Considerations on the EU definition of a nanomaterial: Science to support policy making

Bleeker, Eric A.J.; Jong, Wim H. de; Geertsma, Robert E.; Groenewold, Monique; Heugens, Evelyn H. W.; Koers-Jacquemijns, Marjorie; Meent, Dik van de; Popma, Jan; Rietveld, Anton; Wijnhoven, Susan; Cassee, Flemming R.; Oomen, Agnes G.

doi:10.1016/j.yrtph.2012.11.007

Cited by 192 publications

(101 citation statements)

References 19 publications

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“…2,3 Because of their unique size and high surface area, after surface modifications, many NPs are capable of bypassing or crossing the blood-brain barrier (BBB). Several animal studies have provided direct evidence that NPs could reach and accumulate in the brain parenchyma, including the striatum and hippocampus.…”

Section: Introductionmentioning

confidence: 99%

Central nervous system toxicity of metallic nanoparticles

Feng¹,

Chen²,

Zhang³

et al. 2015

IJN

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Nanomaterials (NMs) are increasingly used for the therapy, diagnosis, and monitoring of disease- or drug-induced mechanisms in the human biological system. In view of their small size, after certain modifications, NMs have the capacity to bypass or cross the blood–brain barrier. Nanotechnology is particularly advantageous in the field of neurology. Examples may include the utilization of nanoparticle (NP)-based drug carriers to readily cross the blood–brain barrier to treat central nervous system (CNS) diseases, nanoscaffolds for axonal regeneration, nanoelectromechanical systems in neurological operations, and NPs in molecular imaging and CNS imaging. However, NPs can also be potentially hazardous to the CNS in terms of nano-neurotoxicity via several possible mechanisms, such as oxidative stress, autophagy, and lysosome dysfunction, and the activation of certain signaling pathways. In this review, we discuss the dual effect of NMs on the CNS and the mechanisms involved. The limitations of the current research are also discussed.

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Section: Introductionmentioning

confidence: 99%

Central nervous system toxicity of metallic nanoparticles

Feng¹,

Chen²,

Zhang³

et al. 2015

IJN

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“…Second, insoluble or biopersistent and intentionally manufactured particles which do not have any dimensions or an internal structure of 1-100nm, but may have a dimension of 101 nm and exhibit the same functionality or novelty, will also not be defined as a nanomaterial for the purposes of the regulation even though there is no scientific evidence to support the appropriateness of this value [26,27]. While the thresholds chosen reflect political compromises and practicality, there is nonetheless the potential that different-and potentially hazardous-properties may also arise for a specific material at sizes above 100 nm [28]. Third, the definition used in the regulation does not make reference to the need for 'special' or 'unique' properties to be displayed within the defined size range.…”

Section: When Is a Nanomaterials Not A Nanomaterials For The Purposes Omentioning

confidence: 99%

“…Such complexities are further exacerbated by the fact that, as of August 2013, three EU regulations contain different definitions of nanomaterials (the Biocidal Products regulation largely incorporates the definition of nanomaterials from the 2011 EC Recommendation on nanomaterials). As a number of commentators have observed [28,36,37], differentiation in the definition of nanomaterials, e.g., with regard to natural, incidental and manufactured nanomaterials, and soluble versus non-soluble, and so on, may be necessary and/or relevant given strong divergences in the application of nanomaterials. However, such differentiation will have important effects in practice.…”

Section: Moving Forwardmentioning

confidence: 99%

The Challenge of Distributing Regulatory Responsibilities for Unknown Risks: Â‘NanoÂ’-Cosmetics and the EU Cosmetics Regulation as a Case Study

