The coming years are expected to bring rapid changes in the nanotechnology regulatory landscape, with the establishment of a new framework for nano-risk governance, in silico approaches for characterisation and Risk assessment of nanomaterials, and novel procedures for the early identification and management of nanomaterial risks. In this context, Safe(r)-by-Design (SbD) emerges as a powerful preventive approach to support the development of safe and sustainable (SSbD) nanotechnology-based products and processes throughout the life cycle. This paper summarises the work undertaken to develop a blueprint for the deployment and operation of a permanent European Centre of collaborating laboratories and research organisations supporting safe Innovation in nanotechnologies. The proposed entity, referred to as “the Centre”, will establish a ‘one-stop shop’ for nanosafety-related services and a central contact point for addressing stakeholder questions about nanosafety. Its operation will rely on significant business, legal and market knowledge, as well as other tools developed and acquired through the EU-funded EC4SafeNano project and subsequent ongoing activities. The proposed blueprint adopts a demand-driven service update scheme to allow the necessary vigilance and flexibility to identify opportunities and adjust its activities and services in the rapidly evolving regulatory and nano risk governance landscape.
The proposed Centre will play a major role as a conduit to transfer scientific knowledge between the Research and commercial laboratories or consultants able to provide high quality nanosafety services, and the end-users of such services (e.g., industry, SMEs, consultancy firms, and regulatory authorities). The Centre will harmonise service provision, and bring novel risk assessment and management approaches, e.g. in silico methodologies, closer to practice, notably through SbD/SSbD, and decisively support safe and sustainable innovation of industrial production in the nanotechnology industry according to the European Chemicals Strategy for Sustainability.
The publicly available document encapsulates the first version of the Catalogue of Services of the future EC4Safenano Centre (CoS 2019).
The CoS 2019 is structured in 12 Service Categories and 27 Service Topics, for each of the 12 categories considered. This architecture configures a 12 x 27 matrix that allows ordering the potential EC4Safenano offer in 324 types of services/groups of services.
Each type of service/group of services is described, in a simple and friendly way, by means of a specific service sheet: the EC4Safenano - Service Data Sheet (EC4-SDS). These EC4-SDSs allow structuring and summarizing the information of each service, providing the customer with a concise view of characteristics of the service and also the contact details with the service provider.
The CoS 2019 deploys a map of services consisting of a set of 100 EC4-SDSs, covering 7 of the 12 Service Categories and 17 of the 27 Service Topics.
The harmonization of services is visualized as a future necessary step in EC4Safenano, in order to strengthen the offer and provide added value to customers with a growing offer of harmonized services in future versions of the CoS.
The information contained in this document is structured in 3 main sections, as follows:
• Catalogue structure. This section describes in short the main characteristics of the CoS 2019.
• Catalogue content. This section represents the core part of the document and encapsulates the set of 100 SDSs displaying the offer proposed by the CoS 2019.
• Online Catalogue. This section describes the resources implemented by EC4Safenano to facilitate the on-line consultation of the CoS 2019 by customers and other interested parties.
For stowage and retention during transport, the International Atomic EnergyAgency (IAEA) Transport regulations (SSR-6) only require that the package shall be securely stowed. Additional information is given in the IAEA guidance material (SSG-26), that includes specific load factors that should be considered in the safety demonstrations.
Nevertheless, applicants commonly use other load factors to justify the design of the packaging attachment points. In particular, acceleration values vary between different countries and this may lead to difficulties during the validation of foreign approval certificates.
Discussions with applicants identified that the load factors presented in the IAEA guidance material are not necessarily relevant for the different transport modes. For some modes, the load factors are representative of situations occurring in routine conditions of transport. For other modes, the load factors are more representative of situations occurring in normal or accident conditions of transport.
Furthermore, the origins of the specified values are not clear. In this context, some IAEA TRANSSC members decided to review the stowage guidance. An international working group was constituted in 2013, including representatives of competent authorities, technical support organizations, and transport stakeholders. Several topics were discussed
and many questions were raised during the two year review. For example, some discussions focused on Paper No.1031 2 the conditions which have to be considered for stowage design, both as relevant to the load factors used for strength and fatigue analysis, as well as the criteria which have to be considered for the package attachment points. In addition, related questions on operational aspects were also discussed. Overall, the working group concluded that new guidance material was warranted as input into SSG-26.
As a result of those discussions, the international working group produced new guidance material for stowage in transport, addressing each of these topics. The proposal to modify the IAEA guidance material (SSG-26, Appendix IV), presented by France to the TRANSSC in the 2015 initiated Review cycle of the Regulations, was unanimously accepted and will be implemented in the next edition of the guidance material.