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REACH绿色合规----高关注度物质(SVHC)
来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-08-24 | 285 次浏览 | 分享到:

注册者自用:

指“注册者在自身行业或职业中使用” (REACH第3.25条) 再进口指物质最初在欧洲经济区境内制造,然后出口(例如:将物质配制成配制品),最后又重新返回到欧洲经济区(如:在市场上销售或进行深加工)。在以下条件下,再进口物质可免于注册: 

• 自欧洲经济区出口前,物质必须已经注册。 

• 已经注册和出口的物质必须与再进口的单独物质或配制品中的物质相同,即必须具有相同的化学成分或化学性质(再进口商必须能够证明再进口物质仍与原注册和出口物质相同) 

• 再进口商必须具有关于出口物质的信息 (REACH第2.7.c条,注册指南第1.6.4.6 款) 

Re-import:

means where a substance is first manufactured in  the EEA, then exported (e.g. to be formulated into a  mixture) and then brought back into the EEA again  (e.g. to be marketed or for further processing). Such  re-imports are exempted from registration under the  following conditions:  

• the substance must have been registered before it  was exported from the EEA  

• the substance already registered and exported must  be the same, i.e. must have the same chemical identity and properties as the substance being re-imported  on its own or in mixture (the re-importer has to be  able to prove that the substance is still the same)  

• re-importer must have been provided with information on the exported substance (Art. 2.7.c REACH,  Guidance on Registration, item 1.6.4.6)


生产修理:

指欧洲汽车制造商协会(ACEA)、日本汽车制造商协会(JAMA)、韩国汽车制造商协会 (KAMA)、欧洲汽车供应商协会(CLEPA) 在REACH法规以报废车辆指令(2000/53/ EC)下豁免的“按生产修理”原则为基础的授权程序中的立场。(即报废车辆指令中所有 新材料限制具有对最初设计不符合新材料限制的备件“按生产修理”豁免)。在日落之期后生产并用于在日落之期前停止生产的汽车中的配件物质,应该从REACH第56条规定中豁免。 

在REACH法规规定的授权程序的基础上,欧洲汽车制造商协会(ACEA)、日本汽车制造商协会(JAMA)、韩国汽车制造商协会(KAMA) 、欧洲汽车供应商协会(CLEPA)在根据报废车辆指令2000/53 / EC豁免的“修理生产”原则 的基础上的立场(即所有新的材料限制在ELV指令中,对于最初未设计为符合新材料限制的备件,具有“生产修复”豁免)。 在日落日期之后制造并用于在日落日期之前停止生产的车辆的备件物质应豁免REACH第56条的规定。

Repair as produced:

means ACEA, JAMA, KAMA, CLEPA position in the context of REACH regulation for authorisation procedure on the basis of the “repair as produced” principle as exempted  under End-of-Life Vehicle Directive 2000/53/EC (i.e.  all new material restrictions in the ELV Directive have  a “repair as produced” exemption for spare parts that  were not originally designed to be compliant with the  new material restrictions). Substances for spare parts  that are manufactured after the sunset date, and which  are used for vehicles that ceased production before the  sunset date, should be exempted from the provisions of  Art. 56 REACH.


安全数据表(SDS): 

指在REACH附件II中定义的文档,是根据 REACH和其他欧洲立法作为传递供应链化学危害数据的主要手段。 

Safety data sheet (SDS):

means the document defined in Annex II REACH, which  is intended under REACH and other European legislation  to be the primary means of transmitting data about chemical hazards along the supply chain.


科学研究与开发:

指“在受控条件下,对每年使用量不超过1吨的化学物质进行的所有科学实验、分析或化学研究” 场地指“一个单独的地点。如果在场地内有多位物质制造商,则某些基础设施和设备共用” (REACH第3.16条)。 特定环境释放类别(SpERC) 化工行业及其下游用户使用物质时,其预计排放量需比环境释放类别(ERC)高1级。 

Scientific research and development :

means “any scientific experimentation, analysis  or chemical research carried out under controlled  conditions in a volume less than 1 tonne per year”  (Art. 3.23 REACH).


