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    7 views6 pages

    HUP Registration Requirements

    Uploaded by

    Crystal Santiago

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    ANNEX B Data Requirements for Registration of Formulated Household Pesticides 1. New Registration A. Identity and Specifications Data Requirements Remarks AA. | Applicant Identity and Administrative Requirements 1.1 Completely Accomplished and Notarized Integrated Application Form with Declaration 1.2 Copy of valid License to Operate as household pesticide mamufacturer, trader or distributor | (importer, wholesaler, exporter) Product Identity ‘ormulator’s name and address rops category ig nso, rodenticide, oi 2.4 Type of formulation 8 EC, SC, WP, et. ‘A.3. | Quantitative and Qualitative Composition of product 3.1 Content of technical grade active ingredient(s) —_/ Newer Becec ste nents. ‘Squat zante 3.2 Content and nature of other components included in the formulation including water or any other solvents A.A, | Technical specifications of the formulated ‘Submit whichever is applicable product 4.1 Appearance (physical state, color, odor) 4.2 Density For iquide only 4.3 Flammability: liquids — flash point; solids — a statement must be made as to whether the product is [flammable — 44 pH 4.5 Wettability For dispersible powder: 4.6 Persistent foam TFor formulations applied in water 4.7 Suspendibility een rie a ape 48 Wet sieve test For dispersible powders and - suspension concentrates 49 Dry sieve test or granules, dusts 4.10 Emulsion stability For emulsifiable concentrates 4.11 Corrosiveness (When necessary) 4.12 Known incompatibilities with other products i po 4.13 Shelf life’ Supported by stability studies AS. Product specifications - Tolerance for the Active Ingredient/s* AG Aq. Certificate of analysis containing the manufacturing date, batch/lot number, name and signature of the laboratory analyst and manager Test procedures/methods conducted on the formulated product | Sal be aligned with the product specifications “Based on the technical specifications of the formulated product AB Safety Data Sheet (SDS) of the formulated product [8.1 Identification 8.2 Hazard identification 8.3 Composition and information of ingredients 8.4 First-aid measures 8.5 Fire-fighting measures 8.6 Accidental release measures 8.7 Handling and storage 8.8 Exposure controls and personal protection '8.9 Physical and chemical properties 8.10 Stability and reactivity 8.1] Toxicological information 8.12 Ecological information 8.13 Disposal considerations 8.14 Transport information 8.15 Regulatory information 8.16 Other information AS. Proof of Manufacturer's Compliance to Good ‘Manufacturing Practices (GMP)* Al0. Substantiation to support special product claims AL Product Stewardship Program AD. ‘Submission of actual sample and reference — standard Min, 1 g for the reference standard Min, 500mL/0.5kg product sample B. Toxicity Data*® Data Requirements ‘Remarks BA. Acute Toxicity Tests 1.1 Acute oral toxicit LD expressed as mg/kg of body weight 1.2 Acute dermal toxicity [EDs expressed as marks of body weight 1.3 Acute inhalation toxicity LC in mg/l oF ppmV B2. Corrosion/irritation tests 2.1 Primary skin corrosion/irritation 2.2 Serious eye damage/irritation B3. ‘Allergy/sensitization test Ba. Sub-chronic toxicity tests ‘Minimum 90 days, oral in rats as pe B.S._| Reproduction effects studies “Minimum two generations in rats B.6. | Teratogenicity studies Ti two species, one in ras and other in | non-rodents B.7. | Neurotoxicity studies Tn hens, for organophosphates, : ___| carbamates, 2" generation pyrethroids B&. | Mutagenicity studies imum of Ames test and in vivo _ ‘micronucleus test B.9. | Carcinogenicity tests and chronic (long term) | toxicity studies in rats - | C. Bio-efficacy Data® | Data Requirements ‘Remarks CA [Report design [1 Abstract ‘This secon ia shor summary oF the whole bio-elicacy stady seport 112 Introduction his section discusses the following: | ‘© Background information of the product (product classification, product owner, formulation type) inchuding the active ingrediont/s usod and its concontation in the product, efficacy ofthe active ingredient against specific pests © Known or confirm acute and/or long-term toxicity ofthe active ingredient ‘+ Potential forthe development of resistance and cross- resistance ‘= Significance of the study + In case of innovative products, justify the need (eg. advantages of using the product) forthe product 1.3 Objectives “This section discusses the specific