Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

EC Proposes to Amend REACH Annexes to Address Nanomaterials

Posted in International, Legal/Regulatory Issues

On October 9, 2017, the European Commission (EC) began a public consultation on a draft regulation that would amend Annexes I, III, VI, VII, VIII, IX, X, XI, and XII of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanoforms of substances.  The draft regulation states that:

  • Clarifications to requirements for the registration of substances with nanoforms and related downstream user obligations should be included in Annexes I, III, and VI to XII;
  • Manufacturers and importers should assess and, where relevant, generate the necessary information and document in the chemical safety report that the risks arising from the identified uses of the substance with nanoforms are adequately controlled;
  • As the majority of nanomaterials are expected to be nanoforms of phase-in substances, the conditions for the requirements for generation of new toxicological and ecotoxicological information on phase-in low volume substances should be elaborated to ensure that the assessment criteria are based also on the predicted properties of nanoforms;
  • All different nanoforms and sets of nanoforms should be considered by the registrant in the demonstration of safety;
  • To allow efficient assessment of the potential exposure for inhalable nanoforms, in particular in workplaces, information on dustiness should be provided for the different nanoforms or sets of nanoforms;
  • Although acute toxicity testing for the lowest tonnage is required via the oral route, for nanoforms, inhalation or in very specific cases the dermal route may be considered as a more appropriate route of exposure;
  • A number of specific physico-chemical properties, in addition to those used to identify the different nanoform or sets of nanoforms, may be considered relevant for scientific understanding of the properties of a nanomaterial, with the necessary parameters depending on the individual case. For reasons of workability and proportionality, only registrants for higher volume substances than 100 tonnes per year should be required to consider explicitly such further information in case other particle properties significantly influence hazard or exposure to those nanoforms; and
  • Compliance with the provisions of the proposed amendment should not be required immediately to allow all registrants and downstream users adequate time to adapt to the more specific requirements for substances with nanoforms. The amendment would apply from January 1, 2020.

Comments are due November 6, 2017.

Registration Open for NNI Workshop on Open Technology Development Pathways

Posted in Federal, Research, United States

As reported in our August 30, 2017, blog item, the “Technology Development Pathways:  Case Studies from the [National Nanotechnology Initiative (NNI)]” workshop will be held November 1, 2017.  According to NNI, the workshop will showcase application areas where nanotechnology has had commercial impact.  Keynote presentations will highlight the pathways companies have taken to get from research to commercialization.   Panel discussions will focus on specific steps of the development pathway, such as scale up and quality control/measurement systems.  The goal of this workshop is to provide case studies and facilitate the exchange of technical information among private sector participants.  NNI notes that federal government representatives will also participate, enabling attendees to learn of ongoing research activities, agency needs, and funding opportunities.  The workshop is free and open to the public.  Registration is on a first-come, first-served basis, but space is limited.

JRC Publishes NANoREG Toolbox for the Safety Assessment of Nanomaterials

Posted in International, Legal/Regulatory Issues

The European Commission (EC) Joint Research Center (JRC) has published the NANoREG Toolbox for the Safety Assessment of Nanomaterials.  As reported in our May 8, 2017, blog item, JRC previously published a Science for Policy report entitled NANoREG framework for the safety assessment of nanomaterials.  The report was developed within the NANoREG project, “A common European approach to the regulatory testing of nanomaterials.”  The NANoREG framework represents the project’s proposal for a common understanding in the field of environmental health and safety assessment of nanomaterials under the current European regulatory framework, with focus on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The Toolbox supports the implementation of the framework by providing an overview of available tools (test methods, datasets, models, guidance documents, and decision trees) useful to regulators and other stakeholders in the European REACH context.  The tools consist not only of those released in the scientific deliverables of NANoREG, but include those from other initiatives, at the European level and beyond, that have addressed one or more “nano-specific hurdles” in safety assessment.  The Toolbox distinguishes between current (presently available and accessible) tools and prospective (promised) ones.  The resulting two Excel® workbooks, zipped into a single file, contain a wide review of categorized tools, with descriptive information and metadata attached to them.  The dataset “is freely available to the global nanoEHS community, be it regulators or industry, for further expansion and exploitation.”

