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某些物质符合持久性有机污染物法规附件一中“PFOA相关化合物”和REACH法规附件XVII第68条中“C9-C14 PFCA相关物质”的定义。这些物质需要遵守哪些监管义务?

问题(中文)
某些物质符合持久性有机污染物法规附件一中“PFOA相关化合物”和REACH法规附件XVII第68条中“C9-C14 PFCA相关物质”的定义。这些物质需要遵守哪些监管义务?
Question (EN)
There are certain substances that meet the definition of "PFOA-related compounds” and “C9-C14 PFCA-related substances” as laid down in Annex I to the POPs Regulation and in entry 68 of Annex XVII of REACH respectively. What regulatory obligations apply to these substances?
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)
关于持久性有机污染物的欧盟法规 (EU) 2019/1021 附件一 A 部分中有关全氟辛酸 (PFOA)、其盐类和 PFOA 相关化合物的条目适用于 PFOA 相关化合物,就《斯德哥尔摩公约》而言,这些化合物指任何可降解为 PFOA 的物质,包括任何以 (C7F15)C 部分为结构要素之一的直链或支链全氟庚基物质(包括盐和聚合物)。以下化合物不包含在内:(i) C8F17-X,其中 X = F、Cl、Br;(ii) CF3[CF2]n-R' 涵盖的含氟聚合物,其中 R'=任意基团,n> 16;(iii) 全氟碳原子数 ≥ 8 的全氟烷基羧酸(包括其盐、酯、卤化物和酸酐);该限制包含在 REACH 附件 XVII 第 68 条中,针对 C9-C14 PFCA、其盐类以及 C9-C14 PFCA 相关物质。第 68 条适用于以下 C9-C14 PFCA 相关物质:(a) 具有分子式为 CnF2n+1- 的全氟基团直接与另一个碳原子相连的物质,其中 n = 8、9、10、11、12 或 13,包括它们的盐类及其任意组合; (b) 它不直接连接到另一个碳原子上,其中 n = 9、10、11、12、13 或 14 作为结构元素之一,包括它们的盐及其任意组合。以下物质不在此指定范围内:-CnF2n+1-X,其中 X = F、Cl 或 Br,其中 n = 9、10、11、12、13 或 14,包括它们的任意组合,以及 -CnF2n+1-C(= O)OX',其中 n> 13 且 X'= 任何基团,包括盐。该条目将 C9-C14 PFCA 相关物质定义为基于其分子结构,被认为具有降解或转化为 C9-C14 PFCA 潜力的物质。有关 REACH 附件 XVII 第 68 条范围内的 PFCA 和 PFCA 相关物质以及哪些物质的更多信息排除在外?可在问答 1906 中找到。诸如 8:2 氟调聚物丙烯酸酯(CAS 编号:27905-45-9)等物质,其结构要素在两个条目中均有描述:欧盟法规 (EU) 2019/1021 附件 I A 部分中关于全氟辛酸 (PFOA)、其盐类及 PFOA 相关化合物的条目,以及 REACH 附件 XVII 中的条目 68。因此,两个条目均适用于该物质。为确定这些物质的相关监管义务,应同时考虑这两个条目。出于实际目的,应适用两个条目中描述的最严格的义务,包括浓度限值。
Answer (EN)
The entry included in Part A of Annex I to Regulation (EU) 2019/1021 on Persistent Organic Pollutants addressing perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds applies to PFOA-related compounds which, for the purpose of the Stockholm Convention, mean any substances that degrade to PFOA, including any substances (including salts and polymers) having a linear or branched perfluoroheptyl group with the moiety (C7F15)C as one of the structural elements. The following compounds are excluded: (i) C8F17-X, where X = F, Cl, Br; (ii) fluoropolymers that are covered by CF3[CF2]n-R’, where R’=any group, n> 16; (iii) perfluoroalkyl carboxylic acids (including their salts, esters, halides and anhydrides) with ≥ 8 perfluorinated carbons; (iv) perfluoroalkane sulfonic acids and perfluoro phosphonic acids (including their salts, esters, halides and anhydrides) with ≥ 9 perfluorinated carbons; (v) perfluorooctane sulfonic acid and its derivatives (PFOS), as listed in this Annex.The restriction included in entry 68 in Annex XVII to REACH for C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances. Entry 68 applies to the following C9-C14 PFCA-related substances:Substances having a perfluoro group with the formula CnF2n+1- (a) directly attached to another carbon atom, where n = 8, 9, 10, 11, 12, or 13, including their salts and any combinations thereof; (b) that it is not directly attached to another carbon atom, where n = 9, 10, 11, 12, 13 or 14 as one of the structural elements, including their salts and any combinations thereof.The following substances are excluded from this designation:-CnF2n+1-X, where X = F, Cl, or Br, where n = 9, 10, 11, 12, 13 or 14, including any combinations thereof, and -CnF2n+1-C(= O)OX' where n> 13 and X'=any group, including salts.The entry defines, for its purposes, C9-C14 PFCA-related substances as substances that, based on their molecular structure, are considered to have the potential to degrade or be transformed to C9-C14 PFCAs.More information on What are the PFCA and PFCA-related substances in the scope of Entry 68 of Annex XVII to REACH and what substances are excluded?  can be found in Q&A 1906.Substances, such as 8:2 Fluorotelomer acrylate (CAS No27905-45-9), show structural elements that are described in both entries: the entry included in Part A of Annex I to Regulation (EU) 2019/1021 for perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds and entry 68 in Annex XVII to REACH. As a consequence, both entries apply to the substance.For determining which are the relevant regulatory obligations for these substances both entries should be considered. For practical purposes, the most restrictive obligations described in the two entries should be applied, including concentration limits.