Opinion of Pesticides Commission in its letter No. 1006/KOMPES/2006 dated December 27, 2006.
REGULATION OF THE MINISTER OF AGRICULTURE CONCERNING CONDITIONS AND PROCEDURES OF PESTICEDE REGISTRATION
In this Regulation, the meaning of:
1. Pesticides Registration referred to process to get registration number and license of pesticide.
2. Pesticide referred to all chemical elements and other chemical materials and microorganisms and viruses are used for:
3. Pesticides for general purpose referred to pesticides which used without condition or special safety equipment as stated in label.
4. Pesticides for limited purpose referred to pesticides which used need conditions and special safety equipment as stated in label.
5. Active material referred to synthetic active material or natural material which is content in technical material or formulation of pesticide which have poisoned power or another biological effect for target organism.
6. Standard active material referred to pure active material which use as a comparison in analyzes process of content of pesticide active material.
7. Technical material referred to raw material of formulation making which is produced byan active material, which contained active material and material of impurities or also content another material needed.
8. Original technical material referred to material which directly produced by synthetic, extraction or other process to produce active materials.
9. Processed technical material referred to material which produces from processing process of original technical material with special purpose like safety, stability or certain needs in the processing of formulation, placed, transportation and storage.
10. Formulation referred to mixture of active material with another material with content and certain form which have work power as pesticide according with the stipulated purpose.
11. Formulation active material referred to formulation with same kind of active material.
12. Owner of formula referred to person of law as owner of pesticide formula.
13. Formula contents referred to explanation about:
14. Applicant referred to person or person in law which proposes registration and license of pesticides.
15. Owner of registration number referred to every person or person in law which gets registration number and license of pesticide of its responsibility.
16. Distribution referred to import-export and sell/buy in domestic includes transportation of pesticide.
17. Storing referred to own pesticide for stock in yard or in the room by importer, trader or in plantation business.
18. Using referred to using pesticide with or without equipment for purpose as intended in point 2.
19. Place referred to a place which directly impacted the pesticide to keep during in handling.
20. Label referred to written and shall be enclosed with pictures or symbols, which gives explanation concerning pesticide, and stuck at place or wrapping of pesticide.
21. Destroying referred to loosen the characteristic and function of pesticide.
22. Certificate of using referred to explanation from Head of Pesticides Control Commission in Province/Regency/City of authorized official which state owner of certificate knows procedure to use limited pesticides.
23. User referred to person or person in law who use pesticide with or without equipment.
24. Named of formulation referred to trading name of pesticide formula which is registered by applicant.
25. Named of technical material referred to trade name of technical material which basically same with active material name which is registered by applicant.
26. Pesticide remainder referred to remain of pesticides, include changes in or on human, animal, plantation, water, air or land.
27. Acute toxicity referred to direct bad influence caused by using one dosage of chemical material or other material, or giving double dosage in period less than 24 hours.
28. Sub-chronic toxicity referred to bad influence in trying animal caused by giving daily dosage for many times of chemical material or other material in 3 months period.
29. Chronic toxicity referred to bad influence in trying animal caused by giving daily dosage of chemical material or other material, in 2 months period.
30. Lethal dose-50 hereinafter called LD50 referred single dosage of chemical material or other material which is reduce statically which can die 50% of organism of population in trying condition which is decided.
31. Lethal concentration-50 hereinafter called LC50 referred to reduce concentration statically which may cause death to 50% of organism population in a row of decided trying.
32. Acceptable Daily intake hereinafter called ADI referred to daily prediction number of chemical material in food along life of human without any risk.
33. Maximum limit of remain hereinafter called BMR referred to maximum limit of remain pesticide allowed in many plantation result.
34. Lethal time-50 hereinafter called LT-50 referred to period required to die 50% of trying animal in certain condition.
35. Decomposition Time-50 hereinafter called DT-50 is time required to make 50% of decomposition of dissipation and degradation of chemical material in media.
36. Efficacy referred to effectively of pesticide to target organism which is registered based on field or laboratory trying result use effective method.
37. Resurgence referred to increasing population of organism after treated with pesticides.
38. Resistance referred to decreasing sensitivity of population organism to pesticide which effective to control the target organism become not effective anymore.
39. Irritation referred to symptom of inflames in the skin or mucosa membrane after treated long or many times use chemical material or other material.
40. Carcinogenic referred to characteristic of Material that causes cancer.
41. Teratogenic referred to character of chemical material which can make physical defect during birth.
42. Mutagenic referred to chemical material which make mutation of gen.
43. Grass referred to corp pestsor weeds.
44. Prohibited Pesticides referred to kinds of prohibited pesticide for all usage to protect human health and the environment, and stipulated by the regulation. This consideration includes kind of rejected pesticide since it is first registered, or prohibited, based on owner request or based on other consideration based on evidence, with reason to protect human health and the environment.
