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BN 399-2009 .doc REPUBLIC INDONESIA No. 399, 2009 MINISTRY OF AGRICULTURE. The Registration Of Pesticides. The procedure. REGULATION of the MINISTER of AGRICULTURE number: 45/Permentan/SR 140/10/2009 on the TERMS and PROCEDURES of REGISTRATION of PESTICIDES with the GRACE of GOD ALMIGHTY MINISTER of AGRICULTURE of the REPUBLIC of INDONESIA, Considering: a. that pesticides can give great benefits to society, but may also be injurious to human health, preservation of natural resources and biodiversity of the environment; b. that with regulation of the Minister of agriculture number 07/Permentan/SR 140/2/2007 concerning the terms and procedures of registration of Pesticides; c. that with the development of science and technology, Agricultural Minister Regulation number 07/Permentan/SR 140/2/2007 it is no longer appropriate; d. that based on the things above, seen the need to review the regulation of the Minister of agriculture number 07/Permentan/SR 140/2/2007; Remember: 1. Act No. 12 of 1992 about the Cultivation System (State Gazette Number 46 in 1992, State Gazette Supplementary Number 3478);
2009, no. 399 2 2. Act No. 23 of 1992 on health (State Gazette Number 100 in 1992, State Gazette Supplementary Number 3495); 3. Act No. 23 of 1997 on environmental management (State Gazette Number 68 in 1997, additional State Gazette Number 3674); 4. Law number 8 of 1999 on the protection of the consumer (State Gazette Number 42 in 1999, an additional State Gazette Number 3821); 5. Government Regulation number 7 in 1973 about the supervision over the Circulation, storage and use of Pesticides (State Gazette No. 12 of 1973); 6. Government Regulation number 6 of 1995 on the protection of the plant (State Gazette No. 12 of 1995, an additional Sheet country number 3598); 7. Government Regulation number 18 in 1999 about the management of hazardous materials and Toxic Waste (State Gazette number 30 of 1999, an additional State Gazette Number 3815); 8. Government Regulation Number 74 in 2001 about the management of Hazardous and toxic Materials (State Gazette Number 138 in 2001, additional State Gazette Number 4153); 9. Government Regulation Number 49 in 2002 about the Tariff Over the kind of Acceptance State Tax is not applicable to the Department of agriculture (State Gazette Number 92 in 2002, an additional Sheet country number 4224) juncto Government Regulation number 7 2004 (State Gazette No. 14 of 2004, an additional Sheet country number 4362); 10. Presidential Decree Number 194/M in 2004 on the establishment of a United Indonesia Cabinet; 11. the presidential Regulation No. 9 of 2005 about the position, tasks, functions, Organization, and the work of Ministries of the Republic of Indonesia;
2009, no. 399 3 12. Presidential Regulation No. 10 in 2005 about the Task and Organizational Unit Echelons I Ministries of the Republic of Indonesia juncto Rule President of Indonesia Number 62 in 2005; 13. the regulation of the Minister of health Number 472/Menkes/XI/PER/1992 of hazardous materials; 14. Decisions along with Minister of agriculture and Minister of health Number 881/Menkes/LCS/VIII/1996, 752/Kpts/TP 270/8/1996 on Maximum pesticide residues On agricultural output; 15. Regulation of the Minister of health Number 1350/Menkes/SK/XII/2001 concerning Pesticides; 16. Regulation of the Minister of health Number 1184/Menkes/Per/X/2004 about Health Tools and Safeguards the health of household Supplies; 17. Regulation of the Minister of agriculture Number 297/Kpts/OT 140/7/2005 about the Organization and the work of the Department of agriculture; 18. Regulation of the Minister of agriculture Number 341/Kpts/OT 140/8/2005 about the completeness of the Organization and the work of the Department of agriculture; 19. Regulation of the Minister of Commerce Number 51/M-DAG/PER/12/2007 about the conditions of the import of Methyl Bromide For quarantine and Pre Shipment. 20. The decision of the Minister of agriculture Number 276/Kpts/OT 160/4/2008 about the Pesticides Commission; Notice: the opinions of the Commission on Pesticides in Letter Number 745/Kompes/2009 dated September 30, 2009; Decide: Define: REGULATION Of The MINISTER Of AGRICULTURE ABOUT The TERMS And PROCEDURES Of REGISTRATION Of Pesticides.
2009, no. 399 4 CHAPTER I GENERAL PROVISIONS article 1 in this rule is: 1. Pesticides are all chemical substances and other materials as well as the remains of miniscule and viruses to be used for:-eradicate or prevent pests-pest and disease damage plants, parts of plants or the outcomes of agriculture; -eradicate grasses; -turn off the leaf and prevent unwanted growth; -organise or stimulating the growth of plants or parts of plants excluding manure; -eradicate or prevent pests-pest out on animals-pets and livestock; -eradicate or prevent pests-Aquatic pests; -eradicate or prevent animals and bodies remains miniscule in households, buildings and in the transport of tools; and/or-eradicate or prevent the animals that can cause disease in humans or animals that need to be protected with the use in plants, soil or water. 2. The registration of a pesticide is the process to get a registration number and permission to pesticides. 3. for general use Pesticides are pesticides in current use do not need the requirements and tools special safeguards beyond the stated on the label. 4. Pesticides pesticides are limited in their use requires the terms and special safeguards tools outside the listed on the label. 5. banned Pesticide is a type of pesticide that is banned for all areas of use. 6. Active ingredients are synthetic chemicals or natural substances contained in pesticides formulation or technical materials that have the power or influence of other biological toxins against target organisms.
