Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

NIOSH Posts AIHA Fact Sheet on PPE for Engineered Nanoparticles

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

Earlier this month the National Institute for Occupational Safety and Health (NIOSH) posted a fact sheet sponsored by the American Industrial Hygiene Association (AIHA) Nanotechnology Working Group entitled Personal Protective Equipment for Engineered Nanoparticles.  The fact sheet defines engineered nanoparticles as intentionally produced solid particles with at least one dimension in the size range of approximately 1 to 100 nanometers.  According to the fact sheet, “[r]ecent studies and experience support the fact that traditional exposure control approaches can also work for intentionally produced nanoparticles when selected and implemented as part of a comprehensive occupational safety and health plan.”  The fact sheet recommends managing exposure risks by following the industrial hygiene hierarchy of controls approach.  For best results, exposure prevention and control measures should be considered early in the planning of experiments, development of products, and design of manufacturing processes, so that appropriate controls can be planned and selected.  The fact sheet describes personal protective equipment (PPE) as “the last line of defense” and states that it should be used when other controls are not feasible or not effective in reducing exposures to acceptable levels, or while controls are in the process of being implemented.  According to the fact sheet, “PPE may also be used to supplement other control measures for added precaution, and should be used as part of a comprehensive workplace PPE program.”

EWG Begins Certification Program for Consumer Products

Posted in United States

The Environmental Working Group (EWG) announced on October 27, 2015, EWG VERIFIED™, a verification program intended “to give consumers peace of mind at point of sale as they try to avoid toxic and potentially harmful chemicals and contaminants commonly found in consumer goods.”  Under the program, products must follow the European Union’s (EU) labeling guidelines for nanomaterials used in cosmetics.  EWG VERIFIED™ items must be free of substances on EWG’s “unacceptable” list and meet limits outlined in EWG’s “restricted” list.  Companies seeking to use the mark must fully disclose their products’ ingredients on their packaging and on their websites.  EWG hopes the mark will “encourag[e] more companies to reformulate their products to achieve top scores and move the marketplace to produce healthier products.”

ProSafe Project Invites Experts to Online Forum on Whether Risk Management Is on Pace with Nanotechnology Innovation

Posted in International, Legal/Regulatory Issues

ProSafe has launched an online Delphi Forum on whether risk management is on pace with innovation for nanomaterial uses.   ProSafe will use expert discussion between those working with manufacture and health and safety of specific nanomaterial uses to develop a white paper proposing a path forward for risk management policies for nanomaterial uses.  To join the Forum, follow the instructions below:

  • Go to;
  • In the access code box for “ProSafe Delphi Poll,” enter “Prosafe2015” as the Access Code and click “take survey”;
  • Enter an e-mail address to enter the poll. A confirmation e-mail will be sent to confirm and create a user account.

The Delphi Forum will include a panel review of the discussion so far at the Society for Risk Analysis annual meeting in early December 2015, so the project team hopes to obtain as much input as possible before November 30, 2015.  The material classes considered in the Delphi Forum are titanium dioxide, silicon dioxide, cerium oxide, barium sulphate, silver, and carbon nanotubes.

EPA Intends to Promulgate Final TSCA 8(a) Rule in October 2016

Posted in Federal, Legal/Regulatory Issues, United States

According to an item in the U.S. Environmental Protection Agency’s (EPA) Fall 2015 Regulatory Agenda, EPA intends to promulgate a final Toxic Substances Control Act (TSCA) Section 8(a) rule in October 2016 concerning reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale.  EPA’s April 6, 2015, proposed rule includes one-time reporting for existing nanoscale materials and one-time reporting for new discrete nanoscale materials before they are manufactured or processed.  EPA states that consistent with the President’s memorandum for Executive Agencies regarding Principles for Regulation and Oversight of Emerging Technologies, the proposed rule would facilitate assessment of risks and risk management, examination of the benefits and costs of further measures, and making future decisions based on available scientific evidence.

