Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Belgium’s Nanomaterials Register Now Available

Posted in Federal, International

This week, Belgium’s Federal Public Service for Health, Food Chain Safety and Environment created an online portal for companies to register nanomaterials they put on the market.  Nanosubstances must be registered before January 1, 2016.  Mixtures containing such substances must be registered before January 1, 2017.  Belgium has posted several documents to help companies determine whether they must register:

  • Who has to register?  The answer is given in a schematic way, with a decision tree for substances and a decision tree for mixtures.  According to the document, the main difference between the decision trees follows from the exemption made in Article 1.8 of the Royal Decree:  “The provisions of this Decree shall not apply to . . . pigments, when placed on the market in a mixture, an article or a complex object.”  The following products are exempt from registration:  biocide; medicinal products for human or veterinary use; products intended to come into contact with foodstuff; animal feed; and technological aid or other products that may be used for processing ingredients of agricultural origin.
  • When do I have to register?  Existing substances produced in nanoparticular state that are already on the market before January 1, 2016, must be registered before January 1, 2016.  Existing mixtures containing substances produced in nanoparticular state that are already on the market before January 1, 2017, must be registered before January 1, 2017.  New substances produced in nanoparticular state after January 1, 2016, and mixtures containing such substances after January 1, 2017, must be registered before being placed on the market.
  • Which type of account?  Creating an account gives users access to the registration tool and allows the submission of one or more registrations.
  • Which type of registration?  A foreign supplier can submit only one type of registration, namely the inverse (of the limited) registration.  A registrant or a representative can submit different types of registrations, depending on whether the registration concerns a substance or a mixture; a first registration or an annual update; a registration using a previous registration number; or a product that is used exclusively within the framework of scientific research and development or within the framework of product and process-oriented research and development.
  • Registration — which info?  This document aims to guide users through the registration process and to provide an overview of the information that will be asked during this process.

Companies Appeal ECHA’s Decision on Silicon Dioxide

Posted in International, Legal/Regulatory Issues

On August 19, 2015, the European Chemicals Agency (ECHA) announced appeals of its March 11, 2015, decision on substance evaluation for silicon dioxideCase A-015-2015 was filed by Evonik Degussa GmbH and 34 others, while Case A-014-2015 was filed by Grace GmbH & Co. KG and Advanced Refining Technologies GmbH.  The appellants in Case A-015-2015 challenge ECHA’s decision to include silicon dioxide on the Community Rolling Action Plan (CoRAP) “due to initial grounds for concern relating to ‘the substance characterisation, nanoparticles and toxicity of different forms of the substance.’”  The appellants argue that none of the alleged grounds for concern are criteria for inclusion of a substance on the CoRAP, and as a result, ECHA’s decision to include silicon dioxide on the CoRAP was adopted in breach of Article 44 of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation and must be set aside.  In addition, the appellants claim further that, since the decision to include the substance on the CoRAP was illegal and must be set aside, the March 11, 2015, decision lacks legal basis as only substances appearing on the CoRAP can be evaluated.  In Case A-014-2015, the appellants’ arguments include:  “The Agency has based its decision very largely on its own classification of [synthetic amporphous silica] as a nanomaterial, a classification that the Agency is not empowered to make and that in any event is irrelevant to the toxicity of [synthetic amporphous silica].”  In the March 11, 2015, decision, ECHA requires silicon dioxide registrants to provide specified data by March 20, 2017.

UK Report Assesses Workplace Exposure and Control Measures During the Manufacture and Handling of Engineered Nanomaterials

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues

The United Kingdom’s Health and Safety Laboratory (HSL) of the Health and Safety Executive (HSE) prepared a report entitled Summary of work undertaken to assess workplace exposure and control measures during the manufacture and handling of engineered nanomaterials.  The report notes that HSE and HSL attempted to identify and engage with companies that manufactured or used nanomaterials, but only four volunteered to take part in this project.  The report cautions that the observations represent a limited data set, and need to be understood in this context and not overgeneralized.  The objectives were to visit companies to assess exposure to airborne nanomaterials during their manufacture, handling, and use, and to assess the effectiveness of the controls used to reduce exposure to nanomaterials.  The key findings include:

  • An increased understanding of some of the tasks and activities undertaken during the manufacturing, handling, or use of nanomaterials and the potential for exposure to airborne nanomaterials;
  • Existing good hygiene control practices can be used to reduce exposure to airborne nanomaterials;
  • An exposure monitoring strategy suited to small businesses to monitor emission of airborne nanomaterials was evaluated and found to be practical and cost effective;
  • The company Control of Substances Hazardous to Health (COSHH) assessments were not specific to nanomaterials and all of the assessments reviewed could have been improved;
  • An effective risk management assessment strategy could include a combination of a simple exposure monitoring approach and an occupational hygiene assessment of the process and the controls; and
  • There is not enough evidence yet to propose a measurement methodology that should be used to underpin separate specific occupational exposure limits (OEL) for nanomaterials if these were to be proposed.

