Nanomaterials in the European chemicals legislation – methodological challenges for registration and environmental safety assessment

Nielsen, Maria Bille; Baun, Anders; Mackevica, Aiga; Thit, Amalie; Wallinder, Inger Odnevall; Gallego, Julián Alberto; Clausen, Lauge Peter Westergaard; Rissler, Jenny; Skjolding, Lars Michael; Nilsson, Alejandra Castro; Cedervall, Tommy; Hansen, Steffen Foss

doi:10.1039/d0en01123a

Cited by 24 publications

(24 citation statements)

References 56 publications

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“…Nanotechnology has captured the attention of a wide range of industries in many sectors, gaining in a short period large attraction and significant public investments in research and development, in addition to increasing private-sector investments. Many governments are implementing the application of nanotechnology notwithstanding the associated risks and uncertainties [ 1 ]. Nanotechnology allows the development and improvement of completely new products, processes, and services [ 2 ].…”

Section: Enm Genotoxicity In Plant: the Current Statementioning

confidence: 99%

Nanomaterials Induced Genotoxicity in Plant: Methods and Strategies

Marmiroli

Marmiroli²,

Pagano

2022

Nanomaterials

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In recent years, plant-nanomaterial interactions have been studied, highlighting their effects at physiological and molecular levels. Transcriptomics and proteomics studies have shown pathways and targets of nanomaterial exposure and plant response, with particular regard to abiotic stress and oxidative stress. Only little information has been reported on engineered nanomaterial (ENMs) interactions with plant genetic material, both at a genomic and organellar DNAs level. Plants can be useful experimental material, considering they both contain chloroplast and mitochondrial DNAs and several plant genomes have been completely sequenced (e.g., Arabidopsis thaliana, Solanum lycoperiscum, Allium cepa, Zea mays, etc.). In this mini review, the methods and the evidence reported in the present literature concerning the level of genotoxicity induced by ENMs exposure have been considered. Consolidated and potential strategies, which can be applied to assess the nanomaterial genotoxicity in plants, are reviewed.

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Section: Enm Genotoxicity In Plant: the Current Statementioning

confidence: 99%

Nanomaterials Induced Genotoxicity in Plant: Methods and Strategies

Marmiroli

Marmiroli²,

Pagano

2022

Nanomaterials

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“…Safety guidelines for nanomaterials are lagging behind more traditional chemicals for the general researcher, with a 2010 survey of university and public research laboratories worldwide showing 90% of respondents being unaware of local or national regulations for safe handling of nanomaterials and almost three-quarters reporting having little or no awareness of internal or lab scale rules. 145 Since then, the EU and the US have issued guidance on nano safety practices through ECHA 146 and NIOSH, 147 respectively, but recent surveys in other regions continue to show a lack of awareness of nanomaterial-specific safety and health policy plans. 148 , 149 Guidelines on ENM exposure specific to pregnant researchers are further lagging, although the routes of ENMs exposure are well-established including dermal and via inhalation.…”

Section: Laboratory Chemical Riskmentioning

confidence: 99%

What to Expect When Expecting in Lab: A Review of Unique Risks and Resources for Pregnant Researchers in the Chemical Laboratory

Lane

Garedew

Deary

et al. 2022

Chem. Res. Toxicol.

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Pregnancy presents a unique risk to chemical researchers due to their occupational exposures to chemical, equipment, and physical hazards in chemical research laboratories across science, engineering, and technology disciplines. Understanding “risk” as a function of hazard, exposure, and vulnerability, this review aims to critically examine the state of the science for the risks and associated recommendations (or lack thereof) for pregnant researchers in chemical laboratories (labs). Commonly encountered hazards for pregnant lab workers include chemical hazards (organic solvents, heavy metals, engineered nanomaterials, and endocrine disruptors), radiation hazards (ionizing radiation producing equipment and materials and nonionizing radiation producing equipment), and other hazards related to the lab environment (excessive noise, excessive heat, psychosocial stress, strenuous physical work, and/or abnormal working hours). Lab relevant doses and routes of exposure in the chemical lab environment along with literature and governmental recommendations or resources for exposure mitigation are critically assessed. The specific windows of vulnerability based on stage of pregnancy are described for each hazard, if available. Finally, policy gaps for further scientific research are detailed to enhance future guidance to protect pregnant lab workers.

