The European Commission (EC) announced on January 14, 2022, that it adopted a ban on the use of titanium dioxide (E171) as a food additive. The ban will apply after a six-month transition period, and beginning summer 2022, this additive should no longer be added to food products. According to the EC, titanium dioxide “is used to impart white colour to many foods, from baked goods and sandwich spreads to soups, sauces, salad dressing and food supplements.” The EC states that European Union (EU) member states unanimously endorsed the EC’s proposal, put forward in October 2021. The EC based its proposal on a scientific opinion of the European Food Safety Authority (EFSA) that concluded that E171 could no longer be considered safe when used as a food additive. More information is available in the EC’s questions and answers (Q&A).

In December 2021, the German Environment Agency (UBA) published a document entitled Risk Governance of Advanced Materials: Considerations from the joint perspective of the German Higher Federal Authorities BAuA, BfR and UBA. The document summarizes the current activities, considerations, and recommendations of UBA, the German Federal Institute for Risk Assessment (BfR), and the Federal Institute for Occupational Safety and Health (BAuA) aiming to establish good governance of advanced materials to ensure their responsible development, use, and recycling considering human and environmental safety. Within the document, advanced materials are understood as “materials that are rationally designed through the precise control of their composition and internal or external structure in order to fulfil new functional requirements.” The document notes that this working definition “is explicitly not intended as a basis for fundamental regulation of [advanced materials] or to be used in an existing regulation!” According to the document, chemicals legislation in the European Union (EU) in general covers advanced materials, although most of the statutes neither explicitly mention advanced materials nor provide specific requirements for most advanced materials. Some regulations include provisions and/or guidance specifically addressing nanomaterials, however. The document states that due to their complexity and broad possibilities for application, the distinction of an advanced material being a substance, mixture, or article “might be hampered which challenges legal clarity on regulatory requirements.” To identify materials that give rise to specific concerns, the agencies propose to implement the term “materials of concern,” along with the following criteria to decide whether a material falls under that term:

  1. A material meeting the criteria for classification as a “hazardous substance” or “hazardous mixture” within the meaning of the criteria set out in Annex I to the Regulation on classification, labeling, and packaging of substances and mixtures (EC 1272/2008);
  2. A material from which hazardous substances or mixtures according to (i) can arise or be released during its production or over its life cycle;
  3. A material that does not meet criteria (i) or (ii) but which, because of its morphological, physico-chemical, chemical, (eco)toxicological, or release properties, could pose a risk to humans or the environment during its production or over its life cycle; or
  4.  A material that could pose a concern regarding additional sustainability aspects.

The agencies’ recommendations include proposals to promote action on safe handling and to foster sustainable development of advanced materials, including:

  • Identifying materials of concern by setting criteria and an early warning system;
  • Enabling regulatory preparedness and shaping regulations to keep the regulatory framework up to date;
  • Promoting safe and sustainable design of advanced materials;
  • Supporting stakeholder exchange and co-creation; and
  • Ensuring adequate regulation by enhancing preparatory research and strengthening regulatory research.

Bergeson & Campbell, P.C. (B&C®) is pleased to provide our Forecast 2022 to Nano and Other Emerging Chemical Technologies Blog readers, offering our best informed judgment as to the trends and key developments we expect to see in the new year. On October 8, 2021, the National Nanotechnology Coordination Office (NNCO) announced the release of the 2021 National Nanotechnology Initiative Strategic Plan, outlining the goals, objectives, and actions for the National Nanotechnology Initiative (NNI) over the next five years. After considering the recommendations from advisory bodies, stakeholders, and input from the public, NNI agencies determined that NNI’s overarching goals to support nanotechnology research and development (R&D), commercialization, infrastructure, and responsible development should remain and that a new goal should be added to focus efforts more clearly on education and the workforce. With the release of the plan, the White House Office of Science and Technology Policy (OSTP) and the NNI agencies launched NNI’s next phase. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.

 

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What to Expect in Chemicals in 2022

January 26, 2022, 12:00 p.m. EST

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B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.

