在什么条件下副产品可以免除 REACH 第 2(7)(b) 条规定的注册义务？

在什么条件下副产品可以免除 REACH 第 2(7)(b) 条规定的注册义务？

Under which conditions can by-products be exempted from registration obligations under REACH Article 2(7)(b)?

根据第2(7)(b)条，附件五所涵盖的物质不受第二、五和六章的约束。附件五第5条列出了“副产品，除非其本身进口或投放市场”。因此，豁免须符合两个累积条件：1) 该物质是副产品； 2) 该物质本身不进口也不投放市场。1) REACH 法规中没有对“副产品”一词进行定义。指导文件《附件 V 注册义务豁免指南》引用了《废物框架指令》第 5 条对“副产品”的定义：“由生产过程产生的物质或物体，其主要目的不是生产该物品，[…] 如果满足以下条件：(a) 确定可以进一步使用该物质或物体；(b) 除正常工业实践外，该物质或物体无需进一步加工即可直接使用；(c) 该物质或物体是作为生产过程的组成部分而生产的；(d) 进一步使用是合法的，即，该物质或物体满足特定用途的所有相关产品、环境和健康保护要求，并且不会导致整体不利的环境或人类健康影响。”某种物质或物品是否为副产品，必须由产品生产商根据适用废物法规的定义来决定。该决定可能需要接受相关国家废物主管部门的审查。当一方生产的物质符合《废物框架指令》对副产品的定义（条件 1）时，如果同时满足豁免条件 2，则可享受 REACH 注册豁免。2) 只有在副产品本身未进口或未投放市场的情况下，才可享受豁免。REACH 法规第 3(10) 条将进口定义为“物理引入共同体关税领土”，而第 3(12) 条将投放市场定义为“向第三方提供或使其获得报酬或免费”。进口应被视为投放市场”。换句话说，为了使物质受益于豁免，它们既不能（i）在欧盟以外生产并引入欧盟海关领土，也不能（ii）在欧盟生产并供应给第三方。满足这些条件的一个例子是，生产副产品的公司也是“进一步”用户（自用）。

Under Article 2(7)(b), substances covered by Annex V are exempted from Titles II, V and VI. Annex V entry 5 lists “By-products, unless they are imported or placed on the market themselves.” Therefore, the exemption is subject to the two cumulative conditions: 1) the substance is a by-product; and 2) the substance is not imported or placed on the market itself.1) The term ‘by-products’ is not defined in the REACH Regulation.The Guidance Document ‘Guidance for Annex V Exemptions from the obligation to register’ refers to article 5 of the Waste Framework Directive for the definition of ‘by-product’:"A substance or object, resulting from a production process, the primary aim of which is not the production of that item, […] if the following conditions are met:(a) further use of the substance or object is certain;(b) the substance or object can be used directly without any further processing other than normal industrial practice;(c) the substance or object is produced as an integral part of a production process; and(d) further use is lawful, i.e. the substance or object fulfils all relevant product, environmental and health protection requirements for the specific use and will not lead to overall adverse environmental or human health impacts." A decision on whether or not a particular substance or object is a by-product must be made by the producer of the product, based on the definition under the applicable waste legislation. This decision may be subject to review by the relevant national competent waste authorities.When a party produces a substance that meets the definition of a by-product under the Waste Framework Directive (condition 1), the exemption from REACH Registration applies if the second condition for the exemption is also met.2) The exemption applies only under the condition that by-products are not imported or placed on the market themselves.Import is defined in Art 3(10) of the REACH regulation as ‘the physical introduction into the customs territory of the Community’, whilst placing on the market is defined in Art 3(12) as ‘supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market’.In other words, in order for substances to benefit from the exemption they must neither (i) be produced outside the EU and introduced into the EU customs territory, nor (ii) be produced in the EU and supplied to a third party.An example of a case fulfilling these conditions is when the company producing the by-product is also the ‘further’ user (own use).