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[药研所]肯尼亚农药登记和资料要求 [复制链接]

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离线派迪斯
只看楼主 倒序阅读 使用道具 楼主  发表于: 2010-05-25
— 本帖被 金绪搏 从 药研所 移动到本区(2016-04-26) —
偶尔有人问起肯尼亚的登记,抽空查了一下,以下是登记要求和具体内容要求REMARKS。需要说明的是肯登记有诸多类别,以下仅为其中之一,不足之处,谅。

ACTIVE INGREDIENT (TECHNICAL GRADE)

1.  DESIGNATION
REQUIREMENTS:    REMARKS:
1.  DESIGNATION/IDENTITY OF a.i.    Specify accordingly.
1.1   Common name (ISO)    
1.2   Manufacturer or Development code    
1.3    Source, Name and Address of  
         manufacturer and address and location of  
         manufacturing plants.    
1.5      Methods of manufacture(synthesis
         pathways)    
1.5    Chemical name (IUPAC)    
1.6    Chemical group    
1.7    Structural formula    
1.8    Empirical formula    
1.9    Patent status          

         Is the a.i. under patent?    
         Who is patent holder    
         Expiry date    
1.10  Molecular mass    
1.11  CAS Number    

2.  PHYSICAL AND CHEMICAL PROPERTIES
     (active ingredient – technical grade)
REQUIREMENTS:    REMARKS:
2.1   Physical state    Where relevant indicate method/test used.
2.2   Colour    
2.3   Odour    
2.4   Density at 20oC    
2.5   Vapour pressure at 20/25oC    
2.6   Volatility    
2.7   Hydrolysis DT50 ….. Days …… 0C  pH    Give the DT50 of the active ingredient, with mention of temperature and pH parameters employed during the determination.
2.8    Photolysis    Give the DT50 of the active ingredient (in days).
2.9    Solubility in water ……….0C ….. pH    Where relevant indicate method/test used.
2.10  Solubility in organic solvents    
2.11  n-octanol/water partition coefficient    
2.12  Boiling point   0C    
2.13  Melting point  0C    
2.14  Decomposition temperature  0C    
2.15  Method of Analysis and Impurities

2.16    Stability in water, hydrolysis rate,    
         effect of light, identity of breakdown    
         products    
2.17    Stability in organic solvents used in    
Formulation    
2.18    Stability in air; effect of light, identityof  
         breakdown products    

REQUIREMENTS:    
REMARKS:
2.19    Thermal stabilty, identity of  
         breakdown product.    Where relevant indicate method/test used.
2.20  Flammability    
2.21  Flash point    
2.22  Explosive properties    
2.23  Oxidizing properties    
2.24    Absorption spectra – UV/Visible,
         infra-red, IMR, MS    
2.25  Reactivity towards container material    


3.  TOXICOLOGY
     (Active Ingredient – technical grade)

Include a copy of an executive summary discussing ALL ISSUES named under section 3 of List I or provide copies of the individual summaries from each study relating to issues mentioned under section 3.  Information on the methods of testing must be provided.

REQUIREMENTS:    REMARKS:
ADI    Acceptable Daily Intake in mg product / kg body weight.
NOEL    Non observable effect level (expressed in mg product / kg weight on animal)
Short term toxicity
Oral cumulative toxicity (28 days study)     Not mandatory, but can be useful.
Sub-chronic toxicity test of 90-day duration.     Oral route on two species – one rodent(rat) and one non-rodent.
Dermal route – 28-days dermal, 90-days dermal.    Specify accordingly.
Inhalation route 28-days inhalation, 90-days inhalation.    Specify accordingly.
3.1   Eye irritation (rabbit)    
3.2   Skin sensitisation (guinea pig)    
3.3   Reproduction (specify species)    
3.4   Subchronic toxicity 90 day NOEL  
        mg/kg/day    
3.5   Chronic toxicity NOEL mg./kg/day    
3.6    Carcinogenicity (life time) NOEL  
         mg/kg/day    
3.7    Neurotoxicity NOEL mg/kg/day    
3.8    Teratogenicity  NOEL mg/kg/day    
3.9     Mutagenicity /Genotoxicity    
3.10   Metabolism (rat)    
3.11   Other studies    Provide further information relevant to the toxicity profile of the product e.g. Toxicity of major metabolites, reaction or breakdown products of the pest control products formed in/or on treated plant/crop etc, which are likely to be consumed – in cases where different from those identified in animal studies.  Toxic effects on livestock, poultry, pests etc. should be given.



