials are not subject to the Regulations?

Substances listed on the DSL whose nanoscale forms do not have unique structures or molecular arrangements are considered existing. Existing nanomaterials are not subject to the Regulations and do not require notification. For example, titanium dioxide (CAS No. 13463-67-7) is listed on the DSL and since its nanoscale form does not have unique structures or molecular arrangements, it is not subject to the Regulations.

In addition, incidentally produced or naturally occurring nanomaterials are not subject to notification.

EC Committee Accepting Comments on Nanomaterials in Cosmetic Products

Until September 6, 2007, the European Commission (EC) Scientific Committee on Consumer Products (SCCP) is accepting comments on its Preliminary Opinion on the Safety of Nanomaterials in Cosmetic Products. According to the SCCP, traditional risk assessment methods -- hazard identification, hazard characterization, and exposure assessment -- may not be suitable for nanomaterials in cosmetics.  The SCCP suggests that either a new method should be developed, or the existing methodologies for hazard characterization and exposure assessment should be validated.  The SCCP recommends that the risk assessment of nanoparticles in cosmetics should be carried out on a case-by-case basis, taking into account the specific physical, chemical, and surface area characteristics of nanomaterials.  Previous safety evaluations on nanomaterials used in cosmetics would also need to be revised.

Study Recommends Amendments to EU Legislation to Address Nanomaterials

The July 2007 issue of Regulatory Toxicology and Pharmacology includes an article entitled “Limits and Prospects of the ‘Incremental Approach’ and the European Legislation on the Management of Risks Related to Nanomaterials.” According to the authors, the European Commission (EC) has adopted an incremental approach, focusing on adopting existing laws to regulate nanotechnologies. The authors concluded that the current regulations fail to address the environmental, health, and safety risks posed by nanomaterials and recommended specific revisions to European regulatory policies and the information on which they are based.

The authors analyzed in a life cycle perspective three commercially available products containing fullerenes to map current applicable regulations, determine their applicability to nanomaterials, identify their gaps, and suggest proper solutions. After mapping the life cycle of the three products, the authors reviewed applicable regulations in the order in which they became relevant in their life cycle, i.e.:

  • The Safety at Workplace Directives;
  • Directive 61/1996 on the Integrated Pollution Prevention and Control;
  • The European Union’s Directive on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH); and
  • The Waste Management Directives.
The authors concluded that the applicability of environmental laws is limited due to difficulties in generating sufficient data on the nanomaterials residing in the products according to their life cycles.  Further, metrology tools, which measure nanoparticles in the environment or at the work site, are unavailable; thresholds are not tailored to the nanoscale and are based on ecotoxicological and toxicological data from larger chemicals; and occupational exposure limits cannot be established with existing methodologies.  According to the authors, the incremental approach can be applicable only with the implementation of due amendments.

European Commission Publishes Results of Intellectual Property Rights Workshop

On May 10, 2007, the European Commission (EC) announced the availability of the results of its April 16, 2007, workshop on intellectual property rights (IPR) in nanotechnology. The objective of the workshop was to identify specific IPR issues for nanotechnology and to discuss possible consequences for patent offices, policy makers, patent consultants, and the research community.  Ongoing academic and political discussions have identified many aspects, such as the costs of patenting and the accessibility of patents for small- and medium-sized enterprises (SME) or developing countries; the need for a transparent and clearly defined scope of patent protection; the implications of “nanopatent land grab” and “patent thickets”; “nanotech patent battles”; and “second nature” and “monopoly patent.”  The discussions were aiming at possible actions specific for nanotechnology, i.e., the need for a better patent monitoring system of nanotechnology for patent application and examining, technology analysis, and policy advice purposes, the possible need for harmonization between the European Union (EU), the U.S., and Japan, the need for a new nanotechnology patent regime, the development of guidelines for the protection of IPR and models for consortium and licensing agreements, lessons for collaborative research projects, and other research collaborations.

PEN Releases LCA Report

On March 20, 2007, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Nanotechnology and Life Cycle Assessment: A Systems Approach to Nanotechnology and the Environment, which summarizes the results of the October 2-3, 2006, workshop organized by PEN and the European Commission on life cycle assessment (LCA). LCA is a cradle-to-grave analysis of how a material affects ecosystems and human health. According to the report, the purpose of the October 2-3, 2006, workshop was to determine whether existing LCA tools and methods are adequate to use on a new technology. The report provides an overview of LCA and nanotechnology, discusses the current state of the art, identifies current knowledge gaps that may prevent the proper application of LCA in this field, and offers recommendations on the application of LCA for assessing the potential environmental impacts of nanotechnology, nanomaterials, and nanoproducts.

The report offers the following main conclusions identified by the workshop participants:

  • There is no generic LCA of nanomaterials, just as there is no generic LCA of chemicals.
  • The International Organization for Standardization (ISO) framework for LCA (ISO 14040:2006) is fully suitable to nanomaterials and nanoproducts, even if data regarding the elementary flows and impacts might be uncertain and scarce. Since environmental impacts of nanoproducts can occur in any life cycle stage, all stages of the life cycle of nanoproducts should be assessed in an LCA study.
  • While the ISO 14040 framework is appropriate, a number of operational issues need to be addressed in more detail in the case of nanomaterials and nanoproducts. The main problem with LCA of nanomaterials and nanoproducts is the lack of data and understanding in certain areas.
  • While LCA brings major benefits and useful information, there are certain limits to its application and use, in particular with respect to the assessment of toxicity impacts and of large-scale impacts.
  • Within future research, major efforts are needed to assess fully potential risks and environmental impacts of nanoproducts and materials (not just those related to LCA).
  • There is a need for protocols and practical methodologies for toxicology studies, fate and transport studies, and scaling approaches.
  • International cooperation between Europe and the U.S., together with other partners, is needed to address these concerns.
  • Further research is needed to gather missing relevant data and to develop user-friendly eco-design screening tools, especially ones suitable for use by small and medium sized enterprises.

The report also offers specific recommendations in the following areas:

  • Case-studies/prioritizing efforts: With limited resources, a case-study research approach could be adopted to enhance significantly knowledge on environmental impacts of nanomaterials and nanoproducts.
  • LCA studies and presentations of results: Any LCA study on nanoproducts and nanomaterials most likely suffers from high uncertainty issues.
  • Approaches.
  • Actions from stakeholders: Different stakeholders/authorities can potentially support the application and use of LCA for nanoproducts and nanomaterials through a large set of actions.