巴拉圭登记要求.docx

Documents needed for registration of pesticide in Paraguay巴拉圭登记要求原药的登记要求序号英文原文中文翻译1Letter of Authorization. （No need to be legalized ）授权信（无需使馆认证）2Registration certificate （Legalized by Embassy of Paraguay）登记证（ICAMA）(使馆认证)3Identity 基本信息1) Applicant 2) Manufacturer 3) Common name: accepted by ISO, or proposed, in its order, by BSI, ANSI, WSSA or the manufacturer, until its acceptance or denomination by ISO. 4) Synonymous 5) Chemical name accepted or proposed by IUPAC 6) Number CAS 7) Empirical formula 8) Structural formula 9) Number of experimental code 10) Chemical(s) group(s) 11) Schematic diagram of the manufacture process 12) Minimum content of active ingredient 13) Isomers 14) Maximum limit of each present impurity whose content is equal or superior to 1g/kg (based on the data of analysis of five lots like minimum). The impurities must be identified and be quantified. The identified fraction of the active substance chemical technical degree does not have to surpass the 20 g/kg. 15) Maximum limit of each excellent impurity whose content is inferior to 1 g/kg 16) Additives (ej.: estabilizantes) 1) 申请人2) 制造商3) 通用名4) 同义的名称5) IUPAC命名6) CAS 号7) 经验式8) 化学式9) 实验代码10) 化学组11) 生产工艺的原理图12) 活性成分的最低含量13) 异构体14) 含量大于等于1 g/kg的杂质的最大含量15) 含量小于1 g/kg的杂质的最大含量16) 添加剂4GPS Position Of The Mufacture工厂的地理坐标5Five batch report5批次报告6Certificate of analysis.分析单7Composition certificate signed by the responsible of the manufacturer company组成8Manufacturing process生产工艺1) Name and address of the manufacturer.2) General characterization of the process. 3) Diagram of manufacture with the different chemical reactions that are happening during the process.4) Identification of the used materials for the production of the product.5) Description of the used equipment.6) General description of the conditions (for example: temperature, pressure, pH, humidity) that are controlled during the process.7) Description of possible reaction after the formulation process between active ingredients o between this and others components of the formulation or the package. Possible migrations of materials of the package and the product.1) 生产商的名称和地址2) 工艺的一般特征3) 生产工艺流程图（化学反应式）4) 生产原料的鉴定5) 设备的描述6) 工艺中的各条件7) 生产中的副反应及材料和产品的可能性迁移。9MSDSMSDS10ANALYTICAL METHOD（Analytical methods for the cuali-quantitative determination of the active substance pure chemistry, of impurities and those impurities greater to 0.1% and, when it corresponds, for the determination of isomers and estabilizantes.）活性成分，杂质、及相应的异构体的定量分析方法。11PHISICAL AND CHEMICAL PROPERTIES (according to methods internationally recognized)物化性质（根据国际公认的分析方法）11.1. Aspect: (Physical state, Color, Scent )11.2. Point of Fusion (for solids to room temperature) 11.3. Boiling point (for liquids to room temperature) 11.4. Density 11.5. Steam pressure 11.6. Volatileness 11.7. Phantom of absorption 11.8. Water solubility 11.9. Solubility in reliable organic 11.10. Coefficient of partition in n-octanol/water11.11. Water stability 11.12. Inflammability or point of ignition (in the case of combustible incendiary fuels) 11.13. Surface tension (aqueous solutions) 11.14. Explosive properties 11.15. Oxidating properties (corrosivity) 11.16. Reactivity with the material of packages 11.17. pH 11.18. Constant of dissosciation in water 11.19. Viscosity (for liquids to room temperature) 11.1. 物化状态、颜色、状态11.2. 沸点（固体）11.3.沸点（液体）11.4. 密度11.5. 蒸汽压11.6.挥发性11.7. 吸附系数11.8. 在水中的溶解性11.9.在有机溶剂中的溶解性11.10.正辛醇/水的比例系数11.11. 在水中稳定性11.12.可燃性11.13.表面张力11.14. 爆炸性11.15. 氧化性（腐蚀性） 11.16.包装材料活泼性11.17. pH 11.18. 水中解离常数11.19.粘度（液体）12Toxicity data毒理资料12.1. Acute Toxicity Oral, Skin, Inhalatory Cutaneous and ocular irritation ,Cutaneous Sensibilizacion. 12.2 Toxicity in the short / medium term a. Cumulative oral (28 days study)b. Oral administration in rodents and non-rodent (90days)c. Other ways: Inhalatory, Dermal12.3 Chronicle Toxicity a. Oral to long term b. Carcinogenicity 6.4 Mutagenicity a. Genetic Mutations (Ames Test or others) b. Chromosomal aberrations c. DNA perturbations 12.5. Effects on Reproduction a Teratogenicity b. Studies of reproductive effects in at least two generations of mammals 12.6 Metabolism in Mammals a. Study of: (after oral and dermal administration) Absorption; Distribution; Excretion. b. Understanding the metabolic pathways 12.1.急性毒性（6项）12.2 短中期毒性a. 经口累积性毒性 (28 d)b. 