REQUIREMENTS FOR THE REGISTRATION OF CHEMICAL PLAGUICIDES The information for registration must be consigned in a plastic folder with

rings, divided into clearly identified sections (4 Sections), adding at the beginning an additional section for correspondences. No applications with incomplete or empty sections will be received. - All requirements must be presented clearly and in the order here established. When some of the points not applied to the characteristics of active ingredient or formulated product, you must be specify the reason. - No sections of attachments allowed, all information should be located in their own section. - You must show the file in Spanish. In case of companies whose studies are in other languages (English, Chinese, Portuguese, etc.) require further translation into Spanish. SECTION 1 CORRESPONDENCE RECEIVED SECTION 2 Bank Deposit Service request form Registration request letter Note: the registration request letter should be developed with the company letterhead SECTION 3 Origin Certificate of each Active Ingredient Free Sale Certificate Note: In the case of import formulated products, you should deliver original of the Free Sale Certificate legalized and apostilled by the Venezuela Embassy in the origin country. For the products that are made in Venezuela with actives ingredient of other country, you should deliver original of the Origin Certificate legalized and apostilled by the Venezuela Embassy in the origin country. SECTION 4 Original of Composition Certificate of each active ingredient, given by the manufacturer clearly identified, in the origin country, sealed and signed by the responsible for the laboratory. You should show the authorization or accreditation of the laboratory where that made the test, issued by the appropriate authority. Original of Composition Certificate of the formulated Product, given by the formulator clearly identified, in the origin country, sealed and signed by the responsible for the laboratory. You should show the authorization or accreditation of the laboratory where that made the test, issued by the appropriate authority.

Original of the Analysis Certificate and the Composition Certificate, given for a laboratory recognized by INSAI, located in Venezuela. Copy of the record of trial supervision of the product in Venezuela. Document in which the manufacturer of each active ingredient or formulated product, authorizes the use of their information like support for product registration. Note: - In case there is no exist IUPAC nomenclature for chemical names, shall be accepted any other internationally recognized. - No be accepted groups or families chemicals in replacement of common names or chemical names. - In those formulations containing synergists, you must submit the information as requested for the active ingredients. The content of the Composition Certificate must be show as follow: For Active Ingredients: Identify clearly the function of the active (s) ingredient (s), isomers, related compounds and impurities, with their common and chemical names, quantified in % w/w (in case of solids) or in %w/v in liquids: CORRECT WAY: Common name tetramethrin 1R tetramethrin Dichlorvos Propoxur

Chemical Name
CICLOHEX-1-ENE-1,2DICARBOXIMIDO CICLOHEX-1-ENE-1,2DICARBOXIMIDO 2,2 DICLOROVINIL DINETIL FOSFATO 2-ISOPROXIPHENIL METILCARBAMATO

Concentration %w/w 95.5 3.3 1.1 0.1

Function Active ingredient Isomer Related compound Impurities

For Formulated Product: Identify clearly active ingredients and the additives ingredients, show the common names, chemical names, CAS number, quantified in %w/w (in case of solids) or in %w/v (for liquids): CORRECT WAY: Common name Chlortoluron Ethilene Glycol Piperonyl Butoxide Edhanol

CAS N
15545-48-9

Chemical Name
3-(3-cloro-p-tolil)1,1dimetilurea 1,2-etanodiol eter 2-( 2-butoxietoxi) etil 6- propil piperonil Linseed oil

Concentration (w/w) 50% 30% 2% 18%

Function Active ingredient Solvent Sinergist Stabilizing

107-21-1 51-03-6

316-42

SECTION 5 Technical Requirements for registration of raw material and chemical products of the agricultural, domestic, health public and industrial use. CHEMICAL REQUIREMENTS INFORMATION REQUIRED BY REQUIREMENTS: 1a) TECHNICAL GRADE ACTIVE INGREDIENT REQUIREMENTS a) TECHNICAL GRADE ACTIVE INGREDIENT 1 Identity 1.1 Aplicant Manufacturer and Origin country 1.2 Common Name: Accepted by ISO or equivalent 1.3 Chemical name: Accepted or proposed for IUPAC 1.4 1.5 1.6 1.7 1.8 1.9 1.10 1.11 1.12 DOCUMENTS TO SUBMIT

