NANOFORCE Nanotechnology for Chemical enterprises – how to link scientific knowledge to the business in the Central Europe REGULATION AND SAFETY IMPLEMENTATION OF NANOTECHNOLOGY FOR CHEMICAL ENTERPRISES IN THE CENTRAL EUROPE SPACE A. Falk1, S. Hartl1, F. Sinner1,2 1 BioNanoNet Forschungsgesellschaft mbH, Graz, Austria JOANNEUM RESEARCH- HEALTH, Graz, Austria Contact: [email protected] Tel.: +43 (0)664 602 876 2115 2 Co-Financed by: Agenda Why are we speaking about nanomaterials and safety? Why Central Europe Region? What are we speaking about? Which regulations already exist and which needs are still there (identified within NANOFORCE-project)? Some (Austrian) efforts to ensure success of nanotechnological developments This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. http://www.nsf.gov/crssprgm/nano/reports/NNI_11-1031_Roco_AVS_NanoManu_62sl.pdf This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. Nanotechnology – potential market segments This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. Source: Allianz; AT Kearney; DIGITIP; Helmut Kaiser Consultancy; ISTAT; Lux Research; NANOFORCE; Nanoposts; Nanotechwire; OECD; SEMI Why Central Europe Region? This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. Why Central Europe Region? This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. NANOFORCE-consortium LP SC - Sviluppo Chimica spa (IT) PP2 Veneto Nanotech S.C.p.A. (IT) PP3 Association of Chemical Industry of the Czech Republic – SCHP (CZ) PP4 Chemie Cluster Bayern (DE) PP5 Polish Chamber Of Chemical Industry - PIPC (PL) PP6 University of Nova Gorica (SI) PP7 BioNanoNet Forschungs GmbH (AT) PP8 Association of Chemical & Pharmaceutical Industry of the Slovak Republic (SK) PP9 Institute of High Pressure Physics, Polish Academy of Sciences (PL) www.nanoforceproject.eu This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. Concerns on Nanosafety • Potential for human toxicity • Lack of knowledge (transfer) • Put the development of nanotechnology in Europe at risk Needs • • • • Enable safe implementation of nanotechnologies Assess potential risks for humans in a transparent manner Assure proper dissemination of reviewed nano-safety knowledge Setting up of an international (communication) framework (science&research/authorities/market) based on “high quality science” This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. What we are speaking about… Definition (ref. EC): • 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 from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:EN:PDF This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. Definition of nanomaterial • The definition will be used to identify materials for which special provisions might apply (e.g. for risk assessment or ingredient labelling) • The safety assessment of the substances must be done on a caseby-case basis • Only the results of the risk assessment will determine whether the nanomaterial is hazardous and whether or not further action is justified • Definition is intended to be used by Member States, European Union and companies • Provisions will be adapted in order to ensure a consistent approach • Review of the definition by the European Commission in 2014 This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. 2nd Regulatory Review on Nanomaterials Some aspects… – current legislation covers in principle the relevant risks relating to nano-materials, and – 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 This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. Chemicals - REACH (1/2) REACH - Registration, Evaluation, Authorisation and Restriction of Chemical substances • Main Aim: “… to produce fewer industrial chemicals, to understand the possible human and ecological hazards of those that are produced, and to insure that any major threat is anticipated, as well as prevented…” • Broadest coverage of nanomaterials of any European legislation This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. Chemicals – REACH (2/2) • Commission remains convinced that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures but… • …more specific requirements for nanomaterials within the framework have proven necessary • …Commission envisages modifications in some of the REACH Annexes • ...encourages ECHA to further develop guidance for registrations after 2013 Source: http://ec.europa.eu/nanotechnology/pdf/second_regulatory_review_on_nanomaterials_-_com(2012)_572.pdf This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. EU regulations with relevance for nanomaterials (1/4) • Cosmetics – • Food – • Regulation (EC) No. 1333/2008 of the European Parliament and of the Council on Food additives Biocidal material – • Commission Regulation (EU) No. 10/2011 on plastics materials and articles intended to come into contact with food Food additives – • Regulation (EU) No. 1169/2011 of the European Parliament and the Council on the provision of food information to consumers … Food contact materials – • Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products Regulation (EU) No. 