Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

ANSI Nanotechnology Standards Panel Will Consider Graphene-Related Topics

Posted in Federal, United States

On March 20, 2018, the American National Standards Institute (ANSI) Nanotechnology Standards Panel (ANSI-NSP) will meet at the U.S. Department of Agriculture in Washington, D.C.  The focus of the meeting will be to consider the observations from the February 28, 2017, ANSI-NSP meeting on graphene standards, including the following issues:

  • Terminology;
  • Characterization methods; and
  • Information sharing.

Participants will discuss recommendations for future standardization activities.  The meeting is open to all interested participants and is free of charge.  Registration is open until March 1, 2018.

CPSC Will Continue to Use Agency Collaborations to Focus on the Environmental Health and Safety of Nanomaterials

Posted in Federal, Occupational Health and Safety Issues, Research, United States

On February 12, 2018, the U.S. Consumer Product Safety Commission (CPSC) posted its Fiscal Year 2017 Annual Performance Report.  According to the Report, in fiscal year (FY) 2017, CPSC exceeded its target of five collaborations by establishing seven research collaborations on the environmental health and safety of nanomaterials.  The collaborations “will increase knowledge of the potential exposure to consumers from products that contain nanomaterials and explore methods to measure their release from consumer products.”  The Report states that to help advance nanotechnology research and development, CPSC continued collaborative work during FY 2017 through established Interagency Agreements with the National Institute of Standards and Technology (NIST), the National Nanotechnology Coordination Office (NNCO), and the National Institute for Occupational Safety and Health (NIOSH):

  • CPSC’s collaboration with NIST: NIST is collaborating with CPSC to evaluate methods for assessing the release of nanomaterials in dust samples collected from the U.S. Department of Housing and Urban Development’s (HUD) Healthy Home Survey and releases from consumer products, as well as validate test methods for nanomaterials;
  • CPSC’s Collaboration with NNCO: In FY 2017, CPSC established an agreement with NNCO to conduct a workshop to highlight the science and measurement challenges associated with assessing the potential release of engineered nanomaterials from manufactured products. The primary focus of the workshop will be to determine the state of the science and the tools and methods available to characterize and quantify the presence of nanomaterials in products, the potential for their release, and the potential for population exposure; and
  • CPSC’s Collaboration with NIOSH: NIOSH, in a collaboration with CPSC, recently conducted Phase 1 of a study to research the following aspects of nanoparticles:  particle generation, characterization, and fractionation; in vitro dosimetric determination; in vitro toxicity investigation in multiple cell lines; and in vivo evaluation of Positive Expiratory Pressure-induced cardiovascular effects via inhalation.  In FY 2017, NIOSH conducted a follow-up, Phase 2 study to investigate environmental health and safety implications from engineered nanomaterials released from nano-enabled products during consumer use in targeted study areas.

Regarding its plans for improving performance, the Report states that in FY 2018, CPSC “has fewer resources for nanomaterial efforts and will continue to focus on environmental health and safety issues through collaborations with other federal agencies.”

JRC Opens Call to Access JRC Nanobiotechnology Laboratory

Posted in International, Research

The European Commission (EC) Joint Research Center (JRC) has opened a call to access its Nanobiotechnology Laboratory.  The Nanobiotechnology Laboratory features state-of-the-art equipped facilities designed to foster interdisciplinary studies, with a special emphasis on the characterization of nanomaterials, nanomedicines, advanced materials and their interactions with biological systems, as well as on the detection, identification, and characterization of nanomaterials in food and consumer products.  Offering access to the Nanobiotechnology Laboratory is part of JRC’s strategy to enhance dissemination of scientific knowledge; boost competiveness; bridge the gap between research and industry; and provide training and capacity building.  To be eligible, the lead user institution and user institutions must be from a European Union (EU) Member State, candidate country, or country associated with the EU Research Program Horizon 2020.  The lead user institution must be from a university, research, or public institution, or from a small- or medium-sized enterprise (SME).  The call will close April 13, 2018.