EPA Will Continue Review of Engineered Nanomaterials in Wastewater

Posted in Federal, Legal/Regulatory Issues, Research, United States

On August 4, 2015, the U.S. Environmental Protection Agency (EPA) announced the availability of its Final 2014 Effluent Guidelines Program Plan.  The Final Program Plan includes the following findings from EPA’s review of engineered nanomaterials in industrial wastewater:

  • Some manufacturing and processing methods likely generate wastewater, but the quantity generated and waste management practices are not documented;
  • Toxicity hazards from engineered nanomaterials have been demonstrated in the laboratory, but the environmental and human health risks are largely unknown;
  • Fate of and exposure to industrial wastewater releases of engineered nanomaterials to the environment have not been studied;
  • The small size, unique properties, and complexity of engineered nanomaterials present a challenge for environmental monitoring, risk assessment, and regulation;
  • Methods for detecting and characterizing nanomaterials in complex media, like industrial wastewater, are under development;
  • EPA has not approved any standardized methods for sampling, detecting, or quantifying of nanomaterials in aqueous media; and
  • Research has shown that common treatment technologies employed at municipal wastewater treatment plants can remove nanomaterials from the wastewater, but that these may then accumulate in the sludge.

EPA states that its review also identified four main areas of further research appropriate to assess better the potential presence and impact of engineered nanomaterials in industrial wastewater:

  • Development of standard methods and sampling techniques to detect and characterize nanomaterials in industrial wastewater;
  • Evaluation of engineered nanomaterial toxicity impacts and potential occurrence in industrial wastewater, taking into consideration relevant forms and concentrations of engineered nanomaterials;
  • Identification of the universe of engineered nanomaterial facilities, their production values, and the waste generated and disposed of during the manufacturing and processing of engineered nanomaterials; and
  • Evaluation and characterization of the fate, transformation, and treatment of engineered nanomaterials in industrial wastewaters.

EPA states that it plans to continue to monitor ongoing research on engineered nanomaterials in future annual reviews and will collect any new information as it becomes available, particularly related to the following data gaps:

  • Development of standard methods and sampling techniques to detect and characterize nanomaterials in industrial wastewater;
  • Evaluation of engineered nanomaterial toxicity impacts and potential occurrence in industrial wastewater, taking into consideration relevant forms and concentrations of engineered nanomaterials;
  • Identification of the universe of facilities, their production values, and the nature of the waste generated and disposed by manufacturing and processing of engineered nanomaterials; and
  • Evaluation and characterization of the fate, transformation, and treatment of engineered nanomaterials in industrial wastewaters.

FDA Issues Final Guidance on Use of Nanomaterials in Food for Animals

Posted in Federal, Legal/Regulatory Issues, United States

On August 4, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance document entitled “Guidance for Industry:  Use of Nanomaterials in Food for Animals.”  The Guidance is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.  FDA states that the Guidance is applicable to food ingredients intended for use in animal food that:  (1) consist entirely of nanomaterials; (2) contain nanomaterials as a component; or (3) otherwise involve the application of nanotechnology.  FDA states:

This final guidance addresses the legal framework for adding nanomaterial substances to food for animals and includes recommendations for submitting a Food Additive Petition (FAP) for a nanomaterial animal food ingredient.  This guidance also recommends manufacturers consult with FDA early in the development of their nanomaterial animal food ingredient and before submitting an FAP.  At this time, we are not aware of any animal food ingredient engineered on the nanometer scale for which there is generally available safety data sufficient to serve as the foundation for a determination that the use of such an animal food ingredient is generally recognized as safe (GRAS).

