在 IUCLID 中报告使用寿命使用情况时，CSR 中需要什么？

在 IUCLID 中报告使用寿命使用情况时，CSR 中需要什么？

What is needed in the CSR when a service life use is reported in IUCLID?

如果您在 IUCLID 的 3.5.6 节“使用寿命”中报告了一种或多种用途，并且您注册的物质符合 REACH 第 14(4) 条关于危险品（或视为 PBT/vPvB）分类的标准，那么您的 CSR 必须包含相应的暴露场景。使用寿命的暴露场景预计会解决导致释放/暴露的条件。这通常包括物质在物品材料中的浓度、物品的活动类型（与 PROC 相关）以及工人的相关使用条件，或物品类型（与 AC* 相关）以及消费者的相关使用条件。 *请注意，对于消费者活动，使用描述符物品类别 (AC) 1、2 和 3 指的是多材料复合体，如果没有关于物质所在材料类型的进一步信息，则无法在贡献场景中对其进行评估。因此，建议注册人参考消费者的贡献活动及其对基于材料的物品类别 AC 4 至 AC 13 的评估。每种贡献情景通常都需要对物品的释放进行估算以及相应的暴露估算和风险表征。有工具可提供帮助：ECHA 的《描述塑料材料中添加剂的用途和估算相关暴露的实用指南》概述了方法和工具，其中包含对其他材料也有用的信息。在考虑如何完成您的 CSR 以评估 IUCLID 第 3.5.6 节中报告的一种或多种用途（使用寿命）时，如果提供相关解释，则可能存在没有进行定量暴露评估的情况。预期的解释取决于您遇到的情况：A. 物品材料中所含物质的浓度低于法规 1272/2008 (CLP) 中关于混合物分类规定的截止值（类比使用 REACH 第 14(2) 条作为基准）。如果是这样，您的档案必须包含对下文A部分所列要点的解释。B. 该物质在使用时会发生反应，因此在使用期限内不会再暴露。如果是这样，您的档案必须包含对下文B部分所列要点的解释。相反，仅仅说明预计某种物质从物品中释放的量非常小（可忽略不计），或者预计在使用期限内会发生少量（可忽略不计）的暴露，并不能作为不进行定量评估的有效理由。物品在处理或加工过程中的释放/暴露程度取决于使用量、使用条件（例如磨损过程、高温、皮肤接触强度）、物品材料中物质的浓度以及物质与物品材料之间的相互作用。此外，物质的危害性在确定释放量是否足够低以保证风险控制方面也起着重要作用。如果情况A/B不适用，则您需要量化使用期限内产生的释放、暴露和风险。但是，当物质存在于预计不会打开的密封集成容器中（例如温度计）时，可能存在例外情况。在这种情况下，预计使用寿命使用的环境和工人/消费者评估中不需要进行释放/暴露量化，但应在适用的贡献场景中记录相应的解释，以证明没有进行释放/暴露量化。A）与低浓度有关的理由为了证明由于物品材料中物质浓度低而导致某些使用寿命用途缺乏定量暴露评估，您的理由必须包括：物品材料中物质的浓度和以下信息：· 如果浓度低于 0.1%（这对应于下表 1 中的最低浓度），则预计 TCC 无需进一步推理，除非混合物分类的特定浓度限值（低于 0.1%）适用于该物质（在这种情况下应使用此类截止值）。此外，对于在环境中被归类为“急性类别 1”或“慢性类别 1”的物质，0.1% 应除以 M 因子，以确定特定物质的截止值。· 如果浓度高于 0.1%，则必须提供物质的危险类别和等级以及相应的 CLP 截止值，表明在混合物分类时必须将物质考虑在内，高于该浓度的物质。基于此，您可以证明物品材料中的浓度低于与您的物质相关的最低截止值。对于符合附件 XIII 中的 PBT/vPvB 标准的物质，任何高于 0.1% 的浓度都需要进行暴露评估。必须为适用的每个暴露场景提供此类理由。 B) 与使用反应相关的论证：如果危险物质在使用过程中发生反应，则该反应可能快速而彻底（没有残留的母体物质可供暴露），也可能残留一些母体物质，且反应产物的危险性可能高于或低于母体物质。因此，仅凭母体物质的“消失”不足以成为未进行暴露评估的理由。要证明某些使用寿命用途未进行定量暴露评估的合理性，必须量化母体物质的残留浓度，并提供转化产物的化学性质及其已知/预期危害的信息。您的理由必须包含以下内容： 说明您的物质未进行评估的理由：· 解释物质的转化方式（包括反应机制和转化产物的特性）· 量化物品材料中物质的剩余浓度（在使用期限内的条件下）。· 将物品材料中物质的浓度与混合物分类规则的截止浓度（见下表 1）进行比较，并提供上述 A 点中指定的信息。 说明未对转化产物进行评估的理由：· 解释您认为转化产物不符合危险标准的原因。应针对适用的每个暴露场景提供此类理由。您可以在下表中找到每个危险类别/类别的适用截止浓度： 混合物分类中忽略物质的浓度截止表 [PDF]