purpose of the study 1.4 Methodology This section discusses the whole test procedures/desian in view of the objectives. I the test design has been patterned after an international ‘guideline said guideline is cited here, Incase deviations are made from the standard, these are also discussed and justified in this, section. Other information discussed in this section ae the following, ‘Duration of the study Adequacy of infastructures and location where the tet is, conducted (ie. laboratory or field) In case of field stady, suitability ofthe location and plot size ‘Size and design (ie. numberof trials per replicate, minimum of three replicates) ‘Test organisms/species and the conditions of their handling, © genus and species of the test insect age and sex laboratory-reared, wild collected, rearing techniques including environmental conditions, food source (© umber oftest insects used per trial, environmental conditions ‘Sampling methods and techniques used Equipment design and dimension ooo i = Treatments/controls used ‘© information on the ingredienvformulation as reference product or positive control Jnclusion/exclusion criteria used Preparations performed such as © Acclimatization © Washing of area of application © Weighing of test animal (rodents) ‘= Application method including equipment used, dilution rate, application rate, amount of treatments per application and timing ofthe application, ifapplicable 1+ _ Schedule of monitoring/ohservation. 1.5 Presentation, Analysis “This section discusses the statistical methods used and its suitability i in achieving the objectives specified in Section 3. Other information od aati a | eee chan © Rawdata, Statistical analyas resus _ = Interpretations _ 1.6 Summary of Findings, | This seoson discusses te resus ofthe Bi-eficacy study Conclusions and Recommendation for further studies are also discussed here in ease Reoommentiations the researcher deems it necessary 1.7 Bibliography | Ti secon ets thelist of references 1.8 Annexes, if any ‘This section contains the Qualifications of the Principal Investigator Researcher (CV, FPA Accreditation) Copy of Ethical Clearance issued by an Ethics Review Commitee ERC) duly registered with andlor accredited by the Philippine Health Fthics Research Board in case human subjects are used D. Human Exposure and Safety Data Requirements Remarks D.l. | Operators exposure data Dermalinhalation exposure, biological = 2 | monitoring ‘D.2. | Bystanders exposure data ‘Dermal/inhalation ‘exposure, biological monitoring | Medical data/Poisoning symptoms/Antidote | — Permissible exposure level For professional hhandlers/applicators Personal protective equipment | Other precautions Environmental Data Data Requirements EL Evaluation of Environmental Fate and Effects 1.1 Data on translocation of pesticides in soil and water 1.2 Primary data on potential hazards (infectivity) to mammals (including humans) 13 Primary data on aquatic toxicity 1.4 Primary data on phytotoxicity effects 1.5. Primary data on treatment of effluents and methods of destruction or disposal F. Labeling/Packaging Data Requirements Remarks 1. ibeling ‘Submit per pack size and EAL, | La include other information suaterials such as leaflets, ee brochure, et. [Ti Product Information — 1.1.1 Brand and Product name 1.1.2 Product or user category Household wie or Professional Use 1.1.3 Type of formulation 1.1.4 Intended use including the target pests ILLS Active ingredients including percentage Tndicate the active concentration in Yew/w or Yw/y - ana ee aay 11.6 Net content — 1.1.7 Bateh/Lot number 1.1.8 Manufacturing date 1.1.9 Expiry date 1.1.10 Registration number Specified as SR No XOX 1.2 Hazard and Safety Information 1.2.1 GHS pietogram, signal word, hazard sialement 1.2.2 Precautionary statement or warnings Tadicate he mando statement, “Keep out of Reach of Children” in the front panel; include other precautionary statements recommended by GHS based on hazard category 123 Color band based on GHS Acute Toxicity 1.24 Signs/symptoms of poisoning 1.2.5 First aid treatment / Antidote information 1.2.6 Medical advice/Note to physician 1.2.7 Accidenial spills advice 13 Directions for Use 13.1 Field of use ~ applicable 1.3.2 Dilution and application rate applicable 1.3.3 Directions for use 1.3.4 Re-entry period applicable 1.3.5 Frequency of re-applivation applicable 1.3.6 Storage and disposal T4 Name, complete address and contact information of the | Incase the MAHI isnot the marketing authorization holder (MAH)

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