生物杀灭剂产品中使用的哪些物质被视为已注册？

生物杀灭剂产品中使用的哪些物质被视为已注册？

Which substances used in biocidal products are regarded as registered?

在下列情况下，为用于生物杀灭剂产品而制造或进口的活性物质被视为已注册用于该生物杀灭剂产品：该活性物质已根据第 528/2012 号法规 (EU)（“BPR”）获得批准，或该活性物质正在根据第 98/8/EC 号指令第 16(2) 条建立的现有活性物质审查计划中进行评估，并根据 BPR 第 89 条继续进行。已批准活性物质清单可从 ECHA 网站获取：http://echa.europa.eu/nformation-on-chemicals/biocidal-active-substances 要查看哪些活性物质处于审查计划中，请参阅委员会授权法规 (EU) No 1062/2014 第一部分附件二，也可从 ECHA 网站获取：http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance 以下情况也可获得 REACH 注册豁免： 活性物质制造/进口用于具有简化授权的杀生物产品（BPR 第 27 条） 活性物质制造/进口用于具有临时授权的杀生物产品（BPR 第 55 条） 活性物质制造/进口仅用于为科学或商业目的进行实验或测试的杀生物产品产品和工艺导向的研究与开发（《生物制剂条例》第 56 条）。如果您生产或进口用于生物杀灭和非生物杀灭用途的物质，则需要注册该物质在非生物杀灭产品中的使用量。

Active substances manufactured or imported for use in biocidal products are regarded as registered for the use in that biocidal product in the following situations: The active substance has been approved in accordance with Regulation (EU) No 528/2012 ("BPR"), or The active substance is under assessment in the review programme of existing active substances established under Article 16(2) of Directive 98/8/EC and continued under Article 89 BPR. The list of approved active substances is available from the ECHA website: http://echa.europa.eu/nformation-on-chemicals/biocidal-active-substances To check which active substances are in the review programme, please see Annex II, part I to Commission Delegated Regulation (EU) No 1062/2014, also available from the ECHA website: http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance An exemption from REACH registration also applies in the following cases: The active substance is manufactured/imported for use in a biocidal product which has a simplified authorisation (Article 27 BPR) The active substance is manufactured/imported for use in a biocidal product which has a provisional authorisation (Article 55 BPR) The active substance is manufactured/imported for use exclusively in a biocidal product which is the subject of experiments or tests for the purposes of scientific or product and process-orientated research and development (Article 56 BPR). If you manufacture or import a substance for biocidal and non-biocidal uses, you need to register it for the quantities of the substance used in non-biocidal products.