If you report one or more uses in Section 3.5.6: Service Life of IUCLID, and the substance you register meets the criteria of Article 14(4) of REACH for classification as hazardous (or considered PBT/vPvB), then your CSR must contain the corresponding exposure scenario(s). The exposure scenario(s) for service life are expected to address the conditions driving the release/ exposure. This usually includes the concentration of the substance in the material forming the article, the type of activity (associated with PROC) with the article and the related conditions of use for workers, or the type of article (associated with AC*) and related conditions of use for consumers. *Note that for consumer activities, the use descriptors Article Category (AC) 1,2 and 3 refer to multi-material complex objects, which cannot be assessed as such in a contributing scenario without further information on the type of material in which the substance occurs. Registrants are therefore advised to refer their contributing activities by consumers and their assessment to the material-based Article categories AC 4 to AC 13. Each contributing scenario usually requires an estimate of the releases from the article and a corresponding exposure estimate and risk characterisation. Tools are available to help with this: ECHA’s Practical Guide on Describing uses of additives in plastic material and estimating related exposure provides an overview on methods and tools that contains useful information also for other materials. When considering how to complete your CSR to assess one or more uses (Service Life) reported in section 3.5.6 of IUCLID there may be situations that justify the absence of quantitative exposure assessment if relevant explanation is provided. The expected explanation depends on the situation you encounter:A.  The substance is contained in concentration in the article material below the cut-off values as laid down in Regulation 1272/2008 (CLP) in relation to the mixture classification (using by analogy Article 14(2) of REACH, as a benchmark). If so, your dossier must contain explanation on the points listed under section A below.B. The substance reacts on use, and hence is not available for exposure anymore during service life. If so, your dossier must contain explanation on the points listed under section B below.In contrast, simply stating that a substance is expected to be released from the article only in very small [negligible] amounts or that small (negligible) exposure is expected to occur during the service life use are not considered valid arguments to justify the absence of a quantitative assessment. The extent of release/exposure during handling or processing of articles depends on the amount of use, the conditions of use (e.g. abrasive processes, elevated temperature, intensity of dermal contact), the concentration of the substance in the article material and the interaction between the substance and the article material. In addition, the hazard of the substance plays a role when determining whether the release is sufficiently low to guarantee control of risk. If situation A/B do not apply, you are therefore expected to quantify the release, exposure and risk resulting from the service life use. However, an exception may apply when the substance exists in a sealed integrated container that is not foreseen to be opened (e.g., thermometer). In such cases, no release/exposure quantification is expected in the environmental and workers/consumer assessment for the service life use but the corresponding explanations, justifying the absence of release/exposure quantification, should be documented in the contributing scenarios where they apply.A) Justification related to low concentration To justify the absence of quantitative exposure assessment for certain service life uses due to the low concentration of your substance in the article material, your reasoning must include: the concentration of the substance in the article material and the following information:· If the concentration is below 0.1% (this corresponds to the lowest concentration in Table 1 below), no further reasoning is expected at TCC, unless a specific concentration limit (below 0.1%) for mixture classification is applicable to the substance (in which case such cut off should be used). In addition, for substances classified for the environment as ‘Acute Category 1’ or ‘Chronic Category 1’, 0.1% is to be divided by the M-Factor to determine the substance-specific cut-off.· If the concentration is above 0.1%, you must provide the hazard category(ies) and class(es) of your substance and the corresponding cut-off(s) from CLP, indicating the concentration above which your substance must be taken into account for the purposes of mixture classification. Based on this, you can demonstrate that the concentration in the article material is below the lowest cut-off relevant to your substance.  For substances meeting the PBT/vPvB criteria in Annex XIII, any concentration above 0.1% would require the presence of an exposure assessment.Such justification must be provided for each exposure scenario to which it applies. B) Justification related to reaction on useIf a hazardous substance reacts on use, such reaction may be fast and complete (no residual parent substance available for exposure) or some parent substance may remain, and the reaction product may be more hazardous or less hazardous compared to the parent substance. Therefore, the “disappearance” of the parent substance alone is not a sufficient argument for the absence of the exposure assessment.To justify the absence of quantitative exposure assessment for certain service life uses you must quantify the residual concentration of the parent substance, and you must provide information on the chemical nature and the known/expected hazard of the transformation products. Your reasoning must include the following elements: To justify the absence of assessment of your substance: · Provide an explanation how the substance transforms (including the reaction mechanism and the identity of the transformation products) · Quantify the remaining residual concentration of the substance in the article material (under the conditions of use of the service life).· Compare the concentration of the substance in the article material with the cut-off concentration from the mixture classification rules (see Table 1 below) and provide the information as specified in point A aboveTo justify the absence of assessment for the transformation product(s):· Explain the reasons why you consider that the transformation product(s) do(es) not meet the criteria for being considered hazardous.Such justification should be provided for each exposure scenario to which it applies. You can find the applicable cut off concentration per hazard class/category in the following table: Table of concentration cut-offs for disregarding substances in mixture classification [PDF]