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AGRICULTURAL MINISTER REGULATION NUMBER: 24 /Permentan/SR.140/4/ 2011
ON THE TERMS AND CONDITIONS OF THE PESTICIDE REGISTRATION
WITH THE GRACE OF THE GOD ALMIGHTY
AGRICULTURE MINISTER,
Stating: a. that with the Regulation of the Minister of Agriculture Number
45 /Permentan/SR.140/10/ 2009 has been defined the Terms and Pesticide Registration Act;
b. that in connection with the presence of organizational changes in the environment of the Ministry of Agriculture, and to improve services as well as certainty in the granting of registration and pesticide permits, the Agriculture Minister Regulation No. 45 /Permentan/SR.140/10/ 2007 needs to be revisited;
Given: 1. Act Number 12 of 1992 on Cultivation System
Plants (1992 State Sheet Number 46, Extra State Sheet Number 3478);
2. Law Number 8 of 1999 on Consumer Protection (State Sheet 1999 Number 42, Additional Gazette Number 3821);
3. Law Number 36 Year 2009 on Health (State Sheet 2009 Number 140, Additional Gazette State Number 5059);
4. Law No. 32 of the Year 2009 on the Protection and Management of the Environment (state Gazette 2009 number 144, additional state sheet number 5063);
5. Government Regulation Number 7 of 1973 on Surveillance of Circular, Storage, and Use of Pesticides (State Sheet 1973 Number 12);
6. Government Regulation No. 6 of 1995 on Plant Protection (State Sheet 1995 Number 12, Extra State Sheet Number 3586);
7. Government Regulation No. 18 of 1999 on Hazardous Waste Management Of Hazardous And Toxic Materials (state Gazette 1999 Number 30, Extra State Sheet Number 3815);
8. Government Regulation No. 74 of 2001 on Hazardous Materials Management and Toxic Substances (State Gazette 2001 Number 138, Additional State Sheet Number 4153);
9. Government Regulation No. 49 Year 2002 on Tariffs On Types Of State Admissions Not Taxes Applicable To The Department Of Agriculture (2002 State Sheet Number 92, Additional State Sheet Number 4224) juncto Regulation Government Number 7 Year 2004 (State Gazette 2004 Number 14, State Sheet Number 4362);
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10. Decision of President 84 /M of the Year 2009 on the Establishment of the United Indonesia Cabinet II;
11. Presidential Decree No. 47 of 2009 on the Establishment and Organization of the Ministry of State;
12. Presidential Decree No. 24 of 2010 on Occupation, Duty, State Ministry Function As Well As The Organization, Duty, And Functions Of The Ministry Of State;
13. Health Minister Regulation No. 472 /Menkes/PER/ XI/1992 on Dangerous Materials;
14. Joint Decision of the Minister of Agriculture and Health Minister Number 881 /Menkes/SKB/VIII/1996,
771/Kpts/TP.270/8/ 1996 on the Maximum Threshold Of Pesticide Residue On Agricultural Output;
15. Health Minister Regulation Number 1350 /Menkes/SK/XII/2001 on Pesticide;
16. Health Minister Regulation No. 1191 /Menkes/Per/VIII/2010 on Health Device Edar and Household Health Supplies;
17. Agricultural Minister Regulation No. 42 /Permentan/SR.140/5/ 2007 on Pesticide Supervision;
18. Regulation Of Trade Minister Number 51/M-DAG/PER/12/2007 on The Import Provisions Of Methyl Bromide For Quarantine And Pre-Shipping Purposes;
19. Agricultural Minister Regulation Number 61 /Permentan/OT.140/710/ 2010 on the Organization and the Working Tata Ministry of Agriculture;
20. Decision of Agriculture Minister Number 847 /Kpts/OT.160/2/ 2011 about the Pesticide Commission.
Noticing: 1. President Number 3's instructions in 1986 about the increased control of the brown Hama Wereng Controls on rice plants;
2. Letter Chairman Of The Pesticide Commission Number 246 /Kompes/2011 dated March 28, 2011;
DECIDED:
SET: AGRICULTURAL MINISTER REGULATIONS ON THE TERMS AND CONDITIONS OF PESTICIDE REGISTRATION.
BAB I
provisions of UMUM
Article 1
In this Regulation referred to: 1. The pesticide is all chemical and other materials as well as trace bodies and viruses
that are used for:
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a. eradicate or prevent pests and diseases that damage crops, plant parts or agricultural products;
b. eradicate the grasses; c. turn off the leaves and prevent unintended growth; d. set or stimulate the growth of plants or parts
plants do not include fertilizers; e. eradicate or prevent external pests in the pets
and livestock; f. eradicate or prevent the pests of water; g. eradicate or prevent the animals and body-body trace
in households, buildings and in transit tools; and/or
h. eradicate or prevent the animals that can cause disease in humans or animals that need to be protected with use on plants, soil or water.
