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北京三浦百草绿色植物制剂有限公司 国际营销中心 周海燕 2015 年 4 月 27 日 生物农药境外登记经验交流和体会.

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Presentation on theme: "北京三浦百草绿色植物制剂有限公司 国际营销中心 周海燕 2015 年 4 月 27 日 生物农药境外登记经验交流和体会."— Presentation transcript:

1 北京三浦百草绿色植物制剂有限公司 国际营销中心 周海燕 2015 年 4 月 27 日 生物农药境外登记经验交流和体会

2 目录 1. 三浦百草公司及产品简介 2. 生物农药境外登记的难点 3. 生物农药境外登记经验分享

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4 生物系列产品 生物杀虫剂 有机肥料生物杀菌剂 生物产品 系列

5 境外登记难点 * 文件要求复杂: GLP 全分析和 GLP 毒理 * 使馆认证:认证授权书,分析证书, ICAMA 等等 * 费用高:登记一个产品需要花费几万甚至十几万 美元 * 时间长:少则 1 年,多则 5 年

6 苦参碱组分

7 乌拉圭登记要求 General description of the pesticide, category and use. Class of pesticide acording to their activity, chemical group and way of action. Indication of target and secondary pest. Physical-Chemical characteristics of the product. Chemical name, common name and No. Cas of all the components. Identification of the active ingredient and possible sinergisym. Specifications and origin of the active ingredient and components of formulation. Identification, concentration and toxicity of the impuritys of the technical product. Methodology of the analysis of each active ingredient and the finished product. Presentation of the oral letal dose 50 (for white male rats) of actives ingredients and finished products (the calculation is admitted settled down by OMS). Evaluation of risk. Considering the following points: Danger identification. Evaluation of the relationship dose/answer. Evaluation of the exposition. Characterization of the risk. Conclusions and recommendations if it corresponds

8 乌拉圭登记要求 Toxicological data for restricted sale products to specialized entities (dermal and oral DL50, dermal and ocular irritability and inhalation toxicity). Data of test of effectiveness for the plague target and bibliographical data for confirmation of effectiveness for secondary plagues. Specifications of the primary and secondary packing. Analysis of staunchness of the closing. Presentation of a complete empty packing. Useful life porposal. Carried out studies and conclusions of the stability of the products. Code for the identification of the lot. Method of impresión of the sameone and of the useful life (expiration date). Toxicological information related with the citizens of the human health. First aids, medical treatments of emergency and antidote for each formulation. Deactivation method and discard of the empty packing. In the case of products in aerosol present characteristic of the valve, specially hole diameter. If 20% or more of the particles presenta n inferior diameter to 20 microns, the concentration inhalation it will be attached. It should be presented descriptive of the divices applicated with confirmation of the user´s security during the application.

9 墨西哥登记要求 Original letter from the supplier for pesticides of import, which it specifies: trade name and common name, as well as its percentage composition; name and supplier address; name and address of the buyer of the product, which will have to be the solicitor of the record, and the number of in force record of the above mentioned product in the country or native lands, when the active ingredients are imported. The letter will have to have been sent in six months before the presentation of the request. Certificate of in force record sent by the competent authority of the country where one elaborates or produces the product. When in the country of origin one does not possess the record of the technical product, it will have present the certificate of in force record of a product formulated based on the same active ingredient, sent by the competent authority of the country where one elaborates or produces the product.

10 墨西哥登记要求 Identity and composition Common name. Scientific Name and, in his case, chemical name of the extract. Minimal and maximum Content of the active ingredients expressed in percentage mass - mass and his equivalent in g/kg or g/l. Inert Ingredients: nomenclature CAS (when it proceeds) and percentage content, as well as his respective functions. Type of formulation. Properties physicist - chemistry (for the following physicochemical properties it will have expire with the Note A) Density for liquids or specific weight of the formulated product Reactivity. Corrosivity. Photolysis. Hydrolysis.

11 墨西哥登记要求 Physical characteristics related to the use: Content of dampness, treating itself about powders and granules. Wettability, in case of wettable powders. Persistence of foam, formulated that are applied by water. Suspensibility, in case of powders wettable and concentrated in suspension. granulometric analysis in dry and average of size of particles in microns, in case of granules and powders Stability of the emulsion and properties of redispersion, treating itself about emulsifiable concentrates. Incompatibility known with others. Information about the getting form and the essential components. Toxicological information. Studies of acute toxicity for mammalian species, which will have to be realized in both sexes of rodent Oral (DL50) Dermal (DL50). Number of technical opinion of biological efficiency issued by SAGARPA (the study of biological efficiency and technical opinion is realized in Mexico) Study of stability that determines the useful life of the product in weeks, with analysis of the physical characteristics and the percentage content of the ingredient I activate before and after the study.

12 沙特登记要求 Application form filled and stamped by manufacturing co. on head paper. Letter of Authorization from the formulator to our company for the registration & marketing of the product in Saudi Arabia. Certificate of Analysis for TC product & the End – Use Product legalized by Chamber of Commerce & Saudi Embassy. Certificate of Registration for TC product & the End – Use Product legalized by Chamber of Commerce & Saudi Embassy. (ICAMA) Certificate of composition for TC product & the End – Use Product up to 100% indicating in details, the inert materials included in the active ingredient legalized by Chamber of Commerce & Saudi Embassy.