4.  ECO-TOXICOLOGY

Provide either an executive summary or individual summaries of studies on the behaviour of the pest control product in the environment.  Provide information requested for in the application form.

REQUIREMENTS:                                                          REMARKS:
4.1  Birds (2 species)    LD50 mg/kg    Provide details of at least one land and one water bird, LD50 in mg product/kg bird weight and the NOEL.  Furthermore provide information on the effect on reproduction.
    NOEL    
    LD50mg/kg    
    NOEL    
    Reproduction    
4.2  Fish (2 species)    LD50 mg/kg    Provide details on at least two species studied, LC50 (in mg of product / litre of water) and the NOEL.  Furthermore provide information on the effect on reproduction.  Indicate the bioconcentration factor (BCF) on the active ingredient in tissues.
    NOEL    
    LD50 mg/kg    
    Reproduction    
    BCF    

REQUIREMENTS:                                                          
                                                           REMARKS
4.3  Daphnia    LC50 mg/l    

Specify and provide details on other organisms according to the information requested on the form.

    NOEL    
4.4  Algae    LC50 mg/l    
    NOEL    
4.5  Bees    LD50 g/bee    
    NOEL    
4.6  Earthworms    LC50 mg/kg    
4.7  Soil micro-organisms        


5.  BEHAVIOUR IN ENVIRONMENT
     (active ingredient – technical grade)

Provide an executive summary or copies of summaries from each study relating to the issues highlighted in the application form.

REQUIREMENTS:    REMARKS:
5.1   Behaviour, ways of degradation,
        degradation products in soil:    Indicate the degradation path of the active ingredient in the soil and the degradation products formed.
5.11  Major metabolites    Specify the major metabolites in the soil and their behaviour.
5.12  DT50 (days)    Specify the half-life of the active ingredient in various types of soils.
5.13  Mobility of the a.i.    Specify the degree of mobility of the active ingredient in the soil hence leaching potential and possibility for ground water contamination.  If high, provide details on further studies i.e. lysimeter study.
5.14   Adsorption    Indicate the degree of adsorption of the active ingredient in the soil.
5.15   Mobility of metabolites    Indicate the degree of mobility of the metabolites in the soil.
5.2    Behaviour, ways of degradation,
        degradation products in water:    Describe ways and speed of degradation of the active ingredient in water.
5.21  Major Metabolites    Specify the major break down products formed and their adsorption/desorption on sediments.
5.22  DT50 (days)    Specify the half-life of the active ingredient in water
5.23. Surface    Describe ways and speed of degradation in surface and ground water.
5.24  Ground    Provide an executive summary or copies of summaries from each study relating to the issues highlighted in the form.
5.3   Behaviour, ways of degradation,
        degradation products in air:    Describe ways and speed of degradation in air and break down products formed. (for fumigants and volatile products).
.


7.  RESIDUES

Provide either an executive summary or individual summaries of studies conducted concerning the issues listed in the application form.

REQUIREMENTS:    REMARKS:
7.1  Major metabolites    Provide either an executive summary or individual summaries of studies conducted concerning the metabolites in plants.  
. Specify the metabolites
. State their toxicological effects.
7.2  Metabolism    Describe the principle of metabolization of the active ingredient in the plant and the degradation products formed.
7.3  Behaviour of residues    Indicate the action and the persistence of the metabolites in the plant and animals.
7.4  Crop    Provide either an executive summary or individual summaries of studies conducted by a GLP certified laboratory or as directed by Secretary, PCPB.
7.5  MRL codex    MRL’s (if available)
When available state for each crop or vegetable product, the Maximum residue Limit (MRL) recommended by the Codex Alimentarius Commission, two effective MRL’s in two different countries and the MRL proposed in the country of application.  If the proposed crop is to be exported provide detailed information in the dossier on MRL or import tolerances in the countries exported to.
7.6  MRL of country of origin    
7.7  Proposed MRL    
7.8 Proposed PHI    
7.9  Method of residue
        analysis    Provide a copy in the dossier for countries requiring it.

