to Indonesian
a. That pesticides are chemicals, with other substances, microorganisms and viruses are substances that may be harmful to human health, conservation of bio natural resources and the environment, but can also provide great benefits to society.
b. That to obtain optimum benefits with minimal negative impact, pesticides that will be distributed, stored, and used should be registered.
c. That existing regulations are no longer relevant to the development of technology and the needs of the society.
d. That based on above considerations and the implementation of Government Regulation Number 7 of 1973 in conjunction with Government Regulation Number 6 of 1995, it is necessary to re-arrange Conditions and Procedures of Pesticide Registration in Decree of the Minister of Agriculture.
1. Law Number 12 of 1992 concerning Plant Cultivation System (Statute Book Number 46 of 1992, Supplement to Statute Book Number 3478).
2. Law Number 23 of 1992 concerning Health (Statute Book Number 100 of 1992, Supplement to Statute Book Number 3495).
3. Law Number 23 of 1997 concerning Environmental Management (Statute Book Number 68 of 1997, Supplement to Statute Book Number 3699).
4. Law Number 8 of 1999 concerning Consumers Protection (Statute Book Number 42 of 1999, Supplement to Statute Book Number 3821).
5. Law Number 22 of 1999 concerning Regional Government (Statute Book Number 60 of 1999, Supplement to Statute Book Number 3839).
6. Government Regulation Number 7 of 1973 concerning Supervision on the Distribution, Storage, and Use of Pesticides (Statute Book Number 12 of 1973).
7. Government Regulation Number 6 of 1995 concerning Plant Protection (Statute Book Number 12 of 1995, Supplement to Statute Book Number 3586).
8. Government Regulation Number 18 of 1999 concerning Hazardous Substances (Statute Book Number 30 of 1999, Supplement to Statute Book Number 3815).
9. Government Regulation Number 25 of 2000 concerning Government Authority and Provincial Authority as an Autonomous Region (Statute Book Number 54 of 2000, Supplement to Statute Book Number 3952).
10. Presidential Decree Number 165 of 2000 in conjunction with Presidential Decree Number 177 of 2000 and Presidential Decree Number 37 of 2001 concerning the Organizational Structure and Tasks of Ministries.
11. Presidential Decree Number 289/M of 2000 concerning the Establishment of the new Cabinet 1999-2004 period.
12. Decree of the Minister of Agriculture Number 536/Kpts/TP.270/7/1985 concerning the Control of Pesticides.
13. Decree of the Minister of Agriculture Number 479/Kpts/KP.150/7/1990 concerning Commission on Pesticides.
14. Decree of the Minister of Health Number 258/Menkes/Per/XI/1992 concerning Pesticide Management Health Requirements.
15. Regulation of the Minister of Health Number 472/Menkes/PER/XI/1992 concerning Hazardous Substances.
16. Decree of the Minister of Health and Minister of Agriculture Number: 881/Menkes/SKB/VIII/1996; 771/Kpts/Tp.270/8/1996 concerning Limit for Pesticide Residue in Agricultural Products.
17. Decree of the Minister of Agriculture Number 01/Kpts/OT.210/1/2001 concerning Organizational Structures and Work Flow of Ministry of Agriculture.
18. Decree of the Minister of Agriculture Number 99/Kpts/OT.210/2/2001 concerning Organizational Structure Divisions and Work Flow of the Ministry of Agriculture.
Pesticides Commission Letter Number 160/Kompes/2001 dated May 9, 2001.
DECREE OF THE MINISTER OF AGRICULTURE CONCERNING CONDITIONS AND PROCEDURES OF PESTICIDE REGISTRATION.
In this decree what is referred as:
1. Pesticide registration is the process to get a registration number and pesticides permit.
2. Pesticides are chemicals and other substances as well as microorganisms and viruses that used for:
3. Pesticides for general use are pesticides in used do not require special requirements and safety tools other than listed on the label.
4. The active substances are chemical substance and or other substances contained in pesticides and in generally are powerful toxic substances.
5. The standard active substances are pure active substances used for comparison in the analysis process of pesticide active substances.
6. Technical substances are the raw materials for making formulation resulting from the production of the active substances, which contains the active substances or and the follow impurities may also contain certain additional substances needed.
7. Origin technical substances are substances produced directly from the process of synthetic, extraction or other processes to produce the active substances.
8. Processed technical substances are substances resulting from the production process of technical substances with certain purpose such as security, stability or certain purposes in the process of formulation, placing, transportation, and storage.
