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Standard Guide for Analytical Testing of Substances of Very High Concern in Materials and Products 材料和产品高度关注物质分析测试标准指南
发布日期: 2019-12-01
1.1 本指南包含欧洲化学品管理局(ECHA)指定的用于分析高度关注物质(SVHC)的潜在测试方法列表。有关所引用试验方法的信息是公开的,并且来自各种来源。本指南旨在帮助选择适用于已识别SVHC的测试方法。 1.2 本指南中涵盖的特定SVHC来自ECHA高度关注物质候选清单。该列表也称为REACH候选列表。 1.3 本指南具体介绍了产品中SVHC的分析方法。它不打算涵盖制造环境中相关的多种多样的分析挑战。 1.4 限制: 1.4.1 本指南旨在为ECHA候选名单上列出的SVHC提供可用测试方法的汇编,并非详尽无遗。本指南中的测试方法不是任何特定物质的唯一可用方法,本指南不推荐任何特定测试方法。 1.4.2 REACH报告所需检测限下的特定物质的测试方法并不总是可用。在某些情况下,有必要通过对其元素的分析和量化来推断存在的物质的数量。尽管通常使用这种方法,但由于测试方法的特异性降低,最终结果中存在一定程度的不确定性。 1.4.3 虽然本指南旨在定期更新,以捕捉该领域的新发展,但无法保证提供的信息是最新的。 1.5 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.6 本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的用户有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 REACH候选名单将物质分类为SVHC,因此使其受到可能的授权。遵守REACH法规要求任何已识别的SVHC的浓度低于物品总重量的0.1%(w/w),以避免触发报告义务。本指南旨在帮助确定有关物质定量分析的可用测试方法。 5.2 如果可能,引用行业公认的标准测试方法。然而,REACH候选列表中所含的所有物质都没有经过行业审查的测试方法。因此,在应用本指南中列出的某些方法时,必须谨慎行事。 5.3 在某些情况下,无法使用特定物质的识别和量化测试方法。例如CoCl 2. . 目前实践中的方法涉及单独测定Co和Cl浓度,并使用其他信息来源或化学判断来分配预期CoCl 2. 浓度这种方法显然有其局限性和缺陷,必须谨慎使用。 5.4 根据REACH法规,欧盟制造商、进口商或经销商的物品中含有超过0.1%(w/w)的物质,该机构已列为SVHC,应向其客户提供该物质的名称和允许安全使用该物品的信息。 含有SVHC的物品的生产商和经销商也应根据要求向消费者提供相同的信息。在供应链无法提供此类信息的情况下,供应商有义务通过实际化学分析或其他方式收集此类信息。本指南旨在帮助在需要化学分析的情况下选择适当的测试方法。
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. ====== Significance And Use ====== 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 CoCl 2 . 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 CoCl 2 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.
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