Standardization activities supporting safe and sustainable development of innovative nanotechnology

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1 Nanotechnologies Standardization activities supporting safe and sustainable development of innovative nanotechnology Phys-chem properties, hazard, risk & life cycle assessment Societal concerns, for a safe a sustainable innovation Pr. Emeric FREJAFON Coordinator NanoReg2 & EC4SafeNano Chairman of the CEN TC 352 OECD WPMN Nat. coordinator Emeric.frejafon@ineris.fr

2 INERIS: French National Institute for Industrial & Environmental Risk Assessment State own private company having >50 years of experience on risk assessment and safety enhancement A staff of 600, including 350 engineers / 80 M /y Full scale facilities (mesocom, animal facilities, battery field test, nano-safety platform, 1000 m 3 chamber) Headquarters extend to 50 ha m² of laboratories More than customers (worldwide) Always ~50 PhD students & 20 Post-doc fellowships A synergy between services for private customers, research activities and technical support for the government, a key player in uncertain regulation where anticipation is a lever

3 Contexte Behave not as a gas, nor particulate mater Ageing effects & transformation surface versus core chemistry Measurands, metrology & measurement : NEW Toxicology descriptors to be adapted Thus routine tools are missing

4 Drivers of safe and sustainable innovation Innovation means risk to be estimated BP, BM & safety Phys-Chem characterization (size, shape, chemistry ) Knowing what we have Hazard (flammability, explosion, dustiness, (eco)toxicology, ) Exposure characterization (workplace, environment ) Knowing their safety characteristics (product, production) Life cycle of products (using, aging & durability) End of Life of products (disposal, incineration, recycling) Socio-Economic analyses (cost-benefice analyses) Knowing their impact on market (product, production, use) Regulatory & Societal awareness Knowing their sustainable capability on the market Risk management for safer by design products/ production/use Awareness for safer & sustainable innovation

5 Standardization purpose terminology and classification, measurement and characterization, health and environmental safety testing, risk assessment and risk management

6 Routes for safe & sustainable innovation Relevant tools, protocols & processes : To support innovation / knowledge properties, functionalities To support B2B exchanges claims, quality, competitiveness To support regulation, consumers & environmental concerns Through Standardization activities on nanotechnologies : At DG RTD/ GROW / ENV / REACH. Product regulation At OECD (WPMN, BNCT) Business regulation At ISO, CEN & National Standardization bodies Encourages innovation and technological development Supports businesses in building competitive advantages Supports business compliance with regulation

7 Standardization Nano World

8 CEN TC 352 activities recent outcomes 34 National Standardization Bodies with 13 regular countries 16 standards already published 12 draft standards Establishes generic standards applicable to a wide range of industries Support through liaisons sectorial concerns (technical comities) Nanotechnologies Guidelines for Life Cycle Assessment Application of EN ISO 14044:2006 to Manufactured Nanomaterials Guidance on detection and identification of nano-objects in complex matrices Guidelines for determining protocols for the explosivity and flammability of powders containing nano-objects (for transport, handling and storage) Guidelines for the management and disposal of waste from the manufacturing and processing of manufactured nano-objects Suitability of particle size and surface area measurement methods for the assessment of the amount of nano-objects in a sample

9 CEN TC 352 activities future projects Guidelines for the characterization of additives containing nanoobjects in food products Safe-by-Design concept dedicated for nanomaterials and nano-enable products Risk Assessment and Life Cycle Assessment of Nanomaterials: synergistic use of data for efficient and effective evaluations Quick start guide for deploying a relevant nano risk management Decision trees and flow charts to structure the sensible toxicity and eco-toxicity testing of engineered nanomaterial Nanomaterials - Business to Business traceability for enhancing transparency Service life time estimation of (nano-)materials subjected to particle release Air-liquid interface (ALI) in-vitro model for respiratory toxicology as early warning tool Among several others dealing with instruments

10 Nanotechnologies, l accompagnement de l INERIS Interested in building harmonized expertise On Risk management & safety enhancement? Visit: & Become EC4SafeNano team of associated partners Get access to NR2 industrial case studies on SbD Attend the NANOSAFE (Nov. 2018, Grenoble) Join the CEN TC352 nanotechnologies Thank you for your attention Pr. Emeric FREJAFON Coordinator NanoReg2 & EC4SafeNano Chairman of the CEN TC 352 OECD WPMN National coordinator Emeric.frejafon@ineris.fr

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