Hazard Banding of Nanomaterials The experience of Solvay 26 April 2018 - Brussels J-A Sergent, PhD ERT Toxicological and Environmental Risk Assessment Unit HSE/PRA-PS Tel + 32 2 264 34 04 @: jacques-aurelien.sergent@solvay.com
OUR ACTIVITIES ARE ORGANIZED INTO OPERATING SEGMENTS Advanced Formulations Functional Polymers Advanced Materials Performance Chemicals 2
ADVANCED MATERIALS Advanced Material s activities are growth drivers that contribute to the Group s performance through leadership in markets with high entry barriers and high return on investment. COMPOSITE MATERIALS SPECIAL CHEM 26 % EBITDA margin Net sales 4,313 million SPECIALTY POLYMERS SILICA EBITDA 1,110 million 2016 underlying results 3
General landscape for nanomaterial applications Source : Commercial scale production of inorganic nanoparticles, T. Tsuzuki, Int. J. of Nanotechnology, 2009 Vol.6, No.5/6, pp.567-578 4
from a large diversity of chemical compositions 5
and a large variety of shapes 6
which are requiring physico-chemical characterization Many potential variables to take into account : Size Shape Chemistry Crystal structure Water solubility Surface area Surface coating Agglomeration state Density Dispersability Porosity Surface charge Conductivity Contaminants Manufacturing method Some may be infuenced by cells or physiological media ZnO forms for a unique chemistry 7
Risk Management of Nanomaterials within Solvay How to handle the large variety of nanomaterials within Solvay to ensure a safe use? How to handle the large variety of nanomaterials within Solvay to ensure regulatory compliance? How to consolidate the necessary expertise to assess the large variety of nanomaterials within Solvay? 8
How to handle the large variety of nanomaterials within Solvay to ensure a safe use?
Worker risk management Tier 1 Tier 2 Tier 3 All substances Control Banding Result Requiring Refinement Expert Banding Strategic substances Full Assessment 10
A general view adapted at Solvay Control banding (CB) has been developed as a pragmatic tool to manage the risk resulting from exposure to a wide variety of potentially hazardous substances in the absence of firm toxicological and exposure information. Currently, the CB approach is applied for emerging risks such as nanoparticles, by the development of various CB-based tools. Six of these are compared. Hazard Banding Exposure Banding Control Banding Control Banding Approaches for Nanomaterials DERK H. BROUWER Ann. Occup. Hyg., Vol. 56, No. 5, pp. 506 514, 2012 11
Control Banding Approaches for Nanomaterials DERK H. BROUWER Ann. Occup. Hyg., Vol. 56, No. 5, pp. 506 514, 2012 NanoTool Precautionary Matrix ANSES Stoffenmanager Nano 1.0 NanoSafer Guidance First description Maynard et al 2007 Developed by Paik et al 2008 and Zalk et al 2009 http://www.controlbanding.net Development in Switzerland (Höck et al 2008) Risk Prioritization tool http://www.nanotechnologie.admin.ch CB for workplace exposure Developed by Ostiguy et al 2010; Riediker et al 2012 http://www.anses.fr Workplace risk prioritization Developed by van Duuren-Stuurman et al 2011, 2012 http://nano.stoffenmanager.nl/ Workplace risk prioritization Semi quantitative risk evaluation http://www.i-bar.dk/nanosafer/ Developed by Dutch social partners Cornelissen et al 2011 Decision matrix included http://fnv.nl 12
Control Banding Approaches for Nanomaterials DERK H. BROUWER Ann. Occup. Hyg., Vol. 56, No. 5, pp. 506 514, 2012 Severity and Hazard Banding approach - Scoring System Precautionary Matrix NanoTool - Binary Decision Tree ANSES StoffenmanagerNano - Mixture Nanosafer - Physico-Chemical Properties Guidance 13
Nanotool : Control Banding Solvay Approach Completed by operators / researchers First line of support : Industrial Hygienist Second line of support : Toxicologist 14
Nanotool : Control Banding Solvay Approach CB 2 CB 5 Ventilation Chemical lab type x x With a H14 filter x LEV x Glove box x Access restriction Restricted x Normal lab access x Vaccum cleaners Housekeeping type forbidden Asbestos type x x Waste and PPE evacuation Domestic waste treatment channel forbidden Special waste treatment channel x x Eyes protection Safety glasses x Close fitting safety goggles NA Respiratory protection FFP3 mask x Mask with assisted ventilation NA Body protection Simple lab coat Non-woven lab coat x Overal with hood - Tyvek style NA Hands protection 1 pair od adapted gloves x 2 pairs of adapted gloves NA 15
How to handle the large variety of nanomaterials within Solvay to ensure regulatory compliance?
EU Recommendation of Definition of Nanomaterials 2011/696/EU - L275/38 18 October 2011 Nanomaterial means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %. By derogation [ ], fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials. 17
Sector Specific definitions Food Information to Customers (N 1169/2011) Engineered nanomaterial means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale. 18
Sector Specific definitions Cosmetics Regulation (N 1233 /2009 since July, 11 2013) nanomaterial means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm. 19
Nano Inventory French Decree (N 2012/232) Substance at nanoscale : substance as defined in article 3 of EC regulation no. 1907/2006, intentionally produced at nanometric scale, containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for a minimum proportion of particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm. 20
Nano Inventory Belgian Royal Decree ( 2014 / 24329) Substance produced in nanoparticular state : a substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range of one nanometer to one hundred nanometers, with the exception of natural, non-chemically modified substances and the substances of which the fraction between one nanometer and one hundred nanometers is a by-product of human activity. Fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below one nanometre shall be deemed to be substances produced in nanoparticular state. 21
Nanomaterial and REACh Centralised support to all business units with respect to substance registrations Central expertise and Inventory Dedicated Follow-up committee REACh framework relevant for Nanomaterial Ongoing discussions on : EU Recommendation of Definition Adaptations to REACh annexes to be published (summer 2018) 22
Nanomaterial and National Nanomaterials Inventories 23
How to consolidate the necessary expertise to assess the large variety of nanomaterials within Solvay?
Solvay implication OECD WPMN : Working Party on Manufactured Nanomaterials ECHA NMWG : NanoMaterials Working Group CEFIC NMT Nanomaterials Management Team (Chairman) NET Nanomaterials Expert Task Force UIC (France) Groupe Support Nanomatériaux EU projects : Gracious, Nanodefine, Nanosolutions and NANoREG Other projects : GlobalNanomaPPP (NIA) and support to internal R&I 26
Risk Management of Nanomaterials within Solvay How to handle the large variety of nanomaterials within Solvay to ensure a safe use? Control Banding approach and cross discipline expertise network How to handle the large variety of nanomaterials within Solvay to ensure regulatory compliance? Development of dedicated tool to centralize and shape data to dedicated templates How to consolidate the necessary expertise to assess the large variety of nanomaterials within Solvay? International discussions and forums with main stakeholders Involvement in international research projects to develop expertise 27
Solvay Headquarters Rue de Ransbeek 310 1120 Neder-Over-Heembeek Belgium Thanks for your attention www.solvay.com 28 Contacts : Jacques-Aurélien Sergent Tel : +32 2 264 34 04 @ : jacques-aurelien.sergent@solvay.com