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物品使用寿命的描述预计是什么时候以及为什么?

问题(中文)
物品使用寿命的描述预计是什么时候以及为什么?
Question (EN)
When is the description of article service life expected and why?
中文内容由 Google Cloud Translation 自动生成,仅供参考;请以英文原文为准。问答资料来自欧盟化学品管理局(ECHA)官方网站。
答案(中文)
REACH 要求注册档案中涵盖物质的所有生命周期阶段,包括物质本身或混合物使用后的生命周期阶段。加工成或加工到物品上的物质可能会在物品的使用寿命期间或使用寿命结束时释放,导致人体或环境暴露。这种暴露程度甚至可能高于工业生产物品或专业人员将混合物应用于物品表面时的暴露程度。在使用寿命期间或之后可能存在显著释放的例子包括:从纺织品迁移到皮肤和/或随洗涤水迁移到环境中;物质从塑料物品或其他与水接触的表面迁移(浸出);或轮胎或刹车片等物品材料的磨损。当物质或其反应产物预计会成为物品的一部分时,应在 IUCLID 第 3.5.6 节中报告物品的使用寿命。例如,这适用于以下物质功能:物质应存在于构成物品的材料基质中。典型的技术功能包括塑料制品中的增塑剂、填料、阻燃剂、颜料或稳定剂;纺织品、纸张和皮革中的染料、整理剂或上浆剂;或金属制品中的合金元素。物质存在于表面层,保护物品或赋予其特定外观。典型的技术功能包括建筑和施工中金属制品或木质/矿物构件涂层中的粘合剂(成膜剂)、缓蚀剂、干燥剂、颜料、增塑剂和稳定剂。物质存在于物品表面,以促进或防止与其他表面的粘附。典型的技术功能包括附着力促进剂、粘合剂中的粘合剂、抗粘剂、矿物建筑构件表面残留的脱模剂。物质是用于包装或印刷介质的印刷油墨中的成分。典型的技术功能包括粘合剂、颜料和染料。物质存在于塑料化合物(或母料)中,以保护材料在加工过程中免受热降解(热稳定剂)。物质并非旨在成为物品的一部分,但预计会在物品的较长使用寿命期间存在于物品表面,例如抛光剂、蜡或浸渍剂。虽然上述技术功能大多表明该物质包含在物品中,但某些功能(例如染料或稳定剂)也会以混合物的形式存在,但不会影响物品的使用寿命(例如润滑剂、燃料、清洁产品中的染料)。对于此类用途,仅凭技术功能不足以断定该物质是否存在于物品中,还需要考虑包含该物质的混合物类型。请注意,如果物质在使用时发生反应,即使预计物品中只存在反应产物,也应报告使用寿命。有关更多信息,请参阅问答 1860:在 IUCLID 中报告使用寿命用途时,CSR 中需要哪些内容?如果物质(或其反应产物)预计不会成为物品的一部分,则不应在 IUCLID 第 3.5.6 节中报告物品的使用寿命。这通常适用于用于从固体表面去除材料的物质、功能性液体和燃料的物质,或在应用于物品表面时会蒸发的物质。示例包括以下物质功能:防冻剂和除冰剂;清洁剂和螯合剂;蚀刻剂;絮凝剂或浮选剂;燃料和燃料添加剂;液压油、传热液或其他功能性液体中的试剂;润滑剂;溶剂。如果将某种物质用作“中间体”,则其结果是制造另一种物质。因此,根据定义,这种用途不能与后续的物品使用寿命相关联。在 IUCLID 第 3.5 节中描述用途时,注册人应指定技术功能 (TF)、产品类别 (PC) 和环境释放类别 (ERC)。对于每种用途,此信息应始终指出后续使用寿命是否相关,并应相应地勾选“与此用途相关的后续使用寿命”框。例如,如果报告了 ERC5 或 ERC8c/f,则也应报告后续使用寿命。此外,彼此不相容的功能(例如阻燃剂和燃料)不应在同一用途中报告。有关如何报告物品中物质用途的更多实际考虑和示例,请参阅 ECHA 的《行业实用指南:描述物品用塑料材料中添加剂的用途并估算相关暴露》。虽然本实用指南重点关注塑料中的添加剂,但其中解释的核心原则也适用于其他物品材料中的物质。
Answer (EN)
REACH requires that all the life-cycle stages of a substance are addressed in the registration dossier. This includes also the life-cycle stages subsequent to the use of the substance as such or in mixture. Substances having been processed into or onto an article may be released during the service life or at end of service life of this article, leading to exposure of humans or the environment. This exposure may even be higher than the exposure occurring during the production of the article in industry or the application of mixtures to article surfaces by professionals. Examples for significant release potential during or after service life include migration from textiles to skin and/or with the washing water to environment, migration (leaching) of substances from plastic articles or from other surfaces in water contact, or abrasion of material from articles like tyres or brake pads.  An article service life is to be reported in section 3.5.6 of IUCLID when the substance or its reaction products are expected to become part of an article. This applies for example to the following substance functions:Substance is meant to be present in the material matrix forming an article. Typical technical functions include plasticisers, fillers, flame retardants, pigments or stabilisers in plastic articles; dyes, finishing or sizing agents in textile, paper and leather; or alloying elements in metal articles.Substance is meant to be present in the surface layer protecting an article or delivering a certain appearance. Typical technical functions include binders (film formers), corrosion inhibitors, driers, pigments, plasticisers, stabilisers in the coatings for metal articles or wooden/mineral elements in building and construction. Substance is meant to be present on the article surface to promote or prevent adhesion to other surfaces. Typical technical functions include adhesion promoters, binders in adhesives, anti-adhesives, release agents remaining on surfaces of mineral construction elements.   