45. Management of plantation referred to management of food plantation, horticulture, plantation, landscaping, and water environment.
46. Head of Centre referred to Head of Centre for License and Investment.
(1) This regulation as basic law to make registration include testing and licensing and control pesticides.
(2) Objectives of this Regulation are:
Scope of this regulation include the classification kinds of license, condition of registration, procedure of registration, place and label of pesticides and administration sanction.
Section to use pesticides covers:
(1) Based on dangerous effect, pesticides are classified to:
(2) Pesticide which can be registered as intendedintended in paragraph (1) letter a cover pesticides are in prohibited pesticides as intended in paragraph (3).
(3) Prohibited pesticides as intendedintended in paragraph (1) sub-paragraph b, are pesticides with following criteria:
(4) Based on way to use, pesticide can be classified to:
(5) Pesticides, based on way to use can be classified as limited pesticide, which has following criteria:
(6) Pesticides which are not in paragraph (3) and paragraph (5) are pesticide for general purpose.
(1) Kinds of active material of prohibited pesticide for all using as attached in Attachment I point 1 of this Regulation.
(2) Kinds of active material of prohibited pesticide for housing as attached in Attachment I point 2 of this Regulation.
(1) Everybody will use limited pesticide as intended in Article 5 paragraph (4) sub-paragraph b, should has certificate to use limited pesticide.
(2) Certificate to use limited pesticide as intended in paragraph (1) is given to person who pass training of use limited pesticides.
(3) Training to use limited pesticide as intended in paragraph (2) is arranged by Head of Pesticide Control Commission of Province/Regency/City or appointed Official.
(4) Certificate to use limited pesticide as intended in paragraph (2), is issued by Head of Pesticide Control Commission of Province/Regency/City or appointed Official.
(5) Certificate to use limited pesticide as intended in paragraph (2) valid all over Indonesia for 5 years and can be extended.
(6) Training to use limited pesticide and giving certificate follow effective regulations.
Person in law can use limited pesticide if applied by personal that has certificate to use limited pesticide as intended in Article 7.
Kind of active material of limited pesticide as attached in Attachment II to this regulation.
Kind of pesticides license consists of:
(1) Trying license as intended in Article 8 sub-paragraph a, is given by Head of Centre in 1 (one) year period and can extended once for 1 (one) year period.
(2) Trying license as intendedintended in paragraph (1) is given to applicant to give evidence of claim about quality, affectivity and safety of registered pesticide.
(3) Pesticides which get trying license cannot be distributed or used for commercial.
(1) Temporary license as intended in Article 8 sub-paragraph b is given by Minister based on suggestion and or consideration of Pesticide Commission to pesticide which fulfill technical and administration condition, for period 1 (one) year and can be extended once for period 1 (one) year.
(2)Pesticides which had obtained permanent license would be produced and distributed and utilzed. Temporary license is given with purpose applicant can give complete data and information follow decided technical and administration condition, if applicant cannot give complete data and information conditions, proposal is pretended cancelled.
(3) Pesticide which obtained the temporary license can be produced/distributed and can be used in limited amount which is decided by Decree of Minister once the applicants had fulfilled all the technical prerequisites on the amount of commodity, dosage or concentrate and application.
(4) If using pesticide as intendedinteded in paragraph (3) make negative impact to human health or life environment, temporary license can be reconsidered or revoked.
(1) Permanent License as intended in Article 8 sub-paragraph c is given by the Minister of Agriculture based on suggestion and or consideration of Pesticide Commission after applicant fulfill all technical and administration conditions decided, valid for 5 (five) years.
(2) Pesticides which get fixed license can be produced, distributed and used.
(3) Fixed license as intendedintended in paragraph (1) can be enlargement of usage to other commodity which not registered. Enlargement license of using is decided by Minister of Agriculture based on suggestion and consideration of Pesticide Commission, after applicant fulfill all decided technical and administration conditions.
(4) If usage of pesticides as intendedintended in paragraph (2) make negative impact for human health or the environment, license can be reconsidered or revoked.
(1) Proposal of pesticide registration can be done by personal of Indonesian Citizen or Indonesian People in law which fulfill registration condition as follows:
(2) Pesticide registration as intendedintended in paragraph (1) is down by owner of formula or the attorney.
(3) For owner of formula from abroad, pesticide registration is done by representatives of the Indonesian legal entities.
(1) Pesticides which can be registered in Indonesia is not included in the prohibited pesticides as intendedintended in Article 5 paragraph (3) and without active material content of prohibited pesticides as intended in Article 6.
(2) Pesticides as intended in paragraph (1) should fulfill condition of active material which fulfill specification of SNI, FAO, WHO, or other international board which accredited or minimum technical condition as stipulated by the Minister.
