1.1 本指南使用案例研究来说明在评估材料和产品是否符合相关要求时，评估材料和材料是否含有可申报物质的决策过程。这可以通过应用现有知识来确定进一步行动的需要（例如，测试）来实现。 1.2 本指南有助于利用和解释所收集的各种形式的信息，以确保遵守或遵守与已确定的可申报物质相关的法规、标准、供应协议或客户查询，包括发布不存在或存在可申报物质的声明所需的证据。参考了几个示例。目标申报物质将特定于产品和产品分类、监管辖区、客户/供应商要求以及其他相关考虑因素。 考虑哪些法规和标准适用于特定产品超出了本指南的范围。 1.3 本指南所涵盖的框架试图协调在缺乏客观数据或具体监管要求或两者兼有的情况下使用的语言。本指南借鉴了将被引用和参考的各种现有文件以及化学品危害和风险传播的基本科学原则，并可作为产品风险评估的一部分，用于评估产品及其成分的组成。 1.4 本指南适用于各种材料，包括聚合物和弹性体材料，这些材料用于受管制的行业和产品。 1.5 本标准并不旨在解决与其使用相关的所有安全问题（如有）。 本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《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====== 4.1 关于化学成分（“感兴趣物质”）合规性和合规性的法规、标准和市场定义的要求越来越多，越来越复杂。 特定的法律和标准可能适用于某些产品和行业领域，例如电气/电子仪器和组件、药品、医疗设备、消费品、农用化学品等。其他可能更广泛，具体涉及多个产品部门和来源的特定化合物或类别的评估和管理，例如参考文献 ( 2. ) 此外，此类要求可由国家当局、国际标准制定小组发布，或在市场定义要求的情况下，甚至由客户倡导组织或客户通过供应合同发布。由此产生的全球需求和市场准入预期是复杂的，合规性/合规性给制造商带来了许多挑战。 注1: 例如，IEC 62474:2012为电工行业的报告阈值和声明声明提供了一些标准化定义。在另一个例子中，ISO 14021:2016解决了自我声明的环境声明。 4.2 可申报物质可在各种清单和表格中找到，包括参考文献 ( 2- 10 ) 以及供应协议和调查表。本指南并非详尽无遗，也不涵盖所有可申报物质。本指南也不涉及这些法规和标准中的具体声明和标签要求，也不涉及法律规定的特定产品、行业或市场区域的产品安全和合规要求。 4.3 除了新的法律和标准，更多的化学物质不断被添加到各种筛选清单中，以审查潜在危害、识别和量化可能的健康或环境危害，或两者兼而有之，并考虑控制措施。 为了满足这些要求，正在努力在整个制造商供应链中收集详细数据，记录是否存在此类可申报物质，并持续“更新”维护结果信息。已经提出了标准化流程，以评估材料含有可能感兴趣/关注物质的可能性。 4.4 由于对材料内（或材料上）可申报物质的浓度提出了要求，因此评估产品的一致性成为一项复杂、耗时且昂贵的任务。本指南旨在帮助用户制定产品评估协议。本指南还针对结果信息的解释和沟通，特别是在没有或无法获得明确的客观/数字数据的情况下，以及在没有直接适用的监管指示的情况下。 本指南旨在协调用于解释和传达这些基于公式或直接基于分析的评估结果的语言。示例包括以下“预期不包含”、“未故意添加”、“配方中未使用” 关于琐事的 水平、“低于分析检测限”、“无毒理学意义”、“不安全物质”、“没有”等等。 4.5 先验的 知识是基于逻辑推理和科学原理的，因此可能不需要对材料进行实际测试来评估是否符合要求。例如，可以推断有机物质无法在生产锻钢所需的温度下生存，因此无需对锻钢中的有机物质进行测试，也不可能制定用于测定锻钢中有机物质的测试方法和参考材料。 4.6 后验 知识基于观察、经验和已知事实。如果 先验的 知识不能排除物质存在于材料内（或材料上）的可能性，可能需要一种测试方法来验证或生成关于该物质在材料内（或者材料上）浓度的信息。 4.7 制造商提供的关于产品中可申报物质的声明可能包含一种或两种 先验的 和 后方的 信息此类声明的接收者可能是下游制造商，他们将多种材料和组件并入其他产品中，并提供其关于申报物质的后续文件。每个生产商对其产品的物质申报负责，包括供应商可能提供的任何潜在不准确信息。 因此，每个制造商在选择依赖供应商声明时应考虑其供应商的风险状况。 4.8 测试方法可用于验证和提供材料中物质的相关信息。同时，当测试方法被错误应用时，可能会产生错误信息或得出不适当的结论。本指南旨在提供有关试验方法应用的建议。 4.9 试验方法可由生产商或材料的中间用户或最终用户使用。然而，在生产的每个阶段测试材料不是必要的，也不是成本有效的。应用测试方法和测试频率的决定应基于用户感知的风险，或者可以是一致的问题。 4.10 鉴于材料和分析评价方法的进步，对不同类型和类别的材料的评估都有其各自的复杂性和细微差别。 4.11 对于某些法规和指令 关于琐事的 已经为一种物质或一组物质定义了阈值。在没有规定的情况下 关于琐事的 ，0.1%（w/w）是合适的阈值。 4.11.1 这个 关于琐事的 水平可以描述为单个限额，也可以描述为累计限额，其细节将取决于具体的法规。在任何情况下 关于琐事的 超过规定的 关于琐事的 用于物质的集合组。 4.12 本指南包括一般流程和案例研究，以提供指导并区分何时 先验的 和 后方的 知识应该被应用。作为材料和产品评估指南的流程图见 附录X1 .