2. Pesticide registration is the process for obtaining registration numbers
and pesticide permits. 3. Pesticides for general use are pesticides that are in
their use does not require specific security requirements and tools on the outside of the label.
4. A limited pesticide is a pesticide which in its use requires
specific security requirements and tools on the outside indicated on the label. 5. Pesticides are prohibited are types of pesticides banned for all fields
use, for household pesticide, and for fisheries fields.
6. An active ingredient is synthetic chemicals or natural materials contained
in a technical material or pesticide formulation that has the toxicity or other biological influence of the target organism.
7. The standard active ingredient is the pure active ingredient used as
sparring in the analysis process of the pesticide active ingredient levels. 8. Technical materials are the raw materials for the manufacture of formulations produced from
an active ingredient, which contains active ingredients and the icotor material (impurities) or may also contain the necessary materials.
9. The origin of the technical material is the material produced directly from the synthetic process,
extraction or other processes to produce an active ingredient. 10. Processing technical materials are materials generated from the processing process
technical materials of origin with specific objectives such as security, stability or specific needs in the process of creating formulations, pewadahan, transport and storage.
11. Formulations are a mixture of active ingredients with additional ingredients with levels of
and certain forms that have a working power as a pesticide according to the planned goal.
12. Additional pesticide material is the material added in the technical materials or pesticide formulation other than the active ingredient of pesticides among others: solvent, smelting, emulation, dye, carrier, perata, adhesives, paste, and heating.
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13. The owner of the formulation is a person or legal entity that has a recipe for a pesticide formulation.
14. A formulation recipe is a statement stating the type and
abundance of active materials and additional materials contained in a pesticide formulation and/or how to formulate a pesticide by using technical materials or active materials. and other constituent materials.
15. Circulation is an import-export and or sale in the country, including the "pesticide transport". 16. Storage is to have a pesticide in the supply in the yard or
in the space used by importers, merchants or in agricultural businesses.
17. Use is to use pesticides with or without tools for
such intent is in number 1. 18. A container is a place that is directly exposed to the pesticide to store
during its handling. 19. The label is written and can be accompanied by an image or symbol, which
provides a description of the pesticide, and is attached to a container or pesticide wrapper.
20. Annihilation is the elimination of the nature and function of pesticides 21. The certificate of use is a caption letter stating that it has passed
the training of the use of pesticides is limited. 22. Users are persons or legal entities that use pesticides
with or without tools. 23. The formulation of the formulation is the trade name of a pesticide formulation that
is registered by the applicant. 24. The technical material designation is the name of a technical material registered
by the applicant. 25. The pesticide is the remnant of the pesticide, including the result of a change that
exists on or in the human tissue, animal, plant, water, air or soil.
26. Acute toxicity is an adverse influence that arises immediately after
exposure with a single dose of a chemical or other material, or a double dose of the dose in a period of less than 24 hours.
27. Subchronicle toxicity is an adverse influence on experimental animals
arising as a result of repeated daily allowance of chemicals or other materials, with periods of exposure over 3 months.
28. The toxicity of the chronicle is an adverse influence on experimental animals
arising as a result of repeated daily allowance from chemicals or other materials, with a 2-year exposure period.
29. Lethal dose-50 further abbreviated as LD50 is a single dose of chemicals
or any other statistically derived material that could lead to the death of 50% of the organism's population in a series of experimental conditions that specified.
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30. Lethal concentration-50 later abbreviated as LC50 is a statistically derived concentration
which can lead to the death of 50% of the organism's population in a series of predetermined experimental conditions.
31. Acceptable Daily Intake which is later shortened to ADI is the
daily intake of chemicals that can be received in food throughout the human life without causing any meaningful health risk.
32. The maximum maximum limit of residues (BMR) is the
limit of the maximum number of possible pesticide residues contained in various agricultural products.
33. Lethal time-50/the next half-life of the LT50 is the time
that is required to shut down 50% of the experimental animals under certain conditions.
34. The toxicity unit is a result of the nominal concentration (ratio) of the concentration of a pesticide in rice paddies at a height of 10 cm with a value of LC50 96 hours. 35. Decomposition time-50 (DT50) is a time that
is required for 50% decomposition of the dissipation and degradation of a chemical in a medium.
36. Efficacy is the effectiveness of pesticides against target organisms that
is registered based on the results of a field or laboratory experiment according to the prevailing method.
37. Resurface is an increase in the target organism's population after
being treated with pesticides. 38. Resisteners are a decrease in the rate of sensitivity of the target organism's population
against pesticides which can cause pesticides that were once effective to control such target organisms to be ineffective again.
39. Irritation is a symptom of inflammation that occurs in the skin or mucous membranes
immediately after prolonged or repeated treatment by using chemicals or other materials.