啮齿和非啮齿动物的90d经口试验c. 其他: 吸入, 经皮12.3 慢性毒性a. 慢性经口试验b. 致癌性6.4 诱变性a. 基因突变b.染色体变异c. DNA 变异12.5.对繁殖的影响A. 致畸性b. 二代生殖的影响12.6 哺乳动物内的新陈代谢a. 经口和经皮处理后的研究：吸收分布排泄b. 代谢路径备注Ing. Agr. Francisco Regis Mereles 的PPT. 江苏好收成同行同事的咨询。制剂登记要求序号英文原文中文翻译1Letter of Authorization. （No need to be legalized ）授权信（无需使馆认证）2IDENTITY 基本信息2.1. Name of the applicant 2.2. Name of the formulador 2.3. Commercial name 2.4. Number of the registry of the active substance chemical technical degree. 2.5. Class of use to that it is destined (herbicida, insecticide, etc.). 2.6. Type of formulation (gravyable, concentrated dust emulsionable, etc.). 2.1 申请者2.2 生产商2.3 商品名2.4 原药的登记证号2.5农药类型(杀菌剂、除草剂、杀虫剂等)3Registration certificate-ICAMA/ Certificate of origin/ Or Manufacturing Certificate for export CERTIFY BY CCPIT and Legalized by Embassy of Argentina in China, preferably.ICAMA,或原产地证明，或生产证明（阿根廷使馆认证）4Certificate of analysis.分析单5 Composition certificate signed by the responsible of the manufacturer company组成证明6Composition certificate of the formulated product made in 5 lots.5批次的组成证明7MSDSMSDS8Manufacturing process生产工艺9Analytical Method分析方法。10PHISICAL AND CHEMICAL PROPERTIES (according to methods internationally recognized)物化性质（根据国际公认的分析方法）10.1. Aspect10.1.1. Physical state 10.1.2. Color 10.1.3. Scent 10.2. Stability in the storage (respect to its composition and to the physical properties related to the use).10.3. Relative density 10.4. Inflammability 10.4.1. For liquids, point of ignition10.4.2. For solids, it must be clarified if the product is or non-inflammable. 10.5. Acidez/Alcalinidad and pH. 10.6. Explosive properties. 10.7.ASPECTS RELATED TO ITS USEa) Wettability (for dispersible powders) b) Persistence of foam (products that are applied with water) c) Suspensibility (for WP, SC) d) Particle size analysis in wet (for WP, SC)e) Particle size analysis in dry (granules and powder) f) Emulsion stability (for EC) g) Corrosivity h) Incompatibility with other productsi) Density at 20oC in g/mL (for liquids) j) Flash Point (oils and solutions) k) Viscosity (oils, suspensions or emulsions) l) Index of sulfonation (oils) m) Dispersion (for WG) n) Detachment of gas (for gas generators) n) Ease and fluidity (for dry powders) o) Iodine index and index of saponification (oils) p) Water solubility q) Solubility/miscibility in reliable organic. u) Surface tension (aqueous solutions) 10.1. 外观（状态，颜色、气味）10.2.储存稳定性（组成和状态等）10.3. 相对密度10.4. 可燃性9.4.1. 着火点（液体）10.4.2. 易燃性（固体）10.5.酸碱度10.6. 爆炸性10.7.使用相关方面a) 可湿性b) 持久起泡性c) 悬浮性d) 粒度分析（湿筛）e) 粒度分析（干筛）f) 乳化稳定性（EC）g) 腐蚀性h) 与其他产品的兼容性i) 密度(液体，20oC)j) 闪点k) 粘度l) 磺化指数(油)m) 分散性n) 气体的脱离性n) 粉末的松软度和流动性o) 皂化和碘化p) 在水中的溶解性q)在有机溶剂中的溶解性u) 表面张力11Studies of Toxic effects in mammal species:毒理报告Acute toxicity for mammals：Oral, Skin, Inhalatoria, Cutaneous and ocular irritation, Cutaneous Sensibilizacin. 急性毒性（6项）经口，经皮，吸入，皮肤和眼睛腐蚀，致敏12OBLIGATORY MEDICAL INFORMATION必要的医学信息12.1. Diagnosis and symptoms of poisoning 12.2. Proposed treatments. 12.3. First aid 12.4. Antidote 1 12.5. Medical Treatment. Complementary information Medical (when they are available). a. Observation on the exhibition of the population in general and studies epidemiologists. b. Direct observation of clinical, accidental and deliberate cases12.1 中毒的症状12.2. 推荐的治疗12.3. 急救12.4.解毒剂12.5.治疗补充的医学信息a.大体人口以及流行病专家研究的报告b. 临床、以外、人为的直接观察13Data of the effects on the atmosphere.生态毒性12.1. Acute toxicity to non-objective organisms. 12.1.1. Aquatic organisms 12.1.2. Bees 112.1.3. Birds12.2 Effects on the environmenta) Behavior in soilResidualityLeachingDegradability b) Behaviour in water and airResidualityDegradabilityVolatility12.1. 非靶标生物的急性毒性 12.1.1. 水生生物 12.1.2. 蜜蜂12.1.3. 鸟类12.2 环境行为a) 在土壤中的行为残留性沥滤降解性b) 在水和空气中的行为残留性降解性14Data on the application应用治疗a) Scope of application 应用范围b) Effects on pests and in vegetablesc) Conditions in which the product may or may not be appliedd) Dose e) Number and times of application f) Application methodsg) Instructions for useh) Time of re-entry into the treated area i) Waiting periods j) Effects on subsequent crops k) Phytotoxicity l) Registration Status in the COSAVE region and in other countries m) Approved uses in the COSAVE region and in other countriesa) 应用范围b) 作用的病害和蔬菜c) 施用的条件d)剂量e) 应用的时间和次数f) 施用方法g) 使用说明h) 施药后可再进入施药区域的间隔时间（RET）i) 等待期(PHI)j)对后茬植物的影响k) 植物毒性l)在其他国家和地区的登记状态m) 在其他国家和地区的使用方法15Proposed packages 包装处理a) CONTAINERS:Typ