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REACH绿色合规----下游用户会收到的安全数据表
来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-08-27 | 285 次浏览 | 分享到:

在大多数情况下,下游用户将收到以下几种安全数据表(REACH第31条): 

In most cases DUs will receive the following kind of SDS  (Art. 31 REACH):


选项1 

对于由单一法人实体制造或进口的数量在10吨每年以上的有害物质(例如:氨等工艺气体或异丙醇等溶剂),下游用户将会收到物质的扩展安全数据表。扩展安全数据表与“基本” 安全数据表的主要区别在于增加了暴露状况附录、第1部分增加相关的确认用途,第8部分增加衍生无影响水平/预测无影响浓度值。 

Option 1

For all hazardous substances that are manufactured  or imported by a single legal entity at above 10 tpa  (for example technical gases like ammonia or solvents  like isopropanol) the DU will receive an Ext-SDS for the  substance. Ext-SDSs mainly differ from “basic” SDSs  by having exposure scenario(s) attached as an annex, relevant identified uses in section 1 and DNEL/PNEC  values in section 8.


下游用户相关的义务: 如果下游用户收到了扩展安全数据表,他必须检查其当前的物质用途是否包含在扩展安全数据表中,其工作场所和环境风险评估及风险管理措施是否包括在暴露状况附录及操作条件中。 

Related DU obligations: If a DU receives an Ext-SDS, he has to check whether  the current use is covered and whether his workplace and environmental risk assessment and the RMMs are covered by the attached exposure scenario as well as the operational conditions described therein.


如果下游用户使用物质(例如:配制配制品时)不符合暴露状况规定的条件、或其使用不在规定的用途中或者被注册者反对,则下游用户可采用多种措施: 

• 下游用户可将其物质用途/使用条件告知供应商,使供应商制定相应的暴露状况。 

• 下游用户可在暴露状况内(换算),改变其使用条件或更改可变换算参数使其符合暴露状况 

• 下游用户可选择另一家提供的暴露状况包括其特定用途/使用条件的供应商。 

• 下游用户可按照REACH第37.4条的规定编制化学品安全报告,并按REACH第38.1条的规定,将附加的用途向欧洲化学品管理局通报。

注意,如果使用量小于1吨每年则下游用户不需要准备化学品安全报告(REACH 第37.4.c条),但是这种情况下需要向欧洲化学品管理局通报其特殊用途(REACH第38.1.b条)。 

• 下游用户可通过更改生产工艺,采用暴露状况/使用中规定的使用条件。 

• 下游用户可采用替代物质或工艺(如可能) ,并停止使用讨论中的物质(替代)。

If a DU uses substances (e.g. formulating a mixture)  outside the conditions described in the exposure  scenario, or if the uses are not covered, or for any  use(s) the registrant advises against, he has several  options: 

• DU may make the use/use conditions known to his  supplier so that the supplier can prepare an exposure  scenario covering them. 

• DU may change the conditions of use or modify the  variable scaling parameters within the ES (scaling)  so that they are covered by the supplier’s exposure  scenario. 

• DU may find another supplier who provides an exposure scenario covering the particular use(s) and conditions of use(s).  

• DU may prepare a CSR according to Art. 37.4 REACH  and notify ECHA of the additional use(s) as described  in Art. 38.1 REACH. Note that the DU does not have to  prepare a CSR if his use is less than 1 tpa (Art. 37.4.c  REACH), but in this case he needs to notify ECHA that  he is taking advantage of this exception (Art. 38.1.b  REACH). 

• DU may implement the conditions of use as described  in the ES/use by modifying his production process.  

• DU may find an alternative substance or process  if possible and discontinue using the substance in  question (substitution).

注:

扩展安全数据表附有注册物质确认用途的相关暴露状况。 通常,暴露状况说明了在给定操作条件下, 安全使用物质的方法及为了控制对人体或环境的风险所采取的风险管理措施(RMM) 。对于年进口量/制造量超过10吨且符合 CLP规定的有害标准的特定单独物质或配制品中的物质,注册者必须制定暴露状况,将其作为注册卷宗的一部分。

NOTE:

The Ext-SDS will include the relevant exposure  scenarios as attachments for the identified uses for  which the substance was registered.  An exposure scenario generally describes how  a substance can be safely used under the given  operational conditions of use and which risk  management measures (RMM) should be applied  to control risk to humans or the environment.  Exposure scenarios must be compiled by the  registrant, as part of the registration dossier, for  certain substances on their own or in mixtures that are  imported/manufactured in quantities over 10 tpa and  hazardous according to CLP.


