REACH法规在REACH第3条对物质和配制品进行了规定。这些规定适用于这些单独物质、配制品中的物质或物品中的物质的制造、投放市场或使用，以及配制品的投放市场。
The REACH Regulation lays down provisions on substances and mixtures within the meaning of Art. 3 REACH. These provisions apply to the manufacture, placing on the market or use of such substances on their own, in mixtures or in articles and to the placing on the market of mixtures.
范围：
然而，REACH不适用于：
• 放射性物质，指令96/29/Euratom。
• 海关监管的临时存放以再出口或转运的单独物质、配制品中的物质或物品中的物质。
• 不分离中间体。
• 通过铁路、陆路、内河航道、海运或航空运输的危险物质及危险配制品中的危险物质。
• 成员国出于国防利益豁免的特定单独物质、 配置品中的物质或物品中的物质。
• 根据REACH第3条的定义，指令2008/12/ EC规定的废弃物不属于物质、配制品或物品。
Scope However：
REACH does not apply to:
• Radioactive substances Directive 96/29/Euratom
• Substances on their own, in mixtures or in articles subject to customs supervision and which are in temporary storage for re-exportation or in transit.
• Non-isolated intermediates.
• The carriage of dangerous substances and dangerous substances in dangerous mixtures by rail, road, inland waterway, sea or air.
• Certain substances on their own, in mixtures or in articles exempted by Member States in the interests of defence.
• Waste, as defined in Directive 2008/12/EC, since this is not a substance, mixture or article within the meaning of Art. 3 REACH.
豁免 REACH的适用以不影响以下法规为前提：
• 欧盟劳动法规，包括：指令89/391/ EEC,98/24/EC与2004/37/EC
• 欧盟环境法规，包括：指令96/61/EC和 2000/60/EC REACH的特定章节规定了很多的豁免项，一般根据以下标准确定：
吨位： 每位制造商/进口商制造量或进口量低于1吨每年的单独物质、配制品中的物质或物品中的物质（为正常或可合理预测使用条件下的有意释放）免于注册（REACH第II篇）。
注：吨位限制不适用于授权、限制、分类、标签或安全数据表的要求。 物质的特点： 注册（REACH第II篇）、下游用户的义务 （REACH第V篇）及评估（REACH第VI篇）
Exemptions REACH applies without prejudice to:
• Community workplace legislation including Directives 89/391/EEC, 98/24/EC and 2004/37/EC.
• Community environment legislation including Directives 96/61/EC and 2000/60/EC.
There are a number of exemptions from certain Titles of REACH, generally defined according to the following criteria:
Tonnage: Substances on their own, in mixtures or in articles (where there is an intended release under normal or reasonably foreseeable conditions of use) manufactured or imported below 1 tonne per manufacturer/importer per year are exempted from registration (Title II REACH). N.B. The tonnage limit does not apply to authorisation, restriction, classification and labelling or safety data sheet requirements.
不适用于：
• 根据法规（欧委会）987/2008 附录I与II修改的REACH附录IV与附录V中列出的物质。
• 已经注册的再进口单独物质或配制品中的物质。
• 已经注册且由废弃物回收利用过程生成的单独物质、配制品中的物质或物品中的物质（ 参见欧洲化学品管理局发布的“废弃物质与回收物质指南”）。
Nature of substance:
Registration (Title II REACH), downstream users’obligations (Title V REACH) and evaluation (Title VI REACH) do not apply to:
• Substances listed in Annex IV and Annex V of REACH as amended by Regulation (EC) No 987/2008 Annex I and II.
• Re-imported substances on their own or in mixtures, already registered.
• Substances, on their own, in mixtures or in articles, already registered and resulting from a waste recovery process (consult the “Guidance on waste and recovered substances” published by ECHA).
以下物质视为已注册：
• 仅用于指令91/414/EEC, 法规 (EEC) 3600/92, 法规 (EC) 703/2001, 法规 (EC) 1490/2002, 指令2003/565/EC 中植物保护产品与指令98/8/EC与法规 (EC) 2032/2003 中生物杀灭剂的活性物质和辅料。
• 已按指令67/548/EEC进行通报的，列在欧洲已通报化学物质目录（ELINCS）中的物质。
The following substances are regarded as being registered:
• Active substances and co-formulants for use in plant protection products only Directive 91/414/EEC, Regulation (EEC) No 3600/92, Regulation (EC) No 703/2001, Regulation (EC) No 1490/2002, Decision 2003/565/EC and biocidal products only Directive 98/8/EC and Regulation (EC) No 2032/2003.
• Substances already notified Directive 67/548/EEC listed in the European List of Notified Chemical Substances (ELINCS).
以产品与工艺为导向的研究与开发 （PRORD）：
物品制造商或进口商或生产商为产品和工艺导向研发（PPORD）制造或进口的物质可豁免REACH第II篇（注册）第5、6、7、17、18与 21条规定的义务5年。对于某些特定物质和用途，欧洲化学品管理局可将期限从5年延长至10年。在这种情况下，物品制造商、进口商或生产商应将相关信息通报给欧洲化学品管理局 （REACH第9条）。
Product and process oriented research and development (PPORD):
Substances manufactured or imported for the purposes of product and process oriented research and development (PPORD) by a manufacturer or importer or producer of articles are exempted from Art. 5, 6, 7, 17, 18 and 21 of Title II REACH (registration) for a period of five years. ECHA may prolong the five years to ten years for certain substances and uses. The manufacturer, importer or producer of articles must in this case notify certain information to ECHA (Art. 9 REACH)
现场分离中间体及运送分离中间体：
现场分离中间体及运送分离中间体豁免REACH第II篇第一章规定的义务（注册） ，REACH第8条与第9条除外。现场分离中间体及运送分离中间体也豁免授权（REACH第 2.8条）。但是，REACH第II篇第3章规定了特定种类的分离中间体的具体注册义务及信息要求。
On-site isolated intermediates and transported isolated intermediates:
On-site isolated intermediates and transported isolated intermediates are exempted from Chapter 1 of Title II REACH (registration) with the exception of Art. 8 and 9 REACH. They are also exempted from authorisation (Art. 2.8 REACH). However, specific registration obligations and information requirements for certain types of isolated intermediates are described in Chapter 3 of Title II REACH.
聚合物： 聚合物豁免注册和评估，但可能仍需要授权和限制。 但是，聚合物制造商或进口商必须就特定条件下的单体物质或供应链中的上游行为人未注册的其他物质，向欧洲化学品管理局申请注册。
Polymers: Polymers are exempted from registration and evaluation but may still be subject to authorisation and restrictions. However, manufacturers or importers of a polymer must submit a registration to ECHA for the monomer substances or any other substances that have not already been registered by an actor up the supply chain under certain conditions (Art. 6.3 REACH). E.g. Vinyl chloride monomer (VCM) must be registered for producing PVC. The polymer PVC is exempted from registration but may be restricted for specific uses depending on the residual monomer content.
如：生产聚氯乙烯的氯乙烯单体（VCM）必须进行注册。聚合物聚氯乙烯无需注册，但根据游离单体的含量，其特定用途可能会受到限制。 关于授权豁免，请参见第5.11章。
For exemptions from authorisation, please refer to Chapter 5.11.
更多信息，详见： REACH第1、2、6、9、138.4、138.6条。
For more details, please refer to: Art. 1, 2, 6, 9, 138.4, 138.6 REACH.
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