9. Formulation is mixed of the active substance with other substances in certain levels and forms that have their power as a pesticide in accordance with the planned objectives.
10. The formulations have active substance are formulations that have all the same type of active substances.
11. National product pesticide formulation is pesticide formulation which is a product of the owner formulation domiciled in the territory of the Republic of Indonesia.
12. Foreign product pesticide formulation is pesticide formulation which is a product of the owner formulation that not domiciled in the territory of the Republic of Indonesia.
13. Owner formulation is an individual or legal entity to be the owner of a pesticide formulation recipe.
14. Formulation recipe is a statement that says:
15. Applicant is any person or legal entity applying for registration and pesticide permit.
16. Registration number holder is any person or business entity that has obtained the registration number and permit of pesticides which are their responsibility.
17. Circulation is import or export and domestic sales including transportation of pesticides.
18. Storage is having a pesticide in stock in the yard or in a space that is used by importers, traders, or in agricultural businesses.
19. The use is use pesticides with or without a tool with the intention as intended in paragraph 2.
20. The container is pesticide exposed directly to store during handling.
21. Labeling is writing and may be accompanied by an image or a symbol, which provides information concerning pesticide and attached at pesticide container or packaging.
22. Destroying is the removal of the pesticide characteristics and functions.
23. Pesticides for limited purposes are pesticides which in the using need special conditions and special safety tools other than said on the label.
24. Certificate usage is a statement issued by the Head of the Province/Regency/Municipality Pesticide Control Commission or authorities official stating that the certificate owner has to know procedures for pesticide use are limited.
25. The user is the person or legal entity that uses pesticides with or without tools.
26. Formulation naming is a trade name of a pesticide formulation that is registered by the applicant.
27. Technical substance naming is the trade name of a technical substance that basically same as the name of the active substances registered by the applicant.
28. Pesticide residue is the residue of pesticides, including the results of the changes that are on or in the net of humans, animals, plants in water, air or soil.
29. Acute toxicity is the adverse effects that arise immediately after exposure to a single dose of a chemical substance or other substance or multiple dosing within approximately 24 hours.
30. Chronic toxicity is the adverse effects that arise as a result of repeated daily dosing of chemical substance or other substance, or exposure to chemicals that mostly of an organism's life that is usually more than 50% of the trying animals this means that the period of exposure for 2 years.
31. Sub chronic toxicity is the adverse effects that arise as a result of repeated dosing of chemical substance or other substances, or exposure to chemicals substances, for a tiny fraction of an organism's life span is usually not more than 10%, the experimental animals exposed for a period of 3 months.
32. Lethal Dose 50, hereinafter called as LD 50 is a single dose of chemical substances or other substances that are derived statistically and predictably lead to death of 50% of the organism population in a series of experimental conditions have been determined.
33. Lethal Concentration 50, hereinafter called as LC 50 is a concentration that is derived statistically that predictable lead to death of 50% of the organisms population in a series of experimental conditions have been determined.
34. Acceptable Daily Intake hereinafter abbreviated as ADI is estimation number of chemicals substance in food that can be ingested in daily human lifetime without appreciable health risk.
35. Maximum residue limits hereinafter abbreviated as BMR is an alleged maximum residue limits of pesticides in the agricultural products are allowed.
36. Lethal Time 50 hereinafter abbreviated as LT 50 is the time in days required to kill 50% of experimental animals under certain conditions.
37. Decomposition Time hereinafter abbreviated as DT 50 is the time required for the 50% decomposition in the form of dissipation and degradation of the chemical substances in the media.
38. Director General is the Director General of Agriculture Facilities Fostering.
39. Efficacy is the effectiveness of pesticides on target organisms listed based on the results of field or laboratory trials according to the method determined by the Director General.
40. Resurgence is the event of target organism population increasing after a pesticide is needed.
41. Pest resistance is a phenomenon changes the pest population is dominated by sensitive individuals to a population dominated by resistant individuals to certain pesticides. These changes led to initially effective pesticides to control pests become ineffective.
42. Irritation is a symptom of inflammation that occurs in the skin or mucous membranes immediately after prolonged or repeated treatments with chemicals substances or other substances.