物质: 

指“自然或经任何制造工艺获得的化学元素及其化合物,包括维持其稳定性的必要添加剂、 以及工艺过程中所产生的夹杂物,但不包括任何可分离且不会影响物质稳定性或改变其成份的溶剂”(REACH第3.1条)。例如:甲烷、烃 类、硫酸、乙醇、碳酸钙、二氧化硅、单质金属(如:铜、铝)(关于REACH中详细的物质的标识与命名信息,请参见“REACH物质标识与命名指南”)

Substance:

means “a chemical element and its compounds in  the natural state or obtained by any manufacturing  process, including any additive necessary to preserve  its stability and any impurity deriving from the process  used, but excluding any solvent which may be separated  without affecting the stability of the substance or changing its composition” (Art. 3.1 REACH). Example:  methane, hydrocarbons, sulphuric acid, ethanol,  calcium carbonate, silicon dioxide, elemental metals  such as copper and aluminium. (Detailed information  on identification and naming of Substances in REACH  can be found in the “Guidance for identification and  naming of substances under REACH”).


高关注度物质(SVHC):

根据REACH第57条规定,以下物质被视为高关注度物质: 

a)符合根据指令67/548/EEC(“CMR – 物 质”)分类为1a类或1b类致癌、致突变或具有生殖毒性的物质。 

b)REACH附录XIII规定的持久性、生物累积性和毒性物质(“PBT – 物质”)。 

c) REACH附录XIII规定的高持久性和高生物累积性物质(“vPvB – 物质”)。 

d)具有内分泌干扰性、持久性、生物累积性、 毒性及高持久性和高生物累积性的物质,与 (a)至(c)项所列物质具有相同的关注度,而且按照REACH第59条所设步骤逐条进行确认的物质。

Substances of very high concern (SVHC):

The following substances are considered of very high concern according to Art. 57 REACH: 

a) Substances meeting the criteria for classification as  carcinogenic, mutagenic, or toxic for reproduction  according to Directive 67/548/EEC (“CMR-substances”) category 1a or 1b. 

b) Substances which are persistent, bioaccumulative  and toxic according to Annex XIII REACH(“PBT-substances”). 

c) Substances which are very persistent and very  bioaccumulative according to Annex XIII REACH  (“vPvB-substances”). 

d) Substances which have endocrine-disrupting, persistent, bioaccumulative and toxic or very persistent  and very bioaccumulative properties, which give rise  to an equivalent level of concern to those of other  substances listed in points (a-c) and which are identified on a case-by-case basis in accordance with the  procedures set out in Art. 59 REACH.


落日日期:

指自此日期开始,如果没有获得特定使用授权,该物质将被禁止投放欧洲经济区市场及使用。物质的具体落日日期,请参见REACH附录XIV。 

Sunset date:

means the date(s) from which the placing on the EEA  market and the use of the substance is no longer  allowed unless an authorisation has been granted for  the specific use. The substance-specific sunset date is  specified in Annex XIV REACH.


物质或配制品供应商:

指“将物质或配制品投放市场的制造商、进口商、下游用户或经销商,物质指单独物质或配制品中的物质。”(REACH第3.32条) 

Supplier of a substance or a mixture:

means “any manufacturer, importer, downstream user  or distributor placing on the market a substance, on its  own or in a mixture, or a mixture” (Art. 3.32 REACH).


物品供应商:

指“物品制造商或进口商,供应链中将物品投放市场的经销商或其他行为人” (REACH第3.33条)

Supplier of an article:

means “any producer or importer of an article,  distributor or other actor in the supply chain placing an  article on the market” (Art. 3.33 REACH) 


使用:

指“所有加工、配制、消耗、贮存、保管、处理、容器填装、容器间转移、混合、物品制造或其他使用”(REACH第3.24条) 

Use:

means “any processing, formulation, consumption,  storage, keeping, treatment, filling into containers,  transfer from one container to another, mixing,  production of an article or any other utilisation”  (Art. 3.24 REACH).


使用暴露类别:

指“涵盖很多流程或使用的暴露状态,对流程或使用进行通报时, 至少需对使用进行简单概述”(REACH第3.38条)

Use and exposure category:

means“an exposure scenario covering a wide range of processes or uses, where the processes or uses are  communicated, as a minimum, in terms of the brief  general description of use” (Art. 3.38 REACH).



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