Product Chemistry Data Requirement for

Product Chemistry Data Requirement For-Free PDF

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Lampiran A,PRODUCT CHEMISTRY DATA REQUIREMENTS, ACTIVE INGREDIENT an ingredient as listed in the First Schedule in the. Pesticides Act 1974 Act 149 which has pesticidal properties and gives pesticidal. properties to a substance material preparation or mixture of which the ingredient. is one of the constituents of substance material preparation of mixture. INERT INGREDIENT also named FORMULANT any substance other than an. active ingredient which is intentionally included in a pesticide product. TECHNICAL GRADE OF ACTIVE INGREDIENT TGAI also named TECHNICAL. MATERIAL TC material containing an active ingredient together with all. impurities from manufacturing process which contains no inert ingredient and which. is produced on a commercial or pilot plant production scale whether or not it is ever. held for sale, TECHNICAL CONCENTRATE TK material consisting in an active ingredient. together with all impurities originating from manufacturing process which contains. also additives not formulants and or a stabilizer For example all safety agents and. may also contain solvent s including water and which is produced on a. commercial or pilot plant production scale whether or not it is ever held for sale. Pure Active Ingredient PAI Active Ingredient which have been purified or not with a. certified purity higher than 980g kg, FORMULATED PRODUCT pesticide product whose labeling includes directions. for use of the product as distributed or sold or after combination by the user with. other substances for controlling pests or defoliating or desiccating or regulating. growth of plant and does not state the product may be used to manufacture of. formulate other pesticide products, STARTING MATERIAL a substance used to synthesize or purify a technical grade. of active ingredient or the practical equivalent of the technical grade ingredient if the. technical grade cannot be isolated by chemical reaction. IMPURITY any substance or group of structurally similar substances present in a. pesticide product other than an active ingredient or an inert ingredient including. unreacted starting materials side reaction products contaminants and degradation. products and pesticide active ingredients other than intended for that product. SIGNIFICANT IMPURITY any impurities find in a TC or TK present at a level of. 1g kg or above, RELEVANT IMPURITY any impurity of the manufacture or storage of a pesticide.
which compared with the active ingredient is toxicologically significant to health or. the environment is phytotoxic to treated plants causes taint in food crops affects. the stability of the pesticide or causes any other adverse effect An impurity may be. non relevant in one pesticide or product and relevant in another even though it. occurs in both because relevance is determined by impurity hazards relative to. those of the active ingredient, MANUFACTURER as per the definition given by FAO in the International Code of. Conduct means a corporation or other entity in the public or private sector including. an individual engaged in the business or function whether directly or through an. agent or entity controlled by or under contract with it of manufacturing a pesticide. active ingredient or preparing its formulation or product A manufacturer may well. have several different manufacturing site legally owned by different legal entities. MANUFACTURING PLANT means the place where a pesticide is produced. CONFIDENTIAL BUSINESS INFORMATION CBI means any data with. commercial value the release of which could harm to the company s business. interest leading to unfair competition as provided for under the Pesticides Act 1974. Product Chemistry Data Requirement for Pesticide Registration. 1 INTRODUCTION, Data requirements on product chemistry include information on the manufacturer. and the manufacturing s plants manufacturing process and manufacturing limits. product composition chemical and physical properties of the pesticides as well as. Method of analysis of the pesticides These data among other things are required. a support the claims made by the applicant, b enable registration authorities to evaluate the pesticide in terms of its. quality potential hazards decomposition products etc. c enable registration authorities to evaluate the pesticide and specify. labeling and packaging requirements and, d support emergency requests on spillage fire poisoning etc. 2 DATA REQUIREMENTS FOR TECHNICAL GRADE OF ACTIVE, INGREDIENT TC TK CONFIDENTIAL BUSINESS INFORMATION.
2 0 Originator,2 0 1 Manufacturer of the active ingredient. Name and address of Manufacturer,2 1 Identity and Composition. 2 1 1 Common Name, I The common name of the active ingredient s shall be clearly stated as. listed in First Schedule Section 2 of the Pesticides Act 1974. II The ISO common name of the active ingredient s shall be stated if. any If no ISO common name is available then the common name. used by Malaysian Standard or other common name as proposed by. other organizations British Standard Institution BSI etc may be. used if not ISO name must be specified clearly, III For products containing biopesticides microorganism for example. Bacillus thuringiensis the scientific systematic name subspecies and. strains of the organism shall be given Please refer to the relevant. guidelines Guidance For Harmonizing Pesticide Regulatory. Management in Southeast Asia 2012 2013 website, http www fao org asiapacific and Asean Guidelines On The.
Regulation Use and Trade of Biological Control Agent BCA. 2 1 2 Chemical Name, I The International Union of Pure and Applied Chemistry IUPAC. chemical name shall be used, II CAS number shall be stated and in addition Collaborative International. Pesticides Analytical Council number CIPAC number shall also be. given if available, III CAS number for each isomer or the mixture of isomers shall be stated. 2 1 3 Chemical Formula, I The molecular formula molecular mass and structural formula of the. active ingredient including its salt or ester wherever applicable shall be. ii Proprietary names synonyms and code names and CIPAC. number to be provided as a guide to identify the products if. applicable, iii Chemical and physical properties of the technical material shall be.
