1. Nano-Safety: Some Future Perspectives Conference on Nano-Safety 22-24 April, Slovenia, Ljubljana Bjorn G. Hansen dHoU Chemicals, DG ENV, European Commission Chair, OECD Working Party on Manufactured Nanomaterials

2. Contents 1.Introduction 2.Problems are not new – the solutions are 3.OECD WPMN – what’s next 4.EU Legislation – what’s next 5.Conclusions

3. 1. Introduction If given the choice, everyone would chose to live in a pristine environment If given the choice, everyone would chose to live in a pristine environment Our standard of living is dependent on our human activities, but all human activity results in some level of pollution Our standard of living is dependent on our human activities, but all human activity results in some level of pollution So environment and health policy is all about finding the balance between these two factors

4. 2. Problems are not new – the solutions are Environment and Health policies are (generally) based on science, but science and policy do not (generally) develop in perfect co-ordination Environment and Health policies are (generally) based on science, but science and policy do not (generally) develop in perfect co-ordination 2 example from the “chemicals area” where policy needs outran scientific knowledge: endocrine disruptors and REACH 2 example from the “chemicals area” where policy needs outran scientific knowledge: endocrine disruptors and REACH Many more: C&L (Dir 67/548), RA (Reg 793/93) Many more: C&L (Dir 67/548), RA (Reg 793/93)

5. 2. Problems are not new – the solutions are The case of endocrine disruptors: Policy concern for the long term effects of exposures to endocrine disruptors triggered significant research activities and a re-assessment of current chemicals policies The case of endocrine disruptors: Policy concern for the long term effects of exposures to endocrine disruptors triggered significant research activities and a re-assessment of current chemicals policies Results: Results: Validated OECD Test Methods Validated OECD Test Methods Re-assurance that (generally) current regulatory systems can identify endocrine disruptors Re-assurance that (generally) current regulatory systems can identify endocrine disruptors Further research Further research

6. 2. Problems are not new – the solutions are So, up to recently, policy drove (regulatory) scientific research and awaited the outcome. So, up to recently, policy drove (regulatory) scientific research and awaited the outcome. However, However, Commission given 4 years to develop legislative criteria for identifying PPPs as EDs Commission given 4 years to develop legislative criteria for identifying PPPs as EDs and so the pressure is on (again)!

7. 2. Problems are not new – the solutions are The case of REACH: Policy concern (among others) for un-tested substances triggered a system for generating sufficient information to assess all chemicals manufactured or imported into the EU The case of REACH: Policy concern (among others) for un-tested substances triggered a system for generating sufficient information to assess all chemicals manufactured or imported into the EU Results: Legislative Results: Legislative Legislative frame developed, but science needs to fill (part of) this frame, e.g., category approaches (including QSAR), exposure scenrios, DNELs, ….. Legislative frame developed, but science needs to fill (part of) this frame, e.g., category approaches (including QSAR), exposure scenrios, DNELs, …..

8. 2. Problems are not new – the solutions are So (chemicals) policy drives (regulatory) scientific research to enable implementation. So (chemicals) policy drives (regulatory) scientific research to enable implementation. However, However, To utilise fully the potential of “alternative” information, much more research is needed To utilise fully the potential of “alternative” information, much more research is needed For many substances (petroleum substances, metals, waste streams, ….), details need to be sorted out (what should be tested, how to test, how to measure, what to measure, …….) For many substances (petroleum substances, metals, waste streams, ….), details need to be sorted out (what should be tested, how to test, how to measure, what to measure, …….) and so the pressure is (still) on!

