On November 4, 2019, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published an updated Guidance on the Safety Assessment of Nanomaterials in Cosmetics.  The Guidance updates SCCS’s 2012 Guidance (SCCS/1484/12) on the safety assessment of nanomaterials in cosmetic products.  It covers the main elements of safety assessment — general considerations (Section 2), material characterization (Section 3), exposure assessment (Section 4), hazard identification and dose-response characterization (Section 5), and risk assessment (Section 6).  The Guidance includes key recommendations for the safety assessment of nanomaterials intended for use in cosmetics on the following topics:

  • Definition: The regulatory definition of nanomaterial is provided in the Cosmetic Regulation (EC) No. 1223/2009, under Article 2(1)(k).  SCCS suggests that when assessing the safety of a material consisting of small particles, applicants should also take into account the EC’s Recommendation (2011/696/EU).  SCCS notes that “[w]here a new or an already-approved cosmetic ingredient fulfils the criteria for defining it as NM, it will be subject to safety assessment based on the data relevant to nano-scale properties.”
  • Material characterization: At a minimum, applicants must provide characterization data on all the specified parameters that are relevant to a given nanomaterial.  According to the Guidance, the nanomaterial characterization needs to be carried out at the raw material stage, in the cosmetic formulation, and during exposure for toxicological evaluations.  The Guidance notes that SCCS may request a detailed description of the production processes, any surface modifications, and the preparatory steps carried out for integrating the nanomaterials in the final cosmetic products as input into the safety assessment process.
  • Exposure assessment: Safety assessment of nanomaterials follows the same procedure as for non-nanoscale ingredients, but with special considerations of the nanoscale aspects.  According to the Guidance, SCCS is of the view that the method for calculating dermal and oral exposure to nanomaterials will not be substantially different from the calculation of exposure to conventional cosmetic ingredients.  The Guidance notes that calculation of exposure to aerosols containing nanomaterials may be more challenging, however.
  • Hazard identification/dose-response characterization: SCCS will require data from toxicological studies for local and — in case of systemic absorption — systemic effects.  According to the Guidance, testing of nanomaterials for hazard identification/dose-response characterization must be carried out in consideration of the nano-related aspects.
  • Safety assessment: The Guidance notes that historically, calculation of the margin of safety of a cosmetic ingredient has been based on a measured toxicological point of departure (POD), along with an estimate of internal exposure in terms of systemic exposure dose (SED).  The Guidance acknowledges that with the European Union’s ban on animal testing of cosmetic ingredients and/or products, derivation of PODsys for systemic adverse effects of a new cosmetic ingredient may not be possible, or possible only in exceptional cases.  Data obtained to comply with other non-cosmetic regulations should be used and submitted when available, however.  For other cases, the applicant will need to assemble relevant information and data from different alternative (non-animal) methods and integrate the data to build an overall weight of evidence to support the safety of the cosmetic ingredient.

SCCS notes that due to the evolving nature of nanomaterials safety research, it may revise the Guidance in the future to take account of any new scientific knowledge.

The most recent episode of the National Nanotechnology Initiative’s (NNI) podcast series, Stories from the NNI, features Lynn L. Bergeson.  Ms. Bergeson shares her perspective on the intersection of nanotechnology and the law.  Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), speaks with Ms. Bergeson regarding her perspective on the intersection of nanotechnology and the law.  To celebrate the 15-year anniversary of the authorization of NNI, NNI is releasing a new podcast episode every Monday.  In each of the episodes, an expert from academia, government, or industry will share his or her perspectives on key research and development advances in nanotechnology and how NNI has changed the nanotechnology landscape.

On September 24 – 26, 2019, the European Commission’s (EC) Joint Research Center (JRC) hosted the 2019 Global Summit on Regulatory Science (GSRS19), which focused on nanotechnology and nanoplastics.  Co-organized with the Global Coalition for Regulatory Science Research, GSRS19 covered nanotechnology research and its role in enhancing regulatory decision making, including methods, standards, and applications.  In addition, GSRS19 also introduced methods and approaches to understand nanoplastics better.  GSRS19 addressed the following topics in plenary and parallel sessions:

  • Global regulatory science perspectives on nanotechnology and nanoplastics;
  • Regulatory research needs for new and follow-on nanomedicines;
  • Safety assessment of nanomaterials;
  • Nanotechnology in the agri/food/feed sector;
  • Documentary standards and reference materials; and
  • Challenges concerning nanoplastics.