2009, no. 399 5 7. The active ingredient of pure active ingredients is the standard that is used as a comparison in the process of the analysis of the levels of pesticide active ingredients. 8. technical Material is the raw material manufacture formulations that result from a manufacture of active ingredients, which contain active ingredients and materials of dopants (impurities) or follow-up can also contain other materials as needed. 9. the technical origin of the Material is material which is produced directly from synthetic process, extraction or other processes to produce the active ingredients. 10. technical Material is processed ingredients are produced from materials processing technical origin with specific objectives such as security, stability or specific purposes in the making process of formulation, pewadahan, transporting and storage. 11. The formulation is a mixture of active ingredients with supplementary materials with levels and certain forms of work which have the power as a pesticide in accordance with the planned goals. 12. Additional material pesticides are ingredients added in pesticide formulations or technical material in addition to the active ingredients of pesticides include: solvents, pembau, emulsifier, dye carriers, grader, adhesive, spreaders, and pemantap. 13. The owner of the formulations are individuals or legal entities who have a prescription formulation of pesticides. 14. Prescription formulations is a description that States the type and the number of active ingredients and additives contained in a pesticide formulation and/or how to memformulasi a pesticide using technical or active ingredients and other constituents. 15. The circulation is the import-export or sale within the country including transport of pesticides. 16. Storage is to have pesticides in stock in the page or in the space used by importers, traders or in agricultural businesses. 17. The use of pesticides is to use with or without a tool such as intent to in Figure 1. 18. The container is exposed to the pesticide directly to save during handling. 19. The Label is text and can be accompanied by a picture or symbol, which provides information about pesticides, and attached to the container or wrapper pesticides.
2009, no. 399 6 20. Culling is removing the nature and function of pesticides. 21. the use of the Certificate is a certificate that States have passed training in use of pesticides is limited. 22. The user is the person or legal entity who uses pesticides with or without tools. 23. The naming of formulations is the trade name of a pesticide formulations that are registered by the applicant. 24. The naming of technical material is the name of a technical material registered by the applicant. 25. Pesticide residues are remnants of pesticides, including the results of the changes found in the network or in humans, animals, plants, water, air or soil. 26. Acute Toxicity is the adverse influence of arising immediately after exposure with a single dose of a chemical or other material, or double dosing within approximately 24 hours. 27. The toxicity of subkronik is an adverse influence on animal experiments which arise as a result of the daily recurring just the granting of chemicals or other ingredients, with the period of exposure for 3 months. 28. the chronic Toxicity is the adverse influence on animal experiments which arise as a result of the daily recurring just the granting of chemicals or other ingredients, with the period of exposure for 2 years. 29. Lethal dose to 50 the next single dose LD50 is abbreviated to chemicals or other materials that are derived statistically that may cause the death of 50% of a population of organisms in a series of experimental conditions have been determined. 30. Lethal concentration 50 hereinafter abbreviated LC50 is statistically derived concentration can cause the death of 50% of a population of organisms in a series of experimental conditions have been determined. 31. Acceptable Daily Intake ADI abbreviated next number is penduga the daily intake of chemicals that can be accepted in food throughout the life of a human being without a meaningful health risk.
2009, no. 399 7 32. Maximum Residue limits hereinafter abbreviated BMR is the limit of hunch's maximum allowable pesticide residues found in a variety of agricultural output. 33. Lethal time 50/a biological half-life hereinafter abbreviated LT50 is the required time in the day to turn off 50% ercobaan animals under certain conditions. 34. The Unit number is a factor of toxicity quotient (ratio) nominal concentrations of pesticides in the water of rice field with a height of 10 cm with a value of 96-hour LC50. 35. Decomposition time-50 hereinafter abbreviated DT50 is the time required for the occurrence of 50% decomposition form of dissipation and degradation of a chemical in a medium. 36. Efficacy is the effectiveness of the target organisms against pesticides be registered based on the results of the experiment field or laboratory according to the applicable methods. 37. Resurjensi is the increasing population of the target organisms after treated with pesticides. 38. Resistance is a decrease in the level of sensitivity of the population of the target organisms against pesticides that can cause pesticides originally effective for control of the target organism becomes not effective anymore. 39. Irritation is a symptom of inflammation that occurs in the skin or mucous membrane immediately after prolonged or repeated treatments with the use of chemicals or other materials. 40. is the nature of a Carcinogenic material that may encourage or lead to cancer. 41. Teratology is the nature of the chemicals that can cause/disability/disability produced body at birth. 42. is Mutagenic properties of the chemicals that cause the occurrence of mutations of genes. 43. The grass is a plant pest or weed. 44. The head of the Centre is the head of the licensing and investment Center. Article 2 (1) of the regulation is intended as a legal basis in organizing registration including testing and licensing as well as supervision of pesticides.
