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RIVM Report 601780003 Nanomaterials Under REACH

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RIVM Report 601780003 Nanomaterials Under REACH Report 601780003/2009 M.E.J. Pronk et al. Nanomaterials under REACH Nanosilver as a case study RIVM report 601780003/2009 Nanomaterials under REACH Nanosilver as a case study M.E.J. Pronk, Centre for Substances and Integrated Risk Assessment, RIVM S.W.P. Wijnhoven, Centre for Substances and Integrated Risk Assessment, RIVM E.A.J. Bleeker, Expertise Centre for Substances, RIVM E.H.W. Heugens, Expertise Centre for Substances, RIVM W.J.G.M. Peijnenburg, Laboratory for Ecological Risk Assessment, RIVM R. Luttik, Expertise Centre for Substances, RIVM B.C. Hakkert, Bureau REACH, Expertise Centre for Risk Assessment, RIVM Contact: B.C. Hakkert Bureau REACH, Expertise Centre for Substances, RIVM [email protected] This investigation has been performed by order and for the account of VROM, within the framework of REACH project number M/601780. RIVM, P.O. Box 1, 3720 BA Bilthoven, the Netherlands Tel +31 30 274 91 11 www.rivm.nl © RIVM 2009 Parts of this publication may be reproduced, provided acknowledgement is given to the 'National Institute for Public Health and the Environment', along with the title and year of publication. 2 RIVM report 601780003 Abstract Nanomaterials under REACH Nanosilver as a case study Some adjustments are needed in the European chemicals legislation REACH to assess and control the risks of nanomaterials. The information on substances to be provided under REACH is not sufficient to determine the specific properties of nanomaterials, nor to assess how these properties affect their behaviour and effects in humans and the environment. RIVM concluded this following research into the suitability of REACH for nanomaterials. RIVM therefore proposes an adapted set of minimum information requirements, to be applied to all nanomaterials to be registered under REACH, independent of their volume of production and import. These requirements allow a risk assessment of nanomaterials. Over the last years the use of nanomaterials has strongly increased. As yet, nanomaterials are defined as substances of which the discrete parts have at least one dimension smaller than one hundred nanometres. Due to their nanosize they have specific properties. Legislation should focus on controlling the potential hazards and risks of these nanomaterials. By conducting a hypothetical registration of nanosilver it was investigated whether REACH is suitable for assessing the safe use of nanomaterials. From this it appeared that no definition of a nanomaterial is present, and that a relevant measure for expressing harmfulness and exposure is as yet not known. In addition, the standard information requirements are insufficient to assess hazard and exposure. They are also insufficient for a proper characterisation of the nanomaterial. Consequently, it cannot be determined to what extent the nanoform of a substance corresponds to the non-nanoform of the same substance. Furthermore, it is unclear whether current risk reduction measures and extrapolation methods in risk assessment, as established for non-nanomaterials, are applicable to nanomaterials. Key words: REACH, nanomaterials, nanosilver, risk assessment RIVM report 601780003 3 4 RIVM report 601780003 Rapport in het kort Nanomaterialen onder REACH Nanozilver als een voorbeeldstudie Om de risico’s van nanomaterialen te kunnen inschatten en beheersen, zijn enkele aanpassingen nodig in de Europese chemicaliënwetgeving REACH. De gegevens over stoffen waar REACH standaard om vraagt, zijn namelijk onvoldoende om de specifieke eigenschappen van nanomaterialen te bepalen. Hetzelfde geldt voor het bepalen van de invloed van deze eigenschappen op het gedrag en de effecten van nanomaterialen in mens en milieu. Dit blijkt uit onderzoek van RIVM naar de geschiktheid van REACH voor nanomaterialen. Het instituut stelt daarom een aangepaste set minimum informatievereisten voor, voor alle te registreren nanomaterialen onder REACH, ongeacht de omvang van productie en import. Deze vereisten maken het mogelijk de risico’s van nanomaterialen te beoordelen. Het gebruik van nanomaterialen neemt de laatste jaren sterk toe. Nanomaterialen worden vooralsnog gedefinieerd als stoffen waarvan de deeltjes minstens één dimensie kleiner dan honderd nanometer hebben. Vanwege hun afmeting hebben ze specifieke eigenschappen. Wetgeving moet erop gericht zijn de potentiële gevaren en risico’s van deze nanomaterialen te beheersen. Aan de hand van een hypothetische registratie van nanozilver is onderzocht of REACH geschikt is om een veilig gebruik van nanomaterialen vast te stellen. Hieruit bleek onder andere dat een definitie van nanomateriaal ontbreekt, en dat de juiste maateenheid om de schadelijkheid en blootstelling in uit te drukken nog niet bekend