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products Restriction of hazardous substances in electrical and electronic equipment – Directive 2001/65/EU of the European Parliament and of the Council on the restriction of the use of … hazardous substances in electrical & electronic equipment This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. EU regulations with relevance for nanomaterials (2/4) • Cosmetics (Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products) cosmetic products containing nanomaterials have to be notified to the Commission need of a "a catalogue of all nanomaterials used in cosmetic products placed on the market, including colorants, preservatives and UV filters” labelling obligations to “list the relevant materials with the word 'nano' in brackets" • Food (Regulation (EU) No. 1169/2011 of the European Parliament and the Council on the provision of food information to consumers) clearly indicating the nanomaterial in the list of ingredients and labelling such ingredient with the word ‘nano’ in brackets This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. EU regulations with relevance for nanomaterials (3/4) • Food contact materials (Commission Regulation (EU) No. 10/2011 on plastics materials and articles intended to come into contact with food) nanoparticles used in food contact materials only be used prior to an explicit authorization • Food additives (Regulation (EC) No. 1333/2008 of the European Parliament and of the Council on Food additives) additives produced by new methods (nanotechnology) leading to alterations in particle size need to be considered as different agents requiring a new entry in the community list or change in the specification prior to market placement This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. EU regulations with relevance for nanomaterials (4/4) • Biocidal material (Regulation (EU) No. 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products) labelling of the product with ‘nano’ in brackets Sept. 2015 Member States have to report to the Commission the correct implementation of the regulation (providing information on the use of nanomaterials in biocidal products including risks) • Restriction of hazardous substances in electrical and electronic equipment (Directive 2001/65/EU of the European Parliament and of the Council on the restriction of the use of … hazardous substances in electrical & electronic equipment) precautionary principle, EEE produced with or using nanotechnology and nanomaterials have to be notified to the Commission substituted by environmentally friendly alternatives to ensure the safe use This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. Summary - Regulatory Needs • simplified registration for nanomaterials manufactured or imported < 1 tonne/year • reporting requirements for all nanomaterials on the market • harmonized labeling of nanomaterials • safety reports with exposure assessment for registered nanomaterials • Adoption of the precautionary principle at all levels of the production cycle – business infrastructure, human resource management, technology development and procurement, inbound logistics, production, outbound logistics, marketing & sales and customer service) • Waste management and recycling schemes-LCA (Life Cycle Assessment) • Communication… This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. EURO-NANOTOX – Austrian hub in Nanotox • Consolidation of knowledge • Standardization of nanotox. Methods and strategies • Critically review of results EURO-NanoTox was founded and serves as Austrian national research hub to: pool nanotoxic expertise in Austria standardize nanotoxic methods in Austria This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. NANOFORCE & EURO-NANOTOX international service hub for nanotechnology – expertise database nanotechnology responsible management tangible sources for nanotechnology & nanotoxioclogy data transfer – communication and dissemination development of standardized testing and evaluation methods safety data sheets and exposure scenarios information pool for governmental bodies – recommendations on safe use of nanotechnology to the European Commission This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. EURO-NANOTOX - Activities international cooperation in research projects European Center for Nanotoxicology Standardized nano-toxic methods helping to establish international standards ONLINE-Journal www.euro-nanotox-letters.com provision of centralized nanotoxicology scientific information with emphasis on human toxicology comparative studies and interlaboratory tests This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. BioNanoNet Your Key to the Austrian Research Community focus areas: 1) 2) 3) 4) nanotoxicology – EURO-NanoTox, NANOFORCE nanomedicine – EHS, nano-health sensor technologies – Medical Sensor Solutions regulatory expertise, communication and management – NANoREG, SPIDIMAN offers scientific expertise and … • regulatory aspects of nanotechnology • coordination, management, communication and dissemination activities This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. Conclusion Findings of the project NANOFORCE • significant needs in standardization of the regulatory body for nanomaterials • better implementation and development of simple and standardized testing methods • a uniform data collection, • harmonization tools for a better knowledge dissemination and transparency for data to be available for stakeholders This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. Thank You … Sonja Hartl, Frank Sinner And to the BioNanoNet-team: Gabriele Katz, Patricia Junk, Birgit Krassnitzer, Nikolaus Ladenhauf, Simone Jagersbacher-Uhl This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF. picture © piCHEM www.bionanonet.at Contact: [email protected] Tel.: +43 (0) 664 602 876 2115 Join us on facebook: www.facebook.com/bionanonet This project is implemented through the CENTRAL EUROPE Programme co-financed by the ERDF.