2009, no. 399 8 (2) this regulation aims to: a. protect the public and the environment from the harmful influences as a result of storage, circulation, and the use of pesticides; b. increasing the efficiency and effectiveness of the use of pesticides; c. supporting the application of the system of integrated pest control (PHT); and/or d. provide certainty in the conduct of business activities of procurement, storage, and release of pesticides. Article 3 scope this regulation setting include classification, type of licensing, admission requirements, registration procedures, labels and containers of pesticides, and administrative sanctions. Article 4 areas of use of pesticides include: a. the management of the plant; b. livestock and animal health; c. fishing; d. forestry; e. agricultural storage; f. households; g. settlement; h. control of vector diseases in humans; i. quarantine and pre-shipment; and j. mode of transportation. CHAPTER II CLASSIFICATION article 5 (1) based on the danger, pesticides may be classified into: a. a banned pesticide. b. the pesticides can be registered; (2) prohibited Pesticides as referred to in paragraph (1) letter a, with the following criteria: 2009, no. 399 9 a. pesticide formulations including class, meaning It is very harmful and class Ib means harmful according to the classification of the WHO; b. active ingredients and/or additional ingredients which have the effect of carcinogenic (category I and IIa on the basis of the classification of the International Agency for Research on Cancer), mutagenic or Teratology. (3) the pesticides can be registered as referred to in paragraph (1) letter b pesticides that do not fall into the category of banned pesticides as referred to in paragraph (2). Article 6 (1) based on how the use of pesticide, can be classified into: a. pesticide is limited; and b. pesticides for general use restricted Pesticides (2) referred to in paragraph (1) letter a, with the following criteria: a. pesticide formulations corrosive on the eyes (causing damage to no ocular tissue terkembalikan), resulting in minimal shrinkage in the cornea or irritation to 7 (seven) days or more; b. formulation of pesticide-corrosive towards leather (causing damage to tissues in the dermis or cuts and scars) or result in severe irritation to 72 (seventy two) hours or more; c. when used as indicated on the label, or according to the usual practice, pesticides are still real cause poisoning in subkronik chronic or delayed, to humans as a result of exposure in single and compound against the pesticides or residunya; and/or d. LC50 inhalation has less than 0.05 mg/I during the 4-hour exposure period; or e. the material included in the destroyer of ozone layer. (3) Pesticides for general use as intended in paragraph (1) letter b pesticides that do not fall into the category of restricted pesticides as referred to in paragraph (2). Article 7 (1) of pesticide active ingredients prohibited for all areas of use as listed in Annex I section 1 as grain an integral part of this Regulation with 2009, no. 399 (2) 10 active ingredients of pesticides prohibited for household pesticides as listed in Annex I section 2 as the grains are not separated by this rule. (3) the pesticide active ingredients prohibited for fishery as it is listed on Appendix I of the 3 rounds as part an integral part of this regulation. (4) the limited pesticide active ingredients as listed in annex II as part an integral part of this regulation. (5) supplementary material that is prohibited for all pesticide field of pesticide use as listed in Annex III as part an integral part with the rules in. (6) additional material pesticides restricted its use to the management of the plant such as listed in Annex IV as part an integral part of this Regulation with article 8 (1) change the classification of the use of pesticides is prohibited from being a general use of pesticides is limited, or into general use, or vice versa can be done after any suggestions and considerations of the Commission on pesticides. (2) the changes referred to in subsection (1) more will be poured in the decision itself. Article 9 (1) every person that will be using pesticides restricted as stipulated in article 6 paragraph (1) letter a, required to have a certificate of use of pesticides is limited. (2) the use of pesticides is limited Certificate referred to in subsection (1) is given to people who have passed training in use of pesticides is limited. (3) the holder of a compulsory registration number carry out pesticide training is limited in accordance with the guidelines. (4) the use of pesticides is limited to Training as referred to in paragraph (2) may be held by the Chairman of the Commission for the supervision of Pesticide provincial/district/municipality or designated officials. (5) the use of pesticides is limited Certificate as referred to in paragraph (1), apply in the entire territory of Indonesia for a period of 5 years, and can be extended.
2009, no. 399 11 (6) the provisions concerning the training of users of pesticides is limited and further certification is set in its own regulations. Article 10 legal entity can make use of pesticides is limited when applied by people who have a limited use of pesticides have a certificate referred to in article 9. CHAPTER III TYPES of LICENSING article 11 types of pesticide permit consists of: a. permit the experiment; b. temporary permits; and c. the permission remains. Article 12 (1) Permits the experiment referred to in article 11 a, is given by the head of the Center applies for a period of 1 year, and may be extended one time for a period of 1 (one) year. (2) Permit the experiment referred to in subsection (1) is granted to the applicant to be able to prove the truth of his claims regarding the quality, efficacy, and safety of pesticides registered. (3) the pesticides that have been banned for trial license distributed and/or used commercially. Article 13 (1) a temporary Permit as referred to in article 11 letter b is given by the Minister on the advice of the Commission consideration and/or pesticides. (2) a temporary Permit as referred to in paragraph (1) was given against the pesticides that meet most requirements of technical and/or administrative. (3) a temporary Permit as referred to in subsection (1) is granted to the applicant to complete the technical and administrative requirements as referred to in paragraph (2) with data and information in accordance with the set. (4) a temporary Permit as referred to in subsection (1) apply for a period of 1 (one) years, and may be extended one time for a period of 1 (one) year.