NGOs Challenge Nanosilva’s Conditional Registration

Posted in Federal, Legal/Regulatory Issues, United States

On July 27, 2015, two petitions for review of the U.S. Environmental Protection Agency’s (EPA) second conditional registration of a nanosilver pesticide product were filed in the U.S. Court of Appeals for the Ninth Circuit. The Natural Resources Defense Council (NRDC) filed a petition (Case Number 15-72308), as well as the Center for Food Safety (CFS) and International Center for Technology Assessment (ICTA) (Case Number 15-72312). Both suits ask the court to set aside EPA’s final order granting a conditional registration for a nanosilver-containing antimicrobial pesticide product named “NSPW-L30SS,” or “Nanosilva.” NRDC challenged EPA’s first conditional registration of a nanosilver product, which it granted to HeiQ in 2011. On November 7, 2013, the U.S. Court of Appeals for the Ninth Circuit granted in part and denied in part NRDC’s petition for review of HeiQ AGS-20 and AGS-20 U (collectively, AGS-20). The court held that “substantial evidence” supported EPA’s decision to use the characteristics of toddlers rather than infants in determining whether AGS-20 placed consumers at risk. The court vacated EPA’s decision “insofar as it concluded that there was no risk concern requiring mitigation for short- and intermediate-term aggregate oral and dermal exposure to textiles that are surface-coated with AGS-20.”

Companies Appeal ECHA’s Requests for Information Concerning Nanoforms

Posted in International, Legal/Regulatory Issues

On July 16, 2015, the European Chemicals Agency (ECHA) announced the following appeals in which the keywords include nanoforms:

The cases all concern silicic acid, aluminum sodium salt. The contested decisions were adopted December 17, 2014, following a compliance check under the dossier evaluation procedure of the submitted registration. In each contested decision, ECHA found that the registration did not comply with the requirements of Article 10(a)(ii), as well as Annex VI, Section 2 of the Registration, Evaluation, Authorization and Restriction of Chemicals Regulation. ECHA requested that each appellant submit the following information:

  • Name, molecular, and structural formula, or other identifier of the substance (Annex VI, 2.1 and 2.2);
  • Composition of the substance (Annex VI, 2.3); and
  • Description of the analytical methods used (Annex VI, 2.3.7).

In each case, the appellant contends that ECHA breached the principle of legal certainty by requesting information related to undefined terms, such as “forms,” “grades,” and “nanoforms.” Each appellant asks the Board of Appeal to annul the contested decision in so far as it requests the appellant to submit information as identified in the appeal.

Canada Begins Mandatory Survey with Respect to Certain Nanomaterials in Canadian Commerce

Posted in International, Legal/Regulatory Issues

The July 25, 2015, Canada Gazette includes a notice announcing that the Minister of the Environment requires, for the purpose of assessing whether the substances described in the notice are toxic or are capable of becoming toxic, or for the purpose of assessing whether to control, or the manner in which to control the listed substances, any person described in the notice who possesses or who may reasonably be expected to have access to the information required to provide that information. The notice applies to a substance that has a size of between 1 and 100 nanometers in at least one external dimension, or internal or surface structure; and is provided in the list in Schedule 1 of the notice. The list includes over 200 substances. The notice applies to any person who, during the 2014 calendar year, manufactured a total quantity greater than 100 kilograms (kg) of a substance set out in Schedule 1. The notice also applies to any person who, during the 2014 calendar year, imported a total quantity greater than 100 kg of a substance set out in Schedule 1, at any concentration, whether alone, in a mixture, or in a product. The notice does not apply to a substance in Schedule 1, whether alone, in a mixture, or in a product, that:

(a) Is in transit through Canada;

(b) Is naturally occurring;

(c) Is incidentally produced;

(d) Is, or is contained in, a hazardous waste or hazardous recyclable material within the meaning of the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations and that was imported in 2014 pursuant to a permit issued under those Regulations;

(e) Is, or is contained in, a pest control product within the meaning of subsection 2(1) of the Pest Control Products Act where that pest control product is registered under the Pest Control Products Act;

(f) Is, or is contained in, a fertilizer or supplement within the meaning of section 2 of the Fertilizers Act where that fertilizer or supplement is registered under the Fertilizers Act;

(g) Is, or is contained in, a feed within the meaning of section 2 of the Feeds Act where that feed is registered under the Feeds Act; or

(h) Is mixed with, or attached to, a seed within the meaning of section 2 of the Seeds Act where that seed is registered under the Seeds Act.