OECD Working Party on Resource Productivity and Waste Posts Documents Concerning Nanomaterials

Posted in Legal/Regulatory Issues, Research

The Organization for Economic Cooperation and Development (OECD) recently posted four reflection papers that discuss the possible release of nanomaterials from waste treatment operations and a literature review on four specific waste treatment processes of recycling, incineration, landfilling, and wastewater treatment.  The papers aim to point out the knowledge gaps and areas where further research is needed.

  • Incineration of Waste Containing Nanomaterials: The paper was developed to attempt to improve the knowledge base and achieve progress on the discussion concerning the environmentally sound management of waste containing nanomaterials;
  • Landfilling of Waste Containing Nanomaterials and Nanowaste: The purpose of the paper is to provide an initial scoping review of readily available scientific information about the source of engineered nanomaterials in landfills, their fate and behavior in landfills, and the effectiveness of treatment technologies;
  • Recycling of Waste Containing Nanomaterials: The main objective of the paper is to review the current state of knowledge on the fate of nanomaterials in the course of recycling operations and identify the areas where further work on the environmentally sound management of waste containing nanomaterials would be needed;
  • The Fate of Engineered Nanomaterials in Sewage Treatment Plants and Agricultural Applications: The paper investigates the current state of knowledge on engineered nanomaterials and their behavior in wastewater treatment processes to identify the current state of knowledge and areas for future research; and
  • Nanomaterials in Waste Streams — Chapter 1: This report surveys the available evidence from the literature for four specific waste treatment processes of recycling, incineration, landfilling, and wastewater treatment to establish the current state of knowledge on the fate and possible impacts of engineered nanomaterials in these processes.

EC Scientific Committee Releases Opinion on Hydroxyapatite (Nano) for Comment

Posted in Legal/Regulatory Issues

The European Commission (EC) Scientific Committee on Consumer Safety (SCCS) has posted for comment its opinion on hydroxyapatite (nano).  According to the opinion, the EC received 35 notifications of cosmetic products containing hydroxyapatite in nano form.  The opinion states that, according to the applicants, the ingredient is used in nano uncoated form both in leave-on and rinse-off oral cosmetics products, including toothpastes, tooth whiteners, and mouth washes with a maximum reported concentration limit of ten percent and specifications.  The opinion states that the EC has concerns because of the potential for nanoparticles of hydroxyapatite to be absorbed and enter into the cells.  It requested from the SCCS a safety assessment of the nano form of hydroxyapatite covered in the notifications, in the above-mentioned categories of products, taking into account the reasonably foreseeable exposure conditions.  The SCCS states that applicants provided only a limited amount of data that corresponded to the SCCS Guidance on Safety Assessment of Nanomaterials in Cosmetics and that the provided data were also not in line with the SCCS Memorandum on Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials.  To facilitate the assessment, the SCCS also considered additional information gathered through a search of the published scientific literature.  The SCCS concluded, however, that the evidence “is insufficient to allow drawing a conclusion on the safety of nano-hydroxyapatite when used in oral cosmetic products.”  The SCCS states that it will need “toxicological data specific for the materials included in the submission for safety assessment, unless a close similarity with the materials used in the available studies can be demonstrated to allow data read-across.”  The SCCS also concluded that the available data indicate that “nano-hydroxyapatite in needle form is of concern in relation to potential toxicity.”  The opinion states that “needle-shaped nano-hydroxyapatite should not be used in cosmetic products.”  Comments are due January 8, 2016.

EP and Council of the EU Reach Agreement on Proposed Novel Food Regulation

Posted in International, Legal/Regulatory Issues

On November 11, 2015, the Council of the European Union (EU) announced that its Permanent Representatives Committee approved the proposed novel food regulation. On November 16, 2015, the European Parliament (EP) and the Council of the EU reached an agreement on the proposal. The European Commission (EC) issued a November 16, 2015, press release and a November 16, 2015, Questions and Answers (Q&A) document concerning the final regulation. The Q&A includes the following concerning nanomaterials:

What are nanomaterials and what are the conditions for their use in food?