40. Carcinogenic properties are the properties of a material that can push or
cause cancer. 41. Teratogenic is the nature of the chemical that can cause/produce
a disabled baby/body defect in birth. 42. Mutagenic is the nature of the chemical that causes the occurrence of gene mutations.
43. The Head of the Center is the Head of the Plant Varietas Protection Center and
Agricultural Licensing. 44. The Director General is the Director General of Prasarana and the Agricultural Sarana.
Article 2
(1) This Regulation is intended as the basis of the law in the holding of
registration including testing and licensing as well as pesticide surveillance.
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(2) This Regulation aims for:
a. protecting the community and the environment of living from harmful influences as a result of storage, circulation, and pesticide use;
b. enhance the efficiency and effectiveness of pesticide use; c. support the application of the Integrated Hama Control system (PHT);
and/or d. provide business certainty in conducting production activities,
procurement, storage, and pesticide circulation.
Section 3
The scope of this regulatory arrangement includes the field of use, classification, licensing type, requirements registration, registration means of registration, container and pesticide label, officer duty and owner of registration number, administrative sanction, pesticide provision of activated methyl bromide, transitional provisions, and closing provisions.
BAB II
FIELD OF USE
Section 4
(1) Use of pesticide use includes:
a. plant management; b. farm; c. fisheries; d. Foresight; e. storage of agricultural produce; f. settlements and households; g. Quarantine and pre-deafers.
(2) Fields of use of plant management are pesticides used
to control target organisms or increase growth in plants (food crops, plantation plants, horticultural plants, plant forests) industry).
(3) The field of farm use is a pesticide used to
control the pests on livestock/animals that need to be protected and or their enclosure.
(4) The field of fishing use is a pesticide used for
controlling target organisms/preventing water-vermin from fishery cultivation (among other fish tambak, shrimp tambak).
(5) The field of forestry use is the pesticide used to
control the target organism in forest results or the preservation of forest results (gergajian wood, wooden gelling, rotan, building foundation).
(6) The field of agricultural output storage is a pesticide that
used to control target organisms in agricultural storage storage.
(7) The area of use of settlements and households is pesticide which
used to control target organisms (animals and
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trace bodies) in households, buildings and prevent animals (vectors) that can cause disease in humans.
(8) The field of quarantine use and pre-decoding is The pesticide that
is used to control the target organism by fumigation in quarantine before or after shipping.
CHAPTER III CLASSIFICATION
Article 5
(1) Based on its dangers, pesticides can be classified into:
a. Banned pesticides b. A pesticide that can be registered
(2) Pesticides are prohibited as referred to in paragraph (1) letter a, with
the criteria as follows: a. Pesticide formulations include classes Ia, meaning extremely dangerous and
class Ib means it is harmful to the WHO classification as listed in the XII annex.
b. active materials and/or additional materials that have carcinogenic, teratogenic or mutagenic effects, (category I and IIa under the classification International Agency for Research on Cancer), and based on FAO, WHO, US-EPA and Other provisions.
(3) Pesticides that can be registered in paragraph (1) letter b
pesticides that are not included in the category of banned pesticides as referred to in paragraph (2).
Article 6
(1) Based on the scope of use, pesticides can be classified into: a. limited pesticides; and b. The pesticide for general use.
(2) The pesticide Criteria is limited as referred to in paragraph (1) the letter a is
as follows: a. Corrosive pesticide formulations in the eyes (cause impairment
return on ocular tissue), resulting in corneal drying or irritation up to 7 (seven) days or more;
b. the corrosive pesticide formulation of the skin (causing tissue damage in the dermis and or scar tissue) or resulting in heavy irritation up to 72 (seventy-two) hours or more;
c. when used as shown on the label, or according to The usual practice
done, such pesticides still cause subchronicles, chronicles or delayed poisonings for humans as a result of a single exposure and compound to that pesticide or its residue;
d. have LC50 inhalation of an active ingredient smaller than 0.05 mg/I for 4 hours
the exposure period; or
e. including in the ozone layer malware group.
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(3) Pesticides for general use as referred to in paragraph (1) letter b of the pesticide that does not enter the restricted pesticide category as referred to in paragraph (2).
Section 7
(1) Prohibited Pesticide materials for all areas of use as set forth in Appendix I item 1 as part inseparable with this Regulation
(2) The active ingredient of pesticides is prohibited for the field of household pesticides such as
listed in Appendix I item 2 as part inseparable with this Regulation.
(3) The active ingredient pesticide is prohibited for fishery fields as listed
on Appendix I item 3 as part inseparable with this Regulation. (4) The active ingredient of banned pesticides used in rice plants according to
Inpres 3 Year 1986 as listed on Appendix I item 4 as part inseparable with this Regulation.
