加拿大害虫防治产品注册申请
临安科达认证技术咨询服务有限公司 时间：2022-03-07 点击：1249 次
一种化学有害生物防治产品，是一种有效成分，其化学名称，通用化学名称和CAS登记号，其在其中所含产品总重量中所占的百分比，每种污染物和其他杂质的名称，它包含每种污染物和杂质的总重量百分比
Application for Registration 申请注册
6 (1) An application to register or amend the registration of a pest control product must include all of the following information:6（1）申请注册或修改害虫防治产品注册的申请必须包括以下所有信息：(a) the applicant’s name, address and signature or, if the application is made by a representative of the applicant, both the representative’s and applicant’s name and address and the representative’s signature;（a）申请人的姓名，地址和签名，或者，如果申请是由申请人的代表提出的，则代表和申请人的姓名和地址以及代表的签名；(b) the name and address of the place of manufacture of the pest control product;(c) the product name referred to in paragraph 26(1)(a);(d) the product type referred to in paragraph 26(1)(b);(e) the product’s physical form referred to in paragraph 26(1)(c);(f) the registration number referred to in paragraph 26(1)(i), if there is one;（f）第26（1）（i）段所指的注册号（如果有的话）；(i) a chemical pest control product that is an active ingredient, its chemical name, common chemical name and CAS registry number, its percentage of the total weight of the product in which it is contained, the name of each contaminant and other impurity that it contains, and the percentage of total weight of each contaminant and impurity,（i）一种化学有害生物防治产品，是一种有效成分，其化学名称，通用化学名称和CAS登记号，其在其中所含产品总重量中所占的百分比，每种污染物和其他杂质的名称，它包含每种污染物和杂质的总重量百分比，(ii) a chemical pest control product other than an active ingredient, the chemical name, common chemical name and CAS registry number of each active ingredient in the product, each active ingredient’s percentage of the total weight of the product, and the registration number of each active ingredient or other pest control product used to manufacture the product, and（ii）除活性成分外的化学害虫防治产品，产品中每种活性成分的化学名称，通用化学名称和CAS登记号，每种活性成分在产品总重量中所占的百分比以及注册号，用于制造产品的每种活性成分或其他害虫防治产品，以及(iii) any other pest control product, any characteristics that are relevant to its health or environmental risks or value;（iii）任何其他害虫防治产品，与其健康或环境风险或价值有关的任何特征；(h) in the case of a pest control product that contains one or more formulants, the name of each formulant, its CAS registry number, if there is one, the name and address of the supplier of each formulant, each formulant’s percentage of the total weight of the product, and the purpose of each formulant in the product;（h）如果有害生物防治产品包含一种或多种配方，则每个配方的名称，其CAS登记号（如果有的话），每个配方的供应商的名称和地址，每个配方的百分比产品的总重量，以及产品中每种配方的用途；(i) the size, type and specifications of the package in which the pest control product is to be distributed; and（i）分发有害生物防治产品的包装的尺寸，类型和规格；和(j) the statement described in paragraph 26(1)(h).(2) The applicant must include an electronic copy of the proposed label with every application to register a pest control product and with any application to amend the registration of a pest control product that would result in a change to the label.（2）申请人必须在每次注册有害生物防治产品的申请以及任何修改有害生物防治产品的注册的申请中均附有建议标签的电子副本，以免更改标签。(3) The applicant must include with every application to register or amend the registration of a pest control product a statement signed by the applicant certifying that the information in the application is accurate and complete.（3）申请人必须在每份申请中注册或修改害虫防治产品的注册，并附有申请人签署的声明，以证明申请中的信息是准确和完整的。7 [Repealed, SOR/2014-24, s. 5]Additional information required 8 In addition to the information required by section 6, the applicant must provide the Minister with any other information that the Minister may require to evaluate the health and environmental risks and the value of the pest control product, including, if relevant to the product and its conditions or proposed conditions of registration, the results of scientific investigations respecting any of the following:8，除了第6条要求的信息外，申请人还必须向部长提供部长可能需要的其他任何信息，以评估卫生和环境风险以及有害生物防治产品的价值，包括与该产品有关的信息以及其条件或拟议的注册条件，以及涉及以下任何方面的科学研究结果：(a) the efficacy of the pest control product for its intended purpose;(b) the risks posed by the pest control product and its derivatives to humans or animals that may be exposed to it, including when it is manufactured, handled, stored, transported or distributed or during or after its use or disposal, in accordance with its conditions or proposed conditions of registration;（b）有害生物防治产品及其衍生物可能对人体或动物造成的风险，包括根据其生产，处理，储存，运输或分发的时间或在其使用或处置过程中或之后，其条件或拟议的注册条件；(c) the effect of the pest control product and its derivatives on host organisms in connection with which it is intended to be used;（c）有害生物防治产品及其衍生物对拟使用的宿主生物的影响；(d) the effect of the pest control product and its derivatives on representative species of organisms not targeted by its intended use;（d）害虫防治产品及其衍生物对非预期用途的代表性生物的影响；(e) the degree of persistence, retention and movement of the pest control product and its derivatives in the environment, including the degree to which the pest control product and its derivatives may leach or dislodge from things treated with the product;（e）有害生物防治产品及其衍生物在环境中的持久性，保留和移动的程度，包括有害生物防治产品及其衍生物可能从用该产品处理过的物体中浸出或清除的程度；(f) methods of analysis for detecting the components and measuring the characteristics of the pest control product;（f）分析方法以检测有害生物防治产品的成分并测量其特征；(g) methods of analysis for detecting and determining the amount of the pest control product and its derivatives in human food, animal feed and the environment when the product is used in accordance with its conditions or proposed conditions of registration;（g）当按照其条件或拟议的注册条件使用该产品时，用于检测和确定该害虫防治产品及其衍生物在人类食品，动物饲料和环境中的含量的分析方法；(h) appropriate methods