请注意,在暴露状况中利用用途描述符系统描述的确认用途,原则上只通过扩展安全数据表提供。还有这种可能性,即确认用途看似包括在扩展安全数据表中,但由于使用条件与风险管理措施主要采用最差暴露状况评估工具(如 定向风险评估12)进行评估,因此与自己的工艺所采取的使用条件和风险管理措施不同。在这些条件下,下游用户必须履行REACH第V篇规定的义务。 

Please consider that in principle identified uses  described with the use descriptor system in ES are  provided in the Ext-SDS only. There may be a possibility  that identified uses appear to be covered in such an  Ext-SDS but the conditions of use and risk management  measures are different from those in your own  processes, because they are mainly estimated by using  worst case ES estimation tools (e.g. ECETOC-TRA12). In  those cases the obligations according to REACH Title V  have to be considered.


选项2:

对于由单一法人实体制造或进口的有害物质的量大于等于10吨每年的配制品(如涂层),可采用两种类型的安全数据表(参见下面的2a或 2b)。第三种安全数据表由行业专家制定(2c): 

a)配制品的“基本”安全数据表无暴露状况附录,所有的安全处理风险管理措施都包括在主体内。 

Option 2:

For mixtures (e.g. coatings) containing hazardous  substances that are manufactured or imported by a  single legal entity at above ≥ 10 tpa, two kinds of SDS  are legally possible (2a or 2b below). A third option was  developed by industry experts (2c): 

a) A “basic” SDS for the mixture without any ES attachment and where all RMMs for safe handling are included in the main body.


注:

这是进行配制品安全数据表信息传递的推荐选项。即使安全数据表中无暴露状况附录,下游用户也必须遵循安全数据表第 1–16部分的规定。 

b)附有每年使用量达到10吨及10吨以上的注册有害物质的所有相关暴露状况的配制品安全数据表(“SDS手册”)。如果下游用户收到这种安全数据表,则其有义务查看所有 的物质暴露状况是否包括自己的物质用途及使用条件(OC)(REACH合规检查)。

NOTE:

This is the recommended option for communication of SDSs for mixtures. Even if no ES is contained  in the SDS as an annex, the DU must still consider  the specifications given in sections 1-16 of the SDS. 

b) An SDS for the mixture where all relevant ES of the  registered hazardous substances ≥ 10 tpa are attached (“SDS book”). If the DU receives such an SDS,  he has the obligation to check each attached ES to  see whether the uses and the conditions of use (OC)  are covered (REACH compliance check).


注:

汽车行业建议,即使选项2b,要求您的供应商提交一份综合SDS,描述SDS主体中的整个混合物的风险(见第2a点)或附上“安全使用配制品信息”(SUMI) (见下文第2c点),而不是提供“SDS手册”,以避免不必要的管理工作在法律上是正确的。 

c) 由行业专家开发的附有“安全使用配制品信 息”(SUMI)的安全数据表。 REACH第V篇规定的下游用户的义务仅与物 质及配制品中的物质有关,但与配制品本身无关,因此,与SUMI有关的义务与物质暴露状况产生的义务不同。下游用户可考虑将SUMI提供的信息用于自己工作场所及环境风险评估,尤其是在没有国家工作场所暴露极限值、与环境相关的极限值或技术设备认可规定的情况下。 

NOTE:

Automotive industry recommendation that even if option 2b is legally correct to ask your supplier to  submit a consolidated SDS describing the risk of  the whole mixture in the main body of the SDS (see  point 2a) or to attach a SUMI (see point 2c below) instead of providing an “SDS book” in order to avoid  unnecessary administrative work. 

c) An SDS with attached “Safe Use Mixtures Information” (SUMI), as developed by industry experts.Because the DU duties of REACH Title V are related  to substances and substances in mixtures only but  not to the mixture itself, the duties resulting from a SUMI are not equivalent to those resulting from an  exposure scenario for substances. DUs should consider the information obtained from such a SUMI for  a mixture for their own workplace and environmental risk assessment, especially in those cases where no national workplace exposure limit value or environmental relevant threshold or technical equipment  approval conditions are yet available.


注:

配制品不是注册对象,因此不存在配制品暴露状况,同时法规也未对配制品安全报告规定要求(参见附录L23-关于配制品暴露状况或配制品扩展安全数据表的汽车行业意见书)。而是参见上面2c。 某些特殊物质可视为CLP与REACH中的配制品(混合物质及/或复杂物质、合金等) 。 这些“物质”适用化学品安全报告。

NOTE:

Exposure scenario(s) for mixtures do not exist,  because mixtures are not subject to registration  and no chemical safety report is legally required  for them (see Annex L23 - “Position Paper of the  Automotive Industry in regard to exposure scenarios for mixtures/extended SDS for mixtures”).  However, see point 2c above. Special substances may be regarded as mixtures  under CLP and REACH (multi-consistent substances and/or complex substances, alloys etc.).  For these “substances” a CSR may be reasonable.



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