43. Carcinogenic is characteristics of a substance that can encourage or cause cancer.
44. Onkogenic is characteristics of a substance that can encourage or cause tumors.
45. Teratogenic is the characteristics of the chemical substance that can result defect of body in birth.
46. Mutagenic is the characteristics of the chemical substance that can result genetic mutation.
47. Weeds are weeds as intended in Government Regulation Number 7 of 1973.
48. Prohibited pesticides are pesticides that are prohibited for all fields of use or the use of certain areas in order to protect human health and the environment, and determined by the regulation. This includes the types of pesticides that have been rejected since it was first registered or prohibited by request of the owner or on other considerations as evidenced by the data for reasons to protect human health and the environment.
49. Risk is the probability of occurrence of harm or damaging effects to humans or the environment from certain exposure to certain chemical substances or pesticides.
50. Risk Evaluation includes qualitative and quantitative correlation between risks and benefits, including complex process in determining dependency identified hazards and the identified risks to organisms or humans that relate to or were influenced by certain pesticides.
1. This decree is intended as legal basis for the implementation of the registration includes testing and licensing of pesticides.
2. This decree aims to:
The scope of this decree setting includes clarification, registration, including testing, licensing, placing, and label of pesticides and administrative sanctions.
Field of pesticides use includes:
(1) Based on the physical chemical characteristics and hazards, pesticides can be clarified into:
(2) Pesticides can be registered as intended in paragraph (1) a covering of pesticides that are not included into the category of prohibited pesticides as intended in paragraph (3).
(3) Prohibited pesticides as intended in paragraph (1) b, are pesticides belonging to the following criteria:
(4) Based on the using method, pesticides can be classified into:
(5) Pesticides based on using method classified as restricted pesticides, are pesticides that have the following criteria:
(6) Pesticides that are not included in paragraph (3) and paragraph (5) are pesticides for general use.
(7) The Minister may change the classification of the use of restricted pesticides for general use or prohibited pesticides based on the advice and consideration of the Pesticide committee based on the results of risk analysis.
The types of pesticides that contain active substances that have been prohibited are as follows:
(1) The use of restricted pesticides must comply with the following provisions:
(2) The types of pesticides that have determined as restricted pesticides are listed in Attachment I.
Pesticide permits type consists of:
(1) Trial permit as intended in Article 8 a, is given by the director general on the advice and consideration or pesticide committee for a period of 1 year and may be extended 2 (two) times each for a period of 1 (one) year.
(2) Trial permit as intended in paragraph (1) is given in order for the applicant to prove the truth of claim on the quality, efficacy, and safety of the pesticide is registered.
(3) Pesticides already obtain trial permit should not be distributed or used commercially.
(1) Temporary permit as intended in Article 8 b is given by the Minister on the advice and consideration of Pesticide Committee to pesticides that meet the technical and administrative requirements, for a period of 1 (one) year and may be extended three (3) times each for a period of 1 (one) year.
(2) Temporary permit is granted in order that the applicant can complete the data and information in accordance with the technical and administrative requirements specified and if the applicant is not able to complete the technical and administrative requirements mentioned above, the application is rejected.
(3) Pesticides that have obtained a temporary permit can be produced/distributed and used in limited numbers determined by the Ministerial Decree in accordance with the number of commodities, the dose or concentration and application.
(4) If the use of pesticides as intended in paragraph (3) proven negative impact on human health or the environment, a temporary permit may be reviewed or revoked.
(1) Permanent permit as intended in Article 8 c is given by the Minister on the advice and consideration of the Pesticide Committee or after the applicant meets the technical and administrative requirements determined, valid for a period of 5 (five) years.
(2) Pesticides that obtained permanent permit can be circulated and used commercially.
(3) If the use of pesticides as intended in paragraph (2) proved to have a negative impact on human health and the environment, permanent permit may be reviewed or revoked.
Application for registration of pesticides can be done by individual Indonesian citizens or Indonesian legal entity that meets the following requirements:
(1) Pesticides which may be registered in Indonesia are pesticides that do not include prohibited pesticides as intended in Article 5 paragraph (3) and Article 6
(2) Pesticides as intended in paragraph (1) include:
(3) National product formulation as intended in paragraph (2) a shall fulfill the following conditions:
(4) Foreign products formulation as intended in paragraph (2) b shall meet the following conditions:
Applications for registration in addition to the requirements as intended in Article 12, must also meet the following requirements:
Pesticide formulation with compound active substances for all fields of use should pose no antagonistic effects and reduce negative impacts on natural enemies and the environment.