2009, no. 399 12 (5) if the applicant within the period referred to in subsection (4) has yet to complete the technical requirements and/or administration referred to in subsection (3), the application is considered withdrawn. Clause 14 of the Pesticides which have obtained a permit while as stipulated in article 13 can be produced, distributed, and used in limited quantities in accordance with the number of commodities, the dose or concentration and application specified by decision of the Minister. Article 15 (1) of the pesticide methyl bromide-based active temporary permission is granted on the basis of the applicable legislation, regulations, with the amount distributed in accordance with the provisions of the applicable (national quota) in the year in question. (2) a temporary Permit as referred to article 11 letter b to the pesticide methyl bromide-based active is given by the Minister on the advice of the Commission consideration and/or pesticides. (3) Permission while the pesticide methyl bromide active material referred to in subsection (1) apply for a period of one (1) year, and restart can be registered with the following conditions. (4) a temporary permit re-Registration as referred to in subsection (1) is performed at least 90 (ninety) days of work before the permit expires. Article 16 (1) a fixed Permission as referred to in article 11 of the letter c is given by the Minister on the advice of the Commission consideration and/or pesticides. (2) the permit remains as intended in paragraph (1) is valid for a period of 5 (five) years and can be extended. (3) the pesticides that have obtained the permit remains as intended in paragraph (1) can be produced, distributed and used. Article 17 (1) pesticides permission Remain as stipulated in article 16 paragraph (1) can be expanded its use on other targets that have not been registered after obtaining permission use of expansion. (2) expanded use of Permit referred to in subsection (1) is given by the Minister on the advice of the Commission and consideration of Pestsida.
2009, no. 399 13 (3) to get the expanded use of permit referred to in subsection (1) the applicant applied for attaching the test results. Article 18 when pesticide use as referred to in articles 14, 15, 16 and 17 proved to pose a negative impact on human health and environmental sustainability, or temporary permit, permission or permit expanded use of can be reviewed or revoked. CHAPTER IV REGISTRATION REQUIREMENTS article 19 (1) application for registration of a pesticide could be done by business entities or legal entities with Indonesia meets the requirements of registration as follows: a. deed of establishment and its changes, for business entities (Trade, Business Firms, CV, NV) and legal entities (PT, cooperatives); b. Business Trade Licence (SIUP)/Tanda list of the trading business (TDUP) pesticides; c. Tax Payer Number (NPWP); d. domicile certificate/Card Sign inhabitants (KTP); e. company profile; f. a statement that has the right to sign in order of registration; g. the guarantee Letter supply active ingredients from suppliers of active ingredients and h. coaching programs the pesticides will be registered. (2) the registration of pesticides as referred to in subsection (1) is done by the owner of the corresponding formulation or its power. Article 20 for the owner of the Formulations dating from overseas, registration of pesticides carried out by his power/incorporated legal representative of Indonesia and domiciled in Indonesia. Article 21 (1) the pesticides can be registered in Indonesia, a pesticide does not enter the classification is prohibited as referred to in article 5 paragraph (1) letter a, containing no active ingredients of pesticides which are prohibited as of 2009, no. 399 14 referred to in article 7 paragraph (1) and/or do not contain banned additives as referred to in article 7 paragraph (4). (2) the pesticides referred to in subsection (1) must qualify the purity levels of active ingredients that meet the specifications of the SNI, the FAO, the WHO or other international bodies. Article 22 application in addition To meeting the requirements referred to in article 19, shall meet the following requirements: (1) any formulations that are generated by each owner, used for every area of use, must be registered on behalf of a claimant; (2) the formulation of pesticides-active compounds to the field of use of the management of the plant, except the ZPT, rodentisida, biology and pesticide pheromones/atraktan does not cause the effects of antagonists. Article 23 (1) the registered Pesticides must be given its own designation, which is the identity of any pesticide formulations which will be circulated. (2) a Designation as referred to in subsection (1) must not be the same or almost the same with the formulation that has been registered on behalf of other companies. (3) a Designation as referred to in subsection (1) must satisfy the following requirements: a. each formulation was given only one name that consists of three (3) elements, namely a trade name which is not related to the common name and/or the name of the active ingredient, a number that shows the levels of active ingredients, and the code letters indicating the form of the formulation; b. any pesticide formulations registered designation attached with a proof of registration has been authorized in accordance with the provisions of the legislation on intellectual property rights (INTELLECTUAL PROPERTY); c. naming the formulations referred to in letters a and b is not agitatif such as the words "awesome", "excellent", "super" or "powerful". (4) technical material Designation must meet the essential requirements referred to in subsection (3) and followed by the code number and the successive consecutive shows levels of active ingredients and a range of technical materials.
2009, no. 399 15 chapter V REGISTRATION PROCEDURES Article 24 (1) pesticide application submitted in writing to the head of the Centre with emblazoned seals to taste based on applicable laws and regulations; (2) the Application referred to in paragraph (1) using the format as listed in Annex VII or VIII or IX as part an integral part of this regulation, accompanied by a complete requirements in accordance with the provisions referred to in CHAPTER IV. Article 25 (1) the head of the Center after receiving a petition as stipulated in article 24 at the latest within a period of 20 (twenty) working days should have reviewed the document and give an answer to the petition, delayed, denied or accepted. (2) if within the period of two twenty-20 working days referred to in subsection (1) the head of the Centre have not provided the answer is delayed, denied or accepted, permohononan considered to be complete and correct. Article 26 (1) deferred Application referred to in Article 24 paragraph (1), if the requirements are not complete or there are still shortcomings that must be completed. (2) the delays referred to in subsection (1) by the head of the Center notified to the applicant in writing, accompanied by an explanation of the delay with the form model-1 as listed in Annex XVII as part an integral part of this Regulation (3) an applicant for a period of not longer than 90 (ninety) working days from receiving the notice referred to in subsection (2) must complete the requirements. (4) if within a period of 90 (ninety) working days referred to in subsection (3) the applicant has not been able to complete the requirements, the application is considered withdrawn. Article 27 (1) of the petition was rejected as stipulated in article 24 paragraph (1) if it does not meet the requirements referred to in CHAPTER IV, or due to technical reasons.
