On July 12, 2019, the European Food Safety Authority (EFSA) published in the EFSA Journal its “Scientific opinion on the proposed amendment of the EU specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution.” The opinion addresses the assessment of data provided by interested business operators in support of an amendment of the European Union (EU) specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution. According to the opinion, titanium dioxide (E 171), which is used as a food additive in food, undergoes no surface treatment and is not coated. The opinion states that interested business operators have proposed to revise the EU specifications for E 171 to include “a specification of more than 100 nm for median Feret min diameter and less than 50% of the number of constituent particles below 100 nm; measured by EM in both cases.” The EFSA Panel on Food Additives and Flavorings, after reviewing the data, “concluded that a specification of more than 100 nm for median minimal external dimension, equivalent to less than 50% of the number of constituent particles with a median minimal external dimension below 100 nm, should be inserted in the current EU specifications.” According to the opinion, the Panel determined that the conclusions made, and the uncertainties identified, in previous EFSA assessments of E 171 remain valid. The Panel reiterates the need for further research as recommended in previous opinions to decrease the level of uncertainty and acknowledges that interested business operators are carrying out additional studies with characterized E 171. More information on EFSA’s 2018 review of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171) is available in our August 6, 2018, blog item.
The Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Nano-registries: Country-specific Solutions for Nano-regulation.” While the European Union (EU) has declined to create an EU-wide nano-registry, several EU Member States have adopted their own nano-registries. Belgium and France created stand-alone nano-registries, but Norway and Sweden added a “tick box” for nano to their product registries. Denmark established a stand-alone registry and added a “tick box” for nano to its product registry. According to the Dossier, Belgium, Denmark, France, Norway, and Sweden all use the European Commission’s (EC) Recommendation on the definition of nanomaterial (2011/696/EU). The NanoTrust Dossier provides an overview of the registries that includes a helpful summary of who must register and the registration threshold and the information required to be reported. The Dossier concludes that “it is necessary to close the information gaps on nanomaterials in the EU through a harmonised regulatory framework.” The Dossier notes that Belgium, France, Sweden, and Denmark communicate closely “to maintain a certain consensus concerning the national registry projects of nanomaterials with a view to allow for future possible harmonisation.” According to the Dossier, registrants do not know if they have to register a given substance, mixture, or product because they either lack information about the ingredients or knowledge about how to complete the registration process. The Dossier states that national registries pose a challenge for industry and free trade across borders within the EU, and small and medium enterprises are particularly affected by the financial burden of a time-consuming registration process. The Dossier suggests that a holistic framework, such as the one proposed in the 2017 article “React now regarding nanomaterial regulation,” “can help gather data on nanomaterials within the European Union, promising increased transparency and benefits for workers, the environment and consumers.”
On July 5, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) released an ex-post evaluation report prepared by the Evaluation Working Group of the European Chemicals Agency (ECHA) with the support of PricewaterhouseCoopers. The ex-post evaluation assessed EUON against the following criteria: effectiveness; coherence; EU added-value; and utility. The recommendations by the external evaluators include:
- Increase the effectiveness and relevance of the information on EUON by providing additional information and increasing the frequency of publishing new information. More specifically:
- Ensure the information and studies displayed on the website are up-to-date and relevant;
- Ensure a wide and balanced range of studies are displayed, especially under the “Safety” section;
- Increase the flow of new information by, e.g., establishing a blog;
- Include more links to and interpretation/synthesis of content from other relevant initiatives;
- Increasing the use of social media channels;
- Develop an inventory of products registered on the market that contain nanomaterials, especially those frequently used by consumers;
- Over the medium-term, prioritize integrating the data received on nanomaterials via the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation database into the EUON;
- Further explore how the issues relating to integration with national nanomaterials registries could be addressed;
- Provide additional information on regulatory developments and risk assessments; and
- Address maintenance issues highlighted by users in the survey.
- Increase the effectiveness of the EUON by increasing its user-friendliness for non-expert audiences. Specifically:
- Make information targeted at non-expert audiences more prominent;
- More clearly segregate the information targeted at non-expert and expert audiences; and
- Streamline the provision of information to the general public between EUON and ECHA’s “Chemicals in our life” webpage.
- Increase awareness of EUON among stakeholders, as a secondary priority to improving and consolidating the website content. Awareness could most effectively be increased by:
- Increasing the promotion of the website/new material on the website in the ECHA newsletter;
- Increasing the promotion of EUON/new material on the EUON website on the ECHA website; and
- Increasing the use of social media channels.
