As reported in our May 7, 2021, blog item, the European Commission (EC) recently held a targeted stakeholder consultation to update, test, and verify the preliminary findings of its review of the 2011 Recommendation on the definition of a nanomaterial. According to a July 23, 2021, news item posted by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES), in its response to the consultation, ANSES maintained that the changes proposed by the EC “tend to restrict the number and type of objects that will ultimately be considered as nanomaterials. For example, nanoplastics, as well as certain emulsions and lipid nanoparticles, might not be considered to fall under this definition.” ANSES states that the EC’s definition “needs to be as comprehensive as possible and define nanomaterials in a unique way based on physico-chemical criteria.” Sectoral regulations, such as for cosmetics, biocides, and food, could then clarify which nanomaterials should be subject to specific measures, including product labeling, specific assessment, and authorization, before the nanomaterials are placed on the market. ANSES “also finds it unfortunate that the size thresholds (1-100 nm) used in the current definition were not open to discussion as part of this consultation, as they have no scientific basis.” According to the news item, ANSES will publish an opinion by 2022, “with the support of a multidisciplinary group of experts,” that provides more information and perspective on its response to the EC.
Pursuant to Article 16 (10) and (11) of Regulation (EC) No 1223/2009 (Cosmetics Regulation), the European Commission (EC) is required to submit to the European Parliament and the Council an annual status report on the use of nanomaterials in cosmetic products and to review the Regulation’s provisions concerning nanomaterials. The July 22, 2021, report includes the following main findings:
- On average, ten new cosmetic products containing nanomaterials are placed on the European Union (EU) market every day; this is only a fraction of the 800 new cosmetic products notified daily in Cosmetic Products Notification Portal (CPNP). Overall, the use of nanomaterials concerns a rather limited number of all cosmetic products (about 1.5% of the total) and has been rather stable over the past five years;
- Most of the cosmetic products notified in the CPNP correspond to nanomaterials with a colorant or ultraviolet (UV) filter function;
- There are differences in the percentage of newly notified cosmetic products containing nanomaterials among EU countries (from 0.8% to 5.5%), as well as in the share of the overall notifications of nanomaterials (from 6.5% to 43.7%);
- The 2019 EC catalogue of nanomaterials “represented a rather accurate picture of the market, albeit with the inherent limitations stemming from the notification process”; and
- Most of the Scientific Committee on Consumer Safety’s (SCCS) opinions on the safety of CPNP-notified nanomaterials were inconclusive due to the lack of or insufficient data. Therefore, there is a need for responsible persons to provide the most accurate information possible when notifying nanomaterials that are present in cosmetic products.
The report states that aligning the nanomaterial definition in the Cosmetics Regulation with a horizontal definition “could increase coherence between legislation but should be thoroughly assessed in order to evaluate its potential effects.” According to the report, because of identified shortcomings in the notification process, the effectiveness of the current process via CPNP “merits specific attention, in particular the duration and effect of the expiry of the deadline as laid out in the Cosmetics Regulation.” The report notes that the scientific safety assessment of nanomaterials “could be strengthened, in particular as experience has shown that the majority of the completed assessments by [SCCS] were inconclusive due to lack of data.” Since most EU citizens “consider it important to be informed about the presence of nanomaterials in products they buy,” the report suggests that digital labeling should be considered to complement and improve further the labeling of nanomaterials in cosmetic products.
The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) has begun a public comment period on its preliminary opinion on HAA299 (nano). The EC asked SCCS whether it considered HAA299 (nano) safe when used as an ultraviolet (UV) filter in cosmetic products up to a maximum concentration of ten percent. According to the preliminary 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 ten percent. The preliminary 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. Therefore, SCCS does not recommend the use of HAA299 (nano) in applications that could lead to inhalation exposure. The EC asked whether in view of SCCS’s previous opinion (SCCS/1533/14) it considers HAA299 non-nano and nano form safe when used as a UV filter in cosmetic products up to a maximum concentration of ten percent. According to SCCS, the data considered in its preliminary opinion have not provided any new or additional concern, and it considers HAA299, either as non-nano or nano form, safe when used as a UV filter in dermally applied cosmetic products up to a maximum concentration of ten percent. The EC asked whether SCCS has any further scientific concerns on human health with regard to the use of HAA299 (nano) in cosmetic products. The preliminary opinion is based on the currently available scientific evidence, showing an overall very low level or lack of dermal absorption of HAA299 (nano) in human skin. SCCS notes that if any new evidence emerges in the future to show that HAA299 (nano) used as a UV filter in cosmetic products can penetrate human skin (healthy, compromised, sunburned, or damaged skin) to reach viable cells, in higher levels than demonstrated in this submission, then it may consider revising its assessment. Comments are due September 27, 2021.