French NGO Claims Many Manufacturers Fail to Comply with Nano Labeling Requirement

Posted in International, Legal/Regulatory Issues

UFC-Que Choisir, a French non-governmental organization (NGO), announced on January 23, 2018, that it filed complaints against nine manufacturers of food and cosmetic products for failure to comply with the requirement to report the presence of nanomaterials on the product label.  UFC-Que Choisir states that its analysis covered 20 consumer products (seven food products, nine cosmetics, and four drugs) and targeted titanium dioxide, silicon dioxide, iron oxide, zinc oxide, and carbon black.  The NGO tested the products for the presence of nanomaterials and then checked the product packaging for reference to nanomaterials.  According to UFC-Que Choisir, all the food and cosmetic products contained nanoparticles, but most labels failed to reflect their presence.  In addition to the complaints filed, UFC-Que Choisir requests that the Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes (DGCCRF) and the Ministry of Economy publish a list of food and cosmetic products containing nanomaterials that fail to meet the labeling requirement, prosecute manufacturers that violate the labeling requirement, and continue to monitor compliance.

NIA Will Hold Webinar on Nanomedicine: Diagnostics and Therapeutics Advancing through Nanotechnology

Posted in International, Legal/Regulatory Issues

On March 7, 2018, the Nanotechnology Industries Association (NIA) will hold a webinar on “Nanomedicine:  Diagnostics and therapeutics advancing through nanotechnology.”  The webinar will focus on the diagnostic and therapeutic applications of nanotechnology, with the agenda including:

  • Regulatory landscape in Europe and beyond for nanomaterials in healthcare applications; and
  • Industry developments within nanomedicine from NIA Members:
    • Endomag — A United Kingdom/U.S. small- or medium-sized enterprise (SME) with minimally-invasive surgical guidance platform using magnetism (magnetized nanoparticles) to improve tissue localization in surgical oncology; and
    • Senolytx — A Spanish/U.S. SME developing a nanoparticle-based theraorutic composed of a mesoporous silica scaffold, loaded with the cyctotoxic doxorubin.

The webinar is open to all interested applicants and presentations will be available to all attendees.  Registration is now open.

NIOSH Final Research Agenda for Manufacturing Addresses Nanomaterials

Posted in Federal, Occupational Health and Safety Issues, United States

The National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice on January 31, 2018, announcing the availability of the final National Occupational Research Agenda for Manufacturing.  NIOSH states that the National Occupational Research Agenda for Manufacturing “is intended to identify the knowledge and actions most urgently needed to identify occupational risk factors to prevent avoidable adverse health outcomes among workers.”  The Agenda “provides a vehicle for stakeholders to describe the most relevant issues, research gaps, and safety and health needs for the Manufacturing sector.”  As reported in our August 24, 2017, blog item, the draft National Occupational Research Agenda for Manufacturing referred to nanomaterials.  The final Agenda includes the following objectives and references to nanomaterials:

  • Objective 1: Reduce the burden of acute and chronic occupational illnesses, injuries, and fatalities in manufacturing by:  (a) enhancing knowledge of occupational safety and health hazards and their effects; and (b) developing effective interventions to reduce exposure to known occupational safety and health hazards.  The final Agenda states:  “Exposure to hazards associated with repetitive hand-intensive work, manual material assembling and handling, nanomaterials, excessive noise, and chemicals contribute greatly to debilitating acute and chronic conditions in the manufacturing industry.”
  • Objective 2: Improve surveillance of work-related hazards, exposures, and illnesses in the manufacturing industry.
  • Objective 3: Examine emerging risks from new technologies and explore ways in which new technologies can advance occupational safety and health in manufacturing.  According to the final Agenda, new technologies that are reshaping the manufacturing industry include nanotechnologies.
  • Objective 4: Improve occupational safety and health for workers in non-traditional employment arrangements.
  • Objective 5: Advance capacity-building and educational efforts in manufacturing.
  • Objective 6: Develop mechanisms for effective translation of research into practice in the manufacturing sector.

