On May 6, 2021, the European Food Safety Association (EFSA) announced that E171 is no longer considered safe when used as a food additive. The European Commission (EC) asked EFSA to update its safety assessment of the food additive titanium dioxide (E171). EFSA states: “Taking into account all available scientific studies and data, the Panel [on Food Additives and Flavorings] concluded that titanium dioxide can no longer be considered safe as a food additive. A critical element in reaching this conclusion is that we could not exclude genotoxicity concerns after consumption of titanium dioxide particles. After oral ingestion, the absorption of titanium dioxide particles is low, however they can accumulate in the body.” According to EFSA, the Panel applied for the first time the 2018 EFSA Scientific Committee guidance on nanotechnology to the safety assessment of food additives. EFSA states that “[t]itanium dioxide E 171 contains at most 50% of particles in the nano range (i.e. less than 100 nanometres) to which consumers may be exposed.” EFSA notes that its evaluation is related to the risks of titanium dioxide used as a food additive, not to other uses. EFSA has not banned E171. Any legislative or regulation decisions on the authorizations of food additives are the responsibility of the EC and member states, who will now “reflect on EFSA’s scientific advice and decide upon any appropriate regulatory measures or advice for consumers.”
In 2011, the European Commission (EC) adopted a Recommendation on the definition of a nanomaterial. The Recommendation invites member states, European Union (EU) agencies, and economic operators to use the definition “in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies.” The EC is now reviewing its Recommendation. It has launched a targeted stakeholder consultation to update, test, and verify the preliminary findings of this comprehensive review, gathering further evidence and feedback from a wide range of stakeholders who have a role in application of the harmonized regulatory definition of nanomaterial in the EU. The EC states that the consultation aims to:
- Verify or complement the findings of the review;
- Gather precise and structured technical feedback on the identified technical elements of the definition that could be addressed by changes to the definition; and
- Gather input on the impact of the changes under consideration: would they influence (different) classification of specific materials placed or emerging on the market?
The consultation includes a summary of the interim findings and links to relevant documents and reports, and provides a short rationale with every question. The online consultation is open until June 30, 2021.
In fall 2020, the Swedish National Platform for Nanosafety (SweNanoSafe) organized three workshops on education within nanosafety, with the goal of starting and consolidating an education network. The first workshop focused on the need for education in nanosafety, the second workshop was on available education on nanosafety in Sweden, and the third workshop discussed concrete opportunities to take various education efforts one step further. On May 5, 2021, SweNanoSafe published Nanosafety and education: Report from workshop series with SweNanoSafe’s education network and Roadmap for 2021, an English translation of its report summarizing the presentations and discussions conducted in the three workshops and presenting a work plan for the education network in the form of a Roadmap for 2021. The Roadmap consists of four steps:
- Step 1:
- Target Groups — Working group identifies and describes relevant target groups for nanosafety education; and
- Teaching Materials — Working group collects teaching materials through SweNanoSafe’s education network and research network;
- Step 2:
- Sorting — Working group sorts teaching materials that are relevant to cases; and
- Development — Several smaller working groups continue to develop materials on specific themes;
- Step 3: Production of teaching modules; and
- Step 4: Communication and dissemination.
The report states that these four steps form the basis of structured work aimed at improving education on nanosafety in Sweden. The goal is to initiate Steps 1 and 2 and form working groups that continue to work as described above. In 2021, according to the report, “the vision is to reach a point where it is possible to test the newly developed education material in the near future on a relevant target group.”
On April 29, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Biotransformation of nanomaterials while transferring in the food chain” by Dr. Fazel A. Monikh. As the application of nanomaterials increases, more of these materials are released in the environment. Monikh states that some nanomaterials that are persistent in the environment raise concerns as they can enter organisms’ bodies, accumulate in their organs, and transfer through different trophic levels in food chains. With the help of his collaborators and the support of the EU’s Horizon 2020, Monikh developed “a sensitive workflow to trace and characterize nanomaterials in organisms’ bodies.” According to Monikh, these methods and techniques allow him to analyze and count the number of nanomaterials in organisms’ tissues and cells and to understand their behavior in organisms and their trophic transfer through food chains. Monikh suggests that adopting the safe-by-design strategy could be a potential solution to balance the benefits and the possible ecological effects of nanomaterials. Monikh states that the aim of his research is to support designing safe nanomaterials by understanding the possible effects of these materials in the environment and in organisms.