Proposal of registration should fulfill condition as intended in Article 14, and also fulfill following conditions:
(1) Registered pesticides shall have different name, which is identity of every distributed pesticide.
(2) Naming as intended in paragraph (1) cannot same or similar with other formula name which should be registered.
(3) Named as intended in paragraph (1) should fulfill following condition:
(4) Naming of technical material should fulfill condition as intended in paragraph (3) and follows with letter and code which shows level of active material and kind of technical material.
(1) Proposal of pesticide registration should be in written to Head of Centre and put enough stamp based on valid regulation, use format as attached in ATTACHMENT IV or V or VI of this regulation.
(2) After receive proposal of pesticide registration as intended in paragraph (1), Head of Centre not late than 20 (twenty) working days shall give answer about approval, cancellation or rejection.
(3) If from checking proposal as intended in paragraph (2) is complete and right, Head of Centre gives trying license.
(4) If from checking proposal as intended in paragraph (2) is not complete, Head of Centre give cancellation letter.
(5) If Head of Centre give cancellation letter, applicant gets opportunity to complete and change requested condition.
(6) If from checking of proposal as intended in paragraph (2) is stated not complete and not right, Head of Centre issues rejection letter.
(1) Applicant after get trying license should give sample of pesticide to Centre of License and Investment;
(2) Laboratory which do testing of pesticide is accredited laboratory or appointed by Minister as stated in Attachment X of this Regulation;
(3) Result of sample testing of pesticide by testing laboratory as intended in paragraph (3) is given to Head of Centre, then Head of Centre in maximum 7 (seven) working days shall finish the evaluation based on limit of tolerance of quantity of testing result as attached in Attachment XIV of this Regulation.
(4) If result of sample testing of pesticide as intended in paragraph (4) does not fulfill condition, Head of Centre notice applicant, and applicant can propose proposal again to do quality testing.
(5) If testing of sample quality of pesticides as intended in paragraph (4) fulfill condition, sample will be sealed by Centre of License and Investment.
(6) Result of quality testing of pesticide sample which sealed as intended in paragraph (5) by Head of Centre, will be given to applicant.
(7) If sealed result of quality testing of pesticide sample as intended in paragraph (7) has been received, applicant shall submit sealed sample to accredited toxicity and efficacy testing board or appointed by Minister as list in Attachment Xi and XII of this Regulation;
(8) In testing Efficacy and toxicity as intended in paragraph (7), testing board should follow effective standard method and give result of efficacy and toxicity testing to Head of Centre.
(9) Report of efficacy and toxicity testing as intended in paragraph (8) will be evaluated by Centre of License and Investment with Technical Team of Pesticide Registration Evaluation, follow technical criteria as stated in Attachment III of this Regulation.
(10) Result of evaluation as intended in paragraph (9) is given to general meeting of Pesticide Commission as evaluation material of Pesticide Commission.
(11) Based on evaluation result as intended in paragraph (10) proposal of registration can be approved or rejected.
(12) If proposal of registration is approved as intended in paragraph (11). Minister of Agriculture, in maximum of 90 (ninety) working days, stipulates the Ministerial Decree concerning the Registration and License of Pesticide.
(13) If proposal of registration is rejected as intended in paragraph (11), Head of Centre in 14 (fourteen) working days will issue a rejection letter.
(1) The Decree of the Minister of Agriculture as intended in Article 20 paragraph (12) is:
(2) Decision of the Minister of Agriculture about registration number and temporary license as intended in paragraph (1) letter a is issued if still need further testing about level of safety to life environment and human health as stated in Attachment III of this Regulation.
(1) Procedure of pesticide registration as intended in Article 18 until Article 20 in mutatis mutandis is also valid for registration of technical material of the pesticide and pesticide for export except testing of Efficacy, toxicity of environment, resurgence and the remaining.
(2) Registration of technical material as intended in paragraph (1) use format as attached in Attachment VII of this regulation.
(1) Registration number which is given in temporary or fixed license can be changed, because:
(2) A party which is appointed as new registration number holder as intended in paragraph (1) should finish all transfer matters between old formulation holder with new formulation holder, and then reports the transfer to Head of Centre, then Head of Centre note that transfer to registration number book and propose deciding about the transfer.
(1) Change in relation with registered pesticides, include change of:
(2) Changing as intended in paragraph (1) sub-paragraphs c, d, e, f, and g can be approved after testing of quality comparison, toxicity and efficacy for one target organism, and the result fulfill technical condition.
(3) Every kind of changing as intended in paragraph (1) should be reported by registration number holder to Head of Centre for further process, and will be write in the registration number book.
(1) Pesticide which get permanent license and will expired it license period can be registered again follow provision about procedure of pesticide registration as intended in this regulation with attachment:
(2) Target organism as intended in paragraph (1) is one of target organism which is registered since the first time the pesticide obtained it’s license.