Information Information Information Information Information Data Data Data Data+Analysis Certificate Data+Analysis Certificate Data+Analysis Certificate Data+Analysis Certificate

Number of experimental code that was assigned by the manufacturer Empirical formula, molecular weight Structural Formula Chemical Group Purity Isomers (identify) Impurity (identify) Aditives (Example: stabilizers) (identify)

2a) CHEMICAL AND PHYSICAL PROPERTIES

REQUIREMENTS 2. Physical and Chemical Properties 2.1 Aspect 2.1.1 Physical state 2.1.2 Color 2.1.3 Odor 2.2 Melting Point 2.3 Boiling Point 2.4 Density 2.5 Vapor pressure 2.6 Absorption spectrum 2.7 Water solubility 2.8 Organic solvent solubility 2.9 Partition coefficient n-octanol/water 2.10 Flash Point 2.11 Surface tension 2.12 Explosives properties 2.13 Oxidatives properties 2.14 Reactivity with the packaging material 2.15 Viscosity
3a) WASTE TREATED

DOCUMENTS TO SUBMIT

Data Data Data Data Data Data Data Data Data Data Data Data Data Descriptive report Descriptive report Descriptive report Descriptive report

REQUIREMENTS

DOCUMENTS TO SUBMIT

3. WASTE TREATED Identification of degradation products and reaction 3.1 Descriptive Report metabolites in plants or products treated Behaviour of the residue of the active substance and its metabolites from application to harvest, when 3.2 relevant. Absorption, distribution or conjugation with Descriptive Report the components of the plant and the dissipation Product for the environment 3.3 Residue data from supervised trials Descriptive Report
Note: this point does not apply to domestic products

4a) EFFECTS ON THE MIDDLE ABIOTIC

REQUIREMENTS 4. EFFECTS ON THE MIDDLE ABIOTIC 4.1 Behavior in soil. Data for 3 types of soil patterns 4.1.1 Degradation: Rate and routes (up to 90%) including the identification of: 4.1.1.1 Processes involved 4.1.1.2 Metabolites and degradation products Absorption and desorption and mobility of the active substance and if 4.1.1.3 relevant, of their metabolites Magnitude and nature of the waste. Methods of disposal of remnants and 4.1.2 off-specification products 4.2 Behavior in water and air 4.2.1 Rate and route of degradation in aqueous medium Hydrolysis and photolysis (if they were not specified in the physical and 4.2.2 chemical properties

DOCUMENTS TO SUBMIT

Descriptive Report Descriptive Report Descriptive Report Descriptive Report Descriptive Report Descriptive Report Descriptive Report

Note: For domestic use products should deliver only the requirements of items 4.1.2 and 4.2.2 5a) INFORMATION REGARDING SAFETY
REQUIREMENTS DOCUMENTS TO SUBMIT 5. INFORMATION REGARDING SAFETY 5.1 Water treatment systems and contaminated soils Descriptive Report 5.2 Procedures for the destruction of the active substance and for the decontamination Descriptive Report 5.3 Recovery methods (if available) Descriptive Report 5.4 Neutralization methods Descriptive Report 5.5 Controlled incineration (conditions) Descriptive Report 5.6 Water purification Descriptive Report Recommended methods and handling precautions during handling, 5.7 Descriptive Report storage, transport and fire 5.8 In case of fire, reaction products and combustion gases Descriptive Report 5.9 Information about personal protective equipment Descriptive Report 5.10 Material Safety Data Sheet in Spanish produced by the manufacturer Information in MSDS

Note: For domestic use products NO applied the requirements of items 5.1; 5.6; 5.9 6a) ANALYTICAL METHODS
REQUIREMENTS 6. ANALYTICAL METHODS 6.1 DOCUMENTS TO SUBMIT Method and validation method Method and validation method Method and validation method Method and validation method

Analytical method for the determination of the active substance pure Analytical methods for the determination of degradation products, isomers, impurities (of toxicological or ecotoxicological) and additives (eg stabilizers) Analytical method for the determination of residues in soil and water. Recovery rates and the limits of methodological sensitivity include Analytical methods for air, tissues and fluids animals or humans (when available)