On December 22, 2021, the Swedish National Platform for Nanosafety (SweNanoSafe) announced the availability of the executive summary for a report entitled “Toward Safe and Sustainable Nanotechnology Innovation.” SweNanoSafe and researchers from the Action Research Center for a Resilient Society, Sari Scheinberg and Sverker Alänge, commissioned a study to contribute to knowledge and understanding, to create new ways of meeting, and to gather information on how stakeholders work with nano innovation and nanosafety today. According to the executive summary, a key question was how to create and maintain a sustainable workflow in industry, government, and academia that strengthens and integrates a safe and responsible process of research, innovation, and utilization at all stages of the life cycle of engineered nanomaterials. Representatives from different stakeholder groups participated in discussions to identify and develop a process that would contribute to the improved implementation of a responsible research and innovation (RRI) approach. The executive summary states that the study “has shown the urgency of establishing collaboration between stakeholders about nanosafety practices in the form of a ‘safety network’ involving all stakeholders to shorten the time to market for safer substances, chemical products, and articles.” The recommendations identified in the project include the following proposals for action on the sustainable development, safe innovation, and safe handling of engineered nanomaterials:

 

  • Enabling online access for small- and medium-sized enterprises (SME) to full-text scientific journals, as well as databases of peer-reviewed literature, books, and conference proceedings. Moreover, aiding SMEs to access research data for any specific nanomaterial, also statistically non-significant;
  • Supporting rapid and safe innovation through effective dissemination of safety research and preparedness for regulatory changes;
  • Enhancing dialogue between industry (SMEs) and government (the Swedish Chemicals Agency (KEMI)) regarding safety issues, services provided, and coming regulation and legislation (regulatory preparedness);
  • Guiding and advising SMEs on safe handling of engineered nanomaterials, safety testing, and implementation of the regulation;
  • Investigating the prospect of realizing a national strategy for safe nanotechnology development; and
  • Developing training that should be available for companies to increase their knowledge and skills, such as how to comply with the regulation and how to identify and manage the risks linked to the engineered nanomaterials they manufacture and/or market.

On December 21, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “ACEnano: Goodbye, Hello” by Dr. Eugenia Valsami-Jones about Project ACEnano, a Horizon2020 project that recently completed its 4.5-year course. The project’s main goal was to strengthen clarity into nanomaterial risk assessment using a tiered approach to the physicochemical characterization of nanomaterials. Valsami-Jones describes the analytical solutions produced by the project, some of which are already available to use (e.g., in mass spectrometry, instrument hyphenation, and automated exposure) and others that require further development but have progressed sufficiently to prove their value (e.g., assays and sample introduction system). Valsami-Jones notes that “[a] further ambition of the project was to create a ‘conceptual toolbox’ to hold all of the project’s analytical achievements, some of which were specifically aimed towards demystifying and simplifying analysis, through interlaboratory comparisons, reliable protocol development and making all these accessible via a centralised hub to the community.”

On December 17, 2021, Canada published the Chemicals Management Plan implementation table for 2021-2024. Under the Canadian Environmental Protection Act, 1999 (CEPA), Canada plans to take the following actions regarding nanomaterials on the Domestic Substances List (DSL): prioritization of substances in commerce according to responses to the CEPA Section 71 Survey and screening assessment of high-priority nanomaterials on the DSL. The deliverables include:

  • Publish a draft Framework for the Risk Assessment of Manufactured Nanomaterials for a 60-day public comment period. According to the implementation table, the framework is targeted for publication in the fourth quarter;
  • Continue gathering information on nanoscale substances on the DSL, including by publishing a new CEPA Section 71 survey for nanoscale substances (expected in 2023); and
  • Continue to conduct assessments, including for titanium dioxide and zinc oxide, between 2021 and 2024.

The rationale for action states that the nanoscale forms of substances listed on the DSL “have not been explicitly considered in the risk assessments of existing substances to date.” Canada is taking action to ensure that nanomaterials currently in commerce in Canada undergo ecological and human health risk assessments to ensure that appropriate control measures are taken, when required.