EPA Promulgates Final SNUR for Bimodal Mixture Consisting of MWCNTs and Other Classes of CNTs

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States

On October 3, 2017, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes (MWCNT) and other classes of carbon nanotubes (CNT), which was the subject of premanufacture notice (PMN) P-11-482.  This action requires persons who intend to manufacture (defined by statute to include import) or process the chemical substance for a use that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity.  Manufacture and processing for the significant new use is unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required with that determination.  According to the June 8, 2017, proposed SNUR, the generic use of the PMN substance will be as a specialty additive.  Based on test data on analogous respirable, poorly soluble particulates and nanocarbon materials, EPA identified concerns for pulmonary toxicity and oncogenicity.  Based on test data for other nanocarbon materials, EPA identified concerns for environmental toxicity.  Under the SNUR, significant new uses are:

  1. Protection in the workplace: Requirements as specified in 40 C.F.R. Section 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6) (particulate), and (c).  When determining which persons are reasonably likely to be exposed as required for Section 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.  A National Institute for Occupational Safety and Health (NIOSH)-certified air purifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 cartridges, or power air purifying particulate respirator with an Assigned Protection Factor (APF) of at least 50 meets the requirements of Section 721.63(a)(4);
  2. Industrial, commercial, and consumer activities: Requirements as specified in Section 721.80(k) and (q).  A significant new use is any use involving an application method that generates a vapor, mist, or aerosol;
  3. Disposal: Requirements as specified in Section 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2); and
  4. Release to water: Requirements as specified in Section 721.90(b)(1) and (c)(1).  Any predictable or purposeful release of a manufacturing stream associated with any use of the substance from any site is a significant new use other than the water releases described in the manufacturing process of PMN P-11-482.

This final rule is effective November 2, 2017.

NIA Will Hold Webinar on Safe by Design for Nanomaterials

Posted in International, Legal/Regulatory Issues, Research

On October 24, 2017, the Nanotechnology Industries Association (NIA) will hold a webinar on Safe by Design for nanomaterials.  NIA states that the webinar is free and open to all actors interested in nanomaterials and their safe management throughout their lifecycle, using the principles of Safe by Design from the earliest development stages.  According to NIA, the webinar will bring together projects active in the creation of Safe by Design across Europe to inform participants of the long-term benefits and commercial sustainability that Safe by Design brings to product development.  Registration is available online.

Switzerland Intends to Require Notification of Fibrous Nanomaterials Placed on the Market

Posted in International, Legal/Regulatory Issues

On September 29, 2017, Switzerland notified the European Commission (EC) of a draft amendment to the Ordinance on Protection against Dangerous Substances and Preparations.  The notification states that the Ordinance on Protection against Dangerous Substances and Preparations regulates the risk assessment of chemicals and the requirements to be fulfilled for using and placing on the market of chemicals that could endanger human health or the environment.  According to the notification, the draft amendment introduces, among other things, a risk-based obligation for the manufacturer/importer to communicate:

  1. Chemical intermediates traded in Switzerland; and
  2. Fibrous nanomaterials placed on the market.

The obligation must be fulfilled within three months after the first placing on the market.  The notification includes the following grounds for the fibrous nanomaterials requirement:  “The new obligation should give an overview to the authorities and the public over the fibrous nanomaterials placed on the market.  Regulatory risk reduction measures are possible if special risks are recognized.”

ECHA Announces RAC Concludes on Opinion for Harmonized Classification and Labeling for Titanium Dioxide