2009, no. 399 16 (2) the refusal referred to in subsection (1) by the head of the Center notified to the applicant in writing, accompanied by an explanation of the denial with the form model-1 as listed in Annex XVII as part an integral part of this Regulation with Article 28 (1) when the results of the examination of the application documents as referred to in article 24 paragraph (1) be declared complete and correct or is deemed complete and correct as stipulated in article 24 paragraph (2) Permit Center, head of the experiment. (2) an applicant who is granted permission to the experiment referred to in subsection (1) must submit samples of the pesticide into the center of licensing and investment for tested quality. (3) quality test referred to in subsection (2) is performed by a laboratory that is accredited or designated as listed in Annex XIII as part an integral part of this regulation. (4) quality Test Results referred to in paragraph (3) by laboratory examiners submitted to the head of the Centre for the assessment carried out in accordance with the limits of tolerance as shown on Annex VI as part an integral part of this regulation. (5) the head of the Center at the latest within 7 (seven) working days has been completed perform the assessment referred to in paragraph (4). (6) if the results of the assessment of the quality test and the samples of pesticides as referred to in subsection (5) does not meet the requirements, the head of the Center inform the applicant in writing to be able to apply for a quality test with the form model-1 as listed in Annex XVII as part an integral part of this regulation. Article 29 (1) when the results of the assessment referred to in Article 28 paragraph (4) to be eligible, the next sample pesticide sealed by the head of the Center. (2) the head of the Centre submit samples of pesticides that have been sealed as mentioned in subsection (1) to Institute examiners toxicity and efficacy that has been accredited or designated as listed in Annex XIV and annex XV as part an integral part of this regulation.
2009, no. 399 (3) Agency examiners in conducting testing of efficacy and toxicity as referred to in paragraph (2) is required to follow applicable default methods and report test results efficacy and toxicity to the head of the Center. (4) the head of the Center after receiving reports the results of test quality, efficacy and/or toxicity as referred to in paragraph (3) together with the Pesticide Registration Evaluation technical team doing an assessment, in accordance with the technical criteria as listed in Annex V as part an integral part of this regulation. (5) the results of the assessment referred to in paragraph (4) of the next plenary meeting of the Commission delivered on Pesticides as material Evaluation Commission on pesticides. Article 30 (1) the results of the Commission's assessment of pesticides as referred to in article 29 paragraph (5) could be postponed, reject or accept the application for registration. (2) if the results of the assessment of the application for registration is rejected as referred to in paragraph (1) the head of the Center at the latest within a period of fourteen (14) working days had told the applicant with the reason for the refusal in writing accompanied with form model-2 as listed in Annex XVIII as part an integral part of this Regulation with article 31 (1) deferred Application article 30 referred to in subsection (1) When the requirements are incomplete or there are still shortcomings that must be completed. (2) the delays referred to in subsection (1) by the head of the Center notified to the applicant in writing, accompanied by an explanation of the delay with the form model-2 as listed in Annex XVIII as part an integral part of this Regulation (3) an applicant for a period of not longer than 7 (seven) working days from receiving the notice referred to in subsection (2) must complete the requirements. (4) if within a period of 7 (seven) working days after the notification referred to in paragraph (3), the applicant has not been able to complete 2009, no. 399 18 requirements, the petition following the assessment by the Commission of the Pesticides on the next period. Article 32 (1) when the Commission assessment of pesticides as referred to in section 30 subsection (1) application was received by the Commission, further proposed to the Minister of agriculture Pesticides for registration and permit number petitioned pesticides. (2) the Minister of agriculture at the latest within a period of 90 (ninety) working days since the Commission accept the proposed Pesticides as referred to in paragraph (1) should provide answers to accept or reject. (3) if the Commission's proposals acceptable Pesticides referred to in subsection (2) by the Minister of agriculture is given a registration number and permission to pesticides. (4) the registration number and permission to pesticides as referred to in paragraph (3) provided in the form of a decision of the Minister of agriculture. Article 33 (1) the granting of permits and pesticide registration number referred to in Article 32 paragraph (1) may include: a. the registration number and the temporary permits; or b. the number of registration and permission to remain. (2) the numbering Mechanism covering the areas of use of pesticides, pesticide Type, the type of permit, year of birth, the number of digits in the year concerned, numbering Procedures as listed in Annex XIX as part an integral part of this regulation. Article 34 (1) if within a period of at least 90 (ninety) working days since the Commission accept the proposed Pesticides as referred to in article 30 paragraph (2) the Minister of agriculture has yet to give an answer to accept or reject the plea, considered to be complete and correct. (2) the Application is considered complete and correct as mentioned in subsection (1) is given a registration number and permission to pesticides in the form of a decision of the Minister by the Secretary General on behalf of the Minister of agriculture. Article 35 (1) the procedures of registration of pesticides as referred to in article 19 to with article 34 are mutatis mutandis apply to the registration of 2009, no. 399 19 technical material pesticides and pesticides for export unless testing efficacy, environmental toxicology, resurjensi, and the residue is not required. (2) the registration of technical material as referred to in paragraph (1) using the format as listed in Annex X as part of an integral part of this regulation. Article 36 (1) a registration number has been given in a temporary or permanent permissions permissions, can be switched or routed, because: a. the owner of the other parties designating the formulation as the holder of the registration number; b. the owner of formulations formulasinya transfer ownership to another party; c. appointment of another party as the holder of the registration number due to the incorporation of the company; d. replacement