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“…The new technical data requirements for NMs, as clarified in the revised Annexes of REACH regulation in force since 1st of January 2020 (and corresponding guidance manuals), include a comprehensive set of information on physico-chemical properties of NMs (e.g., particle size distribution, shape, crystallinity, surface area, solubility/ dissolution rate), as well as knowledge on environmental fate and toxicity. In particular, 20 additional nano-specific information requirements must be satisfied in order to register substances as nanoforms in REACH [72]. If for some information requirements standard methods are available or under development (see [72] for a critical appraisal), current technical guidance entail no assistance on how to measure and report transformations that nanoforms and related nano-enabled products can experience when considering all stages of the life cycle and with regard to their environmental behaviour and fate [73].…”

Section: General Remarks and Conclusionmentioning

confidence: 99%

“…In particular, 20 additional nano-specific information requirements must be satisfied in order to register substances as nanoforms in REACH [72]. If for some information requirements standard methods are available or under development (see [72] for a critical appraisal), current technical guidance entail no assistance on how to measure and report transformations that nanoforms and related nano-enabled products can experience when considering all stages of the life cycle and with regard to their environmental behaviour and fate [73]. Therefore, especially in the case when a Chemical Safety Assessment would be required, methods to identify and investigate relevant exposure scenarios (including the justification of "no exposure" or "low exposure" evaluations) are needed.…”

Section: General Remarks and Conclusionmentioning

confidence: 99%

Leaching of nanoparticles from nano-enabled products for the protection of cultural heritage surfaces: a review

et al. 2021

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The development of highly innovative techniques and technologies to enhance performance and technical sustainability of materials used in the field of cultural heritage conservation is providing conservators with innovative nanocomposites materials, including protective coatings, by merging the performances of engineered nanoparticles (NPs) with conventional chemicals. However, the human health and environmental risks that may potentially arise from these new materials are still largely unknown, requiring an adequate assessment and management along their entire life cycle. Concerns could emerge due to the leaching of the material containing NPs or of the NPs alone, especially during their use (exposure of the treated object to, e.g., heavy or acid rain) and disposal (when the wasted product is processed in, e.g., waste water treatment plants). To date, no standard leaching test methods have been specifically developed for nano-enabled products, with the consequent lack of data on the NPs potential exposure also in the field of cultural heritage. Therefore, an extensive review over the last 10 years by querying to the Scopus database “nanoparticles”, “leaching” and “coatings” has been herein reported to clearly highlight (i) the standard test methods used or adapted to estimate the NPs leaching from nano-based coatings; (ii) the available studies in which the NPs leaching from nano-based coatings was estimated without following any specific standard test method; (iii) the works focusing on other nanocomposite materials performances than leaching, in which standard test methods were applied, potentially useful to indirectly estimate NPs leaching. All the information gathered by this bibliographic search have been used to identify the most promising leaching tests for NPs estimation to be applied in the field of cultural heritage, especially for both large, e.g., building façades, and small, e.g., bronze works of art, surface areas from which the leaching of nano-based materials could be significant in terms of human health and ecological risks, based also on the (eco)toxicity of the leachate. The derived information can thus ultimately support effective risk management of innovative nano-enabled products, including the implementation of Safe by Design approaches.

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Nanomaterials in the European chemicals legislation – methodological challenges for registration and environmental safety assessment

Abstract: In the European Union the Annexes of its chemical legislation (REACH) were revised and now clarifies the technical data requirements for nanomaterials (NMs). These new provisions, effective from January 1,...

Cited by 24 publications

References 56 publications

Nanomaterials Induced Genotoxicity in Plant: Methods and Strategies

Nanomaterials Induced Genotoxicity in Plant: Methods and Strategies

What to Expect When Expecting in Lab: A Review of Unique Risks and Resources for Pregnant Researchers in the Chemical Laboratory

Leaching of nanoparticles from nano-enabled products for the protection of cultural heritage surfaces: a review

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