Support for 3rd regulatory review on nanomaterials – environmental legislation Ricardo Energy & Environment, Milieu Consulting and Danish Technical University October 2016 Support for 3rd regulatory review on nanomaterials – environmental legislation Europe Direct is a service to help you find answers to your questions about the European Union. Freephone number (*): 00 800 6 7 8 9 10 11 (*) The information given is free, as are most calls (though some operators, phone boxes or hotels may charge you). LEGAL NOTICE This document has been prepared for the European Commission however it reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. More information on the European Union is available on the Internet (http://www.europa.eu). Luxembourg: Publications Office of the European Union, 2016 ISBN 978-92-79-63779-7 doi:10.2779/49879 © European Union, 2016 Image © Shutterstock.com EUROPEAN COMMISSION Support for 3rd regulatory review on nanomaterials – environmental legislation Directorate-General for Environment Sustainable Chemicals 2016 EUROPEAN COMMISSION Directorate-General for Environment Directorate B— Circular Economy and Green Growth Unit B.2 Contact: Andrej Kobe E-mail: [email protected] European Commission B-1049 Brussels Support for 3rd regulatory review on nanomaterials – environmental legislation Project Report ___________________________________________________ Report for European Commission DG Environment ENV.A.3/ETU/2015/0030 ED 61552_Final Report | Issue Number 3 | Date 22/11/2016 Ricardo in Confidence Ricardo Energy & Environment Support for 3rd regulatory review on nanomaterials: Project Report | i Customer: Contact: European Commission Dr Mark Broomfield Ricardo Energy & Environment Customer reference: Gemini Building, Harwell, Didcot, OX11 0QR, United Kingdom ENV.A.3/ETU/2015/0030 Confidentiality, copyright & reproduction: t: +44 (0) 1235 75 3493 This report is the Copyright of the European e: [email protected] Commission. It has been prepared by Ricardo Energy & Environment, a trading name of Ricardo-AEA Ltd is certificated to ISO9001 and Ricardo-AEA Ltd, under contract to The ISO14001 European Commission dated 11/11/2015. The contents of this report may not be reproduced in Author: whole or in part, nor passed to any organisation Mark Broomfield, Steffen Foss Hansen and or person without the specific prior written Florent Pelsy permission of the European Commission. Ricardo Energy & Environment accepts no liability Approved by: whatsoever to any third party for any loss or damage arising from any interpretation or use of Ben Grebot the information contained in this report, or reliance on any views expressed therein. Date: 22 November 2016 Ricardo Energy & Environment reference: Ref: ED61552_Final Report- Issue Number 3 Ricardo in Confidence Ref: Ricardo/ED61552_Final Report/Issue Number 3 Ricardo Energy & Environment Support for 3rd regulatory review on nanomaterials: Project Report | ii Executive summary This report Ricardo Energy & Environment, in partnership with subcontractors Milieu Consulting and the Technical University of Denmark (DTU), was commissioned by the European Commission to carry out a project entitled “The preparation of the third regulatory review on nanomaterials - environmental legislation”, specific contract number 070201/ENV/2015/SI2.716613/ENV.A3, Commission reference ENV.C.3/ETU/2015/0030. The study objective was to compile and develop information on nanomaterials and advanced materials in the environment and explore further the regulatory implementation challenges. The study had three main components: A preliminary evaluation of releases of nanomaterials to different media (air, water, land, recycling and waste disposal). A review of progress on the application of environmental and other key legislation to nanomaterials. A prospective view on future developments in advanced materials, and challenges for environmental legislation. Consultation with stakeholders was carried out by email and telephone, and a stakeholder workshop was held on 21 June 2016. At the workshop, the interim findings were presented, and stakeholder feedback and views were discussed. Following the workshop, stakeholders provided feedback in writing. This feedback has been taken into account for the finalisation of the report. Nanomaterials release inventory A prioritised qualitative release inventory for nanomaterials was developed. This was based principally on data from the French registry of nanomaterial production and importation. The first step was to develop indicative production profiles for nanomaterials for the period 2000 to 2035. The profiles were designed to represent the evolution in production of