Nanoparticles in REACH
Consortium members
- Royal Institute of Technology (KTH), Department of Philosophy and the History of Technology
- University College Dublin, School of Chemistry and Chemical Biology
- University of Birmingham, School of Geography, Earth and Environmental Sciences, Environmental Nanos
Overveiw
Nanomaterials in REACH - evaluation of applicability of existing procedures for chemical safety assessment to nanomaterials.
Project website
Royal Institute of technology
Project outputs
Manufactured nanomaterials (NMs) are expected to bring several benefits to society including technological advances and benefits for human health and the environment. While the novel properties that arise when the materials are reduced to nanoscale make them attractive for a wide range of applications, only limited information is available on how those properties will affect human health and environment. These properties may confer unusual behaviors in the environment and interactions with living organisms, leading to new mechanisms, that are difficult to predict and to potential hazards for both humans and the environment. Ensuring a safe use of NMs is a necessary prerequisite for their sustainable use and for the success of nanotechnologies in terms of market and social acceptance. In this context the current EU chemicals regulation – REACH (Registration, Evaluation, and Authorization of Chemicals) needs an evaluation to ensure that the unique characteristics of NMs (and nanoparticles (NPs)) are taken into account in the implementation of the regulatory framework. This may require specific recommendations for NMs and specific recommendations to deal with human and environmental hazards associated with these materials.
Several projects approaching different aspects of the REACH regime have recently been undertaken. The report published by EC (December 2008) (CA/59/2008 rev.1) reflects the current state of ongoing discussions within the REACH Competent Authorities (REACH CA) and its subgroup on nanomaterials, on how REACH applies to nanomaterials. The EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published report concerning proposal of definitions related to products of nanoscience and nanotechnology (SCENIHR, 2006). The problems whether substances in the nanoscale should be regarded as new or existing substances have been approached during the 13th Joint Competent Authorities Meeting (May 2006). Other issues regarding provisions that are applied in REACH, like production volume, and phase-in and non-phase-in, and substance of very high concern (SVHC) criteria are also being discussed, as there are no provisions in REACH referring specifically to nanomaterials (EC, December 2008, CA/59/2008
rev.1).
For the implementation of REACH, recommendations concerning chemicals safety assessment procedures have been developed and extensive guidance documents (TGD) on substance identification, information requirements and chemicals safety assessment have been made available from ECHA (http://guidance.echa.europa.eu/guidance3_en.htm). The principles and approaches in those procedures, although considered to be applicable to the risk assessment of substances at nanoscale, do not address specific properties of those substances and most likely need adjustment (SCENHIR, 2006).
The purpose of this project is to make an assessment, based on currently available scientific evidence, of in what respect the REACH legislation and its associated guidance documents may need adjustment in order to ensure that the purpose of this regulation is satisfied also for nanomaterials. We will evaluate existing principles, definitions, assumptions, approaches and procedures in current chemical safety assessment for human health and environment with respect to their applicability to assess the effects of nanomaterials. The partners in this project have expertise in regulatory toxicology (Partner 1), the chemistry of NMs and their behavior in the environment and ecotoxicity (Partner 2), mechanisms of interactions with living systems (Partner 3). These competences will be combined to produce proposals for adjustments of the framework for safety assessment, leading to better regulation of nanomaterials and resulting in elimination or reduction of potential risks for human and environment. Additionally knowledge gaps that need to be fill before further relevant for nanomaterials changes could be proposed will be highlighted.
We will perform a systematic analysis of the current European procedures for chemical safety assessment of industrial chemicals and identify the different elements of these procedures that need to be evaluated in terms of their appropriateness for nanomaterials (workpackage 2). The available experimental evidence on a specific chemical characteristic of nanomaterials and their effects on human and environment will be analyzed in relation to the identified elements (workpackage 3, 4, 5). In the following phase (workpackage 6) the results of this analysis will be used to develop proposals for adjustment and/or amendments to current regulatory framework. The results of this project will be disseminated to relevant stakeholders; scientific society, industry, importers and down stream users, policy oriented organizations and others interested in the safety assessment of nanomaterials.
Forming international network and bringing together competence from different scientific fields is crucial for this project to achieve the outlined objectives. The competence of each Partner is very specific and technical and is not be easily replicated by other experts on the national level. Furthermore the subject of the project concerns the chemicals legislation on the European level and researchers from different European countries should be given place to contribute using their different national backgrounds and experience. The international collaboration is also beneficial for the efficient international dissemination of the results that in this case are of international concern.
Contacts for further information
Royal Institute of Technology (KTH), Department of Philosophy and the History of Technology, Stockholm, Sweden