6.2

6.3

6.4

1b) FORMULATED PRODUCT

REQUIREMENTS 1) FORMULATED PRODUCT 1. General Description 1.1 Name and address of the applicant 1.2 Name and address of the formulator 1.3 Name of product Name of active substance and quality specification of the item A) 1 and 1.4 2, and a letter of the manufacturer, authorizing to use that information in support of product registration, when be applicable. 1.5 Use of product (eg, herbicide, insecticide) 1.6 Type of formulation (e.g. liquid, powder) 2. COMPOSITION Active substances content, technical grade, expressed in g/Kg or g/L Analytical Composition Certificates, expedited by: 2.1 A laboratory recognized by INSAI Formulator laboratory Content and nature of the others compounds included in the formulation. Analytical Composition Certificate, expedited by: 2.2 A laboratory recognized by INSAI Formulator Laboratory Method or methods of analysis for determining the content of the 2.3 substance (s) active (s) 3. PHYSICAL AND CHEMICAL PROPERTIES 3.1 Aspect 3.1.1 Physical state 3.1.2 Color 3.1.3 Odor Storage stability (with respect to its composition and the physical 3.2 properties related to the use) 3.3 Relative density 3.4 Flammability 3.4.1 For liquids, flash point 3.4.2 For solids, must be clarify if the product is flammable or not 3.5 pH 3.6 Explosivity DOCUMENTS TO SUBMIT

Information Information Information Information Information Information

Information + Analysis Certificate

Information + Analysis Certificate Method and validation method

Information Information Information Information Information Information Information Information Information

4b) PHYSICAL PROPERTIES OF THE FORMULATED PRODUCT, RELATED WITH THE USE

REQUIREMENTS DOCUMENTS TO SUBMIT 4. PHYSICAL PROPERTIES OF THE FORMULATED PRODUCT, RELATED WITH THE USE 4.1 Humidity and wettability (for dispersible powders) Information 4.2 Persistent foam (for formulations that are applied in water) Information 4.3 Suspensibility dispersible powders and suspension concentrates Information Wet sieve analyzes / tenor powder (for dispersible powders and 4.4 Information suspension concentrates) 4.5 Dry sieve analyzes (for granules and powders) Information 4.6 Emulsion stability (for emulsifiable concentrates) Information 4.7 Corrosivity Information 4.8 Incompatibility with other products (eg, phytosanitaries and fertilizers) Information 4.9 Density at 20 C in g / ml (for liquid formulations) Information 4.10 Flash point (oils and solutions) Information 4.11 Viscosity (for suspensions and emulsions) Information 4.12 Sulfonation index (oils) Information 4.13 Dispersion (dispersible granules) Information 4.14 Release of gas (only for gas generators granules or other similar products) Information 4.15 Finesse for fluently or dry powders Information 4.16 Iodine and saponification (for vegetable oils) Information

Note: For domestic use products NO applied the requirement of item 4.8 5b) LABELING OF THE FORMULATED PRODUCT
REQUIREMENTS 5. LABELING OF THE FORMULATED PRODUCT 5.1 Draft Label and instruction sheet, according to the specifications DOCUMENTS TO SUBMIT Label project and istruction sheet project

6b) PACKAGE PROPOSED FOR FORMULATED PRODUCTS

REQUIREMENTS 6. Package and packing proposed 6.1 Package 6.1.1 Type 6.1.2 Material 6.1.3 Capacity 6.1.4 Resistance 6.2 Packing 6.2.1 Type 6.2.2 Material 6.2.3 Capacity 6.2.4 Resistance 6.3 Action of the product on the packaging material 6.4 Procedures for decontamination and destruction of packages DOCUMENTS TO SUBMIT

Information Information Information Information Information Information Information Information Descriptive Report Descriptive Report