Bowman¹

2015

J Clinic Res Bioeth

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The adoption of the European Union's (EU) Cosmetics Regulation-which came into effect as of July 2013-is significant because it was the first piece of legislation at the national or supranational level to include provisions relating specifically to the use of nanomaterials in any products. While the regulation does not change the fundamental aspects of the regulatory regime, which includes putting full responsibility for ensuring the safety of the cosmetic product on the manufacturer/importer, the provision of consumer labelling of nanomaterials suggests a shifting of responsibilities that is new for cosmetics within the EU market. Although this additional shifting of responsibilities is subtle, we argue that it is nonetheless problematic, given current uncertainties about what a 'nano label' actually means, in addition to doubts around the capacity to furnish the consumer with sufficient information to enable them to make a fully informed consumer choice. The aim of this article is to understand the challenge of distributing regulatory responsibilities for unknown or unquantified risks through the lens of the Cosmetics Regulation. We present and discuss data gathered in interviews with a small number of cosmetics stakeholdersincluding industry, representatives of government/regulatory agencies, NGOs/civil society and experts (in industry and dialogue)-as a means of illustrating various elements viewed by stakeholders as necessary to be able to take up responsibilities and identifying the constraining factors to doing so, i.e. regulatory challenges. The overarching aim of the article is to understand the implications of the distribution of responsibilities, as set out by the regulation, for enabling consumers to meaningfully differentiate between conventional cosmetic products and those containing nanomaterials.

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“…5 One bottleneck that hinders the safe and sustainable development of nano-innovations in various industrial sectors is that nano-specific legislative measures at the EU level are currently vague; while a decade of research in nanotoxicology has failed to identify specific modes of action for nanomaterial toxicity, 6 the regulatory framework has been growing disorderly, creating an uncertain environment for industry. 7,8 In the European Union, NMs are considered as a chemical substance and therefore fall in the existing regulatory framework of regulation 1907/ 2006 1 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Since REACH does not explicitly integrate provisions regarding NMs, they are bound to registration like other substances.…”

Section: Introductionmentioning

confidence: 99%

A methodology on how to create a real-life relevant risk profile for a given nanomaterial

Schimpel¹,

Resch²,

Flament³

et al. 2018

J. Chem. Health Saf.

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Please cite this article in press as: Schimpel, C. et al1., A methodology on how to create a real-life relevant risk profile for a given nanomaterial. J. Chem. Health Safety (2017), http://dx.doi.org/10.1016/j.jchas.2017.06.002 RESEARCH ARTICLEA methodology on how to create a real-life relevant risk profile for a given nanomaterial With large amounts of nanotoxicology studies delivering contradicting results and a complex, moving regulatory framework, potential risks surrounding nanotechnology appear complex and confusing. Many researchers and workers in different sectors are dealing with nanomaterials on a day-to-day basis, and have a requirement to define their assessment/management needs. This paper describes an industry-tailored strategy for risk assessment of nanomaterials and nano-enabled products, which builds on recent research outcomes. The approach focuses on the creation of a risk profile for a given nanomaterial (e.g., determine which materials and/or process operation pose greater risk, where these risks occur in the lifecycle, and the impact of these risks on society), using state-of-the-art safety assessment approaches/tools (ECETOC TRA, Stoffenmanager Nano and ISO/TS 12901-2:2014). The developed nanosafety strategy takes into account cross-sectoral industrial needs and includes (i) Information Gathering: Identification of nanomaterials and hazards by a demand-driven questionnaire and on-site company visits in the context of human and ecosystem exposures, considering all companies/parties/downstream users involved along the value chain; (ii) Hazard Assessment: Collection of all relevant and available information on the intrinsic properties of the substance (e.g., peer reviewed (eco)toxicological data, material safety data sheets), as well as identification of actual recommendations and benchmark limits for the different nano-objects in the scope of this projects; (iii) Exposure Assessment: Definition of industry-specific and application-specific exposure scenarios taking into account operational conditions and risk management measures; (iv) Risk Characterisation: Classification of the risk potential by making use of exposure estimation models (i.e., comparing estimated exposure levels with threshold levels); (v) Refined Risk Characterisation and Exposure Monitoring: Selection of individual exposure scenarios for exposure monitoring following the OECD Harmonized Tiered Approach to refine risk assessment; (vi) Risk Mitigation Strategies: Development of risk mitigation actions focusing on risk prevention.

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Considerations on the EU definition of a nanomaterial: Science to support policy making

Cited by 192 publications

References 19 publications

Central nervous system toxicity of metallic nanoparticles

Central nervous system toxicity of metallic nanoparticles

The Challenge of Distributing Regulatory Responsibilities for Unknown Risks: Â‘NanoÂ’-Cosmetics and the EU Cosmetics Regulation as a Case Study

A methodology on how to create a real-life relevant risk profile for a given nanomaterial

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