(5) The active ingredient of pesticide limited as listed on Annex II as
the section is inseparable with this Regulation. (6) Prohibited Pesticide materials for all areas of use
pesticides and household pesticide use fields as listed in Annex III as part inseparable with this Regulation.
(7) Materials additional pesticides restricted use for the field
plant management as listed on Annex IV as part inseparable with this Regulation.
Article 8
(1) Change of usage classification Pesticides from being banned are common use, or from limited pesticides to general use, or otherwise may be done after the suggestion and consideration of the Pesticide Commission.
(2) Changes as referred to in paragraph (1) further shall be poured
in its own Decision.
Article 9 (1) Any person who will use limited pesticides as
referred to in Section 6 of the paragraph (1) letter a, is required to have a limited pesticide use certificate.
(2) Limited pesticide use certificates as referred to in verse (1)
given to people who have passed the pesticide use training limited published by the Chairman of the Provincial Pesticide Supervision Commission.
(3) Licensee's registration number is obliged to carry out limited pesticide training
in accordance with guidelines and coordinate with the Pesticide Supervision Commission Provincial or designated officials
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(4) Limited pesticide use certificates as referred to in paragraph (1), apply throughout the Indonesian region for a period of 5 years, and may be extended.
(5) The provisions regarding the training guidelines as referred to in paragraph (3)
further regulated by the Director General a.n. Minister of Agriculture.
Article 10
The Legal Agency may use a limited pesticide if applied by the person who has had a limited pesticide use certificate as referred to in Article 9.
CHAPTER IV OF THE LICENSING TYPE
Section 11
The type of pesticide permit is made up: a. Experimental permission; b. temporary permission; and c. permissions remain.
Article 12
(1) The trial permit referred to in Article 11 of the letter a, provided by the Director General a.n. Minister of Agriculture applicable for a period of 1 year, and may be extended 1 (one) times for a term of 1 (one) year.
(2) The trial permit as referred to in paragraph (1) is provided to
the applicant to be able to prove the truth of its claim regarding the quality, efficacy, and security of the pesticide listed.
(3) Pesticides that have obtained an experimental permit are banned for release
and/or used commercially.
Article 13
(1) The temporary permit as referred to in Article 11 of the letter b is provided by
the Minister for the advice and/or consideration of the Pesticide Commission. (2) The temporary permit as referred to in paragraph (1) is provided against
a pesticide that has met some technical and/or administrative requirements.
(3) The temporary permit as referred to the paragraph (1) is provided to
the applicant to supplement the technical and administrative requirements as referred to in paragraph (2) with data and information in accordance with the specified.
(4) The temporary permit as referred to the paragraph (1) applies to the term
time 1 (one) year, and may be extended 1 (1) times for a term of 1 (1) year.
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(5) If the applicant in the term as referred to in the paragraph (4) has not completed the technical and/or administrative requirements as referred to in paragraph (3), the application is deemed to be retracted.
section 14
The pesticide that has obtained a temporary permit as referred to in Article 13 may be produced, circulated, and used in limited quantities according to the amount of commodities, doses or concentrations and applications who are specified with the Minister ' s Decision.
Article 15 (1) The permit remains as referred to in Article 11 of the letter c provided by the Minister
on the advice and/or consideration of the Pesticide Commission. (2) The permission to remain as referred to in paragraph (1) applies to a term of 5
(five) years and may be extended. (3) The pesticide that has obtained a fixed permit as referred to in the paragraph
(1) may be produced, circulated and used.
Article 16
(1) Pesticides that have the Fixed Permit as referred to in Section 15
paragraph (1) can be extended to use on other unregistered targets after receiving an expansion permit.
(2) The usage of usage extensions as referred to paragraph (1) is granted
by the Minister of Agriculture on advice and/or Pesticide Commission consideration. (3) To get the usage extension permit as referred to
paragraph (1) the applicant submits a request by attaching the specified test result.
Article 17
If the use of the pesticide is like Referred to in Article 13, Section 14, Section 15, and Pasal16 proved to have a negative impact on human health and or for environmental sustainability, temporary permits, fixed permits or extended use permits may be reevaluated or revoked.
CHAPTER V REQUIREMENTS REGISTRATION REQUIREMENTS
SECTION 18
(1) PLEA The pesticide registration can be performed by an enterprise entity or
the Indonesian legal entity by meeting the registration requirements as follows: a. The deed of foundation and its changes, for the business entity (Trading Effort,
Firm, CV, NV), and the legal entity (PT, Koperation); b. Trade Permit Letter (SIUP) /Sign of Trade Effort
(TDUP) pesticide;
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c. Tax (NPWP); d. Domicile/Population card (KTP); e. The entitled statement signs a letter in the framework of registration
and permits; f. An active ingredient supply warranty letter from an active ingredient supplier.