The Nanotechnology Industries Association (NIA) has published a March 2021 position paper, A changing regulatory landscape and language for the nanoscale, that examines the transition from “nanomaterial” to “nanoforms” to reflect better the differences in nanomaterial properties both in relation to bulk counterparts and to nanoforms of the same substance. In the paper, NIA describes a transition phase where the language of nanoforms is used more widely and examples of nanoform sets can be increasingly demonstrated in the public domain, while there is still a “significant” learning curve for both industry and the European Chemicals Agency (ECHA). NIA recommends that all stakeholders reassess the language they use where relevant, “particularly when discussing hazard, and where non-specific terminology may be misleading and result in confusion and mistrust in the safety of substances at the nanoscale.” NIA calls “for the use of the term ‘nanoform’ as a way of referring to specific nanomaterials within a given class.” NIA states that it believes that the term “nanomaterial,” when used for a hazard profile description, “is too generic and ambiguous for regulatory purposes, and may undermine the long-term development of the nanotechnology industry.” According to NIA, “[t]his change in concept and terminology will lead to greater confidence in nanoforms and support a wider acceptance of this key enabling technology, leading not only to the further development of advanced technologies but also to the growth of the nanoform market in the [European Union (EU)].” Bergeson & Campbell, P.C. is a proud NIA member.
On April 16, 2021, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted two preliminary opinions for comment: Opinion on Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano) and Opinion on Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano). The EC asked SCCS whether the nanomaterials gold and colloidal gold, gold thioethylamino hyaluronic acid, and acetyl heptapeptide-9 colloidal gold are safe when used in leave-on skin cosmetic products according to the maximum concentrations and specifications, taking into account reasonably foreseeable exposure conditions. SCCS states that it considered the information provided by the notifiers and is of the opinion that it is not possible to carry out a safety assessment of the nanomaterials due to limited or missing essential information. The preliminary opinion states that “[m]uch of the information provided on toxicity relates to gold as such, and it is not possible to determine the relevance of the data for nano-forms of any of the materials under the current evaluation due to the absence of full study reports.” To complete a safety assessment of the nanomaterials, detailed data and information need to be provided on physicochemical characterization and toxicological evaluation, along with experiment performance. The preliminary opinion notes that in regard to surface modified gold, all notifications relating to acetyl heptapeptide-9 colloidal gold (nano) were withdrawn by the notifiers and therefore only gold thioethylamino hyaluronic acid is considered in the opinion. The EC asked SCCS if it has any further scientific concerns with regard to the use of materials in nano form in cosmetic products. SCCS states that information obtained from the scientific literature indicates that there is a need for further evaluation of the safety of gold nanomaterials when used as cosmetic ingredients. In the absence of sufficient data to allow a safety assessment, SCCS concluded that there is a basis for concern that the use of gold (nano), colloidal gold (nano), and surface modified gold (nano) materials in cosmetic products can pose a risk to the consumer.
The EC asked SCCS whether the nanomaterials A (platinum and colloidal platinum) and B (acetyl tetrapeptide-17 (and) colloidal platinum) are safe when used in leave-on cosmetic products according to the maximum concentrations and specifications reported, taking into account reasonably foreseeable exposure conditions. SCCS states that having considered all the information provided by the notifiers, and obtained from other sources, SCCS “is of the opinion that it is not possible to carry out a safety assessment of any of the notified platinum nanomaterials due to limited or missing essential information.” SCCS notes that the limited amount of data provided by the notifiers also does not correspond to the requirements and data standards as indicated in the SCCS Guidance (SCCS 1611/19) and the SCCS Memorandum (SCCS/1524/13). The EC also asked if SCCS has any further scientific concerns with regard to the use of materials A and B in nano form in cosmetic products. According to the preliminary opinion, in the absence of sufficient data to allow a safety assessment, SCCS considered the different aspects of platinum nanomaterials that could raise a concern for consumer safety. SCCS “concluded that there is a basis for concern that the use of platinum, colloidal platinum, and acetyl tetrapeptide-17 colloidal platinum (nano) in cosmetic products can pose a risk to the consumer.”
Comments on both preliminary opinions are due June 14, 2021.
On April 12, 2021, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on hydroxyapatite (nano). The EC asked whether SCCS considers the nanomaterial hydroxyapatite safe when used in leave-on and rinse-off dermal and oral cosmetic products according to the maximum concentrations and specifications reported, taking into account reasonably foreseeable exposure conditions. SCCS states that having considered the data provided, and other relevant information available in scientific literature, it “cannot conclude on the safety of the hydroxyapatite composed of rod-shaped nanoparticles for use in oral-care cosmetic products at the maximum concentrations and specifications given in this Opinion.” This is because the available data and information are not sufficient to exclude concerns over the genotoxic potential of hydroxyapatite (nano). The EC also asked whether SCCS has any further scientific concerns with regard to the use of hydroxyapatite in nano form in cosmetic products. The opinion states that although the particle shape of the nanomaterial considered in this opinion is reported as rod-shaped, “SCCS is aware that, depending on the manufacturing process, needle-shaped HAP nanoparticles may also be produced.” According to the opinion, the available information indicates that hydroxyapatite (nano) in needle-shaped form “is of concern in relation to potential toxicity” and “should not be used in cosmetic products.” SCCS concluded that there is a basis for concern that the use of hydroxyapatite (nano) in cosmetic products “can pose a risk to the consumer.”