provided Refer Appendix 1, iv The Safety Data Sheet SDS of the Technical Grade of Active. Ingredient shall be provided The Safety Data Sheet SDS given. must according to the Occupational Safety and Health. Classification labeling and Safety Data Sheet of Hazardous. Chemicals Regulation 2013, The minimum information in appendix 2 shall be included on. Additional information may be required by Pesticide Board. 2 2 Manufacturing Process, The manufacturing activity shall be stated clearly where. a The name and address of the manufacturing plant at which the. pesticide will be produced, b For technical materials TC the manufacturing process starting from. the starting materials partway by product and impurities shall be. provided Chemical equations for chemical reactions involved in the. manufacturing process shall also be provided The purity of each. starting material used to produce technical material also shall be. c A description of any purification procedures including procedures to. recover or recycle starting materials intermediates or the substance. produce shall be provided, d A description of the procedures used to ensure consistent composition.
of substance produces e g calibration of equipment sampling. regimens analytical methods or other quality control methods shall be. stated clearly, e For each starting material chemical name CAS number or other. commercial designation of ingredient, I All information that applicant knows concerning the composition. and if requested by the Pesticide Board chemical and physical. properties of the ingredient including a copy of technical. specifications Safety Data Sheet SDS or other document. describing the ingredient, f Flowchart of the process of manufacturing process of the pesticide. shall be submitted with the application Summarizing the conditions. and solvent employed also shall be provided, g For technical materials minimum active ingredient and manufacturing. maximum limits for impurities content shall be stated in g kg. h Information on relevant impurities with explanation of the effects. observed for example toxicological effects or effects on the stability. of the active ingredient shall be provided Limits set by FAO WHO. Joint Meeting on Pesticide Specifications JMPS and or registration. authorities shall accompany this information identifying the authority. responsible for setting the limit, i For technical material manufacturing maximum limits for significant.
impurities present at or above 1g kg supported by batch analysis data. minimum 5 typical batches The statistical basic for manufacturing. limits confidential data shall be given 5 batch studies are required to. be Good Laboratory Practices GLP studies Relevant impurities must. be identified in the submission Typically the unidentified and or. unaccountable fraction of TC TK should not exceed 20g kg. j Manufacturing maximum limits for impurities proposed as relevant at. 1g kg Maximum limits for these impurities shall also supported with. batch analytical data minimum 5 typical batches all confidential and. proposer shall state the statistical basic for manufacturing limits. k The certification statement shall be signed by an authorized. representative of the manufacturer, 2 3 Method For Analysis and Testing of Technical Grade Active Ingredient. I Validated analytical procedures for determination of the content of. active ingredient and content of impurities of toxicological concern in. the product shall be provided Procedures involving use of. carcinogenic reagents would not be acceptable Sources or authorities. from which the analytical procedure is extracted shall be mentioned. II At least two methods for the identification of the active ingredient shall. be provided, III Reference test methods for physical properties Test methods for. physical properties may be validated by Collaborative International. Pesticides Analytical Council CIPAC or American Society for Testing. and material ASTM or according to the requirements of Organization. for Economic Co operation and Development OECD or European. Community EC or where appropriate by pharmaceutical. organizations, IV Analytical standards required for the use of the analytical methods. mentioned shall be supplied with the application Refer to Appendix 6. Requirement for analytical standard,2 4 Packing, I The type of packing material used shall be stated. II The packaging shall comply with Malaysian Standard MS 409 2012. Code of Practice for Packaging and Storage of Pesticide and other. international standard, III If the packaging does not comply with the Malaysian Standard MS.
409 2012 Code of Practice for Packaging and Storage of Pesticide. the results of a quality evaluation test shall be provide. 2 5 Evidence of Stability on Storage of Technical Grade Of Active Ingredient. Technical Concentrate TK, I Analytical Test Report as evidence of stability on storage shall be. submitted with each application Stability tests shall be conducted in. accordance with the FAO Accelerated Storage Test Procedures. usually at 54 2o C for 14 days or at 45 2o C for 6 weeks or at 40. 2o C for 8 weeks or at 35 2o C for 12 weeks or at ambient. temperature Malaysian for 2 years, II Samples should be analyzed before and after testing using the same. III For a critical scientific assessment of these data to be taken each. study must be reported in sufficient detail The methodology used in. each test must be thoroughly described or if the study has been. conducted to an internationally recognized protocol without significant. deviations then a reference to this method will be sufficient. IV Storage stability studies are required to be performed in Good. Laboratory Practices GLP certified test facilities or in ISO accredited. laboratories,2 6 Specifications, I Specifications for the Technical Grade Active Ingredient shall be. provided The pesticide shall conform to Malaysian Regulation FAO. or WHO requirements or FAO or WHO specifications whenever such. specifications are available This should be indicated in the application. form When such specifications are not available the applicant shall. state the specification that the pesticide complies with. II If the pesticide does not comply with any specifications the reasons for. non compliance must be given with the application Refer to. Appendix 3 for details required in the specification. 3 DATA REQUIREMENTS FOR FORMULATED PRODUCTS CONFIDENTIAL. BUSINESS INFORMATION, Data for Technical Grade of Active Ingredient TGAI is required on cases where. TGAI is not registered with Pesticide Board but its formulated product ready made. is directly imported and is intended to be registered In this case the registrant must. declare the source of the technical grade active ingredient and provide a letter of. undertakings authorization,That it is the sole source.
That if an alternative source is subsequently utilized prior approval must. be obtained from the Board,3 1 Information on the Active Ingredients. I Chemical Systematic Name ISO common name synonyms and code names. interest leading to unfair competition as provided for under the Pesticides Act 1974 Act 149 Product Chemistry Data Requirement for Pesticide Registration

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