(3) Registration as intended in paragraph (1) is at least 90 (ninety) working days before ending period or license and by paying attention to result of pesticide evaluation control by authorized agency.
(4) If registration as intended in paragraph (1) is not registered or registration is rejected, number and registration will be expired based on law.
(1) Pesticides which registered with temporary license or permanent license should be put on place.
(2) Pesticides place shall not easy to broke or protected by other material to prevent damage, not get reaction with pesticide or corrosive, so negative effect to human and environment can be avoid.
(3) Every container should be sealed or folded appropriately so that it can not be easily opened without firstly damaging the cover, or the containeris constructed in a way thatwithout damaging the cover but the pesticide can exit the container in the form of in smoke or fog.
(4) Specification of the container mustbe completely described including the volume, material, shape, size, width of material, color, surface material of inner lining of the container and material of the cover, as attached in Attachment VIII.
(5) Replacement of pesticide only can be done by the holder of pesticide registration or appointed party according to the provision of the regulation.
(1) Every pesticide container should be labeled, which is patched, and not easily to detached or printed on the container.
(2) Pesticide label is proposed by holder of registration, and is one of the prerequisites for the application for registration.
(3) All explanation on the label and additional usage should in be Indonesian language with words "enormous", "super", or "powerful", and it is prohibited to put non-registered target organism. Foreign language can only be used to translate the items which are deemed as important and which had already been mentioned inIndonesian .
(4) Explanation or warning sign on the label should be printed clearly, easy to read and see, easy to understand and not easy to be erased.
(5) Complete explanation about content, warning sentences and safety direction, explanation about symptom of poisoning, explanation about first aid, explanation about storing, explanation about usage, attach the signs, constrained pesticide and arrange label as attached in Attachment IX.
(1) The Officer who serves the registration and the officer of quality, efficacy and toxicity testing board, should maintain the truth and the confidentiality of data and information about pesticide which is confidential.
(2) License and investment centre should make management of registration number book and write all mutation of subject and object of pesticide registration.
(1) Holder of registration number should put all explanation required in pesticide label which is registered as attached in Attachment IX of this regulation.
(2) Holder of registration number should pay registration cost which is State Income Non Tax (PNBP) and should be paid to State Treasury which is decided based on effective regulation.
(3) Holder of registration number should pay all testing costs where the amount and the procedure are stipulated by the testing board.
(1) Holder of registration number should give 1 (one) gram standard active material and certificate of analysis every 2 (two) years to Head of Office and then be stored in Laboratory as intended in Article 20 paragraph (2).
(2) Holder of registration number should submit annual report about production and distribution of pesticide and active material include import, export and domestic selling buying at latest 2 (two) months after end of year, and semester report about production and distribution of limited pesticide to Minister of Agriculture c. q. Head of License and Investment use format as attached in Attachment XIII of this regulation.
(3) Holder of registration number of pesticide should implement training and control on everything that are related with his/her responsibility and undertake the management steps, if there is an incident, which is done by his/herself or together with Government.
Agency and or laboratory which had been proved not able to guarantee secret and result of test will get written warning from Head of Centre and will be reported to the authorized official to give sanction follow effective regulation.
Officer who serves registration which not guarantees secret of pesticide data as intended in Article 28 paragraph (1) will get employee discipline sanction follow effective regulation.
(1) Holder of registration number who is proven tobe unable to place all explanation and conditions on the label as intended in Article 26 paragraph (1) and or guarantee its production quality or does not report any changes of the registration holder will be charged with the sanctions of revoking registration number and license, and the individual should recall the pesticide from distribution within in 3 (three) months.
(2) Holder of registration number who does not produce and or import registered pesticide and does not make any report as intended in Article 30 paragraph (2) for 2 (two) years in a row, will be charged with thesanctions of revocation of number and license of registration, and should recall the pesticide from distribution within 3 (three) months.
(1) Pesticide which in this registration time is decided as one that has been registered, and had already obtained a permanent license or temporary license, will still valid until end of license.
(2) Pesticides which in effective date of this regulation are processing or already tested in registration will be processed accroding to the old regulation.
(3) Pesticides which in effective date of this regulation is processing proposal, will be processed according to this Regulation.
(4) Pesticides which are registered with trade name before effective date of this regulation should be registered with trade name according to this regulation.
Distributed pesticide, which expired number and license of registration, should be take from distribution within 6 (six) month since the expired date of number and license registration of pesticide.
With the enforcement of this regulation, Decree of the Minister of Agriculture No. 434/KPTS/TP.270/7/2001 concerning Conditions and Procedure of Pesticide Registration is be declared null and void.
This regulation shall come into force as from the date of stipulation.
Stipulated in Jakarta
On February 14, 2007
MINISTER OF AGRICULTURE
signed
ANANTO APRIYANTONO