of the name of the owner or holder of the registration number of the formulation. (2) the party was appointed as the new registration number holder referred to in subsection (1) is required solving among holders of the old formulation with the holders of the new formulations, then reported to the head of the Center for the book noted in the mandatory registration number as well as the proposed stipulation regarding the transfer in question. Article 37 (1) changes concerning the registered pesticides, the covering: a. change of name or name and formulation active ingredient; b. container and or wrappers; c. form of the formulation of the technical material/d. the origin of active ingredient; e. material solvent; f. ingredients emulsifiers; g. carrier materials; h. the levels of the active ingredient (within the tolerance levels of the active ingredient); i. levels of the active ingredient in technical materials 2009, no. 399 20 j. registered and permitted use; k. the amount allowed was released; and/or; b. dose and mode of application of pesticides (according to the results of a test of efficacy) (2) the changes referred to in paragraph (1) the letters d, e, f, g and h may be approved when, after testing the appeal of quality, efficacy and toxicity, to one of the target organisms results meet the technical requirements. (3) the changes referred to in subsection (1) is required by the holder of the registration number reported to the head of the Center for the book noted in the registration number and its further processing. Article 38 (1) a permit remains the pesticide can be registered with a pesticide registration procedures follow the provisions as referred to in article 19 to with article 34 with fitted quality test results:-repeated formulation for pesticides re-enrollment odd (first, third .... etc). quality test results re technical materials for each pesticide re-register. -quality test results and efficacy reload against one of the target organism pesticides for re-enrollment evens (second, fourth ... .. etc.), quality test results and efficacy even-numbered anniversary (second, fourth ... .. etc.) against plant pest organisms (OPT) for pesticides used on crops of rice. (2) the target Organism as referred to in paragraph (1) that one of the listed target organisms since first pesticides given permission. (3) registration re permanent consent referred to in subsection (1) is performed at least 90 (ninety) days of work before the permit expires. Article 39 the grant permission remained re-enrollment in addition must meet the conditions as referred to in article 38 also pay attention to the results of the evaluation of pesticide supervision carried out by the authorized Agency.
2009, no. 399 21 article 40 (1) When the application for re-registration as referred to in article 38 was accepted, at the latest within 90 (ninety) days of work have been published the decision of the Minister of agriculture about the registration and Permission of pesticides. (2) if within 90 (ninety) days of work the decision of Minister of agriculture Pesticide registration and permits as referred to in paragraph (1) has not been published, Secretary General on behalf of the Minister of Agriculture published a decision of the Minister of agriculture. (3) When re-enrollment as referred to in paragraph (1) was not performed or rejected, the permit number and the registration ended in favor of the law. (4) a registration permit number and ends when the re-enrollment of pesticides declined then to be pulled from circulation no later than 6 (six) months. CHAPTER VI PESTICIDE CONTAINERS and LABELING Article 41 (1) of pesticides that have been registered with the permission of temporary or permanent permissions should be placed in the container. (2) Containers of pesticides should not easily ruptured or torn, or other container so that the protected is not broken, do not react with pestisidanya or corrosive, so that humans and the environment against hazards can be avoided. (3) every container must be closed or folded properly so that the lid or flap or container that cannot be opened without destroying it unless the container is made in such a way that without damaging the lid pesticides can only come out in the form of smoke or fog. (4) the specification of the container must be described in full volume, which includes the name of the material, shape, size, color, material thickness, material layer of the surface of the container and the inside of the lid of the container, as shown in Annex XI. (5) Pewadahan return a pesticide formulation can only be made by the holder of the registration of the pesticide in question or other party designated in accordance with the applicable provisions. Article 42 (1) any pesticide containers must be labelled, which is taped and not easy to loose or printed on the container.
2009, no. 399 22 (2) pesticide Label proposed by the holder's registration, and is one of the requirements in the application for registration. (3) all of the information on the label and attachments usage instructions should be listed in the Indonesia language with words that are not agitatif such as the words "awesome", "excellent", "super", "strong" or "powerful", as well as prohibited list the image target organisms that are not listed, other pesticides compares to the forbidden who have registered. The use of a foreign language is permitted only when translating things judged important already mentioned also in the language of Indonesia. (4) a description and a warning sign on the label must be printed in clear, easy-to-read or seen, easily understood and are not easily erased. (5) a full description of the contents of the label, sentence anniversaries and security instructions, description of symptoms of toxicity, a description of the help instructions, a description of the storage instructions, description of the usage instructions, inclusion of images, labels, signs of pesticides is limited, and the preparation of labels, as shown in Annex XII. CHAPTER VII LIABILITY of the OFFICERS and the OWNER of the REGISTRATION NUMBER of article 43 (1) officer who served the institution for officers and examiners registration quality, efficacy and toxicity to safeguarding truth and secrecy of data and information on pesticides that are by their nature need to be kept secret. (2) compulsory licensing and Investment Centre organizes the management of books and record the registration number of all mutations of either the subject or the object of registration of pesticides. Article 44 (1) the holder of a compulsory registration number include the entire description required on the labels of pesticides that are registered as listed in Annex XII to this Regulation. (2) the applicant/holder's registration number is obliged to pay the registration fee which is Not State Tax Receipts (PNBP), and must be deposited into the State Treasury which magnitude is specified based on the applicable legislation.
