废弃物的定义:“废弃物是指持有者废弃、打算废弃或被要求废弃的物质或物体”(废弃 物框架指令,“WFD”,2008/98/EC第3.1 条)。
The definition of waste reads: “Waste shall mean any substance or object which the holder discards or intends or is required to discard” (Art. 3.1 Waste Framework Directive, “WFD”, 2008/98/EC).
废弃物框架指令(WFD)中定义的废弃物不能视为REACH所指的物质、配制品或物品 (REACH第2.2条14)。其原因是确保可使用性及鼓励废弃物的再回收和再利用(REACH 引语11)。因此,REACH的要求不适用于废弃物。但是,这并不表示废弃物完全不在法规适用范围内。
Waste as defined in the WFD is not considered a substance, mixture or article under REACH (Art. 2.214 REACH). The reason for that is to ensure workability and to maintain the incentives for waste recycling and recovery (Recital 11 REACH). Consequently REACH requirements do not apply to waste. Nevertheless, this does not mean that waste is totally out of the scope of the Regulation.
按照REACH规定,需进行注册的单独物质、 配制品中的物质或物品中的物质的制造商或进口商必须真正将物质的废弃寿命周期阶段考虑在内,如适用,应详细制定暴露状况或在 REACH第33条(也可参照5.10节,“物品中 候选物质的信息传递要求”)下被认为是“安全使用”。也就是说制造商或进口商必须考虑物质制造和使用过程中产生的废弃物。如适用,物品制造过程中产生的废弃物和与含有物质的物品报废处理有关的废弃物可能也需要考虑。
According to REACH, manufacturers or importers of a substance, in mixtures or in articles, subject to registration are indeed obliged to take the waste stage of the life-cycle of substances into account, where relevant, in particular to create exposure scenarios or when assessing “safe use” under Art. 33 REACH (see also Chapter 5.10 “Communication Requirements for CL Substances in Articles”). That means they have to consider waste produced during the manufacturing and use phases of substances. If relevant, waste produced during article manufacturing as well as waste linked to the end of article life containing substances may need to be considered.
如果材料经过再利用过程不再是废弃物,则其必须符合REACH的要求–有一些豁免。遗憾的是,在编制时,除某些废金属外,对废弃物不再为废弃物的标准尚无明确定义。(参见欧委会法规(EU)333/2011制定某些种类废金属 不再是指令2008/98/EC定义的废弃物的测定标准)。成员国可根据具体情况决定废弃物不再是废弃物的条件(废弃物框架指令第6.4条15 ),或将来可制定具体材料废弃物状态结束标准。
As soon as a material ceases to be waste in a recycling or recovery process, it has to comply with the REACH requirements - with a number of exemptions. Unfortunately at the time of writing there is no clear definition available when waste ceases to be waste with the exception of certain metal scraps (see Council Regulation (EU) No 333/2011 establishing criteria determining when these certain types of scrap metal cease to be waste under Directive 2008/98/EC). Member States may decide on a case by case basis when waste ceases to be waste (Art. 6.4 WFD15) or criteria for the end of waste status will be developed for specific materials in the future.
废弃物框架指令第6.1条给出确定某些特定废物何时不再是废物的标准。例如,DEHP中授权决定在关于PVC再生得出的结论是根据废弃物框架指令再循环材料不再是废物。
根据REACH第2.7.d条,如果材料满足以下条件,回收材料可免于注册、信息传递和评估:
• 与已注册物质相同;
• 可提供充分的符合REACH第31条或32条规定的关于再利用物质的安全信息。
Criteria for defining when certain specified wastes cease to be wastes are given in Art 6.1 WFD. For example, in the authorisation decision on DEHP in recycled PVC it was concluded that recycled materials have ceased to be waste in accordance with the WFD.
According to Art. 2.7.d REACH, recovered materials can be exempt from registration, communication and evaluation, when the material:
• is the same as a substance that has already been registered,
• sufficient safety information according to REACH Art. 31 or 32 is available for this recovered substance.
这意味着对再利用材料来说,制造商/进口商必须保证原物质已经注册并应向回收材料的回收公司或组织提供有害物质的安全数据表或非有害物质的类安全数据表安全信息。
This means that, for recovered material, the manufacturer/importer has to ensure that the raw substances have already been registered and an SDS for hazardous substances or SDS-like safety information for non-hazardous substances must be available to the recovering company or organisation for this recovered material.
