1. 8 th EU/US Joint Conference on Health and Safety at Work Fort Worth, Texas, 17 – 19 September 2015 OSH testing and information requirements for biopersistent particles and fibres Dr. Rolf Packroff Scientific Director of the Division „Hazardous substances and biological agents" BAuA – Federal Institute for Occupational Safety and Health, Dortmund (Germany)

2. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 11 EU regulatory framework for chemical safety R egistration E valuation A uthorisation of CH emicals C lassification L abelling P ackaging Bild: ECHA information about hazards information about risk

3. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 2 Risk and safety communication in the chemicals´supply chain producer / importer exposure scenario eSDS employer risk management control measures effectiveness check CLP / REACH OSH regulation

4. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 33 "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. EU definition for nanomaterials (proposal of 2011)

5. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 44... is not helpful for a legal discrimination of known health risks from inhalation of bio-persistent particles or fibres (better use existing definitions for respirable particles and WHO fibres)... offers only a limited legal security for industry and authorities due to a lack of standardized methods and high costs for identification of nanomaterials For OSH the EU definition of nanomaterials... carcinogenic potency fibre diameter (µm) Pott, F - ASP 8/77

6. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 55 Cosmetics: Label information about nanomaterials (since 2013, regulation (EC) no. 1223/2009 on cosmetic products) Biocides: Requirements for a specific risk assessment of nanoscaled active substances and for label information about nanoscaled ingredients (since 2013, regulation (EC) no. 528/2012 concerning the making available on the market and the use of biocidal products) Food additives: Labelling requirements for manufactured nanomaterials as ingredients in pre-packaged foods (since 2015, regulation (EC) no. 1169/2011 on the provision of food information to consumers) EU regulations for chemicals, which use the definition of nanomaterials

7. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 6 Guidance of the German CA for characterisation of nanomaterials (2012): A nanoscaled morphology generally does not modify a substance to another substance. The nanoscaled form has to be registered together with the bulk material, if their quantity from production or import exceeds 1 ton per year. http://www.reach-clp-biozid-helpdesk.de/de/Downloads/Kurzinfo/Kurzinfo%20Characterisierung%20Nanomaterialien.pdf Nanomaterials and REACH

8. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 7 REACH is lacking in information and testing requirements for coherent workers protection, which... … obliges producers and importers for an exposure and risk assessment of biopersistent substances, which have a relevant potential for release of respirable particles, despite not being classified as hazardous acc. to the CLP regulation, … generates useful information on dustiness of a material during relevant activities for downstream users, … decribes tests to determine bio-persistence of released particles for deduction of toxicological reference values (DNEL / DMEL) and to derive exposure scenarios for a safe use along the supply chain. … enables a targeted identification of materials, which release respirable and biopersistent fibres of high concern for human health.

9. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 88 Testing stategy for particle-related health risks

10. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 99 Dustiness Testing adequate methods? 2 EU standards (EN) 2 + 1 add. national standards (DIN) have to be adopted to NM results depend on type of handling (process category) enforceable methods? acceptable costs broadly applicable communication? type of information (dustiness class) in (M)SDS Projects (with BAuA participation) CarboSafe 2008 - 2012 CarboLifeCycle 2010 - 2014 nanoIndex (EU) 2013 - 2016 NANoREG (EU) 2013 - 2017

11. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 10 Granular Particles BAuA project F 2336 (10/2013 – 10/2016), contracted to Fraunhofer ITEM (Hannover): Method for the identification of granular biopersistent dusts at workplaces NANoREG 2013 – 2018 Default DNEL for GBP from long-term inhalation study („nano-in-vivo“) on CeO2? DNEL: Derived no-effect level

12. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 11 Fibres short term test by inhalation short term test by intratracheal instillation appropriate intra-peritoneal test suitable long term inhalation test Criteria to distinguish between rigid and non-rigid fibres? 0.01 f/ml (German acceptance level) ??? DMEL: Derived maximum exposure level BAuA project: Development of an enforceable test method for determination of the rigidity of respirable biopersistent fibres started, 2015 - 2016

13. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 12 Research vs. Regulation Health and Safety Research antenna function for new risks verification of hypotheses good expert manning development of new methods Regulation practicable enforceable risk-related coherent limited expert manning established methods Do we need a nano definition in OSH regulation? Do we need a nano definition in OSH regulation? Maynard's comment in Nature proposes that a "‘one size fits all' definition of nanomaterials will fail to capture what is important for addressing risk," and suggests that regulators use "a list of nine or ten attributes (including size and surface area) for which certain values trigger action“ Andrew D. Maynard, Nature, 475, 31 (2011) http://www.nanotech-now.com/columns/?article=572

14. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 13 Requirements for a targeted research on health risks and safety of advanced materials early warning system (antenna) detection of risks at an early stage generate scientific evidence hold pace with innovation enable science- based risk communication adequate manning and funds enable long-term basic research balance continuity and project founding allow gathering and exchange of experiences inter- / transdis- ciplinary interdisciplanary risk characterisation consultation of social partners and regulators collaboration of safety research with materials scientists and start-ups

15. Dr. Rolf Packroff OSH testing and information requirements for biopersistent particles and fibres 8 th EU-US Joint Conference on Health and Safety at Work, Fort Worth, 2015 14 packroff.rolf@ baua.bund.de Thank you