EUON Links Nanomaterials Used in Cosmetic Products to Registration Data

Posted in International, Legal/Regulatory Issues

As reported in our June 19, 2017, blog item, the European Commission (EC) published a catalog of nanomaterials used in cosmetic products on the European Union (EU) market.  On February 5, 2018, the European Union Observatory for Nanomaterials (EUON) published a table linking nanomaterials listed in the catalog to their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration data in the European Chemicals Agency’s (ECHA) database.  According to EUON, the linking was done by matching chemical substances in ECHA’s database through their Chemical Abstracts Service (CAS) numbers and/or with the name of the nanomaterial in the catalog.  EUON notes that as the registration of nanomaterials under the Cosmetics Regulation and the registration of substances under REACH have different scopes, it is not always possible to have a perfect match.  Some catalog entries are more specific in scope than the substances registered under REACH.  EUON cautions that a REACH registration may not specifically cover the nanoforms of the substances used in cosmetics.

EFSA Publishes Safety Assessment of Selenium Nanoparticles for Use in Active Food Contact Materials

Posted in International, Legal/Regulatory Issues

The European Food Safety Authority (EFSA) Panel on Food Contact Materials, Enzymes, Flavorings, and Processing Aids evaluated food contact material (FCM) Substance No. 1070, which incorporates selenium nanoparticles into the adhesive middle layer of multilayer laminates with an outside polyethylene terephthalate (PET) layer and an inner polyolefin (food contact) layer.  The results of the Panel’s evaluation are published in the January 2018 issue of the EFSA Journal in an article entitled “Safety assessment of the active substance selenium nanoparticles, for use in active food contact materials.”  According to the abstract, in all tests, migration of selenium was not detectable.  The article states that taking into account current knowledge on the diffusional properties of nanoparticles in polymers, the Panel concluded “there is no safety concern for the consumer if selenium nanoparticles are used in multilayer films and separated from the food by a polyolefin food contact layer for any type of food and under any food contact conditions.”

ACGIH® TLV®-CS Committee Seeks Information on Carbon Nanotubes

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

The American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee has included carbon nanotubes on its 2018 list of chemical substances and other issues under study.  Being placed on the under study list indicates that the TLV®-CS Committee has selected carbon nanotubes for development of a threshold limit value (TLV®).  ACGIH® describes TLVs® as health-based values representing the opinion of the scientific community that exposure at or below the level of the TLV® does not create an unreasonable risk of disease or injury.  The TLV®-CS Committee seeks substantive data and comments, and will consider only those addressing issues of health and exposure, not economic or technical feasibility.  ACGIH® will update the under study list into a two-tier list by July 31, 2018:

  • Tier 1 entries indicate the chemical substances and physical agents that may move forward as a notice of intended change (NIC) or notice of intent to establish (NIE) in the upcoming year, based on their status in the development process; and
  • Tier 2 consists of those chemical substances and physical agents that will not move forward, but will either remain on, or be removed from, the under study list for the next year.

If the Committee decided to proceed with a proposed TLV® for carbon nanotubes, the ACGIH® Board of Directors would first ratify the proposed value and it would be published as an NIE in the 2018 annual report of the TLV®-CS Committee.

Belgium Modifies Royal Decree Regarding the Placement on the Market of Substances Manufactured at the Nanoscale, Requires Registration of Mixtures

Posted in EU Member State, International, Legal/Regulatory Issues

Belgium published in the January 15, 2018, Official Gazette an amendment to the Royal Decree regarding the placement on the market of substances manufactured at the nanoscale.  Under the amendment, cosmetic products as defined by the July 2012 Belgian Royal Decree on cosmetic products are exempt from registration, and provisions regarding the registration of mixtures entered into force on January 1, 2018.  As reported in our October 27, 2014, blog item, substances defined as nanomaterials, and mixtures containing them, must be registered if at least 100 grams of the substance or mixture is placed on the market during the year covered by the registration, and if the entity putting the substance on the market produced the substance or mixture, or puts it on the market for professional users only.  Biocidal products, medicines, food and feed, food contact materials, and pigments are excluded from the scope of the Royal Decree.