(1) All pesticides must be registered with the different name, which is the identity of any pesticide formulation that will be circulated.
(2) Naming as intended in paragraph (1) may not be the same or nearly the same with other formulations are already registered.
(3) Naming as intended in paragraph (1) shall meet the following requirements:
(4) Technical substance naming must meet the requirements as intended in paragraph (3) and followed by a number and a code that indicates successive levels of the active substance and a range of technical substance.
(1) Application for the registration of pesticides shall be submitted in writing to the Director General with sufficient seal based on effective regulations, by using the form as contained in attachment II of this Decree.
(2) The application as intended in paragraph (1) shall complete the requirements in accordance with the provisions of Chapter IV.
(1) Application may be accepted if it meets all the requirements as intended in Chapter IV, by include all the information requested in the registration form as contained in Attachment II of this Decree.
(2) The Director General after received complete and correct pesticide application as intended in paragraph (1) not later than within 30 (thirty) working days have completed the examination and evaluation of the application file with the pesticide committee.
(3) After the evaluation as intended in paragraph (2) on the advice and consideration of the pesticide committee, the Director General no later than 14 (fourteen) working days had to be granted trial permit, delay letter or rejection letter.
(4) If the Director General gives delay letter or rejection letter as intended in paragraph (3) shall be accompanied by reasons for delay or rejection in writing.
(5) If the Director General gives delay letter, the applicant is given the opportunity to complete or renew the necessary requirements.
(1) The applicant after obtaining trying permit should submit sample of pesticide to the Director General, to do quality testing in laboratory that has been accredited by a national standardization agency, and if there is none, then the quality test can be carried out by the laboratory as listed in Attachment III.
(2) Quality test results and sample of pesticide by the examining agency as intended in paragraph (1) shall be submitted to the Director General, and the Director General within the next seven (7) working days has been evaluated by using the standard method determined by the Director General on the advice and consideration of Pesticide Committee, and if fulfill requirements, sample will be sealed to be delivered to the applicant.
(3) If the results of quality tests and samples as intended in paragraph (2) are not fulfill requirements, the Director General shall notify the applicant in order to re-apply for quality testing.
(4) The applicant after received of the sample and the quality testing results as intended in paragraph (2) immediately submit sample that had been sealed by the Director General to an accredited testing agency or examining agency determined by the Director General for testing the efficacy and toxicity.
(5) In testing the efficacy and toxicity as intended in paragraph (4), examining agency shall follow the standard method has been determined by the Director General on the advice and consideration of pesticide committee.
(6) Examining agency after do testing shall report testing result to the with a copy to the Director General.
(7) The applicant submitted results of the testing as intended in paragraph (6) to the Director General to makes an evaluation with pesticide committee, according to the technical data evaluation procedures as contained in Attachment IV of this Decree.
(8) Based on the results of the evaluation as intended in paragraph (7) applications for registration can be accepted or not.
(9) The Director General on the evaluation advice and consideration of pesticide committee, not later than 90 (ninety) days shall make draft of Ministerial Decree concerning pesticide registration.
(10) Decree of the Minister of Agriculture for granting registration number and temporary permit will be stipulated in case of:
(1) Procedures for pesticide registration as intended in Article 17 up to Article 19 shall also apply mutatis mutandis to the pesticide technical substance registration and pesticide for export except for testing the efficacy, environmental toxicology, resistance, resurgence and residues are not required.
(2) Application forms of technical substances is contained in Attachment V of this Decree.
(1) The registration number that has been granted a temporary permit or permanent permit, can be transferred or diverted, because:
(2) The party appointed as the new holder of the registration number as intended in paragraph (1) shall resolve the issues between the old holder of the formulation with the new holder of the formulation, and then report the transfer to the Director General, then Director General shall record the transfer in the registration number book as well as the proposed stipulation on the intended transfer.
(1) Change on the registered pesticides, including changes of:
(2) Any kind of changes as intended in paragraph (1) shall be reported by the holder of the registration number to the Director General for further processing for stipulation, and will be written into a registration number book.
(1) Pesticides that are permitted and have been the end of their permit period can be re-registered to comply with the registration procedures for pesticides as intended in this decree.
(2) Re-registration as intended in paragraph (1) shall not later than 2 (two) months before the expiration of their permit period and if the re-registration is not done, the registration number and permit expire by the law.
(3) In the re-registration of pesticides as intended in paragraph (1), if there is a certain indication of the negative impact that can be responded, re-testing is required to obtain the latest data.