manufactured nanomaterials over time. The uses of each material in the French registry with a quantified production and import quantity were then analysed – a total of 188 materials. Uses of each nanomaterial were classified into 10 separate categories. The next step was to estimate indicative profiles for release of nanomaterials to the environment during manufacture, use and disposal. These indicative release profiles were based on published emission factors or other relevant data where available. In cases where there were no published emission factors, emission factors were estimated using the project team’s best judgment. Applying the manufacturing and usage release factors over the product lifetimes enabled estimates to be made of the quantities of each of the 188 materials released to each of the five media (air, land, water, recycling, waste disposal) in 2015, 2025 and 2035 across Europe. The numerical release estimates were considered to be highly uncertain in view of the number of assumptions used to reach the indicative inventory. Consequently, the releases to each medium were described qualitatively as “high”, “medium”, “low” and “zero.” This initial evaluation makes no reference to the potential toxicity of the nanomaterials listed in the French registry. The following nanomaterials listed in the French registry were identified as having a potentially “high” release to one or more medium. Substances listed as nanomaterials in French registry CAS Number EC Number Aluminium oxide 1344-28-1 215-691-6 Boehmite (Al(OH)O) 1318-23-6 215-284-3 Calcium carbonate 471-34-1 207-439-9 Mixture of ceria and zirconia 53169-24-7 Silicon dioxide, or variations of 7631-86-9 231-545-4 Titanium dioxide 13463-67-7 236-675-5 Zinc oxide 1314-13-2 215-222-5 Carbon black 1333-86-4 215-609-9 Ricardo in Confidence Ref: Ricardo/ED61552_Final Report/Issue Number 3 Ricardo Energy & Environment Support for 3rd regulatory review on nanomaterials: Project Report | iii Substances listed as nanomaterials in French registry CAS Number EC Number Copolymer of vinylidene chloride 9002-86-2 Polyvinyl chloride 9002-86-2 Fuller's earth 8031-18-3 Kaolin 1332-58-7 8031-18-3 Silicic acid, aluminium sodium salt 1344-00-9 215-684-8 Silicic acid, magnesium salt 1343-88-0 215-681-1 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3- 5102-83-0 225-822-9 oxobutyramide] 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)- 5567-15-7 226-939-8 3-oxobutyramide] 3,6-bis-biphenyl-4-yl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione 413-920-6 3,6-diphenyl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione 54660-00-3 601-713-5 Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate 7023-61-2 230-303-5 Clindamycin hydrochloride 21462-39-5 244-398-6 Cerium oxide isostearate Cerium and iron oxide isostearate Iron oxide isostearate Lactose 63-42-3 200-559-2 The substances identified as having a potentially “high” release for one or more pathways were prioritised primarily by consideration of evidence for their potential effects on health, in the absence of systematic information in relation to the potential environmental effects of nanomaterials. The available evidence is insufficient to support the view that the toxicity of a given material increases from larger scale particles to smaller scale particles. There is insufficient evidence in practice to support the view that the toxicity of a given material increases from larger scale particles to smaller scale particles. Nano scale particles of any poorly soluble material could potentially pose a health hazard: however, the nature and scale of any such hazard is likely to depend on the extent of any such exposure and the exposure pathway (e.g. inhalation; dermal contact; dietary exposure). For a subset of 12 nanomaterials from the French registry, further assessment was undertaken and a preliminary estimate of production and release quantities for 2015, 2025 and 2035 was developed. These estimates are subject to an indicative uncertainty factor of 7, due to the assumptions inherent in carrying out generic calculations based on a limited dataset. The preliminary estimate of production and release quantities of prioritised nanomaterials in Europe for 2015 is as follows: Estimated quantity Preliminary release inventory (2015), tonnes produced/ imported (estimated uncertainty factor of 7) Chemical name (Europe 2015), tonnes Air Land Water Recycling Waste Aluminium oxide 16,000 9.0 4.8 19 3522 5921 Mixture of ceria and zirconia 2,300 1.2 0.32 1.3 381 658 Silicon dioxide, or variations of 22,000 119 128 27 3312 6254 spherical silica nanoparticles; silica nanotubes, silica films Titanium dioxide 92,000 183 340 140