The European Chemicals Agency (ECHA) has launched a call for tenders to perform a study “Assessment of the potential impact of graphene, graphene oxide and other 2D materials on health, and the environment” as part of the European Union (EU) Observatory for Nanomaterials (EUON). According to the description, the goal of the study is to conduct a systematic literature review of the health and environmental effects of graphene, graphene oxide, and other two-dimensional (2D) materials, based on existing public information. The objective of the requested services is to collect information from existing public sources, including journal publications and EU-funded research projects. The study should also assess what general conclusions can be made regarding the potential health and environmental properties of 2D materials. Finally, the review should examine to what extent existing approaches to health and environmental testing of chemicals are applicable to graphene, graphene oxide, and other 2D materials, and what challenges and pitfalls exist surrounding the testing of these materials. The deadline for expressing interest is August 13, 2021.
The International Organization for Standardization (ISO) has published ISO/TR 22293:2021, “Evaluation of methods for assessing the release of nanomaterials from commercial, nanomaterial-containing polymer composites.” ISO states that an understanding of what is released from products containing manufactured nanomaterials “is critical to planning and managing safe development and use of those products.” The document aims to provide a guide to the information to be taken into account in determining the methods for identifying and evaluating releases of manufactured nanomaterials from matrices; providing a framework for understanding how these methods and the information they produce can support decision-making; and identifying opportunities for developing standards in this area. According to ISO, the document provides practical support for decisions related to product development and use through early consideration of the potential for release of manufactured nanomaterials and through focus on realistic use scenarios where exposures to the released manufactured nanomaterials might occur. The intended users of the document include:
- Those planning to develop or adapt technical specifications for manufactured nanomaterials used in commercial products;
- Risk managers, product developers, exposure measurement practitioners, and other stakeholders seeking guidance on the availability and utility of methods to measure releases that could occur from uses of specific manufactured nanomaterials in composites;
- Methods and instrumentation developers seeking to identify needs of the risk management community; and
- Those planning basic and applied research programs for measurement and modeling to support decisions about sustainably safe uses of manufactured nanomaterials.
On July 13, 2021, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of a draft technical report entitled Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials: User Guide and Technical Report. 86 Fed. Reg. 36748. NIOSH states that the draft report describes an evidence-based approach to evaluate the scientific information available to derive occupational exposure limits, or bands, for engineered nanomaterials. This draft report contains two main parts: (1) user guide; and (2) full technical report and appendixes. NIOSH seeks comments from individuals, including scientists and representatives from various government agencies, industry, labor, and other stakeholders, and also the public. NIOSH asks that comments note whether there are errors of fact, unsubstantiated claims, evidence of careless experimental work, inclusion of too much information already in the literature, or statements that are inaccurate. NIOSH requests that special emphasis be placed on technical review of the following issues:
- Does the draft document adequately describe the process for gathering and evaluating the information available on occupational exposure limits or bands for engineered nanomaterials?
- Does the draft document adequately describe the development of a framework for categorizing engineered nanomaterials by potential occupational health hazard from inhalation exposure?
- Are the clustering and classification modeling methodologies reasonable for these data?
- Is a revision to current occupational exposure banding guidance needed to incorporate a band F?
- How useful and practical is the approach described in both the user guide and full technical report for deriving categorical occupational exposure limits, and what are the opportunities for improvement?
- Are the current searches and collection of scientific data sufficient, and are there additional opportunities for obtaining data that were not included?
- Would the methods used in the report also be appropriate for a future comprehensive dataset of experimental, toxicological, and physicochemical information for engineered nanomaterials?
Comments are due September 13, 2021.
NanoHarmony aims to support the development of Organization for Economic Cooperation and Development (OECD) test guidelines (TG) and guidance documents (GD) for eight endpoints where nanomaterial-adapted test methods have been identified as a regulatory priority. NanoHarmony states that it is looking to create guidance for the development of other TGs and GDs in the future that will create a more efficient pathway to develop these. To help learn best practice in this area, the NanoHarmony project wants to hear from stakeholders about their experiences with TGs and GDs by asking people to share their experiences in a short survey. According to NanoHarmony, responses will provide valuable information and are vital to understanding the barriers in the TG and GD process and how these can be best overcome. According to NanoHarmony, the survey should take between 10 and 20 minutes and the number of questions varies between 12 and 28, depending on the respondent’s role in the TG/GD process. Participation is anonymous. The survey will close September 10, 2021.