8.  OTHER SPECIFIC REQUIREMENTS

REQUIREMENTS:    REMARKS:
8.1  Residue data from a GLP certified  
       lab or as directed by Secretary, PCPB.    Provide an executive summary or copies of summaries from each study relating to residues.
8.2  Proposed pre-harvest intervals,
       withholding  periods in cases on
       post-harvest use.    
8.3  Effects on taint, odour, taste or other  
       quality aspects due to residues in or      
       on fresh or processed products.    
8.4  Effects of industrial processing  
       and/or household preparation on the  
       nature and magnitude of residues.
    
8.5  Residue data in succeeding  
       rotational crops where presence of  
       residues might be expected.    


GUIDELINE:  FORMULATED PRODUCT DOSSIER

1.  PHYSICAL AND CHEMICAL PROPERTIES OF THE FORMULATED  
     PRODUCT.

Clearly state methods used to determine properties under the appropriate section of the dossier.  CIPAC methods are recommended.
REQUIREMENTS:    REMARKS:
1.1   Physical state / formulation type    Solid, liquid etc.
1.2   Colour    
1.3   Odour    
1.4   Storage stability    Indicate the stability of the preparation after storing at 54oC for 14 days.  Other durations and/or other temperatures (e.g. 8 weeks at 40oC, 18 weeks at 30oC) if the preparation is thermo-sensitive.
1.5   Shelf-life    The shelf-life of the product at room temperatures (30oC) is given in years if it is more than two years, and in months if it is less than two years. The appropriate temperature specifications must be given.
1.6   Density    Indicate the density of the liquids.
1.7   Bulk density    Indicate the density of solids after compression.
1.8   Flammability    Specify if the product is flammable
1.9   Flash point    To determine flammable hazards.
1.10 Compatibility with other pest control    
        products    Indicate types of pest control products which the product is or is not compatible with. Give evidence.
1.11 pH range    State the effect of pH on stability and effectiveness.
1.12 pH of 1% aqueous dilution    Relevant to products to be diluted in water.
1.13 Oxidizing properties    Indicate materials that can be damaged by oxidizing properties of the formulation.
1.14  Corrosiveness    Specify effect on containers, equipment, skin etc.
1.15  Water content    Indicate the maximum water content when it has an influence on the quality.
1.16  Wettability    The wettability has to be indicated for solid formulations used in dilution (wettable powders, powder soluble in water and granules soluble in water).
1.17  Solubility in water    Specify
1.18  Persistent foaming    State the extent to which foaming occurs for formulations diluted in water.
1.19  Particle size    Specify
1.20  Wet sieve test    
1.21  Dry sieve test    
1.22  Suspensibility / emulsifiability    Specify
1.23  Emulsion stability    
1.24  Volatility    
1.25  Viscosity    For formulations to be used at very low volume, it is necessary to know the viscosity.
1.26  Other properties (where applicable)    FAO specifications etc.
1.27  Method of Analysis    

2.  TOXICOLOGY

The dossier must contain a detailed Material Safety Data Sheet(MSDS).  Furthermore an executive summary discussing all aspects mentioned under section 2 must be included, or the summaries from each individual toxicity study under 2.1-2.6.    

Other studies

Provide detailed studies and any other relevant toxicology or ecotoxicological studies conducted on the formulated product.
The FAO/WHO class must be given as per the table hereunder.

WHO-Classification Scheme

Class    LD50 for the rat (mg/kg body weight)

    Solids    Liquids    Solids    Liquids
    Oral    Dermal
Ia Extremely
Hazardous    5 or less    20 or less    10 or less    40 or less
Ib Highly Hazardous    5-50    20-200    10-100    40-400
II Moderately Hazardous    50-500    200-2000    100-1000    400-4000
III Slightly Hazardous    Over 500    Over 2000    Over 1000    Over 4000


3.  EMERGENCY MEASURES IN CASES OF ACCIDENTAL EXPOSURE OR  
      POISONING

Self explanatory. List relevant information of the form and refer to relevant section in MSDS in section 3 of dossier.