Information to be provided includes:

  • The basis on which the substance identified was determined to be in nanoscale form by indicating “research & development sources,” “technical data,” “information available from patents,” “marketing claim,” “assumption,” or “other (specify)”;
  • The total quantity of the substance manufactured or imported;
  • The consumer and commercial codes that apply to the known or anticipated final substance, mixture, or product containing the substance;
  • For each applicable consumer and commercial code, whether any known or anticipated final substance, mixture, or product containing the substance is intended for use in commercial activities;
  • For each applicable consumer and commercial code, whether any known or anticipated final substance, mixture, or product containing the substance is intended for use in consumer activities;
  • For each applicable consumer and commercial code, whether any known or anticipated final substance, mixture, or product containing the substance is intended for use by or for children 14 years of age or younger; and
  • The study title(s) of any unpublished or published data or studies on the substance with regard to physical-chemical properties, bioaccumulation, persistence, toxicity, metabolism, degradation, release, or disposal of the substance from the final mixture or product.

Any person who provides information in response to this notice may submit a written request that the information or part of it be treated as confidential. Responses are due February 23, 2016.

EC JRC Publishes Options for the Review of the EC Nanomaterial Definition

Posted in International, Legal/Regulatory Issues

The European Commission (EC) Joint Research Center (JRC) announced on July 10, 2015, the publication of its third report in its review of the EC recommendation on the definition of a nanomaterial.  The report is the last in a series of three, and provides scientific support to the EC in its review of the definition used to identify materials for which special provisions might apply (e.g., for ingredient labeling or safety assessment).  According to JRC, as the definition should be broadly applicable in different regulatory sectors, “the scope of the definition regarding the origin of nanomaterials should remain unchanged, addressing natural, incidental and manufactured nanomaterials.  Furthermore, size as the sole defining property of a nanoparticle, as well as the range of 1 nm to 100 nm as definition of the nanoscale should be maintained.”  JRC notes that several issues seem to deserve attention in terms of clarification of the definition and/or provision of additional implementation guidance, however, including:

  • The terms “particle,” “particles size,” “external dimension,” and “constituent particles.”
  • Consequences of the possibility of varying the current 50 percent threshold for the particle number fraction (if more than half of the particles have one or more external dimensions between one nanometer (nm) and 100 nm, the material is a nanomaterial).  Variable thresholds may allow regulators to address specific concerns in certain application areas, but may also confuse customers and lead to an inconsistent classification of the same material based on the field of application.
  • Ambiguity on the role of the volume-specific surface area (VSSA).  The potential use of VSSA should be clarified and ambiguities arising from the current wording should be eliminated.
  • The methods to prove that a material is not a nanomaterial.  The definition makes it very difficult to prove that a material is not a nanomaterial.  This issue could be resolved by adding an additional criterion.
  • The list of explicitly included materials (fullerenes, graphene flakes, and single wall carbon nanotubes even with one or more external dimensions below one nm).  This list does not include non-carbon based materials with a structure similar to carbon nanotubes.  A modification (or removal) of the current list could avoid inconsistencies.
  • A clearer wording in the definition could prevent the misunderstanding that products containing nanoparticles become nanomaterials themselves.

According to JRC, many of the issues addressed in the report can be clarified by developing new or improved guidance.  JRC notes that relying only on guidance documents for essential parts of the definition may lead to unintended differences in the implementation and decision making, however.  Therefore, the report identifies and discusses possibilities to introduce more clarity in the definition itself.  JRC states that it will continue to support the review process of the definition and its implementation in European Union legislation.

Australia Publishes Final Report on Regulatory Considerations for Nanotechnologies for Pesticides and Veterinary Medicines

Posted in International, Legal/Regulatory Issues

The Australian Pesticides and Veterinary Medicines Authority (APVMA) published on July 6, 2015, the final report entitled Nanotechnologies for pesticides and veterinary medicines: regulatory considerations. According to the report, its objective is to highlight the regulatory issues that need to be considered when bringing agricultural or veterinary (agvet) chemical products of nanotechnology to the Australian market. The report addresses relevant aspects of nanotechnology including definitions, metrology, physicochemical properties, manufacture, and the potential impacts on human health and the environment. The report states: “Every attempt has been made to ensure the information on this rapidly-evolving field was current at the time of writing. The report represents a first attempt to offer a blueprint on the regulatory considerations applicable to nanotechnology in Australian agriculture and animal husbandry.” According to the report, the general consensus is that, for the foreseeable future, existing regulatory frameworks developed for macroscale chemicals will be used to regulate nanomaterials. Over time, the report states, the framework will evolve as new information highlighting limitations in the current risk assessment paradigm becomes available. APVMA intends to use the report to develop a final regulatory approach for nanotechnology products, including:

  • Building capability and expertise so new products can be evaluated effectively;
  • Analyzing the data requirements;
  • Enhancing the existing regulatory framework if required as knowledge evolves; and
  • Continuing to engage with the international scientific community so that the latest research is being considered.