7b) REMAINING MANAGEMENT OF THE FORMULATED PRODUCT

REQUIREMENTS 7. Remaining management of the formulated product 7.1 Procedures for destruction of active substance and for decontamination 7.2 methods of disposal of waste 7.3 Recovery posibilities (if available) 7.4 neutralization posibilities 7.5 Controled incineration (condictions) 7.6 Water depuration Recommended methods and handling precautions during handling, 7.7 storage, transport and fire 7.8 In case of fire, reaction products an combustion gases 7.9 Report on Personal Security Equipment 7.10 Procedures for cleaning equipment DOCUMENTS TO SUBMIT Descriptive report Descriptive report Descriptive report Descriptive report Descriptive report Descriptive report Descriptive report Descriptive report Descriptive report Descriptive report

Note: For domestic use products NO applied the requirements of items 7.9 and 7.10 8b) WASTE PRODUCT DATA
REQUIREMENTS DOCUMENTS TO SUBMIT 8. WASTE PRODUCT DATA Data obtained on the basis protocolized trials according to international standards (FAO Guidelines for establishing Maximum Residue Limits 8.1 Data (MRLs)

Note: this tem is Not applicable for domestic use products 9b) MATERIAL SAFETY DATA SHEET
REQUIREMENTS 9. SAFETY DATA SHEET in Spanish made for the manufacturer DOCUMENTS TO SUBMIT Information + MSDS

FORMAT OF SAFETY DATA SHEET The safety data sheet for chemical plaguicides (Formulated or active ingredient) must be containing: 1) Identification of the chemical product and the company: Relates MSDS with the plaguicide. Identify the provider od MSDS. Identify the sources for more information. 2) Composition: information about the compounds - List the dangerous compounds regarding with the United Nations - May include important no dangerous compounds - May include additional information about the compounds. 3) Identification of hazards - May give a general vision in case of emergency

4) 5) 6) 7) 8) 9) 10) 11) 12) 13) 14) 15) 16) -

Provides information about the potential adverse effects on human health and Symptoms that could result from misuse and reasonably use of material. First aids measure Provides guidelines to be considered in accidental exposures requiring immediate treatment. May include instructions to medical professionals. Measures for firefighting Provides basic guidance for firefighting, including appropriate means. Describe other useful properties of inflammation and explosion to prevent and extinguish fires that may involve material such as Flash point and explosive limits. Accidental Release Measures Describe the actions that must be followed to minimize the adverse effects of a spill, leak or accidental release of the material. Handling and storage Provides information about the appropriates practices for a safety handling and storage Exposure controls, personal protection Provides information on the practices, equipment, or both, useful for minimizing worker exposure. May include exposure guidelines. Provides guidance on personal protective equipment. Physical and Chemical Properties Provides additional data that can be used to help characterize the material and design safe work practices. Stability and reactivity Describe the conditions that should be avoided, or other materials that may cause reaction that would change the very stability of the material. Toxicological information. It can be used to provide basic toxicological information on the material, its components or both. Ecological information. It can be used to provide information on the effects that the material may have on plants or animals, and the environmental fate of the material. Considerations for products diposition. It can provide useful information to determine appropriate disposal measures. Shipping information It can provide basic information for classification of the shipment. Regulatory information. It can be used to provide additional information on regulations affecting the material. Additional Information It can be used to provide any additional information.