2009, no. 399 23 (3) registration number Holders assume all costs of testing the magnitude and tatacaranya set by the examiners. Article 45 (1) the holder of a compulsory registration number submit the active ingredient standard by as much as 1 (one) gram and its analysis certificate every 2 (two) years to Head the next stored at the laboratory as referred to in article 28 paragraph (3). (2) the holder of a compulsory registration number submit annual reports concerning the production and circulation of pesticide active ingredients as well as covering import, export and domestic sale and purchase at least 2 (two) months after the calendar year ends, and 6 (six) report monthly on production and circulation of pesticide was confined to Agriculture Minister through the Head using the format as listed in Annex XVI to this Regulation. (3) the holder of a pesticide registration obligatory number of coaching and supervision against everything to do with who becomes his responsibility as well as taking penanggulangannya measures in case of irregularities, the activities carried out on its own or together with the apparatus of the Government. CHAPTER VIII Article 46 ADMINISTRATIVE SANCTIONS against the institutions and/or laboratory testers are proven to be no guarantee of the confidentiality of test results, and the truth that he was given a written reprimand by the head of the Center and reported to an authorized officer to be penalized in accordance with the provisions of the applicable legislation. Article 47 officers who serve the registration proved to be no guarantee the confidentiality of the data of pesticides as referred to in article 42 paragraph (1) of the employees disciplinary penalties pursuant to applicable legislation. Article 48 the applicants proved to distribute pesticides that are currently in the process of registration, cancellation penalties and pesticide application permit up to the process of investigation by the competent authority to acquire the force of law.
2009, no. 399 24 Article 49 (1) the holder of a registration number that is proven not to list the entire information required on the label as referred to in section 42 and subsection (5) or does not guarantee the quality of its production or not reporting any change the holder of the registration the registration number for the removal of sanctions imposed and permissions. (2) the holder of a registration number and does not produce or does not import the formulations of pesticides didaftarkannya and does not make a report referred to in Section 45 subsection (2) for 2 (two) years consecutively penalized for the removal of the permit number and registration. (3) the holder of a registration number does not report the change of origin of active ingredient as referred to in Article 37 paragraph (1) letter d penalized repeal registration number and permission. (4) the holder of the registration number referred to in subsection (1), subsection (2) and paragraph (3) compulsory draw pesticides from circulation no later than 3 (three) months from the published decisions of the Minister of agriculture about the revocation of registration number and permission. CHAPTER XI TRANSITIONAL PROVISIONS article 50 (1) of pesticides that have got the registration number and permission to stay temporarily or permission before this regulation was published, was still in force. (2) the solicitation number initial registration and permission to remain or temporary permission was or is already done testing before this Regulation applies the provisions of Regulation published Minister of agriculture number 07/Permentan/SR 140/2/2007. (3) the application for registration number and permission to stay or permission while the testing has not been made before this regulation was published, according to the provisions of this regulation. CLOSING PROVISIONS Article 51 With the establishment of this rule, then the regulation of the Minister of agriculture number 07/Permentan/SR 140/2/2007 concerning the terms and procedures of registration of Pesticides was declared repealed and not applicable.
2009, no. 399 25 Article 52 this Regulation comes into force on the date specified. So everyone knows, this Minister of agriculture Regulations enacted by its placement in the news of the Republic of Indonesia Established in Jakarta on October 10, 2009 MINISTER of AGRICULTURE ANTON APRIYANTONO, Enacted in Jakarta on October 20, 2009 the MINISTER of LAW and HUMAN RIGHTS Republic of INDONESIA, MATTOANGIN 2009, no. 399 26 ANNEX I REGULATIONS the MINISTER of AGRICULTURE number: 45/Permenan/SR 140/10/2009 DATE 10 October 2009: i. active ingredients prohibited for all pesticide use: No. The active ingredients CAS Number 1. 2, 4, 5-T 95-95, 4-2. 2, 4, 6 T-88-06-2 3. Sodium 4-diklorofenol-2.5-bromine 4824-78-6 4. Aldikarb 116-06-3 5. Aldrin 309-00-2 6. 1.2-Dibromo-3-kloropropan (DBCP) 96-12-8 7. Cyhexatin 13121-70-5 8. Dichloro diphenyl trikloroetan (DDT) 50-29-3 9. Dieldrin 60-57-1 10. 2.3-Diklorofenol 576-24-9 11. 2.4-Diklorofenol 120-83-2 12. 2.5-Diklorofenol 583-78-8 13. Dinoseb 88-85-7 14. Ethyl p-nitrophenyl benzenethiophosponate (EPN) 2104-64-5 15. Endrin 106-93-4 16. Endosufan 115-29-7 17. Ethylene dibromida (EDB) 72-20-8 18. Formaldehyde 50-00-0. Phosphorus (Yellow Phosphorus) 7723-14-0. Heptaklor 76-44-8. Kaptafol 2425-06-1 22. Klordan 57-74-9 23. Klordimefon 19750-95-9 24. 21609 Leptofos-90-5 25. Heksakloro Siklo Heksan (HCH) (including lindan) 608-73-1 26. Metoksiklor 72-43-5 27. 26718 Mevinfos-65-0, 28. Sodium metam arsonat (MSMA) 2163-80-6 29. Sodium chlorate 7775-09-9.30 am. Sodium tribromofenol 31. Methyl paration 298-00-0
2009, no. 399 27 32. Halogen phenols (including Penta Kloro Phenol (PCP) and salts) 87-86-5 33. Pesticides-active salmonella 34. Arsenic compounds, 1327-53-3 35. Mercury compounds 10112-91-1, 7546-30-7, 7487-94-1, 21908-53-2 36. Strikhnin 57-24-9 37. Telodrin 297-78-9 38. Toxaphene 8001-35-2 39 Mireks 2385-85-5 II. The active ingredients prohibited for household pesticides used to control insect households are diklorvos and klorpirifos. III. Active ingredients prohibited for fisheries is triklorfon.
