Nanospecific considerations Sample Clauses

Nanospecific considerations. The life cycles of many NMs are determined by their application within products. While the manufacturing stage of the life cycles are likely be in a controlled industrial setting, the use of nano-enabled products by consumers are decidedly less predictable and involve more variables. In particular, it is clear that the released fraction of NMs from nano-enabled products no longer represents the primary particles initially dispersed in the matrix, but rather, a variety of different fragments, agglomerates, and transformed products that may have significantly different physical and chemical properties than the original, as manufactured NMs (▇▇▇▇▇▇▇ et al. 2015). NM aging and transformation processes therefore need to be accounted for. In the course of NANoREG, a selection was made of available Standard Operating Procedures (SOPs) that could be used to simulate, in controlled conditions, the release of nanoparticles from products and their subsequent transformation in the main compartments where exposure is likely to occur (i.e. indoor air, outdoor air, and water) (NANoREG Deliverable D3.3): • Nanoparticle release from textiles to the water compartment during washing cycles; • Nanoparticle release from polymers to the water compartment during accelerated aging; • Nanoparticle release to the indoor air and/or outdoor air during sanding processes; • Nanoparticle release to the indoor air and/or outdoor air as well as to the water compartment during environmental weathering/aging. One of the most important added values of the SOPs described within NANoREG Deliverable D3.3 was to implement previously developed normalized ISO tests. It means that the described tests were accepted as tests that reproduce at best the aging or weathering of materials. Qualitative and quantitative estimation of NM exposure is very complex, as these materials have very low mass, can be highly dynamic in terms of particle aggregation/agglomeration or reactivity and co-exist with ambient particles of the same size range. There are currently no agreed, standardized and validated methods for measuring personal exposure (i.e. measurements in the breathing zone) to NMs. Furthermore, there are currently no validated models providing quantitative estimates of human (worker or consumer) or environmental exposure. The existing Tier 1 and higher Tier exposure models described in ECHA guidance are designed and evaluated for use with chemicals and should not be applied to obtain quantitative estima...

Nanospecific considerations. Using the rules for adaptations of Standard Information Requirements under REACH may present challenges when it comes to NMs. Such nanospecific considerations are illustrated in this sub- section. The currently available tools (e.g. guidance documents, models, protocols, decision trees), including those developed under NANoREG, for addressing the nanospecific considerations discussed in this sub-section are listed in the NANoREG Toolbox (Deliverable D1.12, see worksheet "3.3 REACH Adaptation rules").

Nanospecific considerations. The identification and naming of a substance under REACH may present challenges when it comes to nanomaterials (NMs). Such nanospecific considerations are illustrated in this sub- section. The currently available tools (e.g. guidance documents, models, protocols, decision trees), including those developed under NANoREG, for addressing the nanospecific considerations discussed in this sub-section are listed in the NANoREG Toolbox (Deliverable D1.12, see worksheet "3.1 REACH Substance ID"). REACH deals with substances in whatever size, shape or physical state they come. Substances at the nanoscale, i.e. NMs, are therefore covered by the definition of 'substance' under REACH and are subject to the same obligations as any substance, which means that sufficient information is required to be included in the dossier to enable safe use of the substance. REACH currently does not explicitly address NMs in the legal text (European Commission 2013), just like it does not explicitly refer to fibres, petroleum substances, enzymes, etc. In the second regulatory review on NMs, the European Commission concluded that REACH offers the best possible framework for the risk management of NMs, but also that within this framework, more specific requirements for NMs have proven necessary (European Commission 2012). As a consequence, a process of revision of the REACH Annexes is currently ongoing and explicit obligations both in the reporting and in the information requirements for NMs are foreseen in the near future (mid 2017). According to ECHA, the term 'nanoform' refers to a particular form of a substance that meets the criteria of the European Commission's Recommendation on the definition of 'nanomaterial' (2011/696/EU) (European Commission 2011), here subsequently referred to as the EC Definition (see section 2 for more information), as opposed to the 'bulk form(s)' of the same substance, i.e. (the) form(s) of the substance not meeting the criteria of the EC Definition. ECHA is preparing an appendix on recommendations for NMs applicable to the Guidance on Registration under REACH16. The aim is to define the term nanoform, the minimum criteria for distinguishing between different nanoforms, and the minimum set of parameters which must be reported to characterize a reported nanoform. The Guidance on Substance Identification (ECHA 2016a) does not include any specific advice for the identification and naming of NMs. However, nanotechnology is mentioned in the chapter concerning "...