9. 2. Problems are not new – the solutions are Lessons learned: Problems are not new Problems are not new The solutions are new The solutions are new The way to get solutions is not new The way to get solutions is not new Questions are: If and when policy will require action (regulatory or voluntary) If and when policy will require action (regulatory or voluntary) How far have we reached in finding scientific solutions How far have we reached in finding scientific solutions

10. 3. OECD WPMN – what’s next Thanks to Jim Willis (U.S. E.P.A. and first WPMN Chair) and the OECD Secretariat Nanosafety Team for getting us as far as we are today!!!! Thanks to Jim Willis (U.S. E.P.A. and first WPMN Chair) and the OECD Secretariat Nanosafety Team for getting us as far as we are today!!!! OECD WPMN is about co-operating on the (regulatory) science, developing common (regulatory) scientific understanding, using the well established “learning by doing” approach OECD WPMN is about co-operating on the (regulatory) science, developing common (regulatory) scientific understanding, using the well established “learning by doing” approach

11. 3. OECD WPMN – what’s next SG 4: Manufactured Nanomaterials and Test Guidelines SG 3: Testing a Representative Set of Manufactured Nanomaterials SG 1/2: Database and Research Strategy(ies) on Human Health and Environmental Safety Research SG 7: The Role of Alternative Methods in Nanotoxicology SG 6: Co-operation on Risk Assessment SG 8: Exposure Measurement and Exposure Mitigation SG 5: Co-operation on Voluntary Schemes and Regulatory Programmes

12. 3. OECD WPMN – what’s next SG 6: Co-operation on Risk Assessment SG 5: Co-operation on Voluntary Schemes and Regulatory Programmes Sub-groups who ’ s work provides a platform for co- ordinated (or not conflicting) authority action (regulatory or voluntary), but where different approaches are currently applied for chemicals in general in OECD countries

13. 3. OECD WPMN – what’s next SG 4: Manufactured Nanomaterials and Test Guidelines SG 3: Testing a Representative Set of Manufactured Nanomaterials SG 8: Exposure Measurement and Exposure Mitigation Sub-groups who ’ s work provides the fundament for co- ordinated (or not conflicting) authority/industry action (regulatory or voluntary)

14. 3. OECD WPMN – what’s next SG 4: Manufactured Nanomaterials and Test Guidelines SG 3: Testing a Representative Set of Manufactured Nanomaterials SG 8: Exposure Measurement and Exposure Mitigation Will finish Stage 1 exploratory testing between 2010 and 2011 Will finish phase 1 (occupational) in the medium term Will finish evaluation of changes needed between 2010 and 2011

15. 4. EU Legislation – what’s next Current legislation covers in principle the relevant risks relating to nanomaterials. Current legislation covers in principle the relevant risks relating to nanomaterials. In action, European Parliament have followed this line in the recent co-decision process for Novel Foods and Cosmetics legislation, but nano-safety specific requirements have been introduced In action, European Parliament have followed this line in the recent co-decision process for Novel Foods and Cosmetics legislation, but nano-safety specific requirements have been introduced

16. 4. EU Legislation – REACH REACH is based on the principle that M/I and DUs have to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. REACH is based on the principle that M/I and DUs have to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. REACH requirements apply to nanomaterials, even though there are no specific provisions for nanomaterials. REACH requirements apply to nanomaterials, even though there are no specific provisions for nanomaterials.

17. 4. EU Legislation – REACH Definitions: Definitions: Nanomaterial Nanomaterial Substance at the nanoscale Substance at the nanoscale Nano form vs. bulk form Nano form vs. bulk form Scope includes also e.g. agglomerates and aggregates below/at micro size Scope includes also e.g. agglomerates and aggregates below/at micro size

18. 4. EU Legislation – REACH Registration of substances manufactured/ imported in volumes of 1 tonne or more per year Registration of substances manufactured/ imported in volumes of 1 tonne or more per year Chemicals Safety Report required at volumes of 10 tonne or more per year Chemicals Safety Report required at volumes of 10 tonne or more per year Tonnage triggers apply to the total volume Tonnage triggers apply to the total volume Safety has to be ensured for the substance in whatever size or form and for manufacturing and all identified uses. Safety has to be ensured for the substance in whatever size or form and for manufacturing and all identified uses. A registration has to include all relevant information on the nanomaterial. A registration has to include all relevant information on the nanomaterial.

