A framework for grouping and read-across of nanomaterials- supporting innovation and risk assessment

Stone, Vicki; Gottardo, Stefania; Bleeker, Eric A.J.; Braakhuis, Hedwig; Dekkers, Susan; Fernandes, Teresa F.; Haase, Andrea; Hunt, Neil; Hristozov, Danail; Jantunen, Paula; Jeliazkova, Nina; Johnston, Helinor Jane; Lamon, Lara; Murphy, Fiona; Rasmussen, Kirsten; Rauscher, Hubert; Jiménez, Araceli Sánchez; Svendsen, Claus; Spurgeon, David J.; Vázquez‐Campos, Socorro; Wohlleben, Wendel; Oomen, Agnes G.

doi:10.1016/j.nantod.2020.100941

Cited by 107 publications

(91 citation statements)

References 36 publications

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“…As nanomaterials of the same core chemistry can exist in many different forms (i.e. shape, surfaces, sizes), it would be desirable to apply grouping of substances together with the use of data from structurally related substances (read-across) for risk assessment ( Stone et al, 2020 ; Giusti et al, 2019 ). However, to-date, grouping and read-across are rarely applied in the food sector.…”

Section: Nanotechnology In the Agriculture/food/feed Sectormentioning

confidence: 99%

Regulatory landscape of nanotechnology and nanoplastics from a global perspective

Jacqueline¹,

Belz

Hoeveler

et al. 2021

Regulatory Toxicology and Pharmacology

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161

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Nanotechnology and more particularly nanotechnology-based products and materials have provided a huge potential for novel solutions to many of the current challenges society is facing. However, nanotechnology is also an area of product innovation that is sometimes developing faster than regulatory frameworks. This is due to the high complexity of some nanomaterials, the lack of a globally harmonised regulatory definition and the different scopes of regulation at a global level. Research organisations and regulatory bodies have spent many efforts in the last two decades to cope with these challenges. Although there has been a significant advancement related to analytical approaches for labelling purposes as well as to the development of suitable test guidelines for nanomaterials and their safety assessment, there is a still a need for greater global collaboration and consensus in the regulatory field. Furthermore, with growing societal concerns on plastic litter and tiny debris produced by degradation of littered plastic objects, the impact of micro- and nanoplastics on humans and the environment is an emerging issue. Despite increasing research and initial regulatory discussions on micro- and nanoplastics, there are still knowledge gaps and thus an urgent need for action. As nanoplastics can be classified as a specific type of incidental nanomaterials, current and future scientific investigations should take into account the existing profound knowledge on nanotechnology/nanomaterials when discussing issues around nanoplastics. This review was conceived at the 2019 Global Summit on Regulatory Sciences that took place in Stresa, Italy, on 24–26 September 2019 (GSRS 2019) and which was co-organised by the Global Coalition for Regulatory Science Research (GCRSR) and the European Commission's (EC) Joint Research Centre (JRC). The GCRSR consists of regulatory bodies from various countries around the globe including EU bodies. The 2019 Global Summit provided an excellent platform to exchange the latest information on activities carried out by regulatory bodies with a focus on the application of nanotechnology in the agriculture/food sector, on nanoplastics and on nanomedicines, including taking stock and promoting further collaboration. Recently, the topic of micro- and nanoplastics has become a new focus of the GCRSR. Besides discussing the challenges and needs, some future directions on how new tools and methodologies can improve the regulatory science were elaborated by summarising a significant portion of discussions during the summit. It has been revealed that there are still some uncertainties and knowledge gaps with regard to physicochemical properties, environmental behaviour and toxicological effects, especially as testing described in the dossiers is often done early in the product development process, and the material in the final product may behave differently. The harmonisation of methodologies for quantification and risk assessment of nanomaterials and micro/nanoplastics, the documentation...

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Section: Nanotechnology In the Agriculture/food/feed Sectormentioning

confidence: 99%

Regulatory landscape of nanotechnology and nanoplastics from a global perspective

Jacqueline¹,

Belz

Hoeveler

et al. 2021

Regulatory Toxicology and Pharmacology

Self Cite

161

View full text Add to dashboard Cite

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“…Testing strategy: The testing strategy complies with the recent GRACIOUS framework for the grouping of nanomaterials, 40 and the specific tests comply with the tiered selection of methods in GRACIOUS inhalation grouping, with the nanoGRAVUR grouping framework, 41 and with the tiered DF4nanoGrouping, 42 which were tested in case studies including silica and organic nanomaterials. 41,43 All of these tiered frameworks were previously applied to materials with external dimensions in the nanometer range only, whereas here we apply them to openpore internal nanostructures.…”

Section: Resultsmentioning

confidence: 99%

“…Thus, organic aerogels, as tested here, may be understood as a category "polymer-based aerogels with low toxic potential". The properties recommended by the ECHA guidance for grouping of nanomaterials, 37 and its implementation with specific methods by GRACIOUS 40 , DF4nanogrouping 42 or nanoGRAVUR 41 provide a tiered framework to assess concerns about the content (and potential release) of nanostructures in advanced materials. For more complex advanced materials, one would first assess the form of release, which may have internal or external nanostructures, and more than one chemical component.…”

Section: Discussionmentioning

confidence: 99%

Aerogels are not regulated as nanomaterials, but can be assessed by tiered testing and grouping strategies for nanomaterials

Keller

Wiemann²,

Gröters

et al. 2021

Nanoscale Adv.

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“…To speed up the regulatory process, the risk assessment of groups of substances (including groups of nanomaterials), instead of individual substances, is expected to become more important. Grouping should facilitate the use of read-across of exposure and hazards [ 18 , 19 ]. For nanoforms, the concept of “sets of similar nanoforms” introduced in REACH is an additional type of grouping.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Optical Methods for Zeta Potential Determination of Silica and Polystyrene Particles in Aqueous Suspensions

et al. 2021

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Zeta potential is frequently used to examine the colloidal stability of particles and macromolecules in liquids. Recently, it has been suggested that zeta potential can also play an important role for grouping and read-across of nanoforms in a regulatory context. Although the measurement of zeta potential is well established, only little information is reported on key metrological principles such as validation and measurement uncertainties. This contribution presents the results of an in-house validation of the commonly used electrophoretic light scattering (ELS) and the relatively new particle tracking analysis (PTA) methods. The performance characteristics were assessed by analyzing silica and polystyrene reference materials. The ELS and PTA methods are robust and have particle mass working ranges of 0.003 mg/kg to 30 g/kg and 0.03 mg/kg to 1.5 mg/kg, respectively. Despite different measurement principles, both methods exhibit similar uncertainties for repeatability (2%), intermediate precision (3%) and trueness (4%). These results confirm that the developed methods can accurately measure the zeta potential of silica and polystyrene particles and can be transferred to other laboratories that analyze similar types of samples. If direct implementation is impossible, the elaborated methodologies may serve as a guide to help laboratories validating their own methods.

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A framework for grouping and read-across of nanomaterials- supporting innovation and risk assessment

Cited by 107 publications

References 36 publications

Regulatory landscape of nanotechnology and nanoplastics from a global perspective

Regulatory landscape of nanotechnology and nanoplastics from a global perspective

Aerogels are not regulated as nanomaterials, but can be assessed by tiered testing and grouping strategies for nanomaterials

Development and Validation of Optical Methods for Zeta Potential Determination of Silica and Polystyrene Particles in Aqueous Suspensions

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