(2) The pesticide registration as referred to in paragraph (1) is performed by the owner of the pertinted formulation or its power.
Article 19
For the Owner of the Formulation From abroad, pesticide registration is carried out by its rulers/representative of Indonesian law and based in Indonesia.
Article 20
(1) Pesticides that can be registered in Indonesia, pesticides that are not including the prohibited classification as referred to in Section 5 (1) of the letter a, not contain the active ingredient of the banned pesticide as referred to in Article 7 of the paragraph (1), paragraph (2), and paragraph (3) and/or does not contain any additional materials that are prohibited as referred to in Section 7 of the paragraph (5).
(2) The pesticide as referred to in paragraph (1) must qualify
purity of the active ingredient content that meets the SNI specifications, FAO, WHO or other international bodies.
Article 21
For the request registration in addition to meeting the requirements as referred to in Article 18, must meet the following requirements: (1) Any formulation generated by each owner, used for
any field of use, must be registered on behalf of one applicant; (2) The pesticide formulation of active-active pesticides for the field use of
plant management, excluding ZPT, biological pesticides, rodenticides and pheromones/atractants are not antagonistic.
Article 22
(1) Pesticides registered should be given the naming Its own, which is the identity of any pesticide formulation that will be circulated.
(2) The equivalent of the paragraph (1) should not be the same or nearly
equal to the formulation that has been listed on behalf of another company. (3) The similarity as referred to in paragraph (1) must meet the requirements
as follows:
a. any formulation is given only one name consisting of 3 (three) elements, i.e. trade names that do not correspond to the common name and/or the active ingredient name, the number that indicates the level of the active ingredient, and the letter code indicating the form of the formulation;
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b. any naming of the pesticide formulations listed in the evidence lampeniri has been to register from the authorized instance in accordance with the provisions of Intellectual Property Rights (HKI);
c. naming The formulation as referred to in the letter a and b is not
is agitative such as the words "devastating", "great", "super" or "potent".
(4) Technical materials commoners must meet the terms as intended
on paragraph (3) and followed by successive numbers and codes indicating the active ingredient level and technical material.
CHAPTER VI TATEVENT REGISTRATION
Article 23
(1) To obtain the pesticide license as referred to in Section 11,
the applicant submitted a letter of the request to the Minister of Agriculture through the Head of the Centre by encappening the administration requirements as referred to in Article 18, by using the format as set forth in Annex VII for chemical pesticides, or appendix VIII for biological pesticides or appendix IX for household pesticides and/or disease vector control in humans as part inseparable with this Regulation.
(2) Chief The center for the most recent 3 (three) business days has been completed
examines the completeness of the administrative requirements as referred to in Article 18 of the paragraph (1) and provides an answer for accepting or refusing.
Section 24
(1) Requests are accepted as referred to in Section 23 of the paragraph (2) if it has been meets the requirements of the administration as referred to in Section 18 of the paragraph (1) further by the Head of the Center delivered to the Director General in writing to perform technical assessments using the model-1 form as set forth in the The XVII attachment as part is inseparable with this Regulation.
(2) Requests are rejected as referred to in Section 23 of the paragraph (2) if
the administration requirements as referred to in Section 18 of the paragraph (1) are not complete or Not true, the head of the head told the applicant for a reason of rejection. In writing, using the model form-2 as listed in Appendix XVIII as an integral part of this Regulation.
Section 25
(1) The application is accepted as referred to in section 24 of the paragraph (1) and there has been a technical assessment may be granted an experimental permit by the Director General on behalf of the Minister of Agriculture. The trial permit is delivered to the applicant via the Head of the Center.
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(2) The applicant given the trial permit as referred to in the paragraph (1) must submit a pesticide sample to Director General via the Head of the Center for quality assurance.
(3) the quality test referred to in paragraph (2) is performed by the Institution which
accredited or designated as set forth in Annex XIII as an integral part with this Regulation.
(4) quality assurance results as referred to the verse (3) by the tester laboratory
delivered to Director General through the Head of the Center for a quality assurance assessment in accordance with the limit of tolerance as set forth in Annex VI as part inseparable with this Regulation.
(5) the Director General in the most recent time 3 (three) days work has been completed
performing a quality assurance assessment as referred to in paragraph (4). (6) If the results of a quality assurance assessment and a pesticide sample as intended
in paragraph (5) do not meet the requirements, the Director General informs the applicant via the Head of the Center in writing to be able to apply for a test requality with the model form-3 as set forth in Appendix XIX as part inseparable with this Regulation.
Section 26
(1) If the results of the assessment as referred to in Article 25 of the paragraph (4) meet requirements, subsequent pesticide samples are sealed by Director General.
(2) The applicant handed the sealed pesticide sample as
referred to the paragraph (1) to the institution of toxicity and efficacy that has been accrued or appointed as set forth in Annex XIV and Annex XV as part of inseparable with this Regulation.