The internal evaluators recommend developing measurable indicators and targets to track the progress of the project, as well as developing and monitoring indicators relating to cost, speed, and quality of the relevant milestones to facilitate the assessment of both its effectiveness and efficiency.
The European Union (EU) Observatory for Nanomaterials (EUON) announced on July 3, 2019, that it has added a new search tool for nanomaterials to its website. According to EUON, it will enable regulators to form a better view of available data and give consumers access to chemicals safety information. The search tool combines data submitted by companies in their registration dossiers under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, data collected about nanomaterials used as ingredients in cosmetic products under the Cosmetics Regulation, and data from the Belgian and French public national nanomaterial inventories. According to EUON, the search tool allows users to search easily for nanomaterials that are currently on the EU market. Search results are linked to the European Chemicals Agency’s (ECHA) database of chemicals registered in the EU and, EUON states, “for the first time, summarised information about the substances, their properties as well as detailed safety and characterisation data can be easily found.” EUON notes that due to the differences in defining nanomaterials and tonnage reporting thresholds, the presence of a nanomaterial in any single data source does not mean that it is present in all of them. As the data sources have differing reporting rules and scopes, it is not always possible to match a material reported in one of the data sources with the substance in ECHA’s database. EUON states that where no match is possible, the material in the original data source has not been reported.
According to EUON, while there are over 300 nanomaterials on the EU market, only 37 are currently covered by an existing REACH registration. As reported in our December 4, 2018, blog item, the European Commission (EC) amended the REACH information requirements to include explicit obligations for nanomaterials manufactured in or imported to the EU. The new requirements enter into force in January 2020 and will result in more publicly available information.
On June 26, 2019, the Council of the European Union (EU) announced that it adopted conclusions on chemicals intended to “offer political guidance on the development of a sustainable EU chemicals policy strategy.” The June 26, 2019, press release notes that the conclusions address in particular the topics of Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, endocrine disruptors, nanomaterials, and pharmaceuticals. According to the press release, the Council requests the European Commission (EC) to extend the European Chemicals Agency’s (ECHA) mandate to collect and make available research data on the characterization, hazard, and potential exposure of “nanoforms of substances that were so far not registered under REACH because their yearly tonnage is below the threshold of 1 tonne/year.” The Council also states that the EU should “regularly ask ECHA to evaluate the performance and the impact of the EU-Observatory on Nanomaterials which was launched in 2017.”
On August 1-2, 2019, the National Nanotechnology Initiative (NNI) will hold “The Future of the NNI: A Stakeholder Workshop.” The NNI has played a pivotal role in fostering and advancing a dynamic nanotechnology ecosystem in support of the initiative’s four goals: advance world-class research; foster commercialization; develop and sustain research infrastructure; and support the responsible development of nanotechnology. Building on this foundation, experts from the nanotechnology community will share their perspectives on the key elements required for the nanotechnology enterprise to thrive over the next 15 years.
On June 25, 2019, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) posted two requests for scientific opinions: hydroxyapatite (nano) and copper (nano) and colloidal copper (nano). According to the mandate for hydroxyapatite (nano), the EC received 17 notifications for cosmetic products containing hydroxyapatite in nano form. The EC states that according to the notifications, this ingredient is used in both leave-on and rinse-off dermal and oral cosmetic products, including skin (skin care) and oral hygiene (toothpaste, mouthwash) products, with different concentration and specifications. The EC has concerns about the use of hydroxyapatite in nano form “because of the potential for nanoparticles to be absorbed dermally or across a mucous membrane and to enter cells.” It requests SCCS carry out a safety assessment of the nano form of hydroxyapatite as reported in the notifications.
According to the mandate for copper (nano) and colloidal copper (nano), the EC received 36 notifications for cosmetic products containing copper (31 notifications) and colloidal copper (five notifications) in nano form. According to the notifications submitted, both ingredients are used in nano form in leave-on and rinse-off cosmetic products, including skin, nail and cuticle, hair and scalp, and oral hygiene products with different concentration and specifications. The EC states that it has concerns on the use of copper and colloidal copper in nano form “because of the potential for nanoparticles to be absorbed dermally or across a mucous membrane and to enter cells.” It requests SCCS carry out a safety assessment of the nano form of copper and colloidal copper reported in the notifications.