According to JRC, discussion focused on what needs to be accomplished in these areas; the research gaps and/or priorities in regulatory science and how these can be addressed; and what platforms, mechanisms, communities of practice, and networks exist (or need to be developed) to facilitate effective collaborations between international partners.  JRC has posted the GSRS2019 agenda and abstracts.

Registration has begun for the National Nanotechnology Initiative’s (NNI) November 12, 2019, webinar, “Global Harmonization of Nanoinformatics:  A Case Study in Convergence and Team Science.”  The webinar, part of NNI’s 2019 series on the environmental, health, and safety effects of nanomaterials (nanoEHS), “will share how engaged and collaborative communities in the United States, Europe, and elsewhere have provided an infrastructure capable of supporting sustainable design of nanotechnology-enabled products and robust regulatory decision making.”  The presenters will highlight advances in curation, database design, and ontology development and discuss practical nanoinformatics outputs, such as the European Union (EU)-U.S. Roadmap Nanoinformatics 2030 and how the nanoinformatics community has contributed to standardization to set a computational modeling foundation for predictive nanoEHS and safer-by-design capabilities.  The presenters will include Dr. Christine Ogilvie Hendren, Duke University Center for the Environmental Implications of NanoTechnology (CEINT), and Dr. Fred Klaessig, Pennsylvania Bio Nano Systems.  Webinar viewers will be able to submit questions for the presenters to answer during the question and answer period.  Submitted questions will be considered in the order received and may be posted on the NNI website.  NNI notes that webinar participants may be interested in the Nanotechnology Working Group (Nano WG) webinar on the practical application of eNanoMapper to nanoEHS research that will be held November 14, 2019.

 

The International Organization for Standardization (ISO) has published standard ISO/TS 21236-1:2019, “Nanotechnologies — Clay nanomaterials — Part 1:  Specification of characteristics and measurement methods for layered clay nanomaterials.”  The standard specifies characteristics to be measured of layered clay nanomaterials in powder form and chemically modified ones and describes their relevant measurement methods.  According to the standard abstract, there are numerous industrial applications for layered clay nanomaterials.  Given the wide range of clay nanomaterial applications, various fundamental characteristics play undeniable roles.  According to the abstract, these characteristics are measured and reported by the provider of the layered clay nanomaterials.  ISO states that the determinations of these fundamental and basic characteristics will facilitate the communication between sellers and buyers of these nanomaterials for different applications.  These characteristics are considered for all industrial layered clay nanomaterial applications, such as nanocomposites, paper, ink, purification, and catalysts.  In addition to fundamental characteristics, some other optional characteristics of layered clay nanomaterials are measured and reported subject to the agreement between sellers and buyers.  ISO notes that the standard does not deal with health, safety, and environmental issues.

The European Union (EU) Observatory for Nanomaterials (EUON) announced on October 15, 2019, that it seeks topics that could be addressed in upcoming studies.  EUON conducts up to three studies annually that are intended to address knowledge gaps on nanomaterials that are of interest to the general public and the research community.  EUON states that it is looking for studies that address:

  • Questions relating to the health and safety of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection;
  • Specific issues surrounding the uses of nanomaterials; or
  • Information about markets for nanomaterials, focusing on EU markets.

According to EUON, the scope of the study can be on nanomaterials in general, a specific nanomaterial, or a defined group of nanomaterials.  The study should be possible to execute within three to nine months.  EUON notes that the studies “should be based on desk research and surveys and should not require laboratory research.”  Proposals are due by January 15, 2020.  The EUON secretariat will assess all proposals.  Selected proposals will be carried out through EUON’s existing procurement channels.  EUON will publish the outcome and study reports on its website.

On October 11, 2019, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) for 31 chemical substances, including multiwalled carbon nanotubes (generic), that were the subject of premanufacture notices (PMN).  84 Fed. Reg. 54816.  EPA notes that eight of the chemical substances are subject to orders under the Toxic Substances Control Act (TSCA) issued by EPA.  The effective date of the TSCA Section 5(e) order for multiwalled carbon nanotubes (generic) was May 3, 2019.  According to EPA, the PMN states that multiwalled carbon nanotubes (generic) will be used in heat transfer, heat storage, thermal emission, and general temperature management in heat-generating systems, such as electronics, to improve mechanical properties or electrical conductivities of other materials or products and for light absorption properties.  The proposed SNUR states that EPA identified concerns for pulmonary toxicity based on carbon nanotube analogues and for aquatic toxicity when the substance is at low concentrations and in the presence of natural organic matter.  EPA issued the consent order under TSCA Sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment.  To protect against these risks, the TSCA Section 5(e) order requires:

  1. Use of personal protective equipment by workers to prevent dermal exposure where there is potential dermal exposure;
  2. Use of a National Institute of Occupational Safety and Health (NIOSH) certified respirators with an Assigned Protection Factor (APF) of at least 50 workers to prevent inhalation exposure where there is potential inhalation exposure;
  3. Refrain from using the PMN in applications that generates a dust, vapor, mist, or aerosol, unless such application method occurs in an enclosed process;
  4. Process and use of the PMN substance only as described in the PMN;
  5. No release of the PMN substance to surface waters; and
  6. Disposal only by incineration or landfill.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.  Comments are due November 12, 2019.