19. 4. EU Legislation – CLaP Nanomaterials having specific properties may require a different classification and labelling compared to the bulk material, also when the nanoform is derived from a bulk substance Nanomaterials having specific properties may require a different classification and labelling compared to the bulk material, also when the nanoform is derived from a bulk substance Following CLP: Following CLP: the information shall relate to forms or physical states in which the substance is placed on market / used; the information shall relate to forms or physical states in which the substance is placed on market / used; tests shall be carried out on the substance in the form(s) or physical state(s) in which it is placed on the market and used. tests shall be carried out on the substance in the form(s) or physical state(s) in which it is placed on the market and used.

20. 4. EU Legislation – what’s next? We need to work on Substance Identification Substance identification of nanomaterials takes place on the basis of: - ‘traditional’ parameters, i.e. name of the substance, information re molecular and structural formula, composition of the subst - refinement based on specific parameters characterizing the nanomaterial - properties of the substance allowing for meaningful sharing of data Build on OECD WPMN work!

21. 4. EU Legislation – what’s next? We need to work on Chemical Safety Assessment Guidance on Information requirements and Chemical Safety Assessment (IR-CSA TGD) is available from ECHA; Guidance on Information requirements and Chemical Safety Assessment (IR-CSA TGD) is available from ECHA; The guidance does not yet address specific characteristics of nanomaterials; The guidance does not yet address specific characteristics of nanomaterials; The same assessment principles apply, but guidance needs further work for use on nanomaterials. The same assessment principles apply, but guidance needs further work for use on nanomaterials. SCENIHR opinion provides critical analysis Build on OECD WPMN work!

22. 4. EU Legislation – what’s next? We need to work on Test Guidelines In order to address the specific properties, hazards and risks associated with nanomaterials, additional testing or information may be required. In order to address the specific properties, hazards and risks associated with nanomaterials, additional testing or information may be required. To determine specific hazards associated with nanomaterials, current test guidelines may need to be modified. Until specific test guidelines for nanomaterials exist, testing will have to be carried out according to already existing guidelines. To determine specific hazards associated with nanomaterials, current test guidelines may need to be modified. Until specific test guidelines for nanomaterials exist, testing will have to be carried out according to already existing guidelines. Build on OECD WPMN work!

23. 4. EU Legislation – what’s next? EP Resolution (up for adoption/rejection today): 3.Does not agree, before an appropriate evaluation of current Community legislation, and in the absence of any nano-specific provisions therein, with the Commission's conclusions that a) current legislation covers in principle the relevant risks relating to nanomaterials, and b) that the protection of health, safety and the environment needs mostly be enhanced by improving implementation of current legislation, when due to the lack of appropriate data and methods to assess the risks relating to nanomaterials it is effectively unable to address their risks;

24. 4. EU Legislation – what’s next? EP Resolution (up for adoption/rejection today): 3.Does not agree, before an appropriate evaluation of current Community legislation, and in the absence of any nano-specific provisions therein, with the Commission's conclusions that a) current legislation covers in principle the relevant risks relating to nanomaterials, and b) that the protection of health, safety and the environment needs mostly be enhanced by improving implementation of current legislation, when due to the lack of appropriate data and methods to assess the risks relating to nanomaterials it is effectively unable to address their risks;

25. 5. Conclusions The European Parliament is of the view that the time for policy action (regulatory) has come The European Parliament is of the view that the time for policy action (regulatory) has come The Commission will carefully examine the suggestions made by the European Parliament The Commission will carefully examine the suggestions made by the European Parliament The OECD WPMN is central to inform this discussion in a (internationally) coherent way The OECD WPMN is central to inform this discussion in a (internationally) coherent way Many scientific gaps still exist and need to be addressed, but this will take time Many scientific gaps still exist and need to be addressed, but this will take time The situation of having policy needs which can not (yet) be answered by science is not new The situation of having policy needs which can not (yet) be answered by science is not new If the policy needs increase, then further stepping up of efforts on the (regulatory) science basis will prove the more essential If the policy needs increase, then further stepping up of efforts on the (regulatory) science basis will prove the more essential