(3) The examiner's institute in conduct testing of efficacy and toxicity
as referred to in paragraph (2) is required to follow the standard method set by the Director General on behalf of the Minister Agriculture.
(4) The Director General after getting reports of quality assurance results, efficacy and/or
the toxicity as referred to in paragraph (3) together with the Pesticide Enrollment Evaluation Technical Team performing the assessment, in accordance with the technical criteria as listed in Annex V as part inseparable with the This rule.
(5) The results of the assessment as referred to in paragraph (4) are further delivered
at the plenary meeting of the Pesticide Commission as the evaluation material of the pesticide Commission.
Article 27
(1) Commission assessment results The pesticide as referred to in Article 26 of the paragraph (5) may be deferred, reject or accept the registration application.
(2) If the registration application results are rejected as
referred to in paragraph (1), the Director General via the Head of the Center for the longest term of 5 (5) business days has notified the applicant with a written refusal in writing with the form of model-4 as set forth in Appendix XX as part of this Regulation.
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Article 28
(1) Requests are delayed as referred to in Section 27 of the paragraph (1), if
there is technical data to be equipped. (2) The delay as referred to in paragraph (1) by the Director General
is notified to the applicant in writing via the Head of the Centre which is accompanied by reason of a delay with the form of model -4 as set forth in Annex XX as the section is not integral to this Regulation.
(3) the applicant in the longest term of 7 (seven) of the working day since
receiving the notice as referred to in paragraph (2) must complete the requirements.
(4) If in term 7 (seven) business days after the notice
as intended on verse (3), the applicant may not complete the requirement, the application following the assessment by the Pesticide Commission in the next period.
Article 29
(1) If the assessment of the Pesticide Commission as referred to in Article 27 of the paragraph (1) Application applications were accepted, further by the pesticide Commission to be proposed to the Minister of Agriculture to seek the registration and permit number and the permit for pesticides.
(2) the Minister of Agriculture in the longest term of 90 (ninety) days
work since accepting the proposed Pesticide Commission as referred to in paragraph (1) must already provides an answer for accepting or resisting.
(3) If the proposed Pesticide Commission is acceptable as in
paragraph (2) by the Minister of Agriculture granted the registration number and the pesticide permit.
(4) the registration number and pesticide permissions as referred to in paragraph (3) are given in the form of a Agriculture Minister's Decision.
Article 30
(1) The granting of the registration number and the pesticide license as referred to in Article 29 of the paragraph (1) may be: a. a registration number and a temporary permit; or b. Pesticide number and fixed permits.
(2) The pesticide numbering event includes the Field of Use, pesticide type, type of clearance, Year of Birth, Number of Digit in the year concerned as listed in Annex XXI as part of the "
Article 31
(1) If in the slowest term 90 (ninety) work days since accepting the proposed Pesticide Commission as referred to in Article 29 of the paragraph (2) the Minister of Agriculture has not yet Giving answers to or rejecting, a request is considered acceptable.
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(2) The invocation is considered accepted as referred to in paragraph (1)
given the registration number and the pesticide permit in the form of the Minister of Agriculture's decree signed by the Director General in the name of the Minister of Agriculture.
Article 32
(1) The application that the Minister of Agriculture has published as referred to in Article 29 of the paragraph (4), or in Article 31 of the paragraph (2) is delivered to the applicant via the Head of the Centre.
(2) Rejected Requests as referred to in Article 29 of the paragraph (2)
be notified of the applicant through the Head of the Center.
Section 33
(1) The applicant has obtained the registration number and the permission as referred to in Section 29 of the paragraph (4) and Section 31 of the paragraph (2) in the longest term of 1 (one) year must already be producing or importing.
(2) The product/import report as referred to in paragraph (1) must be accompanied by a producti/import document.
Article 34
(1) The pesticide registration order as referred to in Article 18 to Section 29 mutatis mutandis applies to the registration of the technical materials of pesticides and pesticides for export except testing efficacy, environmental toxicology, resurface, and residues are not required.
(2) The registration of technical materials as referred to in paragraph (1) uses
formats as set forth in Annex X as part inseparable with This rule.
Article 35
(1) The registration number has been granted in the permit while or fixed permission, may switch or be diverted, because:
a. the owner of the formulation designating the other party as the number holder
registration; b. The owner of the formulation shifted ownership of its formulas to other parties; c. other party desigcountries as holders of registration numbers due to the presence of
corporate mergers; d. the renaming of the formulation owner's name or holder of the registration number.
(2) The party that accepts the diversion as the holder of the registration number
is only as contemplated in paragraph (1) is required to resolve the issue between the holders The old formulation with the new formulation holder in the form of a signed letter, subsequently reported to the Director General via the Head of the Center to be duly noted in the registration number book as well as proposing a designation regarding the The diversion is meant.