On October 7, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion by Lise Bitsch, Governing Nanotechnologies through Societal Engagement (GoNano), entitled “Strengthening societal engagement with nanotechnologies.”  Bitsch presents several arguments for why actors in the research and innovation world of nanotechnologies and other key enabling technologies should care about societal engagement.  Bitsch also explains what societal engagement is by using the Horizon 2020 project GoNano as an example.

The European Chemicals Agency (ECHA) issued a press release on October 8, 2019, reminding companies that by January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The new information requirements concern companies that manufacture or import nanoforms of substances that are subject to registration under REACH.  As reported in our December 4, 2018, blog item, the European Commission (EC) amended several REACH Annexes to introduce clarifications and new provisions for:

  • Characterization of nanoforms or sets of nanoforms covered by the registration (Annex VI);
  • The chemical safety assessment (Annex I);
  • Registration information requirements (Annexes III and VII-XI); and
  • Downstream user obligations (Annex XII).

ECHA states that the purpose is to ensure that companies provide enough information to demonstrate the safe use of their nanoforms for human health and the environment.  The amendments apply to all the new and existing registrations covering nanoforms.  ECHA states that it expects registrants to update their existing dossiers with nanoform-specific information by January 1, 2020.

ECHA notes that its new nano-specific guidance is intended to help companies comply with the changes in Annex VI.  In addition, ECHA is updating the guidance on read-across between nanoforms or sets of nanoforms to reflect the changes.  ECHA intends to have both documents ready by the end of 2019.  ECHA is also updating the 2017 ECHA guidance for human health and the environment.  According to ECHA, the Organization for Economic Cooperation and Development (OECD) is revising some of its existing test guidelines used under REACH to ensure that data generated on nanoforms is reliable and meets regulatory standards.  An overview of the revised REACH Annexes and the available test methods is available on the EU Observatory for Nanomaterials (EUON) website.

On October 30, 2019, the International Uniform Chemical Information Database (IUCLID) will be updated with new data fields for reporting the characteristics of nanoforms and sets of nanoforms.  Beginning October 30, 2019, registrants who intend to submit registrations covering substances in nanoform must provide complete characterization information on their nanoforms or sets of nanoforms.  According to ECHA, the completeness check will include a verification that the sets of nanoforms are accompanied by a justification for creating the set.  As before, the IUCLID tool will include the means to link these nanoforms or sets of nanoforms with the relevant data on their properties and hazards in the other parts of the dossier.  ECHA states that companies submitting information on nanoforms must use the new version of IUCLID because it is not possible to prepare a successful submission with previous versions.

As reported in our September 27, 2019, blog item, ECHA is hosting a webinar on November 12, 2019, to introduce the guidance on identifying and reporting nanoforms and sets of nanoforms.  During the webinar, companies will have the opportunity to get advice directly from ECHA’s experts.  ECHA notes that its help desk is available to assist companies prepare for the new requirements.

We are pleased to announce that the Fall 2019 issue of The SciTech Lawyer, published by the American Bar Association’s (ABA) Section of Science and Technology Law, includes an article co-authored by Lynn L. Bergeson and Carla N. Hutton, “Nanotechnology and Regulatory Certainty Closer Now Than Ever.”  Nanoscale technologies and their resultant innovations have long captured the imaginations of scientists and inventors, the scrutiny of regulators, and the apprehension of nongovernmental organizations and consumer watchdogs.  Over the past decade or so, however, a compelling case can be made that the scientific and regulatory communities have done a credible job of allaying these initial concerns and thus can claim victory over nay-sayers who portended global calamity occasioned by the commercialization of nano-enabled products.  The article provides an overview of how the U.S. Environmental Protection Agency (EPA) and U.S. Food and Drug Administration (FDA) are using their existing authorities to ensure that nanomaterials do not pose a risk to human health and the environment.  The complete article is available only to Section members.