Registration has opened for the National Nanotechnology Initiative’s (NNI) July 9, 2019, webinar, “Nanotechnology-Related Standards: Availability and Applications.” According to NNI, the development and use of nanotechnology-related standards is critical to ensuring validated measurements and methods to specify nanomaterial-containing products. NNI states that standards are also necessary for comparative evaluation and assessment of the environmental, health, and safety effects of nanomaterials (nanoEHS). The webinar will discuss existing and ongoing standards efforts and will highlight case studies from industry and government on how these standards are being applied and supporting nanoEHS research and safer product design. The webinar will also discuss how interested stakeholders can engage in these efforts. Dr. Ajit Jillavenkatesa, National Institute of Standards and Technology, will moderate. Speakers will include:
- Mark Ballentine, U.S. Army Corps of Engineers;
- Scott Brown, The Chemours Company; and
- Katherine Tyner, U.S. Food and Drug Administration (FDA).
The European Commission’s (EC) Joint Research Center (JRC) published a press release on June 6, 2019, regarding its contribution to the Organization for Economic Cooperation and Development’s (OECD) development of Test Guidelines for the safety assessment of nanomaterials. According to the press release, scientists from JRC have actively participated in discussions of the OECD’s Working Party on Manufactured Nanomaterials (WPMN) since early on. The press release states that the OECD Working Group of the National Coordinators of the Test Guidelines Program (WNT) is responsible for the final development, discussion, and adoption of Test Guidelines, and JRC “plays an important role as a link between WPMN and this group.” JRC notes WPMN’s work regarding Test Guidelines includes:
- Four new Test Guidelines and five guidance documents currently being developed that address the characterization of nanomaterials, their possible fate in the environment, and possible genotoxic effects;
- Six more new proposals approved for development in April 2019 that will address environmental fate or possible sensitization effects; and
- Discussion and preparation of eight additional proposals for Test Guidelines or guidance documents addressing possible effects on human health and the environment.
More information is available in an article in the June 2019 issue of Regulatory Toxicology and Pharmacology, “Developing OECD test guidelines for regulatory testing of nanomaterials to ensure mutual acceptance of test data.”
On June 12, 2019, the New York State Department of Environmental Conservation (NYSDEC) announced that it will delay enforcement of the Household Cleansing Product Information Disclosure Program (Disclosure Program) from July 1, 2019, to January 1, 2020. NYSDEC states in the June 12, 2019, Environmental Notice Bulletin that it will begin enforcing any violations of the required disclosure as of January 2, 2020. According to the notice, NYSDEC “will continue to work with any manufacturers on the design of their websites, or entertain any questions regarding compliance with website design or safety data sheets.” NYSDEC “remains committed to working with the manufacture[r]s to implement this program in the best manner possible.”
As reported in our January 23, 2019, blog item, NYSDEC previously announced a three-month delay in its enforcement of the Disclosure Program from July 1, 2019, to October 1, 2019. As reported in our June 8, 2018, blog item, the Disclosure Program requires manufacturers of cleaning products sold in New York to disclose chemical ingredients and identify any ingredients that appear on authoritative lists of chemicals of concern on their websites. According to the Disclosure Program Certification Form and Program Policy, for each ingredient that is a nanoscale material, a term describing the nanoscale material should be disclosed. For example, if the nanoscale material is carbon, the disclosure should use the term “nanoscale” carbon. NYSDEC’s Program Policy states that a nanoscale material “is a chemical substance that meets the [Toxic Substances Control Act (TSCA)] definition of a reportable chemical substance manufactured or processed at the nanoscale. That definition provides, in part, that a ‘reportable chemical substance is a chemical substance as defined in Section 3 of TSCA that is solid at 25° C and standard atmospheric pressure, that is manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of 1-100 nanometers in at least one dimension, and that is manufactured or processed to exhibit unique and novel properties because of its size. A reportable chemical substance does not include a chemical substance that is manufactured or processed in a form where less than 1% of any particles, including aggregates, and agglomerates, measured by weight are in the size range of 1-100 nanometers.’”
More information regarding the Disclosure Program and the previous enforcement delay is available in Bergeson & Campbell, P.C.’s January 14, 2019, memorandum, “NYDEC Delays for Three Months Enforcement of its Household Cleansing Product Information Disclosure Program.”