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Article 36
(1) Changes to which pesticides are listed, include changes:
a. the name of the formulation and or the active ingredient name; b. container and or wrapper; c. form the formulation/technical material d. the origin of the active ingredient; e. solvent material; f. The emulsion material; g. Bearer material; h. active ingredient levels (in the limit of active ingredient levels tolerance); i. The quality of the active ingredient in a technical j. use that is registered and permitted; k. the amount permitted is circulated for temporary permission; and/or; l. dose and means of the pesticide application (in accordance with the results of the efficacy test)
(2) Changes as referred to in paragraph (1) letter d, e, f, g and h can
be approved if after the test of the quality appeal, toxicity, and efficacy for one of the target organisms the result meets the technical requirements.
(3) Changes as referred to in paragraph (1) are required to be reported by
holders of the registration number to the Director General via the Head of the Center to be recorded in the book The registration number and the process is further processed by the Director General.
Section 37
(1) Pesticide License Permits may be reregistered by following the terms of the pesticide registration terms as referred to in Section 19 to the following section 30:
-quality assurance results formulations for odd reregistration pesticides
(first, third .... dst). -results of a pesticide technical requality test for any performing
re-registration. -the results of a re-quality test and re-efficacy against one of the target organisms
for even-even reregistering pesticides (second, fourth ..... dst.),-an even-even (second, fourth ..... dst.) re quality test result (second, fourth ..... dst.) against
the organism Plant disrupters (OPT) major for pesticides used in rice plants.
(2) The target organism as referred to in paragraph (1) is one
the target organism registered since the first pesticide was granted permission. (3) The reregistration of fixed permissions as referred to in paragraph (1) is performed
at least 90 (ninety) work days before the end of the permit is terminated.
Section 38
granting permission remains a reregistration other than must be fulfilled The provisions as referred to in Article 37 are also concerned with the results of the pesticide surveillance evaluation implemented by the authorized Instancy.
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Article 39
(1) If a reregistration application is referred to in Section
38 received, at least 90 (ninety) work days have been issued a Decision. Minister of Agriculture on the Registration and Pesticide Permit.
(2) If within 90 (ninety) business days of the Minister ' s Decision
Agriculture on the Registry and Pesticide Permit as referred to in paragraph (1) has not yet been published, The Director General on behalf of the Minister of Agriculture published the Decree of the Minister of Agriculture.
(3) If the reregistration is referred to in paragraph (1) not
is done or rejected, the number and registration permit expires for the sake of the law. (4) The number and registration permit terminates, if the pesticide reregistration
is rejected then must be withdrawn from circulation no later than 6 (six) months.
BAB VII CONTAINER AND PESTICIDE LABEL
Section 40
(1) Pesticide which have been registered with a temporary permit or a fixed permit must
be placed in a container. (2) The pesticide vessel should not be easily broken or torn, or protected the container
another so that it may not be damaged, does not react with its pesticide or corrosive, so the danger to humans and the environment can be avoided.
(3) Each container must be closed or folded properly so that the lid or flap
or the container cannot be opened without damaging it unless the container is made in such a way that without damaging the lid of the pesticide can only be out in smoke or fog.
(4) The container specification must be fully described which includes the volume,
name material, shape, size, thickness of the material, color, surface layer material of the inner container and container lid materials, as set forth in Annex XI.
(5) Return of a pesticide formulation may only be done by
the holder of the pesticide registrant concerned or the other party is shown in accordance with the applicable provisions.
Article 41
(1) Each pesticide container must be labeled, affiated and not easily loose or printed on a container.
(2) The pesticide label is proposed by the registration holder, and is wrong
one requirement in the application application.
(3) All references to the label and the usage hint attachment must be included in Indonesian with non-agitative words such as "catastrophic", "great", "super", "strong" or "potent", and is prohibited from setting images of target organisms that are not
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listed, is prohibited from comparing with other pesticides that have been registered. The use of foreign languages is allowed only if translating important things which are considered important in the Indonesian language.
(4) The warning and warning signs on the label must be printed clearly, easily read
or Viewed, easily understood and not easily erased. (5) Complete description of the label's contents, warning sentences and instructions
security, information about the symptoms of the intoxication, information about the help guide, the description of the storage instructions, the description of the usage instructions, The inclusion of images, labels, limited pesticides, and labeling labels, as set forth in Annex XII.
BAB VIII OBLIGATION OFFICER AND OWNER
REGISTRATION NUMBER
Article 42
(1) Officers who serve the registration and officer of the quality assurance agency, the efficacy and toxicity of keeping the truth and data privacy and information about pesticides that by their nature needs to be kept secret.
(2) The Director General is required to host the management of the number books
registration and record any mutations in both the subject and the object of the pesticide registration.