The European Chemicals Agency (ECHA) has begun a public consultation on a harmonized classification and labeling (CLH) proposal for multi-walled carbon tubes (synthetic graphite in tubular shape) with a geometric tube diameter range ≥ 30 nanometers (nm) to < 3 micrometers (μm) and a length ≥ 5 μm and aspect ratio > 3:1, including multi-walled carbon nanotubes (MWC(N)T). The dossier submitted by Germany’s Federal Institute for Occupational Safety and Health (BAuA) states that the proposal comprises MWCTs that fulfill the European Union’s (EU) recommendation for a definition of nanomaterial and that, in line with the EU definition, have one external dimension (the diameter) in the size range 1 – 100 nm. The proposal extends the applicability domain of the CLH proposal to MWCTs with a diameter up to 3 μm, however, “as it is expected according to the fibre pathogenicity paradigm that MWCT[s] with diameters fitting into the respirable range will possess similar fibre-like properties.” The dossier notes that it is not known if MWCTs beyond a diameter range of > 200 nm (regarding the constituting particle) are manufactured. The proposal is based on the observation that fibers of high-diameter MWCTs (≥ 30 nm) “have equivalent potential with asbestos and asbestiform fibres and thus is consistent with the ‘fibre pathogenicity paradigm’ (Donaldson et al., 2010, 2013).” According to the dossier, low-diameter MWCNTs (< 30 nm) “are not subject to the proposed classification, as it is assumed that due to a more tangled morphology, the fibre pathogenicity paradigm does not apply (to date negative evidence with regard to fibre-related mesotheliomatogenesis is limited to MWCNT[s] with 15 nm mean diameter).” BAuA concluded that data are sufficient for classification with regard to carcinogenicity and specific target organ toxicity after repeated exposure, but not for germ cell mutagenicity. The proposed entry in Annex VI of the Classification, Labeling and Packaging (CLP) Regulation is:
Carc. 1B, H350i
STOT RE 1, H372
The hazard classes open for comment are carcinogenicity and specific target organ toxicity — repeated exposure. Comments are due September 3, 2021.
The European Commission (EC) has requested a scientific opinion from the Scientific Committee for Consumer Safety (SCCS) on fullerenes and hydroxylated fullerenes. According to the request, the EC has received 19 notifications under Article 16 of the Cosmetics Regulation for cosmetic products containing fullerenes and hydroxylated fullerenes. The request states that these ingredients “are reported in CosIng database with the function of ‘antimicrobial’ and ‘skin conditioning-miscellaneous’ and in the open literature as ‘antioxidants’ (scavenging ability against free radicals).” Currently, fullerenes and hydroxylated fullerenes are not regulated under the Cosmetic Regulation (EC) No. 1223/2009. The EC is concerned “because of the potential for nanoparticles to be absorbed dermally or across a mucous membrane and to enter cells.” The EC asks whether SCCS considers fullerenes and hydroxylated fullerenes safe when used in cosmetic products according to the maximum concentrations and specifications as reported, taking into account reasonably foreseeable exposure conditions. The EC also asks SCCS to assess any further scientific concerns with regard to the use of fullerenes and hydroxylated fullerenes in cosmetic products and whether a potential risk to human health can be identified according to Article 16(6) Reg.1223/2009. The deadline for the opinion is six months.
The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published a final opinion on June 28, 2021, on gold (nano), colloidal gold (nano), gold thioethylamino hyaluronic acid (nano), and acetyl heptapeptide-9 colloidal gold (nano). The EC asked SCCS whether the nanomaterials gold, 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 all the information provided by the notifiers “and is of the opinion that it is not possible to carry out safety assessment of the nanomaterials (Gold, Colloidal Gold and Surface Modified Gold) due to limited or missing essential information.” According to SCCS, much of the information provided on toxicity relates to gold as such, and it is not possible to determine the relevance of the data for nanoforms of any of the materials under the current evaluation due to the absence of full study reports. To conduct a safety assessment of the nanomaterials, detailed data and information need to be provided on physicochemical characterization and toxicological evaluation. The final opinion states that with 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 also asked whether SCCS has any further scientific concerns with regard to the use of materials in nanoform in cosmetic products. According to SCCS, the information obtained from the scientific literature suggests possible systemic uptake of gold nanoparticles that may lead to accumulation in certain organs. In addition, the available data from literature indicate potential mutagenic/genotoxic effects of gold nanomaterials. SCCS states that “[t]hese indications raise an alert that warrants further safety evaluation of gold nanomaterials when used as cosmetic ingredients.” In the absence of sufficient data to allow safety assessment, SCCS considered these aspects and “has 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. According to the final opinion, “SCCS will be ready to assess any evidence provided to support safe use of the materials in cosmetic products.”