TOXICOLOGICAL REQUIREMENTS
Establish the procedure to be followed in order to evaluate toxicological studies of chemical plaguicides for agricultural use, domestic, industrial and biological origin or bio-pesticides and fertilizers products in registry process. Modifications in registered products. Re-evaluation of toxicity in registered products. Revision and correction of toxicological information from texts in the product label. Develop special toxicological reports, following INSAIs normative. The requirements to follow in each field are: Agricultural use plaguicides: In this field are requested: acute toxicity studies in case of oral, dermic or inhaled consume. Primary dermic irritation potential, ophthalmic and cutaneous sensibility to active ingredient and product formulated. Sub-chronic toxicity studies in case of oral, dermic or inhalation consume. Chronic toxicity studies for oral consume and special toxicity studies for specific evaluation. Mutagenesis, Carcinogenesis and Teratogenesis, effects on reproductive development, neurotoxicity. Studies about metabolic routes and excretion of active principles. Epidemiological information of the exposed population and unintentional acute poisoning data. Domestic use plaguicides: In this field are requested: acute toxicity studies in case of oral, dermic or inhaled consume. Primary dermic irritation potential, ophthalmic and cutaneous sensibility to active ingredient and product formulated. Sub-chronic toxicity studies in case of oral, dermic or inhalation consume. Chronic toxicity studies for oral consume and special toxicity study for specific evaluation. Mutagenesis, Carcinogenesis and Teratogenesis, effects on reproductive development, neurotoxicity. Studies about metabolic routes and excretion of active principles. Epidemiological information of the exposed population and unintentional acute poisoning data. Public health and industrial use plaguicides: In this field are requested: acute toxicity studies in case of oral, dermic or inhaled consume. Primary dermic irritation potential, ophthalmic and cutaneous sensibility to active ingredient and product formulated. Sub-chronic toxicity studies in case of oral, dermic or inhalation consume. Chronic toxicity studies for oral consume and special toxicity studies for specific evaluation. Mutagenesis, Carcinogenesis and Teratogenesis, effects on reproductive development, neurotoxicity. Studies about metabolic routes and excretion of active principles. Epidemiological information of the exposed population and unintentional acute poisoning data. Biological Plaguicides: acute toxicity studies in case of oral, dermic or inhaled consume; Primary dermic irritation potential, ophthalmic and cutaneous sensibility to active ingredient and product formulated. If at this Stage, the DL50 meets to any classified product cataloged as SLIGHTLY TOXIC, there is no persistence of the micro-organism and no evidence of anatomical and pathological alterations, clinic or from lab, this evaluation is considered complete. If anatomical and pathological alterations are detected, from clinical or labs, of persistance of the micro- organisms

in animals for a longer time that expected, subacute toxicity studies will require complementary. If alterations are observed in this studies of subacute toxicity, the following studies are required: Chronic toxicity studies of oral administration and special studies to specifically assess toxicity, mutagenicity, carcinogenicity, teratogenicity, effects on reproductive development, neurotoxicity. Immunogenicity studies and population studies exposed. Note: In case of active ingredients widely known, accepted summary of the toxicological information from indexed journals or publications, just if this information contains: evaluated specie, regulated doses, way of administration, LD50, NOEL, LOEL, toxic clinical signs , laboratory tests including hematologic evaluation , blood chemistry , urine and pathological anatomy analysis. The mutagenicity information should contain a brief summary of in vitro and in vivo studies, indicating the amount of concentration that was used and test results; should indicate a Bibliographic source of the information. In case of new active ingredients or complete unfamiliar, we will require complete toxicological studies provided by the company manufacturer. The test should be made according to the international standards of Good Practice for a Laboratory . Companies with studies made in a foreign language should translate it into Spanish. Studies to evaluate the formulated product, must have been made with the formulation given.

ENVIROMENTAL RISK
a) Indicate: use, method and application frequency, active ingredient concentration of the formulated product, maximum doses. b) Destination and environmental behavior. -Air: persistence, volatility, photo decomposition, metabolites. -Soil: persistence, degradation, mobility, leaching potential of active ingredient -Water: persistence, mobility, accumulation, hydrolysis (or breakdown), chemical adsorption. - Also consider derive possibility in all scenarios. -Indicate additive and adjuvants. c) Ecotoxicology -Toxicity towards birds -Toxicity towards bees -Toxicity towards aquatic organisms -Toxicity towards batrachians (domestic, industrial, and public health) or mud worms (agricultural). The summary report about the studies, in Spanish, must contain: 1) Studied doses. 2) Involved species in the studies, age, gender. 3) Signs and symptoms 4) Bioaccumulation

ENVIROMENTAL HANDLING PLAN After potential risks were identified from previous section, the handling plan will integrate risk with preventive measures that applies from next options: - Identification and evaluation of the potential impact - Action programs - Waste reduction - Environmental monitoring programs - Emergency and contingency attention programs. The label and the safety sheet must include relevant results about environmental risk evaluation and the preventive measures pointed at the handling plan.

EFFICACY EVALUATION REQUIREMENTS

1. Efficacy test protocol presentation. 2. Presentation of Final report showing test results, this must contain the statistics analysis of them (ANAVAR). This analysis must verify compliance in alleged and respective standard comparisons. 3. Inspection Act, Issued by INSAIs inspector. 4. Field measured tables, certified by INSAIs.