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NanoREG II Report Summary

Project ID: 646221

Periodic Reporting for period 1 - NanoREG II (Development and implementation of Grouping and Safe-by-Design approaches within regulatory frameworks)

Reporting period: 2015-09-01 to 2017-02-28

Summary of the context and overall objectives of the project

One of the greatest challenges facing regulators in the ever changing landscape of novel nano-materials is how to design and implement a regulatory process which is robust enough to deal with a rapidly diversifying system of manufactured nanomaterials (MNM) over time.
To address it, NanoReg2 is built around the challenge of coupling Safe by Design to the regulatory process, and seeks to demonstrate and establish new principles and ideas based on data from industrial value chain implementation studies so that Safe by Design can become a fundamental pillar in the discovery, screening and commercialisation of novel MNMs. So as to say, the challenge is to build a regulatory system, which incorporates the flexibility of keeping pace with innovation by allowing for continuing innovation within its own architecture.The credibility of such a regulatory system, underpinned by the implementation of Safe by Design combined with regulatory relevant Groupings principles, as part of the Safe Innovation Approach, is essential for Industry's ongoing innovation and competitiveness, as well as Industry's early involvement in the process, in order to implement regulation in a cost effective and rapid manner and ultimately strengthen the innovation potential.

The 6 main objectives of the project are :
Objective 1
Identify and define regulatory requirements, build safe-orientated grouping approaches linked with Intelligent Testing and non-testing strategies (ITS). “Grouping approaches” are well established for chemicals, for example through the identification of chemical categories (“category approach”) or analogues (“analogue approach”).
Build a global Intelligent non-Testing & Testing Strategies (ITS) designed for toxicological, eco-toxicological and physical hazards.

Objective 2
Identify and select materials as candidates for value chain demonstrators, develop life cycle maps and identify existing and potential exposure scenarios.

Objective 3
Evaluate the relative change in environmental and human health risk, following implementation of the SbD process (for occupational and product (consumers and environment) safety), estimate any residual risk following SbD and recommend additional risk mitigation/management measures as appropriate.

Objective 4
Develop and adapt supportive technical and organizational tools for Safe by Design, based on regulatory orientated grouping approaches. Based on grouping approaches placed in a general ITS, and based on a defined value chain, develop a comprehensive model supporting SbD principles to reduce uncertainties regarding safety along the value chain and therefore promoting safer innovations. This will be relevant when marketing should be balanced with competitiveness and social constraints.

Objective 5
Identify and overcome barriers to the application of SbD concepts, including development of approaches to adequately address such barriers, taking into consideration grouping approaches and Risk Management (RM) requirements, with a view to ultimately eliminate the barriers and provide examples of guidance towards achieving SbD.

Objective 6
Disseminate Safe by Design tools and SOPs, promoting regulatory orientated guidelines, define Public-private partnerships (PPP) such as helpdesk on SbD or such as pre-validation for nanosafety tools.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

"Gourping stratégies:
- An International Advisory Panel (IAP) was established.
- Regulatory Needs for implementing grouping were identified.
- A Report on existing Grouping Strategies (NANoREG, OECD, ECHA or others) and available datasets from other projects (e.g. NANoREG, NanoTEST, MARINA) State of the Art Analysis has been made.
- A Report on MNM selection, criteria for grouping was also finalized.
- An overview on available methods expertise was collected as a basis for the validation of the grouping approach.
- A solution team of database experts has been established.

Nanomaterials for industrial markets and their corresponding value chains
- The selection of a set of materials for case studies was realised. More than 450 nano-enabled products have been identified.
- The definition of a group of relevant risk assessment (RA) tools for preliminary RA to suit each case study has been accomplished.
- LCA activities have thereby been split into two distinct elements within the Nanoreg2 project: the development of necessary interfaces in order to be able to integrate LCA into the SbD approach and its related tools, and the development of various, currently missing elements for a comprehensive application of the LCA framework in the area of NM applications (development of adequate characterisation factors, CFs, for releases of NMs and the establishment of comprehensive and transparent inventory data covering the production of ENMs).

Safe by Design :
- A first description of a conceptual and operational framework of the Safe Innovation Approach (SIA).
- A literature search was also performed of the current available tools, impact assessments and socio-economic analysis.
- An inventory on Regulatory Preparedness in other domains was performed and the usability for SIA will be elaborated.
- SbD training modules were developed.
- A first version of a safety dossier was used as input for the SbD concept and implementation trainings.

Case studies demonstration:
- 6 case studies are underway. We have also identified data and knowledge gaps. Case studies should be completed within the next 9-12 months.
- A workshop was organised during which a number of focus groups with industrial and technical partners were held.

Liaisons and dissemination activities:
- The project website ( has been established and continues to be maintained. Further dissemination material have been made available to project partners (including the project flyer and newsletter).
- Participation to several meeting such as of the NanoSafety Cluster (NSC), OECD, ECHA, Nanomaterials Working Group (NMWG), CASG Nano.
-Organisation of the workshop on Regulatory Preparedness as part of the NR2 Safe Innovation Approach (SIA) with key regulatory authorities such as ECHA, etc. During this event, finally the open question of the acceptance of the Regulatory Preparedness (prepare regulators for innovations) or ""not-acceptance"" by important organisations can hopefully been answered.
- Important connections have been continued - following ProSafe activities - with potential partners in North America, South Africa and Australia as well as with the CEINT data base at Duke University (US)."

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

For industry:
Safer products, less uncertainties, overall saving of time and money us well us faster time to market thanks to timely identification of uncertainties and risks to manage them, finding alternative solutions as early as possible

For regulators:
Be prepared for up-coming innovations & respective products thanks to insight into the innovation processes, dossier compatible data along the development process, regulation oriented tools and SOPs, etc.

For R&D community:
Strengthening R&D and inno-vation process through the Safe-by-design concept thanks to being well connected to the development and implementation of regulatory driven tools, SOPs, data bases, etc.

For the society:
Transparent and traceable information on the safety of MNMs and nano inspired products but also the capability to understand and compare products on the market

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