Posted in International, Legal/Regulatory Issues

The European Chemicals Agency (ECHA) announced on September 27, 2017, that the Committee for Risk Assessment (RAC) concluded on ten opinions for harmonized classification and labeling (CLH), including titanium dioxide.  In May 2016, France submitted a CLH proposal for titanium dioxide, stating that titanium dioxide should be considered as being potentially carcinogenic to humans when inhaled and thus be classified as category 1B-H350i.  France proposed that the classification apply to both fine particles and nanomaterials of titanium dioxide “without being able of any distinction in terms of morphology, crystal phase, and surface treatment.”  As reported in our June 12, 2017, blog item, during RAC-41, held May 29-June 2 and June 8-9, 2017, RAC “concluded that the available scientific evidence meets the criteria in the [Classification, Labeling and Packaging (CLP)] Regulation to classify titanium dioxide as a substance suspected of causing cancer through the inhalation route.”  The annex to ECHA’s press release states that RAC adopted the final opinion in written procedure before RAC-42, held September 18-22, 2017.  RAC did not agree to the proposal to classify titanium dioxide as category 1B, presumed to have carcinogenic potential for humans, but “agreed to classify titanium dioxide in category 2 as a suspected human carcinogen Carc. 2; H350 (inhalation), i.e. not by the oral or dermal routes.”  ECHA states that the opinion will be available on RAC’s web page “in the near future.”

OECD Tour de Table Highlights International Developments on the Safety of Manufactured Nanomaterials

Posted in International, Legal/Regulatory Issues

On September 27, 2017, the Organization for Economic Cooperation and Development (OECD) published a corrected version of the Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour De Table, which covers developments on the safety of manufactured nanomaterials that were provided by OECD delegations from March to August 2017.  It summarizes relevant information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level.  The reported activities include:

  • The French National Institute for Industrial Environment and Risks (INERIS) “has developed some preliminary guidance values on human toxicity (inhalation, ingestion) as well as for ecotoxicity for the case of [titanium dioxide] at the nanoform.”
  • Germany’s Federal Institute for Occupational Safety and Health (BAuA) and Federal Institute for Risk Assessment (BfR) have “decided on including investigations on nanofibers with special emphasis on fiber rigidity in their research program. The focus shall be on characterization, exposure assessment and inhalation toxicology.”
  • Korea’s Ministry of Environment (MOE) has added nanomaterials to the list for hazard evaluation prescribed in the Act on Registration and Evaluation, etc. of Chemical Substances (K-REACH):
    • Risk assessment decisions, including the type of: (a) nanomaterials assessed; (b) testing recommended; and (c) outcomes of the assessment;
    • Development related to exposure measurement and exposure mitigation;
    • Risk management approaches;
    • Any updates, including proposals or modifications to previous regulatory decisions; and/or
    • New regulatory challenge(s) with respect to any action for nanomaterials.

Based on the policy and research infrastructures developed from the first National Nano-Safety Master Plan (2012-2016) at interministerial levels (including MOE and the Ministries of Trade, Industry, and Energy, and Food and Drug Safety), the Korean government will establish the goal, vision, and implementation plan of the second Master Plan (2017-2021), and intended to make an official announcement by the first half of 2017.  MOE plans to introduce an effective safety management system of nanomaterials and nanoproducts distributed during the second period.  The secondary plan will include assessing the hazards of nanomaterials, and evaluating and managing safety assessments of nanomaterials in nanoproducts.

  • The European Commission (EC) intends to propose the adoption of possible revised Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation addressing nanomaterials in the beginning of 2018, “with further transition arrangement regarding full application.”

EPA Issues Direct Final SNURs for Carbon Nanotube (Generic) and Nanocarbon (Generic)

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States

The U.S. Environmental Protection Agency (EPA) promulgated on September 21, 2017, significant new use rules (SNUR) for 37 chemical substances that were the subject of premanufacture notices (PMN).  Six of the chemical substances, including carbon nanotube (generic) and nanocarbon (generic), are subject to consent orders issued by EPA under Section 4 of the Toxic Substances Control Act.  The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of the 37 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification initiates EPA’s evaluation of the intended use.  Manufacture and processing for the significant new use is unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required with that determination.  The promulgated SNURs include:

  • Carbon nanotube (generic) (PMN Number P-15-672): The generic (non-confidential) use of the PMN substance will be in filtration media.  EPA identified concerns for pulmonary toxicity and oncogenicity, as well as environmental toxicity.  The consent order requires:
  1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with N-100, P-100, or R-100 cartridges (where there is a potential for inhalation exposure);
  2. Processing and use of the PMN substance only for the use specified in the consent order;
  3. Processing and use of the PMN substance only as an aqueous slurry, wet form, or a contained dry form as described in the PMN; and
  4. No use of the PMN substance resulting in releases to surface waters and disposal of the PMN substance only by landfill or incineration.
  • Nanocarbon (generic) (PMN Number P-16-170): The substance will be used as an additive to composite materials.  EPA identified concerns for pulmonary toxicity and oncogenicity, as well as environmental toxicity.  The consent order requires:
  1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a NIOSH-certified respirator with N-100, P-100, or R-100 cartridges (where there is a potential for inhalation exposure);
  2. Submission of a dustiness test within six months of notice of commencement;
  3. Submission of a 90-day chronic inhalation study prior to exceeding the confidential production volume limit specified in the consent order;
  4. Processing and use of the PMN substance only for the use specified in the consent order, including no application method that generates a vapor, mist, or aerosol unless the application method occurs in an enclosed process; and
  5. No use of the PMN substance resulting in releases to surface waters and disposal of the PMN substance only by landfill or incineration.

Both SNURs would designate as a “significant new use” the absence of the specified protective measures.  The notice includes recommended testing for each substance.  The SNURs will take effect November 20, 2017.

EC Begins Consultation on Revising Recommendation on Definition of Nanomaterial

Posted in International, Legal/Regulatory Issues

On September 15, 2017, the European Commission (EC) began a public consultation on the revision of the 2011 EC Recommendation on the definition of nanomaterial.  The EC intended the definition to achieve consistent application of the term nanomaterial across all legislation.  The definition includes descriptors that the EC intended to review by December 2014 to ensure that the definition corresponds to the needs.  In particular, the review must examine issues where there was incomplete information at the time of adoption.  According to the Roadmap, the review generated the following interim findings:

  1.  While the uptake of the Recommendation in European Union (EU) regulation to date has taken place, it has not been as comprehensive as anticipated.  This is not due to the definition itself, however, but due to delays in the processes planned to include the definition, e.g., the possible amendment of Annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanomaterials and the delay in the adoption of the novel food regulation, by which time the review was launched;
  2. There is general consensus on the adequacy of the main elements of the definition.  These are notably the neutral scope in terms of the origin of the materials and the definition’s focus on particles.  It is generally accepted that the definition uses the size of particles as the only defining parameter, applying to a 1-100 nanometer particle size range and bases the threshold for being a nanomaterial on a number concentration instead of mass;
  3. There are currently difficulties in directly applying the Recommendation in legislation.  For example, it includes a threshold that has a default value but is not fully defined in advance and might require an additional process to determine its value:  “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 %.”  Also, application of the additional criteria based on the specific surface area by volume is considered ambiguous by some stakeholders.  These prevent the Recommendation from being referred to in full by different regulations and force individual selection of its elements during each regulatory uptake, which could eventually lead to inconsistencies;
  4. There is a need to clarify some terms in use and how the criteria are applied:  e.g., the definition of “particle,” the precise meaning of particle’s “external dimension” and the use of the concept of the “constituent particle” in respect to agglomerates and aggregates;
  5. There are issues of scope:  e.g., the present Recommendation in addition to the general criteria explicitly identifies three carbon-based materials (graphene flakes, single-wall carbon nanotubes, and fullerenes) as nanomaterials while very similar non-carbon materials are not included; and
  6. Implementation remains challenging; there is no single universally applicable measurement method, and refinement of existing measurement methods is still in progress.  In particular, to quantify “constituent particles” in all cases still poses a challenge.  No easy implementation routes are presently provided to determine quickly for certain when a material is or is not a nanomaterial.

According to the Roadmap, the intention now is to prepare a revised Recommendation to be adopted by the EC, accompanied by a Staff Working Document that will report on the review undertaken and the rationale for the modifications.  The Roadmap states that it is envisaged that the EC will then:

  • Promote the revised Recommendation within the EU and, as appropriate, in the international community;
  • Develop guidance (including technical requirements), sector-specific guidance, and implementation tools;
  • Support the uptake of the Recommendation in the relevant policy areas, such as chemicals, cosmetics, and food; and
  • Set up a system of continuous monitoring of implementation across sectors, facilitate quick dissemination and uptake of any relevant scientific/technical developments, and if considered appropriate, trigger actions to support quality assurance and control of the measurements and their application in the nanomaterial definition.

Comments on the Roadmap are due October 13, 2017.