Nanomaterials are materials engineered at the scale of atoms and molecules. The new Regulation specifies that engineered nanomaterials defined in the new legislation, require a Novel Food authorisation before being used in foodstuffs. Their safety will be assessed by the European Food Safety Authority. The applicants must also demonstrate that most up-to-date test methods have been used for testing the engineered nanomaterials for which an authorisation is sought for.

 The EP and the Council must still formally adopt the regulation before it will be published in the Official Journal of the European Union. The regulation will enter into force 20 days after its publication and will apply two years later (around the end of 2017, according to the EC).

Denmark Posts Several Publications Concerning Nanomaterials

Posted in International, Legal/Regulatory Issues, Research

On November 10, 2015, the Danish Environmental Protection Agency posted the following publications concerning nanomaterials:

  • Environmental assessment of nanomaterial use in Denmark: This is the concluding report of the project “Nanomaterials — occurrence and effects in the Danish environment” (NanoDEN). The projects in NanoDEN aimed to investigate and generate new environmentally relevant knowledge concerning nanomaterials on the Danish market and to assess the possible associated risks to the environment. The report summarizes the results from the sub-projects and assesses whether and how nanomaterials may pose a risk for the environment in Denmark. The assessment is based on investigations of nine selected nanomaterials that are expected to be environmentally relevant based on knowledge of consumption quantities, or how they are used: titanium dioxide; zinc oxide; silver; carbon nanotubes; copper oxide; zero valent iron; cerium dioxide; quantum dots; and carbon black.
  • Consumer risk assessment for nanoproducts on the Danish market: The report:
    • Assesses consumer risks associated with 20 selected consumer exposure/use scenarios;
    • Integrates the learnings from these assessments with findings from previous activities of the project;
    • Discusses and puts into perspective what we know about the overall exposure and risks for Danish consumers, also considering other sources of nanomaterials exposure; and
    • Identifies main gaps in knowledge and methodologies for assessing consumer exposure.
  • Dermal Absorption of Nanomaterials Titanium Dioxide and Zinc Oxide Based Sunscreen: Role of Size and Surface Coating: The conclusion states:

Based on our results using in vitro and in vivo mouse and human skin models we conclude that dermal penetration of TiO2 and ZnO NPs did not occur at or above the limit of detection of the used experimental methods. Should absorption of TiO2 and ZnO nanoparticles occur at levels below the detection limit of the assays used herein, the systemic dose would be very small (far lower than the doses used in the studies discussed above) and so highly unlikely to cause systemic toxicity based on toxicological evidence in rodents. This is in accordance with the conclusions that were made by the SCCS that stated that both kind of nanoparticles are safe to use for dermal applications up to a concentration of 25% in cosmetic products [SCCS (Scientific Committee on Consumer Safety), 2012; SCCS (Scientific Committee on Consumer Safety), 2014].

