【国外标准】 Standard Guide for Analytical Testing of Substances of Very High Concern in Materials and Products

5.1 The REACH Candidate list classifies substances as SVHCs thus making them subject to possible authorization. Compliance to the REACH regulation requires that any identified SVHC be present at a concentration of less than 0.1 % (w/w) of the total article weight to avoid triggering a reporting obligation. This guide is intended to assist in the identification of available test methods for quantitative analysis of the substance(s) of interest.5.2 When possible, industry accepted standard test methods are cited. However, industry vetted test methods are not available for all of the substances contained in the REACH Candidate List. Thus, some caution and due diligence must be exercised when applying some of the methods listed in this guide.5.3 In some cases, test methods for the identification and quantification of a specific substance are not available. An example would include CoCl2. Methods currently in practice involve the individual determination of Co and Cl concentrations and use other sources of information or chemical judgment to assign the expected CoCl2 concentration. This approach obviously has its limitations and pitfalls and must be used judiciously.5.4 Under the REACH regulation, EU manufacturers, importers or distributors of articles containing more than 0.1 % (w/w) of a substance that the Agency has listed as being an SVHC shall provide their customers with the name of the substance and information allowing the safe use of the article. Producers and distributors of articles containing SVHC shall also supply the same information to consumers, upon request. In situations where this information is not readily available from the supply chain it is incumbent upon the supplier to collect this information through actual chemical analysis or other means. This guide is intended to assist in the selection of appropriate test methods in the event that chemical analysis is required.1.1 This guide contains a list of potential test methods for the analysis of Substances of Very High Concern (SVHC) as designated by ECHA, the European Chemicals Agency. Information on the test methods cited is publicly available and is drawn from a variety of sources. The guide is intended to assist in the selection of test methods that are applicable for the SVHCs identified.1.2 The specific SVHCs covered within this guide are compiled from the ECHA Candidate List of Substances of Very High Concern. This list is also referred to as the REACH Candidate List.1.3 This guide specifically addresses methods for the analysis of SVHCs in products. It is not intended to cover the many and varied analysis challenges associated in the manufacturing environment.1.4 Limitations: 1.4.1 This guide is intended to provide a compilation of available test methods for the SVHCs listed on the ECHA Candidate list and is not intended to be exhaustive. The test methods within this guide are not the only ones available for any specific substances and this guide does not recommend any specific test method.1.4.2 Test methods for specific substances at the detection limits required for REACH reporting are not always available. In some cases, it is necessary to deduce the quantity of substance present through the analysis and quantification of its elements. Although this approach is routinely used some degree of uncertainty exists in the final result due to the reduced specificity of the test method.1.4.3 Although this guide is intended to be updated on a periodic basis to capture new developments in the field, there is no assurance that the information provided is the most current.1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.