Registration is open for the U.S. National Nanotechnology Initiative’s (NNI) April 27, 2021, webinar on “What We Know about NanoEHS: Environment.” The webinar will feature experts from diverse disciplines to share their perspectives on key findings on the effects of engineered nanomaterials in the environment. Elijah Petersen, Ph.D., Research Scientist, National Institute of Standards and Technology (NIST), will moderate the panel, which will include:
- Jorge Gardea-Torresdey, Ph.D., Dudley Professor of Environmental Science & Engineering and of Chemistry, The University of Texas at El Paso;
- Patricia Holden, Ph.D., Professor of Environmental Microbiology, University of California, Santa Barbara; and
- Greg Lowry, Ph.D.., Walter J. Blenko, Sr. Professor of Civil and Environmental Engineering, Carnegie Mellon University.
The International Organization for Standardization (ISO) published a news item on April 1, 2021, entitled “The Science of Tiny Little Things.” According to the item, ISO has recently made some revisions and updates to its comprehensive 13-part series of International Standards for nanotechnology. Updated standards include ISO/TS 80004-3, Nanotechnologies – Vocabulary – Part 3: Carbon nano-objects, which defines terms and concepts for carbon nano-objects, ISO/TS 80004-6, Nanotechnologies – Vocabulary – Part 6: Nano-object characterization, and ISO/TS 80004-8, Nanotechnologies – Vocabulary – Part 8: Nanomanufacturing processes. The item states that work is underway “to develop a standard that will consolidate some of the most fundamental terminology in the series.” The item lists the following standards that are in the current series:
- ISO/TS 80004-1, Nanotechnologies – Vocabulary – Part 1: Core terms;
- ISO/TS 80004-2, Nanotechnologies – Vocabulary – Part 2: Nano-objects;
- ISO/TS 80004-4, Nanotechnologies – Vocabulary – Part 4: Nanostructured materials;
- ISO/TS 80004-5, Nanotechnologies – Vocabulary – Part 5: Nano/bio interface;
- ISO/TS 80004-7, Nanotechnologies – Vocabulary – Part 7: Diagnostics and therapeutics for healthcare;
- ISO/TS 80004-9, Nanotechnologies – Vocabulary – Part 9: Nano-enabled electrotechnical products and systems;
- ISO/TS 80004-11, Nanotechnologies – Vocabulary – Part 11: Nanolayer, nanocoating, nanofilm, and related terms;
- ISO/TS 80004-12, Nanotechnologies – Vocabulary – Part 12: Quantum phenomena in nanotechnology; and
- ISO/TS 80004-13, Nanotechnologies – Vocabulary – Part 13: Graphene and related two-dimensional (2D) materials.
The European Commission (EC) has requested a scientific opinion from the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on the safety of titanium dioxide in toys with regard to a possible derogation from its prohibition. The Toy Safety Directive 2009/48/EC prohibits the use of substances in toys if those substances are classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). The use of such substances may be permitted under certain conditions, however. To permit the use of a CMR substance of category 2, the substance has to be evaluated by the relevant Scientific Committee and found to be safe, in particular in view of exposure. An additional condition is that the substance is not prohibited for use in consumer articles under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. Titanium dioxide in powder form containing one percent or more of particles with aerodynamic diameter ≤ ten micrometers (μm) has been classified as carcinogenic category 2 by inhalation.
SCHEER has called for scientific information on:
- The chemical and physical specifications of titanium dioxide used in toys;
- The size distribution of pigment grade titanium dioxide used in toys;
- The migration or release of titanium dioxide from toys; and
- Exposure measurements on titanium dioxide used in toys.
Submissions are due April 28, 2021. The call for information will remain open after this date, however, and additional studies (e.g., ongoing studies and research that are not completed by the deadline) may be passed to the working group at a later stage, if needed.
The EC asked SCHEER:
- To review the available data on the use of titanium dioxide leading to inhalation exposure in particular in toys and toy materials; and
- To evaluate whether the uses of titanium dioxide in toys and toy materials can be considered safe in light of the exposure identified, and in light of the classification of titanium dioxide as carcinogenic category 2. Safe toys and toy materials should be indicated.
According to the timeline in the EC’s request, the preliminary opinion is expected in mid-2021, and the final opinion in fall 2021.