杀生物剂和植物保护产品（PPP）中使用的物质是否必须根据 REACH 注册？

杀生物剂和植物保护产品（PPP）中使用的物质是否必须根据 REACH 注册？

Do substances used in biocides and plant protection products (PPP) have to be registered under REACH?

用于生物杀灭剂产品的活性物质被视为已注册，因为生物杀灭剂产品及其活性成分受法规 (EU) 528/2012（生物杀灭剂产品法规）的约束。但是，必须满足几个条件才能享受豁免。这些条件在 REACH 法规第 15(2) 条中规定，并在注册指南 http://echa.europa.eu/guidance-documents/guidance-on-reach 第 2.2.4.1 节“用于生物杀灭剂产品的物质”中进行了解释。用于植物保护产品 (PPP) 的活性物质被视为已注册，因为植物保护产品及其活性成分受法规 (EC) 1107/2009 的约束。请注意，尽管 REACH 法规第 15(1) 条提到了辅助配方，但它们目前并不符合该条款规定的条件。因此，植物保护产品中使用的辅助配方不符合豁免条件，不视为已注册。注册指南 http://echa.europa.eu/guidance-documents/guidance-on-reach 第 2.2.4.2 节“用于植物保护产品的物质”对此进行了进一步解释。值得注意的是，只有用于生物杀灭产品和植物保护产品 (PPP) 的活性物质数量才视为根据 REACH 注册。因此，如果物质不用作生物杀灭产品或植物保护产品 (PPP) 中的活性成分，则豁免不适用于此其他用途，并且用于非生物杀灭或非植物保护产品 (PPP) 用途的物质数量必须注册。

Active substances for use in biocidal products are regarded as already registered, as biocidal products and their active ingredients are covered by Regulation (EU) 528/2012 (Biocidal Products Regulation). However, several conditions have to be fulfilled to benefit from the exemption. These conditions are laid down in Article 15(2) of the REACH Regulation and explained in section 2.2.4.1- 'Substance for use in biocidal products' of the Guidance on registration http://echa.europa.eu/guidance-documents/guidance-on-reach. Active substances for use in plant protection products (PPPs) are regarded as registered as the plant protection products and their active ingredients are covered by Regulation (EC) 1107/2009. Please note that even though co-formulants are mentioned in Article 15(1) of the REACH Regulation, currently they do not meet the conditions laid down in this Article. Therefore co-formulants used in plant protection products do not qualify for the exemption and are not regarded as registered. This is further explained in section 2.2.4.2- 'Substance for use in plant protection products' of the Guidance on registration http://echa.europa.eu/guidance-documents/guidance-on-reach. It is important to note, that only the quantities of the active substance for use in biocidal products and for use in PPPs are considered registered under REACH. Thus, if the substance is not used as an active ingredient in a biocidal product or a PPP, then the exemption would not apply to this other use and the quantity of the substance for the non-biocidal or non-PPP use would have to be registered.