4.  EMERGENCY PROCEDURES IN CASE OF FIRE/SPILLAGE

Self explanatory.  List relevant information of form and refer to relevant section in MSDS in section 2 of dossier.

5.  EFFICACY DATA
REQUIREMENTS:    REMARKS:
5.1  Crop/area of use    The common name of the crop on which the product is aimed at must be clearly specified.
When the product is not aimed at a crop, indicate the area of use, e.g.
.  Premises and equipment of transportation,
.  Premises of storage.
5.2.  Target organism    Target organisms must be identified by common and scientific name.
Specify the mode of action of the product on its target, and indicate if the active ingredient is translocated inside the organisms.
5.3  Rate    The rate of application must be indicated on the basis of area treated or volume used e.g. l/ha, g/ha, etc.
5.4.  Stage of treatment     Specify the stage of the crop or target organism at which application must be made and/or the minimum interval between the last application and harvest.
5.5  Directions for use    Indicate the recommended directions for use.
5.6  Residue data and pre-harvest interval    Indicate restrictions.
5.7  Phytotoxicity    Indicate restrictions.
5.8  Contraindications    Indicate restrictions i.e. follow up crops, adjacent crops etc. and particular specifications, as well as possible incompatibilities of the formulation with other products.

NB:  Efficacy data from country of origin should be attached.



6.  MINIMUM LABEL REQUIREMENTS

Specify the warnings, use restrictions and safety precautions which must be present on the label in all countries.
The proposed label must be included in the dossier and should contain the specified warnings, use restrictions and safety precautions as well as meet PCPB label requirements, recommendations etc.
The PCPB label requirements will be provided separately.
 
 
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离线bullace

只看该作者 沙发  发表于: 2010-05-25
谢了收藏~
离线cathy110

只看该作者 板凳  发表于: 2010-05-25
收藏了 谢谢楼主
离线ysulpp

只看该作者 地板  发表于: 2010-06-12
谢谢,收藏喽
离线beckmaolin

只看该作者 4楼 发表于: 2010-06-13
谢谢楼主 收藏了
离线yilongchem

只看该作者 5楼 发表于: 2010-07-06
好东西,谢谢楼主
离线tinypiggy
只看该作者 6楼 发表于: 2010-08-05
肯尼亚登记典型的要求不高但要求很多。。。烦哦
离线belinda0314

只看该作者 7楼 发表于: 2010-08-05
谢谢楼主了~
离线pinksakmon
只看该作者 8楼 发表于: 2010-08-09
谢谢分享
离线徐陆洋

只看该作者 9楼 发表于: 2010-08-13
离线xiaoya1022

只看该作者 10楼 发表于: 2010-08-13
肯尼亚现在登记证都要认证啊,难做
离线siyuan007008

只看该作者 11楼 发表于: 2010-08-13
5批次分析报告不要求么?怎么没有看到呢?
只看该作者 12楼 发表于: 2010-12-17
好感谢啊!
只看该作者 13楼 发表于: 2010-12-17
PCPB要求多有提供的理化性文件都必须是国内的认证机构出具的才能提交注册。很麻烦
产品的标签必须显示两种语言,英语和KISWAHILA.
离线syngenta2005

只看该作者 14楼 发表于: 2010-12-20
有官方网站么?
离线龙战骑士

只看该作者 15楼 发表于: 2011-04-21
好详细的说,楼主好人啊
离线huyanfei03

只看该作者 16楼 发表于: 2011-06-03
网站不错,谢谢
离线llff

只看该作者 17楼 发表于: 2011-06-07
领教了
离线jaccica

只看该作者 18楼 发表于: 2011-08-04
路过 学习
离线jaccica

只看该作者 19楼 发表于: 2011-08-09
支持性文件呢?还需要什么
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