Substance is a component in printing inks applied to packages or print media. Typical technical functions include binder, pigment, dyes. Substance is meant to be present in a plastic compound (or masterbatch) in order protect the material against degradation by heat during processing (heat stabiliser).  Substance is not meant to become a part of the article, but it is expected to be present on the article surface during longer periods of article service life, such as polishes, waxes or impregnation agents.  While the technical functions listed above mostly imply that the substance is included in articles, some functions such as a dye or stabiliser are also delivered in mixtures not leading to an article service life (for example dyes in lubricants, fuels, cleaning products). For such uses, the technical function alone is not sufficient to conclude on the presence of the substance in articles, and also the type of mixture in which the substance is contained needs to be taken into account.Note, when a substance reacts on use, the service life should nevertheless be reported even if only the reaction products are expected to be present in an article. Refer to Q&A 1860: What is needed in the CSR when a service life use is reported in IUCLID? for more information. An article service life should not be reported in section 3.5.6 of IUCLID when the substance (or its reaction products) is not expected to become part of the article. This applies typically to substances which are meant to remove material from solid surfaces, substances which are part of functional fluids and fuels, or substances that are meant to evaporate during their application to the article surface. Examples include the following substance functions:Anti-freeze agents and de-icersCleaning and chelating agentsEtching agentsFlocculation or floatation agentsFuels and fuel additivesAgents in hydraulic fluids, heat transfer fluids or other functional fluidsLubricating agentsSolvents If a substance is used as an “intermediate”, the outcome is the manufacture of another substance. Therefore, by definition, this use cannot be associated with a subsequent article service life. When describing a use in section 3.5 of IUCLID, the registrant should assign technical function(s) (TF), product category(ies) (PC) and environmental release categories (ERC). For each use, this information should consistently point to whether a subsequent service life is relevant or not and the box ‘Subsequent service life relevant for this use’ should be checked accordingly. For example, if ERC5 or ERC8c/f are reported, then a subsequent service life is also expected to be reported. Also, functions incompatible with each other (e.g. flame retardant and fuel) should not be reported in the same use. More practical considerations and examples on how to report the uses of substances becoming part of articles can be found in ECHA’s Practical Guide for Industry: Describing uses of additives in plastic material for articles and estimating related exposure. Although focussed on additives in plastic, the core principles explained in this Practical Guide are also applicable to substances in other materials for articles.