2009, no. 399 28 ANNEX II AGRICULTURAL MINISTER REGULATION number: 45/Permenan/SR 140/10/2009 date: 10 October 2009 SET AS the ACTIVE INGREDIENTS of PESTICIDES is LIMITED No. The name of the active ingredient CAS Number Field of use 1. Parakuat dichloride 1910-42-5 management of plants 2. Aluminum fosfida 20859-73-8 agricultural Storage 3. Magnesium fosfida 12057-74-8 agricultural Storage 4. Sulfuril fluoride 2687-79-8 agricultural Storage 5. Methyl bromide 74-83-9 quarantine and pre shipment 6. Zinc fosfida 1314-84-7 management of the plants 2009, no. 399 29 ANNEX III REGULATIONS the MINISTER of AGRICULTURE number: 45/Permenan/SR 140/10/2009 date: 10 October 2009 SUPPLEMENTARY MATERIAL that is PROHIBITED in the PESTICIDE No. Chemical name CAS Number Description 1. Benzene 71-43-2 for all areas of use of pesticides 2. Formaldehyde 50-00-0 for all fields of pesticide use 3. Methanol 67-56-1 to 4 household pesticide field. Toluen 108-88-3 for the fields of household pesticides 5. N-Methyl Pirolidon 872-50-4 to 6 household pesticide field. Silica 14808-60-7 for all areas of pesticide use 7. Methylene chloride 75-09-2 for all areas of pesticide use 8. Ethylene oxide 75-21-8 for all areas of use of pesticides 2009, no. 399 30 ANNEX IV REGULATIONS the MINISTER of AGRICULTURE number: 45/Permenan/SR 140/10/2009 date: 10 October 2009 SUPPLEMENTARY MATERIAL PESTICIDES RESTRICTED ITS USE to the MANAGEMENT of the PLANT No. Chemical name CAS Number maximum limit of exposure 1. N-Methyl Pirolidon 872-50-4 600 ppm 2. Methanol 67-56-1 250 ppm 3. Piridin Base 68391-11-7 a 5 ppm 2009, no. 399 31 APPENDIX V REGULATION of the MINISTER of AGRICULTURE number: 45/Permenan/SR 140/10/2009 date: 10 October 2009 TECHNICAL CRITERIA for the REGISTRATION and LICENSING of PESTICIDES TECHNICAL CRITERIA DATA TYPE a. QUALITY of Data quality test results of pesticide active ingredient levels correspond to the levels of the active ingredients of pesticides persyartan and meets the proposed limit of the tolerance levels of the active ingredient. B. EFFICACY Data target organism population levels, levels of pesticide efficacy, the dry weight biomass, pesticide efficacy, etc. showed that pesticide effective against target organisms. C. the MAMMALIAN TOXICITY of 1. Acute toxicity: LD50 Oral Solid Formulation > 50 mg/kg (Rat) Liquid > 200 mg/kg LD50 Dermal, and Solid >: 100 mg/kg (Rat) Liquid > 400 mg/kg Dermal LD50 or Solid >: 200 mg/kg (Rabbit) does not cause irritation on eye and skin weight, and does not cause sensitization skin inhalation LC50 heavily toward ≥ 0.05 mg/l for 4 hour exposure period 2 Chronic toxicity of active ingredients based on the results of the research poses no carcinogenic influences Teratology, mutagenic and or ENVIRONMENTAL TOXICITY D. *) 1. A time of decomposition DT50 active ingredients on the ground less than 120 days if registered for use on agricultural ecosystems (food crops, horticulture and gardening) 2. The test of toxicity to rice pesticides and aquatic environment 2009, no. 399 32 2.1. Fish toxicity test results Lab a. When unit toxicity > 3.0 (evils principle) not allowed b. when unit toxicity 0.3 – 3.0 (little evils principle) given permission while, requested complete field test c. when unit toxicity < 0.3 (no evils principle) given permission anyway 2.2. Fish Toxicity Test Results of Field a. When a biological half-life > 7 days, the value of productivity and survival rate of different degrees of control (evils principle), then it is not allowed for fields and aquatic environment b. When a biological half-life of 7 days, the value of the < productivity and the degree of survival did not differ with controls (no evils principle) given permission, then it can remain a RESIDUE E.) if the value of the ADI for human ≤ 0.015 mg/kg/day (equivalent to the level of residue which is expected to secure ≤ 1 ppm) for the registration of the use of synthetic insecticides and fungicides on: 1. the plant/commodities of rice, maize, soybean and/or 2. plant/vegetable commodities 3. plants/fruits consumed commodities without peeled his skin 4. crop/commodity ingredients drinks 5. agricultural storage 6. aquaculture and its products 7. drinking water to apply pesticides residue testing data must be accompanied in accordance with the procedures of the international f. RESURJENSI PEST the PEST is not encouraged and elicited resurjensi pests pest Nilaparvata lugens g. IMPACT on BRASSICA PEST PARASITOID does not negatively impact parasitoid Diadegma semiclausum (elevation 750 m above sea level >) Cotesia plutellae or (elevation 750 m above sea level 50 > 500 + 2.5 units (%) + 25 unit (g/l) 25-50 250
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