for detoxifying or neutralizing the pest control product in water, air or soil, or on any surface;（h）在水，空气或土壤或任何表面上解毒或中和害虫防治产品的适当方法；(i) appropriate methods for disposing of the pest control product and its empty packages;(j) the stability of the pest control product under normal conditions of storage and display;（j）有害生物防治产品在正常储存和展示条件下的稳定性；(k) the compatibility of the pest control product with other pest control products with which it is recommended to be, or is likely to be, mixed;（k）有害生物防治产品与建议或可能混合的有害生物防治产品的相容性；(l) the effect of mixing the pest control product or using it simultaneously with other pest control products on its value and the health and environmental risks associated with its use;（l）将有害生物防治产品混合或与其他有害生物防治产品同时使用对其价值以及与使用有关的健康和环境风险的影响；(m) the chemical and physical properties, or the species or strain and biological properties, of the pest control product, its composition, and specifications and processes for its manufacture, including quality control processes;（m）害虫防治产品的化学和物理特性，种类或品系和生物学特性，其组成，制造的规格和过程，包括质量控制过程；(n) the fate of the pest control product in humans or animals exposed to it, including the identity and quantity of all the major metabolites and other derivatives that result from its use;（n）有害生物控制产品在接触该产品的人或动物中的命运，包括其使用所产生的所有主要代谢产物和其他衍生物的身份和数量；(o) the residues of the pest control product and its derivatives that may remain in or on human food or animal feed after its use in accordance with its conditions or proposed conditions of registration;（o）根据其条件或拟议的注册条件使用后，可能残留在人类食品或动物饲料中或之上的虫害防治产品及其衍生物的残留物；(p) the risks posed to humans or animals exposed to the pest control product or its derivatives through their diet or drinking water when the product is used in accordance with its conditions or proposed conditions of registration;（p）当按照其条件或拟议的注册条件使用产品时，通过其饮食或饮用水暴露于该害虫防治产品或其衍生物的人类或动物面临的风险；(q) the effect of storing and processing, including post-market processing, human food or animal feed in relation to which the pest control product was used on the dissipation or degradation of the pest control product and any of its derivatives;（q）与使用害虫防治产品有关的储存和加工（包括上市后加工，人类食品或动物饲料）对害虫防治产品及其任何衍生物的消散或降解的影响；(r) the proposed maximum residue limits for the pest control product and its derivatives in or on human food; and（r）建议在人类食品中或之上的有害生物防治产品及其衍生物的最大残留限量；和(s) the fate of the pest control product and its derivatives in subsequent crops of human food or animal feed.（s）有害生物防治产品及其衍生物在人类食品或动物饲料的后继作物中的命运。Additional information — affidavit and contents9 (1) When, in the context of an application for registration or to amend a registration, the Minister considers additional information under paragraph 7(6)(b) of the Act that is not publicly available, the applicant must be given access to that information by the Minister for the purpose of making representations under that paragraph with respect to the information, if the applicant submits to the Minister an affidavit made under oath or a statutory declaration under the Canada Evidence Act made before a commissioner for oaths or for taking affidavits that9（1）在申请注册或修改注册时，部长根据法令第7（6）（b）款考虑了其他未公开的信息，则必须允许申请人访问，如果申请人向部长提交根据宣誓作出的誓章或根据《加拿大证据法》在法定宣誓书上作出的法定声明，则部长为根据该款作出陈述而作出陈述宣誓书(a) identifies the information to which access is being requested;(b) acknowledges that the access is given only for the purpose of enabling the applicant to make representations to the Minister with respect to the information;（b）确认访问仅是为了使申请人能够就该信息向部长做出陈述；(c) states that the applicant will not use the information or make it available to any person for any other purpose; and（c）声明申请人不会出于任何其他目的使用该信息或将其提供给任何人；和(d) states that the information and any copies of it will be returned to the Minister when the stated purpose has been achieved.（d）声明，在达到所述目的后，信息及其任何副本将退还给部长。(2) The applicant to whom access to additional information is given under subsection (1) must not use the information or provide it to any person for any purpose other than to make representations under paragraph 7(6)(b) of the Act with respect to the information.（2）根据第（1）款获得附加信息访问的申请人，除根据本法第7（6）（b）款作出陈述外，不得出于任何目的使用该信息或将其提供给任何人。(3) Additional information to which access is given under subsection (1) and any copies of it must be returned to the Minister by the applicant immediately after they have made their representations with respect to the information.（3）根据第（1）款获得访问权的其他信息及其任何副本必须由申请人在对信息做出陈述后立即退还给部长。10 For the purpose of subsection 42(4) of the Act, evaluation reports that are placed in the Register under paragraph 42(2)(f) of the Act must include a reference to information placed in the Register under paragraph 42(2)(e) of the Act.10为了该法令第42（4）条的目的，根据该法令第42（2）（f）款放置在注册簿中的评估报告必须包括对根据第42（2）条放置在名册中的信息的引用 （e）该法令。11 On application to register or amend the registration of a pest control product, the applicant must, if requested by the Minister, provide the Minister with a sample of11 在申请注册或修改害虫防治产品的注册时，如果部长要求，申请人必须向部长提供以下样品：(a) the pest control product;(b) the technical grade of its active ingredient; and(c) the laboratory standard of its active ingredient.12 When a pest control product is registered or a registration is amended under section 8 of the Act, the Minister must issue a registration certificate that bears the registration number of the pest control product and sets out any conditions of registration specified by the Minister.
12根据本法第8条对害虫防治产品进行注册或对注册进行修改时，部长必须颁发带有该害虫防治产品注册号的注册证书，并列出部长指定的任何注册条件。
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