(4) This type of testing to get the latest technical data as intended in paragraph (3) shall be determined by the Director General with the advice and consideration of pesticides committee.
(5) The Director General to carry out the test as intended in paragraph (4) shall be submitted to the holder of the registration number of at least 2 (two) years prior to the expired date of the pesticide registration.
(1) Pesticides that have been registered with a temporary permit or permanent permit should be placed in the container.
(2) Containers of pesticide should not easily broken or torn, or protected by other container that is not easy broke, do not react with the pesticide or corrosive, so the danger to human and the environment can be avoided.
(3) Each container must be closed or folded properly so that the cap or crease and the container can not be opened without destroying it unless the container is such that without damaging the cap, pesticides can only come out in the form of smoke or fog.
(4) Specifications of container must be described in detail includes volume, name of substance, shape, size, materials thickness, color, inner surface substances of the container and cap substances, as contained in Attachment VI.
(1) Any pesticide container must be labeled, attached and not easily separated or printed on the container.
(2) Pesticide label proposed by the registration holder, and is one of the requirements in the application for registration.
(3) All information on labels and attachments on the usage instructions should be included in the Indonesian language, foreign language is allowed to use only when translating things that are considered important are mentioned also in the Indonesian language.
(4) Information and warning signs must be printed clearly on the label, easy to read or seen, resistance to pesticides in container and not easily erased.
(5) Full details concerning the content labels, warning sentences and safety instructions, a description of the symptoms of poisoning, information on the aid instructions, information on the storage instructions, information on the usage instructions, listing drawing, labels, restricted pesticides, and the preparation of labels, as contained in Attachment VII.
(1) Testing agency officials, laboratory personnel and officials who serve the registration shall maintain the truth and confidentiality of data and information on the pesticide which by their nature need to be kept secret.
(2) The Directorate General shall make registration number management books and record all mutations in both subject and object of registration of pesticides.
(1) Holders of registration numbers must include the registration number on the label and or container of pesticide registered.
(2) Holders of registration numbers shall pay the registration fee which is the Non Tax State Revenue (PNBP) and shall be deposited into the state treasury in the amount stipulated by regulations.
(3) Holders of registration numbers to bear the costs of testing and procedure of amount determined by the testing agency.
(1) Holder of registration number must submit 2 (two) grams of standard active substance and a certificate of assessment every 2 (two) years to the Director General that then stored in the laboratory as intended in Article 19 paragraph (1).
(2) Holders of registration number is required to submit an annual report on the production and distribution of pesticides and active substances which include import export and domestic trading, and 6 (six) months report of the production and distribution restricted pesticides to the Director General by using the form as contained in Attachment VIII of this Decree.
(3) Holder of restricted pesticide registration number is required to provide guidance and oversight to all things related to its responsibility and take solving measures in case of deviation, the activities conducted by it selves and with government officials.
The agency and or testing laboratory proved not guarantee confidentiality and correctness of test result done will be given a written warning by the Director General and reported to the authorized official to be penalized in accordance with the provisions of the regulation.
Official who serves the registration proved does not guarantee the confidentiality of the pesticide data as intended in Article 26 paragraph (1) shall be liable to discipline employee in accordance with regulations.
(1) The holder of a registration number does not include the registration number on the label and does not guarantee or quality of products or des not report any change in the holder of registration shall be liable to revocation of registration number and permit, and the pesticide should be withdrawn from circulation.
(2) Holders of registration number that never producing or importing or make reports for two (2) consecutive years shall be liable to revocation of the registration number and the pesticide should be withdrawn from circulation.
(1) When this decree is stipulated, pesticides that were registered and obtained permanent permit or temporary permit shall remain valid until the expiry of the permit.
(2) When this decree is stipulated, pesticides that are in process or have been tested in the framework of registration will be processed in accordance with the former pesticide registration.
(3) When this decree is stipulated, pesticides being in application process, but not in the testing phase, the applicant shall comply with provisions of this decree.
(4) Pesticides that have been registered under the trade name prior to the stipulation of this decree, it should be re-registered under the trade name in accordance with this decree.
With the effective of this decree, the decrees of the Minister of Agriculture:
This decree shall come into force from date of stipulation.
Stipulated in Jakarta
On July 20, 2001
MINISTER OF AGRICULTURE
signed,
PROF. DR. IR. BUNGARAN SARAGIH, M.Ec