  • Environmental effects of engineered nanomaterials: Estimations of Predicted No-Effect Concentrations (PNECs): The report provides the following key findings:
    • Investigations have shown that currently accepted PNEC estimation approaches within the present European legislation in principle can be used for nanomaterials. This concerns the assessment factor (AF) and species sensitivity distribution (SSD) approaches. These methods do not take nano-specific processes during the testing of nanomaterials into account, and the tests may therefore not always be representative for natural conditions. Through a literature review carried out within the current project, three other methods were suggested: the probabilistic species sensitivity distribution (PSSD); the dissolved metal ion; and the indicative no effect concentration (INEC).
    • The current approach to select data for PNEC estimation favors effect studies conducted according to Good Laboratory Practice (GLP) and accepted guidelines. A consequence is that effect studies conducted according to guidelines for soluble chemicals may be unreliable as they do not take into account the specific nature of engineered nanomaterials (ENM).
    • Within the current project, an approach was developed for transparent evaluation of the suitability of effect studies to test ENMs and to what extent they are adequate for risk assessment. The approach focused on nano-specific parameters and highlights knowledge gaps and limitations in relation to data availability and relevance.
    • More than 1,200 scientific papers on effect studies of ENMs were found in the open literature. 500 of these revealed data on effects that potentially could be used for PNEC derivation. 50 percent of these studies used daphnia as the test organism, 30 percent used fish, and 20 percent used algae. Hardly any chronic studies were performed with fish. Nevertheless, no single study obtained the best score for risk assessment adequacy.
    • The number of sufficient effect studies adequate for risk assessment was, despite the large number of effect studies found, so low that PNEC estimation only could be made according to the AF approach.
    • Using the available data, silver nanoparticles were found to be the most toxic ENM (PNEC = 12 nanograms per liter (ng/L)), while titanium dioxide was found to be the least toxic (PNEC = 18 micrograms per liter (μg/L)). Due to a lack of adequate data it was not possible to derive PNEC values for carbon black and quantum dots; and
    • The derived PNEC values in this report were generally on the same level or slightly lower than the PNEC values found in the open literature or in the European Union’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registrations. Compared with ion and bulk PNEC values in REACH registrations, the derived nano PNEC values in this report were in the same order of magnitude (silver) or one order of magnitude lower (titanium dioxide, zinc oxide, and copper oxide).

OECD Tour de Table Documents Cover Developments in 2014 and 2015

Posted in International, Legal/Regulatory Issues

The Organization for Economic Cooperation and Development (OECD) has posted two Tour de Table documents.  The documents, dated October 26, 2015, cover activities from January to July 2014 and before September 2015:

  • Current Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table: The document compiles information, provided by delegations, including the European Commission (EC), together with non-member economies, on current developments on the safety of manufactured nanomaterials.  OECD intends the document to provide delegations with background information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level.  The purpose of the Tour de Table is to provide delegations the opportunity to describe recent or planned national initiatives and/or events related to the safety of manufactured nanomaterials.  OECD states that this will facilitate delegations to share their experiences and preoccupations with respect to safety, and will identify opportunities for future cooperation and coordination.  The information provided in this document captures activities that occurred in delegations between January and July 2014.
  • Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table: The document compiles information, provided by delegations, including the EC, together with other organizations, on current developments on the safety of manufactured nanomaterials.  OECD intends the document to provide background information on activities related to manufactured nanomaterials at the national and international level.  According to OECD, the purpose of the information exchange is to facilitate delegations to share their experiences and preoccupations with respect to safety, and serve as the basis to identify opportunities for future cooperation and coordination.  The information provided in the document captures activities that occurred in delegations before September 2015.

JRC Publishes Part Three of Its Review of EC’s Recommendation for a Definition of the Term Nanomaterial

Posted in International, Legal/Regulatory Issues

The Joint Research Center (JRC) published on October 19, 2015, a report entitled Towards a review of the EC Recommendation for a definition of the term “nanomaterial”:  Part 3:  Scientific-technical evaluation of options to clarify the definition and to facilitate its implementation.  The report provides JRC’s scientific-technical evaluation of options to clarify the European Commission’s (EC) 2011 Recommendation on a definition of nanomaterial.  In 2013, JRC started to develop a series of three scientific-technical reports based on a list of tasks addressing specific points of the EC’s Recommendation.  In this third report, JRC describes scientific and technical options intended to clarify the wording and facilitate the implementation of the definition.  JRC states that the scope of the definition regarding the origin of nanomaterials should remain unchanged, addressing natural, incidental, and manufactured nanomaterials.  According to JRC, because of the regulatory purpose of the definition, there is little evidence to support deviating from size as the sole defining property of a nanoparticle or from the range of 1 nanometer (nm) to 100 nm as the definition of the nanoscale.  JRC notes that clarification of some terms used in the definition and additional implementation guidance would be useful.  JRC cautions, however, that relying only on guidance documents for essential parts of the definition could lead to unintended differences in the implementation and decision making.