The European Commission (EC) published a regulation on November 30, 2021, in the Official Journal of the European Union that denies the authorization of titanium dioxide (E171) as an additive in animal nutrition, in the additive category “sensory additives,” and in the functional group “colourants: substances that add or restore colour in feedingstuffs.” Under the regulation, existing stocks of the additive must be withdrawn from the market by March 20, 2022. Feed materials and compound feed produced with the additive or premixtures containing it before March 20, 2022, must be withdrawn from the market by June 20, 2022.

As reported in our October 13, 2021, blog item, the EC announced on October 8, 2021, that the Standing Committee on Plants, Animals, Food and Feed approved the EC’s proposal to ban the use of titanium dioxide (E171) as a food additive. The European Union (EU) notified the World Trade Organization (WTO) of the draft regulation on October 13, 2021. The regulation would remove the authorization to use titanium dioxide (E171) in foods. The text also includes a commitment to review the necessity to maintain titanium dioxide (E171) or otherwise delete it from the EU list of food additives for exclusive use as a color in medicinal products within three years of the regulation entering into force. To allow for a smooth transition, the regulation would allow foods that contain titanium dioxide (E171) used in accordance with the rules applicable before the date of entry into force to be placed on the market until six months after that date. Those foods may then continue to be marketed until their date of minimum durability or “use by” date. More information on the draft proposal is available in the EC’s questions and answers on titanium dioxide.

In December 2021, the German Environment Agency (UBA) published a report entitled Development of a specific OECD Test Guideline on Particle Size and Particle Size Distribution of Nanomaterials. The UBA commissioned the Federal Institute for Occupational Safety and Health (BAuA) (project coordinator) and the Federal Institute for Materials Research and Testing (BAM) to develop an Organization for Economic Cooperation and Development (⁠OECD)⁠ Test Guideline for the determination of particle size and particle size distributions of nanomaterials. The report describes the considerations, essential steps, and organizational aspects of the development of the Test Guideline. It provides insights into the selection, preparation, and pre-validation of test materials used in an interlaboratory comparison and presents the results of the comparison tests and their impact on the final version of the OECD Test Guideline. Upon adoption at OECD level, the Test Guideline for the determination of particle size and particle size distributions of nanomaterials will be available on the website of the OECD Test Guideline Program. The draft Test Guideline is available online.

The American National Standards Institute (ANSI), which administers the U.S. Technical Advisory Group for the International Organization for Standardization (ISO) Technical Committee (TC) 229 on Nanotechnologies, announced a survey seeking feedback on the use of terms related to advanced materials as part of its newly launched study group, Advanced and Emerging Materials. According to ANSI, the study group is charged with identifying and clarifying differences between the use of terms related to advanced materials across stakeholder groups. According to ANSI, the concept of advanced materials is of increasing importance to the nanotechnology community. In recent years, a number of nanotechnology-focused professional groups have expanded their scope to include advanced materials. ANSI states that regulatory research organizations have also included advanced and emerging materials or technologies within the scope of groups previously focused on nanotechnologies. The Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials recently decided to include advanced materials within their scope. The survey seeks comments from subject matter experts, stakeholders, and other interested parties and is aimed at identifying the scientific, technical, and social views of select terms and definitions related to advanced and emergent materials.

The Scientific Committee on Consumer Safety (SCCS) published its final opinion on HAA299 (nano) on November 25, 2021. The European Commission (EC) asked SCCS whether HAA299 (nano) is considered safe when used as an ultraviolet (UV) filter in cosmetic products up to a maximum concentration of ten percent. According to the final opinion, SCCS considers that HAA299 (nano) as covered within the provided characteristics “is safe when used as a UV-filter in dermally-applied cosmetic products up to a maximum concentration of 10%.” The final opinion states that based on the inflammatory effects on the lung after acute inhalation exposure, SCCS has concerns regarding the repeated use of products containing HAA299 (nano) in applications that could lead to inhalation exposure and does not recommend the use of HAA299 (nano) in applications that could lead to exposure of consumers’ lungs via inhalation. SCCS based its opinion on the currently available data that show “an overall very low or lack of dermal absorption of HAA299 (nano) in human skin.” If any new evidence shows that HAA299 (nano) used as a UV filter in cosmetic products can penetrate human skin (healthy, compromised, sunburned, or damaged) to reach viable cells in higher levels than demonstrated in this submission, SCCS may consider revising the assessment.