13 沙特登记要求 Source of the active ingredients: In case the active ingredient (TC) is not manufactured by the formulator, then the formulator should have to provide a letter issued by the official government authority of the country of the manufacturer of the active ingredient stating that he is Basic Producer. Manufacturing process or formulation procedure. Storage stability declaration & storage stability cold (0 o C) & heat (14 o C). Analytical methods of TC product. Analytical methods of Formulated Product. Residue analysis and study in (plant, water, soil, …) Toxicity of TC & End – Use Product (Summary). Environmental fate study (soil, water, plant,) (summary of environmental behavior). Material safety data sheet. Label used in country of origin and a copy of its translation. Samples for trial.

14 突尼斯登记要求 Date on active ingredient: Chemistry of active ingredient: Physical and chemical properties of the active ingredient Data on formulated products: Type of formulation: Formulation composition: Physical and chemical properties of formulated products: Methods of analysis: Toxicology of the active ingredient & end use product: Fate in animal: Acute toxicity: Sub chronic feeding studies Chronic toxicity & carcinogenic studies: Carcinogenic:

15 突尼斯登记要求 Delayed neurotoxicity: Teratogenicity & reproduction: Teratogenicity Reproduction Mutagencity: Acceptable daily intake: Consumer risk assessment: Environmental fate: Hydrolysis: Photolysis: Fate in soil: Leaching (mobility) in soil Eco-toxicology Effect on non-target organisms: Aquatic toxicity: Accumulation in aquatic organisms: Effect on natural enemies: Effect on earthworm: Effect on birds: Biological properties & target pests: Target Crops: Mode of action: Uses and recommendations: Crop tolerance: Compatibility: Safety handling: Symptoms: First Aid Measures: If in eyes: If swallowed: If on skin or clothing: If inhaled: Storage & disposal: Type of container and packaging material

16 孟加拉登记要求 Chemistry and other relevant particulars Type(Pheromone/Allomone/Kairomone/Synomone/Hormone/NPR/IGR/ Botanical)2 Natural or Synthetic Identity of Natural Source Chemical Abstract Name IUPAC nomenclature Structural formula Empirical formula and Molecular weight Manufacturer’s development code number(s) Manufacturing Process(Attach details) Certified percentage (Purity%) (Attach detailed method of purity identification by GC/SP techniques) Physical and chemical properties

17 孟加拉登记要求 Biological Properties Mode of Action Degree of specificity Target pest (s) Target crop (s) Dosage rate (g/acre/year of a,i.) Technical grade material: Source: Name and address of manufacturerand address where manufactured Physical and chemical properties Formulated product : (1). Type of formulation (2). Content of active ingredient (s) g/Kg or g/L (3). Content and nature (4) Physical and chemical properties

18 孟加拉登记要求 Toxicology Data of Technical Grade Active Ingredient (TGAI) and Formulated product (FP) Acute oral toxicity in rats and mice Acute dermal toxicity Acute inhalation toxicity Skin irritation Irritation to mucous membrane Eye irritation Short term (90 days) oral feeding effect only for TGAI (1 species)3,4 Short term (90 days)dermal toxicity for TGAI: only (1 species)3,4: Metabolic studies in animals3,4 Cellular immune response/immunotixicity3: Reproduction studies3,4 only for TGAI Embryotoxicity, including teratogenicity3 only for TGAI

19 孟加拉登记要求 Mutagenicity3 only for TGAI Long term toxicity including carcinogenicity4 Potentiation Direct observations, e.g. clinical cases Health records, both from industry and agriculture. Treatment of poisoning First aid measure Supplementary treatment Waiting period (last application to harvesting) for FP: Rate of release of active ingredient: Bio Efficacy of FP Laboratory Test Field Test Application Purpose of application Target pest (s) Target crop (s) Time of application Method of application Rate of application (g/acre/year) Limitation (s) of use 11. Residue studies5 Chemical identity of residues Nature of residue in plants, commodity and livestock Reliable residue data from supervised trials Estimation of maximum residue Proposed Maximum Residue Limit Estimation residue level on commodity on sale Data on disappearance on food preparation Assessment of actual consumer intake :

20 孟加拉登记要求 Persistence of the product Prediction of environment effects Concentration of naturally occurring substance Rate of use (gm/acre/year) Desorption Degradation Persistence Effect on birds Effect on fish Effect on fish food species Effect on honey bees Degradation product in soil Possibilities of accumulation with stable lipophillic compounds Effect on local aquatic species Effect on soil organisms Disposal of used condemned and surplus pesticides and pesticides containers.

21 美国与欧盟要求 欧盟农药登记指令91/414/EEc虽然采用OECD关于生物 农药的定义,但在登记 时仍将信息素、植物提取物等视作化学农药, 而且不允许转基因植物登记。 美国环保局(EPA)界定的生物农药包括微生物农药(指活体微生 物)、生物化学农药(包括信息素、 激素、天然的昆虫或植物生长调 节剂、驱避剂以及作为农药活性成分的酶)和转基因植物。其中 “ 生 物 化学农药 ” 还必须具备两个条件: ① 对防治对象没有直接毒性,而 只有调节生长、干扰交配或引诱等特 殊作用; ② 必须是天然产物,如 果是人工合成的,其结构必须和天然产物相同(允许异构体比例的差 异)。 显然EPA没有将抗生素列为生物农药,也没笼统地将植物提 取物列为生物农药(除非植物提取物符合生物化学农药的条件。

22 美国与欧盟要求 在韩国和部分中东, 欧洲国家, 生物农药可以登记为有 机农药, 需要提供 1. 产品由国际有机认证机构出具的有机证书 2. 产品的分析证书 3. 产品的成分表 4. 产品的工艺流程 5. 原材料投入配比表

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