is. Ook is de verplichte standaardinformatie ontoereikend om de blootstelling en gevaren in te kunnen schatten, en om het nanomateriaal goed te kunnen karakteriseren. Mede door de laatste beperking is niet vast te stellen in hoeverre de nanovorm van een stof overeenkomt met de niet-nanovorm van dezelfde stof. Bovendien is het onduidelijk of de huidige extrapolatiemethoden in de risicobeoordeling en de maatregelen om risico’s te beheersen geschikt zijn voor nanomaterialen. Deze methoden en maatregelen zijn immers vastgesteld voor niet-nanomaterialen. Trefwoorden: REACH, nanomaterialen, nanozilver, risicobeoordeling RIVM report 601780003 5 6 RIVM report 601780003 Preface This report describes a hypothetical registration of nanosilver under the new EU REACH regulation on chemicals, taking into account the ongoing discussions within the REACH Competent Authorities and its Subgroup on Nanomaterials on how REACH applies to nanomaterials (as described in documents of this subgroup dated December 2008-March 2009). The case study on nanosilver is purely a scientific exercise, with the aim to generate recommendations for future policy guidance on how to deal with first generation nanomaterials under REACH. Given this, it is stressed that this report does not pretend to provide a complete overview of all available toxicity data on (nano)silver, and is as such not to be used for an actual registration under REACH. RIVM report 601780003 7 8 RIVM report 601780003 Contents Summary ........................................................................................................................................... 11 1 Introduction..................................................................................................................... 13 2 REACH and its requirements for registration ............................................................. 15 2.1 Gathering and generating information .............................................................................. 15 2.2 Substance identification .................................................................................................... 16 2.3 Classification and labelling............................................................................................... 16 2.4 Chemical Safety Assessment and Chemical Safety Report .............................................. 17 2.5 Exposure-related information............................................................................................ 17 3 General risk assessment issues for nanomaterials........................................................ 19 3.1 Introduction....................................................................................................................... 19 3.2 Suitability of current test guidelines for nanomaterials..................................................... 19 3.2.1 Physicochemical tests........................................................................................................ 19 3.2.2 Human health toxicity tests............................................................................................... 20 3.2.3 Ecotoxicity tests ................................................................................................................ 21 3.2.4 Additional OECD results .................................................................................................. 22 3.3 Currently proposed risk assessment approaches for nanomaterials .................................. 23 4 Nanosilver as a case study for registration under REACH......................................... 25 4.1 Substance identity and physicochemical properties.......................................................... 26 4.1.1 Information requirements and availability ........................................................................ 26 4.1.2 Summary of available data for substance identity and physicochemical properties ......... 26 4.1.3 Discussion on substance identity and physicochemical properties ................................... 27 4.2 Environmental hazard and exposure assessment............................................................... 29 4.2.1 Information requirements and availability ........................................................................ 29 4.2.2 Summary of available hazard data for environment.......................................................... 30 4.2.3 Summary of environmental exposure assessment............................................................. 31 4.2.4 Discussion on fate and behaviour and ecotoxicity ............................................................ 31 4.2.5 Additional information needs............................................................................................ 33 4.3 Human health hazard and exposure assessment...............................................................
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