1.1 This guide uses case studies to illustrate the decision process to assess materials and products for declarable substances when evaluating conformance to relevant requirements. This may be accomplished by applying existing knowledge to determine the need for further action (for example, testing). 1.2 This guide assists in utilization and interpretation of various forms of information gathered to enable compliance or conformance or both to regulations, standards, supply agreements, or customer enquiries related to identified declarable substances, including the evidence required to issue declarations for the absence or presence of a declarable substance. Several examples are referenced. The target declarable substances will be specific to the product and product classification, the regulatory jurisdiction, customer/supplier requirements, and other relevant considerations. Consideration of which regulations and standards apply to a given product is beyond the scope of this guide. 1.3 The framework covered in this guide attempts to harmonize language used in the absence of objective data or specific regulatory requirements or both. This guide draws on a variety of existing documentation, which will be cited and referenced, as well as basic scientific principles for communication of chemical hazard and risk, and may be used as an approach for assessing composition of products and their components as part of product risk assessment. 1.4 This guide is applicable to a variety of materials, including polymeric and elastomeric materials, which are used in regulated industries and products. 1.5 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. 1.6 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 ====== 4.1 Regulations, standards, and market-defined requirements for chemical constituent (“substances of interest”) compliance and conformance have become increasing numerous and complex. Specific laws and standards may pertain to certain product and industry segments, for example, electrical/electronic instruments and components, pharmaceuticals, medical devices, consumer products, agrichemicals, and so forth. Others may be broader and relate specifically to assessment and management of specific chemical compounds or classes across multiple product sectors and sources, for example Ref ( 2 ) . In addition, such requirements may be issued by national authorities, international standards setting groups, or, in the case of market-defined requirements, even by customer advocacy organizations or customers through supply contracts. The resulting global landscape of requirements and market access expectations is complex, and compliance/conformance presents numerous challenges for manufacturers. Note 1: For example, IEC 62474:2012 provides some standardized definitions for reporting thresholds and declaration statements for electrotechnical industry. In another example, ISO 14021:2016 addresses self-declared environmental claims. 4.2 Declarable substances may be found on various lists and forms, including those listed in Refs ( 2- 10 ) and on supply agreements and questionnaires. This guide is not intended to be exhaustive nor cover all declarable substances. Nor does this guide address specific declaration and labeling requirements within these regulation and standards nor address product safety and compliance requirements as dictated by law for specific products, industries, or market regions. 4.3 In addition to new laws and standards, more chemical substances are continually added to a variety of screening lists for review of potential hazards, identification and quantification of possible health or environmental hazards, or both, and consideration of control measures. To comply with these requirements, significant efforts are being directed to detailed data gathering throughout manufacturer supply chains, documentation of presence or absence of such declarable substances, and continual “update” maintenance of the resultant information. Standardized processes have been proposed to assess the potential for a material to contain a possible substance of interest/concern. 4.4 Because of requirements being placed on concentrations of declarable substances within (or on) materials, assessing conformance of products has become a complex, time-consuming, and expensive task. This guide is intended to assist the user in developing a protocol for product assessment. This guide is also directed toward interpretation and communication of the resultant information, specifically where clear objective/numeric data are not available or obtainable, and in the absence of directly applicable regulatory direction. This guide is intended to harmonize language used to interpret and communicate results of these formulation-based or direct-analysis based assessments. Examples include “not expected to contain,” “not intentionally added,” “not used in formulation,” “below de minimis levels,” “below analytical detection limits,” “not toxicologically significant,” “not material to safety,” “free of,” and so forth. 4.5 A priori knowledge is based on logical deduction and scientific principles, so actual testing of a material may not be required to assess conformance to requirements. For example, it is possible to deduce that organic substances will not survive the temperatures required to produce wrought steel, so there is no need to test for organic substances in wrought steel nor is it possible to develop test methods and reference materials for determination of organic substances within wrought steel. 4.6 A posteriori knowledge is based on observation, experience and known facts. If a priori knowledge cannot rule out the possibility that a substance is present within (or on) a material, a test method may be required to verify or generate information on the concentration of that substance within (or on) the material. 4.7 Statements provided by a manufacturer about declarable substances in a product may contain either or both a priori and a posteriori information. The recipient of such statements may be downstream manufacturers who incorporate multiple materials and components into other products with their own subsequent documentation on declarable substances. Each producer is responsible for its own products’ substance declarations, including any potential inaccuracies that may be provided by suppliers. Thus, each manufacturer should take into account its suppliers’ risk profiles when choosing to rely on supplier declarations. 4.8 Test methods can be used to verify and provide information related to substances within materials. At the same time, misinformation can be generated or inappropriate conclusions drawn when test methods are misapplied. This guide is intended to provide recommendations on the application of test methods. 4.9 Test methods may be applied by producers or by interim or end users of materials. However, it is not necessary or cost effective to test materials at each stage of production. The decision to apply test methods and the frequency of testing should be based on risk perceived by the user or can be a matter of agreement. 4.10 Assessment of different types and classes of materials each have their individual complexities and nuances given the advancements in both materials and analytical evaluation methods. 4.11 For some regulations and directives, a clear de minimis threshold has been defined for a substance or group of substances. In the absence of a prescribed de minimis , 0.1 % (w/w) is a suitable threshold. 4.11.1 The de minimis level may be described as an individual limit, or as an aggregated limit, whose details will be dependent on a specific regulation. In no instance shall an aggregated de minimis exceed the sum of the prescribed de minimis for the collective group of substances. 4.12 This guide includes a general process and case studies in order to provide guidance and to distinguish when a priori and a posteriori knowledge should be applied. Flow charts as a guide for assessment of materials and products are provided in Appendix X1 .