Background Document to the Opinions on the Annex XV Dossier Proposing Restrictions on Mercury in Measuring Devices
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BACKGROUND DOCUMENT TO RAC AND SEAC OPINIONS ON MERCURY IN MEASURING DEVICES Committee for Risk Assessment (RAC) Committee for Socio-economic Analysis (SEAC) Background document to the opinions on the Annex XV dossier proposing restrictions on Mercury in measuring devices ECHA/RAC/ RES-O-0000001363-81-02/F ECHA/SEAC/ RES-O-0000001363-81-03/S1 Mercury EC number: 231-106-7 CAS number: 7439-97-6 This Background Document (BD) shall be regarded as further reference material to the opinions of the Committees for Risk Assessment and Socio-economic Analysis. It contains further details and assessment in addition/beyond the justifications provided in the opinions including, where relevant, information that has been received during the opinion making process and may be used to better understand the opinions and their justifications. The BD is a supporting document based on the Annex XV restriction report submitted by MS, and updated to support the opinions of the Committees . 15 September 2011 i Preface The existing restriction in Entry 18a of Annex XVII to the REACH Regulation on mercury in measuring devices includes a review clause. According to the clause, the Commission was to carry out a review of the availability of reliable safer alternatives that are technically and economically feasible for mercury containing measuring devices and where such alternatives are available present, if appropriate, a proposal to extent the existing restriction. The Commission sent its review report to ECHA on 20 November 2009 and requested ECHA to prepare a corresponding Annex XV restriction report. This Background Document (BD) concerns the industrial and professional uses of mercury in measuring devices as the existing entry in Annex XVII already restricts the placing on the market of mercury containing measuring devices for general public. The following measuring devices are covered: • Barometers • Manometers (including tensiometers) • Metering devices for the determination of softening point • Mercury electrodes (used in voltammetry) • Mercury probes used for capacitance-voltage determinations • Porosimeters • Pycnometers • Sphygmomanometers • Strain gauges (used with plethysmographs) • Thermometers (including hygrometers) Barometers, manometers, sphygmomanometers and strain gauges are used to measure pressure and thermometers temperature. Porosimeters, pycnometers and metering devices for determination of softening point measure different parameters related to the structure and porosity of a sample. Mercury electrodes are used with specific devices like polarographs, for instance to determine trace elements in the environment and in biological fluids. Mercury probes are used to measure several parameters related to the purity of the material such as permittivity, doping, oxide charge and dielectric strength. Barometers, manometers, sphygmomanometers, strain gauges and thermometers contain mercury as an integral part of the device whereas metering devices (for determination of softening point), mercury probes (for capacitance-voltage determinations), polarographs (using mercury electrodes), porosimeters and pycnometers use mercury during the measurement. This difference has an effect on the assessment of the devices as will be described later in this report. The devices included in the BD are also significantly different with regard to other factors, such as number of devices in the EU, the amount of mercury involved, the type of users (private practitioners, laboratories and research institutions, meteorological stations, airfields, ships, different industries etc), and reasons for the continued use. The main focus of this document is on the assessment of the technical and economic feasibility of alternatives for the mercury devices. This emphasis on possibilities to transfer to alternatives stems from the review clause in the existing restriction. ii Furthermore, extensive amount of work has already been carried out on the hazard properties, fate, emissions of and exposures to mercury at international, EU and national levels and there is a wide agreement on the human health and the environmental concerns related to mercury and on the need for further actions where technically and economically possible. Based on this, the hazard profile is discussed only briefly. Furthermore, a qualitative approach is taken to the emission and exposure assessment. The approach taken to describe the hazard, emissions and exposure in this report is presented and justified in Section B.2. Based on this approach taken, Part B of the BD deviates from the standard format for an Annex XV restriction report, as published by ECHA (2009). Furthermore, the number and different nature of the devices covered in this BD have led to the development of device specific annexes that discuss the following information: • Technical description of the device • Description of release and exposure • Available information on the alternatives (Part C) • Justification why the proposed restriction is the most appropriate Community- wide measure (Part E). Consequently, Part E in the main document is in practise a summary of the proposed restrictions and provides a short justification for proposed actions / non-actions on different devices while Part C in the main document is reduced to a general introduction. The main information source used for the assessments of the technical and economic feasibility of alternatives to mercury measuring devices is Lassen et al. (2008). This report called “ Options for reducing mercury use in products and applications, and the fate of mercury already circulating in society” was commissioned by the European Commission (DG Environment). Lassen et al. (2008) and other information sources have an extensive amount of data on mercury in measuring devices, but still there were some data gaps for the remaining specific uses. Therefore, ECHA complemented this information by commissioning a consultant for the preparation of this restriction report. The results from the additional work are referred to as Lassen et al. (2010) in this report and can be found as Appendix 3. In addition, ECHA staff carried out literature and internet searches. These are reported in the relevant sections as well as in Appendix 2. To keep the workload proportionate, the efforts were targeted to gather data that could support the conclusion as to whether technically and economically feasible alternatives exist. iii BACKGROUND DOCUMENT TO RAC AND SEAC OPINIONS ON MERCURY IN MEASURING DEVICES Content Preface ...................................................................................................................... ii Content .................................................................................................................... iv A. Proposal................................................................................................................ 1 A.1 Proposed restriction(s) ........................................................................................ 1 A.1.1 The identity of the substance(s)................................................................ 1 A.1.2 Scope and conditions of restriction(s)....................................................... 1 A.2 Summary of the justification............................................................................... 3 B. Information on hazard and risk.............................................................................. 6 B.1 Name and other identifiers of the substance ........................................................ 6 B.2 Scope and approach ............................................................................................ 6 B.3 General description of hazard and fate .............................................................. 14 B.4 General qualitative description of potential release and exposure ...................... 18 B.4.1 Mercury emissions from measuring devices containing mercury ............ 19 B.4.2 Mercury emissions from measuring devices using mercury .................... 25 B.5 Summary of existing legal requirements and their effectiveness........................ 26 B.6 Summary of hazard and risk.............................................................................. 32 C. Available information on the alternatives............................................................ 34 C.1 Identification of potential alternative substances and techniques ....................... 34 C.2 Human health and environment risks related to alternatives .............................. 34 C.2.1. Measuring devices containing mercury -Comparison of risks posed by mercury devices and their alternatives ............................................................. 34 C.2.2 Measuring devices using mercury........................................................... 39 C.3 Technical feasibility of alternatives................................................................... 39 C.4 Economic feasibility ......................................................................................... 40 D. Justification for action on a Community-wide basis ............................................ 41 D.1 Considerations related to human health and environmental risks....................... 41 D.2 Considerations related to internal market .......................................................... 41 D.3 Other considerations ......................................................................................... 42 D.4 Summary.........................................................................................................