某些再利用过程也可减少REACH规定的义务。例如,在再利用过程结束时,再利用物品可视为物品的情况。由于只有物质才需要注册,因此在这种情况下,无需进行注册(不包括物品有意释放的物质)。但是制造商或进口商必须履行其他义务,如第33条规定的义务( 如适用)。
Some recovery processes can also limit the obligations under REACH. This is the case for example if at the end of the recovery process, the recovered product can be considered an article. In that case, there is no need to register (except substances intentionally released from that article) since registration is only relevant to substances. But the manufacturer or the importer has to comply with other obligations like Art. 33 if applicable.
但是,如果物质已经被包含在REACH授权清单中,则义务适用于循环或回收材料中使用的物质(见第5.11节,“授权程序”)
Obligations on substances used in recycled or recovered materials, however, apply if the substances have been included into the REACH Authorisation list (see Chapter 5.11, “Authorisation procedure”).
为了在将投入欧盟市场的再生材料中使用该物质,回收公司按照授权程序进行操作。只有申请人能够证明收益大于风险且更安全的替代品在经济和技术上不可行时,授权才会通过。
This requires recycling companies to undergo the authorisation process for the use of the substance in a recycled material that they would like to place on the EU market. An authorisation will only be granted if the applicant can prove that the benefits outweigh the risks and that safer alternatives are economically and technologically not feasible.
关于PVC再生中DEHP的第一个案例证明,提供此类证据非常困难且受到严重挑战。
A first case on DEHP in recycled PVC has proven that the provision of such evidence is very difficult and heavily challenged.
注:由于在大多数情况下,物品生产商和回收商之间的沟通链处于中断状态,因此,履行此义务极其困难。其他信息,请参见附录L7“ 备件和二手零件立场书”。
NOTE:The fulfilment of this obligation is considered to be extremely difficult because in most cases the communication chain between the article producer and the recycler is disrupted. For further information please refer to Annex L7 “Position Paper Spare & Used Parts”
再利用过程中无意再利用的物质也可免于注册。也就是说,如果某过程旨在再利用如聚合物等材料,且其含有有意或无意添加的不再有意用于再利用材料的成分,成分浓度如低于20%w/w,则其可视为杂质。在这种情况下, 这些成分本身无需进行单独的注册。如果因为存在某成分而专门选用再利用材料,即使此成分浓度低于20%w/w,也应视为单独物质,例如:聚氯乙烯中的阻燃剂。此成分可能需要进行注册,除非以前已经进行注册。
Another exemption covers substances unintentionally recovered in a process. That means if the process is designed to recover a material like a polymer that contains constituents, intentionally added or not, that are unintended for the recovered material, these constituents can be considered as impurities when they are below 20% w/w. In this case they do not require separate registration on their own. When the recovered material is intentionally selected for the presence of a certain constituent, the constituent is considered a separate substance even when below 20% w/w, for example a desired flame retardant in PVC. In this case the constituent may fall under the registration obligation unless it has been registered before.
注:即使无需对“杂质”进行注册,也必须考虑暴露状况、安全数据表或其他风险的评估。
NOTE Even if there is no need to register “impurities”, they have to be taken into account for exposure scenarios, SDSs and other risk assessments.
根据REACH规定,对于成分未知或成分可变的物质、复杂反应产物或生物材料(UVCB物质),如果其有害性不发生显著变化且属于同一类别,无论其可变成分如何,都可按照单独物质进行注册(REACH引言45)。根据REACH第2.7.d条规定,在这种情况下,制造商或进口商需履行注册义务。
Substances of unknown or variable composition, complex reaction products or biological materials (UVCB substances) may be registered as a single substance under REACH, despite their variable composition, provided that the hazardous properties do not differ significantly and warrant the same classification (Recital 45 REACH). In that case, the manufacturer or importer cannot use the exemption according to Art. 2.7.d REACH.
欧洲化学品管理局于2010年5月发布的废弃物和再利用物质指南第2版附录1列出了详细的再利用材料,可对确定再利用材料是否需要注册提供帮助。
Annex 1 of the ECHA Guidance on waste and recovered substances, Version 2 dated May 2010 lists particular streams of recovered materials, which may help when deciding whether or not to register a recovered material.
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