Article 43 (1) Licensee's registration number is required to list the entire description which
requires on the pesticide label listed as set forth in this Attachment XII Regulation.
(2) The applicant/holder of the registration number is required to pay the registration fee
which is the State Reception. No Tax (PNBP), and must be paid to the State Kas specified under applicable law-invitation rules.
(3) The registration number bears all testing costs that
the magnitude and the show is set. by the tester institute.
Article 44
(1) Licensee's registration number required to submit standard active materials as much as 1 (one) gram and analysis certificate every 2 (two) years once to Director General that is next stored in the laboratory as referred to in Section 25 of the paragraph (3).
(2) Licensee's registration number is required to deliver an annual report on
the production and circulation of pesticides as well as its active materials which include imports, exports and selling in the country at least 2 (two) months after year. The calendar ends, and a monthly 6 (six) monthly report on pesticide production and circulation is limited to the Minister of Agriculture through Director General by using the format as set forth in Appendix XVI of this Regulation.
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(3) The pesticide registration numbers are required to perform coaching and supervision of everything related to that of its responsibility and take steps In response to a deviation, the activity is conducted alone or with the Government apparatus.
CHAPTER IX SANCTION ADMINISTRATION
Article 45
Against the tester institution and/or the tester laboratory It's proven that it doesn't guarantee confidentiality and the truth of the tests The reprimand was written by the Director General and reported to the official to be charged in accordance with the provisions of the applicable law-invitation regulations.
Article 46
The officer who serves the proven registration Does not guarantee the confidentiality of the pesticide data as referred to in Article 42 of the paragraph (1) is subject to employee disciplinary sanction under applicable law.
Article 47
The applicant who is proven to distribute the pesticide are in the registration process, imposed cancellation of the registration application and pesticide permission up to the investigation process by authorized officials until obtaining legal force.
Article 48
(1) The proven registration number holder does not list all the captions required on the label as referred to in Section 42 of the paragraph (5) and or does not report any changes in the registration holder subject to the revocation of the registration number and the permissions.
(2) The proven registration number holder is not a guarantee Pesticide quality produced and/or circulated, sanctioned revocation numbers register and permit.
(3) Licensee's registration number does not produce and or not
import the pesticide formulation that is registered as referred to in Section 33 as well as not making the report referred to in Article 44 paragraph (2) for 2 consecutive years imposed revocation number and registration permits.
(4) Licensee's registration number who does not report the change of origin of the material
is active as referred to in Section 36 of the paragraph (1) the letter d is subject to the revocation of the registration number and permission.
(5) Holder of the registration number as referred to in paragraph (1), paragraph (2),
paragraph (3) and paragraph (4) shall withdraw the pesticide from the circulation-slow 3 (three) months since the Minister of Agriculture's Decision on Revocation Number (2). Registration and Permission.
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CHAPTER X OF THE PESTICIDE PROVISION METHYL BROMIDE
Section 49
(1) The methyl bromide's active pesticide is granted a temporary permit based on
the rules of the invitation that apply, with the amount circulated in accordance with the applicable provisions (national quota) in the year in question.
(3) The temporary permit referred to Section 11 of the letter b for the pesticide-based pesticide methyl bromide is given by the Minister on the advice and/or consideration of the Pesticide Commission.
(3) Temporal pesticide permit active methyl bromide as intended
on the paragraph (1) applies to the term 1 (one) year, and may be reregistered with following the applicable provisions.
(4) Reregistration of the temporary permit as referred to in paragraph (1)
done at least 90 (ninety) work days before the permit expired.
CHAPTER XI Transitional provisions
section 50
(1) The pesticide that has obtained registration numbers and fixed or permission permits
while before these regulations were published, it was declared still to be valid. (2) Request registration and fixed permission or temporary permission that
under or already testing prior to this rule is issued in effect of the Regulation of Agriculture Minister Number 45 /Permentan/SR.140/10/ 2009.
(3) The invocation of registration and fixed permission or temporary permission not
is conducted testing before this regulation is published, processed according to the provisions of this regulation.
BAB XII CLOSING provisions
Section 51
By promulgating this Regulation, then the Regulation of the Minister of Agriculture Number 45 /Permentan/SR.140/10/ 2009 about the Pesticide Registration Terms and Tatevents, declared revoked and not applicable.
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Article 52
The rules are in effect on the date of the promulgated. In order for everyone to know, the Minister of Agriculture Regulation is promulred by its placement in the News of the Republic of Indonesia.
Specified in Jakarta on 8 April 2011 MINISTER OF AGRICULTURE, SUSWONO Diundfiled in Jakarta on April 20, 2011 MINISTER OF LAW AND HUMAN RIGHTS REPUBLIC OF INDONESIA, PATRIALIS AKBAR
NEWS OF THE REPUBLIC OF INDONESIA IN 2011 NUMBER 232
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